Part A Product code Draft Registration Report –Central Zone National Assessment - 008562-00/00 Vintec Page 1 of 23 Federal Republic of Germany
REGISTRATION REPORT Part A
Risk Management
Product name: Vintec Product code: Vintec Active Substance: Trichoderma atroviride strain SC1 150 g/kg (1 × 1013 CFU/kg)
COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany
NATIONAL ASSESSMENT
Applicant: Bi-PA nv/sa Submission date: 24.09.2015 Finalisation date: 30.08.2018
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Table of Contents
PART A – Risk Management 5 1 Details of the application 5 1.1 Application background 5 1.2 Annex I inclusion 5 1.3 Regulatory approach 6 1.4 Data protection claims 6 1.5 Letters of Access 6 2 Details of the authorisation 6 2.1 Product identity 6 2.2 Classification and labelling 6 2.2.1 Classification and labelling under Regulation (EC) No 1272/2008 6 2.2.3 Standard phrases under Regulation (EC) No 547/2011 7 2.3 Other phrases notified under Regulation (EC) No 547/2011 7 2.3.1 Restrictions linked to the PPP 7 2.3.2 Specific restrictions linked to the intended uses 8 2.4 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) 12 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 12 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 12 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 12 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 12 3.1.3.2 Operator, Worker, Bystander and Resident Exposure (Part B, Section 3, Point 7.3 to 7.5) 12 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 13 3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 14 3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) 14 3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 14 3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) 14
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3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) 15 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 15 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 15 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 16 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 16 3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) 17 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 17 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 17 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 18 3.1.6 Efficacy (Part B, Section 7, Point 8) 18 3.2 Conclusions 19 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 19 Appendix 1 – Copy of the product authorisation (see Appendix 4) 20 Appendix 2 – Copy of the product label 21 Appendix 3 – Letter of Access 22 Appendix 4 – Copy of the product authorisation 23
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PART A – Risk Management This document describes the acceptable use conditions required for the registration of Vintec containing Trichoderma atroviride SC1 for field use in the EU.
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 (B.8 and B.9).
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 Trichoderma atroviride SC1 and all data are part of the EU evaluation doosier. assessments for the safe use of Trichoderma atroviride SC1 have been made using endpoints agreed in the EU review of Trichoderma atroviride SC1.
This document describes the specific conditions of use and labelling required for Germany for the registration of Trichoderma atroviride SC1.
Appendix 1 should include the authorisation of the final product in Germany. Due to technical reasons, the authorisation of the final product in Germany is inserted under Appendix 4.
Appendix 2: 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 31 of Regulation (EC9 No 1107/2009.
Appendix 3: Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
Appendix 4 of this document provides a copy of the final product authorisation Germany.
1 Details of the application
1.1 Application background
This application was submitted by GAB Consulting on behalf of Bi-PA on 24 September 2015.
The application was for approval of Vintec, a wetable granulate containing 150 g/kg Trichoderma atroviride strain SC1 for use as a fungicide in viticulture.
1.2 Annex I inclusion
Trichoderma atroviride Stamm SC1 was approved as low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation /EU) No 540/2011:
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In this overall assessment Member States shall pay particular attention to the protection - of operators and workers, taking into account that microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate.
Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. These concerns were all addressed in the submission.
1.3 Regulatory approach
This application was submitted in order to allow the first authorisation of this product/use in Germany in accordance with the above.
1.4 Data protection claims Where protection for data is being claimed for information supporting registration of Vintec, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1, 5, 6 and 7.
1.5 Letters of Access LoA is not necessary. The applicant addressed all data requirements by own data.
2 Details of the authorisation
2.1 Product identity
Product name Vintec Product codes Trichoderma granule, Trichoderma atroviride SC1WG, BCP511B, SC1 WG Authorization number (for re- 008562-00 registration) Function fungicide Applicant Bi-PA nv (Biological Products for Agriculture) Composition EU: 9 x 109 cfu/g of Trichoderma atroviride SC1 Germany: 1 × 1013 CFU/kg Trichoderma atroviride SC1 Eq. 150 g/kg Trichoderma atroviride SC1 Formulation type water dispersible granules [Code: WG] Packaging 50 g PE/AL/PE bag in cardboard boxes; 400 g and 1 kg PE/AL/PE bag
2.2 Classification and labelling
2.2.1 Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:
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Hazard classes and categories: None Hazard pictograms: None Signal word: None Hazard statements: None Precautionary statemtents: None
Special rule for labelling of PPP: EUH401 To avoid risks to man and the environment, comply with the instructions for use. Further labelling statements under Regulation (EC) No 1272/2008: None
2.2.3 Standard phrases under Regulation (EC) No 547/2011 None
2.3 Other phrases notified under Regulation (EC) No 547/2011
2.3.1 Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling):
Human health protection SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB005 If medical advice is needed, have product container or label at hand. SB010 Keep out of the reach of children. SB111 Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection prod-ucts" of the Federal Office of Consumer Protection and Food Safety (www.bvl.bund.de) must be observed. SB166 Do not eat, drink or smoke when using this product. SF245-02 It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. SS110-1 Protective gloves (plant protection) must be worn when handling the undiluted product.
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SS206 Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. VH650 The packaging must be provided with the wording "micro-organisms may have the potential to provoke sensitising reactions". Integrated pest management (IPM)/sustainable use WMFBM02 Mode of action (FRAC-group): BM02 (for Trichoderma atroviride) Ecosystem protection SP1 Do not contaminate water with the product or its container (Do not clean application equipment near surface water/Avoid contamination via drains from farmyards and roads).
The authorization of the PPP is linked to the following conditions (voluntary labelling):
Integrated pest management (IPM)/sustainable use NN1001 The product is classified as non-harmful for populations of relevant beneficial insects. NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders. NB6641 The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4)
2.3.2 Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling): See 2.4 (Product uses)
Ecosystem protection NW642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR. Integrated pest management (IPM)/sustainable use NN134 The product is classified as harmless for populations of the species Typhlodromus pyri (predatory mite).
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2.4 Product uses
GAP-Table of intended uses for Germany Reg.-No. 008562-00/00 GAP rev.1, date: 2018-03-07 PPP (product name/code): Vintec Formulation type: WG (a, b) Active substance 1: Trichoderma atroviride Stamm SC1 Cont. of as 1: 150.00 g/kg (c) (1*1013 CFU/kg) Applicant: Bi-PA nv/sa Professional use: Yes Zone(s): central/interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungicide
1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: No. state(s) or situation Fn, pests controlled Method / Timing Max. Min. kg or L g or kg as/ha Water (days) (e) Fpn Kind / number interval product / ha L/ha e.g. g (crop G, (additionally: Growth a) per between a) max. rate a) max. rate safener/synergist destination / Gn, developmental stage of use applications per appl. per appl. min / per ha purpose of Gpn stages of the pest crop & b) per (days) b) max. total b) max. total max (f) crop) or or pest group) season crop/ rate per rate per I season crop/season crop/season 001 DE grape vine F esca of vinegrape spraying a) 2 7 days a) 0.2 kg/ha a) 0.03kg/ha 100 - F *) *) The PHI is covered (VITVI) (Phaeomoniella or fine from 00 b) 2 b) 0.4 kg/ha b) 0.06kg/ha 200 by the conditions of use and/or the chlamydospora) spraying during L/ha vegetation period (PHMOCH), esca (low dormant remaining between of vinegrape volume period the application of the (Togninia minima) spraying) plant protection product and the use of (TOGNMI) the product (e. g. harvest) or the setting of a PHI in days is not required resp.
Remarks (a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (d) Select relevant (GR)
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table (b) Catalogue of pesticide formulation types and international coding (e) Use number(s) in accordance with the list of all intended GAPs in Part B, heading: system Crop Life International Technical Monograph n°2, 6th Section 0 should be given in column 1 Edition Revised May 2008 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.
Remarks 1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use columns: must be provided. 2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of used; when relevant, the use situation should be described (e.g. fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose fumigation of a structure) expression for plant protection products. 4 F: professional field use, Fn: non-professional field use, Fpn: 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per professional and non-professional field use, G: professional treatment (usually g, kg or L product / ha). greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds 12 If water volume range depends on application equipment (e.g. ULVA or LVA) or, when relevant, the common names of the pest groups (e.g. it should be mentioned under “application: method/kind”. biting and sucking insects, soil born insects, foliar fungi, weeds) 13 PHI - minimum pre-harvest interval and the developmental stages of the pests and pest groups at the 14 Remarks may include: Extent of use/economic importance/restrictions moment of application must be named. 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated. 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application
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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: 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 pale green solid with a characteristic odour. It is not explosive, has no oxidising properties. It has a self ignition temperature of > 140 °C. In aqueous solution, it has a pH value around 7.6. The stability data indicate a shelf life of at least 2 years at 4 °C temperature. The technical characteristics are acceptable for a water dispersible granules concentrate formulation.
In an experimental examination of the formulation significant deviations from the data submitted by the applicant were detected for density (tapped 513 g/L instead of 670 g/L), wettability (not completely wettable instead of 60 s) and suspensibility (53 instead of 71 %). Further clarification has been submitted by the applicant. The differences in suspensibility could be explained by the different kind of determination (gravimetric vs. analytical). According to the applicant the measured dynamic wettability is acceptable. A sentence will be added to the label, that stirring is compulsory at preparation and application of the spray broth.
Implications for labelling: No classification based on physical hazards. Vintec can be kept at 4 °C for long period storage (at least 2 years following manufacturing date). According to the draft label, Vintec can be kept at 20 °C at max. for 6 months (no data submitted).
Compliance with FAO guidelines: The product Vintec complies with the general requirements for WG-formulations contain microorganisms according to the FAO/WHO manual (2016).
Compatibility of mixtures: No tank mixtures are recommended on the label.
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 Vintec has been provided and is considered to be acceptable.
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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) A sufficiently validated method for the enumeration of T. atroviride SC1 is available.
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) No residue definition is applicable for T. atroviride SC1 or its metabolites. Therefore, no post-registration monitoring methods are needed.
3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) If the product is used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected. EFSA (EFSA Journal 2015;13(4):4092) concluded that the strain is resistant to 4 antibiotics used in human or veterinary medicine. Therefore the criteria for low-risk active substances (COMMISSION REGULATION (EU) 2017/1432, ANNEX, 5.2.1) are not fulfilled and the plant protection product cannot be classified as low-risk product.
3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) Vintec, containing 150 g/L T. atroviride SC1 has shown no toxicity in respect to oral and acute inhalation toxicity. No study on the acute dermal toxicity of T. atroviride SC1 was submitted. Since Trichoderma does not penetrate intact human skin and the formulation Vintec does not contain any components with classification regarding acute dermal toxicity, this is acceptable. The product is neither irritating to skin nor to eyes. No study on the sensitisation potential of T. atroviride SC1 was submitted. This is acceptable as none of the components is a skin sensitizer. As microorganisms in general are considered sensitising unless there is sufficient experimental evidence that there is no concern the labelling phrase “Microorganisms may have the potential to provoke sensitising reactions” is required.
3.1.3.2 Operator, Worker, Bystander and Resident Exposure (Part B, Section 3, Point 7.3 to 7.5) Based on the lack of significant toxicity, infectivity or pathogenicity in the available toxicological studies, no Acceptable Operator Exposure Level (AOEL) was derived for T. atroviride SC1. Therefore, a quantitative assessment of the operator, worker, bystander and resident exposure is not deemed necessary. Considering the potential sensitizing properties of T. atroviride SC1, protection equipment must be worn by operators (gloves and coverall).
Implications for labelling resulting from operator, worker, bystander assessments: See 2.2
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3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) Since T. atroviride SC1 is listed in Annex IV of Regulation (EC) No 396/2005, neither a residue definition nor MRLs were established. Based on the lack of significant toxicity, infectivity or pathogenicity in the available toxicological studies, no Acceptable Daily Intake (ADI) or Acute Reference Dose (ARfD) were derived for T. atroviride SC1. The chronic and the short-term intakes of T. atroviride SC1 residues are unlikely to pose a health risk for consumers. Therefore, no detailed food intake assessment is required.
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3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) No new studies are presented; all data were reviewed in the EU review Trichoderma atroviride SC1. Appropriate endpoints from the EU review were used to calculate PECs for Vintec, Trichoderma atroviride SC1 and metabolites in soil, surface water, ground water and air for the intended use patterns.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5)
According to the PEC calculation, the expected initial concentration in soil is 0.53 mg product/kg dry weight soil corresponding to 0.08 mg T. atroviride SC1/kg dry weight soil. In terms of CFU, this is equivalent to 0.53 × 107 CFU/kg dry weight soil. The environmental behavior of T. atroviride SC1 in soils can be summarized as follows: after reaching the soil environment, the fungus may establish stable populations in the surface soil and the rhizosphere. Due to competition and also abiotic factors population densities decline over time. Long time persistence may occur in the form of dormant conidia at levels not exceeding those of natural Trichoderma populations. Although vertical movement of the fungus appears possible, survival in deeper sediment layers is strongly restricted. Horizontal spread in the soil, as well as spread to above ground plant parts might occur but to a limited extend. The impact of T. atroviride SC1 onto soil microbial communities is short and no adverse effects are to be expected as the fungus appears to become an integrated part of the autochthonous soil community at the treatment site.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)
As an ubiquitous saprophytic fungus, T. atroviride is living in the upper layer of soils, rich in organic matter. As for other soil-inhabiting fungi, there is little horizontal movement of T. atroviride in soil. Vertical movement is limited and may only occur after heavy water supply. Colonization of the plant rhizosphere may result in wider spreading. However, the leaching potential of the species is considered to be low. T. atroviride does not produce any toxins or secondary metabolites of toxicological concern at substantial quantities and therefore leaching to groundwater is not relevant to this fungus.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)
1 Calculation of PECSW values presented in the EFSA conclusions , based on the following proposed uses of the product: in consideration of two applications, resulting in an accumulated application rate of 0.8 kg 12 Vintec/ha (72 g a.s./ha, equivalent to 0.8 × 10 CFU/ha). Therefore, PECSW value of 108 µg Vintec/L (equivalent to 9.14 µg a.s./L or 1.02 × 106 CFU/L) was calculated. However, the use was adapted as presented below, in order to meet the conditions according to the intended use (please refer to chapter 2.4: GAP-table) and the product composition (please refer to Part C, Point IIIM 1.7.2). Thus, calculation was performed in consideration of 2 applications of 0.2 kg Vintec/ha (60 g a.s./ha, equivalent to 4 × 1012 CFU/ha).
1 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain SC1. EFSA Journal 2015;13(4):4092, 33 pp. doi:10.2903/j.efsa.2015.4092 ______
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According to the PEC calculation, the expected initial concentration in surface water is 10.69 µg product/L, corresponding to 1.60 µg T. atroviride SC1/L. In terms of CFU, this is equivalent to 1.07 × 105 CFU/L.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9)
Trichoderma spp. occasionally has been isolated from the air. Hence, members of the genus appear to occur in the air naturally, however at low frequency and low concentrations. Dispersal of spores via spray drift following an application of T. atroviride SC1 may lead to temporary concentrations in the atmosphere which are capable of drifting with wind currents before the spores and crystals in finer spray droplets settle out. However, long term persistence is not expected as it was shown for Trichoderma harzianum that even under protected conditions in the greenhouse fungal spores disappeared within one day from the air. Further information on the persistence in air is not required, since the toxicological studies and the temperature growth profile of this strain prove that it is not able to infect humans, and imposes no risk for workers, operators or bystanders via inhalation or any other exposure route. Likewise, long-distance transport of spores is not likely to occur.
3.1.6 Ecotoxicology (Part B, Section 6, Point 10) Vintec is intended to be used in grapes in the field. Application of Vintec is done during winter dormancy onto pruning wounds of grape vine. Under these conditions, exposure to birds and mammals may be considered negligible also. Moreover, Trichoderma spp. in general are not considered to be pathogenic to mammals or birds and absence of growth of the fungus at 35°C and above renders the risk for growth in their body tissues and liquids negligible. Finally, T. atroviride is a common saprophytic soil fungus and it might be expected that wild birds and mammals are naturally exposed to this fungal species without knowledge on any adverse effects. According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to any of the non-target species.
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Birds The presented screening assessment for birds was conducted on the basis of published data for other Trichoderma biocontrol strains. The LD50 of T. harzianum T22 to mallard ducks and bobwhite quail, for example was determined to be > 2000 mg/kg bw. Due to the general absence of toxicity, pathogenicity and infectivity of the genus Trichoderma in birds and the specific properties of T. atroviride SC1, neither acute nor long-term effects are expected in birds upon GAP directed use of the fungus.
Mammals An acute oral toxicity study on rats was carried out with the fungal strain demonstrating absence of toxicity, pathogenicity and infectiveness upon oral administration of 4.1 × 108 CFU/rat. The fungal spores did not spread from the intestine to other organs and were readily cleared from faeces. According to EFSA conclusions on the risk assessment of T. atroviride SC1 (EFSA Journal, 2015), a LD50 value of 212 mg Vintec/kg b.w. was considered, corresponding to 31.8 mg a.s./kg b.w. Due to the absence of pathogenicity in the acute study and the general properties of the fungus, acute or long-term effects in mammals due to field application of T. atroviride SC1 according to GAP can be excluded.
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3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) Due to the application of T. atroviride SC1 onto the pruning wounds of grapevine during winter dormancy, the exposure for aquatic non-target species, including fish, is generally considered to be very low.
Aquatic organisms (fish, aquatic invertebrates, algae) Calculating the risk assessment on aquatic organisms, TER values were calculated for T. atroviride SC1 on rainbow trout, Daphnia magna and Desmodesmus subspicatus. According to EFSA conclusions on the risk assessment of T. atroviride SC1 (EFSA Journal, 2015), LC50 value for O. mykiss, Daphnia magna and Desmodesmus subspicatus were > 6.3 × 108 CFU/L, > 7.6 × 108 CFU/L and > 7.1 × 108 CFU/L, respectively. 5 In consideration of a calculated PECSW value of 1.07 × 10 CFU/L, the TER values exceeded the trigger values by far.
Aquatic plants Although T. atroviride might be able to survive and persist in aquatic habitats to a certain extend there is no case report linking the species or genus to adverse effects in aquatic plants. Considering the general absence of phytotoxicity, the absence of adverse effects observed in the algal growth test and the low exposure risk, no adverse effects are to be expected in aquatic plants upon field application of Vintec according to GAP. The results of the risk assessment indicate an acceptable risk for aquatic organisms according to the intended use 001 of Vintec according to the label. However, the application of PPP in the immediate vicinity of surface or coastal waters is not permitted in Germany, minimum buffer zones stipulated by state law must be observed. The condition of use NW642-1 is assigned.
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
Bees Effects on bees for Vintec were evaluated as part of the EU review of trichoderma atroviride SC1. Therefore all relevant data were assessed in the EU review.
As the product Vintec is intended for application onto pruning grapevine wounds in winter time, exposure of honeybees is very unlikely.
Test Exposure LD50 Reference substance route
> 113.0 µg product/bee* oral 48 h Conclusion on the peer review (> 1.13 x 106 CFU/bee)* of trichoderma atroviride strain Vintec SC1, EFSA Journal 2015; 13(4): > 100 µg product/bee* contact 48 h 4092 (> 1 x 106 CFU/bee)* * EU agreed endpoint # tested as Trichoderma atroviride SC1 WG
The recommended use pattern for Vintec includes an application in viticulture at a maximum application rate of up to 0.2 kg product/ha. This maximum single application rate is equivalent to 200 g product/ha.
Pathogenicity
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No data was submitted. The acute toxicity study according to OECD 213 and 214 are not appropriate to address pathogenicity.
Hazard quotients Determination of a HQ-trigger is not assignable to microorganisms, therefore no calculation was made.
Vintec is considered to be practically non-toxic to bees and the exposure to bees is unlikely due to proposed pattern of use in winter. Adverse effects on bees can be excluded when used as recommended.
Other non-target arthropods
Several literature reports demonstrate the absence of toxicity of Trichoderma spp. to bumble bees up to dosages of 1 × 1010 CFU/L for both, oral and contact exposure. This value is comparable to the conidia load of T. atroviride SC1 in the spraying suspension when Vintec is used according to GAP (0.5 - 2 × 1010 CFU/L). Therefore, and due to the limited exposure, bumble bees are not at risk upon GAP directed use of T. atroviride SC1. Effects of the end-use product Trichoderma atroviride SC1 WG (synonym for Vintec) on the parasitic hymenopteran Aphidius rhopalosiphi and the predatory mite Typhlodromus pyri were assessed in laboratory glass plate tests. Due to the absence of toxicity at any dose tested the LR50 values for both species are considered to be > 3.2 kg/ha corresponding to at least 3.2 × 1013 CFU/ha. It can be concluded that non- target arthropods are not considered to be at risk upon GAP directed field application of Vintec.
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6)
Earthworms Due to the envisaged field of use of Vintec, exposure to earthworms is considered negligible. Moreover, T. atroviride is a naturally occurring fungus and earthworms are expected to be frequently exposed to this fungal species in nature. Various interactions between Trichoderma spp. and earthworm species are described in the literature all without any hind for adverse effects in earthworms due to exposure to Trichoderma spp. Nevertheless, to address the data point, endpoints from open literature ad which no adverse effects have been observed in the test animals are in the same range as the highest predicted density of T. atroviride SC1 in soil, calculated assuming worst case conditions (accumulated application rate, no plant interception). Therefore, earthworms are not considered to be at risk upon GAP directed use of Vintec.
Effects on other soil non-target macro-organisms No EU data requirement for MPCP.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) No EU data requirement for MPCP.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Trichoderma spp. including T. atroviride, are ubiquitous in soils and it is generally considered that if even occurring, any effect on the soil microbial community is not long-lasting. This was confirmed by a study assessing the development of T. atroviride SC1 upon introduction into a vineyard soil available in the published literature. As expected, only directly after application a difference between the treated and the control plots was observed and the introduced fungus disappeared more or less quickly from the soil ______
Applicant (insert company name) Evaluator Date .August 2018 Part A Product code Draft Registration Report –Central Zone National Assessment - 008562-00/00 Vintec Page 18 of 23 Federal Republic of Germany depending on the soil depth. The density of the fungus directly after inoculation was approximately 109 CFU/g. As this value is considerable higher than the highest load of T. atroviride SC1 expected upon treatment with Vintec even under worst case assumptions it can be concluded that GAP directed use of Vintec does not pose a risk to soil microbial communities.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Non-Target Plants According to EU assessment, no studies on non-target terrestrial plants are required.
Other non-target species (Flora and Fauna) No additional studies are required.
Implications for labelling resulting from ecotoxicological assessment:
See 2.2
3.1.6 Efficacy (Part B, Section 7, Point 8)
Preliminary range finding test No preliminary range finding test were submitted for the maritime EPPO zone. Nevertheless, the submitted data demonstrated that T. atroviride SC1 significantly reduces the growth of Phaeomoniella chlamydospora and Phaeoacremonium aleophilum.
Minimum effective dose test The submitted data was inconclusive, no dose-response relationship could be determined.
Efficacy T. atroviride SC1 is supposed to be used as a preventive measure. The data showed, that T. atroviride SC1 is successful in colonising grape wines and the effectiveness is superior to the reference product Esquive WP.
Effects on yield and quality The quality of plants or plant products is not negatively affected and adverse effects on the processing of treated grapes can be excluded.
Phytotoxicity The effect of T. atroviride SC1 was tested on several varieties of grape and no phytotoxicity was detected.
Impact on succeeding crops or on other plants including adjacent crops As T. atroviride is a naturally occurring microorganism in soil an impact on succeeding crops is not expected. No adverse effects on other plants including adjacent crops were observed.
Adverse effects on parts of plant used for propagating purposes No adverse effects on parts of plants used for propagation purposes were detected.
Adverse effects on beneficial organisms (other than bees) A detrimental impact on beneficial or non-target organisms was not observed throughout the field trials on effectiveness and selectivity.
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Possible development of resistance or cross-resistance T. atroviride is a naturally occurring microorganism and already present in the environment. Due to the multiple modes of action against the target pathogens the risk of developing resistance is considered to be very small.
The submitted data demonstrate that Vintec fulfils all criteria for the authorization of preparations described in Directive 97/57/EC (Uniform Principles, Annex VI to Directive 91/414/EEC). No phytotoxicity, effects on neighboring or following crops were observed.
3.2 Conclusions
Vintec showed a sufficient effect against the diseases and no unacceptable effects on the plants or plant products occur. The use applied for can be authorised.
With regard to identity, physical, chemical and technical properties, further information and analytical methods (product and residues) an authorisation can be granted.
Considering an application of the product in accordance with the intended and evaluated use pattern and good agricultural practice as well as compliance with imposed risk mitigation measures no harmful effects on groundwater or unacceptable effects on non-target organisms are to be expected.
With respect to toxicology, residues and consumer protection an authorisation can be granted. Based on EFSA´s conclusion (EFSA Journal 2015;13(4):4092) that the strain is resistant to 4 antibiotics used in human or veterinary medicine the criteria for low-risk active substances are not fulfilled. Accordingly, Vintec cannot be classified as low-risk product.
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
No further information is required.
Annex II and Data III point
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Appendix 1 – Copy of the product authorisation (see Appendix 4)
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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 made by the competent authority. The final version of the label has to fulfil the requirements according to Article 31 of Regulation (EU) No 1107/2009.
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Appendix 3 – Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
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Appendix 4 – Copy of the product authorisation
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Applicant (insert company name) Evaluator Date .August 2018 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Birgit Schreiber Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referentin
TELEFON +49 (0)531 299-3457 Bi-PA nv/sa TELEFAX +49 (0)531 299-3002 Technologielaan 7 E-MAIL [email protected] 1840 Londerzeel IHR ZEICHEN BELGIEN IHRE NACHRICHT VOM
AKTENZEICHEN 200.22100.008562-00/00.134778 (bitte bei Antwort angeben)
DATUM 30. August 2018
ZV1 008562-00/00 Vintec Zulassungsverfahren für Pflanzenschutzmittel Bescheid
Das oben genannte Pflanzenschutzmittel
mit dem Wirkstoff: 150 g/kg Trichoderma atroviride Stamm SC1 (1.0E+13 cfu/kg)
Zulassungsnummer: 008562-00
Versuchsbezeichnungen: BPA-08562-F-0-WG
Antrag vom: 24. September 2015
wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzen- schutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen:
Zulassungsende
Die Zulassung endet am 6. Juli 2032.
Festgesetzte Anwendungsgebiete bzw. Anwendungen
BVL_FO_05_2437_200_V1.8 Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1):
Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de SEITE 2 VON 8
Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 008562-00/00-001 Esca-Erreger der Weinrebe Weinrebe (Phaeo- moniella chlamydos- pora), Esca-Erreger der Weinrebe (Togni- nia minima)
Festgesetzte Anwendungsbestimmungen
Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 84 des Gesetzes vom 18. Juli 2016 (BGBl. I S. 1666), festgesetzt: (SS110-1) Beim Umgang mit dem unverdünnten Mittel sind Schutzhandschuhe (Pflanzenschutz) zu tra- gen. Begründung: Aufgrund der gefahrstoffrechtlichen Einstufung und Kennzeichnung des Mittels (vgl. Bundes- anzeiger: "Bekanntmachung über die Ableitung von gefahrenbasierten Kennzeichnungsaufla- gen zur Anwendungssicherheit im Zulassungsverfahren für Pflanzenschutzmittel nach Inkrafttreten der CLP-Verordnung für Gemische (BVL 15/02/13) vom 23. September 2015" (BAnz AT 19.10.2015 B2)).
(SS2101) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen beim Umgang mit dem unverdünnten Mittel. Begründung: Aufgrund der gefahrstoffrechtlichen Einstufung und Kennzeichnung des Mittels (vgl. Bundes- anzeiger: "Bekanntmachung über die Ableitung von gefahrenbasierten Kennzeichnungsaufla- gen zur Anwendungssicherheit im Zulassungsverfahren für Pflanzenschutzmittel nach Inkrafttreten der CLP-Verordnung für Gemische (BVL 15/02/13) vom 23. September 2015" (BAnz AT 19.10.2015 B2)).
Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3. BVL_FO_05_2437_200_V1.8 SEITE 3 VON 8
Verpackungen
Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen:
Verpackungs- Verpackungs- Anzahl Inhalt art material von bis von bis Einheit Beutel Verbundmate- 1 400,00 g rial Beutel Verbundmate- 1 1,00 kg rial Faltschachtel Verbundmate- 1 4 50,00 g mit Innenbeutel rial
Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen: Anwendung nur durch berufliche Anwender zulässig.
Auflagen
Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden: Kennzeichnungsauflagen: (EB001-2) SP 1: Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen. (Ausbringungsge- räte nicht in unmittelbarer Nähe von Oberflächengewässern reinigen./Indirekte Einträge über Hof- und Straßenabläufe verhindern.)
(SB001) Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschä- den führen.
(SB005) Ist ärztlicher Rat erforderlich, Verpackung oder Etikett des Produktes bereithalten.
(SB010) Für Kinder unzugänglich aufbewahren.
(SB111) Für die Anforderungen an die persönliche Schutzausrüstung beim Umgang mit dem Pflan- zenschutzmittel sind die Angaben im Sicherheitsdatenblatt und in der Gebrauchsanweisung des Pflanzenschutzmittels sowie die BVL-Richtlinie "Persönliche Schutzausrüstung beim BVL_FO_05_2437_200_V1.8 SEITE 4 VON 8
Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebens- mittelsicherheit (www.bvl.bund.de) zu beachten.
(SB166) Beim Umgang mit dem Produkt nicht essen, trinken oder rauchen.
(SF245-02) Es ist sicherzustellen, dass behandelte Flächen/Kulturen erst nach dem Abtrocknen des Pflanzenschutzmittelbelages wieder betreten werden.
(SS206) Arbeitskleidung (wenn keine spezifische Schutzkleidung erforderlich ist) und festes Schuh- werk (z.B. Gummistiefel) tragen bei der Ausbringung/Handhabung von Pflanzenschutzmit- teln.
(WMFBM02) Wirkungsmechanismus (FRAC-Gruppe): BM02
Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.
Sonstige Auflagen: (VH650) Die Verpackung ist mit der Aufschrift "Mikroorganismen können ein Potential zur Auslösung von Sensibilisierungsreaktionen enthalten" zu versehen.
(WH952) Auf der Verpackung und in der Gebrauchsanleitung ist die Angabe zur Kennzeichnung des Wirkungsmechanismus als zusätzliche Information direkt jedem entsprechenden Wirk- stoff-namen zuzuordnen.
Vorbehalt
Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.
Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG) Nr. 1272/2008
Signalwort: - keine - BVL_FO_05_2437_200_V1.8 SEITE 5 VON 8
Gefahrenpiktogramme: - keine -
Gefahrenhinweise (H-Sätze): (EUH 401) Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.
Sicherheitshinweise (P-Sätze): - keine -
Abgelehnte Anwendungsgebiete bzw. Anwendungen
Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine -
Hinweise
Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden: (NB6641) Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienen- gefährlich eingestuft (B4).
(NN1001) Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft.
(NN1002) Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen eingestuft.
Weitere Hinweise und Bemerkungen Zu KMP 2: Nach Lagerung bei Umgebungstemperatur über 2 Jahre liegt der Nasssiebrückstand deutlich überhalb von 2%. Es muss belegt werden, dass es nicht zu einer Verstopfung der Düsen und Filter kommt.
Zum Etikett: Auf dem Etikett muss ein Hinweis ergänzt werden, dass beim Ansetzen und Ausbringen der
BVL_FO_05_2437_200_V1.8 Spritzflüssigkeit ständig zu rühren ist. SEITE 6 VON 8
Zum Etikett: Auf dem Etikett ist zusätzlich zum Wirkstoffgehalt anzugeben: "Enthält ca. 160 g /kg Kaolin (Al.-silikat) als Trägerstoff" Begründung: Kaolin (Al.-silikat) (CAS 1332-58-7) wurde in der EU als Wirkstoff betrachtet. Eine Verwen- dung von Kaolin (Al.-silikat) als Beistoff in Pflanzenschutzmitteln ist daher nach Auffassung des BVL deklarationspflichtig.
Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben, soweit sie noch nicht erfüllt sind.
Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulas- sungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen.
Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid.
Rechtsbehelfsbelehrung
Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur Niederschrift einzulegen.
Mit freundlichen Grüßen im Auftrag
gez. Dr. Rainer Savinsky
Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.
Anlage BVL_FO_05_2437_200_V1.8 SEITE 7 VON 8
Anlage 1 zugelassene Anwendung: 008562-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Esca-Erreger der Weinrebe (Phaeomoniella chlamy- dospora), Esca-Erreger der Weinrebe (Togninia minima) Pflanzen/-erzeugnisse/Objekte: Weinrebe Verwendungszweck:
2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung
Einsatzgebiet: Weinbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: ab 00 Anwendungszeitpunkt: - Erläuterungen: in der Vegetationsruhe Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: 7 Tage Anwendungstechnik: spritzen oder sprühen Aufwand: - 0,2 kg/ha in 100 bis 200 l Wasser/ha
2.2 Sonstige Kennzeichnungsauflagen (NN134) Das Mittel wird als nichtschädigend für Populationen der Art Typhlodromus pyri (Raubmilbe) eingestuft.
(NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstenge- wässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorge- gebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden. BVL_FO_05_2437_200_V1.8 SEITE 8 VON 8
2.3 Wartezeiten (F) Freiland: Weinrebe Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.
3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2437_200_V1.8 Part B – Section 1 BCP511B Registration Report – Central Zone Core Assessment – Germany Vintec Page 1 of 28
REGISTRATION REPORT Part B
Section 1: Identity, physical and chemical properties, other information Detailed summary of the risk assessment
Product code: BCP511B (Vintec) Active Substance: Trichoderma atroviride SC1 1.0 × 1013 CFU/kg (150 g/kg)
Central Zone Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: Bi-PA nv Submission Date: 24/09/2015 Date: July 2018
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Table of Contents
IIIM1 1 IDENTITY OF THE MICROBIAL PEST CONTROL AGENT ...... 6
IIIM1 1.1 Applicant ...... 6
IIIM1 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation ...... 6
IIIM1 1.5 Type of Preparation and Code ...... 6
IIIM1 1.6 Function ...... 7
IIIM1 1.7 Other/Special Studies ...... 7
IIIM1 1.7.1 Content of active substance and formulants ...... 7
IIIM1 1.7.1.1 Scientific name and strain/serotype of MCPA, its accession number in a recognised culture collection ...... 7
IIIM1 1.7.1.2 Development phase (e.g. spore) of MCPA in MPCP ...... 7
IIIM1 1.7.2 Composition in terms of g/kg and % of each ingredient in MPCP ...... 7
IIIM1 1.7.3 Quality criteria for the production and storage of the MPCP ...... 8
IIIM1 1.7.4 Quality control data (measures of quality criteria) from 3-5 production batches ...... 8
IIIM1 1.7.5 The formation, presence and/or impact of unintentional ingredients, metabolites, degradation products ...... 10
IIIM1 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT ...... 11
IIIM1 2.7 Summary and evaluation of of data on properties of MPCP presented under points 2.1 to 2.7 ...... 17
IIIM1 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT ...... 17
IIIM1 3.1 Field of Use: Pest to be controlled, crop to be protected, available information on mode of action ...... 17
IIIM1 3.2 Available information on the development of resistance in target pest and appropriate mitigation strategy ...... 17
IIIM1 3.3 Application rate in terms of mass/vol of MPCP per unit area/volume (e.g. kg/ha, CFU/ha,…). Content of micro-organism in material used (diluted spray, bait, treated seed) ...... 17
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IIIM1 3.4 Application rate in terms of units of micro-organisms per unit area/volume ...... 18
IIIM1 3.5 Method of application (incl. type of equipment and volume of diluent) ...... 18
IIIM1 3.6 Number, timing and conditions of applications, related to: host/pest phenology, duration of protection, application of other pesticides, pre- harvest interval ...... 18
IIIM1 3.7 Precautions to avoid phytotoxic/phytopathogenic effects on protected crop or on succeeding crops, if appropriate ...... 18
IIIM1 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops ...... 18
IIIM1 4 FURTHER INFORMATION ON THE MPCP...... 19
IIIM1 4.1 Packaging: description ...... 19
IIIM1 4.2 Specifications of the packaging and mesasures of its suitability ...... 19
IIIM1 4.3 Label instructions regarding cleaning equipment and protective clothing ...... 19
IIIM1 4.4 Procedures for cleaning application equipment and protective clothing; measures of their effectiveness ...... 19
IIIM1 4.5 Nessessary waiting period (in days) for re-entry; recommended protective measures to reduce occupational exposure ...... 19
IIIM1 4.6 Label instructions (safe handling and storage)...... 20
IIIM1 4.7 Recommendations (handlimg, storage, transport, fire: specific risks, specify procedures to minimise hazards and the generation of waste ...... 20
IIIM1 4.8 Label instructions (clean up of spills) ...... 21
IIIM1 4.9 Detailed procedures in case of accident to: contain a spillag, decontaminate an area or vehicle, disposal of packaging and adsorbents, protect workers and bystanders, first aid...... 21
IIIM1 4.10 Procedures for destruction/ disposal of MPCP and its package ...... 21
IIIM1 4.10.1 Controlled incineration ...... 21
IIIM1 4.10.2 Methods other than controlled incineration ...... 22
IIIM1 11 SUMMARY AND ASSESSMENT OF IMPACT ON THE ENVIRONMENT AND THE ENVIRONMENTAL RISK ...... 22
Applicant: Bi-PA nv Evaluator: DE Date: July 2018 Part B – Section 1 BCP511B Registration Report – Central Zone Core Assessment – Germany Vintec Page 4 of 28
IIIM1 11.1 Information on distribution and disposion of the MPCP ...... 22
IIIM1 11.2 Identification of the vulnerable organisms not belonging to the target group, and the degree of its exposion ...... 22
IIIM1 11.3 Identification of precautionary measures to reduce the impact on the environment and to prevent the non targeted organisms ...... 22
Appendix 1 - List of data used in support of the evaluation ...... 23
Appendix 2: Critical Uses – justification and GAP tables ...... 25
Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics: ...... 28
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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 BCP511B (Vintec) containing trichoderma atroviride SC1 which was approved according to Regulation (EC) No 1107/2009.
Vintec is the representative formulation in the dossier submitted for approval of trichoderma atroviride SC1 as an active ingredient under Regulation (EC) 1107/2009.
The following table provides the EU endpoints to be used in the evaluation.
Agreed EU End-points End-Point Trichoderma atroviride strain SC1 (Reg. (EU) No. 2016/951) Purity of active substance min 1 × 1010 CFU/g
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 BCP511B (Vintec) can be found in the confidential dossier of this submission (Registration Report - Part C).
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IIIM1 1 IDENTITY OF THE MICROBIAL PEST CONTROL AGENT
IIIM1 1.1 Applicant
Name: Bi-PA (Biological Products for Agriculture) nv Adress: Technologielaan 7 1840 Londerzeel Belgium
Contact person: XXXXX Tel.no.: XXXXX Fax no: XXXXX e-mail: XXXXX
IIIM 1.2 Manufacturer(s) of the preparation and producer of the microbial pest control agent
IIIM 1.2.1 Manufacturer(s) of the preparation (name, address, contact, telephone and telefax numbers) Manufacturer of the preparation: CONFIDENTIAL information – data provided separately (Part C).
Location of the manufacturing site(s): CONFIDENTIAL information – data provided separately (Part C).
IIIM 1.2.2 Producer of the microbial pest control agent (name, address, contact, telephone and telefax numbers) Manufacturer of the preparation: CONFIDENTIAL information – data provided separately (Part C).
Location of the manufacturing site(s): CONFIDENTIAL information – data provided separately (Part C).
IIIM1 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation Trade name: Vintec Other names: Trichoderma granule Company code number: BCP511B, SC1 WG
IIIM1 1.5 Type of Preparation and Code Type : water dispersible granules Code : WG
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IIIM1 1.6 Function The product will be used as a fungicide.
IIIM1 1.6.1 Biological sphere of action and area of application
Function Fungicide Field of use Viticulture
IIIM1 1.7 Other/Special Studies
IIIM1 1.7.1 Content of active substance and formulants
IIIM1 1.7.1.1 Scientific name and strain/serotype of MCPA, its accession number in a recognised culture collection
Strain Trichoderma atroviride SC1 Species Trichoderma atroviride Genus Trichoderma Family Hypocreaceae Order Hypocreales Class Sordariomycetes Phylum Ascomycota
IIIM1 1.7.1.2 Development phase (e.g. spore) of MCPA in MPCP The formulation Vintec contains conidiospores of Trichoderma atroviride SC1.
IIIM1 1.7.2 Composition in terms of g/kg and % of each ingredient in MPCP Pure active substance: Conidia of trichoderma atroviride, 150 g/kg strain SC1: (min. 1 × 1013 CFU/kg)
Technical active substance: Conidia of trichoderma atroviride, 150 g/kg (15 %) strain SC1:
Further information on the active substances and on the certified limits of formulants is considered confidential and is provided separately (Part C). The content of microbial contaminants is determined in the formulated product using the methods described in Part B Section 2, Point IIIM 5.1.5. Thresholds for contaminants are applied as outlined in the “OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products” and listed in Table IIIM 1.7.2-1.
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Table IIIM 1.7.2-1. Maximum acceptable levels for microbial impurities and human pathogens adapted from the OECD issue paper.
Contaminants Threshold level
Aerobic Plate Count < 105 CFU/g Anaerobic spore-formers < 105 CFU/g Coliforms < 10 CFU/g Staphylococcus aureus Absence in 1 g Shigella Absence in 25 g Salmonella Absence in 25 g Listeria monocytogenes Absence in 25 g
IIIM1 1.7.3 Quality criteria for the production and storage of the MPCP The nominal content of viable spores of Trichoderma atroviride SC1 in the formulated product is 1 × 1010 CFU/g, corresponding to 1 × 1013 CFU/kg. No relevant non-microbial impurities are contained in the product as T. atroviride SC1 is not able to produce any toxin. T. atroviride SC1 is not related to a toxigenic pathogen. Details on the content of microbial contaminants are reported under Point IIIM 1.7.2 and in Part C, confidential information. The following indicators listed in the “OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products” are not analysed for the following reasons: Vibrio does not occur at the production site and the low levels of other contaminants demonstrates that the process is sufficiently controlled to exclude the risk of contamination by Vibrio. Vibrio is considered an optional requirement and the conditions for testing are not fulfilled. Yeast and Mould Counts were not determined as this is not feasible in a fungal product. Trichoderma would overgrow any potential yeast or mould and no contamination would be visible. Pseudomonas aeruginosa is not tested because the analyses did not reveal any risk of contamination with Pseudomonas spp. A Mouse IP/SC assay is only recommended if contamination with a primary mammalian pathogen is suspected or if a toxin is produced. This is not the case for T. atroviride SC1. Furthermore, the study on intraperitoneal toxicity, pathogenicity, or infectivity did not reveal any negative effect.
IIIM1 1.7.4 Quality control data (measures of quality criteria) from 3-5 production batches The nominal content of viable spores of trichoderma atroviride SC1 in the formulated product is 1 x 1010 CFU/g, corresponding to 1 x 1013 CFU/kg. The content of spores was determined in four batches (Eiben 2012). Data are presented in Table IIIM 1.7.4-1. Coranelli (2012a) analyzed the same four batches of the formulated product as listed above for the presence of microbial contaminants. The results are listed in Table IIIM 1.7.4-2. The content of T.
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atroviride SC1 and of microbials contaminants were also determined in one batch before and after 2 years storage. The results are presented in Tables IIIM 1.7.4-3 and IIIM 1.7.4-4.
Table IIIM 1.7.4-1 Contents of viable spores of T. atroviride SC1 in the formulated product Vintec in CFU/g. Batch Batch Batch Batch Nominal number number number number T. atroviride SC1 content 18102800820 18103201220 18103301320 18103401420 (large scale) (pilot scale) (pilot scale) (pilot scale) Viable spores 1 x 1010 1.01 x 1010 1.08 x 1010 1.10 x 1010 1.13 x 1010
Table IIIM 1.7.4-2 Contents of contaminants in the formulated product Vintec in CFU/g. Batch Batch Batch Batch Threshol Contaminant number number number number d level 18102800820 18103201220 18103301320 18103401420 Aerobic Plate < 105 4.27 x 103 4.14 x 103 4.77 x 103 3.41 x 103 Count Anaerobic spore- < 105 < 40 < 40 < 40 < 40 formers Coliforms < 10 < 10 < 10 < 10 < 10 Staphylococcus Absence absent absent absent absent aureus in 1 g Shigella Absence absent absent absent absent in 25 g Salmonella Absence absent absent absent absent in 25 g Listeria Absence absent absent absent absent monocytogenes in 25 g
Table IIIM 1.7.4-3 Contents of viable spores of T. atroviride SC1 in the formulated product Vintec before and after storage for 2 years in CFU/g.
