G/TBT/N/EU/595  
 
31 August 2018  
(18-5438) 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): Copper 
compounds (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation renewing the approval of the active substances 
copper compounds, as candidates for substitution, in acc ordance 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 Implementing 
Regulation (EU) No 540/2011 (and its accompanying annexes) (4 pages + Annexes 3 
pages, in English)   
6. Description of content: This draft Commission Implementing Regulation  provides that 
the approval of the active substances copper compounds are renewed in accordance with 
Regulation (EC)  No 1107/2009 under restricted conditions and for a period of 5 years. 
Existing authorised plant protection products containing copper compo unds will have to be 
re-authorised in accordance with the proposed restrictions. The renewal of approval is 
based on the first evaluation of the substances for use as pesticide active substances in the 
EU under Regulation (EC) No 1107/2009. The substances were formerly approved under 
Directive  91/414/ EEC.  
This regulation only concerns the placing on the market of these substances and does not 
affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. 
However, following non -approval, separate action may be taken on MRLs and if so a 
separate notification will be made in accordance with SPS procedures.  G/TBT/N/EU/ 595 
 
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  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 t hat 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 the subst ances, 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).  
In particular, the Authority identified some areas of concern with respect to high risk f or 
birds and mammals, aquatic organisms and soil macro -organisms. It is therefore 
necessary to restrict the uses to the maximum application rate per year and per hectare to 
4 Kg/ha/year of copper to limit the potential environmental exposure due to its use  in 
plant protection products. In addition, copper is a metal, which occurs in nature and as 
other metals shows a distinct chemical behaviour in the environment for which the 
Authority has recognised that the current scientific guidance for pesticides risk  assessment 
might not be fully appropriate. Hence, given that specific guidance is available under the 
European regulatory framework concerning biocides, the Commission will request the 
Authorityto develop guidance on environmental risk assessment of metal s and metals 
compounds used in plant protection products to take into account the new scientific 
approach already incorporated in other European regulatory framework. In view of the 
above it is hence considered appropriate to propose the renewal of copper for a limited 
period of 5 years ensuring a priority re -assessment of copper compounds over other active 
substances as soon as specific guidance for environmental risk assessment of metals and 
metal compounds will be available.   
Existing authorisations of p lant protection products containing copper compounds will need 
to be re -examined by Member States in accordance with Article 43 of Regulation 
No 1107/2009.   
8. Relevant documents:   
Regulation (EC) No 1107/2009 of the European Parl iament 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  
EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the 
pesticide risk assessment of the active substance copper compounds EFSA Journal 
2018;16(1):5152  
https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2018.5152  
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 
16 December  2008 on classification, labelling 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) 
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=uriserv:OJ.L_.2008.353.01.0001.01.ENG&toc=OJ:L:2008:353:TOC   G/TBT/N/EU/595  
 
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  9. Proposed date of adoption:  4th quarter 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  
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_4676_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_4676_01_e.pdf