G/TBT/N/EU/712  
17 April 2020  
(20-3060) 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):  Mancozeb 
(pesticide active subs tance used as fungicide)   
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 mancozeb, 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 dr aft Commission Implementing Regulation provides that 
the approval of the active substance mancozeb is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorisations of plant protection products 
containing mancozeb will be withdrawn an d such products can then no longer be placed on 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 European Food Safet y Authority (EFSA).  
This decision only concerns the placing on the market of mancozeb 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, sepa rate 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 
mancozeb will become non -compliant and can no longer be placed on the EU market.  G/TBT/N/EU/712  
 
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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 mancozeb, a number of concerns were identified. These are detailed in 
a statement of the European Food Safety Authority (EFSA):  
• A reprotoxic potential of mancozeb, classified as Toxic for reproduction cat.  1B in 
accordance with the criteria set out in Commission Regulation (EC) No 1272/2008.  
• The non -dietary exposure estimates  exceed the reference values for tomatoes, 
potatoes, cereals and grapevines.  
• Moreover, endocrine disruptors criteria are met for humans and likely for non -target 
species.  
• This means that mancozeb 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; EU Member States must withdraw 
existing authorisations for plant protection products containing mancozeb at the 
latest by 3 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 
6 months from the entry into force.  
Protection of human health or safety; Protection of animal or plant life or healt h; 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  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 a ctive substances ( OJ L 153, 11.6.2011, 
p. 1–186) http://eur -lex.europa.eu/legal -
content/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, amendin g 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   
• EFSA conclusions on the peer review of the active substance mancozeb. EFSA 
Journal 2019;17(7):5755. DOI:10.2903/j.efsa.2019.5755. 
https://www.efsa.europa.eu/en/efsajournal/pub/5755  
9. Proposed date of adoption:  3rd quarter 2020  
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  G/TBT/N/EU/712  
 
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  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 te xt is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://member s.wto.org/crnattachments/2020/TBT/EEC/20_2778_00_e.pdf