Nominal Batch number 18102200220 Batch number 18102200220 T. atroviride SC1 content before storage after storage Viable spores 1 x 1010 1.1 x 1010 1.18 x 1010
Table IIIM 1.7.4-4 Contents of contaminants in the formulated product Vintec before and after storage for 2 years in CFU/g.
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Batch number Batch number 18102200220 18102200220 Contaminant Threshold level before storage after storage
Aerobic Plate Count < 105 < 10 1.9 x 103 Anaerobic spore- < 105 < 40 < 10 formers Coliforms < 10 < 10 < 10 Staphylococcus aureus Absence in 1 g absent absent Shigella Absence in 25 g absent absent Salmonella Absence in 25 g absent absent Listeria monocytogenes Absence in 25 g absent absent
All data are compliant with the “OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products” from 2011. The batches 18102200220 and 18102800820 were produced at large scale, batches 18103201220, 18103301320, and 18103401420 were produced at pilot scale (Wolf, 2013).
IIIM1 1.7.5 The formation, presence and/or impact of unintentional ingredients, metabolites, degradation products No EU data requirement.
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IIIM1 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT BCP511B (Vintec) was the representative formulation. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. Recommendes application rate: 0.1 – 0.2 %.
Table 2- 1: Summary of the physical, chemical and technical properties of the plant protection product Test or study & Method used Test material Findings GLP Reference Acceptability / Annex point / deviations purity and comments specification Y/N
Colour, odour and Visual Trichoderma The preparation is a pale green (RAL 6021) Y Coranelli, 2014, Acceptable physical state assessment Granule, batch solid with a characteristic odour. BT195/11! 34814 (IIIM1 2.1) and No. 18102200220 organoleptic determination
Storage stability and shelf-life for MPCP (IIIM1 2.2)
Storage stability after freeze-thaw cycles not required for solid formulations. Acceptable (IIIM1 2.2.1)
Storage stability No Trichoderma Storage material: Aluminium sachet Y Coranelli, 2014, Acceptable after 24 months at Guidelines Granule, batch BT195/11! 34814 4°C No. 18102200220 Biological titration BCP511B (Vintec) is (IIIM1 2.2.1) Method stable when stored at provided by The content of the active substance does not +4°C during 24 the sponsor: decrease > 5 %. The changes of the physical and months. POS BT 154 chemical properties are negligible. New data; in EU Content of: trichoderma atroviride SC1: evaluation only 10 Before storage: 1.1 × 10 viable spores/g interim report after 12 After 3 months storage: 1.1 × 1010 v. spores/g
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Test or study & Method used Test material Findings GLP Reference Acceptability / Annex point / deviations purity and comments specification Y/N After 12 months storage: 1.13 × 1010 v. spores/g month was available. After 24 months storage: 1.18 × 1010 v. spores/g
Viable mesophiles Before storage: <10 CFU/g After 24 months storage: 1.9 × 103 CFU/g
Anaerobic spore –formers: Before storage: < 40 CFU/g After 24 months storage: < 10 CFU/g
Coliforms: Before storage: < 10 CFU/g After 24 months storage: < 10 CFU/g
Staphylococcus aureus: Before storage: Absent in 1 g of test item After 24 months storage: Absent in 1 g of test item
Shigella spp. and Salmonella spp.: Before storage: Absent in 25 g of test item After 24 months storage: Absent in 25 g of test item
Listeria monocytogenes: Before storage: Absent in 10 g of test item After 24 months storage: Absent in 10 g of test item
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Test or study & Method used Test material Findings GLP Reference Acceptability / Annex point / deviations purity and comments specification Y/N Trichoderma Explosive properties EC A.14 Granule, batch Decomposition energy (DSC) of the test item was Y Möller, 2012a, Acceptable. (IIIM1 2.3.1.1) < 500 J/g, so the main test was not conducted. CSL-12-0230.02 No. 18102200220 Formulation has no explosive properties. Trichoderma Oxidizing properties EC A.17 Granule, batch burning rate of: Y Möller, 2012b, Acceptable. (IIIM 2.3.1.2) No. 18102200220 CSL-12-0230.03! barium nitrate + cellulose (55:45 %): 1.59 mm/s 36842 test item + cellulose (5:95 %): 0.93 mm/s The test item has no oxidising properties.
Flash point not required for solid formulations Acceptable. (IIIM1 2.3.2.1)
Trichoderma Auto-flammability EEC A 10 Granule, batch Flammability: Y Möller, 2012c, Acceptable. (IIIM1 2.3.2.2) No. 18102200220 The test item Trichoderma Granule could not be CSL-12-0230.01! 36843 ignited applying a flame as ignition source for at least 2 minutes. The product has to be classified neither as highly flammable solid according to EC 440/2008, Part A, A.10., nor as readily combustible solid in class 4.1 according to the UN-Transport Regulation and nor as flammable solid according to GHS. Trichoderma Bowes- Granule, batch No self-heating was observed at 140 °C Y Möller, 2012d, Acceptable. Cameron- (100 mm cube). CSL-12-0230.04!
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Test or study & Method used Test material Findings GLP Reference Acceptability / Annex point / deviations purity and comments specification Y/N Cage Test No. 18102200220 The test item Trichoderma Granule has not to be 36844 classified as self-heating substance according to UN Test N.4 EC 1272/2008 (CLP-Guideline). The test item Trichoderma Granule has not to be classified as self-heating according to the UN Transport regulation Division 4.2. pH of a 1% aqueous CIPAC MT Trichoderma Before storage: Y Coranelli, 2014, Acceptable. dilution 75.3 Granule, batch deionised water, 22.8 °C: 7.64 BT195/11! 34814 (IIIM1 2.3.3.2) No. 18102200220 After 24 months, 4 °C: deionised water, 22.5 °C: 7.69
Viscosity, surface Not required by regulation (EU) 2011/545. Acceptable tension (IIIM1 2.3.4)
Wettability CIPAC MT Trichoderma 58.5 s (static) Y Coranelli, 2014, Acceptable. (IIIM1 2.4.1) 53.3.1 Granule, batch BT195/11! 34814 No. 18102200220 13.5 s (dynamic) Trichoderma Persistence of CIPAC MT Granule, batch CIPAC water D, 0.2 %: Y Coranelli, 2012, Acceptable. foaming 47.2 No. 18102200220 Before storage 10 s: 2 mL BT194/11! 39006 (IIIM1 2.4.2) 1 min: 1.3 mL 3 min: 0.6 mL 12 min: 0 mL
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Test or study & Method used Test material Findings GLP Reference Acceptability / Annex point / deviations purity and comments specification Y/N Trichoderma Suspensibility CIPAC MT Granule, batch Before storage: Y Coranelli, 2014, Acceptable (IIIM1 2.4.3.1) 184 No. 18102200220 CIPAC water D, 0.05 %: 78.8 % BT195/11! 34814 CIPAC water D, 0.2 %: 71.4 % After 24 months, 4 °C: CIPAC water D, 0.05 %: 88.0 % CIPAC water D, 0.2 %: 94.8 %
Spontaneity of Trichoderma CIPAC water D, 1 %: CIPAC MT Y Coranelli, 2014, Acceptable dispersion Granule, batch Before storage: 103.5 % 174 No. 18102200220 BT195/11! 34814 (IIIM1 2.4.3.2) After 24 months, 4 °C: 62.5 % Dry sieve test Trichoderma Before storage: 1 - 2 mm CIPAC MT Granule, batch Y Coranelli, 2014, Acceptable. (IIIM1 2.4.4.1) 170 After 24 months, 4 °C: 1 - 2 mm BT195/11! 34814 No. 18102200220
Trichoderma Wet sieve test CIPAC MT Granule, batch Before storage Y Coranelli, 2014, Acceptable, although (IIIM1 2.4.4.2) 185 No. 18102200220 1.40 % on 75 µm sieve BT195/11! 34814 the residue after 24 month is above After 24 months, 4 °C: general limit of 2%. 4.65 % on 75 µm sieve
Particle size Not required by regulation (EU) 2011/545. distribution (IIIM1 2.4.5.1) Trichoderma Dust content CIPAC MT Granule, batch Before storage: nearly dust-free 1.6 mg Y Coranelli, 2014, Acceptable (IIIM1 2.4.5.2) 171 After 24 months, 4 °C: Nearly dust-free 1.1 mg BT195/11! 34814 No. 18102200220
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Test or study & Method used Test material Findings GLP Reference Acceptability / Annex point / deviations purity and comments specification Y/N Trichoderma Friability and CIPAC MT Granule, batch Before storage: 99.89 % Y Coranelli, 2014, Acceptable attrition 178.2 No. 18102200220 After 24 months, 4 °C: 99.66 % BT195/11! 34814 (IIIM1 2.4.5.3) Emulsifiability, emulsion stability and re-emulsifiability (IIIM1 2.4.6) not required for solid formulations Acceptable
Pourability (rinsability) and dustability (IIIM1 2.4.7) not required for solid formulations Acceptable
Trichoderma Flowability CIPAC MT Granule, batch spontaneous, no residue on sieve Y Coranelli, 2012, Acceptable. (IIIM1 2.4.7) 172 BT194/11! 39006 No. 18102200220
Trichoderma Density CIPAC MT Granule, batch pour:: 0.665 g/mL Y Coranelli, 2012, Acceptable. (IIIM1 2.5) 186 tapped: 0.677 g/mL BT194/11! 39006 No. 18102200220
Adherence and distribution to seeds, for seed treatment products not required, formulation is not intended for (IIIM1 2.6) seed treatment
Other studies no tank mixes are intended Physical compability
Chemical compability no tank mixes are intended
Biological compability no tank mixes intended
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IIIM1 2.7 Summary and evaluation of of data on properties of MPCP presented under points 2.1 to 2.7 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 a pale green solid with a characteristic odour. It is not explosive, has no oxidising properties. It has a self ignition temperature of > 140 °C. In aqueous solution, it has a pH value around 7.6. The stability data indicate a shelf life of at least 2 years at 4 °C temperature. The technical characteristics are acceptable for a water dispersible granules concentrate formulation. Vintec is stable at 4 °C for at least 2 years following manufacturing date. According to the draft label, Vintec can be kept at 20 °C at max. for 6 months (no data submitted).
Experimental testing of the product's physico-chemical and technical characteristics: See Appendix 3
Implications for labelling: No classification based on physical hazards.
IIIM1 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT IIIM1 3.1 Field of Use: Pest to be controlled, crop to be protected, available information on mode of action
Field of Use Agriculture
Pests to be controlled esca of vinegrape (Phaeomoniella chlamydospora), esca of vinegrape (Togninia minima)
Crop to be protected grape vine
Mode of action T. atroviride SC1 has several modes of action. For detailed information refer to Part B Section 7.
IIIM1 3.2 Available information on the development of resistance in target pest and appropriate mitigation strategy Please refer to Part B Section 7.
IIIM1 3.3 Application rate in terms of mass/vol of MPCP per unit area/volume (e.g.
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kg/ha, CFU/ha,…). Content of micro-organism in material used (diluted spray, bait, treated seed) Please refer to Appendix – Critical Uses – and Part B Setion 7.
IIIM1 3.4 Application rate in terms of units of micro-organisms per unit area/volume Please refer to Appendix – Critical Uses – and Part B Setion 7.
IIIM1 3.5 Method of application (incl. type of equipment and volume of diluent) Please refer to Appendix – Critical Uses – and Part B Setion 7.
IIIM1 3.6 Number, timing and conditions of applications, related to: host/pest phenology, duration of protection, application of other pesticides, pre- harvest interval IIIM1 3.6.1 Number, timing and conditions of applications Please refer to Appendix – Critical Uses – and Part B Setion 7.
IIIM1 3.6.2 Pre-harvest interval (PHI) The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in days is not required resp.
IIIM1 3.7 Precautions to avoid phytotoxic/phytopathogenic effects on protected crop or on succeeding crops, if appropriate Please refer to Part B Section 7.
IIIM1 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops This is not an EC data requirement/ not required by Directive 91/414/EEC
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IIIM1 4 FURTHER INFORMATION ON THE MPCP 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. IIIM1 4.1 Packaging: description BCP511B (Vintec) is to be marketed in three-layer plastic bags in cardboard boxes.
For professionnal use only: bag: material: Polyethylene – aluminium – polyethylene capacity: 50 g bag 4 bags a 50 g packed in a cardboard container 400 g bags 1 kg bag opening: No info to size, bags have to be cut open with a pair of scissors Closure and plastic bags are heat sealed and have to be cut open with a seal: pair of scissors
IIIM1 4.2 Specifications of the packaging and mesasures of its suitability Taking into account the composition of the product and its anticipated physical properties, Vintec is characterized as non-reactive and non-hazardous; no further investigations and tests were conducted. The chemically inert product does not require special stability or resistance properties of the packaging or the material used in packaging.
IIIM1 4.3 Label instructions regarding cleaning equipment and protective clothing After application, clean the interior of the tank with clean water. It is not necessary to use special cleaning agents. Protective clothing can be cleaned using regular washing powder. No specific treatment is necessary.
IIIM1 4.4 Procedures for cleaning application equipment and protective clothing; measures of their effectiveness After application, clean the interior of the tank with clean water. It is not necessary to use special cleaning agents. Protective clothing can be cleaned using regular washing powder. No specific treatment is necessary.
IIIM1 4.5 Nessessary waiting period (in days) for re-entry; recommended protective measures to reduce occupational exposure Pre-harvest interval for each relevant crop: Vintec is not supposed to produce any relevant residues on the crop due to the favourable toxicological
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properties of the microbial pest control agent. Furthermore, Vintec is applied very early in the season before leaves appear. Fruits are not present at all at the time of product application. Fixing a pre- harvest interval is therefore not relevant. Re-entry period for livestock, to areas to be grazed: Not relevant (see above). Furthermore, it is not supposed that livestock will graze in vines and vine nurseries. Re-entry period for man to crops, buildings or spaces treated: Not relevant (see above). Withholding periods for animal feeding stuffs: Not relevant (see above). Furthermore, grapes are not supposed to be used as animal feeding stuff. Waiting period between application and handling treated products: Not relevant (see above). Waiting period between last application and sowing or planting succeeding crops: Vintec was never shown to cause injuries to plants. The setting of a waiting period is therefore not required.
IIIM1 4.6 Label instructions (safe handling and storage) Please refer to Point IIIM 4.7.
IIIM1 4.7 Recommendations (handlimg, storage, transport, fire: specific risks, specify procedures to minimise hazards and the generation of waste Handling: Wear gloves and goggles when handling the product. Store the product only in its original closed packaging Wash hands after handling with the product.Remove contaminated clothing and wash before reuse. Keep product away from waters. Do not store under wet conditions. Avoid long-term exposure to temperatures above 20°C (70°F). Susceptible to fungicides, acids and hydroxides, and products attacking organic material. Storage requirements: Store the product in the original package, in a closed room. The storage room should be cool and ventilated. Vintec contains living organisms. Transport: Transport of Vintec does not require special precautions since neither the ingredients nor the formulated end product own corrosive, reactive or flammable properties. Fire:
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All regular fire extinguishing media can be employed: water, foam, carbon dioxide and dry powder. Procedures to minimize the generation of waste: Pick up mechanically. Do not wash residues into drains but distribute on field in liquid manure. Small amounts can be added to compost. Hazardous combustion products: Thermal decomposition will form non-hazardous gases or residues.
Please, for any further information refer to the Safety Data Sheets submitted in document H.
IIIM1 4.8 Label instructions (clean up of spills) Please refer to Point IIIM 4.9.
IIIM1 4.9 Detailed procedures in case of accident to: contain a spillag, decontaminate an area or vehicle, disposal of packaging and adsorbents, protect workers and bystanders, first aid. Containment of spillages: Prevent entry into drains, waters, sewages etc. of the product, contact immediately the municipal technical management if the product enters such bodies. Pick up mechanically. Do not wash residues into drains but distribute on field in liquid manure. Small amounts can be added to compost. Decontamination of areas, vehicles and buildings: Refer to the above statement on spillages Disposal of damaged packaging, adsorbents and other materials: Refer to the above statement on spillages Protection of emergency workers: Avoid direct contact with skin and eyes. Remove contaminated clothing and wash before reuse. Wear gloves in the case of an allergenic sensitivity, long shirt and pants, and shoes. Wash hands and skin with soap after handling with the product. First aid measures: After inhalation: Move to fresh air. After skin contact: Wash hands and skin. After eye contact: Rinse opened eye. After swallowing: In case of persistent symptoms seek medical advice. Further medical treatment: No symptoms are known. No special advices for treatment after contact with the product are known..
Please, for any further information refer to the Safety Data Sheets submitted in document H.
IIIM1 4.10 Procedures for destruction/ disposal of MPCP and its package Send empty containers MPCP wastage to a specialized recycling company.
IIIM1 4.10.1 Controlled incineration
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The disposal of product has to be performed in accordance with all applicable federal, state and local environmental regulations. Wastes resulting from the use of Vintec, i.e. residual water dispersions can be disposed of at an approved waste disposal facility. Remainder of spray can also be diluted and sprayed over already treated areas. Totally cleaned packages can be given to the regular waste disposal.
IIIM1 4.10.2 Methods other than controlled incineration No other methods other than controlled incineration are required.
IIIM1 11 SUMMARY AND ASSESSMENT OF IMPACT ON THE ENVIRONMENT AND THE ENVIRONMENTAL RISK IIIM1 11.1 Information on distribution and disposion of the MPCP
IIIM1 11.2 Identification of the vulnerable organisms not belonging to the target group, and the degree of its exposion
IIIM1 11.3 Identification of precautionary measures to reduce the impact on the environment and to prevent the non targeted organisms
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Appendix 1 - List of data used in support of the evaluation
Annex point/ Author(s) Year Title Data Owner How considered reference No. Source (where different from protection in dRR OECD company) claimed Study-Status / Report-No. Usage* GLP or GEP status (where relevant), Published or not KIIIM1 2.1, Coranelli, 2014 Chemical-physical properties Y Bi-PA 1 2.2, S. of product Trichoderma nv/sa (in DAR only 2.3.3, granule after two years shelf 12 month 2.4.1, life interim report 2.4.3, BT195/11! 34814 was available) 2.4.4, GLP: Y, published: N 2.4.5, 4.2.1, 4.2.2 KIIIM1 2.3.1 Möller, M. 2012 Determination of physico- Y Bi-PA cited in DAR chemical properties - nv/sa explosive properties EC A.14 CSL-12-0230.02! 36841 GLP: Y, published: N KIIIM1 2.3.1 Möller, M. 2012b Determination of physico- Y Bi-PA cited in DAR chemical properties - nv/sa oxidizing properties of solids EC A.17 CSL-12-0230.03! 36842 GLP: Y, published: N KIIIM1 2.3.2 Möller, M. 2012c Determination of physico- Y Bi-PA cited in DAR chemical properties Bowes- nv/sa Cameron-Cage test UN Test N.4 CSL-12-0230.04! 36844 GLP: Y, published: N KIIIM1 2.3.2 Möller, M. 2012d Determination of physico- Y Bi-PA cited in DAR chemical properties - nv/sa flammability of solids EC A.10 UN test N.1a CSL-12-0230.01! 36843 GLP: Y, published: N KIIIM1 2.4.2, Coranelli, 2012 Chemical-physical Y Bi-PA cited in DAR 2.4.7, S. characterization of Product nv/sa 2.5 Trichoderma Granule BT194/11! 39006 GLP: Y, published: N
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* 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)
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Appendix 2: Critical Uses – justification and GAP tables
GAP rev. , date: year-month-day PPP (product name/code) Vintec Formulation type: WG Active substance 1 Trichoderma atroviride SC1 Conc. of as 1: 1 × 1013 CFU/kg Active substance 2 - Conc. of as 2: - Active substance - Conc. of as: -
Safener - Conc. of safener: - Synergist - Conc. of synergist: -
Applicant: Bi-PA Professional use Zone(s): Central/EU Non professional use
Verified by MS: y/n
1 2 3 4 5 6 7 8 10 11 12 13 14 Application Application rate Crop and/ Pests or Group of Max. number g, kg as/ha or situation pests controlled kg product / ha F (min. interval Timing / Water Remarks: Use- G between PHI Member state(s) (crop (additionally: Growth a) max. rate L/ha No. or Method / applications) a) max. rate per (days) destination / developmental stages stage of per appl. e.g. g safener/synergist per ha I Kind appl. purpose of of the pest or pest crop & a) per use b) max. total min / crop) group) season b) per crop/ b) max. total rate rate per max season per crop/season crop/season Germany Austria Phaeomoniella Hungary Winter a) 2 × 1012 Grapes, chlamydospora Spray dormancy 1- 2 (1 week a) 0.2 kg/ha CFU/ha 100 - Not 1 Belgium established F Phaeoacremonium appli- - period interval) 12 200 relevant vines (VITVI) aleophilum cation b) 0.4 kg/ha b) 4 × 10 Romania BBCH0 CFU/ha
Slovakia Czech Republic
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GAP as authorised for Germany
GAP-Table of intended uses for Germany Reg.-No. 008562-00/00 GAP rev.1, date: 2018-03-07 PPP (product name/code): Vintec Formulation type: WG (a, b) Active substance 1: Trichoderma atroviride Stamm SC1 Cont. of as 1: 150.00 g/kg (c) (1*1013 CFU/kg) Applicant: Bi-PA nv/sa Professional use: Yes Zone(s): central/interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungicide
1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: No. state(s) or situation Fn, pests controlled Method / Timing Max. Min. kg or L g or kg as/ha Water (days) (e) Fpn Kind / number interval product / ha L/ha e.g. g (crop G, (additionally: Growth a) per between a) max. rate a) max. rate safener/synergist destination / Gn, developmental stage of use applications per appl. per appl. min / per ha purpose of Gpn stages of the pest crop & b) per (days) b) max. total b) max. total max (f) crop) or or pest group) season crop/ rate per rate per I season crop/season crop/season 001 DE grape vine F esca of vinegrape spraying a) 2 7 days a) 0.2 kg/ha a) 0.03kg/ha 100 - F *) *) The PHI is covered (VITVI) (Phaeomoniella or fine from 00 b) 2 b) 0.4 kg/ha b) 0.06kg/ha 200 by the conditions of use and/or the chlamydospora) spraying during L/ha vegetation period (PHMOCH), esca (low dormant remaining between of vinegrape volume period the application of the (Togninia minima) spraying) plant protection product and the use of (TOGNMI) the product (e. g. harvest) or the setting of a PHI in days is not required resp.
Remarks (a) e.g. wettable powder (WP), emulsifiable concentrate (EC), (d) Select relevant table granule (GR)
Applicant: Bi-PA nv Evaluator: DE Date: March 2018 Part B – Section 1 BCP511B Registration Report – Central Zone Core Assessment – Germany Vintec Page 27 of 28
heading: (b) Catalogue of pesticide formulation types and international coding (e) Use number(s) in accordance with the list of all intended GAPs in Part B, system Crop Life International Technical Monograph n°2, 6th Section 0 should be given in column 1 Edition Revised May 2008 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use. Remarks 1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use columns: must be provided. 2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of used; when relevant, the use situation should be described (e.g. fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose fumigation of a structure) expression for plant protection products. 4 F: professional field use, Fn: non-professional field use, Fpn: 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per professional and non-professional field use, G: professional treatment (usually g, kg or L product / ha). greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds 12 If water volume range depends on application equipment (e.g. ULVA or LVA) or, when relevant, the common names of the pest groups (e.g. it should be mentioned under “application: method/kind”. biting and sucking insects, soil born insects, foliar fungi, weeds) 13 PHI - minimum pre-harvest interval and the developmental stages of the pests and pest groups at the 14 Remarks may include: Extent of use/economic importance/restrictions moment of application must be named. 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated. 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application
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Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics: The following physical, chemical and technical properties of the plant protection product were experimentally tested: pour and tap density, colour, pH, wettability, persistent foaming, suspensibility, content of dust/fines, attrition and flowability. Significant deviations from the data submitted by the applicant were detected for density (tapped 513 g/L instead of 670 g/L), wettability (not completely wettable instead of 60 s) and suspensibility (53 instead of 71 %). Further clarification has been submitted by the applicant. The differences in suspensibility could be explained by the different kind of determination ( gravimetric vs. analytical). According to the applicant the measured dynamic wettability is acceptable. A sentence will be added to the label, that stirring is compulsory at preparation and application of the spray broth.
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REGISTRATION REPORT Part B
Section 2: Analytical Methods Detailed summary of the risk assessment
Product code: BCP511B (Vintec) Active Substance: Trichoderma atroviride SC1 1.0 × 1013 CFU/kg (150 g/kg)
Central Zone Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: Bi-PA nv Submission Date: 24/09/2015 Date: July 2018
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Table of content
IIIM 5 METHODS OF ANALYSIS; MANUFACTURING; QUALITY CONTROL AND POST-REGISTRATION MONITORING OF THE MICROBIAL PEST CONTROL PRODUCT ...... 3
IIIM 5.1 Methods for the Analysis of the preparation - Quality control and post-registration monitoring methods ...... 3 IIIM 5.1.2 Methods to detect spontaneous change in major characteristics of micro-organism ...... 3
IIIM 5.1.3 Methods to define contents of micro-organism in appropriate terms ...... 4
IIIM 5.1.4 Methods to identify contaminant micro-organisms in MPCP ...... 4
IIIM 5.1.5 Methods to show control to a specified and acceptable level, of microbial impurities and of any other impurities of toxicological concern ...... 5
IIIM 5.1.6 Methods to show presence of any human and mammalian pathogens ...... 5
IIIM 5.2 Storage stability test and determination of shelf life (methods of analysis) ...... 5
IIIM 5.3 Production process for MPCP, describing techniques used to ensure a uniform product ...... 5
IIIM 5.4 Method for determination of residues ...... 5
Appendix 1 – List of data submitted in support of the evaluation ...... 8
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IIIM 5 METHODS OF ANALYSIS; MANUFACTURING; QUALITY CONTROL AND POST-REGISTRATION MONITORING OF THE MICROBIAL PEST CONTROL PRODUCT
Introduction This document reviews the methods of analysis for the product Vintec containing Trichoderma atroviride SC1, which is approved under Regulation (EC) 1107/2009. Vintec is the representative formulation in the dossier submitted for approval of Trichoderma atroviride SC1 as an active ingredient under Regulation (EC) 1107/2009.
Vintec is a biological fungicide formulated as water dispersible granules, containing 1 × 1013 colony forming units (CFU) Trichoderma atroviride SC1 in 1 kg product.
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 Vintec can be found in the confidential dossier of this submission (Registration Report - Part C).
IIIM 5.1 Methods for the Analysis of the preparation - Quality control and post- registration monitoring methods
IIIM 5.1.1 Methods to detect, isolate, and enumerate the microorganismn. Methods to differentiate a mutant or genetically-modified micro-organism from the parent strain
Not required, because T. atroviride SC1 is of natural origin and not a mutant or genetically modified organism.
IIIM 5.1.2 Methods to detect spontaneous change in major characteristics of micro- organism The T. atroviride SC1 conidia are plated on Potato Dextrose Agar (PDA). Plates are examined phenotypically for the colour and shape of the mycelium and conidiophores. Changes in mycelium and conidiophore morphology or growth behaviour will be visible by observation under the microscope or to the naked eye. These will be compared to standard descriptions of the species. Moreover, variability of the seed stock can be excluded as the seed stock was prepared once from a single colony. As spores are inactive under the storage conditions applied, no change will occur. The same examination will give information on any contaminations other than the ones assessed by plating techniques as described in Part B, Section2, Point III 5.1.4.
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IIIM 5.1.3 Methods to define contents of micro-organism in appropriate terms Report: KIIIM1 5.1.3/01, Coranelli, 2012 Title: Analytical method validation for the determination of the active ingredient content in the formulated product Trichoderma Granule and in aqueous dilutions by spore counting method Document No: 34806, BT193/11 Guidelines: SANCO/3030/99 rev.4 (11/07/00) GLP Yes
A method for the enumeration of T. atroviride SC1 was validated by Coranelli (2012). Spores were counted in a Thoma counting chamber under the microscope, and viability of spores was determined by plating on potato dextrose agar and subsequent incubation at 20 °C for 24 hours. After this time, germinated and non-germinated spores were counted. The following validation criteria obtained in the study are listed in Table below.
Parameter Formulated product Aqueous suspension Linearity for total spores R2 = 0.992 R2 = 0.991 Linearity for viable spores R2 = 0.993 R2 = 0.991 Prescision for total spores % RSD = 4.94 % % RSD = 9.08 % Precision for viable spores % RSD = 5.39 % % RSD = 8.42 % Interference Absence of interference Not determined
IIIM 5.1.4 Methods to identify contaminant micro-organisms in MPCP Report: KIIIM1 5.1.4/01, Coranelli, 2012 Title: Determination of contaminants and pathogens on four batches of Trichoderma Granule product Document No: BT125/12 Guidelines: GLP Yes
Coranelli (2012) analysed 4 batches of the formulated product for the presence of microbial contaminants. The methods used are standard methods applied in food industry. The aerobic plate count, anaerobic spore formers and coliforms were detected by plating of dilutions on appropriate media. Staphylococcus aureus, Shigella, Salmonella, and Listeria monocytogenes were plated following enrichment in liquid culture. Methods are listed in Table below.
Contaminant Method used Aerobic Plate Count ISO 4833: 2003 Anaerobic spore-formers MFLP-44, April 1998 Coliforms NF EN ISO 4832: 2006 Staphylococcus aureus NF EN ISO 6888-3: 2003 Shigella NF EN ISO 21567: 2005 Salmonella NF EN ISO 6579:2002
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Listeria monocytogenes NF EN ISO11290-1/A1: 2005
IIIM 5.1.5 Methods to show control to a specified and acceptable level, of microbial impurities and of any other impurities of toxicological concern Please refer to Point IIIM 5.1.4 for methods for determination of microbial contaminants. No relevant non-microbial impurities are contained in the product as T. atroviride SC1 is not able to produce any toxin.
IIIM 5.1.6 Methods to show presence of any human and mammalian pathogens Please refer to Point IIIM 5.1.4 for methods for determination of microbial contaminants.
IIIM 5.2 Storage stability test and determination of shelf life (methods of analysis) A two-years shelf life study is submitted in Part B, Section 1, Point IIIM 2.2.
IIIM 5.3 Production process for MPCP, describing techniques used to ensure a uniform product Confidential information, please refer to Part C, Point IIIM 5.3.
IIIM 5.4 Method for determination of residues
IIIM 5.4.1 Evaluation of Trichoderma atroviride stain SC1
The conclusion regarding the peer review of the analytical methods for residues of trichoderma atroviride stain SC1 are summarized in SANTE/10389/2016 rev. 1 (22 March 2016) and EFSA conclusion (EFSA Journal 2015;13(4):4092, ASB2015-4071).
IIIM 5.4.1.1 Overview of residue definitions and levels for which compliance is required
Neither a legal residue definition for food of plant and animal origin exists, nor was one proposed in the respective EFSA conclusion. According to Commission Regulation (EU) 2017/171 Trichoderma atroviride stain SC1 is included in Annex IV to Regulation (EC) No 396/2005. For commodities of plant and animal origin no MRLs were set.
Table 5.3-1: Relevant residue definitions
Matrix Relevant residue Reference Remarks Plant material Not defined / no MRL required Commission Regulation (EU) 2017/171; annex IV to Regulation (EC) No 396/2005
EFSA conclusion, EFSA Journal 2015;13(4):4092, ASB2015-4071
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Matrix Relevant residue Reference Remarks Foodstuff of animal origin Not defined /no MRL required Commission Regulation (EU) 2017/171; annex IV to Regulation (EC) No 396/2005
EFSA conclusion, EFSA Journal 2015;13(4):4092, ASB2015-4071 Soil Not defined EFSA conclusion, EFSA Journal 2015;13(4):4092, ASB2015-4071 Surface water Not defined EFSA conclusion, EFSA Journal 2015;13(4):4092, ASB2015-4071 Drinking/ground water Not defined EFSA conclusion, EFSA Journal 2015;13(4):4092, ASB2015-4071 Air Not defined Not classified as T / T+/ Xi/ Xn Body fluids/tissue Not defined Not classified as T / T+
Table 5.3-2: Levels for which compliance is required
Matrix MRL Reference for MRL/level Remarks Plant, high water content No MRL Commission Regulation (EU) 2017/171; annex IV to Regulation (EC) Plant, acidic commodities No 396/2005 Plant, dry commodities Plant, high oil content Meat Milk Eggs Fat Liver, kidney Soil Not defined Common limit not applicable Drinking water Not defined Common limit not applicable Surface water Not defined EFSA conclusion, EFSA Journal 2015;13(4):4092, ASB2015-4071 Air Not defined Not classified as T / T+/ Xi/ Xn Tissue (meat or liver) Not defined Not classified as T / T+ Body fluids Not defined Not classified as T / T+ ,
IIIM 5.4.1.2 Description of Analytical Methods for the Determination of Residues of Trichoderma atroviride stain SC1 in Plant Matrices (OECD KIII A 5.3.1) Based on the conclusions of the peer review for trichoderma atroviride stain SC1 no residues have to be monitored in crops. According to Commission Regulation (EU) 2017/171 Trichoderma atroviride stain
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SC1 is included in Annex IV to Regulation (EC) No 396/2005. Thus, residue analytical methods are not required.
IIIM 5.4.1.3 Description of Analytical Methods for the Determination of Residues of Trichoderma atroviride stain SC1 in Animal Matrices (OECD KIII A 5.3.1) Based on the conclusions of the peer review for trichoderma atroviride stain SC1 no residues have to be monitored in animal matrices. According to Commission Regulation (EU) 2017/171 Trichoderma atroviride stain SC1 is included in Annex IV to Regulation (EC) No 396/2005. Thus, residue analytical methods are not required.
IIIM 5.4.1.4 Description of Methods for the Analysis of Trichoderma atroviride stain SC1 in Soil (OECD KIII A 5.4) Based on the conclusions of the peer review for trichoderma atroviride stain SC1 no residues have to be monitored in soil. Thus, residue analytical methods are not required.
IIIM 5.4.1.5 Description of Methods for the Analysis of Trichoderma atroviride stain SC1 in Water (OECD KIII A 5.6) Based on the conclusions of the peer review for trichoderma atroviride stain SC1 no residues have to be monitored in water. Thus, residue analytical methods are not required.
IIIM 5.4.1.6 Description of Methods for the Analysis of Trichoderma atroviride stain SC1 in Air (OECD KIII A 5.7) Based on the conclusions of the peer review for trichoderma atroviride stain SC1 no residues have to be monitored in air. Thus, residue analytical methods are not required.
IIIM 5.4.1.7 Description of Methods for the Analysis of Trichoderma atroviride stain SC1 in Body Fluids and Tissues (OECD KIII A 5.8) Methods for body fluids and tissues are not required, because trichoderma atroviride stain SC1 is not considered to be toxic or very toxic (T / T+) nor is it classified according to GHS as follows: Acute toxicity (cat. 1 - 3), CMR (cat. 1) or STOT (cat. 1).
IIIM 5.4.1.8 Other Studies/ Information None
IIIM 5.5 Conclusion on the availability of analytical methods for the determination of residues
Analytical methods to determine residues of trichoderma atroviride stain SC1 are not required. Consequently data gaps do not exist.
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Appendix 1 – List of data submitted in support of the evaluation Annex point/ Author(s) Year Title Data Owner How reference No. Source (where different from protection considere OECD company) claimed d in dRR Report-No. Study- GLP or GEP status (where Status / relevant), Usage* Published or not KIIIM1 5.1.3 Coranelli, 2012 Analytical method validation for Y Bi-PA 1 S. the determination of the active nv/sa ingredient content in the formulated product Trichoderma Granule and in aqueous dilutions by spore counting method 34806! BT193/11 GLP: Y, published: N KIIIM1 5.1.4 Coranelli, 2012 Determination of contaminants Y Company 1 S. and pathogens on four batches of Bi-PA nv Trichoderma Granule product BT125/12 GLP: Y, published: N
* 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)
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DRAFT REGISTRATION REPORT Part B
Section 3: Mammalian Toxicology Detailed summary of the risk assessment
Product name: Vintec Active Substance: 150.0 g/kg Trichoderma atroviride SC1 (1.0 × 1013 CFU/kg)
Central Zone Zonal Rapporteur Member State: DE
CORE ASSESSMENT Zonal Rapporteur Member State: DE
Applicant: BPA - Bi-PA nv/sa Date: April 2018 Revision: July 2018
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Table of Contents
3 Mammalian Toxicology (KCP 7) ...... 3 3.1 Summary ...... 3 3.2 Toxicological Information on active substance(s) ...... 5 3.3 Toxicological Evaluation of Plant Protection Product ...... 5 3.4 Toxicological Evaluation of Groundwater Metabolites ...... 7 3.5 Exposure Assessment of Plant Protection Product (KCP 7.2) ...... 7 3.5.1 Selection of critical use and justification ...... 7 3.5.2 Operator, worker, resident and bystander exposure: monitoring data (if available) ...... 7 3.5.3 Reporting of hypersensitivity incidents before and after registration ...... 8 3.5.4 Combined exposure ...... 8
Appendix 1 Reference list ...... 9
Appendix 2 Detailed evaluation of the studies relied upon ...... 10 A 2.1 Data on co-formulants (KCP 7.4) ...... 10 A 2.1.1 Material safety data sheet for each co-formulant ...... 10 A 2.1.2 Available toxicological data for each co-formulant ...... 10
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3 Mammalian Toxicology (KCP 7)
3.1 Summary
Table 3.1-1: Information on Vintec*
Product name and code Vintec (BPA-08562-F-0-WG) Formulation type Water dispersible granule (WG) Active substance (incl. content) Trichoderma atroviride strain SC1 (150.00 g/kg; 1.0 × 1013 CFU/kg) Function Fungicide Product already evaluated as the ‘representative Yes formulation’ during the approval of the active substance Product previously evaluated in another MS according No to Uniform Principles * Information on the detailed composition of Vintec can be found in the confidential dRR Part C.
Justified proposals for classification and labelling
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 for Vintec according to Regulation (EC) No 1272/2008
Hazard class, category None Hazard pictograms or Codes) for None hazard pictogram(s) Signal word None Hazard statement(s) None Precautionary statement(s) None Additional labelling phrases To avoid risks to man and the environment, comply with the instructions for use. [EUH401] Microorganisms may have the potential to provoke sensitising reactions.
Table 3.1-3: Summary of risk assessment for operators, workers, residents and bystanders for Vintec
Result PPE / Risk mitigation measures Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to health damage. [SB001] - If medical advice is needed, have product container or label at hand. [SB005] - Keep out of children’s reach. [SB010] - Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection prod-
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Result PPE / Risk mitigation measures ucts" of the Federal Office of Consumer Protection and Food Safety (www.bvl.bund.de) must be observed. [SB111] - Do not eat, drink or smoke when using this product. [SB166] - Protective gloves (plant protection) must be worn when handling the undiluted product. [SS110-1] - Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. [SS206] - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. [SS2101] - The packaging must be provided with the wording "microorganisms may have the potential to provoke sensitising reactions". [VH650] Workers Acceptable - It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. [SF245-02] Residents Acceptable None Bystanders Acceptable None
No unacceptable risk for operators, workers, residents and bystanders was identified when the product is used as intended and provided that the PPE/ risk mitigation measures stated in Table 3.1-3 are applied.
A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and residents / bystanders is presented in the following table.
Further reduction of exposure is to be expected due to necessary PPE allocated according to dangerous substances regulations.
Table 3.1-4 Critical uses and overall conclusion of exposure assessment
1 2 3 4 5 6 7 8 9 10
Use- Crops and F. Application Application rate PHI Remarks: Acceptability of No.* situation Fn. (d) (e.g. exposure (e.g. growth Fpn safener/s assessment stage of crop) G. ynergist Gn. Method / Max. number Max. application Water [L/ha]) Gpn. Kind (min. interval rate [kg as/ha] min – max between I. In. (incl. Ipn** applications) [L/ha] application a) per application technique a) per use b) per crop and b) per crop/ season season Operator Worker Residents Bystander Grape vine F Spraying a) 2 (7) a) 0.03 100 - 200 n.a. n.a. A A A A (from BBCH 00) b) 2 (7) (2 × 1012 CFU/ha) b) 0.06 (4 × 1012 CFU/ha) * Use number(s) in accordance with the list of all intended GAPs in Part A/Part B. Section 0 should be given in column 1 ** F: professional field use. Fn: non-professional field use. Fpn: professional and non-professional field use. G: professional greenhouse use. Gn: non-professional greenhouse use. Gpn: professional and non-professional greenhouse use. I: indoor application. In: non-professional indoor use; Ipn: professional and non-professional indoor use
Explanation for column 10 “Acceptability of exposure assessment” A Exposure acceptable without PPE / risk mitigation measures R Further refinement and/or risk mitigation measures required N Exposure not acceptable/ Evaluation not possible
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Data gaps The following data gaps were noticed in the EU review of the active substance: • Ability or lack of ability of Trichoderma atroviride strain SC1 to produce trichothecenes • Non-dietary risk assessment to secondary metabolites/toxins
The applicant argues that Trichoderma atroviride strain SC1 is naturally present in our environment and its application in pest control represents only a fluctuation of the fungal population in the biotope of the pest insect. However, no satisfactory information is available to demonstrate that, under the conditions of use, any secondary metabolites/toxins produced by Trichoderma atroviride strain SC1 will not occur in the environmental compartments in concentrations considerably higher than under natural conditions. Therefore the risk assessment for the secondary metabolites/toxins cannot be finalised for operators, workers, residents and bystanders.
Despite these data gaps, there are no serious concerns, which would preclude an authorisation of the product Vintec (see Review report for the active substance Trichoderma atroviride strain SC1; SANTE/10389/2016 rev. 1; 22 March 2016).
3.2 Toxicological Information on active substance(s)
The active substance was evaluated under directive No 94/414/EEC (as amended) or regulation (EC) No 1107/2009 (as amended). Information regarding classification of the active substances and on EU endpoints identified during the EU review is given in the following table. Further information on active substances is included in the reports on the results of the peer review process and in the respective background documents.
Table 3.2-1: Information on Trichoderma atroviride strain SC1
Classification and labelling With regard to toxicological Hazard class, category: none endpoints (according to the Code for hazard pictogram: none criteria in Regulation (EC) No Signal word: none 1272/2008. as amended) Hazard statement: none Proposals for additional “Microorganisms may have the potential to provoke sensitising reactions” classification and labelling (EFSA Journal 2015;13(4):4092, ASB2015-4071) Agreed EU endpoints AOEL systemic Not applicable based on the lack of pathogenicity and infectivity in the available data. Reference EFSA Conclusion (EFSA Journal 2015;13(4):4092, ASB2015-4071)
3.3 Toxicological Evaluation of Plant Protection Product
The studies summarised in the following tables were conducted with the formulation Trichoderma atroviride SC1 WG, which according to the applicant is identical to the product Vintec. These studies have been previously considered within the EU peer review process for the approval of Trichoderma atroviride strain SC1 as an active substance under regulation (EC) 1107/2009, for which Vintec was the representative formulation.
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Table 3.3-1: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for Vintec / Trichoderma atroviride SC1 WG
Classification and labelling Type of test, species, model Dose level Result Acceptability (acc. to the Reference system (Guideline) criteria in Reg. 1272/2008) Acute oral 10 mg/animal No toxicity Yes None XXXXX, toxicity/pathogenicity, rats (4.1 × 108 CFU) no infectivity 2012 (OCSPP 885.3050) [ASB2016- 6262] Acute dermal toxicity ------Acute pulmonary 10 mg/animal No toxicity Yes None XXXXX, toxicity/pathogenicity (4.7 × 108 CFU) no infectivity 2012 (intratracheal instillation), [ASB2016- rats (OCSPP 885.3150) 6263] Skin irritation, rabbit 500 mg/animal Not irritating Yes None XXXXX, (OECD 404) (5.5 × 109 CFU) 2012 [ASB2016- 6274] Eye irritation, rabbit 100 mg/animal Not irritating Yes None XXXXX, (OECD 405) (1.1 × 109 CFU) 2012 [ASB2016- 6275] Skin sensitisation ------
No study on the acute dermal toxicity of Trichoderma atroviride strain SC1 was submitted. Since Trichoderma does not penetrate intact human skin and the formulation Vintec does not contain any co- formulant with classification regarding acute dermal toxicity, no percutaneous toxicity study has been required.
No study on the sensitisation potential of Trichoderma atroviride strain SC1 was submitted. None of the formulants is a skin sensitizer. However, microorganisms in general are considered sensitising unless there is sufficient experimental evidence that there is no concern. Therefore, the labelling phrase “Microorganisms may have the potential to provoke sensitising reactions” is required.
