G/SPS/N/EU/384  
 
24 April 2020  
(20-3227) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -
General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Mancozeb (pestici de active substance used as fungicide)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title 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 . Language(s):  English . 
Number of pages:  4 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_2907_00_e.pdf  
6. Description of content:  
This draft 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withdrawn and such products can then no longer be placed on the marke t. The 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 Safety Authority (EFSA).  
This decision only concerns the placi ng 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, separate action will be taken to 
swiftly lower all existing MR Ls 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.  
This draft Commission Implementing Regulation was also notified under the TBT 
Agreement in notice G/TBT/N/EU/712 . G/SPS/N/EU/384  
 
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  7. Objective and rationale: [X]  food safety, [  ] animal health, [X]  plant protection,  
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.  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 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 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, cer eals 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 approve d 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 s 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 health; 
Protection of the environment.  
8. Is there a re levant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 October 2009 concerning the placing of plant protection p roducts 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 active 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, label ling 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). G/SPS/N/EU/384  
 
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  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   
10. Proposed date of adoption (dd/mm/yy) : 3rd quarter 2020.  
Proposed date of publication (dd/mm/yy) : 3rd quarter 2020.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 days following publication in the Official Journal of the EU.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notifi cation and/or (dd/mm/yy) : 17 June 2020 - Comments are to be addressed to 
the TBT Enquiry Point.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: +(322) 299 8043  
E-mail: grow-eu-tbt@ec.europa.eu   
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: +(322) 299 8043  
E-mail: grow-eu-tbt@ec.europa.eu