EN    ENEN 
  
EN    ENBrussels, 
 
DRAFT 
COMMISSION DECISION ../…/EC 
of 
concerning the non-inclusion of diniconazole-M in Annex I to Council Directive 
91/414/EEC and the withdrawal of authoris ations for plant protection products 
containing that substance 
(Text with EEA relevance) 
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 market1, 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 th e 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 no tification, 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 the third stage of the programme of work referred to in Ar ticle 8(2) of Directive 91/414/EEC and 
establish a list of active substances to be  assessed with a view to their possible 
                                                
 
1  OJ L 230, 19.8.1991, p. 1. Directive as last amended by [ INSERT LAST AMENDMENT ]. 
2  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ 
L 151, 19.6.2003, p.32). 
3  OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regulation (EC) No 1095/2007 
(OJ L 246, 21.9.2007, p. 19).  
EN    ENinclusion in Annex I to Directive 91/ 414/EEC. That list includes diniconazole-
M. 
(3) For diniconazole-M 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 fo r a range of uses proposed by the 
notifier. Moreover, those Regulations de signate the rapporteur Member States 
which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (E FSA) in accordance with Article 8(1) 
of Regulation (EC) No 451/2000. For dini conazole-M the rapporteur Member 
State was France and all relevant information was submitted on 31 May 2007. 
(4) The Commission examined diniconazole-M in accordance with Article 11a of 
Regulation (EC) No 1490/2002. A draft revi ew report for that substance was 
reviewed by the Member States a nd the Commission within the Standing 
Committee on the Food Chain and Animal  Health and finalised on 20 May 
2008 in the format of the Commission review report. 
(5) During the examination of this active substance by the Committee, taking into 
account comments received from Member States, it was concluded that there 
are clear indications that it may be e xpected that it has harmful effects on 
human health and in particular on operators, because the exposure is greater than 100 % of the AOEL. Moreover, othe r 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 examination of diniconazole-M a nd 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 forwards by the 
notifier, the concerns identified coul d not be eliminated, and assessments 
made on the basis of the information s ubmitted have not demonstrated that it 
may be expected that, under the proposed conditions of use, plant protection products containing diniconazole-M satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. 
(7) Diniconazole-M should therefore not be  included in Annex I to Directive 
91/414/EEC. 
(8) Measures should be taken to ensure th at authorisations granted for plant 
protection products containing diniconazole-M are withdrawn within a fixed 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  State for the disposal, storage, 
placing on the market and use of existi ng stocks of plant protection products 
containing diniconazole-M 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 diniconazole-M remain available for 18 months from the adoption of this Decision.  
EN    EN(10) This Decision does not prejudice the submission of an application for 
diniconazole-M in accordance with Article 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 Directive 91/414/EEC as regards a 
regular and an accelerated procedure fo r 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
4, in view of a possible 
inclusion in its Annex I.  
(11) The measures provided for in this D ecision are in accordance with the opinion 
of the Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DECISION: 
Article 1 
Diniconazole-M 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 protecti on products containing diniconazole-M are 
withdrawn by [INSERT DATE 6 MONTHS FROM THE DATE OF 
ADOPTION OF THIS DECISION];  
(b)  no authorisations for plant protection products containing diniconazole-M 
are granted or renewed from the date of publication of this Decision. 
Article 3 
Any period of grace granted by Member Stat es 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    ENArticle 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla Vassiliou   
 Member of the Commission