G/TBT/N/EU/409  
 
5 October 2016  
(16-5295) 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/  
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):  Linuron (pesticide 
active substance)  
5. Title, number of pag es and language(s)  of the notified document:  Draft Commission 
Implementing Regulation concerning the non -renewal of approval of the active substance 
linuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of 
the Council conc erning the placing of plant protection products on the market, and amending 
the Annex to Implementing Regulation (EU) No 540/2011 (5 pages, in English) .  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval o f the active substance linuron is not renewed in accordance with Regulation 
(EC) No 1107/2009. Existing authorised plant protection products containing linuron will be 
withdrawn from the market. The non -approval is based on the first evaluation of the 
substance for use as a pesticide active substance in the EU under Regulation 
(EC) No 1107/2009. The substance was formerly approved under Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and does not affect 
the Max imum Residue Levels (MRLs) for residues of the concerned pesticide. However, 
following non -approval, separate action will be taken to lower MRLs to the limit of 
quantification (LOQ). A separate notification will be made in accordance with SPS procedures 
in relation to action taken on MRLs.   
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 ac tive 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 that 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.  G/TBT/N/EU/409  
 
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  During the evaluation and peer -review of the substance, a number of concerns and areas 
that could not be finalised were identified. Th ese are detailed in the conclusion of the 
European Food Safety Authority (EFSA). The Authority identified several specific concerns: 
in paticular, child resident exposure is above the relevant toxicological reference value 
(AOEL) and operator exposure cons idering handheld sprayer application was also in 
exceedance of the AOEL even taking into account the use of personal protective 
equipment.  Furthermore, a high risk to birds and wild mammals, non -target arthropods and 
non-target soil macro -organisms was ide ntified. The consumer risk asse ssment could not be 
finalised due to a number of serious deficienc ies in the data package. The exposure and risk 
assessment for several environmental compartments including groundwater could also not be 
finalised.  
Linuron is  classified as toxic for reproduction category  1B in accordance with Regulation 
(EC) No 1272/2008. Child resident exposure is above the AOEL for the proposed uses, 
therefore use of linuron under realistic proposed conditions of use so that exposure of 
huma ns to the substance is negligible is excluded. Such negligible exposure is further 
excluded as it cannot be concluded that residues of the active substance do not exceed the 
default value set in accordance with point (b) of Article 18(1) of Regulation (EC)  
No 396/2005, given that a Maximum Residue Level could not be derived from the available 
data. 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.  
Furthermore, in addition to  the classification of linuron as toxic for reproduction category 
1B, linuron is also classified as carcinogenic category  2 in accordance with Regulation 
(EC) No 1272/2008 and therefore shall be considered to have endocrine disrupting 
properties in accorda nce with the third paragraph of Point 3.6.5 of Annex II to Regulation 
(EC) No 1107/2009. In addition, the available scientific evidence shows that linuron has 
endocrine disrupting properties that may cause adverse effects on endocrine organs in 
humans and non-target organisms. Negligible e xposure of humans to linuron under 
realistic conditions of use is excluded for the reasons detailed in 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.  
These concerns mean that linuron does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdrawn; EU Membe r States must withdraw 
existing plant protection products containing linuron at the latest by 3 months from the 
date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is 
allowed for and shall expire at the latest 15 mon ths from the entry into force (allowing for a 
final season of use).  
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:  
http://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988 988&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     
9. Proposed date of adoption: 1st quarter 2017  
Proposed date of entry into force: 20 days following publication in the OJ (likely to be in 
early part of 1st quarter of 2017)   
10. Final date for comments:  60 days from notification  G/TBT/N/EU/409  
 
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  11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and email and website address es, 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 Website: http://ec.europa.eu/growth/tools -databases/tbt/  
https://members.wto.org/crnattachments/2016/TBT/EEC/16_4110_00_e.pdf