Table 3.3-2: Additional toxicological information relevant for classification/labelling of Vintec
Substance Classification and Reference Classification and (Concentration labelling of the substance labelling of product (acc. in product. (acc. to the criteria in to the criteria in Reg. % w/w) Reg. 1272/2008) 1272/2008) Toxicological Trichoderma Considering that all EFSA “Microorganisms may properties of active atroviride strain microorganisms should be Conclusion have the potential to substance(s) (relevant SC1 (15% regarded as potential (ASB2015- provoke sensitising for classification of (w/w)) sensitizers, the agreed 4071) reactions” Vintec) warning phrase is “Microorganisms may have the potential to provoke sensitising reactions”
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3.4 Toxicological Evaluation of Groundwater Metabolites
A relevance assessment of metabolites in groundwater is not required.
3.5 Exposure Assessment of Plant Protection Product (KCP 7.2)
Table 3.5-1: Product information and toxicological reference values used for exposure assessment
Product name and code Vintec (BPA-08562-F-0-WG) Formulation type Water dispersible granule (WG) Category Fungicide Container sizes 50 g, 400 g and 1 kg bags Active substance (incl. content) Trichoderma atroviride strain SC1 (150.00 g/kg; 1.0 × 1013 CFU/kg) AOEL systemic Not derived Inhalation absorption 100% Oral absorption 100% Dermal absorption Considered non-relevant for microorganisms
3.5.1 Selection of critical use and justification
The critical GAP used for the exposure assessment of the plant protection product is shown in Table 3.1-4.
3.5.2 Operator, worker, resident and bystander exposure: monitoring data (if available)
According to the EFSA Conlusion on Trichoderma atroviride strain SC1 (EFSA Journal 2015;13(4):4092), several species of the saprophytic genus Trichoderma have been identified as the cause of infections in immune-suppressed humans. Therefore, it cannot be excluded that Trichoderma atroviride strain SC1 could be involved in clinical cases. However, in most of the cases, the route of exposure was not relevant for the use of Trichoderma as plant protection product.
Moreover, no harmful effects have been observed on personnel in research or industrial mass production, over a production period of more than 10 years.
Based on the lack of significant toxicity, infectivity or pathogenicity in the available toxicological studies, no Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD) or Acceptable Operator Exposure Level (AOEL) were derived for Trichoderma atroviride strain SC1. Therefore, a quantitative assessment of the operator, worker, bystander and resident exposure is not deemed necessary.
Considering the potential sensitizing properties of Trichoderma atroviride strain SC1, protection equipment must be worn by operators (gloves and coverall). When the appropriate protection equipment is worn, the intended uses are considered safe based on the low toxicity profile.
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3.5.3 Reporting of hypersensitivity incidents before and after registration
No cases on hypersensitivity have been reported in production or application of Trichoderma atroviride SC1 WG. However, considering the potential sensitizing properties of Trichoderma atroviride strain SC1, the following labelling phrase is deemed necessary: “Microorganisms may have the potential to provoke sensitising reactions”.
3.5.4 Combined exposure
Not relevant. The product contains only one active substance.
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Appendix 1 Reference list
Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * EFSA 2015 Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain SC1 EFSA Journal 2015;13(4):4092 ! EFSA- Q-2014-00334 ASB2015-4071 KIIM 5.3.2 XXXXX 2012 Acute oral toxicity/pathogenicity study No Company Y in rats with Trichoderma atroviride SC1 Yes Bi-PA nv 16043-12 GLP: Open Published: Open BVL-2466314, ASB2016-6262 KIIIM1 7.1.3, XXXXX 2014 Trichoderma atroviride SC1: Acute Yes Bi-PA Y KIIM 5.3.3 pulmonary toxicity/pathogenicity study nv/sa in rats with Trichoderma atroviride SC1 - Amended report 16044-12 GLP: Yes Published: No BVL-2932126, BVL-3101232, ASB2016-6263 KIIIM1 7.1.4 XXXXX 2012 Acute dermal irritation/corrosion test Yes Bi-PA Y (patch test) of Trichoderma atroviride nv/sa SC1 WG in rabbits 35402 ! 27785 GLP: Yes Published: No BVL-2932127, ASB2016-6274 KIIIM1 7.1.5 XXXXX 2012 Acute eye irritation/corrosion test of Yes Bi-PA Y Trichoderma atroviride SC1 WG in nv/sa rabbits 35403 ! 27786 GLP: Yes Published: No BVL-2932128, ASB2016-6275 *Y. Yes/relied on; N. No/not relied on; Add. Additional. Relied on/study not submitted by applicant but necessary for evaluation
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Appendix 2 Detailed evaluation of the studies relied upon
A 2.1 Data on co-formulants (KCP 7.4)
A 2.1.1 Material safety data sheet for each co-formulant
Information regarding material safety data sheets of the co-formulants can be found in the confidential dossier of this submission (Registration Report - Part C).
A 2.1.2 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).
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REGISTRATION REPORT Part B
Section 4: Metabolism and Residues Detailed summary of the risk assessment
Product name: Vintec Active Substance: 150.0 g/kg Trichoderma atroviride strain SC1 (1.0 × 1013 CFU/kg)
Central Zone Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: BPA - Bi-PA nv/sa Date: March 2018 Revision: July 2018 9752-X00 / ZV1 008562-00/00 Part B – Section 4 - Core Assessment Applicant: Bi-PA Nv/sa/ zRMS
Table of Contents
4 Metabolism and residue data (KCA section 6) ...... 3 4.1 Summary and zRMS Conclusion ...... 3 4.1.1 Critical GAP and overall conclusion ...... 3 4.1.2 Summary of the evaluation ...... 5 4.1.2.1 Summary for Trichoderma atroviride strain SC1 ...... 5 4.1.2.2 Summary for Vintec ...... 5 4.2 Trichoderma atroviride strain SC1 ...... 6 4.2.1 Stability of Residues (KCA 6.1) ...... 6 4.2.2 Nature of residues in plants, livestock and processed commodities ...... 6 4.2.3 Magnitude of residues in plants (KCA 6.3) ...... 7 4.2.4 Magnitude of residues in livestock ...... 7 4.2.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) (KCA 6.5.2-6.5.3) ...... 7 4.2.6 Magnitude of residues in representative succeeding crops ...... 7 4.2.7 Other / special studies (KCA6.10, 6.10.1) ...... 7 4.2.8 Estimation of exposure through diet and other means (KCA 6.9) ...... 7 4.3 References ...... 7
Appendix 1 Lists of data considered in support of the evaluation ...... 8
Appendix 2 Detailed evaluation of the additional studies relied upon ...... 9
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4 Metabolism and residue data (KCA section 6)
4.1 Summary and zRMS Conclusion
4.1.1 Critical GAP and overall conclusion
Selection of critical uses and justification The critical GAP with respect to consumer intake and risk assessment for the preparation Vintec is presented in Table 4.1-1. It has been selected from the individual GAPs in the central zone for wine grapes.
Overall conclusion The data available are considered sufficient for risk assessment.
According to the Standing Committee on Plants, Animals, Food and Feed Trichoderma atroviride strain SC1 is unlikely to produce metabolites of significant toxicity or at levels leading to an exposure higher than negligible (SANTE/10389/2016 re.1). Therefore Trichoderma atroviride strain SC1 has been included in Annex IV to Reg. (EC) No 396/2005 as a substance for which no MRLs are required (Reg. (EU) 2017/171).
The chronic and the short-term intakes of Trichoderma atroviride residues are unlikely to pose a health risk for consumers.
As far as consumer health protection is concerned, Germany agrees with the authorization of the intended use.
According to available data, no specific mitigation measures should apply.
Data gaps No data gaps are noticed with relevance to the intended use.
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Table 4.1-1: Acceptability of critical GAPs (and respective fall-back GAPs, if applicable)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of pests Application Application rate PHI Conclusion / No. state(s) or situation Fn, controlled (days) Fpn Method / Timing / Growth Max. Min. interval kg product / ha CFU/ha Water Remarks: (crop destination / G, (additionally: developmental Kind stage of crop & number between a) max. rate per L/ha e.g. g purpose of crop) Gn, stages of the pest or pest group) season a) per use applications appl. a) max. rate per appl. safener/synergist Gpn b) per (days) b) max. total b) max. total rate per min / per ha or crop/ rate per crop/season max I season crop/season Zonal uses (field or outdoor uses, certain types of protected crops) 1 DE, BE, wine grapes, F esca of grapevine spraying BBCH 00, a) 2 7 days a) 0.2 kg/ha a) 2x1012 CFU/ha 100- F A AT, RO, established (Phaeomoniella chlamydospora), or low winter dormancy b) 2 b) 0.4 kg/ha b) 4x1012 CFU/ha 200 SK, CZ, (0151000) esca of grapevine volume period HU (Togninia minima) spraying
Remarks 1 Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, columns: be given in column 1. Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of 2 Use official codes/nomenclatures of EU Member States application 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the 8 The maximum number of application possible under practical conditions of use must be provided. use situation should be described (e.g. fumigation of a structure). Use also code numbers 9 Minimum interval (in days) between applications of the same product according to Annex I of Regulation (EU) No 396/2005. 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty 4 F: professional field use, Fn: non-professional field use, Fpn: professional and non- rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, Gpn: professional and non-professional greenhouse use, I: indoor application kg or L product / ha). 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the 12 If water volume range depends on application equipments (e.g. ULVA or LVA), it should be common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar mentioned under “application: method/kind”. fungi, weeds) and the developmental stages of the pests and pest groups at the moment of 13 PHI - minimum pre-harvest interval application must be named. 14 Remarks may include: Extent of use/economic importance/restrictions 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated.
Explanation for Column 14 “Conclusion” A Exposure acceptable without risk mitigation measures, safe use R Further refinement and/or risk mitigation measures required N Exposure not acceptable, no safe use
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4.1.2 Summary of the evaluation
The preparation Vintec contains the active substance Trichoderma atroviride strain SC1.
Table 4.1-2: Toxicological reference values for the dietary risk assessment of Trichoderma atroviride strain SC1
Reference Source Year Value Study relied upon Safety factor value
Trichoderma atroviride strain SC1 ADI Reg. (EU) 2016 Not applicable 2016/951 ARfD Reg. (EU) 2016 Not applicable 2016/951
4.1.2.1 Summary for Trichoderma atroviride strain SC1
Table 4.1-3: Summary for Trichoderma atroviride strain SC1
Sample storage Chronic Acute risk Plant Sufficient PHI Use- covered MRL risk for for Crop metabolism residue sufficiently No.* by compliance consumers consumers covered? trials? supported? stability identified? identified? data?
1 Wine No data No data not applicable No data No MRLs Not Not grapes (Annex IV) assessed assessed * Use number(s) in accordance with the list of all intended GAPs in Part A / Part B, Section 0 should be given in column 1
As Trichoderma atroviride strain SC1 is included in Annex IV to Reg. (EC) No 396/2005, no MRLs are set.
4.1.2.2 Summary for Vintec
Table 4.1-4: Information on Vintec (KCA 6.8)
PHI for PHI sufficiently supported for PHI for zRMS Comments Vintec Vintec Crop (if different PHI proposed by proposed by Trichoderma atroviride strain SC1 proposed) applicant zRMS
Grapes NR NR NR -- NR: not relevant
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Assessment
4.2 Trichoderma atroviride strain SC1
General data on Trichoderma atroviride strain SC1 are summarized in the table below (last updated 21/03/2018)
Table 4.2-1: General information on Trichoderma atroviride strain SC1 Active substance (ISO Common Name) Trichoderma atroviride strain SC1 IUPAC Not applicable Chemical structure Not applicable Molecular formula Not applicable Molar mass Not applicable Chemical group Not applicable Mode of action (if available) T. atroviride SC1 acts through several mechanisms, including competition for space and nutrients at the infection sites, parasitic activity on target fungi including production of inhibitory compounds and lytic enzymes, and induction of defense responses in host plants. Due to its mode of action, T. atroviride SC1 has a solely preventive activity. When a pathogenic fungus has already colonized the host plant, Trichoderma is not able to control the infection currently in progress (rev. DAR 2015, ASB2015-1487). Systemic A few systemic infections in immuno-suppressed people have been reported for Trichoderma spp. (ASB2015- 4071). Company (ies) Bi-PA nv (Biological Products for Agriculture) Rapporteur Member State (RMS) FR Approval status Approved (06/07/2016) Restriction No Review Report SANTE/10389/2016 rev. (22 March 2016) Current MRL regulation Reg. (EU) 2017/171: substance included in Annex IV to Reg. (EC) No 396/2005 Peer review of MRLs according to Article 12 of Reg No No 396/2005 EC performed EFSA Journal: Conclusion on the peer review Yes (EFSA 2015, ASB2015-4071) Current MRL applications on intended uses None * Notifier in the EU process to whom the a.s. belong(s)
4.2.1 Stability of Residues (KCA 6.1)
Information about stability of Trichoderma atroviride strain SC1 was neither available nor required.
4.2.2 Nature of residues in plants, livestock and processed commodities
As Trichoderma atroviride strain SC1 has been included in Annex IV to Reg. (EC) No 396/2005 (Reg.
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(EU) 2017/171), no MRLs are currently required and no information on residues in plants, livestock and processed commodities is necessary.
4.2.3 Magnitude of residues in plants (KCA 6.3)
No data available and none required.
4.2.4 Magnitude of residues in livestock
No data available and none required.
4.2.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) (KCA 6.5.2-6.5.3)
No data available and none required.
4.2.6 Magnitude of residues in representative succeeding crops
No data available and none required.
4.2.7 Other / special studies (KCA6.10, 6.10.1)
No special studies conducted.
4.2.8 Estimation of exposure through diet and other means (KCA 6.9)
No dietary risk assessment is performed as toxicological reference values were not derived.
4.3 References
EFSA (European Food Safety Authority), 2012. Conclusion on peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain SC1. EFSA Journal 2015; 13(4):4092 (ASB2015-4071) Review report for the active substance Trichoderma atroviride strain SC1. SANTE/10389/2016 rev.1. France, 2015. Trichoderma atroviride SC1: Draft Assessment Report, revised Vol. 1-3 ASB2015-1487
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Appendix 1 Lists of data considered in support of the evaluation
List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review
Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not
------
List of data submitted by the applicant and not relied on
Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not
KIIM 6.1, Longa, C. M. O.; 2008 Ecophysiological requirements and survival of a Trichoderma atroviride isolate with biocontrol No LIT KIIM 6.2, Pertot, I.; Tosi, S. potential KIIM Page: 269-277 6.4.2 GLP: No Published: Yes BVL-2466293, BVL-2466317, BVL-2466321, BVL-2466327, BVL-2466339, BVL-2466347, BVL- 2466360, ASB2016-6253 KIIM 6.1, Pertot, I. 2011 Ecology, identification, spectrum, effect on fermentation, survival on phyllosphere and long term Yes Company Bi- KIIM 6.2, survival of Trichoderma SC1 PA nv KIIM 6.3 GLP: No Published: No BVL-2466346, BVL-2466350, BVL-2466354, ASB2016-6247
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Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not
KIIM 6.1, Longa, C. M. O.; 2009 Evaluating the survival and environmental fate of the biocontrol agent Trichoderma atroviride SC1 in No LIT KIIM 6.2, Savazzini, F.; Tosi, vineyards in northern Italy KIIM 6.3, S.; Elad, Y.; Pertot, Page: 1549-1557 KIIM I. GLP: No Published: Yes 6.4.2 BVL-2466340, BVL-2466348, BVL-2466355, BVL-2466359, ASB2016-6254 KIIM 6.2 Migheli, Q.; 1994 Fate of transformed Trichoderma harzianum in the phylloplane of tomato plants No LIT Herrera-Estrella, A.; page 153-159 Avataneo, M. et al. GLP: No Published: Yes BVL-2466349, ASB2011-13940 KIIM 6.2, Harvey, I. C.; Hunt, 2006 Penetration of Trichoderma harzianum into grapevine wounds from treated pruning wounds No LIT KIIM 6.3 J. S. page 343-347 GLP: GLP: No Published: Yes BVL-2466351, BVL-2466353, ASB2010-2923 KIIM 6.3, Harman, G. E.; 2004 Trichoderma species – opportunistic, avirulent plant symbionts No LIT KIIM Howell, C. R.; 6.4.1 Viterbo,A.; Chet, I. GLP: No Published: Yes et al. BVL-2466352, BVL-2466357, ASB2010-2960 KIIM Schirmböck, M.; 1994 Parallel formation and synergism of hydrolytic enzymes and peptaibol antibiotics, molecular No LIT 6.4.1 Lorito, M.; Wang, mechanisms involved in the antagonistic action of Trichoderma harzianum against phytopathogenic Y. et al. fungiu pp. 4364-4370 Appl Environ Microbiol, 60 (12) (1994) 4364-4370 GLP: No Published: Yes BVL-3101334, ASB2010-2984
Appendix 2 Detailed evaluation of the additional studies relied upon
No studies submitted.
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DRAFT REGISTRATION REPORT Part B Section 8 (old dRR format B5) Environmental Fate Detailed summary of the risk assessment
Product code: ZV1 008562-00/00 Product name(s): Vintec Microbial Pest Control Agent: Trichoderma atroviride SC1, 1x1013 CFU/kg (150 g/kg)
Central Zone Zonal Rapporteur Member State: Germany
CORE ASSESSMENT(authorization)
Applicant: BI-PA nv/sa Submission date: 24/09/2015 MS Finalisation date: 20/03/2018 ZV1 008562-00/00 / Vintec Page 2 / 20 Part B – Section 8 - Core Assessment zRMS version
ZV1 008562-00/00 / Vintec Page 3 / 20 Part B – Section 8 - Core Assessment zRMS version
Version history
When What
March 2018 First Draft RR by UBA
ZV1 008562-00/00 / Vintec Page 4 / 20 Part B – Section 8 - Core Assessment zRMS version
Table of Contents
8 Fate and behaviour in the environment (KCP 9) ...... 6 8.1 Critical GAP and overall conclusions ...... 7 8.1.1 Table of critical GAPs ...... 7 8.1.2 Overall conclusion ...... 9 8.1.3 Grouping of intended uses for risk assessment ...... 9 8.2 Metabolites considered in the assessment ...... 10 8.3 Rate of degradation in soil (KCP 9.1.1) ...... 11 8.3.1 Aerobic degradation in soil (KCP 9.1.1.1) ...... 11 8.3.1.1 Trichoderma atroviride SC1 ...... 11 8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1) ...... 11 8.4 Field studies (KCP 9.1.1.2) ...... 11 8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) . 11 8.4.1.1 Trichoderma atroviride SC1 and its metabolites ...... 11 8.4.2 Soil accumulation testing (KCP 9.1.1.2.2) ...... 11 8.5 Mobility in soil (KCP 9.1.2) ...... 11 8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1) ...... 11 8.5.1.1 Trichoderma atroviride SC1 and its metabolites ...... 11 8.5.2 Column leaching (KCP 9.1.2.1) ...... 11 8.5.3 Lysimeter studies (KCP 9.1.2.2) ...... 11 8.5.4 Field leaching studies (KCP 9.1.2.3) ...... 12 8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3) ...... 13 8.6.1.1 Trichoderma atroviride SC1 ...... 13 8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 13 8.7.1 Justification of new endpoints ...... 13 8.7.2 Active substance and relevant metabolite(s) ...... 13 8.7.2.1 PECsoil ...... 13 8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1) ...... 15 8.8.1 Justification of new endpoints ...... 15 8.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1) ...... 15 8.8.2.1 Trichoderma atroviride SC1 and its metabolites ...... 15 8.8.3 Additional field test (KCP 9.2.4.2) ...... 15 8.8.4 Summary of the risk assessment for groundwater ...... 15 8.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5) ...... 15 8.9.1 Justification of new endpoints ...... 15 8.9.2 Active substance, relevant metabolite(s) and the formulation (KCP 9.2.5) 15 8.9.2.1 Trichoderma atroviride SC1 and its metabolites ...... 17 8.9.2.2 PECsw/sed of formulation ...... 17 8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ...... 17
Appendix 1 Lists of data considered in support of the evaluation ...... 18
Appendix 2 Detailed evaluation of the new Annex II studies ...... 20 A 2.1 Author, year ...... 20 ZV1 008562-00/00 / Vintec Page 5 / 20 Part B – Section 8 - Core Assessment zRMS version
Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data) ...... 20
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8 Fate and behaviour in the environment (KCP 9)
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8.1 Critical GAP and overall conclusions
8.1.1 Table of critical GAPs
Table 8.1-1: Critical use pattern of the formulated product
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/or situ- F, Fn, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fpn controlled (days) e.g. g saf- * (crop destination G, (additionally: develop- Method / Kind Timing / Max. number Min. interval kg or L g or kg as/ha Water L/ha ener/ syner- Groundwater / purpose of Gn, mental stages of the Growth a) per use between ap- product/ha min/max gist per ha crop) Gpn pest or pest group) stage of crop b) per crop/ plications a) max. rate a) max. rate or & season season (days) per appl. per appl. I ** b) max. total b) max. total rate per rate per crop/season crop/season Zonal uses (field or outdoor uses, certain types of protected crops)
001 BE, Grapes, estab- F Phaenomoniella spraying Winter dor- a) 1-2 7 days a) 0.2 kg/ha a) 2 x 1012 100-200 l/ha n.a. -- A AT; lished vines chlamydospora, mancy pe- CFU/ha RO; b) 2 b) 0.4 kg/ha (VITVI) riod 12 SK; Togninia minima b) 4 x 10 CZ; BBCH 0 CFU/ha HU;
Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms) -- Minor uses according to Article 51 (zonal uses) -- Minor uses according to Article 51 (interzonal uses) --
* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: ZV1 008562-00/00 / Vintec Page 8 / 20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015
professional and non-professional greenhouse use, I: indoor application
Explanation for column 15 “Conclusion” A Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use
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8.1.2 Overall conclusion
No risk mitigation is required on Member State level.
8.1.3 Grouping of intended uses for risk assessment
The following table documents the grouping of the intended uses to support application of the risk envelope approach (according to SANCO/11244/2011).
Table 8.1-2: Critical use pattern of Vintec grouped according to soil
Grouping according to soil
Group Intended uses max. total rate per crop/season Soil-relevant effective applic. (kg/ha) (no interception) rate, cumulative (kg/ha) 001 Grapes, established vines 2 x 0.2 kg MPCP/ha = 0.4 kg 0.4 kg MPCP/ha MPCP/ha, equivalent to 4 x 1012 CFU/ha
Table 8.1-3: Critical use pattern of Vintec grouped according to spray drift
Grouping according to spray drift
Group Intended uses max. total rate per crop/season Drift scenario (g/ha) (interval, 7 d) 001 Grapes, established vines 0.4 kg MPCP/ha (= 2 x 0.2 kg Vines (total accumulated dose: MPCP/ha) 90%-ile, worst-case-scenario)
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8.2 Metabolites considered in the assessment
Metabolites of Trichoderma atroviride SC1 Metabolites are covered by the EU assessment, no further risk assessment is necessary.
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8.3 Rate of degradation in soil (KCP 9.1.1)
According to EU assessment, no further data required.
8.3.1 Aerobic degradation in soil (KCP 9.1.1.1)
8.3.1.1 Trichoderma atroviride SC1
According to EU assessment, no further data required.
8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1)
Not relevant for assessment.
8.4 Field studies (KCP 9.1.1.2)
8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)
8.4.1.1 Trichoderma atroviride SC1 and its metabolites
According to EU assessment, no further data required
8.4.2 Soil accumulation testing (KCP 9.1.1.2.2)
No data available, not required.
8.5 Mobility in soil (KCP 9.1.2)
Studies on mobility in soil with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.
8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1)
8.5.1.1 Trichoderma atroviride SC1 and its metabolites
According to EU assessment, no further data required.
8.5.2 Column leaching (KCP 9.1.2.1)
No data, not required for assessment.
8.5.3 Lysimeter studies (KCP 9.1.2.2)
No data, not required for assessment. ZV1 008562-00/00 / Vintec Page 12 /20 Part B – Section 8 - Core Assessment zRMS version
8.5.4 Field leaching studies (KCP 9.1.2.3)
No data, not required for assessment. ZV1 008562-00/00 / Vintec Page 13 /20 Part B – Section 8 - Core Assessment zRMS version
8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3)
Studies on degradation in water/sediment systems with the formulation not required for assessment.
8.6.1.1 Trichoderma atroviride SC1
According to EU assessment, no further data required
8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)
8.7.1 Justification of new endpoints
Not applicable as no new endpoints used.
8.7.2 Active substance and relevant metabolite(s)
Table 8.7-1: Input parameters related to application for PECsoil calculations
Use No/use group 001 Crop Vines Application rate (g as/ha) 30 Number of applications/interval 2 Crop interception (%) 0 Depth of soil layer (relevant for plateau concentra- 5 tion) (cm)
8.7.2.1 PECsoil
In order to perform a risk assessment for non-target organisms the actual population of viable spores of T. atroviride SC1 is calculated for soil, based on the maximum accumulated application rate of 0.4 kg product/ha, assuming two treatments of 0.2 kg/ha and as a worst case no degradation between the applica- tions and no interception by plants. The resultant load of active substance will be related to the top 5 cm of soil to achieve the highest theoretical soil concentration. Calculation of PEC values presented in the EFSA conclusions1, based on the following proposed uses of the product: two applications of 0.4 kg Vintec/ha (36 g a.s./ha, equivalent to 0.4 × 1012 CFU/ha). However, the use was adapted as presented below, in order to meet the conditions according to the intended use (see Table 8.1.1: Table of critical GAPs) and the product composition (please refer to Part C, Point IIIM 1.7.2). Thus, calculation was performed in consideration of 2 applications of 0.2 kg Vintec/ha (60 g a.s./ha, equiv- alent to 4 × 1012 CFU/ha).
1 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain SC1. EFSA Journal 2015;13(4):4092, 33 pp. doi:10.2903/j.efsa.2015.4092 ZV1 008562-00/00 / Vintec Page 14 /20 Part B – Section 8 - Core Assessment zRMS version
Application rate Vintec: - 0.2 kg/ha (30 g a.s./ha, equivalent to 2 × 1012 CFU/ha) - Accumulated application rate (2 treatments): 0.4 kg product/ha, equivalent to 60 g a.s./ha (4 × 1012 CFU/ha) - Incorporation into the top 5 cm layer (resulting soil volume V = 0.05 m × 10000 m² = 500 m³) - Soil density ρ of 1.5 g/cm³ (= 1.5 × 103 kg/m³) - Soil mass / ha: V × ρ = 750 000 kg soil dry weight -No plant interception
According to the PEC calculation, the expected initial concentration in soil is 0.53 mg product/kg dry weight soil corresponding to 0.08 mg T. atroviride SC1/kg dry weight soil. In terms of CFU, this is equiv- alent to 0.53 × 107 CFU/kg dry weight soil. The environmental behavior of T. atroviride SC1 in soils can be summarized as follows: after reaching the soil environment, the fungus may establish stable populations in the surface soil and the rhizosphere. Due to competition and also abiotic factors population densities decline over time. Long time persistence may occur in the form of dormant conidia at levels not exceeding those of natural Trichoderma populations. Although vertical movement of the fungus appears possible, survival in deeper sediment layers is strongly restricted. Horizontal spread in the soil, as well as spread to above ground plant parts might occur but to a limited extend. The impact of T. atroviride SC1 onto soil microbial communities is short and no adverse effects are to be expected as the fungus appears to become an integrated part of the autochthonous soil community at the treatment site.
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8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1)
Groundwater contamination by direct leaching of the active substance and its metabolites, degradation or reaction products through soil is not expected to occur. The overall view of available information on Trichoderma species in general and T. atroviride in particular reveals that movement beyond the rhizosphere is restricted. Leakage of the spores through the soil to groundwater habitats may occur. However, as T. atroviride SC1 is ubiquitously distributed in soils, it is likely that spores occur naturally in groundwater. Spores do not germinate and grow in groundwater due to insufficient nutrient availability. Dilution as a result of continuous water flow and predation by groundwater inhabiting organisms will cause a continuous decline of the spores. Therefore, accumulation of the spores in groundwater is very unlikely.
8.8.1 Justification of new endpoints
Not applicable as no new endpoints used.
8.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1)
8.8.2.1 Trichoderma atroviride SC1 and its metabolites
8.8.3 Additional field test (KCP 9.2.4.2)
8.8.4 Summary of the risk assessment for groundwater
As an ubiquitous saprophytic fungus, T. atroviride is living in the upper layer of soils, rich in organic matter. As for other soil-inhabiting fungi, there is little horizontal movement of T. atroviride in soil. Vertical move- ment is limited and may only occur after heavy water supply. Colonization of the plant rhizosphere may result in wider spreading. However, the leaching potential of the species is considered to be low. T. atro- viride does not produce any toxins or secondary metabolites of toxicological concern at substantial quanti- ties and therefore leaching to groundwater is not relevant to this fungus.
8.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5)
8.9.1 Justification of new endpoints
Not applicable as no new endpoints used.
8.9.2 Active substance, relevant metabolite(s) and the formulation (KCP 9.2.5)
According to information from the published literature it can be assumed that Trichoderma spp. including T. atroviride might be able to survive in aquatic environments under certain favourable conditions. How- ever, germination and population growth is likely prevented in most cases due to nutrient depletion. Spores eventually reaching surface waters upon field application of T. atroviride SC1 are likely to settle down and ZV1 008562-00/00 / Vintec Page 16 /20 Part B – Section 8 - Core Assessment zRMS version survive in the sediments. However, the risk for contamination of surface waters is negligible, as T. atro- viride SC1 is directly applied onto pruning wounds. Due to restricted growth of the fungus in deeper soil layers groundwater contamination appears very unlikely. As an ubiquitous saprophytic fungus, T. atroviride is living in the upper layer of soils, rich in organic matter. As for other soil-inhabiting fungi, there is little horizontal movement of T. atroviride in soil. Vertical move- ment is limited and may only occur after heavy water supply. Colonization of the plant rhizosphere may result in wider spreading. However, the leaching potential of the species is considered to be low. T. atro- viride does not produce any toxins or secondary metabolites of toxicological concern at substantial quanti- ties and therefore leaching to groundwater is not relevant to this fungus.
Predicted Environmental Populations in water (PECSW) for the Active Substance Predicted environmental populations in natural waters 2 Calculation of PECSW values presented in the EFSA conclusions , based on the following proposed uses of the product: in consideration of two applications, resulting in an accumulated application rate of 0.8 kg 12 Vintec/ha (72 g a.s./ha, equivalent to 0.8 × 10 CFU/ha). Therefore, PECSW value of 108 µg Vintec/L (equivalent to 9.14 µg a.s./L or 1.02 × 106 CFU/L) was calculated. However, the use was adapted as pre- sented below, in order to meet the conditions according to the intended use (please refer to Table 8.1.1: Table of critical GAPs) and the product composition (please refer to Part C, Point IIIM 1.7.2). Thus, calcu- lation was performed in consideration of 2 applications of 0.2 kg Vintec/ha (60 g a.s./ha, equivalent to 4 × 1012 CFU/ha). The accumulated application rate and the drift for a single treatment at early stages in grapevine was con- sidered as a worst case scenario. According to Rautmann et al. (2001)3 the maximum drift rate for a single treatment in grapes is 8.02% of the applied amount at a distance of 3 m to surface waters. Table 8.9-1: Calculation of the predicted environmental population of T. atroviride SC1 in len- tic surface water bodies (PECSW).
Amount of drift Initial PECSW 30 cm [µg/L] Application rate Rate Distance Drift [kg/ha] [mg/m2] [m] (%)a T. atroviride [g/ha] [mg/m2] Vintec [CFU/L] SC1
0.4 40.0 3 8.02 32.08 3.21 10.69 1.60 1.07 × 105 a according to Rautmann et al., 2011
According to the PEC calculation, the expected initial concentration in surface water is 10.69 µg product/L, corresponding to 1.60 µg T. atroviride SC1/L. In terms of CFU, this is equivalent to 1.07 × 105 CFU/L. This value is lower than the proposed endpoint according to the EFSA conclusion because the drift value was chosen for crops up to 2 m height and not above 2 m height, to represent a more realistic scenario.
2 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain SC1. EFSA Journal 2015;13(4):4092, 33 pp. doi:10.2903/j.efsa.2015.4092 3 Rautmann et al. (2001), New basic drift values in the authorisation procedure for plant protection. In For- ster, R. & Streloke, M. Workshop on Risk Assessment and Risk Mitigation Measures in the Context of the Authori- sation of Plant Protection Products (WORMM). Mitt. Biol. Bundesanst. Land-Forstwirtsch. Berlin-Dahlem, Heft 381. ZV1 008562-00/00 / Vintec Page 17 /20 Part B – Section 8 - Core Assessment zRMS version
8.9.2.1 Trichoderma atroviride SC1 and its metabolites
Metabolite(s) of Trichoderma atroviride SC1 Metabolites are covered by the EU assessment, no further risk assessment is necessary.
8.9.2.2 PECsw/sed of formulation
Not relevant.
8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)
Trichoderma spp. occasionally has been isolated from the air. Hence, members of the genus appear to occur in the air naturally, however at low frequency and low concentrations. Dispersal of spores via spray drift following an application of T. atroviride SC1 may lead to temporary concentrations in the atmosphere which are capable of drifting with wind currents before the spores and crystals in finer spray droplets settle out. However, long term persistence is not expected as it was shown for Trichoderma harzianum that even under protected conditions in the greenhouse fungal spores disappeared within one day from the air. Further information on the persistence in air is not required, since the toxicological studies and the temperature growth profile of this strain prove that it is not able to infect humans, and imposes no risk for workers, operators or bystanders via inhalation or any other exposure route. Likewise, long-distance transport of spores is not likely to occur. In conclusion, T. atroviride may survive in soil for several months as a saprophyte, but there is no risk for uncontrolled growth, since this widespread and naturally occurring soil fungus is subject to competition and antagonism in its natural habitat. As parasitism of T. atroviride is limited to other micro-organisms and since the fungus is unable to grow at 37°C, any potential dispersal of this fungus imposes no health or environmental risk.
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Appendix 1 Lists of data considered in support of the evaluation
List of data submitted by the applicant and relied on
Title Verte- Company Report No. brate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Published or not Y/N
KCP XX Author YYYY Title Y/N Owner Company Report No Source GLP/non GLP/GEP/non GEP Published/Unpublished
List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review
Title Verte- Company Report No. Data brate Author(s) Year Source (where different from company) Owner point study GLP or GEP status Published or not Y/N
KCP XX Author YYYY Title N Nufarm Company Report N Source GLP/non GLP/GEP/non GEP Published/Unpublished
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List of data submitted by the applicant and not relied on
Title Verte- Company Report No. Data brate Author(s) Year Source (where different from company) Owner point study GLP or GEP status Published or not Y/N
KCP XX Author YYYY Title Y/N Owner Company Report N Source GLP/non GLP/GEP/non GEP Published/Unpublished
List of data relied on not submitted by the applicant but necessary for evaluation
Title Verte- Company Report No. Data brate Author(s) Year Source (where different from company) Owner point study GLP or GEP status Published or not Y/N
KCP XX Author YYYY Title Y/N Owner Company Report N Source GLP/non GLP/GEP/non GEP Published/Unpublished
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Appendix 2 Detailed evaluation of the new Annex II studies
A 2.1 Author, year
Comments of zRMS: Comment on study; acceptable or not; deficiencies, corrections, according to recent guidelines or not, used in evaluation or only as additional information
Reference: Data point Report Title, author(s), year, report No, document No, Authority registration No Guideline(s): Yes/No (If yes, give guidelines; If no, give justification, e.g., “ no guidelines available” or “ methods used comparable to guideline(s) xxx” ) Deviations: Yes/No (If yes, describe deviations from test guidelines) GLP: Yes/No (If no, give justification, e.g., state that GLP was not compulsory at the time the study was performed) Acceptability: Yes/No/Supplementary
Materials and methods
Results and discussions
Conclusion
Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data)
DRAFT REGISTRATION REPORT Part B Section 8 (old dRR format B5) Environmental Fate Detailed summary of the risk assessment
Product code: ZV1 008562-00/00 Product name(s): Vintec Microbial Pest Control Agent: Trichoderma atroviride SC1, 1x1013 CFU/kg (150 g/kg)
Central Zone Zonal Rapporteur Member State: Germany
NATIONAL ADDENDUM – GERMANY (authorization)
Applicant: BI-PA nv/sa Submission date: 24/09/2015 MS Finalisation date: 20/03/2018 ZV1 008562-00/00 / Vintec Page 2 / 8 Part B – Section 8 - National Addendum zRMS version
ZV1 008562-00/00 / Vintec Page 3 / 8 Part B – Section 8 - National Addendum zRMS version
Version history
When What
March 2018 First Draft RR by UBA
ZV1 008562-00/00 / Vintec Page 4 / 8 Part B – Section 8 - National Addendum zRMS version
Table of Contents
8 Fate and behaviour in the environment (KCP 9) ...... 5 8.1 Critical GAP and overall conclusions ...... 6 8.1.1 Table of critical GAPs ...... 6 8.1.2 Overall conclusion ...... 8
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8 Fate and behaviour in the environment (KCP 9)
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8.1 Critical GAP and overall conclusions
8.1.1 Table of critical GAPs
Table 8.1-1: Critical use pattern of the formulated product
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/or situ- F, Fn, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fpn controlled (days) e.g. g saf- * (crop destination G, (additionally: develop- Method / Kind Timing / Max. number Min. interval kg or L g or kg as/ha Water L/ha ener/ syner- Groundwater / purpose of Gn, mental stages of the Growth a) per use between ap- product/ha min/max gist per ha crop) Gpn pest or pest group) stage of crop b) per crop/ plications a) max. rate a) max. rate or & season season (days) per appl. per appl. I ** b) max. total b) max. total rate per rate per crop/season crop/season Zonal uses (field or outdoor uses, certain types of protected crops)
001 DE Grapes, estab- F Esca-Erreger der Wein- spraying or fine Winter dor- 2 7 days a) 0.2 kg/ha a) 2 x 1012 100-200 l/ha n.a. -- A lished vines rebe (Phaenomoniella spraying (low mancy pe- b) 0.4 kg/ha CFU/ha (VITVI) chlamydospora), volume spray- riod b) 4 x 1012 PHMOCH ing) BBCH 0 CFU/ha Esca-Erreger der Wein- rebe (Togninia minima) TOGNMI
Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms) -- Minor uses according to Article 51 (zonal uses) -- Minor uses according to Article 51 (interzonal uses) --
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* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application
Explanation for column 15 “Conclusion” A Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use
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8.1.2 Overall conclusion
The national exposure assessment fully complies with the assessment presented in the core assessment. No specific risk mitigation measures are needed.
DRAFT REGISTRATION REPORT Part B Section 9 (old dRR format B.6) Ecotoxicology Detailed summary of the risk assessment
Product code: ZV1 008562-00/00 Product name(s): Vintec Microbial Pest Control Agent: Trichoderma atroviride SC1, 1x1013 CFU/kg (150 g/kg)
Central Zone Zonal Rapporteur Member State: zRMS
Core Assessment zRMS version (authorisation)
Applicant: BI-PA nv/sa Submission date: 24/09/2015 MS Finalisation date: 20/03/2018 Page 2 /25
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Version history
When What
March 2018 First Draft RR by UBA
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Table of Contents
9 Ecotoxicology (KCP 10) ...... 5 9.1 Critical GAP and overall conclusions ...... 5 9.1.1 Overall conclusions ...... 7 9.1.1.1 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 7 9.1.1.2 Effects on aquatic organisms (KCP 10.2) ...... 7 9.1.1.3 Effects on bees (KCP 10.3.1) ...... 8 9.1.1.4 Effects on arthropods other than bees (KCP 10.3.2) ...... 8 9.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5) ...... 8 9.1.1.6 Effects on non-target terrestrial plants (KCP 10.6) ...... 9 9.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 9 9.1.2 Grouping of intended uses for risk assessment ...... 9 9.1.3 Consideration of metabolites ...... 9 9.2 Effects on birds (KCP 10.1.1) ...... 9 9.2.1 Toxicity data ...... 9 9.2.1.1 Justification for new endpoints ...... 9 9.2.2 Risk assessment for spray applications ...... 9 9.2.3 Overall conclusions ...... 11 9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) ...... 11 9.3.1 Toxicity data ...... 11 9.3.1.1 Justification for new endpoints ...... 11 9.3.2 Risk assessment for spray applications ...... 11 9.3.3 Overall conclusions ...... 13 9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 13 9.5 Effects on aquatic organisms (KCP 10.2) ...... 13 9.5.1 Toxicity data ...... 13 9.5.1.1 Justification for new endpoints ...... 14 9.5.2 Risk assessment ...... 14 9.5.3 Overall conclusions ...... 17 9.6 Effects on bees (KCP 10.3.1) ...... 17 9.6.1 Hazard quotients for bees ...... 18 9.6.1.1 Oral exposure QHO ...... 18 9.6.1.2 Contact exposure QHC ...... 18 9.6.2 Acute toxicity of the formulation to bees ...... 18 9.6.2.1 Contact ...... 19 9.6.3 Effects on bees of residues on crops ...... 19 9.6.4 Cage tests ...... 19 9.6.5 Field tests ...... 19 9.6.6 Investigation into special effects ...... 19 9.6.6.1 Larval toxicity ...... 19 9.6.6.2 Long residual effects ...... 19 9.6.6.3 Disorienting effects on bees ...... 19 Page 4 /25
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9.6.7 Tunnel tests ...... 19 9.7 Effects on arthropods other than bees (KCP 10.3.2) ...... 20 9.7.1 Toxicity data ...... 20 9.7.1.1 Justification for new endpoints ...... 20 9.7.2 Risk assessment ...... 20 9.7.3 Overall conclusions ...... 21 9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) ...... 21 9.8.1 Toxicity data ...... 21 9.8.1.1 Justification for new endpoints ...... 21 9.8.2 Risk assessment ...... 21 9.8.3 Overall conclusions ...... 22 9.9 Effects on soil microbial activity (KCP 10.5) ...... 23 9.9.1 Toxicity data ...... 23 9.9.1.1 Justification for new endpoints ...... 23 9.9.2 Risk assessment ...... 23 9.9.3 Overall conclusions ...... 24 9.10 Effects on non-target terrestrial plants (KCP 10.6) ...... 24 9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 24 9.12 Monitoring data (KCP 10.8) ...... 24 9.13 Classification and Labelling ...... 24
Appendix 1 Lists of data considered in support of the evaluation ...... 25
Appendix 2 Detailed evaluation of the new studies ...... 25
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9 Ecotoxicology (KCP 10)
9.1 Critical GAP and overall conclusions
Table 9.1-1: Table of critical GAPs
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Use- Member Crop and/or situ- F, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fn, controlled (days) e.g. g saf- * (crop destination Fpn (additionally: develop- Method / Timing / Max. num- Min. interval kg or L g or kg as/ha Water L/ha ener/ syn-
/ purpose of G, mental stages of the Kind Growth ber between ap- product/ha min/max ergist per crop) Gn, pest or pest group) stage of crop a) per use plications a) max. rate a) max. rate ha Gpn & season b) per crop/ (days) per appl. per appl. season b) max. total b) max. total or
I ** rate per rate per arthro- -target plants -target
crop/season crop/season Mammals Birds organisms Aquatic Bees organisms Soil Non pods Non Zonal uses (field or outdoor uses, certain types of protected crops)
001 BE, Grapes, estab- F Phaenomoniella spraying Winter dor- a) 1-2 7 days a) 0.2 kg/ha a) 2 x 1012 100-200 n.a. -- A A A A A A A AT; lished vines chlamydospora, mancy pe- CFU/ha l/ha RO; b) 2 b) 0.4 kg/ha (VITVI) riod 12 SK; Togninia minima b) 4 x 10 CZ; BBCH 0 CFU/ha HU; DE;
Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms)
Minor uses according to Article 51 (field uses)
Minor uses according to Article 51 (interzonal uses) Page 6 /25
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application
Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use
Remarks (1) Numeration necessary to allow references (7) Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Black- table: (2) Use official codes/nomenclatures of EU well, ISBN 3-8263-3152-4), including where relevant, information on season at time of application (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) The maximum number of application possible under practical conditions of use must be provided situation should be described (e.g. fumigation of a structure) (9) Minimum interval (in days) between applications of the same product. (4) F: professional field use, Fn: non-professional field use, Fpn: professional and non-profes- (10) For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty sional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products professional and non-professional greenhouse use, I: indoor application (11) The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, (5) Scientific names and EPPO-Codes of target pests/diseases/ weeds or when relevant the com- kg or L product / ha). mon names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, (12) If water volume range depends on application equipments (e.g. ULVA or LVA) it should be men- weeds) and the developmental stages of the pests and pest groups at the moment of applica- tioned under “application: method/kind”. tion must be named (13) PHI - minimum pre-harvest interval (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (14) Remarks may include: Extent of use/economic importance/restrictions Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated
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9.1.1 Overall conclusions
Vintec is intended to be used in grapes in the field. Application of Vintec is done during winter dormancy onto pruning wounds of grape vine. Under these conditions, exposure to birds and mammals may be con- sidered negligible also. Moreover, Trichoderma spp. in general are not considered to be pathogenic to mammals or birds and absence of growth of the fungus at 35°C and above renders the risk for growth in their body tissues and liquids negligible. Finally, T. atroviride is a common saprophytic soil fungus and it might be expected that wild birds and mammals are naturally exposed to this fungal species without knowledge on any adverse effects. According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to any of the non-target species.
