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): Beta-cypermethrin (pesticide active substance).

5.

Title, number of pages and language(s) of the notified document: Draft Commission Implementing Regulation concerning the non-approval of the active substance beta-cypermethrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (4 pages, in English)

6.

Description of content: This draft Commission Implementing Regulation provides that the active substance beta-cypermethrin is not approved in accordance with Regulation 1107/2009 and cannot be placed on the market in plant protection products in the EU. The substance is not currently authorized in plant protection products in the EU; the non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation 1107/2009.

This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, following non-approval, separate action may be taken on MRLs, if necessary, and if so a separate notification will be made in accordance with SPS procedures.

7.

Objective and rationale, including the nature of urgent problems where applicable: In order for an active substance to be approved in accordance with Regulation 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. Beta-cypermethrin, however, is subject to the approval conditions as laid down in Directive 91/414/EEC as it falls under the transitional provisions as detailed in Article 80(1)(a) of Regulation 1107/2009. Therefore the conditions as laid down in Article 5 of Directive 91/414/EEC must be fulfilled before approval can be granted.

During the evaluation and peer-review of the substance, a number of concerns and areas that could not be finalized were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA); importantly EFSA concluded that for the uses of beta-cypermethrin assessed there is a high risk to aquatic organisms, bees and non-target arthropods. In addition, the risk assessment for soil and aquatic organisms and the exposure assessment for groundwater could not be finalized as insufficient information was provided in relation to the fate and behaviour of the cyclopropyl ring moiety of beta-cypermethrin. Furthermore, information on metabolism in livestock in order to confirm the residue definition for animal products and further information on the toxicity profile of metabolite PBA and its relevance for consumer risk assessment were not provided.

These concerns mean that beta-cypermethrin does not meet the conditions for approval as outlined in Article 5 of Directive 91/414/EEC.

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

·         Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:31991L0414

·         Conclusion on the peer review of the pesticide risk assessment of the active substance beta-cypermethrin.

·         EFSA Journal 2014;12(6):3717, 90 pp. doi:10.2903/j.efsa.2014.3717 http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3717/epdf

9.

Proposed date of adoption: 3rd quarter 2017

Proposed date of entry into force: 20 days from publication in the Official Journal of the European Union

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/2017/TBT/EEC/17_1597_00_e.pdf