Proposal for a Council Decision concerning the non-inclusion of paraffin oils CAS 64742-46-7, CAS 72623-86-0 and CAS 97862-82-3 in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing those substances (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

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.5.2009 
COM(2009) 246 final 

Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of paraffin oils CAS 64742-46-7, CAS 72623-86-0 and CAS 
97862-82-3 in Annex I to Council Directive 91/414/EEC and the withdrawal of 
authorisations for plant protection products containing those substances  

(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

The attached draft proposal for a Council Decision concerns the non inclusion of paraffin oils 
CAS 64742-46-7, CAS 72623-86-0 and CAS 97862-82-3 as active substances in the positive 
list  (Annex  I)  of  Council  Directive  91/414/EEC  and  the  withdrawal  of  plant  protection 
products containing those substances. The proposal for a non inclusion is based on a number 
of concerns identified during the evaluation of these active substances. 

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 oils CAS 64742-46-7, CAS 
72623-86-0 and CAS 97862-82-3 on 19 December 2008. 

During the evaluation of these active substances, 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: 

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21 Member States voted in favour (254 votes) 

3 Member States voted against (21 votes) 

3 Member States abstained (60 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). 

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Proposal for a 

COUNCIL DECISION 

concerning the non-inclusion of paraffin oils CAS 64742-46-7, CAS 72623-86-0 and CAS 
97862-82-3 in Annex I to Council Directive 91/414/EEC and the withdrawal of 
authorisations for plant protection products containing those substances  

(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 oils CAS 64742-46-7, CAS 72623-86-
0 and CAS 97862-82-3. 

For paraffin oils CAS 64742-46-7, CAS 72623-86-0 and CAS 97862-82-3 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  oils  CAS  64742-46-7, 
CAS 72623-86-0 and CAS 97862-82-3 the rapporteur Member State was Greece and all 
relevant information was submitted on 6 May 2008. 

(4) 

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 

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

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(5) 

(6) 

the  pesticide  risk  assessment  of  the  active  substances  paraffin  oils  CAS  64742-46-7, 
CAS 72623-86-0 and CAS 97862-82-34. 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 oils CAS 64742-46-7, CAS 72623-86-0 and CAS 97862-82-3.  

During  the  evaluation  of  these  active  substances,  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.  Moreover,  other 
concerns  which  were  identified  in  the  EFSA  conclusions  are  included  in  the  review 
report for these substances. Consequently, it was not possible to conclude, on the basis 
of the information made available, that paraffin oils CAS 64742-46-7, CAS 72623-86-0 
and  CAS  97862-82-3  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  substances.  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  oils  CAS  64742-46-7,  CAS  72623-86-0  and 
CAS 97862-82-3 satisfy in general the requirements laid down in Article 5(1)(a) and 
(b) of Directive 91/414/EEC. 

(7) 

Paraffin oils CAS 64742-46-7, CAS 72623-86-0 and CAS 97862-82-3 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  oils  CAS  64742-46-7,  CAS  72623-86-0  and  CAS  97862-
82-3 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 
oils  CAS  64742-46-7,  CAS  72623-86-0  and  CAS  97862-82-3  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  oils  CAS 
64742-46-7,  CAS  72623-86-0  and  CAS  97862-82-3  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  oils 
CAS  64742-46-7,  CAS  72623-86-0  and  CAS  97862-82-3  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) 

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EFSA  Scientific  Report  (2008)  216,  Conclusion  regarding  the  peer  review  of  the  pesticide  risk 
assessment of the active substances paraffin oils CAS 64742-46-7, CAS 72623-86-0 and CAS 97862-82-
3, finalised 19 December 2008. 

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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, 

HAS ADOPTED THIS DECISION: 

Paraffin oils CAS 64742-46-7, CAS 72623-86-0 and CAS 97862-82-3 shall not be included as 
active substances in Annex I to Directive 91/414/EEC. 

Article 1 

Member States shall ensure that: 

Article 2 

(a) 

(b) 

authorisations for plant protection products containing paraffin oils CAS 64742-46-7, 
CAS  72623-86-0  and  CAS  97862-82-3  are  withdrawn  by  […  INSERT  DATE 
6 MONTHS FROM THE DATE OF ADOPTION OF THIS DECISION]; 

no  authorisations  for  plant  protection  products  containing  paraffin  oils  CAS  64742-
46-7, CAS 72623-86-0 and CAS 97862-82-3 are granted or renewed from the date of 
publication of this Decision. 

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 3 

This Decision is addressed to the Member States. 

Done at Brussels, 

Article 4 

For the Council 
The President 

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OJ L 15, 18.1.2008, p. 5. 

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