EN    EN EN 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of paraffin oil CAS 64742-54-7 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 paraffin oil CAS 64742-54-7 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 list incl udes paraffin oil CAS 64742-54-7. 
                                                 
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 paraffin oil CAS 64742-54-7 the effects on human health and the environment have 
been assessed in accordance with the provi sions laid down in Regulations (EC) No 
1112/2002 and (EC) No 2229/2004 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 21(3) of Regulation (EC) No 
2229/2004. For paraffin oil CAS 64742-54-7 th e Rapporteur Member State was Greece 
and all relevant information was submitted in April 2008. 
(4) The Commission examined paraffin oil CAS 64742-54-7 in accordance with Article 
24a of Regulation (EC) No 2229/2004. A draft review report for that substance was 
reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and fi nalised on 12 March 2009 in the format of 
the Commission review report. 
(5) During the examination of paraffin oil CAS 64742-54-7 by the Committee, it was 
concluded, taking into account comments recei ved from Member States, that there are 
clear indications that it has to be considered  that there are clear indications that it may 
be expected that that active substance ha s harmful effects on human health and in 
particular on consumers and operators becau se the existing evidence is not sufficient 
to allow the establishment of an ADI, ARfD and an AOEL.  
(6) The Commission invited the notifier to s ubmit its comments on the results of the 
examination of paraffin oil CAS 64742-54- 7 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 notifier, the concerns 
identified could not be eliminated, a nd 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 protec tion products containing paraffin oil CAS 
64742-54-7 satisfy in general the requirement s laid down in Article 5(1)(a) and (b) of 
Directive 91/414/EEC. 
(7) Paraffin oil CAS 64742-54-7 should therefore not be included in A nnex I to Directive 
91/414/EEC. 
(8) Measures should be taken to ensure that authorisations grante d for plant protection 
products containing paraffin oil CAS 64742-54- 7 are withdrawn within a fixed period 
of time and are not renewed and that no ne w authorisations for such products are 
granted.  
(9) Any period of grace granted by a Member St ate for the disposal, storage, placing on the 
market and use of existing stocks of plant protection products containing paraffin oil 
CAS 64742-54-7 should be limited to twelve months in order to allow existing stocks to 
be used in one further growing season, wh ich ensures that plant protection products 
containing paraffin oil CAS 64742-54-7 remain  available to users fo r 18 months from the 
adoption of this Decision. 
(10) This Decision does not prejud ice the submission of an application for paraffin oil CAS 
64742-54-7 in accordance with Article 6(2)  of Directive 91/414/EEC and Commission 
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 EN 4   EN 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 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 
Paraffin oil CAS 64742-54-7 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 plant protection products  containing paraffin oil CAS 64742-54-7 are 
withdrawn by [INSERT DATE 6 MONTHS FROM THE DATE OF ADOPTION OF 
THIS DECISION];  
(b) no authorisations for plant protection products  containing paraffin oil CAS 64742-54-7 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. 
                                                 
4 OJ L 15, 18.1.2008, p. 5. EN 5   EN Article 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla Vassiliou  Member of the Commission