Art. 51 Extension of authorisation for minor uses. Risk Management

Transcription

1 Page 1 of 16 REGISTRATION REPORT Risk Management Product code: Active Substances: lambda-cyhalothrin 100 g/l COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT : Dienstleistungszentrum Ländlicher Raum (DLR) - Rheinpfalz - Phytomedizin - Date: 05/01/2017

2 Table of Contents Page 2 of 16 PART A Risk Management Details of the application Application background Annex I inclusion Regulatory approach Uses applied for and registration decision Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Regulation (EC) No 1272/ R and S phrases under Regulation (EC) No 547/ Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Residues and Consumer Exposure Residues Consumer exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access... 16

3 Page 3 of 16 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of Karate Zeon containing lambda-cyhalothrin in Germany. The risk assessment conclusions are based on the already existing registration of the PPP. Assessments for the safe use of have been made using endpoints agreed in the EU reviews of lambda-cyhalothrin. Appendix 1 of this document provides a copy of the final product authorisation in Germany. 1 Details of the application Application to extend the authorisation of a plant protection product (PPP) already authorised in Germany to minor uses not yet covered by that authorisation. The application is intended for use in Germany only. 1.1 Application background Details on applicant and application Plant protection product Type of application Zonal application according to Article 51, ZRMS = DE, first application (GV1) Registration number /22 Dienstleitungszentrum Ländlicher Raum (DLR) - Rheinpfalz - Phytomedizin -, Breitenweg 71, Neustadt a. d. Weinstraße, Deutschland Authorisation holder Function Type of formulation Syngenta Agro GmbH, Am Technologiepark 1-5, Maintal, Deutschland Insecticide Capsule suspension Expiration of authorisation

4 Page 4 of Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) lambda-cyhalothrin (0751) Content in PPP Approval status Approval 100 g/l Deemed to have been approved under Regulation (EC) No 1107/2009 Annex I to COMMISSION IMPLEMENTING REGULATION (EU) 2016/146 Expiration of approval 31/03/ Regulatory approach The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. Therefore the evaluation of the current application is limited to the points not covered by the existing registration Uses applied for and registration decision Number of use Plant/commodity/object Harmful organism/purpose decision 001 grape vine vine louse Authorise Public interest and minor use According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. In Germany the cultivated area of grape vine (potted plants (greenhouse)) is about 0,33 ha, of which approx. 0,05 ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested use. Upon this calculation and the examination of available alternative measures for the applied use it can be stated that the applied use is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims No new studies have been submitted. 1.5 Letters of Access

5 Page 5 of 16 Since no new studies have been submitted a Letter of Access is not required Authorisation holder agrees to the current application to extend the authorisation. 2 Details of the authorisation 2.1 Product identity Product name Authorisation number Composition Type of formulation Function Authorisation holder lambda-cyhalothrin 100 g/l Capsule suspension (CS) Insecticide 2.2 Classification and labelling Syngenta Agro GmbH, Am Technologiepark 1-5, Maintal Classification and labelling under Regulation (EC) No 1272/2008

6 Page 6 of 16 Hazard classes and categories: Acute toxicity 4, sensitisation respirat. 1, sensitisation - skin 1, Aquatic acute 1, Aquatic chronic 1 Hazard pictograms: GHS08 GHS09 Signal word: Danger Hazard statements: H302 H317 H332 H334 H400 H410 Precautionary statemtents: P101 P102 P270 P280 P284 P302+P352 P304+P340 P308+P310 P362+P364 Health hazard environment Harmful if swallowed. May cause an allergic skin reaction. Harmful if inhaled. May cause allergy or asthma symptoms or breathing difficulties if inhaled. Very toxic to aquatic life. Very toxic to aquatic life with long lasting effects. If medical advice is needed, have product container or label at hand. Keep out of reach of children. Do no eat, drink or smoke when using this product. Wear protective gloves/protective clothing/eye protection/face protection. [In case of inadequate ventilation] wear respiratory protection. IF ON SKIN: Wash with plenty of water/... IF INHALED: Remove person to fresh air and keep comfortable for breathing. IF exposed or concerned: Immediately call a POISON CENTER or a doctor/physician. Take off contaminated clothing and wash it before reuse. P501 Dispose of contents/container to... Special rule for labelling of PPP: EUH EUH Contains 1,2-benzisothiazole-3(2H)-one. May produce an allergic reaction. Contains lambda-cyhalothrin. May produce an allergic reaction. 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

