| 1. | 通報(bào)成員：歐盟 |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：European Commission |
| 3. |
通報(bào)依據(jù)的條款：Technical Regulation (Article 2.9.2)
通報(bào)依據(jù)的條款其他：
|
| 4. | 覆蓋的產(chǎn)品：Methiocarb (pesticide active substance)
ICS：[] HS：[] |
| 5. |
通報(bào)標(biāo)題：根據(jù)歐洲議會(huì)和理事會(huì)條例(EC) No 1107/2009關(guān)于將植物保護(hù)產(chǎn)品投放市場(chǎng)的內(nèi)容，擬稿委員會(huì)實(shí)施條例關(guān)于活性物質(zhì)甲硫威的不續(xù)期批準(zhǔn)，以及修訂委員會(huì)實(shí)施條例(EU)?No?540/2011的附件。頁(yè)數(shù)：5 page(s) 使用語(yǔ)言：in English 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡(jiǎn)述： This draft Commission Implementing Regulation provides that the approval of the active substance methiocarb is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing methiocarb will be withdrawn from the market. The non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/ EEC. This decision only concerns the placing on the market of this substance. Following non approval and the expiry of all grace periods for stocks of products containing this substance, separate action may be taken on MRLs and a separate notification will be made in accordance with SPS procedures.
|
| 7. | 目的和理由：Protection of human health or safety; protection of animal or plant life or health; protection of the environment. In order for an active substance to be approved in accordance with Regulation (EC)?No?1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex?II) which must be met to enable approval. During the evaluation and peer-review of methiocarb, a number of concerns and areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA). Critical area of concerns were identified, in particular, exposure for workers loading and sowing the treated seed was above the AOEL (628 % of the AOEL) and AAOEL (826 % of the AAOEL) even with the use of personal protective equipment. Furthermore, high risks to birds, mammals and earthworms have been identified. Moreover, the Authority could not conduct the consumer risk assessment because the residue definition for risk assessment in plant commodities could not been finalised since the genotoxic potential of metabolite M01 could not be ruled out based on the available data. These concerns mean that methiocarb does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently. Existing authorisations will need to be withdrawn; EU Member States must withdraw existing plant protection products containing methiocarb at the latest by 3 months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest 6 months from the entry into force.; Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment |
| 8. | 相關(guān)文件： Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN Commission Implementing Regulation (EU) No?540/2011 of 25?May 2011 implementing Regulation (EC) No?1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1–186) http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540 Conclusion on the peer review of the pesticide risk assessment of the active substance methiocarb. The EFSA Conclusions regarding the peer review of the pesticide risk assessment of methiocarb (EFSA Journal 2018;16(10):5429) https://www.efsa.europa.eu/en/ efsajournal/pub/rn-79 |
| 9. |
擬批準(zhǔn)日期：
3rd quarter 2019 擬生效日期： 3 days following publication in the Official Journal of the EU |
| 10. | 意見反饋截至日期：60 days from notification |
| 11. |
文本可從以下機(jī)構(gòu)得到：
European Commission, EU-TBT Enquiry Point, Fax: + (32) 2 299 80 43, E-mail: grow-eu-tbt@ec.europa.eu
|
This draft Commission Implementing Regulation provides that the approval of the active substance methiocarb is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing methiocarb will be withdrawn from the market. The non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/ EEC.
This decision only concerns the placing on the market of this substance. Following non approval and the expiry of all grace periods for stocks of products containing this substance, separate action may be taken on MRLs and a separate notification will be made in accordance with SPS procedures.
粵公網(wǎng)安備 44010602010620號(hào)