Notification of an Emergency Authorisation issued by Belgium

1. Member State, and MS notification number

BE-Be-2020-02

2. In case of repeated derogation: no. of previous derogation(s)

None

3. Names of active substances

Tefluthrin - 15.0000 g/kg

4. Trade name of Protection Product

Force 1.5 GR

5. Formulation type

GR

6. Authorisation holder

KDT

7. Time period for authorisation

01/04/2020 - 29/07/2020

8. Further limitations

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9. Value of tMRL if needed, including information on the measures taken in order to confine the commodities resulting from the treated crop to the territory of the notifying MS pending the setting of a tMRL on the EU level. (PRIMO EFSA model to be attached)

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10. Validated analytical method for monitoring of residues in and plant products.

Source: Reasoned opinion on the setting of maximum residue levels for tefluthrin in various crops1 EFSA Journal 2015;13(7):4196: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2015.4196 1. Method of analysis 1.1.Methods for enforcement of residues in food of plant origin Analytical methods for the determination of tefluthrin residues in plant commodities were assessed in the DAR and during the peer review under Directive 91/414/EEC (Germany, 2006, 2009; EFSA, 2010). The modified multi-residue DFG S 19 analytical method using GC-MSD quantification and its ILV were considered as fully validated for the determination of tefluthrin in high water content- (sugar beet ), high acid content- (orange), high oil content- (oilseed rape) and dry/starch- (maize grain) commodities at an LOQ of 0.01 mg/kg. However a confirmatory method is missing. Since the commodities under consideration belong to the group of high water content commodities, EFSA concludes that a sufficiently validated analytical method for enforcing the proposed MRLs for tefluthrin in these crops is available. A validated confirmatory method is however required. Damage of ( antiqua) is caused by larvae boring into the base plate and followed by secondary breakdown of tissues either in the field or during storage. Each year, there are 2 or 3 generations. Late-generation pupae overwinter in the soil. The first are monitored at the end of April or begin of Mai. The eggs are laid in the ground, near young plants or between the shoots of bulbs. The larvae are white and cylindrical and hatch in 3 to 8 days. The larvae create large cavities in bulbs and roots. The first generation of larvae is the most harmful, because it occurs when the plants are small. Seedlings of /spring onions can be severely affected. The leaves start to turn yellow and the bulbs rot quickly or will be malformed. 1.2.Methods for enforcement of residues in food of origin The analytical methods for the determination of tefluthrin residues in commodities of animal origin were evaluated in the DAR and during the peer review under Directive 91/414/EEC (Germany, 2006, 2009; EFSA, 2010) and also in the framework of this MRL application (France, 2013, 2015). The multi-residue DFG S 19 analytical method using GC-MSD quantification and its ILV were considered as fully validated for the determination of tefluthrin in animal commodities at an LOQ of 0.002 mg/kg for muscle, liver, kidney, eggs and fat and at an LOQ of 0.001 mg/kg for milk. EFSA concludes that a sufficiently validated analytical method for enforcing the proposed MRLs for tefluthrin in food of animal origin is available.

11. Function of the product (E.g. systemic long acting insecticide; foliar fungicide, used for regular control, elimination scenario etc)

insecticide

12. Type of danger to plant production or ecosystem (Provide reasoning for what category the 120 day authorisation is given: quarantine pest; emergent pest, either invading non-native, or native; emerging resistance in a pest, etc. Whereas reference to the EU quarantine legislation may suffice for quarantine pests elaborate reasoning should be provided for the category 'any harmful pest')

