EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2008) final 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of 2-Naphtyloxyacet ic acid 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)  
EN 2   EN Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of 2-Naphtyloxyacet ic acid 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 1112/2002
2 and (EC) No 2229/20043 lay down the 
detailed rules for the implementation of th e fourth 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 list includes 2-Naphtyloxyacetic acid. 
                                                 
1 OJ L 230, 19.8.1991, p. 1. 
2 OJ L 168, 27.6.2002, p. 14.  
3 OJ L 379, 24.12.2004, p. 13.  
EN 3   EN (3) For 2-Naphtyloxyacetic acid the effects on hum an health and the environment have 
been assessed in accordance with the provi sions laid down in Regulations (EC) No 
1112/2002 and (EC) No 2229/2004 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 and recommendations to the European Food Safety Authority (EFSA) in accordance wi th Article 20 of Regulation (EC) No 
2229/2004. For 2-Naphtyloxyacetic acid the Rap porteur Member State was France and 
all relevant information was submitted in October 2007. 
(4) The Commission examined 2-Naphtyloxyacetic acid in accordance with Article 24a of 
Regulation (EC) No 2229/2004. A draft review report for that substance was reviewed 
by the Member States and the Commissi on within the Standing Committee on the 
Food Chain and Animal Health and finalise d on 28 October 2008 in the format of the 
Commission review report. 
(5) During the examination of this active substance by the Committee, it was concluded, 
taking into account comments received from  Member States, that there are clear 
indications that it may be expected that it has harmful effects on human health and in 
particular the crucial missing data does not allow to set an ADI and such value is 
necessary to conduct the risk assessment. Moreover, other concerns which were 
identified by the rapporteur Member States in its assessment 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 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 forwards by the notifier, the concerns identified could not be 
eliminated, and assessments made on the ba sis of the information submitted have not 
demonstrated that it may be expected that , under the proposed condi tions of use, plant 
protection products containing 2-Naphtyloxy acetic acid satisfy in general the 
requirements laid down in Article 5(1 )(a) and (b) of Directive 91/414/EEC. 
(7) 2-Naphtyloxyacetic acid should therefore not  be included in Annex I to Directive 
91/414/EEC. 
(8) Measures should be taken to ensure that authorisations grante d for plant protection 
products containing 2-Naphtyloxyacetic acid ar e withdrawn within a fixed period of 
time and are not renewed and that no new au thorisations 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 2-
Naphtyloxyacetic acid 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 products containing 2-Naphtyloxyacetic acid remain available to farmers for 18 months from the adoption of this Decision. 
(10) This Decision does not prejudice the su bmission of an application for 2-
Naphtyloxyacetic acid in accordance with Ar ticle 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 Directiv e 91/414/EEC as regards a regular and an 
accelerated procedure for the a ssessment of active substances which were part of the  
EN 4   EN programme of work referred to  in Article 8(2) of that Directive but have not been 
included into its Annex I4, 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, 
HAS ADOPTED THIS DECISION: 
Article 1 
2-Naphtyloxyacetic acid 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 plan t protection products containi ng 2-Naphtyloxyacetic acid are 
withdrawn by [INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF 
THIS DECISION];  
(b) no authorisations for plant protection pr oducts containing 2-Na phtyloxyacetic acid 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. 
                                                 
4 OJ L 15, 18.1.2008, p. 5.  
EN 5   EN Article 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla Vassiliou  Member of the Commission