G/TBT/N/EU/848  
1 November 2021  
(21-8274) 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/tb t/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):  Pesticide 
plant protection products; Pesticides and other agrochemicals (ICS 65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Regulation (EU) No 546/2011 as regards specific 
uniform principl es for evaluation and authorisation of plant protection products containing 
micro -organisms (5 page(s), in English; 55 page(s), in English)  
6. Description of content:  This draft Commission Regulation includes the amendments of 
the Annex to the Commission Regulation (EU) No 546/2011 implementing Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council as regards uniform principles 
for evaluation and authorisation of plant protection product.  
7. Objective and rationale, including the natur e of urgent problems where 
applicable:  The Farm to Fork Strategy, aims at reducing dependency from chemical plant 
protection products, also by facilitating the placing on the market of biological substances, 
including micro -organisms. To support this objec tive, this Regulation aims at improving 
the suitability of the legal framework by adapting the overall structure of the uniform 
principles for evaluation and authorisation of plant protection products, and the content 
of Part II to the characteristics of m icro-organisms, which are different from chemical 
substances. This initiative is complemented by others concerning:  
• the Commission Regulation (EU) No 283/2013 setting out the data requirements 
for active substances which are micro -organisms (submitted in parallel for TBT),  
• the Commission Regulation (EU) No 284/2013 setting out the data requirements 
for plant protection products including active substances which are micro -
organisms (submitted in parallel for TBT),  G/TBT/N/EU/848  
 
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  • the Annex II to Regulation (E C) No 1107/2009 specifying approval criteria for 
active substances which are micro -organisms (submitted in parallel for TBT),  
• two Commission Communications in the framework of the implementation of 
Commission Regulation (EU) No 283/2013 and Commission Regu lation (EU) No 
284/2013 (will be submitted for TBT).  
; 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: 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex%3A32009R1107  
• Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data 
requirements for active substances, in accordance with Reg ulation (EC) No 
1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market Text with EEA relevance 
https:/ /eur-lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32013R0283  
• Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data 
requirements for plant protection products, in accordance with Regulation (EC) 
No 1107/2009 of the European Parliame nt and of the Council concerning the 
placing of plant protection products on the market Text with EEA relevance 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex:32013R0284  
• Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council as 
regards uniform principles for evaluation and authorisation of plant protection 
products Text with EEA relevance https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32011R0546  
9. Proposed date of adoption:  First half 2022  
Proposed date of entry into force:  Twenty days following its publication in the Official 
Journal of the EU (The provisions shall apply six months after the 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 EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_6922_01_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_6922_00_e.pdf