G/TBT/N/EU/849  
1 November 2021  
(21-8282) 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 
active substances; Pesticides and other agrochemicals (ICS 65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex II to Regulation (EC) No 1107/2009 as regards 
specific criteria fo r the approval of active substances that are micro -organisms (5 page(s), 
in English; 3 page(s), in English)  
6. Description of content:  This draft Commission Regulation includes the amendments of 
the approval criteria of microbial active substances set in Annex II to Regulation (EC) 
No 1107/2009 which needed to be complemented in order to appropriately reflect the 
particularities of micro -organisms.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The Farm to Fork Strat egy aims, among others, at reducing dependency on 
chemical pesticides, also by facilitating the placing on the market of biological active 
substances, including micro -organisms. To support this objective, this Regulation aims at 
specifying approval criteri a for microbial active substances in Annex II to Regulation (EC) 
No 1107/2009, in order to appropriately reflect the particularities of microbial active 
substances, which are different from chemical substances. This initiative is complemented 
by others con cerning:  
• 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/849  
 
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  • the Commission Regulation (EU) No 546/2011 setting out the uniform principles 
for evaluation and authorisation of plant protection products (submitted in 
parallel for TBT),  
• two Commission Communications in the framework of the implementation of 
Commission Regulation (EU) No 283/2013 and Commission Regulation (EU) 
No 284/2013 (will be submitted for TBT).  
 Protection of human health or safety; Protection of anim al 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  
9. Proposed date of adoption:  First half 2022  
Proposed date of entry into force:  Twenty days follow ing its publication in the Official 
Journal of the EU (The provisions shall apply from 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_6923_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_6923_01_e.pdf