Part A BAS 310 62 I Registration Report –Central Zone National Assessment – STORANET Germany Page 1 of 22

REGISTRATION REPORT Part A

Risk Management

Product code: BAS 310 62 I (STORANET) Active Substance: Alpha-cypermethrin 1.57 g/kg or 100 mg per net m2

COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT

Applicant: BASF SE Date: June 2014

Applicant: BASF SE Evaluator: DE Date: 12/06/2014

Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 2 of 22

Table of Contents

PART A – Risk Management 4

1 Details of the application 4

1.1 Application background 4

1.2 Annex I inclusion 5

1.3 Regulatory approach 5

1.4 Data protection claims 5

1.5 Letters of Access 5

2 Details of the authorisation 6

2.1 Product identity 6

2.2 Classification and labelling 6

2.2.1 Classification and labelling under Directive 99/45/EC and Regulation (EC) No 1272/2008 6

2.2.2 R and S phrases under Regulation (EU) No 547/2011 7

2.2.3 Other phrases 7

2.2.3.1 Restrictions linked to the PPP 7

2.3 Product uses 9

3 Risk management 11

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 11

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 11

3.1.2 Methods of analysis (Part B, Section 2, Point 5) 11

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 11

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 12

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 12

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 12

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 13

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 3 of 22

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 13

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 14

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 14

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 14

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 17

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 17

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 17

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 18

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) 19

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 19

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 19

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 19

3.1.7 Efficacy (Part B, Section 7, Point 8) 20

3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 21

Appendix 1 – Copy of the product authorisation 22

Appendix 2 – Copy of the product label 22

Appendix 3 – Letter of Access 22

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment – STORANET Germany Page 4 of 22

PART A – Risk Management This document describes the acceptable use conditions required for the registration of BAS 310 62 I (STORANET) containing alpha cypermethrin in Germany. This evaluation is required subsequent to the inclusion of alpha cypermethrin on Annex 1.

The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to BAS 310 62 I (STORANET) where that data has not been considered in the EU review. Otherwise assessments for the safe use of BAS 310 62 I (STORANET) have been made using endpoints agreed in the EU review of alpha cypermethrin.

This document describes the specific conditions of use and labelling required for Germany for the registration of BAS 310 62 I (STORANET).

Appendix 1 of this document provides a copy of the final product authorisation Germany.

Appendix 2 of this document is a copy of the approved product label for Germany

The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive 91/414/EEC.

Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation.

Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

1 Details of the application

1.1 Application background

This application was submitted by BASF SE on 27 February 2012.

The application was for approval of BAS 310 62 I (STORANET), a long lasting insecticide net containing 1.57 g/kg or 100 mg per m2 net alpha-cypermethrin for use as an insecticide (net) against bark beetles, longhorn beetles and jewel beetles in hard- and softwood logs stored in forestry.

Applicant: BASF SE Evaluator: DE Date: 12/06/2014

Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 5 of 22

1.2 Annex I inclusion

Alpha-cypermethrin

Alpha-cypermethrin was included on Annex I of Directive 91/414/EEC on 1 March 2005 under Inclusion Directive 2004/58/EC and is approved according to Regulation (EC) No 1107/2009 and implemented under Regulation (EU) No 540/2011.

Only uses as insecticide may be authorised.

The Annex I Inclusion Directive for alpha-cypermethrin (2004/58/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004, shall be taken into account. In this overall assessment:

- Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. - Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures.

These concerns were all addressed in the submission.

1.3 Regulatory approach To obtain approval the product BAS 310 62 I (STORANET) must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points.

This application was submitted in order to allow the first approval of this product in Germany in accordance with the above.

1.4 Data protection claims Where protection of data is being claimed for information supporting registration of STORANET, it is indicated in the reference lists in Appendix 1 of the Registration Report, part B, sections 1, 2, 4 – 7 and Part C.

1.5 Letters of Access Data access has been proven. BASF provided own data. So a letter of access is not necessary.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 6 of 22

2 Details of the authorisation

2.1 Product identity

Product Name BAS 310 62 I; STORANET Authorization Number 007598-00/00 (for registration) Function insecticide (net) Applicant BASF SE Composition alpha-cypermethrin 1.57 g/kg or 100 mg per m2 net Formulation type Long lasting insecticide net [Code: LN] Packaging PE-bag (thickness 120 µm) net dimensions: 8 x 12,5 m, 0,8 x 20 m and 10 x 20 m, roll (8 x 100 m)

2.2 Classification and labelling

2.2.1 Classification and labelling under Directive 99/45/EC and Regulation (EC) No 1272/2008 The following is proposed in accordance with Directive 99/45/EC in combination with the latest classification and labelling guidance under Directive 67/548/EEC and according to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008:

C&L according to Directives 67/548/EEC and 1999/45/EC

Hazard symbols: N Indications of danger: Dangerous for the environment Risk phrases: R50/53 Safety phrases: S24, S35, S57 Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. C&L according to Regulation (EC) No 1272/2008

Hazard classes, categories: Acute Aquatic 1 Chronic Aquatic 1 Pictogram GHS09 Signal word: Warning Hazard statements: H410 Additional labelling phrases: To avoid risks to human health and the environment, comply with the instructions for use. [EUH401]

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 7 of 22

2.2.2 R and S phrases under Regulation (EU) No 547/2011 None.

2.2.3 Other phrases

2.2.3.1 Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling):

PPE / Risk mitigation measures  Avoid any unnecessary contact with the product. Misuse can lead to health damage.  Keep out of the reach of children.  The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed.  Wear standard protective gloves (plant protection) when handling/applying the product.  Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product.  If the plant protection product comes into contact with skin (especially facial), it can cause burning or itching, without external signs of irritation. These effects must be regarded as a warning to avoid further exposure at all costs. If the symptoms do not disappear, or if they are joined by further symptoms, a doctor must be consulted.  Information plates have to be installed at prominent places close to treated wood requesting all non- occupational persons to avoid contact with the net material.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 8 of 22

Ecosystem protection

NW262 The product is toxic to algae. NW264 The product is toxic for fish and aquatic invertebrates. NW467 The product and its remains, empty containers and packaging and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. NW704 Due to the danger of run-off, there must be a buffer zone of at least 10 m between treated areas and surface waters - including periodically but excluding occasionally water-bearing surface waters - when applying the product. NT800 Use in nature reserves is not allowed. NT181 This insecticide is not only specifically effective against the target harmful organisms. Its use can therefore damage other arthropod populations. The operator should therefore refrain from treatment if it is known that arthropod species which are listed in Annex II or IV of Directive (EEC) 92/43 are present.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Draft Registration Report –Central Zone National Assessment - Germany

Page 9 of 22

2.3 Product uses

PPP (product name/code) STORANET Formulation: Type: LN active substance 1 alpha-cypermethrin Conc. of as 1: 1,57 g/kg

Applicant: BASF professional use non professional use Zone(s): central

Verified by MS: Yes

1 2 3 5 6 7 8 9 10 11 Use-No. Member Crop and/ F Pests or PHI Remarks: state(s) or situation G Group of pests Formulation Application Application rate per treatment (days) or controlled I (a) (b) (c) (l) (m) Type Conc. method growth number interval g as/treatment water L/ha kg as/ha of as kind stage & min max between season applications min max min max min max (min) (d-f) (i) (f-h) (j) (k) (n)

1, 2 Central Single F Bark and wood LN 1.57g/kg complete post harvest 1 50 m2 net / not not formal zone trunk boring bark (100mg/m²) wrapping of treatment single trunk applicable applicable not application beetles trunk rate: 41 g / DE, AT, 5 g as / single relevant ha PL, CZ, Longhorn trunk) SK, SI beetles and metallic wood- boring beetles

Applicant BASF SE Evaluator: Germany Date: 12/06/2014

Part A BAS 310 62 I Draft Registration Report –Central Zone National Assessment

Page 10 of 22

3, 4 Central Lumber F Bark and wood LN 1.57g/kg Application post harvest 1 100 m2 net not not formal zone stock boring bark (100mg/m²) over the top of treatment /lumber stock applicable applicable not application beetles the stock rate: 2 g / DE, AT, (20 m3) 10 g as / relevant ha PL, CZ, Longhorn lumber stock

SK, SI beetles and metallic wood- boring beetles 5, 6 Central Large F Bark and wood LN 1.57g/kg Application post harvest 1 200 m2 net / not not formal zone lumber boring bark (100mg/m²) over the top of treatment large lumber applicable applicable not application stock beetles the stock stock rate: 2 g / DE, AT, relevant (40 m3) ha PL, CZ, Longhorn 20 g as / large SK, SI beetles and lumber stock metallic wood- boring beetles

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (i) g/kg or g/l situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds application (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions of use (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 must be provided (f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of (n) The formal application dose rate per ha was calculated according to the approach which was equipment used must be indicated accepted by the BVL in the Registration report for Fastac Forst (PSM-Zulassungsbescheid SVA2006-05-17 NO--024012-00-00 Lft Nr. 28, Anlage 4, Seite 29) Therefore, the annual amount of timber harvest per ha was considered to calculate more realistic area-dependent application rates. The calculations were based on statistical data provided from German authorities [Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (2004): http://www.bundeswaldinventur.de/enid/ 43296d7208c4a827134d0a3176325a9e,0/75.html. Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (BMELV), Bonn, 2004]. These can be considered as a worst case, since the annual timber harvest amounts per hectare in Germany usually exceed those in Eastern European countries [EUROSTAT: (2009): http://epp.eurostat.ec.europa.eu/ portal/page/portal/ statistics/search_database, status September 2009]. According to BMELV (2004), 3-14 m3 timber ha-1 forestry area in use were harvested annually from 1987 to 2002. Assuming the 90th percentile of 9.9 m3 ha-1 a-1, an average of 8.2 single trunks, 0.2 small lumber stocks [or 0.1 large lumber stocks] per hectare and year can be derived.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 11 of 22

3 Risk management

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) Overall Summary: The LN formulation BAS 310 62 I has not been the representative formulation. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a dark green net fabric without discernable odour. It is not explosive, has no oxidising properties. The auto-ignition temperature of the carrier net is 515 °C. The stability data indicate a shelf life of at least 2 years at ambient temperature, but an experimental determination has to be submitted to proof this. The technical characteristics are acceptable for a LN formulation.

Implications for labelling: None

Compliance with FAO specifications: There is no FAO specification for alpha-cypermethrin LN formulations.

Compliance with FAO guidelines: The product BAS 310 62 I complies with the general requirements as stated in FAO/WHO manual (2010).

Compatibility of mixtures: No application with other plant protection products is intended.

Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.

Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of BAS 310 62 I has been provided and is considered to be acceptable.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) The active substance of BAS 310 62 I can be quantified using the modified CIPAC method MT 454/LN.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 12 of 22

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) All analytical methods are active substance data and were provided in the EU review of alpha- cypermethrin and were considered adequate. Adequate analytical methods are available to monitor alpha-cypermethrin in soil, water, air and in body fluids and tissues. Due to the intended uses of the product in forestry only, no residues in food of plant and animal origin are expected. Alpha-cypermethrin can be determined by GC-MS and GC-ECD.

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)

If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected.

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) The product STORANET (BAS 310 62 I) consists of a PET insect net coated with 1.8 % of the insecticidal SC-formulation BAS 310 18 I. This insecticidal coating is fixed using a binder and protected from sunlight by an UV-absorber. Due to the nature of the plant protection product STORANET, the acute toxicity studies presented in section 3 were performed with BAS 310 18 I, i. e. the liquid formulation containing 100 g/L alpha- cypermethrin used for coating the net. All relevant data are considered adequate.

BAS 310 18 I has a low toxicity in respect to acute oral, dermal and inhalation toxicity and is not irritating to the rabbit eye or skin. It has also no skin sensitising properties in the Buehler test to the guinea pig. Taking into account all submitted data no classification is required for STORANET according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) Operator exposure to STORANET was not evaluated as part of the EU review of alpha-cypermethrin for this submitted rate/crop. Therefore all relevant data and risk assessments have been provided and are considered to be adequate. Operator exposure was assessed against the AOEL agreed in the EU review (AOEL: 0.01 mg/kg bw/day). No dermal absorption study was submitted which was conducted with STORANET. Data on dermal absorption of BAS 308 04 I was provided and considered acceptable and a ‘worst case’ surrogate for BAS 310 62 I/STORANET. There are no representative data available in exposure calculation models reflecting the intended uses. Therefore, a field study measuring the operator exposure has been provided. Overall, the combined estimate for dermal and inhalation exposure of operators handling STORANET (BAS 310 62 I) results in an exhaustion of 4.3 % of the AOEL.

No dermal body exposure was determined in the above mentioned operator exposure study and the probability of body exposure is considered low for the intended working tasks by the applicant. But, since body contact with the insecticidal net by operators cannot be excluded, operators are supposed to wear protective garment mandatorily, as it was the case during the exposure study, too. According to the above mentioned, it can be concluded that the risk for the operator using STORANET in forestry is acceptable with the use of personal protective equipment.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 13 of 22

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) Bystander exposure to STORANET was not evaluated as part of the EU review of alpha-cypermethrin.

Bystander exposure estimations carried out and considerations concerning possible resident exposure indicated that the acceptable operator exposure level (AOEL) for alpha-cypermethrin will not be exceeded under conditions of intended uses. Therefore, it is concluded that there is no undue risk to any bystander after accidental short-term exposure to alpha-cypermethrin.

In addition, treated logs shall bear information plates at prominent places requesting hikers, bikers and other non-occupational persons to avoid contact with the net material.

Resident exposure in its original sense is not considered relevant for the intended type and location of use (i.e. in or close to logging areas in forests) as the transfer of alpha-cypermethrin residues to adjacent residential areas can be ruled out. Furthermore, the low vapour pressure of alpha-cypermethrin does not suggest a relevant release and thus, a relevant airborne concentration is not anticipated.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) Worker exposure to STORANET was not evaluated as part of the EU review of alpha-cypermethrin. Workers are considered to substantially perform the same type of operations as the operators when removing used net material. Therefore, the exposure and risk evaluation for operators does also meet the requirements for the re-entry worker assessment. Exposure and risk evaluations for workers are thus considered of being adequately addressed by operator evaluations. It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing and protective gloves, when working with STORANET. The use of STORANET is thus considered to be in compliance with the Uniform Principles.

Implications for labelling resulting from operator, worker, bystander assessments: PPE / Risk mitigation measures Operators - Avoid any unnecessary contact with the product. Misuse can lead to health damage. - Keep out of the reach of children. - The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. - Wear standard protective gloves (plant protection) when handling/applying the product. - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product. - If the plant protection product comes into contact with skin (especially facial), it can cause burning or itching, without external signs of irritation. These effects must be regarded as a warning to avoid further exposure at all costs. If the symptoms do not disappear, or if they are joined by further symptoms, a doctor must be consulted. Workers 1) See operator Bystanders Information plates have to be installed at prominent places close to treated wood requesting all non-occupational persons to avoid contact with the net material. Residents In this particular scenario there is no conventional resident. 1) In the case of this particular plant protection product workers are considered to substantially perform the same type of operations as operators do. Therefore, workers are supposed to wear the same PPE as operators.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 14 of 22

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) The residue behaviour of the active substance alpha-cypermethrin has been evaluated within the EU review process. The intended uses on deciduous trees, conifers and lying wood in forestry are not relevant in terms of consumer health protection. Therefore, no results of supervised residue trials are required and no assessment of the intake by consumers is necessary.

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) No results of supervised residue trials are required since the intended uses in forestry (post harvest application) are not relevant in terms of consumer health protection. Pre-harvest intervals (PHI) and withholding periods are not necessary.

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) Consumers are not exposed to residues of alpha-cypermethrin following treatment of deciduous trees, conifers and lying wood in forestry with STORANET.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 15 of 22

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)

A full exposure assessment for the plant protection product STORANET (BAS 310 62 I) in its intended uses is documented in detail in Part B Section 5 Core assessment of the plant protection product. The specific exposure assessment for soil and surface water and the specific risk assessment for groundwater for the authorisation of STORANET in Germany according to its intended use (Use No. 00-001 to 00- 006) is displayed in Part B Section 6 National addendum Germany.

Metabolites No new study on the fate and behaviour of alpha-cypermethrin has been performed. However, the soil metabolite DCVA is missing in the LoEP.

The risk assessment for the metabolite mPBA of alpha-cypermethrin has already been performed for EU approval (see SANCO/4335/2000 final). The metabolite mPBA is considered ecotoxicologically not relevant and does not penetrate into groundwater (addendum to the monograph - November 2002). Therefore no new risk assessment hence no exposure assessment for this metabolite is necessary.

For details see Part B, core assessment, section 5, chapter 5.3.1.3.

In the specific groundwater risk assessment for Germany considering the entry path surface run-off and drainage with subsequent bank filtration the soil metabolites mPBA and DCVA of alpha-cypermethrin are included.

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5)

BAS 310 62 I is an insecticidal net used to protect stored wood from bark beetles. The concentration in soil was taken from a field study where wash-off of alpha-cypermethrin was determined after simulated heavy rainfall (see Part B, Section 5 Core assessment, Appendix 2, KIIIA1 9.2). For the national assessment of the intended uses of the plant protection product STORANET PECsoil was recalculated for considering a soil depth of 1 cm. Details are given in Part B National Addendum-Germany, Section 5, chapter 5.5.

The results for PECsoil for the active substance and its metabolites were used for the eco-toxicological risk assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)

1. Direct leaching into groundwater Leaching to ground water was assessed by performing model simulation according to FOCUS considering a theoretical worst case application rate of alpha-cypermethrin assuming a total release of the contained active substance to the area covered by the stack of wood. According to the results of the groundwater simulation with FOCUS-PELMO 4.4.3, a groundwater contamination of the active substance alpha-cypermethrin in concentrations of ≥ 0.1 µg/L is not expected for the intended uses.

For the metabolites DCVA and mPBA a groundwater concentration of ≥ 0.1 µg/L can be excluded

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 16 of 22

according to the results of the groundwater simulation with FOCUS-PELMO 4.4.3. For details see Part B, National Addendum-Germany, Section 5, chapter 5.7.1.

Consequences for authorisation: None

2. Ground water contamination by bank filtration due to surface water exposure via run-off and drainage According to modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded. For details see Part B, National Addendum-Germany, Section 5, chapter 5.7.2.

Consequences for authorisation: None

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)

For the intended uses of the plant protection product STORANET PECsw was evaluated for the active substance alpha-cypermethrin considering run-off as route of entry under consideration of two experimental run-off studies showing that the active substance can still be detected in small concentrations in litter at 5 m distance from the treated wood stack. Due to the nature of the formulated product other routes of exposure for adjacent surface waters are not considered relevant.

Details are given in Part B, National Addendum-Germany, Section 5, chapter 5.6. The results for PECSW for the active substance and its metabolites were used for the eco-toxicological risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9)

Due to the properties of the active substance which is considered to be non-volatile and the type of formulation the predicted environmental concentration of alpha-cypermethrin in air is deemed to be negligible.

Implications for labelling resulting from environmental fate assessment: (Phrase Rxx should be added to the label)

As the active substance alpha-cypermethrin is not readily biodegradable assigning of R-Phrase R53 should be considered for classification and labelling according to Directive 1999/45/EC.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 17 of 22

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) A full risk assessment according to Uniform Principles for the plant protection product STORANET (BAS 310 62 I) in its intended uses as a wood net is documented in detail in Part B Section 6 Core assessment for the plant protection product BAS 310 62 I. The intended use of STORANET in Germany is generally covered by the uses evaluated in the course of the core assessment by zonal rapporteur member state Germany.

Details on the specific risk assessment for non-target organisms and hence risk mitigation measures for the authorisation of STORANET in Germany are displayed in Part B Section 6 National addendum Germany.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

Birds

There is no unacceptable risk for wildlife birds as a consequence of the intended uses of the product. Additional specific risk mitigation measures are not required.

For details of the risk assessment see Part B, Section 6, Core Assessment Point 6.2 and Part B Section 6, National Addendum Germany, Point 6.1, respectively.

Terrestrial vertebrates (other than birds)

There is no unacceptable risk for wildlife mammals as a consequence of the intended uses of the product. Additional specific risk mitigation measures are not required.

For details of the risk assessment see Part B, Section 6, Core Assessment 6.3 and Part B Section 6, National Addendum Germany, Point 6.2, respectively.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)

The active substance alpha-cypermethrin contained in the plant protection product STORANET is very toxic to aquatic organisms, especially aquatic invertebrates. Considering the type of formulation and the kind of application the only route of exposure for surface water is wash-off of the active substance during rainfall followed by run-off of contaminated water or erosion of contaminated particles. The results of experimental studies showed that alpha-cypermethrin can be detected in litter at 5 m distance to the treated wood stacks. Therefore, in order to exclude completely the exposure of surface water a distance of more than 5 m between the treated wood and the nearest water body is required (risk mitigation measure: buffer zone of 10 m width).

For details of the risk assessment see Part B, Section 6 Core Assessement, Point 6.4 and Part B, Section 6 National Addendum Germany, Point 6.3 respectively.

The product STORANET as well as the active substance alpha-cypermethrin is very toxic to the aquatic environment. Therefore, additional labelling with risk phrases (NW262, NW264) and safety phrases (NW467) is assigned, particularly to encourage prevention of any point source entry into surface waters

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 18 of 22

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees Alpha-cypermethrin is known as toxic to honeybees. Present results of laboratory tests confirm this rating. However, exposure of honeybees is negligible since BAS 310 62 I is intended for use in forestry as a net application for protection of single trunks or lumber stocks. Therefore no further assessment is required and results provided by the notifier are not presented and discussed by the assessment authority. The calculations of hazard quotients are not required, since exposure is negligible. It is concluded that BAS 310 62 I will not adversely affect bees or bee colonies when used as a net wrapping application.

Other non-target arthropods

Since the product is applied in forestry as a wood net for protection of single trunks or lumber stocks, a specific approach concerning the risk assessment and the use of studies with alpha-cypermethrin containing formulations is necessary.

For spray applications recovery could be demonstrated for BAS 310 41 I at a rate of 33 g a.s./ha with the most sensitive species Typhlodromus pyri. Also, the soil dwelling species Poecilus cupreus and Aleochara bilineata were far less susceptible than T. pyri. There are three full fauna field studies carried out with alpha-cypermethrin containing formulations showing low effects of alpha-cypermethrin on the arthropod fauna in cereals and in forestry.

Exposure of non-target arthropods is limited to accidental contact of individuals to the net or to soil- dwelling arthropods exposed to the wash-off after a rainfall containing alpha-cypermethrin.

The intended use of the product STORANET is not comparable to a typical use of a plant protection product (i.e. spray application) and the exposure pattern is different. On the one hand, avoiding spray drift is the main advantage of using a net as carrier for the active substance when compared to spray application. On the other hand, the configuration enables a long-lasting insecticidal effectiveness of alpha-cypermethrin in the product.

The insecticidal net STORANET acts/kills unspecifically. Therefore, in the risk assessment for non-target arthropods consideration of the affected not-target arthropods (“by-effect, by-kill or by-catch”) of the product is necessary. Considering that not each harvested tree trunk or lumber stock in the forest is covered with nets, as well as focusing on endangered arthropod species, it is preliminarily concluded, that the intended uses of STORANET pose an acceptable risk to non-target arthropods. Non-target arthropods should be able to re-colonise areas from untreated areas of the forest, when trunks and lumber stocks with STORANET are removed. It is expected that populations will compensate losses caused by contact to the product if a small number of harvested trees are covered with STORANET. It is, however, deemed necessary to verify possible effects on non-target arthropods (especially large insects) by performing a dedicated monitoring. For the time being the use of STORANET should not be authorised in nature protection areas and areas inhabited by endangered insect species listed in Annex II or Annex IV to Directive 92/43/EEC.

For details of the risk assessment see Part B, Section 6 Core Assessment, Point 6.5 and 6.6 and Part B, Section 6 National Addendum Germany, Point 6.4 and 6.5, respectively.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 19 of 22

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6)

There is no unacceptable risk for earthworms and other soil macro-organisms as a consequence of the intended uses of the product. Additional specific risk mitigation measures are not required.

For details of the risk assessment see Part B, Section 6 Core Assessment, Point 6.7 and Part B, Section 6 National Addendum Germany, Point 6.6 respectively.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) There is no unacceptable effect on organic matter breakdown as a consequence of the intended uses of the product. Additional specific risk mitigation measures are not required.

For details of the risk assessment see Part B, Section 6 Core Assessment, Point 6.7.8.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) There is no unacceptable risk for soil micro-organisms as a consequence of the intended uses of the product. Additional specific risk mitigation measures are not required.

For details of the risk assessment see Part B, Section 6 Core Assessment, Point 6.8.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) There is no unacceptable risk for non-target plants as a consequence of the intended uses of the product. Additional specific risk mitigation measures are not required.

For details of the risk assessment see Part B, Section 6 Core Assessment, Point 6.9.

Implications for labelling resulting from ecotoxicological assessment:

Hazard Symbol: N Indication of danger: Dangerous for the environment Risk Phrases: R50 Safety Phrases: S35, S57

Hazard classes, categories: Acute Aquatic 1, Chronic Aquatic 1 Pictogram: GHS09 Signal word: Warning Hazard statements: H410

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 20 of 22

Other phrases: NW262 The product is toxic for algae. NW264 The product is toxic for fish and aquatic invertebrates. NW467 The product and its remains, empty containers and packaging and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. NW704 Due to the danger of run-off, there must be a buffer zone of at least 10 m between treated areas and surface waters - including periodically but excluding occasionally water-bearing surface waters - when applying the product. NT800 Use in nature reserves is not allowed. NT181 This insecticide is not only specifically effective against the target harmful organisms. Its use can therefore damage other arthropod populations. The operator should therefore refrain from treatment if it is known that arthropod species which are listed in Annex II or IV of Directive (EEC) 92/43 are present.

3.1.7 Efficacy (Part B, Section 7, Point 8) The minimum effective dose tests showed a very good efficacy at the target dose rate of 100 mg alpha- cypermethrin/m2, which did not increase after application of a higher dose rate. These results are supported by the preliminary range-finding test, which was performed with an artificially controlled attack by Ips typhographus.

Against the three important bark beetles Ips typographus, Trypodendron lineatum and Pityogenes chalcographus in spruce logs the efficacy of the test product STORANET –wrapped around the logs– is sufficient, being significantly better than the control and comparable to the standard products.

Against less important bark beetles the efficacy of the test product STORANET –wrapped around the logs– was limited. As no control and standard product was tested in those trials no conclusion can be made regarding the degree of efficacy and the comparability of the test and standard product.

The product STORANET does not have effects on yield and quality of timber logs. Impacts on succeeding crops or on other plants including adjacent crops are not relevant for timber logs stored at forest tracks.

All the data regarding the efficacy of the product have been submitted. These data demonstrate that STORANET fulfils all criteria for the authorization of preparations described in Directive 97/57/EC (Uniform Principles, Annex VI to Directive 91/414/EEC).

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 21 of 22

3.2 Conclusions

Regarding phys.-chem. data and analytical methods for formulation and residues an authorisation can be granted.

Mammalian toxicology/residue behaviour: The intended uses do not affect commodities relevant for human consumption or animal feed. The uses in forestry do not represent a consumer health risk. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected.

As conclusion from the efficacy risk assessment all intended uses can be authorised.

Harmful effects on ground water consequent to the intended uses of the product STORANET have not to be apprehended. To prevent unacceptable effects on aquatic organisms and terrestrial non-target arthropods specific additional risk mitigation measures are required.

An authorisation can be granted.

3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation The applicant needs to submit following confirmatory data :

Annex III point Data

2.7.5 A study is requested showing acceptable storage stability of the net for two years at ambient temperature.

10.5.2 Monitoring studies to verify possible effects of the use of STORANET on non-target arthropods focussing on large insect species at relevant, representative and realistic worst-case application sites in conifer forest ecosystems Special consideration should be given to species composition as well as varying population densities, attractiveness of STORANET nets as seat or vantage point for large insects, delayed mortality effects on escaping non-target arthropods, improvement of methodological deficits and mortalities of endangered species.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment Country – Germany Page 22 of 22

Appendix 1 – Copy of the product authorisation See below

Appendix 2 – Copy of the product label The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions drawn by the competent authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive 91/414/EEC.

Appendix 3 – Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 1 of 38

REGISTRATION REPORT Part B

Section 1: Identity, physical and chemical properties, other information Detailed summary of the risk assessment

Product code: BAS 310 62 I Active Substance: alpha-Cypermethrin 1.57 g/kg (or 100 mg per m2 net)

Central Zone Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: BASF Date: October 2013

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 2 of 38

Table of Contents

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT...... 8

IIIA 1.1 Applicant...... 8

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s) ...... 8

IIIA 1.2.1 Manufacturer(s) of the preparation ...... 8

IIIA 1.2.2 Manufacturer(s) of the active substance(s)...... 8

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s)...... 8

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation...... 8

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation...... 9

IIIA 1.4.1 Content of active substance and formulants...... 9

IIIA 1.4.2 Certified limits of each component...... 9

IIIA 1.4.3 Common names and code numbers for the active substance(s)...... 10

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function...... 10

IIIA 1.4.5 Formulation process...... 10

IIIA 1.4.5.1 Description of formulation process...... 10

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern...... 10

IIIA 1.5 Type of Preparation and Code...... 10

IIIA 1.6 Function...... 10

IIIA 1.7 Other/Special Studies...... 10

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT ...... 12

IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15...... 21

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 3 of 38

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT ...... 21

IIIA 3.1 Field of Use...... 21

IIIA 3.2 Nature of the Effects on Harmful Organisms...... 21

IIIA 3.3 Details of Intended Use ...... 21

IIIA 3.3.1 Details of existing and intended uses ...... 21

IIIA 3.3.2 Details of harmful organisms against which protection is afforded...... 21

IIIA 3.3.3 Effects achieved ...... 21

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) ...... 21

IIIA 3.5 Concentration of the Active Substance in the Material Used ...... 22

IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent ...... 22

IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection...... 22

IIIA 3.7.1 Maximum number of applications and their timings ...... 22

IIIA 3.7.2 Growth stages of crops or plants to be protected...... 22

IIIA 3.7.3 Development stages of the harmful organism concerned...... 22

IIIA 3.7.4 Duration of protection afforded by each application...... 22

IIIA 3.7.5 Duration of protection afforded by the maximum number of applications ...... 22

IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops ...... 22

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops...... 22

IIIA 3.8.2 Limitations on choice of succeeding crops ...... 22

IIIA 3.8.3 Description of damage to rotational crops...... 22

IIIA 3.9 Proposed Instructions for Use as Printed on Labels...... 23

IIIA 3.10 Other/Special Studies...... 23

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 4 of 38

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT ...... 24

IIIA 4.1 Packaging and Compatibility with the Preparation ...... 24

IIIA 4.1.1 Description and specification of the packaging ...... 24

IIIA 4.1.2 Suitability of the packaging and closures...... 24

IIIA 4.1.3 Resistance of the packaging material to its contents...... 24

IIIA 4.2 Procedures for Cleaning Application Equipment...... 25

IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing...... 25

IIIA 4.2.2 Effectiveness of the cleaning procedures...... 25

IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment ...... 25

IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop ...... 25

IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed...... 25

IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces treated...... 25

IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs...... 25

IIIA 4.3.5 Waiting period (in days) between application and handling of treated products...... 25

IIIA 4.3.6 Waiting period (in days) between last application and sowing or planting succeeding crops...... 26

IIIA 4.3.7 Information on specific conditions under which the preparation may or may not be used ...... 26

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks...... 26

IIIA 4.4.1 Warehouse storage ...... 26

IIIA 4.4.2 User level storage...... 26

IIIA 4.4.3 Transport ...... 26

IIIA 4.4.4 Fire...... 27

IIIA 4.4.5 Nature of protective clothing proposed...... 27

IIIA 4.4.6 Characteristics of protective clothing proposed...... 27

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 5 of 38

IIIA 4.4.7 Suitability and effectiveness of protective clothing and equipment ...... 27

IIIA 4.4.8 Procedures to minimise the generation of waste ...... 27

IIIA 4.4.9 Combustion products likely to be generated in the event of fire ...... 27

IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During Transport, Storage or Use ...... 27

IIIA 4.5.1 Containment of spillages...... 28

IIIA 4.5.2 Decontamination of areas, vehicles and buildings...... 28

IIIA 4.5.3 Disposal of damaged packaging, adsorbents and other materials...... 28

IIIA 4.5.4 Protection of emergency workers and bystanders ...... 28

IIIA 4.5.5 First aid measures ...... 28

IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage...... 28

IIIA 4.6.1 Details of proposed procedures for small quantities...... 28

IIIA 4.6.2 Evaluation of products of neutralization (small quantities)...... 28

IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste ...... 28

IIIA 4.6.4 Details of proposed procedures for large quantities ...... 29

IIIA 4.6.5 Evaluation of products of neutralization (large quantities) ...... 29

IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste...... 29

IIIA 4.7 Pyrolytic Behaviour of the Active Substance...... 29

IIIA 4.8 Disposal Procedures for the Plant Protection Product...... 29

IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging...... 29

IIIA 4.8.2 Methods other than controlled incineration for disposal ...... 30

IIIA 4.9 Other/Special Studies...... 30

IIIA 11 FURTHER INFORMATION...... 30

IIIA 11.1 Information of Authorisations in Other Countries...... 30

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries...... 30

IIIA 11.3 Justified Proposals for Classification and Labelling...... 30

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 6 of 38

IIIA 11.4 Proposals for Risk and Safety Phrases...... 31

IIIA 11.5 Proposed Label ...... 31

IIIA 11.6 Specimens of Proposed Packaging...... 31

Appendix 1: List of data used in support of the evaluation ...... 32

Appendix 2: Critical Uses – Justification and GAP tables...... 34

Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics:...... 36

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 7 of 38

Introduction This document summarises the information related to the identity, the physical and chemical properties, the data on application, further information and the classification for the product BAS 310 62 I containing alpha-Cypermethrin which was included into Annex I of Directive 91/414 (2004/58/EC from 23 April 2004) and is approved according to Regulation (EC) No 1107/2009 and Regulation (EU) No 540/2011.

This product was not the representative formulation. The product has not been previously evaluated according to Uniform Principles.

The following table provides the EU endpoints to be used in the evaluation.

Agreed EU End-points

End-Point Alpha-Cypermethrin (Regulation (EU) No 540/201)

Purity of active substance min 930 g/kg CIS-2

Appendix 1 of this document contains the list of references included in this document for support of the evaluation.

Appendix 2 of this document is the table of intended uses for BAS 310 62 I.

Information on the detailed composition of BAS 310 62 I can be found in the confidential dossier of this submission (Registration Report - Part C).

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 8 of 38

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT

IIIA 1.1 Applicant BASF SE 67056 Ludwigshafen Germany Crop Protection Division: P.O. Box 120 67114 Limburgerhof Germany

Contact person: XXXXXXXXXXXXXXXX Tel.No.: XXXXXXXXXXXXXXXX Fax No: XXXXXXXXXXXXXXXX e-mail: XXXXXXXXXXXXXXXX

Affliates or representatives in the countries submitting the dossier are given in part A.

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s)

IIIA 1.2.1 Manufacturer(s) of the preparation

Confidential information - data provided separately (Part C).

IIIA 1.2.2 Manufacturer(s) of the active substance(s)

Confidential information - data provided separately (Part C).

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s) Alpha- cypermethrin:

Minimun purity: 930 g/kg Typical purity: 949 g/kg

Further information/justification is provided in Part C.

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation

Trade name: STORANET

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 9 of 38

Company code number: BAS 310 62 I

The manufacturer’s code for the active substance alpha-cypermethrin is BAS 310 I, reg.-No. 4078193.

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation

IIIA 1.4.1 Content of active substance and formulants BAS 310 62 I was not the representative formulation for Annex I submission.

Pure active substance:

content of pure alpha-cypermethrin: 1.57 g/kg

limits alpha-cypermethrin: 1.18 – 1.96 g/kg (according to FAO, 2010)

Technical active substance:

content of technical alpha-cypermethrin 1.69 g/kg 100 mg per m2 of net

at minimum purity (93.0 %):

The active substances in the formulation is not present in the form of a salt, ester, anion or cation.

Further information on the active substances and on the certified limits of formulants is considered confidential and is provided separately (Part C).

IIIA 1.4.2 Certified limits of each component

This is not an EC data requirement/ not required by regulation (EU) 2011/545.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 10 of 38

IIIA 1.4.3 Common names and code numbers for the active substance(s)

Data Type Name/Code Number Point

1.4.3.1 ISO common name Alpha- cypermethrin

1.4.3.2 CAS No. 67375-30-8

1.4.3.2 EINECS No. formerly 257-842-9, now included in CLP/GHS

1.4.3.2 CIPAC No. 454

1.4.3.2 ELINCS formerly 257-842-9, now included in CLP/GHS

1.4.3.3 Salt, ester anion or cation present no

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function.

CONFIDENTIAL information - data provided separately (Part C).

IIIA 1.4.5 Formulation process

IIIA 1.4.5.1 Description of formulation process

This is not an EC data requirement/ not required regulation (EU) 2011/545.

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern

Alpha-cypermethrin does not contain any impurities of toxicological or ecotoxicological concern.

IIIA 1.5 Type of Preparation and Code

Type : Long lasting insecticide net Code : LN

IIIA 1.6 Function

The product will be used as an insecticide (net on wood).

IIIA 1.7 Other/Special Studies

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 11 of 38

There is a new study available to derive the Kow and logPow of the active substance. The purity of the material tested (99.3%) is higher than the purity in the study evalutated during the EU process (95.4%). See appendix 4.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 12 of 38

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT The LN formulation BAS 310 62 I has not been the representative formulation. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a dark green net fabric without discernable odour. It is not explosive, has no oxidising properties. The auto-ignition temperature of the carrier net is 515 °C. The stability data indicate a shelf life of at least 2 years at ambient temperature, but an experimental determination has to be submitted to proof this. The technical characteristics are acceptable for a LN formulation.

Tabelle 1: Summary of the physical, chemical and technical properties of the plant protection product

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

Colour, odour and RLA 11803.04 0403001 (Battelle Dark green solid net fabric free Y Stickland L.J. 2010 Acceptable physical state Ref. M3654): 0.153% from foreign matter. 2010/1110701 (IIIA 2.1) No discernable odour.

No change after storage.

Explosive properties - - Based on the chemical structure - MSDS Acceptable. (IIIA 2.2.1) there is no indication of explosive properties .

Oxidizing properties - - Based on its structural properties - MSDS Acceptable. (IIIA 2.2.2) the product is not classified as oxidizing.

Flash point - - not applicable for LN formulations - - Acceptable. (IIIA 2.3.1)

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 13 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

The data is derived Flammability - - not easily flammable - please refer to Part C (IIIA 2.3.2) from the MSDS of the PET carrier net. Data are acceptable. Auto-flammability DIN 51794 – Not relevant PET 515 °C - Please refer to Part C The data is derived (IIIA 2.3.3) bibliographical from the MSDS of the reference PET carrier net. Data are acceptable.

Acidity or alkalinity - - not applicable for LN formulations - - Acceptable. and pH (IIIA 2.4.1) pH of a 1 % aqueous - - not applicable for LN formulations - - Acceptable. dilution, emulsion or dispersion (IIIA 2.4.2)

Kinematic viscosity - - not applicable for LN formulations - - Acceptable. (IIIA 2.5.1)

Dynamic viscosity - - not applicable for LN formulations - - Acceptable. (IIIA 2.5.2)

Surface tension - - not applicable for LN formulations - - Acceptable. (IIIA 2.5.3)

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 14 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

Relative density - - not applicable for LN formulations - - Acceptable (IIIA 2.6.1)

Bulk or tap density - - not applicable for LN formulations - - Acceptable; (IIIA 2.6.2) for further information see 2.15 (mass per unit).

CIPAC MT 0403001 (Battelle After storage for 2 weeks at 54 °C, Y Acceptable; net Storage Stability after Stickland L.J. 2010 14 days at 54º C 454/LN/M/3.1 Ref. M3654): 0.153% the determined total active content 2010/1110701 formulation is stable. (IIIA 2.7.1) (modified) was 101 % of the active content deternmined from the same sample of net before storage. Isomer ratio cis II : cis I = 100 : 0, remains unchanged. No change in appearance and odour. 0.4 % loss on mass. Stability after storage - - - - - Acceptable. for other periods and/or temperatures (IIIA 2.7.2)

Minimum content - - Not necessary, since the decrease - - Acceptable. after heat stability of the active substance did not testing exceed 5 %

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 15 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

(IIIA 2.7.3)

Effect of low - - Product is not cold sensitive. - - Acceptable. temperatures on stability (IIIA 2.7.4)

Ambient temperature - - no data submitted - - Not acceptable. shelf life Storage stability (IIIA 2.7.5) under ambient temperature must be determined with regard to content of active substance and mechanical stability of netting.

Shelf life in months - - - - - No data submitted. (if less than 2 years) Results of storage (IIIA 2.7.6) stability (2.7.5) must be awaited.

Wettability - - not applicable for LN formulations - - Acceptable. (IIIA 2.8.1)

Persistence of - - not applicable for LN formulations - - Acceptable. foaming (IIIA 2.8.2)

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 16 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

Suspensibility - - not applicable for LN formulations - - Acceptable. (IIIA 2.8.3.1)

Spontaneity of - - not applicable for LN formulation - - Acceptable. dispersion (IIIA 2.8.3.2)

Dilution stability - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.4)

Dry sieve test - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.5.1)

Wet sieve test - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.5.2)

Particle size - - not applicable for LN formulation - - Acceptable. distribution (IIIA 2.8.6.1)

Nominal size range of - - not applicable for LN formulation - - Acceptable. granules (IIIA 2.8.6.2)

Dust content - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.6.3)

Particle size of dust - - not applicable for LN formulation - - Acceptable.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 17 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N (IIIA 2.8.6.4)

Friability and attrition - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.6.5)

Emulsifiability - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.7.1)

Dispersibility - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.7.1)

Flowability - - not applicable for LN formulation - - Acceptable. (IIIA 2.8.8.1)

Pourability (including - - not applicable for LN formulation - - Acceptable. rinsed residue) (IIIA 2.8.8.2)

Dustability following - - not applicable for LN formulation - - Acceptable. accelerated storage (IIIA 2.8.8.3)

Physical - - not applicable for LN formulation - - Acceptable. compatibility of tank mixes (IIIA 2.9.1)

Chemical - - not applicable for LN formulation - - Acceptable. compatibility of tank

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 18 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N mixes (IIIA 2.9.2)

Distribution to seed - - not applicable for LN formulation - - Acceptable. (IIIA 2.10.1)

Adhesion to seeds - - not applicable for LN formulation - - Acceptable. (IIIA 2.10.2)

Miscibility - - Not required by regulation (EU) - - Acceptable. (IIIA 2.11) 2011/545.

Dielectric breakdown - - Not required by regulation (EU) - - Acceptable. (IIIA 2.12) 2011/545.

Corrosion - - Not required by regulation (EU) - - Acceptable. characteristics 2011/545. (IIIA 2.13)

- - - - Acceptable Container material - (IIIA 2.14)

C-329-2010: Due to the fact that wood nets are N The method was Other/special studies (IIIA 2.15) 0.178% not washed with soap like Tilting N., 2011 developed in order to household nets no washing study 2011/1269064 generate data on wash according to CIPAC MT off of the active 454/LN/(M)/- was carried out, but substance from the a) leaching an irrigation study was performed. net, simulating a Irrigation of the net with a water single heavy rain.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 19 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

loading of 55.7 L/m² (calculated The study is on the wood stock area) resulted in acceptable. a mean alphacypermethrin concentration in the drained water of 32.8 µg/L. Taking into account the nominal concentration of alphacypermethrin in the net of 100 mg/m² this corresponds to a leached amount of 0,55 % of the contained alphacypermethrin. DIN EN ISO 13938-2 0403001 (Ref. bursting strength: N Acceptable b) bursting strength Kroehl T., 2011 a and -distension M3654): 0.153% initial: 472.3 – 528.9 kPa Mechanical stability after storage (14 d at 54 °C): 2011/1124077 of net does not 466.4 – 500.4 kPa decrease significantly after storage. bursting distension: initial: 9.6 – 10.7 mm after storage (14 d at 54 °C): 10.3 – 10.7 mm DIN EN ISO 5077 0403001 (Ref. initial: N c) dimensional Kroehl T., 2011 a Acceptable change and DIN EN ISO M3654): 0.153% lengthwise: - 0.3 % 6330 (washing crosswise: no change 2011/1124077 procedure 8A, drying procedure C) after storage (14 d at 54 °C): lengthwise: - 0.1 % crosswise: + 0.4 %

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 20 of 38

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

DIN EN 12127 0403001 (Ref. initial: N d) mass per unit Kroehl T., 2011 a Acceptable (conditioned at 20 °C, M3654): 0.153% 62.6 – 63.6 g/m2

65 % rel. humidity) 2011/1124077 after storage (14 d at 54 °C): 64.1 – 65.6 g/m2 Specific weight data 0403001 (Battelle The specific weight of BAS 310 Y Stickland L.J. 2010 Additional provided by study Ref. M3654): 0.153% 62 I is 63.0 g/m² 2010/1110701 information, for data sponsor were provided by sponsor and not determined within the study.

ISO 7211/2 0403001 (Ref. initial: N e) number of holes Kroehl T., 2011 a Acceptable M3654): 0.153% 46.3 – 47.0 holes/cm2 2 300 holes /in 2011/1124077

after storage (14 d at 54 °C): 46.9 – 48.9 holes/cm2 309 holes/in2

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 21 of 38

IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15 The product BAS 310 62 I is a LN formulation. All studies have been performed in accordance with the current requirements, the critical GAP and the results are deemed to be acceptable. The appearance of the product is that of a dark green net fabric without discernable odour. It is not explosive, has no oxidising properties. The auto-ignition temperature of the carrier net is 515 °C. The stability data indicate a shelf life of at least 2 years at ambient temperature, results of a determination are not available yet. The technical characteristics are acceptable for a LN formulation.

Experimental testing of the product's physico-chemical and technical characteristics:

No experimental testing was performed at BVL.

Implications for labelling:

No labelling necessary due to physical or chemical properties described above.

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT

IIIA 3.1 Field of Use

The plant protection product STORANET is intended for application (wrapping) around a cord of logs against bark beetles before their flight and to prevent bark beetle flight from attacked logs.

IIIA 3.2 Nature of the Effects on Harmful Organisms

The mode of action of the active substance alpha-cypermethrin as described by IRAC (2010) as sodium channel modulators.

IIIA 3.3 Details of Intended Use

IIIA 3.3.1 Details of existing and intended uses

See GAP table Appendix 2.

IIIA 3.3.2 Details of harmful organisms against which protection is afforded

See GAP table Appendix 2.

IIIA 3.3.3 Effects achieved

See GAP table Appendix 2.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 22 of 38

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation)

See GAP table Appendix 2.

IIIA 3.5 Concentration of the Active Substance in the Material Used

Insert summary information.

IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent

See GAP table Appendix 2.

IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection

IIIA 3.7.1 Maximum number of applications and their timings

See GAP table Appendix 2.

IIIA 3.7.2 Growth stages of crops or plants to be protected

See GAP table Appendix 2.

IIIA 3.7.3 Development stages of the harmful organism concerned

See GAP table Appendix 2.

IIIA 3.7.4 Duration of protection afforded by each application

See GAP table Appendix 2.

IIIA 3.7.5 Duration of protection afforded by the maximum number of applications

See GAP table Appendix 2.

IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops

Not relevant.

IIIA 3.8.2 Limitations on choice of succeeding crops

Not relevant.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 23 of 38

IIIA 3.8.3 Description of damage to rotational crops

Not relevant.

IIIA 3.9 Proposed Instructions for Use as Printed on Labels

See Registration Report – Part A, Appendix 2.

IIIA 3.10 Other/Special Studies

This is not an EC data requirement/ not required by Directive 91/414/EEC or Regulation (EC) No. 1107/2009.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 24 of 38

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT

IIIA 4.1 Packaging and Compatibility with the Preparation

Packaging Summary

Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.

IIIA 4.1.1 Description and specification of the packaging The product will be sold in polyethylene bags with a thickness of min. 120µm. The product is supplied in customized sizes of 12.5 x 8 m, 10 x 20 m or 0.8 x 20 m. Alternatively the net is supplied as rolls with a length of 100 m and width of 8 m to be cut in sections as needed.

IIIA 4.1.2 Suitability of the packaging and closures The suitability of the packaging for the product BAS 310 62 I is proven by an accelerated storage test. The packaging was not influenced by its content (see study below).

IIIA 4.1.3 Resistance of the packaging material to its contents 4.1.3/1, Stickland L.J., 2010a Report: Alpha-cypermethrin: Accelerated storage stability and certificate of analysis of Title: treated wood net; formulation BAS 310 62 I - generation of data for batch 0403001 BASF DocID 2010/1110701 Document No: EEC 91/414 Annex III 2.7.1, OECD Principles of Good Laboratory Practice, GLP Guidelines: Principles of the German Chemikaliengesetz (Chemicals Act) Yes GLP

During the manufacture, handling or storage of BAS 310 62 I, corrosiveness on apparatus, containers or packing material (polythene bag) was not observed. End-use according to the instructions is not impaired by any corrosion.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 25 of 38

IIIA 4.2 Procedures for Cleaning Application Equipment

IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing The product is applied without using any application equipment. Thus, no procedures for cleaning can be provided.

Protective clothing for applicators of the woodnet is usually made of cotton. The polar surface of the fiber presents little affinity to the unpolar active ingredient. Therefore, usual laundering with detergents will either suspend or dissolve any contamination efficiently.

IIIA 4.2.2 Effectiveness of the cleaning procedures Protective clothing will be cleaned effectively when washed with usual laundry detergents.

IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment

IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop

See section 4.

IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed

See section 4.

IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces treated

See section 4.

IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs

See section 4.

IIIA 4.3.5 Waiting period (in days) between application and handling of treated products

See section 4.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 26 of 38

IIIA 4.3.6 Waiting period (in days) between last application and sowing or planting succeeding crops

See section 4.

IIIA 4.3.7 Information on specific conditions under which the preparation may or may not be used

See section 4.

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks

Report: 4.4/1, Anonymous, 2012a

Title: Safety data sheet - Storanet 8x12.5 M

Document No: BASF DocID 2012/1016674 - dRR

Guidelines: EEC 1907/2006

GLP No, not subject to GLP regulations

The safety data sheet complies with actual EEC regulations and is based on the present state of knowledge.

IIIA 4.4.1 Warehouse storage

See chaper 4.4.

IIIA 4.4.2 User level storage

See chaper 4.4.

IIIA 4.4.3 Transport

See chaper 4.4.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 27 of 38

IIIA 4.4.4 Fire

See chaper 4.4.

IIIA 4.4.5 Nature of protective clothing proposed

See chaper 4.4.

IIIA 4.4.6 Characteristics of protective clothing proposed

See chaper 4.4.

IIIA 4.4.7 Suitability and effectiveness of protective clothing and equipment

See chaper 4.4.

IIIA 4.4.8 Procedures to minimise the generation of waste

See chaper 4.4.

IIIA 4.4.9 Combustion products likely to be generated in the event of fire

See chaper 4.4.

IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During Transport, Storage or Use

Report: 4.5/1, Anonymous, 2012a Title: Safety data sheet - Storanet 8x12.5 M Document No: BASF DocID 2012/1016674 - dRR Guidelines: EEC 1907/2006 GLP No, not subject to GLP regulations

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 28 of 38

The safety data sheet contains advice for the use and transportation of the product based on scientific tests.

IIIA 4.5.1 Containment of spillages see chapter 4.5

IIIA 4.5.2 Decontamination of areas, vehicles and buildings see chapter 4.5

IIIA 4.5.3 Disposal of damaged packaging, adsorbents and other materials see chapter 4.5

IIIA 4.5.4 Protection of emergency workers and bystanders see chapter 4.5

IIIA 4.5.5 First aid measures see chapter 4.5

IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage For BAS 310 62 I, no neutralization procedures can be proposed.

IIIA 4.6.1 Details of proposed procedures for small quantities See chapter 4.6

IIIA 4.6.2 Evaluation of products of neutralization (small quantities) See chapter 4.6

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 29 of 38

IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste See chapter 4.6

IIIA 4.6.4 Details of proposed procedures for large quantities See chapter 4.6

IIIA 4.6.5 Evaluation of products of neutralization (large quantities) See chapter 4.6

IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste See chapter 4.6

IIIA 4.7 Pyrolytic Behaviour of the Active Substance Due to halogen content in the active ingredient and the formulants of less than 60 %, combustion of BAS 310 62 I in a waste incinerator plant does not raise concern about the formation of halogenated dibenzodioxins/-furans. IIIA 4.8 Disposal Procedures for the Plant Protection Product

IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging For purposes of disposal, combustion of BAS 310 62 I in a licensed incinerator is required. This method of disposal applies also to contaminated packages, which cannot be cleaned or reused.

Although it is possible to incinerate the product at lower temperatures, combustion at approximately 1100°C with a residence time of about 2 seconds is advised. By doing so, i.e., operating the incinerator according to the conditions laid down in council directive 94/67/EEC resp. directive 2000/76/EC of the European Parliament, one will achieve complete combustion and minimize the formation of undesired by-products in the off-gases.

Triple rinsing is not applicable for LN packaging, because an application of the rinsate on the previously treated surface - as recommendet by WHO - is not possible.

The remainder of the active substance in the LN bag is very small due to the net's resistance against attrition. A concentration of the active substance of 100-200 mg/m² net would therefore result in an overall contamination of the container of << 0.1%. The bag would not be classified as "hazardous", even if not rinsed at all after taking out the net. Hence, disposal of the bag in accordance with BASF proposal (incineration in a licensed incineration plant) would not be impaired by not rinsing it.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 30 of 38

To minimize waste of packages it is recommended that empty containers are delivered to local container collection stations. If these do not exist, empty containers must be rendered unusable and disposed according to local regulations.

IIIA 4.8.2 Methods other than controlled incineration for disposal No other methods for disposal of BAS 310 62 I than those described in chapter 4.8.1 are available.

IIIA 4.9 Other/Special Studies

No additional studies were performed.

IIIA 11 FURTHER INFORMATION

IIIA 11.1 Information of Authorisations in Other Countries BAS 310 62 I is not yet registered in the Member States. However, products containing alpha-cypermethrin are registered for use in agriculture and forestry in several Member States ( e.g. for forestry use FASTAC FORST is registered in Germany and Austria).

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries Not applicable as based on the intended uses in forestry no agricultural commodities will be treated.

IIIA 11.3 Justified Proposals for Classification and Labelling

Proposals for classification and labelling of BAS 512 16 F in accordance with the EC Directive on dangerous preparations 1999/45/EC and Directive 2001/59/EC (as amended) are presented below:

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 31 of 38

Physico-chemical properties

Table 11.3-1 Physico-chemical properties

Study Type Findings Reference

(triggered risk phrase)

Explosivity Not explosive (-) based on composition

Oxidizing Not oxidizing (-) based on composition properties

Flammability auto-ignition temperature of netting: 515 °C MSDS

Content of not applicable (-) - hydrocarbon

Viscosity not applicable (-) - (dynamic)

Surface tension not applicable (-) -

Toxicology see section 3.

Ecotoxicology/Environment see section 6.

IIIA 11.4 Proposals for Risk and Safety Phrases

Please refer to Registration Report – Part A.

IIIA 11.5 Proposed Label

Please refer to Registration Report – Part A.

IIIA 11.6 Specimens of Proposed Packaging

Specimens of the packaging were not provided as there was no request..

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 32 of 38

Appendix 1: List of data used in support of the evaluation

Annex point/ Author(s) Year Title Data Owner How considered in reference No Source (where different from protection dRR company) claimed Study-Status / Usage* Report-No. GLP or GEP status (where relevant), Published or not KIIIA Stickland 2010 a Alpha-cypermethrin: Yes BASF 1 2.1/1 L.J. Accelerated storage stability and 2.6.1: 5 certificate of analysis of treated 2.6.1/1 wood net; formulation BAS 310 2.14: 5 2.7.1/1 62 I - generation of data for batch 0403001 2.14/1 Battelle UK Ltd., United 2.15/2 Kingdom 4.1.3/1 2010/1110701 Yes Unpublished KIIIA 2.15/1 Tilting N. 2011 a Run-off study with BAS 310 I Yes BASF 1 (Alpha-Cypermethrin) in the formulation BAS 310 62 I (Storanet) on stored wood at two different forest sites in Germany, 2011 BASF SE, Limburgerhof, Germany 2011/1269064 Yes Unpublished KIIIA 2.15/3 Kroehl T. 2011 a Supplemental information to Yes BASF 1 BASF DocID 2010/1110701 BASF SE, Limburgerhof, Germany Fed.Rep. 2011/1124077 No Unpublished KIIIA Anonymou 2012 a Safety data sheet - Storanet Yes BASF 1 2.2.1 s 8x12.5 M 2.2.2 BASF SE, Ludwigshafen/Rhein, Germany Fed.Rep. 4.4/1 2012/1016674 - dRR 4.5/1 No, not subject to GLP regulations Unpublished

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 33 of 38

* 1 accepted (study valid and considered for evaluation) 2 not accepted (study not valid and not considered for evaluation) 3 not considered (study not relevant for evaluation) 4 not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 34 of 38

Appendix 2: Critical Uses – Justification and GAP tables

not relevant for section 1

PPP (product name/code) Storanet Formulation: Type: LN active substance 1 alpha-Cypermethrin Conc. of as 1: 1,57 g/l

Applicant: BASF professional use non professional use Zone(s): central

Verified by MS: Yes

1 2 3 5 6 7 8 9 10 11

Use-No. Member Crop and/ F Pests or PHI Remarks: state(s) or situation G Group of pests Formulation Application Application rate per treatment (days) or controlled I (a) (b) (c) (l) (m) Type Conc. method growth number interval g as/treatment water L/ha kg as/ha of as kind stage & min max between season applications min max min max min max (min) (d-f) (i) (f-h) (j) (k) (n)

1, 2 Central Single F Bark and wood LN 1.57g/kg complete post harvest 1 50 m2 net / not not formal zone trunk boring bark wrapping of treatment single trunk applicable applicable application beetles trunk rate: 41 g / 5 g as / single (100mg/m²) not ha DE, AT, Longhorn trunk) relevant PL, CZ, beetles and SK, SI metallic wood- boring beetles

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 35 of 38

3, 4 Central Lumber F Bark and wood LN 1.57g/kg Application post harvest 1 100 m2 net not not formal zone stock boring bark over the top of treatment /lumber stock applicable applicable application beetles the stock rate: 2 g / (20 m3) 10 g as / (100mg/m²) not ha DE, AT, Longhorn lumber stock relevant

PL, CZ, beetles and SK, SI metallic wood- boring beetles

5, 6 Central Large F Bark and wood LN 1.57g/kg Application post harvest 1 200 m2 net / not not formal zone lumber boring bark over the top of treatment large lumber applicable applicable application stock beetles the stock stock rate: 2 g /

(40 m3) (100mg/m²) not ha DE, AT, Longhorn 20 g as / large relevant PL, CZ, beetles and lumber stock SK, SI metallic wood- boring beetles

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (i) g/kg or g/l situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds application (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions of use (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 must be provided (f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of (n) The formal application dose rate per ha was calculated according to the approach which was equipment used must be indicated accepted by the BVL in the Registration report for Fastac Forst (PSM-Zulassungsbescheid SVA2006-05-17 NO--024012-00-00 Lft Nr. 28, Anlage 4, Seite 29) Therefore, the annual amount of timber harvest per ha was considered to calculate more realistic area-dependent application rates. The calculations were based on statistical data provided from German authorities [Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (2004): http://www.bundeswaldinventur.de/enid/ 43296d7208c4a827134d0a3176325a9e,0/75.html. Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (BMELV), Bonn, 2004]. These can be considered as a worst case, since the annual timber harvest amounts per hectare in Germany usually exceed those in Eastern European countries [EUROSTAT: (2009): http://epp.eurostat.ec.europa.eu/ portal/page/portal/ statistics/search_database, status September 2009]. According to BMELV (2004), 3-14 m3 timber ha-1 forestry area in use were harvested annually from 1987 to 2002. Assuming the 90th percentile of 9.9 m3 ha-1 a-1, an average of 8.2 single trunks, 0.2 small lumber stocks [or 0.1 large lumber stocks] per hectare and year can be derived.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 36 of 38

Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics:

No experimental testing was performed at BVL.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Federal Republic of Germany Page 37 of 38

Appendix 4: Physical and chemical properties of the active substance alpha-cypermethrin These following data refer to studies that have been submitted after the EU peer review.

Section Study Purity Method Results Reference Acceptability / (Annex [%] Comments point)

B.2.1.8 Partition 99.3 EEC A 8 log Po/w = 5.67 (20 °C) Daum, 2005 Acceptable (IIA 2.8) coefficient OECD 117 (DocID Purity higher than in (HPLC- 2005/1004705) study for EU method) (BVL 2240245) evaluation

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Federal Republic of Germany Page 38 of 38

List of data Annex point/ Author(s) Year Title Data Owner How reference No Source (where different protection considered in from company) claimed dRR Report-No. Study-Status / GLP or GEP status (where Usage* relevant), Published or not Authority registration No IIA 2.8 Daum, A. 2005 Determination of the Yes BASF 3 octanol/water partition coefficient of alpha- Cypermethrin (BAS 310 I, Reg.No. 4 078 193) TGAI at 20°C BASF DocID 2005/1004705 GLP: yes Published: no (BVL 2240245) * 1 accepted (study valid and considered for evaluation) 2 not accepted (study not valid and not considered for evaluation) 3 not considered (study not relevant for evaluation) 4 not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013 Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 1 of 16

REGISTRATION REPORT Part B

Section 2: Analytical Methods Detailed summary of the risk assessment

Product code: BAS 310 62 I Active Substance: Alpha-Cypermethrin 1.57 g/kg (or 100 mg per m2 net)

Central Zone Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: BASF Date: October 2013

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 2 of 16

Table of Contents

IIIA 5 METHODS OF ANALYSIS...... 4

IIIA 5.1 Analytical Standards and Samples ...... 4

IIIA 5.1.1 Samples of the preparation...... 4

IIIA 5.1.2 Analytical standards for the pure active substance ...... 4

IIIA 5.1.3 Samples of the active substance as manufactured...... 4

IIIA 5.1.4 Analytical standards for relevant metabolites and all other components included in the residue definition...... 4

IIIA 5.1.5 Samples of reference substances for relevant impurities ...... 4

IIIA 5.2 Methods for the Analysis of the Plant Protection Product...... 4

IIIA 5.2.1 Description of the analytical methods for the determination of the active substance in the plant protection product...... 4

IIIA 5.2.2 For preparations containing more than one active substance, description of method for determining each in the presence of the other ...... 6

IIIA 5.2.3 Applicability of existing CIPAC methods ...... 6

IIIA 5.2.4 Description of analytical methods for the determination of relevant impurities ...... 6

IIIA 5.2.5 Description of analytical methods for the determination of formulants...... 6

IIIA 5.3 Description of Analytical Methods for the Determination of Residues...... 6

IIIA 5.3.1 Evaluation of alpha-cypermethrin...... 6 IIIA 5.3.1.1 Overview of residue definitions and levels for which compliance is required...... 7 IIIA 5.3.1.2 Description of Analytical Methods for the Determination of Residues of Alpha-Cypermethrin in Plant Matrices (OECD KIII A 5.3.1) ...... 8 IIIA 5.3.1.3 Description of Analytical Methods for the Determination of Residues of Alpha-Cypermethrin in Animal Matrices (OECD KIII A 5.3.1)...... 8 IIIA 5.3.1.4 Description of Methods for the Analysis of Alpha-Cypermethrin in Soil (OECD KIII A 5.4)...... 9 IIIA 5.3.1.5 Description of Methods for the Analysis of Alpha-Cypermethrin in Water (OECD KIII A 5.6) ...... 9 IIIA 5.3.1.6 Description of Methods for the Analysis of Alpha-Cypermethrin in Air (OECD KIII A 5.7)...... 10

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 3 of 16

IIIA 5.3.1.7 Description of Methods for the Analysis of Alpha-Cypermethrin in Body Fluids and Tissues (OECD KIII A 5.8)...... 10 IIIA 5.3.1.8 Other Studies/ Information ...... 10

Conclusion on the availability of analytical methods for the determination of residues...... 11

Appendix 1 – List of data submitted in support of the evaluation ...... 12

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 4 of 16

IIIA 5 METHODS OF ANALYSIS This document summarises the information related to the analytical methods for the product BAS 310 62 I containing alpha-cypermethrin which was included into Annex I of Directive 91/414 (2004/58/EC from 23 April 2004) and is approved according to Regulation (EC) No 1107/2009 and Regulation (EU) No 540/2011.

