1 EN 
 
 2  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
  
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of buprofezin 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) 3 Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of buprofezin 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 Dir ective 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, authorise the placing on 
the market of plant protection products containing active substa nces 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 Directiv e 91/414/EEC and estab lish a list of active 
substances to be assessed with a view to their possibl e inclusion in  Annex I to 
Directive 91/414/EEC. That list includes buprofezin. 
                                                 
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, 
21.09.2007, p. 19). 4 (3) For buprofezin 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 rappo rteur 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 (E C) No 1490/2002. For 
buprofezin the rapporteur Member State was Fi nland and all relevant information was 
submitted on 7 July 2005. 
(4) The assessment report has been peer reviewed by the Member States and the EFSA 
within its Working Group Evaluation and presented to the Commission on 3 March 
2008 in the format of the EFSA  conclusion regarding the pe er review of the pesticide 
risk assessment of the active substance buprofezin
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 20 May 2008 in the format of the 
Commission review report for buprofezin. 
(5) During the evaluation of th is active substance, a numbe r of concerns have been 
identified. In particular it was not possibl e to perform a reliable consumer exposure 
assessment as data are missing to dete rmine an appropriate residue definition. 
Consequently, it was not possible to conclude on the basis of the information available 
that buprofezin 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 c oncerns 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 protection products containing buprofezin satisfy 
in general the requirements laid down in  Article 5(1)(a) a nd (b) of Directive 
91/414/EEC. 
(7) Buprofezin should therefore not be include d in Annex I to Directive 91/414/EEC. 
(8) Measures should be taken to ensure that au thorisations granted for plant protection 
products containing buprofezin 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 buprofezin 
should be limited to twelve months in order to allow existing stocks  to be used in one 
further growing season, which ensures that  plant protection pr oducts containing 
buprofezin 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 buprofezin 
according to the provisions of Article 6 (2) of Directive 91/414/EEC, the detailed 
                                                 
4 EFSA Scientific Report (2008) 128, 1-XX, Conclusion regarding the peer review of the pesticide risk 
assessment of the active substance buprofezin, finalised 3 March 2008, version of (…) 5 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 
Buprofezin shall not be include d as active substance in Anne x I to Directive 91/414/EEC. 
Article 2 
Member States shall ensure that: 
(a) authorisations for plant protection pr oducts containing buprofezin are withdrawn by 
[INSERT DATE 6 MONTHS FROM TH E DATE OF ADOPTION OF THIS 
DECISION];  
(b) no authorisations for plant protection pr oducts containing buprofezin 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. 
                                                 
5 OJ L 15, 18.1.2008, p. 5–12.  6 Article 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla Vassiliou  Member of the Commission