G/TBT/N/EU/683  
3 October 2019  
(19-6380) 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 Commission  
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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Chlorpyrifos -methyl (pesticide active substance)  
5. Title, number of pages and language(s ) of the notified document:  Draft 
Commission Implementing Regulation concerning the non -renewal of the approval of the 
active substance chlorpyrifos -methyl, in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council conce rning the placing of plant protection 
products on the market, and amending the Annex to Commission Implementing 
Regulation (EU) No 540/2011 (5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance chlorpyrifos -methyl is not renewed in accordance 
with Regulation (EC)  No 1107/2009. Existing authorisations of plant protection products 
containing chlorpyrif os-methyl will be withdrawn and such products can then no longer 
be placed on the market. The non -renewal of the approval is based on a scientific 
assessment conducted under Regulation (EC) No 1107/2009 by experts from the Member 
States of the European Uni on and the European Food Safety Authority (EFSA).  
This decision only concerns the placing on the market of chlorpyrifos -methyl and plant 
protection products containing it. Following non -renewal of approval and the expiry of all 
grace periods for stocks of  products containing this substance, separate action will be 
taken to swiftly lower all existing MRLs to the limit of quantification and a separate 
notification will be made in accordance with SPS procedures. As soon as the lowered MRLs 
will be applicable (expected in the third quarter of 2020), foodstuffs with higher levels of 
chlorpyrifos -methyl will become non -compliant and can no longer be placed on the EU 
market.     G/TBT/N/EU/683  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order for an active substance to be approved in accordance 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 o r the environment. Criteria are listed in Article 4 of the Regulation (and 
further detailed in Annex  II) which must be met to enable approval. During the evaluation 
and peer -review of chlorpyrifos -methyl, a number of concerns were identified. These are 
detailed in a statement of the European Food Safety Authority (EFSA):  
• A genotoxic potential of chlorpyrifos -methyl, which cannot be ruled out based on 
the information available, taking into account the concerns raised for chlorpyrifos 
(During the peer review, experts considered read across between the two 
substances justified as they are structurally similar and have similar toxicokinetic 
behaviour). Consequently, health based reference values cannot be established 
for chlorpyrifos -methyl and the dietar y and non -dietary risk assessments cannot 
be conducted.  
• Developmental neurotoxicity (DNT) – the available DNT study on 
chlorpyrifos -methyl did not allow for a full assessment of effects on brain 
development, in particular since effects on cerebellum height  could not be 
evaluated due to the lack of controls in females and a no observed adverse effects 
level 'NOAEL' for DNT could not be established. Since DNT effects were observed 
in the available developmental neurotoxicity on chlorpyrifos (adverse effects w ere 
seen at the lowest dose tested in rats and a NOAEL could not be established) 
concerns exist also for chlorpyrifos -methyl. Moreover, epidemiological evidence 
exists showing an association between exposure to chlorpyrifos -methyl during 
development and ad verse neurodevelopmental outcomes in in children.  
• During the peer review, experts suggested that classification of chlorpyrifos -
methyl as toxic for the reproduction category 1B, H360D 'May damage the unborn 
child', in accordance with the criteria set out in Commission Regulation 
(EC) No 1272/2008[1] would be appropriate.  
These concerns mean that chlorpyrifos -methyl does not meet the approval criteria as 
outlined in Article 4 of Regulation (EC) No 1107/2009 and cannot be approved cu rrently. 
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
authorisations for plant protection products containing chlorpyrifos -methyl at the latest 
by 1 month from the date of entry into force. A period of grace in li ne with Article 46 of 
Regulation 1107/2009 is allowed for and shall expire at the latest 3 months from the entry 
into force.  
[1] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 
2008 on classification, 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). 
Protection of human health or safety; Protection of ani mal 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:320 09R1107&qid=1437730988988&from=EN  
• Commission Implementing Regulation (EU) No 540/2011 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, 
11.6.2 011, p. 1 –186): http://eur -lex.europa.eu/legal -
conte nt/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
• Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 
16 December 2008 on classification, labelling and packaging of substances and 
mixtures, amending and repealing Directives 67/548 /EEC and 1999/45/EC, and G/TBT/N/EU/683  
 
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  amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1): 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32008R1272   
• Statement on the available outcomes of the human health assessment in the 
context of the pesticides peer review of the active substance chlorpyrifos -methyl 
EFSA Journal 2019 ;17(5):5810. DOI: 10.2903/j.efsa.2019.5810: 
https://www.efsa.europa.eu/sites/default/files/scientific_output/5810 -
chlorpyrifos -methyl.pdf  
9. Proposed date of adoption:  4th quarter 2019  
Proposed date of entry into force:  3 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@ec.europa.eu  
The text is available on the EU -TBT Website:  
http://ec.europa.eu/growth/tools -databases/tb t/en/ 
https://members.wto.org/crnattachments/2019/TBT/EEC/19_5426_00_e.pdf