EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10505/2018  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substances copper compounds, as candidates for 
substitution, 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  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substances copper compounds, as candidates for 
substitution, 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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council of 21 October 2009 concerning the placing of p lant protection products on the market 
and repealing Council Directives  79/117/EEC and 91/414/EEC1, and in particular Article  24 
in conjunction with Article 20(1) thereof,  
Whereas:  
(1) Commission Directive 2009/37/EC2 included copper compounds as active substance s 
in Annex I to Council Directive  91/414/EEC3. 
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No  1107/2009 and are listed in Part  A of the 
Annex to Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance s copper compounds, as set out in Part  A of the 
Annex to Implementing Regulation (EU) No 540/2011 , expires on 31 January 2019.  
(4) An application for the renewal of the approval of copper compou nds was submitted in  
accordance with Article  1 of Commission Implementing Regulation (E U) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Implemen ting Regulation (EU) No  844/2012. The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2009/37/EC of 23 April 2009 amending Council Directive 91/414/EEC to 
include chlormequat, copper compounds, propaquizafop, quizalofop -P, teflubenzuron and zeta -
permethrin as active substances  (OJ L 104, 24.4.2009 , p. 23). 
3 Council  Directive 91/414/EEC  of 15 July 1991 concerning the placing of plant protection products on 
the market  (OJ L 230, 19.8.1991, p. 1).  
4 Commission Implementing Reg ulation (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).  
5 Commission Implementing Regulation (EU) No 844/ 2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of pl ant protection products on the market  (OJ L 252, 19.9.2012, p. 26 ).  
EN 2  EN (6) The rapporteur Member State prepared a  renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European  Food Safety 
Authority ( ‘the Aut hority’) and the Commission on 16 December  2016 . 
(7) The Authority communicated the renewal assessment report to the applicant  and to the 
Member States for comments and forwarded the comments received to the 
Commission. The Authority also made the supplementary summary dossier  available 
to the public.  
(8) On 20 December 2017 t he Authority communicated  to the Commission its 
conclusion s6 on whether copper compounds can be expected to meet the approval 
criteria provided for in Article  4 of Regulation (EC) No  1107/2009. The Commission 
presented the draft renewal report for copper compounds  to the Standing Committee on 
Plant s, Animals, Foo d and Feed  on 25 May 2018.  
(9) The applicant was given the opportunity to submit comments on the draft renewal 
report.  
(10) It has been established with respect to one or more representative uses of at least one 
product for each of the copper compounds that the app roval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009 are satisfied. It is therefore appropriate to 
renew the approval of copper compounds.  
(11) The risk assessment for the renewal of the approval of copper compounds is based on a 
limited number of representative uses, which however do not restrict the uses for 
which plant protection products containing copper compounds  may be authorised. It is 
therefore appropriate to remove the restriction for use only as fungicide and 
bactericide.  
(12) The Co mmission, however, considers that copper compounds are candidate s for 
substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Copper 
compounds are persistent and toxic substance s in accordance with points  3.7.2.1 and 
3.7.2.3 , respectively, of Annex  II to Regulation (EC) No  1107/2009,  given that the 
half-life in soil is greater than 120  days and the long -term no -observed effect 
concentration for aquatic organisms is less than 0.01  mg/L . Copper compounds 
therefore fulfil the condition set in the second indent of point  4 of Annex  II to 
Regulation (EC) No  1107/2009.  
(13) It is therefore appropriate to renew the approval of copper compounds as candidate s 
for substitution  pursuant to Article 24 of regulation (EC) No 1107/2009 . 
(14) In accordance with Article  14(1) of Regulation (EC) No  1107/2009 in conjunction 
with Article  6 thereof, and, in the light of current scientific and technical knowledge, it 
is, however, necessary to include certain conditions and restrictions.  It is, in particular, 
appropriate to restr ict the use of plant protection products containing copper 
compounds to a maximum application rate of 4  kg/ha/year of copper in order to 
minimise the potential accumulation in soil and the exposure for not target organisms.  
It is also appropriate to limit the maximum content of certain impurities of 
toxicological concern.  
(15) Bearing in mind the need to ensure a level of safety and protection consistent with the 
high level of protection within the Union, it is appropriate to renew the approval of 
copper compounds for a period of five years ensuring a priority re -assessment of 
copper compounds over other active substances.   
                                                 
6 EFSA Journal 2018;16(1):5152 .  
EN 3  EN (16) The Annex to Implementing Regulation (EU) No  540/2011 should therefore be 
amended accordingly.  
(17) Commission Implementing Regulat ion (EU)  2018/847 extended the approval period of 
copper compounds to 31  January  2019 in order to allow the renewal process to be 
completed before the expiry of the approval of these  substance s. However, given that a  
decision on renewal has been taken ahea d of this extended expiry date, this Regulation 
should apply from 1  January  2019 .  
(18) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Renewal of the approval of the active substance s as candidate s for substitution  
The approval of the active substance s copper compounds , as candidate s for substitution, is 
renewed as set out in Annex  I. 
Article 2  
Amendments to Implementing Regulation  (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with 
Annex  II to this Regulation.  
Article 3 
Entry into force and date of application  
This Regulation shall enter into force on the twentieth day following that  of its publication in 
the Official Journal of the European Union . 
It shall apply from 1 January  2019 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                 
7 Commission Implementing Regulation (EU) 2018/84 of 19 January 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
chlorpyrifos, chlorpyrifos -methyl, clothianidin, copper compounds , dimoxystrobin, mancozeb, 
mecoprop -p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and 
zoxamide (OJ L 16, 20.1.2018, p. 8).