Carrot fly (Psila rosae) is a well known pest in carrots and other root vegetables. overwinters as a pupa in the soil. The adults appear over an extended period, from the end of April/begin of May until July. The flies take flight on fine days, flying slowly, landing frequently on the leaves of a large variety of low-growing plants. They mate and lay eggs shortly afterwards in the ground near host plants, carrots. Embryo development: 8 to 10 days. Larvae move in the soil and penetrate the roots. One larvae can penetrate more than one root. Larval development lasts one month after which it pupates. Damage of the larvae can vary form twisting galleries, notably in the external layer to falling down of the leaves (if roots are highly affected by the larvae). Since 2001, is monitoring of the Psila rosae population ongoing in the different production regions of Belgium. The Belgian research stations and growers monitor the populations and developed a system to control the pest well-reasoned (economic threshold on 3 flies/trap). In case of an exceedance on a field, the grower is advised to treat the field. It’s important to control the carrot fly at the right time. If carrot fly is present or not and at what time is extremely dependent from field to field. That’s why a general warning system is not used, but each field needed to be monitored with traps. Growers were supervised to recognize carrot fly and to count them weekly on the orange traps. Depending on the results of the count, a grower needs to decide to take action or not. About 300 growers of carrots are participating in the monitoring system, which represents about 350 fields with carrots and means a 1.260 ha. Generally three distinct periods of adult flight activity are observed, indicating three generations of Psilae rosae a year. Depending on the weather conditions, population pressure in the region, type of crops in the region… the first flight peaked in May/begin June, followed by a second peak in July/August, and a third peak September to November. A period with a lot of rain is favorable for egg development. Since many years is cabbage fly (Delia radicum) in cauliflower, broccoli, Brussels sprouts, head cabbages, Chinese cabbage, kale, swedes and kohlrabi a very serious problem. It’s also a problem in turnips, Generated by PPPAMS - Published on 04/02/2020 - Page 2 of 7

Phyllotreta cruciferae. Control of cabbage fly and turnip fly is a major problem in Belgium and in other European countries. The larvae of cabbage feed on the roots of cabbages (turnips) and on the buttons of Brussels sprouts, with yield reduction as result. More severe infestations cause stunting, bluish or purple/red discoloration of the leaves, plants may wilt and die. Infested buttons will rot. Life cycle: Each year, there are 2 or 3 generations, starting from emergence and egg laying in April and extending, with some overlapping into September. Eggs are laid at the feet of the plant, where larvae tunnel into the roots. This cause growth retardation and infested plants become more sensitive to dryness. With the development of the cabbage the plant falls down. Delia (Phorbia) platura is in peas and beans a well-known pest in seedling stage. Female deposits eggs in the soil, near the . The larvae penetrate into the seeds and feed on germinating seeds, seedlings, forming galleries in the cotyledons, small stems and the young shoots before they emerge from the soil. The seeds and seedlings are susceptible for 3 to 4 weeks after sowing. Afterwards is the skin too hard to penetrate. An infestation of Delia platura can cause serious damage in the fields: some seeds can’t germinate anymore, others germinate, but the cotyledons and first leaves are destroyed. They often cause the plant to rot. And secondly, infested and wounded plants are highly susceptible to fungi.

13. Size and effect of danger (Describe shortly the area affected, the development over time of the infestation, and the agronomic and economic effects it has)

Beetroots: 35 ha (2018) 40 ha (2019) 520 ton (2019) Carrots: 5.650 ha (2018) 5.750 ha (2019) 323.500 ton (2019) Horseradishes small acreage (no detailed statistics available) Parsnips: 225 ha (2018) 270 ha (2019) 7.875 ton (2019) Parsley/chervil roots: small acreage (no detailed statistics available) Black small acreage (no detailed statistics available) Salsifies 580 ha (2018) 525 ha (2019) 11.600 ton (2019) Swedes/turnips 520 ha (2018) 490 ha (2019) 15.000 ton (2018) Onions: 3.700 ha (2018) 2.142 ha (2019) 105.375 ton (2018) : small acreage (no detailed statistics available) Cauliflower: 5.470 ha (2018) 5.540 ha (2019) 118.000 ton (2018) Broccoli: 248 ha (2018) 275 ha (2019) 3.300 ton (2018) Brussels sprouts: 2.450 ha (2018) 2.700 ha (2019) 55.000 ton (2018) Head cabbage: 1.000 ha (2018) 1.075 ha (2019) 52.900 ton (2018) Chinese cabbage: 47 ha (2018) 52 ha (2019) 3.250 ton (2018) Kale 100 ha (2018) 115 ha (2019) 2.500 ton (2018) Kohlrabi: 108 ha (2018) 100 ha (2019) 10.800 ton (2018) Beans: 7.900 ha (2018) 7.600 ha (2019) 89.700 ton (2018) Peas: 11.300 ha (2018) 10.200 ha (2019) 62.150 ton (2018) 3.775 ha (2018) 4.025 ha (2019) 130.000 ton (2018) VBT-data, annual statistics There is a zero tolerance for damage of different vegetable flies and Agriotes. If vegetables are infested with vegetable flies and/or Agriotes, the crops can’t be sold on the market, even not in a lower quality class. Infested crops will rot already on the field or after harvest. A crop infested by a vegetable fly or Agriotes contains internally larvae and the consumer doesn’t appreciate larvae in his vegetables.

