EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2009) final 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of chlorthal- dimethyl 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 chlorthal- dimethyl 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 list includes chlorthal-dimethyl. 
(3) For chlorthal-dimethyl the effects on huma n health and the environment 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 chlorthal-dimethyl the rapport eur Member State was Greece and all 
                                                
 
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 relevant information was submitted on 31 October 2006. An addendum was submitted 
on 3 April 2008. 
(4) The assessment report has been peer reviewed  by the Member States and the EFSA. In 
accordance with Article 11c of Regulat ion (EC) No 1490/2002 the peer review 
focused on the following points, the toxicit y, the relevance of the metabolite MPA and 
its possible leaching to groundwater. The E FSA presented it to the Commission on 
4 September 2008, re-issued on 26 November 2008, in the format of the EFSA conclusion regarding the focused peer review of the pesticide risk  assessment of the 
active substance chlorthal-dimethyl
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 12 June 2009 in the format of th e Commission review 
report for chlorthal-dimethyl. 
(5) During the evaluation of this active substa nce it was found that its metabolite MPA 
leaches to groundwater. On the basis of the information available, it cannot be 
concluded that it may be expected that th e plant protection products containing that 
active substance fulfil the conditions provided for in Article 5(1) of Directive 91/414/EEC, in particular as regards toxico logical significance of that metabolite. 
(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 protection products containing chlorthal-
dimethyl satisfy in general the requirement s laid down in Articl e 5(1)(a) and (b) of 
Directive 91/414/EEC. 
(7) Chlorthal-dimethyl 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 chlorthal- dimethyl are withdrawn with in a fixed period of time 
and are not renewed and that no new author isations for such products are granted. 
(9) Any period of grace granted by a Member Stat e for the disposal, storage, placing on the 
market and use of existing stocks of plan t protection products containing chlorthal-
dimethyl should be limited to twelve months in order to allow existing stocks to be used 
in one further growing season, which ensure s that plant protection products containing 
chlorthal-dimethyl remain available to farm ers for 18 months from the adoption of this 
Decision. 
(10) This Decision does not prejudice the submi ssion of an application for chlorthal-
dimethyl according to the provisions of Ar ticle 6 (2) of Directive 91/414/EEC, the 
detailed implementation rules of which have been laid down in Commission 
                                                
 
4 EFSA Scientific Report (2008), 156. Conclusion regarding the focused peer review of the pesticide risk 
assessment of the active substance chlorthal-dimethyl finalised 4 September 2008 and re-issued on 
26 November 2008.  
EN 4   EN Regulation (EC) No 33/2008 of 17 January 200 8 laying down deta iled rules for the 
application of Council Direct ive 91/414/EEC as regards a regular and an accelerated 
procedure for the assessment of active subs tances 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 I5, 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 
Chlorthal-dimethyl 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 chlorthal-dimethyl are 
withdrawn by [INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF 
THIS DECISION];  
(b) no authorisations for plant protection pr oducts containing chlo rthal-dimethyl 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. 
Article 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla VASSILIOU  Member of the Commission 
                                                
 
5 OJ L 15, 18.1.2008, p. 5–12.