EN    ENEN 
  
EN    ENBrussels, 
 
DRAFT 
COMMISSION DECISION ../…/EC 
of 
concerning the non-inclusion of tricyclazole 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 tricyclazole. 
                                                
 
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 tricyclazole the effects on human health 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 tricycl azole the rapporteur Member State 
was France and all relevant information was submitted on 26 June 2006. 
(4) The Commission examined tricyclazole 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 received from Member States, it was concluded that there 
are clear indications that it may be e xpected that it has harmful effects on 
human health and in particular the cr ucial missing data does not allow to set 
reliable ADI, ARfD and AOEL and such values are necessary to conduct the 
risk assessment. Moreover, other concerns which were identified by the rapporteur Member States in its assessm ent 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 tricyclazole 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 tricyclazole satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. 
(7) Tricyclazole 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 tricycl azole 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 tricyclazole 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 icyclazole 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 
tricyclazole in accordance with Article 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 
Tricyclazole 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 protection products containing tricyclazole are 
withdrawn by [INSERT DATE 6 MONTHS FROM THE DATE OF 
ADOPTION OF THIS DECISION];  
(b)  no authorisations for plant protec tion products containing tricyclazole 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