9.1.1.1 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)
Birds The presented screening assessment for birds was conducted on the basis of published data for other Tricho- derma biocontrol strains. The LD50 of T. harzianum T22 to mallard ducks and bobwhite quail, for example was determined to be > 2000 mg/kg bw. Due to the general absence of toxicity, pathogenicity and infectivity of the genus Trichoderma in birds and the specific properties of T. atroviride SC1, neither acute nor long- term effects are expected in birds upon GAP directed use of the fungus.
Mammals An acute oral toxicity study on rats was carried out with the fungal strain demonstrating absence of toxicity, pathogenicity and infectiveness upon oral administration of 4.1 × 108 CFU/rat. The fungal spores did not spread from the intestine to other organs and were readily cleared from faeces. According to EFSA conclu- sions on the risk assessment of T. atroviride SC1 (EFSA Journal, 2015), a LD50 value of 212 mg Vintec/kg b.w. was considered, corresponding to 31.8 mg a.s./kg b.w. Due to the absence of pathogenicity in the acute study and the general properties of the fungus, acute or long-term effects in mammals due to field applica- tion of T. atroviride SC1 according to GAP can be excluded.
9.1.1.2 Effects on aquatic organisms (KCP 10.2)
Due to the application of T. atroviride SC1 onto the pruning wounds of grapevine during winter dormancy, the exposure for aquatic non-target species, including fish, is generally considered to be very low.
Aquatic organisms (fish, aquatic invertebrates, algae) Calculating the risk assessment on aquatic organisms, TER values were calculated for T. atroviride SC1 on rainbow trout, Daphnia magna and Desmodesmus subspicatus. According to EFSA conclusions on the risk assessment of T. atroviride SC1 (EFSA Journal, 2015), LC50 value for O. mykiss, Daphnia magna and Desmodesmus subspicatus were > 6.3 × 108 CFU/L, > 7.6 × 108 CFU/L and > 7.1 × 108 CFU/L, respectively. Page 8 /25
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5 In consideration of a calculated PECSW value of 1.07 × 10 CFU/L, the TER values exceeded the trigger values by far.
Aquatic plants Although T. atroviride might be able to survive and persist in aquatic habitats to a certain extend there is no case report linking the species or genus to adverse effects in aquatic plants. Considering the general absence of phytotoxicity, the absence of adverse effects observed in the algal growth test and the low ex- posure risk, no adverse effects are to be expected in aquatic plants upon field application of Vintec accord- ing to GAP.
9.1.1.3 Effects on bees (KCP 10.3.1)
Appropriate assessments for bees to exposure from Vintec (synonym: Trichoderma atroviride SC1 WG) were conducted during EU review of trichoderma atroviride SC1. The intended use pattern for national registration is within the use pattern considered for Annex I approval.
9.1.1.4 Effects on arthropods other than bees (KCP 10.3.2)
Other arthropods Several literature reports demonstrate the absence of toxicity of Trichoderma spp. to bumble bees up to dosages of 1 × 1010 CFU/L for both, oral and contact exposure. This value is comparable to the conidia load of T. atroviride SC1 in the spraying suspension when Vintec is used according to GAP (0.5 - 2 × 1010 CFU/L). Therefore, and due to the limited exposure, bumble bees are not at risk upon GAP directed use of T. atroviride SC1. Effects of the end-use product Trichoderma atroviride SC1 WG (synonym for Vintec) on the parasitic hymenopteran Aphidius rhopalosiphi and the predatory mite Typhlodromus pyri were assessed in labora- tory glass plate tests. Due to the absence of toxicity at any dose tested the LR50 values for both species are considered to be > 3.2 kg/ha corresponding to at least 3.2 × 1013 CFU/ha. It can be concluded that non- target arthropods are not considered to be at risk upon GAP directed field application of Vintec.
9.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5)
Earthworms Due to the envisaged field of use of Vintec, exposure to earthworms is considered negligible. Moreover, T. atroviride is a naturally occurring fungus and earthworms are expected to be frequently exposed to this fungal species in nature. Various interactions between Trichoderma spp. and earthworm species are de- scribed in the literature all without any hind for adverse effects in earthworms due to exposure to Tricho- derma spp. Nevertheless, to address the data point, endpoints from open literature ad which no adverse effects have been observed in the test animals are in the same range as the highest predicted density of T. atroviride SC1 in soil, calculated assuming worst case conditions (accumulated application rate, no plant interception). Therefore, earthworms are not considered to be at risk upon GAP directed use of Vintec. Page 9 /25
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Soil microorganisms Trichoderma spp. including T. atroviride, are ubiquitous in soils and it is generally considered that if even occurring, any effect on the soil microbial community is not long-lasting. This was confirmed by a study assessing the development of T. atroviride SC1 upon introduction into a vineyard soil available in the pub- lished literature. As expected, only directly after application a difference between the treated and the control plots was observed and the introduced fungus disappeared more or less quickly from the soil depending on the soil depth. The density of the fungus directly after inoculation was approximately 109 CFU/g. As this value is considerable higher than the highest load of T. atroviride SC1 expected upon treatment with Vintec even under worst case assumptions it can be concluded that GAP directed use of Vintec does not pose a risk to soil microbial communities.
9.1.1.6 Effects on non-target terrestrial plants (KCP 10.6)
According to EU assessment, no studies on non-target terrestrial plants are required.
9.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)
No additional studies are required.
9.1.2 Grouping of intended uses for risk assessment
Not required.
9.1.3 Consideration of metabolites
T. atroviride does not produce any toxins or secondary metabolites of toxicological concern at substantial quantities. According to EU assessment, no further risk assessment is necessary.
9.2 Effects on birds (KCP 10.1.1)
9.2.1 Toxicity data
Effects on birds were evaluated as part of the EU assessment.
9.2.1.1 Justification for new endpoints
Not applicable as no new endpoints used.
9.2.2 Risk assessment for spray applications
Effects on birds Page 10 /25
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Vintec is intended to be used in grapes in the field. Application of Vintec is done during winter dormancy onto pruning wounds of grape vine. Under these conditions, exposure to birds may be considered negligible as well. Moreover, Trichoderma spp. in general are not considered to be pathogenic in birds and absence of growth of the fungus at 35°C and above renders the risk for birds negligible. Finally, T. atroviride is a common saprophytic soil fungus and birds are naturally exposed to this fungal species without any report on adverse effects. However, in order to address the data requirement a risk assessment for birds is presented basing on the intended GAP table for Vintec and data of other Trichoderma biocontrol strains available from the open literature. Guidance to estimate the exposure of birds to plant protection products (PPP) is provided in the EFSA guidance document published in 2009 in the EFSA Journal1 representing a revision of SANCO document 4145/2000. A standard exposure scenario for the application of PPP in vine crops is therein described. With multiple applications at early stages (BBCH 0) small omnivorous birds are considered not to be at risk.
The published LD50 value of T. harzianum T22 to mallard ducks and bobwhite quail was determined to be > 2000 mg/kg bw (refer to Annex II, Section 6, Point IIM 8.1). Considering that Trichoderma spp. is gen- erally not considered to be pathogenic to birds and the natural exposure of birds to fungi of this genus it deems feasible to extrapolate the risk for T. atroviride SC1 from data on other strains.
Risk assessment: The present screening assessment was performed according to the EFSA guidance document based on data on the MPCA using the following formula:
LD50 [mg a.i./kg b.w.] TER = Application rate [kg a.i./ha] short cut value × MAF
The short cut value combines food intake ratios based on the daily energy expenditure of the species of concern, the energy in the food, the “energy” assimilation efficiency of the species and the moisture content of the food. In the EFSA guidance document a short cut value (based on the 90th percentile residues) of 95.3 is provided for small omnivorous birds in vineyards. Due to two applications at an interval of 7 days a MAF (multiple application factor) of 1.4 was used (EFSA guidance document, 2009)2.
Table 9.2-1: Screening assessment for small omnivorous birds (indicator species), following two applications of T. atroviride SC1 in grape.
Number of Indicator Toxicity Short cut TER Test item1) Application rate applica- MAF species value2) LD50 tions > 10
Small omni- T. harzi- > 2000 0.03 kg T. atro- 2 1.4 95.3 > 499.7 vorous bird anum T22 mg/kg b.w viride SC1/ha
1) Published LD50 of T. harzianum was used for calculation in consideration that T. atroviride is in general not patho- genic on birds.
1 Guidance of EFSA, Risk assessment for Birds and Mammals, EFSA Journal 2009; 7(12):1438, European Food Safety Authority, Parma, Italy, 27.11.2009 Page 11 /25
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2) Short cut value based on the 90th percentile of residues provided in EFSA Guidance document 20092.
The calculated TER exceeds the limit value of 10 by far (Table 9.2-1). Thus, no adverse effects on birds are expected after application of T. atroviride SC1 at recommended use rates. Due to the general absence of toxicity, pathogenicity and infectivity of the genus Trichoderma in birds and the specific properties of T. atroviride SC1, no long-term effects are expected in birds upon GAP directed use of Vintec.
9.2.3 Overall conclusions
According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to birds.
9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)
9.3.1 Toxicity data
8 Mammalian toxicity studies have been carried out with the formulation (LD50 > 4.1 x 10 CFU/animal, equivalent to > 212 mg Vintec/kg b.w.). Full details of these studies are provided in the respective EU DAR.
9.3.1.1 Justification for new endpoints
Not applicable as no new endpoints used.
9.3.2 Risk assessment for spray applications
Effects on mammals An acute oral toxicity study on rats was carried out with the fungal strain demonstrating absence of toxicity, pathogenicity and infectiveness upon oral administration of 4.1 × 108 CFU/rat. The fungal spores did not spread from the intestine to other organs and were readily cleared from faeces. Assuming a mean body 10 weight of 200 g/rat and a CFU content of 10 per g Vintec the LD50 value obtained from the acute oral toxicity study corresponds to > 2.05 × 109 CFU/kg bw or 205 mg Vintec/kg bw. Guidance to estimate the exposure of mammals to plant protection products (PPP) is provided in the EFSA guidance document pub- lished in 2009 in the EFSA Journal representing a revision of SANCO document 4145/20002. A standard exposure scenario for the application of PPP in vine crops is therein described. With multiple applications at early stages (BBCH 00) small herbivorous mammals are considered at risk.
Risk assessment: The present screening assessment was performed according to the EFSA guidance document based on data on the formulated product using the following formula:
2 Guidance of EFSA, Risk assessment for Birds and Mammals, EFSA Journal 2009; 7(12):1438, European Food Safety Authority, Parma, Italy, 27.11.2009
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LD [mg product/kg b.w.] TER = 50 Application rate [kg product/ha] × short cut value × MAF
The short cut value combines food intake ratios based on the daily energy expenditure of the species of concern, the energy in the food, the “energy” assimilation efficiency of the species and the moisture content of the food. In the EFSA guidance document a short cut value (based on the 90th percentile residues) of 136.3 is provided for small herbivorous mammals in vineyards. Due to two applications at an interval of 7 days a MAF (multiple application factor) of 1.4 was used (EFSA guidance document, 2009)2.
Table 9.3-1: Screening assessment for mammals following two applications of T. atroviride SC1 in grape.
Indicator spe- Toxicity Application Short cut TER Test item MAF a) cies LD50 rate value > 10
> 212 mg Vintec/kg b.w.; 0.2 kg prod- Small herbivo- T. atroviride > 31.8 mg a.s./kg uct/ha 1.4 136.4 > 5.6 rous mammal SC1 b.w.; 0.03 kg a.s./ha 4.1 × 108 CFU/animal a) Short cut value based on the 90th percentile of residues provided in EFSA Guidance document 20092.
As the TER value obtained though the screening assessment was below the trigger value of 10, a First Tier risk assessment was carried out. For the refinement, generic focal species and corresponding short cut val- ues depending on the crop stage are provided in the Annex I of the EFSA Guidance document (2009)2. According to the intended GAP for Vintec the risk assessment was performed assuming two ground directed applications. Since grapevine plants would not represent common food source for mammals during appli- cation (BBCH00), ground direct application represents the most realistic scenario for assessing risk. Thus, risk assessment was performed in consideration the consumption of plant matter, grass, weeds and weed seeds, as well as ground arthropods.
2 Guidance of EFSA, Risk assessment for Birds and Mammals, EFSA Journal 2009; 7(12):1438, European Food Safety Authority, Parma, Italy, 27.11.2009 Page 13 /25
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Table 9.3-2: First Tier risk assessment for mammals following two applications of T. atroviride SC1 in grape.
Toxicity Application Short cut TER Scenario Generic focal species MAF LD50 rate value > 10
Large herbivorous 27.2 > 27.8 mammal „lagomorph“ > 205 mg Vineyard applica- product/kg 0.2 kg prod- tion, ground di- Small herbivorous b.w. uct/ha 1.4 136.4 > 5.6 mammal “vole” rected > 30.75 mg 0.03 kg a.s./ha Small omnivorous a.s./kg b.w. 17.2 > 44.0 mammal “mouse”
The calculated TER for small herbivorous mammals is below the trigger value of 10 (Table 9.3-2). How- ever, no adverse effects on mammals are expected as the risk assessment was performed on the basis of a study in which no signs of toxicity or pathogenicity have been observed in the test animals at the tested doe. Thus, a real LD50 value was not determined and the presented risk assessment likely overestimates the actual risk for mammals by far. Due to the absence of pathogenicity in the acute study and the general properties of the fungus long-term effects in mammals due to field application of T. atroviride SC1 accord- ing to GAP table can be excluded.
9.3.3 Overall conclusions
According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to mammals.
9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)
According to EU assessment, no further data required.
9.5 Effects on aquatic organisms (KCP 10.2)
9.5.1 Toxicity data
Studies on the toxicity to aquatic organisms have been carried out with Vintec (Trichoderma atroviride SC1 WG). Full details of these studies are provided in the respective EU DAR.
Table 9.5-1: Endpoints and effect values relevant for the risk assessment for aquatic organ- isms – formulation
Species Substance Exposure Results Reference System
8 Oncorhynchus mykiss Vintec (Trichoderma 96 h, s LC50 > 6.3 x 10 EFSA Conclusion atroviride SC1 WG) CFU/L Page 14 /25
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Species Substance Exposure Results Reference System
8 Daphnia magna Vintec (Trichoderma 48 h, s EC50 > 7.6 x 10 EFSA Conclusion atroviride SC1 WG) CFU/L
8 Desmodesmus sub- Vintec (Trichoderma 72 h, s EC50 > 7.1 x 10 EFSA Conclusion spicatus atroviride SC1 WG) CFU/L
Higher-tier studies (micro- or mesocosm studies) Not required s: static; ss: semi-static; f: flow-through; nom: based on nominal concentrations; mm: based on mean measured concentrations; im: based on initial measured concentrations
9.5.1.1 Justification for new endpoints
Not applicable as no new endpoints used.
9.5.2 Risk assessment
Effect on fish In order to demonstrate the absence of adverse effects an acute toxicity study with the formulated product Trichoderma atroviride SC1 WG (synonym for Vintec) was conducted (please refer to Annex III, Section 6, Point IIIM 10.2). The product proved to be not toxic to fish at a rate of 100 mg/L (> 1 × 109 spores/L), 8 corresponding to measured viable spore concentration of > 6.3 × 10 CFU/L. The 96 hour-LC50 value was therefore considered to be above 6.3 × 108 viable spores/L.
Risk assessment: Based on the available data the acute TER value of fish to T. atroviride SC1 was calculated (Table 9.5-2). A worst-case exposure scenario was chosen that assumes complete accumulation of CFUs following two applications in grapes. 5 Based on the predicted environmental concentration (PECSW), calculated as 1.07 × 10 CFU/L, the acute toxicological exposure ratio (TERA) for freshwater fish is derived from the 96 hour-LC50 value according to the formula:
TERA = LC50 [CFU/L]
PECSW [CFU/L]
The calculated TER value strongly exceeds the Annex IV acute trigger value of 100 (please refer to Table 9.5-2) indicating that fish are not at risk upon field application of T. atroviride SC1 according to the in- tended GAP for Vintec.
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Table 9.5-2: Acute toxicity/exposure ratio (TERA) for fish exposed to T. atroviride SC1 after use of Vintec in grapes.
b) TERA Crop sce- a) Test substance PECSW LC50 nario (100)
Grape Trichoderma atroviride SC1 WG 1.07 × 105 CFU/L > 6.3 × 108 CFU/L 5887.9 a) Based on drift from accumulated applications in grapes, assuming no degradation between applications b) Toxicity-to-exposure ratio (Trigger)
Effects on aquatic invertebrates - Effects on freshwater invertebrates Due to the application of T. atroviride SC1 onto the pruning wounds of grapevine during winter dormancy, the exposure for aquatic non-target species, including daphnids, is generally considered to be very low. However, in order to demonstrate the absence of adverse effects an acute toxicity study with the formulated product Trichoderma atroviride SC1 WG (synonym for Vintec) was conducted (please refer to Annex III, Section 6, Point IIIM 10.2). The product proved to be not toxic to daphnids at a rate of 100 mg/L (> 1 × 109 spores/L), corresponding a measured viable spore concentration of at least 7.6 × 108 viable spores/L. The 8 48 hour-EC50 value was therefore considered to be above 7.6 × 10 viable spores/L.
Risk assessment: Based on the available data the acute TER value of daphnids to T. atroviride SC1 was calculated (Table 9.5-3). A worst-case exposure scenario was chosen that assumes complete accumulation of CFUs following two applications in grapes. 5 Based on the predicted environmental concentration (PECSW), calculated as 1.07 × 10 CFU/L, the acute toxicological exposure ratio (TERA) for daphnids is derived from the 48 hour-EC50 value according to the formula:
EC50 [CFU/L] TERA = PECSW [CFU/L]
The calculated TER value strongly exceeds the Annex IV acute trigger value of 100 (please refer to Table 9.5-3) indicating that daphnids are not at risk upon field application of T. atroviride SC1 according to the intended GAP.
Table 9.5-3: Acute toxicity/exposure ratio (TERA) for daphnids exposed to T. atroviride SC1 after use of Vintec in grapes.
b) Crop TERA a) Test substance PECSW LC50 scenario (100)
Grape Trichoderma atroviride SC1 WG 1.07 × 105 CFU/L > 7.6 × 108 CFU/L 7102.8 a) Based on drift from accumulated applications in grapes, assuming no degradation between applications b) Toxicity-to-exposure ratio (Trigger)
Effects on algal growth Page 16 /25
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Due to the application of T. atroviride SC1 onto the pruning wounds of grapevine during winter dormancy, the exposure for aquatic non-target species, including algae, is generally considered to be very low. However, in order to demonstrate the absence of adverse effects a 72-hour toxicity study with the formu- lated product Trichoderma atroviride SC1 WG (synonym for Vintec) was conducted (please refer to Annex III, Section 6, Point IIIM 10.2). The product proved to have no adverse effects on the algal growth rate and the yield at 100 mg/L (1 × 109 spores/L), corresponding to a measured viable spore rate of 7.1 × 108 CFU/L. 8 The 72 hour- ErC50 value was therefore considered to be above 7.1 × 10 viable spores/L.
Risk assessment: Based on the available data the TER value of algae to T. atroviride SC1 was calculated (Table 9.5-4). A worst-case exposure scenario was chosen that assumes complete accumulation of CFUs following two ap- plications in grapes. 5 Based on the predicted environmental concentration (PECSW), calculated as 1.07 × 10 CFU/L, the long- term toxicological exposure ratio (TERLT) for algae is derived from the 72 hour- ErC50 value according to the formula:
ErC50 [CFU/L] TERLT = PECSW [CFU/L]
The calculated TER value strongly exceeds the Annex IV acute trigger value of 10 (please refer to Table 9.5-4) indicating that algae are not at risk upon field application of T. atroviride SC1 according to the intended GAP. Table 9.5-4: Long-term toxicity/exposure ratio (TER) for algae exposed to T. atroviride SC1 WG after use of Vintec in grapes.
b) TERLT Crop a) Test substance PECSW LC50 scenario (10)
Grape Trichoderma atroviride SC1 WG 1.07 × 105 CFU/L > 7.1 × 108 CFU/L 6635.5 a) Based on drift from accumulated applications in grapes, assuming no degradation between applications b) Toxicity-to-exposure ratio (Trigger)
Effects on aquatic plants other than algae Due to the application of T. atroviride SC1 onto the pruning wounds of grapevine during winter dormancy, the exposure risk for aquatic non-target species, including aquatic plants, is generally considered to be very low. Although T. atroviride might be able to survive and persist in aquatic habitats to a certain extend there is no case report linking the species or genus to adverse effects in aquatic plants. Considering the general absence of phytotoxicity (please refer to Annex II, Doc IIM, Point IIM 8.6), the absence of adverse effects observed in the algal growth test (please refer to Annex III, Doc IIIM, Point IIIM 10.2), and the low expo- sure risk no adverse effects are to be expected in aquatic plants upon field application of Vintec according to GAP. Furthermore Vintec is not supposed to cause damage to plants which was confirmed by the absence of phytotoxic symptoms in all presented efficacy trials (please refer to Annex III, Doc IIIM Section 7, Points IIIM 6.1, 6.2 and 6.7). Due to the method of the intended uses of Vintec, the product is applied directly to pruning wounds. Thus, it is extremely unlikely that surface water is subject to contamination by Vintec, rendering exposure of non-target aquatic plants negligible. If even reaching adjacent water bodies, the ac- tive ingredient T. atroviride SC1, might be able to survive in aquatic environments under certain favorable Page 17 /25
ZV1 008562-00/00 / Vintec Part B – Section 9 - Core Assessment zRMS version conditions. However, germination and population growth is likely prevented in most cases due to nutrient depletion.
9.5.3 Overall conclusions
According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to aquatic organisms.
9.6 Effects on bees (KCP 10.3.1)
Appropriate assessments for bees to exposure from Vintec (synonym: Trichoderma atroviride SC1 WG) were conducted during EU review of trichoderma atroviride SC1. The intended use pattern for national regis- tration is within the use pattern considered for Annex I approval. However, for the sake of completeness all relevant data are provided here and are considered adequate.
Toxicity presents the results of laboratory bee toxicity studies with the formulation. Further details regarding the tests with the formulation are provided in section
Table 9.6-1: Results of laboratory bee toxicity studies
Test sub- Exposure LD50 Reference stance route
> 113.0 µg product/bee* oral 48 h Conclusion on the peer review (> 1.13 x 106 CFU/bee)* of trichoderma atroviride strain Vintec SC1, EFSA Journal 2015; 13(4): > 100 µg product/bee* contact 48 h 4092 (> 1 x 106 CFU/bee)* * EU agreed endpoint # tested as Trichoderma atroviride SC1 WG
Exposure The recommended use pattern for Vintec includes application in viticulture at a maximum application rate of up to 0.2 kg product/ha. This maximum single application rate is equivalent to 200 g product/ha.
As the product Vintec is intended for application onto pruning grapevine wounds in winter time, exposure of honeybees is very unlikely.
Pathogenicity No data submitted. The acute toxicity study according to OECD 213 and 214 are not appropriate to ad- dress pathogenicity.
Hazard quotients Determination of a HQ-trigger is not assignable to micro organisms, therefore no calculation was made.
Risk assessment Due to the results of laboratory tests Vintec is considered to be practically non-toxic to bees. Furthermore, exposure to bees with Vintec can widely be excluded due to the intended application onto pruning grape- vine wounds in winter time. Hence, a risk for honeybees can be excluded. Page 18 /25
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Overall conclusion: It is concluded that Vintec will not adversely affect bees or bee colonies when used as recommended.
9.6.1 Hazard quotients for bees
Determination of a HQ-trigger is not assignable to micro organisms, therefore no calculation was made.
9.6.1.1 Oral exposure QHO
Refer to 9.6.1.
9.6.1.2 Contact exposure QHC
Refer to 9.6.1.
9.6.2 Acute toxicity of the formulation to bees
The following bee acute oral toxicity study performed on Trichoderma atroviride SC1 WG has been pre- viously evaluated during the EU review. Therefore only a brief summary and the endpoints are presented below.
Report: KIIIA1 10.4.2.1/01
Document No: Vergé, E., 2012, Trichoderma atroviride SC1 WG – Acute Oral and Contact Toxicity to the Honeybee Apis mellifera L. in the Laboratory
Guidelines: OECD 213 and 214
GLP Yes
Summary
In a dose-response test under laboratory conditions Vintec (synonym: Trichoderma atroviride SC1 WG) was offered to adult honey bees (Apis mellifera L.) in oral and contact route. An untreated sugar/water solu- tion was used as water control. Dimethoate was used as toxic standard. Treatments with the test sub- stance, the control and the reference item were carried out in five replicates containing 10 bees each. The tested concentrations in the oral test were 7.49, 14.7, 28.7, 55.0 and 113 µg Vintec/bee. The tested con- centrations in the contact test were 6.25, 12.5, 25, 50 and 100 µg Vintec/bee. Biological observations in- cluding mortality and behavioural changes were recorded at 4, 24 and 48 hours after dosing.
The LD50 (48h) was > 113 µg Vintec/bee in the oral toxicity test and > 100 Vintec/bee in the contact tox- icity test.
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No sublethal or behavioural effects were observed in the oral toxicity test during the 48-hour observation period. In the contact toxicity test after 4-hours some affected and moribund bees were recorded in the lowest and the two highest treatment groups. At the following assessments (24 and 48-hours after application) no re- markable behavioural effects were observed.
9.6.2.1 Contact
Refer to 9.6.2.
9.6.3 Effects on bees of residues on crops
Not required.
9.6.4 Cage tests
Not required.
9.6.5 Field tests
Not required.
9.6.6 Investigation into special effects
Not required.
9.6.6.1 Larval toxicity
Not required since the test item is not an IGR.
9.6.6.2 Long residual effects
Not required.
9.6.6.3 Disorienting effects on bees
Not required.
9.6.7 Tunnel tests
Not required.
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9.7 Effects on arthropods other than bees (KCP 10.3.2)
9.7.1 Toxicity data
Studies on the toxicity to non-target arthropods have been carried out with Vintec (Trichoderma atroviride SC1 WG). Full details of these studies are provided in the respective EU DAR.
Table 9.7-1: Endpoints and effect values relevant for the risk assessment for non-target ar- thropods
Species Substance Exposure Results Reference System
13 Typhlodromus pyri Vintec (Trichoderma Laboratory test LR50 = 3.2 x 10 EFSA Conclusion (protonymphs) atroviride SC1 WG) glass plates (2D) CFU/ha
13 Aphidius Vintec (Trichoderma Laboratory test LR50 = 3.2 x 10 EFSA Conclusion rhopalosiphi atroviride SC1 WG) glass plates (2D) CFU/ha (adults) Field or semi-field tests Not required
9.7.1.1 Justification for new endpoints
Not applicable as no new endpoints used.
9.7.2 Risk assessment
No new studies on effects on arthropods other than bees were conducted for T. atroviride SC1, as studies for comparable strains indicate no side effects. For further details, please refer to the dossier submitted for approval of the active ingredient, Annex III, Doc IIIM, Section 6 Point IIIM 10.4 (studies on Aphidius rhopalosiphi, Typhlodromus pyri and published literature). T. atroviride is a naturally occurring fungus. Soil and leaf-dwelling arthropods are therefore expected to be frequently exposed to this fungal species in nature. However, Trichoderma fungi might not be a preferred food source for arthropods, as the mites Rhizoglyphus robini. Published data on the interaction between the mycophagous collembolan species (Proistoma minuta) and three fungal species, including T. harzianum, used for biological plant protection against Rhizoctonia solani did not reveal any effects on collembolan T. harzianum on wheat bran was incorporated at 200 mg/kg soil. Each fungus was applied alone or with P. minuta population. Not side effects on the collembolan species P. minuta were observed. Moreover, when P. minuta was combined with T. harzianum, a moderate disease control was detected. The sensitivity of beneficial arthropods like Orius laevigatus and Macrolophus caliginosus, the predatory mite Phytoseiulus persimilis, and the predatory wasp Encarsia formosa, to two microbial and diverse chem- ical pesticides was studied in semi-field trials. One of the microbial pesticide was Trichodex 25 WP, con- taining T. harzianum at 1010 cfu/g. Following exposure to Trichodex 25 WP at its MFRC corrected mortality of larvae, pupae and/or adults of O. laevigatus, M. caliginosus, P. persimilis, and E. formosa was below 25%. The preparation was therefore classified harmless (Class 1). In contrast, the toxic standard biphentrine Page 21 /25
ZV1 008562-00/00 / Vintec Part B – Section 9 - Core Assessment zRMS version was categorised into Class 4 (harmful).It can be concluded, that under the conditions of the study T. harzi- anum can be regarded as safe for beneficial arthropods. A value of > 1010 CFU/L can be considered to be the contact LR50 for non-target arthropod exposure of T. harzianum. It has to be also taken into account that T. atroviride SC1 is intended for application onto pruning wounds of grapevines in winter time. Due to the low exposure for soil- and leaf dwelling non-target arthropods, additional toxicity tests with T. atroviride SC1 are considered not necessary.
9.7.3 Overall conclusions
According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to non-target arthropods.
9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)
9.8.1 Toxicity data
Open literature information on the toxicity of the genus Trichoderma to earthworms are available. Full details of these study findings are provided in the respective EU DAR.
Table 9.8-1: Endpoints and effect values relevant for the risk assessment for earthworms
Species Substance Exposure Results Reference System
Lumbricus terrestris Trichoderma spp. Trichoderma koningii NOEC > 6.65 × 106 EFSA Conclusion was fed to eathworms CFU/kg d.w. soil at a level of 8× 107 mg/kg dw CFU/kg pressmud, corresponding to 6.65 6 × 10 CFU/kg d.w. soil Field studies Not required
9.8.1.1 Justification for new endpoints
Not applicable as no new endpoints used.
9.8.2 Risk assessment
T. atroviride SC1 is intended for application onto pruning grapevine wounds in winter time. Earthworms will therefore be exposed to the fungus only to a limited extend or not at all. Moreover, it has to be taken into consideration that T. atroviride is a naturally occurring fungus. Earth- worms are thus frequently exposed to this fungal species in nature. In contrast to arthropods the earthworms’ digestive tract does not contain chitin. Chitinolytic enzymes produced by T. atroviride will therefore not have a negative effect on earthworms. Production of toxins at significant levels has not been demonstrated Page 22 /25
ZV1 008562-00/00 / Vintec Part B – Section 9 - Core Assessment zRMS version and a long-term effect of the fungus on earthworms by application of T. atroviride according to Good Agricultural Practice is not expected. T. atroviride, as any other microorganism is not known to be patho- genic to earthworms. Various interactions between Trichoderma spp. and earthworm species are described in the literature all without a hint for adverse effects in earthworms due to exposure to the fungi. The use of earthworms (Pheretima hawayana) has been described as a vector species for T. harzianum. The fungus was administered to the earthworms via the diet and then transported to avocado roots artificially infected with P. cinnamoni. While considerable effectiveness was reached resulting in improved health of the avocado roots no adverse health effects were noted in the earthworms. Soil microbes in general serve as a food source for earthworms. Nine fungal species (including T. viride) were offered to various earthworm species (Lumbricus terrestris, L. rubellus, Aporrectodae celiginosa, A. rosea, Octolasion cyaneum). Although none of the earthworm species preferred T. viride, the earthworm did not refuse this fungus as food source. Consumption of T. viride was in the range of 5 to 20% per g b.w. fresh without causing any adverse effects. Eisenia andrei was also shown to feed on Trichoderma spp. The fungus contributed considerably to the fungal microflora in the earthworm cast suggesting that it readily passed the earthworms guts. Additionally, the worms were not adversely affected by exposure to the fungi. A number of researchers observed proliferation of microorganisms in the gut and vermicomposts of earth- worms suggesting that they may contribute to the distribution of microorganisms in the environment. To get an insight into which microbes are able to pass the earthworms gut and probably selectively grow therein, The gut and cast microflora of four earthworm species, Eudrilus eugeniae, Lampito mauratii, Ei- senia fetida and Perionyx excavatus, reared on different substrates, was investigated with regard to selective proliferation of certain microbial species. Besides a variety of bacteria, yeasts and protozoans, Trichoderma koningii was found in the gut and cast of earthworms reared on press mud. However, in most cases the genus was not detected in the surrounding soil and as a consequence was also not found in the earthworms suggesting that the worms do not have their own gut commensals but are only colonised by members of the surrounding soil microflora. Populations of the fungus were low in the soil (8 × 104 CFU/g) and did not increase significantly in the gut (18-30 × 104/cm) and the cast (13-21 × 104/g) of the worms. According to EFSA conclusions2, highest published exposure levels from feeding studies were 6.7 × 106 CFU T. ko- nigii/kg d.w. soil, without causing any adverse effects. The fate of Trichoderma spores in earthworm guts was also investigated. The authors found that only 1% of the viable spores of Trichoderma spp. fed to Lumbricus terrestris survived gut passage through the worm. This was considerably lower than survival rates observed for other fungi, e.g. Chaetomium globosum, which even germinated and grew in the earthworms. These data confirm earlier observations of indicating a quick passage or even digestion of the fungal spores through the earthworms gastrointestinal tract. Trichoderma ssp. was fed at a level of 665 CFU/100 mg d.w. soil, while only 8/100 mg were detected in the hind gut resulting in a ratio of viable spores in the hind gut/viable spores fed of 0.01. None of the studies obtained from the literature demonstrated a negative effect of Trichoderma spp. on earthworms. Due to the general absence of toxicity of Trichoderma spp. to earthworms and considering that the way of application renders exposure negligible, no adverse effects are expected in earthworms upon field applica- tion of T. atroviride SC1 and additional studies on earthworm toxicity are considered not required.
9.8.3 Overall conclusions
According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to non-target soil meso- and macrofauna.
2 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain SC1. EFSA Journal 2015;13(4):4092, 33 pp. doi:10.2903/j.efsa.2015.4092 Page 23 /25
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9.9 Effects on soil microbial activity (KCP 10.5)
9.9.1 Toxicity data
No laboratory studies on the effects of Vintec on soil microorganisms were submitted in the EU assessment. A published report assessing the development of T. atroviride SC1 upon introduction into a vineyard soil confirmed the absence of adverse effects on soil microbial communities. Only directly after application a difference between the treated and the control plots was observed and the introduced fungus disappeared more or less quickly from the soil depending on the soil depth. The density of the fungus directly after inoculation was approximately 109 CFU/g.
9.9.1.1 Justification for new endpoints
Not applicable as no new endpoints used.
9.9.2 Risk assessment
Trichoderma spp. including T. atroviride, are ubiquitous in soils and can be found at substantial numbers in all agricultural soils and in particular in the rhizosphere. Reported background levels of Trichoderma spp. in soils are in the range of 102 – 103 CFU/g (please refer to Doc. IIM, Sec. 5, Point IIM 7.1.1). Due to the different modes of action like competition with plant pathogens for space and substrates in the rhizosphere, mycoparasitism and the secretion of cell wall degrading enzymes and the production of anti- fungal substances, effects on plant pathogenic fungi are expected and intended to achieve efficacy. Negative effects on beneficial fungi or natural microbial communities, however, are not expected. It is generally considered, that, artificial introduction of antagonistic fungi into agricultural fields does not cause adverse or long-lasting effects, as the number of microbes already present in the soils is several orders of magnitude higher than the highest predicted load of the fungi that is expected upon the treatment. More- over, natural, highly diverse soil assemblages usually return quickly to their original status or even resist slight disturbances. This is confirmed by a meta-regression analysis aiming to investigate the influence of microbial control agents on soil microbial communities. Based on data (CFU counts) available from the open literature, that were chosen following strict criteria regarding their usefulness and reliability, they compared the quantitative effect of bacterial and fungal antagonists on the total (culturable) number of different soil non-target organisms means soil bacteria, soil fungi, actinomycetes and protozoa. It was shown that if even, application of microbial antagonists could have a short-term effect on the abundance of the fungal communities in soils. However, this effect was observed directly after the treatment only and complete recovery was demonstrated upon 70 days at latest. The initial effect on soil fungi was even more pronounced in the case of fungal antagonists than upon use of bacterial antagonists. Soil bacterial and pro- tozoan communities were, in contrast to chemical treatments, not affected. A confirmation that the above made assumption also applies for T. atroviride SC1 comes from an investi- gation on the impact of the fungus on soil communities in a vineyard where only a transient, short-term effect was observed when T. atroviride SC1 was inoculated at high levels. Due to the absence of any long-lasting effect on soil bacteria and fungi and considering that T. atroviride SC1 will be applied directly onto pruning wounds of grapevines the exposure risk for soil microbes is considered negligible and further testing is not required.
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9.9.3 Overall conclusions
According to the presented risk assessment, the use of Vintec at the proposed label rates according to good agricultural practice poses no risk to soil micro-organisms.
9.10 Effects on non-target terrestrial plants (KCP 10.6)
According to EU assessment, no studies on non-target terrestrial plants are required.
9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)
No additional studies are required according to the outcome of the EU assessment.
9.12 Monitoring data (KCP 10.8)
No additional data are required.
9.13 Classification and Labelling
Not applicable for microorganisms.
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Appendix 1 Lists of data considered in support of the evaluation
Appendix 2 Detailed evaluation of the new studies
DRAFT REGISTRATION REPORT Part B Section 9 (old dRR format B.6) Ecotoxicology Detailed summary of the risk assessment
Product code: ZV1 008562-00/00 Product name(s): Vintec Microbial Pest Control Agent: Trichoderma atroviride SC1, 1x1013 CFU/kg (150 g/kg)
Central Zone Zonal Rapporteur Member State: Germany
NATIONAL ADDENDUM – GERMANY (authorisation)
Applicant: BI-PA nv/sa Submission date: 24/09/2015 MS Finalisation date: 20/03/2018 Page 2 /6
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Version history
When What
March 2018 First Draft RR by UBA
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Table of Contents
9 Ecotoxicology (KCP 10) ...... 4 9.1 Critical GAP and overall conclusions ...... 4 9.1.1 Overall conclusions ...... 6
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9 Ecotoxicology (KCP 10)
9.1 Critical GAP and overall conclusions
Table 9.1-1: Table of critical GAPs
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Use- Member Crop and/or situ- F, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fn, controlled (days) e.g. g saf- * (crop destination Fpn (additionally: develop- Method / Timing / Max. num- Min. interval kg or L g or kg as/ha Water L/ha ener/ syn-
/ purpose of G, mental stages of the Kind Growth ber between ap- product/ha min/max ergist per crop) Gn, pest or pest group) stage of crop a) per use plications a) max. rate a) max. rate ha Gpn & season b) per crop/ (days) per appl. per appl. season b) max. total b) max. total or
I ** rate per rate per arthro- -target plants -target
crop/season crop/season Mammals Birds organisms Aquatic Bees organisms Soil Non pods Non Zonal uses (field or outdoor uses, certain types of protected crops)
001 BE, Grapes, estab- F Phaenomoniella spraying Winter dor- a) 1-2 7 days a) 0.2 kg/ha a) 2 x 1012 100-200 n.a. -- A A A A A A A AT; lished vines chlamydospora, mancy pe- CFU/ha l/ha RO; b) 2 b) 0.4 kg/ha (VITVI) riod 12 SK; Togninia minima b) 4 x 10 CZ; BBCH 0 CFU/ha HU;
Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms)
Minor uses according to Article 51 (field uses)
Minor uses according to Article 51 (interzonal uses)
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application
Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use
Remarks (1) Numeration necessary to allow references (7) Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Black- table: (2) Use official codes/nomenclatures of EU well, ISBN 3-8263-3152-4), including where relevant, information on season at time of application (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) The maximum number of application possible under practical conditions of use must be provided situation should be described (e.g. fumigation of a structure) (9) Minimum interval (in days) between applications of the same product. (4) F: professional field use, Fn: non-professional field use, Fpn: professional and non-profes- (10) For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty sional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products professional and non-professional greenhouse use, I: indoor application (11) The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, (5) Scientific names and EPPO-Codes of target pests/diseases/ weeds or when relevant the com- kg or L product / ha). mon names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, (12) If water volume range depends on application equipments (e.g. ULVA or LVA) it should be men- weeds) and the developmental stages of the pests and pest groups at the moment of applica- tioned under “application: method/kind”. tion must be named (13) PHI - minimum pre-harvest interval (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (14) Remarks may include: Extent of use/economic importance/restrictions Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated
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9.1.1 Overall conclusions
The national effect and risk assessment fully complies with the assessment presented in the core assessment. No specific risk mitigation measures are needed.
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DRAFT REGISTRATION REPORT Part B Section 7: Efficacy Data and Information Detailed Summary
Product Code: Vintec Reg. No.: ZV1 008562-00/00 Active Substance: 1.0 × 1013 CFU Trichoderma atroviride SC1/kg
Central Zone Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: BI-PA nv Date: September 2015 revised August 2016 revised December 2017
Evaluator: Julius Kühn-Institut Date: 2018-07-27
Applicant: BI-PA nv Evaluator: Germnay Applicant Document ID: dRR Section 7 Date:2018-07-27 Applicant Author : GAB Consulting GmbH
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Table of Contents IIIM 6 Efficacy Data and Information (including Value Data) for the Microbial Pest Control Product ...... 7 IIIM 6.1. Preliminary range-finding tests ...... 7 IIIM 6.2 Performance assessment field studies ...... 18 IIIM 6.2.1 Efficacy tests ...... 18 IIIM 6.2.1/1 Efficacy trials: use 1 – Grapes, indoor (nursery)/ESCA ...... 18 IIIM 6.2.1/2 Efficacy trials: use 2 – Grapes, Field (pruning)/ESCA ...... 19 IIIM 6.2.1/3 Efficacy trials: Long term studies – Grapes, Nursery and/or Field/ESCA ...... 42 IIIM 6.2.2 Minimum effective dose test ...... 62 IIIM 6.3 Toxic or pathogenic effects on the crop or host which is to be protected ...... 62 IIIM 6.4 Compatibility with products in tank mixtures ...... 63 IIIM 6.4.1 Physical compatibility ...... 63 IIIM 6.4.2 Chemical compatibility ...... 64 IIIM 6.4.3 Biological compatibility ...... 65 IIIM 6.5 Contribution to risk reduction and integrated pest management strategies, for the target crop or resource...... 65 IIIM 6.6 Effects on yield and quality ...... 65 IIIM 6.6.1 Impact on the quality of plants and plant products ...... 65 IIIM 6.6.2 Effects on the processing procedure ...... 65 IIIM 6.6.3 Effects on the yield of treated plants and plant products ...... 66 IIIM 6.7 Adverse effects ...... 66 IIIM 6.7.1 Impact on succeeding crops ...... 66 IIIM 6.7.2 Impact on other plants including adjacent crops ...... 67 IIIM 6.7.3 Adverse effects on parts of plant used for propagating purposes ...... 67 IIIM 6.7.4 Adverse effects on beneficial organisms (other than bees) ...... 67 IIIM 6.8 Summary and assessment of data according to points 6.1 to 6.7 ...... 69 IIIM 6.9 List of test facilities including the corresponding certificates ...... 71 Appendix 1: List of data submitted in support of the evaluation ...... 84 Appendix 2: GAP-Tables ...... 97
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The following data and information were mainly provided by the applicant submitted as dRR and BAD.
Additional comments and the final evaluation by the zRMS in this Registration Report are marked by green boxes.