This product was not the representative formulation. The product has not been previously evaluated according to Uniform Principles.

Appendix 1 of this document contains the list of references included in this document for support of the evaluation.

Information on the detailed composition of BAS 310 62 I can be found in the confidential dossier of this submission (Registration Report - Part C).

IIIA 5.1 Analytical Standards and Samples

IIIA 5.1.1 Samples of the preparation No samples were provided because there was no request.

IIIA 5.1.2 Analytical standards for the pure active substance No samples were provided because there was no request.

IIIA 5.1.3 Samples of the active substance as manufactured No samples were provided because there was no request.

IIIA 5.1.4 Analytical standards for relevant metabolites and all other components included in the residue definition No samples were provided because there was no request.

IIIA 5.1.5 Samples of reference substances for relevant impurities Alpha-cypermethrin does not contain any impurity of toxicological or ecotoxicological concern.

IIIA 5.2 Methods for the Analysis of the Plant Protection Product Analytical methods for determination of alpha-cypermethrin and the impurities and relevance of CIPAC methods were evaluated as part in the EU review. The respective data are considered adequate and are not included in this submission. Additional studies to support the registration of BAS 310 62 I not previously assessed are given below. All relevant data are provided and are considered adequate.

IIIA 5.2.1 Description of the analytical methods for the determination of the active substance in the plant protection product

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 5 of 16

The following analytical method for the determination of the active substance in the plant protection product performed on BAS 310 62 I has not previously been reviewed as it is a modification of CIPAC MT 454/LN/M/3.1. Therefore, it is provided in support of this assessment.

Report: 5.2.1/1, Stickland L.J., 2010a Title: Alpha-cypermethrin: Accelerated storage stability and certificate of analysis of treated wood net; formulation BAS 310 62 I - generation of data for batch 0403001 Document No: BASF DocID 2010/1110701 Guidelines: EEC 91/414 Annex III 2.7.1, OECD Principles of Good Laboratory Practice, GLP Principles of the German Chemikaliengesetz (Chemicals Act) GLP Yes

The general description of CIPAC MT 454/LN/M is publicly available. Therefore, only the modifications of this method applied for the analysis of alpha-cypermethrin in BAS 310 62 I are presented in this submission:

Preparation: • Internal standard solution was prepared at quarter stated concentration, and the dilution volume quadrupled for improved volumetric accuracy; the final concentration was unchanged. • Calibration stock solution was prepared at half stated concentration, and the dilution volume doubled for improved volumetric accuracy; the final concentration was unchanged. • An additional calibration solution was prepared at 0.01 mg/mL to ensure the linear range of calibration solutions extended to include the expected sample concentration. • A heating mantle was used in place of an oil bath, and the flasks were refluxed gently for 30 minutes (as opposed to 5 minutes) to ensure full extraction of active from the net. • Approximately 1.5 mL sample solution was transferred to each GC vial, and four drops of citric acid added.

Chromatography: • The split ratio was altered to achieve appropriate response. • Determination details cover the use of duplicate analytical standards. An injection sequence suitable for four standards was adopted.

• To maintain a free running syringe whilst injecting citric acid, a THF/H20 75/25 syringe wash solvent was used. • Equilibration of system and standard suitability: The system is deemed to be equilibrated and the standards suitable for the determination if the bracketing standards throughout the run are linear (i.e. correlation coefficient >0.99).

These modifications would have no impact upon the results obtained.

Characteristic chromatograms prove the applicability of CIPAC MT 454/LN to BAS 310 62 I; no interferences of the matrix to the detection of alpha-cypermethrin could be observed.

Summary The active substance of BAS 310 62 I can be quantified using the modified CIPAC method MT 454/LN.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 6 of 16

IIIA 5.2.2 For preparations containing more than one active substance, description of method for determining each in the presence of the other

Please refer to 5.2.1 as BAS 310 62 I does not contain more than one active substance.

IIIA 5.2.3 Applicability of existing CIPAC methods CIPAC MT 454/LN/M is applicable for BAS 310 62 I. As it has been slightly modified, please refer to 5.2.1 for more details.

IIIA 5.2.4 Description of analytical methods for the determination of relevant impurities Alpha-cypermethrin and the LN formulation BAS 310 62 I do not contain any impurities of toxicological or ecotoxicological concern.

IIIA 5.2.5 Description of analytical methods for the determination of formulants No formulants with toxicological or ecotoxicological relevant compounds are present in the formulation. Therefore, no analytical methods for the determination of formulants are necessary.

IIIA 5.3 Description of Analytical Methods for the Determination of Residues

IIIA 5.3.1 Evaluation of alpha-cypermethrin The conclusion regarding the peer review of the analytical methods for residues of alpha-cypermethrin are summarized in the Review Report (SANCO/4335/2000 final, 2004-02-13).

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1: Information on the active substance alpha-cypermethrin Name of component of residue definiton Structural formula substance code IUPAC name formula Alpha-cypermethrin racemate comprising (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate and (S)-α-cyano- 3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)- 2,2-dimethylcyclopropanecarboxylate

C22H19Cl2NO3

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 7 of 16

Alpha-cypermethrin, cypermethrin and zeta-cypermethrin are EU approved active substances and represent mixtures of up to 8 stereoisomers. Zeta-cypermethrin and cypermethrin are mixtures of 8 isomers whereas alpha-cypermethrin is a mixture of 2 isomers. When using non-chiral columns for chromatographic separation, 4 peaks can be expected for cypermethrin and zeta-cypermethrin. Alpha- cypermethrin shows only 1 peak. It is expected that the analytical properties are similar for all stereoisomers. Therefore, validation experiments conducted for alpha-cypermethrin only are also accepted for cypermethrin.

IIIA 5.3.1.1 Overview of residue definitions and levels for which compliance is required

The current legal residue definition includes cypermethrin and other mixtures of constituent isomers (sum of isomers).

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-2: Relevant residue definitions Matrix Relevant residue Reference Remarks Plant material Cypermethrin including other Regulation (EU) No 520/2011, annex mixtures of constituent isomers II, annex III part B (sum of isomers) Foodstuff of animal origin Cypermethrin including other Regulation (EU) No 520/2011, annex mixtures of constituent isomers II, annex III part B (sum of isomers) Soil Cypermethrin including other common limit mixtures of constituent isomers (sum of isomers) Surface water Cypermethrin including other EFSA Scientific Report (2008) 196,1- mixtures of constituent isomers 119 (zeta-cypermethrin), ASB2012- (sum of isomers) 3575 Drinking/ground water Cypermethrin including other General limit for drinking water mixtures of constituent isomers (sum of isomers) Air Cypermethrin including other EFSA Scientific Report (2008) 196,1- mixtures of constituent isomers 119 (zeta-cypermethrin), ASB2012- (sum of isomers) 3575 Body fluids/tissue Cypermethrin including other Classified as T, Dir. 67/548/EEC mixtures of constituent isomers (sum of isomers)

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-3: Levels for which compliance is required Matrix MRL Reference for MRL/level Remarks

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 8 of 16

Plant, high water content 0.05 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Plant, acidic commodities 0.05 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Plant, dry commodities 0.05 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Plant, high oil content 0.05 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Plant, difficult matrices Regulation (EU) No 520/2011, annex hops 30 mg/kg II, annex III part B tea 0.5 mg/kg Meat 0.1 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Milk 0.05 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Eggs 0.05 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Fat 0.1 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Liver, kidney 0.05 mg/kg Regulation (EU) No 520/2011, annex II, annex III part B Soil 0.05 mg/kg common limit Drinking water 0.1 µg/L general limit for drinking water Surface water 0.02 µg/L NOEC Chironomus riparius: 0.024 µg/L, Review Report Alpha-cypermethrin, SANCO/4335/2000 final, 2004-02-13 Air 3 µg/m3 AOELsys: 0.01 mg/kg bw/d, Review Report Alpha-cypermethrin, SANCO/4335/2000 final, 2004-02-13 Tissue (meat or liver) 0.1 mg/kg classified as T, Dir. 67/548/EEC Body fluids 0.05 mg/L classified as T, Dir. 67/548/EEC

IIIA 5.3.1.2 Description of Analytical Methods for the Determination of Residues of Alpha- Cypermethrin in Plant Matrices (OECD KIII A 5.3.1)

In the DAR including its addenda residue analytical methods for products of plant origin based on the DFG S19 multi-residue method are available. Additional data were provided in the context of this dossier but not considered. Due to the intended uses of the product in forestry only, no residues in food of plant origin are expected.

IIIA 5.3.1.3 Description of Analytical Methods for the Determination of Residues of Alpha- Cypermethrin in Animal Matrices (OECD KIII A 5.3.1)

In the DAR including its addenda residue analytical methods for products of animal origin based on the DFG S19 multi-residue method are available. Additional data were provided in the context of this dossier

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 9 of 16

but not considered. Due to the intended uses of the product in forestry only, no residues in food of animal origin are expected.

IIIA 5.3.1.4 Description of Methods for the Analysis of Alpha-Cypermethrin in Soil (OECD KIII A 5.4)

In the DAR including its addenda residue analytical methods for soil are described. Additional data were not considered in the context of this dossier.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-4: Overview of suitable primary and confirmatory methods for soil Component(s) of residue Matrix Primary method Confirmatory method definition Alpha-cypermethrin Soil Werle, 1999 Xu, 2001

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-5: Methods for soil Author(s), year Method LOQ Principle of method Comment Evaluated in Werle, 1999 0.05 mg/kg GC-ECD, DB-5 No DAR Alpha- (MET2005-36) column confirmation cypermethrin, vol. 3, B.4.2.2.2, ASB2010-10372 Xu, 2001 0.05 mg/kg GC-MS, DB-5MS Only for DAR Alpha- (MET2005-37) column , NCI, m/z confirmation cypermethrin, 207, 209, 211 Addendum, vol. 3, B.4.2.3, 12/2002

IIIA 5.3.1.5 Description of Methods for the Analysis of Alpha-Cypermethrin in Water (OECD KIII A 5.6)

An overview of the acceptable methods for analysis of alpha-cypermethrin in surface and drinking water is given in the following table. Further studies were not considered.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-6: Overview of suitable primary and confirmatory methods for water Component(s) of residue Matrix Primary method Confirmatory method definition Alpha-cypermethrin Drinking water Werle, 1999 Xu, 2001

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-7: Methods for drinking water and surface water Author(s), year Method LOQ Principle of method Comment Evaluated in Werle, 1999 0.05 µg/L GC-ECD, DB-5 No DAR Alpha- (MET2005-39) column confirmation, cypermethrin, vol. validated for 3, B.4.2.2.2, drinking water ASB2010-10372 Xu, 2001 0.05 GC-MS, DB-5MS, Only for DAR Alpha-

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 10 of 16

(MET2005-37) NCI, m/z 207, 209, confirmation, cypermethrin, 211 validated for Addendum, vol. 3, drinking water B.4.2.3, 12/2002

IIIA 5.3.1.6 Description of Methods for the Analysis of Alpha-Cypermethrin in Air (OECD KIII A 5.7)

An overview of the acceptable method for analysis of alpha-cypermethrin in air is given in the following table. Further studies were not considered.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-8: Overview of suitable primary and confirmatory methods for air Component(s) of residue definition Primary method Confirmatory method Cypermethrin Bacher, 2000 Not required

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-9: Methods for air Author(s), year Method LOQ Principle of method Comment Evaluated in Bacher, 2000 1.7 µg/m3 GC-ECD, CP Sil 8 DAR Zeta-cyper- (MET2003-53) CB column methrin, vol. 3, B.5.3.3, ASB2010- 10491

IIIA 5.3.1.7 Description of Methods for the Analysis of Alpha-Cypermethrin in Body Fluids and Tissues (OECD KIII A 5.8)

An overview of the acceptable methods for analysis of alpha-cypermethrin in body fluids and tissues is given in the following table. Further studies were not considered.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-10: Overview of suitable primary and confirmatory methods for body fluids and tissues Component(s) of residue definition Primary method Confirmatory method Cypermethrin Class, 2002 Class, 2002 Xu, 2001

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-11: Methods for body fluids and tissues Author(s), year Method LOQ Principle of method Comment Evaluated in Class, 2001 0.05 mg/kg GC-ECD, CP Sil 5 Confirmation DAR Zeta-cyper- (MET2003-255) (meat, liver/ column by GC-MS methrin, vol. 3, kidney, blood) included B.5.2.2, ASB2010- 10491 Xu, 2001 0.005 mg/L GC-MS, DB-5MS Only for DAR Alpha- (MET2005-37) column, NCI, m/z confirmation, cypermethrin, 207, 209, 211 validated for Addendum, vol. 3, blood B.4.2.3, 12/2002

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 11 of 16

IIIA 5.3.1.8 Other Studies/ Information

No further studies were provided.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 12 of 16

Conclusion on the availability of analytical methods for the determination of residues Sufficiently sensitive and selective analytical methods are available for all analytes included in the residue definition for all relevant compartments.

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 13 of 16

Appendix 1 – List of data submitted in support of the evaluation Table A 1: Reference list Annex point/ Author(s) Year Title Data Owner How considered in reference No Source (where different from protection dRR company) claimed Study-Status / Usage* Report-No. GLP or GEP status (where relevant), Published or not Authority registration No KIIIA 5.2.1/1 Stickland 2010 a Alpha-cypermethrin: Yes BASF 1 L.J. Accelerated storage stability and certificate of analysis of treated wood net; formulation BAS 310 62 I - generation of data for batch 0403001 Battelle UK Ltd., Havant Hampshire PO9 1SA, United Kingdom 2010/1110701 Yes Unpublished

* 1 accepted (study valid and considered for evaluation) 2 not accepted (study not valid and not considered for evaluation) 3 not considered (study not relevant for evaluation) 4 not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * Bacher, R. 2000 Validation of an Analytical Method for Yes FMC Add the Determination of Zeta-Cypermethrin in Air B 433 G GLP: Yes Published: No MET2003-53 Belgium 1999 alpha-cypermethrin (Monograph) Open Add September 1999 GLP: Open Published: Yes ASB2010-10372 Belgium 2006 Zeta-cypermethrin: (Draft Assessment Open Add Report) Vol. 1-4

GLP: Open Published: Yes ASB2010-10491 Class, Th. 2002 Zeta-Cypermethrin: Validation of the Yes FMC Add multi-residue DFG enforcement method S19 for the determination of residues of zeta-cypermethrin in foodstuffs of animal origin and in blood P/B 635 G GLP: Yes Published: No MET2003-255

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 14 of 16

Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * EFSA 2008 Conclusion regarding the peer review of Add the pesticide risk assessment of the active substance zeta-cypermethrin

EFSA Scientific Report (2008) 196, 1- 119 ASB2012-3575 KIIA 4.3 Anon. Not Determination of residues of Yes BAS N stated Alphacypermethrin in crops - Gas chromatographic method SAMS 351-2 ! AL-244-001 GLP: No Published: No BVL-2268637, MET2004-981 KIIA 4.3 Atkinson, S. 2002 Validation of the analytical procedure Yes BAS N carried out for the analysis of Cypermethrin isomers in cabbage, carrots, and lettuce carried out in study 83265 AL-244-012 ! CEMR-1787 GLP: Yes Published: No BVL-2268630, MET2005-33 KIIA 4.3 Doran, A. M.; Mayer, I. H.; 1999 Renegade Alphacypermethrin Yes BAS N Khunachak, A. (CL900049): Validation of analytical methods SAMS 461-1 and SAMS 456-1 for the determination of Alphacypermethrin residues in cattle tissues (muscle, fat, kidney and liver) and milk AL-245-006 ! RES 99-014 GLP: Yes Published: No BVL-2268628, MET2005-35 KIIA 4.3 Hausmann, S. 2000 Alphacypermethrin (CL 900049): Yes BAS N Validation of the multi-residue method DFG S19 with modified extraction for the determination of Alphacypermethrin residues in milk and eggs REA945 (CFS) ! P 388 G (PTRL Europe) ! AL-245-007 GLP: Yes Published: No BVL-2268639, MET2004-979 KIIA 4.3 Hitchings, E. J.; Sherren, J. 1983 The development of methods for the Yes BAS N A.; Woodbridge, A. P. determination of metabolites of 'ripcord' - WL044776 and WL044607 in crops and soil AL-230-001 GLP: No Published: No BVL-2268638, MET2004-980 KIIA 4.3 Smalley, R. 2000 Method validation of RLA 12594.01 Yes BAS N "Analysis of Alphacypermethrin (AC900049) in olives and olive oil". AL-244-007 ! 4560 GLP: Yes Published: No BVL-2268629, MET2005-34 KIIA 4.3 Smalley, R. 2002 Validation of method RLA 12644 for Yes BAS N the analysis of Cypermethrin isomers in wheat straw and grain AL-244-011 ! 4830 GLP: Yes Published: No BVL-2268631, MET2005-32

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 15 of 16

Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIA 4.3 Walker, B.; Linkerhägner, 2000 Alphacypermethrin (AC900049): Yes BAS N M. Validation of the DFG method S 19 (extended revision) for the determination of residues of Alphacypermethrin in/on grapes, wheat grain, cabbage, and oilseed rape Final report CYA-0002V ! Az. G00- 0030 ! AL-244-008 GLP: Yes Published: No BVL-2268634, MET2005-29 KIIA 4.3 Walker, B.; Linkerhägner, 2000 Alphacypermethrin (AC900049): Yes BAS N M. Validation of the DFG method S 19 (extended revision) for the determination of residues of Alphacypermethrin in processed fractions of cabbage and oilseed rape Final report CYA-0003V ! Az. G00- 0031 ! AL-244-009 GLP: Yes Published: No BVL-2268633, MET2005-30 KIIA 4.3 Young, H. 2001 Confirmatory analysis of BAS 101 Yes BAS N (Alphacypermethrin) in cabbage, oilseed rape, barley grain u. grapes using RLA 12644 AL-244-010 ! 4738 GLP: Yes Published: No BVL-2268632, MET2005-31 KIIA 4.3, KIIA 4.8 Anon. 1988 Determination of residues of Yes BAS N Alphacypermethrin in milk - Gas liquid chromatographic method SAMS 456-1 ! AL-245-003 GLP: No Published: No BVL-2268635, BVL-2268652, MET2005-28 KIIA 4.3, KIIA 4.8 Anon. 1988 Determination of residues of Yes BAS N Alphacypermethrin in animal tissues - Gas liquid chromatographic method SAMS 461-1 ! AL-245-001 GLP: No Published: No BVL-2268636, BVL-2268653, MET2005-27 KIIA 4.3, KIIIA1 Bretz M. 2007 Technical procedure: Method for the Yes BAS N 5.3.1 determination of Alphacypermethrin in plant matrices by GC-MS - BASF method number 567/1 2007/1010254 ! 567/1 GLP: No Published: No BVL-2255330, BVL-2268657, ASB2012-7356 KIIA 4.3, KIIIA1 Ennis, D.; Kochan, C.; 2007 Independent laboratory validation of Yes BAS N 5.3.1 Nelson, S. BASF method number 567/0 "Method for the determination of Alphacypermethrin and Cypermethrin in plant matrices" 07ILV01BASF ! 07BSF17.REP ! 2007/7007768 GLP: Open Published: No BVL-2364645, BVL-2365673, ASB2012-14419

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 16 of 16

Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIA 4.3, KIIIA1 Stewart, J. 2005 Method validation of BASF analytical Yes BAS N 5.3.1 method 567/0 entitled: “Method for determination of Alphacypermethrin and Cypermethrin in plant matrices” including standard stability and extract stability 206560 ! 2005/5000063 GLP: Open Published: No BVL-2364642, BVL-2365671, ASB2012-14418 KIIA 4.4 Anon. 1900 Determination of residues of Yes BAS N Alphacypermethrin in soils - Gas chromatographich method SAMS 354-2 ! AL-242-001 GLP: No Published: No BVL-2268642, MET2004-982 KIIA 4.4 Werle, H. 1999 Alphacypermethrin (CL900049): Yes BAS Y Validation of method SAMS 354-2 for the determination of residues in soils AL-242-006 ! 98 50 40 421 GLP: Yes Published: No BVL-2268641, MET2005-36 KIIA 4.4, KIIA 4.5, Xu, B. 2001 BAS 310 I (Alpha-cypermethrin): Yes BAS Y KIIA 4.8 Validation of method M 3499 for the confirmation of BAS 310 I residues in water, soil and blood by GC/MS AL-210-012 ! BASF Protocol 130428 ! RES 01-058 GLP: Yes Published: No BVL-2268640, BVL-2268645, BVL- 2268651, MET2005-37 KIIA 4.5 Anon. 1900 Determination of residues of Yes BAS N Alphacypermethrin in water - Gas chromatographic method SAMS 469-2 ! AL-243-001 GLP: No Published: No BVL-2268646, MET2004-984 KIIA 4.5 Fuchsbichler, G. 1999 Validation of method SAMS 469-2 for Yes BAS N the determination of Alphacypermethrin (AC 900049) in pond water and treatment solutions AL-243-008 ! HVA 17/99 GLP: Yes Published: No BVL-2268655, MET2003-216 KIIA 4.5 Kwasniok, A.; Pelz, S.; 1997 Validation of method SAMS 469-2 for Yes BAS N Christensen, G. W. the determination of AC 900049 (Alphacypermethrin) applied as a formulation (Fastac TM 100 g/l OESC insecticide) in pond water AL-243-003 ! CYA-9702V ! Az. 52908/97 GLP: Yes Published: No BVL-2268644, MET2005-38 KIIA 4.5 Sherren, A. J. 1989 Development of methods for the Yes BAS N analysis of water for residues of Permethrin, Cypermethrin and Alphacypermethrin SBGR.89.128 ! AL-243-002 GLP: No Published: No BVL-2268647, MET2004-983 KIIA 4.5 Werle, H. 1999 Alphacypermethrin (CL 900049): Yes BAS Y Validation of method SAMS 469-2 for the determination of residues in surface water AL-243-006 ! CFS 1999-051 GLP: Yes Published: No BVL-2268643, MET2005-39

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Part B – Section 1 BAS 310 62 I Registration Report – Central Zone Core Assessment – Germany Page 17 of 16

Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIA 4.7 Anon. 1900 Determination of crystalline "fastac" in Yes BAS N aerosols AL-210-002 ! AMS 887-1 GLP: Yes Published: No BVL-2268650, MET2004-985 KIIA 4.7 Anon. 1992 Determination of Alphacypermethrin in Yes BAS N air using an adsorbent trap - gas chromatographic method SAMS 534-1 ! AL-241-001 GLP: No Published: No BVL-2268649, MET2004-986 KIIA 4.7 Müller-Kallert, H. M. 1992 Development of a method for the Yes BAS N determination of Alphacypermethrin in air AL-241-002 ! 249120 GLP: Yes Published: No BVL-2268648, MET2005-40 KIIA 4.8 Walker, B.; Linkerhägner, 2000 Alphacypermethrin (AC900049): Yes BAS N M. Validation of the DFG-method S 19 (extended version) for the determination of residues of Alphacypermethrin in blood and urine of animal origin (swine) AL-245-008 ! CYA-0001V ! Az. G00- 0029 GLP: Yes Published: No BVL-2268654, MET2005-41 * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation

Applicant: BASF SE Evaluator: BVL / DE Date: October 2013

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

REGISTRATION REPORT Part B

Section 3: Mammalian Toxicology Detailed summary of the risk assessment

Product code: Storanet Active Substance: alpha-Cypermethrin, 1.57 g/kg

Central Zones Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: BASF SE Date: November 2013

Page 1 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Table of Contents 3 Mammalian Toxicology (IIIA 7)...... 4 3.1 Summary...... 4 3.2 Toxicological Information on Active Substance(s) ...... 8 3.3 Toxicological Evaluation of Plant Protection Product ...... 8 3.4 Dermal Absorption (IIIA 7.6)...... 9 3.4.1 Justification for proposed values – alpha-cypermethrin ...... 10 3.5 Exposure Assessment of Plant Protection Product...... 11 3.5.1 Selection of critical uses and justification ...... 11 3.5.2 Operator exposure (IIIA 7.3) ...... 11 3.5.2.1 Estimation of operator exposure...... 11 3.5.2.2 Measurement of operator exposure ...... 12 3.5.3 Worker exposure (IIIA 7.5) ...... 13 3.5.3.1 Estimation of worker exposure...... 13 3.5.3.2 Measurement of worker exposure ...... 13 3.5.4 Bystander and resident exposure (IIIA 7.4)...... 13 3.5.4.1 Estimation of bystander and resident exposure ...... 14 3.5.4.2 Measurement of bystander and/or resident exposure ...... 16 3.5.5 Statement on combined exposure ...... 16 Appendix 1 Reference list ...... 17 Appendix 2 Detailed evaluation of the studies relied upon...... 18 A 2.1 Statement on product characteristics ...... 18 A 2.2 Acute oral toxicity (IIIA1 7.1.1)...... 18 A 2.3 Acute percutaneous (dermal) toxicity (IIIA1 7.1.2) ...... 19 A 2.4 Acute inhalation toxicity (IIIA1 7.1.3)...... 20 A 2.5 Skin irritation (IIIA1 7.1.4) ...... 22 A 2.6 Eye irritation (IIIA1 7.1.5)...... 23 A 2.7 Skin sensitisation (IIIA1 7.1.6)...... 24 A 2.8 Supplementary studies for combinations of plant protection products (IIIA1 7.1.7) ...... 26 A 2.9 Data on co-formulants (III1 7.9)...... 26 A 2.9.1 Material safety data sheet for each co- formulant...... 26 A 2.9.2 Available toxicological data for each co-formulant ...... 26 A 2.10 Studies on dermal absorption (IIIA 7.6)...... 26 A 2.11 Comparative dermal absorption, in vitro using rat and human skin...... 30 A 2.12 Other/Special Studies ...... 30 Appendix 3 Exposure calculations...... 31

Page 2 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

A 3.1 Operator exposure calculations (IIIA1 7.3.1) ...... 31 A 3.1.1 Calculations for alpha-cypermethrin ...... 31 Appendix 4 Detailed evaluation of exposure studies relied upon (IIIA 7.3.3)...... 32 Appendix 5 Additional Information ...... 37 A 5.1 Photographs to illustrate the mode of application of Storanet (i.e. BAS 310 62 I) provided by the applicant ...... 37 A 5.2 Example for information plate...... 38

Page 3 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

3 Mammalian Toxicology (IIIA 7)

3.1 Summary

Table 3.1-1: Information on Storanet (BAS 310 62 I) *

Product name and code Storanet, i.e. BAS 310 62 I (BAS-31062-I-0-LN) Formulation type Long lasting insecticide net Active substance (incl. content) Alpha-cypermethrin; 1.57 g/kg Function Insecticide Product already evaluated as the ‘representative No formulation’ during the Annex I inclusion Product previously evaluated in an other MS according No to Uniform Principles * Information on the detailed composition of BAS-310 62 I, Storanet can be found in the confidential dRR Part C.

Justified proposals for classification and labelling

In accordance with Directives 67/548/EEC and 1999/45/EC and according to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 the following classification and labelling with regard to toxicological data is proposed for the preparation:

Table 3.1-2: Justified proposals for classification and labelling

C&L according to Directives 67/548/EEC and 1999/45/EC

Hazard symbols: None Indications of danger: None Risk phrases: None Safety phrases: S24 Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. C&L according to Regulation (EC) No 1272/2008

Hazard classes, categories: None Signal word: None Hazard statements: None Precautionary statements: None Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. [EUH401]

Page 4 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents for Storanet (BAS 310 62 I)

Result PPE / Risk mitigation measures Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to health damage. - Keep out of the reach of children. - The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. - Wear standard protective gloves (plant protection) when handling/applying the product. - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product. - If the plant protection product comes into contact with skin (especially facial), it can cause burning or itching, without external signs of irritation. These effects must be regarded as a warning to avoid further exposure at all costs. If the symptoms do not disappear, or if they are joined by further symptoms, a doctor must be consulted. Workers 1) Acceptable See operator Bystanders Acceptable - Information plates have to be installed at prominent places close to treated wood requesting all non-occupational persons to avoid contact with the net material. Residents In this particular scenario there is no conventional resident (for explanations, please, see text 3.5.4.) 1) In the case of this particular plant protection product workers are considered to substantially perform the same type of operations as operators do (see 3.5.3) Therefore, workers are supposed to wear the same PPE as operators.

No unacceptable risk for operators, workers, bystanders and residents was identified when product is used as intended and provided that the PPE stated in Table 3.1-3 are applied.

A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and bystanders/residents is presented in Table 3.1-4.

Page 5 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Table 3.1-4 Critical uses and overall conclusion of exposure assessment 1 2 3 4 5 6 7 8 10 11 12 13 14 15 Use- Zone Crop and/or F/G Pests or Group of Application Application rate PHI Remarks: Acceptability of situation or I pests controlled (days) exposure assessment (crop destination Method / Timing / Number m² Storanet/ g as/treated Water critical gap for / purpose of crop) (additionally: Kind Growth stage min max treated item item L/ha operator, worker, developmental (incl. of crop & bystander or resident stages of the pest application season exposure based on or pest group) technique) exposure study

a) b) Operator Worker Bystander Residents 1 Central Deciduous trees, F Wood-breeding lay out, Before beetles 1 , 1 50 m² net/ 5 --- n.relev. Operator, worker and Conifers beetle, complete fly out or (for a single trunk bystander Lying wood Bark beetle wrapping in case of maximum of of trunk established 24 weeks of hazard or from storage) beginning of infestation 2 Central Deciduous trees, F Longhorn beetle lay out, Before beetles 1 , 1 50 m² net/ 5 --- n.relev. Operator, worker and Conifers species, complete fly out or (for a single trunk bystander Lying wood Jewel beetle wrapping in case of maximum of of trunk established 24 weeks of hazard or from storage) beginning of infestation 3 Central Deciduous trees, F Wood-breeding lay out, Before beetles 1 , 1 100 m² net/ 10 --- n.relev. Operator, worker and Conifers beetle, application fly out or (for a lumber stock, bystander Lying wood Bark beetle over the in case of maximum of i.e. per 20 m³ top of the established 24 weeks of wood stock hazard or from storage) beginning of infestation 4 Central Deciduous trees, F Longhorn beetle lay out, Before beetles 1 , 1 100 m² net/ 10 --- n.relev. Operator, worker and Conifers species, application fly out or (for a lumber stock, bystander Lying wood Jewel beetle over the in case of maximum of i.e. per 20 m³ top of the established 24 weeks of wood stock hazard or from storage) beginning of infestation 5 Central Deciduous trees, F Wood-breeding lay out, Before beetles 1 , 1 200 m² net/ 20 --- n.relev. Operator, worker and Conifers beetle, application fly out or (for a large lumber bystander Lying wood Bark beetle over the in case of maximum of stock, i.e. per top of the established 24 weeks of 40 m³ wood stock hazard or from storage) beginning of infestation 6 Central Deciduous trees, F Longhorn beetle lay out, Before beetles 1 , 1 200 m² net/ 20 --- n.relev. Operator, worker and Conifers species, application fly out or (for a large lumber bystander Lying wood Jewel beetle over the in case of maximum of stock, i.e. per

Page 6 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

top of the established 24 weeks of 40 m³ wood stock hazard or from storage) beginning of infestation

Remarks: (a) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (b) n. relev.: not relevant

Exposure acceptable without PPE / risk mitigation measures Further refinement and/or risk mitigation measures required Exposure not acceptable/ Evaluation not possible There is no resident according to the normal definition (cf. explanations in the text,3.5.4)

Page 7 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

3.2 Toxicological Information on Active Substance

Information regarding classification of the active substances and on EU endpoints and critical areas of concern identified during the EU review are given in Table 3.2-1.

Table 3.2-1: Information on active substance alpha-cypermethrin

Classification and proposed labelling

With regard to toxicological Regulation (EC) No 1272/2008 (as amended by ATPs, Annex enpoints (according to the VI, Table 3.2): criteria in Dir. 67/548/EEC) T - Toxic R25 - Toxic if swallowed R37 - Irritating to the respiratory system R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed

With regard to toxicological Regulation (EC) No 1272/2008 (as amended by ATPs, Annex enpoints (according to the VI, Table 3.1): criteria in Reg. 1272/2008) Acute toxicity, cat. 3* Specific target organ tox.-single exp., cat. 3 Specific target organ tox.-repeated exp., cat. 2* H301* - Toxic if swallowed H373** - May cause damage to organs through prolonged or repeated oral exposure ** H335 - May cause respiratory irritation

Agreed EU endpoints AOEL systemic 0.01 mg/kg bw/d Reference SANCO/4335/2000 final (2004-02-13)

3.3 Toxicological Evaluation of Plant Protection Product

The product Storanet (BAS 310 62 I) consists of a PET insect net coated with 1.8 % of the insecticidal SC-formulation BAS 310 18 I. This insecticidal coating is fixed using a binder and protected from sunlight by an UV-absorber. Due to the nature of the plant protection product Storanet, the acute toxicity studies presented in this section were performed with BAS 310 18 I, i.e. the liquid formulation containing 100 g/L alpha- cypermethrin used for coating the net. A summary of the toxicological evaluation for BAS 310 18 I is given in Table 3.3-1. Full summaries of studies on this SC-formulation are presented in Appendix 2.

MSDS on all components of Storanet (BAS 310 62 I), can be found in the confidential dRR Part C.

Table 3.3-1: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for BAS 310 18 I (insecticidal SC-formulation for coating a PET net)

Type of test, model Result Acceptability Classification Classification Reference system (Guideline) (acc. to the (acc. to the criteria in Dir. criteria in Reg. 67/548/EEC) 1272/2008)

LD50 oral, rat 4932 mg/kg bw Yes None None Xxxxxxxxxxxx (OECD 401) (both sexes) 1992

Page 8 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

LD50 dermal, rat > 2000 mg/kg bw Yes None None Xxxxxxxxxxxx (OECD 402) 1992

LC50 inhalation, rat > 5.5 mg/L air Yes None None Xxxxxxxxxxxx (OECD 403) 2011 Skin irritation, rabbit Non-irritant Yes None None Xxxxxxxxxxxx (OECD 404) 2010 Eye irritation, rabbit Non-irritant Yes None None Xxxxxxxxxxxx (OECD 405) 2010 Skin sensitisation, Non-sensitising Yes None None Xxxxxxxxxxxx guinea pig 2010 (OECD 406, Buehler (3 applications) Supplementary studies No data – not for combinations of required plant protection products

Table 3.3-2: Additional toxicological information relevant for classification/labelling of BAS 310 62 I (Storanet), i.e. all components of Storanet included

Substance Classification of the Reference Classification of product (Concentration substance (acc. to the criteria in in product, (acc. to the criteria in Dir. 67/548/EEC, in Dir. % w/w) Dir. 67/548/EEC and/or 1999/45/EC and/or in in Reg. 1272/2008) Reg. 1272/2008)

Toxicological None None properties of active substance (relevant for classification of product) Toxicological None None properties of non-active substances (relevant for classification of product) Further toxicological No data – not information required 1Material safety data sheet by the applicant

3.4 Dermal Absorption (IIIA 7.6)

Dermal absorption of alpha-cypermethrin in the product BAS 310 62 I was not evaluated as part of the EU review of alpha-cypermethrin. Therefore, all relevant data are provided here, which were submitted in support of the application. No study was submitted that was conducted with BAS 310 62 I. The dermal absorption rate of alpha-cypermethrin formulated as BAS 308 04 I which is considered a ‘worst case’ surrogate for BAS 310 62 I/Storanet is summarised in Table 3.4-1. A summary of the in vivo dermal absorption study in rats with BAS 308 04 I is presented in Annex 2.

Page 9 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Table 3.4-1: Dermal absorption endpoint for the active substance in BAS 310 62 I/Storanet used for risk assessment

Alpha-cypermethrin Value Reference Concentration of a.s. present on New study on BAS 308 04 I reported in Appendix 2; 19 % the insecticidal ASB2012-7326 net (1.57 g/kg)

3.4.1 Justification for proposed values – alpha-cypermethrin Based on formulation comparisons and taking into account relevant exposure scenarios for which estimations are presented in this dossier, it is considered that the dermal absorption estimate derived for alpha-cypermethrin in the diluted product BAS 308 04 I is predictive of the dermal absorption potential of alpha-cypermethrin under use conditions of BAS 310 62 I (the net treated with BAS 310 18 I).

The in-vivo rat dermal penetration of BAS 308 04 I, a dispersible concentrate, was investigated as a worst-case surrogate for BAS 310 18 I, which is a suspension concentrate (SC) containing almost 3.5- times the concentration of alpha-cypermethrin. Details on the composition of the formulations are given in the confidential dossier (see Registration Report - Part C). .

With spray dilutions, where the resulting solution is composed predominantly of water, the percent composition of the inert ingredients approach zero and become quantitatively less important to the dermal absorptivity of the alpha-cypermethrin active ingredient. With alpha-cypermethrin, where dermal absorptivity follows saturation kinetics due to its large molecular size, the contribution of inerts is further reduced. Therefore, with the spray diluted formulation, the alpha-cypermethrin in BAS 310 18 I is expected to have similar dermal penetrating properties as the alpha-cypermethrin in BAS 308 04 I, in spite of the significant quantitative differences in the alpha-cypermethrin content. A rationale for the dermal absorption profile similarity under dilute conditions is that the large molecular size of alpha- cypermethrin becomes the rate determining step for dermal penetration. The dermal absorption study on BAS 308 04 I is summarised in Table 3.4-2. A full summary of this study that has not previously been evaluated within an EU peer review process is given in detail in Appendix 2.

Table 3.4-2: Summary of the dermal absorption study for alpha-cypermethrin Test Concentrate Spray Formulation Acceptability Justification Acceptability of Reference dilution in study of study provided on justification (1:200) representativ ity of study formulation for current product In- 9 % 19 % BAS 308 04 I Yes Yes Justification Xxxxxxx vivo containing 30 accepted. 2006 (rat) g/L alpha- Endpoint for cypermethrin spray dilution can be used for current product.

Page 10 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

3.5 Exposure Assessment of Plant Protection Product

Table 3.5-1: Product information and toxicological reference values used for exposure assessment Product name and code Storanet, i.e. BAS 310 62 I (BAS-31062-I-0-LN) Formulation type Long lasting insecticide net, LN Category Insecticide Container sizes, short description Polyethylene bags containing either customised sizes of the net: 12.5 x 8, 10 x 20 or 0.8 x 20 m or rolls of the net: 8 x 100 m Active substance Alpha-cypermethrin (incl. content) 1.57 g/kg, corresponding to 100 mg a.s./m² net AOEL systemic 0.01 mg/kg bw/d Inhalative absorption 100 % Oral absorption 45 % Dermal absorption Dilution: 19 % (Dilution rate: 1:200) BAS 308 04 I (SC-formulation containing 30 g/L alpha- cypermethrin + 30 g/L of a second active substance) used as a ‘worst case’ surrogate for Storanet

3.5.1 Selection of critical uses and justification The critical GAPs used for the exposure assessment of the plant protection product are shown in Table 3.1-4.

3.5.2 Operator exposure (IIIA 7.3) Storanet is a PET/Polyester-net coated with alpha-cypermethrin and a polymeric binder system. This net is intended to be used as a cover of lying hardwood and coniferous wood in the forest, e.g. lumber stocks, so that the net can unfold its insecticidal contact action since the active substance is available at the net’s surface. The nominal loading of the net material is 100 mg alpha-cypermethrin per m² (corresponding to 63 g/m² grammage of the net). The Storanet is supplied in customised sizes of 8x12.5 m. Alternatively the product is marketed as rolls with a length of 100 m to be cut in sections as needed.

The Storanet is stretched over the lumber stocks and secured to the ground around the logs to form a beetle-tight cover. Nets will be spread out at one end of the stocks allowing some overlap with the soil and subsequently rolled out until the other end of the pile is completely covered including some overlap of soil. In a second step all sides need to be secured by clamping the net material between logs and soil or by fixing the net material close to the lumber stock by stones or wood. The final operation will consist of attaching information plates at prominent places of each lumber stock to inform the population (e.g. hikers) on the treatment for avoidance of exposure. All steps are essentially done by manual operations with potential exposure primarily of the hand region of operators. The insecticidal activity is warranted for a maximum of 24 weeks. Nets need to be removed afterwards with subsequent controlled disposal, or can be used once again as long as the use period of 24 weeks has not been expired. For removing the Storanet substantially the same type of hand labour is needed as for the application. For both works operators will be advised to wear working clothing and protective gloves. 3.5.2.1 Estimation of operator exposure Since there are no representative data available in exposure calculation models reflecting the above described intended use, no estimation of operator exposure could be carried out in this way. Therefore, a field study measuring the operator exposure has been provided. A summary of the study is presented below. For the detailed evaluation of the new study it is referred to Appendix 4.

Page 11 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

3.5.2.2 Measurement of operator exposure

Operator exposure was estimated using a GLP study performed for the generic assessment of the use of insecticidal nets. For detailed considerations and calculations as well as a summary of the respective study it is referred to Appendix 4.

Estimation of operator exposure based on measured values as well as general considerations concerning inhalation exposure and risk assessment Dermal exposure

Table 3.5-2: Exposure data for intended uses

Critical use Deciduous trees or conifers; Lying wood (50 m² net/single trunk or 200 m² net/large lumber stock, corresponding to 5 g as/treated item to 20 g as/treated item, max. 8 complete cover tasks/day, effective working time: 360 min) Model Exposure study according to Xxxxxxxxxxxx (2011), ASB2012-7325

Table 3.5-3: Estimated dermal operator exposure

Alpha-cypermethrin Data Level of PPE Totally absorbed dose from % of systemic AOEL potential hand exposure (mg/kg bw/day) 1) Covering lumber stocks with Storanet Application rate: 5 g as/treated item to 20 g as/treated item, depending on the size of the pile of lying wood Exposure study no PPE 2) 0.04174 417 Body weight: + Gloves 3) 0.00042 4.2 individual as given in the study 1) 75th percentile of study results 2) no gloves but personal protection clothing (e. g. cotton vest and cotton trousers) 3) gloves during all shifts but not during breaks, exposure reduction factor: 0.01 Inhalation exposure Since inhalation exposure was not considered to be a relevant route of exposure for the type of use of Storanet (alpha-cypermethrin is non-volatile, the whole application is done outdoors with instant dilution of the minute amounts that may be released into the air) no respective measurements were carried out within the study by Xxxxxxxxxxxx (see above). However, to roughly estimate the worst case operator exposure via inhalation the theoretical maximum air concentration can be assessed from the vapour pressure of alpha-cypermethrin. The predicted saturation of air concentration of alpha-cypermethrin is shown in:

Table 3.5-4: Predicted maximum air concentration of alpha-cypermethrin

Temperature Vapour pressure 1) Max. air concentration of 2) [°C] alpha-cypermethrin [Pa] [bar] [mg/m³] 25 3.4 x 10-7 3.4 x 10-12 6.31884 x 10-5 1) EU-review report on alpha-cypermethrin, LoEP (SANCO/4335/2000) 2) Calculated as: vapour pressure [bar] x molecular weight [i.e. 416.3] x 1000000 / 22.4

As a worst case assumption the operator may be assumed to be exposed to a saturated air concentration of 6.31884 x 10-5 mg alpha-cypermethrin at 25°C. For a default breathing rate of 1.25 m³/h and a default work day of 8 h this would result in a predicted inhalation exposure of 6.31884 x 10-4 mg alpha-

Page 12 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version cypermethrin. For a default body weight of 70 kg and a default assumption of 100 % systemic availability for the active substance inhaled the predicted systemic exposure is 9.027 x 10-6 mg alpha-cypermethrin/kg body weight. The AOEL of alpha-cypermethrin is 0.01 mg/kg body weight/day. In conclusion the predicted exposure under worst case considerations corresponds to 0.09 % of the AOEL.

It is thus concluded that the risk for operators via the inhalation route is negligible.

Combined operator exposure Overall, the combined estimate for dermal and inhalation exposure of operators handling Storanet (BAS 310 62 I) results in 0.00043 mg/kg bw/day when using gloves and work clothing during all working activities (0.00042 mg/kg bw/d + 0.000009027 mg/kg bw/day). This corresponds to 4.3 % of the AOEL (AOEL: 0.01 mg/kg bw/day).

No dermal body exposure was determined in the above mentioned operator exposure study and the probability of body exposure is considered low for the intended working tasks by the applicant. But, since body contact with the insecticidal net by operators cannot be excluded, operators are supposed to wear protective garment mandatorily, as it was the case during the exposure study, too.

3.5.3 Worker exposure (IIIA 7.5) Workers are considered to substantially perform the same type of operations when removing used net material. Principal operations are unfolding and folding of the net material in combination with placing (removing) the net material on (from) the lumber stocks. All these operations were adequately covered in the operator exposure study. Therefore, the exposure and risk evaluation for operators does also meet the requirements for the re-entry worker assessment. Exposure and risk evaluations for workers are thus considered of being adequately addressed by operator evaluations (c.f. 3.6.2). Therefore, all relevant data and risk assessments have been provided and are considered adequate. It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing and protective gloves, when working with Storanet. The use of Storanet is thus considered to be in compliance with the Uniform Principles. 3.5.3.1 Estimation of worker exposure No assessment was performed because there is no model available which is adequately adjusted to this specific use. 3.5.3.2 Measurement of worker exposure Worker exposure and risk estimates were adequately addressed by operator evaluations. Therefore, no measurements of worker exposure were necessary.

3.5.4 Bystander and resident exposure (IIIA 7.4) Bystander exposure in its original sense is not considered a relevant scenario since any spray drift during application can be ruled out when handling the net material. In addition treated logs will bear information plates at prominent places requesting hikers, bikers and other non-occupational persons to avoid contact with the net material. Nevertheless, for adults and children (in this particular context called bystanders in the following, even though the‘definition’ is quite different from the normal one) eventually disregarding this advice risk assessments are presented below.

Resident exposure in its original sense is not considered relevant for the intended type and location of use (i.e. in or close to logging areas in forests) as the transfer of alpha-cypermethrin residues to adjacent residential areas can be ruled out. Furthermore, the low vapour pressure of alpha-cypermethrin does not suggest a relevant release and thus, a relevant airborne concentration is not anticipated.

Page 13 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

3.5.4.1 Estimation of bystander and resident exposure The basic assumptions for bystander risk assessment are subjects taking a rest while sitting on treated logs. This specific type of bystander exposure is considered to mainly occur via dermal contact with the net material, whereas inhalation exposure is not considered relevant following the same arguments as for operators (see above). For children additional hand-to mouth contact is considered. Object-to-mouth is considered a less relevant scenario because children are unlikely to pick up the net material by hand for subsequent mouthing.

Like for operators there is no model available which is adequately adjusted to this specific bystander situation. Nevertheless, the below mentioned model is used as a conservative approach for estimation of bystander exposure towards alpha-cypermethrin (Table 3.5-5), but several input parameters are modified in order to account for this particular bystander scenario, e.g. exposure time since it is unlikely that a person taking a rest on the logs stays there for two hours or even longer. A detailed comparison of original terms/input parameters concerning dermal exposure or child exposure via hand-to-mouth contact is given in Table 3.5-6 or Table 3.5-8. Outcome of the estimation of dermal bystander exposure is presented in Table 3.5-7.

Table 3.5-5: Exposure models for intended uses

Critical uses Deciduous trees or conifers; Lying wood (50 m² net/single trunk or 200 m² net/large lumber stock, corresponding to 5 g as/treated item to 20 g as/treated item) Model Martin, S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and Residents Exposed to Plant Protection Products During and After Application; J. Verbr. Lebensm. 3 (2008): 272-281 Birkhäuser Verlag Basel and Bundesanzeiger (BAnz), 06 January 2012, Issue No. 4, pp. 75-76] adjusted for this particular scenario

Table 3.5-6: Terms and parameters used for dermal bystander exposure estimation

Term Original use in (original) resident assessment Transfer to the Storanet scenario

SDER Systemic dermal exposure AR Application rate [kg as/ha] Net loading one sided [µg/cm2] 5 1) D Drift % Not required for this specific approoach TTR Turf transferable residues Transferable residues from net material 5 % 5 % TC Transfer coefficient (cm2/h) adult/child 7300/2600 2) T Duration [h] Duration [h] 2 h 0.5 h DA Dermal absorption 19 % BW Body weight [kg] adult/child 60 kg/16.15 kg 1) The nominal loading of the net material with alpha-cypermethrin is 100 mg/m² with an even distribution of the active substance over the material's surface. Provided a person sits on the net to take a rest, a one-sided contact can be assumed. This will imply the potential transfer of 50 % of the nominal loading corresponding to 5 µg/cm². 2) No specific data on potential contact areas for a person sitting while taking a rest are available. For this reason a conservative approach was chosen by assuming that adults and children will have the same dermal contact as residents spending their leisure time on turf as originally proposed by the German guidance.

Page 14 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

According to the following formula, the systemic dermal bystander exposure can be estimated:

SDER = (AR x TTR x TC x T x DA) / BW

Table 3.5-7: Estimated dermal bystander exposure

Alpha-cypermethrin

Model data Total absorbed dose (mg/kg % of systemic AOEL bw/day)

Covering lumber stocks with Storanet Application rate: 5 g as/treated item to 20 g as/treated item, depending on the size of the pile of lying wood Bystanders (adult) 0.002889 28.9 Body weight: 60 kg Bystanders (children) 0.003823 38.2 Body weight: 16.15 kg

Table 3.5-8: Terms and parameters used for estimation of child exposure via hand-to-mouth contact

Term Original use in (original) resident assessment Transfer to the Storanet scenario

SDER Systemic dermal exposure AR Application rate [kg as/ha] Nominal net loading one sided [mg/cm2] 0.005 1) D Drift % Not relevant for this scenario TTR Turf transferable residues Transferable residues from net material 5 % 5 % SE Salivation extraction factor 50 % SA Surface area of hands [cm2] 20 FR Frequency of hand-to-mouth events [events/hour] 20 T Duration [h] Duration [h] 2 h 0.5 h OA Oral absorption 45 % BW Body weight [kg] 16.15 kg 1) In analogy to the assessment for dermal exposure via skin contact the nominal loading of the net material with alpha- cypermethrin is 100 mg/m² with an even distribution of the active substance over the material's surface. Provided a person sits on the net to take a rest, a one-sided contact can be assumed. This in turn suggests a one-sided net loading of 50 mg/m² (corresponding to 0.005 mg/cm²).

According to the following formula, the systemic oral exposure can be estimated:

SOEH = (AR x TTR x SE x SA x FR x T x OA)/BW

SOEH = 0.000697 mg/kg bw/day corresponding to 7 % of the systemic AOEL.

Taken all together children’s exposure amounts to 45.2 % of the AOEL.

Page 15 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

3.5.4.2 Measurement of bystander and/or resident exposure

Since the bystander exposure estimations carried out and considerations concerning possible resident exposure indicated that the acceptable operator exposure level (AOEL) for alpha-cypermethrin will not be exceeded under conditions of intended uses, a study to provide measurements of bystander/resident exposure was not necessary and was therefore not performed.

3.5.5 Statement on combined exposure Not relevant. The product contains only one active substance.

Page 16 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Appendix 1 Reference list

Table A 1: Reference list

Annex point/ Author(s) Year Title Owner How reference No Report-No. considered * Authority registration No. in dRR OECD: KIIIA1 Xxxxxxxxxxxx 1992 Fastac 100 g/L SC (SF07379): Acute oral and Y 7.1.1, OECD: dermal toxicity in rat KIIIA1 7.1.2 AL-460-028 ! SBGR.91.019 BVL-2255331, BVL-2255332, ASB2012-7320 OECD: KIIIA1 Xxxxxxxxxxxx 2011 BAS 310 18 I: 4-hour acute inhalation toxicity Y 7.1.3 study in the rat 2010/1178744 ! 13I0160/10X153 BVL-2255334, ASB2012-7321 OECD: KIIIA1 Xxxxxxxxxxxx 2010 BAS 310 18 I: Acute dermal irritation/corrosion Y 7.1.4 in rabbits 2010/1057049 ! 18H0160/10X034 ! 10-BF-DI50 BVL-2255336, ASB2012-7322 OECD: KIIIA1 Xxxxxxxxxxxx 2010 BAS 310 18 I: Acute eye irritation in rabbits Y 7.1.5 2010/1057048 ! 11H0160/10X035 ! 10-EI049 BVL-2255338, ASB2012-7323 OECD: KIIIA1 Xxxxxxxxxxxx 2010 Skin sensitisation test of BAS 310 18 I in guinea Y 7.1.6 pigs - according to the E. V. BUEHLER Method 2010/1057050 ! 25767 ! 32H0160/10X036 BVL-2255340, ASB2012-7324 OECD: KIIIA1 Xxxxxxxxxxxx 2011 Determination of operator glove and hand Y 7.3.3 exposure to BAS 310 I (Alpha-Cypermethrin) associated to typical activities during handling of Storanet insecticidal nets (BAS 310 62 I) 2011/1278506 ! 419682 BVL-2255341, ASB2012-7325 OECD: KIIIA1 Xxxxxxxxxxxx 2006 Study on the dermal penetration of 14C-BAS Y 7.6.1 310 I and BAS 307 I in BAS 308 04 I in rats 2006/1009589 ! 01B0440/036008 BVL-2255343, ASB2012-7326 * Y, Yes/relied on; N, No/not relied on; Add, Additional, Relied on/study not submitted by applicant but necessary for evaluation

Page 17 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Appendix 2 Detailed evaluation of the studies relied upon A 2.1 Statement on product characteristics The product Storanet (BAS 310 62 I) consists of a PET insect net coated with the insecticidal SC- formulation BAS 310 18 I. The acute toxicity studies presented in this section were performed with BAS 310 18 I, i.e. a liquid formulation containing 100 g/L alpha-cypermethrin.

Comments of zRMS: Acceptable

A 2.2 Acute oral toxicity (IIIA1 7.1.1)

Comments of zRMS: Acceptable, with shortcomings, used for evaluation

Reference: IIIA1 7.1.1 Report FASTAC 100 g/L SC (SF07379) – Acute oral and dermal toxicity study in rats, Xxxxxxxxxxxx, 1992, BASF DocID AL-460-028, SBGR.91.019, ASB2012-7320 Guideline: OECD 401 Deviations: Yes, see remarks below GLP: Yes Acceptability: Yes, with shortcomings, cf. Remarks

Materials and methods

Test material (Lot/Batch No.) BAS 310 18 I (= FASTAC 100 g/L SC (SF07370) 001, PSD Ref. 151/90); SC-formulation for coating a PET net to produce Storanet Species Rat, Fischer 344 (Charles River U.K.) No. of animals (group size) 5 males and 5 females Doses 1820, 2550, 3570, 5000 and 6400 mg/kg bw Exposure Once by gavage Vehicle/Dilution None Post exposure observation period 14 days Remarks No conditions of animal husbandry, food, etc. described in the study report

Results and discussions

Table A 2: Results of acute oral toxicity study in rats of BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet)

1) Dose Toxicological results Duration of signs Time of death LD50 (mg/kg bw) (mg/kg bw) (14 days) Male rats 1820 0 / 5 / 5 3 h – d 10 -- 2550 1 / 5 / 5 4 h – d 14 d 3 3570 1 / 5 / 5 3.5 h – d 15 d 2 4922 5000 2 / 5 / 5 2 h – d 15 d 1 6400 4 / 5 / 5 3 h – d 10 d 1-2 Female rats

Page 18 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

1820 0 / 5 / 5 3 h – d 8 -- 2550 3 / 5 / 5 3 h – d 14 d 1 3570 1 / 5 / 5 2 h – d 7 d 2 4966 5000 0 / 5 / 5 2 h - termination -- 6400 5 / 5 / 5 3 h - dead d 1 1) Number of animals which died/number of animals with clinical signs/number of animals used

Table A 3: Summary of findings of acute oral toxicity study in rats of BAS 310 18 I (SC- formulation for coating a PET net to produce Storanet) Mortality: Yes, see above. Clinical signs: The principal clinical signs generally developed in all affected dose groups within 6 hours of dosing. The majority of treated rats developed a hunched posture, an unkempt appearance and/or soiling or staining (yellow) of the anogenital fur. Tremor and abnormalities of locomotory movements, particularly abasia and a splayed gait, were common among rats treated at 2550 mg/kg and above, and occurred rarely among rats treated at the lower dose level. Writhing and prostration were common among animals treated at 5000 or 6400 mg/kg bw and were also apparent among females dosed at 2550 and 3570 mg/kg bw. Other clinical signs included:  Lethargy and blood staining around the mouth at all dose levels  Diarrhoea at all dose levels with the exception of 1820 mg/kg bw  Isolated cases of lacrimation, salivation, blood staining on the face, voiding of soft feces and pallor of the eyes. Body weight: All surviving rats gained weight relative to their day 1 body weights by the end of the observation period. Macroscopic Apparent abnormalities in all animals that died were inflammation and abnormal fluid examination: contents in the stomach and small intestines. Darkening of the thymus or liver, lung congestion were less common findings and single cases of exaggerated hepatic lobular pattern, pallor of the spleen and darkening of the spleen or kidneys occurred. The observation that the testes were retained within the abdominal cavity of seven males was considered to be unrelated to treatment. Among surviving rats exaggerated hepatic lobular pattern and, in one case, diffuse areas of pallor on the liver were apparent at 2550 mg/kg and above. Testes were retained within the abdominal cavity of a single rat dosed at 3570 mg/kg bw.

Conclusion

Under the experimental conditions, the oral LD50 of BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet) is 4922 mg/kg bw in male and 4966 mg/kg bw in female rats (LD50 4932 mg/kg bw for both sexes). Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

A 2.3 Acute percutaneous (dermal) toxicity (IIIA1 7.1.2)

Comments of zRMS: Acceptable, with shortcomings, used for evaluation

Reference: IIIA1 7.1.2 Report Fastac 100 g/L SC(SF07379): Acute oral and dermal toxicity in rat, Xxxxxxxxxxxx, 1992, BASF DocID AL-460-028, SBGR.91.019, ASB2012-7320 Guideline: OECD 402 Deviations: Yes, see remarks below GLP: Yes Acceptability: Yes, with shortcomings, cf. Remarks

Page 19 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Materials and methods

Test material (Lot/Batch No.) BAS 310 18 I (= FASTAC 100 g/L SC (SF07370); SC-formulation for coating a PET net to produce Storanet Species Rat, Fischer 344 (Charles River U.K.) No. of animals (group size) 5 males and 5 females Dose 2000 mg/kg bw Exposure 24 hours (dermal, semi-occlusive) Vehicle/Dilution None Post exposure observation period 14 days Remarks No conditions of animal husbandry, food, etc. described in the study report

Results and discussions

Table A 4: Results of acute dermal toxicity study in rats of BAS 310 18 I (SC- formulation for coating a PET net to produce Storanet)

1) Dose Toxicological results Duration of signs Time of death LD50 (mg/kg bw) (mg/kg bw) (14 days) Male rats 2000 0/0/5 -- -- > 2000 Female rats 2000 0/0/5 -- -- > 2000 1) Number of animals which died/number of animals with clinical signs/number of animals used

Table A 5: Summary of findings of acute dermal toxicity study in rats of BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet) Mortality: No mortality occurred. Clinical signs: No clinical signs of toxicity were observed. Body weight: Slight body weight loss observed in all animals up to d 8, afterwards all animals gained weight relative to their day 1 body weight by the end of the 14-day observation period. Macroscopic There were no macroscopic findings seen in any of the animals that were sacrificed at the examination: end of the observation period.

Conclusion

Under the experimental conditions, the dermal LD50 of BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet) is greater than 2000 mg/kg bw in rats. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

A 2.4 Acute inhalation toxicity (IIIA1 7.1.3) Comments of zRMS: Acceptable, used for evaluation

Reference: IIIA1 7.1.3 Report BAS 310 18 I: 4-hour acute inhalation toxicity study in the rat, Xxxxxxxxxxxx, 2011, BASF DocID 2010/1178744, ASB2012-7321 Guidelines: OECD 403 (2009), Reg. (EC) No. 440/2008 of 30 May 2008 laying down

Page 20 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

test methods pursuant to Reg. (EC) No. 1907/2006 of European Parliament and of Council - Part B No. B.2, U.S. EPA 870.1300, JMAFF 12 NohSan No. 8147 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) BAS 310 18 I (batch: 0003558765); SC-formulation for coating a PET net to produce Storanet Species Rat, RccHan™: WIST(SPF) No. of animals (group size) 5 males and 5 females Concentrations 5.5 mg/L air Exposure 4 hours (nose-only) Vehicle/Dilution None Post exposure observation period 14 days Remarks Numerical codes used for description of intensity and/or particular time points to record clinical signs within the study report are not self-explanatory and given explanations are not totally sufficient. Nevertheless, symptoms and corresponding numbers of animals can be figured out.

Results and discussions

Table A 6: Concentrations and exposure conditions

Target conc. Nominal conc. Actual conc. MMAD 1) GSD 2) [mg/L air] [mg/L air] [mg/L air] [µm] 5.5 9.1 mg/L air 1.6 2.95 – 3.82 2.30 – 2.58 (gravimetric) (gravimetric) (gravimetric) 5.5 3) 3.50 – 4.08 2.11 – 2.19 (chemical) (chemical) (chemical) 1) MMAD = Mass Median Aerodynamic Diameter 2) GSD = Geometric Standard Deviation 3) relied on, applicant considered the difference between gravimetric and chemical aerosol concentration to be due to the content of volatile substances

Table A 7: Results of acute inhalation toxicity study in rats of BAS 310 18 I (SC- formulation for coating a PET net to produce Storanet)

Concentration Toxicological results Duration of signs Time of death LC50 (mg/L air) [mg/L air] 1) (14 days) Male rats 5.5 0/5/5 until day 1 -- > 5.5 Female rats 5.5 0/5/5 until day 1 -- > 5.5 1) Number of animals which died/number of animals with clinical signs/number of animals used

Page 21 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Table A 8: Summary of findings of acute inhalation toxicity study in rats of BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet) Mortality: No mortality occurred. Clinical signs: Clinical signs consisted of tachypnea, salivation, decreased activity and ruffled fur. These findings were limited to the day of treatment. From test day 2 onwards, all animals were free of clinical signs. Body weight: Slight to marked body weight loss was noted in all animals until the day after exposure. Thereafter normal body weight development was recorded. Macroscopic No gross pathologic abnormalities were detected in the necropsied animals treated at the examination: limit concentration of 5.5 mg/L.

