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 triazoxide 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) 
(Memorandum from Ms A. Vassiliou)  
EN 2   EN Proposal for a 
COMMISSION DECISION 
concerning the non-inclusion of triazoxide 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 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 triazoxide. 
(3) For triazoxide the effects on human health a nd 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 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 
triazoxide the rapporteur Member State was the United Kingdom and all relevant 
information was submitted on 25 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 the active substance triazoxide4. 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 triazoxide. 
(5) During the evaluation of this active substa nce, a number of concerns have been 
identified. In particular it was not possi ble to perform a relia ble consumer risk 
assessment as data are missing to determine th e nature of residues in plant commodities 
and the possible transfer of re sidues in animal products. Moreover, the available data did 
not demonstrate that the long term risk to mammals, birds, fish and earthworms are 
acceptable. Consequently, it was not possi ble to conclude on the basis of the 
information available that triazoxide 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 protec tion products containing triazoxide satisfy 
in general the requirements laid down in Article 5(1) (a) and (b) of Directive 
91/414/EEC. 
(7) Triazoxide 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 triazoxide are withdrawn within a fixe d period of time and are not 
renewed and that no new authorisations 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 plan t protection products containing triazoxide 
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 
triazoxide remain available to farmers for 18  months from the adoptio n of this Decision. 
(10) This Decision does not prejudice the submi ssion of an application for triazoxide 
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 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 
                                                
 
4 EFSA Scientific Report (2008), 193. Conclusion regarding the peer review of the pesticide risk 
assessment of the active substance triazoxide  finalised 26 September 2008. 
5 OJ L 15, 18.1.2008, p. 5–12.   
EN 4   EN 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 
Triazoxide shall not be included as an active substance in Annex I to  Directive 91/414/EEC.  
EN 5   EN Article 2 
Member States shall ensure that: 
(a) authorisations for plant protection products co ntaining triazoxide are withdrawn by 
[… INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS 
DECISION] ; 
(b) no authorisations for plant protection pr oducts containing triazo xide 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