Proposal for a Council Decision concerning the non-inclusion of paraffin oil CAS 8042-47-5 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)
Date: 2009-05-25
Institutions: European Commission
Subjects: dangerous substance, environmental protection, health risk, market approval, marketing standard, pharmaceutical product, plant health product

EN 

EN 

   EN 

 
 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.5.2009 
COM(2009) 245 final 

Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of paraffin oil CAS 8042-47-5 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 

   EN 

 
 
 
  
 
 
EXPLANATORY MEMORANDUM 

The attached draft proposal for a Council Decision concerns the non inclusion of paraffin oil 
CAS  8042-47-5  as  active  substance  in  the  positive  list  (Annex  I)  of  Council  Directive 
91/414/EEC  and  the  withdrawal  of  plant  protection  products  containing  that  substance.  The 
proposal for a non inclusion is based on a number of concerns identified during the evaluation 
of this active substance. 

Council  Directive  91/414/EEC  creates  a  harmonised  framework  for  the  authorisation  and 
placing  on  the  market  of  plant  protection  products.  Active  substances  to  be  used  as  plant 
protection products are assessed and authorised at Community level and are listed in Annex I 
to  the  Directive.  Individual  plant  protection  products  containing  active  substances  are 
assessed and authorised by Member States under harmonised rules. 

The data submitted by industry have been initially evaluated by a rapporteur Member State, in 
this  case  Greece,  which  submitted  a  draft  assessment  report.  The  European  Food  Safety 
Authority  has  organised  a  peer  review  of  the  initial  evaluation  and  has  provided  the 
Commission  with  a  conclusion  of  the  risk  assessment  for  paraffin  oil  CAS  8042-47-5  on 
19 December 2008. 

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  have  been  identified.  In 
particular,  the  existing  evidence  is  not  sufficient  to  demonstrate  a  safe  use  with  respect  to 
operators, workers, bystanders and consumers.  

The  draft  decision  for  a  non  inclusion  was  submitted  on  12  March  2009  to  the  Standing 
Committee on the Food Chain and Animal Health, where: 

– 

– 

– 

18 Member States voted in favour (223 votes) 

5 Member States voted against (48 votes) 

4 Member States abstained (74 votes) 

The  Committee  delivered  no  opinion.  Consequently,  pursuant  to  article  19  of  Directive 
91/414/EEC  and  in  accordance  with  Article  5  of  Council  Decision  1999/468/EC  the 
Commission  is  required  to  submit  to  the  Council  a  proposal  relating  to  the  measures  to  be 
taken, the Council having three months in which to act by a qualified majority. 

The draft Decision is not subject to the right of scrutiny of the European Parliament (Article 8 
of Council Decision 1999/468/EC). 

EN 

2 

   EN 

 
Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of paraffin oil CAS 8042-47-5 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 COUNCIL OF THE EUROPEAN UNION, 

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) 

(2) 

(3) 

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. 

Commission Regulations (EC) No 1112/20022 and (EC) No 2229/20043 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 8042-47-5. 

For paraffin oil CAS 8042-47-5 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  Regulations  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 8042-47-5 the rapporteur Member State was Greece 
and all relevant information was submitted on 30 April 2008 and 7 May 2008. 

1 
2 
3 

OJ L 230, 19.8.1991, p. 1. 
OJ L 168, 27.6.2002, p. 14.  
OJ L 379, 24.12.2004, p. 13. 

EN 

3 

   EN 

 
                                                 
(4) 

(5) 

(6) 

The  assessment  report  has  been  peer  reviewed  by  the  Member  States  and  the  EFSA 
within  its  Working  Group  Evaluation  and  presented  to  the  Commission  on  19 
December 2008 in the format of the EFSA conclusion regarding the peer review of the 
pesticide  risk  assessment  of  the  active  substance  paraffin  oil  CAS  8042-47-54.  This 
report  has  been  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 for paraffin oil CAS 8042-47-5.  

During  the  evaluation  of  this  active  substance,  a  number  of  concerns  have  been 
identified. In particular, the existing evidence is not sufficient to demonstrate a safe use 
with  respect  to  operators,  workers,  bystanders  and  consumers.  Consequently,  it  was 
not possible to conclude, on the basis of the information made available, that paraffin 
oil CAS 8042-47-5 met the criteria for inclusion in Annex I to Directive 91/414/EEC. 

The Commission invited the notifier to submit its comments on the results of the peer 
review  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 forward 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  8042-47-5  satisfy  in  general  the 
requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. 

(7) 

Paraffin oil CAS 8042-47-5 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 8042-47-5 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  existing  stocks  of  plant  protection  products  containing  paraffin  oil 
CAS 8042-47-5 should be limited to twelve 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 8042-47-5 remain available to users for 18 months from the 
adoption of this Decision. 

(10)  This Decision does not prejudice the submission of an application for paraffin oil CAS 
8042-47-5 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 I5, in view of a possible inclusion in its Annex I. 

(11)  The Standing Committee on the Food Chain and Animal Health has not delivered an 

opinion within the time-limit laid down by its Chairman, 

4 

5 

EFSA  Scientific  Report  (2008)  219-220,  Conclusion  regarding  the  peer  review  of  the  pesticide  risk 
assessment of the active substance paraffin oil CAS 8042-47-5, finalised 19December 2008. 
OJ L 15, 18.1.2008, p. 5. 

EN 

4 

   EN 

 
                                                 
HAS ADOPTED THIS DECISION: 

Article 1 

Paraffin oil CAS 8042-47-5 shall not be included as active substance in Annex I to Directive 
91/414/EEC. 

Member States shall ensure that: 

Article 2 

(a) 

(b) 

authorisations for plant protection products containing paraffin oil CAS 8042-47-5 are 
withdrawn  by  […  INSERT  DATE  6  MONTHS  FROM  THE  DATE  OF  ADOPTION 
OF THIS DECISION]; 

no authorisations for plant protection products containing paraffin oil CAS 8042-47-5 
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 DATE 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 Council 
The President 

EN 

5 

   EN