Conclusion

Under the experimental conditions, the inhalation LC50 of BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet) is higher than 5.5 mg/L air in rats. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

A 2.5 Skin irritation (IIIA1 7.1.4)

Comments of zRMS: Acceptable, used for evaluation

Reference: IIIA1 7.1.4 Report BAS 310 18 I - Acute dermal irritation / corrosion in rabbits, Xxxxxxxxxxxx,2010, BASF DocID 2010/1057049, ASB2012-7322 Guidelines: OECD 404, Reg. (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to Reg. (EC) No. 1907/2006 of European Parliament and of Council - Part B No. B.4, U.S. EPA 870.2500, JMAFF No. 12 NohSan No. 8147 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) BAS 310 18 I (batch: 0003558765), SC-formulation for coating a PET net to produce Storanet Species Rabbit, New Zealand White Crl:KBL(NZW) – Charles River No. of animals (group size) 1 male, 2 females Initial test using one animal Yes Exposure 0.5 mL (4 hours, semi-occlusive) Vehicle/Dilution None Post exposure observation period 7 days Remarks None

Page 22 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Results and discussions

Table A 9: Skin irritation of BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet)

Animal Effects Scores after treatment 1) Mean scores Reversible No. (24-72 h) [day] 1 h 24 h 48 h 72 h 1 Erythema 1 1 1 1 1.0 7 Oedema 0 0 0 0 0.0 - 2 Erythema 1 1 1 0 0.7 7 Oedema 0 0 0 0 0.0 - 3 Erythema 1 1 1 0 0.7 7 Oedema 0 0 0 0 0.0 - 1) scores in the range of 0 to 4

Clinical signs: Very slight erythema (barely perceptible) (grade 1) was observed in all three animals immediately after removal of the patch, persisted in two animals up to 48 hours and in one animal for up to 72 hours. Body weight of animal 1 slightly decreased until d 7. No other clinical signs were observed.

Conclusion Under the experimental conditions, BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet) is not a skin irritant. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

A 2.6 Eye irritation (IIIA1 7.1.5)

Comments of zRMS: Acceptable, used for evaluation

Reference: IIIA1 7.1.5 Report BAS 310 18 I - Acute eye irritation in rabbits, Xxxxxxxxxxxx, 2010, BASF DocID 2010/1057048, ASB2012-7323 Guidelines: OECD 405, Reg. (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to Reg. (EC) No. 1907/2006 of European Parliament and of Council - Part B No. B.5, U.S.EPA 870.2400, JMAFF No. 12 NohSan No. 8147 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) BAS 310 18 I (0003558765), SC-formulation for coating a PET net to produce Storanet Species Rabbit, New Zealand White Crl:KBL(NZW) – Charles River No. of animals (group size) 2 males, 1 female Initial test using one animal Yes Exposure 0.1 mL (single instillation into conjunctival sac)

Page 23 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Irrigation (time point) Yes, for 1 to 2 minutes using hand warm tap water about 24 h after application of the test substance Vehicle/Dilution None Post exposure observation period 14 days Remarks Eye examination using fluorescein solution 24 h (3 animals) and 48 h (1 animal) after instillation of test item

Results and discussions

Table A 10: Eye irritation of BAS 310 18 I (SC- formulation for coating a PET net to produce Storanet)

Animal Scores after treatment 1) Mean scores Reversible No. (24-72 h) [day] 1 h 24 h 48 h 72 h 1 Corneal opacity 0 1 0 0 0.3 Iritis 0 0 0 0 0.0 7 Redness conjunctivae 1 1 1 1 1.0 Chemosis conjunctivae 1 2 0 0 0.7 2 Corneal opacity 0 0 0 0 0.0 Iritis 0 0 0 0 0.0 7 Redness conjunctivae 1 1 1 1 1.0 Chemosis conjunctivae 1 2 0 0 0.7 3 Corneal opacity 0 0 0 0 0.0 Iritis 0 0 0 0 0.0 7 Redness conjunctivae 1 1 1 1 1.0 Chemosis conjunctivae 1 1 0 0 0.3 1) scores in the range of 0 to 4 for cornea opacity and chemosis, 0 to 3 for redness of conjunctivae and 0 to 2 for iritis

Clinical signs: None

Conclusion Under the experimental conditions, BAS 310 18 I (SC- formulation for coating a PET net to produce Storanet) is not an eye irritant. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

A 2.7 Skin sensitisation (IIIA1 7.1.6)

Comments of zRMS: Acceptable, used for evaluation; Although an adjuvant-type test should be the preferred test method for skin sensitisation acc. to Reg. (EC) No. 440/2008 no justification is given to use the Buehler test. Since there were no signs of skin irritation after challenge in any of the test animals and since BAS 310 18 does not contain any known sensitising substances ≥ 0.1 % w/w, the test is considered acceptable.

Reference: IIIA1 7.1.6 Report Skin sensitisation test of BAS 310 18 I in guinea pigs - according to the E. V. BUEHLER Method, Xxxxxxxxxxxx, 2010, BASF DocID 2010/1057050, ASB2012-7324

Page 24 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Guidelines: OECD 406 (1992), (EC) No. 440/2008 of 30 May 2008 laying down test methods pursuant to (EC) No. 1907/2006 of European Parliament and of Council on the REACH - Part B No. B.6, U.S. EPA 870.2600, JMAFF No. 12 NohSan No. 8147 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) BAS 310 18 I (0003558765), SC-formulation for coating a PET net to produce Storanet Species Guinea pigs / Dunkin Hartley No. of animals (group size) Test substance group: 20 male guinea pigs Vehicle control goup: 10 male guinea pigs Positive control group: 20 guinea pigs (not carried out concurrently with this study) Range finding: Yes Exposure (concentrations, no. of Topical induction: undiluted (3 x ) applications) Challenge: 50 % Vehicle Aqua ad iniectabilia Pretreatment prior to topical application No Reliability check aqueous p-phenylene diamine dihydrochloride solution (2 % topical induction and 2 % challenge) Remarks Flank region of the guinea pigs was shaved but not depilated prior to induction application but shaved and depilated prior to challenge.

Results and discussions

24 hours 48 hours After challenge BAS 310 18 I 0/20 0/20 Test Vehicle 0/10 0/10 Control Group Positive control 20/20 20/20 1) Number of animals with positive dermal response (scores of 1-3) /number of animals in dose group

Clinical signs: None

Conclusion Under the experimental conditions, BAS 310 18 I (SC-formulation for coating a PET net to produce Storanet) not a skin sensitiser. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

Page 25 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

A 2.8 Supplementary studies for combinations of plant protection products (IIIA1 7.1.7) Additional supplementary studies are not necessary. A 2.9 Data on co-formulants (III1 7.9) A 2.9.1 Material safety data sheet for each co- formulant Material safety data sheets of the co-formulants can be found in the confidential dossier of this submission (Registration Report - Part C). A 2.9.2 Available toxicological data for each co-formulant Available toxicological data for each co-formulant can be found in the confidential dossier of this submission (Registration Report - Part C). A 2.10 Studies on dermal absorption (IIIA 7.6)

Study The summary prepared by the applicant was revised to be in line with the Comments: information given in the report. The study is considered to be acceptable. IIIA 7.6.1/01 The amount in excreta, carcass and (surrounding and treated) skin is considered as absorbed. The maximum of this sum for the concentrate and the dilution is considered the study result. Rounding was performed according to the recommendations in EFSA Journal 2012;10(4):2665. Agreed endpoint: Dermal absorption of alpha-cypermethrin formulated as BAS 308 04 I was IIIA 7.6.1/01 9 % for the concentrate and 19 % for the dilution.

Report: 7.6.1, Xxxxxxxxxxxx, 2006 Title: Study on the dermal penetration of 14C-BAS 310 I and BAS 307 I in BAS 308 04 I in rats Document No: BASF DocID 2006/1009589 Guidelines: OECD 427, EPA 870.7600 GLP Yes BfR study number ASB2012-7326

Executive Summary

The objective of the study was to provide information on the absorption, distribution and excretion of alpha-cypermethrin in a formulation concentrate (BAS 308 04 I) and in a dilution of this concentrate.

Single dermal administrations of the test materials were employed, simulating user-specific exposure scenarios. This study also measured the dermal penetration of the BAS 307 I (flufenoxuron) in additional dose groups, but only the results with alpha-cypermethrin will be presented.

The nominal dose levels of the alpha-cypermethrin administrations were 0.3 and 0.0015 mg/cm2. The exposure period was six hours and the dose groups (consisting of four animals each) were sacrificed at 6, 24 and 120 hours. Excreta (urine and feces) were collected during the observation period, and at sacrifice the following specimens were collected: blood cells, plasma, liver, kidneys, treated skin, skin surrounding the treated area and the carcass. In addition, the cage and skin washes as well as the protective cover (including the glass ring) were retained for the determination of radioactivity.

Page 26 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

According to the applicant, for alpha-cypermethrin in the BAS 308 04 I formulation concentrate (0.3 mg/cm2), the 120 hr dermal absorption was to 1.1 %. For the dilution of the formulation concentrate (0.0015 mg/cm2), the 120 hr dermal absorption was 13.4 %. In summary, the maximum in vivo dermal absorption observed with alpha-cypermethrin in rat skin was 13.42 %.

The amount in excreta, carcass and (surrounding and treated) skin is considered as absorbed by the zRMS. The maximum of this sum for the concentrate and the dilution is considered the study result. Dermal absorption of alpha-cypermethrin formulated as BAS 308 04 I was 9 % for the concentrate and 19 % for the dilution.

Materials and methods

14C-BAS 310 I (Batch 775-0203, Radiochemical purity >95 %, specific activity 3.46 MBq/mg) was used to spike the blank formulation BAS 308 04 I (containing flufenoxuron but not alpha-cypermethrin) to create the concentrate. Similarly, the concentrate was prepared and further diluted to create a 1:200 aqueous spray dilution, corresponding to alpha-cypermethrin concentrations of 30 and 0.15 mg/mL, respectively. The dosing suspension for testing the undiluted product was prepared by adding a respective amount of radiolabelled alpha-cypermethrin (14C-BAS 310 I) mixed with non-radiolabelled alpha- cypermethrin technical (Batch COD-000165, purity 98.8 % w/w) to an adequate volume of non- radioactive BAS 308 04 I blank formulation (Batch 95002, containing 0 g/L alpha-cypermethrin) [The targeted amount of radioactivity per animal was about 50 - 100 kBq/animal].

Male Wistar rats (CRl: WI, Charles River, Sulzfeld) were thoroughly clipped free of hair at the application site and washed with acetone 24 hours before treatment. On the day of dosing, a (glass) spacer was glued to the skin with tissue glue. Groups of 4 male Wistar rats were administered the test item preparation to the application site (dosing volume: 10 µl/cm²; treated area: about 10 cm²). The nominal dose levels were 0.3 mg/cm² and 0.0015 mg/cm² (corresponding nominally to about 3 mg/animal and about 10 mg/kg body weight at the high dose level and 0.015 mg/animal and 0.05 mg/kg body weight at the low dose level). To protect the test area, a nylon mesh was glued to the glass ring and a porous bandage was used to encircle the trunk of the animal. The exposure period was 6 hours. At the end of exposure, exposed skin was washed with a mild detergent solution and covered again with new gauze and new bandage. Subsets of the dose groups (consisting of 4 animals each) were sacrificed at 6, 24 and 120 hours, and skin washing was again performed. Excreta (urine and feces) were collected during the observation periods and at sacrifice the following specimen were collected: blood cells, plasma, treated skin, skin surrounding the treated area and carcass. For balance estimates the cage wash, skin washes, the gauze with bandage and the glass ring were also assayed for radioactivity. No tape stripping was performed in this study.

The samples were treated according to standard procedures (e.g., bleaching) and analysed for the amount of radioactivity.

Results and discussions

Mean recoveries of radioactivity from all dose groups ranged from 95.93 % to 113.95 % of the total radioactivity administered (see Table A 11).

The largest proportion of radioactivity was recovered from the skin wash and dressing (mean recoveries of between 85.36 - 95.64 % of the high dose and between 83.15 - 95.16 % of the low dose).

The amount of radioactivity absorbed at the high dose (including excreta, cage wash, carcass, blood cells and plasma) was 0.12 % after 6 hr. At 24 and 120 hr the absorbed material were 0.30 and 1.13 % of the

Page 27 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version high dose applied. At the designated time points of 6, 24 and 120 h, the total radiolabel at and surrounding the application site amounted to 8.78 %, 2.36 % and 0.76 % of the administered dose.

The amount of radioactivity absorbed at the low dose was 4.09 % after 6 hr. At 24 and 120 hr the absorbed material were 8.12 and 13.42 % of the dose applied. At the designated time points of 6, 24 and 120 h, the total radiolabel at and surrounding the application site amounted to 14.46 %, 4.92 % and 0.78 % of the administered dose.

Higher levels of radioactivity were excreted via urine than via feces.

At the end of the 120-h observation period, the remaining skin residues were less than 1 % of the radiolabel administered. From the data available, 6 h exposure plus 120 h post-observation period was seen as the most relevant in the context of this report as a worst case estimation of dermal absorption. Based on the total percentage of administered radiolabel actually absorbed within a 120-h period, overall mean estimates for dermal absorption of alpha-cypermethrin in BAS 308 04 I are 1.1 % for the undiluted formulation and 13.4 % for the spray-strength dilution.

Page 28 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Table A 11: Rat in-vivo dermal absorption of alpha-cypermethrin in BAS 308 04 I - Recovery data (% dose administered)

Nominal dose [mg/cm²] 0.3 0.0015 Exposure time [h] 6 6 Sacrifice time [h] 6 24 120 6 24 120 Actual dose [mg/cm²] 0.3413 0.3125 0.3461 0.0015 0.0015 0.0015 Urine -6 0.01 0.01 0.02 0.23 0.29 0.16 Urine -24 - 0.08 0.07 - 3.05 2.51 Urine -48 - - 0.15 - - 1.69 Urine -72 - - 0.11 - - 1.01 Urine -96 - - 0.13 - - 0.43 Urine -120 - - 0.12 - - 0.40 Urine subtotal 0.01 0.09 0.61 0.23 3.34 6.19 Feces -6 0.00 0.00 0.01 0.11 0.12 0.08 Feces -24 - 0.01 0.01 - 0.60 0.88 Feces -48 - - 0.07 - - 0.97 Feces -72 - - 0.05 - - 0.56 Feces -96 - - 0.05 - - 0.65 Feces -120 - - 0.10 - - 0.32 Subtotal Feces 0 0.01 0.29 0.11 0.72 3.44 Cage wash 0.02 0.07 0.08 0.26 0.44 0.93 Blood cells 0.00 0 0 0.13 0.09 0.08 Plasma 0.00 0 0 0.02 0.02 0.01 Carcass 0.09 0.13 0.15 3.34 3.52 2.77 Percentage absorbed 0.12 0.30 1.13 4.09 8.12 13.42 Surrounding skin 0.65 0.43 0.26 0.25 0.28 0.12 Application site 8.13 1.93 0.50 14.21 4.64 0.66 Subtotal skin 8.78 2.36 0.76 14.46 4.92 0.78 Protective cover 0.09 1.17 8.50 0.12 2.96 4.29 Skin wash 95.08 95.64 85.36 83.15 83.70 95.16 2nd skin wash n/a 2.14 0.19 n/a 3.75 0.32 Total recovery 104.07 101.59 95.93 101.82 103.44 113.95 Percentage absorbed + 8.90 2.66 1.89 18.55 13.04 14.20 Subtotal skin

Page 29 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Conclusion Following single dermal administration of 14C BAS 310 I in formulation blank BAS 308 04 I at two different dose levels (0.3 and 0.0015 mg/cm2), absorption amounted to a maximum of 13.4 %.

A 2.11 Comparative dermal absorption, in vitro using rat and human skin No in vitro dermal penetration study was submitted.

A 2.12 Other/Special Studies No other/special studies are available.

Page 30 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Appendix 3 Exposure calculations A 3.1 Operator exposure calculations (IIIA1 7.3.1) A 3.1.1 Calculations for alpha-cypermethrin

Table A 12: Input parameters considered for the estimation of operator exposure Formulation type: LN Loading of a.s. on net (both 100 mg a.s./m² sides): Dermal absorption (DA): 19 % AOEL 0.01 mg/kg bw/d

Operator hand exposure towards alpha-cypermethrin Alpha-cypermethrin Alpha-cypermethrin % % Body [mg/day] [mg/kg bw/day] Test AOEL AOEL weight subject Potential Potential without with [kg] Actual hand Potential hand 2) Gloves 1) hand systemic hand PPE PPE exposure exposure exposure exposure TS 1 62 9.53 0.00448 9.534 0.15378 0.0292 292 2.9 TS 2 79 17.31 0.0176 17.328 0.21933 0.0417 417 4.2 TS 3 70 12.97 0.0131 12.983 0.18547 0.0352 352 3.5 TS 4 79 16.45 0.02656 16.477 0.20856 0.0396 396 4.0 TS 5 84 18.52 0.02208 18.542 0.22073 0.0419 419 4.2 TS 6 140 15.85 0.00448 15.854 0.11324 0.0215 215 2.2 TS 7 110 17.20 0.01952 17.220 0.15654 0.0297 297 3.0 TS 8 91 20.08 0.03040 20.110 0.22099 0.0420 420 4.2 75th 17.61 0.0232 17.631 0.21968 0.0417 417 4.2 Percentile 1) Aggregate measurements of hand wash samples. i.e. total actual hand exposure with adjustment by factor 3.2 (see Table A 15) 2) Gloves during all tasks handling the insecticidal net, reduction factor: 0.01

Page 31 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Appendix 4 Detailed evaluation of exposure studies relied upon (IIIA 7.3.3) Comments of zRMS: Acceptable, used for evaluation Some figures reported by the applicant were slightly adjusted. Unlike proposed by the applicant the zRMS uses potential hand exposure data for risk assessment. Since corrected figures of aggregated hand wash samples, i.e. 3.2 x the sum of measured values (cf. below) only correspond to maximal 69 % recovery actual hand exposure could be underestimated.

Reference: IIIA 7.3.3 Report Xxxxxxxxxxxx. 2011; Determination of operator glove and hand exposure to BAS 310 I (Alpha-Cypermethrin) associated to typical activities during handling of Storanet insecticidal nets (BAS 310 62 I). BASF DocID 2011/1278506. conducted in Germany. Dates of work November 2011 – December 2011, ASB2012-7325 Guidelines: Following the OECD guidance document for the conduct of studies of occupational exposure to pesticides during agricultural application, Series on Testing and Assessment No. 9, 1997 (OECD/GD(97)148) GLP: Yes Acceptability: The study is considered to be acceptable.

Materials and methods The measurement of operator exposure was performed with the commercial product Storanet (BAS 310 62 I) sized 8x25 m. The product is PET (polyethylenterephthalat) material coated with a polymer mixture in which the active substance alpha-cypermethrin is embedded (LN formulation type). The nominal content of active substance is 100 mg alpha-cypermethrin/m² net material corresponding to 0.157 % alpha-cypermethrin. The analysed content of the test item used (batch A-328-2010) was 0.164 % alpha- cypermethrin. The test system comprised the test subjects undertaking the various activities associated with the handling of Storanet® insecticidal nets. Eight operators were monitored for typical activities associated with the handling of Storanet® insecticidal nets during an 8 hour working day. Handling insecticidal nets will predominantly result in hand exposure because the size and structure of lumber stocks will not allow too much of occasion to climb and crawl at and to thus result in dermal exposure of other body parts to a relevant extent. In order to monitor glove exposure nitrile coated working gloves were worn by the operators during the net handling activities. For the determination of hand exposure hand washes were collected from the test subjects prior the lunch break, at the end of the working day and at any time when the test subjects requested a hand wash for natural breaks.

The study was performed at greenhouse premises of BASF Agricultural Center Limburgerhof sufficiently large to allow for net handling operations which compare with those needed for the treatment of lumber stocks in forestry practice. A total of 8 test subjects (identified as TS1 through TS8) were engaged in the study. All of these were BASF employees who had no special practical experience with the handling of the product prior to study initiation, but were advised on the handling according to label recommendations. As a surrogate for lumber stocks long tables available in the greenhouse were used. Tables were considered to have a length similar to that of lumber and a height comparable to that of small lumber stocks. The test subjects were unpacking the 25 m x 8 m net from the bag and were then cutting the net into four equally sized sections. Four teams of test subjects were using these net sections to simulate lumber stock covering procedures by placing the nets over greenhouse tables, followed by removing the nets from the tables and folding them again to transportable packs. Subsequently the nets

Page 32 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version were again unfolded and the procedure started from the beginning. This or equivalent manual net handling activities were conducted during each of eight 45 minute shifts.

The test subjects performed four shifts in the morning with a 15 minute break between the shifts. The breaks were included in the work routine to account for the time needed under field conditions to change locations when the treatment of lumber stocks is completed and operators have to relocate their equipment to another place of lumber stocks. After the fourth shift a lunch break was included. In the afternoon another four shifts were conducted separated from each other by 15 minute breaks.

Dosimeters Dosimeters of the test subjects were nitrile coated working gloves as the nature of the net handling has been considered to predominantly be hand exposure. After each shift the gloves were carefully taken off to avoid hand contamination and stored in plastic bags until being used again for the follow-up shift. Upon completion of the last working shift gloves were transferred to plastic bottles for subsequent storage in a refrigerator until analysis on the following day. Hand washes were performed at the end of both working shifts and at times when operators were expected to wash hands as a rule. All hand wash specimens collected during the monitoring period were stored cooled in temporary storage until transfer to the refrigerator where storage was maintained until analysis.

Field fortifications, recoveries and analytical procedures Field fortification experiments were performed concomitant with the exposure study. Due to the vicinity of the trial site and the analytical laboratory no travel fortification experiments were conducted. Field fortifications were performed for the gloves and the hand washes in triplicate at a low and high fortification rate. A single control for each matrix was included. Fortified gloves were left uncovered and were exposed to the environmental conditions of the greenhouse during the experimental phase. Hand wash solutions were fortified at the beginning of the exposure monitoring period and transferred to cooled storage immediately after fortification. Fortification levels were as shown in Table A 13 below.

Table A 13: Field fortifications

Matrix Number of Specimen size LOQ 1) (proposed) Fortification levels replicates Gloves 1 1 glove 10.0 µg / glove not fortified (control) Gloves 3 1 glove 10.0 µg / glove 1 mg/glove Gloves 3 1 glove 10.0 µg / glove 100 mg/glove not fortified Hand wash 1 100 mL 2.5 µg / L (control) Hand wash 3 100 mL 2.5 µg / L 2.5 µg/L Hand wash 3 100 mL 2.5 µg / L 250 µg/L 1) Limit of quantification

All dosimeters and field fortification specimens were analysed for alpha-cypermethrin residues. The gloves were extracted with a mixture of cyclohexane and tetrahydrofuran (80/20). For each 1 g of specimen weight an amount of approximately 10 mL extraction solution mixture was used.

The extraction was performed by shaking the gloves on a reciprocating shaker for a period of 1 hour at ambient temperature. 0.5 mL of the extraction solution was subsequently diluted with cyclohexane / tetrahydrofuran (80/20) to a final volume of 1 mL. Where needed further dilutions with cyclohexane / tetrahydrofuran (80/20) were performed to meet the concentrations of the calibration. For hand wash solutions 2 x 500 mL (0.01 % Aerosol OT-B in water) was used to wash both hands. A subsample of 50 mL was collected. 0.5 mL of the hand wash solution was subsequently diluted with methanol to a final volume of 1 mL. Analyses were performed by GC-MS/MS for gloves and for hand wash solutions and LC-MS/MS for hand wash solutions alternatively.

Page 33 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Method validation In order to demonstrate the validity of the analytical methods on nitrile coated working gloves and in hand wash solutions fortification experiments were conducted. Fortification solutions were prepared from analytical standard solutions prior to the fortification experiments. The fortification experiment specimens were worked up in analogy to the specimens from the operator exposure study as described above and analysed together with these specimens. All test subject and field fortification specimens were analysed in analytical series together with control specimens from untreated matrix material and laboratory fortification specimens. In none of the control specimens residues of alpha-cypermethrin at or above the limit of quantification were found which proved that in general no interferences of the specimen material with the analytical procedures occurred. Results Field fortification recoveries and procedural laboratory recoveries The glove field and laboratory fortification specimens were analysed by GC-MS/MS and the mean recoveries of about 100 % demonstrated that the method applied is suitable to analyze gloves for alpha- cypermethrin residues (mean recovery of 98.8 % + 17.7 %for field fortifications, mean recovery of 100.3 % + 21.1 % for procedural laboratory recoveries). For hand wash specimens final analytical work was done based on LC-MS/MS when analyses based on GC-MS/MS failed to provide satisfactory results at the target LOQ of 2.5 µg/L. For this reason the analysis of the hand wash specimens was only conducted after five days of refrigerated storage of the fortification and exposure specimens (“aged specimens”). Although the repeatability of the analytical methodology could be demonstrated by an overall standard deviation of 6.8 % the procedural recovery level was low (22.8 % + 6.8 %). Therefore another set of freshly prepared fortification specimens (“fresh specimens”) was run under identical conditions using the same equipment and parameter to demonstrate that the method generates acceptable procedural recovery results. The average recovery results of the freshly prepared fortifications were in the acceptable range of 72.3 % with a standard deviation of only 3.4 % demonstrating that the method is valid for the analysis of alpha-cypermethrin in hand wash specimens. Field fortification measurements based on LC-MS/MS performed five days after sampling gave mean recovery levels of 21.5 % + 6.5 % which compares well with the aged procedural recoveries of 22.8 % + 6.8 %. This indicates that alpha-cypermethrin in refrigerated hand wash solution is declining with time and that the results obtained from the analysis of the field fortification specimens need to be corrected for the decline seen in the laboratory fortification results.

The decline factor obtained from the analysis of fresh relative to aged laboratory fortifications is 3.2 for the conditions of this study. A summary of results is shown in Table A 14.

Table A 14: Summarized results of recoveries for hand wash solutions

Matrix Fortification levels Recovery range Mean recovery Correction factor [%] + SD [%] Procedural laboratory recoveries 2.5 µg/L Hand wash (fresh) 66-78 72.3 + 3.4 (n = 10) 250 µg/L 72.3 / 22.8 = 3.2 2.5 µg/L Hand wash (aged) 14-31 22.8 + 6.8 (n = 10) 250 µg/L Corrected recovery Field fortification recoveries for field specimens 2.5 µg/L Hand wash (aged 1)) 15-30 21.5 + 6.5 (n = 6) 68.8 % 250 µg/L 1) Performed with LC-MS/MS five days after sampling

Page 34 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Exposure measurements As discussed above the hand wash results obtained have been adjusted by a correction factor of 3.2 for hand wash samples and are shown in Table A 15. As the data were generated on a LC-MS/MS equipment the calibration curve could be shown to be linear to the lowest standard calibrated (0.25 µg/L). Therefore it was possible to use the numerical data presented as together with

Table A 15: Measured exposure specimens and exposure estimates

Alpha-cypermethrin [mg] Test subject Gloves Hand wash Hand wash Hand wash Hand wash Aggregate 1 2 3 4 estimate 2)

Conclusion A study was conducted to determine the glove and hand exposure of operators originating from typical activities during the handling of Storanet® insecticidal nets containing alpha-cypermethrin. These nets are used to protect commercial goods from insect attacks. Typical operator activities comprise of but are not limited to removing such nets from outer packaging, unfolding the nets, covering goods, removing nets from covered goods and readjusting nets to assure proper coverage.

Eight test subjects performed Storanet® handling activities during a typical 8 hour working day. The procedures applied by the test subjects were considered representative of the commercial use of Storanet®. The test subjects were all wearing gloves for the net handling activities which were collected as exposure specimens at the end of the working day. In addition hand washes were collected from the test subjects prior to the lunch break, at the end of the working day and when the test subjects wanted to wash their hands for natural breaks. Additionally fortification experiments with gloves and hand wash solution were conducted on the day of test subject monitoring.

Page 35 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

The method applied for analyzing the glove specimens by GC-MS/MS were shown to be valid for the tested range. The results obtained from the glove analysis demonstrate that the individual test subject exposure ranges from 9.53 to 20.08 mg/operator.

The hand wash specimens were to be analysed by GC-MS/MS but the equipment response from the analysis of the hand wash fortifications at the target LOQ was unsatisfactory. Therefore, it was decided to change to an LC-MS/MS equipment. For this reason the analysis was conducted only after five days of refrigerated storage of the fortification and exposure specimens once the shift to the new equipment was accomplished. Although the repeatability of the analytical methodology could be demonstrated by a standard deviation of 6.8 % over all fortification specimens at both levels analysed the recovery level of the laboratory fortifications was low. Therefore freshly fortified hand wash solution was prepared and analysed and it was shown that the method applied produced acceptable recoveries at 72.3 % with a standard deviation of 3.4 %.

The field fortification specimens were stored refrigerated together with the laboratory fortifications and the field fortification recovery data were almost identical to the results of the aged laboratory fortifications (21.5 % ± 6.5 % versus 22.8 % ± 6.8 %). This indicates that alpha-cypermethrin in refrigerated hand wash solution is declining with time and that the results obtained from the analysis of the field fortification specimens needed to be corrected for the decline seen in the laboratory fortification results. The decline factor obtained from the analysis of fresh and aged laboratory fortifications is 3.2. Applying this factor to the mean field fortification recovery would result in a theoretical field fortification recovery of about 69 % which is considered just acceptable.

The results obtained from the analysis of the test subject hand wash specimens therefore also had to be considered in the context of the differences seen in freshly prepared laboratory fortifications and fortifications which were stored together with the exposure specimens in a refrigerator (aged fortifications) for a period of five days. A correction factor of 3.2 as described above was applied to the results to address the low field fortification recoveries.

The results obtained from summing up the individual results of each test subject’s hand washes were therefore ranging from 0.0044 to 0.0301 mg/test subject and are considered representative of operators hand exposure resulting from the commercial use of Storanet® insecticidal nets.

Page 36 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

Appendix 5 Additional Information A 5.1 Photographs to illustrate the mode of application of Storanet (i.e. BAS 310 62 I) provided by the applicant

Use of Storanet (BAS 310 62 I)

Page 37 / 38

Storanet – 007598-00/00 Part B – Section 3 - Core Assessment zRMS Version

A 5.2 Example for information plate

Information plates to inform the general public (English version)

Page 38 / 38

Storanet – 007598-00/00 Part B – Section 4 - Core Assessment zRMS Version

REGISTRATION REPORT Part B

Section 4: Metabolism and Residues Detailed summary of the risk assessment

Product code: Storanet Active Substance: alpha-Cypermethrin, 1.57 g/kg

Central Zones Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: BASF SE Date: August 2012

Page 1 / 7 Storanet – 007598-00/00 Part B – Section 4 - Core Assessment zRMS Version Table of Contents

IIIA 8 METABOLISM AND RESIDUES DATA ...... 3 IIIA 8.1 Evaluation of the active substances ...... 3 IIIA 8.2 Evaluation of the intended uses ...... 3 IIIA 8.2.1 Selection of critical use and justification...... 3 IIIA 8.2.2 Forestry (deciduous trees, conifers)...... 6 IIIA 8.2.2.1 Residues in primary crops ...... 6 IIIA 8.2.2.2 Distribution of the residue in peel/pulp ...... 6 IIIA 8.2.2.3 Residues in processed commodities ...... 6 IIIA 8.2.2.4 Proposed pre-harvest intervals, withholding periods...... 6 IIIA 8.3 Consumer intake and risk assessment...... 6 IIIA 8.4 Proposed maximum residue levels (MRLs)...... 6 IIIA 8.5 Conclusion...... 6 Appendix 1 List of data submitted in support of the evaluation ...... 7 Appendix 2 Detailed evaluation of the additional studies relied upon...... 7 A 2.1 Storage stability ...... 7 A 2.2 Residues in primary crops ...... 7 A 2.3 Residues in processed commodities ...... 7 A 2.4 Residues in rotational crops...... 7 A 2.5 Residues in livestock ...... 7 A 2.6 Other studies/information ...... 7

Page 2 / 7 Storanet – 007598-00/00 Part B – Section 4 - Core Assessment zRMS Version

IIIA 8 METABOLISM AND RESIDUES DATA

IIIA 8.1 Evaluation of the active substances

Due to intended uses of the product in forestry only, no agricultural commodities are anticipated to get affected. The uses are therefore not relevant in terms of consumer health protection. Since alpha-cypermethrin is included in Annex I of Council Directive 91/414/EEC it is referred to the underlying evaluations at EU level. Data, which has been previously evaluated at EU level is described in detail in the DAR (RMS: BE, 1999; ASB2010-10372) as well as in EFSA´s Reasoned Opinion on the Modification of the existing MRLs for cypermethrin in various crops (EFSA Journal 2011; 9(6):2280; ASB2012-3262).

IIIA 8.2 Evaluation of the intended uses

IIIA 8.2.1 Selection of critical use and justification The critical GAP used for consumer intake and risk assessment is presented in Table IIIA 8.2-1. It has been selected from the individual GAPs in the central zone for uses in forestry.

Page 3 / 7 Storanet – 007598-00/00 Part B – Section 4 - Core Assessment zRMS Version

Table IIIA 8.2-1: Critical Use (worst case) used for consumer intake and risk assessment

1 2 3 4 5 6 7 8 9 10 11 12 13 Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number kg product / ha kg as/ha Water (i) e.g. safener/synergist per ha (crop destination / I (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) developmental stages of season between per appl. a) max. rate e.g. recommended or (b) the pest or pest group) (d-f) applications) b) max. total per appl. min / max mandatory tank mixtures (a) (g) a) per use rate per b) max. total (c) b) per crop/ crop/season rate per (j) season crop/season (h) 1 DE, AT, Deciduous trees, F Wood-breeding beetles, Wrapping Before beetles fly a) 1 a) a) Not XN Post harvest treatment, PL, CZ, Conifers Bark beetle of trunk out or in case of b) 1 b) b) applicable 50 m2 net/ single trunk SK, SI established hazard or from beginning of infestation 2 DE, AT, Deciduous trees, F Longhorn beetle species, Wrapping Before beetles fly a) 1 a) a) Not XN Post harvest treatment, PL, CZ, Conifers Jewel beetle of trunk out or in case of b) 1 b) b) applicable 50 m2 net/ single trunk SK, SI established hazard or from beginning of infestation 3 DE, AT, Deciduous trees, F Wood-breeding beetle, Wrapping Before beetles fly a) 1 a) a) Not XN Post harvest treatment, PL, CZ, Conifers Bark beetle of wood out or in case of b) 1 b) b) applicable 100 m2 net/ lumber stacks SK, SI stacks established hazard or from beginning of infestation 4 DE, AT, Deciduous trees, F Longhorn beetle species, Wrapping Before beetles fly a) 1 a) a) Not XN Post harvest treatment, PL, CZ, Conifers Jewel beetle of wood out or in case of b) 1 b) b) applicable 100 m2 net/ lumber stacks SK, SI stacks established hazard or from beginning of infestation 5 DE, AT, Deciduous trees, F Wood-breeding beetles, Wrapping Before beetles fly a) 1 a) a) Not XN Post harvest treatment, PL, CZ, Conifers Bark beetle of wood out or in case of b) 1 b) b) applicable 200 m2 net/ large lumber stacks SK, SI stacks established hazard or from beginning of infestation 6 DE, AT, Deciduous trees, F Longhorn beetle species, Wrapping Before beetles fly a) 1 a) a) Not XN Post harvest treatment, PL, CZ, Conifers Jewel beetle of wood out or in case of b) 1 b) b) applicable 200 m2 net/ large lumber stacks SK, SI stacks established hazard or from beginning of infestation

Page 4 / 7 Storanet – 007598-00/00 Part B – Section 4 - Core Assessment zRMS Version Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, the use situation should be described (e.g. fumigation of a structure) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) at time of application (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (h) The minimum and maximum number of application possible under practical (d) All abbreviations used must be explained conditions of use must be provided (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, (i) PHI - minimum pre-harvest interval drench (j) Remarks may include: Extent of use/economic importance/restrictions (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

Page 5 / 7 Storanet – 007598-00/00 Part B – Section 4 - Core Assessment zRMS Version

IIIA 8.2.2 Forestry (deciduous trees, conifers)

IIIA 8.2.2.1 Residues in primary crops No residues in commodities for human consumption are expected from the intended uses. The uses are therefore not relevant in terms of consumer health protection. Consequently, the submission of supervised residue trials is not necessary. IIIA 8.2.2.2 Distribution of the residue in peel/pulp Not relevant. IIIA 8.2.2.3 Residues in processed commodities Not relevant. IIIA 8.2.2.4 Proposed pre-harvest intervals, withholding periods Based on the intended uses in forestry pre-harvest intervals (PHI) and withholding periods are not necessary.

IIIA 8.3 Consumer intake and risk assessment

No residues of alpha-cypermethrin are expected to arise from the intended uses in forestry. As a consequence, overall dietary intake will not be affected and the envisaged uses are regarded as not relevant in terms of consumer health protection. For long-term risk assessment reference is made to EFSA´s Reasoned Opinion concerning the Modification of the existing MRLs for cypermethrin in various crops (EFSA Journal 2011; 9(6):2280; ASB2012-3262).

IIIA 8.4 Proposed maximum residue levels (MRLs)

Based on the intended uses in forestry no new MRL is required.

IIIA 8.5 Conclusion

The intended uses in forestry (post harvest application) are not relevant in terms of consumer health protection. The submission of residue data is not necessary.

As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended uses.

Page 6 / 7 Storanet – 007598-00/00 Part B – Section 4 - Core Assessment zRMS Version Appendix 1 List of data submitted in support of the evaluation No new studies have been submitted in support of the evaluation Appendix 2 Detailed evaluation of the additional studies relied upon

A 2.1 Storage stability No further study on storage stability submitted/needed. A 2.2 Residues in primary crops No further study on primary crops submitted/needed. A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted and none is needed. A 2.4 Residues in rotational crops No new study on residues in rotational crops has been submitted. A 2.5 Residues in livestock No new study on residues in livestock has been submitted. A 2.6 Other studies/information None

Page 7 / 7 Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 1 of 32

REGISTRATION REPORT Part B

Section 5 Environmental Fate Detailed summary of the risk assessment

Product code: BAS 310 62 I Storanet Active Substance: Alpha-Cypermethrin 1.57 g/kg (0.157% w/w)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: BASF Date: October 2013

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 2 of 32

Table of Contents TABLE OF CONTENTS...... 2 SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9)...... 3 5.1 GENERAL INFORMATION ON THE FORMULATION ...... 3 5.2 PROPOSED USE PATTERN ...... 3 5.3 INFORMATION ON THE ACTIVE SUBSTANCES...... 4 5.3.1 Alpha-cypermethrin ...... 4 5.4 SUMMARY ON INPUTPARAMETER FOR ENVIRONMENTAL EXPOSURE ASSESSMENT...... 6 5.4.1 Rate of degradation in soil ...... 6 5.4.2 Adsorption/desorption...... 10 5.4.3 Rate of degradation in water ...... 11

5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (PECSOIL) (KIIIA1 9.4)...... 12

5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (PECSW/PECSED) (KIIIA1 9.7) 13 5.7 RISK ASSESSMENT GROUND WATER (KIIIA1 9.6)...... 14 5.7.1 Predicted environmental concentration in groundwater (PECGW) calculation for alpha-cypermethrin and its metabolites DCVA and mPBA ...... 14 5.8 POTENTIAL OF ACTIVE SUBSTANCE FOR AERIAL TRANSPORT...... 16 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION...... 17 APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON...... 19 KIIA 7 FATE AND BEHAVIOUR IN THE ENVIRONMENT – ACTIVE SUBSTANCE...... 19 KIIA 7.2 Huber 2008...... 19 KII A1 7.4.2 Malinsky 2005 ...... 20 KIIIA1 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT – PLANT PRODECTION PRODUCT ...... 21 KIIIA1 9.2. Huber, 2007 ...... 21 KIIIA1 9.10.2/1, Tilting N., 2011c...... 22 KIIIA1 9.10.2/2, Tilting N., 2011d ...... 26 APPENDIX 3 TABLE OF INTENDED USES JUSTIFICATION AND GAP TABLES...... 31

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 3 of 32

Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) This document comprises the risk assessment for groundwater and the exposure assessment of surface water and soil for the plant protection product STORANET containing the active substance alpha- cypermethrin in its intended uses in wood according to Appendix 3. National Addenda are included containing country specific assessments for some annex points.

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation BAS 310 62

Code BAS 310 62 I plant protection product STORANET applicant BASF date of application Formulation type Long lasting insecticide net [Code : LN] (WP, EC, SC, …; density) active substance alpha-cypermethrin Concentration of as 1.57 g/kg (0.157% w/w)

5.2 Proposed use pattern

The list of all intended uses used for STORANET is presented in Table 5.2-1. Table 5.2-1: Critical use pattern of STORANET

Group/ Crop/growth Application Number of applications, Application rate, Soil effective use No stage method Drift Minimum application cumulative application rate scenario interval, application (g as/ha) (g as/ha) time, interception A/ Single trunks No drift 1 50 m2 5g 00-001 00-002 B/ Lumber stack No drift 1 100 m2 10g 00-003 (20 m3) 00-004 C/ Lumber stack No drift 1 200 m2 20 g 00-005, (40 m3) 00-006

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 4 of 32

5.3 Information on the active substances

5.3.1 Alpha-cypermethrin 5.3.1.1 Identity, further information of alpha-cypermethrin Table 5.3-1: Identity, further information on alpha-cypermethrin

Active substance (ISO common name) alpha-cypermethrin IUPAC Racemate comprising (S)-α- cyano-3 phenoxybenzyl- (1R)-cis-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropane carboxylate and (R)-α- cyano-3 phenoxybenzyl- (1S)-cis-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropane carboxylate (= cis-2 isomer pair of cypermethrin) Function (e.g. fungicide) insecticide Status under Reg. (EC) No 1107/2009 approved Date of approval 23 February 2004 Conditions of approval Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures. Confirmatory data - RMS Belgium Minimum purity of the active substance 930 as manufactured (g/kg)

Molecular formula C22H19Cl2NO3 Molecular mass 416.3

Structural formula

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 5 of 32

5.3.1.2 Physical and chemical properties of alpha-cypermethrin Physical and chemical properties of alpha-cypermethrin as agreed at EU level (see SANCO4335/2000 final – 13/02/2004) and considered relevant for the exposure assessment are listed in Table 5.3-2. Table 5.3-2: EU agreed physical chemical properties of alpha-cypermethrin relevant for exposure assessment

Value Reference Vapour pressure (at 20 °C) (Pa) 3.4 x 10-7 Pa at 25 °C SANCO/4335/2000 final – (97.3%) 13/02/2004

³ -1 Henry’s law constant (Pa × m × mol ) 0.069 at 20 °C Solubility in water at 20°C (98%) : 0.67 µg/L (pH 4) 3.97 µg/L (pH 7) 4.54 µg/L (pH 9) 1.25 µg/L (double distilled water)

Partition co-efficient (at 25 °), log POW 5.5 at 20°C (95.4%) no effect of pH (no dissociation) Dissociation constant, pKa no dissociation of the a.s. Hydrolytic degradation at pH 4, 50 °C: hydrolytical stability (no degradation after 10 days) at pH 7, 20 °C : DT50 = 101 d at pH 9, 20 °C : DT50 = 7.3 d

Photolytic degradation at pH 5, 22 °C : DT50 = 1.2 d (Cp-label) – 2.2 d (Bz-label)

5.3.1.3 Metabolites of alpha-cypermethrin Metabolites of alpha-cypermethrin in soil are summarized in Table 5.3-3. Potential ground water contamination by the soil metabolites mPBA was evaluated for EU approval of alpha-cypermethrin. PECgw modelled was less than 0.001 µg/L for the metabolites in all scenarios based on an application of 2x 15 g as/ha at cereals, cabbage or oilseed rape. However, the intended use is not comparable and the maximal amount of the soil metabolite DCVA is >10% too, so that the leaching potential of the soil metabolites DCVA needs to be assessed. Therefore the leaching potential into groundwater of the soil metabolites mPBA and DCVA will be assessed for the application of the plant protection product and its intended uses.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 6 of 32

Table 5.3-3: Metabolites of alpha-cypermethrin potentially relevant for exposure assessment (> 10 % of as or > 5 % of as in 2 sequential measurements or > 5 % of as and maximum of formation not yet reached at the end of the study)

Metabolit Structural occurence in compartements Satus of Relevance formula/Molecular (Max. at day/ formula mPBA C13H10O3 Soil: Max. 29.5 % at day 112 Addendum to the monograph- 3-PBA Water: 18% at day 7 (23% in November 2002: not relevant CL 206128 whole system) 3- phenoxybenzoi c acid cis-DCVA C8H10Cl2O2 Soil: Max. 17.4 % at day 56 Not considered in the CL 912554 Water: 47% at day 14 monograph dimethylcyclop Sediment: 19.5% at day 14 ropane carboxylic acid

5.4 Summary on Inputparameter for environmental exposure assessment

5.4.1 Rate of degradation in soil 5.4.1.1 Laboratory studies alpha-cypermethrin The rates of degradation in soil of alpha-cypermethrin were evaluated during the Annex I inclusion. No additional studies have been performed.

According to the LoEP for alpha-cypermethrin the DT50 values in aerobic soil at 20°C ranged from 25 to 125 days. However, in the meantime a Q10 factor of 2.58 is used for temperature correction instead of the former Q10 factor of 2.2 and moisture correction to pF2 is commonly. Additionally there are for some soils kinetic reevaluations for the laboratory dissipation available.

Therefore the DT50 values of alpha-cypermethrin or cis-cypermethrin given in the DAR and Addendum for alpha-cypermethrin were normalized by zRMS with a Q10 factor of 2.58 and the FOCUS default soil moisture for pF2 with the tool Input Decision 3.2, and are summarized in Table 5.4-1.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 7 of 32

Table 5.4-1 Summary of aerobic degradation rates for alpha-cypermethrin laboratory studies

Soil type pH T Moi- DT50 DT90 DT50 (d) Kinetic, Fit Reference (oC) sture (d) (d) 20 C pF2/10kPa Brenes, sandy 8.0 25 18.4% 31 103 31.8 SFO Standen, 1976 clay w/w Recalculation Beigel, Huber Los Palacios, 7.7 25 14.4% 84 > 58.1 1st Standen, DAR clay w/w study duratio n Leiston, Sandy 6.8 25 18.9% 29 96.2 46.4 SFO Standen, 1976 loam w/w Recalculation Beigel (is mentioned in Addendum) Sandy loam* 6.5 20 50% 20.6 104 16.2 SFO Gedik, Keirs MWHC 2001, study is mentioned in addendum, but not presented in detail Pfaffenberg, 5 20-22 40% 88 792 (71.6)** Not given Andre, 1989- Sandy loam MWHC Mitchell Cotts, DAR Queichwald, 4.2 20-22 40% 107 354 (110.6)** Not given Andre, 1989 sand MWHC DAR Römerberg, 6.4 20-22 40% 31 102 28.8 Not given Andre, 1989 Loamy sand MWHC DAR Geometric mean of 5 soils 33.1

Coefficient of variation (%) 45

*) DT50 values at 10°C for this soil not reported here, as a study at 20°C was performed too. **) not considered for statistics, pH < 5.4

The DT50 values for alpha-cypermethrin in aerobic soil at 20°C and at pF2 range from 16.2 to 110.6 days, whereat the pH values of the soils Pfaffenberg and Queichwald of Andre (1989) are lower than the pH range of 5.5-8.0 given for representative soils in the OECD No. 307. These soils were therefore not considered for the calculation of the geometric mean. Furthermore the type of kinetic is not given in the DAR for this study nor the percentages at the sample points for a possible kinetic reevaluation.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 8 of 32

Metabolites Studies with cis and trans cypermethrin (Standen 1976) and alpha-cypermethrin Gedik and Keirs 2001) have shown that the major route of degradation of alpha-cypermethrin in soil is ester cleavage to form mPBA and Cis DCVA (former CL 206128 and CL 912554). Metabolite mPBA In a clay soil with limited soil moisture (28% of MWHC), treated with cis-cypermethrin and incubated at 25°C, mPBA increased to up to 29.5% of AR at day 112. In all other cases, mPBA appeared only in small amounts, less than 7%, and declined rapidly, with a DT50 of 2.9 days. No study on the soil degradation of the metabolite mPBA has been submitted. However, recalculated DT50 values for mPBA from the study Standen (1976) together with temperature and moisture normalizations are listed in the addendum to the monograph (Beigel, 2002). The recalculated and normalized DT50 values for mPBA are summarized in Table 5.4-2.

Table 5.4-2: Summary of aerobic degradation rates for metabolite mPBA - laboratory studies

Soil type pH T Moisture DT50/ f.f. DT50 (d) Kinetic, Reference o (H2O) ( C) DT90 20 C Fit (d) pF2/10kPa Brenes, Sand 8 25 2.92 2.24 1st Addendum 2002, clay recalculation Beigel (2002) for study of Standen, (1976)

The DT50 value for the Leiston sandy loam is not presented here, because the estimate of the DT50 for the soil metabolite mPBA in this soil is according to the study itself not reliable. This results from the low levels (<2% ) of mPBA observed in this soil, and the small number of data points for this estimation.

So there is only one DT50 value for the metabolite, normally there should be three DT50 values for metabolites.

Metabolite cis-DCVA A new evaluation of the formation rate for cis-DCVA was performed by Huber (2008).

The DT50 value of the new study is summarized in Table 5.4-3. Table 5.4-3: Aerobic degradation rate for metabolite cis-DCVA - laboratory studies

Soil type pH DT50 (d) DT50 (d) Reference 20 C pF2/10 kPa

Brenes, sandy clay 8 39.2 40.2 Huber, 2008

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 9 of 32

5.4.1.2 Field studies alpha-cypermethrin The field dissipation rates of alpha-cypermethrin were evaluated during EU assessment. No additional studies have been performed. Three field soil dissipation studies have been performed for three years from 1981 to 1983 in order to obtain degradation rates of BAS 310 I under field conditions. In total, nine trials have been performed in the United Kingdom. Alpha-cypermethrin was sprayed in the formulation FASTAC (EC formulation, alpha-cypermethrin content: 100 g/L) at a target rate of 500 g a.s./ha on bare ground. Samples were taken up to one year with up to 7 samplings. The soil cores were analysed with method SAMS 354-1 which determines BAS 310 I down to a LOQ of 0.01 mg/kg.

Finally, in the Review Report on alpha-cypermethrin (SANCO/4335/2000; final), a range of field DT50 values of 14 - 112 days (median = 35 days, 90th percentile 102 days) was given in the list of endpoints. The Applicant did a recalculation of the field data according to 1st order kinetics (Beigel 2006 and Huber 2007).

The DT50 values are summarized in Table 5.4-4. Table 5.4-4: Field degradation studies of alpha-cypermethrin soil / location Year pH DT50 DT50 DT90 (d) DT50 (d) err Reference (d) (d) Non SFO [%] Linear Non first Re- regress first order calculated ion order DAR DAR DAR Reculver loamy 1 4.7 101 35 >280 55.2 34.8 Forbes, Knight sand, UK 1983/ DAR 2 5.5 98 14-28 163-345 15.2 19.5 Forbed, Burden 1983a/ DAR 3 5.5 89 100 220-364 110.9 17.8 Forbes, Wales, 1985c/ DAR Hoath sandy 1 8.0 - < 14 35 5.0 3.6 Bosio 1983/ clay loam, UK DAR 2 8.0 96 26 <345 23.3 24.1 Forbes, Burden 1983b/ DAR 3 8.0 67 14 126-220 19.9 18.4 Forbes, Wales 1985b/ DAR Coates sandy 1 7.6 94 56 <385 37.2 19.8 Forbes, Knight clay loam, UK 1983/ DAR 2 7.6 97 28-56 224 61.8 19.3 Forbes, Wales 1985b/ DAR 3 7.6 112 112 >350 136.1 25.6 Coveney, Forbes 1986/ DAR

The worst case recalculated field DT50 for soil is 136.1 days.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 10 of 32

5.4.2 Adsorption/desorption alpha-cypermethrin No new studies have been submitted regarding adsorption/desorption in soil of alpha-cypermethrin. The exposure modeling is based on the EU Kfoc values as summarized in Table 5.4-5.

Table 5.4-5: Kf, Kfoc and 1/n (Freundlich exponent) values for alpha-cypermethrin

Soil Type OC pH Kf Kfoc 1/n Reference (%) (-) (mL g-1) (mL g-1) (-) Sand 0.6 6.7 868 144652 0.478 (SANCO/43 35/2000 final– 13/02/2005) Sandy loam 1.8 7.1 1042 57889 0.493

Silty clay 3.1 6.8 821 26492 0.571

Minimum 26492 0.514

The minimum Kfoc value of alpha-cypermethrin will be used, because there are only three Kfoc values for alpha-cypermethrin available. Additionally there is a Kfoc value of 159208 for cypermethrin in loamy sand with an OC content of 1.2 and a pH value of 5.4. The latter value confirms the order of magnitude of the other three values.

Metabolite mPBA (phenoxybenzoic acid) No new studies have been submitted regarding adsorption/desorption in soil of metabolite phenoxybenzoic acid. The exposure modeling is based on the EU Kfoc values as summarized in Table 5.4-6Table 5.4-5

Table 5.4-6: Kf, Kfoc and 1/n (Freundlich exponent) values for metabolite mPBA

Soil Type OC pH Kf Kfoc 1/n Reference (%) (-) (mL g-1) (mL g-1) (-) Silt loam 2.27 7.4 1.038 46 0.7466

Sandy loam 1.33 7.6 0.897 67 0.8165

Silt loam 1.09 5.9 0.949 87 0.7043

Loamy sand 2.29 5.9 2.076 91 0.8608

Arithmetic mean 73 0.7821 (SANCO/43 35/2000 final– 13/02/2005)

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 11 of 32

Metabolite cis-DCVA A new study (Malinsky, 2005) on the adsorption of cis-DCVA has been submitted. A detailed evaluation of this study is presented in Appendix 2. The exposure modeling is based on the Kfoc values as summarized in Table 5.4-5

Table 5.4-7: Kf, Kfoc and 1/n (Freundlich exponent) values for metabolite cis-DCVA

Soil Type OC pH Kf Kfoc 1/n (%) (-) (mL g-1) (mL g-1) (-) Sandy loam 0.9 5.5 1.718 191 0.836

Silt loam 1.3 6.5 0.743 57 0.692

Sandy loam 0.7 4.4 2.223 318 0.889

Clay loam 1.4 7.1 0.514 37 0.754

Clay silt 1.5 6.4 0.711 47 0.728

Arithmetic mean 130 0.780

5.4.3 Rate of degradation in water No new water/sediment study has been submitted. The exposure modeling is based on the results of the water/sediment studies of alpha-cypermethrin (Manoumi, 1993 and Völkl, 1993, Recalculation Beigel 2001) reviewed in the Addendum. The DT50 values of the water/sediment studies are summarized in Table 5.4-8. Table 5.4-8: Degradation in water/sediment of alpha-cypermethrin

Water/sediment DegT50 Kinetic, DissT50/ Kinetic, DissT50/ Kinetic, Reference system / DegT90 Fit DegT50 Fit DegT50 sed. Fit whole water system N=4 ( two 6.4-35.4d/ 1st 0.4-2.1d 1st SANCO/4335 systems with two 21.1-117.5d /2000 final- different labels) 13.02.2004

5.4-9 Degradation in water/sediment of metabolite mPBA (3 phenoxybenzoic acid)

Water/sediment DegT50 Kinetic, DissT50/ Kinetic, DissT50/ Kinetic, Reference system / DegT90 Fit DegT50 Fit DegT50 sed. Fit whole water system 2.1-3d 1st SANCO/4335 /2000 final- 13.02.2004

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 12 of 32

Tabelle 5.4-1 Degradation in water/sediment of metabolite cis-DCVA (dimethylcyclopropane carboxylic acid)

Water/sediment DegT50 Kinetic, DissT50/ Kinetic, DissT50/ Kinetic, Reference system / DegT90 Fit DegT50 Fit DegT50 sed. Fit whole water system 13.9-36.8d SANCO/4335 /2000 final- 13.02.2004

5.5 Estimation of concentrations in soil (PECsoil) (KIIIA1 9.4) BAS 310 62 I is an insecticidal net used to protect stored wood from bark beetles. The product is applied to single trunks, small and large wood stacks. The wood is covered by the net, which has a nominal a.s. content of 100 mg/m2. The active substance is bound to the net fabric, therefore no distribution of the compound over a large area is possible. Spray drift will not occur. Usual PEC calculations that are based on application rates per hectare are not appropriate.

Release of active substance from the net can be expected by wash-off during rainfall. The amount released is relatively small and will only affect the soil under and in the vicinity of the treated wood stack.

This was confirmed by two field trials which were described in section IIIA 9.10.2 (Tilting N., 2011 c and d). A net covered wood stack was irrigated to simulate a heavy rainfall of 50 L/m2 and soils samples from 0 - 5 cm depth were taken and analysed for alpha-cypermethrin.

-3 Table 5.5-1: Results of the experimental determination of PECsoil (soil bulk density 1.5 g/cm , soil depth 5 cm) plant protection product: BAS 310 62 I use: insecticidal net Number of applications/intervall 1 application rate: 100 m2 net with a nominal a.s. content of 100 mg/m2

active soil relevant Soil depth PECact substance/preparati application rate ( cm) (mg/kg) on (g/ha) 100 m2 net = 10g alpha- 5 0.05 cypermethrin

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 13 of 32

The environmental concentration of BAS 310 62 I in soil were determined by an experiment. The worst case concentration of 0.05 mg/kg was found in soil in direct contact to the insecticidal net. Outside the close vicinity of a treated wood stack the PEC in soil is 0 mg/kg. The study refers only to the indications 00-003 and 00-004 with 100 m2 net. There was no experiment with a 200 m2 net. According to Becker and Weltje (2012) as a worst case conservative assumption it can be assumed that if two STORANET insecticide nets are placed on top of each other, residues of alpha-cypermethrin in soil and leaf-litter after runoff will be twice as high as measured after application of a single net, e.g. highest exposure in leaf litter will be around 1.36 mg alpha- cypermethrin/kg and in soil around 0.1 mg alpha-cypermethrin/kg at 0 cm distance from the net. Metabolites were not determined. A calculation in consideration of the correction factors of molecular weight (0.515 and 0.502) and the maximum occurrence in soil (29.5% and 17.4%) for the metabolites mPBA and DCVA respectively results in concentrations of 0.007 mg/kg mPBA and 0.004 mg/kg DCVA. c

5.6 Estimation of concentrations in surface water and sediment (PECsw/PECsed) (KIIIA1 9.7)

PECSW and PECsed calculations are provided according to the recommendations of the FOCUS working group on surface water scenarios in a stepwise approach considering the pathways drainage and runoff.

In case of insecticidal nets, no spray drift is possible due to the net technology. In comparison to a spray application, active substance is not directly released to the target or to the environment. It is fixed to the net fabric. Contamination of the vicinity of the wood stack can occur via contact of the net with the soil surface, or carry-over by the worker applying the net (e.g. via shoes), but these amounts were low and limited to the surrounding 1 to 3 meters. The net itself must not come into contact with surface water.

As forest soils are not drained, drainage as entry pathway can also be excluded for the planned use in forestry. The remaining cause for release of active substance is rainfall. It is known from other types of insecticidal nets, that low amounts of active substance are released by rain and can reach the surrounding environment. No FOCUS models exist for the special type of use in forestry. Therefore no PEC calculations were performed for alpha-cypermethrin. Instead two run-off studies were performed to investigate the actual release of the compound from nets (studies are represented in KIIIA1 9.10.2/1 and KIIIA1 9.10.2/2 in Appendix 2 of this document). According to the study of Tilting (2011c) in forestry, no alpha-cypermethrin can be found in soil after removing of leaf litter at a distance of 1 m to the wood stack ('not detected', see Table A 6 in Appendix 2). The bottles to collect run-off water in 5 m distance to the wood stack remained empty. However, in a distance of 5 m from the net, alpha-cypermethrin was detected in the litter, but the concentration was below the limit of quantification of 0.005 mg/kg (see Table A7 in Appendix 2). Residues were found in water dripping through the net. The amount washed out during a heavy rain event was estimated to be 0.55% of the total content of active substance in the net.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 14 of 32

In a non-GLP study by Tilting (2011d) , which can serve as supplementary information, where soil and leaf litter samples were collected next to a wood stack after it had been covered by a net for 5 month, the result were confirmed. The net had been exposed to natural rainfall. Analysis of the samples showed that in 3 m distance residues in leaf litter were below the LOQ of the method (0.01 mg/kg). Analysis of the samples showed that no residues above 0.01 mg/kg were found in soil.

Summary

No PECsw and PECsed calculations were performed with the FOCUS SW and/or Ganzelmeier drift models, as these models are not suitable for insecticidal nets. Instead, results from two run-off studies in the forest demonstrated that alpha-cypermethrin can not been found in soil in a distance of 1m. At a distance of 5 m from the net, the concentration in the leaf litter was below the LOQ (limit of quantification = 0.005 mg/kg), even if the bottles for run-off water in 5 m distance to the wood stack remained empty. There are no leaf litter samples available that were collected at a distance of more than 5 m away and with concentrations below the limit of detection. Alpha-cypermethrin is not observed to reach soil horizons at a distance of more than 1 m from the stack. However, alpha-cypermethrin was absorbed in the litter above the soil horizons up to a distance of 5 m, even if in small amounts (< LOQ). Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required.

5.7 Risk assessment ground water (KIIIA1 9.6)

5.7.1 Predicted environmental concentration in groundwater (PECGW) calculation for alpha-cypermethrin and its metabolites DCVA and mPBA Groundwater contamination by direct leaching of the active substance and its metabolites, degradation or reaction products through soil is generally assessed by groundwater model calculations. The PEC of alpha-cypermethrin and its metabolites in ground water have been assessed with standard FOCUS scenarios to obtain outputs from the FOCUS PELMO. The FOCUS calculation was performed by zRMS. According to the summary of the simulation of the applicant PECs in groundwater were calculated for fallow soil (all FOCUS scenarios) with respect to worst-case conditions, considering the highest proposed application rate among the presented situations, 82g. a.s. ha-1. As a worst case assumption, interception was set to zero. Based on expert judgment, with respect to the typical occurrence of the pests controlled, the application date for the simulations was set to the 21st of March. But no study report of the calculation and no echo files were delivered. From the inputs of the applicant only the application date was taken. A reduction of the area is not accepted for PECs in groundwater by RMS. For the purpose of worst-case exposure assessment it is assumed that the total amount of alpha- cypermethrin will be released at once application of the net. The 20 g alpha-cypermethrin of a 200m2 net were assumed to reach an area of 60 m2. This area was estimated for the rough rounded up area of soil exposed from the net around the lumber stock with 20m length and 4 m width, considering that alpha-cypermethrin has been found in a outside distance from the woodnet of 50 cm but not in a distance of 100 cm and inside in a distance of 10 cm . The concentration was than extrapolated for an area of 1 ha.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 15 of 32

As crop apple trees were choosen, because it is assumed that the lumber stock is surrounded by trees in the forest.