14. Absence of any other reasonable means (Describe the alternative control measures (chemical, non-chemical and cultural) and indicate why they do not (in combination) suffice. Describe which, if any, authorisations for the pest to be controlled exist in other Member States.

Against Psila rosae (carrot fly): - beetroots and horseradish no authorisations; - carrots: withdrawal of dimethoate and recently thiamethoxam, means that only pyrethrins (cypermethrin, deltamethrin and lambda-cyhalothrin), next to chlorantraniliprole will be available. - parsnips, parley/chervil roots: pyrethrins and chlorantraniliprole are authorised. Knowing that 3 generations are present in Belgium and more than one treatment is needed to control each flight peak, the availability of only 2 groups of active substances with a different mode of action (IRAC 3 and IRAC 28) is not a good agricultural practice. This will advance resistance. Tefluthrin is also a pyrethrine, but the efficacy of a granulate is better than a spray application. (see also trial information) In France is Force 1,5 G authorised in different root vegetables: swedes, turnips, celeriac, and black radish. Label in attachment or https://ephy.anses.fr/ppp/force-15-g . Against Delia antiqua (onion fly) Onions, garlic and : No authorisations available. Last years, loss of fipronil, dimethoate (onions) and withdrawal of the granulate application of chlorpyrifos (onions). In Germany was an art. 53 granted for tefluthrin from 21/12/2018 till 18/04/2019. https://www.bvl.bund.de/SharedDocs/Downloads/04_Pflanzenschutzmittel/01_notfallzulassungen/Force_20_CS_ Drahtwurm_Speisezwiebeln_2018_2019.pdf?__blob=publicationFile&v=2 Against Delia radicum (cabbage fly) and against Phyllotreta cruciferae (turnip fly) in turnips; - all types of cabbages: withdrawal of chlorpyrifos, only spinosad and pyrethrins are authorised; - black radish: withdrawal of chlorpyrifos, chlorantraniliprole and lambda-cyhalothrin are authorised. The withdrawal of dimethoate and chlorpyrifos means that only spinosad and a pyrethroïds are available. But these active substances are not enough to control the cabbage fly in different cabbages. In one season are 3 peaks of cabbage fly monitored, so the active substance, tefluthrin as a granulate application can help to control cabbage fly in an early stage in a growing season. Against Delia (Phorbia) platura (bean fly) Withdrawal of the treatment with chlorpyrifos. No alternatives are authorised. In France is Force 1,5 G authorised in peas and beans (with pods) and was an art. 53 granted for beans without pods. French label in attachment or https://ephy.anses.fr/ppp/force-15-g . Documents with art. 53 is attached.

15. Rationale (Reason the risk management decision based on the findings of 15 to 18, containing especially a description of measures taken to ensure consumer protection).

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16. Mitigation measures (Describe what mitigation measures are taken if needed for minimising risk to humans, , and the environment, attach summary risk assessment. Describe what measures are taken to limit and control use)

This request is for use in root and tuber vegetables, cabbages, leek, onions, garlic, peas and beans (with and without pods).

17. Applications in progress (The use notified may have been applied for already, or a suitable alternative PPP may be in the process of authorisation. Describe such applications, including a possible date of authorisation)

The first authorization of Force 1,5 GR was granted in August 2019. The company and sector want to submit a dossier for extensions, but as we noticed some changes in residue definition, it’s not possible to have all this new residue information available on a very short time. The company and sector will discuss how to proceed with extensions and performing new residue data. But that process will take time. Meanwhile, the need of an authorization for tefluthrin is urgent in different crops, because of the withdrawal of chlorpyrifos and the lack of other alternatives to control vegetable flies and soil . Research station has already done a lot of trials, where the efficacy of a granulate application of tefluthrin is proven.

