EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10943/2016 rev. 1 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
concerning the non-renewal of approval of th e active substance linuron, 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 Implementing Re gulation (EU) No 540/2011 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
concerning the non-renewal of approval of th e active substance linuron, in accordance 
with Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
concerning the placing of plant protection pr oducts on the market, and amending the 
Annex to 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 plant protection products on the market 
and repealing Council Direc tives 79/117/EEC and 91/414/EEC
1, and in particular 
Article 20(1) and Article 78(2) thereof, 
 Whereas: (1) Commission Directive 2003/31/EC
2 included linuron as active substance 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 s ubstance linuron, as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011, expires on 31 July 2017. 
(4) An application for the renewal of the approval of linuron was submitted in accordance 
with Article 1 of Commission Impl ementing Regulation (EU) No 844/20125 within the 
time period provided for in that Article. 
                                                 
1 OJ L 309, 24.11.2009, p. 1. 
2 Commission Directive 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to 
include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as 
active substances (OJ L 101, 23.4.2003, p. 3). 
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 Regulation (EU) No 540/2011 of 25 May 2011 amending 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 plant protection products on th e market (OJ L 252, 19.9.2012, p. 26).  
EN 3   EN (5) The applicant submitted the supplementary dossiers required in accordance with 
Article 6 of Regulation (EU) No 844/2012. Th e application was found to be complete 
by the rapporteur Member State. 
(6) The rapporteur Member State prepared a re newal assessment report in consultation 
with the co-rapporteur Member State and submitted it to the European Food Safety 
Authority (hereinafter ‘the Authority’) and th e Commission on 15 April 2015. 
(7) The Authority communicated the renewal assess ment report to the applicant and to the 
Member States for comments and fo rwarded the comments received to the 
Commission. The Authority also made the supplementary summary dossier available 
to the public. 
(8) On 8 June 2016 the Authority communicat ed to the Commission its conclusion6 on 
whether linuron can be expected to meet the approval criteria provided for in Article 4 
of Regulation (EC) No 1107/2009. Specific concerns were identified, in particular, child resident exposure is above the toxicologi cal reference value ('AOEL') and operator 
exposure considering handheld sprayer applic ation is also in exceedance of the AOEL 
even when personal protective equipment is used. Furthermore, a high risk to birds and wild mammals, non-target arthropods and non-target soil macro-organisms was 
identified. The consumer risk assesment could not be finalised  due to a number of serious 
deficiencies in the data packag e. In addition, the exposure and risk assessment for several 
environmental compartments including grou ndwater could also not be finalised.  
(9) Linuron is classified as toxic for repr oduction category 1B in accordance with 
Regulation (EC) No 1272/2008
7. Child resident exposure is above the AOEL for the 
proposed uses. To demonstrate negligible exposure of humans to the substance under 
realistic proposed conditions of use, e xposure cannot be above the AOEL, therefore 
use of linuron under realistic proposed conditions  of use so that exposure of humans to 
the substance is negligible, is exclude d. In addition, a further requirement to 
demonstrate negligible exposure is that re sidues of the active substance shall not 
exceed the default value set in accordance with  point (b) of Article 18(1) of Regulation 
(EC) No 396/2005. A Maximum Residue Leve l could not be derived from the 
available data for the proposed use of linuron, however, the available residue trial data 
for the proposed uses indicate that residue s of linuron above the default value would 
be expected and therefore this condition is not fulfilled. Based on these considerations, the requirements set out in Point 3.6.4 of  Annex II to Regulation (EC) No 1107/2009 
are not fulfilled.  
(10) Furthermore, in addition to the classifi cation of linuron as toxic for reproduction 
category 1B, linuron is also classified as carcinogenic category 2 in accordance with 
Regulation (EC) No 1272/2008 a nd therefore shall be considered to have endocrine 
disrupting properties in accordance with th e third paragraph of Point 3.6.5 of Annex II 
to Regulation (EC) No 1107/2009. In addition, th e available scientif ic evidence shows 
that linuron has endocrine disrupting prope rties that may cause adverse effects on 
endocrine organs in humans and non-target or ganisms. Negligible exposure of humans 
to linuron under realistic condi tions of use is excluded for the reasons detailed in 
                                                
 
6 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance linuron. EFSA Journal 2016;14(2):4406, 173 pp. 
doi:10.2903/j.efsa.2016.4406. Availa ble online: www.efsa.europa.eu . 
7  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).  
EN 4   EN recital 9. Based on these considerations, the requirements set out in the first paragraph 
of Point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 are not fulfilled.  
(11) The Commission invited the applicant to s ubmit its comments on the conclusion of the 
Authority. Furthermore, in accordance wi th third paragraph of Article 14 of 
Implementing Regulation (EC) No 844/2012, th e Commission invited the applicant to 
submit comments on the renewal report. The applicant submitted its comments, which have been carefully examined. 
(12) However, despite the arguments put forward by  the applicant, the concerns related to 
the substance could not be eliminated.  
(13) Consequently,  it has not been established with resp ect to one or more representative 
uses of at least one plant pr otection product that the approva l criteria provided for in 
Article 4 are satisfied. The approval of th e active substance linuron should therefore 
not be renewed. 
(14) Commission Implementing Regulation (E U) No 540/2011 should therefore be 
amended accordingly. 
(15) Member States should be provided with tim e to withdraw authorisations for plant 
protection products containing linuron.  
(16) For plant protection products containing linuron, 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 [insert date 15 months from  the date of entry into 
force] .   
(17) Commission Implementing Regulation (EU) 2016/950
8 extended the expiry date of 
linuron to 31 July 2017 in order to allow the renewal process to be completed before 
the expiry of the approval of  that substance. Given that a decision is taken ahead of 
this extended expiry date, this Regula tion should apply as soon as possible. 
(18) This Regulation does not prejudice the subm ission of a further application for the 
approval of linuron in accordance with Article 7 of Regulation (EC) No 1107/2009. 
(19) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Non-renewal of approval of active substance 
The approval of the active subs tance linuron is not renewed.  
                                                 
8 Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans  Strain CON/M/91-08 (DSM 9660), 
cyazofamid, deltamethrin, dimeth enamid-P, ethofumesate, fenami done, flufenacet, flurtamone, 
foramsulfuron, fosthi azate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, 
mesotrione, oxasulfuron, pendimethalin, picoxystr obin, silthiofam and trifloxystrobin (OJ L 159, 
16.6.2016, p. 3).   
EN 5   EN Article 2 
Transitional measures 
Member States shall withdraw authorisations for plant protec tion products containing linuron 
as active substance by [ Office of Publications please inse rt date 3 months from the date of 
entry into force ] at the latest.  
Article 3 
Grace Period 
Any grace period granted by Member States in acco rdance with Article 46  of Regulation (EC) 
No 1107/2009 shall be as short as possible and shall expire by [insert date 15 months from the 
date of entry into force] at the latest.   
Article 4 
Amendment to Implementing Regulation (EU) No 540/2011 
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 51, on linuron, is 
deleted. 
Article 5 
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