Table 5.7-1: Input parameters related to application for PECGW modelling use evaluated 7598-005 / 7598-006 application rate (kg as/ha) 200 m2 net (8m x 25m) x100 mg alpha-cypermethrin= 20 g/ 60 m2 (minimised assumed area around the stock) = 3,3 kg/ha crop (crop rotation) Apple date of application 21.3. interception (%) - soil moisture 100 % FC Q10-factor 2.58 moisture exponent 0.7 plant uptake 0 simulation period (years) 20

Table 5.7-2: Input parameters related to active substance for PECGW modelling

Parent Alpha-cypermethrin Remarks/Reference molecular mass 416.3

DT50 in soil (d) 33.1 .

Kfoc 26492 Minimum ( range 26492-144652), n=3

1/n 0.9

Table 5.7-3: Input parameters related to metabolites of DCVA for PECGW modelling

Metabolite 1 DCVA Remarks/Reference molecular mass 209.1 Formation fraction 100

DT50 in soil (d) 40.2

Kfoc 130 1/n 0.780

Table 5.7-4: Input parameters related to metabolites of mPBA for PECGW modelling

Metabolite 2 mPBA Remarks/Reference molecular mass 214.2 Formation fraction 100

DT50 in soil (d) 2.24

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 16 of 32

Kfoc 73 1/n 0.782

Table 5.7-5: PECGW at 1 m soil depth for alpha-cypermethrin and the metabolites DCVA and mPBA

th -1 Use No /crop Szenario 80 Percentile PECGW at 1 m Soil Depth (g L ) groundwater model: FOCUS Pelmo 4 alpha- metabolite DCVA metabolite mPBA cypermethrin Apples Châteaudun <0.001 0.003 <0.001 Hamburg <0.001 <0.001 <0.001 Jokioinen <0.001 <0.001 <0.001 Kremsmünster <0.001 <0.001 <0.001 Okehampton <0.001 <0.001 <0.001 Piacenza <0.001 <0.001 <0.001 Porto <0.001 <0.001 <0.001 Sevilla <0.001 <0.001 <0.001 Thiva <0.001 <0.001 <0.001

According to the PECGW modelling with FOCUS Pelmo 4.4.3 a groundwater contamination of the active substance alpha-cypermethrin at a concentration of ≥ 0.1 µg/L is not expected for all FOCUS groundwater scenarios. For the metabolites DCVA and mPBA a groundwater concentration of ≥ 0.1 µg/L can be excluded in all FOCUS groundwater scenarios.

5.8 Potential of active substance for aerial transport

The vapour pressure at 20 °C of the active substance alpha-cypermethrin is < 10-5 Pa. Hence the active substance alpha-cypermethrin is regarded as non-volatile. Therefore exposure of surface water by the active substance alpha-cypermethrin due to deposition following volatilization need not be considered.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 17 of 32

Appendix 1 List of data submitted in support of the evaluation Table A 1: List of data submitted in support of the evaluation

Annex Author(s) Year Title Data Owner How considered point/referenc Source (where different from protection in dRR e No company) claimed Study- Report-No. Status/Usage* GLP or GEP status (where relevant), Published or not Authority registration No KIIIA 9.1.1/1 Huber S. 2008 b Kinetic evaluation of the Yes BASF laboratory dissipation of cis-

cypermethrin and metabolite cis-DCVA in one soil BASF SE, Limburgerhof, Germany Fed.Rep. 2008/1031382 No, not subject to GLP regulations Unpublished

KIIIA 9.2.1/1 Huber S. 2007 b Predicted environmental Yes BASF concentrations of BAS 310 I

and metabolites in soil, groundwater, surface water, and sediment following applications of BAS 310 06 I, BAS 310 08 I and BAS 310 40 I to brassicas, peas, beans, oilseed rape, cereals, UK BASF AG Agrarzentrum Limburgerhof, Limburgerhof, Germany Fed.Rep. 2007/1018405 No, not subject to GLP regulations Unpublished

KIIIA 9.3/1 Malinsky 2005 a Adsorption/desorption of Yes BASF D.S. BAS 310 I metabolite (CL

912554) on soil BASF Agro Research RTP, Research Triangle Park NC, United States of America 2004/5000486 Yes Unpublished

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 18 of 32

KIIIA 9.10.2/1 Tilting N. 2011 c Run-off study with BAS 310 I Yes BASF 5 (Alpha-Cypermethrin) in the

formulation BAS 310 62 I (Storanet) on stored wood at two different forest sites in Germany, 2011 BASF SE, Limburgerhof, Germany Fed.Rep. 2011/1269064 Yes Unpublished

KIIIA 9.10.2/2 Tilting N. 2011 d Assessment of potential risk Yes BASF 5 of run-off from Complion nets

BASF SE, Limburgerhof, Germany Fed.Rep. 2011/1140882 No, not subject to GLP regulations Unpublished

* 1) accepted (study valid and considered for evaluation) 2) not accepted (study not valid and not considered for evaluation) 3) not considered (study not relevant for evaluation) 4) not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 19 of 32

Appendix 2 Detailed evaluation of studies relied upon Report only studies, which have not previously been evaluated within a peer reviewed process at EU level (Annex I inclusion of active substance). Present the authority's evaluation of the study below each individual study. KIIA 7 Fate and Behaviour in the Environment – Active Substance KIIA 7.2 Huber 2008 Reference: KIIIA 9.1.1/1 Author: Huber S. Report: Kinetic evaluation of the laboratory dissipation of cis-cypermethrin and metabolite cis-DCVA in one soil BASF SE, Limburgerhof, Germany Fed.Rep. 2008/1031382 Date: 26.05.2008 Guideline(s): No (no guidelines available, recalculation) Deviations: - GLP: - Acceptability: Yes, with

The goal of the kinetic modeling was to evaluate the formation and degradation of cis-DCVA (cis-3-2,2- dichlorovinyl)-2,2-dimethylcyclopropane carboxylic acid; also referred to as WL43480 and CL912554) in soil from a laboratory study. Degradation data were taken from the Brenes soil, investigated by Standen (1976). The kinetic evaluation was performed with the KinGUI tool and followed the recommendations given by FOCUS (EC Document Reference SANCO/10058/2005). The kinetic models employed in present study are: Single-First-Order (SFO-SFO).

Table A 2 Recalculated DT50 values for soil Brenes

DT50 [d] at 25°C DT50 (d) 20 C pF2/10kPa cis-cypermethrin 30.7 31.8 Cis-DCVA 39.2 40.2

Degradation rates of parent and metabolite were normalized from study conditions (25°C; 18.4% w/w) to FOCUS standard conditions (20°C; pF2) by zRMS with the Q10 value 2.58 for the temperature correction and the FOCUS default soil moisture for a sandy clay of 35% at pF2. . Comments of zRMS Acceptable, but the benzyl label was used in the kinetic calculation for the parent, whereas for the metabolite cis-DCVA the cyclopropyl label was used. The metabolite cannot be detected with the benzyl label. No sample point for day 0 with cyclopropyl label was given in Standen (1976). The percental amounts of the parent for the days 14, 28, 56 and 112 deviate slightly at the both labels as can be seen in the DAR.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 20 of 32

KII A1 7.4.2 Malinsky 2005

Reference: IIIA 9.3 Author: Malinsky D.S. Report: Adsorption/desorption of BAS 310 I metabolite (CL 912554) on soil Date: 22.06.2005 Guideline(s): Yes, OECD No. 106 Deviations: No GLP: Yes Acceptability: Yes

In laboratory batch experiments, the adsorption / desorption behaviour of radiolabelled cis-DCVA (CL 912554) was investigated on five European soils. The five soils covered a range of pH (CaCl2) from 4.4 to 7.1, a range of organic carbon content from 0.7 % to 1.5 % and four different USDA textural classes: sandy loam, silt loam, clay loam and clay silt..

For the determination of the adsorption isotherm, four different concentrations (0.125, 0.251, 0.506 and 1.05 µg/ml) of the test item in 0.01 M CaCl2 solutions were used. The ratio of soil versus test solution was 1/2, and the measurements were performed at the adsorption equilibrium time of 48 hours for the four soils. The desorption part was carried out in two steps with the soil residue remaining from the adsorption isotherm determination by adding 0.01 M CaCl2 solution without test items.

The following adsorption parameters were measured for the test item cis-DCVA in each soil: distribution coefficients Kd and Koc at four concentration levels, the Freundlich adsorption coefficient Kf, the Freundlich exponent 1/n, and the corresponding Kfoc values.

Table A 3 Results from the adsorption experiments with cis-DCVA

Soil Type OC pH Kf Kfoc 1/n (%) (-) (mL g-1) (mL g-1) (-) Sandy loam 0.9 5.5 1.718 191 0.836

Silt loam 1.3 6.5 0.743 57 0.692

Sandy loam 0.7 4.4 2.223 318 0.889

Clay loam 1.4 7. 1 0.514 37 0.754

Clay silt 1.5 6.4 0.711 47 0.728

Arithmetic mean 130 0.780

Within the five soils studied Kfoc values from 37 to 318 mL g-1 were measured. Ranging from 1/n = 0.889 to 0.692 the Freundlich adsorption exponent indicated a significant non-linearity of the adsorption with the concentration.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 21 of 32

Comments of zRMS acceptable

KIIIA1 9 Fate and Behaviour in the Environment – Plant prodection product

KIIIA1 9.2. Huber, 2007

Reference: IIIA 9.2.1/1 Author: Huber S. Report: Predicted environmental concentrations of BAS 310 I and metabolites in soil, groundwater, surface water, and sediment following applications of BAS 310 06 I, BAS 310 08 I and BAS 310 40 I to brassicas, peas, beans, oilseed rape, cereals, UK Date: 04.03.2007

Guideline(s): No, study is only considered with regard to the recalculation of field DT50 values for soil Deviations: - GLP: -

Acceptability: Yes (recalculation of DT50 values)

Materials and methods Data from the field dissipation studies with BAS 310 I given in mg/kg were used as input for the kinetic modeling approach. The modeled residue data represent a sum of the residue in the total horizon sampled. The raw data were modified considering the generic guidance of FOCUS regarding values below the limit of detection (LOD) and the limit of quantification (LOQ). Results and discussions

Table A 4: DT50 of alpha-cypermethrin Field trial Cinitial DT50 r² err [mg kg-1] [d] [%]

Reculver year 1 0.0519 55.2 0.594 34.8 Reculver year 2 0.1930 15.2 0.914 19.5 Reculver year 3 0.1755 111 0.854 17.8 Hoath year 1 0.1499 5.02 0.999 3.6 Hoath year 2 0.1362 63.1 0.783 24.1 Hoath year 3 0.2690 19.9 0.939 18.4 Coates year 1 0.6037 36.9 0.922 19.8 Coates year 2 0.5442 61.8 0.872 19.3 Coates year 3 0.4939 136.1 0.654 25.6

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 22 of 32

Conclusion

According to the recalculation the worst case field DT50 value is 136.1 days. Comments of zRMS The recalculation is considered as acceptable.

KIIIA1 9.10.2/1, Tilting N., 2011c

Reference: KIIIA1 9.10.2 Author: Tilting N Report: Run-off study with BAS 310 I (Alpha-Cypermethrin) in the formulation BAS 310 62 I (Storanet) on stored wood at two different forest sites in Germany, BASF SE, Limburgerhof, Germany Fed.Rep. 2011/1269064

Date: 16.12.2011 Guideline(s): No (no guidelines available) Deviations: - GLP: Yes Acceptability: Supplementary

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 23 of 32

Materials and methods BAS 310 62 I is an insecticidal net coated with the active ingredient alpha-cypermethrin. The nominal content is 100 mg alpha-cypermethrin /m2 net. In this study a net from Batch C-329-2010 was used. The study was conducted at two sites in Germany near Hauenstein in Rheinland-Pfalz. The selected sites were in a typical forest area of a medium altitude mountain range. Trial L110507 was located in a deciduous forest, trial L110506 in a mainly coniferous forest with approximately 10% deciduous trees. The inclination was 30% for trial L110506 and 32% for trial L110507. The field part of each trial was performed within one day. Control samples of leaf litter and soil were taken from areas more than 10 m uphill from the trial areas, but with the same soil/leaf litter composition at that place. The slope at both sites was determined before start of the trial using a spirit level and foot-rule. The inclination ranged from 30% to 32%. The wood stacks used for the trials were placed at the trial sites before begin of the trials They were approximately 10 meters long, 3 meters wide and 1.8 meters high Before application of the net, five 2.5 L wide-neck bottles were placed between the logs in order to catch water dripping through the net during irrigation. In 5 m distance from the wood stack, two plastic drains of 4 meters length each were placed in parallel to the stack. At the downhill end of the drains, plastic bottles were placed into the ground to recover water that flows on the surface of the leaf litter or the soil. There was no rainfall during the study. Influence of wind could be excluded, as wind speed in the forest was 0. The temperature was between 7°C and 10°C respectively.

Application of test item The original test item had a size of 25 x 8 m. As the wood stack was about 10 m long, the net was cut into two halves of 12.5 x 8 m each (This will equal the future size of the commercially available product). The net was rolled over the wood stack by two persons and pulled over the logs so that the net at the sides of the stack was touching the soil surface. The net was fixed to the soil by pieces of wood. It was covering the wood stack completely.

Irrigation After the net was fixed over the wood, two commercially available lawn sprinklers (Gardena Aquazoom 250/2) and three rain gauges (TFA Dostmann) were placed on top of the net. The sprinklers were placed approximately 2.5 m from each end of the stack and spray width and length were adjusted to spray over the whole net area. Water from Hauenstein water supply was used for the irrigation. It was transported to the trial sites in a tank, which was sufficient to reach the target amount of 50 mm of simulated “rainfall”. (Calculation: area 30 m2 appr. 1500 L + 25 % safety factor). The sprinklers were connected to the tank via a hose and a pump manufactured by SMDO/Honda type TR 3.60H was used. During irrigation the amount of water in the rain gauges was controlled and the irrigation was stopped after all gauges indicated more than 50 mm of "rainfall". Approximately 1.5 hours were required.

Sampling Samples of the irrigation water were taken out of the tank before irrigation started. No samples of run off water at five meter distance from wood stack could be obtained. Sampling of leaf litter samples was performed after the irrigation was stopped. Starting at distance of 5 meters from the wood stack, leaf litter was taken at 5 spots. The samples were immediately pooled. In the same spots, where the leaf layer was

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 24 of 32

now removed (> 100 cm2), soil samples were taken down to 5 cm, using a metal cylinder of 8.5 cm in diameter. The soil samples were also pooled immediately. The procedure was repeated at 3 meter, 1 meter, 50 cm, 10 cm at the contact area of net and soil and 10 cm inside the covered area (= -10cm). Water bottles under net were taken after removal of the net. The volume of water obtained was measured and the water filled into smaller bottles. Samples were taken to the specimen management facility in Limburgerhof by car unfrozen. All treated samples arrived within 3 hours after sampling. As untreated samples were taken prior to irrigation, they arrived within 5 hour after sampling. Soil and leaf samples were homogenized prior to analysis.

Analytical method Water samples: Alpha-cypermethrin was determined in water samples by liquid/liquid partition into hexane and GC/MS measurement using internal calibration. The limit of quantitation was 0.005 µg/L. Soil and leaf litter samples: Alpha-cypermethrin was determined in soil and leaf litter samples using a modified DFG S19 method including a GPC clean-up step and GC/MS determination with internal calibration. The limit of quantitation was 0.005 mg/kg. The validity of the method used was demonstrated by an abbreviated method validation, using 3 (soil and leaf litter) or 4 (water) spiked samples at the LOQ. In addition spikes at a higher concentration level were measured. GC/MS sensitivity, specificity and linearity of the calibration were also checked. For quantification the fragment of m/e = 207 was used.

Results and discussions Observations The amount of simulated rainfall measured by the rain gauges ranged from 52 to 56 L/m2 for trial L110506 and 52 to 60 L/m2 for trial L110507. No puddles were found on the net, and water reached the bottles under the net. Water that reached the soil was immediately absorbed by the soil, so that no flow of water could be observed. Therefore the drains in 5 m distance to the wood stack did not collect water. The bottles to collect run-off water remained empty.

Results of the validation of the analytical method The analytical method for water was validated with tap water samples fortified at the limit of quantitation (LOQ) of 5 ng/L. The average recovery was 95 % the relative standard deviation (RSD) +/- 19% (n=4). At higher levels up to 75 µg/L the average recovery was 82 % with +/- 13% RSD (n=5). The analytical method for soil was validated with untreated soil from the trial and LUFA 2.1 soil at the limit of quantitation of 0.005 mg/kg and 0.4 mg/kg. The average recovery at the LOQ was 96 % (+/- 5% RSD, n=3) and 100 % (+/-2% RSD, n=3 at 0.4 mg/kg). The analytical method for leaf litter was validated with control material from the trials at the LOQ (0.005 mg/kg) and at 0.4 mg/kg. The average recovery at the LOQ was 95 % (+/- 5 % RSD n=3) and at the higher level 83 % (+/- 12 % n=3).

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 25 of 32

Concentrations in water dripping through the net The concentration of alpha-cypermethrin in percolate water ranged from 14 to 59 µg/L in trial L110506 with an average of 28 µg/L and from 22 to 54 µg/L in trial L110507 with an average of 32.8 µg/L. These concentrations exceed the solubility of alpha-cypermethrin in water, so that it can be assumed the particle bound active substance was also washed into the bottles. Higher average concentrations in water and a higher amount of simulated rainfall were observed in trial L110507. Based on these findings the release of active substance from the net during a heavy rainfall was estimated using the following calculation:

30 m2 x 55.7 L/m2 x 32.8 µg/L = 54809 µg = 55 mg.

The Storanet® has a nominal concentration of 100 mg/m2 and the trial was performed with 100 m2 of net containing 10 g alpha-cypermethrin. Therefore the release during a heavy rainfall event can be estimated to be 0.55% or 0.55 mg/m2. Water that reached the soil was immediately absorbed by the soil, so that no flow of water could be observed. Therefore the drains in 5 m distance to the wood stack did not collect water. The bottles to collect run-off water remained empty. The results (see Table A6) show that small amounts of alpha-cypermethrin are washed out to the forest surface. Consequently the residues found at the contact area of net and forest leaf layer are the highest found (Distance 0 cm). With increasing distance to the contact point, residues decline fast, and no residues above LOQ can be found in a distance of 5 m. In soil, residues are an order of magnitude lower than in litter, which can be expected as the soil is partially covered by the leaf layer and water has to flow through the organic matter to the soil below. In soil no residues could be detected beyond 50 cm from the wood stack. Table A 5: Summary of analytical results for soil Trial L110506 L110507 Distance from the Soil Soil place where the net [mg/kg] [mg/kg] touched the soil Control nd nd Distance - 10 cm* 0.016 0.008 Distance 0 cm 0.031 0.050 Distance 10 cm 0.022 0.007 Distance 50 cm 0.037 nd Distance 100 cm nd nd Distance 300 cm nd nd Distance 500 cm nd nd

*) samples from the inside, between stack and net

Table A 6: Summary of analytical results leaf litter Trial L110506 L110507 Distance from the Leaf litter Leaf litter

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 26 of 32

place where the net [mg/kg] [mg/kg] touched the soil Control < LOQ < LOQ Distance - 10 cm 0.13 0.12 Distance 0 cm 0.68 0.58 Distance 10 cm 0.43 0.15 Distance 50 cm 0.40 0.008 Distance 100 cm 0.037 0.008 Distance 300 cm 0.009 < LOQ Distance 500 cm < LOQ < LOQ

Comments of zRMS Acceptable , the study shows, that exposition in soil and leaf litter is restrained to a certain distance from the net. Uptake of alpha-cypermethrin in a concentration which exceeds the solubility of alpha- cypermethrin in water through particle bound active substance via the water dripping through the net is possible. A future transfer from the litter in the soil can not be excluded. In the leaf litter 0.009 mg alpha- cypermethrin/kg were found in a distance of 3 m from the net and in a distance 5 m the concentration in the leaf litter was below the limit of quantitation of 0.005 mg/kg.

KIIIA1 9.10.2/2, Tilting N., 2011d Reference: KIIIA1 9.10.2 Author: Tilting N Report: Assessment of potential risk of run-off from Complion nets, BASF SE, Limburgerhof, Germany Fed.Rep. 2011/1140882

Date: 06.10.2011 Guideline(s): No (no guidelines available) Deviations: - GLP: No (not subject to GLP regulations) Acceptability: Supplementary

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 27 of 32

Materials and methods The potential movement of released active substance in the environment was investigated. To this end samples were taken below and in the vicinity of a protected wood stack. The wood stack was part of a biological trial and was located in a forest near Seeheim-Jugenheim in Hesse Germany. The wood was covered on 19 April 2010 with a Complion® net and left under natural weather conditions in the forest. The wood stack was placed near an unpaved forestry road at the downhill side of a slope. Therefore a preferential direction for rainwater flow was given. At the end of the usual wood storage period, 23 September 2010, samples of soil, and leaf litter were taken downhill from the wood stack. In addition net samples were taken.

Daily air temperature measured at the weather station Darmstadt and the calculated precipitation values for Seeheim-Jugenheim showed that the total precipitation from application to sampling was 546 mm including seven rain events above 20 mm (max = 27.5 mm 19 May, one month after application). The last heavy rain event of 25 mm occurred on September 12, which was only 11 days prior to sampling.

Leaf litter and soil samples were taken downward from the stack of wood to determine contamination coming from the wood net. Leaf litter and soil samples from the upward slope on the other side of the forest road were taken to serve as controls.

Sampling scheme for leaf litter and soil downwards the wood stack. The objective was to take five samples at 3, 1, 0.5, 0.0 meter distance from the place where the net touched the soil. Additionally 5 samples from the inside, i.e between stack and net were taken: these samples are characterized with the distance -10 cm. For the sample at distance 0 m, the net was first lifted from the soil on the trunks and afterwards 5 samples were taken. Finally the samples between net and stack were collected. Samples of the net containing the active ingredient alpha-cypermethrin, which covered the stack of wood for more than 5 months, were also taken. Five 20 x 20 cm net squares were cut with a scissor and packed in 5 different plastic bags.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 28 of 32

Results and discussions Net samples: 5 samples were analysed separately and the results are presented as mg/m2 net. The remaining concentration on the net samples was 38.4, 57.0, 57.1, 61.9 and 69.2 mg / m2 mean = 56.7 mg/m2. The nominal content of a Complion® net is 100 mg/m2. No isomers other than cis 2 were detected. Based on the low concentrations of active in soil and leaf litter samples this loss of active substance on the net samples is considered to be caused only to a low extend by rain, but by other processes. Due the physical properties of alpha-cypermethrin photolysis is most likely leading to the loss of active on the net samples after exposing the net to natural weather conditions and sunlight for 5 months.

Soil samples: Soil samples from the same sampling distance were pooled and homogenized prior to analysis. No residues above the LOQ of 0.01 mg/kg were detected.

Leaf litter samples: Leaf litter samples from the same distance to the tree stack were pooled and homogenized. As could be expected the highest residues were found in the area in contact with the net and concentrations were constantly decreasing with the longer distance to the net. Residues could be quantified (LOQ of 0.01 mg/kg) up to a distance of 1 m from the wood stack. The following concentrations were found:

Table A 7: Concentrations of alpha-cypermethrin in leaf litter samples Distance to tree stack Residues of alpha- cypermethrin Under net cover: 0.26 mg/kg 0.5 m from wood stack 1.7 mg/kg 1.0 m from wood stack 0.22 mg/kg

1.0 m from wood stack 0.027 mg/kg 3.0 m from wood stack < 0.01 mg/kg

In leaf litter samples the highest residue occurred directly under the net, while findings decreased with increasing distance from the net. After three meters, residues were below the LOQ of the method (0.01 mg/kg).

KIIIA1 9.10.2/2, Becker, R. and Weltje,L., 2012 Reference: KIIIA1 10.5 Author: Becker, R. and Weltje, L. Report: Additional information on the risk assessment for non-target arthropods, soil organsims and aquatic organisms after application of Storanet (BAS 310 62 I) in forestry

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 29 of 32

Date: 16.10.2012 Guideline(s): No (no guidelines available) Deviations: - GLP: No (not subject to GLP regulations) Acceptability: Supplementary

During the evaluation of Storanet (BAS 310 62 I), ZV1 007598-00/00, concerns were raised that the presented ecotoxicological risk assessment is not covered by extrapolating the runoff trial with the 100 m2 Storanet to the 200 m2 Storanet. A detailed description of the application of the 200 m2 nets is requested to elucidate differences and similarities in exposure and risk assessment compared to applications with the 100 m2 nets. In general, wood piles are covered with a single 100 m² Storanet. In case of large tree trunks with stem lengths of up to 20 m, two 100 m² Storanets are placed next to each other with a minimal overlap. Exposure of adjacent litter and soil through runoff was investigated in a separate study (Tilting, BASF DocID 2011/1269064) using the 100 m2 Storanet. The results demonstrated that after simulated heavy rainfall the washed out active substance was mainly found in the soil at the edge of the wood stack, whereas under the stack only a very low exposure was measurable. However, in case nets are overlapping (to cover longer stems) the maximum overlap is 30 cm in order to achieve a complete seal of wood piles with the Storanet (see Fig. 1). Thus, only in this narrow, limited area, concentrations of the active substance from the Storanet are expected to be slightly higher compared to application of a single net. For the risk assessment, the placing of two Storanets over a wood pile may lead to a higher exposure after wash-out. Also here, exposure is likely to be increased only in a very narrow and limited area directly adjacent to the covered wood pile. The area containing residues is not expected to increase. However, as a worst-case conservative assumption considering no degradation of the active substance, it can be assumed that if two Storanet insecticide nets are placed on top of each other, residues of alpha-cypermethrin in soil and leaf-litter after runoff will be twice as high as measured after application of a single net, e.g. highest exposure in leaf litter will be around 1.36 mg alpha-cypermethrin/kg and in soil around 0.1 mg alpha- cypermethrin/kg at 0 cm distance from the Storanet.

Comments of zRMS The worst case assumption that after application of 200 m2 Storanet residues of alpha-cypermethrin in soil and leaf-litter after runoff will be twice as high than after application of 100 m2 net is accepted.

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 31 of 32

Appendix 3 Table of Intended Uses justification and GAP tables

Crop and/ Zone Product code F Pests or PHI Remarks: or situation G Group of pests Formulation Application Application rate per treatment (days) or controlled I (a) (b) (c) (l) (m) Type Conc. method growth number interval kg as/hL water L/ha kg as/ha of as kind stage & season min max between applications (j) min max min max min max (min) (d‐f) (i) (f‐h) (k)

Single trunk Central BAS 310 62 I F Bark and wood boring LLIN 1.57 Complete Post harvest 1 50 m2 net / Not zone bark beetles wrapping of treatment single trunk applicable - DE, AT, Lonhorn beetles and trunk 5 g as / single PL, CZ, metallic wood-boring trunk) SK, SI beetles Lumber Central BAS 310 62 I F Bark and wood boring LLIN 1.57 Application Post harvest 1 100 m2 net Not stock zone bark beetles over the top treatment /lumber stock applicable - (20 m3) DE, AT, Lonhorn beetles and of the stock 10 g as / PL, CZ, metallic wood-boring lumber stock SK, SI beetles Large Central BAS 310 62 I F Bark and wood boring LLIN 1.57 Application Post harvest 1 200 m2 net / Not lumber stock zone bark beetles over the top treatment large lumber applicable - (40 m3) DE, AT, Lonhorn beetles and of the stock stock PL, CZ, metallic wood-boring 20 g as / large SK, SI beetles lumber stock

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report Core Assessment Central Zone STORANET Page 32 of 32

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (i) g/kg or g/l situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3‐8263‐3152‐4), including where relevant, information on season at time of (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds application (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions of use (e) GCPF Codes ‐ GIFAP Technical Monograph No 2, 1989 must be provided (f) All abbreviations used must be explained (l) PHI ‐ minimum pre‐harvest interval (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants ‐ type of equipment used must be indicated

Applicant BASF Evaluator: DE zRMS Date: October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 1 of 14

REGISTRATION REPORT Part B

Section 5 Environmental Fate Detailed summary of the risk assessment

Product code: BAS 310 62 I STORANET Active Substance: Alpha-Cypermethrin 1.57 g/kg (0.157% w/w

Central Zone Zonal Rapporteur Member State: Germany (DE)

NATIONAL ADDENDUM – Germany

Applicant: BASF Date: October 2013

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 2 of 14

Table of Contents TABLE OF CONTENTS...... 2 SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9)...... 3 5.1 GENERAL INFORMATION ON THE FORMULATION ...... 3 5.2 PROPOSED USE PATTERN ...... 3 5.3 INFORMATION ON THE ACTIVE SUBSTANCE ...... 4 5.3.1 Alpha-cypermethrin ...... 4 5.4 SUMMARY ON INPUTPARAMETER FOR ENVIRONMENTAL EXPOSURE ASSESSMENT...... 4 5.4.1 Rate of degradation in soil ...... 4 5.4.2 Adsorption/desorption...... 4 5.4.3 Rate of degradation in water ...... 4 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4)...... 4 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7)...... 6 5.6.1 PECSW after exposure by spraydrift and deposition following volatilisation ...... Fehler! Textmarke nicht definiert. 5.6.2 PECSW after exposure by surface run-off and drainage...... Fehler! Textmarke nicht definiert. 5.7 RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6)...... 7 5.7.1 Direct leaching into groundwater...... 7 5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage...... 8 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION...... 11 APPENDIX 2 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 03.05.2012Y).13

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 3 of 14

Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) The exposure assessment of the plant protection product STORANET in its intended uses in wood is documented in detail in the core assessment of the plant protection product STORANET. This document comprises the risk assessment for groundwater and the exposure assessment of surface water and soil for authorization of the plant protection product STORANET in Germany according to uses listed in Appendix 2. Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document. PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary (see Part B Section 6 National addendum and Part A).

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation STORANET

Code BAS 310 62 I plant protection product STORANET applicant BASF date of application Spring, 21.3. (declaration of the applicant with respect to the typical occurrence of the pests controlled) Formulation type Long lasting insecticide net [Code : LN] active substance alpha-cypermethrin Concentration of as 1.57 g/kg (0.157% w/w), 100 mg/ m2

5.2 Proposed use pattern

The intended uses in Germany classified according the soil effective application rate (cumulative, disregarding degradation in soil) is presented in Table 5.2-1. Full details of the proposed uses that will be assessed are included in Appendix 2. Table 5.2-1: Classification of intended uses in Germany for STORANET

Group/ Crop/growth Application Number of applications, Size of net alpha- use No stage method Drift Minimum application cypermethrin scenario interval, application (g as/ha) time, interception A/ Single trunks No drift 1 50 m2 5g 00-001 00-002 B/ Lumber stack No drift 1 100 m2 10g 00-003 (20 m3) 00-004 C/ Lumber stack No drift 1 200 m2 20 g 00-005, (40 m3) 00-006

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 4 of 14

5.3 Information on the active substance

5.3.1 Alpha-cypermethrin See core assessment

5.4 Summary on Inputparameter for environmental exposure assessment

5.4.1 Rate of degradation in soil

Alpha-cypermethrin See core assessment

5.4.2 Adsorption/desorption

Alpha-cypermethrin See core assessment

5.4.3 Rate of degradation in water Alpha-cypermethrin See core assessment

5.5 Estimation of concentrations in soil (KIIIA1 9.4)

BAS 310 62 I is an insecticidal net used to protect stored wood from bark beetles. The product is applied to single trunks, small and large wood stacks. The wood is covered by the net, which has a nominal a.s. content of 100 mg/m2. The active substance is bound to the net fabric, therefore no distribution of the compound over a large area is possible. Spray drift will not occur. Usual PEC calculations that are based on application rates per hectare are not appropriate. Release of active substance from the net can be expected by wash-off during rainfall. The amount released is small and will only affect the soil under and in the vicinity of the treated wood stack. This was confirmed by two field trials which were described in the Core Dossier section AIII 9.10.2 (Tilting N., 2011a). A net covered wood stack was irrigated to simulate a heavy rainfall of 50 L/m2 and soils samples from 0 - 5 cm depth were taken and analysed for alpha-cypermethrin. . Table 5.5-1: Concentration of alpha-cypermethrin found in soil after artificial rainfall and recalculated concentration for 1 cm soil depth

Distance from net Trial L110506 Trial L110506 Trial L110507 Trial L110507 5 cm 1 cm 5 cm 1 cm [mg/kg] [mg/kg] [mg/kg] [mg/kg] Control n.d. n.d. n.d. n.d.

Soil under net 0.016 0.080 0.008 0.04

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 5 of 14

Soil in contact with net 0.031 0.155 0.050 0.250

Soil in 10 cm distance from 0.022 0.110 0.007 0.035 net Soil in 50 cm distance from 0.037 0.185 n.d n.d. net Soil in 100 cm distance from n.d. n.d. n.d. n.d. net Soil in 300 cm distance from n.d. n.d. n.d. n.d. net Soil in 500 cm distance from n.d. n.d. n.d. n.d. net

The worst case PEC in soil was 0.05 mg/kg (0.25 mg/kg for 1 cm depth) for the soil in contact with the net. Concentrations in soil decrease with increasing distance to the wood stack. No residues were detected beyond a 50 cm distance. Therefore it can be concluded that the PEC in soil for areas not in the close vicinity of a covered wood stack is 0 mg/kg.

-3 Table 5.5-2 Results of the experimental determination of PECsoil (soil bulk density 1.5 g/cm , calculation for soil depth 1cm) plant protection product: BAS 310 62 I use: insecticidal net Number of applications/intervall 1 application rate: 100 m2 net with a nominal a.s. content of 100 mg/m2

active soil relevant Soil depth PECact substance/preparati application rate ( cm) (mg/kg) on (g/ha) 100 m2 net = 10g alpha- 1 0.25 cypermethrin

In a non-GLP trial that can be used as additional information (AIII 9.10.2 Tilting N., 2011b) soil samples were taken close to a treated wood stack that had been covered by an insecticidal net for 5 month. In a 0 - 10 cm soil layer, no residues above the LOQ (0.01 mg/kg) could be detected, neither under the net nor in a distance up to 3 m.

The study refers only to the indications 00-003 and 00-004 with 100 m2 net. Extrapolations to the indications with 200 m2 net are not possible.

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 6 of 14

5.6 Estimation of concentrations in surface water and sediment (KIIIA1 9.7)

The GAP in the formulated product BAS 310 62 I foresees a single post-harvest application to wood trunks and stocks: the wood is covered with a net which is impregnated with the active substance alpha-cypermethrin. In case of insecticidal nets, no spray drift is possible due to the net technology. In comparison to a spray application, active substance is not directly released to the target or to the environment. It is fixed to the net fabric. Contamination of the vicinity of the wood stack can occur via contact of the net with the soil surface, or carry-over by the worker applying the net (e.g. via shoes), but these amounts were low and limited to the surrounding 1 to 3 meters. The net itself must not come into contact with surface water. As forest soils are not drained, drainage as entry pathway can also be excluded for the planned use in forestry. The remaining cause for release of active substance is rainfall. It is known from other types of insecticidal nets, that low amounts of active substance are released by rain and can reach the surrounding environment. No FOCUS models exist for the special type of use in forestry. Therefore no PEC calculations were performed for alpha-cypermethrin. Instead, two run-off studies were performed to investigate the actual release of the compound from nets (studies are represented in KIIIA1 9.10.2 in the CA). According to the study of Tilting (2011c) in forestry no alpha-cypermethrin can be found in soil after removing of leaf litter at a distance of 1 m to the wood stack ('not detected', see Table A 6 in Appendix 2 of the CA). The bottles to collect run-off water in 5 m distance to the wood stack remained empty. However, in a distance of 5 m from the net, alpha-cypermethrin was detected in the litter, but the concentration was below the limit of quantification of 0.005 mg/kg (see Table A7 in Appendix 2 of the CA). In a non-GLP study by Tilting (2011d) , which can serve as supplementary information, where soil and leaf litter samples were collected next to a wood stack after it had been covered by a net for 5 month, the result were confirmed. The net had been exposed to natural rainfall. Analysis of the samples showed that in 3 m distance residues in leaf litter were below the LOQ of the method (0.01 mg/kg). Analysis of the samples showed that no residues above 0.01 mg/kg were found in soil.

Summary

No PECsw and PECsed calculations were performed with the FOCUS SW and/or Ganzelmeier drift models as these models are not suitable for insecticidal nets. Instead results from two run-off studies in the forest demonstrated that alpha-cypermethrin can not been found in soil in a distance of 1m. At a distance of 5 m from the net, the concentration in the leaf litter was below the LOQ (limit of quantification = 0.005 mg/kg), even if the bottles for run-off water in 5 m distance to the wood stack remained empty. There are no leaf litter samples available that were collected at with a distance of more than 5 m away and with concentrations below the limit of detection. Alpha-cypermethrin is not observed to reach surface water via soil, when the distance of the wood stack to the nearest water body is 5m. However, alpha-cypermethrin was absorbed in the litter above the soil horizons, even if in small amounts (< LOQ). Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required.

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 7 of 14

5.7 Risk assessment for groundwater (KIIIA1 9.6)

Results of PECgw calculation of alpha-cypermethrin for the intended uses of STORANET according to EU assessment using FOCUS PELMO 4.4.3 are given in Table 5.7.5 of Part B, Section 5.7 of the core assessment. For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and drainage of the active substance into an adjacent ditch with subsequent bank filtration into the groundwater. Direct leaching after soil passage is assessed following the recommendations of the publication of Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011) for tier 1 and tier 2 risk assessment. According to Hold et al, 2011, endpoints for groundwater modelling are derived with the program INPUT DECISION 3.1 and subsequent simulations are performed for the groundwater scenarios “Hamburg” or with the scenarios “Hamburg” and “Kremsmünster” of FOCUS PELMO 4.4.3. Surface run-off and drainage into an adjacent ditch with subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3. The German risk assessment for groundwater is given in the following chapters.

5.7.1 Direct leaching into groundwater

5.7.1.1 PECGW modelling The worst case scenario used for PECgw modelling is summarized in Table 5.7-1. It covers the intended uses of STORANET according to Table 5.2-1.

Table 5.7-1 Input parameters related to application for PECGW modelling with FOCUS PELMO 4.4.3 use evaluated 005/ 006 application rate (kg as/ha) 200 m2 crop (crop rotation) Apple date of application 21.3. interception (%) - soil moisture 100 % FC Q10-factor 2.58 moisture exponent 0.7 plant uptake 0 simulation period (years) 26

The endpoints used for groundwater modelling for alpha-cypermethrin and its metabolites DCVA and mPBA 1 are given in Part B, Section 5.7 of the core assessment.

The results of the groundwater simulation are presented in Table 5.7-2.

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 8 of 14

Table 5.7-2 PECGW at 1 m soil depth of alpha-cypermethrin and its metabolites DCVA and mPBA considered relevant for German exposure assessment

th -1 80 Percentile PECGW at 1 m Soil Depth (g L ) modeled by FOCUS PELMO 4.4.3 Use No. Szenario alpha-cypermethrin Metabolite DCVA Metabolite mPBA

C (005/ Hamburg <0.001 <0.001 <0.001 006)

According to the results of the groundwater simulation with FOCUS-PELMO 4.4.3, a groundwater contamination of the active substance alpha-cypermethrin in concentrations of ≥ 0.1 µg/L is not expected for the intended uses. For the metabolites DCVa and mPBA a groundwater concentration of ≥ 0.1 µg/L can be excluded according to the results of the groundwater simulation with FOCUS-PELMO 4.4.3.

5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage The input parameters for alpha-cypermethrin used for modelling surface water exposure via run-off and drainage in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.0 are summarized in Table 5.7-3.

Table 5.7-3 Input parameters for alpha-cypermethrin used for PECGW calculations with EXPOSIT 3.0 Parameter alpha-cypermethrin Reference to Part B, Section 5, Core assessment

K foc, Runoff 26492

Kfoc, mobility class 26492

DT50 soil (d) 136.1 Solubility in water (mg/L) 0.004 Mobility class 1 Reduction by bank filtration 100

For the Exposit tool the input of the application rate is required. This requires for the intended uses as net considerations. . - The worst case PEC in soil was 0.25 mg/kg for 1 cm depth for the soil in contact with the net of a size of 100m2 (see 5.5). Because of the high KOC values of alpha-cypermethrin the soil depth of 1 cm is adequately. An application rate of 38 g alpha-cypermethrin/ha would produce such a concentration in soil over 1 cm (soil density 1.5 kg/L). This concentration cannot be found in an area of 100m x 100m beside the water body. However, the model is not suitable for insecticidal nets In each case the PECGW concentration will be <0.001 µg/l because of the mobility class 1 with 100% bank filtration. Therefore for PECGW a worst case assumption considering the total amount of alpha-cypermethrin in the net is considered.

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 9 of 14

The calculated PECgw for alpha-cypermethrin after surface run-off with subsequent bank filtration are summarized in Table 5.7-4. Entry via drainage is not relevant for the intended uses.

Table 5.7-4 PECgw for alpha-cypermethrin after surface run-off and drainage with subsequent bank filtration (modelled with EXPOSIT 3.01 ) Active substance alpha-cypermethrin Use No. application PECgw due to rate/ run-off drainage factor reduction vegetated buffer bank filtrate Time of bank filtrate strip (µg/L) application (µg/L) (m) B 38 g/ha6 0 <0.001 autumn/winter/ Not relevant 5 <0.001 early spring 10 <0.001 spring/summer Not relevant 20 <0.001 required labelling no

According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance alpha-cypermethrin due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

For use C as a worst-case conservative assumption it can be assumed that with two Storanet insecticide nets are placed on top of each other, residues of alpha-cypermethrin in soil and leaf-litter after runoff will be twice as high as measured after application of a single net e.g. highest exposure in soil will be around 0.5 mg alpha-cypermethrin/kg at 0 cm distance from the Storanet. An application rate of 76 g alpha-cypermethrin/ha would produce such a concentration in soil over 1 cm (soil density 1.5 kg/L). PECGW concentration will be again <0.001 µg/l , as the bank filtration is 100%.

Metabolites The soil metabolites mPBA and DCVA of alpha-cypermethrin (see Part B core assessment, Section 5, Table 5.3-6) are formed > 10 % in soil. Therefore potential ground water contamination due to bank filtration via surface water exposure by run-off and drainage needs to be assessed using EXPOSIT 3.01.

The input parameter for the model EXPOSIT 3.01 are taken from Part B core assessment, Section 5, and summarized in Table 5.7-5, the results are given in Table 5.7-6.

Table 5.7-5: Input parameter for soil metabolites of alpha-cypermethrin for EXPOSIT 3.01 Parameter Metabolite mPBA Metabolite DCVA Molecular weight (g/mol) 214.2 209.1 Correction factor molecular weight 0.515 0.502 Maximum occurrence in soil 29.5 17.4

K foc, Runoff 73 130

Kfoc, mobility class 73 130 1) DT50 soil (d) 2.24 39.2

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 10 of 14

Solubility in water (mg/L) 24.7 129 Mobility class 1) only relevant for mobility class

Table 5.7-6: PECgw for soil metabolites of alpha-cypermethrin after surface run-off and drainage with subsequent bank filtration (modelled with EXPOSIT 3.01 beta) Metabolit mPBA Use No. application PECgw due to rate run-off drainage

vegetated buffer bank filtrate Time of bank filtrate strip (µg/L) application (µg/L) (m) 100m2 net 1.2 g/ha 0 <0.001 autumn/winter/ Not relevant 5 <0.001 early spring 10 <0.001 spring/summer Not relevant 20 <0.001 required labelling none Metabolit DCVA Use No. application PECgw due to rate run-off drainage interception vegetated buffer bank filtrate Time of bank filtrate strip (µg/L) application (µg/L) (m) 100 m2 net 0.7 g/ha 0 <0.001 autumn/winter/ Not relevant 5 <0.001 early spring 10 <0.001 spring/summer Not relevant 20 <0.001 required labelling none

According to modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1µg/L by the soil metabolites of alpha-cypermethrin due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

Consequences for authorization: The authorization of the plant protection product BAS 310 62 I is linked with following labeling:

Use No. - NG -

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 11 of 14

Appendix 1 List of data submitted in support of the evaluation No additional data for national assessment submitted.

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 13 of 14

Appendix 2 Table of Intended Uses in Germany (according to BVL 03.05.2012y) PPP (product name/code) Storanet/ BAS-31062-I-0-LN Formulation type: … active substance 1 alpha Cypermethrin - Conc. of as 1: -

1 2 3 4 5 6 7 8 10 11 12 13 14

Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number kg, L product / ha g, kg as/ha Water L/ha e.g. safener/synergist per ha Kind stage of crop & (min. interval (crop destination / I (additionally: a) max. rate per appl. season between min / max purpose of crop) developmental stages of b) max. total rate per a) max. rate e.g. recommended or mandatory tank applications) the pest or pest group) crop/season per appl. mixtures a) per use Der Mittelaufwand b) max. total b) per crop/ rate per entspricht dem season crop/season Netzaufwand

0075 DE Freiland, liegendes Holz Holzbrütende auslegen Vor dem 1 maximal 50 m² Not Borkenkäfer, Ausfliegen der 98- Laubholz, Nadelholz Netz/Einzelstamm applicable 00/00 Rindenbrütende Käfer oder bei -001, Borkenkäfer festgestellter Gefährdung oder bei Befallsbeginn 0075 Freiland, liegendes Holz Bockkäfer-Arten, Vor dem 1 maximal 50 m² Ausfliegen der 98- Laubholz, Nadelholz Prachtkäfer Netz/Einzelstamm 00/00 Käfer oder bei - festgestellter Gefährdung oder bei Befallsbeginn

Applicant BASF Date October 2013

Part B – Section 5 BAS 310 62 I Registration Report National Addenda – Germany Central Zone STORANET zRMS: DE Page 14 of 14

0075 DE Freiland, liegendes Holz Holzbrütende auslegen Vor dem 1 maximal 100 m² Not Borkenkäfer, Ausfliegen der 98- Laubholz, Nadelholz Netz/Schichtholzpolter applicable 00/00 Rindenbrütende Käfer oder bei

-003 , Borkenkäfer festgestellter Gefährdung oder bei Befallsbeginn /

0075 Freiland, liegendes Holz Bockkäfer-Arten, auslegen Vor dem 1 maximal 100 m² Ausfliegen der 98- Laubholz, Nadelholz Prachtkäfer Netz/Schichtholzpolter 00/00 Käfer oder bei -004 festgestellter Gefährdung oder bei Befallsbeginn /

0075 DE Freiland, liegendes Holz Holzbrütende auslegen Vor dem 1 maximal 200 m² Not Borkenkäfer, Ausfliegen der 98- Laubholz, Nadelholz Netz/Langholzpolter applicable 00/00 Rindenbrütende Käfer oder bei

-005, festgestellter Gefährdung oder bei Befallsbeginn / 0075 Freiland, liegendes Holz Borkenkäfer auslegen Vor dem 1 maximal 200 m² Ausfliegen der 98- Laubholz, Nadelholz Netz/Langholzpolter 00/00 Käfer oder bei -006 festgestellter Gefährdung oder bei Befallsbeginn /

Applicant BASF Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 1 of 78

REGISTRATION REPORT Part B

Section 6 Ecotoxicological Studies Detailed summary of the risk assessment

Product code: BAS 310 62 I STORANET Active Substance: Alpha-Cypermethrin 1.57 g/kg (0.157% w/w)

Central Zone Zonal Rapporteur Member State: Germany (DE)

CORE ASSESSMENT

Applicant: BASF Date: October 2013

Applicant BASF Evaluator: zRMS DE Applicant Document ID 2011/1122476 Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 2 of 78

Table of content

SEC 6 ECOTOXICOLOGICAL STUDIES ...... 4 6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES...... 5 6.1.1 Proposed use pattern...... 5 6.1.2 Consideration of metabolites...... 6 6.2 EFFECTS ON BIRDS...... 6 6.2.1 Overview and summary ...... 6 6.2.2 Toxicity to exposure ratio for birds (K III A 10.2.1) ...... 11 6.2.3 Drinking water exposure ...... 13 6.2.4 Details on formulation type in proportion per item...... 14 6.2.5 Acute toxicity of the formulation...... 14 6.2.6 Metabolites...... 14 6.2.7 Supervised cage or field trials ...... 14 6.2.8 Acceptance of bait, granules or treated seeds (palatability testing) ...... 14 6.2.9 Effects of secondary poisoning ...... 15 6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS...... 17 6.3.1 Overview and summary ...... 17 6.3.2 Toxicity exposure ratio...... 18 6.3.3 Drinking water exposure ...... 21 6.3.4 Details on formulation type in proportion per item...... 22 6.3.5 Acute toxicity of the formulation...... 22 6.3.6 Metabolites...... 23 6.3.7 Supervised cage or field trials ...... 23 6.3.8 Acceptance of bait, granules or treated seeds (palatability testing) ...... 23 6.3.9 Effects of secondary poisoning ...... 23 6.4 EFFECTS ON AQUATIC ORGANISMS...... 25 6.4.1 Overview and summary ...... 25 6.4.2 Acute toxicity and chronic toxicity of the formulation ...... 28 6.4.3 Metabolites of alpha-cypermethrin ...... 28 6.4.4 Accumulation in aquatic non-target organisms...... 29 6.5 EFFECTS ON BEES ...... 30 6.6 EFFECTS ON ARTHROPODS OTHER THAN BEES...... 31 6.6.1 Overview and summary ...... 31 6.6.2 Risk assessment for Arthropods other than Bees ...... 37 6.7 EFFECTS ON EARTHWORMS, OTHER NON-TARGET SOIL ORGANISMS AND ORGANIC MATTER BREAKDOWN ...... 41 6.7.1 Overview and summary ...... 41 12.1.2 Toxicity to Exposure Ratio ...... 44 12.1.3 Residue content of earthworms...... 45 12.2 EFFECTS ON SOIL MICROBIAL ACTIVITY ...... 46 12.2.1 Overview and summary ...... 46 12.3 EFFECTS ON NON-TARGET PLANTS...... 47 12.3.1 Overview and summary ...... 47 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ...... 49 APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON ...... 59 A2-1 ACTIVE SUBSTANCE (GENERALLY ONLY RELEVANT IN THE CASE THAT NEW ANNEX II DATA IS PROVIDED AFTER ALPHA-CYPERMETHRIN APPROVAL) ...... 59

Applicant BASF Evaluator: zRMS DE Applicant Document ID 2011/1122476 Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 3 of 78

A2-2 FORMULATION...... 59 IIIA 10.1 Effects on birds ...... 59 IIIA 10.2 Effects on aquatic organisms...... 59 IIIA 10.5 Effects on arthropods other than bees ...... 62 IIIA 10.6 Effects on earthworms and other makro soil-organisms ...... 72 IIIA 10.8 Effects on non-target plants...... 73 APPENDIX 3 TABLE OF INTENDED USES JUSTIFICATION AND GAP TABLES ...... 76

Applicant BASF Evaluator: zRMS DE Applicant Document ID 2011/1122476 Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 4 of 78

Sec 6 ECOTOXICOLOGICAL STUDIES This document reviews the ecotoxicological studies for the product BAS 310 62 I STORANET containing the active substance alpha-cypermethrin, which is currently evaluated for approval according to Regulation (EC) 1107/2009.

BAS 310 62 I was not the representative formulation considered in the EU review process as part of active substance approval.

A full risk assessment according to Uniform Principles is provided which predicts acceptable environmental risks for the product BAS 310 62 I if applied according to the proposed uses. The key document from the EU review of alpha-cypermethrin (SANCO/4335/2000 final) is considered to provide the relevant review information or a reference to where such information can be found.

Addenda are included containing country specific assessments for some annex points. In those cases this document should be read in conjunction with the relevant addenda.

Where appropriate, this document refers to the conclusions of the EFSA, especially when data on the active substance is relied upon in the risk assessment of the formulation. Each section will begin with a table providing the EU endpoints used in this evaluation.

Appendix 1 of this document contains the list of references included in this document for support of the evaluation. Appendix 2 of this document is the table of intended uses for BAS 310 62 I.

Appendix 3 of this document contains a table summarising studies of the active substance and metabolites. Information on the detailed composition of BAS 310 62 I can be found in the confidential dossier of this submission (Registration Report - Part C).

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 5 of 78

6.1 Proposed use pattern and considered metabolites

Introduction Section 6 of the submission summarizes the ecotoxicological effects of the formulation BAS 310 62 I containing the active substance alpha-cypermethrin and evaluates the potential risk to various representatives of terrestrial, aquatic and soil organisms. Full details of the proposed use patterns that will be assessed are shown in Appendix 3 of this document and summarized below. Moreover, an overview of the metabolites of alpha-cypermethrin that will be addressed in the risk assessment is given below.

6.1.1 Proposed use pattern The GAP used for exposure assessment are presented in Table 6.1-1 that reports also a classification of intended uses for BAS 310 62 I (see also Section 5). A list of all intended uses within the zone is given in Appendix 3.

The product BAS 310 62 I is a polyethylene terephthalate (PET) net, which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system. BAS 310 62 I is used for the protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest. Table 6.1-1: Critical use pattern of BAS 310 62 I

Group/ use Crop/growth Application Number of Application rate, Soil effective No stage method Drift applications, Minimum cumulative (g application rate (g scenario application interval, as/ha)* as/ha) application time, interception A/ Single trunks No drift 1 50 m2 net 5 g a.i./ single trunk 00-001, =41 g/ha* 00-002 B/ Lumber stack (20 No drift 1 100 m2 10 g a.i./ lumber stock 00-003, m3) = 2 g/ha 00-004 C/ Lumber stack (40 No drift 1 200 m2 10 g a.i./ lumber stock 00-005, 00- m3) = 2 g/ha 006

*The nets are not applied on a per hectare basis. Therefore, the annual amount of timber harvest per ha was considered to calculate more realistic area-dependent application rates. The calculations were based on statistical data provided from German authorities1. These calculations can be considered as a worst case, since the annual timber harvest amounts per hectare in Germany usually exceed those in Eastern

1 Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz BMELV (2004): http://www.bundeswaldinventur.de/ enid/43296d7208c4a827134d0a3176325a9e,0/75.html. Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 6 of 78

European countries [EUROSTAT: (2009): http://epp.eurostat.ec.europa.eu/ portal/page/portal/ statistics/search_database, status September 2009].

According to BMELV (2004), 3-14 m3 timber per ha forestry area in use were harvested annually from 1987 to 2002. Assuming the 90th percentile of 9.9 m3 ha-1 a-1, an average of 8.2 single trunks, 0.2 small lumber stacks [or 0.1 large lumber stacks] per hectare and year can be derived.

For risk assessment purposes, a risk envelope approach was used to cover highest risk arising to non target organisms from intended use 00-001 with highest application rate.

6.1.2 Consideration of metabolites The occurrence and risk from potentially ecotoxicologically relevant metabolites have been considered in the EU review of alpha-cypermethrin. Further information is provided and environmental occurring metabolites of alpha-cypermethrin requiring further assessment according to the results of the assessment of alpha-cypermethrin for EU approval are summarized in Part B, Section 5.

Table 6.1-2: Metabolites of alpha-cypermethrin potentially relevant for exposure assessment (> 10 % of a.s. or > 5 % of a.s. in 2 sequential measurements or > 5 % of a.s. and maximum of formation not yet reached at the end of the study)

Metabolit Structural occurence in compartements Satus of Relevance formula/Molecular (Max. at day/ (SANCO/4335/2000 final formula mPBA C13H10O3 Soil: Max. 29.5 % at day 112 Addendum to the monograph- 3-PBA Water: 18% at day 7 (23% in November 2002: not relevant CL 206128 whole system)

Cis-DCVA C8H10Cl2O2 Soil: Max. 17.4 % at day 56 Not considered in the CL 912554 Water: 47% at day 14 monograph Sediment: 19.5% at day 14

6.2 Effects on Birds

6.2.1 Overview and summary Avian acute oral and long-term reproduction studies have been carried out with alpha-cypermethrin.

Effects on birds of BAS 310 62 I were not evaluated as part of the EU review of alpha-cypermethrin. However, the provision of further data on the formulation BAS 310 62 I is not considered essential as the available data on alpha-cypermethrin are deemed to be sufficient to assess the risk of birds exposed to BAS 310 62 I.

The risk assessment for effects on birds and other terrestrial vertebrates is carried out according to the European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438).

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 7 of 78

6.2.1.1 Toxicity Avian acute oral and long-term reproduction studies have been carried out with the active substance alpha-cypermethrin. Full details of avian toxicity studies conducted with alpha-cypermethrin are provided in EU DAR.

The studies with the relevant acute and long-term endpoints which are used in the risk assessment procedure are listed in the following table. Table 6.2-1: Toxicity of alpha-cypermethrin to birds with reference to agreed endpoints

Species Substance Exposition Results Reference ICS-No. Duration Toxicity Author System Date Report No. Colinus virginianus Alpha- 1 d LD50 > 2025 mg/kg XXXXXXX. 48180 Cypermethrin acute BW1 01.09.2000 105-046-03 Colinus virginianus Alpha- 154 d NOAEC = 150 mg XXXXXXXX 48205 Cypermethrin Long-term a.s./kg food XXXXXXX corresponding to 19.09.2001 NOAEL = 15.69 mg CYD 630 a.s./kg b.w./day2 1) SANCO/4335/2000 final

2) For the active substance alpha-cypermethrin, a 22-week avian reproduction study was conducted with bobwhite quail (Colinus virginianus) (BASF DocID AL-534-002). The NOEC was reported as 150 mg a.s./kg diet, which corresponds to a NOAEL of 16 mg/kg b.w./day based on the group mean body weight (197.6 g) and food consumption (21 g) data. This study and the related endpoint were used for the avian long-term risk assessment in the dossier for the formulated product BAS 310 06 I which contains alpha- cypermethrin (BAS 310 I)

As indicated above, an acute oral study with the formulated product has not been conducted. Consequently, the toxicity of BAS 310 62 I has been assessed considering data generated on the active substance.

The EU-LoEP (2004) from the Review Report for the active substance alpha-cypermethrin (SANCO/4335/2000 final, 13. Febr. 04) cites the above BASF owned avian reproduction study (AL-534- 002; ICS-No. 48205) in Appendix IIIB (list of studies submitted during the evaluation process, p57). However, the list of endpoints (Appendix II, p12) gives a 20-week avian reproduction study in the Japanese quail (Coturnix coturnix japonica) with a NOEC of 130 mg a.s./kg diet.

For conversion of the NOEC of 130 mg a.s./kg diet to a daily dose (mg/kg b.w./day), a generic factor of 0.1 can be applied according to EFSA/2009/1438, unless food avoidance occurred in the study (EFSA/2009/1438, 2.3.1.1, p. 20). Since BASF has no access to this study cited in the list of endpoints for alpha-cypermethrin, it cannot be ruled out that food avoidance might have been observed, and consequently, for avian long-term risk assessments regarding alpha-cypermethrin, BASF can only refer to Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 8 of 78

the BASF property reproduction study in bobwhite quails with a NOEC of 150 mg a.s./kg diet, corresponding to a NOAEL of 15.69 mg/kg b.w./day. Note that a conversion of NOEC of 130 mg a.s./kg diet, using the conversion factor 0.1, would result in a NOEL of 13 mg/kg b.w./day which is very close the NOAEL of 16 mg/kg b.w./day as used in TER calculations and would therefore result in very similar TER values not affecting the overall outcome of the reproductive risk assessment.

6.2.1.2 Exposure The product BAS 310 62 I is a polyethylene terephthalate (PET) net, which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system. BAS 310 62 I is used for the protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest.

Since the application of alpha-cypermethrin incorporated into a woodnet does not fall into regular uses of insecticides (i.e. spray application of crops in the field), the exposure pattern is different from standard exposure patterns included in the current Guidance Document on bird and mammal risk assessment (EFSA/2009/1438). Therefore, the standard approach to quantify exposure according to the formula: Exposure to standard generic focal species was estimated according to the Guidance Document on Risk Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438) PD  FIR DDD  i total  RUD AR  PT  bw i FIR   i  RUD AR  PT i bw where: DDD = Daily dietary dose (mg/kg bw/day) PDi = composition of diet obtained from treated area FIRi = Food intake rate of indicator species i (g fresh weight/d) bw = Body weight (g) RUD = Residue per unit dose, bases on an application rate of 1 kg a.s./ha and assuming broadcast seedling AR = Application rate (kg/ha) PT = Proportion of diet obtained in the treated area (0…1) is not applicable.

The following exposure approach of the applicant is accepted by UBA Germany:

The risk assessment is based on an alternative approach, which is outlined in the following. The main task is a) to identify possible routes of exposure and b) thereafter to quantify the exposure from the different routes of exposure.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 9 of 78

Possible routes of exposure For the assessment of the risk for bird and mammal, the following routes of exposure could theoretically occur and should be considered: Exposure to earthworm-eating birds via earthworms ingesting contaminated soil (see – Secondary poisoning)

Exposure to fish-eating birds via potential contamination of surface water bodies (see – Secondary poisoning)

Exposure to insectivorous birds via arthropods being in contact with the woodnet and containing residues of alpha-cypermethrin Other routes of exposure are considered irrelevant. Other food matrices of birds and mammals (i.e. green plant leaves or weed seeds) are not expected to be contaminated with alpha-cypermethrin from a woodnet application.

Quantification of exposure Exposure after spray application in the field is clearly higher (large-scale exposure) than the point-source- like exposure after application of a woodnet to single trunks and lumber stocks (small-scale exposure). Concerning residues in arthropods, which may be a food source for insectivorous birds, no default RUD values from EFSA/2009/1438 are available, as the RUD values listed in the guidance document refer to spray application scenarios. The following approach was provided by the applicant and is taken to conservatively estimate the alpha- cypermethrin residues in arthropods after contact to the woodnet.

An insect could theoretically move / sit on the woodnet until the lethal dosis via contact is reached. After that it will fall off the net and an insectivorous bird could feed on it.

Lethal doses for alpha-cypermethrin have been measured for bees, i.e. oral and contact LD50 values. The oral LD50 is not relevant for the woodnet scenario as insects will not feed on the woodnet made out of plastic polymers.

The contact LD50 determined for bees can serve as conservative estimate of residue levels that could occur in insects via contact of the woodnet. With this approach it is assumed that insectivorous birds would mainly feed on dead insects, i.e. insects that contain alpha-cypermethrin residues equivalent to the insect LD50 dose. Live insects would have clearly lower residue values, and it is well known that live insects are preferred as food source by insectivorous birds.

In conclusion, the maximum contact LD50 value measured for alpha-cypermethrin in honey bees correlates to a residue value of 0.33 mg/kg (Knight 1982). This residue value will be used in the risk assessment to estimate the exposure for insectivorous birds. The following calculation was adopted from the applicant:

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 10 of 78

As regards indicator species, no species for a woodnet scenario is proposed by the EFSA guidance document. Hence, to ensure a worst-case approach, a small insectivorous bird being common in woodland all over Europe, the wren (Troglodytes troglodytes), is proposed as focal species. According to Dunning (2008), the body weight of the wren is 8.9 g. Assuming a diet consisting entirely of insects, this correlates to a FIR/bw of 0.985.

6.2.1.3 Risk Assessment –overall conclusions For risk assessment purposes, a risk envelope approach was used to cover highest risk for birds from intended use 00-001 (see also Table 6.1-1, page 5). The results of the acute and reproductive risk assessments are summarized in the following table. Table 6.2-2: TER for birds

Compound Risk assessment Indicator species Time scale TER TER Annex level VI trigger

Alpha-cypermethrin Screening small insectivorous bird: wren Acute >6231 10

Screening small insectivorous bird: wren Long-term 48.3 5

Based on the presumptions of the screening step, the calculated TER values for the acute and long-term risk resulting from an exposure of birds to the active substance alpha-cypermethrin according to the GAP of the formulation BAS 310 62 I achieve the acceptability criteria TER ≥ 10 and TER ≥ 5, respectively, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for birds.