18. Research activities (Describe the research efforts undertaken and/or in progress, their aims, their funding, and their expected date of results. This is needed for all categories of dangers, except quarantine pests that can still be eliminated, or infrequent pests, for which no official application for a normal authorisation or extension of use of the plant protection product exists. In case of a repeated notification: indicate the state of works of the research projects.)

Carrot fly in root vegetables: An observation and warning system for carrot fly is active. In function of the pressure of carrot fly is advice given to the growers to treat or not to treat against carrot fly. - Trial at PSKW, 2017: Koolvliegbestrijding in raap: plantbakbehandeling tegen koolvlieg interessant voor primeurteelt van raap. – reference: rp17drmi Cabbage fly: Since many years is cabbage fly a major problem in Belgium and also in other European countries. Since many years is research done at the Belgian trial stations to find a solution/strategy to control cabbage fly: A short overview of trials is described in a separate document in attachment. In different trials were different types of applications and combinations tested. Trials were done with tray treatments with spinosad, cyantraniliprole and spinetoram, trials were done with an application of a granulate with chlorpyrifos (redrawn) and with alternatives as a granulate: tefluthrin, cypermethrin, lambda-cyhalothrin and Nemguard GR. And trials were done with combinations of tray treatments and a granulate application. Conclusion is that the combination of a tray treatment and a granulate application with chlorpyrifos or one of the alternatives had a clear added value to control cabbage fly. In different trials is the efficacy of a tray application in combination with a granulate application of tefluthrin demonstrated. - Trial at PSKW, 2015: Control of cabbage fly in early cauliflower - reference bl15drmi; - Trial at PCG, 2018: Werkzaamheid van diverse plantbakbehandelingen en granulaten tegen koolvlieg (Delia radicum / HYLERA) in bloemkool (Brassica oleracea var. botrytis / BRSOB) – reference OL18 BKVL01; - Trial at PSKW 2018: Koolvliegbestrijding in bloemkool. – reference BL18drmi; - Trial at PCG, 2019: Bestrijding van koolvlieg (Delia radicum / HYLERA) in bloemkool (Brassica oleracea var. botrytis / BRSOB) – reference OL19 BKVL01; - Trial at PSKW, 2017: Koolvliegbestrijding in bloemkool – late weeuwenteelt. – reference bl17drlw. Onion fly - Trial at PSKW, 2019: Bestrijding preivlieg op zaaibed prei – reference PV-pr19dami.

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20 GAP

1 3 4 5 6 7 8/9 10 a/b 11 a/b 12 13 Use-No. Crop and/ Pests or Group of Application Application Rate PHI Remarks: or situation pests controlled Method / Timing / Max. number kg, L g, kg as/ha Water (days) (crop destination (additionally: Kind Growth [min. interval product L/ha e.g. safener/synergist per / purpose of F developmental stage between / ha a) max. rate ha crop) G stages of the pest of crop & applications(days)] a) max. rate per appl. min / e.g. recommended or or or pest group) season per appl. max mandatory tank mixtures I a) per use b) max. total b) max. total rate per b) per crop/ rate per crop/season season crop/season redroot(BEAVD) scorzonera(SCVHI) a) turnip-rooted [ None ] (days) a) 10 150 g/ha Chamaepsila rosae (Chamaepsila at sowing 1 chervil(CHPBU) F row to a) 1 kg/ha (Tefluthrin) / rosae) Major Use turnip-rooted b) b) parsley(PARCT) b) wild carrot(DAUCA) wild parsnip(PAVSA) a) [ None ] (days) a) 10 swedish turnip(BRSNA) Delia radicum (Delia radicum) 150 g/ha at sowing 4 F row to a) 1 kg/ha / turnip(BRSRR) mouche du navet (Delia floralis) (Tefluthrin) Major Use b) b) b) a) garlic(ALLSA) [ None ] (days) a) 10 150 g/ha at sowing 5 purret(ALLPO) F Delia antiqua (Delia antiqua) row to a) 1 kg/ha / (Tefluthrin) Major Use scallion(ALLCE) b) b) b) brussels sprouts(BRSOF) cauliflower(BRSOB) a) pak-choi(BRSCH) [ None ] (days) a) 10 individual 150 g/ha bbch 12, at planting 6 scottish kale(BRSOC) F Delia radicum (Delia radicum) to a) 1 kg/ha / plant (Tefluthrin) Major Use sprouting broccoli(BRSOK) b) b) turnip kale(BRSOG) b) tyfon(BRSPK) white cabbage(BRSOL) a) field bean(VICFX) [ None ] (days) a) 10 pea(PIBSS) 150 g/ha at sowing 7 F Delia platura (Delia platura) row to a) 1 kg/ha / (Tefluthrin) Major Use snow pea(PIBSX) b) b) string bean(PHSVX) b)

