G/TBT/N/EU/1034  
24 November 2023  
(23-7943) 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/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addit ion, where applicable):  Pesticide 
active substances  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation defining data requirements for the approval of safeners and 
synergists and establishing a work programme f or the gradual review of safeners and 
synergists on the market in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council; (8 page(s), in English), (4 page(s), in English)  
6. Description of content:  This draft Commission  Regulation describes the data 
requirements for safeners and synergists and establishes the work programme for the 
gradual review of safeners and synergists as provided by Article 25 and 26 of Regulation 
(EC) No 1107/2009.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Article 29 of Regulation (EC) No 1107/2009 requires safeners and synergists 
contained in a plant protection product to be approved in order for that product to be 
authorised pursuant to A rticle 28 of that Regulation. Article 25(1) of that Regulation 
provides for the approval of safeners and synergists when the criteria for the approval of 
active substances, laid down in Article 4 of that Regulation, are fulfilled. Furthermore, 
Article 25(2 ) of that Regulation provides that the general rules applicable to the procedure 
for the approval of active substances, or the renewal thereof, set out in Articles 5 to 21 
of that Regulation apply to safeners and synergists as well. Therefore, similar data  
requirements to those applicable for the approval of active substances should be defined 
for the approval of safeners and synergists, with the addition of a supplementary data 
requirement related to the demonstration of efficacy of the safeners or synergi sts. In G/TBT/N/EU/1034  
 
- 2 - 
 
  addition, to assess whether safeners and synergists contained in plant protection products 
that are already on the market on the date that this Regulation enters into force, a work 
programme for the gradual review of those safeners and synergists s hould be established. 
In order to ensure alignment with the derogation of Article 81(1) of Regulation (EU) No 
1107/2009, procedures should be established allowing these safeners and synergists to 
be reviewed within five years of the adoption of that work p rogramme; 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 Regulation (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 2024  
Proposed date of entry into force:  Twenty days following publication in the Official 
Journal of the EU (The provisions shall apply from six months after the adoption)  
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/to ols-
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_13761_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_13761_01_e.pdf