EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
COM(2009) final 
Proposal for a 
COMMISSION DECISION 
concerning the non-inclusion of diphen ylamine 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) 
(Memorandum from Ms A. Vassiliou)  
EN 2   EN Proposal for a 
COUNCIL DECISION 
concerning the non-inclusion of diphen ylamine 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 to that Directive that 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 diphenylamine. 
(3) For diphenylamine the effects on human health and the envi ronment have been 
assessed in accordance with the provision s 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 ra pporteur 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 diphenylamine the rapporteur  Member State was Ireland and all 
relevant information was submitted on 20 June 2007. 
                                                
 
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 th e active substance diphenylamine4. 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 26 February 2009 in the format of the Commission review report for diphenylamine. 
(5) During the evaluation of this active substa nce, a number of concerns have been 
identified. In particular, it was not possibl e to perform a reliable consumer exposure 
assessment, as data are missin g on the presence and toxicity of unidentified metabolites 
of the substance, as well as on the possible formation of n itrosamines during storage of 
the active substance and during processing of treated apples. Moreover, no data was available on the potential breakdown or r eaction product of diphenylamine residues in 
processed commodities. Consequently, it was not possible to conclude on the basis of 
the information available that diphenylamine 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 pr otection products containing diphenylamine 
satisfy in general the requirements laid dow n in Article 5(1)(a) and (b) of Directive 
91/414/EEC. 
(7) Diphenylamine 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 diphenylamine are withdr awn within a fixed period of time and 
are not renewed and that no new authoris ations 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 diphenylamine 
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 
diphenylamine remain available to farmers for 18 months from the adoption of this 
Decision. 
(10) This Decision does not prejud ice the submission of an application for diphenylamine 
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. 
                                                 
4 EFSA Scientific Report (2008) 188, Conclusion on the peer review of diphenylamine, finalised 30 
September 2008.  
5 OJ L 15, 18.1.2008, p. 5–12.   
EN 4   EN (11) The Standing Committee on the Food Chain a nd Animal Health has not delivered an 
opinion within the time-limit laid down by its Chairman and the Commission therefore submitted to the Council a proposal relating to these measures. The Council concluded the proceeding neither adopting the propos ed implementing act nor indicated its 
opposition to the proposal for implementing m easures and it is accordingly for the 
Commission to adopt these measures, 
HAS ADOPTED THIS DECISION: 
Article 1 
Diphenylamine shall not be includ ed as active substance in A nnex I to Directive 91/414/EEC.  
EN 5   EN Article 2 
Member States shall ensure that: 
(a) authorisations for plant protection produc ts containing diphenylamine are withdrawn 
by [… INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS 
DECISION] ; 
(b) no authorisations for plant protection products containing diphenylamine 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 DATE 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