Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Greece of genetically modified spring swede rape (Brassica napus L. ssp. oleifera) derived from transformation event Topas 19/2, pursuant to Directive 2001/18/EC
Date: 2005-04-26
Institutions: European Commission
Subjects: Greece, cereal product, genetically modified organism, market approval, oil seed rape

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.4.2005 
COM(2005) 164 final 

Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in Greece of genetically 
modified spring swede rape (Brassica napus L. ssp. oleifera) derived from 
transformation event Topas 19/2, pursuant to Directive 2001/18/EC 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

Concerning  the  placing  on  the  market  of  genetically  modified  spring  swede  rape 
(Brassica  napus  L.  ssp.  oleifera)  derived  from  transformation  event  Topas  19/2,  it 
has been decided by Commission Decision 98/291/EC of 22 April 1998, pursuant to 
Council  Directive  90/220/EEC,  that  consent  shall  be  given  for  the  placing  on  the 
market of the product. 

On  9  June  1998  the  authorities  of  the  United  Kingdom  granted  consent  for  the 
placing on the market of that product. 

Pursuant  to  Article  35(1)  of  Directive  2001/18/EC  which  replaced  Directive 
90/220/EEC  procedures  in  respect  of  notifications  concerning  the  placing  on  the 
market  of  genetically  modified  organisms  which  have  not  been  completed  by  
17 October 2002 are subject to the provisions of Directive 2001/18/EC. 

In  accordance  with  Article  16  of  Directive  90/220/EEC,  the  Greek  authorities 
informed  the  Commission  on  3  November  1998  of  their  decision  to  provisionally 
prohibit  the  use  and  sale  of  the  genetically  modified  spring  swede  rape  in  question 
and gave reasons therefore. 

The  Scientific  Committee  on  Plants  considered  that  the  information  submitted  by 
Greece did not constitute new relevant scientific evidence which had not been taken 
into account during the original evaluation of the dossier and which would occasion a 
review of its original opinion on this product. 

On  5  March  2004  Greece  submitted  to  the  Commission  additional  information  in 
support  of  its  national  measures  concerning  spring  swede  rape  derived  from 
transformation event Topas 19/2. 

The  European  Food  Safety  Authority  considered  that  the  information  submitted  by 
Greece  did  not  constitute  new  scientific  evidence  which  would  invalidate  the 
environmental  risk  assessment  of  spring  swede  rape  derived  from  transformation 
event Topas 19/2 and therefore would justify a prohibition of the use and sale of this 
product in Greece. 

Under  such  circumstances  Article  23  of  Directive  2001/18/EC  requires  the 
Commission  to  take  a  decision  in  accordance  with  the  procedures  laid  down  in 
Article  30(2)  of  the  Directive  to  which  Articles  5  and  7  of  Decision  1999/468/EC 
shall apply, having regard to the provisions of Article 8 thereof. 

Since both the Scientific Committee on Plants as well as the EFSA considered that 
the  product  did  not  constitute  a  risk  to  human  health  or  the  environment  the 
Commission  prepared  a  draft  Decision  asking  Greece  to  repeal  its  measures 
concerning spring swede rape derived from transformation event Topas 19/2. 

10. 

The  draft  Decision  was  submitted,  in  accordance  with  Article  5(2)  of  Decision 
1999/468/EC,  for  opinion,  to  the  Committee  set  up  under  Article  30  of  Directive 
2001/18/EC. 

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11. 

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No  opinion  was  delivered  by  the  Committee,  following  its  consultation,  on  
29 November 2004, which requires that, the Commission, in accordance with Article 
5(4) of Decision 1999/468/EC, shall, without delay, submit to the Council a proposal 
relating to the measures to be taken and shall inform the European Parliament. 