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21 MRL: Reference to product code number in Annex I of regulation (EC) No 396/2005 MRL: reference to products Pesticide residues EPPO Code for CROP Product Tefluthrin (F) BRSOF Brussels sprouts 0.05 Brussels sprouts Reg. (EU) 2018/685 (Brassica oleracea var. gemmifera) PIBSS 0.05 Peas (with pods) Reg. (EU) 2018/685 (Pisum sp.) HELTU canada potato 0.05 Jerusalem artichokes Reg. (EU) 2018/685 (Helianthus tuberosus) BRSOB cauliflower 0.05 Cauliflowers Reg. (EU) 2018/685 (Brassica oleracea var. botrytis) VICFX faba bean 0.05 Beans (without pods) Reg. (EU) 2018/685 (Vicia faba) RAPSN garden radish 0.1 Radishes Reg. (EU) 2018/685 ( sativus var. niger) ALLSA garlic 0.07 Garlic Reg. (EU) 2018/685 ( sativum) ARWLA horseradish 0.05 Horseradishes Reg. (EU) 2018/685 (Armoracia rusticana) BRSCH pak-choi 0.05 Chinese cabbages/pe-tsai Reg. (EU) 2018/685 (Brassica rapa subsp. chinensis) BRSPK pe-tsai 0.05 Chinese cabbages/pe-tsai Reg. (EU) 2018/685 (Brassica rapa subsp. pekinensis) ALLPO purret 0.05 Leeks Reg. (EU) 2018/685 (Allium porrum) BEAVD redroot 0.08 Beetroots Reg. (EU) 2018/685 (Beta vulgaris subsp. vulgaris var. conditiva) ALLCE scallion 0.07 Onions Reg. (EU) 2018/685 (Allium cepa) SCVHI scorzonera 0.05 Salsifies Reg. (EU) 2018/685 (Scorzonera hispanica) BRSOC scottish kale 0.05 Kales Reg. (EU) 2018/685 (Brassica oleracea var. sabellica) PIBSX snow pea 0.05 Peas (without pods) Reg. (EU) 2018/685 (Pisum sativum) BRSOK sprouting broccoli 0.05 Broccoli Reg. (EU) 2018/685 (Brassica oleracea var. italica) PHSVX string bean 0.05 Beans (with pods) Reg. (EU) 2018/685 (Phaseolus vulgaris) BRSNA swedish turnip 0.08 Swedes/rutabagas Reg. (EU) 2018/685 (Brassica napus subsp. rapifera) BRSRR turnip 0.08 Turnips Reg. (EU) 2018/685 (Brassica rapa) BRSOG turnip kale 0.05 (d) kohlrabies Reg. (EU) 2018/685 (Brassica oleracea var. gongylodes)

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CHPBU turnip-rooted chervil 0.05 Parsley roots/Hamburg roots parsley Reg. (EU) 2018/685 (Chaerophyllum bulbosum) PARCT turnip-rooted parsley 0.05 Parsley roots/Hamburg roots parsley Reg. (EU) 2018/685 (Petroselinum crispum var. tuberosum) BRSOL white cabbage 0.05 Head cabbages Reg. (EU) 2018/685 (Brassica oleracea var. capitata) DAUCA wild carrot 0.08 Carrots Reg. (EU) 2018/685 (Daucus carota) PAVSA wild parsnip 0.05 Parsnips Reg. (EU) 2018/685 (Pastinaca sativa)

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