EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2008) final 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of bone oil in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for pl ant protection products containing that 
substance 
(Memorandum from Ms A. VASSILIOU)  
EN 2   EN Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of bone oil 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 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 list includes bone oil. 
                                                 
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 bone oil acid 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 bone oil the Rapporteur Member State wa s Belgium and all relevant information 
was submitted in October 2006. 
(4) The Commission examined bone oil in accordance 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) and acute reference dose (ARfD) and such values are necessary to conduct the 
risk assessment. In addition, the operato r exposure is greater  than 100% of the 
acceptable operator exposure level (AOEL) in all modelled scenarios. 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 bone oil 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 forwards by the notif ier, the concerns identified could not be 
eliminated, and assessments made on the ba sis of the information submitted have not 
demonstrated that it may be expected that , under the proposed condi tions of use, plant 
protection products containing bone oil satisfy  in general the requirements laid down 
in Article 5(1)(a) and (b) of Directive 91/414/EEC. 
(7) Bone oil 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 bone oil ar e 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 Stat e for the disposal, storage, placing on 
the market and use of existing stocks of plant protection produc ts containing bone oil 
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 pr oducts containing bone 
oil remain available for 18 months from the adoption of this Decision.  
EN 4   EN (10) This Decision does not prejudice the submi ssion of an application for bone oil 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 
Bone oil 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 bone oil are withdrawn by 
[INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS 
DECISION];  
(b) no authorisations for plant protection products containing bone oil 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.