1.

Notifying Member: European Union

If applicable, name of local government involved (Article 3.2 and 7.2):  

2.

Agency responsible: European Commission

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

European Commission

EU-TBT Enquiry Point

Fax: +(32) 2 299 80 43

E-mail: grow-eu-tbt@ec.europa.eu

Website: http://ec.europa.eu/growth/tools-databases/tbt/

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Buprofezin (pesticide active substance)

5.

Title, number of pages and language(s) of the notified document: Draft Commission Implementing Regulation amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance buprofezin (4 pages, in English)

6.

Description of content: This draft Commission Implementing Regulation provides that the conditions of approval of the active substance buprofezin are amended. Existing authorisations for plant protection products containing buprofezin will be amended or withdrawn from the market. The amendment is based on evaluation of confirmatory information submitted following the approval of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009.

This specific decision concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; protection of animal or plant life or health; protection of the environment.

During the evaluation and peer-review of the confirmatory data provided on buprofezin following its approval (Commission Directive 2011/6/EU), it was identified that during high temperature processing the metabolite aniline may form. Aniline is a carcinogen for which a genotoxic mechanism cannot be excluded and no reference values for exposure can be derived since no threshold for such a substance can be assumed. This is indicated as an issue that should be considered a priori as a concern in the conclusion of the European Food Safety Authority (EFSA) published in July 2015.

In order to ensure the protection of consumers from exposure to aniline, it is necessary to amend the approval to include a restriction of use. Buprofezin will be restricted to use on non-edible crops only.

Existing authorisations will need to be amended or withdrawn; Member States must amend or withdraw existing plant protection products containing buprofezin 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 15 months from the entry into force.

8.

Relevant documents:

·                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

·                Commission Directive 2011/6/EU of 20 January 2011 amending Council Directive 91/414/EEC to include buprofezin as active substance(OJ L 18, 21.1.2011, p. 38?40): http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L0006&from=EN

·                EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment for the active substance buprofezin in light of confirmatory data. EFSA Journal 2015;13(8):4207, 24 pp. doi:10.2903/j.efsa.2015.4207: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4207/epdf

9.

Proposed date of adoption: 1st quarter 2017

Proposed date of entry into force: 20 days following publication in the OJ (amendment or withdrawal of existing authorisations at the latest by 3 months after entry into force).

10.

Final date for comments: 60 days from notification

11.

Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

European Commission

EU-TBT Enquiry Point

Fax: + (32) 2 299 80 43

E-mail: grow-eu-tbt@ec.europa.eu

The text is available on the Website: http://ec.europa.eu/growth/tools-databases/tbt/

https://members.wto.org/crnattachments/2016/TBT/EEC/16_4537_00_e.pdf