Drinking water risk assessment Drinking water assessment is not required as the ratio of effective treatment rate to toxicological endpoint does not exceed the trigger. Please refer to chapter 6.2.3.

Food chain behaviour

An assessment of the risk from secondary poisoning is required due to log POW value of alpha- cypermethrin being over the trigger of 3. Please refer to chapter 6.2.9.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 11 of 78

6.2.2 Toxicity to exposure ratio for birds (K III A 10.2.1)

6.2.2.1 Acute toxicity to exposure ratio (TERA)

Screening step In the screening step, the risk to indicator bird species from an exposure to BAS 310 62 I is assessed. These indicators are considered to have highest exposure in a specific crop at a particular time due to their size and feeding habits and represent a worst case scenario. The indicator bird species for the intended uses of BAS 310 62 I are listed in the following table.

Table 6.2-3: Avian indicator species for the use of BAS 310 62 I

Crop Indicator species

Lumber trunks Wren (see explanation chapter 6.2.1.2)

In this section, the TER acute values are presented for the Tier 1. The acute daily dietary dose (DDD) and

TERA are calculated as follows: Equation: DDD = FIR/bw x Residue value LD TER  50 DDD The following risk assessment is based on a comparison of toxicity and possible exposure of birds to the active substance alpha-cypermethrin.

The resulting TERA values are summarised in the following table.

Table 6.2-4: Acute screening risk assessment (TERA) for birds. See text for details

Compound Indicator LD50 FIR/bw Residues Acute DDD TERA species (mg a.s./kg (mg a.s./kg bw/day) bw/day) Alpha- Wren LD50 > 2025 0.985 0.33 0.325 >6231 cypermethrin mg/kg BW

Based on the highly conservative presumptions of the screening step, the calculated TER values for the acute risk resulting from an exposure of birds to the active substance alpha-cypermethrin according to the GAP of the formulation BAS 310 62 I achieve the acceptability criteria TER ≥ 10, according to

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 12 of 78

commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for acute effects. The results of the assessment indicate an acceptable risk for birds.

6.2.2.2 Short -term toxicity exposure ratio (TERST)

There is no requirement for the calculation of TERST for birds under the EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) and, consequently, a risk assessment for short- term toxicity will not be conducted.

6.2.2.3 Long-term toxicity exposure ratio (TERLT)

Screening step

For the reproductive risk assessment, the calculation of the long-term toxicity exposure ratio (TERLT) in principle follows the same procedure as for the acute risk assessment. In this section, the TER long-term values are presented. Table 6.2-5: Avian generic focal species for the intended uses of BAS 310 62 I

Crop Indicator species

Alpha- Wren cypermethrin

The reproductive daily dietary dose (DDD) and TERLT are calculated as follows: DDD = FIR/bw x Residue value NOAEL TER  DDD The following risk assessment is based on a comparison of toxicity and possible exposure of birds to the active substance alpha-cypermethrin. The reproductive toxicity endpoint for alpha-cypermethrin is NOAEL=15.6 mg a.s./kg bw/d.

The relevant long-term endpoint is provided in the following table as well as calculated long-term toxicity exposure ratios (TERLT) for birds exposed to alpha-cypermethrin following applications of BAS 310 62 I.

Table 6.2-6: Long-term screening risk assessment (TERLT) for birds exposed to BAS 310 62 I according to the intended uses

Compound Indicator NOAEL FIR/bw Residues Long-term TERLT species (mg a.s./kg DDD bw/day) (mg a.s./kg bw/day) Alpha- Wren 15.69 0.985 0.33 0.325 48.3 cypermethrin

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 13 of 78

Based on the highly conservative presumptions of the screening step, the calculated TER values for the long-term risk resulting from an exposure of birds to the active substance alpha-cypermethrin according to the GAP of the formulation BAS 310 62 I achieve the acceptability criteria TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects. The results of the assessment indicate an acceptable risk for birds.

6.2.3 Drinking water exposure In case of the uses as intend for BAS 310 62 I birds might be exposed via drinking water from puddles. According to the new Guidance Document (EFSA, 2009), no specific calculations of drinking water exposure and TER are necessary when the ratio of effective application rate (in g/ha) to the relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg). This is due to the characteristics of the exposure scenario in connection with the standard assumptions for water uptake by birds (for further details please refer to chapter 5.5. of the Guidance Document). The puddle scenario has been taken into account to calculate the exposure concentration of alpha-cypermethrin formed on a field after rainfall. The ratios do not exceed the value of 3000 for alpha-cypermethrin (Koc = 26.492 L/kg) thus it is not necessary to conduct a drinking water risk assessment for birds.

Table 6.2-7 Risk assessment for the active substance alpha-cypermethrin concerning drinking water, Application 00-001

Parameter Alpha-cypermethrin Reference Koc (arithmetic mean) [L/kg] 26.492 Sec 5 CA DT50 (soil) [days] n.a. Not relevant for a woodnet application Number of applications 1 GAP table Interval [days] n.a. Not relevant for a woodnet application MAFm 1) n.a. Not relevant for a woodnet application Max use rate [g/ha] 41 D1 GAP table AReff [g/ha] 2) 41 LD50 [mg a.s./kg b.w.] 2025 See above Ratio (acute) 3) 0.02 -- NOEL [mg a.s./kg b.w./d] 15.7 See above Ratio (repro) 3) 2.6 -- Trigger 4) 3000 -- Drinking water assessment No -- required [Yes/No] 5) -nki -ki 1 MAFm = (1-e ) / (1-e ) with k = ln(2)/DT50 (rate constant), n = number of applications and i = application interval [d] according to EFSA/2009/1438 2 AReff = Application rate (g/ha) * MAFmean 3 Ratio of AReff and relevant toxicity endpoint 4 Trigger according to EFSA/2009/1438 for substances with Koc ≥ 500

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 14 of 78

5 Drinking water risk assessment is not necessary when trigger value is not exceeded

6.2.4 Details on formulation type in proportion per item

6.2.4.1 Baits: Concentration of active substance in bait in mg/kg BAS 310 62 I is not formulated as bait. The product BAS 310 62 I is a polyethylene terephthalate (PET) net, which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system and therefore this information is not required.

6.2.4.2 Pellets, granules, prills or treated seed BAS 310 62 I is not formulated as pellets, granules, prills or treated seeds. The product BAS 310 62 I is a polyethylene terephthalate (PET) net, which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system and therefore this information is not required.

Amount of active substance in or on each item Not applicable.

Proportion of active substance LD50 per 100 items and per gram of items Not applicable.

Size and shape of pellet, granule or prill Not applicable.

6.2.5 Acute toxicity of the formulation Avian toxicity tests with the formulation were not performed and are not considered necessary.

6.2.6 Metabolites Avian toxicity tests with metabolites of alpha-cypermethrin were not performed and are not considered necessary.

6.2.7 Supervised cage or field trials The risk assessment above has demonstrated that the proposed uses of BAS 310 62 I pose no unacceptable acute or long-term risks to birds, and therefore further studies are not considered necessary.

6.2.8 Acceptance of bait, granules or treated seeds (palatability testing) BAS 310 62 I is intended for use as a wood net, and therefore this information is not required.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 15 of 78

6.2.9 Effects of secondary poisoning The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6

"Bioaccumulation and food chain behaviour"). Since the log Kow values of alpha-cypermethrin is 5.5 (20°C), this active substance is deemed to have a negligible potential to bioaccumulate in animal tissues.

The assessment of the risk for birds through secondary poisoning is based on the evaluation of an earthworm eating bird (100 g bw, food intake rate, FIR = 104.6 g fresh weight /d). The calculation is performed for the worst case intended use 00-001 with the maximal soil relevant amount of the formulation BAS 310 62 I. Table 6.2-8: Assessement of the risk for earthworm eating birds from an exposure to alpha- cypermethrin through secondary poisoning

Parameter Alpha- comments cypermethrin

PECsoil (twa = 21 d) [mg/kg soil] 0.05 See chapter 5.5 Sec 5

Kow 316228 Log POW= 5.5

Koc 26492

Foc 0.02 Default

BCFworm 7.164* BCFworm = (PECworm/PECsoil) = (0.84 + 0.012 x Kow)/ foc x Koc

PECworm 0.371 PECworm = PECsoil x BCF

Daily dietara dose (mg/kg bw/d) 0.376 DDD = PECworm x 1.05 NOEL (mg/kg bw/d) 15.69

TERlt 41.7

* Bioconcentration factor (BCF) = (0.84 + 0.012 * Kow) / foc * Koc The risk assessment for fish eating bird according to the Guidance Document EFSA/2009/1438 is performed for a bird with 1000 g bw and a FIR (Food intake rate) of 4159 g (fresh weight) fish is not necessary for BAS 310 62 I.

Exposure to aquatic organisms is not expected as BAS 310 62 I is applied in forestry as a woodnet for single trunks or lumber stocks. Any potential exposure would be related to the active ingredient, which might wash off from the net. Run off studies by the applicant have demonstrated that there is an exposure at 5 m within the range below LOQ (LOQ is 0.005 mg/kg) from the application site, i.e. the woodstack. Alpha-cypermethrin was not detected in the soil horizons at 1 m distance from the wood stack. However, alpha-cypermethrin was absorbed in the litter above the soil horizons up to a distance of 5 m from the stack, even if in small amounts (< LOQ). Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 16 of 78

Risk mitigation measures involving a distance of 10 m to surface waters in using BAS 310 62 I as a woodnet have to be implemented. No further PEC calculations are necessary.since no exposure of aquatic organisms will occur, no risk to fish-eating birds is expected. It can therefore be concluded that the application of BAS 310 62 I does not provide a reason for concern for bioaccumulation in the food chain.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 17 of 78

6.3 Effects on Terrestrial Vertebrates Other Than Birds

6.3.1 Overview and summary The risk assessment for effects on mammals is carried out according to the European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438).

6.3.1.1 Toxicity Table 6.3-1: Toxicity of alpha-cypermethrin/ BAS 310 62 I to mammals with reference to agreed endpoints

Species Substance Exposition Results Reference ICS-No. Duration Toxicity Author System Date Report No. Rat Alpha-cypermethrin Acute oral LD50 = 57 mg a.i../kg XXXXXXX 79110 toxicity bw/d1, 2 16.03.1993 SBTR.92.033 ! AL-410-003 Rat Alpha-cypermethrin Reproductive NOAEL = 5 mg a.i../kg LOEP toxicity bw/d1 (long-term) 1) SANCO/4335/2000 final 2) geometric mean LD50 value from acute mammal studies by the applicant is not accepted by UBA, because it was derived from different test endpoints. Instead, the toxicity value reported in the LOEP is used for risk assessment

6.3.1.2 Exposure Exposure to standard generic indicator species was estimated according to the ‘EC Guidance Document on Risk Assessment for Birds and Mammals (EFSA/2009/1438). Please see chapter 6.2.1.2, page 8 for detailed information on the estimation of daily intake rates and the assessment of mixture toxicity.

6.3.1.3 Risk assessment –overall conclusions The overall conclusion on the risk assessment for mammals and the calculated TER-values are shown in the following table. Table 6.3-2: Minimum TER values for mammals after uses of BAS 310 62 I in the intended uses

Substance Risk assessment Indicator species Time scale TER TER level trigger

Alpha- Screening Common shrew Acute 313.3 10 cypermethrin Screening Common shrew Long-term 27.3 5

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 18 of 78

Based on the presumptions of the screening step , the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to the active substance alpha-cypermethrin according to the GAP of the formulation BAS 310 62 I achieve the acceptability criteria TER ≥ 10 and TER ≥ 5, respectively, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for mammals.

6.3.2 Toxicity exposure ratio

6.3.2.1 Acute toxicity exposure ratio (TERA)

Screening step The product BAS 310 62 I is a polyethylene terephthalate (PET) net, which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system. BAS 310 62 I is used for the protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest. Since the application of alpha-cypermethrin incorporated into a woodnet does not fall into regular uses of insecticides (i.e. spray application of crops in the field), the exposure pattern is different from standard exposure patterns included in the current Guidance Document on bird and mammal risk assessment (EFSA/2009/1438). Therefore, the standard approach is not applicable.

The explanation of risk assessment submitted by the applicant will be accepted by UBA:

Therefore, the risk assessment is based on an alternative approach, which is outlined in the following. The main task is a) to identify possible routes of exposure and b) thereafter to quantify the exposure from the different routes of exposure.

Possible routes of exposure Following routes of exposure for birds and mammals could theoretically occur:

Exposure to earthworm-eating mammals via earthworms ingesting contaminated soil (see 6.3.9– Secondary poisoning) Exposure to fish-eating mammals via potential contamination of surface water bodie (see 6.3.9– Secondary poisoning)

Exposure to insectivorous mammals via arthropods being in contact with the woodnet and containing residues of alpha-cypermethrin

Other routes of exposure are considered irrelevant. Other food matrices of birds and mammals (i.e. green plant leaves or weed seeds) are not expected to be contaminated with alpha-cypermethrin from a woodnet application.

Quantification of exposure Exposure after spray application in the field is clearly higher (large-scale exposure) than the point-source- like exposure after application of a woodnet to single trunks and lumber stocks (small-scale exposure).

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 19 of 78

Concerning residues in arthropods, which may be a food source for insectivorous mammals, no default RUD values from EFSA/2009/1438 are available, as the RUD values listed in the guidance document refer to spray application scenarios. Please refer to Section 6.2.1.2 for further details. In the screening step, indicator species are used. These indicators are considered to have highest exposure in a specific crop at a particular time due to their size and feeding habits and represent a worst case scenario. As regards indicator species, no species for a woodnet scenario is proposed by the EFSA guidance document. Hence, to ensure a worst-case approach a small insectivorous mammal, the common shrew (Sorex aranaeus), is proposed as focal species. According to EFSA/2009/1438 the body weight of the common shrew is 9.7 g. Assuming a diet consisting entirely of insects, this correlates to a FIR/bw of 0.553.

The indicator mammal species for the intended uses are listed in the following table. Table 6.3-3: Indicator species for mammals according to intended use of BAS 310 62 I

Crop Indicator species

Lumber trunks Common shrew (see explanation chapter 6.3.2.1)

In this section, the TER acute values are presented for the Tier 1. The acute daily dietary dose (DDD) and

TERA is calculated as follows: Equation: DDD = FIR/bw x Residue value LD TER  50 DDD The following risk assessment (Table 10.3.1.1-1) is based on a comparison of toxicity and possible exposure of mammals to the active substance alpha-cypermethrin. The acute toxicity endpoint for alpha- cypermethrin is LD50 = 57 mg a.s./kg bw.

Table 6.3-4: Acute screening risk assessment (TERA) for mammals. See text for details

Compound Indicator LD50 FIR/bw Residues Acute DDD TERA species [mg a.s./kg bw] [mg a.s./kg bw/day] Alpha- Common shrew 57 0.553 0.33 0.182 313.2 cypermethrin

Based on the highly conservative presumptions of the screening step, the calculated TER values for the acute risk resulting from an exposure of mammals to the active substance Alpha-cypermethrin according

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 20 of 78

to the GAP of the formulation BAS 310 62 I achieve the acceptability criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for acute effects. The results of the assessment indicate an acceptable risk for mammals due to the intended use of BAS 310 62 I in lumber trunks according to the label, further refinement is not necessary.

6.3.2.2 Short-term toxicity exposure ratio (TERST)

There is no requirement for the calculation of TERST for mammals under the EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) and, consequently, a risk assessment for short- term toxicity has not been performed.

6.3.2.3 Long-term toxicity exposure ratio (TERLT)

Screening step

For the reproductive risk assessment, the calculation of the long-term toxicity exposure ratio (TERLT) follows in principle the same procedure as for the acute risk assessment. According to EFSA/2009/1438 the short-term exposure scenario is not required and therefore TER short- term values are not calculated. In this section, the TER long-term values are presented.

The reproductive daily dietary dose (DDD) and TERLT are calculated as follows: DDD = FIR/bw x Residue value NOAEL TER  DDD

The following risk assessment is based on a comparison of toxicity and possible exposure of mammals to the active substance alpha-cypermethrin. The reproductive toxicity endpoint for alpha-cypermethrin is NOAEL = 5 mg a.s./kg bw/d. Table 6.3-5: Mammal generic focal species for the intended uses of BAS 310 62 I

Crop Indicator species

Common shrew (see explanation chapter Lumber trunks 6.3.2.1)

The relevant lowest NOEL for the reproduction exposure scenario for alpha-cypermethrin is 5 mg a.s./kg bw/d. Full details of the toxicity studies are provided in the respective Review Report for the active substance alpha-cypermethrin (SANCO/4335/2000 final). The following table reports the calculated long-term toxicity exposure ratios (TERLT) for mammals exposed to alpha-cypermethrin following applications of BAS 310 62 I.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 21 of 78

Table 6.3-6: Long-term screening risk assessment (TERLT) for mammals exposed to BAS 310 62 I according to the intended use as woodnet

Compound Indicator NOAEL FIR/bw Residues Long-term TERLT species [mg a.s./kg DDD bw/day] [mg a.s./kg bw/day] Alpha- Common shrew 5 0.553 0.33 0.183 27.3 cypermethrin

Based on the highly conservative presumptions of the screening step, the calculated TER values for the long-term risk resulting from an exposure of mammals to the active substance alpha-cypermethrin according to the GAP of the formulation BAS 310 62 I achieve the acceptability criteria TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects. The results of the assessment indicate an acceptable risk for mammals due to the intended use of BAS 310 62 I in wood nets on lumber trunks according to the label, further refinement is not necessary.

6.3.3 Drinking water exposure In case of the uses as intend for BAS 310 62 I mammals might be exposed via drinking water from puddles. According to the new Guidance Document (EFSA, 2009), no specific calculations of drinking water exposure and TER are necessary when the ratio of effective application rate (in g/ha) to the relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg). This is due to the characteristics of the exposure scenario in connection with the standard assumptions for water uptake by mammals (for further details please refer to chapter 5.5. of the Guidance Document). The puddle scenario has been taken into account to calculate the exposure concentration of alpha-cypermethrin formed on a field after rainfall. The ratios do not exceed the value of 3000 for alpha-cypermethrin (Koc = 26.492 L/kg) thus it is not necessary to conduct a drinking water risk assessment for mammals. In conclusion, the risk through drinking water from the intended use of BAS 310 62 I as a woodnet is acceptable. Table 6.3-7 Risk assessment for the active substance alpha-cypermethrin concerning drinking water, Application 00-001

Parameter Alpha-cypermethrin Reference Koc (arithmetic mean) [L/kg] 26.492 Sec 5 CA DT50 (soil) [days] n.a. Not relevant for a woodnet application Number of applications 1 GAP table Interval [days] n.a. Not relevant for a woodnet application MAFm 1) n.a. Not relevant for a woodnet application Max use rate [g/ha] 41 D1 GAP table AReff [g/ha] 2) 41

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 22 of 78

LD50 [mg a.s./kg b.w.] 57 See above Ratio (acute) 3) 0.72 -- NOEL [mg a.s./kg b.w./d] 5 See above Ratio (repro) 3) 8.2 -- Trigger 4) 3000 -- Drinking water assessment No -- required [Yes/No] 5) -nki -ki 1) MAFm = (1-e ) / (1-e ) with k = ln(2)/DT50 (rate constant), n = number of applications and i = application interval [d] according to EFSA/2009/1438

2) AReff = Application rate (g/ha) * MAFmean 3) Ratio of AReff and relevant toxicity endpoint

4) Trigger according to EFSA/2009/1438 for substances with Koc ≥ 500

5) Drinking water risk assessment is not necessary when trigger value is not exceeded

6.3.4 Details on formulation type in proportion per item Please refer to section 6.2.4 for details on the formulation type of BAS 310 62 I.

6.3.4.1 Baits: Concentration of active substance in bait in mg/kg Please refer to section 6.2.4.

6.3.4.2 Pellets, granules, prills or treated seed Please refer to section 6.2.4.

Amount of active substance in or on each item Please refer to section 6.2.4.

Proportion of active substance LD50 per 100 items and per gram of items

Please refer to section 6.2.4

Size and shape of pellet, granule or prill

Please refer to section 6.2.4

6.3.5 Acute toxicity of the formulation Mammal toxicity tests with the formulation were not performed and are not considered necessary.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 23 of 78

6.3.6 Metabolites Mammal toxicity tests with metabolites of alpha-cypermethrin were not performed, since it is possible to extrapolate from data obtained with the active substances.

6.3.7 Supervised cage or field trials The risk assessment above has demonstrated that the proposed uses of BAS 310 62 I pose no unacceptable acute or long-term risks to mammals, and therefore further studies are not considered necessary.

6.3.8 Acceptance of bait, granules or treated seeds (palatability testing) BAS 310 62 I is intended for use as a wood net, and therefore this information is not required.

6.3.9 Effects of secondary poisoning The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6

"Bioaccumulation and food chain behaviour"). Since the log Kow values of alpha-cypermethrin is 5.5 (20), this active substance is deemed to have a negligible potential to bioaccumulate in animal tissues. No formal risk assessment from secondary poisoning is therefore required. The assessment of the risk to mammals exposed to BAS 310 62 I through secondary poisoning is based on the evaluation of an earthworm eating mammal (10 g bw, food intake rate, FIR = 12.8 g fresh weight/d). The calculation is performed for the worst case intended use as wood net on lumber trunks (Indication 00-001) with the maximal soil relevant amount of the formulation. Table 6.3-8: Assessement of the risk for earthworm eating mammal from an exposure to alpha- cypermethrin through secondary poisoning

Parameter Alpha- comments cypermethrin

PECsoil (twa = 21 d) [mg/kg soil] 0.05 See chapter 5.5 Sec 5

Kow 316228 Log POW= 5.5

Koc 26492

Foc 0.02 Default

BCFworm 7.164* BCFworm = (PECworm/PECsoil) = (0.84 + 0.012 x Kow)/ foc x Koc

PECworm 0.358 PECworm = PECsoil x BCF

Daily dietary dose (mg/kg bw/d) 0.458 DDD = PECworm x 1.28 NOEL (mg/kg bw/d) 5

TERlt 10.9

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 24 of 78

The risk assessment for fish eating mammals according to the Guidance Document EFSA/2009/1438 is performed for a mammal with 3000 g bw and a food intake rate FIR =425 g fresh weight fish/ d is not necessary for BAS 310 62 I.

Exposure to aquatic organisms is not expected as BAS 310 62 I is applied in forestry as a woodnet for single trunks or lumber stocks. Any potential exposure would be related to the active ingredient, which might wash off from the net. Run off studies by the applicant have demonstrated that there is an exposure at 5 m within the range LOQ (LOQ: is 0.005 mg/kg) from the application site, i.e. the woodstack. Alpha- cypermethrin was not detected in the soil horizons at 1 m distance from the wood stack. However, alpha- cypermethrin was absorbed in the litter above the soil horizons up to a distance of 5 m from the stack, even if in small amounts (< LOQ). Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required. Since no exposure of aquatic organisms will occur, no risk to fish eating mammals is expected.

It can therefore be concluded that the application of BAS 310 62 I does not provide reason for concern for bioaccumulation in the food chain.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 25 of 78

6.4 Effects on Aquatic Organisms

6.4.1 Overview and summary The following EU agreed endpoints for aquatic organisms exposed to the active substances alpha- cypermethrin are reported in the Review Report on alpha-cypermethrin (SANCO/4335/2000-final) and the Monograph with its Addenda for alpha-cypermethrin. Further details regarding the tests with alpha- cypermethrin, its metabolites and a representative solo-formulation are provided in the EU Review for alpha-cypermethrin.

The applicant provides no further studies on the risk for aquatic organisms with the formulation BAS 310 62 I – the explanation of the applicant is that BAS 310 62 I is applied in forestry as a woodnet for single trunks or lumber stocks and no exposure to aquatic organisms is expected.

6.4.1.1 Toxicity The endpoints for aquatic organisms relevant for the risk assessment are indicated in the following table. Table 6.4-1: Ecotoxicological endpoints for aquatic species exposed to alpha-cypermethrin and BAS 310 62 I with indication to agreed endpoints

Species Substance Exposition Results Reference ICS-No. Duration Toxicity Date System author Report No. Acute toxicity to fish

O. mykiss alpha-cypermethrin Acute 96 h LC50 = 2.8 µg/L XXXXXXXX. 31168 01.01.1982 SBGR.81.277

L. macrochirus mPBA Acute 96 h LC50 > 100 mg/L XXXXXXX 48057 2002/1004683

L. macrochirus cis-DCVA Acute 96 h LC50 > 10 mg/L XXXXXXX 48055 2002/1004682 Chronic toxicity to fish P. promelas (ELS) alpha-cypermethrin Long-term 34 d NOEC = 0.03 µg/L XXXXXXXX. 31199 19.03.1983 SBGR.82.298 Pimephales BAS 310 I (Alpha- Long-Term 34 d NOEC = 0.3 µg/L XXXXXXX 79103 promelas cypermethrin 31.03.2009 (98,8% purity) 2009/1031203

BCF fish O. mykiss cypermethrin Fullfish 1204 LOEP - Cyprinus carpio alpha-cypermethrin 910*** XXXXXXXXX - 06.06.1997

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 26 of 78

AL-519-004 Acute toxicity to aquatic invertebrates

D. magna alpha-cypermethrin Acute 48 h EC50 = 0.3 µg/L Stephenson, R. 31168 01.01.1982 SBGR.81.277

D. magna mPBA Acute 48 h EC50 = 39000 µg/L Jatzek 48062 12.09.2001 01/0418/50/1

D. magna 3-phenoxybenzalde- Acute 48 h EC50 = 800 µg/L Jatzek 48070 hyde 12.03.2002 01/0419/50/2

D. magna cis-DCVA Acute 48 h EC50 = 61900 µg/L Jatzek 48058 29.11.2001 01/0420/50/1 Chronic toxicity to aquatic invertebrates D. magna alpha-cypermethrin Long-Term 21 d NOEC = 0.03 µg/L Garforth, B. 31167 01.04.1982 SBGR.82.119 Sediment dwellers C. riparius alpha-cypermethrin 28 d NOEC = 0.024 µg/L Heintze, A. 38765 (spiked water) 30.09.1997 96178/02-ASCr; ECO-96-325 Toxicity to algae

Selenastrum alpha-cypermethrin 72 h ErC50 > 100 µg/L Stephenson, R. 31168 capricornutum 72 h EyC50 > 100 µg/L 01.01.1982 SBGR.81.277 Pseudokirchneriella BAS 310 I (Alpha- 72 h ErC50 >1000 µg/L Jatzek 48005 subcapitata Cypermethrin), 72 h EbC50 >1000 µg/L 18.03.2002 96,1% a.i. Growthrate 01/0265/60/1 72 h EbC10 <50 µg/L

P. subcapitata mPBA 72 h ErC50 = 85000 µg/L Werner, D. I. 48078 72 h EyC50 = 38100 13.02.2002 µg/L 01/0418/60/2

P. subcapitata cis-DCVA 72 h ErC50 = 70000 µg/L Werner, D. I. 48075 72 h EyC50 = 31600 13.02.2002 µg/L 01/0420/60/2 Mesocosm macroinvertebrates alpha-cypermethrin Huber, W.; 42964 Appendix 1 EAC* = Zieris, F.-J.; 0.015 µg/L Meyer-Tuve, H.; Nunn, A.; Safety factor = 1** Sandmann, E., (for single application) Mitchell, G.C. and Horton, W. 09.03.2000

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 27 of 78

Report ETX-99- 101

* EAC: ecologicaly acceptable concentration Endpoint from LOEP relevant for uses with single application. Endpoint is based on effects on macroinvertebrates from a series of studies including mesocosm studies and population modelling.

** Note (Umweltbundesamt): if multiple applications occur, the endpoint to be used should be the NOECmesocosm= 0.003 µg a.i./L, combined with a Safety Factor = 1 Study: Huber, W. and Dawo, U., date: 05.08.2001, Report No. ECO 00-268; ETX-00-268, Evaluation of the effects of multiple applications of a 100 g/L SC formulation (FASTAC OESC; CF 06677) of Alphacypermethrin (AC 900049) on macroinvertebrates, zooplankton and algae in pond-enclosures, ICS-Nr. 31072. Summary: 3 applications induce stronger and long lasting effects on sensitive populations (C. crystallinus, Ephemoptera, Trichoptera) than single application. Thus, instead of the reported EAC in the table above, the NOEC of 0.003 µg as/L from study with single application (Huber, 2000, Report-Nr. ETX-99-101.01) should be considered as relevant endpoint without additional safety factor.

*** According to OECD 305C this study is not valid. This is because a high loading rate, this can lead to an underestimation of BCF value. Furthermore there are no information about pH-value and differences in number of fishes in test and control group. But: reasoned by animal protection, no new bioaccumulation test is claimed. BCF of 910 will be used for risk assessment of alpha-cypermethrin.

6.4.1.2 Exposure The product BAS 310 62 I is a polyethylene terephthalate (PET) net, which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system. BAS 310 62 I is used for the protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest. A GAP table of intended uses can be found in Appendix 3.

Aquatic organisms may be exposed to plant protection products as a result of run-off from treated trunks or stocks. The studies and data provided a risk assessment relevant to the exposure of aquatic organisms to BAS 310 62 I under practical conditions of use.

In case of insecticidal nets, no spray drift is possible due to the net technology. In comparison to a spray application, the active substance is not directly released to the target or to the environment. It is fixed to the net fabric. Contamination of the vicinity of the wood stack can occur via contact of the net with the soil surface, or carry-over by the worker applying the net (e.g. via shoes), but these measured amounts would be low and limited to the surrounding 1 to 5 meters. The net itself should not come into contact with surface water.

As forest soils are not drained, drainage as entry pathway can also be excluded for the planned use in forestry.

The remaining cause for release of the active substance is rainfall. It is known from other types of insecticidal nets, that low amounts of active substance are released by rain and can reach the surrounding environment. Residues were found in water dripping through the net.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 28 of 78

As measured by the applicant in field study (Tilting 2011, see Part B Sec 5 CA for detailes) the amount washed out during a heavy rain event was estimated to be 0.55% of the total content of active substance in the net. The water reaching the soil was absorbed by the forest soil and no run-off water could be directly observed in 5 m from the nets. There is an exposure of Alpha-Cypermethrin at 5 m within the range below LOQ (LOQ: is 0.005 mg/kg) from the application site, i.e. the woodstack. Alpha- cypermethrin was not detected in the soil horizons at 1 m distance from the wood stack. However, alpha- cypermethrin was absorbed in the litter above the soil horizons up to a distance of 5 m from the stack, even if in small amounts (< LOQ). Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required.

6.4.1.3 Risk assessment – overall conclusions According to use of insecticidal nets no contact of run-off should reach water bodies. The water reaching the soil was absorbed by the forest soil and no run-off water could be directly observed in 5 m from the nets. There is an exposure of Alpha-Cypermethrin at 5 m within the range below LOQ (LOQ: is 0.005 mg/kg) from the application site, i.e. the woodstack. Alpha-cypermethrin was not detected in the soil horizons at 1 m distance from the wood stack. However, alpha-cypermethrin was absorbed in the litter above the soil horizons up to a distance of 5 m from the stack, even if in small amounts (< LOQ).

Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required. Risk mitigation measures have to be implemented involving a distance of 10 m to surface waters when using BAS 310 62 I as a woodnet. No further PEC calculations are necessary. Metabolites:

Toxicity of relevant metabolites mPBA and cis-DCVA is covered by the active substance alpha- cypermethrin, because toxicity of metabolites are less toxic for fish, aquatic invertebrates and algae. As no parent will reach surface water, and only low amounts can reach soil, the risk of metabolites reaching surface water is negligible

6.4.2 Acute toxicity and chronic toxicity of the formulation Please refer to section 6.4.1.1 for a summary of the provided studies on the effects of BAS 310 62 I on aquatic organisms.

6.4.3 Metabolites of alpha-cypermethrin Please refer to section 6.4.1.1 for a summary of endpoints of the provided studies on the effects of alpha- cypermethrin metabolites on aquatic organisms.

Alpha-cypermethrin forms two major metabolites in surface water: alpha-cypermethrin metabolites mPBA (18% at day 7) and cis-DCVA (47% at day 14).

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 29 of 78

Contamination via run-off can be excluded. Ecotoxicological studies are available for the metabolites mPBA and cis-DCVA for species of fish (L. macrochirus), Daphnia (D. magna) and algae (P. subcapitata). The comparison of the study results for the metabolites mPBA and cis-DCVA with the results of studies performed with alpha-cypermethrin shows that alpha-cypermethrin is more toxic for aquatic organisms than the metabolites. It is predicted that the risk for aquatic organisms exposed to alpha-cypermethrin metabolites according to the intended use of BAS 310 62 I will be low.

6.4.4 Accumulation in aquatic non-target organisms Bioaccumulation of the active substance under natural conditions is expected to occur (log POW >3) and a study is necessary to determine bioaccumulation in aquatic non-target organisms. In the LoEP, a study with the active substance cypermethrin in fish is reported with a BCF value of 1204. Applicant provided a study in fish for active substance alpha-cypermethrin with a BCF value of 910.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 30 of 78

6.5 Effects on Bees

Alpha-cypermethrin is known as toxic to honeybees. Present results of laboratory tests confirm this rating. However, exposure of honeybees is negligible since BAS 310 62 I is intended for use in forestry as a net application for protection of single trunks or lumber stocks. Therefore no further assessment is required and results provided by the notifier are not presented and discussed by the assessment authority. The calculations of hazard quotients are not required, since exposure is negligible. It is concluded that BAS 310 62 I will not adversely affect bees or bee colonies when used as a net wrapping application.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 31 of 78

6.6 Effects on Arthropods Other Than Bees

6.6.1 Overview and summary Effects on non-target arthropods of BAS 310 62 I were not evaluated as part of the EU review of the active substance, as a consequence, no EU agreed endpoints exist for this particular formulation. In order to be comprehensive, data of different OESC formulations, which are similar to BAS 310 18 I, are provided here and are considered adequate to address the toxicity of BAS 310 62 I and for the risk assessment.

Data on alpha-cypermethrin formulations have been submitted by the applicant and are evaluated here. They are considered adequate to assess the risk for non-target arthropods following the use of BAS 310 62 I according to the intended uses.

Since the product BAS 310 62 I is applied in forestry as a woodnet for protection of single trunks or lumber stocks, a specific approach concerning the risk assessment and the use of studies with alpha- cypermethrin containing formulations is necessary.

For spray applications recovery could be demonstrated for BAS 310 41 I at a rate of 33 g a.s./ha with the most sensitive species Typhlodromus pyri. Also, the soil dwelling species Poecilus cupreus and Aleochara bilineata were far less susceptible than T. pyri.

There are three full fauna field studies carried out with alpha-cypermethrin containing formulations showing low effects of alpha-cypermethrin on the arthropod fauna in cereals and in forestry. Exposure to non-target arthropods is limited to accidental contact of individals to the woodnet or to soil- dwelling arthropods exposed to the wash-off after a rainfall containing alpha-cypermethrin.

The intended use of the product BAS 310 62 I does not represent a regular use of a plant protection product (i.e. spray application of crops in the field) and the exposure pattern is different from regular exposure patterns. On one hand, reducing drift is the main advantage of using a net as carrier for the active substance when compared to spray application. On the other hand, the configuration enables a long-lasting insecticidal effectiveness of alpha-cypermethrin in the the product BAS 310 62 I for at least 6 months, with regard to long lasting rain-periods and temperatures permanently above 20°C (see BASF product description).

The insecticidal net Storanet acts/kills unspecifically. Therefore, in the risk assessment for non-target arthropods consideration of the affected not-target arthropods (“by-effect, by-kill or by-catch”) of the product BAS 310 62 I is nessessary

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 32 of 78

6.6.1.1 Toxicity The critical endpoints employed in the risk assessment for non-target arthropods are indicated in the table below. Table 6.6-1: Toxicity of Alpha-Cypermethrin/ BAS 310 62 I to non-target arthropods with reference to agreed endpoints

Species Substance Exposition Results Reference ICS-No. Duration Toxicity Author System g a.i./ha Date Report No. Tier 1

Typhlodromus BAS 310 41 I laboratory test, LR 50 = 0.00930 g a.s./ha Rosenkranz 17.08.2004 79069 pyri (100 g a.s. artificial substrate 2004/1015021 (nominal), 98.2 g/L (analysed) alpha- cypermethrin)

Aphidius BAS 310 41 I laboratory test, LR 50 = 0.392 g a.s./ha Moll and Buetzler 79070 rhopalosiphi ((100 g a.s. artificial substrate 17.09.2004 (nominal), 98.2 2004/1020915 g/L (analysed) alpha- cypermethrin)

Typhlodromus BAS 310 03 I * laboratory test, LR 50 = 0.00204 g Taruza and Strnad, 48210 pyri (100 g a.s./L artificial substrate a.s./ha1 10.05.2001 OESC) AL-560-049 1 Aphidius BAS 310 03 I * laboratory test, LR 50 = 0.256 g a.s./ha Vinall and Strnad, 48216 rhopalosiphi (100 g a.s./L artificial substrate 10.04.2001 OESC) AL-560-045 Tier 2

1 Typhlodromus BAS 310 03 I * extended LR 50 = 0.0626 g a.s./ha Taruza and Strnad, 48214 pyri (100 g a.s./L laboratory test, 06.02.2002 OESC alpha- natural substrate AL-560-065 cypermethrin) 1 Aphidius BAS 310 03 I * extended LR 50 = 0.954 g a.s./ha Vinall and Strnad, 48220 rhopalosiphi (100 g a.s./L laboratory test, 08.02.2002 OESC alpha- natural substrate AL-560-066 cypermethrin) Poecilus BAS 310 03 I * Baxter and Strnad, 42960 1 cupreus (100 g a.s./L laboratory test, LR 50 = > 1.2 g a.s./ha 10.04.2000 OESC alpha- artificial substrate AL-549-024 cypermethrin) 1 Aleochara BAS 310 03 I * laboratory test, LR50 > 1.2 g a.s./ha Vinall and Strnad, 42959 bilineata (100 g a.s./L artificial substrate 31.05.2000 OESC alpha- AL-560-030 cypermethrin)

Orius BAS 310 03 I * extended LR 50 = 0.09688 g Vinall and Strnad 42960 laevigatus 100 g a.s./L laboratory test, a.s./ha1 10.04.2000

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 33 of 78

OESC alpha- natural substrate AL-560-064 cypermethrin) 1 Chrysoperla BAS 310 03 I * laboratory test, LR 50 = 0.68 g a.s./ha Manley 48228 carnea 100 g a.s./L natural substrate 14.02.2002 OESC alpha- AL-560-067 cypermethrin) 1 Typhlodromus BAS 310 03 I * aged residue LR 50 = 0.0626 g a.s./ha Taruza 48214 pyri (100 g a.s./L extended 06.02.2002 OESC alpha- laboratory test, AL-560-053 cypermethrin) natural substrate Chrysoperla BAS 310 03 I * aged residue Mortality of 50-79 % at Manley, B. 48229 carnea 100 g a.s./L extended day 0 to 42 at 15 g 14.02.2002 (larvae) OESC alpha- laboratory test, a.s./ha with 1 or 2 appl.; Report No: 108451 cypermethrin) natural substrate effects on reproduction BASF DocID: AL-560- in all treatments 1) 070 Typhlodromus BAS 310 03 I * aged residue Mortality and Taruza, S. 48213 pyri (100 g a.s./L extended Reproduction: Harmless 06.02.2002 (protonymphs) OESC alpha- laboratory test, at 0.21 g a.s./ha, cypermethrin) natural substrate Harmless at 1.5 g a.s./ha, Appendix 2 Project DAT 14 and Harmless at No.: ETX-00-260 30 g a.s./ha, DAT 341) BASF DocID: AL-560- 053

Aleochara BAS 310 03 I * aged residue Mortality and Taruza, S. and Strnad, 48226 bilineata (100 g a.s./L extended Reproduction: Harmless S. (adult) OESC alpha- laboratory test, at 1.2 g a.s./ha, DAT 0 02.04.2001 cypermethrin) natural substrate and 71) Project No.: ETX-00- 261 BASF DocID: AL-560- 046 Tier 3

Natural BAS 310 03 I* Cereal field No long-term effects Knaebe, S. 79071 arthropod (100 g a.s./L study - Germany beyond one season up to 05.03.2009 field OESC alpha- 3 x 15 g a.s./ha2) Project No.: population cypermethrin) 20011138/G1-FNTO BASF Doc ID : 2008/1091409 Natural BAS 310 03 I* Field study - No long-term effects Knaebe, S. 79072 arthropod (100 g a.s./L France beyond one season up to 01.12.2009 populations OESC alpha- 3 x 15 g a.s./ha2) Project No.: cypermethrin) 20031097/F1-FNTO BASF Doc ID: 2009/1117839 Ground- BAS 310 20 I* Spruce forest No long-term effects on Klein, W. 80434 dwelling (15 g a.s./L field study – abundance of arthropods 21.05.1992 arthropods OESC alpha- Germany at month 14 and 18 after BASF Doc ID: cypermethrin) Long-Term effect one application2) 1992/1002198 at 1,5 years after 1 x application of 2.2 L FASTAC/ha (equivalent to 33

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 34 of 78

g a.s./ha)

Additionally, for the Section 7 “Efficacy Data and Information on the Plant Protection Product”, the applicant provided summaries of field-studies with the product BAS 310 62 I:

Polish spruce forests - Forest Research Institute, Raszyn, Poland (2011): Evaluation of BASF WOODNET effectiveness in spruce timber protection against european spruce bark beetle (Scolytinae spp.) BAS DocID 2011/1040748 - Forest Research Institute, Raszyn, Poland (2011): Evaluation of BASF WOODNET effectiveness in spruce timber protection against european spruce bark beetle (Scolytinae spp.) BAS DocID 2011/1040753 - Forest Research Institute, Raszyn, Poland (2011): Evaluation of BASF WOODNET effectiveness in spruce timber protection against european spruce bark beetle (Scolytinae spp.) BAS DocID 2011/1040749 - Forest Research Institute, Raszyn, Poland (2011): Evaluation of BASF WOODNET effectiveness in spruce timber protection against european spruce bark beetle (Scolytinae spp.) BAS DocID 2011/1040752 - Forest Research Institute, Raszyn, Poland (2011): Evaluation of BASF WOODNET effectiveness in spruce timber protection against european spruce bark beetle (Scolytinae spp.) BAS DocID 2011/1040750 - Forest Research Institute, Raszyn, Poland (2011): Evaluation of BASF WOODNET effectiveness in spruce timber protection against european spruce bark beetle (Scolytinae spp.) BAS DocID 2011/1040751 - Skrzecz, I. & W. Grodzki (2010): Protection of mountain tree stands from the european spruce bark beetle, with particular emphasis on reducing populations of secondary pests using WoodNet netting applied to lumber infested by insects BAS DocID 2011/1040755 - Hrasovec, B. (2010): Woodnet/Trenet trials 2010- first tests of new timber forest protecting material – Complion- Faculty of Forestry Croatia, BAS DocID 2011/1040754

Austrian spruce forests, used for the risk assessment for non-target arthropods (by-catch) in this section: - Perny, B. (2011): Ergebnisse der Testung der Wirkung und Praxistauglichkeit von WoodNet und TriNet (mit dem Wirkstoff Alpha-Cypermethrin) in der Borkenkaeferbekaemfpung – 2. Versuchsjahr. BAS Doc ID 2011/1040756

* BAS 310 03 I is identical with CF06677 or 100 g/L OESC of AC 900049 and contains 100 g/L oil-emulsion suspension concentrate (OESC) alpha-cypermethrin.

1) EU agreed endpoints (alpha-cypermethrin: Review report SANCO/4335/2000-final, Feb. 2004)

2) New study submitted by the applicant

According to the mechanism of action of Pyrethroids (“knock-down-effect”), mortality is the most sensitive endpoint compared to the endpoint reproduction of surviving animals with the ER50 > 0.075 g as/ha. Relevant for the risk assessment is the LR50 of 0.0626 g a.s./ha from a dose-response study with Typhlodromus pyri under extended laboratory conditions on leaves (Taruza, S. and Strnad, S. 2002).

For the risk assessment for non-target arthropods other than bees, the applicant submitted three field studies on natural arthropod field populations carried out with alpha-cypermethrin containing formulations (Klein, W. (1992) and Knaebe, S. (2009 a, b)).

The two studies from Knaebe, S. (2009), conducted in grainfields with up to three spray applications of the BAS 310 03 I formulation (100 g alpha-cypermethrin/L OESC) corresponding to 3 x 15 g a.s./ha, showed no long-term effects of alpha-cypermethrin on the abundance of natural arthropod species in cereals beyond one season. The authors show results for ground dwelling arthropods due to analysis by pitfall traps, but also for leaf dwelling arthropods (D-VAC sampling). Results could be used for the range of arthropods in cereals, but not for the species in a forest.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 35 of 78

For determination of short and long term effects of alpha-cypermethrin on the soil arthropod fauna, one field study (Klein 1992) was carried out in a spruce forest with a single spray application of the formulation BAS 310 20 I (100 g alpha-cypermethrin/L OESC), corresponding to 1 x 33 g a.s./ha. The abundance of natural arthropod species was documented at month 14 (pitfall traps) and month 18 (photeclectors), thus focusing on ground dwelling arthropods. No long-term effects on ground-dwelling non-target arthropods were observed and it can be concluded that the application of alpha-cypermethrin caused no unacceptable long-term effects on the population development of ground dwelling non target arthropods (Coleoptera, Diptera-Brachycera, Diptera-Nematocera) under field conditions in a spruce forest. For the product BAS 310 62 I no field study regarding the long-term effects on non-target arthropods in the concerned areas of the use of the product was submitted for Section 6. However, for Section 7 “Efficacy data and information on the plant proctection product”, the applicant submitted study summaries of several field studies for spruce forests in Poland (Forest Research Institute, Raszyn, Poland (2011), BAS DocID 2011/1040748, BAS DocID 2011/1040753, BAS DocID 2011/1040749, BAS DocID 2011/1040752, BAS DocID 2011/1040750, BAS DocID 2011/1040751 and Skrzecz, I. & W. Grodzki (2010) BAS DocID 2011/104075, Kroatia (Hrasovec, B. (2010): BAS DocID 2011/1040754) and Austria (Perny, B. (2011), BAS DocID 2011/1040756).

In the studies of the Forest Research Institute, Raszyn, Poland (BAS DocID 2011/1040748, BAS DocID 2011/1040753, BAS DocID 2011/1040749, BAS DocID 2011/1040752, BAS DocID 2011/1040750, BAS DocID 2011/1040751) a longer list of non target-beetle-species was observed as by-catch (some of the species does not occur in Germany). Found species: Otiorhynchus tenebricosus (Herbst), Hylobius pinastri (Gyll.), Hylobius abietis (Li.), Carabus linnei (Panzer.), Carabus sylvestris (Panzer.), Pterostichus oblongopunktatus (Fabr.), Thanasimus formicarius (L.), Ampedus pomorum (Herbst.) Due to their main focus on efficacy aspects such as the catching efficacy for the target organism they are only of limited use for the assessment of the effects on non-target arthropods. Except of the following studies by Perny from 2011, and 2012 these field studies on the efficacy of the product TriNet P were, therefore, not further considered for the risk assessment. Skrzecz, I. & W. Grodzki (2010, BAS DocID 2011/104075) wrote: “WoodNet was found to have low selectivity, shown in a great number of dead insects which have been in direct contact with the net, including insects that weren´t intended to be included in the experiment.”. Hrasovec (2010, BAS DocID 2011/1040754) wrote “(..) Masses (more than 100) cadavers of forest dung beetles from the genus Geotrupes that were found near and under the net folds close to the logs.”

In the more detailed studies by Perny (2011) the efficacy of the product Storanet was investigated in Austrian forests with common spruce (Picea abies). The summaries from Perny, B. from the years 2011 (BAS DocID 2011/1040756) provide few but limited information about “by-catch” of non-target arthropods, because the study focus was on the efficacy of Storanet against bark beetles. However, the results from Perny, B. (2011) allow a preliminary assessment of species composition and the relative quantity of the Storanet by-catch on non-target arthropods in forest ecosystems. Differences among sites depending high and barkbeetle-situation were found. Main groups were: ground beetles, ant beetles

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 36 of 78

(Thanasimus formicarius, ladybeetles, parasitic wasps, hymenoptera, diptera. Perny wrote in his conclusion: more information about by-catch species of non target arthropods could achieved, if there were a more exact observation and a more frequent pick up of dead individuals from the sourrounding of the nets.

However, the results from Perny, B. (2011) allow, together with the other submitted studies, a preliminary risk assessment for non-target arthropods in forest ecosystems.

6.6.1.2 Exposure

In field The product BAS 310 62 I is a polyethylene terephthalate (PET) net which is coated with 1.8% of an alpha-cypermethrin (BAS 310 18 I) using a polymeric binder binder system. The product BAS 310 62 I is used for protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest.

Regular foliar applications of insecticides can potentially result in exposure of honeybees either through direct overspray, or by contact with residues on plants. BAS 310 62 I is intended to be applied in forestry uses as a woodnet, which is placed over single trunks or whole lumber stocks. Thus, exposure due to overspray of bees or via spray drift does not occur. Furthermore, trunks and lumber is no vegetation, therefore the woodnet is not attractive to foliage dwelling non-target arthropods. However, it cannot be fully excluded that individual insects are exposed by accidently getting contact with the woodnet.

Since the product BAS 310 62 I is applied in forestry as a woodnet for protection of single trunks or lumber stocks, a specific approach concerning the risk assessment and the use of studies with alpha- cypermethrin containing formulations is necessary.

Non-target arthropods living in the forest can be exposed to residues from product BAS 310 62 I by direct contact through contact with residues on the woodnet. For I. typographus the insecticidal lethal effect of Storanet is unspecifical and can occur already after one second of contact (Perny, B., 2011), but also decelerated after two to three hours after contact with the net. Thus, any other insects, getting in contact with the net, will be exposed with an adverse effect concentration of alpha-cypermethrin which does very likely lead to acute or delayed mortality.

Storanet woodnets are no vegetation, and should therefore, be less attractive for insects in the forest. But Storanets can be applied in forest glades or outskirts of the forest and can be, due to its form and dark colour, attractive as overtop, seat or vantage point for non-target insects. Storanet coated treetrunks are expected to be attractive as seat or vantage point for insects species as well as large insects, such as butterflys (Lepidoptera) and dragonflys (Odonata).

The woodnet is placed over single trunks and lumber stocks, therefore the main exposure occurring is the wash-off of active ingredient after rainfall which partly leaches into the upper soil. Therefore, the main

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 37 of 78

focus of the risk assessment is on soil-dwelling non-target arthropods, while negligible exposure is anticipated for foilage-dwelling non-target arthropods.

In conclusion, it cannot be excluded that insects are exposed by getting in contact with the net or with wash-off after rainfall. The predominant exposure routes on non-target arthropods would be (i) direct contact to the net as well as (ii) contact to contaminated upper soil and contaminated affected or dead arthropods. In summary, non-target arthropods either directly and indirectly attracted by Storanet woodnets or soil-dwellers inhabiting or feeding in surrounding areas are expected to be at risk due to the use of Storanet woodnets.

By accidental contact to the woodnet non-target insect individuals could be poisend, which are possibly relevant for the population.

6.6.2 Risk assessment for Arthropods other than Bees Since the application of alpha-cypermethrin coated on a woodnet does not represent a regular use of a plant protection product (i.e. spray application of crops in the field), the exposure pattern is different from regular exposure patterns. Therefore, the approach recommended in the published ESCORT 2 document and the EC Guidance Document on Terrestrial Ecotoxicology (SANCO/10329, 17 October 2002) by calculating hazard quotients (HQ) is not applicable.

As a consequence the risk assessment for BAS 310 62 I is based on predominant exposure routes of non- target arthropods, such as direct contact to the net as well as contact to contaminated upper soil and contaminated affected or dead arthropods.

For the risk assessment of Storanet woodnets for non-target arthropods, extended laboratory studies for acute effects after direct contact of non-target arthropods, higher tier or field studies for long-term effects on ground dwelling arthropods as well as from the publicly available literature are considered.

Alpha-Cypermethrin – effects on non-target arthropods High acute toxicity to non-target arthropods is expected, since Storanet is protects and kill net intended to be used to protect tree trunks against bark beetles. It is known, that insecticidal systems cause by-catch, consequently the risk assessment will focus on (1) long-term effects on the population of non-target arthropods, (2) the combination of by-catch of non-target arthropods.

As expected from a pyrethroid acute effects on non-target arthropods were observed with the OESC formulation. A potential risk to non-target arthropods cannot be excluded based on laboratory studies with artificial substrate for the general indicator species T. pyri and A. rhopalosiphi. However, with these species, a comprehensive study package of Tier II studies (extended laboratory studies on natural substrate, including the ageing of residues) was generated. Besides T. pyri and A. rhopalosiphi, four additional species (C. carnea, O. laevigatus, P. cupreus and A. bilineata) were tested in laboratory tests on inert and natural substrate. Among these species, T. pyri was the most sensitive.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 38 of 78

Exposure of these organisms on natural substrate leads to a clear decrease in toxicity compared to exposure on inert substrate. The aged-residue studies demonstrated that the initially observed effects decrease over time indicating a reduction in bioavailability and/or dissipation of the residue level. Thus, the initially observed effects are of transient nature and recovery and re-colonization of potentially affected populations takes place after an acceptable time period.

Relevant for the risk assessment is the LR50 of 0.0626 g a.s./ha from a dose-response study with Typhlodromus pyri under extended laboratory conditions on leaves. According to the mechanism of action of Pyrethroids (“knock-down-effect”), mortality is the most sensitive endpoint compared to the endpoint reproduction of surviving animals with the ER50 > 0.075 g as/ha. Additionally, Perny, B. (2011, BASF DocID 2011/1040756) observed lethal effects on the target species Ips typographus already after one second of contact with the net of TriNet (similar with Alpha- Cypermethrin impregnated net to Storanet) but also delayed lethal effects up to two hours after such short contact with the net. Comparable effects are expected to occur on non-target arthropods.

Storanet-Net – effects on ground-dwelling non-target arthropods The two studies from Knaebe, S. (2009), conducted in grainfields with up to three spray applications of the BAS 310 03 I formulation (100 g alpha-cypermethrin/L OESC) corresponding to 3 x 15 g a.s./ha, showed no long-term effects of alpha-cypermethrin on the abundance of natural arthropod species in cereals beyond one season. However, study results for the effects on non-target arthropods after use of alpha-cypermethrin in a grainfield are not suitable to conclude on the risk for non-target arthropods in forest ecosystems because of very different species compositions, especially regarding ecologically sensitive species, different potential for recovery, other environmental conditions as well as higher complexity of forest ecosystems compared to grainfields.

For determination of short and long term effects of alpha-cypermethrin on the soil arthropod fauna, one field study was carried out by Klein, W. (1992) in a german spruce forest with one single spray application of the formulation BAS 310 20 I (100 g alpha-cypermethrin/L OESC), corresponding to 33 g a.s./ha. No long-term effects on ground-dwelling non-target arthropods were observed 14 and 16 months since application and it can be concluded that the application of alpha-cypermethrin caused no unacceptable long-term effects on the population development of ground dwelling non-target arthropods, such as Coleoptera, Diptera-Brachycera and Diptera-Nematocera, under field conditions in a spruce forest.

The provided higher tier- and field studies are suitable to assess the long-term risk for soil-dwelling non- target arthropods affected by alpha-cypermethrin due to contaminated soil or wash-off from Storanet nets.

In the field studies, for spray applications of OESC formulations containing alpha-cypermethrin (application of 1 x 33 g a.s./ha and 3 x 15 g a.s./ha) no long-term effects to ground-dwelling arthropod populations could be demonstrated. Regular field uses, such as one or three spray applications of alpha- cypermethrin in one year, were demonstrated to pose no unacceptable long-term risk to ground-dwelling

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 39 of 78

non-target arthropods. The presented higher tier studies show acceptable risk of the use of alpha- cypermethrin OESC formulations to non-target ground dwelling arthropods, which also covers the risk of an insecticidal net in forestry, because the use of Storanet nets results in significantly lower exposure than regular field uses, i.e. spray application. The long-term risk for soil-dwelling non-target arthropods after intended use of Storanet nets is acceptable.

However, due to its focus on soil-dwelling arthropods, the study from Klein, W. (1992) is not sufficient for the risk assessment of Storanet nets for the entire arthropod fauna in conifer forest ecosystems. Furthermore, Storanet nets are coated with a long lasting alpha-cypermethrin formulation, protected against UV-radiation and rain. Its insecticidal activity lasts for at least 6 months.

Storanet nets – effects on arthropod fauna other than soil-dwelling arthropods The proposed use of Storanet nets is the application in coniferous trees. The applicant submitted study summaries of field studies with the product BAS 310 18 I in Austrian forests with common spruce (Picea abies). These summary from Perny, B. from the years 2011 (BAS DocID 2011/1040756) provide few but limited information about “by-catch” of non-target arthropods, because the study focus was on the efficacy of Storanet and TriNet P regarding skimming of populations of the target species Ips typographus and Pityogenes chalcographus. However, the results from Perny, B. (2011) allow a preliminary assessment of species composition and the relative quantity of the Storanet by-catch on non- target arthropods in forest ecosystems. Differences among sites depending high and barkbeetle-situation were found. Main groups found were: ground beetles, ant beetles (Thanasimus formicarius, ladybeetles, parasitic wasps, hymenoptera, diptera. However, because biotic and abiotic factors influence the population density of organisms in forest ecosystems, the application site of Storanet nets will be crucial regarding the by-catch number and species composition.

In investigations in Poland Skrzecz, I. & W. Grodzki (2010, BAS DocID 2011/104075) found, that “WoodNets have low selectivity, shown in a great number of dead insects which have been in direct contact with the net, including insects that weren´t intended to be included in the experiment.”. In other polish studies of the Forest Research Institute, Raszyn, Poland (BAS DocID 2011/1040748, BAS DocID 2011/1040753, BAS DocID 2011/1040749, BAS DocID 2011/1040752, BAS DocID 2011/1040750, BAS DocID 2011/1040751) a longer list of non target-beetle-species was observed as by-catch (some of the species does not occur in Germany).

Storanet nets– effects on large insects

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 40 of 78

The Storanet woodnets are placed over single trunks and lumber stocks and should be less attractive for insects in the forest. But Storanets can be applied in forest glades or outskirts of the forest and can be, due to its form and dark colour, attractive as overtop, seat or vantage point for non-target insects. Storanet coated treetrunks are expected to be attractive as seat or vantage point for insects species as well as large insects, such as butterflys (Lepidoptera) and dragonflys (Odonata).

The submitted studies give no information about mortalities of large arthropod species due to the use of Storanet nets, thus, there are uncertainties for risk assessment for large insect species (of whom many species are endangered.

Conclusions for Risk assessment In conclusion, submitted studies enable just a preliminary assessment of the risk for adverse effects on the entity of non-target arthropod populations due to the use of Storanet nets, because of methodological and descriptive deficits as well as the missing focus on non-target arthropods of the studies in treated forest ecosystems.

The risk for soil-dwelling non-target arthropods inhabiting or feeding in surrounding areas of single trunks and lumber stocks covered with Storanet nets is expected to be low. Effects on soil-dwelling arthropod populations living directly adjacent to Storanet covered trunks might occur but not each harvested tree trunk or lumber stock will be covered with Storanet nets. Thus, fast recolonisation is expected to take place from surrounding area. Alpha-cypermethrin concentrations in soil fastly decrease with increasing distance from Storanet nets. Therefore, chronic risk for non-target arthropods arising from long-term use of Storanet nets is considered to be acceptable without considering special mitigation measures.

However, especially the risk for large insects (and possibly endangered species) and bark beetle predators is, due to insufficient suitability of the presented studies (sampling site, delayed mortality, etc.), not finally assessable. Uncertainties in risk assessment result from insufficient information regarding the by- catch number and non-target species composition still exists.

The preliminary results indicate, considering that not each harvested tree trunk or lumber stock in the forest is covered with Storanet nets, as well as focusing on endangered arthropod species, that Storanet nets poses an acceptable risk to non-target arthropods, following application according to the intended use in standing coniferous forrests. Non-target arthropods should be able to re-colonize areas from untreated areas of the forest, when trunks and lumber stocks with woodnets are removed. It is expected that populations will compensate losses caused by woodnets if a small number of harvested trees are covered with woodnets.

For further examples of risk management for non-target arthropods, please see German National Addendum of this submission.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 41 of 78

6.7 Effects on Earthworms, other Non-target Soil Organisms and Organic Matter Breakdown

6.7.1 Overview and summary Earthworms, other soil non-target macro and mesofauna as well as soil organisms involved in the breakdown of dead organic matter will be exposed to plant protection products containing alpha- cypermethrin whenever contamination of soil may occur as a result of the intended uses of BAS 310 18 I.

For the active substance alpha-cypermethrin the EU agreed endpoints are used for the risk assessment on earthworms. Effects on earthworms and other soil non-target macro-organisms of BAS 310 62 I were not evaluated as part of the EU review of the active substance, therefore no EU agreed endpoints exist for this particular formulation. Since the product BAS 310 62 I is applied in forestry as a woodnet for protection of single trunks or lumber stocks, a specific approach concerning the risk assessment and the use of studies with alpha-cypermethrin containing formulations is necessary.

Data of different 100 g/L OESC formulations, which are similar to the formulation BAS 310 18 I used for the net coating, are provided here and are considered adequate to address the toxicity of BAS 310 62 I and for the risk assessment.

Therefore, all relevant study data for the assessment of the risk to earthworm and other soil non-target macro-and mesofauna from the inteded uses of BAS 310 18 I are provided here, listed in in Appendix 3 and summarized Appendix 4 (new studies).

6.7.1.1 Toxicity Table 6.7-1: Ecotoxicological endpoints for terrestrial non-target soil fauna and organic matter breakdown following exposure to alpha-cypermethrin and BAS 310 18 I with indication to agreed endpoints

Species Substance Exposition Results Reference ICS-No. Duration Toxicity Author System Date Report No.

Eisenia fetida alpha-cypermethrin 14-d acute LC50 > 100 mg a.s./kg Inglesfield & 31232 toxicity dry soil Sherwood, LC50 > 50 mg a.s./kg dry 05.04.1983 soil 1 SBGR.83.071 1) Eisenia fetida 100 g a.s./L OESC 14-d acute LC50 > 66.7 mg a.s./kg Fleischer, 79112 toxicity dry soil 30.01.2004 LC50 > 33.3 mg a.s./kg 2004/1003941 dry soil 1) 1) Eisenia fetida 100 g a.s./L OESC 14-d acute LC50 = 100 mg a.s./kg Luehrs, 2001 48247 toxicity dry soil AL-560-042 LC50 = 50 mg a.s./kg dry soil 1)

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 42 of 78

Eisenia fetida 100 g a.s./L OESC 1) 56-d NOEC ≥ 0.4 mg a.s./kg Luehrs, 31228 chronic dry soil 12.02.2001 reproduction (=300 g a.s./ha) ETX-00-129; test NOEC ≥ 0.2 mg a.s./kg 7541022 dry soil 1) (IBACON) 1) Toxicity endpoint is re-adjusted by a factor of 2 to address the low bioavailability of the substance due to the hight organic content of the soil, since the log Pow for the substance is > 2.

