G/TBT/N/EU/552  
 
1 March 2018  
(18-1307) 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): Thiram 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the active 
substance thiram, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council concerning the placing of plant protection products on t he 
market, and amending Commission Implementing Regulation (EU) No 540/2011 
(6 page(s), in English)   
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance thiram is not renewed in accor dance with 
Regulation  (EC) No 1107/2009. Existing authorised plant protection products containing 
thiram will be withdrawn from the market. The non -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 approved under 
Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerne d pesticide. However, 
following non -approval, separate action may be taken on MRLs. Any subsequent action on 
MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety; protection of animal or plant life or 
health; protection of the environment.  
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 G/TBT/N/EU/552  
 
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  the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in 
Annex  II) which must be met to enable approval.  
During the evaluation and peer -review of thiram, a number of concerns and areas that 
could not be finalised were identified. These are detailed in the conclusion of the European 
Food Safety Authority (EFSA).  
Specific concerns were identified as follows: A high acute risk to consumers and to workers 
from the foliar uses assessed and a high risk to birds and mammals from all uses assessed, 
including as a seed treatment, even taking into account the application of higher tier 
refinements in the risk assessme nt. Residue definitions for risk assessment purposes could 
not be derived from the incomplete information available on metabolite  M1, consequently 
the assessment of consumer risk through dietary intake could not be completed and 
maximum residue levels coul d not be established. Furthermore, the formation of N -N-
dimethylnitrous amide (NDMA), a substance of concern given its intrinsic hazard, in 
drinking water when surface water and groundwater containing thiram and its metabolite 
DMCS is subject to water trea tment processes could not be excluded by the Authority 
based on the available information and in addition a high risk to aquatic organisms from 
exposure to DMCS was concluded by the Authoritybased on the limited information 
available. Also, based on the in formation available the Authority could not conclude on the 
endocrine disrupting potential of thiram.  
These concerns mean that thiram does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing thiram at the latest by 6 months from the date of 
entry into force. A period of grace in line with Article 46 of Regulation 1107/20 09 is allowed 
for and shall expire at the latest 15 months from the entry into force.  
Furthermore, a transitional period for placing on the market and use of seeds treated with 
thiram is provided for (for a period of 15 months from the date of entry into f orce).  
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 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  
 Conclusion on the peer review of the pesticide risk assessment of the active 
substance thiram. EFSA Journal 2017;15(7):4700, 2 9 pp. 
doi:10.2903/j.efsa.2017.4700. 
https://www.efsa.europa.eu/en/efsajournal/pub/4700  
9. Proposed date of adoption: June 2018  
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/552  
 
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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 text is available on the EU -TBT Website:  
http://ec.europa.eu/growth/tools -databases/tbt/en/  
https://members.wto.org/crnatta chments/2018/TBT/EEC/18_1142_00_e.pdf