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United Nations Rc UNITED NATIONS RC UNEP/FAO/RC/CRC.6/5/Add.1 Rotterdam Convention on the Prior Distr.: General 1 December 2009 Informed Consent Procedure for Certain Hazardous Chemicals and English only Pesticides in International Trade Chemical Review Committee Sixth meeting Geneva, 15–19 March 2010 Item 5 (b) (i) of the provisional agenda* Listing of chemicals in Annex III to the Rotterdam Convention: review of notifications of final regulatory actions to ban or severely restrict a chemical: amitraz Amitraz Note by the Secretariat Addendum Supporting documentation provided by the European Community The Secretariat has the honour to provide, in the annex to the present note, documentation received from the European Community to support its notification of final regulatory action for amitraz as a pesticide. The documentation has been reproduced as received, without formal editing by the Secretariat. * UNEP/FAO/RC/CRC.6/1. K0953651 040110 For reasons of economy, this document is printed in a limited number. Delegates are kindly requested to bring their copies to meetings and not to request additional copies. UNEP/FAO/RC/CRC.6/5/Add.1 Annex 1. Commission decision of 12 February 2004 concerning the non-inclusion of amitraz in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance (2004/141/EC) Available at: http://ec.europa.eu/food/plant/protection/evaluation/existactive/oj_amitraz.pdf 2. Review report for the active substance amitraz: Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 4 July 2003 in support of a decision concerning the non-inclusion of amitraz in Annex I of Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance Available at: http://ec.europa.eu/food/plant/protection/evaluation/existactive/list_amitraz.pdf 3. Excerpt of a report of a tripartite meeting between the European Commission, Austria as Rapporteur Member State and the main data submitter: Amitraz 4. List of end points: Amitraz 5. Monograph prepared in the context of inclusion of following active substance in Annex I of the Council Directive 91/414/EEC: Amitraz. Volume 1: Report and proposed decision. 6. Amitraz: Addendum II to Volume 1 to the Draft Assessment Report and Proposed Decision of Austria prepared in the context of the possible inclusion of the above mentioned active substance in Annex I of Council Directive 91/414/EEC 7. Amitraz: Addendum II to Volume 3 Annex B: Summary, Scientific Evaluation and Assessment 8. Excerpt of the report of a European Commission Co-ordination (ECCO) peer review meeting: Concise outline report of ECCO 78 peer review meeting 9. Excerpt of the report of a European Commission Co-ordination (ECCO) peer review meeting: Concise outline report of ECCO 80 peer review meeting 10 Excerpt of the report of a European Commission Co-ordination (ECCO) peer review meeting: Concise outline report of ECCO 82 peer review meeting 11. Excerpt of the report of a European Commission Co-ordination (ECCO) peer review meeting: Concise outline report of ECCO 84 peer review meeting 2 17.2.2004 EN Official Journal of the European Union L 46/35 COMMISSION DECISION of 12 February 2004 concerning the non-inclusion of amitraz in Annex I to Council Directive 91/414/EEC and the with- drawal of authorisations for plant protection products containing this active substance (notified under document number C(2004) 332) (Text with EEA relevance) (2004/141/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (4) In accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92, Austria, being the designated rapporteur Member State, submitted on 6 January 1998 to the Having regard to the Treaty establishing the European Commission the report of its assessment of the informa- Community, tion submitted by the notifiers in accordance with Article 6(1) of that Regulation. Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on (5) On receipt of the report of the rapporteur Member 1 the market ( ), as last amended by Commission Directive 2003/ State, the Commission undertook consultations with 2 119/EC ( ), and in particular the third and the fourth sub- experts of the Member States as well as with the main paragraph of Article 8(2) thereof, notifier Bayer CropScience, as provided for in Article 7(3) of Regulation (EEC) No 3600/92. Having regard to Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the (6) The Commission organised two tripartite meeting with implementation of the first stage of the programme of work the main data submitter and the rapporteur Member referred to in Article 8(2) of Council Directive 91/414/EEC State for this active substance on 9 June 2000 