The log KOW value for alpha-cypermethrin is above the agreed trigger value of 2. Therefore, correction of the endpoints is required in order to account for the relatively high organic matter content of the artificial test soil compared to agricultural soils and a resulting lower bioavailability of the active substance to soil organisms. The endpoints obtained from the studies on earthworms and collembolans with the alpha-cypermethrin containing formulations were only corrected if the artificial soil used in these tests contained 10% peat. The product BAS 310 62 I is a polyethylene terephthalate (PET) net which is coated with 1.8% of an alpha-cypermethrin (BAS 310 18 I) using a polymeric binder system. The product BAS 310 62 I is used for protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest. Since the product BAS 310 62 I is applied in forestry as a woodnet for protection of single trunks or lumber stocks, no specific trials on soil organisms had been conducted with this formulation. Therefore, toxicity data with alpha-cypermetrhin of 100 g a.s./L OESC formulations (BAS 310 41 I and predecessor formulations) on soil organisms are presented here as they are similar to the formulation BAS 310 18 I used for the coating of the woodnet (BAS 310 62 I).

6.7.1.2 Exposure The product BAS 310 62 I is a polyethylene terephthalate (PET) net which is coated with 1.8% of an alpha-cypermethrin (BAS 310 18 I) using a polymeric binder system. The product BAS 310 62 I is used for protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest.

According to the GAP, BAS 310 62 I is applied as a woodnet with a maximum application rate of 10 g alpha-cypermethrin (use: 00-003/00-004 100 m2 net with 10 g alpha-cypermethrin). For the predicted environmental concentrations in soils (PEC soil), reference is made to the environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values for the active substance alpha-cypermethrin are presented in the table below.

Experimental determination of PECsoil was confirmed by two field trials which were described in Part B, Section 5. Results assumed an even distribution of the substances in the top 5 cm horizon with a soil bulk density of 1.5 g/mL.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 43 of 78

-3 Table 6.7-2: Results of the experimental determination of PECsoil (soil bulk density 1.5 g/cm , soil depth 5 cm) plant protection product: BAS 310 62 I use: insecticidal net Number of applications/intervall 1 application rate: 100 m2 net with 10 g alpha-cypermethrin Indication: 00-003/00-004 active soil relevant Soil depth PECact substance/preparatio application rate ( cm) (mg/kg) n (g/ha) 100 m2 net = 10g alpha- 5 0.05* cypermethrin *Worst-case PEC soil value from the woodnet in a deciduous forest (study: Tilting 2011, see Part B Sec 5 CA for detailes) Metabolites:

Occurrence of metabolite mPBA in soil with max. 29.5% at day 112 and metabolite cis-DCVA occurs in soil with max. 17.4% at day 56. According to Addendum to the monograph-November 2002 metabolite mPBA is not relevant. Metabolite cis-DCVA is not considered in the monograph. There are no acute and chronic data available for both metabolithes.

6.7.1.3 Risk assessment –TER vaulues and overall conclusions The risk assessment results are summarized in the following table: Table 6.7-3: Ecotoxicological endpoints, PECsoil values and Toxicity to Exposure ratios to assess the risk for earthworms and other soil macro- and mesofauna following application of BAS 310 18 I according to the intended uses.

Test Intended use Timescale Endpoint PEC TER TER trigger substance (g a.s./ha) (mg/kg dw soil) (mg/kg soil dw) Earthworms (Eisenia fetida) Alpha- Use 00-003/00-004 Acute >501 0.05* >1000 10 cypermethrin 1x 10 g a.i. Soil Acute >501 >1000 10 depth: 5 cm Acute >33.31 >666 10 Long-Term >0.21 >4 5

1Toxicity endpoint is re-adjusted by a soil factor of 2 to address the organic content of the soil, since the log Pow for the active substance is >2.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 44 of 78

* Worst-case PEC soil value from the woodnet in a deciduous forest (study: Tilting 2011, see Part B Sec 5 CA for detailes)

TER values in bold fall below the relevant trigger. The long-term TER values calculated for alpha-cypermethrin as contained in a 100 g a.s./L OESC formulation are below the Commission Regulation (EU) 546/2011 trigger of 5 for soil exposure. However, dissipation of alpha-cypermethrin from soil is expected to be fast due to the low average residence time of alpha-cypermethrin in soil (median DT50, field of 35 days, EC Review Report, February 2004).

Metabolites There are no acute or chronic data available for alpha-cypermethrin metabolites mPBA and DCPA. As shown in aquatic risk assessment, alpha-cypermethrin is more toxic for aquatic organisms than the metabolites. Together with the low PECsoil values of mPBA and DCPA it is predicted that the risk for soil organisms exposed to alpha-cypermethrin metabolites according to the intended use of BAS 310 62 I will be low.

Based on the predicted concentrations of alpha-cypermethrin in soils, the TER values describing the longterm risk for earthworms and other non-target soil organisms following exposure to alpha- cypermethrin according to the GAP of the formulation BAS 310 18 I does not achieve the acceptability criteria TER ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. „Storanet“-woodnets are applicated on single trunks or lumber stacks which are laying on the ground. Significante contamination of soil is expected only in directe surrounding and below of trunks or lumber stacks. In the light of small affected areas in relation to not affected forest areas in the surrounding, there is no risk for local earthworm populations.

The results of the assessment indicate an acceptable risk for soil organisms due to the intended use of BAS 310 18 I as an insect woodnet according to the label. Risk mitigation measures will not have to be implemented to reduce the exposure of earthworms and other non-target soil organisms to BAS 310 18 I.

6.7.2 Toxicity to Exposure Ratio

6.7.2.1 Acute risk The potential acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure to BAS 310 62 I, alpha-cypermethrin was assessed by comparing the PECsoil with the 14-day

LC50 value to generate acute TER values. The TERA was calculated as follows:

LC50 (mg/kg) TER A = PECsoil (mg/kg)

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 45 of 78

The resulting TERA values are shown in Table 6.7-3 above. All the acute TER values are above the Commission Regulation (EU) 546/2011 acute trigger value of 10, indicating that BAS 310 62 I poses low acute risk to earthworms when applied according to the proposed use rates.

6.7.2.2 Chronic risk The potential long-term risk of alpha-cypermethrin to earthworms was assessed by calculating long-term TER (TERLT) values by comparing the NOEC values and the maximum instantaneous PECsoil using the following equation:

The potential chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breackdown resulting from an exposure to BAS 310 62 I as well as the major soil degradation products of alpha-cypermethrin were assessed by comparing the maximum PECsoil with the NOEC value to generate chronic TER values. The TERLT was calculated as follows: NOEC (m g/kg) TER = LT PEC (mg/kg) soil

The resulting TERLT values are shown in Table 6.7-3 above. The long-term TER values calculated for alpha-cypermethrin as contained in a 100 g a.s./L OESC formulation are above the Commission Regulation (EU) 546/2011 trigger of 5 for soil exposure considering a distance from the woodnet of 10 cm and slightly failed it at 0 cm. However, dissipation of alpha-cypermethrin from soil is expected to be fast due to the low average residence time of alpha- cypermethrin in soil (median DT50, field of 35 days, EC Review Report, February 2004).

Run off studies by the applicant have demonstrated that there is an exposure at 5 m within the range LOQ (LOQ: is 0.005 mg/kg) from the application site, i.e. the woodstack, in the leaf litter.

If effects on earthworm populations living directly adjacent to the treated trunks or lumber stocks might occur, fast recolonisation is expected to take place from surrounding. Alpha-cypermethrin concentrations in soil fastly decrease with increasing distance from the woodnet. Therefore, chronic risk for earthworm populations arising from long-term use of BAS 310 62 I is considered to be acceptable without considering special mitigation measures.

6.7.3 Residue content of earthworms The log Kow values of alpha-cypermethrin is > 3. Thus, alpha-cypermethrin is deemed to bioaccumulate in earthworms. As shown in chapter 6.2.9 (secondary poisioning in birds) and 6.3.9 (secondary poisoning in mammals) there is no bioaccumulation in birds or mammals. Studies determining residue content of alpha-cypermethrin in earthworms are not necessary.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 46 of 78

6.8 Effects on Soil Microbial Activity

6.8.1 Overview and summary Soil microorganisms will be exposed to plant protection products containing Alpha Cypermethrin whenever contamination of soil may occur as a result of the intended uses of BAS 310 62 I.

Effects on soil non-target micro-organisms of BAS 310 62 I were not evaluated as part of the EU review of the active substance, therefore no EU agreed endpoints exist for this particular formulation. Application of BAS 310 62 I is foreseen as a woodnet, with the active substance, alpha-cypermethrin, being incorporated into the net. As the formulation itself is not used as a spray application, studies on soil-microorganisms were not conducted. All relevant study data for the assessment of the risk to soil microorganisms from the intended uses of BAS 310 62 I are provided here, listed in in Appendix 3 and summarized Appendix 4 (new studies).

6.8.1.1 Toxicity Table 6.8-1: Ecotoxicological endpoints for soil microbial activity following exposure to alpha- cypermethrin and BAS 310 62 I with indication to agreed endpoints

Process Substance Exposition Results Reference ICS-No. Duration Toxicity Author System Date Report No. N-tranformation Alpha-cypermethrin 28d NOEC = 0.4 mg/kg dry Chapleo, S. 79107 soil, 06.04.2000 equivalent to 0.3 kg/ha1 ETX-00-108 C-transformation Alpha-cypermethrin 28d NOEC = 0.4 mg/kg dry Chapleo, S. 79107 soil, 06.04.2000 equivalent to 0.3 kg/ha1 ETX-00-108 1) EU agreed endpoints (alpha-cypermethrin: Review report SANCO/4335/2000-final, Feb. 2004; Monograph Vol. 1, Sep. 1999

6.8.1.2 Exposure Please refer to section 6.7.1.2 above for the predicted environmental concentrations in soil (PECsoil) of Alpha Cypermethrin.

6.8.1.3 Risk assessment –overall conclusions The Predicted Environmental Concentrations of the formulation the active substance alpha-cypermethrin is below the concentrations at which no unacceptable effects (< 25%) regarding the soil microbial activity were observed after 28 days of exposure. No relevant metabolites were identified in soil studies at concentrations > 10% applied active substance (see EC Review Report, February 2004). For the active substance alpha-cypermethrin and its metabolites the EU agreed endpoints are used for the risk assessment on on soil mico-organisms. Effects on soil non-target micro-organisms of BAS 310 62 I

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 47 of 78

were not evaluated as part of the EU review of the active substance, therefore no EU agreed endpoints exist for this particular formulation.

Application of BAS 310 62 I is foreseen as a woodnet, with the active substance, alpha-cypermethrin, being incorporated into the net. As the formulation itself is not used as a spray application, studies on soil-microorganisms were not conducted. The study on the active substance is used for the risk assessment of this product. The results of the comparison expressed as Margin of Safety (MoS) are presented in the following table. Table 6.8-2: Summary of risk assessment for soil micro-organisms exposed to Alpha Cypermethrin

Substance Test type Maximum initial PEC Effects <25% (mg/kg MoS (mg/kg soil dw) soil dw) Alpha N transformation 0.05* NOEC = 0.4 8 Cypermethrin (equivalent to 0.3 kg/ha) C transformation NOEC = 0.4 8 (equivalent to 0.3 kg/ha) *Worst-case PEC soil value from the woodnet in a deciduous forest (study: Tilting 2011, see Part B Sec 5 CA for detailes) Considering concurrent exposure to both the active ingredients in BAS 310 62 I at the time of application, a low risk to soil microflora is also concluded. The active substance of BAS 310 62 I, a

Alpha-cypermethrin, had no significant effect on soil micro-organisms up to 0.40 mg alpha- cypermethrin/kg dry soil. This endpoint is 8 times higher than the respective maximum PECsoil value of 0.050 mg alpha-cypermethrin/kg dry soil.

Under field conditions, the use of BAS 310 62 I as a woodnet poses no unacceptable risk to non-target soil micro-organisms.

Based on the predicted concentrations of Alpha Cypermethrin in soils, the risk to soil microbial processes following exposure to alpha-cypermethrin / BAS 310 62 I according to the GAP of the formulation BAS 310 62 I is considered to be acceptable according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2.

6.9 Effects on Non-Target Plants

6.9.1 Overview and summary The product BAS 310 62 I is a polyethylene terephthalate (PET) net which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system. The product BAS 310 62 I is used for protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest. No studies on potential effects of BAS 310 62 I on non-target terrestrial

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 48 of 78

plants have been conducted since exposure of non-target plants is not relevant as BAS 310 62 I is applied in forestry as a woodnet for single trunks or lumber stocks.

Additionally, in studies available with other alpha-cypermethrin formulations no effects on non-target terrestrial plants have been observed at test rates higher than the intended regular field application rates.

6.9.1.1 Toxicity Table 6.9-1: Summary of effects on terrestrial non-target plants in greenhouse and field trials following exposure to BAS 310 62 I

Species Substance Exposition Results Reference ICS-No. Duration Toxicity Author System Date Report No.

Vegetative vigour

Onion, oat, pea, carrot, oilseed rape, BAS 310 41 I Vegetative ER50 > 25 g Sack D. 79111 sunflower vigour a.i./ha 05.04.2007 2007/1020098

Onion, oat, sugar beet, radish, alpha- Vegetative ER50 > 90 g Ortlip, C. 48250 soybean, cucumber cypermethrin vigour a.i./ha 18.01.2001 Report No. AC 12704:008

6.9.1.2 Exposure The product BAS 310 62 I is a polyethylene terephthalate (PET) net which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 18 I) using a polymeric binder system. The product BAS 310 62 I is used for protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest.

Effects on non-target plants are of concern in the off-field environment, where they may be exposed to spray drift. Since BAS 310 62 I is intended to be applied in forestry uses as a woodnet being placed over single trunks or whole lumber stocks, exposure due to spray drift does not occur.

6.9.1.3 Risk assessment –TER values and overall conclusions BAS 310 62 I is an insecticide, therefore this product is not expected to have any significant herbicidal activity, as also has been demonstrated in studies presented in the table below. Furthermore, as BAS 310 62 I is applied in forestry as a woodnet for single trunks or lumber stocks, exposure of non- target terrestrial plants is negligible.

In conclusion, BAS 310 62 I poses no unacceptable risk to terrestrial non-target plants in off-crop areas following the proposed uses.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 49 of 78

Appendix 3 List of data submitted in support of the evaluation Table A 1: List of data submitted in support of the evaluation

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Knight R.J. 1982 The toxicity of the pyrethroid WL No BASF 10.1/1 b 85871 against the honey bee Apis mellifera Shell Research Ltd., Sittingbourne Kent ME9 8AG, United Kingdom AL-541-002 No, studies were conducted prior to the implementation of GLP but are scientifically valid Unpublished

KIIIA Dunning, J.B 2008 CRC handbook of avian body 10.1/1 masses. 2nd edition. CRC Press, Boca Raton.

KIIIA XXXXX 1977 The acute toxicity to rainbow trout No BASF 3 10.2.2.1/1 a (Salmo gairdneri) of some compounds involved with the manufacture of pyrethroid insecticide WL 43467 XXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXX CY-570-001 No, studies were conducted prior to the implementation of GLP but are scientifically valid Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 50 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Janson G.-M. 2011 Acute toxicity of Alpha- Yes BASF 3 10.2.2.2/1 et al. a cypermethrin (BAS 310 I) and of Cypermethrin (BAS 311 I) to the non-biting midge Chironomus riparius in a 48 hour static test BASF SE, Limburgerhof, Germany Fed.Rep. 2009/1102214 Yes Unpublished

KIIIA Janson G.- 2009 Acute toxicity of BAS 310 I Yes BASF 3 10.2.2.2/2 M., a (Reg.No. 4078193) to larvae of the Weltje L. phantom midge Chaoborus crystallinus in a 48 hour static test BASF SE, Limburgerhof, Germany Fed.Rep. 2009/1085205 Yes Unpublished

KIIIA XXXXXX 2009 BAS 310 I - Early life-stage test on Yes BASF 2 10.2.5.2/1 a the fathead minnow (Pimephales promelas) with pulse dose exposure XXXXXXXXXXXXXXXXXX XXXXXXXXXXX 2009/1031203 Yes Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 51 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Bergtold M. 2007 Chronic toxicity of BAS 310 I to Yes BASF 3 10.2.6.1/1 a Daphnia magna STRAUS in a 21 day semi-static test - A time to effect study BASF AG Agrarzentrum Limburgerhof, Limburgerhof, Germany Fed.Rep. 2007/1016502 Yes Unpublished

KIIIA Rosenkranz 2004 Effects of BAS 310 41 I on the Yes BASF 3 10.5.1/1 B. a predatory mite Typhlodromus pyri in the laboratory - Dose response test Institut fuer Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany Fed.Rep. 2004/1015021 Yes Unpublished

KIIIA Moll M., 2004 Effects of BAS 310 41 I on the Yes BASF 3 10.5.1/2 Buetzler R. a parasitoid Aphidius rhopalosiphi in the laboratory - Dose response test Institut fuer Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany Fed.Rep. 2004/1020915 Yes Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 52 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Taruza S., 2001 A rate-response laboratory test to Yes BASF 1 10.5.1/3 Strnad S. b determine the effects of Alpha- cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677), on the predatory mite, Typhlodromus pyri (Acarina: Phytoseiidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-049 Yes Unpublished

KIIIA Vinall S., 2001 A rate-response laboratory test to Yes BASF 1 10.5.1/4 Strnad S. a determine the effects of Alpha- cypermethrin (AC900049) in a 100 g/L OESC formulation (CF 06677), on the parasitic wasp Aphidius rhopalosiphi (Hymenoptera, Braconidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-045 Yes Unpublished

KIIIA Baxter I., 2000 A laboratory test to determine the No BASF 3 10.5.1/5 Strnad S. a effects of Alpha-cypermethrin, in a 100 g/L OESC formulation (CF 06677), on the ground-dwelling predator, Poecilus cupreus (Coleoptera, Carabidae) Agrochemical Evaluation Unit, Southampton SO16 7PX, United Kingdom AL-549-024 Yes Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 53 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Vinall S., 2000 A laboratory test to determine the No BASF 3 10.5.1/6 Strnad S. a effects of Alpha-cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677), on the ground-dwelling parasitic beetle, Aleochara bilineata (Coleoptera, Staphylinidae) Agrochemical Evaluation Unit, Southampton SO16 7PX, United Kingdom AL-560-030 Yes Unpublished

KIIIA Taruza S., 2002 A rate-response extended laboratory Yes BASF 3 10.5.2/1 Strnad S. a test to determine the effects of Alpha-cypermethrin (AC 900049), in a 100 g/L OESC formulation (BAS 310 I), on the predatory mite, Typhlodromus pyri (Acari: Phytoseiidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-065 Yes Unpublished

KIIIA Taruza S. 2001 An extended laboratory test to Yes BASF 3 10.5.2/2 a determine the effects of fresh and aged residues of the insecticide Alpha-cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677) on the predatory mite Typhlodromus pyri (Phytoseiidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-053 Yes Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 54 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Vinall S., 2002 A rate-response extended laboratory Yes BASF 3 10.5.2/3 Strnad S. a test to determine the effects of Alpha-cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-066 Yes Unpublished

KIIIA Taruza S., 2001 An extended laboratory test to Yes BASF 3 10.5.2/4 Strnad S. a determine the effects of Alpha- cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677) on the ground dwelling parasitic beetle, Aleochara bilineata (Coleoptera, Staphylinidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-046 Yes Unpublished

KIIIA Vinall S., 2002 A rate-response extended laboratory Yes BASF 3 10.5.2/5 Strnad S. b test to determine the effects of Alpha-cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator Orius laevigatus (Heteroptera: Anthocoridae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-064 Yes Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 55 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Manley B. 2002 A rate-response extended laboratory Yes BASF 3 10.5.2/6 a test to determine the effects of Alpha-cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator Chrysoperla carnea (Neuroptera, Chrysopidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-067 Yes Unpublished

KIIIA Manley B. 2002 An aged-residue extended Yes BASF 3 10.5.2/7 b laboratory test to determine the effects of Alpha-cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator, Chrysoperla carnea (Neuroptera: Chrysopidae) Mambo-Tox Ltd., Southampton SO16 7PX, United Kingdom AL-560-070 Yes Unpublished

KIIIA Knaebe S. 2009 A field trial assessing the impact of Yes BASF 5 10.5.4/1 a multiple applications of Alphacypermethrin (100 g/L,SC) on the non-target arthropod fauna in cereals in Germany Eurofins-GAB GmbH, Niefern- Oeschelbronn, Germany Fed.Rep. 2008/1091409 Yes Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 56 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Knaebe S. 2009 A field trial assessing the impact of Yes BASF 5 10.5.4/2 b multiple applications of Alphacypermethrin (100 g/L, SC) on the non-target arthropod fauna of a winter wheat crop (France) Eurofins-GAB GmbH, Niefern- Oeschelbronn, Germany Fed.Rep. 2009/1117839 Yes Unpublished

KIIIA Klein W. 1992 Auswirkungen einer Fastac- No BASF 5 10.5.4/3 a Anwendung gegen Forstschaedlinge auf die Bodenfauna des Waldes Fraunhofer-Institut fuer Umweltchemie und Oekotoxikologie, Schmallenberg, Germany Fed.Rep. 1992/1002198 No Unpublished

KIIIA Luehrs U. 2001 Acute toxicity (14 days) of Yes BASF 1 10.6.2/1 a Alphacypermethrin (AC 900049) in a 100 g/L oil emulsion suspension concentrate formulation (Fastac 10% OESC) (CF 06677) to the earthworm Eisenia fetida (Savigny 1826) in artificial soil Institut fuer Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany Fed.Rep. AL-560-042 Yes Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 57 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Fleischer G. 2004 Effect of BAS 310 41 I on the Yes BASF 1 10.6.2/2 a mortality of the earthworm Eisenia fetida BASF AG Agrarzentrum Limburgerhof, Limburgerhof, Germany Fed.Rep. 2004/1003941 Yes Unpublished

KIIIA Luehrs U. 2001 Effects of Alpha-cypermethrin (AC Yes BASF 1 10.6.3/1 c 900049) in a 100 g/L oil emulsion suspension concentrate formulation (Fastac 10% OESC) (CF 06677) on reproduction and growth of earthworms Eisenia fetida (Savigny 1826) in artificial soil Institut fuer Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany Fed.Rep. AL-560-041 Yes Unpublished

KIIIA Sack D. 2007 BAS 310 41 I: Effects on non-target Yes BASF 1 10.8.1.2/1 a plants in the greenhouse - A multiple dose test BASF AG Agrarzentrum Limburgerhof, Limburgerhof, Germany Fed.Rep. 2007/1020098 No Unpublished

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – DE Central Zone STORANET Page 58 of 78

Annex Author Year Title Data Owner How point Source (where different from protection considered company) claimed in dRR Company, Report No. Yes/No Study- GLP or GEP status (where Status/ relevant) Use* Published or Unpublished KIIIA Ortlip C. 2001 Effect of Alpha-cypermethrin 100 Yes BASF 1 10.8.1.2/2 a g/L OESC formulation at 30 and 90 g a.i./ha on vegetative vigor of six terrestrial plant species BASF Corp. Agro Research, Princeton NJ, United States of America AL-549-025 No Unpublished

*

1) accepted (study valid and considered for evaluation) 2) not accepted (study not valid and not considered for evaluation)

3) not considered (study not relevant for evaluation)

4) not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 59 of 78

Appendix 4 Detailed evaluation of studies relied upon A2-1 Active substance (generally only relevant in the case that new annex II data is provided after Alpha-cypermethrin approval) A2-2 Formulation IIIA 10.1 Effects on birds IIIA 10.2 Effects on aquatic organisms

IIIA 10.2.2.2 Acute toxicity (24 & 48 h) for Daphnia preferably Daphnia magna Report: 10.2.2.2/1, Janson G.-M. et al., 2011a Title: Acute toxicity of Alpha-cypermethrin (BAS 310 I) and of Cypermethrin (BAS 311 I) to the non-biting midge Chironomus riparius in a 48 hour static test Document No: BASF DocID 2009/1102214 Guidelines: OECD 202 GLP Yes

Executive Summary In a 48 hours static acute toxicity study, non-biting midge larvae (Chironomus riparius) were exposed to BAS 310 I at nominal test concentrations of 0 (control), 5, 10, 20, 40 and 80 ng a.s./L in 4 replicates per concentration, containing 5 larvae each. Chironomids were observed for immobility 24 hours and 48 hours after start of exposure.

In a 48 h static acute toxicity study with Chironomus riparius the EC50 of BAS 310 I was determined to be 12.6 ng/L, based on mean measured concentrations.

CONCLUSION

In a 48 h static acute toxicity study with Chironomus riparius the EC50 of BAS 310 I was determined to be 12.6 ng/L, based on mean measured concentrations. Study Comments: The study is acceptable, as no deviations from guideline occurred and all validity criteria are 10.2.2.2/3 fullfilled. Agreed endpoints: EC50 (48 h) = 12.6 ng/L 10.2.2.2/3 NOEC (48 h) = 6.5 ng/L, based on measured concentrations.

Report: 10.2.2.2/2, Janson G.-M.,Weltje L., 2009a Title: Acute toxicity of BAS 310 I (Reg.No. 4078193) to larvae of the phantom midge Chaoborus crystallinus in a 48 hour static test Document No: BASF DocID 2009/1085205 Guidelines: OECD 202 GLP Yes

Executive Summary

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 60 of 78

In a static acute toxicity laboratory study, larvae of the phantom midge Chaoborus crystallinus (Diptera, Chaoboridae) were exposed to alpha-cypermethrin (BAS 310 I) at nominal concentrations of 0 (control), 0 (solvent control), 6.25, 12.5, 25, 50 and 100 ng/L in 4 replicates per concentration, containing 5 larvae each. Additionally, a solvent control and a 50 ng/L treatment were initiated with four replicates, containing 5 pupae in each. Midge larvae and pupae were observed for immobility and other signs of toxicity 24 hours and 48 hours after start of exposure.

In a 48-hour static acute toxicity study with Chaoborus crystallinus the EC50 of alpha-cypermethrin was 44.54 ng a.s./L based on measured concentrations. The NOEC was determined to be 24.87 ng a.s./L (measured).

Study The study is acceptable, as no deviations from the guideline occurred and all validity Comments: criteria are fullfilled. 10.2.2.2/2

Agreed EC50 (48 h): = 44.54 ng a.s./L, endpoints: NOEC (48 h) = 24.87 ng a.s./L 10.2.2.2/2 based on measured concentrations.

IIIA 10.2.5.2 Fish early life stage toxicity test. Analytical data on concentrations in the test media

Report: 10.2.5.2/1, XXXXXX, 2009a

Title: BAS 310 I - Early life-stage test on the fathead minnow (Pimephales promelas) with pulse dose exposure

Document No: BASF DocID 2009/1031203

Guidelines: OECD 210, EPA 72-4 (a), EPA 850.1400, EPA 540/9-86-138

GLP Yes

Executive Summary

The chronic toxicity of alpha-cypermethrin (BAS 310 I) to fathead minnow (Pimephales promelas) was evaluated in a 34-day early life-stage test with pulse dose exposure under flow-through conditions. Two exposure peaks spaced by 7 days were applied to each test group. The peak concentrations declined with a half life of one day. Two different peak concentrations of 0.15 and 0.30 µg a.s./L) were tested and the peaks were applied according to two different time schedules, to cover the most sensitive life stages. Additionally to the 4 test groups with peak exposure scheme, a dilution water control was tested. Hatchability, post-hatch survival rate, signs of toxicity and growth parameters of fathead minnow embryos were assessed at intervals throughout the study.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 61 of 78

In an early life stage study applying a realistic pulse dose exposure pattern with two peaks of alpha- cypermethrin, no substance-related effects on fathead minnow (Pimephales promelas) were observed at a nominal peak exposure concentration of 0.30 µg a.s./L.

Study The study is acceptable, as no deviations from the guideline occurred and all Comments: validity criteria are fullfilled. 10.2.5.2/1

Agreed NOEC (34 d) ≥ 0.3 µg a.s./L endpoints: 10.2.5.2/1

IIIA 10.2.6.1 Chronic toxicity in Daphnia magna (21-day). Analytical data on concentrations in the test media

Report: 10.2.6.1/1, Bergtold M., 2007a

Title: Chronic toxicity of BAS 310 I to Daphnia magna STRAUS in a 21 day semi-static test - A time to effect study

Document No: BASF DocID 2007/1016502

Guidelines: OECD 211, EPA 850.1300

GLP Yes

Executive Summary

In a semi-static chronic toxicity laboratory study, water flea neonates (between 2 and 24 hours old) were exposed to alpha-cypermethrin (BAS 310 I) at peak concentrations of 0.0372, 0.0744, 0.1117 and 0.1489 µg a.s./L. To evaluate chronic effects after a realistic exposure scenario, a semi-static test has been conducted simulating peak concentrations after two applications of the test item (7 days interval) with subsequent dissipation. Daphnids were observed for parent mortality; body length and reproductive performance throughout the test period.

In a 21-day semi-static chronic toxicity study with Daphnia magna no significant effects of the test item were observed up to and including a peak concentration of 0.112 µg/L alpha-cypermethrin (BAS 310 I). Reproduction remained unaffected at the highest treatment comprising two peaks of 0.149 µg a.s./L, whereas body length was reduced with 3.2%.

Study Comments: The study is acceptable, as no deviations from guideline occurred and all 10.2.6.1/1 validity criteria are fullfilled.

Agreed endpoints: NOEC (21 d) reproduction = 0.149 µg/L 10.2.6.1/1 NOEC (21 d) body length = 0.112 µg/L

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 62 of 78

IIIA 10.5 Effects on arthropods other than bees

IIIA 10.5.1 Effects on sensitive species already tested, using artificial substrates

Report: 10.5.1/1, Rosenkranz B., 2004a

Title: Effects of BAS 310 41 I on the predatory mite Typhlodromus pyri in the laboratory - Dose response test

Document No: BASF DocID 2004/1015021

Guidelines: Bluemel et al. (2000)

GLP Yes

Executive Summary

In a worst-case laboratory study, Typhlodromus pyri Scheuten was exposed to dried residues of alpha- cypermethrin (BAS 310 41 I) 100 g/L OESC on glass plates. Endpoint for the study was mortality, including the calculation of the LR50. Mortality was assessed 2 and 7 days after treatment. After 7 days, the mortality in the test item rates was between 5.0% and 95.0% in comparison to 11.0% in the control. Based on these results the corrected mortality for the different rates ranged between -6.7% and 94.4%. Statistically significant differences compared to the control were observed in the 0.10 g a.s./ha test item treatment and above.

In a worst-case laboratory study with alpha-cypermethrin 100 g/L OESC (BAS 310 41 I), the LR50 for Typhlodromus pyri was determined to be 0.00930 g a.s./ha in 200 L water/ha.

Study As the results of the study are considered to be unequivocal and the validity criteria Comments: were fulfilled, the test is considered to be acceptable. IIIA 10.5.1/1

Agreed Endpoint: LR50 = 0.00930 g a.s./ha IIIA 10.5.1/1

Report: 10.5.1/2, Moll M.,Buetzler R., 2004a

Title: Effects of BAS 310 41 I on the parasitoid Aphidius rhopalosiphi in the laboratory - Dose response test

Document No: BASF DocID 2004/1020915

Guidelines: Mead-Briggs M. et al. (2000) A laboratory test for evaluating the effects of plant protection products on the parasitic wasp Aphidius rhopalosiphi (DeStephani-Perez) (Hymenoptera Braconidae)

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 63 of 78

GLP Yes

Executive Summary

Adults of Aphidius rhopalosiphi (Hymenoptera: Braconidae) were exposed to dried residues of alpha- cypermethrin (AC 900049, BAS 310 I) 100 g/L OESC in a worst-case laboratory study. The test item was applied to glass plates at application rates of 0.033, 0.10, 0.30, 0.90, 2.7 and 8.1 g a.s./ha. Dimethoate at a rate 0.3 mL/ha was used as a reference item, glass plates treated with water were used as a control treatment. Once dry, the treated glass plates were used to form the floor and ceiling of the test units. In each test unit 10 adult wasps were introduced. Four replicates were prepared for each treatment. The condition of the wasps was assessed after 24 and 48 hours.

The LR50 obtained under worst-case laboratory conditions on the parasitic wasp Aphidius rhopalosiphi was 0.392 g a.s./ha.

Study Comments: As the results of the study are considered to be unequivocal and the validity criteria IIIA 10.5.1/2 were fulfilled, the test is considered to be acceptable.

Agreed Endpoint: LR50 = 0.392 g a.s./ha IIIA 10.5.1/2

Report: 10.5.1/3, Taruza S.,Strnad S., 2001b

Title: A rate-response laboratory test to determine the effects of Alpha-cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677), on the predatory mite, Typhlodromus pyri (Acarina: Phytoseiidae)

Document No: BASF DocID AL-560-049

Guidelines: EEC 91/414 Annex III 10.5.1, EEC 96/12, Louis F. Ufer A. (1994) Open test design as a standard laboratory test for predatory mites, Louis F. Ufer A. (1995) Methodical improvements of standard laboratory tests for determining the side- effects of agrochemicals on predatory mites (Acari Phytoseiidae), Bluemel et al. (2000), Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods

GLP Yes

In a worst-case laboratory study, Typhlodromus pyri Scheuten (Acarina: Phytoseiidae) was exposed to dried residues of alpha-cypermethrin (AC 900049, BAS 310 I) 100 g/L OESC on glass plates. Endpoints

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 64 of 78

for the study were mortality, including the calculation of the LR50 and reproduction. Mortality was assessed 1 and 7 days after treatment, reproduction 3 times between day 7 and 14 after treatment.

In a worst-case laboratory study with alpha-cypermethrin 100 g/L OESC, the LR50 for Typhlodromus pyri was determined to be 0.00204 g a.s./ha in 200 L water/ha.

Study Comments: As the results of the study are considered to be unequivocal and the validity criteria IIIA 10.5.1/3 were fulfilled, the test is considered to be acceptable.

Agreed Endpoint: LR50 = 0.00204 g a.s./ha IIIA 10.5.1/3

Report: 10.5.1/4, Vinall S.,Strnad S., 2001a

Title: A rate-response laboratory test to determine the effects of Alpha-cypermethrin (AC900049) in a 100 g/L OESC formulation (CF 06677), on the parasitic wasp Aphidius rhopalosiphi (Hymenoptera, Braconidae)

Document No: BASF DocID AL-560-045

Guidelines: EEC 91/414 Annex III 10.5.1, EEC 96/12, Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods, Mead-Briggs M. et al. (2000)

GLP Yes

Executive Summary

Adults of Aphidius rhopalosiphi (Hymenoptera: Braconidae) were exposed to dried residues of alpha- cypermethrin (AC 900049, BAS 310 I) 100 g/L OESC in a worst-case laboratory study. The test item was applied to glass plates at application rates of 0.015, 0.03, 0.15, 0.3, 1.0 and 3.0 g a.s./ha. Dimethoate at a rate 0.3 mL/ha was used as a reference item, glass plates treated with water were used as a control treatment.

The LR50 obtained under worst-case laboratory conditions on the parasitic wasp Aphidius rhopalosiphi was 0.256 g a.s./ha. Alpha-cypermethrin 100 g/L OESC caused adverse effects on reproduction if applied at 0.03 g a.s./ha and above.

Study Comments: As the results of the study are considered to be unequivocal and the validity criteria IIIA 10.5.1/4 were fulfilled, the test is considered to be acceptable.

Agreed Endpoint: LR50 = 0.256 g a.s./ha IIIA 10.5.1/4

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 65 of 78

Report: 10.5.1/5, Baxter I.,Strnad S., 2000a

Title: A laboratory test to determine the effects of Alpha-cypermethrin, in a 100 g/L OESC formulation (CF 06677), on the ground-dwelling predator, Poecilus cupreus (Coleoptera, Carabidae)

Document No: BASF DocID AL-549-024

Guidelines: Heimbach U. (1991) Auswirkungen von Pflanzenschutzmitteln auf Imagines von Poecilus cupreus L. als Vertreter der Familie Carabidae (= Laufkaefer) im Laboratorium

GLP Yes

Executive Summary

A laboratory study was performed to determine the effect of alpha-cypermethrin 100 g/L OESC on the carabid beetle Poecilus cupreus. The beetles were introduced into the test units directly before application. The test item was applied to test units filled with inert quartz sand as test substrate via direct overspray at an application rate of 1.2 g a.s./ha and a water volume corresponding to 400 L/ha. Under worst-case laboratory conditions alpha-cypermethrin 100 g/L OESC caused no unacceptable effects on survival, behaviour and food consumption of the carabid beetle Poecilus cupreus when applied at a rate of 1.2 g a.s./ha in 400 L water/ha.

Study Comments: As the results of the study are considered to be unequivocal and the validity criteria IIIA 10.5.1/5 were fulfilled, the test is considered to be acceptable.

Agreed Endpoint: LR50 > 1.2 g a.s./ha IIIA 10.5.1/5

Report: 10.5.1/6, Vinall S.,Strnad S., 2000a

Title: A laboratory test to determine the effects of Alpha-cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677), on the ground-dwelling parasitic beetle, Aleochara bilineata (Coleoptera, Staphylinidae)

Document No: BASF DocID AL-560-030

Guidelines: Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods, EEC 96/12

GLP Yes

Executive Summary

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 66 of 78

A laboratory study was carried out to determine the effect of alpha-cypermethrin 100 g/L OESC on a ground-dwelling predator, the staphylinid beetle Aleochara bilineata. This study included the complete life cycle of the beetles: parental generation, mating and oviposition of parental generation, hatching of F1 larvae and parasitation period until emergence of the F1 adults. Endpoints of the study were mortality and the effect on reproduction represented by the living offspring hatched from the onion fly pupae, which were added to the test substrate during the first 3 weeks of the study. The test item was applied to test units filled with inert quartz sand as test substrate at application rates of 0.036, 0.105, 0.24, 0.5, 0.7 and 1.2 g a.s./ha.

In a worst-case laboratory test with Aleochara bilineata, the ER50 was determined to be > 1.2 g a.s./ha. Alpha-cypermethrin 100 g/L OESC caused no unacceptable effects on survival and reproduction if applied at rates up to 1.2 g a.s./ha.

Study Comments: As the results of the study are considered to be unequivocal and the validity criteria IIIA 10.5.1/6 were fulfilled, the test is considered to be acceptable.

Agreed Endpoint: ER50 >1.2 g a.s./ha IIIA 10.5.1/6 No unacceptable effects on survival and reproduction up to 1.2 g a.s./ha.

IIIA 10.5.2 Effects on non-target terrestrial arthropods in extended laboratory tests

Report: 10.5.2/1, Taruza S.,Strnad S., 2002a

Title: A rate-response extended laboratory test to determine the effects of Alpha- cypermethrin (AC 900049), in a 100 g/L OESC formulation (BAS 310 I), on the predatory mite, Typhlodromus pyri (Acari: Phytoseiidae)

Document No: BASF DocID AL-560-065

Guidelines: EEC 96/12, EEC 91/414 Annex III 10.5.1, Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods

GLP Yes

Study Comments: As the results of the study are considered to be unequivocal and the validity criteria IIIA 10.5.2/1 were fulfilled, the test is considered to be acceptable.

Agreed Endpoint: LR50 = 0.0626 g a.s./ha IIIA 10.5.2/1 No unacceptable effects on reproduction at 0.075 g a.s./ha.

Report: 10.5.2/2, Taruza S., 2001a

Title: An extended laboratory test to determine the effects of fresh and aged residues of the insecticide Alpha-cypermethrin (AC 900049), in a 100 g/L OESC formulation

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 67 of 78

(CF 06677) on the predatory mite Typhlodromus pyri (Phytoseiidae)

Document No: BASF DocID AL-560-053

Guidelines: EEC 91/414 Annex III 10.5.1, EEC 96/12, Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods

GLP Yes

Executive Summary The effects of fresh and aged residues of alpha-cypermethrin 100 g/L OESC on the predatory mite Typhlodromus pyri were evaluated under extended laboratory conditions. A dose-response relationship and a time dependency of the degree of acute effects were observed. Fresh dried residues caused no effects on either survival or reproduction of T. pyri when applied at a rate equivalent to 0.21 g a.s./ha. After 14 days of aging no effects on T. pyri exposed to 1.5 g a.s./ha were observed. No effects in the group treated with 30 g a.s./ha were observed after 34 days.

Study As the results of the study are considered to be unequivocal and the validity criteria Comments: were fulfilled, the test is considered to be acceptable. IIIA 10.5.2/2

Agreed Endpoint: No unacceptable effects on survival and reproduction up to 0.21 g a.s./ha at DAT 0. IIIA 10.5.2/2 No unacceptable effects on survival and reproduction up to 1.5 g a.s./ha at DAT 14.

No unacceptable effects on survival and reproduction up to 30 g a.s./ha at DAT 34.

Report: 10.5.2/3, Vinall S.,Strnad S., 2002a

Title: A rate-response extended laboratory test to determine the effects of Alpha- cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae)

Document No: BASF DocID AL-560-066

Guidelines: EEC 91/414, EEC 96/12, Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods

GLP Yes

Executive Summary

An extended laboratory study was carried out to determine the effects of alpha-cypermethrin (AC 900049) 100 g/L OESC on the parasitic wasp, Aphidius rhopalosiphi. For determination of the mortality,

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 68 of 78

adult wasps were exposed to fresh, dry residues of the test item on treated excised leaves of the French bean applied at rates of 0.075, 0.15, 0.75, 1.5 and 3.0 g a.s./ha.

In an extended laboratory study with alpha-cypermethrin 100 g/L OESC, the LR50 for Aphidius rhopalosiphi was 0.954 g a.s./ha. No unacceptable effects on fecundity occurred, when alpha- cypermethrin 100 g/L OESC was applied up to and including an application rate of 0.75 g a.s./ha.

Study As the results of the study are considered to be unequivocal and the validity criteria Comments: were fulfilled, the test is considered to be acceptable. IIIA 10.5.2/3

Agreed Endpoint: LR50 = 0.954 g a.s./ha IIIA 10.5.2/3 No unacceptable effects on reproduction up to 0.75 g a.s./ha

Report: 10.5.2/4, Taruza S.,Strnad S., 2001a

Title: An extended laboratory test to determine the effects of Alpha-cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677) on the ground dwelling parasitic beetle, Aleochara bilineata (Coleoptera, Staphylinidae)

Document No: BASF DocID AL-560-046

Guidelines: Naton (1988) Richtlinie zur Pruefung der Nebenwirkung von Pflanzenschutzmitteln auf Aleochara bilineata Gyll. (Col. Staphylinidae), Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods, EEC 96/12

GLP Yes

Executive Summary

The effects of fresh and aged residues of alpha-cypermethrin on the rove beetle Aleochara bilineata were evaluated under extended laboratory conditions. No unacceptable effects on reproduction of the beetles were observed after exposure to freshly dried and 7-days old residues of alpha-cypermethrin applied at a rate of 1.2 g a.s./ha.

Study As the results of the study are considered to be unequivocal and the validity criteria Comments: were fulfilled, the test is considered to be acceptable. IIIA 10.5.2/4

Agreed Endpoint: No unacceptable effects on reproduction up to 1.2 g a.s./ha at DAT 0 IIIA 10.5.2/4

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 69 of 78

Report: 10.5.2/5, Vinall S.,Strnad S., 2002b

Title: A rate-response extended laboratory test to determine the effects of Alpha- cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator Orius laevigatus (Heteroptera: Anthocoridae)

Document No: BASF DocID AL-560-064

Guidelines: EEC 91/414, EEC 96/12, Bakker F. et al. (2000) A laboratory test for evaluation of the effects of plant protection products on the predatory bug Orius laevigatus (Fieber) (Heteroptera Anthocoridae), Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods

GLP Yes

Executive Summary In an extended laboratory study, nymphs of Orius laevigatus Fieber (Heteroptera: Anthocoridae), were exposed to fresh residues of alpha-cypermethrin 100 g/L OESC, applied to bean leaves (Phaseolus vulgaris). Mortality was determined over a 10-day period. Sublethal effects on reproduction capacity (fecundity) were assessed on two consecutive 48 hours intervals and hatching rate (fertility) of the eggs was determined.

In this extended laboratory study the LR50 of alpha-cypermethrin 100 g/L OESC on Orius laevigatus was determined to be 0.09688 g a.s./ha in 200 L water/ha. No effects on reproduction (i.e. fecundity and fertility) were observed at an application rate of 0.05 g a.s./ha.

In this extended laboratory study the LR50 of alpha-cypermethrin 100 g/L OESC on Orius laevigatus was determined to be 0.09688 g a.s./ha in 200 L water/ha. No effects on reproduction (i.e. fecundity and fertility) were observed at an application rate of 0.05 g a.s./ha.

Study As the results of the study are considered to be unequivocal and the validity criteria Comments: were fulfilled, the test is considered to be acceptable. IIIA 10.5.2/5

Agreed Endpoint: LR50 = 0.09688 g a.s./ha IIIA 10.5.2/5 No unacceptable effects on reproduction up to 0.05 g a.s./ha

Report: 10.5.2/6, Manley B., 2002a

Title: A rate-response extended laboratory test to determine the effects of Alpha- cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator Chrysoperla carnea (Neuroptera, Chrysopidae)

Document No: BASF DocID AL-560-067

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 70 of 78

Guidelines: EEC 91/414, Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods, EEC 96/12

GLP Yes

Executive Summary

In an extended laboratory study with alpha-cypermethrin 100 g/L OESC the LR50 for the green lacewing Chrysoperla carnea was 0.68 g a.s./ha. No unacceptable effects on mortality and reproduction occurred, when alpha-cypermethrin 100 g/L OESC was applied up to and including an application rate of 1.0 g a.s./ha in 200 L water/ha.

Study As the results of the study are considered to be unequivocal and the validity criteria Comments: were fulfilled, the test is considered to be acceptable. IIIA 10.5.2/6

Agreed Endpoint: LR50 = 0.68 g a.s./ha IIIA 10.5.2/6 No unacceptable effects on survival and reproduction up to 1.0 g a.s./ha

Report: 10.5.2/7, Manley B., 2002b

Title: An aged-residue extended laboratory test to determine the effects of Alpha- cypermethrin (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator, Chrysoperla carnea (Neuroptera: Chrysopidae)

Document No: BASF DocID AL-560-070

Guidelines: EEC 91/414 Annex III 10.5.1, EEC 96/12, Barrett K.L. et al. (1994) Guidance Document on regulatory testing procedures for pesticides with non-target arthropods

GLP Yes

Executive Summary

The effects of aged residues of alpha-cypermethrin 100 g/L OESC on the green lacewing Chrysoperla carnea were evaluated under extended laboratory conditions following either one application or two sequential applications at a rate equivalent to 15 g a.s./ha. After 8 days of aging the effects in treatments with one application started to decrease. This trend continues until 22 DAT. No effects on either survival or reproduction were observed after 42 DAT at least in the 1-fold application rate of 1 x 15 g a.s./ha.

IIIA 10.5.3 Effects on non-target terrestrial arthropods in semi-field tests

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 71 of 78

IIIA 10.5.4 Field tests on arthropod species

Report: 10.5.4/1, Knaebe S., 2009a

Title: A field trial assessing the impact of multiple applications of Alphacypermethrin (100 g/L,SC) on the non-target arthropod fauna in cereals in Germany

Document No: BASF DocID 2008/1091409

Guidelines: IOBC Guidelines Hassan (1992), Candolfi et al. 2000

GLP Yes

Executive Summary Short-term effects on a wide range of non-target arthropods were observed after two and three applications of 15 g/ha alpha-cypermethrin, which are expected after use of an insecticide. No long-term effects beyond one season are expected for the majority of arthropods related to the agro ecosystem after two as well as three applications of the test item. The remaining groups (mainly spiders) show a clear recovery within one year after the first application. It can be concluded from the results of this study, that three consecutive applications with 15 g alpha-cypermethrin/ha caused no unacceptable effects on the population development of ground - and foliar dwelling arthropods under field conditions in cereals.

Report: 10.5.4/2, Knaebe S., 2009b

Title: A field trial assessing the impact of multiple applications of Alphacypermethrin (100 g/L, SC) on the non-target arthropod fauna of a winter wheat crop (France)

Document No: BASF DocID 2009/1117839

Guidelines: Candolfi et al. 2000, Anonymous (1991) - A3 Appendix 2

GLP Yes

Executive Summary

Short-term effects on a wide range of non-target arthropods were observed after two and three applications of 15 g alpha-cypermethrin/ha, which are expected after use of an insecticide. No long-term effects beyond one season are expected for the arthropods related to the agro ecosystem after two as well as three applications of the test item. It can be concluded from the results of this study, that three consecutive applications with 15 g alpha-cypermethrin/ha caused no unacceptable effects on the population development of ground - and foliar dwelling arthropods under field conditions in cereals.

Report: 10.5.4/3, Klein W., 1992a

Title: Auswirkungen einer Fastac-Anwendung gegen Forstschaedlinge auf die Bodenfauna des Waldes

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 72 of 78

Document No: BASF DocID 1992/1002198

Guidelines:

GLP No

Executive Summary

Long-term effects on a wide range of non-target arthropods were not observed after one application of 36 L solution containing 1% BAS 310 20 I (equivalent to approx. 2.2 L BAS 310 20 I/ha and approx. 33 g alpha-cypermethrin/ha) on clustered brushwood in a wind-thrown forest. It can be concluded from the results of this study, that application of alpha-cypermethrin caused no unacceptable effects on the population development of non target arthropods (Coleoptera, Diptera-Brachycera, Diptera-Nematocera) under field conditions in a spruce forest. IIIA 10.6 Effects on earthworms and other makro soil-organisms

IIIA 10.6.2 Acute toxicity to earthworms

Report: 10.6.2/1, Luehrs U., 2001a

Title: Acute toxicity (14 days) of Alphacypermethrin (AC 900049) in a 100 g/L oil emulsion suspension concentrate formulation (Fastac 10% OESC) (CF 06677) to the earthworm Eisenia fetida (Savigny 1826) in artificial soil

Document No: BASF DocID AL-560-042

Guidelines: EEC 91/414 Annex III 10.6.1.1, EEC 96/12, OECD 207, ISO 11268-1

GLP Yes

Executive Summary

Adult earthworms of the species Eisenia fetida, were exposed to BAS 310 03 I. The test item was mixed into artificial soil at rates of 62.5, 125, 250, 500, and 1000 mg BAS 310 03 I/kg dry soil (nominal). For the control treatment, the soil was treated with deionized water. The test soil was prepared according to OECD 207.

In a 14-d toxicity study on earthworms (Eisenia fetida) with BAS 310 03 I the LC50 was > 1000 mg/kg dry soil. The NOEC based on weight loss was 62.5 mg BAS 310 03 I/kg dry soil. Based on the concentration of the active substance in the formulation, the LC50 and NOEC values were determined to be > 100 and 6.25 mg a.s./kg dry soil, respectively.

Report: 10.6.2/2, Fleischer G., 2004a

Title: Effect of BAS 310 41 I on the mortality of the earthworm Eisenia fetida

Document No: BASF DocID 2004/1003941

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 73 of 78

Guidelines: ISO 11268-1

GLP Yes

Executive Summary

Adult earthworms of the species Eisenia fetida, were exposed to BAS 310 41 I. The test item was mixed into artificial soil at rates of 87.8, 131.7, 197.5, 296.3, 444.4 and 666.7 mg BAS 310 41 I/kg dry soil (nominal). For the control treatment, the soil was treated with deionized water. The test soil was prepared according to ISO 11268-1.

In a 14-d toxicity study on earthworms (Eisenia fetida) with BAS 310 41 I the LC50 was > 66.67 mg a.s./kg dry soil. The NOEC based on mortality and biomass was 66.67 mg a.s./kg dry soil.

IIIA 10.6.3 Sublethal effects on earthworms

Report: 10.6.3/1, Luehrs U., 2001c

Title: Effects of Alpha-cypermethrin (AC 900049) in a 100 g/L oil emulsion suspension concentrate formulation (Fastac 10% OESC) (CF 06677) on reproduction and growth of earthworms Eisenia fetida (Savigny 1826) in artificial soil

Document No: BASF DocID AL-560-041

Guidelines: ISO 11268-2 (1998), BBA VI 2-2

GLP Yes

Executive Summary

The effects of BAS 310 03 I on mortality, biomass development and reproduction of the earthworm Eisenia fetida Savigny (Annelida: Oligochaeta) were investigated in an extended laboratory study over 56 days. Two application rates (0.6 and 3.0 L BAS 310 03 I/ha) were sprayed via laboratory-spraying equipment on the test substrate containing the earthworms. In a 56-day earthworm reproduction study with BAS 310 03 I, no adverse effects on survival reproduction and feeding activity could be determined at concentrations up to 3.0 L BAS 310 03 I/ha. The NOAEC for mortality, feeding activity and reproduction was equivalent to 3.0 L BAS 310 03 I/ha corresponding to 300 g a.s./ha (0.4 mg a.s./kg dry soil), the highest rate tested. IIIA 10.8 Effects on non-target plants

IIIA 10.8.1.1 Seed germination

IIIA 10.8.1.2 Vegetative vigour

Report: 10.8.1.2/1, Sack D., 2007a

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 74 of 78

Title: BAS 310 41 I: Effects on non-target plants in the greenhouse - A multiple dose test

Document No: BASF DocID 2007/1020098

Guidelines: OECD 208

GLP No

Executive Summary

In a vegetative vigor test four species of dicotyledonous plants (sunflower, pea, oilseed rape, carrot) and two species of monocotyledonous plants (onion, oat) were exposed to BAS 310 41 I. Nominal application rates tested were 31.25, 62.5, 125 and 250 mL BAS 310 41 I/ha. Following the application the plants were cultivated for 20 days under greenhouse conditions. Assessment of phytotoxicity was carried out 7 and 20 days after application. Fresh weight was determined at study termination 20 DAA. Based on the results of this study it can be concluded that application of BAS 310 41 I has no phytotoxic potential to onion, oats, pea, carrot, oilseed rape and sunflower at a rate up to 250 mL BAS 310 41 I/ha (25 g a.s./ha). In oilseed rape and sunflower significant effects on plant biomass could be observed at the lowest tested rate of 31.25 mL BAS 310 41 I/ha (3.125 g a.s./ha). However, oilseed rape and sunflower treated with higher concentrations did not show significant reductions. Significant effects in plant biomass were observed in oats when exposed to the lowest rate of 31.25 mL BAS 310 41 I/ha (3.125 g a.s./ha) and to the highest tested rate of 250 mL BAS 310 41 I/ha (25 g a.s/ha). The reduction was 24.80% and 13.67%, respectively. The NOAER (no observed adverse effect rate) based on visible damages was 250 mL BAS 310 41 I/ha (25 g a.s./ha) for all tested species. The NOAER (no observed adverse effect rate) based on fresh weight was 250 mL BAS 310 41 I/ha (25 g a.s./ha) for onion, pea, carrot rapeseed and sunflower. For oats the NOAER could not be determined.

Report: 10.8.1.2/2, Ortlip C., 2001a

Title: Effect of Alpha-cypermethrin 100 g/L OESC formulation at 30 and 90 g a.i./ha on vegetative vigor of six terrestrial plant species

Document No: BASF DocID AL-549-025

Guidelines: OECD 208, EPA 850.4150

GLP No

Executive Summary

In a vegetative vigour test four species of dicotyledonous plants (cucumber, radish, soybean, sugar beet) and two species of monocotyledonous plants (onion, oat) were exposed to alpha-cypermethrin 100 g/L OESC formulation (FASTAC®). Nominal application rates tested were 30 and 90 g a.s./ha. Following the application the plants were cultivated for 21 days under greenhouse conditions. Assessment of

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central Zone STORANET Page 75 of 78

phytotoxicity was carried out 7, 14 and 21 days after application. Fresh and dry weight was determined at study termination 21 DAA.

Based on the results of this study it can be concluded that application of alpha-cypermethrin 100 g/L OESC does not result in an adverse effect greater than 50% on any one of the plant species tested. No phytotoxic potential was observed, when alpha-cypermethrin 100 g/L OESC Formulation was applied up to 90 g a.s./ha in five of six tested species (oat, cucumber, radish, soybean, sugar beet). Slight phytotoxic effects could be observed for onion in all tested rates. The NOAER (fresh and dry weight) for oat, radish, soybean, sugar beet was 90 g a.s./ha. Cucumber showed in both rates tested slight reduction in weight and onion showed a significant reduction in plant biomass in both rates. Thus, the NOAER could not be determined.

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central STORANET Page 76 of 78

Appendix 5 Table of Intended Uses justification and GAP tables

Crop and/ Zone Product code F Pests or or situation G Group of pests Formulation Application Application rate per treatment or controlled I (a) (b) (c) Type Conc. method growth number interval kg as/hL water L/ha kg as/ha of as kind stage & season min max between applications (j) min max min max min max (min) (d-f) (i) (f-h) (k)

Single trunk Central zone BAS 310 62 I F Bark and wood boring bark LLIN 1.57 Complete Post harvest 1 50 m2 net / single Not DE, AT, PL, beetles wrapping of treatment trunk applicable CZ, SK, SI Lonhorn beetles and metallic trunk 5 g as / single wood-boring beetles trunk)

Lumber stock Central zone BAS 310 62 I F Bark and wood boring bark LLIN 1.57 Application Post harvest 1 100 m2 net Not (20 m3) DE, AT, PL, beetles over the top of treatment /lumber stock applicable the stock CZ, SK, SI Lonhorn beetles and metallic 10 g as / lumber wood-boring beetles stock

Large lumber Central zone BAS 310 62 I F Bark and wood boring bark LLIN 1.57 Application Post harvest 1 200 m2 net / Not stock DE, AT, PL, beetles over the top of treatment large lumber applicable (40 m3) CZ, SK, SI Lonhorn beetles and metallic the stock stock wood-boring beetles 20 g as / large lumber stock

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report Core Assessment – Germany Central STORANET Page 77 of 78

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (i) g/kg or g/l situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds application (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions of use (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 must be provided (f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Core Assessment – Germany STORANET

Applicant BASF Evaluator zRMS DE Applicant Document ID 2011/1122476 Date October2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 1 of 12

REGISTRATION REPORT Part B

Section 6 Ecotoxicological Studies Detailed summary of the risk assessment

Product code: BAS 310 62 I STORANET

Active Substance: Alpha-Cypermethrin 1.57 g/kg (0.157% w/w)

Central Zone Zonal Rapporteur Member State: Germany (DE)

NATIONAL ADDENDUM – Germany

Applicant: BASF Submission Date: October 2013

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 2 of 12

TABLE OF CONTENTS SEC 6 ECOTOXICOLOGICAL STUDIES...... 3 6.1 EFFECTS ON BIRDS ...... 3 6.2 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS...... 3 6.3 EFFECTS ON AQUATIC ORGANISMS ...... 3 6.3.1 Overview and summary ...... 3 6.4 EFFECTS ON BEES...... 4 6.5 EFFECTS ON ARTHROPODS OTHER THAN BEES (IIIA1 10.5) ...... 4 6.6 EFFECTS ON EARTHWORMS AND OTHER SOIL NON-TARGET MACRO-ORGANISMS (IIIA1 10.6)...... 5 6.6.1 Overview and summary ...... 5 6.6.2 Overall conclusion ...... 6 6.6.3 Effects on organic matter breakdown (IIIA1 10.7) ...... 7 6.7 EFFECTS ON SOIL MICROBIAL ACTIVITY (IIIA1 10.7)...... 7 6.8 EFFECTS ON NON-TARGET PLANTS (IIIA1 10.8)...... 7 6.8.1 Terrestrial plants...... 7 6.8.2 Predicted distribution and fate in the environment and time courses involved (IIIA1 10.11.1)...... 7 6.8.3 Non-target species at risk and extent of potential exposure (IIIA1 10.11.2)...... 7 6.8.4 Short- and long-term risks for non-target species. populations. communities and processes (IIIA1 10.11.3) ...... 7 6.8.5 Risk of fish kills and fatalities in large vertebrates or terrestrial predators (IIIA1 10.11.4)...... 9 6.8.6 Precautions necessary to avoid/minimise environmental contamination and to protect non-target species (IIIA1 10.11.5)...... 9 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION...... 10 APPENDIX 2 TABLE OF INTENDED USES ...... 11 APPENDIX 3 ADDITIONAL INFORMATION PROVIDED BY THE APPLICANT...... 12

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 3 of 12

Sec 6 ECOTOXICOLOGICAL STUDIES Please refer to the core dossier for the central zone.

6.1 Effects on Birds

Please refer to the core dossier for the central zone.

6.2 Effects on Terrestrial Vertebrates Other Than Birds

Please refer to the core dossier for the central zone.

6.3 Effects on Aquatic Organisms

6.3.1 Overview and summary Please refer to the core assessment. 6.3.1.1 Toxicity Please refer to the core assessment. Because of the toxicity of the active ingredients as well as the formulation following labels must be signed out:

NW 262: The product is toxic for algae. NW 264: The product is toxic for fish and aquatic invertebrates.

6.3.1.2 Exposure The product BAS 310 62 I is a polyethylene terephthalate (PET) net, which is coated with 1.8% of an alpha-cypermethrin formulation (BAS 310 62 I) using a polymeric binder system. BAS 310 62 I is used for the protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest. Aquatic organisms may be exposed to plant protection products as a result of run-off from treated trunks or stocks. The studies and data provided a risk assessment relevant to the exposure of aquatic organisms to BAS 310 62 I under practical conditions of use. In case of insecticidal nets, no spray drift is possible due to the net technology. In comparison to a spray application, the active substance is not directly released to the target or to the environment. It is fixed to the net fabric. Contamination of the vicinity of the wood stack can occur via contact of the net with the soil surface, or carry-over by the worker applying the net (e.g. via shoes), but these measured amounts would be low and limited to the surrounding 1 to 5 meters. The net itself should not come into contact with surface water. As forest soils are not drained, drainage as entry pathway can also be excluded for the planned use in forestry. The remaining cause for release of the active substance is rainfall. It is known from other types of insecticidal nets, that low amounts of active substance are released by rain and can reach the surrounding environment. Residues were found in water dripping through the net.

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 4 of 12

As measured by the applicant in field study (Tilting 2011, see Part B Sec 5 CA for detailes) the amount washed out during a heavy rain event was estimated to be 0.55% of the total content of active substance in the net. The water reaching the soil was absorbed by the forest soil and no run-off water could be directly observed in 5 m from the nets. There is an exposure of Alpha-Cypermethrin at 5 m within the range below LOQ (LOQ: is 0.005 mg/kg) from the application site, i.e. the woodstack. Alpha-cypermethrin was not detected in the soil horizons at 1 m distance from the wood stack. However, alpha-cypermethrin was absorbed in the litter above the soil horizons up to a distance of 5 m from the stack, even if in small amounts (< LOQ). Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required. Risk mitigation measures have to be implemented involving a distance of 10 m to surface waters when using BAS 310 62 I as a woodnet. No further PEC calculations are necessary.

The risk to aquatic organisms following exposure to BAS 310 62 I according to the GAP for the indication, as well as to the active substance alpha-cypermethrin and the relevant water metabolites is acceptable, if an unsprayed drift-buffer of 10 is used (NW 608 distance of 10m).

