1 EN 
 2  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
  
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of naprop ramide 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) 3 Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of naprop ramide 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 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 Directive 91/414/EEC and establis h 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 li st includes napropramide. 
                                                 
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 napropramide 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 de signate the rapporteur Memb er States which have to 
submit the relevant assessment reports a nd recommendations to the European Food 
Safety Authority (EFSA) in accordance with  Article 10 (1) of Regulation (EC) No 
1490/2002. For napropramide the rapporteur Member State was Denmark and all 
relevant information was submitted on 6 September 2005. 
(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 26 March 
2008 in the format of the EFSA  conclusion regarding the pe er review of the pesticide 
risk assessment of the ac tive substance napropamide
4. This report has been reviewed 
by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 July 2008 in the format of the Commission review report for napropamide. 
(5) During the evaluation of th is active substance, a numbe r of concerns have been 
identified. In particular it was not possible to perform a reliable risk assessment for the 
leaching of the metabolite NOPA to the groundw ater on the basis of the available data. 
. Moreover, the available data did not demons trate that the risks to aquatic organisms 
and fish eating birds and mammals are accep table. Consequently, it was not possible 
to conclude on the basis of the information available that napropamide 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 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 napropamide satisfy in general the requirements laid dow n in Article 5(1)(a) and (b) of Directive 
91/414/EEC. 
(7) Napropamide should therefore not be incl uded in Annex I to Directive 91/414/EEC. 
(8) Measures should be taken to ensure that au thorisations granted for plant protection 
products containing napropamide 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 napropramide 
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 
napropamide remain available to farmers for 18 months from th e adoption of this 
Decision. 
                                                 
4 EFSA Scientific Report (2008), 140, 1-72. Conclusion regarding the peer review of the pesticide risk 
assessment of the active substance napropamide finalised 26 March 2008. 5 (10) This Decision does not prejudice the submi ssion of an application for napropamide 
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
5, 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 
Napropamide shall not be included as active substance in Annex I to  Directive 91/414/EEC. 
Article 2 
Member States shall ensure that: 
(a) authorisations for plant protection produc ts containing napropamide are withdrawn by 
[INSERT DATE 6 MONTHS FROM TH E DATE OF ADOPTION OF THIS 
DECISION];  
(b) no authorisations for plant protection prod ucts containing napropamide 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 
 
P:\New Pesticide\Actives - S3 - 3rd Stage\Napropamide(271)\decision\napropramid decision rev 0.doc