EN    EN EN 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2008) final 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of antraquinone in Annex I to Council 
Directive 91/414/EEC and the withdrawal of authorisations for plant protection 
products containing that substance 
(Memorandum from Ms A. VASSILIOU) EN 2   EN Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of antraquinone 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 1112/2002
2 and (EC) No 2229/20043 lay down the 
detailed rules for the implementation of th e fourth 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 antraquinone. 
                                                 
1 OJ L 230, 19.8.1991, p. 1. 
2 OJ L 168, 27.6.2002, p. 14.  
3 OJ L 379, 24.12.2004, p. 13. EN 3   EN (3) For antraquinone the effects on human health and the environment have been assessed 
in accordance with the provisions laid dow n in Regulations (EC) No 1112/2002 and 
(EC) No 2229/2004 for a range of uses pr oposed by the notifier.  Moreover, those 
Regulations designate the Rapporteur Memb er States which have to submit the 
relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 20 of Regulat ion (EC) No 2229/2004. 
For antraquinone the Rapporteur Member State was Belgium and all relevant 
information was submitted in September 2006. 
(4) The Commission examined antraquinone in a ccordance with Article  24a of Regulation 
(EC) No 2229/2004. A draft review report fo r that substance was reviewed by the 
Member States and the Commission with in the Standing Committee on the Food 
Chain and Animal Health and finalised on 26 September 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 expected that it has harmful effects on human health and in 
particular the crucial missing data does not allow to set reliable acceptable daily intake 
(ADI), acute reference dose (ARfD) and acceptable operator exposure level (AOEL) 
and such values are necessary to conduc t the risk assessmen t. Moreover, other 
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 s ubmit its comments on the results of the 
examination of antraquinone and on its in tention 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 
could not be eliminated, and assessments  made on the basis of the information 
submitted have not demonstrated that it may be expected that, under the proposed 
conditions of use, plant prot ection products containing antr aquinone satisfy in general 
the requirements laid down in Article 5(1)(a) and (b) of Di rective 91/414/EEC. 
(7) Antraquinone 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 antraquinone  are withdrawn within a fi xed period of time and are 
not renewed and that no new authorisa tions 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 plant protection products containing 
antraquinone should be limited to 12 months in  order to allow exis ting stocks to be 
used in one further growing season, whic h ensures that plant protection products 
containing antraquinone remain available fo r 18 months from the adoption of this 
Decision. EN 4   EN (10) This Decision does not prejudi ce the submission of an appl ication for antraquinone in 
accordance with Article 6(2) of Direc tive 91/414/EEC and Commission Regulation 
(EC) No 33/2008 of 17 January 2008 laying dow n detailed rules for the application of 
Council Directive 91/414/EEC as regards a re gular and an accelerated procedure for 
the assessment of active substances whic h were part of the programme of work 
referred to in Article 8(2) of that Dir ective but have not been included into its 
Annex I4, 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 
Antraquinone 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 pr oducts containing antraquinone are withdrawn 
by [INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS 
DECISION];  
(b) no authorisations for plant protection products containing antraquinone 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 
                                                
 
4 OJ L 15, 18.1.2008, p. 5.