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Introduction to Vintec
The product Vintec (identical to the product BCP511B) is intended to be used to protect grapevine (Vitis vinifera L.) against the vascular diseases Esca and Petri disease. The main causal agents of young Esca and Petri disease are Phaeoacremonium spp. (most frequently Phaeoacremonium aleophilum (renamed Togninia minima; Pal), Phaeomoniella chlamydospora (formerly known as Phaeoacremonium chlamydosporum; Pch). While Petri disease is occurring on young plants during nursery stage and in young plantations, young Esca symptoms are observed on adult plants. On the other hand, the white rot of wood is associated with esca and esca proper and it is caused by the basidiomycete Fomitiporia mediterranea. Although the symptoms of both diseases differ, causal agents of Petri disease and young Esca are expected to be the same. Phaeomoniella chlamydospora and Phaeoacremonium aleophilum cause vascular disorders when naturally or artificially inoculated in healthy plants. A very important way of entrance of these pathogens is through the pruning wounds. The active ingredient of Vintec, Trichoderma atroviride strain SC1, is an antagonistic fungus that acts through several mechanisms, including competition for space on infection sites, competition for nutrients, production of inhibitory compounds and lytic enzymes, direct parasitic activity on several pathogenic fungi, and induction of defence responses in host plants. Thus, pathogen’s growth inhibition -has been demonstrated for e.g. the leaf pathogen Botrytis cinerea and the soil borne pathogen Armillaria mellea, both in vitro and natural conditions Moreover, laboratory trials were conducted, demonstrating that T. atroviride SC1 is active against a broad range of plant pathogenic fungi under both laboratory conditions and conditions simulating possible field applications (please refer to the study by Pertot (2011a), submitted under IIIM 6.1/1). On the basis of comprehensive findings of studies carried out, it appears reasonable to assume that Trichoderma atroviride SC1 acts mainly by colonization of the treated wounds where it competes for space and nutrients with the pathogens. Other modes of action, such as direct parasitic attack (hyperparasitism) and production of lytic enzymes should result as accessory mechanisms which can provide integration or a synergistic effect to the main mode. T. atroviride SC1 exerts a strong competition for space and nutrients, which is highlighted by the fact that it quickly colonizes dead or fresh wood and once the colonization is achieved the subsequent growth of other microorganisms is impeded. T. atroviride SC1 also produces lytic enzymes, which are known to degrade cell walls of fungal pathogens. The mechanism of action against grapevine trunk diseases is based on the fact that after spraying, the conidia of T. atroviride SC1 quickly germinate and colonize the wound protecting the plant from subsequent infection of wood pathogens. The efficacy in controlling the pathogens is therefore linked to the extent of colonization. Due to its mode of action, T. atroviride SC1 has a solely preventive activity. Nevertheless, Vintec does also act against other fungal pathogens on grape, e.g. Diplodia seriata (the anamorph of Botryosphaeria obtusa) and other species of Botryosphaeriaceae (less frequently encountered) which are involved in Botryosphaeria dieback. The effective prevention of these pathogens was tested and demonstrated in several efficacy trials. Vintec is to be applied on grapes by spraying onto pruning wounds in field. The spraying is to be applied by 0.2 kg product/hL for one application with a maximum of two applications per year (maximal rate per crop/season: 0.4 kg product/ha). The second application is recommended only in case of unfavourable weather conditions during or directly after the first application (strong precipitation or temperatures too low for germination of the conidia). This dossier is intended for the registration of Vintec in Germany, Austria, Hungary, Belgium, Romania, Slovakia and Czech Republic. It reviews the information related to the efficacy for the microbial plant protection product Vintec containing T. atroviride SC1. The product BCP511B is identical to Vintec. Thus, all trials on the product BCP511B are considered for the efficacy evaluation of Vintec. The ingredients of Vintec formulated as WG are inert. Vintec is the representative formulation in the dossier submitted for approval of Trichoderma atroviride SC1 as an active ingredient under Regulation (EC) 1107/2009. The same data and additional data are presented in this dRR. The evaluation of Trichoderma atroviride SC1 for approval as an active ingredient under Regulation (EC) 1107/2009 is still ongoing. Vintec is a biological fungicide formulated as water dispersible granules, containing 1 × 1013 colony forming units (CFU) of Trichoderma atroviride strain SC1 in 1 kg of product, or 1 × 1010 CFU/g. With regard to safety issues, it is important to note that the species T. atroviride, along with several other species belonging to the same genus, is naturally present in the environment where it colonizes the soil and decaying organic materials. Therefore, its application in the agro-ecosystem results only in a transient fluctuation of the Trichoderma population. Population of T .atroviride SC1 is expected to decrease to natural levels. No addition of
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extraneous organisms is made. The fact that T. atroviride SC1 presents no risk for the environment has been confirmed by numerous studies.
Nomenclature (Name and species description, strain characterization) The strain T. atroviride SC1 was isolated from decaying hazelnut wood in northern Italy. It belongs to the Phylum of Ascomycota, Order of Hypocreales, Family of Hypocreaceae and Genus of Trichoderma. Trichoderma species are dominant members of most of soil and rhizosphere fungal communities, but population compositions may vary among different soils. The strain T. atroviride SC1 was identified by its morphology and through DNA analysis by comparison of the ITS (Intertranscribed Spacer) sequences using the TrichOKEY identification tool, version 2.0 (www.isth.info, Longa, 2008). For more details, please refer to dRR Part B, Section 1, Identity of the Microbial Pest Control Agent / Active Substance.
Other Properties No other properties are described.
Mode of Action The product Vintec is intended to be used against the vascular pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum, which cause symptoms associated to Esca and Petri disease complex. T. atroviride SC1 acts through several mechanisms, the more relevant is the competition for space and nutrients at the infection sites. Other mechanisms that complete its efficacy include parasitic activity on target fungi with production of inhibitory compounds and lytic enzymes (please refer to the study performed by Pertot (2011a), submitted under IIIM 6.1/1). Due to its mode of action, T. atroviride SC1 has a solely preventive activity. If a pathogenic fungus related to the above mentioned diseases has already colonized the host plant, Trichoderma atroviride SC1 cannot cure the infection. The label of Vintec will state that Vintec must be applied on the pruning wounds during the winter dormancy period, in the days following pruning, as soon as the temperature reaches 10°C for minimum 5 hours with a relative humidity above 70%. Also, there should be no rainfall or frost in the 48h following the application. In these environmental conditions, T. atroviride SC1 is able to colonize the pruning wounds, preventing entry of the pathogens. However, in case the conditions for T. atroviride SC1 are not yet optimal immediately after pruning, it is recommended to wait for the above mentioned conditions. It must be noted that in that case, the environmental conditions are also not right for the pathogens therefore the risk for infection by pathogens will be low.
Target organisms T. atroviride SC1 is intended to be used against the vascular pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum, the main causal agents of the esca disease complex in vine nurseries and vineyards. The Esca disease complex comprises five described symtoms, which are are brown wood streaking (mostly affecting rooted cuttings), Petri disease, young esca, esca and esca proper. Phaeomoniella chlamydospora and Phaeoacremonium aleophilum (renamed Togninia minima) are associated with brown wood streaking, Petri disease and young esca, whereas esca (white rot occurring in the trunk and branches of mature standing vines) is caused by Fomitiporia mediterranea and ⁄ or other basidiomycetes. Esca proper, usually encountered in mature vineyards, indicates the co-occurrence of young esca and esca on the same plant. Phaeomoniella chlamydospora and Phaeoacremonium aleophilum as the causal agents of brown wood streaking (mostly affecting rooted cuttings), Petri disease and young esca, are isolated from the discoloration found in the wood of plants showing the above mentioned symptoms. The inoculation of the Phaeomoniella chlamydospora and Phaeoacremonium aleophilum reproduces the symptoms of brown wood streaking (mostly affecting rooted cuttings), Petri disease and young esca. The typical ‘tiger stripe’ foliar symptoms of Esca complex appear only on adult plants and include wilting of leaves and canes, tiger stripe necrotic spots on leaves (acute and chronic syndromes). Shoots and plants may also dry out and die during winter. Berries may have black to brown spots, especially in white varieties. Symptoms may vary in intensity from one year to another. Finally, the plant completely dies. Branches of diseased plants show degraded wood with a white, porous structure when cut longitudinally (esca). Symptoms of brown wood streaking (mostly affecting rooted cuttings), Petri disease and young esca, are always
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associated with the presence of Phaeomoniella chlamydospora and Phaeoacremonium aleophilum. Although the fungi can also be isolated from plants showing Esca proper and esca symptoms, they are not identified as the causal agents of the white rot of wood. The pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum enter preferentially through wounds (caused by winter pruning, cracks caused by broken branches in the trunk or in shoots more than one-year-old) or during cuttings preparation and grafting in nurseries. In the latter case, both rootstocks and scions can be affected. Control of wood diseases by chemical plant protection products is not possible as the available plant protection products do not penetrate efficiently into the infected wood and thus do not reach the fungal infection sites. In addition the available chemical protection products when sprayed on pruning wound do not persist enough to protect them for the entire season of pathogen’s conidia dispersal. The protection of wound with chemicals would need at least weekly application from pruning to harvest, which is not sustainable. In contrast to this, T. atroviride SC1 can grow in the dead wood tissue and occupy potential infection sites before the pathogens can establish (competition for space and nutrients, production of cell wall lytic enzymes). Although not part of this dRR, it is worth mentioning that there are indications that T. atroviride SC1 is also efficient against Botrytis, Rhizoctonia, Pythium, Nectria, Chondrostereum purpureum, Armillaria and other soil- borne plant pathogens (please refer to Point IIM 6.1/01).
IIIM 6 Efficacy Data and Information (including Value Data) for the Microbial Pest Control Product This document summarizes the information related to the efficacy of the plant protection product Vintec (containing Trichoderma atroviride SC1). A full evaluation of the trial data is provided in the Biological Assessment Dossier (Scholze, 2015) The SANCO report for Trichoderma atroviride is considered to provide the relevant review information or a reference to where such information can be found. Aim of this Biological Assessment Dossier is to support the registration of the product Vintec in the central zone after the approval of the active substance Trichoderma atroviride SC1. The efficacy studies summarized in this document were conducted in grapevine to show that Vintec provides a good protection against the pathogens related to Petri disease and young Esca. Appendix 1 of this document contains the list of references included in this document for support of the evaluation. Appendix 2 of this document presents the uses of Vintec (GAP table). Appendix 3 of this document presents the data on trial sites and application details for the efficacy trials with Vintec. Appendix 4 of this document presents the results of efficacy trials with Vintec. Appendix 5 of this document gives an overall summary of the data on effectiveness trials.
Information on the detailed composition of Vintec can be found in the confidential dossier of this submission (Registration Report - Part C).
IIIM 6.1. Preliminary range-finding tests In the following parts, experiments are presented screening the antifungal activity of T. atroviride SC1 in the laboratory and assessing the colonization ability of the strain upon treatment of pruning wounds in grapevine. Furthermore, trials conducted to test the effect of different co-formulants on the activity against plant pathogenic fungi in grapevine are summarized. Aspects such as temperature, rain fastness and UV stability were considered. In addition, preliminary trials in field applications are presented. Finally, information regarding weather conditions supporting the effectiveness of Vintec is provided. Table 6.1-1 summarises all preliminary trials.
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Table 6.1-1 Overview of preliminary range-finding tests Conditions of test Testing of Test report Country EPPO zone performance (year) Laboratory tests Screening the antifungal activity of T. IIIM 6.1/01 Italy - atroviride SC1 Pertot, I. (2011a) IIIM 6.1/02 France - Liminana et al., 2009 Semi-field and field Assessing the colonization ability of the IIIM 6.1/03 Italy Mediterranean trials strain upon treatment of pruning wounds in Pertot, I. (2009) grapevine Testing the effect of different co-formulants IIIM 6.1/04 Italy Mediterranean on the activity against plant pathogenic fungi Pertot, I. et al. in grapevine (2010) Semi-field and field Field testing e.g. of the influence of sticking IIIM 6.1/05 Italy Mediterranean trials agents on the performance of T. atroviride Pertot, I. SC1 (2011b) Field trial with application via soil irrigation IIIM 6.1/06 Hungary South-East to the root zone Dula, B. & Dula, T. (2011) Laboratory and Screeening for effects of temperature, pH, IIIM 6.1/07 Italy - greenhouse tests water activity and carbon and nitrogen Longa et al. sources on growth of T. atroviride SC1 as (2008) well as survival on leaves and in soil
Report: IIIM 6.1/01 – Pertot, I. (2011a): Ecology, identification, spectrum, effect on fermentation, survival on phyllosphere and long term survival of Trichoderma SC1: Microbial species which can be controlled by T. atroviride SC1 (pathogen host range) and efficacy. Unpublished report 2011.
Guideline: Not specified
GLP/GEP: No
Materials and Methods: The study was conducted in 2011 by Fondazione Edmund Mach, S. Michele all´Adige, Italy. Dual cultures on PDA (Potato Dextrose Agar) with T. atroviride SC1 and several plant pathogenic fungi (including the pathogens involved in Esca disease complex) were carried out to determine the host range of the biocontrol agent. In addition, activity against Rhizoctonia solani on lettuce seeds, Armillaria mellea on wood pieces and Botrytis cinerea on strawberries was assessed in laboratory experiments. In these tests, a conidia suspension of T. atroviride SC1 (105 conidia/mL) was used to drench horticultural substrate or to pre-treat barks, barks and shrimp shell mixtures or shrimp shells. The treated substrates were inoculated with R. solani prior to planting of lettuce seeds. The control of R. solani was assessed three weeks after seeding. In the case of A. mellea, wood pieces were inoculated with the pathogen and placed on the treated substrates. After five and six months samples were collected and survival of T. atroviride and A. mellea were assessed via plating on semi-selective or PDA medium, respectively.
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To test effectiveness against B. cinerea, strawberry plants were sprayed once a week with T. atroviride SC1 (107 conidia/mL) until run-off. The pathogens were inoculated just before harvest by foliar spraying. Assessment of the efficacy of T. atroviride SC1 was carried out by scoring B. cinerea symptoms on fruits seven days after harvest.
Findings: T. atroviride SC1 significantly reduced the growth of Phaeomoniella chlamydospora, Phaeoacremonium aleophilum, Armillaria mellea, A. gallica, Rhizoctonia solani, Fusarium spp., Botrytis cinerea, Pythium spp., Verticillium spp., Penicillium spp., Aspergillus spp. and Alternaria alternate in dual culture on Petri dishes. In the second set of experiments, pest control achieved with T. atroviride SC1 reached values of up to 100%. With 80-100% of samples still containing at least 104 conidia per g after 6 months, survival of the fungus was very good in barks, shrimp shells and a mixture of both. In soil, survival rates were lower. Here, only 20% of the samples contained 104 conidia/g after 6 months. Accordingly, control of the fungal pathogens was also less effective (20-50%). Applied as a foliar spray, T. atroviride SC1 was able to reduce B. cinerea related incidence of rotten fruits in strawberries from 90% to below 10%.
Conclusions: In addition to activity against Phaeomoniella chlamydospora and Phaeoacremonium aleophilum in dual culture tests, T. atroviride SC1 exhibits also activity against a broad range of plant pathogenic fungi under both, laboratory conditions and conditions simulating possible field applications (spectrum of activity).
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A laboratory research trial was conducted to test the antagonistic activity of Trichoderma atroviride SC1 against plant pathogenic fungi in grapevine, namely Eutypa lata associated with Eutypiosis in vines, Phaeomoniella chlamydospora and Phaeoacremonium aleophilum related to the Esca wood disease and Botryosphaeria obtusa related to the black dead arm disease (Liminana et al., 2009).
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Report: IIIM 6.1/02 – Liminana J.M., Mayet, V., and Lecomte, P. (2009): Studies of the effect of antagonistic fungi on the mycelial growth of fungi associated with grapevine wood diseases (Esca, Eutypiosis, Botryosphaeria canker) Assessment of their capacity to protect pruning wounds. Unpublished report 2009
Guideline: Not specified
GLP/GEP: No
Materials and Methods: The study was conducted in 2009 by the Institut National de la Recherche Agronomique Centre de Bordeaux – Unité Mixte de Recherches en Saté Végétale (France). In this in vitro study, SC1 as well as two Trichoderma strains, one from the formulated product “Esquive” and strain “Tricho common” usually used as control strain in the laboratory, were subjected to confrontation tests on agar plates (full medium consisting of 15 g malt and 20 g agar). The pathogens and the antagonists were either inoculated simultaneously (simultaneous seeding) or with a delay of seven days between the pathogen and the antagonists seeding (delayed seeding). The second set of experiments was set up only with the slower growing pathogens (Eutypa, P. chlamydospora and P. aleophilum) and was intended to give information on the curative potential of the Trichoderma strain SC1. The seeding was done by putting two 5 mm discs (one with the antagonist and one with the pathogen), punched out in the growth area of a fungus mother culture, on the dish. For each type of confrontation, 2-4 replicates were carried out. The agar plates were incubated at 22°C with an alternating photoperiod of 12/12 hours. Assessments of the mycelial growth were carried out after 4 and 7 days.
Findings: The Trichoderma strains showed excellent antagonistic activity against E. lata in the simultaneous seeding test with Trichoderma SC1 showing the strongest inhibition of the pathogen. In the delayed seeding test, when the pathogens where already well established, a barrier marking the territory of both fungi was observed but not a clear antagonistic effect. In the delayed seeding tests with P. aleophilum and P. chlamydospora, the growth of the pathogens was limited but swarming of the parent colonies, as observed in the case of P. aleophilum, indicated that the pathogens were still alive. In all simultaneous seeding tests, Trichoderma SC1 showed excellent antagonistic activity invading and covering the pathogens colonies. Compared to the other two Trichoderma strains, activity of Trichoderma SC1 was superior (Tricho common strain) or at least similar (Esquive).
Conclusion: Under laboratory conditions, T. atroviride SC1 exhibits excellent antagonistic activity against grapevine wood associated pathogenic fungi.
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Pertot (2009) tested the ability of T. atroviride SC1 to act as antagonist against fungi causing esca disease and to colonize pruning wounds and adjacent wood material and to prevent infection with Esca related fungi in a semi-field trial using potted grapes.
Report: IIIM 6.1/03 – Pertot, I. (2009): Report 2009: Detailed protocols and results of trials that were carried out by Fondazione Edmund Mach, S. Michele all´Adige, Italy to test the efficacy of Trichoderma atroviride SC1 and Esquive against the main causal agents of Esca disease on grape (year 2009).
Unpublished report
Guideline: Not specified
GLP/GEP: No
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Materials and Methods: Two studies were conducted in 2009 by the Fondazione Edmund Mach, S. Michele all´Adige, Italy, one with 2-year-old potted plants, a second one with 20-year-old plants in the field. In the first experiment effects of antagonists against fungi causing esca disease on young potted vines (cultivar Chardonnay) were assessed. The potted plants were kept open air under natural conditions in the vineyard. One pruning wound per vine was inoculated on March 10th by spraying a conidial suspension (106 cfu/ mL) of Trichoderma atroviride SC1 or Trichoderma atroviride Esquive (reference product) on the wound surface. After 24h, 30 µL of P. chlamydospora (Pch) and P. aleophilum (Pal) conidial suspensions (107 cfu/ mL) were inoculated on the pre-treated wounds. Control vines (treated only with sterile water) were inoculated with the pathogens following the same procedure. Altogether 45 plants were treated with T. atroviride SC1 (3x5 plants with Pch, 3x5 plants with Pal, 3x5 plants with sterile water), 45 plants treated with T. atroviride Esquive and 45 plants with sterile water, giving a total of 135 plants. This experiment was carried out twice. Four months after inoculation (July 20th) the wood below the covered pruning wound was cut (7 cm long) and starting from the point of inoculum 20 equal pieces of 1 mm were sliced off. The slices were plated onto malt extract agar, incubated and evaluated daily to verify the presence of the colonies of Trichoderma and of Pal and Pch. The isolated fungi were identified by colony and spore morphology and by PCR. A plant with at least one section with presence of Pch or Pal was considered infected. Percentage of infected wounds was calculated. For each shoot effectively colonized by Trichoderma the extent of antagonistic penetration inside the wood was measured. In the second experiment the survival of Trichoderma atroviride SC1 and Trichoderma atroviride Esquive (reference product) on pruning wounds of 20-year-old grapevine plants (Pinot noir) was assessed. Each Trichoderma strain was applied directly onto the pruning wounds cut in February and March on a total of 20 plants by spraying conidia suspensions (108 conidia/mL for test and reference product). For each replicate 60 plants were treated, 20 with SC1, 20 with Esquive and 20 with sterile water, into 9 different replicates (3 per treatment) in randomised block design. 15 days after inoculation the wood below the covered pruning wound was cut (7 cm long) and starting from the point of inoculum 18 equal sections of 1 mm were sliced off and treated as described above for the first experiment.
Findings: In the first experiment, T. atroviride SC1 and T. atroviride Esquive were able to effectively colonize pruning wounds and were found at 2 cm from the point of inoculum. At the same inoculum rate colonisation with T. atroviride SC1 was even more efficient than that of the Esquive strain. The rate of infection in the inoculated control was successful (100% of plants infected). Under this high infection pressure both SC1 and Esquive were able to control Pch. SC1 was also capable of reducing Pal to a level of 40% compared to the untreated variant, whereas Esquive could only reduce Pal slightly to 80% of the infestation in untreated. In the second experiment, again, SC1 were able to colonise better and also penetration was deeper than with Esquive. Table IIIM 6.1-1 gives all results for this second experiment with the pruning in February (first trial) and March (second trial) listed separately. The fungi were not detected in untreated control plants. In the second trial (starting in March), the incidence at the last assessment day was considerably lower than in Trial 1 suggesting that suitable formulations are required to protect biocontrol agents from UV exposure. During cultivation of the two Trichoderma atroviride strains it became obvious that T. atroviride SC1 growth and conidia production proceeds much faster than that of the strain present in Esquive.
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Table IIIM 6.1-1 Colonisation of pruning grape wounds (n=541) by T. atroviride SC1 and Esquive checked by re-isolation. Results with 20-year old plants. Distance Incidence at 15 days [%] Incidence at 30 days [%] Incidence at 90 days [%] to inoculum Treatment Treatment Treatment
SC1 Esquive Untreated SC1 Esquive Untreated SC1 Esquive Un- treated
Trial 1 0 mm 87.7 92.6 0 98.1 92.6 0 72.2 68.5 0 5 mm 94.4 96.3 0 94.0 83.3 0 90.7 90.7 0 10 mm 92.6 75.9 0 92.6 81.5 0 90.7 79.6 0 15 mm 90.7 72.2 0 90.7 79.6 0 77.8 72.2 0 20 mm 92.6 79.6 0 88.9 79.6 0 87.7 59.2 0 Trial 2 0 mm 96.3 90.7 0 81.5 81.5 0 40.72 35.2 0 5 mm 92.6 92.6 0 83.3 85.2 0 40.7 31.5 0 10 mm 87.0 85.2 0 90.7 68.5 0 40.7 29.6 0 15 mm 83.3 64.8 0 85.2 70.4 0 40.7 29.6 0 20 mm 88.9 62.9 0 72.2 68.5 0 38.9 29.6 0
Conclusions: T. atroviride SC1 is able to establish stable populations in treated wounds and to penetrate the adjacent wood tissue thereby ensuring efficient protection from infection with pathogenic fungi.
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In a further experiment, the same authors investigated different co-formulants for their effect on T. atroviride SC1 growth promotion, conidia protection and rain fastness.
Report: IIIM 6.1/04 – Pertot, I. et al. (2010): Trichoderma atroviride SC1: trials on formulation. Unpublished report, FEM – Research and Innovation Centre
Guideline: Not specified
GLP/GEP: No
Materials and Methods: The study was conducted in 2010 by the Fondazione Edmund Mach Research and Innovation Centre, S. Michele all´Adige, Italy. A probable positive effect of co- formulants on the effectiveness of T. atroviride SC1 due to enhanced resistance against harsh environmental conditions (temperature, desiccation and UV exposure) or due to enhanced rain
1 20 plants per replicate; 3 replicates, 3 treatment, 18 pruning wounds per replicate. 18 x 3 = 54 2 When a certain percentage of the pruning wound is colonized, it is common to find the microorganism at the same percentage at the different distances.
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fastness was tested. In the first step all substances were screened to test their impact on fungal growth. Therefore, 1, 2 and 4% solutions of the substances were added to T. atroviride SC1 suspensions and the germination rate of the fungus was determined after 16 hours of incubation. In the next step, the substances were added to the fungus at concentrations of 0.01, 0.5, 1.0, 2.0 and 4.0%. All substances with known positive effect on the survival of T. atroviride SC1 were subjected to further experiments to test their effectiveness in conidia protection and increasing rain fastness of the conidia. In first experiments, the different concentrations of the substances were added to T. atroviride SC1 suspensions and 100 µL of the suspensions were then dropped on a microscope slide. Germination and growth under different temperature, desiccation and UV conditions was then assessed by microscopy estimating the percentage of germinated conidia on at least 100 conidia per slide. In a further experiment some ingredients were also tested in combination at final concentrations of 0.05% in the fungal suspensions. Moreover the compatibility of T. atroviride SC1 with different plant oils was tested. Rain fastness was assessed after adding T. atroviride SC1 conidia to aqueous solutions containing combinations of different substances (at 0.05%) and inoculating the resulting suspensions onto paper squares, drying them and dropping different volumes of sterile water onto the paper to simulate rain fall. Afterwards the number of conidia, still present on the paper pieces and the germination rate were assessed. Finally the survival of T. atroviride SC1 on pruning wounds of grapevine cuttings was studied at high temperatures and two levels of relative humidity (RH) by assessing the percentage of colonized wounds.
Findings: In the germination tests on glass slides, most of the tested substances provided protection to the fungal conidia resulting in a better survival of T. atroviride SC1 at the chosen conditions. In the first experiments, the germination rate of the fungus was relatively low but it became obvious that several substances did not provide sufficient protection and were therefore not tested again. Agrotonic (Laminaria digitata extract), cocoa, SDP, vaseline and whey provided good protection against UV exposure. At low temperatures, only Agrotonic and SDP showed a small protective effect. The same applied for high temperatures at which also MEB showed good protection at both low and high RH. At optimal temperatures all substances provided protection against desiccation. Only Agrotonic, SDP and MEB were tested in the different regimes with Agrotonic providing best protection. When effectiveness of mixtures of different substances was tested, combinations containing Agrotonic worked better than all others under all experimental conditions. Addition of SDP, xanthan gum, glycerol, hyaluronic acid and aloe showed a positive effect in UV protection and germination at high temperatures. Moreover it was found that T. atroviride SC1 was not compatible with some plant oils tested, e.g. sunflower oil, soybean oil and corn oil. Germination was 100% in peanut oil, linen seed oil and vaseline. Rain fastness of T. atroviride SC1 was significantly enhanced in the presence of Agrotonic and SDP, and an additional treatment with hyaluronic acid, vaseline, cellulose, xanthan gum, aloe and linen seed oil even further increased the rain fastness of the fungus. Survival of T. atroviride SC1 on pruning wounds of grapevine wood pieces at high temperatures (35°C) was first tested using two different concentrations of the fungus, 103 and 105 CFU/mL (100 µL per wound), with assessments after 2, 4 and 7 days. Survival of T. atroviride was highest at day 2 with 103 CFU/mL and medium at day 4 with 105 CFU/mL. After 7 days, survival was 0. In the following experiments the fungus was inoculated at 104 CFU/mL and survival was assessed after 2 and 4 days. In these experiments, the positive effect of Agrotonic, SDP and MEA on survival of T. atroviride SC1 was confirmed for high temperatures and high RH conditions. SDP treatment even increased persistence of the fungus to 4 days. The positive effect of SDP could be increased by additional treatment with hyaluronic acid or xanthan gum, both combinations enabling restricted
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survival at high temperatures and dry conditions.
Conclusions Agrotonic promotes germination of T. atroviride SC1 better than standard nutritional components, particularly under dry conditions. SDP is also a good nutritional component and strongly enhances survival of the fungus on pruning wounds at high temperatures. Both adjuvants show a positive effect on rain fastness of the fungus.
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In 2010, GEP trials on the effectiveness in pathogen control under semi-field (potted plants) and field conditions (established vines) were conducted in Italy, which are presented under IIIM, Point IIIM 6.2.1/1 reports 2 and 3. In addition, it was tested whether the addition of sticking agents improves the capability of T. atroviride SC1 to colonize pruning wounds under field conditions. Also, survival of the strain under different climatic conditions due to seasonal variance was investigated. However, none of these adjuvants showed any effect on the rate of colonization of Trichoderma, nor on the rate of the infection by the pathogens. Thus, these products were not considered in the efficacy evaluation of BCP511B.
Report: IIIM 6.1/05 – Pertot, I. (2011b): Report 2010.
Unpublished report
Guideline: Not specified
GLP/GEP: No
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Materials and Methods: 1. Two trials, one field study and one semi-field study, were conducted between March and October 2010 by Fondazione Edmund Mach/ Instituto Agrario, S. Michele all´Adige, Italy, to investigate the efficacy of Trichoderma atroviride SC1 against Phaeomoniella chlamydospora and Phaeoacremonium aleophilum on grape. In the field trial conducted in a vineyard in Rovereto, pruning wounds were treated immediately with two spray applications of either T. atroviride SC1 solo or with formulation BCP423D or SDP or with the reference product T. atroviride Esquive. Two days after the application of test and reference products, the pathogens Phaeomoniella chlamydospora (Pch) and Phaeoacremonium aleophilum (Pal) were inoculated by placing one drop of conidial suspension directly on each wound. Sample collection (27 weeks after inoculation) was by cutting the pruned shoots and preparing some pieces of their internal wood at increasing distances from the point of the inoculum (0-2cm). These prepared pieces of wood were placed on culture medium. For the semi-field study the same procedure was followed as described above but on potted plants. The only difference was the earlier sample collection, this time already 19 weeks after inoculation.
2. In a semi-field study the ability of T. atroviride SC1 to colonize pruning wounds in the presence or absence of two different sticking agents was tested, namely BCP423D and SDP Sticker, both mixed with the Trichoderma suspension to make a final concentration of 0.05%. The commercial product Esquive WP was used as reference. The conidial suspensions (107 conidia/ mL) were applied twice onto pruning wounds of potted grape plants immediately after pruning. The fungal pathogens Pch and Pal were inoculated 48 hours after the second treatment by pipetting 20 µL of conidial suspensions containing 104 CFU/mL onto the pre-treated wounds. Samples were collected 4 months after the inoculation. The assessment of Trichoderma growth was carried out according to Pertot (2009, IIIM, 6.1/03). In addition, the survival of T. atroviride SC1 in pruning wounds was investigated under different climatic conditions (< 30°C and > 30°C). For these experiments, the fungus was inoculated into the wounds at the 1st and the 15th of March 2010, respectively. Wood samples were taken after 15, 30 and 90 days and investigated as described previously. The percentage of pruning wound colonized by the two BCA or the pathogens after treatments with SC1 with and without adjuvants and Esquive was monitored to evaluate the colonization of pruning wounds under natural condition with formulation. Untreated wound were analyzed as control. Analyses of variance (Anova), followed by HSD Tukey post hoc determinations or non parametric statistics were performed.
Findings: 1. In the field experiment T. atroviride SC1 treatments added with BCP423D or SDP controlled very well both microorganisms (Pal and Pch), significantly reducing the percentage of Pal or Pch infected shoots. Even the SC1 used without formulation significantly reduced the percentage of infections and its efficacy was high against Pal, while it showed a slightly lower efficacy, compared to the formulated treatments, against Pch. In general, colonization of wood tissue by T. atroviride SC1 was more effective than by the Esquive strain. The ability to colonize deeper wood parts was more pronounced in the case of SC1 compared to the Esquive strain. In the semi-field experiment the treatment SC1 + BPC423D controlled very well Pal (94.4% effectiveness) and Pch (95.7% effectiveness). The SC1 solo variant was comparable with the SC1 + SDP variant, showing >70% effectiveness against Pal and Pch. 2. T. atroviride SC1 had a very good efficacy on Pch and Pal on the surface as well as in deeper layers of the wood. Furthermore a higher effectivity than for the reference product Esquive was shown.
Conclusions: T. atroviride SC1 had a good efficacy against the Esca related pathogens Pch and Pal, slightly higher than the reference product Esquive.
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In addition to field treatment after pruning in autumn or winter, T. atroviride SC1 is intended to be used in grape nurseries. Dula & Dula (2011) report on the effect of T. atroviride SC1 applied via root zone irrigation of young plants directly after planting.
Report: IIIM 6.1/06 – Dula, B. & Dula, T. (2011): Efficacy trial report on Trichoderma SC1 against Esca related diseases in vineyard, nursery and small plot trial. Unpublished report
Guideline: Not specified
GLP/GEP: No
Materials and Methods: The study was conducted between May 2010 and January 2011 in Hungary. The ability of T. atroviride SC1 to prevent the attack of young grape plants by the Esca related pathogens was tested. Esca related pathogens are not further defined. No artificial inoculation was performed. The experiments were set up in three different nurseries in Hungary located in Pécs, Tapolca and Aldebrö. The varieties of the grapes were Kadarka, Olaszrizling and Sauvignon blanc. The vines were planted between the 10th and the 26th of May 2010. Directly after planting, the root zone of the plants was irrigated with suspensions of the test item and reference products (2.5 L/plot), whereby one plot comprised 4 × 50 grafts. The second treatment was performed two weeks later. Besides Trichoderma SC1, two commercial Trichoderma products (Esquive and Trifender) and miclobutanil were tested. The trial was set up in randomized blocks with four replicates. Efficacy evaluation was done between August 2010 and January 2011. The following parameters were assessed:
1. Percentage of plants living and sprouting; 2. After digging out the grafts determination of a. first class and salable plants b. total weight c. root mass weight d. evenness and round shape of roots 3. Length of necrotic xylem 4. Presence of Agrobacterium vitis 5. Identification of pathogens Findings: At all locations the percentage of sprouted living plants assessed at beginning of August 2010 was found to be highest after treatment with Trichoderma SC1 (average: 91.17%). Good results were also obtained with Trifender and Esquive (av. 88.17 and 89.67%, respectively) while in the case of the hot water treatment and treatment with miclobutanil (av. 81.67 and 79.57 %) the sprouting success was even lower than in the untreated group (av. 88.0%). Very similar results were obtained with regard to the percentage of living plants at uprooting time (15./17./6.11.2010 at Aldebrö, Tapolca or Pécs, respectively). Again, the highest percentage of living plants was observed after treatment with Trichoderma SC1 (av. 105% compared to untreated control), followed by Esquive (104.6%). The differences between the untreated control and the other treatments were marginal. Trichoderma SC1 treatment gave best results when the number of first class plants (av. 110.1% compared to untreated control), the weight of the grafts and the reduction of necrosis in the cross section of roots caused by soil borne pathogens were assessed. No differences in the root mass were observed between the untreated control and the Trichoderma SC1 treatment.
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Conclusions: Use of Trichoderma SC1 in nurseries by irrigation of the root zones of newly planted grafts is advantageous for the development of the plants.
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Recommendations for use according to ecophysiological requirements of T. atroviride SC1 and trials on the formulation The physiological properties of T. atroviride SC1 were analysed in detail by Longa et al. (2008). The strain grows at temperatures between 10 and 30°C with optimal growth at 25°C. It does not grow at 35°C or above. No growth was observed at -1°C or 5°C, but the fungus was still alive after 30 days at these temperatures and grew again during subsequent incubation at 25°C. The strain requires a relatively high water potential for growth, with an optimum at the highest tested level of 0.998. Due to these particular traits, treatments in the field should be applied preferably when day temperature is higher than 10°C for a few hours, and relative humidity is ≥ 70%, in order to ensure a fast germination and wood colonization. If day temperature does not rise above 10°C in the 7 day post treatment period a second treatment is recommended. The same applies if more than 10 mm of rain occurs as the fungal spores might be washed-off.
Report: IIIM 6.1/07 - Longa, C.M.O, Pertot, I., Tosi, S. (2008), Ecophysiological requirements and survival of a Trichoderma atroviride isolate with biocontrol potential, published report J Basic Microbiol, 48, 269-277 Guideline: no GLP/GEP: no Abstract: T. atroviride SC1, isolated from decayed hazelnut wood in northern Italy in 2000, is a promising fungal agent for biological control of soil-borne plant pathogens. The objective of this research was to characterize the biology and ecology of this fungus, in order to determine its environmental parameter tolerance levels and its behaviour in the phylloplane and soil systems. To better characterize T. atroviride SC1, the influences of pH, temperature, water activity and different nitrogen and carbon sources on its in vitro growth were evaluated. T. atroviride SC1 survival was assessed on strawberry leaves under controlled conditions in a greenhouse and in sterilized and non- sterilized soil samples kept at room temperature. Results showed that isolate SC1 is mesophilic and grows best at 25°C. The fungus tolerates a wide range of pH levels, but growth was reduced on alkaline media (pH ≥ 8). The nitrogen and carbon sources peptone, tryptone, nitrate, mannose, galactose and sucrose were associated with the highest mycelial biomass production, as compared with other potential sources of nitrogen and carbon. The fungus survived on strawberry leaves under greenhouse conditions (25 ± 2°C, RH = 60 ± 10%) and grew in sterilized soils at room temperature (23 ± 2°C) for 45 d. T. atroviride SC1 survived under the test conditions, showing a good potential for use in soil and foliar biocontrol applications.
Summary Preliminary range finding tests Different preliminary range finding tests were conducted. This included laboratory tests, greenhouse tests, semi-field and field trials. The trials were carried out in the mediterranean and the south-east EPPO zone. No preliminary range finding tests are available for the maritime EPPO zone. The trials were not done according to GLP/GEP or specific EPPO-Guidelines.
Table 6.1-1 Overview of preliminary range-finding tests Conditions of test Testing of Test report Country EPPO zone performance (year) Laboratory tests Screening the antifungal activity of T. IIIM 6.1/01 Italy - atroviride SC1 Pertot, I.
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(2011a) IIIM 6.1/02 France - Liminana et al., 2009 Semi-field and Assessing the colonization ability of the IIIM 6.1/03 Italy Mediterranean field trials strain upon treatment of pruning wounds in Pertot, I. grapevine (2009) Testing the effect of different co- IIIM 6.1/04 Italy Mediterranean formulants on the activity against plant Pertot, I. et al. pathogenic fungi in grapevine (2010) Semi-field and Field testing e.g. of the influence of IIIM 6.1/05 Italy Mediterranean field trials sticking agents on the performance of T. Pertot, I. atroviride SC1 (2011b) Field trial with application via soil IIIM 6.1/06 Hungary South-East irrigation to the root zone Dula, B. & Dula, T. (2011) Laboratory and Screeening for effects of temperature, pH, IIIM 6.1/07 Italy - greenhouse tests water activity and carbon and nitrogen Longa et al. sources on growth of T. atroviride SC1 as (2008) well as survival on leaves and in soil
T. atroviride SC1 significantly reduced the growth of Phaeomoniella chlamydospora and Phaeoacremonium aleophilum, in culture on Petri dishes. In simultaneous laboratory seeding tests, Trichoderma SC1 showed excellent antagonistic activity invading and covering the pathogens colonies. In semi-field trials using potted grapes kept open air under natural conditions in the vineyard T. atroviride SC1 was able to establish stable populations in treated wounds and to penetrate the adjacent wood tissue thereby ensuring efficient protection from infection with pathogenic fungi. In field trials T. atroviride SC1 had a good efficacy against the Esca related pathogens Pch and Pal, slightly higher than the reference product Esquive. The use of Trichoderma SC1 in nurseries by irrigation of the root zones of newly planted grafts is advantageous for the development of the plants.
IIIM 6.2 Performance assessment field studies
IIIM 6.2.1 Efficacy tests The aim of the tests was to demonstrate that Vintec (Trichoderma atroviride SC1) is effective against Esca related pathogens Pal and Pch. The efficacy trials included in this dossier were performed with Vintec containing T. atroviride SC1 compared with other products containing other strains of T. atroviride (Esquive WP).
IIIM 6.2.1/1 Efficacy trials: use 1 – Grapes, indoor (nursery)/ESCA The intended first use of Vintec is the indoor application during nursery process. This use is not considered in this BAD, since it is part of the interzonal application, submitted in June 2015 in France as the interzonal rapporteur member state. Germany is one of the concerned member states for this interzonal application.
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IIIM 6.2.1/2 Efficacy trials: use 2 – Grapes, Field (pruning)/ESCA The proposed critical GAP for Vintec on grape against Esca related pathogens in established vines during pruning procedure is 0.2 kg/ha (per application) in 100-200 L water/ha (equivalent to 1-2 g/L) with 1-2 applications per year. The water volume is given as a range (100-200 L/ha) so that the grower can adopt an appropriate volume for full wet application based on the crop situation. Therefore, the concentration ranges between 1 g/L and 2 g/L. This is recommended to provide flexibility to the grower under different conditions.. The applications should be made after pruning at BBCH 00.
A total of 8 single-year trials were carried out in the Maritime EPPO zone to investigate the effectiveness of Vintec against ESCA disease of grapevine. Trials were conducted in Austria (1 trial) and Germany (7 trials) during 2011 and 2014. In addition, 5 multi-year trials were carried out in the Maritime part of France, representing 20 single-year assessments. In total, this means 28 trials in the Maritime EPPO zone. All trials were performed by officially recognised testing facilities in accordance with the principles of Good Experimental Practice (GEP).
Eight single-year trials were carried out to investigate the effectiveness of Vintec against ESCA disease of grapevine after an artificial inoculation with the pathogens Pal and Pch (Point 6.2.1/2). Table 6.2.1/2-1 summarises the regional and temporal distribution of all effectiveness trials with Vintec. All performance assessment field studies were conducted on grapes during winter dormancy period (BBCH00), which was from the beginning of March until mid of April. Treatment with the test product was mostly performed via spray application with hand sprayers shortly after the pruning process with a spray concentration of 1 or 2 g/L according to the intended GAP with a dose rate of 0.2 kg product/ha in 100-200 L water/ha. Different application rates were tested: • 2 x 20 g/ha (equivalent to 2 x 0.1 g/L) and 2 x 200 g/ha (equivalent to 2 x 1 g/L) (2 trials, presented in detail under Point 6.2.1/2 A and B), • 1 x 120 g/ha (equivalent to 1 x 1 g/L in 120 L spray volume/ha) (2 trials, presented in detail under Point 6.2.1/2 C and D) • and 1 x 200 g/ha (equivalent to 1 x 2 g/L in 100 L spray volume/ha) (4 trials, presented in detail under Point 6.2.1/2 E to H). For a microbial plant protection product (living organism) like this, some flexibility in the determination of the dose rate applies, since the concentration of spores in the spray solution is not as important as favorable environmental conditions at the point of time of spraying.
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Table 6.2.1/2-1 Overview of efficacy trials summarized in support of the intended use of Vintec against Pal and Pch (Phaeomoniella chlamydospora and Phaeoacremonium aleophilum) Target Efficacy trials performed with BCP Crop: grapevine species 511B Application rate
Age of crop tested EPPO Test report Cultivar Pal Pch Country [years] Zone (year)
2 x 20 g/ha (2 x 0.1 g/L in 200 L spray BF13-VITVI- volume/ha) A Müller-Thurgau 6 Pal Pch Germany Maritime 19-DE01 2 x 200 g/ha (2 x 1 (2013) g/L in 200 L spray volume/ha) 2 x 20 g/ha (2 x 0.1 g/L in 200 L spray BF13-VITVI- volume/ha) B Sylvaner 4 Pal Pch Germany Maritime 20-DE01 2 x 200 g/ha (2 x 1 (2013) g/L in 200 L spray volume/ha) 1 x 120 g/ha (1 x 1 BF13-VITVI- Sauvignon C 10 - Pch g/L in 120 L spray Austria Maritime 06-AU01pch Blanc volume/ha ) (2013) 1 x 120 g/ha (1 x 1 BF13-VITVI- Sauvignon C 10 Pal - g/L in 120 L spray Austria Maritime 06-AU01pal Blanc volume/ha) (2013) BF13-VITVI- D Portuguese 5 Pal Pch 1 x 1 g/L Germany Maritime 35-DE01 (2013) Not stated (field trial in F11-VITVI- E Dornfelder Pal Pch 1 x 2 g/L Germany Maritime established 13 (2011) vineyard) BF14-VITVI- Müller Thurgau F 7 Pal Pch 1 x 2 g/L Germany Maritime 02-DE01 / SO4 (2014) BF14-VITVI- G Portuguese 6 Pal Pch 1 x 2 g/L Germany Maritime 02-DE02 (2014) 1 x 200 g/ha (1 x 2 BF14-VITVI- H Spätburgunder 11 Pal - g/L in 100 L/ha Germany Maritime 02-DE04- spray volume) PAL (2014) 1 x 200 g/ha (1 x 2 BF14-VITVI- H Spätburgunder 11 - Pch g/L in 100 L/ha Germany Maritime 02-DE04- spray volume) PCH (2014) n = n = - Total - - - - n = 10 8 8
In all trials, artificial inoculation followed one day or a very few days after treatment with Phaeomoniella chlamydospora (Pch) or Phaeoacremonium aleophilum (Pal), respectively. Although Vintec use is intended to be preventive, artificial inoculation was done already shortly after treatment to ensure exposure of the vines to spores of the disease and to challenge the performance of Vintec. As explained below, this corresponds to the use of Vintec in practice, since in practice, there will also be a rather short time window for infection from pruning and application and the start of shooting of vines. Variants were randomly distributed. For artificial inoculation, the Esca related pathogens described above, were pipetted at a concentration and amount sufficient to infect the plant successfully, 20-50 µL spore suspension with
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concentrations between 4x104 and 2x105spores/mL were used. Since there is only a short period of time between the cold weather in spring and the start of the shooting of vines at increasing temperatures, and therefore there are only a few days available for an application or inoculation, a dependency on the weather conditions during this time span exists. Especially night frost and heavy rains can influence the infection rate negatively. For this reason for protection of pathogen treated area inoculated area and to guarantee a high humidity – which improves the probability of infection with pathogens – tips of shoots were covered with finger size latex hoods or Eppendorf tubes for some days. To verify successful infection, non treated plants were inoculated with either Pal or Pch, as well. These plants were considered for the calculation of efficacy (see Abbott’s formula below). Additionally, in some trials a reference product was tested. On top of that in nearly all trials a further control variant with no inoculation of harmful species and no treatment with Vintec or reference product was established. Thus, in general the following variants were tested: 1. Untreated control: No application of test product, no inoculation 2. Control inoculated with Pch: No application of test products, only artificial inoculation with Pch 3. Control inoculated with Pal: No application of test products, only artificial inoculation with Pal 4. Vintec treatment, inoculated with Pch 5. Vintec treatment, inoculated with Pal
Around four to six months after treatment, the growing tips of the shoots (about 7-10 cm long) were cut from the plants for the estimation of disease incidence and establishment of the biocontrol agent in the laboratory (basing on presence or absence of microorganisms), Most of the laboratory analysis was performed either at DLR Rheinpfalz, Neustadt an der Weinstraße, Germany, or at Instituto Agrario S. Michele all’ Adige, Italy. A general description of laboratory analysis, relevant for the estimation of efficacy is described below. Further details are given in the individual trial summaries and their respective reports under the KIIIM number. Standard Laboratory analysis at DLR Rheinpfalz, Neustadt an der Weinstraße, Germany, and Hiebler Agricultural Engeneering Service, Austria The barks were removed from the growing tips of the shoots and after that the shoots were cut in half longitudinally. Subsequently, the tips were dipped in alcohol shortly, flamed and placed an organic malt agar (BA; 1.8% malt extract, 2% agar, 0.1% tetracycline). All samples were incubated in a growth chamber at 21 °C. Growth of pathogens (and Trichoderma) was assessed on the media. The species and the position of the fungus in the vine shoot part were recorded. For the calculation of efficacy, please refer to the Abbot’s formula, below. Laboratory analysis at Instituto Agrario S. Michele all’ Adige, Italy Before cutting, the branches were disinfected by use of ethanol (90%, 30 seconds), sodium hypochlorite (2%, 90 seconds and ethanol (90%, 30 seconds). Each branch was longitudinally cut. At different distance from the point of inoculum (0, 1.5, 1, 1.5, 2 cm) one piece of the internal wood (2-3 mm) was collected with a scalpel, each and placed on culture medium (malt extract agar, added with the bactericide chloramphenicol). Growth on pathogens was assessed to estimate the efficacy.
