COMMISSION DECISION  
of 17 August 2009  
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  
(notified under document C(2009) 6305)  
(Text with EEA relevance)  
(2009/617/EC)  
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 market (  1 ), 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 the 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 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 2229/2004 (  3 ) lay down the detailed rules for the 
implementation of the 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 inclusion in 
Annex I to Directive 91/414/EEC. That list includes 
paraffin oil CAS 64742-54-7.  
(3) For paraffin oil CAS 64742-54-7 the effects on human 
health and the environment have been assessed in 
accordance with the provisions laid down in Regulations 
(EC) No 1112/2002 and (EC) No 2229/2004 for a range 
of uses proposed by the notifier. Moreover, those Regu ­
lations designate the rapporteur 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 the 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 finalised 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 received from Member States, that there are 
clear indications that it may be expected that the active 
substance has harmful effects on human health and in 
particular on consumers and operators because the 
existing evidence is not sufficient to allow the estab ­
lishment of an ADI, ARfD and an AOEL.  
(6) The Commission invited the notifier to submit 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, 
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 protection products containing paraffin oil 
CAS 64742-54-7 satisfy in general the requirements 
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 Annex I to Directive 91/414/EEC.  
(8) Measures should be taken to ensure that authorisations 
granted 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 new authori ­
sations 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 
existing stocks of plant protection products containing 
paraffin oil CAS 64742-54-7 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 paraffin oil 
CAS 64742-54-7 remain available to users for 18 
months from the adoption of this Decision.EN L 213/28 Official Journal of the European Union 18.8.2009  
( 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.(10) This Decision does not prejudice 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 2008 laying down detailed rules for the 
application of Council Directive 91/414/EEC as regards 
a regular and an accelerated procedure for 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 (  1 ), in view of a 
possible inclusion 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 
17 February 2010;  
(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 17 February 
2011 at the latest.  
Article 4  
This Decision is addressed to the Member States.  
Done at Brussels, 17 August 2009.  
For the Commission  
Androulla VASSILIOU  
Member of the CommissionEN 18.8.2009 Official Journal of the European Union L 213/29  
( 1 ) OJ L 15, 18.1.2008, p. 5.