G/TBT/N/EU/535  
 
18 January 2018  
(18-0499) Page: 1/2 
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): Malathion 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation amending Implementing Regulation (EU) 
No 540/2011 as regards the conditions of approval of the active substance malathion (and 
its accompanying annex) (4 + 2 pages,  in English)   
6. Description of content: The draft  provides that malathion is restricted to uses in 
greenhouses with a permanent structure and that Member States have to withdraw 
authorisations for outdoor use of plant protection products containing that substance. This 
draft Regulation only concerns the placing on the market of this substance and does not 
affect the European Union or national Maximum Residue Levels (MRLs) for residues of the 
concerned pesticide.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protect ion of the environment.  
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning 
the placing of plant protection products on the market and repealing Council 
Directives  79/117/EEC and 91/414/EEC, sets up a harmonised framework  for the 
authorisation and placing on the market of plant protection products in order to protect 
human health and the environment.  
Malathion is a substance that has been approv ed through Commission 
Directive  2010/17/EU under the condition that the notifie r submits, within defined 
deadlines, additional confirmatory information intended to increase the confidence on the 
acceptability in use of the said substance, in this case specifically on the consumer risk 
assessment and the risk to insectivorous birds.  G/TBT/N/EU/535  
 
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  The intended restriction is justified by the shortcomings in the information submitted by 
the notifier which failed to demonstrate that an acceptable acute and long -term risk for 
insectivorous birds can be presumed.  
As a consequence on the basis of the info rmation submitted it cannot be adequately 
concluded that malathion meets the approval criteria laid down in Article 4 of the above 
Regulation as regards uses outdoors and it is therefore appropriate to restrict the current 
approval to application in perman ent greenhouses.  
A grace period for placing on the market, disposal, storage and use of existing stocks of plant 
protection products containing malathion for uses outdoors may be allowed by Member 
States, in accordance with the provisions of Article 46 of the Regulation, but shall not exceed 
15 months, as from the entry into force of this draft Implementing Regulation.  
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, OJ L 309, 24.11.2009, p. 1  
http://eur -
lex.eu ropa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF  
Commission Directive 2010/17/EU of 9 March 2010 amending Council 
Directive  91/414/EEC to include malathion as active substance, OJ L 60, 10.3.2010, p. 17  
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1516099539349&uri=CELEX:32010L0017  
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing 
Regulation (EC) No 11 07/2009 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.euro pa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540   
9. Proposed date of adoption: 1 May 2018  
Proposed date of entry into force:  Member States have to withdraw the existing 
authorizations for outdoor use of plant protection products containing malathion 6 months 
after the date of entry into force. A grace period of maximum 15 months may be granted 
by the EU Member States for disposal, storage, placing on the market and use of existing 
stocks.  
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/2018/TBT/EEC/18_0443_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_0443_01_e.pdf