Calculation of efficacy Efficacy estimation based on the presence of pathogens on the shoots (outgrowth from wood pieces on culture media). A branch was considered as infected when at least one piece showed the growth of Pch or Pal, respectively. Calculation of efficacy was performed by use of Abbot’s formula, stated below:
infection of treated branches × 100 % of efficacy = 100 - infection of untreated branches
For information on the overall dose response, please refer to Table 6.2.2-1. Overall results of efficacy trials are summarised in Table 6.2.1/2-2 for Pal and Table 6.2.1/2-3 for Pch. The data indicate that the concentrations of 1 g/L and 2 g/L are comparable. In some trials there is an indication of an increase of the effectiveness with the higher rate.
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With the relatively late pruning (March to mid of April in the presented trials) it might be suspected that the bleeding of wounds could be a problem of washing out Trichoderma spores from the pruning wounds, leading to reduced or no colonization of the pruning wound. The bleeding of wounds is not explicitly evaluated in the presented trials. However, it should be noted that if there should have been any bleeding its influences are already part of the results presented below. But in general it has been noted over the years that even if some bleeding of the wounds occurs, it will not affect the colonization by Trichoderma atroviride in a negative way. There are even signs that a little moisture may increase the growth rate of the Trichoderma.
Table 6.2.1/2-2 Summary of effectiveness against Esca related pathogen Phaeoacremonium aleophilum (Pal); Maritime zone, after artificial inoculation of pathogen Pal
Efficacy Vintec Efficacy reference Number of trials (1) product (5) Infestation (2) Trial numbers Single Single mean (3) mean (3) results (4) results (4)
Efficacy achieved with 1 g Vintec/L 3 Trials: BF13-VITVI-06-AU01-PAL 80 33.5 21.9 42.9 26.0 BF13-VITVI-19 81.7 15.8 - BF13-VITVI-35-DE01 20 79.5 30.0 Efficacy achieved with 2 g Vintec/L 4 Trials: F11-VITVI-13 40.6 44.4 BF14-VITVI-02-DE01 1.1 52.6 100.0 - BF14-VITVI02-DE02 80.0 25.0 BF14-VITVI-02-DE04-PAL 24.6 40.9 (1): Number of trials in which the fungi were isolated, (2): Disease incidence of untreated control (%) (3): Mean efficacy according to Abbott (%) (4): Single trial results of efficacy according to Abbott observed (%)
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Table 6.2.1/2-3 Summary of effectiveness against Esca related pathogen Phaeomoniella chlamydospora (Pch); Maritime zone, after artificial inoculation of pathogen Pch
Efficacy Vintec Efficacy reference Number of trials (1) product (5) Infestation (2) Trial numbers Single Single mean (3) mean (3) results (4) results (4)
Efficacy achieved with 1 g Vintec/L 4 Trials: BF13-VITVI-06-AU01-PCH 93.5 50.0 53.3 BF13-VITVI-19 87.5 59.8 83.9 39.2 - BF13-VITVI-20-DE01 4.6 50.0 - BF13-VITVI-35-DE01 72 55.6 25.0 Efficacy achieved with 2 g Vintec/L 4 Trials: F11-VITVI-13 50.0 74.2 BF14-VITVI-02-DE01 21.4 52.7 81.8 - BF14-VITVI02-DE02 91.1 54.9 BF14-VITVI-02-DE04-PCH 11.1 0.0 (1): Number of trials in which the fungi were isolated, (2): Disease incidence of untreated control (%) (3): Mean efficacy according to Abbott (%) (4): Single trial results of efficacy according to Abbott observed (%)
Dose response trials (BF13-VITVI-19-DE01, BF13-VITVI-20-DE01)
A) BF13-VITVI-19-DE01
TITLE: Evaluation of treatment with Trichoderma atroviride against Esca in grapevine Trials (total/ year): 1/2013
Reference-No.: KIIIM 6.2.1/2/04
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Malterdingen, Germany
This trial was carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in vineyard against Esca related pathogens Pal and Pch. • evaluate varying product rates.
Referenced guideline(s) EPPO
PP 1/152(3) Design and analysis of efficacy evaluation trials PP 1/35(3) Phytotoxicity assessment PP 1/181(4) Conduct and reporting of efficacy evaluation trials including GEP
Test location Malterdingen (Baden-Württemberg)
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Region Maritime EPPO zone Country Germany Crop Grape Cultivar Müller-Thurgau Age of crop 6 years Trial design Randomized Complete Block Number of replicates 4 Plot size 12 m × 2 m
Formulations and applied dose rates The test product BCP511B was compared with an untreated control. No reference product was used since no plant protection product is currently authorised in Germany specifically against Esca, nor was one authorized at the time of the trial.
Details of application Test items are reported below: Product Active Formulation No. of Content of a.i. Product rate name ingredient(s) type treatments 20 g/ha (0.1 g/L or 0.1 × 1010 BCP511B T. atroviride SC1 1 x 1010 CFU/g WG CFU/L in 200 L spray 2 volume/ha) 200 g/ha (1 g/L or 1 × 1010 BCP511B T. atroviride SC1 1 x 1010 CFU/g WG CFU/L in 200 L spray 2 volume/ha)
Treatments Stage Date of treatment Date of pruning T1 BBCH 00 08.04.13 10.04.2013 T2 BBCH 02 15.04.13 10.04.2013
Details of artificial inoculations are reported below: Pathogen Pathogen rate Type of inoculation Timing of inoculation Pal 2 × 105 conidia/mL drop 2 d after T1 Pch 2 × 105 conidia/mL drop 2 d after T1
During the trial, no extreme weather conditions that could lead to anticipation of having had negative impact on the products performances occurred. This is one of the early trials when two treatments were tested in order to reduce the risk of not reaching all pruning wounds with only one treatment. Crop stage at the first application was BBCH 00 and at the time of the 2nd application BBCH was 02. Shoots of grapevine were treated with test product, two days later inoculated and 5 days later again treated with the test product. The application of the test product was conducted by spray application. Pathogens were inoculated with a pipette (drop inoculation) 2 days after the first product application.
Assessment The efficacy evaluation based on the presence or absence of the microorganisms (Pal and Pch) was conducted by DLR Rheinpfalz, Neustadt an der Weinstraße, Germany. The shoots were cut in parts and the barks were removed. Then the shoots were halved and briefly dipped in alcohol and flamed. At different depths in the wood (meaning at different distances from the pruning wound), cross sections were taken, cut in smaller pieces and placed on Biomalz-Agar (20g/L Agar, 20g/L Biomalz). All samples were incubated in an acclimatized room and the occurrence of fungi was observed. Both species and the position of the fungus in the vine shoot part were recorded.
Kind of assessment Date DAA Presence of pathogens 22.10.13 190
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Statistical analysis Trial management, data capture, statistical analysis and reporting were done with ARM9 software by Gylling data management (www.GDMDATA.com). In terms of statistics the following was performed: 1) In a first step the normality as well as the homogeneity of the data were checked in order to meet the prerequisites to do an analysis of variance. 2) In the next step an analysis of variance (AOV) was performed using the “least square estimation” method: Estimate sum of squares using least squares method to minimize sum of squared residuals. 3) Following the analysis of variance a mean separation test (Student-Newman-Keuls) was applied at a 5% significance level.
Results No natural infection with any pathogen was found in the untreated control. Re-isolation of Trichoderma in both pathogen series showed a significant rate response which was consistent to the test product amounts applied. Regarding Pal, no rate response was visible. Both treatments reduced the re-isolated pathogen in a range of 16-20%. Regarding Pch, a significant rate response against this pathogen was visible. Efficacy was high for both application rates with 51% for lower application rate and 83% for higher application rate according to re-isolated pathogen. The re-isolation ratio of Trichoderma atroviride in variants inoculated with Pal was 54.0% for the variant with lower application rate of the test product and 89.6% for the variant with the higher application rate. In variants inoculated with Pch the re-isolation ratio of Trichoderma atroviride was 47.0% for the variant with lower application rate of the test product and 85.9% for the variant with the higher application rate. For the summary of the results, please refer to Table 6.2.1/2-4:
Table 6.2.1/2-4 Summary of efficacy trial Report EPPO Untreated, Treated, Efficacy: No. of Numbe zone; Harmful Product re-isolation re-isolation of Abbott2) [%] treat- r F/G; species rate1) of harmful harmful species ments Test product N/A species 3) 3) 0.1 g/L or 0.1 × 1010 65.2% 20.2 CFU/L Pal (81.7%) 1 g/L or 1 × 1010 68.8% 15.8 BF13- Maritime; CFU/L VITVI- F; 2 0.1 g/L or 19 A 0.1 × 1010 42.5% 51.4 CFU/L Pch (87.5%) 1 g/L or 1 × 1010 14.1% 83.9 CFU/L 1) Rate of active ingredient: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis percentage of infested shoots 3) Re-isolation rate expressing the presence or absence of Pal/Pch in inner wood infected shoots
B) BF13-VITVI-20-DE01
TITLE: Evaluation of treatment with Trichoderma atroviride against Esca in grapevine Trials (total/ year): 1/2013
Reference-No.: KIIIM 6.2.1/2/05
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Bad-Kreuznach, Germany
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This trial was carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in vineyard against Esca related pathogens Pal and Pch. • evaluate varying product rates.
Referenced guideline(s) EPPO
PP 1/152(3) Design and analysis of efficacy evaluation trials PP 1/35(3) Phytotoxicity assessment PP 1/181(4) Conduct and reporting of efficacy evaluation trials including GEP
Test location Bad-Kreuznach (Rheinland-Pfalz) Region Maritime EPPO zone Country Germany Crop Grape Cultivar Sylvaner Age of crop 4 years old Trial design Randomized Complete Block Number of replicates 4 Plot size 27.72 m²
Formulations and applied dose rates The test product BCP511B was compared with an untreated control. No reference product was used since no plant protection product is currently authorised in Germany specifically against Esca, neither was one authorized at the time of the trial.
Details of application Test items are reported below: Product Active Content of Formulation No. of Product rate name ingredient(s) a.i. type treatments 1 × 1010 20 g/ha (0.1 g/L or 0.1 × 1010 BCP511B T. atroviride SC1 WG 2 CFU/g CFU/Lin 200 L spray volume/h) 200 g/ha (1 g/L or 1 × 1010 1 × 1010 BCP511B T. atroviride SC1 WG CFU/L in 200 L spray 2 CFU/g volume/ha)
Treatments Stage Date of treatment Date of pruning T1 BBCH00 08.04.13 Not stated T2 BBCH00 15.04.13 Not stated
Details of artificial inoculations are reported below: Pathogen Pathogen rate Type of inoculation Timing of inoculation Pal 2 × 105 conidia/mL drop; 20 µL/wound 2 d after T1 Pch 2 × 105 conidia/mL drop; 20 µL/wound 2 d after T1
During the trial, no extreme weather conditions that could lead to anticipation of having had negative impact on the products performances occurred. Crop stage at the first application was BBCH 00. Shoots of grapevine were treated with test product, two days later inoculated and 5 days later again treated with the test product. The application of the test product was conducted by spray application. Pathogens were inoculated with a pipette (drop inoculation).
Assessment The efficacy evaluation based on the presence or absence of the microorganisms (Pal and Pch) was conducted by DLR Rheinpfalz, Neustadt an der Weinstraße, Germany.
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Kind of assessment Date DAA Presence of pathogens 18.10.13 186
Statistical analysis Trial management, data capture, statistical analysis and reporting were done with ARM9 software by Gylling data management (www.GDMDATA.com). In terms of statistics the following was performed: 1) In a first step the normality as well as the homogeneity of the data were checked in order to meet the prerequisites to do an analysis of variance. 2) In the next step an analysis of variance (AOV) was performed using the “least square estimation” method: Estimate sum of squares using least squares method to minimize sum of squared residuals. 3) Following the analysis of variance a mean separation test (Student-Newman-Keuls) was applied at a 5% significance level.
Results No natural infection with any pathogen was found in the untreated control. Re-isolation of Trichoderma in both pathogen series showed a significant rate response which was consistent to the test product amounts applied. Against accompanying fungal pathogens (e.g. Botryosphaeria), a significant effect against undefined fungi was found. Regarding Pch, infection was very low (4.6%) disease incidence. No infection was determined, regarding Pal, most probably because the environmental conditions at the time .of the inoculation were unsuitable for the infection.
For the summary of the results, please refer to Table 6.2.1/2-5.
Table 6.2.1/2-5 Summary of efficacy trial Report EPPO Untreated, Treated, Efficacy: No. of Numbe zone; Harmful Product re-isolation re-isolation of Abbott2) [%] treat- r F/G; species rate1) of harmful harmful species ments Test product N/A species 3) 3) 0.1 g/L or 0.1 × 1010 0.0% n.a. CFU/L Pal (0%) 1 g/L or BF13- 1 × 1010 0.0% n.a. Maritime; VITVI- CFU/L F; 2 20- 0.1 g/L or A DE01 0.1 × 1010 2.5% 45.7 CFU/L Pch (4.6%) 1 g/L or 1 × 1010 2.3% 50.0 CFU/L 1) Rate of active ingredient: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis percentage of infested shoots 3) Re-isolation rate expressing the presence or absence of Pal/Pch in inner wood infected shoots n.a.: Not applicable, due to absence of pathogen infestation
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Efficacy trials (BF13-VITVI-06-AU01pch, BF13-VITVI-06-AU01pal, BF13-VITVI-35-DE01, F11- VITVI-13, BF14-VITVI-02-DE01, BF14-VITVI-02-DE02, BF14-VITVI-02-DE04-PAL, BF14- VITVI-02-DE04-PCH)
C) BF13-VITVI-06-AU01
TITLE: a) BF13-VITVI-06-AU01pch: Field test to evaluate the efficacy of BCP511B against Phaeomoniella chlamydospora (=Pch) Reference-No.: KIIIM 6.2.1/2/02 b) BF13-VITVI-06-AU01pal: Field test to evaluate the efficacy of BCP511B against Phaeoacremonium aleophilum (= Togninia minima, Pal) Reference-No.: KIIIM 6.2.1/2/03
Trials (total/ year): 2/2013
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Gamlitz, Austria
These trials were carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in vineyard against Esca related pathogens Pal and Pch.
Referenced guideline(s) EPPO
PP 1/152(4) Design and analysis of efficacy evaluation trials PP 1/35(3) Phytotoxicity assessment PP 1/181(4) Conduct and reporting of efficacy evaluation trials including GEP
Test location Gamlitz Region Maritime EPPO zone Country Austria Crop Grape Cultivar Sauvignon Blanc Age of crop 10 years Trial design Randomized Complete Block Number of replicates 3 Plot size 48 m²
Formulations and applied dose rates The test product BCP511B was compared with the reference product Esquive® and an untreated control. Although Esquive® is not registered in Austria against esca diseases it was taken as a reference since there is currently no plant protection product authorised in Austria specifically against Esca.
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Details of application Test and reference items are reported below: Trial number Product Active Content of Formulation No. of Product rate name ingredient(s) a.i. type treatments BF13-VITVI- 1 x 120 g/ha (1 g/L 06-AU01pch 1 × 1010 or 1 × 1010 CFU/L in BCP511B T. atroviride SC1 WG 1 CFU/g 120 L spray volume/ha) Esquive T. atroviride 1237 WP 4 kg/ha 1 BF13-VITVI- 1 x 120 g/ha (1 g/L 06-AU01pal 1 × 1010 or 1 × 1010 CFU/L in BCP511B T. atroviride SC1 WG 1 CFU/g 120 L spray volume/ha) Esquive T. atroviride 1237 WP 4 kg/ha 1
Trial number Stage Date of treatment Date of pruning BF13-VITVI- BBCH 00 20.03.13, after pruning 20.03.13 06-AU01pch BF13-VITVI- BBCH 00 20.03.13, after pruning 20.03.13 06-AU01pal
Details of artificial inoculations are reported below: Trial number Pathogen Inoculation rate of Type of Timing of Pathogen concentration pathogens per shoot inoculation inoculation BF13-VITVI-06- 20 µL corresponding to 2 d after T1 Pch 2 × 105 conidia/mL 20 µL AU01pch 4000 spores BF13-VITVI-06- 20 µL corresponding to 2 d after T1 Pal 2 × 105 conidia/mL drop AU01pal 4000 spores
Crop stage at the first application was BBCH 00. Shoots of grapevine were treated with test product and two days later inoculated either with Pch (trial number BF13-VITVI-06-AU01pch) or with Pal (trial number BF13-VITVI- 06-AU01pal). The application of the test and reference product was conducted by spraying. Pathogens were inoculated with a pipette (drop inoculation).
Assessment The efficacy evaluation based on the presence or absence of the microorganisms (Pal and Pch). The top of the shoots (ca. 9 cm in length) were cut and afterwards the bark was removed. The debarked top of the shoots were cut into halves, dipped into alcohol and flamed. At different depths in the wood (meaning at different distances from the pruning wound), cross sections were taken, cut in smaller pieces and plated out on bio malt-agar (1.8% Bio malt; 2% agar; 0.1% tetracyclin). All samples were then incubated at 20°C.
Kind of assessment Date DAA Presence of pathogens 24.09.13 190
Statistical analysis A mean separation test (Student-Newman-Keuls) was applied at a 5% significance level.
Results The trials were located in the southern growing area of Austria, in an area with humid climate. No problems were encountered during mixing or application of any of the product formulations under test. There were no deviations from the trials protocol as supplied by the sponsor. There were no phytotoxic effects on the target plants and no positive or negative effects on non-target plants. No effects on the incidence of pests, natural enemies or natural pollinators or wildlife were observed in these trials.
The trial on Pch (Phaeomoniella chlamydospora, BF13-VITVI-06-AU01pch) showed the following results:
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The infection on untreated inoculated modality was 93.5%. BCP511B as well as the reference product Esquive significantly reduced the Pch infection: 46.8% disease incidence on BCP511B treated plants and 43.7% disease incidence on plants treated with the reference product. Thus, the efficacy on treated plants was about 50% for BCP511B and 53% for Esquive. The re-isolation ratio of Trichoderma atroviride in the inoculated and treated variants was 59.7% in the BCP511B object and 63.7% for Esquive.
The trial on Pal (Phaeoacremonium aleophilum, BF13-VITVI-06-AU01pal) showed a high infection with pathogens on untreated modality. The infection on treated modalities were reduced: 53.2% disease incidence at BCP511B treatment and 62.5% disease incidence at Esquive treatment. Thus, the efficacy of BCP511B against Pal was higher (33.5%) than of the reference product Esquive (21.9%). The re-isolation ratio of Trichoderma atroviride was 70.2% in the BCP511B object and 45.9% for Esquive.
For the summary of the results, please refer to Table 6.2.1/2-6.
Table 6.2.1/2-6 Summary of efficacy trial Treated, EPPO Test Untreated, Efficacy Report Inoculated No. of re-isolation of zone; product re-isolation of according to Number harmful treat- harmful F/G; rate1) harmful Abbott2) [%] species ments species 3) N/A species 3) TP RP TP RP BF13- 1 g/L or VITVI- Pch 1 × 1010 1 (93.5%) 46.8% 43.7% 50.1% 53.3% 06- Maritime; CFU/L AU01pch F; BF13- A 1 g/L or VITVI- Pal 1 × 1010 1 (80.0%) 53.2% 62.5% 33.5% 21.9% 06- CFU/L AU01pal 1) Content of active ingredient in the formulated product: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis of percentage of infested shoots 3) Re-isolation rate expressing the presence or absence of Pal/Pch in inner wood infected shoots TP: Test product BCP511B RP: Reference product Esquive
D) BF13-VITVI-35-DE01 TITLE: Impact of study preparation BCP 511B of the company Belchim Crop Protection against Esca pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum – Field trial 2013
Reference-No.: KIIIM 6.2.1/2/06 Trials (total/year): 1/2013 TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Neustadt an der Weinstraße, Germany This trial was carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in grapevine against Esca related pathogens Pal and Pch.
Referenced guideline(s)
- no guideline mentioned in test report
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Test location Neustadt an der Weinstraße Region Maritime EPPO zone Country Germany Crop Grape Cultivar Portuguese Age of crop 5 years Trial design not stated Number of replicates 50 shoots Plot size not stated
Formulations and applied dose rates This study was carried out to evaluate the efficacy of BCP511B against Esca related pathogens. The test product BCP511B was compared with the reference product Esquive® and an untreated control. Although Esquive® is not registered in Germany against esca diseases it was taken as a reference since there is currently no plant protection product authorised in Germany specifically against Esca.
Details of application Test item is reported below: Formulation No. of Product Name Active ingredient(s) Content of a.i. Rate type treatments 1 g/L BCP511B T. atroviride SC1 1 × 1010 CFU/g WG 1 or 1 × 1010 CFU/L
Treatments Stage Date of treatment Date of pruning T1 BBCH 00 08.04.13, after pruning 08.04.13
Details of artificial inoculations are reported below: Pathogen Pathogen rate Type of inoculation Timing of inoculation Pal 4 × 104 spores/mL pipetting 20 µL 10.04.13 Pch 2 × 105 spores/mL pipetting 20 µL 10.04.13
Tested variants considered for the efficacy evaluation were: 1. Untreated control: No application, no inoculation 2. Control inoculated with Pch: No application of test products, only artificial inoculation with Pch 3. Control inoculated with Pal: No application of test products, only artificial inoculation with Pal 4. BCP511B inoculated with Pch 5. BCP511B inoculated with Pal 6. Esquive, inoculated with Pch 7. Esquive, inoculated with Pal
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At the beginning of the test, the shoots were marked and cut down to produce new wounds. These were then treated with the test preparations. Two days after the application of the test preparation an inoculation with the pathogens followed. Per shoot 20 µL of a spore suspension (corresponding to 4000 spores/wound) were added using a pipette. Finally the inoculation surface and the shoot tops were covered with finger stalls to guarantee a high humidity – and by this an improvement of the infection probability. At the end of the trial, all marked shoots were removed and prepared for a microbiological analysis.
Assessment The shoots were cut in parts and the barks were removed. Then the shoots were halved and briefly dipped in alcohol, flamed and placed on Biomalz-Agar (20g/L Agar, 20g/L Biomalz). All samples were incubated in an acclimatized room and the occurrence of fungi was observed. Both species and the position of the fungus in the vine shoot part were recorded.
Kind of assessment Date Presence of pathogens 26.08.13-06.09.13
Statistical analysis No information on statistical analysis is stated in this report.
Results As expected, the pathogens Pch and Pal could not be detected in the control shoots (not treated, not inoculated). In the inoculated control shoots, the re-isolation rate on the number of inoculated shoots amounted to 72% for Pch and to 20%, i.e. much lower, for Pal. In most cases, the pathogens Pch and Pal could be detected at about 1-2 cm from the growing tips, exceptionally however propagating up to about 2.5 cm from the wound surface. With an efficiency of about 80%, the test item BCP511B proved to be more effective against Pal than against Pch (55.6%). The pre-treatment with the reference product was much lower in effectiveness compared to BCP511B. Colonization of T. atroviride on treated grapevine was between 63% to 66% for BCP511B.
For the summary of the results, please refer to Table 6.2.1/2-7.
Table 6.2.1/2-7 Summary of efficacy trial Treated, EPPO re-isolation of Efficacy: Abbott2), zone; Rate of Untreated Report Harmful No. of harmful species infected shoots3) [%] active infected Number F/G; species treatments 3) ingredient1) shoots3) N/A TP RP TP RP
BF13- Maritime; Pal 1 g/L (20%) 4.1% 14.0% 79.5 30 VITVI- F; or 1 × 1010 1 35- Pch CFU/L (72%) 32.0% 54.0% 55.6 25 DE01 A 1) Content of active ingredient in the formulated product: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis of percentage of infested shoots
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3) Re-isolation rate expressing the presence or absence of Pal/Pch in inner wood infected shoots TP: Test product BCP511B RP: Reference product Esquive
E) Field testing 2011 (DLR) / F11-VITVI-13 TITLE: Efficacy of various test preparations of the Belchim Crop Protection company against the Esca pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum
Reference-No.: KIIIM 6.2.1/2/01
Trials (total/ year): 1/2011
TARGET: Esca related fungi Pal and Pch
Locations (Trial Site): Neustadt an der Weinstraße, Germany
This trial was carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in vineyard against Esca related pathogens Pal and Pch. • compare different adjuvants.
Referenced guideline(s) - no guidelines mentioned in the test report
Test location Neustadt a.d. Weinstraße Region Maritime EPPO zone Country Germany Crop Grape Cultivar Dornfelder Age of crop Not stated Trial design Randomized blocks Number of replicates 3 Plot size 10 vine stocks with 3 wounds each per plot Formulations and applied dose rates The test product BCP511B was compared with an untreated control. No reference product was used since no plant protection product is currently authorised in Germany specifically against Esca, neither was one registered at the time of the study.
Details of application Test item is reported below: Formulation No. of Product Name Active ingredient(s) Content of a.i. Rate type treatments 2 g/L or BCP511B T. atroviride SC1 1 × 1010 CFU/g WG 1 2 × 1010 CFU/L
Treatments Stage Date of treatment Date of pruning T1 BBCH 00 02.03.11, after pruning 02.03.11
Details of artificial inoculations are reported below:
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Pathogen Pathogen rate Type of inoculation Timing of inoculation Pal 5 × 104 spores/mL pipetting 50 µL 03.03.11 Pch 5 × 104 spores/mL pipetting 50 µL 03.03.11
At the beginning of the test, the shoots were marked and cut down to produce new wounds. These were then treated with the test preparations. For this purpose, each object of 10 vine stocks with 3 wounds per plant was treated via spray application with ca. 50 µL of spore suspension, containing 2 g product/L equivalent with 2 × 1010 CFU/L. One day after the application of the test preparation an inoculation with the pathogens followed on the control objects (see object 2 and 3 in the description of the tested variants below) and treated objects (see object 4 and 5 in the description of test variants below). Per shoot 50 µL of a spore suspension (50 × 104 spores/mL) were added using a pipette. Finally the inoculation surface and the shoot tops were covered by means of 1.5 mL or 2 mL Eppendorf- Tubes, or with latex covers, to guarantee a high humidity – and by this an improvement of the infection probability by Phaeomoniella chlamydospora and Phaeoacremonium aleophilum. At the end of the trial, all marked shoots were removed and prepared for a microbiological analysis.
Tested variants considered for the efficacy evaluation were: 1. Untreated control: No application, no inoculation 2. Control inoculated with Pch: No application of test products, only artificial inoculation with Pch 3. Control inoculated with Pal: No application of test products, only artificial inoculation with Pal 4. BCP511B inoculated with Pch 5. BCP511B inoculated with Pal
Assessment The shoots were cut in parts and the barks were removed. Then the shoots were halved and briefly dipped in alcohol, flamed and placed on Biomalz-Agar (20g/L Agar, 20g/L Biomalz). All samples were incubated in an acclimatized room and the occurrence of fungi was observed. Both species and the position of the fungus in the vine shoot part were recorded.
Kind of assessment Date Presence of pathogens 25.-31.08.11
Statistical analysis No information on statistical analysis is given in this report. Results The pathogens Pch and Pal could, as expected, not be detected in the non-inoculated control shoots. In the inoculated controls (no treatment with the test product, only artificial inoculation with the pathogen) the re-isolation ratio found for Pch was at 50%, for Pal at 40.6%. Overall, the weather conditions at the time of the application or inoculation during the year 2011 can be considered very favourable for the pathogens. In most cases the pathogens Pch and Pal could be found at a distance of ca. 1-2 cm from the top of the shoot, with a few exceptions however up to a distance of ca. 7 cm measured starting from the surface of the wound. In the objects treated with BCP511B and artificially inoculated with Pch or Pal, the re-isolation ratio found for Pch was 12.9% and for Pal 22.6%. Compared to the untreated control with artificial inoculation of the pathogens, that results in an efficacy of 74.2% of the test product BCP511B against Pch, and an efficacy of BCP511B against Pal of 44.4%. In the objects treated with BCP511B alone, the re-isolation ratio of Trichoderma atroviride was 64.5% for both Pal and Pch inoculated objects.
For the summary of the results, please refer to Table 6.2.1/2-8 below.
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Table 6.2.1/2-8 Summary of efficacy trial EPPO Untreated, Treated, Efficacy of test Report Inoculated Test No. of zone; re-isolation of re-isolation of product Number harmful product treat- F/G; harmful harmful according to species rate1) ments N/A species 3) species 3) Abbott2) [%] Field Testing Pal 2 g/L (40.6%) 22.6% 44.4 Maritime 2011 or 2 × G; 1 (DLR) / 1010 A F11- Pch CFU/L (50%) 12.9% 74.2 VITVI-13 1) Content of active ingredient in the formulated product: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis of percentage of infested shoots 3) Re-isolation rate expressing the presence or absence of Pal/Pch in inner wood of infected shoots.
F) BF14-VITVI-02-DE01 TITLE: Evaluation of the efficacy of BCP511B against Pal and Pch in established vines
Reference-No.: KIIIM 6.2.1/2/07 Trials (total/year): 1/2014 TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Veitshöchheim, Germany This trial was carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in vineyard against Esca related pathogens Pal and Pch.
Referenced guideline(s)
- No guidelines mentioned in the test report.
Formulations and applied dose rates The test product BCP511B was compared with an untreated control. No reference product was used since no plant protection product is currently authorised in Germany specifically against Esca, neither was one authorised at the time of the trial.
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Test location Veitshöchheim Region Maritime EPPO zone Country Germany Crop Grape Cultivar Müller Thurgau / SO4 Age of crop 7 years Trial design Randomized blocks Number of replicates 3 Plot size 30 vines
Details of application Test items are reported below:
Formulation No. of Product name Active ingredient(s) Content of a.i. Rate type treatments
2 g/L BCP511B T. atroviride SC1 1 × 1010 CFU/g WG 1 or 2 × 1010 CFU/L
Treatments Stage Date of treatment Date of pruning
T1 BBCH 05-07 04.04.2014 04.04.2014
Details of artificial inoculations are reported below:
Type of Pathogen Pathogen rate Timing of inoculation inoculation
Pal 2 × 105 conidia/mL, 20 µL pipette 07.04.14 Pch 2 × 105 conidia/mL, 20 µL pipette 07.04.14
The vineyard was winter pruned to two canes per vine. One of these two canes in all plots was shorted to 5-6 buds. Fresh wounds were treated with BCP 511B. Inoculation was performed 3 days after treatment by pipetting the spore suspension.
Assessment The efficacy evaluation was based on the presence or absence of the microorganisms (Pal and Pch), above and below the grafting point, in the treated grapevine plants compared to untreated. Wood pieces were sampled on 06.10.2014. Assessment was performed by Fondazione E. Mach. General assessment procedure is described below: Under sterile hood each branch was longitudinally cut with scissors, one piece (2-3 mm) of internal wood was collected with a scalpel at different distance from the point of grafting, from both sides (0, 1, 2, -1, -2 cm) and placed on culture medium. Results were firstly expressed as the number of branches infected by Pal or Pch versus the total number of analysed branches and then the percentage of infection was calculated. The efficacy was calculated by Abbott’s formula.
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Thus, the method judges the efficacy of the treatment through the percentage of infected branches per treatment. A branch is considered infected when at least one piece or one slice shows the isolation of Pal and Pch. This is a stringent criterion of evaluation for efficacy.
Statistical analysis No information on statistical analysis is stated.
Results The level of infected plants by Pal and Pch in untreated-inoculated-control plots reached 1.1% and 21.4% for Pal and Pch, respectively. Disease incidence on plants was zero and 3.9% on plants treated with Pal and Pch, respectively. Thus, efficacy was high against both pathogens. Re-isolation of Trichoderma atroviride SC1 was 46.42% and 57.12% in variants treated with BCP 511B and inoculated with Pal and Pch respectively. For the summary of the results, please refer to Table 6.2.1/2-9.
Table 6.2.1/2-9 Summary of efficacy trial Untreated, Treated, EPPO zone; No. of Report Harmful Product re-isolation re-isolation of Efficacy: F/G; treat- Number species rate1) of harmful harmful Abbott2) [%] ments N/A species 3) species 3)
2 g/L BF14- Maritime; Pal (1.1%) 0% 100 or 2 × VITVI- F; 1 1010 02-DE01 Pch (21.4%) 3.9% 81.8 A CFU/L 1) Rate of active ingredient: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis of data presented in the report (percentage of invested shoots), wood pieces were taken 0, 0.5, 1, 1.5 and 2 cm from the point of inoculum, presence of at least one infected wood piece 3) Re-isolation rate expressing the presence or absence of Pal/Pch in internal wood of untreated, inoculated branches (untreated control).
G) BF14-VITVI-02-DE02 TITLE: Efficacy of test product BCP511B of Belchim Crop Protection against Esca pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum
Reference-No.: KIIIM 6.2.1/2/08
Trials (total/ year): 1/2014
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Neustadt/Weinstraße, Germany
This trial was carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in vineyard against Esca related pathogens Pal and Pch.
Referenced guideline(s) EPPO
- no guidelines mentioned in the test report
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Test location Neustadt/Weinstraße (Rheinland-Pfalz) Region Maritime EPPO zone Country Germany Crop Grape Cultivar Portugieser Age of crop 6 years Trial design randomized (no further information) Number of replicates 90 shoots Plot size not stated
Formulations and applied dose rates The test product BCP511B was compared with an untreated control. No reference product was used since no plant protection product is currently authorised in Germany specifically against Esca, neither was one authorised at the time of the trial.
Details of application Test items are reported below: Active Content of Formulation No. of Product name Product rate ingredient(s) a.i. type treatments 1 x 200 g/ha (2 g/L or 2 × 1 x 1010 BCP511B T. atroviride SC1 WG 1010 CFU/L in 100 L/ha 1 CFU/g spray volume)
Treatments Stage Date of treatment Tate of pruning T1 BBCH 00 17.03.2014 17.03.2014
Details of artificial inoculations are reported below: Type of Timing of inoculation Pathogen Pathogen rate inoculation Pal 2 × 105 conidia/mL drop 2 d after T1 Pch 2 × 105 conidia/mL drop 2 d after T1
Several steps for trial implementation and gathering of data were taken in a given sequence. At first a rough pre- cutting of grapes was performed to remove unsuitable shoots resp. to adjust remaining shoots to suitable length (approx. 30 cm, min of 3 eyes). At start of trial shoots were marked and cut to produce fresh wounds. Those were treated with test product BCP 511B by spraying. Variants were randomly distributed. Two days after application of test product inoculation with pathogen was performed. Via pipette 20 µL of spore suspension (equivalent to 4000 spores/wound) were transferred to wound. For protection of inoculated area and to guarantee a high humidity – which improves probability of infection – tips of shoots were covered with finger size latex hoods for two days. At end of trial all marked shoots were removed, cut and prepared for microbiological analysis.
Assessment The efficacy evaluation based on the presence or absence of the microorganisms (Pal and Pch) was performed. Three samplings were obtained. However, only the third and most extensive sampling is considered here. It was performed 6 months after inoculation. Tips of shoots were cut (approx. 9 cm lengths) and completely stripped. After that approx. 5 mm thick slices were taken at given distance from tip (0,5 cm; 1,0 cm and 2,0 cm), breamed and placed on Malt extract agar (BA; 1,8% Malt extract , 2% Agar, 0,1 % Tetracycline). All samples were incubated in a dark growth chamber at 21 °C and growth of Trichoderma, as well as Pal and Pch were assessed at different times (7d, 14d).
Kind of assessment Date Presence of pathogens 23.09.-30.10.2014
Statistical analysis:
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Not stated
Results Weather conditions at beginning of trial were considered to be beneficial as a moderate mean daily temperature of 10°C was recorded. Application of test product and inoculation were performed on days without almost no precipitation. After removal of hoods from shoots, temperature remained definitely above 0 °C giving favourable conditions for spore germination and growth of fungi.
Re-isolation rate referring to number of inoculated shoots (disease incidence) was 80 % for Pal and 91 % for Pch. Efficacies referring to disease incidence were 25 % for Pal and 55 % for Pch. Efficacies referring to disease severity (re-isolation rate in sample pieces per slice and shoot) was 33 % for Pal and 77 % for Pch (data is not presented here).
Frequency of re-isolation decreased with distance to site of inoculation (tip).
Test product BCP 511B was more effective against Pch compared to Pal. In German wine-growing areas Pal is the less important pathogen of the two.
For the summary of the results, please refer to Table 6.2.1/2-10.
Table 6.2.1/2-10 Summary of efficacy trial Untreated, EPPO Treated, Report Product No. of re- zone; Harmful re-isolation of Efficacy: Number rate1) treat- isolation of F/G; species harmful Abbott2) [%] [g/L] ments harmful N/A species 3) species 3) BF14- Maritime; Pal 2 g/L (80.0%) 60.0% 25.0 VITVI-02- F; or 2 × 1010 1 DE02 A Pch CFU/L (91.1%) 41.1% 54.9 1) Rate of active ingredient: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis of data presented in the report (percentage of invested shoots), wood pieces were taken 0, 0.5, 1, 1.5 and 2 cm from the point of inoculum, presence of at least one infected wood piece 3) Re-isolation rate expressing the presence or absence of Pal/Pch in internal wood of untreated, inoculated branches (untreated control)
H) BF14-VITVI-02-DE04
TITLE a): BF14-VITVI-02-DE04-PAL: Evaluation of treatment with Trichoderma atroviride against ESCA in grapevine Reference-No.: KIIIM 6.2.1/2/09
TITLE b): BF14-VITVI-02-DE04-PCH: Evaluation of treatment with Trichoderma atroviride against ESCA in grapevine Reference-No.: KIIIM 6.2.1/2/10
Trials (total/ year): 2/2014
TARGET: Esca related fungus Pal Locations (Trial Site): Endingen-Kiechlingsbergen, Germany
This trial was carried out to: • evaluate the efficacy of Trichoderma atroviride SC1 in vineyard against Esca related pathogen Pal.
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Referenced guideline(s) EPPO
PP 1/152(3) Design and analysis of efficacy evaluation trials PP1/181(3) Conduct and reporting of efficacy evaluation trials including GEP PP 1/135(3) Phytotoxicity assessment
Test location Endingen-Kichlingsbergen (Baden-Württemberg) Region Maritime EPPO zone Country Germany Crop Grape Cultivar Spätburgunder Age of crop 11 years Trial design Randomized Complete Block Number of replicates 3 Plot size 75 m²
Formulations and applied dose rates The test product BCP511B was compared with an untreated control. No reference product was used since no plant protection product is currently authorised in Germany specifically against Esca, neither was one authorised at the time of the trial.
Details of application Test items are reported below: Product Active Formulation No. of Content of a.i. Product rate name ingredient(s) type treatments 1 x 200 g/ha (2 g/L or 2 × 1010 CFU/L in BCP511B T. atroviride SC1 not stated WG 1 100 L/ha spray volume)
Treatments Stage Date of treatment Date of pruning T1 BBCH 00 19.03.2014 not stated
Details of artificial inoculations are reported below: Type of Pathogen Pathogen rate Timing of inoculation inoculation Pal 2 × 105 conidia/mL drop 27.03.2014 Pch 2 × 105 conidia/mL drop 27.03.2014
Branches of VITVI were inoculated with ESCA pathogens Pal or Pch, respectively. For treatment 2 those branches had been treated with BCP511B – active ingredient Trichoderma atroviride strain SC1 – before inoculation. In surrounding plots of trial a few trees were treated only with BCP115B (treatment 3) to verify establishment of BCP511B and to verify that vineyard was free of natural pathogens.
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Assessment Three months after application a few samples were taken from treatment 3 (only treated with BCP115B). At end of season tips of marked branches of treatments 1 and 2 were cut and analyzed in laboratory. These data were not generated by Martin Feldversuchswesen, but they are summarized in the same report. Laboratory data were assessed at DLR Rheinpfalz.
Kind of assessment Date Presence of pathogens 13.10.2014
Statistical analysis: Trial management, data capture, statistical analysis and reporting have been done with ARM9 software by Gylling data management (www.GDMDATA.com).In terms of statistics the following was performed: 1) In a first step the normality as well as the homogeneity of the data are checked in order to meet the prerequisites to do an analysis of variance. 2) In the next step an Analysis of variance (AOV) was performed using the “least square estimation” method: Estimate sum of squares using least squares method (sometimes called Linear Model) to minimize sum of squared residuals. 3) Following the Analysis of variance a mean separation test (Student-Newman-Keuls) was applied at a 5% significance level.
Results There were no problems in terms of product handling during preparation of the spray solution or application. Products dissolved without any problems. No problems with foam were observed. All treatments were fully selective – there were no observations of phytotoxicity in any treatment at any assessment timing. There were no effects observed on non target organisms. At both trials, Trichoderma atroviride could be re-isolated from the wood, indication effective colonization. Regarding Pal infestation, artificial inoculation led to a medium disease incidence of about 25%. Application of BCP511B reduced the disease incidence to 15% on treated plants. Thus, the efficacy of BCP511B was calculated to be 50%. Regarding Pch infestation, no effective control was detected. Moreover, Pch infestation was low (11%).
For the summary of the results, please refer to Table 6.2.1/2-11.
Table 6.2.1/2-11 Summary of efficacy trial Untreated, EPPO Treated, Report Harmf Product No. of re- zone; re-isolation of Efficacy: Number ul rate1 treat- isolation F/G; harmful species Abbott2) [%] species ments of harmful N/A 3) species 3) BF14-VITVI- 2 g/L Maritime; Pal (24.6%) 14.52% 40.9 02-DE04-PAL or 2 × F; 1 BF14-VITVI- 1010 A Pch (11.11%) 11.43% 0 02-DE04-PCH CFU/L 1) Rate of active ingredient: 1 × 1013 CFU/kg 2) Abbott efficacy was calculated on the basis percentage of infested shoots 3) Re-isolation rate expressing the presence or absence of Pal/Pch in inner wood infected shoots
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IIIM 6.2.1/3 Efficacy trials: Long term studies – Grapes, Nursery and/or Field/ESCA Since 2011, five long term studies have been performed to evaluate the efficacy of the product BCP511B or the active ingredient T. atroviride SC1 on grapes. Studies were conducted over multiple years, starting during pruning process (4 trials) or during nursery process (1 trial) and were continued during the following years. Trials were conducted in France in the maritime EPPO zone. Multi-year trials started in 2011 and continued until 2016. The results of the first 4 years (2011-2014) of trials are presented below. In general, no artificial inoculation was performed at multi-year trials. Hence, infection with ESCA related pathogens was very low and trials could not demonstrate efficacy of BCP511B (Vintec). Nevertheless, these data demonstrate the good colonization of T. atroviride SC1 on grape as well as preventive control of pathogens. Overall results showed a low Esca disease pressure on grapevine plants and very low infestation with Pal and Pch, hence no clear efficacy of Vintec could be estimated. Nevertheless, a clear reduction of pathogen, especially Pch, could be determined. Furthermore, the application of Vintec enhanced clearly the colonisation of Trichoderma.