NW 262: The product is toxic for algae. EbC10 Alpha-Cypermethrin < 0.05 mg/L (Pseudokirchneriella subcapitata)

NW 264: The product is toxic for fish and aquatic invertebrates. LC50 Alpha-Cypermethrin =0.0028 mg/L (O. Mykiss), NOEC Alpha-Cypermethrin = 0.00003 mg/L (P. promelas ), LC50 Alpha-Cypermethrin = 0.0003 mg/L (D. magna)

6.4 Effects on Bees

Please refer to the core dossier for the central zone.

6.5 Effects on Arthropods Other Than Bees (IIIA1 10.5)

6.5.1 Overview and summary Please refer to the core dossier for the central zone. 6.5.1.1 Toxicity Please refer to the core dossier for the central zone. Because of the toxicity of the active ingredient as well as the formulation, the following labels must be signed out:

NT new(1) The product is not authorised for use in nature protection areas.

NT new(2) The product is not authorised for use in or known habitats of insect species, listed in Annex II and IV of directive 92/43/EWG.

6.5.2 Overall conclusion Please refer to the core dossier for the central zone. The preliminary results summarized in the corresponding core dossier indicate an acceptable risk of Storanet nets covering tree trunks or lumber stocks to non-target arthropods, following application Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 5 of 12 according to the intended uses, if not each harvested tree trunk is coverd as well as focusing on endangered arthropod species. However, uncertainties in risk assessment result from insufficient information and methodology of submitted studies, for example about the by-effects on non-target arthropods (by-catch number and non-target species composition), as well as methodological deficiencies (e.g. sampling site, delayed mortality) Thus, the risk assessment for non-target arthropods, especially for large insect species (and possibly endangered species) and bark beetle predators, is not finalized. As shown by Perny (2011) it is possible to get more information about by-catch species of non target arthropods as well as on number of non target arthropod species individuals, if there were a more exact observation and a more frequent pick up of dead individuals from the sourrounding of the nets in the studies. Hence, for the finalization of the risk assessment additional monitoring studies should be submitted, focusing on the effects of Storanet net on large insect species at relevant, representative and realistic worst-case application sites in conifer forest ecosystems, exemplarily considering:

o Species composition as well as varying population denisities of non-target arthropods depending on biotic and abiotic factors

o attractiveness of Storanet nets as seat or vantage point for large insects (possibly protected species) without further towering structure in a forest

o delayed mortality effects on escaping non-target arthropods (2-3 hours)

o improvement of methodological deficits (collection system for dead insects, frequency of data sampling, observation of landing and departuring non-target arthropods, etc.)

o Mortalities of endangered arthropod species.

6.6 Effects on Earthworms and Other Soil Non-target Macro-organisms (IIIA1 10.6)

6.6.1 Overview and summary Please refer to the core dossier for the central zone. 6.6.1.1 Toxicity Information about ecotoxicological endpoints for earthworms and other soil non-target macro- organisms is considered to be relevant for all countries. Therefore please refer to the core assessment Part B, section 6, chapter 6.7.

6.6.1.2 Exposure Earthworms, other soil non-target macro and mesofauna as well as soil organisms involved in the breakdown of dead organic matter will be exposed to plant protection products containing alpha- cypermethrin whenever contamination of soil may occur as a result of the intended uses of BAS 310 62 I. For the active substance alpha-cypermethrin the EU agreed endpoints are used for the risk assessment on earthworms. Effects on earthworms and other soil non-target macro-organisms of BAS 310 62 I were not evaluated as part of the EU review of the active substance, therefore no EU agreed endpoints

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 6 of 12 exist for this particular formulation. Since the product BAS 310 62 I is applied in forestry as a woodnet for protection of single trunks or lumber stocks, a specific approach concerning the risk assessment and the use of studies with alpha-cypermethrin containing formulations is necessary. According to the GAP, BAS 310 62 I is applied as a woodnet with a maximum application rate of 10 g alpha-cypermethrin (use: 00-003/00-004 100 m2 net with 10 g alpha-cypermethrin). For the predicted environmental concentrations in soils (PEC soil), reference is made to the environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values for the active substance alpha-cypermethrin are presented in the table below. Experimental determination of PECsoil was confirmed by two field trials which were described in Part B, Section 5. Results assumed an even distribution of the substances in the top 1 cm horizon with a soil bulk density of 1.5 g/mL (based on a KOC > 500 L/kg).

The resulting PECsoil value for the active substances alpha-cypermethrin is presented in the table below. Table 6.6-1: Maximum PECs for BAS 310 62 I and Alpha-Cypermethrin after applications of BAS 310 62 I plant protection product: BAS 310 62 I use: insecticidal net Number of applications/intervall 1 application rate: 100 m2 net with a nominal a.s. content of 100 mg/m2

active soil relevant Soil depth PECact substance/preparati application rate ( cm) (mg/kg) on (g/ha) 100 m2 net = 10g alpha- 1 0.25 cypermethrin

Relevance of metabolites The major soil metabolites of alpha-cypermethrin to be considered for risk assessments are mPBA and DCPA. There are no acute and chronic data available for both metabolithes.

6.6.2 Overall conclusion The results of the risk assessment are summarized in the following table. PECs were calculated in line with German national requirements. Table 6.6-2: Risk for soil-macroorganisms, indication 00-003 and 00-004

Test Intended use Timescale Endpoint PEC TER TER trigger substance (g a.s./ha) (mg/kg dw soil) (mg/kg soil dw) Earthworms (Eisenia fetida) Alpha- Use 00-003/00-004 Acute >501 0.25* >200 10 Cypermethrin 1x 10 g a.i. Acute >501 >200 10

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 7 of 12

Acute >33.31 >133.2 10 Soil depth: 1 cm Long-Term >0.21 >0.8 5

1) Toxicity endpoint is re-adjusted by a soil factor of 2 to address the organic content of the soil, since the log Pow for the active substance is >2. * Worst-case PEC soil value from the woodnet in a deciduous forest (study: Tilting 2011, see Part B Sec 5 CA for detailes) TER values in bold fall below the relevant trigger.

Alpha-cypermethrin is known to have a fast dissipation in soil (median DT50, field of 35 days, EC Review Report, February 2004). Therefore, chronic risk for earthworms arising from long-term use of BAS 310 62 I is considered to be acceptable without considering special mitigation measures. In addition, a full-fauna field study in a forest showed no effects of alpha-cypermethrin on soil- populations (see core dossier Chapter 6.6). Based on the predicted concentrations of alpha-cypermethrin in soils, the TER values describing the longterm risk for earthworms and other non-target soil organisms following exposure to alpha- cypermethrin according to the GAP of the formulation BAS 310 62 I does not achieve the acceptability criteria TER ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. „Storanet“-woodnets are applicated on single trunks or lumber stacks which are laying on the ground. Significante contamination of soil is expected only in directe surrounding and below of trunks or lumber stacks. In the light of small affected areas in relation to not affected forest areas in the surrounding, there is no risk for local earthworm populations.

6.6.3 Effects on organic matter breakdown (IIIA1 10.7) Please refer to the core dossier for the central zone.

6.7 Effects on Soil Microbial Activity (IIIA1 10.7)

Please refer to the core dossier for the central zone.

6.8 Effects on Non-Target Plants (IIIA1 10.8)

6.8.1 Terrestrial plants Please refer to the core dossier for the central zone.

6.8.2 Predicted distribution and fate in the environment and time courses involved (IIIA1 10.11.1) Please refer to the core dossier for the central zone.

6.8.3 Non-target species at risk and extent of potential exposure (IIIA1 10.11.2) Please refer to the core dossier for the central zone.

6.8.4 Short- and long-term risks for non-target species. populations. communities and processes (IIIA1 10.11.3)

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 8 of 12

6.8.4.1 Birds Please refer to the core dossier for the central zone. 6.8.4.2 Aquatic organisms The following EU agreed endpoints for aquatic organisms exposed to the active substances alpha- cypermethrin are reported in Review Report on alpha-cypermethrin (SANCO/4335/2000-final) and the Monograph with its Addenda for alpha-cypermethrin. Further details regarding the tests with alpha- cypermethrin, its metabolites and a representative solo-formulation are provided in the EU Review for alpha-cypermethrin. Section 6.3 gives the details of the risk assessment for aquatic organisms on the basis of all available data.

6.8.4.3 Terrestrial vertebrates other than birds Please refer to the core dossier for the central zone. 6.8.4.4 Honeybees Please refer to the core dossier for the central zone. 6.8.4.5 Arthropods other than bees Please refer to the core dossier for the central zone. 6.8.4.6 Earthworms and other soil macro-organisms Earthworms, other soil non-target macro and mesofauna as well as soil organisms involved in the breakdown of dead organic matter will be exposed to plant protection products containing alpha- cypermethrin whenever contamination of soil may occur as a result of the intended uses of BAS 310 62 I. „Storanet“-woodnets are applicated on single trunks or lumber stacks which are laying on the ground. Significante contamination of soil is expected only in directe surrounding and below of trunks or lumber stacks. In the light of small affected areas in relation to not affected forrest areas in the surrounding, there is no risk for local earthworm populations.

6.8.4.7 Soil Microbial Activity Soil microorganisms will be exposed to plant protection products containing alpha-cypermethrin whenever contamination of soil may occur as a result of the intended uses of BAS 310 62 I. Under field conditions, the use of BAS 310 62 I as a woodnet poses no unacceptable risk to non-target soil micro-organisms. Based on the predicted concentrations of Alpha Cypermethrin in soils, the risk to soil microbial processes following exposure to alpha-cypermethrin / BAS 310 62 I according to the GAP of the formulation BAS 310 62 I is considered to be acceptable according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2.

6.8.4.8 Non-target organisms (flora and fauna) Please refer to the core dossier for the central zone.

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum – DE STORANET Central zone

Page 9 of 12

6.8.5 Risk of fish kills and fatalities in large vertebrates or terrestrial predators (IIIA1 10.11.4) Please refer to the core dossier for the central zone.

6.8.6 Precautions necessary to avoid/minimise environmental contamination and to protect non-target species (IIIA1 10.11.5) Exposure to aquatic organisms is not expected as BAS 310 62 I is applied in forestry as a woodnet for single trunks or lumber stocks. Any potential exposure would be related to the active ingredient, which might wash off from the net. Run off studies by the applicant have demonstrated that there is an exposure at 5 m within the range below LOQ (LOQ is 0.005 mg/kg) from the application site, i.e. the woodstack. Alpha-cypermethrin was not detected in the soil horizons at 1 m distance from the wood stack. However, alpha-cypermethrin was absorbed in the litter above the soil horizons up to a distance of 5 m from the stack, even if in small amounts (< LOQ). Therefore, in order to exclude completely the exposure of surface water with alpha-cypermethrin, a distance of more than 5 m between the wood stack and the nearest water body is required. Risk mitigation measures involving a distance of 10 m to surface waters in using BAS 310 62 I as a woodnet have to be implemented.

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum Central Germany Page 10 of 12

Appendix 1 List of data submitted in support of the evaluation Please refer to the core dossier for the central zone.

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum Central Germany Page 11 of 12

Appendix 2 Table of Intended Uses Please refer to the core dossier for the central zone.

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 6 BAS 310 62 I Registration Report – National Addendum Central Germany Page 12 of 12

Appendix 3 Additional information provided by the applicant Please refer to the core dossier for the central zone.

Applicant BASF Evaluator zRMS DE Date October 2013

Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 1 of 56

REGISTRATION REPORT Part B Section 7: Efficacy Data and Information Detailed Summary

Product Code: Storanet Reg. No.: 007598-00/00 Active Substance: 1,57 g/kg (0,157% w/w) alpha- Cypermethrin

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: BASF Date: 2012-01-31

Evaluator: Julius Kühn-Institut Date: 2013-04-16

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 2 of 56

Table of Contents

IIIA1 6 Efficacy Data and Information on the Plant Protection Product...... 3 General information ...... 4 Recent registration situation/history of the PPP...... 4 Information on the active ingredients (Uptake and mode of action)...... 4 Information on crops and pests ...... 5 Information on the intended uses ...... 4 IIIA1 6.1 Efficacy data ...... 6 IIIA1 6.1.1 Preliminary range-finding tests ...... 6 IIIA1 6.1.2 Minimum effective dose tests ...... 8 IIIA1 6.1.3 Efficacy tests...... 10 IIIA1 6.1.4 Effects on yield and quality ...... 26 IIIA1 6.1.4.1 Impact on the quality of plants and plant products ...... 26 IIIA1 6.1.4.2 Effects on the processing procedure ...... 27 IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products ...... 27 IIIA1 6.2 Adverse effects ...... 27 IIIA1 6.2.1 Phytotoxicity to host crop...... 27 IIIA1 6.2.2 Adverse effects on health of host animals ...... 27 IIIA1 6.2.3 Adverse effects on site of application ...... 27 IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees)...... 27 IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ...... 329 IIIA1 6.2.6 Impact on succeeding crops ...... 35 IIIA1 6.2.7 Impact on other plants including adjacent crops...... 35 IIIA1 6.2.8 Possible development of resistance or cross-resistance...... 35 IIIA1 6.3 Economics ...... 36 IIIA1 6.4 Benefits...... 36 IIIA1 6.4.1 Survey of alternative pest control measures...... 36 IIIA1 6.4.2 Compatibility with current management practices including IPM...... 36 IIIA1 6.4.3 Contribution to risk reduction ...... 36 IIIA1 6.5 Other/special studies ...... 36 IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ...... 37 IIIA1 6.7 List of test facilities including the corresponding certificates...... 40 Appendix 1: List of data submitted in support of the evaluation ...... 43 Appendix 2: GAP tables...... 52 Appendix 3: Additional information provided by the applicant ...... 54 Appendix 4: Summary of data on trials site and application details per use...... 54

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 3 of 56

Appendix 5: Summary of data on effectiveness trials per use...... 54 Appendix 6: Summary of detailed data on herbicide effectiveness trials...... 54

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 4 of 56

IIIA1 6 Efficacy Data and Information on the Plant Protection Product

General information This document summarises the information related to the efficacy of the plant protection product BAS 310 62 I, trade name Storanet containing the active substance alpha-cypermethrin which was included into Annex I of Directive 91/414 (Commission directive 2004/58/EC). Storanet is a net made of polyester yarn coated with a formulation consisting of alpha- cypermethrin and a polymer binder system. The binder system effectively prevents the active substance from being washed out by rainfall. The product Storanet (BAS 310 62 I) is intended for application (wrapping of single trunk, appli- cation over the top of lumber stocks) in hard- and softwood against bark and wood boring bark beetles, longhorn beetles and jewel beetles for protection of harvested wood from infestation and for protection against flight of beetles from attacked wood. Germany is the zRMS and belongs according to Regulation EC No 1107/2009 to the central registration zone. According to the EPPO standard PP1/241 (zones of comparable climate in the EPPO region) Germany is part of the maritime climatic zone.

DE acts as the zonal rapporteur member state, AT, PL, CZ SK, SL, UK and RO are concerned member states.

Recent registration situation/history of the PPP Storanet is intended to be authorised the first time in the central zone. Therefore in Germany and in countries of EU central zone different insecticidal products are registered with this active substance. Several products with the a. s. cypermethrin, thus contain- ing the isomer alpha-cypermethrin are registered in Germany. Comparable insecticidal products with this active substance are registered in other EU-Countries for insect control in different crops.

Information on the active ingredients (Uptake and mode of action) Alpha-cypermethrin is a pyrethroid. Pyrethroids possess a predominant residual effect. They are not systemic in plants and have a low vapour pressure and long term persistent action. A fea- ture of pyrethroids is the fast initial efficacy by many species of insects known as “knock down effect”. Comparable to other pyrethroids of the new generation, the effect of alpha-cypermethrin is dependent on temperature. Low temperatures lead to a high toxicity of the active substance alpha-cypermethrin. Pyrethroide have only a restricted effect on temperatures above 25° Cel- sius. Mainly contact but also ingestion by feeding lead to effects. Pyrethroids as Alpha- cypermethrin act stereoselectively on the fast-voltage–dependent sodium channels in excitable nerve membranes in several parts of the insect nervous system. The major initial effect is to delay the closing of the sodium channel activation gate. This results in a pronounced prolonga- tion of the inward sodium current that leads to the nerve membrane depolarization, causing a block of nerve impulses. This disruption of nerve transmission results in hyperexcitation, tremors and convulsions, followed by paralysis and the death of the affected insect. Different insect species with different feeding modes, biting and sucking, are targeted as the active ingredient Alpha-cypermethrin acts by contact as well as by ingestion of treated plant parts. The main target pests in arable and horticultural crops are sucking and biting insects. The active has good action on beetles. Crop damages due to the active ingredient are usually not expected. Resistance to pyrethroids (all in IRAC Mode of Action Group 3A), combined with cross resis- tance between different pyrethroids, has been observed for several different pest insects al-

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 5 of 56 ready. In Europe resistance to pyrethroids is known to occur e.g. in the peach-potato aphid (Myzus persicae), the Colorado potato beetle (Leptinotarsa decemlineata), the pollen beetle (Meligethes aeneus) and in pest insects of stored products. Resistance mechanisms between different species may differ. In some species like Myzus persicae even different resistance mechanisms were detected in different individuals.

Information on crops and pests Bark beetles are a natural component of ecosystem forest. Only if the attack is heavy, a healthy forest is endangered. i Outbreaks of bark beetles appear after storm and snow breakage with high storm- or snow- damaged timber and lead to a high number of dying trees. Healthy trees can only be attacked by bark beetles, if the number of drilling beetles is so high, that the natural defence system of the trees breaks down. The most important species in spruce are Ips typographus (Buchdrucker) and Pityogenes cha- lographus (Kupferstecher). Trypodendron lineatum is nowadays a dreaded technical wood pest. Platypus cylindrus is the most damaging one in oak logs. Dryocoetes autographus (zottiger nordischer Fichtenborkenkäfer) and Hylurgus ligniperda (ac- cording to trial report Hylastes ligniperda, Fichtenbastkäfer) belong to less harmful bark beetle species appearing late in the year. Less important bark beetles are bark beetles of minor pest potential in forestry. Dryocoetes autographus and Hylurgus ligniperda (according to trial report Hylastes ligniperda) belong to these less harmful bark beetle species. Weevil beetles (also known as snout beetles) are among the most destructive insects on the planet and belong to the order of Coleoptera. They are tiny beetles that do enormous damage to growing plants and stored grains. The mouthparts of a typical weevil are formed into a long snout. The snout varies according to the weevil species, in some species the snout is even longer than the body. Storanet has applied for applications to the protection of harvested wood and not for the stand- ing timber.

Information on the intended uses AWG‐No. 007598‐00/00‐001 Field of Application Forestry Crop/Situation deciduous trees, conifers pest/purpose wood‐breeding beetle, bark beetle Area of Use Outdoors, felled wood Time of Treatment Before beetles fly out or in case of established hazards or from begin‐ ning of infestation Max. Number Appl. use 1 Max. Number Appl. 1 Crop/Season Application Method lay out App. Rate Product/Water App. Circulation Pre‐harvest Interval Outdoors, felled wood: conifers, deciduous trees The setting of an PHI is without any relevance:(N) App. Rate comment The dose corresponds to the size of the netting / max. 50 m² net‐ ting/individual tree

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 6 of 56

AWG‐No. 007598‐00/00‐002 Field of Application Forestry Crop/Situation deciduous trees, conifers pest/purpose longhorn beetle species, jewel beetle Area of Use Outdoors, felled wood Time of Treatment Before beetles fly out or in case of established hazards or from begin‐ ning of infestation Max. Number Appl. use 1 Max. Number Appl. 1 Crop/Season Application Method lay out App. Rate Product/Water App. Circulation Pre‐harvest Interval Outdoors, felled wood: conifers, deciduous trees The setting of an PHI is without any relevance:(N) App. Rate comment Max. 50 m² netting/individual tree / the dose corresponds to the size of the netting

AWG‐No. 007598‐00/00‐003 Field of Application Forestry Crop/Situation deciduous trees, conifers pest/purpose wood‐breeding beetle, bark beetle Area of Use Outdoors, felled wood Time of Treatment Before beetles fly out or in case of established hazards or from begin‐ ning of infestation Max. Number Appl. use 1 Max. Number Appl. 1 Crop/Season Application Method lay out App. Rate Product/Water App. Circulation Pre‐harvest Interval Outdoors, felled wood: conifers, deciduous trees The setting of an PHI is without any relevance:(N) App. Rate comment The dose corresponds to the size of the netting / max. 100 m² net‐ ting/short wood deck

AWG‐No. 007598‐00/00‐004 Field of Application Forestry Crop/Situation deciduous trees, conifers pest/purpose longhorn beetle species, jewel beetle Area of Use Outdoors, felled wood Time of Treatment Before beetles fly out or in case of established hazards or from begin‐ ning of infestation Max. Number Appl. use 1 Max. Number Appl. 1 Crop/Season Application Method lay out Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 7 of 56

App. Rate Product/Water App. Circulation Pre‐harvest Interval Outdoors, felled wood: conifers, deciduous trees The setting of an PHI is without any relevance:(N) App. Rate comment Max. 100 m² netting/short wood deck / the dose corresponds to the size of the netting

AWG‐No. 007598‐00/00‐005 Field of Application Forestry Crop/Situation deciduous trees, conifers pest/purpose wood‐breeding beetle, bark beetle Area of Use Outdoors, felled wood Time of Treatment Before beetles fly out or in case of established hazards or from begin‐ ning of infestation Max. Number Appl. use 1 Max. Number Appl. 1 Crop/Season Application Method lay out App. Rate Product/Water App. Circulation Pre‐harvest Interval Outdoors, felled wood: conifers, deciduous trees The setting of an PHI is without any relevance:(N) App. Rate comment The dose corresponds to the size of the netting / max. 200 m² net‐ ting/long wood deck

AWG‐No. 007598‐00/00‐006 Field of Application Forestry Crop/Situation deciduous trees, conifers pest/purpose longhorn beetle species, jewel beetle Area of Use Outdoors, felled wood Time of Treatment Before beetles fly out or in case of established hazards or from begin‐ ning of infestation Max. Number Appl. use 1 Max. Number Appl. 1 Crop/Season Application Method lay out App. Rate Product/Water App. Circulation Pre‐harvest Interval Outdoors, felled wood: conifers, deciduous trees The setting of an PHI is without any relevance:(N) App. Rate comment The dose corresponds to the size of the netting / max. 200 m² net‐ ting/long wood deck

IIIA1 6.1 Efficacy data The applicant supposed that all trials submitted follow the EPPO standards and they were car- ried out by officially recognized test units in accordance with the principles of Good Experimen- tal Practice (GEP). On the basis of the EPPO standard 1/241(1) Guidance on comparable cli-

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 8 of 56 mates, the trials reported in the dossier are grouped and summarized by EPPO zones. EPPO zones have been defined by taking into account differences between the agro-climatic sub- areas of the EPPO region. The trials were carried out in accordance with relevant EPPO stan- dards.

Table 6.1-1: Spatial distribution of trials submitted to support the efficacy section in the central zone Country EPPO zone Regulatory zone United Kingdom (UK), Germany (DE) maritime central Poland (PL) north-east central - south-east central

IIIA1 6.1.1 Preliminary range-finding tests The target rate of the test product is tested to be the minimal but still effective dose determined in an artificial field test.

Materials and methods BASF produced Interceptor mosquito nets with different contents of the active substance alpha- cypermethrin: 200 (200 %), 100 (target rate), 50 (50%), 25 (25%) and 0 mg a.s./m2 net. In one trial these nets were tested against the bark beetle Ips typographus according to GEP in Lower Saxony (Germany) by an Official Research Institute (Nordwestdeutsche Forstliche Versuchsan- stalt - Abteilung Waldschutz) in the year 2008. The nets (28 x 48 cm) were tightened in wooden frameworks and repeated four times per vari- ant and tested under field conditions in Göttingen from 25.05.2008 until 14.10.2008. On 29.05., 05.06., 24.09. and 14.10.2008 (4, 10, 121, 141 d after beginning of the trial) respec- tively 20 spruce bark beetles (Ips typographus) per replicate were set on the treated nets for 30 seconds and for 60 seconds. After 24 hours waiting time the condition of the spruce bark bee- tles was rated in three classes. The first class were vital living beetles, the second class beetles with abnormal behaviour and the third class dead beetles. As the total number of bark beetles was not the same in each variant and replicate the part of rated classes [%] per variant and evaluation date was calculated as followed: Part of rated classes [%] per variant and evaluation date = number of rated beetles / number of tested bark beetles * 100. Detailed information is given in the report 2011/1040744 Anonymous 2008 a.

Results At the first evaluation (4 d after beginning of the trial) only dead beetles or beetles with abnormal behaviour were found in all treated nets (25-200 mg a.s./m2). The percentage of dead beetles did not increase with the dose rate in the net. In the control samples 6-8% dead beetles and 45- 59 % beetles with an abnormal behaviour were found (see 2011/1040744 Anonymous 2008 a; excel sheet “Ergebnis 1. Ansatz” and “Zusammenfassung”). At the second evaluation (10 days after beginning of the trial) 13% of vital bark beetles were found after exposure to the lowest dose rate tested (25 mg a.s./m²) for 30 seconds. After expo- sure for 60 seconds, 8% of vital bark beetles were found at the dose rate of 25 mg a.s./m² and 3% at the dose rate of 50 g a.s./m². The remaining bark beetles were killed or behaved abnor- mal. The number of dead beetles increased with increasing dose rate. In control samples 1-4% dead beetles and 1-18% beetles with abnormal behaviour were found (see 2011/1040744 Anonymous 2008 a; excel sheet “Ergebnis 2. Ansatz” and “Zusammenfassung”). At the third evaluation (121 d after beginning of the trial) 18-37 % of the bark beetles in control samples were dead and 20-32 % behaved abnormal. The content of active substance on nets seemed to decrease slowly. After 30-60 seconds exposure to the dose rate of 200 mg a.s./m2, the percentage of vital beetles was 2-8 %. When exposing beetles to 100 mg a.s./m², 0-4% of the beetles were vital, at 50 g a.s./m² 13-9% and at 25 mg a.s./m² 2-5% vital beetles were Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 9 of 56 found. Overall the efficacy of the active substance on the net (25-200 mg a.s./m2) was good to very good. 68-92 % dead, 8-22 % abnormal and 2-13 % vital bark beetles were found after 30 s exposure (see 2011/1040744 Anonymous 2008 a; excel sheet “Ergebnis 3. Ansatz” and “Zusammenfassung”). At the last evaluation (141 d after beginning of the trial) a clear loss of efficacy was observed after 30-60 s exposure. The percentage of vital, abnormal and dead beetles after application of the lowest dose rate was comparable to that of the untreated control. 29-70 % vital, 13-36 % abnormal and 18-43% dead bark beetles were found when exposing beetles for 30 s to 50-200 mg a.s./m2. 14-18 % vital, 20-30 % abnormal and 56-63 % dead bark beetles were found after exposure for 60 s (see 2011/1040744 Anonymous 2008 a; excel sheet “Ergebnis 4. Ansatz” and “Zusammenfassung”). To compare the overall efficacy, the average values of rated classes [%] per treatment are summarised for the assessments performed 4-141 days after the beginning of the trial (Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1). When exposing beetles for 60 seconds to the nets, the percentage of dead bark beetles rose from 11% (0 mg a.i/m²) to 82% (100 mg a.s./m2) and stayed at the level of 80 % (200 mg a.s./m2). The percentage of bark beetles with abnormal behaviour was similar to that of the un- treated control and the percentage of vital bark beetles decreased from 72 % (0 mg a.s./m²) to 5 % (100 mg a.s./m2) and stayed at the level of 6 % vital bark beetles (200 mg a.s./m2). The data for 30 s exposure showed the same tendencies for treated variants with a higher percent- age of vital bark beetles and a lower percentage of dead bark beetles.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1: Mean per- centage of rated classes [%] of Ips typographus evaluated 4-141 days after the beginning of the trial

Amount of active Vital bark Bark beetles Dead bark substance in the beetles with abnormal beetles net behaviour [mg a.s./m2] Time of expo- 30 60 30 60 30 60 sure sec sec sec sec sec sec 200 Mean 8 6 19 13 74 80 SD 14 8 14 9 24 15 100 Mean 10 5 17 13 73 82 SD 21 8 15 11 34 19 50 Mean 21 6 11 19 68 75 SD 33 6 5 8 35 13 25 Mean 24 17 19 19 56 64 SD 40 26 15 17 36 32 0 Mean 57 72 28 17 15 11 SD 28 21 24 20 15 8

Conclusion The preliminary range-finding tests showed an optimal dose-efficacy-proportion at a target ap- plication rate of 100 mg alpha-cypermethrin/m2 in the field. The active substance content on nets seemed to decrease slowly after four months.

IIIA1 6.1.2 Minimum effective dose tests The target rate of the test product is tested to be the minimal but still effective dose in field trials.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 10 of 56

Materials and methods A minimum effective dose test was performed in cords of spruce logs for the control of Ips ty- pographus with nets containing 100 mg alpha-cypermethrin/m2 (100 %) and 200 mg alpha- cypermethrin/m2 (200 %). The minimum effective dose rate was determined in one field trial carried out by the Official Re- search institute “Nordwestdeutsche Forstliche Versuchsanstalt” during the year 2009. Each cord of spruce logs was completely wrapped in the net. The number of bark beetle galleries was rated and the degree of efficacy was calculated (details are given in 2011/1040779 Zuehlke T. 2011 a in Table 6.1.2/1.1). The report for determination of the minimum effective dose is provided in 2011/1040741 Anonymous 2009 a. The minimum effective dose trial was conducted in Lower Saxony (Germany) according to GEP principles. Nordwestdeutsche Forstliche Versuchsanstalt is GEP-certifiedii (see overview of test facilities in KIIIA 6.7/1 (DocID 2011/1040781). Detailed information on trial locations and design as well as information on application proce- dure are given in 2011/1040779 Zuehlke T. 2011 a in Table 6.1.2/1A. Description of nets, application date, application procedure and rating methods is provided be- low.

Trial description The following dose rates of the nets were tested in the minimum effective dose trial:

100 % = 100 mg alpha-cypermethrin/m2 net (no UV protection, 100 Denier, 156 mesh/sq inch, product name: Fendozin braun) = target application rate 200 % = 200 mg alpha-cypermethrin/m2 net (no UV protection, 100 Denier, 156 mesh/sq inch, product name: Fendozin braun)

A lower dose rate was not tested under natural field conditions. Spruce trees were cut at end of February (size 2b-4).The cord of spruce logs was completely wrapped in the net and roof batten were set at the bottom side parallel to the logs and at the front sides on the 18th and 19th of March. The trial comprised two replicates except of the control with only one replicate. The dif- ferently treated cords of logs were placed in randomised trial design along a forest track.

Rating method The evaluation of efficacy of the insecticide Storanet (BAS 310 62 I) against Ips typographus was based on the number of bark beetle galleries developed under the bark and was performed on August 4th. Eight areas of 20 x 50 cm were rated per log and eight logs per replicate. As an exception, eight areas of 20 x 50 cm per log for only seven logs were evaluated for one replicate of the high dosed variant.

Calculation method The degree of efficacy was calculated according to Abbott: Degree of efficacy [%] = (No. of galleriescontrol – No. of galleriestreatment) / No. of galleriescontrol * 100

Results The attack of the bark beetle Ips typhographus was not very high. 39 galleries were counted in the single control cord of logs. In both treatments (100 and 200 mg a.s./m2) no bark beetle gal- leries were found, resulting in 100 % efficacy. It is therefore not necessary to apply a higher dose rate of Storanet for reliable control of Ips typographus. This is supported by the results of the preliminary range-finding test, which was performed with an artificially controlled infestation of Ips typographus. At the beginning of April holes were found in the net of a high dosed replicate. The author as- sumed that the holes were caused by people. The holes were closed with a stapler.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 11 of 56

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1: Number of bark bee- tle galleries caused by Ips typographus under the bark of spruce logs and percent efficacy

Number of bark beetle galleries per variant Efficacy [%] Fendozin-Net Fendozin-Net Fendozin-Net Fendozin-Net Untreated brown brown brown brown control 100 mg 200 mg 100 mg 200 mg a.s./m2 a.s./m2 a.s./m2 a.s./m2 39 0 0 100 100

Conclusion The minimum effective dose test showed 100% efficacy after application of the target dose rate of 100 mg alpha-cypermethrin/m2. This result is supported by the preliminary range-finding test, which was performed with an artificially controlled infestation of Ips typographus.

IIIA1 6.1.3 Efficacy tests Bark beetles (Scolytinae) in soft- and hardwood Introduction As this is a core dossier for the Central Zone, the trial locations are grouped into the climate zones according to the SANCO/6896/2009 rev.1 of the European commission and the EPPO guideline 1/241(1) Guidance on comparable climates. The trials were conducted in Germany, Austria, Czech Republic, Poland and Croatia. Germany, Austria, Czech Republic and Poland are grouped in the Central zone. Croatia does not belong to the EU and is, therefore, not part of the climate zones established by the European Commis- sion. The trial in Croatia was performed near Pisarovina, only 35 km from the border to Slove- nia, which is part of the Central Zone. Therefore, it is assumed that the climatic conditions in the north and north-west of Croatia are comparable to those of the Central Zone. In the EPPO guideline PP 1/241(1) four zones are distinguished: Maritime, North-east, South- east and Mediterranean zone. These zones, however, are not identical to the zones established by the European Commission. Germany, Austria and the Czech Republic belong to the Maritime zone. Poland is grouped in the North-east zone and Croatia is split in two zones: the coast in the West and South of the country are part of the Mediterranean zone and the north and east are part of the South-east zone.

Geographically and meteorologically the trial sites in Poland and Croatia do not differ much from locations of the maritime zone. All trials in Poland were conducted at Katowice (50°N19°O) located 60-70 km north-east of the border to Czech Republic, which belongs to the Maritime zone. The elevation of Katowice is 266-352 meters and Katowice has got predominantly maritime to continental climate. The mean annual temperature is 7.9 C with 723 mm precipitation per yeariii. In East Germany (Maritime zone) the climate is also more continental. In Berlin, for example, the climate is described as maritime to continental, having a mean annual temperature of 8.9 C and 571 mm precipitation per year, or Prague in the Czech Republic (Maritime zone) with an annual temperature of 8 C and annual precipitation of 527 mm. The trial reported from Croatia was conducted near Pisarovina (45°N15.5°O; next bigger town is Zagreb), which is located approximately 160 km south of the border to Austria. In January the temperature is 0.2 C and in July 22 C, the precipitation is 56 mm and 79 mm, respectively. The mean annual temperature is 11.6 C with an annual precipitation of 864 mm. In Mannheim the temperature and precipitation are 1.8 C and 40 mm in January and 19.9 °C and 83 mm in July. The annual temperature is 10.5 C with 668 mm precipitation per year.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 12 of 56

As this is a core dossier of the central zone and the climates of the trials conducted in Poland and Croatia are comparable with locations in maritime zones all trials are reported together without splitting into EPPO climate zones.

To visualise the comparability of climates, maps with climate data of the “Diercke Weltatlas” are presented below.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 13 of 56

Katowice

Pisarovina

Figure Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1: Temperatures in January (Diercke Atlas)

Katowice

Pisarovina

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 14 of 56

Figure Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-2: Temperatures in July (Diercke Atlas)

Katowice

Pisarovina

Figure Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-3: Precipitation per year (Diercke Atlas)

Materials and methods To show the efficacy of Storanet (BAS 310 62 I) in comparison to authorised standard products, 25 trials were performed for authorisation of the test product in the indication bark beetles in part of logs, single logs and cord of logs during the years 2008-2010. Eight of these trials were con- ducted in Germany (Lower Saxony (7x), Brandenburg (1x)), seven trials in Poland (Katowice), one trial in Croatia (Jastrebarski lugovi), 5 trials in Austria (Wien, Bruck an der Mur, Weyersdorf, Inneres Salzkammergut, Breitenau am Hochlantsch) and four trials in Czech Republic (Praha, Dobris, Pribram (2x)) by contractor companies and Official Research institutes on behalf of BASF SE. These trials belong to the EPPO zone and EU zone as described in Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1: Trials sorted by country, EPPO zone and EU zone

Sequential Number Country EPPO zone EU zone DocID 1-5 (8 trials) Germany Maritime Central 2011/1040740, 2011/1040743, 2011/1040745 – 2011/1040747 6-12 (7 trials) Poland North-east Central 2011/1040748 – 2011/1040753, 2011/1040755 13 (1 trial) Croatia On the border of Mediter- No EU member 2011/1040754 ranean to South-east 14 (5 trials) Austria Maritime Central

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 15 of 56

2011/1040756 15-18 (4 trials) Czech Republic Maritime Central 2011/1040757 – 2011/1040760

Test facility in Germany, Poland and Czech Republic was GEP-certified and the efficacy trials were conducted according to GEP principles, except one Polish trial. An overview of the test facilities is given in KIIIA 6.7/1 (DocID 2011/1040781). In all trials each piece of log, single log or cord of logs was completely wrapped in the net. Ap- plication was made either before the logs were attacked or after attack by bark beetles (preven- tion of flight). As additional variant in some trials the efficacy of over the top treatment and a one year old used net were tested. The standard product applied in five trials was Fastac Forst and applied in four trials was Vaztak. Both products are based on alpha-cypermethrin as active sub- stance. The standard product was sprayed once at the same application date as Storanet. De- tailed information on the used standard products is given in 2011/1040777 Zuehlke T. 2011 b. The number of bark beetle galleries, of boring holes in the log, of holes in the netting, of at- tacked logs, of living beetles and/or of dead beetles was assessed and the degree of efficacy was calculated whenever possible (see summarised in 2011/1040778 Zuehlke T. 2011 c in Ta- ble 6.1.3/1.1 and /1.2).

The reports for determination of efficacy are provided in 2011/1040740 Anonymous 2009 b, 2011/1040743 Anonymous 2008 b, 2011/1040745 Anonymous 2010 a, 2011/1040746 Anony- mous 2010 b, 2011/1040747 Anonymous 2010 c, 2011/1040748 Skrzecz I. 2010 a, 2011/1040749 Skrzecz I. 2010 b, 2011/1040750 Skrzecz I. 2010 c, 2011/1040751 Skrzecz I. 2010 d, 2011/1040752 Skrzecz I. 2010 e, 2011/1040753 Skrzecz I. 2010 f, 2011/1040754 Anonymous 2010 d, 2011/1040755 Skrzecz I.,Grodzki W. 2010 a, 2011/1040756 Perny B. 2011 a, 2011/1040757 Gerakova M. 2011 a, 2011/1040758 Gerakova M. 2011 b, 2011/1040759 Gerakova M. 2011 c and 2011/1040760 Gerakova M. 2011 d. Detailed information on trial locations and design as well as information on application proce- dure are given in 2011/1040778 Zuehlke T. 2011 c in Table 6.1.3/1A.

Descriptions of nets, application date, application procedure and rating methods are described below.

Trial description Spruce trees were cut in Germany (8 trials) during a time period of November (year before ap- plication) to February (year of application). In Poland (7 trials) Norway spruce trees, in Austria spruce (4 trials) and larch trees (1 trial) and in Czech Republic (4 trials) spruce trees were cut. Pedunculate oak trees were cut in Croatia (1 trial) at the beginning of June (application year).

Application dates: Country: Not attacked logs: attacked logs: Germany: Mid March to mid April (spruce) Mid July (spruce) Poland: Mid April (spruce) second half of June (spruce) Croatia: Beginning of June (oak) Austria: April to May (spruce) April to May (spruce, larch) Czech Republic: End of April to End of May (spruce)

In efficacy trials the following application rates were used:

Storanet = 200 mg alpha-cypermethrin/m2 net (additional information) a) Precursor No.1: Interceptor Net with Fendozin (trial with the sequential no. 2) = 100 mg alpha-cypermethrin/m2 net

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 16 of 56

b) Precursor No.2: no UV protection, 100 Denier, 156 mesh/sq inch, product name: Fendozin braun (trial with the sequential no. 1) c) Precursor No.3: with UV protection , 100 Denier, 156 mesh/sq inch, product name: Fendozin olive (trial with the sequential no. 1)

d) To be authorised product: olive green with UV-protection, 75 denier, 306 mesh/sq inch (trials with the sequential no. 3-18)

Fastac Forst (15 g/L alpha-cypermethrin) = application concentration 2 % (trial with the sequential no. 1-4) application concentration 1 % (trial with the sequential no. 5) Vaztak 10 EC (100 g/L alpha-cypermethrin) = application rate is 3.97 ml/m2 (trial with the sequential no.15-18)

The trial design was a randomized block design with 1-12 replicates. The trials were performed according to EPPO 1/128(2), 1/152(2) and/or 18-2.2/1980 in Germany, EPPO 1/128(2) in Po- land and EPPO 1/135, 1/152, 1/181, 1/226, 1/239 and VÚLHM, v.v.i. únor 2010/2010 in Czech Republic.

Rating method The evaluation of efficacy of the insecticidal Storanet (BAS 310 62 I) against bark beetles and other wood and bark boring beetles is based on the number of bark beetle galleries, of boring holes in the log, of holes in the netting, of attacked logs (percentage of attacked logs), of living beetles and/or of dead beetles. Assessments were performed 29-180 days after treatment in case of preventive application (logs not yet attacked) and 3-210 days after treatment on at- tacked logs. The percentage of attacked logs was calculated from the number of attacked logs divided by the total number of logs used for one variant to get comparable values, as the trials were performed with a different number of logs per variant. The percentage of living beetles on the bark was calculated by dividing the number of living beetles by the number of all beetles having left the bark. The arithmetic mean was calculated from the parameters % of living beetles under the bark and % of living beetles in total. For de- tails see “Tab.1: Auswertung Buchdrucker Eklektorenfeld Göttingen” in the single trial report [see 2011/1040747 Anonymous 2010 c]. The degree of efficacy was calculated whenever pos- sible. In some trials no untreated control was included.

Calculation method The degree of efficacy was calculated according to Abbott: Degree of efficacy [%] = (No. Xcontrol – No. Xtreatment) / No. of Xcontrol * 100 X = No. of galleries, No. of boring holes, % of living beetles on the bark, % of living beetles un- der the bark.

Statistic To analyze the differences between variants for the number of galleries in the logs, a one-way analysis of variance was applied. To separate homogeneous groups the post-hoc RIR Tukey test was used. The STATISTICA ver. 8 program was used for statistical calculations purposes.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 17 of 56

Results In a total of 25 trials the insecticidal efficacy of Storanet against bark beetles and other wood and bark boring beetles timber logs stored in the forest was investigated (2008: n=1, 2009: n=1, 2010 n=23). Detailed results are summarised in Table 6.1.3/1.1 for preventive applications and in Table 6.1.3/1.2 for already attacked logs [see 2011/1040778 Zuehlke T. 2011 c].

Preventive treatment for the protection of cut timber logs against bark and wood breed- ing insects in the forest:

Precursors: Two trials were performed with precursors Interceptor with Fendozin, Fendozin braun (brown) and Fendozin olive on not attacked spruce logs, which were completely wrapped in the net. In one trial the precursor Interceptor with Fendozin and the standard product Fastac Forst achieved 100 % efficacy against the ambrosia bark beetle Trypodendron lineatum as measured by the number of boring holes (see Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-2). The precursor was applied at a higher concentration (200 mg alpha- cypermethrin/m2 net) than the target dose rate (100 mg alpha-cypermethrin/m2 net). The trial was performed in the same year (2008) as the preliminary range-finding test without knowing the results of the latter. As the efficacy after application of 100 and 200 mg a.s./m2 was similar in the range-finding test, it is assumed that the same level of efficacy will be achieved at the target application rate. The untreated control showed a high degree of attack with 950 boring holes. The untreated Interceptor Net possesses no efficacy against Trypodendron lineatum.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-2: Number of boring holes by the ambrosia bark beetle Trypodendron lineatum and percent ef- ficacy 29-102 after application (1 trial, Maritime Zone) No. of boring holes per variant (no. of replicates = Efficacy [%] 12) Untreated Untreated Interceptor Fastac Untreated Interceptor Fastac control Intercep- with Fendozin Forst Intercep- with Fendozin Forst tor Net 200 mg a.s./m2 2% tor Net 200 mg a.s./m2 2% 950 1035 0 0 0 100 100

The precursors Fendozin braun (brown) and olive were tested in a further trial against the bark boring beetle Ips typographus on spruce logs in the year 2009 (see results in Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-3). No difference in efficacy was observed between both products and the level of efficacy was excellent (100 %). The standard product Fastac Forst was comparable and achieved 99 % efficacy - only one gallery was found. The untreated control showed 87 galleries in the three replicates.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-3: Number of boring holes by the bark boring beetle Ips typographus and percent efficacy 96 days after application (1 trial, Maritime Zone)

No. of bark beetle galleries (no. of replicates = 3) Efficacy [%] Untreated Fendozin Fendozin olive Fastac Fendozin Fendozin olive Fastac control braun 100 mg a.s./m2 Forst braun 100 mg a.s./m2 Forst 100 mg a.s./m2 2 % 100 mg a.s./m2 2 % 87 0 0 1 100 100 99

Storanet trials – evaluation parameter "number (No.) of boring holes": Assessments of the number of boring holes in the logs are reported from five trials performed in Germany and one trial performed in Croatia.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 18 of 56

The trial report with the sequential number 3 consisted of 4 trials, but only in one trial the control was attacked by bark beetles. The results are reported in Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-3. Spruce logs (5 trials) and oak logs (1 trial) were completely wrapped in the Storanet. In 5 trials the efficacy of the test product Storanet and the standard product Fastac Forst against the bark boring beetle Ips typographus and the wood boring beetle Trypodendron lineatum on spruce logs was 100 %, showing that the products are comparable in their efficacy. 21 to 242 boring holes were found in the control logs of these five trials. In one trial 24 boring holes of bark beetles were found in one oak log treated with the test prod- uct. The author of this report assumed, that the log was attacked before application. Holes were found near and around the scars that were either old ones (on the bottom part of the largest log) or dated from the time of manipulation of the logs. According to trap catches bark beetles (Xy- loterus spp. and Xyleborus spp.) were active at application. No control and no standard product were included in this trial. Six vital wood boring beetles of the species Xyleborus spp. were found in the Storanet treated oak logs but no living bark beetles of the species Xyloterus spp. and Platypus cylindrus were found in the treated logs. In the traps Xyleborus spp. Xyloterus spp. and Platypus cylindrus were caught during the trial period (0-550 beetles per species and week). Platypus cylindrus is the most damaging bark beetle in oak logs (see 2011/1040754 Anonymous 2010 d). This trial demonstrates that the efficacy of Storanet is very good (100% efficacy), if the application is performed before bark beetle flight. This is demonstrated by the efficacy achieved against Platypus cylindrus, which started flying after application. The active substance of Storanet, alpha-cypermethrin, seemed not to penetrate deep into the log.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 19 of 56

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-4: Number of boring holes by bark beetles and percent efficacy 85-133 days after application of Storanet by wrapping not attacked timber logs (6 tri- als)

Seqen- EPPO Target Crop No. of boring holes Efficacy [%] tial No. zone organism Control Storanet Fastac Storanet Fastac (100 mg Forst (100 mg Forst a.s./m2) (2 %) a.s./m2) (2 %) 3 Maritime TRYDLI spruce 21 0 0 100 100 4 (V1) Maritime IPSXTY spruce 242 0 0 100 100 4 (V2) Maritime IPSXTY spruce 111 0 0 100 100 4 (V3) Maritime IPSXTY spruce 129 0 0 100 100 4 (V4) Maritime IPSXTY spruce 205 0 0 100 100 13 On the Bark bee- peduncu- - 24* - - - border of tles late oak Mediter- ranean and South- east * 24 pin holes in total were found, all of them near and around the scars that were either old ones (thick, bot- tom part of the largest log) or those originating from the time the logs were manipulated (morning 8. June, applicationdate). In trap catches XLTRSP (Xyloterus spp.) and XYBSP (Xyleborus spp.) were active at ap- plication date, while PLTPCS (Platypus cylindrus) was still not flying at that time.

Storanet trials – evaluation parameter "No. of galleries/development of gallery systems": Six trials performed in Poland and three trials performed in Austria are reported for the assess- ment of the number of galleries in treated logs. Four trials were conducted in the Czech Repub- lic with slightly different assessment parameters, as the magnitude and not the frequency of galleries were assessed. The completely developed gallery system was rated with a zero and no gallery with hundred. Spruce logs were completely wrapped in the Storanet. In 10 out of 13 trials no bark beetle galleries of the bark boring beetles Ips typographus and Pityogenes chalcographus and the wood boring beetle Trypodendron lineatum were found in spruce logs wrapped in the test product Storanet (

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 20 of 56

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-5). Hence the efficacy of the test product was 100 %. The standard product Vaztak (4 trials) was comparable to Storanet having also an efficacy of 100 %. The control logs showed a total of 142-488 bark beetles per trial (6 trials) or completely developed gallery systems (4 trials). In 3 out of 13 trials 20-38 galleries of less important bark beetles (Dryocoetes autographus and Hylurgus ligniperda (according to trial report Hylastes ligniperda)) were found in logs wrapped in Storanet (Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-6). Unfortu- nately, no control and standard product was tested in comparison. Therefore no conclusion can be drawn regarding percent of efficacy and comparability of test and standard product.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 21 of 56

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-5: Number of bark bee- tle galleries and percent efficacy 66-180 days after application of Storanet by wrapping not attacked timber logs (9 trials)

Seqen- EPPO Target Crop No. of galleries Efficacy [%] tial No. zone organism Control Storanet Storanet (100 mg (100 mg a.s./m2) a.s./m2) 6 North- IPSXTY Norway 422a 0b 100 East spruce 7 North- bark beetles Norway 300a 0b 100 East IPSXTY spruce 131 0 100 TRYDLI 61 0 100 PITYCH 108 0 100 8 North- bark beetles Norway 488a 0b 100 East IPSXTY spruce 187 0 100 TRYDLI 301 0 100 9 North- IPSXTY Norway 225a 0b 100 East spruce 10 North- bark beetles Norway 183a 0b 100 East IPSXTY spruce 56 0 100 TRYDLI 49 0 100 PITYCH 78 0 100 11 North- IPSXTY Norway 142a 0b 100 East spruce 14b Maritime DRYOAU and HYLGLI spruce - 33 (14 logs) - (less important bark bee- tles) 14c Maritime DRYOAU and HYLGLI spruce - 20 (20 logs) - (less important bark bee- tles) 14d Maritime less important bark beetles spruce - 38 (62 logs) -

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-6: Development of bark beetle galleries and percent efficacy 74-155 days after applica- tion of Storanet by wrapping not attacked timber (4 trials)

Seqen- EPPO Target Crop Development of galleries* Efficacy [%] tial No. zone organism Control Storanet Vaztak Storanet Vaztak (1.57 g (3.97 (1.57 g (3.97 a.s./kg**) ml/m2) a.s./kg**) ml/m2) 15 Maritime IPSXTY spruce 0 100 100 100 100 16 Maritime IPSXTY spruce 0 100 100 100 100 17 Maritime IPSXTY spruce 0 100 99.86 100 100 18 Maritime IPSXTY spruce 0 100 100 100 100 * 0 = completely developed gallery system; 100 = no gallery ** 1.57 g a.s./kg is equal to 100 mg a.s./m2

Storanet trials – evaluation parameter "Percentage. of attacked logs" and – influence of application forms and the ageing of net material: One trial was performed in the Czech Republic and 4 trials were performed in Austria for the evaluation of percentage of attacked logs (no. of attacked logs per no. of logs in one variant)

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 22 of 56 after wrapping the not attacked spruce or oak logs in the test product Storanet. Three trials were conducted in Austria to detect differences of application forms (completely wrapped spruce logs and nets thrown over spruce logs) and aging of the net material (wrapped spruce logs with a 1- year-old used Storanet) based on the number of galleries and percentage of attacked logs. In all trials no control and standard product was tested. Based on the trap catches at application date in one trial the bark beetle flight was estimated (Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-7).

In one trial bark beetle attack in Storanet treated oak logs was examined (logs wrapped in the net). No (0%) logs attacked by the wood boring beetles Xyloterus spp. and Platypus cylindrus and 67 % of logs attacked by Xyleborus spp were found. The author of this report assumed, that the logs were attacked before application, as attack was located around scars, which were ei- ther old ones or dated the time from manipulating the logs. According to trap catches bark bee- tles (Xyloterus spp. and Xyleborus spp.) were active at application. No control and standard product was tested in this trial. Six living wood boring beetles of the species Xyleborus spp. were found in the Storanet treated oak logs and no living bark beetles of the species Xyloterus spp. and Platypus cylindrus were found in the treated logs. In the traps Xyleborus spp., Xy- loterus spp. and Platypus cylindrus were caught (0-550 beetles per species and week, in total seven species) during the trial period. Platypus cylindrus is the most damaging one in oak logs (see 2011/1040754 Anonymous 2010 d).

In 4 trials bark beetle attack in Storanet treated spruce logs was examined (logs wrapped in the net). In one trial no treated log was attacked by bark beetles. 0% attack of treated logs by the bark boring beetle Ips typographus was reported from three trials and 1% attack from one trial. The bark boring beetle Pityogenes chalcographus (4 trials) and the wood boring beetle Trypo- dendron lineatum (4 trials) had attacked 0% of the treated logs. In 4 trials other bark beetles than Ips typographus, Pityogenes chalcographus and Trypoden- dron lineatum caused 0% (for wrapped logs), 28.6 % (for wrapped logs, over the top applied net and 1-year-old wrapped logs together), 32.5 % and 9 % (for wrapped logs and over the top ap- plied net together) attacked logs. The less important bark boring bark beetles Dryocoetes auto- graphus and Hylurgus ligniperda (according to trial report Hylastes ligniperda) were assessed together in four further trials with 0-35.7 % (mean: 18.4 %) attacked logs (for wrapped logs). In four trials the longhorn beetle (Cerambycidae) and the Curculionidae attacked 0-11.3 % (mean 2.8 %) of the logs. It is assumed by the author that the attack (oviposition) by the long- horn beetle and Curculionidae happened prior to felling the spruce, as the intensity of drill dust was massive and larvae were partially to fully develop.

In three trials the application methods "completely wrapped logs" and "over the top application" of the test product Storanet were compared by evaluation of less important bark beetles and other bark and wood boring beetles, as the efficacy against the main bark beetles Ips typog- raphus, Pityogenes chalcographus and Trypodendron lineatum in both variants seemed to be very good and was comparable. No remarkable difference existed between both methods on average with respect to the percentage of logs attacked by less important bark beetles. Only a slightly better efficacy seemed to be achieved on completely wrapped logs, as half of the galler- ies per log caused by less important bark beetles appeared in completely wrapped logs and the percentage of logs attacked by Cerambycidae and Curculionidae of completely wrapped logs was lower in comparison to over top application. Wrapping logs resulted in 20.8 % logs attacked by less important bark beetles, 0.9 galleries by less important bark beetles per log and 7.3 % logs attacked by longhorn beetle (Cerambycidae) and Curculionidae. After over the top applica- tion 18 % of the logs were attacked by less important bark beetles, 1.9 galleries per log formed by less important bark beetles were found and 10.5 % of the logs were attacked by longhorn beetle (Cerambycidae) and Curculionidae.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 23 of 56

In one trial logs wrapped in a new net, a 1-year-old used net and a new net applied over the top were compared. The main bark beetles Ips typographus, Pityogenes chalcographus and Trypo- dendron lineatum had not attacked the logs of all three variants. Regarding less important bark beetles, the best efficacy was achieved by logs wrapped in a new net, followed by logs wrapped in a one year old used net and the over the top application. The logs wrapped in a new net showed 35.7% attacked logs and 2.4 galleries per log, the logs wrapped in a one year old net showed 35.7 % attacked logs and 6.9 galleries per log and the net applied over the top had 42.9 % attacked logs and 11.8 galleries per log caused by less important bark beetles.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-7: Percentage of by bark and wood boring beetles attacked logs, number of galleries per log (in brackets) and percent efficacy 85-180 days after application of Storanet by wrapping not attacked timber logs (new and one year old net) and/or by over the top application (5 trials) Seqen- EPPO Target organism Crop Control Storanet Storanet Storanet 2 tial No. zone [EPPO code] Trap catches (100 mg (100 mg (100 mg a.s./m ) 2 2 at application a.s./m ) a.s./m ) completely date completely over the top wrapped in 1 wrapped application year old net 13 On the XLTRSP Pe- was already well 0 - - border of dun- ahead and slowing Mediterra- culate down nean and XYLBSP oak were still active 67 - - South- and swarming East PLTPCS was still not 0 - - flying at that time 14a Maritime IPSXTY, PITYCH spruce - 0 - - and TRYDLI Other bark bee- - 0 - - tles 1CERAF and - 0 - - 1CURCF DRYOAU and - 0 - - HYLGLI (less important bark beetles) 14b Maritime IPSXTY, PITYCH spruce - 0 and TRYDLI Other bark bee- - 28.6 tles 1CERAF and - 0 1CURCF DRYOAU and - 35.7 42.9 35.7 HYLGLI (less (no. of galleries (no. of galleries (no. of galleries important bark per log 2.4) per log 11.8) per log 6.9) beetles) 14c Maritime IPSXTY, PITYCH spruce - 0 - and TRYDLI Other bark bee- - 32.5 - tles 1CERAF and - 0 - 1CURCF DRYOAU and - 20 45 - HYLGLI (less (no. of galleries (no. of galleries important bark per log 1.0) per log 4.65) beetles) 14d Maritime IPSXTY spruce - 1 - PITYCH and - 0 - TRYDLI Other bark bee- - 9 - tles 1CERAF and - 13.5 - 1CURCF

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 24 of 56

Seqen- EPPO Target organism Crop Control Storanet Storanet Storanet 2 tial No. zone [EPPO code] Trap catches (100 mg (100 mg (100 mg a.s./m ) 2 2 at application a.s./m ) a.s./m ) completely date completely over the top wrapped in 1 wrapped application year old net Less important - 17.7 11.6 - bark beetles (no. of galleries (no. of galleries per log 0.6) per log 0.4) 1CERAF and - 11.3 13.0 - 1CURCF 14b,c,d Maritime Less important spruce - 20.8* 18.0* - bark beetles (no. of galleries (no. of galleries per log 0.9) per log 1.9) 1CERAF and - 7.3* 10.5* - 1CURCF * calculated out of the values for Inneres Salzkammergut, Weyersdorf and Bruck given in Figure 6 and 7 of the trial report [see 2011/1040756 Perny B. 2011 a]

Treatment of attacked logs for prevention of bark and wood boring insect flight: One trial was performed in Germany, 2 trials in Austria and one trial in Poland to evaluate the possibility of preventing the flight of bark and wood boring insects from attacked spruce or larch logs completely wrapped in the test product Storanet. This treatment was compared to a spray application of the standard reference product Fastac Forst. Rating parameters were percent of living insects in an “Eklektor” test, the number of holes in the netting, dead and living insects and effective pre-flight protection in the field (Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-8). The test product Storanet showed 100 % efficacy against beetles of Ips typographus on the bark, 77 % efficacy against beetles of Ips typographus under the bark and 96 % efficacy against beetles of Ips typographus in total (under and on the bark). The standard product Fastac Forst achieved 100 % efficacy against Ips typographus under and on the bark, having a better pene- tration under the bark. The efficacy against Ips typographus on the bark and against Ips typog- raphus in total is comparable to the efficacy achieved by the test product. In the control logs 68 to 97 % of the beetles under and on the bark were living. An effective pre-flight protection against beetles on the bark (Ips typographus, Pityogenes chal- cographus, Cerambycidae) was demonstrated in two trials. In one trial only dead bark beetles were found after treatment inside the net and no holes were made of bark beetles in the Stora- net. Hence an effective pre-flight protection was also achieved in this trial.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-8: Per- cent/number of living beetles, number of dead insects, effective pre- flight protection, number of holes in the netting and percent efficacy 3-210 days after application of Storanet by wrapping attacked timber logs (4 trials)

Seqen- EPPO Target Rating variable Control Storanet Fastac Storanet Fastac tial No. zone organism (100 mg Forst (100 mg Forst 2 2 [EPPO a.s./m ) (1%) a.s./m ) (1%) code] Efficacy [%] Efficacy [%] 5 Maritime IPSXTY % of living beetles on 97 0 0 100 100 the bark % of living beetles un- 68 16 0 77 100 der the bark % of living beetles 94 4 0 96 100 14a Maritime IPSXTY, Effective protection - yes - - - PITYCH, against flying out bee- 1CERAF tles and not

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 25 of 56

Seqen- EPPO Target Rating variable Control Storanet Fastac Storanet Fastac tial No. zone organism (100 mg Forst (100 mg Forst 2 2 [EPPO a.s./m ) (1%) a.s./m ) (1%) code] Efficacy [%] Efficacy [%] wanted by- catches 14e Maritime IPSXTY, Effective protection - yes* - - - PITYCH, against flying out bee- 1CERAF tles and not wanted by- catches 12 North- Bark No. of holes in the log 519 east beetle No. of dead insects 389 No. of living insects 0 No. of holes in the net- 0 ting * 2 small holes were found inside the net, but not caused by the beetles

Additional information: In Poland in six trials (Sequential No. 6-11) dead beetles (by-catches) of the following secon- dary target species were found on the net: Secondary target species: insects, which do not have the risk potential like Ips typographus and Pityogenes chalcographus, but have the potential to devalue the timber (for example bark bee- tles, Cerambycidae, Hylobius abietis, Tenthredinidae)  Otiorhynchus tenebricosus (Herbst) = Otiorhynchus clavipes = red-legged weevil = Rüsselkäfer (adults feed on buds, leaves and other above ground plant parts (young shoots) of trees and larvae feed on roots of trees)  Hylobius pinastri (Gyll.) = weevil = kleiner brauner Rüsselkäfer (adults feed on the bark of young trees and branches of old trees, larvae develop in dead stems and in roots of cut trees)  Hylobius abietis (Li.) = fir weevil = grosser brauner Nadelholzrüssler (adults feed on the bark of young trees (Douglas fir, larch) and branches of old trees, larvae develop in dead stems and in roots of cut trees) In one further Polish trial (Sequential No. 12) dead insects (by-catches) of the following secon- dary target species were found on the net:  Cerambycidae (longhorn beetle, Bockkäfer): o Molorchus minor = longhorn beetle = dunkelschenkliger Kurzdeckenbock o Oxymirus cursor = longhorn beetle = Schulterbock o Tetropium castaneum = longhorn beetle = gemeiner Fichtensplintbock o Rhagium inquisitor = longhorn beetle = Schrotbock o Pidonia lurida = longhorn beetle = bleichgelber Schnürhalsbock  Curculionidae („true“ weevils = Rüsselkäfer): o Otiorhynchus tenebricosus = red-legged weevil = Rüsselkäfer o Hylobius pinastri = weevil = kleiner brauner Rüsselkäfer o Hylobhts abietis = fir weevil = grosser brauner Nadelholzrüssler o Ips typographus = spruce bark beetle = Buchdrucker  Formicidae (Ameisen)

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 26 of 56

o Camponotus herculeanus = ant = schwarze Rossameise (ant lives in wood and makes corridors into the wood; nests are built in healthy heart wood (predomi- nantly in living spruce trees but also in logs))

Holes in the net: In all trials no holes were caused by the insects and no holes were caused at application. In one (sequential number 14e) out of 25 trials two small holes appeared during application of Stora- net, assumed to be damaged by people. In the attachment of the trial with the sequential num- ber 14 it is stated that 2010 more holes were in the net than 2009.

