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

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1 Page 1 of 16 DRAFT REGISTRATION REPORT Part A Risk Management Product code: Active Substance: Propamocarb 604 g/l COUNTRY: Germany Interzonal Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT : Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 25/07/2016

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 containing propamocarb in Germany. The risk assessment conclusions are based on the already existing registration of the PPP. No new sections of Registration Report, Part B were prepared on basis of new data: Assessments for the safe use of have been made using endpoints agreed in the EU reviews of propamocarb. Appendix 1 of this document provides a copy of the final product authorisation in Germany. Will be inserted in final version. 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 Registration number /02 Authorisation holder Function Type of formulation Interzonal application according to Article 51, ZRMS=DE, first application (GV1) Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen, Siebengebirgsstraße 200, Bonn, Deutschland Arysta LifeScience Benelux, Rue de Renory 26, 4102 Ougrée, BELGIEN Fungicide Expiration of authorisation Water soluble concentrate (SL)

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) Propamocarb (0516) Content in PPP 604 g/l Approval status Approved according Regulation (EC) No 1107/2009 Approval Expiration of approval 31/07/2018 Regulation (EC) No 540/2011; Regulation (EC) No 2015/ 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 ornamentals (NNNZZ) downy mildew (Peronosporaceae) Authorise 002 ornamentals (NNNZZ) downy mildew (Peronosporaceae) 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 001 (open field) is about ha, of which approx ha need to be controlled. 002 (greenhouse) is about 4705 ha, of which approx ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested uses. Upon this calculation and the examination of available alternative measures for the applied uses it can be stated that the applied uses is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims No new studies submitted.

5 Page 5 of Letters of Access No new studies submitted. 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 Propamocarb 604 g/l Type of formulation Water soluble concentrate (SL) Function Fungicide Authorisation holder Arysta LifeScience Benelux, Rue de Renory 26, 4102 Ougrée, BELGIEN 2.2 Classification and labelling Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: Hazard classes and categories: (kein Labelling-Requirement!) Sens. Skin 1 Hazard pictograms: GHS07 exclamation mark Signal word: Warning Hazard statements: H317 May cause an allergic skin reaction. Precautionary statemtents: P101 If medical advice is needed, have product container or label at hand. P102 Keep out of reach of children. P280 Wear protective gloves/protective clothing/eye protection/face protection. P302+P352 IF ON SKIN: Wash with plenty of water/... P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash before reuse. P501 Dispose of contents/container to...

6 Page 6 of 16 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: EUH Contains propamocarb-(hydrochloride). May produce an allergic reaction R and S phrases under Regulation (EC) No 547/2011 None Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Operator protection SB001 SB110 SB166 SF1891 SS110 SS206 SS2101 SS610 Avoid any unnecessary contact with the product. Misuse can lead to health damage. 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. Do not eat, drink or smoke when using this product. 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. Wear standard protective gloves (plant protection) when handling the undiluted product. Wear work clothing (if no specific protecting clothing is necessary) and sturdy shoes (e.g. rubber boots) during handling and applying plant protection products. Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. Wear a rubber apron when handling the undiluted product. Ecosystem protection SP 1 Do not contaminate water with the product or its container. Integrated Pest Management (IPM) Mode of action (FRAC/HRAC/IRAC-Group: F4 Active substance None The authorization of the PPP is linked to the following conditions (voluntary labelling): Honeybee

7 Page 7 of 16 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) Integrated Pest Management (IPM) NN130 NN160 NN165 The product is classified as harmless for populations of the species Pardosa amentata and palustris (lycosid spiders). The product is classified as harmless for populations of the species Aleochara bilineata (staphylinid beetle). The product is classified as harmless for populations of the species Poecilus cupreus (ground beetle) Specific restrictions linked to the intended uses Some of the authorized uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) Ecosystem protection For use 001- 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 EUR.

8 Page 8 of Product uses PPP (product name/code) ( ) active substance Propamocarb Formulation type: Conc. of as: SL 604 g/l safener - synergist - Conc. of safener: - Conc. of synergist: - : Zone(s): Verified by MS: j Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Interzonal professional use non professional use 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 Max. number kg, L product / g, kg as/ha Water L/ha (days) (min. interval ha between a) max. rate per a) max. rate min / max applications) appl. per appl. a) per use Timing / Growth stage of crop & season b) per crop/ season b) max. total rate per crop/season b) max. total rate per crop/season Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 001 DE ornamentals (NNNZZ) F downy mildew (Peronosporaceae) spraying from BBCH 11 in case of risk of infection a) 3 (7 to 14 days) b) 3 a) 1,5 L/ha b) 4.5 L/ha a) 0,906 kg as/ha b) 2,718 kg as/ha 1000 N* Restrictions (see ) NW642-1 *The setting of a PHI is without any relevance. 002 ornamentals (NNNZZ) G downy mildew (Peronosporaceae) spraying from BBCH 11 in case of risk of infection a) 3 (7 to 14 days) b) 3 a) 1,5 L/ha b) 4.5 L/ha a) 0,906 kg as/ha b) 2,718 kg as/ha N

9 Page 9 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 Not relevant. Ornamentals are not used as food or feeding stuff 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 propamocarb has been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended uses in ornamentals Residues The intended use is not relevant in terms of consumer health protection. No MRL necessary Consumer exposure The envisaged uses are not relevant in terms of consumer health protection. No residues have to be considered for consumer risk assessment Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. The conditions of use NW is assigned for the outdoor uses, see also 2.2. Risk Assessment for Honeybees

10 Page 10 of 16 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 uses 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 uses 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. 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 uses. With respect to toxicology, residues and consumer protection an authorisation can be granted. Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. An authorisation can be recommended. 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

11 Page 11 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 new studies submitted. Authorisation holder agrees to the current application to extend the authorisation.