G/TBT/N/EU/784  
15 March 2021  
(21-2083) Page: 1/2 
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 Comm ission  
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/e n/  
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):  Abamectin 
(pesticide active substance); Pesticides and other agrochemicals (ICS 65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation concerning the approval of the active substance 
abamectin , 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, and 
amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (4 
page(s), in English; 3 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance abamectin is renewed with restriction to uses in 
permanent greenhouses, as defined by Art 3(27) of Regulation (EC)  No 1107/2009. EU 
Member States shall amend/withdraw authorisations for plant protection products 
containing abamectin as an active substance. The restricted renewal 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 assessed and 
approved under Directive  91/414/EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products cont aining it. Separate action is likely to be taken on MRLs and 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 (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 o r the environment. Criteria are listed in Article 4 of the Regulation (and 
also detailed in Annex  II thereto) which must be met to enable approval. During the G/TBT/N/EU/784  
 
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  evaluation and peer -review of abamectin, a number of concerns and areas that could not 
be finalis ed were identified. These are detailed in the conclusion of the European Food 
Safety Authority (EFSA) and reported here after:  
• Risk to wild non -target terrestrial vertebrates  
• Risk to wild non -target terrestrial organisms other than vertebrates  
• Risk to aqu atic organisms  
These concerns and areas that could not be finalised mean that not all abamectin's uses 
meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and only uses 
restricted to greenhouses as defined in Art 3(27) of Regulation (EC)  No 1107/2009 can 
be currently approved. Existing authorisations will need to be amended or withdrawn; EU 
Member States must withdraw existing plant protection products containing abamectin 
for in -field uses at the latest by 6 months from the date of entry  into force of this draft 
measure. In line with Article 46 of Regulation 1107/2009, there is a period of grace, which 
shall expire at the latest 12 months from the date of entry into force of the draft measure 
(allowing for a final season of use).; Protect ion 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  
Conclusion on the peer review of the pesticide risk assessment of the active substance 
abamectin.  
EFSA (European Food Safety Authority), 2020. Conclusion on the peer review of the 
pesticide risk assessment of the active substance abamectin. EFSA 
Journal2020;18(8):6227.  
9. Proposed date of adoption:  1 July 2021  
Proposed date of entry into force:  1 July 2021  
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 EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_ 1889_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_1889_01_e.pdf