EN    EN EN 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2008) final 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of flurprim idol in Annex I to Council Directive 
91/414/EEC and the withdrawal of authorisations for plant protection products 
containing that substance  EN 2   EN Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of flurprim idol in Annex I to Council Directive 
91/414/EEC and the withdrawal of authorisations for plant protection products 
containing that substance  
(Text with EEA relevance)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing 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 provi des that a Member State may, during a 
period of 12 years following the notification of that Directive, au thorise the placing on 
the market of plant protection products containing active substances not listed in 
Annex I of that Directive th at are already on the market two years after the date of 
notification, 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 th e third stage of the programme of work 
referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active 
substances to be assessed with a view to their possible incl usion in Annex I to 
Directive 91/414/EEC. That li st includes flurprimidol. 
                                                 
1 OJ L 230, 19.8.1991, p. 1.  
2 OJ L 55, 29.2.2000, p. 25. 
3 OJ L 224, 21.8.2002, p. 23. EN 3   EN (3) For flurprimidol 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 pr oposed by the notifier.  Moreover, those 
Regulations designate the rappor teur Member States which have to submit the relevant 
assessment reports and recommendations to  the European Food Safety Authority 
(EFSA) in accordance with Article 10 (1 ) of Regulation (EC) No 1490/2002. For 
flurprimidol the rapporteur Member State was Finland and all re levant information 
was submitted on 20 April 2007. 
(4) The assessment report has been peer reviewed by the Member States and the EFSA 
within its Working Group Evaluation and presented to the Co mmission on 31 July 
2008 in the format of the EFSA  conclusion regarding the pe er review of the pesticide 
risk assessment of the active substance flurprimidol
4. This report has been reviewed by 
the Member States and the Commission w ithin the Standing Committee on the Food 
Chain and Animal Health and finalised on 26 September 2008 in the format of the 
Commission review repo rt for flurprimidol. 
(5) During the evaluation of this active substa nce, a number of concerns have been 
identified. In particular, based on the available information, the operator and worker exposure exceed the AOEL (acceptable opera tor exposure level) in all evaluated 
scenarios and conditions of use. Moreover, no data was available on the impurity profile 
of batches used in toxicological studies. C onsequently, it was not possible to conclude 
on the basis of the information available that flurprimidol met the criteria for inclusion in Annex I to Directive 91/414/EEC. 
(6) The Commission invited the notifier to submit its comments on the results of the peer 
review and on its intention or not to fu rther support the substance. The notifier 
submitted its comments which have been carefully examined. However, despite the arguments put forward by the notifier, the conc erns identified could not be eliminated, 
and assessments made on the basis of the information submitted and evaluated during 
the EFSA expert meetings have not demonstr ated that it may be expected that, under 
the proposed conditions of use, plant prot ection products containing flurprimidol 
satisfy in general the requirements laid dow n in Article 5(1)(a) and (b) of Directive 
91/414/EEC. 
(7) Flurprimidol should therefore not be incl uded in Annex I to Directive 91/414/EEC. 
(8) Measures should be taken to ensure that authorisations grante d for plant protection 
products containing flurprimi dol are withdrawn within a fixed period of time and are 
not renewed and that no new authorisa tions for such products are granted.  
(9) Any period of grace granted by a Member St ate for the disposal, storage, placing on the 
market and use of existing stocks of plant protection products containing flurprimidol 
should be limited to twelve months in order to  allow existing stocks to be used in one 
further growing season, which ensures th at plant protection products containing 
flurprimidol remain available to farmers for 18 months from the adoption of this 
Decision. 
                                                 
4 EFSA Scientific Report (2008) 151, Conc lusion on the peer review of flurprimidol, finalised 31 July 
2008.  EN 4   EN (10) This Decision does not prejudice the submi ssion of an application for flurprimidol 
according to the provisions of Article 6 (2) of Directive 91/414/EEC, the detailed 
implementation rules of which have been laid down in Commission Regulation (EC) 
No 33/20085, in view of a possible in clusion in its Annex I.  
(11) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DECISION: 
Article 1 
Flurprimidol shall not be incl uded as active substance in An nex I to Directive 91/414/EEC. 
Article 2 
Member States shall ensure that: 
(a) authorisations for plant protection produc ts containing flurprim idol are withdrawn by 
[INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS 
DECISION];  
(b) no authorisations for plant protection produc ts containing flurprimidol are granted or 
renewed from the date of publication of this Decision. 
Article 3 
Any period of grace granted by Member States 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. 
Article 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla VASSILIOU  Member of the Commission 
                                                
 
5 OJ L 15, 18.1.2008, p. 5–12.