EN    ENEN 
  
EN    ENBrussels, 
 
DRAFT 
COMMISSION DECISION ../…/EC 
of 
concerning the non-inclusion of triflumizole 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 triflumizole. 
                                                
 
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 triflumizole the effects on human h ealth 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 triflumi zole the rapporteur Member State 
was the Netherlands and all relevant information was submitted on 4 January 2006. 
(4) The Commission examined triflumizole 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, taking into 
account comments from Member States, it was concluded that there are clear 
indications that it may be expected that it has harmful effects on human health and in particular on operators and work ers, 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 triflumizole and on its intention 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 triflumizole satisfy in genera l the requirements laid down in Article 
5(1)(a) and (b) of Directive 91/414/EEC. 
(7) Triflumizole 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 triflumi zole are 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 triflumizole should be limite d to 12 months in order to allow 
existing stocks to be used in one further growing season, which ensures that plant protection products containing tr iflumizole remain available for 18 
months from the adoption of this Decision.  
EN    EN(10) This Decision does not prejudice the submission of an application for 
triflumizole in accordance with Artic le 6(2) of Directive 91/414/EEC and 
Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a 
regular and an accelerated procedure fo r 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 
Triflumizole shall not be included as an active substance in Annex I to Directive 
91/414/EEC. 
Article 2 
Member States shall ensure that: 
(a)  authorisations for plant protecti on products containing triflumizole are 
withdrawn by [INSERT DATE 6 MONTHS FROM THE DATE OF 
ADOPTION OF THIS DECISION];  
(b)  no authorisations for plant protec tion products containing triflumizole 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