Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Austria of genetically modified maize (Zea mays L. line Bt 176) pursuant to Directive 2001/18/EC
Date: 2005-04-26
Institutions: European Commission
Subjects: Austria, genetically modified organism, maize, market approval, public health, seed

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.04.2005 
COM(2005) 169 final 

Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in Austria of genetically 
modified maize (Zea mays L. line Bt 176) 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  maize  (Zea  mays 
L. line  Bt  176),  it  has  been  decided  by  Commission  Decision  97/98/EC  of 
23 January 1997,  pursuant  to  Council  Directive  90/220/EEC,  that  consent  shall  be 
given for the placing on the market of the product. 

On  5  February  1997  the  French  authorities  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  Austrian  authorities 
informed  the  Commission  on  14  February  1997  of  their  decision  to  provisionally 
prohibit  the  use  and  sale  of  the  genetically  modified  maize  in  question  and  gave 
reasons therefore.  

The  Scientific  Committee  on  Food,  the  Scientific  Committee  for  Animal  Nutrition 
and  the  Scientific  Committee  for  Pesticides  considered  that  the  information 
submitted  by  Austria  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 their original opinions on this product.  

On 9 May 1997 the Austrian authorities submitted additional information concerning 
the likely rate of development of insect resistance to the Bt-toxin. 

The aspect of the environmental effects of the development of insect resistance to the 
Bt-maize  had  already  been  fully  considered  by  the  Scientific  Committee  for 
Pesticides.  

On  9  January  as  well  as  on  9  and  17  February  2004  Austria  submitted  to  the 
Commission  additional  information  in  support  of  its  national  measures  concerning 
maize line Bt 176. 

The  European  Food  Safety  Authority  considered  that  the  information  submitted  by 
Austria  did  not  constitute  new  scientific  evidence  which  would  invalidate  the 
environmental  risk  assessment  of  maize  line  Bt  176  and  therefore  would  justify  a 
prohibition of the use and sale of this product in Austria. 

10. 

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  Food,  the  Scientific  Committee  for  Animal 
Nutrition and the Scientific Committee for Pesticides 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  Austria  to  repeal  its  measures 
concerning maize line Bt 176. 

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 Austria of genetically 
modified maize (Zea mays L. line Bt 176) pursuant to Directive 2001/18/EC 

(Text with EEA relevance) 
(Only the German 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) 

By Commission Decision 97/98/EC of 23 January 1997 concerning the placing on the 
market of genetically modified maize (Zea mays L.) with the combined modification 
for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance 
to the herbicide glufosinate ammonium 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  5  February  1997  the  French  authorities  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. 

1 
2 
3 

OJ L 106, 17.4.2001, p. 1 
OJ L 31, 1.2.1997, p. 69 
OJ L 117, 8.5.1990, p. 15 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

On  14  February  1997  Austria  informed  the  Commission  of  its  decision  to 
provisionally  prohibit  the  use and  sale  of  the  genetically modified  maize  in  question 
action  and  gave  reasons  therefore  in  accordance  with  Article  16(1)  of  Directive 
90/220/EEC. 

The  Scientific  Committees  considered  that  the  information  submitted  by  Austria  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 
their original opinions on this product. 

On 9 May 1997 the Austrian authorities submitted additional information concerning 
the likely rate of development of insect-resistance to the Bt-toxin. 

The aspect of the environmental effects of the development of insect resistance to the 
Bt-maize had already been fully considered by the Scientific Committee for Pesticides.  

On  9  January  as  well  as  on  9  and  17  February  2004  Austria  submitted  to  the 
Commission  additional  information  in  support  of  its  national  measures  concerning 
maize line Bt 176. 

The  European  Food  Safety  Authority  considered  that  the  information  submitted  by 
Austria  did  not  constitute  new  scientific  evidence  which  would  invalidate  the 
environmental  risk  assessment  of  maize  line  Bt  176  and  therefore  would  justify  a 
prohibition of the use and sale of this product in Austria. 

(10)  Under the circumstances there is no reason to consider that the product constitutes a 

risk to human health or the environment. 

(11)  Austria should therefore repeal those measures. 

(12)  No opinion was delivered by the Committee established under Article 30 of Directive 
2001/18/  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  Austria  to  prohibit  the  use  and  sale  of  genetically  modified  maize 
authorised  for  placing  on  the  market  by  Decision  97/98/EC  are  not  justified  under  the 
provisions of Article 23 of Directive 2001/18/EC. 

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

Article 2 

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Article 3 

This Decision is addressed to the Republic of Austria. 

Done at Brussels, […] 2005. 

For the Council 
The President 

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