Proposal for a Council Decision concerning the provisional prohibition of the use and sale in France of genetically modified hybrid swede rape (Brassica napus L. ssp. oleifera Metzg. MS1Bn x RF1Bn) pursuant to Directive 2001/18/EC
Date: 2005-04-26
Institutions: European Commission
Subjects: France, genetically modified organism, market approval, oil seed rape, public health, seed

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.4.2005 
COM(2005) 162 final 

Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in France of genetically 
modified hybrid swede rape (Brassica napus L. ssp. oleifera Metzg.  
MS1Bn x RF1Bn) 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  hybrid  swede  rape 
(Brassica  napus  L.  ssp.  oleifera  Metzg.  MS1Bn  x  RF1Bn),  it  has  been  decided  by 
Commission Decision 96/158/EC of 6 February 1996, pursuant to Council Directive 
90/220/EEC, that consent shall be given for the placing on the market of the product. 

On 28 February 1996 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  French  authorities 
informed  the  Commission  on  20  November  1998  of  their  decision  to  provisionally 
prohibit the use and sale of the genetically modified hybrid swede rape in question 
for two years and gave reasons therefore. This measure has been renewed on 26 July 
2001. 

The  Scientific  Committee  on  Plants  considered  that  the  information  submitted  by 
France did not constitute new relevant scientific evidence to indicate that the placing 
on the market of the product would cause adverse effects on human health and the 
environment. 

On  6  October  2003  and  27  August  2004  France  informed  the  Commission  of  its 
decision to renew the above mentioned prohibition measure for one year and until 17 
October  2006  respectively  and  of  reasons  therefore  with  reference  to  Article  23  of 
Directive 2001/18/EC. 

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  having  direct  implications  on  the  scientific 
assessment of the current national measures taken by France with respect to hybrid 
swede rape MS1Bn x RF1Bn. 

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. 

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. 

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Since the Scientific Committee on Plants with respect to hybrid swede rape MS1Bn x 
RF1Bn as well as both the Scientific Committee on Plants and the EFSA with respect 
to spring swede rape Topas 19/2 considered that the products did not constitute a risk 
to  human  health  or  the  environment  and  since  the  assessment  of  the  spring  swede 

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rape  has  direct  implications  on  the  assessment  of  the  hybrid  swede  rape,  the 
Commission  prepared  a  draft  Decision  asking  France  to  repeal  its  measures 
concerning hybrid swede rape MS1Bn x RF1Bn. 

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. 

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 France of genetically 
modified hybrid swede rape (Brassica napus L. ssp. oleifera Metzg.  
MS1Bn x RF1Bn) pursuant to Directive 2001/18/EC 

(Text with EEA relevance) 
(Only the French 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 Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

By  Commission  Decision  96/158/EC  of  6  February  1996  concerning  the  placing  on 
the  market  of  a  product  consisting  of  a  genetically  modified  organism,  hybrid 
herbicide-tolerant  swede  rape  seeds  (Brassica  napus  L.  oleifera  Metzg.  MS1Bn  x 
RF1Bn), pursuant to Council Directive 90/220/EEC2 it has been decided that consent 
shall be given for the placing on the market of the product. 

On  28  February  1996  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/EEC3  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  20  November  1998  France  informed  the  Commission  of  its  decision  to 
provisionally prohibit the use and sale of the genetically modified hybrid swede rape 
in question for two years and gave reasons therefore in accordance with Article 16(1) 
of Directive 90/220/EEC. This measure has been renewed on 26 July 2001. 

(5) 

The  Scientific  Committee  on  Plants  considered  that  the  information  submitted  by 
France did not constitute new relevant scientific evidence to indicate that the placing 

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OJ L 106, 17.4.2001, p. 1 
OJ L 37, 15.2.1996, p. 30 
OJ L 117, 8.5.1990, p. 15 

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on  the  market  of  the  product  would  cause  adverse  effects  on  human  health  and  the 
environment. 

(6) 

(7) 

(8) 

On  6  October  2003  and  27  August  2004  France  informed  the  Commission  of  its 
decision to renew the above mentioned prohibition measure for one year and until 17 
October 2006 respectively4,5 and of reasons therefore with reference to Article 23 of 
Directive 2001/18/EC. 

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  having  direct  implications  on  the  scientific 
assessment of the current national measures taken by France. 

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. 

(9) 

Under the circumstances there is no reason to consider that the product hybrid swede 
rape MS1Bn x RF1Bn constitutes a risk to human health or the environment. 

(10)  France should therefore repeal its measures. 

(11)  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  France  to  prohibit  the  use  and  sale  of  genetically  modified  hybrid 
swede  rape  authorized  for  placing  on  the  market  by  Decision  96/158/EC  are  not  justified 
under the provisions of Article 23 of Directive 2001/18/EC. 

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

Article 2 

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Arrêté du 25 juillet 2003 portant suspension de la mise sur le marché de colza génétiquement modifié 
au  titre  de  l'article  23  de  la  directive  2001/18/CE,  J.O.  de  la  République  française  n°  187  du  14  août 
2003, p. 14061 
Arrêté du 19 juillet 2004 portant suspension de la mise sur le marché de colza génétiquement modifié 
au  titre  de  l'article  23  de  la  directive  2001/18/CE,  J.O.  de  la  République  française  n°  194  du  21  août 
2004, p. 28 

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Article 3 

This Decision is addressed to the French Republic. 

Done at Brussels, […] 2005. 

For the Council 
The President 

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