and on concerning the placing of plant protection products on the 21 March 2003. market (3), as last amended by Regulation (EC) No 2266/ 2000 (4), and in particular Article 7(3A)(b) thereof, (7) The assessment report prepared by Austria has been reviewed by the Member States and the Commission Whereas: within the Standing Committee on the Food Chain and Animal Health. This review was finalised on 4 July 2003 in the format of the Commission review report for (1) Article 8(2) of Directive 91/414/EEC provided for the amitraz. Commission to carry out a programme of work for the examination of the active substances used in plant protection products which were already on the market (8) Assessments made on the basis of the information on 25 July 1993. Detailed rules for the carrying out of submitted have not demonstrated that it may be this programme were established in Regulation (EEC) No expected that, under the proposed conditions of use, 3600/92. plant protection products containing amitraz satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. In particular, Article 5(2)(b) (2) Commission Regulation (EC) No 933/94 of 27 April provides that an acceptable daily intake (ADI) for man 1994 laying down the active substances of plant protec- must be taken into account in deciding on the inclusion tion products and designating the rapporteur Member of an active substance in Annex I. In setting the ADI the States for the implementation of Commission Regulation possible neurological effects of amitraz had to be consid- 5 (EEC) No 3600/92 ( ), as last amended by Regulation ered. These effects were also considered for setting the 6 (EC) No 2230/95 ( ), designated the active substances Acute Reference Dose, i.e. the estimate of the amount of which should be assessed in the framework of Regu- the substance that can be ingested over a short period of lation (EEC) No 3600/92, designated a Member State to time without appreciable health risk to the consumer. It act as rapporteur in respect of the assessment of each has not been demonstrated for the proposed uses that substance and identified the producers of each active consumers might not be exposed to amitraz exceeding substance who submitted a notification in due time. the Acute Reference Dose. A probabilistic risk assess- ment was prepared by the notifier. It must however be taken into consideration that agreed criteria for the inter- (3) Amitraz is one of the 89 active substances designated in pretation of such a probabilistic risk assessment are not Regulation (EC) No 933/94. yet established and it would not be appropriate, in view of the possible risks, to delay decision-making further 1 ( ) OJ L 230, 19.8.1991, p. 1. until such criteria are agreed. (2) OJ L 325, 12.12.2003, p. 41. (3) OJ L 366, 15.12.1992, p. 10. (4) OJ L 259, 13.10.2000, p. 27. (5) OJ L 107, 28.4.1994, p. 8. (9) Amitraz should therefore not be included in Annex I to (6) OJ L 225, 22.9.1995, p. 1. Directive 91/414/EEC. L 46/36EN Official Journal of the European Union 17.2.2004 (10) Measures should be taken to ensure that existing author- 2. from 17 February 2004 no authorisations for plant protec- isations for plant protection products containing amitraz tion products containing amitraz are granted or renewed are withdrawn within a prescribed period and are not under the derogation provided for in Article 8(2) of Direc- renewed and that no new authorisations for such tive 91/414/EEC; products are granted. 3. in relation to the uses listed in column B of the Annex, a Member State specified in column A may maintain in force (11) In the light of the information submitted to the Commis- authorisations for plant protection products containing sion it appears that, in the absence of efficient alterna- amitraz until 30 June 2007 provided that it: tives for certain limited uses in certain Member States, there is a need for further use of the active substance so (a) ensures that such plant protection products remaining as to enable the development of alternatives. It is there- on the market are relabelled in order to match the fore justified in the present circumstances to prescribe restricted use conditions; under strict conditions aimed at minimising risk a longer (b) imposes all appropriate risk mitigation measures to period for the withdrawal of existing authorisations for reduce any possible risks in order to ensure the protec- the limited uses considered as essential for which no effi- tion of human and animal health and the environment; cient alternatives appear currently to be available for the and control of harmful organisms.
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