7 Page 7 of R and S phrases under Regulation (EC) No 547/2011 EO005-2 SPo 5: Ventilate greenhouses thoroughly before re-entry Other phrases Restrictions linked to the PPP The authorisation of the PPP is linked to the following conditions (mandatory labelling): Operator protection SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB110 The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. SB193 If the plant protection product comes into contact with skin (especially facial), it can cause burning or itching, without external signs of irritation. These effects must be regarded as a warning to avoid further exposure at all costs. If the symptoms do not disappear, or if they are joined by further symptoms, a doctor must be consulted. SB199 When applying the product with tractor-mounted, trailed or self-propelled application equipment, only vehicles with closed pressurized cabins (e.g. cabin category 3, if no respiratory protective equipment or particle-filtering masks are necessary or category 4, if gastight respiratory protective equipment is needed acc. to EN and -2) are suited to replace personal protective equipment during application. During all other activities outside of the cabin the prescribed personal protective equipment must be worn. In order to avoid contamination of the cabin, it is not permitted to enter the cabin with contaminated personal protective equipment (it should be deposited e.g. in an appropriate storage facility). Contaminated gloves should be washed before removing the gloves and hands should be washed before entering the cabin with pure water, respectively. SS110 Wear standard protective gloves (plant protection) when handling the undiluted product. SS2101.Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. SS530 Wear face protection when handling the undiluted product. SS610 Wear a rubber apron when handling the undiluted product. SF1891 Re-entering the treated areas/crops is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. Ecosystem protection NW262 The product is toxic for algae. NW264 The product is toxic for fish and aquatic invertebrates. NW468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This

8 Page 8 of 16 Honeybee also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. NB6623 The product may only be used in a mixture of fungicides of the ergosterol-biosynthesisblocker group on flowering plants and on plants which are visited by bees in the evening after the daily bee flight until 11 p.m., unless the use of this mixture on flowering plants and plants which are visited by bees is explicitly allowed during bee flight in the fungicide's instructions for use. Bee Protection Ordinance of 22 July 1992, BGBI, I, p Integrated Pest Management (IPM) NN291 The product is classified as slightly harmful for populations of the species Episyrphus balteatus (hover fly). NN330 The product is classified as harmful for populations of the species Pardosa amentata and P. palustris (lycosid spiders). NN361 The product is classified as harmful for populations of the species Coccinella septempunctata (seven-spotted ladybird). NN3842 The product is classified as harmful for populations of the species Aphidius rhopalosiphi (braconid wasp). NN400 The product is classified as harmful for populations of relevant beneficial organisms. NN410 The product is classified as harmful for populations of pollinating insects. The application of the product onto flowering crops should be avoided or performed in the evening in particular to protect wild bees. WH950 A suitable form of resistance management must be stated on the packaging. Mode of action (IRAC-Group): 3A Active substance The authorisation of the PPP is linked to the following conditions (voluntary labelling): Honeybee 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) Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) Operator protection SS120 Wear standard protective gloves (plant protection) when handling/applying the product ready for application. Ecosystem protection

9 Page 9 of Product uses PPP (product name/code) ( ) active substance 1 lambda-cyhalothrin Formulation type: CS Conc. of as 1: 100 g/l : DLR Rheinpfalz - Phytomedizin Zone(s): all zones professional use non professional use Verified by MS: j Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Application Application rate PHI (days) Timing / Growth stage of crop & season Max. number (min. interval between applications) a) per use b) per crop/ season kg, L product / ha a) max. rate per appl. b) max. total rate per crop/season g, kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha min / max Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 001 DE grape vine (seedling production) G vine louse (Eggs and larvae to Adults) watering singleplant treatment, planted pots BBCH at beginning of infestation and/or when first symptoms become visible, in case of infestation, in case of reinfestation a) 2 (12 to 14 days) b) 2 a) 0.1 ml per L substrate b) 0.2 ml per L substrate a) 0.01 g as per L substrate b) 0.02 g as per L substrate 200 ml per L substrate F Restrictions (see ) potted plants (greenhouse),