A) MYT-02 TITLE: Vascular disease caused by Phaeomoniella chlamydospora and Phaeoacremonium aleophilum associated with Esca disease / VINE NURSERY
Reference-No.: KIIIM 6.2.1/3/01 Trials (total/ year): 4/2011-2014
Year Trial location Trial number in report MYT-02 2011 (initiation of trial) Nursery, Sainte Terre, France F11-VITVI-02-FR03 2012 Vineyard, Genissac, France BF12-VITVI-04 2013 Vineyard, Genissac, France BF13-VIITVI-09-FR02 2014 Vineyard, Genissac, France BF14-VITVI-09-FR02
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Sainte Terre, France (nursery) (Maritime EPPO zone) and Genissac, France (vineyard) (Maritime EPPO zone). Plants were harvested after the first season at the nursery and planted in the vineyard in 2012. This trial was carried out to • evaluate the long-term efficacy of T. atroviride SC1 against grapevine trunk diseases Esca and Eutypiosis (by E. lata). • evaluate the efficacy of T. atroviride SC1 alone or in combination with adjuvants. However, these adjuvants did not show efficacy during evaluation process over the years. Thus, data of adjuvants should not be considered.
Relevant guideline(s)
2011-2012 no guideline stated 2013-2014 PP 1/135(3), PP 1/152 (3), PP 1/181(3)
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Test location Sainte Terre, France (nursery) and Genissac, France (vineyard) Region Maritime EPPO zone Country France Crop Grape Cultivar Cabernet Sauvignon Trial design Fisher blocks Nursery: 2 Number of replicates Vineyard: 4 Nursery: 4 rows of 22.5 m Plot size Vineyard: 202.3 m²
Formulations and applied dose rates The test product BCP511B applied alone (2013, 2014) or combined with adjuvants (2011 and 2012) and compared to untreated controls.
Details of application The products were applied as summarized in the table below.
Product rate No. of Date of Year Active ingredient(s) Timing of treatment [g/L]1) treatments treatment
untreated - A: After harvest of canes 22.02.11 BCP511B 2 2011 3 B: before stratification 06.04.11 + BCP428D 2 C: before planting 11.05.11 + BCP423D 2 untreated - After cutting of roots and before 2012 1 03.06.12 BCP511B 2 planting + BCP428D 2
untreated - 2013 1 After pruning 20.03.13 BCP511B 1
untreated - 2014 1 After pruning 21.03.14 BCP511B 1 1) 1 g/L corresponds to 1 × 1010 CFU/L
Details of artificial inoculations: The grapevine plants were naturally infected. An artificial inoculation with pathogens was not performed.
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Assessment Assessment of presence on wood pieces in Year Assessment of Symptoms in field laboratory
Assessment of plant vigor1, plant death rate2 and Laboratory assessment of disease incidence Pal and 2011 phytotoxicity on plants Pch, as well as Trichoderma colonization Assessment of plant vigor1, plant death rate2 and 2012 No assessment wood disease symptoms3
2013 Assessment of dead/missing or symptomatic Laboratory assessment of disease incidence Pal and plants Pch, as well as Trichoderma colonization 2014
1 Plant vigor (0 – 10 scale, 0: dead plants, 5: moderate vigor, 10: strong vigor) 2 Plant death rate based on 450 plants 3 Wood disease symptoms assessed on plant foliage on 75 plants
Statistical analysis Information on statistical analysis is not stated.
Results In 2011, no Pal infection was detected. Pch infestation was about 20% on untreated plants and zero on treated. Trichoderma colonization was 92% on treated plants (4% were detected on untreated plants). No differences of plant vigor and death rate could be observed between untreated and treated modalities. In 2012, no laboratory assessment was obtained. Neither any symptoms, nor dead plants were detected in untreated and treated modalities. Thus no efficacy could be estimated. In 2013, slightly Pch infections were detected on untreated modalities. Nevertheless, the infestation on untreated modalities was much lower (1.7%). Thus, the efficacy on Pch was estimated to be 59%. Because of no disease pressure of Pal, no efficacy on this pathogen could be calculated. Trichoderma colonization was clearly higher than in the untreated modality (10%). In 2014, Pal infestation was detected. However it was very low (0.8%) in untreated modalities and zero in treated modalities (efficacy 100%). Pch infestation was a bit higher (7.5%). Nevertheless, BCP511B application clearly reduced Pch infestation. Thus the efficacy on Pch was 89%. From the overall results it can be concluded, the disease pressure was very low over the four years of application. Nevertheless a clear reduction of pathogens, especially Pch could be determined. Furthermore, application of BCP511B enhanced clearly the colonization of Trichoderma. The highest Trichoderma colonization was observed by nursery application of grafted shoots. For the summary of the results, please refer to Table 6.2.1/3-1.
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Table 6.2.1/3-1 Summary of efficacy trial Efficacy: Abbott2), Coloni- Report Application details Assessment details infected zation Number, shoots3) Subordinated [%] Modality report Date numbers, Product vigor; Timing of Plant Plant rate death; Symptoms Pal Pch SC1 Year treatments vigor death [g/L]1) symptoms; infection
Untreated - T2: 9.0 25.3 - (0) (20) 4 22.02.11 MYT-02, 18.07.11; F11-VITVI- BCP511B T3: 13.12.11; 02-FR03, + 06.04.11 -; 2011 BCP423D 2 +2 +2 23.01.12 9.0 24 - * 100 92 + T4: BCP428D 11.05.11
MYT-02, Untreated - 05.09.12; 7.9 0 0 - - - BF12-VITVI- BCP511B T4: 05.09.12; 04, + 2 + 2 03.06.12 05.09.12; 7.9 0 0 - - - 2012 BCP428D -
MYT-02, Untreated - -; - 0 0 0 (3.4) 1.7 BF13-VITVI- 12.09.13; 20.03.13 09-FR02, 12.09.13; BCP511B 1 - 0 0 * 58.8 10.0 2013 03.09.13
MYT-02, Untreated - -; - 0 0 (0.8) (7.5) 0.0 BF14-VITVI- 16.09.14; 21.03.14 09-FR02, 16.09.14; BCP511B 1 - 0 0.2 100 89.3 29.5 2014 12.09.14 1) 1 g/L corresponds to 1 × 1010 CFU/L 2) Abbott efficacy was calculated on the basis of data presented in the report (percentage of infested shoots) 3) Presence or absence of Pal/Pch in internal wood of treated branches, wood pieces were taken 0, 0.5, 1, 1.5 and 2 cm from the point of inoculum, presence of at least one infected wood piece (Untreated control: mean values presence of the pathogen) * no infestation on untreated modality (no calculation of efficacy)
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B) MYT-09 TITLE: Fungicide efficacy against the pathogens related to Esca wood disease on grapevine
Reference-No.: KIIIM 6.2.1/3/02 Trials (total/ year): 4/2011-2014 Trials belonging to one multiyear trial:
Year Trial number in report MYT-09 2011(initiation of trial) F11-VITVI-18-FR01 2012 BF12-VITVI-11 2013 BF13-VITVI-15-FR01 2014 BF14-VITVI-15-FR01
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Saint Vincent de Paul, France, Maritime EPPO zone This trial was carried out to • evaluate the long-term efficacy of T. atroviride SC1 against grapevine trunk diseases Esca and Eutypiosis (by E. lata). • evaluate the efficacy of the product when applied at different application timings
Relevant guideline(s)
- no guideline
Test location Saint Vincent de Paul (Bordeaux) Region Maritime EPPO zone Country France Crop Grape Cultivar Cabernet Sauvignon Age of crop in the first year of trial 23 years Trial design - Number of replicates 10 Plot size w, l, other 40 plants per plot (in 2010)
Formulations and applied dose rates The test product BCP511B was compared to an untreated control.
Details of application The products were applied as summarized in the table below.
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Product No. of Year Active ingredient(s) Timing of treatment Date of treatment rate1) treatments T. atroviride SC1 0.8 g/L 1 24 h after pruning 30.03.11 2011 A: 24 h after pruning A: 30.03.11 T. atroviride SC1 0.8 g/L 2 B: 7 d after pruning B: 06.04.11 T. atroviride SC1 0.66 g/L 1 24 h after pruning 08.03.12 2012 A: 24 h after pruning A: 08.03.12 T. atroviride SC1 0.66 g/L 2 B: 7 d after pruning B: 15.03.12 T. atroviride SC1 1 g/L 1 48 h after pruning 11.03.13 2013 T. atroviride SC1 1 g/L 1 15 d after pruning 26.03.13 T. atroviride SC1 1 g/L 1 24 h after pruning 14.03.14 2014 T. atroviride SC1 1 g/L 1 14 d after pruning 28.03.14 1) Product rate 2011: 0.4 kg/ha in 500 L/ha (80g/hL); 2012: 0.2 kg/ha in 300 L/ha (66g/hL); 1 g/L corresponds to 1 × 1010 CFU/L
Details of artificial inoculations: The grapevine plants were naturally infected. An artificial inoculation with pathogens was not performed. The trial was set up in the Bordeaux area, on a Cabernet sauvignon variety with SO4 rootstock. Their association favours the expression of trunk diseases. The 24-year-old vineyard presents regularly symptoms of trunk diseases.
Assessment
Assessment of presence on wood pieces Year Assessment of Symptoms in field in laboratory
2011 Plants with Esca symptoms localised No assessment
Laboratory assessment of disease Location of the missing, dead, alive, restored plants and 2012 incidence Pal and Pch, as well as plants with Esca or Eutypiosis symptoms Trichoderma colonization Assessment Esca symptoms on leaves: scale (1= light symptoms (small spots on leaf blade with chlorosis and sometimes with necrosis), 2 = strong symptoms (tiger-stripes and/or spots in all the plant), 3 Laboratory assessment of disease 2013 = vine with Esca/BDA as apoplexy form) incidence Pal and Pch, as well as And on grapes (only the plants with symptoms on the leaves Trichoderma colonization. were assessed on grapes): scale (1 = no symptoms, 2 = incipient symptoms of black measles, 3 = manifestly symptoms of black measles, 4 = berries dry up) Assessment Esca symptoms: on leaves: scale (Class 0 = no symptoms, Class 1= light symptoms (small spots on leaf blade with chlorosis and sometimes with necrosis), Class 2 = strong symptoms (tiger- Laboratory assessment of disease 2014 stripes and/or spots in all the plant), Class 3 = vine with incidence Pal and Pch, as well as Esca/BDA as apoplexy form) Trichoderma colonization. And on grapes (only the plants with symptoms on the leaves were assessed on grapes): scale (Class 1 = no symptoms, Class 2 = incipient symptoms of black measles, Class 3 = manifestly symptoms of black measles, Class 4 = berries dry
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up)
Statistical analysis After BARTLETT test, when necessary, the results on frequency were transformed into Arcsine square root to be submitted to a statistical analysis (ANOVA). The classification of the average values was done according to the test of the average value comparison of NEWMAN-KEULS. The statistical analysis was done with the ARM software (Agriculture Research Manager).
Results In 2011, a weak attack of trunk diseases was observed. BCP511B, applied (first year) 24 hours after the pruning, showed a good efficacy against ESCA. The second application, done one week after the first one, did not increase significantly the BCP511B efficacy. In 2012, the symptoms of Esca, even if low, were more important than those of the year before. None of the BCP511B treatments showed a significant efficacy. There was no Pal infestation on untreated modalities. Thus, no efficacy could be estimated for presence of pathogens on wood pieces. The Pch infestation on untreated modalities was very low (5% presence on wood pieces). The results therefore do not provide reliable information on efficacy. As expected, the colonization by T. atroviride was higher on treated plants, in comparison to untreated. In 2013, the percentage of attacked plants with Esca (12.7 % in the untreated plots), was more important than the year before. BCP511B, applied at both timings, showed a similar significant efficacy on leaves, while no efficacy could be significantly proven on grapes. The colonization by T. atroviride was higher on treated plants, in comparison to untreated. Whereas, the colonization on twice-treated plants was much lower (4%) than on single-treated plants (36%). In 2014, the Esca on leaf, the percentage of attacked plants was still important this year with 13.9 % attack in the untreated plots. BCP511B, applied at both timings, showed significant efficacy. Concerning the Esca on grape, the percentage of attacked plants increased to 6.8 % in the untreated plots. BCP511B, applied at both timings, showed significant efficacy. As in the years before, the presence of pathogens was extremely low: 1.1% Pal and Pch on untreated modalities. Thus, the results do not provide reliable information.
In none year, no phytotoxicity symptoms were observed in the vine plants. For the summary of the results, please refer to Table 6.2.1/3-2.
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Table 6.2.1/3-2 Summary of efficacy trial Efficacy: Report Efficacy: Abbott2), Coloni- Number Application details Assessment Abbott2), attack3) infected zation on: [%] shoots4) Subordinated Modality leaf; [%] report grape; numbers Product Date of 1) wood pieces Esca Esca on rate treat- Pal Pch SC1 Year on leaf grape [g/L] ments Untreated - - (3.5) 1 application MYT-09, 03.10.11; (24 h after 0.8 30.03.11 - 62.9 F11-VITVI-18- pruning) -; - FR01 2011 2 applications 30.03.11 - (24 h and 7 d 0.8 - 62.9 after pruning) 06.04.11 Untreated - - - (6.6) (0.0) (5.0) 2.5 1 application MYT-09, 25.06.12; (24 h after 0.66 08.03.12 - 28.3 * 0 10.0 BF12-VITVI- pruning) 25.06.12; 11, 2012 2 applications 08.03.12, 22.11.12 (24 h and 7 d 0.66 - 9.1 * 0 10.0 after pruning) 15.03.12 Untreated - - (12.7) (5.9) (0.0) (2.0) 4.0 1 application MYT-09, 17.06.13; (48 h after 1.0 11.03.13 64.3 48.3 * 0 36.5 BF13-VITVI- pruning) 17.06.13; 15-FR01, 2013 1 application 30.09.13 (15 d after 1.0 26.03.13 54.7 35.8 * 100 4.0 pruning) Untreated - - (13.9) (6.8) (1.1) (1.1) 0 1 application MYT-09, 30.06.14; (24 h after 1.0 14.03.14 41.8 57.7 100 100 3.1 BF14-VITVI- pruning) 15.09.14; 15-FR01, 2014 1 application 22.09.14 (14 d after 1.0 28.03.14 61.0 45.4 100 0 0 pruning) 1) 1 g/L corresponds to 1 × 1010 CFU/L 2) Abbott efficacy was calculated on the basis of data presented in the report (percentage of infested shoots) 3) Presence or absence of symptoms 4) Presence or absence of Pal/Pch in internal wood of treated branches, wood pieces were taken 0, 0.5, 1, 1.5 and 2 cm from the point of inoculum, presence of at least one infected wood piece (Untreated control: mean values presence of the pathogen) * no infestation on untreated modality (no calculation of efficacy)
C) MYT-08 TITLE: Assessment of the impact of Trichoderma (TSC1) on vineyard esca disease
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Reference-No.: KIIIM 6.2.1/3/03 Trials (total/ year): 4/2011-2014 Trials belonging to one multiyear trial:
Year Trial number in report MYT-08
2011(initiation of trial) F11-VIVI-18-FR02 2012 BF12-VITVI-15 2013 BF13-VITVI-13-FR01 2014 BF14-VITVI-13-FR01
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Coursay, France This trial was carried out to • evaluate the long-term efficacy of T. atroviride SC1 against grapevine trunk diseases Esca and Eutypiosis (by E. lata). • evaluate the efficacy of the product when applied at different application timings
Relevant guideline(s)
- no guideline
Formulations and applied dose rates The test product BCP511B was compared to an untreated control.
Test location Coursay (Bordeaux) Region Maritime EPPO zone Country France Crop Grape Cultivar Melon de Bourgogne Age of crop in the first year of trial 20 years Trial design Randomized blocks Number of replicates 5 Plot size 200 plants
Details of application The products were applied as summarized in the table below.
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Product Active No. of Year rate Timing of treatment Date of treatment ingredient(s) treatments [g/L]1)
T. atroviride SC1 2 1 24 h after pruning 08.03.2011 2011 A: 24 h after pruning 08.03.2011 + T. atroviride SC1 2 2 B: 7 d after pruning 15.03.20112) T. atroviride SC1 2 1 24 h after pruning 09.03.2012 2012 A: 24 h after pruning 09.03.2012 + T. atroviride SC1 2 2 B: 7 d after pruning 16.03.20122) T. atroviride SC1 1 1 7 d after pruning 04.03.2013 2013 T. atroviride SC1 2 1 7 d after pruning 04.03.2013 T. atroviride SC1 1 1 9 d after pruning 06.03.2014 2014 T. atroviride SC1 2 1 9 d after pruning 06.03.2014 1) 1 g/L corresponds to 1 × 1010 CFU/L 2) Dates according to report
Details of artificial inoculations: The grapevine plants were naturally infected. An artificial inoculation with pathogens was not performed.
Assessment
Assessment of presence on wood Year Assessment of Symptoms in field pieces in laboratory
2011 Leaf symptoms of Esca disease: No assessment. 2012 % of dead/missing plants % of replanted plants 2013 % of symptomatic plants Severity leaves (1 score/plant): (1-4) (1 = no symptoms, 2 = Laboratory assessment of disease small spots on leaf blade with chlorosis and sometimes with incidence Pal and Pch, as well as necrosis, 3 = spots with chlorosis and necrosis over the whole Trichoderma colonization 2014 leaf blade, 4 = leaf blade with ‘tiger-stripes’) Fruits (1 score/plant): (1-4) (1 = no symptoms, 2 = incipient symptoms of black measles, 3 = manifestly symptoms of black measles, 4 = berries dry up)
Statistical analysis No information on statistical analysis is provided in this report
Results In 2012, significant differences were shown between the untreated control and the treated objects for the occurrence of Pch, whereas no differences were observed between treated and untreated objects for Pal due to the very low occurrence of Pal. Regarding the presence of Trichoderma, significant differences between the treated and the untreated plots were shown. This observation confirms that the presence of Trichoderma is derived from the application.
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In 2013, there was a significant difference between the untreated control and the treated objects for the presence of Pch, even though the difference was minimal, since the occurrence of this pathogen was low. For Pal, the rate was too low to obtain differences. There was a significant difference in the presence of Trichoderma in the stocks between the treated and the untreated. This observation confirms that the presence of Trichoderma was derived from the application. In 2014, it was difficult to observe differences between the untreated control and treated modalities in terms of symptoms because of low evolution of disease symptoms compared to 2013. Regarding the analysis of wood pieces, statistical differences were shown. The treatment was effective against Pal, because the two modalities of treatments differed significantly from the untreated control (assessment in June). In the second analysis, only the 2nd modality (high dose) differed from the untreated. Regarding the presence of pathogen Pch, the rate was too low to judge efficacy. For the summary of the results, please refer to Table 6.2.1/3-3.
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Table 6.2.1/3-3 Summary of efficacy trial Efficacy: Abbott2), Coloni- Application details Observation of plants Report infected shoots3) [%] zation Number, Subordinated Modality Produc Co- Symp- 1) Alive Death report number, t rate Date of treatments planted toms Pal Pch Bot SC1 Year [%] [%] [g/L] [%] [%] Untreated - - 14.5 75 10 0.5
1 application (24 h after pruning) 2 08.03.2011 16.5 73 8.5 2 not assessed MYT-08, F11-VITVI-18- 2 applications (24 h and 7 d after pruning) 2 08.03.2011 + 15.03.2011 13 71.5 12.5 3 FR02, Untreated - -- 10 70.5 16 3.5 2011 1 application (24 h after pruning) 2 08.03.2011 14 60 18.5 7.5 not assessed 2 applications (24 h and 7 d after pruning) 2 08.03.2011 + 15.03.2011 12 63.5 17 7.5 MYT-08, Untreated - - 7.5 59 16.5 17 (2.0) (16.0) 0 BF12-VITVI- 1 application (24 h after pruning) 2 11 60 13.5 15.5 100 87.5 - 48.0 15, 09.03.2012 2012 2 applications (24 h and 7 d after pruning) 2 09.03.2012 + 16.03.2012 9 58.5 15.5 17 0 100 54.0 MYT-08, Untreated - - 10 55 18 17 (0.4) (3.2) 0.0 BF13-VITVI- 1 04.03.2013 7.5 57.5 17.5 17.5 100 75 - 25.2 13-FR01, 1 application (7 d after pruning) 2013 2 04.03.2013 10.5 60.5 11 18 100 100 39.2 MYT-08, Untreated - - 26.5 62.5 11 0 (20) (4) (94) 0 BF14-VITVI- 1 06.03.2014 23.5 65.0 9 0 30 0 19.1 34.0 13-FR01, 1 application (9 d after pruning) 2014 2 06.03.2014 25.5 65.0 11.5 0 100 100 33.5 22.5 1) 1 g/L corresponds to 1 × 1010 CFU/L 2) Abbott efficacy was calculated on the basis of data presented in the report (percentage of infested shoots) 3) Presence or absence of Pal/Pch in internal wood of treated branches, wood pieces were taken 0, 0.5, 1, 1.5 and 2 cm from the point of inoculum, presence of at least one infected wood piece (Untreated control: mean values presence of the pathogen)
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D) MYT-04 TITLE: Efficacy trials in vineyards of BCP511B against Pal and Pch, agents of vascular diseases of grape and associated to Esca disease
Reference-No.: KIIIM 6.2.1/3/04 Trials (total/ year): 4/2011-2014 Trials belonging to one multiyear trial:
Year Trial number in report MYT-04
2011(initiation of trial) F11-VITVI-11-FR02 2012 BF12-VITVI-05-FR02 2013 BF13-VITVI-11-FR02 2014 BF14-VITVI-11-FR02
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Saint Vincent de Paul, France This trial was carried out to • evaluate the long-term efficacy of T. atroviride SC1 against grapevine trunk diseases Esca and Eutypiosis (by E. lata). • evaluate different adjuvants (2011 and 2012) • evaluate the efficacy of the product when applied at varying application rates (2013 and 2014)
Relevant guideline(s)
PP 1/152(2) Design and analysis of efficacy evaluation trials PP 1/181(3) Conduct and reporting of efficacy evaluation trials including good experimental practice PP 1/135(2) Phytotoxicity assessment CEB MG02 Principes généraux – Efficacité produits de protection maladies
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Test location Mosnes Region Maritime EPPO zone Country France Crop Grape Cultivar Sauvignon blanc Age of crop in the first year of trial 3 years Trial design Randomized complete blocks Number of replicates 3 plants; 20 samples Plot size w, l, other 33 m
Formulations and applied dose rates In 2011: The test product BCP511B combined with varying adjuvants was evaluated In 2012: The test product BCP511B alone was compared to the application with additional adjuvants In 2013: Varying dose rates of test product BCP511B alone were compared In 2014: Varying dose rates of the test product BCP511B were compared to an untreated control
Details of application The products were applied as summarized in the table below.
Product No. of Date of Year Active ingredient(s) Timing of treatment rate [g/L]1) treatments treatment
BCP511B 2 + BCP428D + 2 A: 24 h after pruning A: 23.03.11 2011 BCP511B 2 3 B: 7 d after T1 B: 01.04.11 + BCP428D + 2 C: 1 d after mechanical debudding C: 27.05.11 + BCP423D + 2 BCP511B 2 BCP511B 2 A: 50 d after pruning A: 24.04.12 2012 + BCP428D + 2 3 B: 7 d after T1 B: 01.05.12 BCP511B 2 C: 1 d after mechanical debudding C: 31.05.12 + BCP423D + 2 BCP511B 1 A: 13 d after pruning A: 28.03.13 2013 BCP511B 2 2 B: 13 d after T1 B: 10.04.13 BCP511B 4 Untreated -
BCP511B 1 A: 6 d after pruning A: 17.03.14 2014 2 BCP511B 2 B: 7 d after T1 B: 24.03.14 BCP511B 4 1) 1 g/L corresponds to 1 × 1010 CFU/L
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Details of artificial inoculations: The grapevine plants were naturally infected. An artificial inoculation with pathogens was not performed.
Assessment
Assessment of presence on wood pieces in Year Assessment of Symptoms in field laboratory
2011 Visual foliar and bunch assessment of plant-lesion- 2012 infections and phytotoxicity Laboratory assessment of disease incidence Pal 2013 % of dead/missing, replanted, symptomatic & and Pch, as well as Trichoderma colonization. asymptomatic plants per plot 2014
Statistical analysis Not stated
Results In 2011, no Pch infection was detected on the treated plants. However, no comparison to untreated modalities was obtained. Furthermore, no Trichoderma colonization was observed on treated plants. No signs of plant-lesion- infections were visible. In 2012, no Pch infection was detected on treated modalities. However, no comparison to untreated modalities was obtained. Nevertheless on all treatments, Trichoderma colonization was observed (20-30%). However there were only slight differences between BCP511B as solo treatment and the tank mixes with adjuvants. In 2013, slight Pch infections were detected on treated modalities. However, no comparison to untreated modalities was obtained. No Pch infection was observed at the modality with the highest application rate (4 g/L). Trichoderma colonization was shown on all treatments and didn’t differ between application rates. In 2014, Pch infestation was very low (0.4% on untreated modality). However, higher Pch infestation was observed at modality with the highest application rate (2.4%). Trichoderma colonization at 1 g/L application rate was 3.0%. From the overall results it can be concluded, that the disease pressure was very low over the four years of application. The combination of the product BCP511B with the adjuvants BCP423D and BCP428D did not have an added value to the efficacy. However the disease pressure was too low to observe any efficacy. For the summary of the results, please refer to Table 6.2.1/3-4.
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Table 6.2.1/3-4 Summary of efficacy trial Efficacy: Abbott2), Report Number, Application details Plant assessment Presence on Colonization Subordinated report wood pieces Modality numbers, [%]3) Year Product Plant – Number of Phyto- rate leison- Pch Bot SC1 applications toxicity [g/L]1) infected BCP511B + 2 + 2 0 - 0 - 0 MYT-04, BCP428D F11-VITVI11-FR02, BCP511B + 3 2 + 2 + 2 2011 BCP428D + 0 - 0 - 0 mL/L BCP423D BCP511B 2 0 0 0 - 20 MYT-04, BCP511B + 2 + 2 0 0 0 - 23 BF12-VITVI05-FR02, BCP428D 3 2012 BCP511B + 2 + 2 0 0 0 - 30 BCP423D mL/L BCP511B 1 - 0 2 23 15 BCP511B 2 - 0 2 17 14 MYT-04, BCP511B 4 - 0 0 27 11 BF13VITVI11FR02, 2 2013 BCP511B 1 - 0 0 - 1 BCP511B 2 - 0 0 - 5 BCP511B 4 - 0 0 - 1 Untreated - - 0 0 - - BCP511B 1 - 0 0 - - BCP511B 2 - 0 0 - - MYT-04, BF14-VITVI-11- BCP511B 4 - 0 0 - - 2 FR02, Untreated - - 0 0.44 - 0 2014 BCP511B 1 - 0 0 - 3.03 BCP511B 2 - 0 0 - 0 BCP511B 4 - 0 2.44 - 0 1) 1 g/L corresponds to 1 × 1010 CFU/L 2) Abbott efficacy was calculated on the basis of data presented in the report (percentage of infested shoots) 3) Presence or absence of Pch in internal wood of treated branches, presence of at least one infected wood piece (Untreated control: mean values presence of the pathogen)
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E) MYT-01 TITLE: Vascular disease caused by Phaeomoniella chlamydospora and Phaeoacremonium aleophilum associated with Esca disease / Grapevine
Reference-No.: KIIIM 6.2.1/4/05 Trials (total/ year): 4/2011-2014 Trials belonging to one multiyear trial:
Year Trial number in report MYT-01
2011 (initiation of trial) F11-VITVI11-FR04 2012 BF12-VITVI-03 2013 BF13-VITVI-09-FR01 2014 BF14-VITVI-09-FR01
TARGET: Esca related fungi Pal and Pch Locations (Trial Site): Coursay, France This trial was carried out to • evaluate the long-term efficacy of T. atroviride SC1 against grapevine trunk diseases Esca.
Relevant guideline(s)
- no guideline
Formulations and applied dose rates The test product BCP511B was compared to an untreated control.
Test location Lignan de Bordeaux Region Maritime EPPO zone Country France Crop Grape Cultivar Cabernet Sauvignon Age of crop in the first year of trial 9 years Trial design Randomized blocks Number of replicates varying Plot size 60 stocks
Details of application The products were applied as summarized in the table below.
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Active No. of Date of Year Product rate [g/L]1) Timing of treatment ingredient(s) treatments treatment
11.03. BCP511B + 2 g/L + 18.03. 2011 BCP423D + 2 mL/L + 4 BCP428D 2 g/L 18.05. 0 and 7 days after pruning and 28.06. after each process causing wounds 16.03. BCP511B + 0.2 kg/ha + 23.03. 2012 4 BCP428D 0.2 kg/ha 10.06. 13.07. 2013 BCP511B 0.4 kg/ha 1 2 days after pruning 23.03. 2014 BCP511B 0.4kg/ha 1 20 days after pruning 13.03. 1) 1 g/L corresponds to 1 × 1010 CFU/L
Details of artificial inoculations: The grapevine plants were naturally infected. An artificial inoculation with pathogens was not performed.
Assessment
Year Assessment of Symptoms in field Assessment of presence on wood pieces in laboratory
2011 No assessment of symptoms
2012 No assessment of symptoms Laboratory assessment of disease incidence Pal and Pch, as well as Trichoderma colonization 2013 Assessment of symptomatic, asymptomatic 2014 and dead plants.
Statistical analysis Statistical analyses of the trial data was performed with trial data. For individual trials, variance analysis was conducted with a significance level of 5% using ANOVA. The multiple comparisons of the treatment means based on the Student-Newman-Keuls test.
Results In 2011, the shoots of treated and untreated modalities were not infected with Pal and Pch. On treated shoots, 42% Trichoderma colonization was determined. In 2012, no Pal infestation was determined. Pch infestation was visible. However, disease severity was still very low (4.5% at second assessment). Nevertheless, efficacy of BCP511B against Pch was determined to be 50%. In 2013, Pal infestation was still zero. Nevertheless, Pch infestation could be determined to be 3.4% infestation at first assessment and 8% infestation in the untreated at second assessment. Because of this very low infestation, no clear effect of BCP511B application was measurable (100% at first assessment and -38% at second assessment). In 2014, no Pal infestation was observed. Pch infestation of untreated modalities was about 13% at second assessment. Hence, efficacy was not clear. For the summary of the results, please refer to Table 6.2.1/3-5.
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Table 6.2.1/3-5 Summary of efficacy trial Report Efficacy: Abbott2), infected Coloni- Application details Assessment of foliar symptoms Number, shoots3) [%] zation Sub- ordinated Product asymptom. symptom. dead report Modality Date Pal Pch SC1 rate1) plants plants plants numbers, Year Untreated - 17.10. (0) (0) 0 MYT-01, BCP511B 2 kg/ha F11-VITVI- + + 2 L/ha no assessment 11-FR04, BCP423D 17.10. * * 42.2 + 2 2011 + kg/ha BCP428D 02.05. (0) (0) 40 Untreated - MYT-01, 07.11. (0) (4.5) 0 BF12- 0.2 BCP511B no assessment VITVI-03 kg/ha + 02.05. * * + 13.8 2012 0.2 07.11. * 50.1 BCP428D kg/ha MYT-01, 12.06. (0) (3.4) 0 Untreated - 53.9 39.5 6.7 BF13- 03.09. (0) (8.0) 0 VITVI-09- 0.2-0.4 12.06. * 100 0 FR01, BCP511B 66.1 31.7 2.2 kg/ha 03.09. * -37.5 6.7 2013 MYT-01, 15.07. (0) (0) 7.0 Untreated - 37.8 52.2 10.0 BF14- 18.09. (0) (12.5) 0 VITVI-09- 0.2-0.4 15.07. * * 37.8 FR01, BCP511B 41.7 53.9 4.4 kg/ha 18.09. * 11.2 8.9 2014 1) 1 g/L corresponds to 1 × 1010 CFU/L 2) Abbott efficacy was calculated on the basis of data presented in the report (percentage of invested shoots) 3) Presence or absence of Pal/Pch in internal wood of treated branches, wood pieces were taken 0, 0.5, 1, 1.5 and 2 cm from the point of inoculum, presence of at least one infected wood piece (Untreated control: mean values presence of the pathogen) * no infestation on untreated modality (no calculation of efficacy)
Summary Efficacy tests The efficacy trials included in this dossier were performed with Vintec containing T. atroviride SC1 compared with one other product containing another strain of T. atroviride (Esquive WP as reference product). A total of 8 single-year trials were carried out in the Maritime EPPO zone to investigate the effectiveness of Vintec against ESCA disease of grapevine. Trials were conducted in Austria (1 trial) and Germany (7 trials) during 2011 and 2014. In addition, 5 multi-year trials were carried out in the Maritime part of France, representing 20 single-year assessments. All trials were performed by officially recognised testing facilities in accordance with the principles of Good Experimental Practice (GEP). Not all trials were done in accordance with relevant EPPO guidelines. use 1: Grapes, indoor (nursery) The intended first use of Vintec is the indoor application during nursery process. This use is not considered in this BAD, since it is part of the interzonal application, submitted in June 2015 in France as the interzonal rapporteur member state. use 2: Grapes, Field (pruning) Eight single-year trials were conducted on grapes during winter dormancy period (BBCH00), which was from the beginning of March until mid of April. For artificial inoculation, the Esca related pathogens were pipetted at a concentration and amount sufficient to infect the plant
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successfully. Treatment with the test product was mostly performed via spray application with hand sprayers shortly after the pruning process and inoculation. Although Vintec use is intended to be preventive, artificial inoculation was done already shortly after treatment to ensure exposure of the vines to spores of the disease and to challenge the performance of Vintec. A dependency on the weather conditions exists; especially night frost and heavy rains can influence the infection rate negatively. Efficacy estimation based on the presence of pathogens on the shoots (outgrowth from wood pieces on culture media). A branch was considered as infected when at least one piece showed the growth of Pch or Pal in laboratory on petridishes, respectively. In 2 of 8 trials an efficacy reference product was tested. Vintec was superior to the reference product Esquive WP in all cases. use 3: Long term studies – Grapes, Nursery and/or Field/ESCA Five long term studies have been performed to evaluate the efficacy of the product with the active ingredient T. atroviride SC1 on grapes. Studies were conducted over multiple years, starting during pruning process (4 trials) or during nursery process (1 trial) and were continued during the following years. Trials were conducted in France in the maritime EPPO zone. In general, no artificial inoculation was performed at multi-year trials. Hence, infection with ESCA related pathogens was very low and trials could not demonstrate efficacy of Vintec. Nevertheless, these data demonstrate the good colonization of T. atroviride SC1 on grape.
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IIIM 6.2.2 Minimum effective dose test On established plants, two trials were performed with application rates of 0.1 g/L and 1 g/L. Inoculations were done with Pal and Pch to evaluate the efficacy of Vintec on the different fungal pathogens causing trunk diseases. Trials are presented in detail under Point 6.2.1/2.1 Dose response trials A and B. Results are summarized in Table 6.2.2-1. Depending on the application rate, increase of efficacy was not clear. It was shown, that Vintec was more effective against Pch when applied at the highest application rate. Although, in both trials efficacy was not compared to application of 200 g Vintec/ha in 100 L water/ha (equivalent to 2 g Vintec/L), it was tested in four other trials and showed good efficacy against both, Pal and Pch. Thus, an application rate of 200 g Vintec/ha in 100-200 L water/ha (equivalent to 1-2 g/L) is considered for the intended use. Additionally it is referred to EPPO PP1/276(1). Since Vintec is a micro-organism based product, there is no need to demonstrate a minimum effective dose. EPPO PP1/276(1) explains the principle of the minimum recommended dose required to achieve the desired effect is primarily concerned with conventional chemical pesticides. For micro- organisms that occur naturally in the environment in any case, this concern may be less critical. Additionally for those that are capable of reproducing (and which may therefore multiply), the concept of a minimum effective dose is both less relevant and may be more difficult to determine practically and a range of doses should be appropriate.
Table 6.2.2-1 Comparison of different dose rates and resulting effectiveness of Vintec (spray application, grape pruning)
Trial BF13-VITVI-19-DE01 BF13-VITVI-20-DE01
Target Organism Pal Pch Pal Pch
Number of applications 2 1
Results at last Efficacy: Abbott, infected shoots [%] assessment
Untreated control1) (81.7) (87.5) (0) (4.6)
2 x 20 g/ha (2 x 0.1 g/L in 200 L spray 20.2 51.4 n.a. 45.7 volume/ha)
2 x 200 g/ha (2 x 1 g/L in 200 L spray 15.8 83.9 n.a. 50.0 volume/ha) 1) Colonization on untreated plants [%] n.a.: not applicable due to absence of pathogen infestation
Summary minimum effective dose test Two trials were performed with application rates of 0.1 g/L and 1 g/L. Inoculations were done with Pal and Pch to evaluate the efficacy of Vintec on the different fungal pathogens causing trunk diseases. Depending on the application rate, increase of efficacy was not clear.
IIIM 6.3 Toxic or pathogenic effects on the crop or host which is to be protected In the field trials conducted in southern and central Maritime and Mediterranean EPPO zone and reported in Point IIIM 6.2.1 above, no phytotoxicity was detected during the trials. Furthermore, Trichoderma atroviride SC1 was
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tested on several varieties of grape without inducing any toxic effects. All the results confirmed clearly the crop safety of T. atroviride SC1 when applied on grape following the Good Agricultural Practice.
No phytotoxicity was detected during the trials. Trichoderma atroviride SC1 was tested on several varieties of grape without inducing any toxic effects.
IIIM 6.4 Compatibility with products in tank mixtures
IIIM 6.4.1 Physical compatibility Vintec is not intended to be used together with adjuvants in tank mixes. Nevertheless, in some of the studies reported in this BAD the product was tested in association with adjuvants. In these studies the compatibility of T. atroviride SC1 with diverse fungicides used in vineyards has been tested (Pertot, 2012) via microtiter plate bioassays assessing growth of the fungus in the presence of the plant protection products. No problems were encountered in the preparation of the tank mix or during application of the mix.
Cited references (abstracts):
Report: IIIM 6.4.1/01 – Pertot, I. (2012): Compatibility of Trichoderma atroviride SC1 with products in authorised tank mixes and with other products that could be applied on grapevine. Unpublished report Guideline: Not specified GLP: No Materials and Methods: The study was conducted in June 2012 by Fondazione Edmund Mach/ Istituto Agrario, S. Michele all´Adige, Trentino, Italy. The biological compatibility of T. atroviride SC1 with 14 different products which are commonly used in vineyards (refer to Table IIIM 6.4.3-1) was tested. The products represented the following use categories: fungicides, mycorrhiza as plant growth promoters, hormones as rooting agents and insecticides. In microtiter plates T. atroviride SC1 at approximately 107 CFU/mL (2 g/L) was co-inoculated with the products at their recommended application rate, and four 10-1 dilutions thereof, in nutrient medium (potato dextrose broth). All combinations as well as a control containing only the fungal suspension in the nutrient broth were set up in three replicates. After 5 – 7days of incubation at 25°C growth of the fungus was assessed. Findings: The untreated control showed normal growth and conidiation at all tested concentrations. Growth was inhibited in the presence of undiluted suspensions of most of the products except for copper hydroxide, Bacillus subtilis QST 713 and mycorrhiza. The inhibitory effect often decreased with a decreasing concentration of the products. However, in none of the dilutions of ciazofamide and iproduione growth of T. atroviride SC1 was detectable. In the case that use of T. atroviride SC1 follows treatment with these active substances it must be ensured that the substances are no longer present at the treated plants.
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Table 6.4.1-1 Biological compatibility of T. atroviride SC1 with plant protection products commonly used in grapes
Growth1) (+) and not growth (-) Recommended of T. atroviride SC1 at Active ingredient Product field rate (concentration) Field (per 100 mL) 10-1 10-2 10-3 10-4 rate
Fungicides
Mildicut Ciazofemide (2.05% w/w) 0.45 mL - - - - - Forum Dimetomorf (50% w/w) 0.05 g - - - - + Copper hydroxide (15% Kocide 3000 0.3 g + + + + + w/w) Fluopicolide + Fosetil R6 Albis aluminium (4.44% + 66.67% 0.3 g - - + + + w/w) Mancozeb Difiocarbammate (80% w/w) 0.22 g - - - - + Rovral FL Iprodione (25% w/w) 0.3 g - - - - - B. subtilis QST 714 (5.13 × Serenade 0.5 g + + + + + 1010 CFU/g) Propser 300 Spiroxamine (30.9% w/w) 0.08 mL - + + + + CS Flint Trifloxystrobin (50% w/w) 0.025 g - - - - + Topas Penconazole (19% w/w) 0.02 mL - - + + + Vivando Melrafenone (42.37% w/w) 0.025 mL - + + + + Plant growth promoter
Solrize Mycorrhiza 0.032 g + + + + + Rooting agent NAD+NAA (0.018 + 0.002% Toniplant 0.5 g - - + + + w/w) Insecticide
Actara 25 WG Thiamethoxan (25% w/w) 0.03 g - - + + +
1) Growth indicates that the product is compatible in tank mixtures with T. atroviride SC1. The tested concentrations are the dose rate indicated in the label (Field rate) and 4 serial dilutions from it.
Conclusions: T. atroviride SC1 can be used in tank mixes together with copper hydroxide, B. subtilis QST 713 and mycorrhiza and in integrated pest management programs with chemical standard fungicides except for ciazofamide and iprodione-based products.
T. atroviride SC1 can be used in tank mixes together with copper hydroxide, B. subtilis QST 713 and mycorrhiza and in integrated pest management programs with chemical standard fungicides except for ciazofamide and iprodione-based products.
IIIM 6.4.2 Chemical compatibility See Point IIIM 6.4.1
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IIIM 6.4.3 Biological compatibility See Point IIIM 6.4.1
IIIM 6.5 Contribution to risk reduction and integrated pest management strategies, for the target crop or resource Trichoderma atroviride is naturally present in the environment. Therefore, its application in pest control means only a temporary fluctuation of the microbial population in the agricultural biotope. The understanding that Trichoderma atroviride SC1 presents no risk for the environment has been confirmed by numerous studies. Moreover, T. atroviride SC1 does not pose any risk on humans, as it was described in Section 3. Trichoderma is already known as an important tool for resistance management. No development of risk is expected due to multiple modes of action towards the target pathogens.
IIIM 6.6 Effects on yield and quality
IIIM 6.6.1 Impact on the quality of plants and plant products A late pruning and treatment might bear the risk of xylem sapping. The treatment is recommended to be conducted during the dormant period of vines (BBCH 00). In the presented efficacy trials pruning took place from beginning of March until mid of April. No or minimal plant bleeding was recorded in the trials. Even though no specific assessments were foreseen for this aspect, it is a task for every efficacy trial to watch out for negative side effects. Since nothing was reported in the whole lot of trials presented, it can be taken for sure there was apparently no problem with this. Moreover, based on the favourable yield and phytotoxicity situation, no negative effects on the quality of plants or plant products are expected.
IIIM 6.6.2 Effects on the processing procedure A study was conducted to evaluate the possible side effects of T. atroviride SC1 on Saccharomyces cerevisiae and fermentation (Pertot, I., 2011): No abnormal smells or turbidity were noted.
Cited references (abstracts):
Report: IIIM 6.6.2/01 – Pertot, I. (2011): Ecology, identification, spectrum, effect on fermentation, survival on phyllosphere and long term survival of Trichoderma SC1.
Guideline: Not specified
GLP/GEP: No
Materials and Methods: The study was conducted in 2011 by Fondazione Edmund Mach/ Istituto Agrario, S. Michele all´Adige, Trentino, Italy. Samples of healthy grapes from commercial vineyards were collected, crushed and pressed. After sedimentation of particles, T. atroviride SC1 was added to three aliquots of the clear must (107 conidia/L) while three remained untreated. All samples received a S. cerevisiae inoculum. Analysis of the yeast and fungal development as well as the pH and the sugar content in the must were carried out after 1, 8 and 12 days.
