G/TBT/N/EU/690  
4 November 2019  
(19-7371) 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):  Metalaxyl -M 
(pesticide active s ubstance); Pesticides and other agrochemicals (ICS 65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation renewing the approval of the active substance 
metalaxyl -M, and restricting the use of s eeds treated with plant protection products 
containing it, 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 pages plus Annexes 4 pages, in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance metalaxyl -M is renewed in accordance with Regu lation 
(EC) No 1107/2009, subject to certain restrictions including to the use of seeds treated 
with product containing metalaxyl -M. Use as seed treatment is permitted, however, 
treated seeds shall only be sown in greenhouses. Other uses e.g. foliar sprayi ng can still 
be authorised by EU Member States.  
Existing authorised plant protection products containing metalaxyl -M will be reviewed in 
accordance with the proposed restrictions. The renewal of approval is based on the first 
evaluation of the substance f or 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 and use of metalaxyl -M and plant 
protection products containing it. The decision does not affect existing Maximum Reside 
Levels (MRLs).    G/TBT/N/EU/690  
 
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  7. Objective and rationale, including the nature of urgent prob lems 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 placin g 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 also detailed in Annex  II) which must be met  to enable approval. During 
the evaluation and peer -review of metalaxyl -M, a number of concerns were identified. 
These are detailed in the conclusion of the European Food Safety Authority (EFSA). EFSA 
concluded that based on the information available, the genotoxic potential of one impurity 
(2-[(2,6-dimethyl -phenyl) -(2-methoxyacetyl) -amino] -propionic acid 1 -methoxycarbonyl -
ethyl ester) in the technical active substance as manufactured could not be ruled out. 
However, the evaluation showed that if the impuri ty is present below a certain level (0.18 
g/kg) that a concern does not exist.  Furthermore, two other impurities (2,6 -
dimethylphenylamine and 4 -methoxy -5-methyl -5H-[1,2]oxathiole 2,2 -dioxide) are 
considered toxicologically relevant. It is therefore necess ary to establish maximum levels 
for those three impurities in the technical active substance as manufactured.   EFSA also 
identified a high risk to birds and mammals from the use of metalaxyl -m as a seed 
treatment. In order to address this concern, seeds t reated with metalaxyl -M shall only be 
sown in greenhouses. The risk from consumption of seedlings was considered acceptable 
for the two representative crops considered (sunflowers and spinach). For the use on 
spinach, residue data allow to conclude that se edlings can be planted in the field after 
21 days. For other crops, such data are not available. EU Member States therefore need to 
pay particular attention to the period before seedlings can be planted in open fields. 
Existing authorisations will need to be amended or withdrawn following renewal of 
authorisation in accordance with Article 43 of Regulation (EC) No 1107/2009.  
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=144 2928512004&uri=CELEX:32011R0540  
Conclusion on the peer review of the pesticide risk assessment of the active substance 
metalaxyl -M. EFSA Journal 2015;13(3):3999. DOI: 10.2903/j.efsa.2015.3999  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2015.3999   
9. Proposed date of adoption:  1st quarter 2020  
Proposed date of entry int o force:  20 days following publication in the Official Journal 
of the EU.  
The Regulation will apply from 1 April 2020.  
The restriction to sowing of treated seeds in greenhouses will apply from 1 November 
2020.  
10. Final date for comments:  60 days from notification  G/TBT/N/EU/690  
 
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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/crnattachments/2019/TBT/EEC/19_6145_01_e.pdf  
https://members.wto.org/c rnattachments/2019/TBT/EEC/19_6145_00_e.pdf