10 Page 10 of 16 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Not relevant for extension of authorisation according article Methods of analysis Analytical method for the formulation Not relevant for extension of authorisation according article Analytical methods for residues Grapes belong to the group of high water content commodities. Sufficiently validated analytical methods are available for enforcing lambda-cyhalothrin in grapes Mammalian Toxicology The PPP is already registered in Germany according to Directive 91/414/EEC. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected Residues and Consumer Exposure The residue behaviour of the active substance lambda-cyhalothrin has been evaluated within the EU review process. The intended use on grape vine for seedling production is not relevant in terms of consumer health protection. Therefore, no results of supervised residue trials are required and no assessment of the intake by consumers is necessary Residues No results of supervised residue trials are required since the intended use on grape vine for seedling production is not relevant in terms of consumer health protection Consumer exposure Consumers are not exposed to residues of lambda-cyhalothrin following treatment of grape vine for seedling production with Environmental fate and behaviour No new studies were presented; all data were reviewed within the EU review for the active substance λ- cyhalothrin and the national authorisation procedure for the product ( /00), respectively, and assessed according to the uniform principles of Directive 91/414/EEC. The environmental exposure due to the minor use extension applied for (watering of potted young vine plants in greenhouse) is considered to be low. During and after application in greenhouses significant exposure of the environmental compartments soil, water and air is not expected. Depending on the time interval between application and planting of the young plants into the field and the degradation of the active substance during this time, remaining residues of λ-cyhalothrin in the substrate may reach the soil of the

11 Page 11 of 16 vineyard. Since the active substance is neither systemic nor mobile in soil (very strong adsorption according to K OC ) the residues will be retained in the substrate directly around the subsoil vine plant. Neither accumulation in soil nor leaching to groundwater of the active substance or relevant metabolites in concentrations above 0.1 µg/l has to be expected. Specific additional risk mitigation measures are not required Ecotoxicology No new studies were presented; all data were reviewed within the EU review for the active substance λ- cyhalothrin and the national authorisation procedure for the product ( /00), respectively, and assessed according to the uniform principles of Directive 91/414/EEC. The risk for non-target organisms as a consequence of the minor use extension applied for is considered acceptable since exposure due to the intended uses (watering of potted young vine plants in greenhouse) is considered to be negligible and thus covered by the uses already authorised. Additional risk mitigation measures for the protection of aquatic organisms and terrestrial non-target arthropods are not required. After planting the treated young plants in the field possibly remaining residues of the active substance in the substrate will be retained in the substrate directly around the subsoil vine plant. Exposure of soil organisms will therefore only occur in a very small portion of the area of the vineyard. Unacceptable effects on soil organisms are therefore not expected. The product as well as the active substance λ-cyhalothrin is very toxic to the aquatic environment. Therefore, additional labelling with risk phrases (NW262, NW264) and safety phrases (NW468) is assigned, particularly to enforce prevention of any point source entry into surface waters; see also chapter 2.2. Risk Assessment for Honeybees The honeybee risk assessment for the main application covers the use(s) in accordance with Article 51 of regulation (EC) No 1107/2009 (see also point 2.2) Efficacy Labelling in accordance with the requirements of ANNEX III General Principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the use applied for under the terms of Article 51 of regulation (EC) No 1107/ The categories and labelling for mode of action for the main application cover the use applied for under the terms of Article 51 of regulation (EC) No 1107/2009. According to Article 51 of the regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products not need to be checked. 3.2 Conclusions PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI.

12 Page 12 of 16 The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of use. The intended use does not affect commodities relevant for human consumption or animal feed. The use on grape vine for seedling production does not represent a consumer health risk. Considering the minor use extension applied for neither harmful effects on groundwater nor unacceptable effects on the environment have to be apprehended as a consequence of proper use consistent with good plant protection practice. Additional risk mitigation measures are not required. 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 None

13 Page 13 of 16 Appendix 1 Copy of the product authorisation

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16 Page 16 of 16 Appendix 2 Copy of the product label No product label available. Not mandatory according to Article 51 (5) Appendix 3 Letter of Access No letter of access necessary.