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

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.4.2005 
COM(2005) 167 final 

Proposal for a  

COUNCIL DECISION 

concerning the provisional restriction of the use and sale in Germany of genetically 
modified maize (Zea mays L. line Bt 176) pursuant to Directive 2001/18/EC 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

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  German  authorities 
informed the Commission on 28 February as well as on 2 March and 4 April 2000 of 
their  decision  to  provisionally  restrict  the  use  and  sale  of  the  genetically  modified 
maize in question and gave reasons therefore.  

The  Scientific  Committee  on  Plants  considered  that  the  information  submitted  by 
Germany  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  the  earlier  opinions  of  the  Scientific  Committee  on  Food,  the 
Scientific  Committee  for  Animal  Nutrition  and  the  Scientific  Committee  for 
Pesticides on this product. 

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. 

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

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. 

EN 

2 

   EN 

 
11. 

12. 

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. 

EN 

3 

   EN 

 
Proposal for a  

COUNCIL DECISION 

concerning the provisional restriction of the use and sale in Germany 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) 

(4) 

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 competent 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. 

On  28  February  as  well  as  on  2  March  and  4  April  2000  Germany  informed  the 
Commission of its decision to provisionally restrict the use and sale of the genetically 
modified  maize  in  question  and  gave  reasons  therefore  in  accordance  with  Article 
16(1) of Directive 90/220/EEC. 

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 

EN 

4 

   EN 

 
 
 
                                                 
(5) 

(6) 

(7) 

(8) 

The  Scientific  Committee  on  Plants  considered  that  the  information  submitted  by 
Germany 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 the earlier Scientific Committees’ opinions on this product.  

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

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. 

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

(9) 

Germany should therefore repeal its 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  Germany  to  restrict  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. 

Germany 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 Federal Republic of Germany. 

Done at Brussels, […] 2005. 

For the Council 
The President 

EN 

5 

   EN