G/TBT/N/EU/890  
5 May 2022  
(22-3541) Page: 1/3 
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 addition, where applicable):  penflufen 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation amending Implementing Regulation (EU) No 
540/2011 as regards the conditions of approval of the active substance penflufen and 
repealing Implementing Regulation (EU) 2018/185 (4 page(s), in English; 3 page(s), in 
English)  
6. Description of conte nt: This draft Commission Implementing Regulation provides that 
the approval conditions of the active substance penflufen are amended in accordance with 
Regulation (EC) No 1107/2009 based on the absence of submission of the confirmatory 
data as requested i n Commission Implementing Regulation (EU) No 1031/2013 of 24 
October 2013, approving the active substance penflufen for use in the EU. Existing 
authorised plant protection products containing penflufen will be reviewed in accordance 
with the restriction se t in this act.  
This decision however only concerns the placing on the market of this substance. 
Following restriction of the approval and the consequent expiry of all grace periods for 
stocks of products, separate legal action will likely be taken on Maximum Residue Levels 
and a separate notification will be made in accordance with SPS procedures in due time.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order for an active substance to be approved in accorda nce 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 or 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.  G/TBT/N/EU/890  
 
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  Commission Implementing Regulation (EU) No 1031/2013 approved penflufen as active 
substance for use in plant protection products and required the applicant to provide 
confirmatory information with regard to the relevance of the metabolite M01 (penflufen -
3-hydroxy -butyl) for groundwater if penflufen was classified under Regulation (EC) No 
1272/2008 of the European Parliament and of the Council as 'carcinogen category 2'.  
On 15 October 2018 the Committee for Risk Assessment (RAC) adopted an opinion in 
which RAC agreed with the dossier's submitter's conclusion that classification as 
"carcinogen category 2" for penflufen is warranted. This classification was subsequently 
agreed by EU Member States and considered appropriate to introduce the harmonised 
classification in Annex VI to Regulation (EC) No 1272/2008. Within 6 months from the 
notification of the classification decision concerning that substance, that is on 15 March 
2019, the applicant informed that it would not submit the confirmatory information 
required in the approval as regards the relevance of the metabolite M01 (penflufen -3-
hydroxy -butyl) for groundwater, which was, after the amendment, only relevant for the 
representative use seed potato tubers, before or during planting.  
Since the information required in accordance with Article 6(f) of Regulation (EC) No 
1107/2009 has not been provided, the Commission is obliged to adopt a Regulation to 
restrict the approval of  the active substance penflufen. Following the requirements of 
Article 21 of Regulation (EC) No 1107/2009, on 19 February 2021 the applicant was given 
the possibility to submit comments and any relevant information to the Commission. Since 
the available da ta is not sufficient to address the critical area of concern identified for 
potential groundwater contamination, it is therefore necessary and appropriate to restrict 
the approval of penflufen to use only to treat cereal seeds before or during sowing, limi ted 
to one application every third year on the same field. The treatment of seed potato tubers 
before or during planting with penflufen is therefore prohibited.  
EU Member States shall, where necessary, withdraw or amend authorisations for plant 
protection products containing penflufen as active substance at the latest by 3 months 
from the date of entry into force. A period of grace in line with Article 46 of Regulation 
1107/2009 is allowed for and shall expire at the latest 6 months from the entry into forc e; 
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 5 40/2011 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) 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A02011R0540 -
20220301&qid=1651582218896  
  
Regulation (EC) No 1272/2008 of the European Parliament and of the Council, of 16 
December 2008, on class ification, labelling and packaging of substances and mixtures, 
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1)  
EUR-Lex - 32008R1272 - EN - EUR-Lex (europa.eu)  
  
EFSA (European Food Safety Authority), 6 October 2016. Conclusion on the peer review 
of the pesticide risk assessment of the active substance penflufen. EFSA Jour nal 
2016;14(11):4604.  
https://doi.org/10.2903/j.efsa.2016.4604  
Opinion of 15 October 2018 concerning 5 -fluoro -1,3-dimethyl -N-[2-(4-methylpentan -2-
yl)phenyl] -1Hpyrazole -4-carboxamide;2' -[(RS) -1,3-dimethylbutyl] -5-fluoro -1,3-
dimethylpyrazole -4-carboxanilide; penflufen (CLH -O-0000001412 -86-233/F)  
https://echa.europa.eu/documents/10162/9cc30b92 -d86c-d75e-74b7-a92ba d9e3379  G/TBT/N/EU/890  
 
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  9. Proposed date of adoption:  3rd quarter 2022  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  
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@e c.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/2022/TBT/EEC/22_3267_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_3267_01_e.pdf