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Findings: The sugar content (20.8 ± 0.2 °Brix), the pH (3.8 ± 0.1) and the alcohol content of the must (10.7 – 11.2 %) where not affected by the presence of T. atroviride SC1. No abnormal smells or turbidity were noted. Although the added amount of the fungus was 100 to 1000 times higher than the expected population density that might be found on the berries after field application the population development of S. cerevisiae was not negatively affected.
Conclusions: Even if present at high population densities in grape musts T. atroviride SC1 will not have any adverse impact on the processing of the treated grapes.
IIIM 6.6.3 Effects on the yield of treated plants and plant products See Point IIIM 6.6.1
No negative effects on the quality of plants or plant products are expected. Even if present at high population densities in grape musts T. atroviride SC1 will not have any adverse impact on the processing of the treated grapes.
IIIM 6.7 Adverse effects
IIIM 6.7.1 Impact on succeeding crops Vintec is used on grapes in the field. Since grape is a perennial crop, no other crops than grape are affected and there will be no succeeding crops. T. atroviride SC1 may survive in soil for several months as a saprophyte, there is no risk for uncontrolled growth, since this widespread and naturally occurring soil fungus is subject to competition and antagonism in its natural habitat. Furthermore, T. atroviride is a naturally occurring microorganism in soil and no impact on succeeding crops is expected. Furthermore, the MPCA is not intended to persist or to multiply in the phylloplane in amounts considerably higher than naturally appearing (Pertot, 2011). Longa et al. (2009) investigated the survival of T. atroviride SC1 in soil. As a result, the fungus showed capability to survive and limited ability to disperse in soil for at least 18 weeks after application. T. atroviride SC1 integrates to the local microbial community, showing the same abundance level as indigenous Trichoderma species. As mentioned above, T. atroviride SC1 can be spread from soil to above ground parts of the plants, by translocation of soil particles through rain splashes (Longa et al, 2009). However, contamination of grapes with T. atroviride SC1 is expected to be comparable to those of naturally occurring Trichoderma populations and therefore regarded negligible. Cited references (abstracts):
Report: KIIM 6.7.1/01 –Pertot, I. (2011), Ecology, identification, spectrum, effect on fermentation, survival on phyllosphere and long term survival of Trichoderma SC1: Survival of T. atroviride SC1 on the phyllosphere. Unpublished report 2011. Fondazione Edmund Mach, S. Michele all´Adige, Italy Report-no. not applicable
Guideline: Not specified GLP: No Abstract: AIM: Evaluation of the survival of T. atroviride SC1 on strawberry leaves (phyllosphere) METHODS: A T. atroviride SC1 conidia/water suspension (1 × 107 conidia/L; conidia viability = 97%) was sprayed on strawberry leaves. T. atroviride CFU were counted for up to 45 days after application by washing the leaves (3 leaf discs of 2 cm of diameter in 10 mL of water). Washing suspensions were serially
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diluted and plated on the semi-selective medium. After incubation, colony forming units were counted. RESULTS and CONCLUSION: The survival of T. atroviride SC1 is very short. After 7 days the level is very low and reaches undetectable levels at day 45. Persistence of isolate SC1 is very unlikely to occur in the phyllosphere.
Report KIIM 6.7.1/02 - Longa, C.M.O., Savazzini, F., Tosi, S., Elad, Y., Pertot, I. (2009), Evaluating the survival and environmental fate of the biocontrol agent Trichoderma atroviride SC1 in vineyards in northern Italy, published report J. Appl. Microbiol., 106, 269-277
Abstract: AIMS: To study the survival in the soil and the dispersion in the environment of Trichoderma atroviride SC1 after soil applications in a vineyard. Methods and Results: Trichoderma atroviride SC1 was introduced into soil in two consecutive years. The levels of T. atroviride populations at different spatial and temporal points following inoculation were assessed by counting the colony-forming units and by a specific quantitative real- time PCR. A high concentration of T. atroviride SC1 was still observed at the 18th week after inoculation. The vertical migration of the fungus to a soil depth of 0.4 m was already noticeable during the first week after inoculation. The fungus spread up to 4 m (horizontally) from the point of inoculation and its concentration decreased with the increasing distance (horizontal and vertical). It was able to colonize the rhizosphere and was also found on grapevine leaves. One year after soil inoculation, T. atroviride SC1 could still be recovered in the treated areas. Conclusions: Trichoderma atroviride SC1 survived and dispersed becoming an integrant part of the local microbial community under the tested conditions. Significance and Impact of the Study. The persistence and rapid spread of T. atroviride SC1 represent good qualities for its future use as biocontrol agent against soil borne pathogens.
T. atroviride is a naturally occurring microorganism in soil and no impact on succeeding crops is expected.
IIIM 6.7.2 Impact on other plants including adjacent crops No adverse effects on plants including adjacent crops have been observed in the efficacy trials discussed above and no effects are expected. Furthermore, it has been shown, that it does not multiply and not persist on the phylloplane in amounts considerably higher than naturally appearing (please refer to Point IIIM 6.7.1).
IIIM 6.7.3 Adverse effects on parts of plant used for propagating purposes Vintec is also intended to be used in grape nursery (please refer to Point IIIM 6.2.1/1). Several studies were performed to assess the positive effect of Vintec during the grafting process, the main propagating process in grape production. No adverse effects on parts of plants used for propagation purposes were detected during these studies.
IIIM 6.7.4 Adverse effects on beneficial organisms (other than bees) T. atroviride SC1 is intended for application onto pruning wounds of grapevines in the dormant stage of vine, which is in winter time or early spring. Due to the low exposure for soil- and leaf dwelling non-target arthropods, specific tests with T. atroviride SC1 are considered not necessary. For more details, please refer to dRR Part B, Section 6, Point IIIM 10.4. The fungicide Vintec (1.0 × 1013 CFU Trichoderma atroviride SC1/kg) has been proposed for application in grapes at a total maximum application rate of 0.4 kg/ha and year (2 applications). This corresponds to 4.0 × 1012 CFU Trichoderma atroviride SC1 active ingredient/ha and year. Throughout the field trials on effectiveness and selectivity there have been no reports or observations to suggest a detrimental impact of Vintec on beneficial or non-target organisms.
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Appropriate studies on the potential adverse effects on beneficial arthropods were available from Draft Assessment Report Trichoderma atroviride SC1 Volume 3, Annex B.9.4. Effects on arthropods other than bees (Annex IIM 8.8; Annex IIIM 10.4).
The toxicity of Vintec has been investigated by carrying out
- laboratory tests on Aphidius rhopalosiphi and Typhlodromus pyri.
When laboratory tests and higher tier tests were available for the same species, only the results from the higher tier test are being used for the assessment. These results are presented in Table 6.2.4-1.
Table 6.2.4-1: Effects Trichoderma atroviride SC1 WG on beneficial arthropods in extended laboratory tests on natural substrates. Species Substrate substance Rate Corrected Sublethal Reference [kg product/ha] mortality effect [%] (Exposed [%] Stage)
T. pyri (PN) glass Trichoderma 0.2 -8.2 n.d. IIIM 10.4/02 atroviride Höhn, P. SC1 0.4 -4.2 n.d. (2012b)
0.8 -1.4 n.d.
1.6 -4.2 n.d. Unpublished Report No. 3.2 -4.2 n.d. S12-01189
A. glass Trichoderma 0.2 2.5 n.d. IIIM 10.4/01 rhopalosiphi atroviride Höhn, P. (A) SC1 0.4 2.5 n.d. (2012a)
0.8 5.0 n.d.
1.6 15.0 n.d. Unpublished Report No. 3.2 2.5 n.d. S12-01188
A =Adulte, PN = Protonymphen
On the basis of the presented results no lethal effects > 25% are expected for populations of Aphidius rhopalosiphi and Typhlodromus pyri when Vintec is applied according to the recommended use pattern. However, sublethal effects have not been assessed in the submitted studies. Hence, no assessment is possible for Aphidius rhopalosiphi and Typhlodromus pyri. Aphidius rhopalosiphi is not a relevant antagonist in the proposed crops; hence, assessment is similarly not possible for beneficial insect species.
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Classification scheme of the effects:
Laboratory tests on artificial substrates (glass, quartz sand) < 30% = not harmful 30 – 80% = slightly harmful > 80% = harmful Extended laboratory tests on natural substrates, semi-field and field tests < 25% = not harmful 25 – 50% = slightly harmful > 50% = harmful
Proposal for classification:
No proposal for classification is possible for the fungicide product Vintec.
Adverse effects on soil quality indicators (e. g. microorganisms, earthworms) are considered in Section 6 Ecotoxicological Studies in the Registration Report.
IIIM 6.8 Summary and assessment of data according to points 6.1 to 6.7 Vintec is a fungicide against Esca related pathogens Phaeoacremonium aleophilum (Pal) and Phaeomoniella chlamydospora (Pch) on grapes. As it acts mainly through competition for nutrients, space, production of inhibitory compounds and lytic enzymes, as well as induction of defense responses in host plants, its fungicidal effect considers a broad spectrum of pathogenic fungi. Thus, Vintec is expected to act also against other diseases, caused by fungal pathogens as Botryosphaeria obtusa (anamorph Diplodia seriata). Vintec is to be applied on grapes by spraying onto pruning wounds in field at a rate of 0.2 kg product/hL for one application with a maximum of two applications per year (maximal rate per crop/season: 0.4 kg product/ha). The second application is recommended only in case of unfavourable weather conditions during or directly after the first application (strong precipitation or low temperatures). The label of Vintec will state that Vintec must be applied on the pruning wounds during the winter dormancy period, in the days following pruning, as soon as the temperature reaches 10°C for minimum 5 hours with a relative humidity above 70%. Also, there should be no rainfall or frost in the 48h following the application. In case the conditions for T. atroviride SC1 are not yet optimal immediately after pruning, it is recommended to wait for the above mentioned conditions. This dossier is intended for the registration of Vintec in Germany. A total of 8 efficacy trials were carried out in the Maritime EPPO zone in order to investigate the effectiveness of Vintec (BCP511B) against Esca disease on grapevine. Trials were conducted in Austria (1 trial), Germany (7 trials) during 2011 to 2014. The data indicate that the concentrations of 1 g/L and 2 g/L are comparable. In some trials there is an indication of an increase of the effectiveness with the higher concentration. Results showed that effectiveness of Vintec was comparable to that of the reference product based on T. atroviride (Esquive), though 100% control cannot be reached. In two trials, application concentrations of 0.1 g/L and 1 g/L were compared. Effectiveness against Pch was considerably better with the higher product concentration in one of the trials (please refer to Point IIIM 6.2.2). It is furthermore referred to EPPO PP1/276(1) which explains the concept of a minimum effective dose is both less relevant and may be more difficult to determine practically and a range of doses should be appropriate, so that it is not mandatory for products based on micro-oranisms.
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A total of 10 one-year efficacy trials have been presented to support the label claims for the uses in grapes against Esca related pathogens Pal and Pch. As part of the data package, 5 multi-year trials were conducted in France in the maritime EPPO zone. Multi-year trials started in 2011 and continued until 2016. With this dossier data until 2014 are submitted. Thus, each multi- year trial presents data of four single trials (2011 – 2014). In these trials, no artificial inoculation was performed at multi-year trials. Hence, infection with ESCA related pathogens is very low. Nevertheless, these data demonstrate the good colonization of T. atroviride SC1 on grape as well as preventive control of pathogens. Phytotoxicity assessments during the efficacy trials showed no adverse effects on grape. Furthermore the active substance T. atroviride SC1 belongs to a ubiquitous and naturally present species. Therefore, and due to the normal fast establishment of a natural stable microbial population of Trichoderma spp., also no adverse effects on the yield are expected. It is also not expected that adjacent crops may be affected by spray drift. Due to the natural presence of T. atroviride, no risk of the targeted species to develop resistance against the active substance is expected. In conclusion, Vintec was shown to be as effective in reduction of new infestations with Esca related pathogens Pal and Pch as other registered fungicides. It is therefore considered as a valuable tool in the disease management and reduction of the abovementioned grape ESCA disease.
Overall conclusion: It is accepted that the topic of Grapevine Trunk Diseases and the possible control of it represents a considerable challenge. The data provided by the applicant with regard to efficacy are considered as sufficient in order to possibly reduce the amount of infection caused by the particular pathogens. A 100% control of GTDs is not to be reached though, and this should be clearly stated by the applicant. One of the backgrounds for accepting the presented data as sufficient lies in the fact that Trichoderma based products are on the market since several years in the Southern hemisphere. Besides, it is accepted by JKI that so far no definite guideline exists for the conducting of clearcut trials in the field. Still more, the possible control of success of such trials is – as widely accepted – very complicated and time-consuming, and only the application of the compound over severel years, accompanied by serious monitoring, is thought to deliver more accurate results.
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IIIM 6.9 List of test facilities including the corresponding certificates GEP Concerned studies and year Official testing station Address certificate
Bayerische Landesanstalt An der Steige 15, yes - BF14-VITVI-02-DE01 für Weinbau und 97209 Veitshöchheim Gartenbau Dienstleistungszentrum Breitenweg 71, yes - F11-VITVI-13 ländlicher Raum (DLR) 67435 Neustadt an der - BF13-VITVI-35-DE01 Rheinpfalz Weinstrasse, Germany - BF14-VITVI-02-DE02 Hiebler Agricultural Pöllau 21, yes - BF13-VITVI-06-AU01pch, 2013 Engineering Service 8311 Markt - BF13-VITVI-06-AU01pal, 2013 Hartmannsdorf Austria Martin Im Grund 20 yes - BF13-VITVI-19-DE01 Feldversuchswesen 78359 Orsingen- - BF13-VITVI-20-DE01 Nenzingen - BF14-VITVI-02-DE04-PAL (Nenzingen), Germany - BF14-VITVI-02-DE04-PCH PROMO-VERT SA Rue Aste Béon - BP yes - MYT-09 27 - 64121 Serres- Castet, France Vita Consult Rue du pré Neuf – ZA yes - MYT-08 du Pré Neuf 44190 GORGES, France Sciences Agro Atlantique Lartigue, 2 Route de yes - MYT-02 Creon, - MYT-01 33370 Loupes, France SynTech Research 613 route du Bois de yes - MYT-04 France Loyse 71570 La Chapelle de Guinchay, France Instituto Agrario di San FEM Research and no - Pertot, I. (2011) (report number not Michele all’Adige Innovation Center applicable) Via Mach 1 - Pertot, I. (2009) (report number not S. Michele all’Adige applicable) 38010 TN, Italy Institut National de la Centre de Bordeaux no - F09-NNNXX.01(2009) Recherche Agronomique Unité Mixte de - Pertot, I. et al. (2010) (report number not Recherches en Santé applicable Végétale France Dr Dula Bence Eszterházy tér 9 no - F10-VITVI-16, F10-VITVI-17 (2011) Private enterpriser 3300 Eger Hungary
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Bayerische Landesanstalt für Weinbau und Gartenbau
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DLR Rheinpfalz
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Hiebler Agricultural Engineering Service
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Martin Feldversuchswesen
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Promo-Vert SA
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Vita Consult
Science Agro Atlantique
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SynTech Research France
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Instituto Agrario di San Michele all’Adige
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Appendix 1: List of data submitted in support of the evaluation
Data point Author(s) Year Title Vertebrate Data Justification Owner Owner Report No. study protection if data Source (where different from owner) Y/N claimed protection is GLP or GEP status Y/N claimed Published or not KIIM 6/01 Scholze, I. 2015 BIOLOGICAL ASSESSMENT no yes New data for BIP DOSSIER new BI-PA, Londerzeel, Belgium, not formulation, available not GAB Consulting GmbH, Heidelberg, previously Germany submitted nor GLP/GEP: no evaluated Published: no KIIM Pertot, I. 2011a ECOLOGY, IDENTIFICATION, no yes New data for BIP 6.1/01 SPECTRUM, EFFECT ON new FERMENTATION, SURVIVAL formulation, ON PHYLLOSPHERE AND not previously LONG TERM SURVIVAL OF submitted TRICHODERMA SC1. nor BI-PA, Londerzeel, Belgium, not evaluated applicable Fondazione Edmund Mach, S.Michele all´Adige, Italy GLP/GEP: no Published: no KIIM Liminana, 2009 STUDIES OF THE EFFECT OF no yes New data for BIP 6.1/02 J.M., ANTAGONIST FUNGI ON THE new Mayet, V., MYCELIAL GROWTH OF formulation, Lecomte, FUNGI ASSOCIATED WITH not P. previously GRAPEVINE WOOD DISEASES submitted (ESCA, EUTYPIOSIS, nor BOTRYOSPHAERIA CANKER) evaluated ASSESSMENT OF THEIR CAPACITY TO PROTECT PRUNING WOUNDS RESEARCH BI-PA, Londerzeel, Belgium, F09- NNNXX.01 Institut National de la Recherche Agronomique, France GLP/GEP: no Published: no
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Data point Author(s) Year Title Vertebrate Data Justification Owner Owner Report No. study protection if data Source (where different from owner) Y/N claimed protection is GLP or GEP status Y/N claimed Published or not KIIM Pertot, I. 2009 REPORT 2009 - DETAILED no yes New data for BIP 6.1/03 PROTOCOLS AND RESULTS OF new TRIALS THAT WERE CARRIED formulation, OUT BY FEM TO TEST THE not previously EFFICACY OF TRICHODERMA submitted ATROVIRIDE SC1 AND nor ESQUIVE AGAINST THE MAIN evaluated CAUSAL AGENTS OF ESCA DISEASE ON GRAPE (YEAR 2009) BI-PA, Londerzeel, Belgium, not stated Fondazione Edmund Mach, S.Michele all´Adige, Italy GEP: yes Published: no KIIM Pertot, I., 2010 TRICHODERMA ATROVIRIDE no yes New data for BIP 6.1/04 Leoni, V., SC1: TRIALS ON new Micheli, S. FORMULATION formulation, BI-PA, Londerzeel, Belgium, not stated not previously Fondazione Edmund Mach, S.Michele submitted all´Adige, Italy nor GLP/GEP: no evaluated Published: no KIIM Pertot, I. 2011b REPORT 2010 no yes New data for BIP 6.1/05 BI-PA, Londerzeel, Belgium, not stated new Fondazione Edmund Mach, S.Michele formulation, all´Adige, Italy not GLP/GEP: no previously submitted Published: no nor evaluated KIIM Dula, B., 2011 EFFICACY TRIAL REPORT ON no yes New data for BIP 6.1/06 Dula, T. TRICHODERMA SC1 AGAINST new ESCA RELATED DISEASES IN formulation, VINEYARD, NURSERY AND not previously SMALL PLOT TRIAL 2010 submitted BI-PA, Londerzeel, Belgium, F10- nor VITVI-16, F10-VITVI-17 evaluated Dr. Dula Bence, Eger, Hungary GLP/GEP: no Published: no KIIM Longa, 2008 ECOPHYSIOLOGICAL no no not protected - 6.1/07 C.M.O, REQUIREMENTS AND Pertot, I., SURVIVAL OF A Tosi, S. TRICHODERMA ATROVIRIDE ISOLATE WITH BIOCONTROL POTENTIAL , not applicable J Basic Microbiol, 48, 269-277 GLP/GEP: no Published: yes
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Data point Author(s) Year Title Vertebrate Data Justification Owner Owner Report No. study protection if data Source (where different from owner) Y/N claimed protection is GLP or GEP status Y/N claimed Published or not KIIM Kortekamp, 2011 EFFICACY OF VARIOUS TEST no yes New data for BIP 6.2.1/2/01 A. PREPARATIONS OF THE new BELCHIM CROP PROTECTION formulation, COMPANY AGAINST THE not previously ESCA PATHOGENS submitted PHAEOMONIELLA nor CHLAMYDOSPORA AND evaluated PHAEOACREMONIUM ALEOPHILUM - FIELD TESTING 2011 BI-PA, Londerzeel, Belgium, F11- VITVI-13 DLR-Rheinpfalz, Neustadt, Germany GLP/GEP: no Published: no KIIM Hiebler, A., 2014a FIELD TEST TO EVALUATE no yes New data for BCP 6.2.1/2/02 Rieger, D. THE EFFICACY OF BCP511B new AGAINST PHAEOMONIELLA formulation, CHLAMYDOSPORA (=PCH) not previously Belchim Crop Protection, Isernhagen, submitted Germany, BF13VITVI06-AU01pch, nor BF13-VITVI-06-AU01pch evaluated Hiebler Agricultural Engineering Service, Austria GEP: yes Published: no KIIM Hiebler, A., 2014b FIELD TEST TO EVALUATE no yes New data for BCP 6.2.1/2/03 Rieger, D. THE EFFICACY OF BCP511B new AGAINST formulation, PHAEOACREMONIUM not previously ALEOPHILUM (= TOGNINIA submitted MINIMA, PAL) nor Belchim Crop Protection, Isernhagen, evaluated Germany, BF13-VITVI-06-AU01pal Hiebler Agricultural Engineering Service, Austria GEP: yes Published: no KIIM Martin, T. 2014 EVALUATION OF TREATMENT no yes New data for BNV 6.2.1/2/04 WITH TRICHODERMA new ATROVIRIDE AGAINST ESCA formulation, IN GRAPEVINE not previously Belchim Crop Protection, nv/sa, submitted Belgium, BF13-VITVI-19-DE01 nor Martin - Feldversuchswesen, Orsingen- evaluated Nenzingen, Germany GLP/GEP: no Published: no
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Data point Author(s) Year Title Vertebrate Data Justification Owner Owner Report No. study protection if data Source (where different from owner) Y/N claimed protection is GLP or GEP status Y/N claimed Published or not KIIM Martin, T., 2014 EVALUATION OF TREATMENT no yes New data for BNV 6.2.1/2/05 Rieger, D. WITH TRICHODERMA new ATROVIRIDE AGAINST ESCA formulation, IN GRAPEVINE not previously Belchim Crop Protection, nv/sa, submitted Belgium, BF13-VITVI-20-DE01 nor Martin - Feldversuchswesen, Orsingen- evaluated Nenzingen, Germany GEP: yes Published: no KIIM Kortekamp, 2013 IMPACT OF STUDY no yes New data for BIP 6.2.1/2/06 A. PREPARATION BCP 511B OF new THE COMPANY BELCHIM formulation, CROP PROTECTION AGAINST not previously ESCA PATHOGENS submitted PHAEOMONIELLA nor CHLAMYDOSPORA AND evaluated PHAEOACREMONIUM ALEOPHILUM - FIELD TRIAL 2013 BI-PA, Londerzeel, Belgium, BF13- VITVI-35-DE01 DLR-Rheinpfalz, Neustadt, Germany GLP/GEP: no Published: no KIIM Hofmann, 2015 EVALUATION OF THE no yes New data for BIP 6.2.1/2/07 H. EFFICACY OF BCP511B new AGAINST PAL AND PCH IN formulation, ESTABLISHED VINES not previously BI-PA, Londerzeel, Belgium, BF14- submitted VITVI-02-DE01 nor Bayerische Landesanstalt f. Wein- und evaluated Gartenbau, Veitshöchheim, Germany GEP: yes Published: no KIIM Kortekamp, 2014 EFFICACY OF TEST PRODUCT no yes New data for BNV 6.2.1/2/08 A. BCP 511 B OF BELCHIM CROP new PROTECTION AGAINST ESCA formulation, PATHOGENS not previously PHAEOMONIELLA submitted CHLAMYDOSPORA AND nor PHAEOACREMONIUM evaluated ALEOPHILUM Belchim Crop Protection, nv/sa, Belgium, BF14-VITVI-02-DE02 DLR-Rheinpfalz, Neustadt, Germany GLP/GEP: no Published: no
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Data point Author(s) Year Title Vertebrate Data Justification Owner Owner Report No. study protection if data Source (where different from owner) Y/N claimed protection is GLP or GEP status Y/N claimed Published or not KIIM Martin, T. 2015a EVALUATION OF TREATMENT no yes New data for BNV 6.2.1/2/09 WITH TRICHODERMA new ATROVIRIDE AGAINST ESCA formulation, IN GRAPEVINE not previously Belchim Crop Protection, nv/sa, submitted Belgium, BF14-VITVI-02-DE04-PAL nor Martin - Feldversuchswesen, Orsingen- evaluated Nenzingen, Germany GEP: yes Published: no KIIM Martin, T. 2015b EVALUATION OF TREATMENT no yes New data for BNV 6.2.1/2/10 WITH TRICHODERMA new ATROVIRIDE AGAINST ESCA formulation, IN GRAPEVINE not previously Belchim Crop Protection, nv/sa, submitted Belgium, BF14-VITVI-02-DE04-PCH nor Martin - Feldversuchswesen, Orsingen- evaluated Nenzingen, Germany GEP: yes Published: no KIIM Pollet, N. 2012a VASCULAR DISEASE CAUSED no yes New data for BIP 6.2.1/3/01 BY PHAEOMONIELLA new CHLAMYDOSPORA AND formulation, PHAEOACREMONIUM not previously ALEOPHILUM ASSOCIATED submitted WITH ESCA DISEASE / VINE nor NURSERY evaluated BI-PA, Londerzeel, Belgium, 11BPA02, MYT-02 Sciences Agro Atlantique, Loupes, GEP: yes Published: no KIIM Paratte, J.- 2011 FUNGICIDE EFFICACY no yes New data for BIP 6.2.1/3/02 L. AGAINST THE PATHOGENS new RELATED TO ESCA WOOD formulation, DISEASE ON GRAPEVINE not previously BI-PA, Londerzeel, Belgium, 11 F VI submitted BE 01, MYT-09 nor Promo-Vert S.A., Serres Castet, France evaluated GEP: yes Published: no KIIM Chene, J. 2011 ASSESSMENT OF THE IMPACT no yes New data for BIP 6.2.1/3/03 OF TRICHODERMA (TSC1) ON new VINEYARD ESCA DISEASE formulation, BI-PA, Londerzeel, Belgium, not MDB02/02/MON/2011, MYT-08 previously submitted SARL VitaConsult, Gorges, France nor GEP: yes evaluated Published: no
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Data point Author(s) Year Title Vertebrate Data Justification Owner Owner Report No. study protection if data Source (where different from owner) Y/N claimed protection is GLP or GEP status Y/N claimed Published or not KIIM Montier, L. 2012 EFFICACY TRIALS IN no yes New data for BIP 6.2.1/3/04 VINEYARDS OF BCP 511 B new AGAINST PAL AND PCH, formulation, AGENTS OF VASCULAR not previously DISEASES OF GRAPE AND submitted ASSOCIATED TO ESCA nor DISEASE evaluated BI-PA, Londerzeel, Belgium, F11- VITVI-11-FR-02, MYT-04 SynTech Research France S.A.S. GEP: yes Published: no KIIM Pollet, N. 2012b VASCULAR DISEASE CAUSED no yes New data for BIP 6.2.1/3/05 BY PHAEOMONIELLA new CHLAMYDOSPORA AND formulation, PHAEOACREMONIUM not previously ALEOPHILUM ASSOCIATED submitted WITH ESCA DISEASE / nor GRAPEVINE evaluated BI-PA, Londerzeel, Belgium, 11 BPA 01, MYT-01 Sciences Agro Atlantique, Loupes, GEP: yes Published: no KIIM Pertot, I. 2012 COMPATIBILITY OF no yes New data for BIP 6.4.1/01 TRICHODERMA ATROVIRIDE new SC1 WITH PRODUCTS IN formulation, AUTHORISED TANK MIXES not previously AND WITH OTHER PRODUCTS submitted THAT COULD BE APPLIED ON nor GRAPEVINE evaluated BI-PA, Londerzeel, Belgium, not stated FEM - Research and Innovation Center GLP/GEP: no Published: no KIIM Pertot, I. 2011a ECOLOGY, IDENTIFICATION, no yes protected BIP 6.6.2/01 SPECTRUM, EFFECT ON FERMENTATION, SURVIVAL ON PHYLLOSPHERE AND LONG TERM SURVIVAL OF TRICHODERMA SC1. BI-PA, Londerzeel, Belgium, not applicable Fondazione Edmund Mach, S.Michele all´Adige, Italy GLP/GEP: no Published: no Submitted in: KIIIM 6.1/01
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Data point Author(s) Year Title Vertebrate Data Justification Owner Owner Report No. study protection if data Source (where different from owner) Y/N claimed protection is GLP or GEP status Y/N claimed Published or not KIIM Pertot, I. 2011a ECOLOGY, IDENTIFICATION, no yes New data for BIP 6.7.1/01 SPECTRUM, EFFECT ON new FERMENTATION, SURVIVAL formulation, ON PHYLLOSPHERE AND not previously LONG TERM SURVIVAL OF submitted TRICHODERMA SC1. nor BI-PA, Londerzeel, Belgium, not evaluated applicable Fondazione Edmund Mach, S.Michele all´Adige, Italy GLP/GEP: no Published: no Submitted in: KIIIM 6.1/01 KIIM Longa, 2009 EVALUATING THE SURVIVAL no no not protected - 6.7.1/02 C.M.O., AND ENVIRONMENTAL FATE Savazzini, OF THE BIOCONTROL AGENT F., Tosi, S., TRICHODERMA ATROVIRIDE Elad, Y., SC1 IN VINEYARDS IN Pertot, I. NORTHERN ITALY , not applicable J Appl Microbiol, 106, 269 - 277 GLP/GEP: no Published: yes
Lists of data considered in support of the evaluation (List of data submitted by the applicant and relied on) Data Author(s) Year Title Vertebrate Data Justificatio Owner Point Report-No. study protectio n if data Source (J=Yes protection GLP/GEP O=Open n is claimed Published N=No) claimed Authority registration No./JKI-No. (J=Yes O=Open N=No) KIIIM1 6 Scholze, I. 2015 Biological Assessment Dossier N J Bi-PA (BAD) 2015 (pdf) nv/sa
k.A. N/N N 2932098/441926 KIIIM1 6.1 Pertot, I. 2011 Ecology, identification, spectrum, N J Bi-PA effect on fermentation, survival on nv/sa phyllosphere and long term survival of Trichoderma SC1. 38357 k.A. N/N N 2932099/441927
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KIIIM1 6.1 Liminana, J.M., 2009 Studies of the effect of antagonist N J Bi-PA Mayet, V., fungi on the mycelial growth of nv/sa Lecomte, P. fungi associated with grapevine wood diseases (Esca, Eutypiosis, Botryosphaeria canker) Assessment of their capacity to protect pruning wounds Research 32232 k.A. N/N N 2932100/441928 KIIIM1 6.1 Pertot, I. 2009 Report 2009 - Detailed protocols N J Bi-PA and results of trials that were nv/sa carried out by FEM to test the efficacy of Trichoderma atroviride SC1 and Esquive against the main causal agents of Esca disease on grape (year 2009)
k.A. J/J N 2932101/441929 KIIIM1 6.1 Pertot, I., 2010 Trichoderma atroviride SC1: trials N J Bi-PA Leoni, V., on formulation nv/sa Micheli, S. k.A. N/N N 2932102/441930 KIIIM1 6.1 Pertot, I. 2011 Report 2010 N J Bi-PA nv/sa k.A. N/N N 2932103/441931 KIIIM1 6.1 Dula, B., Dula, 2011 Efficacy trial report on N J Bi-PA T. Trichoderma SC1 against Esca nv/sa related diseases in wineyard, nursary and small plot trial 2010
k.A. N/N N 2932104/441932 KIIIM1 6.1 Longa, C.M.O, 2008 Ecophysiological requirements N N Bi-PA Pertot, I., Tosi, and survival of a Trichoderma nv/sa S. atroviride isolate with biocontrol potential 34871 J Basic Microbiol N/N J 2932105/441933 KIIIM1 Kortekamp, A. 2011 Efficacy of various test N J Bi-PA 6.2.1 preparations of the Belchim Crop nv/sa Protection Company against the Esca pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum - Field testing 2011 39324 k.A. N/N N 2932106/441934
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KIIIM1 Hiebler, A., 2014 Field test to evaluate the efficacy N J Belchim 6.2.1 Rieger, D. of BCP511B against Crop Phaeomoniella chlamydospora Protection (=PCH) Burgd. BF13VITVI06-AU01pch k.A. J/J N 2932107/441935 KIIIM1 Hiebler, A., 2014 Field test to evaluate the efficacy N J Belchim 6.2.1 Rieger, D. of BCP511B against Crop Phaeoacremonium aleophilum (= Protection Togninia minima, PAL) Burgd. BF13VITVI06-AU01pal k.A. J/J N 2932108/441936 KIIIM1 Martin, T. 2014 Evaluation of treatment with N J Belchim 6.2.1 Trichoderma atroviride against Crop ESCA in grapevine Protection BF13-VITVI-19-DE01 k.A. N/J N 2932109/441937 KIIIM1 Martin, T., 2014 Evaluation of treatment with N J Belchim 6.2.1 Rieger, D. Trichoderma atroviride against Crop ESCA in grapevine Protection BF13-VITVI-20-DE01 k.A. N/J N 2932110/441938 KIIIM1 Kortekamp, A. 2013 Impact of study preparation BCP N J Bi-PA 6.2.1 511B of the company Belchim nv/sa Crop Protection against Esca pathogens Phaeomoniella chlamydospora and Phaeoacremonium aleophilum - Field trial 2013 53735 k.A. N/J N 2932111/441940 KIIIM1 Hofmann, H. 2015 Evaluation of the efficacy of N J Bi-PA 6.2.1 BCP511B against Pal and Pch in nv/sa established vines W3-16-14-1!BF14-VITVI-02-DE-01 k.A. N/J N 2932112/441941 KIIIM1 Kortekamp, A. 2014 Efficacy of test product BCP 511 B N J Belchim 6.2.1 of Belchim Crop Protection against Crop Esca pathogens Phaeomoniella Protection chlamydospora and Phaeoacremonium aleophilum -fild trial 2014
k.A. N/J N 2932113/441942
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KIIIM1 Martin, T. 2015 Evaluation of treatment with N J Belchim 6.2.1 Trichoderma atroviride against Crop ESCA in grapevine Protection BF14-VITVI02-DE04-PAL k.A. N/J N 2932114/441943 KIIIM1 Martin, T. 2015 Evaluation of treatment with N J Belchim 6.2.1 Trichoderma atroviride against Crop ESCA in grapevine Protection BF14-VITV!02-DE04-PCH k.A. N/J N 2932115/441944 KIIIM1 Pollet, N. 2012 Vascular disease caused by N J Bi-PA 6.2.1 Phaeomoniella chlamydospora nv/sa and Phaeoacremonium aleophilum associated with Esca disease / Vine nursery 11BPA02!F11-VITVI-02 k.A. N/J N 2932116/441945 KIIIM1 Chene, J. 2011 Assessment of the impact of N J Bi-PA 6.2.1 Trichoderma (TSC1) on vineyard nv/sa esca disease MDB02/02/MON/2011 k.A. N/J N 2932118/441946 KIIIM1 Montier, L. 2012 Efficacy trials in vineyards of BCP N J Bi-PA 6.2.1 511 B against Pal and Pch, agents nv/sa of vascular diseases of grape and associated to Esca disease -1St Year-2011 F11-VITVI-11-FR k.A. N/J N 2932119/441947 KIIIM1 Pollet, N. 2012 Vascular disease caused by N J Bi-PA 6.2.1 Phaeomoniella chlamydospora nv/sa and Phaeoacremonium aleophilum associated with Esca disease / Grapevine 11 BPA 01! F11-VITVI-11-FR04 k.A. N/J N 2932120/441948 KIIIM1 Pertot, I. 2012 Compatibility of Trichoderma N J Bi-PA 6.4.1 atroviride SC1 with products in nv/sa authorised tank mixes and with other products that could be applied on grapevine 39328 k.A. N/N N 2932121/441949
Applicant: BI-PA nv Evaluator: Germany Applicant Document ID: dRR Section 7 Date: 2018-07-27 Applicant Author : GAB Consulting GmbH
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KIIIM1 Pertot, I. 2011 Ecology, identification, spectrum, N J Bi-PA 6.6.2 effect on fermentation, survival on nv/sa phyllosphere and long term survival of Trichoderma SC1.
k.A. N/N N 2932122/441950 KIIIM1 Pertot, I. 2011 Ecology, identification, spectrum, N J Bi-PA 6.7.1 effect on fermentation, survival on nv/sa phyllosphere and long term survival of Trichoderma SC1.
k.A. N/N N 2932123/441951 KIIIM1 Longa, C.M.O., 2009 Evaluating the survival and N J LIT 6.7.1 Savazzini, F., environmental fate of the Tosi, S., Elad, biocontrol agent Trichoderma Y., Pertot, I. atroviride SC1 in vineyards in northern Italy
J Appl Microbiol N/N J 2932124/441952 MIIIM1 Bi-PA 2015 dRR - B6 - core assess - DE - N O Bi-PA Sec 6 008562-00/00 - Vintec 2015 (pdf) nv/sa
N/N N 2932147/441959 MIIIM1 Bi-PA 2015 dRR - B6 - core assess - DE - N O Bi-PA Sec 6 008562-00/00 - Vintec 2015 (word) nv/sa
N/N N 2932148/441960 MIIIM1 Bi-PA 2015 dRR - B7 - core assess - DE - N O Bi-PA Sec 7 008562-00/00 - Vintec 2015 (pdf) nv/sa
N/N N 2932149/441961 MIIIM1 Bi-PA 2015 dRR - B7 - core assess - DE - N O Bi-PA Sec 7 008562-00/00 - Vintec 2015 (word) nv/sa
N/N N 2932150/441962 Document Bi-PA 2015 dRR - A - DE - 008562-00/00 - N O Bi-PA N Vintec 2015 (pdf) nv/sa
N/N N 2932151/441963 Document Bi-PA 2015 dRR - A - DE - 008562-00/00 - N O Bi-PA N Vintec 2015 (word) nv/sa
N/N N 2932152/441964
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KIIIM1 6 Scholze, I. 2015 Biological Assessment Dossier N J Bi-PA (BAD) 2015 (Word) nv/sa
N/N N 2977115/441967 KIIIM1 Paratte, J.-L. 2011 Fungicide efficacy against the N N Bi-PA 6.2.1 pathogens related to Esca wood nv/sa disease on grapevine
N/J N 2977116/441968 MIIIA1 BI-PA nv 2016 dRR - B7 - core - DE - 008562- N O Bi-PA Sec 7 00/00 - Vintec (überarbeitete nv/sa Version) (pdf)
N/N N 3158549/525059 MIIIA1 BI-PA nv 2016 dRR - B7 - core - DE - 008562- N O Bi-PA Sec 7 00/00 - Vintec (überarbeitete nv/sa Version) (word)
N/N N 3158550/525060 MIIIM1 Bi-PA nv/sa 2015 dRR - B6 - core - DE - 008562- N N Bi-PA Sec 6 00/00 - Vintec (word) nv/sa k.A. k.A. N/N N 3462690/525080 MIIIM1 Bi-PA nv/sa 2018 dRR - B7 - core - DE - 008562- N N Bi-PA Sec 7 00/00 - Vintec - update nv/sa k.A. k.A. N/N N 3462691/525081 MIIIM1 Bi-PA nv/sa 2018 dRR - B7 - core - DE - 008562- N N Bi-PA Sec 7 00/00 - Vintec - update (word) nv/sa k.A. k.A. N/N N 3462692/525082 Document Bi-PA nv/sa 2017 dRR - A - DE - 008562-00/00 - N N Bi-PA N Vintec - update nv/sa k.A. k.A. N/N N 3462693/525083 Document Bi-PA nv/sa 2017 dRR - A - DE - 008562-00/00 - N N Bi-PA N Vintec - update (word) nv/sa
k.A. N/N N 3462694/525084
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Lists of data considered in support of the evaluation (List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review) Data Author(s) Year Title Vertebrate Data Point Report-No. study protection Source (J=Yes GLP/GEP O=Open claimed Published N=No) (J=Yes Authority registration No./JKI-No. O=Open N=No)
Lists of data considered in support of the evaluation (List of data submitted by the applicant and not relied on) Data Author(s) Year Title Vertebrate Data protection Justification if data prote tion i Point Report-No. study claimed claimed Source (J=Yes (J=Yes GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI- No.
Lists of data considered in support of the evaluation (List of data relied on and not submitted by the applicant but necessary for evaluation) Data Point Author(s) Year Title Vertebrate Data protection Justification if data Report-No. study claimed protection i laimed Source (J=Yes (J=Yes GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. MIIIM1 Bi-PA 2018 dRR - B7 - core - DE - 008562-00/00 - N N Sec 7 nv/sa Vintec - update (word) k.A. k.A. N/N N 3462692/525551
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Appendix 2: GAP-Tables
GAP table of intended uses GAP rev. , date: year-month-day PPP (product name/code) Vintec Formulation type: WG Active substance 1 Trichoderma atroviride SC1 Conc. of as 1: 1 × 1013 CFU/kg Active substance 2 - Conc. of as 2: - Active substance - Conc. of as: -
Safener - Conc. of safener: - Synergist - Conc. of synergist: -
Applicant: Bi-PA Professional use Zone(s): Central/EU Non professional use
Verified by MS: y/n
1 2 3 4 5 6 7 8 10 11 12 13 14 Application Application rate Crop and/ Pests or Group of Max. number g, kg as/ha or situation pests controlled kg product / ha F (min. interval Timing / Water Remarks: Use- G between PHI Member state(s) (crop (additionally: Growth a) max. rate L/ha No. or Method / applications) a) max. rate per (days) destination / developmental stages stage of per appl. e.g. g safener/synergist per ha I Kind appl. purpose of of the pest or pest crop & a) per use b) max. total min / crop) group) season b) per crop/ b) max. total rate rate per max season per crop/season crop/season Germany Austria Phaeomoniella Hungary Winter a) 2 × 1012 Grapes, chlamydospora Spray dormancy 1- 2 (1 week a) 0.2 kg/ha CFU/ha Not 1 Belgium established F Phaeoacremonium appli- 100 - 200 - period interval) 12 relevant vines (VITVI) aleophilum cation b) 0.4 kg/ha b) 4 × 10 Romania BBCH0 CFU/ha
Slovakia Czech Republic
Applicant: BI-PA nv Evaluator: Germany Applicant Document ID: dRR Section 7 Date: 2018-07-27 Applicant Author : GAB Consulting GmbH
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Reg.-No. 008562-00/00 GAP rev.1, date: 2018-03-07 PPP (product name/code): Vintec Formulation type: WG (a, b) Active substance 1: Trichoderma atroviride Stamm SC1 Conc. of as 1: 150.00 g/kg (c) Active substance 2: Conc. of as 2: 0 (c) Active substance 3: Conc. of as 3: 0 (c) Active substance 4: Conc. of as 4: 0 (c) Active substance 5: Conc. of as 5: 0 (c) Applicant: Bi-PA nv/sa Professional use: Yes Zone(s): central/interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungicide
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: Conclusion No. state(s) or situation Fn, pests controlled (days) (efficacy) (e) Fpn Method / Timing / Max. Min. interval kg or L g or kg as/ha Water e.g. g (crop G, (additionally: Kind Growth number between product / ha L/ha safener/synergist destination / Gn, developmental stages stage of a) per applications a) max. rate a) max. rate per ha purpose of Gpn of the pest or pest crop & use (days) per appl. per appl. min / max (f) crop) or group) season b) per b) max. total b) max. total I crop/ rate per rate per season crop/season crop/season 001 DE grape vine F esca of vinegrape spraying a) 2 7 days a) 0.2 kg/ha a)0.03kg/ha 100 - 200 - A (VITVI) (Phaeomoniella or fine b) 2 b) 0.40 kg/ha b)0.06kg/ha kg/ha from 00 chlamydospora) spraying during (PHMOCH), esca of (low dormant vinegrape (Togninia volume period minima) (TOGNMI) spraying)
Remarks (a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (d) Select relevant table (b) Catalogue of pesticide formulation types and international coding system (e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should heading: Crop Life International Technical Monograph n°2, 6th Edition Revised May be given in column 1 2008 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.
Remarks 1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use must be columns: provided.
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2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be used; when 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of relevant, the use situation should be described (e.g. fumigation of a structure) empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 4 F: professional field use, Fn: non-professional field use, Fpn: professional and 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment non-professional field use, G: professional greenhouse use, Gn: non- (usually g, kg or L product / ha). professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when 12 If water volume range depends on application equipment (e.g. ULVA or LVA) it should be relevant, the common names of the pest groups (e.g. biting and sucking mentioned under “application: method/kind”. insects, soil born insects, foliar fungi, weeds) and the developmental stages 13 PHI - minimum pre-harvest interval of the pests and pest groups at the moment of application must be named. 14 Remarks may include: Extent of use/economic importance/restrictions 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, 15 A: Acceptable drench R: Acceptable with further restriction Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between C: To be confirmed by cMS the plants - type of equipment used must be indicated. N: Not acceptable / evaluation not possible 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of n.r.: Not relevant for section 3 Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application
Applicant: BI-PA nv Evaluator: Germany Applicant Document ID: dRR Section 7 Date: 2018-07-27 Applicant Author : GAB Consulting GmbH