Article  5(6)  of  Decision  1999/468/EC  provides  that  the  Council  may,  where 
appropriate in view of any such position, act by qualified majority within a period set 
at three months in accordance with Article 30(2) of Directive 2001/18/EC. If within 
that  three-month  period,  the  Council  has  indicated  by  qualified  majority  that  it 
opposes the proposal, the Commission shall re-examine it; whereas if, on expiry of 
that  period  the  Council  has  neither  adopted  the  proposed  implementing  act  nor 
indicated its opposition, then the proposed implementing act shall be adopted by the 
Commission. 

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Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in Greece of genetically 
modified spring swede rape (Brassica napus L. ssp. oleifera) derived from 
transformation event Topas 19/2, pursuant to Directive 2001/18/EC 

(Text with EEA relevance) 
(Only the Greek text is authentic) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  
12  March  2001  on  the  deliberate  release  into  the  environment  of  genetically  modified 
organisms  and  repealing  Council  Directive  90/220/EEC1,  and  in  particular  Article  23(2) 
thereof, 

Having regard to the proposal from the Commission2, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

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2 
3 
4 

By Commission Decision 98/291/EC of 22 April 1998 concerning the placing on the 
market  of  genetically  modified  spring  swede  rape  (Brassica  napus  L.  ssp.  oleifera), 
pursuant  to  Council  Directive  90/220/EEC3  it  has  been  decided  that  consent  shall  be 
given for the placing on the market of the product. 

On 9 June 1998 the competent authorities of the United Kingdom granted consent for 
the placing on the market of that product. 

Pursuant  to  Article  35(1)  of  Directive  2001/18/EC  which  replaced  Directive 
90/220/EEC4  procedures  in  respect  of  notifications  concerning  the  placing  on  the 
market  of  genetically  modified  organisms  which  have  not  been  completed  by  
17 October 2002 are subject to the provisions of Directive 2001/18/EC. 

On 3 November 1998 Greece informed the Commission of its decision to provisionally 
prohibit the use and sale of the genetically modified spring swede rape in question and 
gave reasons therefore in accordance with Article 16(1) of Directive 90/220/EEC. 

The  Scientific  Committee  on  Plants  considered  that  the  information  submitted  by 
Greece did not constitute new relevant scientific evidence which had not been taken 

OJ L 106, 17.4.2001, p. 1. 
OJ C […], […], p. […]. 
OJ L 131, 5.5.1998, p. 26. 
OJ L 117, 8.5.1990, p. 15. 

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(6) 

(7) 

into account during the original evaluation of the dossier and which would occasion 
a review of its original opinion on this product. 

On  5  March  2004  Greece  submitted  to  the  Commission  additional  information  in 
support  of  its  national  measures  concerning  spring  swede  rape  derived  from 
transformation event Topas 19/2. 

The  European  Food  Safety  Authority  considered  that  the  information  submitted  by 
Greece  did  not  constitute  new  scientific  evidence  which  would  invalidate  the 
environmental  risk  assessment  of  spring  swede  rape  derived  from  transformation 
event  Topas  19/2  and  therefore  would  justify  a  prohibition  of  the  use  and  sale  of 
this product in Greece. 

(8) 

Under  the  circumstances there is  no  reason to consider that the product constitutes a 
risk to human health or the environment. 

(9) 

Greece should therefore repeal those measures. 

(10)  No opinion was delivered by the Committee established under Article 30 of Directive 
2001/18/EC on the measures laid down in a draft Commission Decision, following the 
Committee’s  consultation,  on  29  November  2004,  in  accordance  with  the  procedure 
laid down in Article 30(2) of that Directive, 

HAS ADOPTED THIS DECISION: 

Article 1 

The  measures  taken  by  Greece  to  prohibit  the  use  and  sale  of  genetically  modified  spring 
swede rape authorised for placing on the market by  Decision  98/291/EC  are  not  justified 
under the provisions of Article 23 of Directive 2001/18/EC. 

Greece shall take the necessary steps to comply with this Decision at the latest 20 days after 
its notification. 

Article 2 

Article 3 

This Decision is addressed to the Hellenic Republic. 

Done at Brussels, 

For the Council 
The President 

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