G/TBT/N/EU/682  
3 October 2019  
(19-6379) 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 (pesticide active substance, also known as chlorpyrifos -ethyl)  
5. Title, num ber 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, 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, 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 is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorisations of plant protection products 
containing chlorpyrifos will  be withdrawn and such products can then no longer be placed 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 Union and the Eur opean Food Safety Authority (EFSA).  
This decision only concerns the placing on the market of chlorpyrifos 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 thir d quarter of 2020), foodstuffs with higher levels of 
chlorpyrifos will become non -compliant and can no longer be placed on the EU market.  G/TBT/N/EU/682  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order for an active substanc e 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 or 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, a number of concerns were identified. These are detailed 
in a statement of the European Fo od Safety Authority (EFSA):  
• A genotoxic potential of chlorpyrifos cannot be ruled out based on the information 
available. Consequently, health based reference values cannot be established for 
chlorpyrifos and the dietary and non -dietary risk assessments cannot be 
conducted.  
• Developmental neurotoxicity (DNT) - effects were observed in the available study 
on developmental neurotoxicity in rats (adverse effects were seen at the lowest 
dose tested in rats and a no observed adverse effects level 'N OAEL' could not be 
established) and epidemiological evidence exists showing an association between 
exposure to chlorpyrifos during development and adverse neurodevelopmental 
outcomes in children.  
• During the peer review experts suggested that classificatio n of chlorpyrifos as 
toxic for 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 chl orpyrifos does not meet the approval criteria as outlined in 
Article 4 of Regulation (EC) No 1107/2009 and cannot be approved currently. Existing 
authorisations will need to be withdrawn; Member States must withdraw existing 
authorisations for plant protec tion products containing chlorpyrifos at the latest by 1 
month 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 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 am ending Regulation (EC) No 1907/2006 (OJ L 353, 
31.12.2008, p.  1). 
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: 
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 
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 EFSA 
Journal 2019;17(5): 5809. DOI: 10.2903/j.efsa.2019.5809: G/TBT/N/EU/682  
 
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  https://www.e fsa.europa.eu/sites/default/files/scientific_output/5809 -
chlorpyrifos.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/tbt/en/  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_5425_00_e.pdf