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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): Tall oil crude (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 orthosulfamuron, 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 orthosulfamuron is non-approved. The non-approval is based on the evaluation of the new active substance orthosulfamuron, made in the context of the work provided for in Articles 5 and 6 of Directive 91/414/EEC concerning the placing of plant protection products on the market, to be read in conjunction with Regulation (EU) No 188/2011, laying down detailed rules for the assessment of new active substances and the transitional provisions foreseen in Article 80(1)(a) of Regulation (EC) No 1107/2009, repealing Directive 91/414/EEC.

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 substances.

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.

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. For orthosulfamuron, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant.

During the evaluation and peer-review of the substance, 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); the Authority concluded that with the available information, the risk assessment to consumers, soil dwelling organisms except microorganisms and aquatic organisms could not be finalised. In addition, the Authority identified concerns that the exposure assessment to groundwater could not be finalised.

These concerns mean that orthosulfamuron does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently.

The substance was allowed to be authorised provisionally for a period not longer than three years in EU member States. As all such authorisations have expired, it is not necessary to provide an additional period to withdraw authorisations for plant protection products containing orthosulfamuron.

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 Implementing Regulation (EU) No 637/2012 of 13 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil crude.OJ L 186, 14.7.2012, p. 20?24  

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012R0637&from=EN  

9.

Proposed date of adoption:   2nd quarter 2017

Proposed date of entry into force:   20 days following publication in the Official Journal of the EU

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_5246_00_e.pdf