EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10859/2017 
[…](2017) XXX  draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance malathion 
(Text with EEA relevance) 
  
EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance malathion 
(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 Par liament and of the 
Council of 21 October 2009 concerning the placing  of plant protection products on the market 
and repealing Council Direc tives 79/117/EEC and 91/414/EEC
1, and in particular the second 
alternative of Article 21(3) and Article 78(2) thereof, 
Whereas: (1) The active substance malathion was included in Annex I to Council 
Directive 91/414/EEC of 15 July 1991 concer ning the placing of plant protection 
products on the market by Commission Directive 2010/17/EU
2 under the condition 
that the Member States concerned ensure that the applicant at whose request malathion was approved provides inter alia  further confirmatory information on the acute and 
long-term risk to insectivorous birds. 
(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 540/2011
3. 
(3) On 25 April 2012 the applicant submitted ad ditional informati on to address the 
confirmatory data requirement s as regards the consumer risk assessment and the acute 
and long-term risk assessment for insecti vorous birds and the quantification of the 
different potency of malaoxon and malathion  to the rapporteur Member State, the 
United Kingdom, within the time period provided for its submission. 
(4) The United Kingdom assessed the additional information submitted by the applicant 
and submitted its assessment, in the form of an addendum to the draft assessment 
report, to the other Member States, the Commission and the European Food Safety 
Authority (‘the Authority’), on 11 May 2015. 
(5) The other Member States, the applicant and the Authority were consulted and asked to 
provide comments on the assessment of the ra pporteur Member State. The Authority 
                                                 
1 OJ L 230, 19.8.1991, p. 1. 
2 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). 
3 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).  
EN 3  EN published a technical report summarising the outcome of this consultation for 
malathion on 2 February 20164. 
(6) The draft assessment report, the addendum a nd the technical report of the Authority 
were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised in January 2018 in the format of a Commission review report for malathion.  
(7) The Commission invited the applicant to submit its comments on the review report for 
malathion. The applicant submitted its comments whic h have been carefully 
examined. 
(8) However, the information submitted by the applicant is insufficient and prevents the 
Commission from concluding that the level of acute and long-term risks to birds arising from the use of malathion is acceptabl e. Furthermore, mitigating such risk with 
risk mitigation measures other than the app lications in greenhouse cannot realistically 
be implemented.  
(9) Therefore, taking into account the identifie d high risk for birds, it is appropriate to 
further restrict the conditions of use of mala thion, and in particular to only allow for  
applications in greenhouses with a permanent structure . The Annex to Implementing 
Regulation (EU) No 540/2011
5 should therefore be amended accordingly. 
(10) Member States should be allo wed sufficient time to amend or  withdraw authorisations 
for plant protection produc ts containing malathion. 
(11) For plant protection products containing malathion, where Member States grant any 
grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that 
period should, at the latest, expire on [Office of Publications please insert date 
15 months from the date of entry into force] . 
(12) 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 
Amendment to Implementing Regulation (EU) No 540/2011 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation. 
Article 2  
Transitional measures 
Member States shall, in accordance with Regulation (EC) No 1107/2009, where necessary 
amend or withdraw existing authorisations for plant protection products containing malathion 
as active substance by [ Office of Publications please inse rt date 6 months from the date of 
entry into force ] at the latest. 
                                                 
4 EFSA, Technical report on the outcome of the consultation with Member States, the applicant and 
EFSA on the pesticide risk assessment of confirmatory data for malathion. EFSA Supporting publication 2016:EN-951. 61 pp. 
5 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).  
EN 4  EN Article 3 
Grace period 
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possible and shall expire by [Office of Publications please 
insert date 15 months from the date of entry into force] at the latest.   
Article 4 
Entry into force 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
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