G/TBT/N/EU/646  
 
18 March 2019  
(19-1657) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
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/en/  
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):  
Tolclofos -methyl (pesticide active substance); Pesticides and other agrochemicals 
(ICS 65.100)  
5. Title, number of pages and language(s) of t he notified document:  Draft 
Commission Implementing Regulation renewing the approval of the active substance 
tolclofos -methyl, in accordance with Regulation (EC) No  1107/2009 of the European 
Parliament and of the Council concerning the placing of plant pro tection products on the 
market, and amending the Annex to Commission Implementing Regulation 
(EU) No 540/2011 (5 pages + annexes 3 pages, in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of th e active substance tolclofos -methyl is renewed in accordance with 
Regulation (EC)  No 1107/2009. It is, however, necessary to include certain conditions 
and restrictions. In particular, only the use on ornamentals and on potatoes can be 
approved.  Existing a uthorised plant protection products containing tolclofos -methyl will 
be amended or withdrawn from the market. The restriction of 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.  
Following the use restriction of products containing this substance, separate action will 
likely be taken on MRLs and a separate notification will be made in accordance with SPS 
procedures.  G/TBT/N/EU/646  
 
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  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 environ ment. 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 tolclofos -methyl, a number of  concerns and 
areas that could not be finalised were identified. These are detailed inthe conclusion of 
the European Food Safety Authority (EFSA).  
In particular, the consumer risk assessment could not be finalised for lettuces which were 
initially proposed  as representative use considering the outstanding data to finalise the 
residue definitions for risk assessment. In order to minimise the exposure for consumers 
to certain metabolites and to reduce the exposure for aquatic organisms and wild 
mammals, only the use in ornamentals and potatoes are considered acceptable.  
These concerns mean that tolclofos -methyl can only meet the approval criteria as outlined 
in Regulation (EC) No 1107/2009 if the approval is restricted to use in ornamentals and 
on potatoes onl y. 
Existing authorisations of plant protection products containing tolclofos -methyl will be re -
examined by Member States in accordance with Article 43 of Regulation No  1107/2009. 
Uses that do not comply with the conditions of approval of tolclofos -methyl, in particular 
uses on crops other than ornamentals and potatoes must be withdrawn.  ; Protection of 
human health or safety; Protection of animal or plant life or health; Protection of the 
environment  
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  
• EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of 
the pesticide risk assessment of the active substance tolclofos -methyl. EFSA 
Journal EFSA Journal 2018;16(1):5130, 25 pp. doi: 10.2903/j.efsa.2018.5130 
https://www.efsa.europa.eu/en/efsajournal/pub/5130  
9. Proposed date of adoption:  3rd quarter 2019.  
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  G/TBT/N/EU/646  
 
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  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 EU -TBT Website:  
http://ec.europa.eu/growth/tools -databases/tbt/en/  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_ 1547_00_e.pdf  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_1547_01_e.pdf