EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2008) final 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of triflumuron in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for pl ant protection products containing that 
substance 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of triflumuron in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for pl ant 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 triflumuron. 
(3) For triflumuron 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 
triflumuron the rapporteur Member State wa s Italy and all relevant information was 
submitted on 15 July 2005. 
                                                
 
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 (4) The assessment report has been peer reviewed by the Member States and the EFSA 
within its Working Group Evaluation a nd presented to the Commission on 30 
September 2008 in the format of the EFSA c onclusion regarding the peer review of the 
pesticide risk assessment of the active substance triflumuron4. This report has been 
reviewed by the Member States and th e Commission within the Standing Committee 
on the Food Chain and Animal Health and finalised on 2 December 2008 in the format of the Commission review  report for triflumuron. 
(5) During the evaluation of this active substa nce, a number of concerns have been 
identified. In particular, based on the availa ble information, it has not been demonstrated 
that the consumer exposure is acceptable due to lack of data in terms of nature and 
level of the relevant residues. In fact, it was not possible to pe rform an acute risk 
assessment for the me tabolite M07, because da ta was not sufficient to allocate an acute 
reference dose for this me tabolite. Moreover, data were  missing to determine an 
appropriate residue defi nition and to estimate the level of residues in processed fruit 
commodities. In addition, a high risk to aquatic organisms ha s been identified. 
Consequently, it was not possible to conclude on the basis of the information available 
that triflumuron met the criteria for incl usion 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 pr otection products containing triflumuron 
satisfy in general the requirements laid dow n in Article 5(1)(a) and (b) of Directive 
91/414/EEC. 
(7) Triflumuron 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 triflumuron are withdraw n 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 triflumuron 
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 
triflumuron remain available to farmers for 18 months from th e adoption of this 
Decision. 
(10) This Decision does not prejudice the submi ssion of an application for triflumuron 
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 33/2008 of 17 January 2008 laying down deta iled rules for the application of 
Council Directive 91/414/EEC as regards a re gular and an accelerated procedure for 
                                                
 
4 EFSA Scientific Report (2008) 194, Conclusion on the peer review of triflumuron, finalised 30 
September 2008.   
EN 4   EN the assessment of active substances whic h were part of the programme of work 
referred to in Article 8(2) of that Directiv e but have not been in cluded into its Annex 
I5, in view of a possible inclusion 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, 
                                                 
5 OJ L 15, 18.1.2008, p. 5–12.   
EN 5   EN HAS ADOPTED THIS DECISION: 
Article 1 
Triflumuron 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 triflumu ron are withdrawn by 
[INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS 
DECISION];  
(b) no authorisations for plant protection pr oducts containing triflumuron 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