EN    ENEN 
  
EN    ENBrussels, 
 
DRAFT 
COMMISSION DECISION ../…/EC 
of 
concerning the non-inclusion of butralin in Annex I to Council Directive 
91/414/EEC and the withdrawal of authoris ations for plant protection products 
containing that substance 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European Community, 
Having regard to Council Directive 91/ 414/EEC of 15 July 1991 concerning the 
placing of plant protection products on the market1, and in particular the fourth 
subparagraph of Article 8(2) thereof, 
Whereas:  (1) Article 8(2) of Directive 91/414/EEC provides that a Member State may, 
during a period of 12 years following th e notification of that Directive, 
authorise the placing on the market of  plant protection products containing 
active substances not listed in Annex I to  that Directive that are already on the 
market two years after the date of no tification, while those substances are 
gradually being examined within the framework of a programme of work. 
(2) Commission Regulations (EC) No 451/2000
2 and (EC) No 1490/20023 lay 
down the detailed rules for the implementation of the third stage of the programme of work referred to in Ar ticle 8(2) of Directive 91/414/EEC and 
establish a list of active substances to be  assessed with a view to their possible 
inclusion in Annex I to Directive 91/414/EEC. That list includes butralin. 
                                                
 
1  OJ L 230, 19.8.1991, p. 1. Directive as last amended by [ INSERT LAST AMENDMENT ]. 
2  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ 
L 151, 19.6.2003, p.32). 
3  OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regulation (EC) No 1095/2007 
(OJ L 246, 21.9.2007, p. 19).  
EN    EN(3) For butralin the effects on human hea lth and the environment have been 
assessed in accordance with the provisions  laid down in Regulations (EC) No 
451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which 
have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of 
Regulation (EC) No 451/2000. For butralin  the rapporteur Member State was 
France and all relevant information was submitted on 20 February 2006. 
(4) The Commission examined butralin in  accordance with Article 11a of 
Regulation (EC) No 1490/2002. A draft revi ew report for that substance was 
reviewed by the Member States a nd the Commission within the Standing 
Committee on the Food Chain and Animal  Health and finalised on 20 May 
2008 in the format of the Commission review report. 
(5) During the examination of this active substance by the Committee, it was 
concluded, taking into account comments received from Member States, that 
there are clear indications that it may be expected that it has harmful effects on human health and in particular on operators, because the exposure is greater than 100 % of the AOEL. Moreover, othe r concerns which were identified by 
the rapporteur Member States in its assessment report are included in the review report for the substance. 
(6) The Commission invited the notifier to submit its comments on the results of 
the examination of butralin and on its in tention or not to further support the 
substance. The notifier submitted its comments which have been carefully examined. However, despite the argumen ts put forwards by the notifier, the 
concerns identified could not be eliminated, and assessments made on the basis of the information submitted have  not demonstrated that it may be 
expected that, under the proposed conditions of use, plant protection products containing butralin satisfy in general the requirements laid down in Article 
5(1)(a) and (b) of Directive 91/414/EEC. 
(7) Butralin should therefore not be included in Annex I to Directive 91/414/EEC. 
(8) Measures should be taken to ensure th at authorisations granted for plant 
protection products containing butralin ar e withdrawn within a fixed period of 
time and are not renewed and that no new authorisations for such products are 
granted. 
(9) Any period of grace granted by a Member  State for the disposal, storage, 
placing on the market and use of existi ng stocks of plant protection products 
containing butralin should be limited to 12 months in order to allow existing 
stocks to be used in one further gr owing season, which ensures that plant 
protection products containing butralin re main available for 18 months from 
the adoption of this Decision. 
(10) This Decision does not prejudice the subm ission of an application for butralin 
in accordance with Article 6(2) of Directive 91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 Ja nuary 2008 laying down detailed rules  
EN    ENfor the application of Council Directiv e 91/414/EEC as regards a regular and 
an accelerated procedure for the assessment of active substances which were part of the programme of work referred to  in Article 8(2) of that Directive but 
have not been included into its Annex I
4, in view of a possible inclusion in its 
Annex I.  
(11) The measures provided for in this D ecision are in accordance with the opinion 
of the Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DECISION: 
Article 1 
Butralin shall not be included as an ac tive substance in Annex I to Directive 
91/414/EEC. 
Article 2 
Member States shall ensure that: 
(a)  authorisations for plant prot ection products containing butralin are 
withdrawn by [INSERT DATE 6 MONTHS FROM THE DATE OF 
ADOPTION OF THIS DECISION];  
(b)  no authorisations for plant prot ection products containing butralin are 
granted or renewed from the date of publication of this Decision. 
Article 3 
Any period of grace granted by Member Stat es in accordance with the provisions of 
Article 4(6) of Directive 91/414/EEC, shall be  as short as possible and shall expire on 
[INSERT DATA 18 MONTHS FROM ADOPTION OF THIS DECISION]  at the latest. 
                                                 
4 OJ L 15, 18.1.2008, p. 5.  
EN    ENArticle 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla Vassiliou   
 Member of the Commission