Conclusion Preventive treatment for the protection of cut timber logs against bark and wood boring insects in the forest: Against the three important bark beetles Ips typographus, Trypodendron lineatum and Pityo- genes chalcographus in spruce logs, the efficacy of the test product Storanet –wrapped around the logs– is excellent, significantly better than the control and comparable to the standard prod- ucts Fastac Forst and Vaztak. The spruce logs, which were not attacked at application, were kept 100 % clean from the bark boring beetle Ips typographus in all trials treated with the test product Storanet (17 trials, Mari- time and North-east zone) except in trial 14d. In that trial 1 % of the logs were attacked, repre- senting a very low portion of the tested logs. The standard products Fastac Forst (5 trials, Mari- time zone) and Vaztak (4 trials, Maritime zone) are comparable to the test product showing an efficacy of 99-100 %. The control logs of all reported trials were always attacked by Ips typog- raphus (13 trials, Maritime and North-east zone). The bark boring beetle Pityogenes chalcographus (6 trials, Maritime and North-east zone) and the wood boring beetle Trypodenderon lineatum (9 trials, Maritime and North-east zone) were controlled in all trials with 100 % efficacy. The standard product Fastac Forst (2 trials, Maritime zone) was comparable to the test product showing an efficacy of 100 %. The control logs of all reported trials were always attacked by Pityogenes chalcographus (2 trials, North-east zone) and Trypodenderon lineatum (5 trials, Maritime and North-east zone).

Less important bark beetles like the bark boring beetles Dryocoetes autographus and Hylurgus ligniperda (according to trial report Hylastes ligniperda) are of minor importance for the quality of spruce logs, as the attacks are late in the year and high grade timber cannot be stored for longer than 2-3 months without losing quality. Less important bark beetles appeared only in Austria (3 trials, Maritime zone). Against less important bark beetles the efficacy of the test product Storanet – wrapped around the logs – was limited. The Storanet treatment led to 17.7-35.7 % (mean 20.8) attacked logs. The severity of attack measured by number of galleries per treated log reached 0.6-2.4 (mean 0.9) galleries, which is not very high. As no control and standard product was tested in these trials no conclusion can be made regarding percent efficacy and the comparability of the test and standard product.

The application method “logs completely wrapped in Storanet” (3 trials, Maritime zone) was slightly better than the application method “logs completely wrapped in a 1-year-old used Stora- net” (1 trial, Maritime zone) followed by the application method “Storanet over the top applica- tion” (3 trials, Maritime zone). Efficacy was expressed as percent attacked logs and number of galleries caused by less important bark beetles, longhorn beetle (Cerambycidae) and Curculi- onidae. Against the three important bark beetles Ips typographus, Trypodendron lineatum and Pityogenes chalcographus the different application methods have a high and comparable level of efficacy (0-1 % attacked logs). The use of the application method “logs completely wrapped in Storanet” is the preferred method protecting the wood logs also from attacks of bark and wood boring beetles from the bottom of the cord of logs (beetles hibernating on the ground).

In oak logs application of the test product Storanet provided an excellent level of efficacy (0 % attacked logs) against the biggest and most damaging wood boring bark beetle Platypus cylin- Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 27 of 56 drus and against the wood boring bark beetle Xyloterus spp (1 trial, Mediterranean/South-east zone). As no control and standard product was tested in these trials it is not possible to express the efficacy as % control. However, 0% attack is the highest possible level of control and no better control can be achieved by a reference product. Platypus cylindrus, Xyloterus and Xyle- borus species were found in trap catches during application period, which showed the actual bark beetle flight. No conclusion can be made regarding the wood boring bark beetle Xyleborus spp., because at application date Xyloterus spp. and Xyleborus spp. were active as demon- strated by trap catches and the author assumed that the logs were attacked before application.

Treatment of attacked logs for prevention of bark and wood boring insect flight: The test product Storanet effectively prevented flight of bark and wood boring insects (Maritime and North-east zone). The efficacy of the test product and the standard product Fastac Forst was 100% against the bark beetle Ips typograpus (1 trial, Maritime zone). In contrary to the sprayed standard product Fastac Forst the test product Storanet had a lower penetrating effect, showing 77 % efficacy against living beetles (Ips typographus) under the bark in comparison to 100 % efficacy of the reference product. In three further field trials against Ips typographus, Pityogenes chalcographus, in general bark beetles and Cerambycidae an effective pre-flight protection was achieved (Maritime and North- east zone).

Stability of the net The net possesses a high stability. No holes were caused by insects or caused at application.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 28 of 56

Longhorn beetles (Cerambycidae) in soft- and hardwood

Nearly all efficacy trials conducted with Storanet showed no natural infestation with longhorn beetles, except of the trial with the sequential no. 14, where longhorn beetles (Cerambycidae) and weevils (Curculionidae) were rated together and no control samples were made (see Point IIIA1 6.1.3.1). Therefore, no conclusions can be made over the efficacy of Storanet against longhorn beetles in field. Two efficacy trials with the longhorn beetle Monochamus galloprovin- cialis (Westeuropäischer Kiefernbock) were performed in Portugal, belonging to the Mediterra- nean zone and reported under Point IIIA1 6.5. Those two trials show 100 % efficacy against Monochamus galloprovincialis beetles for prevention of insect flight in a sheltered room with ambient temperature (common storing conditions). The adults of the longhorn beetle died after 12 h exposure in a square 1x1 m wood frame, covered with the Storanet and filled with a pile of maritime pine wood, proving the very good efficacy against Monochamus galloprovincialis. Regarding the active substance alpha-cypermethrin included in the plant protection product Fastac Forst the indication protection of timber logs against longhorn beetles before beetle flight is already authorised in Germany (Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-9). The application rate, number of applications and application time of the plant protection product for longhorn beetles is equal to bark beetles.

Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-9: Authorised indications of Fastac Forst (active substance: alpha-cypermethrin) in soft- and hardwood for forest in Germany

Pest Crop Application time and Application rate number of applications Hylobius abietis softwood Before planting 1 drunk 4 % in 10 to 20 L water/ (large brown pine weevil; application 1000 plants Großer Brauner Rüsselkä- After infestation 4 % in 25 to 40 L water/ fer) 1 spray application 1000 plants (plant high 50 cm) Bark and wood boring bark soft- and hardwood, At risk of infestation 1 % (up to 12 weeks pro- beetles except of Xylosan- timber logs 1 spray application tection) drus germanus (smaller 2 % (12-24 weeks protec- alder bark beetle, Schwar- tion) zer Nutzholzborkenkäfer) Wood boring bark beetles soft- and hardwood, After infestation 1 % except of Xylosandrus timber logs 1 spray application germanus (smaller alder bark beetle, Schwarzer Nutzholzborkenkäfer) Bark boring bark beetles soft- and hardwood, Before flying out of beetles 1% (single logs, cord of timber logs 1 spray application logs) Longhorn beetle species soft- and hardwood, Before flying out of beetles 1 % (up to 12 weeks pro- timber logs 1 spray application tection) 2 % (12-24 weeks protec- tion) Jewel beetles soft- and hardwood, Before flying out of beetles 2 % timber logs 1 spray application

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 29 of 56

Taking into account the important longhorn beetle spruce longicorn beetle (Fichtenböcke: Monochamus sutor, Tetropium castaneum, Monochamus saltuarius) compared to the important bark beetles Ips typographus, Pityogenes chalcographus, Trypodendron lineatum and Platypus cylindrus, longhorn beetles have a similar mode of live as bark beetles. Adult beetles fly in spring and during the whole vegetation period, laying the eggs at/ in timber logs. Larvae feed on the bast and/ or on wood, finalising their development in a sealed cell with pupae by metamor- phosis to the young beetle. The larval development lasts > 3 months respectively there are ≤ 2- 3 generations per year. The target stage of both pests is the adult beetle before oviposition. Both pests attack timber logs and causes damage of high grade wood.

The plant protection product Storanet is intended for application (wrapping of single trunk, appli- cation over the top of lumber stocks) in hard- and softwood against longhorn beetles for protec- tion of harvested wood from infestation and for protection against flight of beetles from attacked wood. This indication is based on extrapolation from bark beetles, taking the very good efficacy of two artificial trials with Storanet against longhorn beetles, the similar mode of live and the already proven efficacy of the active substance alpha-cypermethrin against longhorn beetles into account.

Jewel beetles (Buprestidae) in soft- and hardwood

In all efficacy trials conducted with Storanet no natural infestation with jewel beetles occurred. Jewel beetles are bark boring beetles in different species of trees. The forestal importance exist mainly in the lost of wood growth. Regarding bark boring beetles in hardwood (European beeches and oaks) especially jewel beetles are of importance. Only one trial was performed with hardwood in Croatia. Regarding the active substance alpha-cypermethrin included in the plant protection product Fastac Forst the indication protection of timber logs against jewel beetles before beetle flight is already authorised in Germany (Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-9). The application rate, number of applications and application time of the plant protection product for jewel beetles is comparable to bark beetles. Taking into account the jewel beetles Agrilus biguttatus (Gefleckter Eichenprachtkäfer) and Phaenops cyanea (Blauer Kiefernprachtkäfer) compared to the important bark beetles Ips ty- pographus, Pityogenes chalcographus, Trypodendron lineatum and Platypus cylindrus, jewel beetles have a similar mode of live as bark beetles. Adult beetles fly in spring and during the whole vegetation period, laying the eggs at/ in timber logs. Larvae feed on the bast or on wood, finalising their development in a sealed cell with pupae by metamorphosis to the young beetle. In a year ≤ 2-3 generations develop. The target stage of both pests is the adult beetle before oviposition. Both pests attack timber logs and causes damage of high grade wood.

The plant protection product Storanet is intended for application (wrapping of single trunk, appli- cation over the top of lumber stocks) in hard- and softwood against jewel beetles for protection of harvested wood from infestation and for protection against flight of beetles from attacked wood. This indication is based on extrapolation from bark beetles, taking the similar mode of live and the proven efficacy of the active substance alpha-cypermethrin against jewel beetles into account.

IIIA1 6.1.4 Effects on yield and quality

IIIA1 6.1.4.1 Impact on the quality of plants and plant products The test product Storanet does not have an impact on the quality of timber logs. Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 30 of 56

In the efficacy trial 13 it is mentioned that the mesh size of the Storanet seemed to be suffi- ciently transparent to enable the aeration and release of extensive moisture after rainfall. The treated logs did not visually differ from shaded logs on the trial site (KIIIA 6.1.3/15, DocID 2011/1040754). According to EPPO guideline PP1/128(2) the evaluation of qualitative yield is not required.

IIIA1 6.1.4.2 Effects on the processing procedure No processing trials were conducted; this is not of importance for timber.

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products Effects on yield are not expected in cut timber. According to EPPO guideline PP1/128(2) “In- sects on conifer timber” this is not a requirement.

IIIA1 6.2 Adverse effects

IIIA1 6.2.1 Phytotoxicity to host crop Material and methods Within the efficacy trials 6-11 phytotoxicity was rated at spruce logs wrapped in the test product Storanet. Information about material and methods can be found in KIIIA 6.1.3/2 in Table 6.1.3/1A (DocID 2011/1040778) or in the single trial reports KIIIA 6.1.3/8-13 (DocID 2011/1040748 - /1040753).

Results No phytotoxic effect of Storanet on spruce timber was observed KIIIA 6.1.3/8-13 (DocID 2011/1040748 - /1040753). In all minimum effective dose trials (KIIIA 6.1.2/2, DocID 2011/1040741) and efficacy trials (KIIIA 6.1.3/3-20, DocID 2011/1040740, /1040743, /1040745 - /1040760) no negative effects were observed.

Conclusion In all trials and on all varieties of tested timber (spruce, oak and larch) no phytotoxic effect of Storanet was observed or reported.

IIIA1 6.2.2 Adverse effects on health of host animals This is not an EC data requirement.

IIIA1 6.2.3 Adverse effects on site of application This is not an EC data requirement.

IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) Effects on relevant beneficial organisms

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 31 of 56

Storanet is applied in forestry as a woodnet for protection of single trunks or lumber stocks. No specific trials on beneficial organisms had been conducted with this formulation. But, data of adverse effects on beneficial organisms were evaluated in some efficacy trials. In trials reported from Poland dead insects (by-catches) of the following beneficial organisms were found on the net: Carabus linnaei, Carabus sylvestris, Pterostichus oblongopunctatus, other Pterostichus species, Cantharis rustica, Thanasimus formicarius. Pollinators (Bombus species) were also caught. No negative impact of Storanet on Ichneumonidae and Tachinidae parasitoids playing a significant role in the natural regulation of harmful insects, including bark beetle, was observed. (DocID 2011/1040748, DocID 2011/1040753, DocID 2011/1040755). In investigations from Austria the following beneficial organisms were found as by-catches: Thanasimus formicarius (predominantly), Thanasimus rufipes and species of the families of Carabidae, Staphylinidae, Coccinellidae and Ichneumonidae, respectively. (DocID 2011/1040756). In the trials of Germany and Czech Republic no by-catches of beneficial organisms were re- ported.

In forestry an average of 8.2 single trunks, 0.2 small lumber stocks (or 0.1 large lumber stocks) per ha and year can be derived (for details see chapter effects of soil quality below). Therefore, it can be concluded that the number of woodnets/ha and consequently the area covered is low leading to a very limited exposure in forest areas. On these grounds with today’s level of knowl- edge, populations of beneficial organisms relevant in forestry should not be influenced ≥ 25% when Storanet is applied according to recommended use pattern.

Conclusions Storanet is classified as not harmful for populations of relevant beneficial insect species. Storanet is classified as not harmful for populations of relevant predatory mites and spiders.

Effects on soil quality Effects on soil macro-organisms being used as indicators of soil quality Effects on earthworms

Toxicity

The product BAS 310 62 I is a polyethylene terephthalate (PET) net which is coated with 1.8% of an alpha-cypermethrin (BAS 310 18 I) using a polymeric binder system. The product BAS 310 62 I is used for protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest.

Since the product BAS 310 62 I is applied in forestry as a woodnet for protection of single trunks or lumber stocks, no specific trials on soil organisms had been conducted with this formulation. Therefore, toxicity data with alpha-cypermethrin of 100 g a.s./L OESC formulations (mainly BAS 310 41 I and predecessor formulations) on soil organisms are presented here as they are similar to the formulation BAS 310 18 I used for the coating of the woodnet (BAS 310 62 I).

To show acceptability of the use of alpha-cypermethrin formulations as normal field application and with that also for the use as a woodnet placed on trees/lumber stocks, toxicity data with alpha-cypermethrin containing formulations to earthworms and collembolans are presented. Further details on the acute studies with alpha-cypermethrin are given in the Monograph of al- pha-cypermethrin.

For substances with log Pow values > 2 and a high content of organic material in the artificial soil (i.e. 10% peat), the resulting endpoints have to be corrected by a soil factor of 2 (foc) in the risk assessment in order to address lower contents of organic material in soil. Since the log Pow for alpha-cypermethrin is > 2 (i.e. 5.5 for alpha-cypermethrin), a soil factor of 2 (foc) was included for

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 32 of 56 the toxicity data in order to account for the organic content (i.e. 10%) of the artificial soil in the test system.

The endpoints obtained from the studies on earthworms and collembolans with the alpha- cypermethrin containing formulations were only corrected, if the artificial soil used in these tests contained 10% peat.

The acute and chronic earthworm toxicity endpoints are summarised in the following Table.

Summary of earthworm toxicity endpoints for alpha-cypermethrin and relevant metabo- lites Parent com- Test sub- Value Endpoint Reference pound stance [mg/kg dry soil] Acute toxicity, 14 d Inglesfield & Sher- alpha-cypermethrin alpha- 2) LC > 50 wood, 1) cypermethrin 50 CY-531-002

alpha- 2) Luehrs, 2001 100 g a.s./L OESC LC > 50 cypermethrin 50 AL-560-042

alpha- 2) Fleischer, 100 g a.s./L OESC LC > 33.3 cypermethrin 50 2004/1003941 Chronic toxicity, 56 d

alpha- 2) Luehrs, 100 g a.s./L OESC NOEC ≥ 0.2 cypermethrin 2008/1010607 1) Tested as mixture of cypermethrin (WL 85871). 2) Toxicity endpoint is re-adjusted by a soil factor of 2 to address the organic content of the soil, since the log Pow for the active substance is > 2.

Exposure

The product BAS 310 62 I is a polyethylene terephthalate (PET) net which is coated with 1.8% of an alpha-cypermethrin (BAS 310 18 I) using a polymeric binder system. The product BAS 310 62 I is used for protection of stored wood against infestation by bark beetles, wood boring beetles and longhorn beetles after harvest.

Proposed uses considered in risk assessment Application rate per treatment Application Number of Interval Crop type applications [d] alpha- BAS 310 62 I cypermethrin (woodnet) 10 g a.s./single single trunk woodnet 1 -- 100 m2 net/single trunk trunk 20 g a.s./lumber 2x 100 m2 net/lumber lumber stock woodnet 1 -- stock stock

The leaching of alpha-cypermethrin from woodnets into soil below the protected wood stacks cannot be avoided and represent the only exposure route for soil organisms. The potential movement of released active substance in the environment was investigated in a field run-off study in a conifer forest and a deciduous (or broadleaf) forest (see BASF DocID 2011/1269064). The measured concentration of the active substance in soil was used as a basis for a worst- case exposure scenario in the risk assessment on earthworms and other soil non-target macro-

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 33 of 56 organisms. For full details please refer to Part B, section 5, chapters 9.4 and 9.5. The resulting measured concentrations in soil are presented in the following Table

Residues of alpha-cypermethrin in soil and leaf litter after run-off Measured residues in Distance from the Measured residues in leaf soil Study site woodnet litter PEC PEC leaf litter [cm] soil [mg/kg] [mg/kg] -10 0.016 0.13 0 0.031 0.68 10 0.022 0.43 conifer forest 50 0.037 0.40 100 n.d. 0.037 300 n.d. 0.009 500 n.d. n.d. -10 0.008 0.12 0 0.050 0.58 10 0.007 0.15 deciduous forest 50 n.d. 0.008 100 n.d. 0.008 300 n.d. 0.004 500 n.d. 0.004 n.d.: not detected. Bold values: worst-case PEC-values used in the risk assessment

The annual amount of timber harvest per ha was considered to obtain a realistic estimate of the potential exposure. The calculations were based on statistical data provided from German authorities [Bundesministerium für Ernährung, Landwirtschaft und Verbraucher-schutz (2004):http://www.bundeswaldinventur.de/enid/296d7208c4a827134d0a3176325a9e,0/75.html. Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (BMELV), Bonn, 2004]. These can be considered as a worst-case, since the annual timber harvest amounts per hectare in Germany usually exceed those in Eastern European countries

[EUROSTAT: (2009): http://epp.eurostat.ec.europa.eu por- tal/page/portal/statistics/search_database, status September 2009].

According to BMELV (2004), 3-14 m3 timber/ha forestry area in use were harvested annually from 1987 to 2002. Assuming the 90th percentile of 9.9 m3 per hectare per year, an average of 8.2 single trunks, 0.2 small lumber stocks (or 0.1 large lumber stocks) per hectare and year can be derived. Therefore, it can be concluded that the number of woodnets/ha and consequently the area covered is low leading to a very limited exposure in forest areas.

Also, the washed-off active substance drops down onto a small area around the edge of the covered wood stacks, while only limited exposure under the stacks themselves occurred (see the -10 cm values in the above Table). Due to the limited mobility of the active substance, expo- sure of soil organisms may occur only in a small rectangle shaped band around the covered

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 34 of 56 wood stacks. Therefore, most of the soil and litter area remains unexposed to the active sub- stance.

Measured concentrations of alpha-cypermethrin in leaf litter were higher than in soil. This might be due to the high Koc of alpha-cypermethrin (median Koc = 57889, see EC Review Report for alpha-cypermethrin, October 2003). Thus, alpha-cypermethrin strongly adsorbs to organic mate- rial. It is assumed that the bioavailability of alpha-cypermethrin from leaf litter for earthworms and other non-target soil-macroorganisms is low. Nevertheless, PECleaf litter values will be ad- dressed in the risk assessment as additional worst-case information.

Toxicity exposure ratios, TERA and TERLT

Acute risk

The potential acute risk of alpha-cypermethrin and the relevant metabolites to earthworms was assessed by comparing the maximum measured residue concentration of alpha-cypermethrin in soil (PECsoil) and leaf litter (PECleaf litter) with the 14-day LC50 value to generate acute TER val- ues.

The TERA was calculated as follows:

LC50 [mg/kg] TER A = PECsoil [mg/kg]

The resulting TERA values are shown in the following Table

Acute TER values for earthworms LC PEC TER 50 PEC leaf TER A TER trig- Test substance [mg/kg dry soil A (leaf lit- [mg/kg] * litter (soil) ger value soil] [mg/kg] # ter) alpha- > > 50 1) 0.050 0.68 > 74 10 cypermethrin 1000 alpha- > cypermethrin in > 50 1) 0.050 0.68 > 74 10 1000 100 g a.s./L OESC alpha- cypermethrin in > 33.3 0.050 0.68 > 666 > 49 10 100 g a.s./L OESC

* Worst-case PECsoil value for a distance of 0 cm from the woodnet in a broadleaf forest. # Worst-case PECleaf litter value for a distance of 0 cm from the woodnet in a conifer forest. 1) Toxicity endpoint is re-adjusted by a soil factor of 2 to address the organic content of the soil, since the log Pow for the active substance is > 2.

All the acute TER values are above the Commission Regulation (EU) 546/2011 acute trigger value of 10, indicating that BAS 310 62 I poses low acute risk to earthworms when applied ac- cording to the proposed use rates.

Long-term risk

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 35 of 56

The potential long-term risk of alpha-cypermethrin to earthworms was assessed by calculating long-term TER (TERLT) values by comparing the NOEC values and the maximum instantaneous PECsoil using the following equation:

NOEC [mg/kg] TER LT = PEC soil [mg/kg]

The resulting TERLT values are presented below:

Long-term TER values for earthworms Mitigation TER NOEC PEC TER (distance PEC leaf TER LT trig- Test substance [mg/kg dry soil LT (leaf from [mg/kg] litter (soil) ger soil] [mg/kg] litter) woodnet) value 0 cm 0.050 * 0.68 # ≥ 4.0 ≥ 0.3 5 # alpha-cypermethrin 10 cm -- 0.43 -- ≥ 0.5 5 in ≥ 0.2 1) 50 cm 0.037 # -- ≥ 5.4 -- 5 100 g a.s./L OESC 100 cm -- 0.036 * -- ≥ 5.6 5 300 cm -- 0.009 # -- ≥ 22 5 TER values in bold fall below the relevant trigger. * Worst-case PECsoil value for runoff from the woodnet in a broadleaf forest. # Worst-case PECleaf litter value for runoff from the woodnet in a conifer forest. 1) Toxicity endpoint is re-adjusted by a soil factor of 2 to address the organic content of the soil, since the log Pow for the active substance is >2.

The long-term TER values calculated for alpha-cypermethrin as contained in a 100 g a.s./L OESC formulation are above the Commission Regulation (EU) 546/2011 trigger of 5 for soil exposure considering a distance from the woodnet of 10 cm and slightly failed it at 0 cm. How- ever, dissipation of alpha-cypermethrin from soil is expected to be fast due to the low average residence time of alpha-cypermethrin in soil (median DT50, field of 35 days, EC Review Report, February 2004).

For exposure from leaf litter, the TER trigger value of 5 is exceeded if a distance of 100 cm from the woodnet is considered. As already mentioned alpha-cypermethrin strongly adsorbs to or- ganic material. It is assumed that the bioavailability of alpha-cypermethrin from leaf litter for earthworms and other non-target soil-macroorganisms is low. Even if effects on earthworm populations living directly adjacent to the treated trunks or lumber stocks might occur, fast recolonisation is expected to take place. On the one hand, alpha-cypermethrin concentrations in soil fastly decrease with increasing distance from the woodnet and, on the other hand, dissipa- tion of alpha-cypermethrin from soil is expected to be fast due to the low average residence time of alpha-cypermethrin in soil (median DT50, field of 35 days, EC Review Report, February 2004). Therefore, chronic risk for earthworms arising from long-term use of BAS 310 62 I is considered to be acceptable without considering special mitigation measures. On the one hand, alpha- cypermethrin concentrations in soil fastly decrease with increasing distance from the woodnet and, on the other hand, dissipation of alpha-cypermethrin from soil is expected to be fast due to the low average residence time of alpha-cypermethrin in soil (median DT50, field of 35 days, EC Review Report, February 2004).

In addition, a full-fauna field study in a forest showed no effects of alpha-cypermethrin on soil- populations.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 36 of 56

Field tests Further studies on earthworms under field conditions were not triggered, since (a) the acute toxicity to earthworms is low (TER > 10) and (b) chronic toxicity to earthworms is low (TER > 5). However, in the EU Dossier, a field study is provided showing that the application of cyperme- thrin at a rate of 100 g a.s./ha did not lead to significant effects on earthworm populations. The RMS considered the study to be valid and representative for alpha-cypermethrin as well.

Residue content of earthworms A study on residue determination on earthworms is not triggered, since (a) the acute toxicity to earthworms is low (TER > 10) and (b) the earthworm reproduction study with the formulation resulted in TER values > 5.

The log Pow value of alpha-cypermethrin is 5.5, which triggers an assessment for the potential risks of secondary poisoning of birds and mammals according to SANCO/4145/2000. Reference is made to Part B – Section 6, chapter 10.1 and 10.3.

Effects on other non-target soil macro-organisms For determination of short- and long-term effects of alpha-cypermethrin on the soil arthropod fauna, a field test with Fastac Forst (BAS 310 20 I, 15 g a.s./L) was carried out (BASF DocID 1992/1002198) in a forest in Germany. The populations of ground-dwelling arthropods were monitored in the spring and autumn of 1990 and in the spring and summer of 1991 (pitfall traps) and in the spring and summer of 1991 (photo-eclectors).

A single BAS 310 20 I spraying treatment with approx. 33 g a.s./ha on areas covered with brushwood did not significantly reduce the abundance of the main taxonomic groups. In four of the five groups the number of arthropods was higher in the treated areas. Two species of Carabidae (Coleoptera), showed significant differences compared to the control plot. Neverthe- less, this is not considered to be treatment related, but rather due to a natural competitive phe- nomenon.

No long-term effects on a wide range of non-target arthropods were observed after one applica- tion of approx. 2.2 L BAS 310 20 I/ha (approx. 33 g a.s./ha) on clustered brushwood in a wind- thrown forest. It can be concluded from the results of this study, that application of alpha- cypermethrin caused no unacceptable effects on the population development of non target ar- thropods (Coleoptera, Diptera-Brachycera, Diptera-Nematocera) under field conditions in a spruce forest.

Conclusion

The results of the field study confirm that the use of alpha-cypermethrin will not adversely affect soil-dwelling arthropods in forests. Also the forestry uses of BAS 310 62 I as a woodnet pose no unacceptable risk to non-target arthropods, as it causes even lower exposure than the spray application in the presented study.

Effects on organic matter breakdown A study on organic matter decomposition for alpha-cypermethrin was not triggered, because (a) the DT90, field of alpha-cypermethrin is < 365 days and (b) effects on soil micro-organisms are < 25% (deviation from control) after 28 days (Reference is made to chapter 10.7) and (c) earth- worm reproduction studies exceed the Commission Regulation (EU) 546/2011 trigger value of 5.

Overall conclusion with respect to effects on soil macro-organisms Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 37 of 56

It is concluded that the proposed use of Storanet will not pose an unacceptable risk to popula- tions of earthworms or other soil macro-organisms, when applied according to the recom- mended use pattern.

Instructions and information: None

Overall conclusion with respect to effects on soil quality

There is no indication of any unacceptable adverse effects on soil macro- or soil micro- organisms relevant for the maintenance of soil quality.

Effects on soil non-target micro-organisms exposed to Storanet

Ecotoxicological endpoints for soil micro-organisms Test de- Test item EU agreed endpoints Reference sign1 No significant effect > 25% at day 28 at Chapleo, S. & Stmad, C 30 g, 150 g or 300 g a.s./ha (0.4 mg S.P. (2000) AC 900049 in a a.s./kg soil dw.) Inveresk report No. 100 g/L OESC 18463; America Cya- formulation No significant effect > 25% at day 28 at N 30 g, 150 g or 300 g a.s./ha (0.4 mg nanmid Study No. ETX- a.s./kg soil dw.) 00-108 CL 206128 (me- No significant effect > 25% at day 28 at tabolite of alpha N Krieg, W. (2001) 0.02 mg metabolite/kg soil dw. Cypermethrin 1 C = Carbon Mineralization, N = Nitrogen transformation.

Risk assessment for soil microflora functions

Risk assessment for soil microflora functions NOEC Maximum PEC Test substance soil MoS* (< 25% effect at 28 d) [mg/kg]

Alpha-cypermethrin 0.4 mg a.s./kg soil dw. 0.050 8,0

* Margin of Safety

The results of these studies showed no effects of > ± 25% compared to the control on soil mi- crobial activity up to a maximum tested concentration of 0.4 mg a.s./kg soil, after 28 days. As this maximum tested concentration was much higher than the maximum initial PECsoil (0.05 mg a.s./kg) calculated based on a distance of 0 cm wash-off from woodnet. As the proposed use of Storanet an acceptable risk to soil microbial activity can be concluded.

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes This point “Adverse effects on parts of plant used for propagating purposes” is not of relevance for timber logs.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 38 of 56

IIIA1 6.2.6 Impact on succeeding crops This point “Impact on succeeding crops” is not of relevance for timber logs stored at forest tracks.

IIIA1 6.2.7 Impact on other plants including adjacent crops This point “Impact on other plants including adjacent crops” is not of relevance for timber logs wrapped in treated nets stored at forest tracks.

IIIA1 6.2.8 Possible development of resistance or cross-resistance After 15 years of use, there is published report of strong alpha-cypermethrin resistance only in Myzus persicae, Meligethes aeneus and Bemisia tabaci in Europe. The mentioned pests Myzus persicae and Bemisia tabaci have a short lifecycle and a high reproduction rate bearing a high risk for resistances.iv According to EPPOv, Meligethes aeneus resistance is due to almost exclu- sive use of pyrethroid insecticides for the control of this pest. In the past years resistance man- agement has become an important task in crop protection.

Mechanisms of resistance: Insecticide resistance to synthetic pyrethroids occurs via four basic mechanisms. The first is modification of the target site, reducing its sensitivity to the insecticide (e.g., the kdr gene). The second mechanism involves metabolism or sequestration of the insecticide molecule by various enzymes (Anspaugh et al. 1995, Argentine et al. 1995, Valles 1998). This is achieved by increased activity levels of specific esterases (Metcalf 1989, Ishaaya 1993), mixed function oxidases (Scott et al. 1998), glutathione S-transferase or GSTs (Sawicki 1985, Kostaropoulos et al. 2001), or a combination of these enzyme systems. A third mechanism occurs when insects absorb toxins slower than susceptible insects (penetration resistance). And the last recog- nized resistance mechanism occurs when insects detect or recognize a danger and avoid the toxin (behavioral resistance). Target site resistance and metabolic resistance are the most important forms of resistance in key economic insect pests. Penetration and behavioral resis- tance have not been reported in Europe with regards to pyrethroids (and especially not to alpha- cypermethrin).

Cross resistance: The kdr or “knockdown” gene confers resistance to DDT (Metcalf 1989) and synthetic pyre- throids. Esterases are known to detoxify a number of organophosphate and carbamate insecti- cides as well as pyrethroids (Shchukin and Wool 1994). M. persicae has recently been shown to possess a target-site knockdown (kdr) resistance, which affects pyrethroids and DDT (Devon- shire et al. 1998, Martinez-Torres et al. 1999). Mixed function oxidases confer resistance to or- ganophosphates, organochlorine and carbamates in addition to pyrethroids. Alpha-cypermethrin and other pyrethroids can therefore be affected by a number of resistance mechanisms, or combinations of these mechanisms.

Product risk: The sodium channel modulators- insecticidesvi have in general as medium to high risk com- pounds according to the resistance risk analysis of Langewald et al. [see 2011/1067044 Lange- wald J. et al. 2011 a].

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 39 of 56

Pathogen risk: Bark boring bark beetles as well as wood boring bark beetles shows a medium risk to build up resistances, as they have predominantly 0.5-2 generations per year (three in warm years) in case of the important bark beetle pests Ips typographusvii Pityogenes chalcographusviii, Trypo- dendron lineatumix and Platypus cylindrusx. Longhorn beetles and jewel beetles have also a medium risk to build up resistances, as they develop 1/3-2 generations per year in case of the important longhorn beetle pest Monochamus sutorxi, Tetropium castaneumxii and Monochamus saltuariusxiii and the jewel beetle pests Agrilus biguttatusxiv and Phaenops cyaneaxv.

Combined risk: The inherent combined resistance risk of wood and bark boring bark beetles, longhorn beetles and jewel beetles with alpha-cypermethrin is medium.

Management strategy: The general recommendations for resistance management of using Storanet (100 mg/m2 alpha- cypermethrin) can be summarised as follows:  Follow the recommendations on the label.  As precaution of a high pest pressure of bark beetles, the principles of “clean forest economy” have to be considered, to reduce the resistance risk.  Monitoring the population frequency with pheromone traps.

More detailed information is shown in 2011/1067044 Langewald J. et al. 2011 a “Alphacyperme- thrin Resistance Risk Analysis”.

IIIA1 6.3 Economics This is not an EC data requirement.

IIIA1 6.4 Benefits

IIIA1 6.4.1 Survey of alternative pest control measures This is not an EC data requirement.

IIIA1 6.4.2 Compatibility with current management practices including IPM This is not an EC data requirement.

IIIA1 6.4.3 Contribution to risk reduction This is not an EC data requirement.

IIIA1 6.5 Other/special studies

Materials and methods

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 40 of 56

Two experiments were conducted to evaluate the efficacy of the insecticide-net on adult Mono- chamus galloprovincialis. These experiments were performed in Portugal. At the first experiment large branches from dead maritime pine trees were cut and divided into 60-80 cm sections. The wood was taken to the INRB laboratories in Oeiras (Portugal), divided in two piles and placed inside a square 1x1m wood frame to support the nets. One frame was covered with the insecticide-net (not touching the wood), while the other was covered with a plastic fishing net to serve as control (also not touching the wood). Experiments were conducted in a sheltered room with natural temperature, and the two trials were seven meters apart. 31 adult M. galloprovincialis (Cerambycidae, westeuropäischer Kiefernbock) beetles of both sexes from a laboratory rearing colony were released inside the wood nettings on three distinct occa- sions and remained there for 12, 24 and 48 consecutive hours. After the assigned time spaces the nets were opened to see if the beetles recovered or were dead. In a further experiment, which took place in the INRB laboratories, two adult M. galloprovincialis beetles were kept during 24 hours inside a 40 x 40 cm section of insecticide-net, which was closed. Inside the net there were two small maritime pine branches for the feeding of the bee- tles. The same procedure was repeated using plastic fishing net as control. The experiments were replicated three times, in a total of 12 insects of both sexes.

Results At the first experiment no beetles escaped, either from the insecticide-net or from the control- net. All beetles died in the insecticide-net experiment. After 12 and 24 hours a few of the recovered insects were still moribund (not actively moving, with erratic and sporadic movements of some legs), although they died shortly after being recovered. Only two beetles died in the experiments with the control (fishing net).

In the second experiment no beetles escaped, either from the insecticide-net or from the con- trol-net. As in the previous experiment the insecticide-net was again very efficient, as all the beetles (n=6) died while in the control treatment only two of the beetles died.

Conclusion In the southern zone (Mediterranean zone) the insecticidal Storanet, showed 100 % efficacy against adult Monochamus galloprovincialis beetles for prevention of insect flight in a sheltered room with ambient temperature (common storing conditions). To get additional information on the efficacy of Storanet influenced by temperature, further field trials will be conducted in the Southern Zone in 2011.

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5

Storanet is intended to be authorised for the first-time in the central European zone against bark beetles, longhorn beetles and jewel beetles in hard- and softwood logs stored in forestry. Stora- net is applied by wrapping of single trunk or application over the top of lumber stocks for protec- tion of harvested wood from infestation and for protection against flight of beetles from attacked wood. Germany was chosen as zonal Rapporteur Member State. Storanet contains the active substance alpha-cypermethrin at the rate of 100 mg/m2 net. The maximal application size of Storanet is 200 m2 total net surface for up to 38 m3 cord of logs. Alpha-cypermethrin as active substance is authorised against bark beetles nesting in the wood or in the bark of soft- and hardwood, except of the smaller alder bark beetle (Xylosandrus ger- manus, Schwarzer Nutzholzborkenkäfer), against longhorn beetles and against jewel beetles, in Germany till 31.12.2016 (Fastac Forst, authorisation No. 024012-00). Avoiding drift is the main advantage of using a net as carrier for the active substance when compared to spray application. As watercourses often are located next to forest tracks (place of application), the entry of active substances into the water is reduced by drift avoidance and thus

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 41 of 56 aquatic organisms are protected. The protection time of Storanet is extended as only one spray application per log pile is allowed. Storanet is effective already at low temperatures. Therefore it is suitable especially for an appli- cation, when risk of infestation exists in early spring. Storanet used in forest (>20°C and rain) has a residual efficacy against bark beetles up to 24 weeks (6 months). Therefore it can be reused, if it is not damaged, and rolled up on the empty roller system.

Small damages in the net of size up to 5 cm have no negative influence on the protection of timber. Bigger damages in the net have to be closed for example with twine. The attack of bark beetle species and wood boring insects cause economic damage to timber. Damaged timber cannot be used for the production of furniture or for other intended uses of high grade wood. The trials reported in the Biological Assessment Dossier were performed against the most harmful bark beetles species Ips typographus, Trypodendron lineatum, Pitogenes chal- cographus, Platypus cylindrus, and the less important bark beetles Dryocoetes autographus and Hylurgus ligniperda (according to trial report Hylastes ligniperda) and species of Xyloterus spp., Xyleborus spp., Cerambycidae as well as Curculionidae.

The preliminary range-finding tests showed an optimal dose-efficacy-relation at the target application rate of 100 mg alpha-cypermethrin/m2 in field. The active substance content on nets seemed to decrease slowly after four months.

The minimum effective dose tests showed a very good efficacy at the target dose rate of 100 mg alpha-cypermethrin/m2, which did not increase after application of a higher dose rate. These results are supported by the preliminary range-finding test, which was performed with an artifi- cially controlled attack by Ips typhographus.

Against the three important bark beetles Ips typographus, Trypodendron lineatum and Pityo- genes chalcographus in spruce logs the efficacy of the test product Storanet –wrapped around the logs– is excellent, being significantly better than the control and comparable to the standard products Fastac Forst and Vaztak.

Against less important bark beetles the efficacy of the test product Storanet –wrapped around the logs– was limited. As no control and standard product was tested in those trials no conclu- sion can be made regarding the degree of efficacy and the comparability of the test and stan- dard product.

The application method “logs wrapped in Storanet” seems to be slightly better than the applica- tion method “logs wrapped in a 1-year-old used Storanet” followed by the application method “Storanet over the top application”. Efficacy was expressed as percent attacked logs and num- ber of galleries caused by less important bark beetles, longhorn beetle (Cerambycidae) and Curculionidae. Against the three important bark beetle species Ips typographus, Trypodendron lineatum and Pityogenes chalcographus all of these application methods showed a very high level of efficacy (0-1 % attacked logs).

In oak logs the test product Storanet achieved excellent efficacy (0 % attacked logs) against the most damaging wood boring bark beetle Platypus cylindrus and against Xyloterus spp.

The test product Storanet is suitable for prevention of bark and wood boring insect flight from treated logs. The efficacy of the test product Storanet and the standard product Fastac Forst was 100% against Ips typograpus.

Nearly all efficacy trials conducted with Storanet in forest showed no natural infestation with longhorn beetles. A very good efficacy was shown against Monochamus galloprovincialis bee-

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 42 of 56 tles for prevention of insect flight in a sheltered room with ambient temperature (common storing conditions) in Portugal (Mediterranean zone, 2 artificial trials). The indication applications in hard- and softwood against longhorn beetles for protection of harvested wood from infestation and for protection against flight of beetles from attacked wood is based on extrapolation from bark beetles, taking the very good efficacy of two artificial trials with Storanet against longhorn beetles, the similar mode of live and the already proven efficacy of the active substance alpha- cypermethrin (Fastac Forst) against longhorn beetles into account.

In all efficacy trials conducted with Storanet no natural infestation with jewel beetles occurred. The indication applications in hard- and softwood against jewel beetles for protection of har- vested wood from infestation and for protection against flight of beetles from attacked wood is based on extrapolation from bark beetles, taking the similar mode of live and the already proven efficacy of the active substance alpha-cypermethrin (Fastac Forst) against jewel beetles into account.

The net possesses a high physical stability. In all trials no holes were caused by insects or at application.

Storanet does not have effects on yield and quality of timber logs.

In all trials a very good selectivity on timber (spruce, oak and larch) was confirmed. No phyto- toxic effect of Storanet was observed or reported.

In some trials beneficial organisms were caught in Storanets. As Storanet treatments usually are conducted as spot treatments next to forest tracks and predominantly on high grade timber, no unacceptable risk for beneficial insects is expected.

Adverse effects on parts of plant used for propagating purposes are not of relevance for timber logs.

The impact on succeeding crops is not relevant for timber logs stored at forest tracks.

The impact on other plants including adjacent crops is not relevant for timber logs wrapped in treated nets stored at forest tracks.

The combined resistance risk of bark boring bark beetles, longhorn beetles and jewel beetles with alpha-cypermethrin is medium. As precautionary measure to reduce the resistance risk, the principles of “clean forest economy” have to be followed.

Other/special studies in the Mediterranean zone using Storanet to cover wood logs showed 100 % efficacy against Monochamus galloprovincialis in a sheltered room at ambient tempera- ture.

As result of this biological assessment dossier the recommended use, use conditions and re- strictions are summarized in tabular form below.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 43 of 56

Table 0-1: Recommended use of Storanet, use conditions and restrictions Application, impact on pathogen and resistance data Crop Timber logs Species Various hard- and softwood species Application time Preventive, with application before beetle flight or at risk of infestation to keep the logs clean or Application of attacked logs to prevent beetle flight Application rate 100 mg alpha-cypermethrin/m2 net for wrapping of single trunk or application over the top of lumber stocks Application number 1 Maximal application size 200 m2 total net surface for up to 38 m3 cord of logs Preharvest interval n.a. Target pest Indication applied for: Bark and wood boring bark beetles, longhorn beetles, jewel beetles Pest stage Adults

Resistance No resistance of bark beetles, longhorn beetles and jewel beetles is reported so far. The principles of “clean forest economy” should be followed and the bark beetle populations should be monitored with pheromone traps to avoid unnecessary applications. Miscibility with n.a. Product, hazard, ecotoxicological and environmental data Formulation n.a. Active substance 100 mg alpha-cypermethrin/m2 net Chemical class Pyrethroids (3A) CAS-number 67375-30-80 Mode of action Impact on nerve system Target site The active substance delays the close-down and inacti- vation of the voltage-dependent sodium channels. Danger symbol, risk and safety dangerous to environment (N), R50/53, S2, S13, S20/21, phrases S29, S35, S37, S56 Water protection area requirement None Surface water indication related restrictions for uses in timber logs: open Bees and other beneficial organisms not dangerous to bees, if applied as intended (B3, NB663), classification for water organisms and beneficial organ- isms: open

IIIA1 6.7 List of test facilities including the corresponding certificates The list of test facilities including corresponding certificates is shown in 2011/1040781 Zuehlke T. 2011 e

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 44 of 56

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 45 of 56

Appendix 1: List of data submitted in support of the evaluation

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Rosenkra Effects of BAS 310 41 I on the predatory mite 2004 2004/101 10.5.1 nz, B. Typhlodromus pyri in the laboratory - Dose 5021 response test 260325

KIIIA1 Moll M. Effects of BAS 310 41 I on the parasitoid 2004 2004/102 10.5.1 Aphidius rhopalosiphi in the laboratory - Dose 0915 response test 260326

KIIIA1 Taruza S. A rate-response laboratory test to determine the 2001 AL-560- 10.5.1 effects of Alpha-Cypermethrin (AC 900049), in a 049 100 g/L OESC formulation (CF 06677), on the predatory mite, Typhlodromus pyri (Acarina: 260327 Phytoseiidae)

KIIIA1 Vinall S. A rate-response laboratory test to determine the 2001 AL-560- 10.5.1 effects of Alpha-Cypermethrin (AC900049) in a 045 100 g/L OESC formulation (CF 06677), on the parasitic wasp Aphidius rhopalosiphi 260328 (Hymenoptera, Braconidae)

KIIIA1 Baxter I. A laboratory test to determine the effects of 2000 AL-549- 10.5.1 Alpha-Cypermethrin, in a 100 g/L OESC 024 formulation (CF 06677), on the ground-dwelling predator, Poecilus cupreus (Coleoptera, 260329 Carabidae)

KIIIA1 Vinall S. A laboratory test to determine the effects of 2000 AL-560- 10.5.1 Alpha-Cypermethrin (AC 900049), in a 100 g/L 030 OESC formulation (CF 06677), on the ground- dwelling parasitic beetle, Aleochara bilineata 260330 (Coleoptera, Staphylinidae)

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 46 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Taruza S. A rate-response extended laboratory test to 2002 AL-560- 10.5.2 determine the effects of Alpha-Cypermethrin 065 (AC 900049), in a 100 g/L OESC formulation (BAS 310 I), on the predatory mite, 260331 Typhlodromus pyri (Acari: Phytoseiidae)

KIIIA1 Taruza S. An extended laboratory test to determine the 2001 AL-560- 10.5.2 effects of fresh and aged residues of the 053 insecticide Alpha-Cypermethrin (AC 900049), in a 100 g/L OESC formulation (CF 06677) on the 260332 predatory mite Typhlodromus pyri (Phytoseiidae)

KIIIA1 Vinall S. A rate-response extended laboratory test to 2002 AL-560- 10.5.2 determine the effects of Alpha-Cypermethrin 066 (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the parasitic wasp, Aphidius 260334 rhopalosiphi (Hymenoptera, Braconidae)

KIIIA1 Taruza S. An extended laboratory test to determine the 2001 AL-560- 10.5.2 effects of Alpha-Cypermethrin (AC 900049), in a 046 100 g/L OESC formulation (CF 06677) on the ground dwelling parasitic beetle, Aleochara 260335 bilineata (Coleoptera, Staphylinidae)

KIIIA1 Vinall S. A rate-response extended laboratory test to 2002 AL-560- 10.5.2 determine the effects of Alpha-Cypermethrin 064 (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator Orius 260336 laevigatus (Heteroptera: Anthocoridae)

KIIIA1 Manley B. A rate-response extended laboratory test to 2002 AL-560- 10.5.2 determine the effects of Alpha-Cypermethrin 067 (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator 260337 Chrysoperla carnea (Neuroptera, Chrysopidae)

KIIIA1 Manley B. An aged-residue extended laboratory test to 2002 AL-560- 10.5.2 determine the effects of Alpha-Cypermethrin 070 (AC 900049) in a 100 g/L OESC formulation (BAS 310 I), on the foliar-active predator, 260338 Chrysoperla carnea (Neuroptera: Chrysopidae)

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 47 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Knaebe S. A field trial assessing the impact of multiple 2009 2008/109 10.5.4 applications of Alphacypermethrin (100 g/L,SC) 1409 on the non-target arthropod fauna in cereals in Germany 260339

KIIIA1 Knaebe, A field trial assessing the impact of multiple 2009 2009/111 10.5.4 S. applications of Alphacypermethrin (100 g/L, SC) 7839 on the non-target arthropod fauna of a winter wheat crop (France) 260340

KIIIA1 Klein W. Auswirkungen einer Fastac-Anwendung gegen 1992 1992/100 10.5.4 Forstschaedlinge auf die Bodenfauna des 2198 Waldes 260341

KIIIA1 Luehrs U. Acute toxicity (14 days) of Alphacypermethrin 2001 AL-560- 10.6.2 (AC 900049) in a 100 g/L oil emulsion 042 suspension concentrate formulation (Fastac 10% OESC) (CF 06677) to the earthworm 260342 Eisenia fetida (Savigny 1826) in artificial soil

KIIIA1 Fleischer Effect of BAS 310 41 I on the mortality of the 2004 2004/100 10.6.2 G. earthworm Eisenia fetida 3941

260343

KIIIA1 Luehrs U. Effects of Alpha-Cypermethrin (AC 900049) in a 2001 AL-560- 10.6.3 100 g/L oil emulsion suspension concentrate 041 formulation (Fastac 10% OESC) (CF 06677) on reproduction and growth of earthworms Eisenia 260344 fetida (Savigny 1826) in artificial soil

KIIIA1 6 Zuehlke T. Registration report - Biological Assessment 2012 2012/104 Dossier - BAS 310 62 I Core C - ZRMS: 7787 Germany 260347

KIIIA1 6 Zuehlke T. Attachment: BAS 310 62 I Core C BAD 2012 2012/104 7787

260348

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 48 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Anonymou Tastversuch zur Feststellung der 2008 2011/104 6.1.1 s Wirksamkeitsdauer unterschiedlich stark 0744 beladener Interzeptor-Moskitonetze 260349

KIIIA1 Zuehlke T. WoodNet (BAS 310 62 I) - Data on minimum 2011 2011/104 6.1.2 effective dose in indication: Bark beetle in a cord 0779 of wood (hard- and pinewood) - OECD-data point number III 6.1.2 260350

KIIIA1 Anonymou Ergebnisbericht Mittelpruefung - Hier: Einsatz 2009 2011/104 6.1.2 s von WoodNet als Schutz von Fichten-Poltern vor 0741 der Besiedlung mit Buchdruckern 260351

KIIIA1 Zuehlke T. WoodNet (BAS 310 62 I) - Standard products - 2011 2011/104 6.1.3 OECD-data point number III 6.1.3 0777

260352

KIIIA1 Zuehlke T. Wood Net (BAS 310 62 I) - Data on efficacy in 2011 2011/104 6.1.3 indication: Bark beetle in a cord of wood (hard- 0778 and pinewood) - OECD-data point number III 6.1.3 260353

KIIIA1 Anonymou Ergebnisbericht Mittelpruefung - Hier: Einsatz 2009 2011/104 6.1.3 s von WoodNet als Schutz von Fichten- 0740 Einzelstaemmen vor der Besiedlung mit Buchdruckern 260354

KIIIA1 Anonymou Abschlussbericht Mittelpruefungen - Hier: 2008 2011/104 6.1.3 s Pruefung des Moskitonetzes Interceptor mit 0743 Fendozin LLIN der Fa. BASF zum vorbeugenden Schutz von Hoelzern gegen den 260356 Befall holzbruetender Borkenkaefer

KIIIA1 Anonymou Schlussbericht Mittelpruefung - Pruefung des 2010 2011/104 6.1.3 s insektizid-impraegnierten Netzes WoodNet zur 0745 vorbeugenden Behandlung gegen holzbruetende Borkenkaefer 260357

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 49 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Anonymou Schlussbericht Mittelpruefung - Pruefung des 2010 2011/104 6.1.3 s insektizid-impraegnierten Netzes WoodNet zur 0746 vorbeugenden Behandlung gegen rindenbruetende Borkenkaefer 260358

KIIIA1 Anonymou Schlussbericht Mittelpruefung - Pruefung des 2010 2011/104 6.1.3 s insektizid-impraegnierten Netzes WoodNet zur 0747 Vorausflugbehandlung gegen rindenbruetende Borkenkaefer 260359

KIIIA1 Skrzecz I. Evaluation of BASF WoodNet effectiveness in 2010 2011/104 6.1.3 spruce timber protection against European 0748 spruce bark beetles (Scolytinae spp.) 260360

KIIIA1 Skrzecz I. Evaluation of BASF WoodNet effectiveness in 2010 2011/104 6.1.3 spruce timber protection against European 0749 spruce bark beetles (Scolytinae spp.) 260361

KIIIA1 Skrzecz I. Evaluation of BASF WoodNet effectiveness in 2010 2011/104 6.1.3 spruce timber protection against European 0750 spruce bark beetles (Scolytinae spp.) 260362

KIIIA1 Skrzecz I. Evaluation of BASF WoodNet effectiveness in 2010 2011/104 6.1.3 spruce timber protection against European 0751 spruce bark beetles (Scolytinae spp.) 260363

KIIIA1 Skrzecz I. Evaluation of BASF WoodNet effectiveness in 2010 2011/104 6.1.3 spruce timber protection against European 0752 spruce bark beetles (Scolytinae spp.) 260364

KIIIA1 Skrzecz I. Evaluation of BASF WoodNet effectiveness in 2010 2011/104 6.1.3 spruce timber protection against European 0753 spruce bark beetles (Scolytinae spp.) 260365

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 50 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Skrzecz I. Protection of mountain tree stands from the 2010 2011/104 6.1.3 European spruce bark beetle, with particular 0755 emphasis on reducing populations of secondary pests using WoodNet netting applied to lumber 260366 infested by insects

KIIIA1 Anonymou Woodnet/Trenet trials 2010 - First tests of new 2010 2011/104 6.1.3 s timber/forest protecting material - Complion 0754

260367

KIIIA1 Perny B. Ergebnisse der Testung der Wirkung und 2011 2011/104 6.1.3 Praxistauglichkeit von WoodNet und TriNet (mit 0756 dem Wirkstoff Alpha-Cypermethrin) in der Borkenkaeferbekaempfung - 2. Versuchsjahr 260368

KIIIA1 Gerakova Trial report of plant protection products 2011 2011/104 6.1.3 M. 0757

260369

KIIIA1 Gerakova Trial report of plant protection products 2011 2011/104 6.1.3 M. 0758

260371

KIIIA1 Gerakova Trial report of plant protection products 2011 2011/104 6.1.3 M. 0759

260372

KIIIA1 Gerakova Trial report of plant protection products 2011 2011/104 6.1.3 M. 0760

260373

KIIIA1 Langewal Alphacypermethrin - Resistance risk analysis 2011 2011/106 6.2.8 d J. et al. 7044

260374

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 51 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Langewal Attachment: 2011/1067044 2011 2011/106 6.2.8 d J. et al. 7044

260375

KIIIA1 6.5 Anonymou Efficacy of the insecticide-net 2012 2011/104 s 0761

260376

KIIIA1 6.6 Zuehlke T. Storanet (BAS 310 62 I) - Provisional 2011 2011/104 instructions for use - OECD-data point number 0776 III 6.6 260380

KIIIA1 6.7 Zuehlke T. BAS 310 62 I: Information of test facilities and 2011 2011/104 corresponding certificates - OECD-data point 0781 number III 6.7 260381

MIIIA1 BASF Registration Report - Part B - Storanet - DE - 2012 2011/112 Sec 6 Section 6 - Ecotoxicology -- Core assessment 2476

260400

MIIIA1 BASF Registration Report - Part B - Storanet - DE - 2012 2011/112 Sec 6 Section 6 - Ecotoxicology -- Core assessment 2476

260402

MIIIA1 BASF Registration Report - Part B - Storanet - DE - 2012 2011/118 Sec 6 Section 6 - Ecotoxicology --National addendum 3012

260403

MIIIA1 BASF Registration Report - Part B - Storanet - DE - 2012 2011/118 Sec 6 Section 6 - Ecotoxicology --National addendum 3012

260404

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 52 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

MIIIA1 BASF Registration Report - Part B - Storanet - DE - 2012 2012/102 Sec 7 Section 7 - Efficacy Data and Information - Core 6825 assessment 260405

MIIIA1 BASF Registration Report - Part B - Storanet - DE - 2012 2012/102 Sec 7 Section 7 - Efficacy Data and Information - Core 6825 assessment 260406

KIIA 8.9.1 Inglesfield, Toxicity of cypermethrin and WL85871 to the 1983 SBGR.83. C. earthworm, Eisenia foetida L. (Oligochaeta: 071 Lumbriculidae) in laboratory tests 260422

KIIIA1 Lührs, U. Effects of alpha-cypermethrin (AC 900049) in a 2001 ETX-00- 10.6.3 100 g/l oil emulion suspension concentrate 129 formulation (Fastac 10% OESC) (CF06677) on reproduction and growth of earthworms Eisenia 260423 fetida (Savigny 1826) in artificial soil

KIIIA1 Chapleo, The effect of alpha-cypermethrin (AC 900049) in 2000 ETX-00- 10.7.1 S. a 100 g L-1 OESC formulation on carbon and 108 nitrogen transformations of the soil microflora 260424

KIIIA1 Chapleo, The effect of alpha-cypermethrin (AC 900049) in 2000 ETX-00- 10.7.1 S. a 100 g L-1 OESC formulation on carbon and 108 nitrogen transformations of the soil microflora 260425

KIIIA1 Cook, K.A. Determination of the effects of WL 43467 on 1978 AL-620- 10.7 microbial activity in soil I. Effects on carbon 001 Dioxide Evolution 260426

KIIIA1 Loveridge, Determination of the effects of WL 43467 on 1978 AL-620- 10.7 D. and microbial activity in soil II. Effects on oxigen 002 Cook, K.A. uptake 260427

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 53 of 56

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Bromley, Determination of the effects of WL 43467 on 1978 CY-625- 10.7 S and microbial activity in soil V. Effects on glucose 003 Cook, K.A. utilisation 260428

KIIIA1 Chapleo, The effect of alpha-cypermethrin (AC 900049) in 2000 ETX-00- 10.7.1 S. a 100 g L-1 OESC formulation on carbon and 108 nitrogen transformations of the soil microflora 260429

KIIIA1 Becker, R. Additional information on the risk assessment for 2012 BASF 10.5 and non-target arthropods, soil organsims and DocID Weltje, L. aquatic organisms after application of Storanet 2012/127 (BAS 310 62 I) in forestry 1438

286039

KIIIA1 Niggeweg, Erhebung der Totholzmenge im Wald 2012 10.5 R. 286040

KIIIA1 Becker, R. Additional information on the risk assessment for 2012 BASF 10.6 and non-target arthropods, soil organsims and DocID Weltje, L. aquatic organisms after application of Storanet 2012/127 (BAS 310 62 I) in forestry 1438

286043

KIIIA1 Niggeweg, Erhebung der Totholzmenge im Wald 2012 10.6 R. 286045

Julius Kühn-Institut 2013-04-16 Part K BAS 310 62 I Biological Assessment Dossier

Page 54 of 56

Appendix 2: GAP table

GAP date: 2012-7-04

PPP (product name/code) Storanet Formulation: Type: LN Conc. of as 1: 1,57 g/l active substance 1 alpha-Cypermethrin

Applicant: BASF professional use non professional use

Zone(s): central

Verified by MS: Yes

1 2 3 5 6 7 8 9 10 11

Applicant BASF Evaluator Applicant Document ID 2012/1047787 Date Applicant Author Thomas Zuehlke Part K BAS 310 62 I Biological Assessment Dossier

Page 55 of 56

Use-No. Member Crop and/ F Pests or PHI Remarks: state(s) or situa- G Group of pests Formulation Application Application rate per treatment (days) tion or controlled I (b) (c) (l) (m) (a) Type Conc. method growth number interval g as/treatment water L/ha kg of as kind stage & min max between as/ha season applica- min max min max (j) tions min (d-f) (i) (f-h) (k) (min) max (n)

1, 2 Central Single F Bark and wood LLIN 1.57g/ Complete Post harvest 1 50 m2 net / Not Not formal zone trunk boring bark kg wrapping of treatment single trunk applica- appli- - applica- DE, AT, beetles (100m trunk 5 g as / single ble cable tion rate: PL, CZ, Longhorn bee- g/m²) trunk) 41 g / ha SK, SI tles and metallic wood-boring beetles 3, 4 Central Lumber F Bark and wood LLIN 1.57g/ Application Post harvest 1 100 m2 net Not Not formal zone stock boring bark kg over the top of treatment /lumber stock applica- appli- - applica- DE, AT, (20 m3) beetles (100m the stock 10 g as / ble cable tion rate: 2 g / ha PL, CZ, Longhorn bee- g/m²) lumber stock SK, SI tles and metallic wood-boring beetles 5, 6 Central Large F Bark and wood LLIN 1.57g/ Application Post harvest 1 200 m2 net / Not Not formal zone lumber boring bark kg over the top of treatment large lumber applica- appli- - applica- DE, AT, stock beetles (100m the stock stock ble cable tion rate: PL, CZ, (40 m3) Longhorn bee- g/m²) 20 g as / large 2 g / ha SK, SI tles and metallic lumber stock wood-boring beetles

Applicant BASF Evaluator Applicant Document ID 2012/1047787 Date Applicant Author Thomas Zuehlke Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 56 of 56

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data)

The site details report is given in KIIIA 6.1.2/1 (DocID 2011/1040779) Table 6.1.2/1A for minimum effective dose tests and in KIIIA 6.1.3/2 (Doc ID 2011/1040778) in Table 6.1.3/1A for efficacy trials.

Appendix 4 Summary of data on trials site and application details per use (EPPO code). This information is given in KIIIA 6.1.3/2 (Doc ID 2011/1040778) in Table 6.1.3/1A for description of treatments and in Table 6.1.3/1.1 (protection of not attacked logs against bark beetles) and in Table 6.1.3/1.2 (prevention of bark beetle flight out of attacked logs) for description of harmful organ- ism and assessed part and variable. Appendix 5 Summary of data on effectiveness trials per use (crop/harmful organism); (EPPO code) No typical phytotoxicity trials were performed. Please refer to point 6.2.1.

Appendix 6 Summary of detailed data on herbicide effectiveness trials. Observations of adverse effects on beneficial organisms were only evaluated in some efficacy trials (detailed data under point 6.2.4). No HQ can be calculated out of this data.

Julius Kühn-Institut 2013-04-16 Part B – Section 7 Storanet Registration Report Core Assessment 007598-00/00 Central Zone Page 57 of 56

i Binner et al. (1999): Abdrift und Kontamination des Waldbodens nach praxisüblicher Behandlung liegender Einzelstämme im Forst. Nachrichtenblatt Deutscher Pflanzenschutz- dienst: 51. iihttp://www.bvl.bund.de/SharedDocs/Downloads/04_Pflanzenschutzmittel/zul_dok_GEP_liste.pdf?__blob=publicationFile iii http://de.wikipedia.org/wiki/Katowice#Klima iv Alford, D.V. (1997): Farbatlas der Schädlinge an Zierpflanzen. Ferdinant Enke Verlag, Stuttgart. v http://archives.eppo.org/MEETINGS/2007_meetings/meligethes/meligethes_workshop.htm vi http://www.irac-online.org/wp-content/uploads/2009/09/MoA-classification_v7.0.4-5Oct10.pdf vii http://www.wald-rlp.de/index.php?id=313 viiihttp://www.faunistik.net/DETINVERT/COLEOPTERA/SCOLYTIDAE/PITYOGENES/pityogenes.chalcographus.html ix http://www.wsl.ch/forest/wus/diag/show_singlerecord.php?TEXTID=141 xhttp://www.forestresearch.gov.uk/pdf/fr_advice_note_oak_pinhole_borer.pdf/$FILE/fr_advice_note_oak_pinhole_borer.pdf xi http://wiki.bugwood.org/Archive:Atlas/Monochamus_sutor xii http://de.wikipedia.org/wiki/Tetropium_castaneum xiii http://www.fs.usda.gov/Internet/FSE_DOCUMENTS/fsbdev2_026444.pdf#page=77 xiv http://www.lwf.bayern.de/waldbewirtschaftung/waldschutz/schaedlinge-und-baumkrankheiten/verzeichnis/eichenprachtkaefer/35276/index.php xv http://www.faunistik.net/DETINVERT/COLEOPTERA/BUPRESTIDAE/phaenops_cyanea.html

Julius Kühn-Institut 2013-04-16