G/TBT/N/EU/846  
1 November 2021  
(21-8272) 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 Regulation (EU) No 283/2013 as regards the 
information to be submitted f or active substances and the specific data requirements for 
micro -organisms (5 page(s), in English; 41 page(s), in English)  
6. Description of content:  This draft Commission Regulation includes the amendments of 
the general introduction and the Part B of t he Annex to the Commission Regulation (EU) 
No 283/2013 setting out the data requirements for micro -organisms used as active 
substances in plant protection products.  
7. Objective and rationale, including the nature 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 objective, this Regulation aims at improving 
the suitability of the legal framework by adapting the existing data requirements in Part 
B of the Annex to Regulation (EU) No 283/2013 to the characteristics of the micro -
organisms, which are different from those of chemical active substances. This initiativ e is 
complemented by others concerning:  
• 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),  
• the Annex II to Regulation (EC) No 1107/2009 specifying appro val criteria for 
active substances which are micro -organisms (submitted in parallel for TBT),  G/TBT/N/EU/846  
 
- 2 - 
 
  • the Commission Regulation (EU) No 546/2011 setting out the uniform principles 
for evaluation and authorisation of plant protection products (submitted in 
paralle l 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 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  
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 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_6918_01_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_6918_00_e.pdf