G/TBT/N/EU/996  
20 July 2023  
(23-4943) 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):  Metiram 
(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 Metiram, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council, and amending Commission Implementing 
Regulat ion (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 Metiram is not renewed in accordance with 
Regulation (EC) No 1107/2009. EU Member Sta tes shall withdraw authorisations for plant 
protection products containing Metiram as an active substance. The non -renewal of 
approval is based on the first evaluation of the substance for use as a pesticide active 
substance in the EU under Regulation (EC)  No 1107/2009. The substance was formerly 
assessed and approved under Directive 91/414/ EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following non -approval and the expiry of all grace 
periods for stocks of products containing this substance, separate action will likely be 
taken on MRLs and a separate notification will be made in accordance with SPS 
procedures.  G/TBT/N/EU/996  
 
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  7. Objective and rationale, including the nature of urgent problem s 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 hea lth, 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.  
During the evaluation and peer -review of Metiram, a number of concerns and areas that 
could not be finalised were identified. These are detailed in the statement of the European 
Food Safety Authority (EFSA).  
The decision is based on a risk assessment carried out by a rapporteur EU Member State 
and peer reviewed by the European Food Safety Authority together with all EU Member 
States, taking into account other factors legitimate to the matter.  
In the case of Metiram, the outcome of the risk assessment, as documented in the EFSA 
Conclusion, is not favourable and identifies critical are as of concern.  
These critical areas of concern have been identified: Metiram is considered to meet the 
criteria for endocrine disruption (ED) for humans for the T modalities. Operator, bystander 
and resident exposure estimates are exceeding the reference v alues (relevant for all 
representative uses evaluated). High risk to aquatic organisms was identified for all 
representative uses. A high in -field risk for non -target arthropods was identified for all 
representative uses.  
Moreover, part of the risk assessm ent could not be finalised by EFSA, thus precluding the 
renewal, such as, among others, the consumer dietary risk assessment, the genotoxic 
potential and general toxicity of metabolite M222F001, the assessment of the long -term 
risk to birds and the risk to  honey bee larvae. Therefore, the outcome of the risk 
assessment is not favourable to the renewal given that it can be concluded that several 
application scenarios are not acceptable. These concerns mean that Metiram does not 
meet the approval criteria as outlined in Regulation (EC) No 1107/2009.  
Existing authorisations will need to be withdrawn; EU Member States must withdraw 
existing plant protection products containing Metiram at the latest by 6 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 12 months from the entry into force (allowing 
for a final season of use).  
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  
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32009R1107  
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) 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32011R0540  
Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing 
Article 80(7) of Regulation (EC) No 1107/2009 of  the European Parliament and of the 
Council concerning the placing of plant protection products on the market and establishing 
a list of candidates for substitution ( OJ L 67, 12.3.2015, p. 18 –22) 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32015R0408  
EFSA (European Food Safety Authority), 2022. Peer review of the pesticide risk 
assessment of the active substance metiram. https://doi.org/10.2903/j.efsa.2023.7937  G/TBT/N/EU/996  
 
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  9. Proposed date of adoption:  4th quarter 2023  
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@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/2023/TBT/EEC/23_11161_00_e.pdf