COMMISSION DECISION  
of 30 November 2009  
concerning the non-inclusion of triazoxide in Annex I to Council Directive 91/414/EEC and the 
withdrawal of authorisations for plant protection products containing that substance  
(notified under document C(2009) 9271)  
(Text with EEA relevance)  
(2009/860/EC)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European 
Community,  
Having regard to Council Directive 91/414/EEC of 15 July 
1991 concerning the placing of plant protection products on 
the market (  1 ), and in particular the fourth subparagraph of 
Article 8(2) thereof,  
Whereas:  
(1) Article 8(2) of Directive 91/414/EEC provides 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 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 1490/2002 (  3 ) lay down the detailed rules for the 
implementation of the 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 inclusion in Annex I to 
Directive 91/414/EEC. That list includes triazoxide.  
(3) For triazoxide 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 
rapporteur 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.  (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 
30 September 2008 in the format of the EFSA 
conclusion regarding the peer review of the pesticide 
risk assessment of the active substance triazoxide (  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 
26 February 2009 in the format of the Commission 
review report for triazoxide.  
(5) During the evaluation of this active substance, a number 
of concerns have been identified. In particular it was not 
possible to perform a reliable consumer risk assessment 
as data are missing to determine the nature of residues in 
plant commodities and the possible transfer of residues 
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 possible 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 further support the substance. The 
notifier submitted its comments which have been 
carefully examined. However, despite the arguments put 
forward by the notifier, the concerns identified could not 
be eliminated, and assessments made on the basis of the 
information submitted and evaluated during the EFSA 
expert meetings have not demonstrated that it may be 
expected that, under the proposed conditions of use, 
plant protection 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 
granted for plant protection products containing 
triazoxide are withdrawn within a fixed period of time 
and are not renewed and that no new authorisations for 
such products are granted.EN 1.12.2009 Official Journal of the European Union L 314/81  
( 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.  ( 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).(9) Any period of grace granted by a Member State for the 
disposal, storage, placing on the market and use of 
existing stocks of plant protection products containing 
triazoxide should be limited to 12 months in order to 
allow existing stocks to be used in one further growing 
season, which ensures that plant protection products 
containing triazoxide remain available to farmers for 
18 months from the adoption of this Decision.  
(10) This Decision does not prejudice the submission of an 
application for triazoxide according to the provisions of 
Article 6(2) of Directive 91/414/EEC, the detailed imple ­
mentation rules of which have been laid down in 
Commission Regulation (EC) No 33/2008 of 
17 January 2008 laying down detailed rules for the 
application of Council Directive 91/414/EEC as regards 
a regular and an accelerated procedure for the assessment 
of active substances which were part of the programme 
of work referred to in Article 8(2) of that Directive but 
have not been included into its Annex I (  1 ), in view of a 
possible inclusion in its Annex I.  
(11) The Standing Committee on the Food Chain and Animal 
Health did not deliver an opinion on the measures 
provided for in this Decision within the time limit laid 
down by its Chairman and the Commission therefore 
submitted to the Council a proposal relating to these 
measures. Since, on the expiry of the period laid down 
in the second subparagraph of Article 19(2) of Directive 
91/414/EEC, the Council had neither adopted the 
proposed measures nor indicated its opposition to 
them, they should be adopted by the Commission,  HAS ADOPTED THIS DECISION:  
Article 1  
Triazoxide shall not be included as an active substance in 
Annex I to Directive 91/414/EEC.  
Article 2  
Member States shall ensure that:  
(a) authorisations for plant protection products containing 
triazoxide are withdrawn by 30 May 2010;  
(b) no authorisations for plant protection products containing 
triazoxide are granted or renewed from the date of publi ­
cation 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 30 May 
2011 at the latest.  
Article 4  
This Decision is addressed to the Member States.  
Done at Brussels, 30 November 2009.  
For the Commission  
Androulla VASSILIOU  
Member of the CommissionEN L 314/82 Official Journal of the European Union 1.12.2009  
( 1 ) OJ L 15, 18.1.2008, p. 5.