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

Transcription

1 Page 1 of 17 DRAFT REGISTRATION REPORT Part A Risk Management Product code: Active Substance: Potassium hydrogen carbonate 850 g/kg COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT : Spiess-Urania Chemicals GmbH Date: 25/07/2016

2 Table of Contents Page 2 of 17 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... 17

3 Page 3 of 17 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of containing potassium hydrogen carbonate 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 potassium hydrogen carbonate. Appendix 1 of this document provides a copy of the final product authorisation in Germany. Will be inserted in the 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 /06 Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS=DE, first application (GV1) Spiess-Urania Chemicals GmbH, Frankenstraße 18 b, Hamburg, Deutschland Spiess-Urania Chemicals GmbH, Frankenstraße 18 b, Hamburg, Deutschland Fungicide Expiration of authorisation Water soluble powder (SP)

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) Potassium hydrogen carbonate (1042) Content in PPP 850 g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Expiration of approval 31/08/2019 Regulation (EC) No 540/2011, Regulation (EC) No 735/ Regulatory approach The PPP is already registered in Germany according to Regulation (EC) No 1107/2009 taking into account the uniform principles of Commission Regulation (EU) No 546/2011. 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 apple (MABSD) plum (PRNDO) thinning of fruit (YFRAD) thinning of fruit (YFRAD) Use withdrawn by applicant Use withdrawn by applicant 003 apricot (PRNAR) blight (Monilinia laxa) (MONILA) 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 apple is about 4700 ha, of which approx. 470 ha need to be controlled. 002 plum is about 4352 ha, of which approx ha need to be controlled. 003 apricot is about 53 ha, of which approx. 21 ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested uses. All data are valid for open field. 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.

5 Page 5 of Data protection claims No new studies submitted. 1.5 Letters of Access Not necessary. The applicant is authorisation holder. 2 Details of the authorisation 2.1 Product identity Product name Authorisation number Composition Type of formulation Function Authorisation holder Potassium hydrogen carbonate 850 g/kg Water soluble powder (SP) Fungicide 2.2 Classification and labelling Spiess-Urania Chemicals GmbH, Frankenstraße 18 b, Hamburg, Deutschland Classification and labelling under Regulation (EC) No 1272/2008 To avoid risks to human health and the environment, comply with the instructions for use 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): Human health protection SB001 SB010 Avoid any unnecessary contact with the product. Misuse can lead to health damage. Keep out of children's reach. SF Treated areas/crops may not be entered until the spray coating has dried. Integrated Pest Management (IPM) NN334 The product is classified as harmful for populations of the species Typhlodromus pyri (predatory mite). Mode of action (FRAC-Group): UN

6 Page 6 of 17 Active substance None The authorization 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) Integrated Pest Management (IPM) NN1001 The product is classified as non-harmful for populations of relevant beneficial insects 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 NW642-1 for use 003 NT105 for use 003 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. In a strip at least 20 m wide which is adjacent to other areas, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 % (except agriculturally or horticulturally used areas, roads, paths and public places). If it is not possible to apply the product with loss reducing equipment, a buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (e.g. field boundaries, hedges, groups of woody plants) are less than 3 m wide or if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures. A buffer zone of at least 5 m is also not necessary if evidence can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on agriculturally or horticulturally used areas.

7 Page 7 of Product uses PPP (product name/code) ( ) active substance Potassium hydrogen carbonate Formulation type: Conc. of as: SP 850 g/kg safener - synergist - Conc. of safener: - Conc. of synergist: - : Zone(s): Verified by MS: j Spiess-Urania Chemicals GmbH central EU 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) 001 DE apple (MABSD) F thinning of fruit (YFRAD) 002 DE plum (PRNDO) F thinning of fruit (YFRAD) Method / Kind spraying or fine spraying (low volume spraying) spraying or fine 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 BBCH b) per crop/ season (3-5 days) a) 2 b) 6 b) max. total rate per crop/season a) 5 kg/ha and per m crown height b) 30 kg/ha and per m crown height b) max. total rate per crop/season a) 4.25 kg/ha and per m crown height b) 25.5 kg/ha and per m crown height L/ha Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 1 Restrictions (see ) Upon the regulation of active substance approval 735/2012 the use of the active is only allowed for fungicide and insecticide action. Use withdrawn by applicant BBCH days) 1 Upon the regulation of active substance approval 735/2012 the

8 Page 8 of 17 spraying (low volume spraying) a) 2 b) 2 a) 5 kg/ha and per m crown height b) 10 kg/ha and per m crown height a) 4.25 kg/ha and per m crown height b) 8.5 kg/ha and per m crown height L/ha use of the active is only allowed for fungicide and insecticide action. Use withdrawn by applicant 003 DE apricot (PRNAR) F blossom blight (Monilinia laxa) (MONILA_1) spraying or fine spraying (low volume spraying) BBCH (8-12 days) a) 6 a)1,5 kg/ha and per m crown height a) kg/ha and per m crown height L/ha 1 NW642-1 NT105 b) 6 b) 9 kg/ha and per m crown height b) 7.65 kg/ha and per m crown height

9 Page 9 of 17 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. No MRL is proposed. Potassium hydrogen carbonate has been included in Annex IV to Reg. (EC) No 396/ 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 Residues Residue studies were not considered relevant for evaluation nor were they considered necessary for Annex I inclusion (Commission Directive 2008/127/EC) due to the nature and properties of the active substance. As no MRLs are required; the substance was included in annex IV to Regulation (EC) No 396/ Consumer exposure No risk assessment is necessary due to the intrinsic properties of the active ingredient. Chronic as well as short-term intake of potassium hydrogen carbonate residues is unlikely to present a public health concern 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. No risk mitigation is necessary to avoid harmful effects on the Groundwater 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 PPP ARMICARB and the active substance Potassium hydrogen carbonate are not toxic to the aquatic environment (Algae: EC50: mg/l). However, no additional entries as those according to the

10 Page 10 of 17 evaluated use pattern and good agricultural practise are acceptable. Therefore the default conditions of use SP1 and NW are assigned to avoid point sources of contamination and to reference to state law, see also 2.2. Towards non-target arthropods effects were demonstrated with an ER50 of 2688 g/ha measured with the PPP ARMICARB. To demonstrate an acceptable risk the safety phrases and conditions of use NT105 is assigned for the use in orchards (06-003). Risk Assessment for Honeybees The honeybee risk assessment for the main application covers the use in accordance with Article 51 of regulation (EC) No 1107/2009 (see also point 2.2) Efficacy Use no 001 and 002 can not be authorised because the active substance is not approved as growth regulator.upon the regulation of active substance approval 735/2012 the use of the active is only allowed for fungicide and insecticide action. 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(s) 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(s) 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 Regulation (EC) No 1107/2009 taking into account the uniform principles of Commission Regulation (EU) No 546/2011. 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. Use no 001 and 002 can not be authorised because the active substance is not approved as growth regulator. Upon the regulation of active substance approval 735/2012 the use of the active is only allowed for fungicide and insecticide action. The intended use is not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary. There is no special risk mitigation necessary which deviate from the existing registration. 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 for use no 003 (apricot). Use no 001 and no 002 cannot be authorised. However, the applicant withdrew these uses meanwhile.

11 Page 11 of Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation None

12 Page 12 of 17 Appendix 1 Copy of the product authorisation

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17 Page 17 of 17 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. The applicant is authorisation holder.