Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Luxembourg 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
Date: 1998-06-02
Institutions: European Commission
Subjects: Luxembourg, genetically modified organism, maize, plant health product, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 02.06.1998 
COM(1998) 340  final 

Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in 
Luxembourg 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 

(presented by the Commission) 

EXPLANATORY  MEMORANDUM 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

In  accordance  with  Article  21  of  Directive  90/220/EEC,  the  Commission  adopted  a 
Decision on the placing on the market of genetically modified  maize notified  by Ciba-
Geigy  on  23  January  1997.  The  Decision  was  taken  following  the  opinions  of  the 
Scientific  Committee  for  Pesticides  (SCP),  the  Scientific  Committee  for  Animal 
Nutrition (SCAN) and the Scientific  Committee for Food (SCF). 

In  accordance  with  Article  13 of  the  Directive,  the  Competent  Authorities  of  France 
granted the necessary consent on 5 February  1997. 

On  17 March  1997 Luxembourg  informed  the Commission  that  it had banned  the use 
and sale of the Bt-maize  in its territory with a Decree signed on 7 February  1997. The 
arguments  forwarded  by Luxembourg  were in substance the same as those  submitted 
by the Austrian authorities on the same matter. 

Following  the  Opinion  of  the  Scientific  Committees  on  the  Austrian  case,  the 
Commission  adopted  a  draft  Decision  requesting  Luxembourg  to  repeal  its  national 
provision prohibiting the use and sale of the Bt-maize in its territory  on  10 September 
1997.  This  draft  measure  was  then  submitted  to  the  Regulatory  Committee  under 
Article 21 of the Directive. 

On  13  April  1998  the  Regulatory  Committee,  which  was  consulted  by  written 
procedure, failed  to deliver an opinion  on the Draft  Commission  Decision.  According 
to Article  21 of the  Directive, the Commission  must  therefore,  without  delay,  submit 
to the Council  a proposal  relating  to the  measures  to be  taken.  The Council  must  act 
by qualified  majority. 

The same Article stipulates that  if,  on the expiry of a period of three months  from  the 
date of the referral  to the Council, the latter has not acted, the proposed measures shall 
be adopted by the Commission. 

In  the  framework  of  the  adoption  of  its  Decision  on  the  placing  on  the  market,  the 
Commission  decided  on  18 December  1996  to  launch  a programme  for  monitoring 
insect resistance to Bt-maize. The Expert Group on monitoring insect resistance to Bt, 
established by the Competent  Authorities under Directive 90/220/EEC, has developed 
a  draft  monitoring  protocol  intended  to  be  applied  when  cultivation  of  Bt  plants 
commences  in  the  EC.  The  relevant  Scientific  Committees  are  fully  involved  in  the 
preparation of this monitoring programme. 

At  the  same  time  a  subgroup  of  the  Competent  Authorities  under  Directive 
90/220/EEC has been set up to assess the general issue of any potential  adverse  effects 
for  human  health  and  the  environment  on  the  transfer  of  antibiotic  resistance  genes 
from  plants to micro organisms. The relevant  Scientific  Committees  are fully  involved 
in this work. 

Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in 
Luxembourg 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 

(Presented by the Commission) 

U 

2  Ko 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having regard to Council Directive 90/220/EEC of 23 April  1990 on the deliberate release into 
the environment of genetically modified organisms(1), as last amended by Commission Directive 
97/35/EC(2), and in particular Article 16 (2) thereof; 

Having regard to the Proposal from the Commission, 

Whereas 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/EEC^  it  has  been 
decided that consent shall be given for the placing on the market of the product; 

Whereas on 5 February  1997 the French authorities granted such consent; 

Whereas  pursuant  to  Article  13  (5)  of  Directive  90/220/EEC,  the  product  may  be  used 
throughout the Community; 

Whereas  Luxembourg  provisionally  prohibited  the  use  and  sale  of  the  genetically  modified 
maize in question by a measure which entered into force on 7 February 1997; 

Whereas  on  17 March  1997, Luxembourg  informed  the Commission  of such action and  gave 
reasons for its decision relying on Article 16 (1) of Directive 90/220/EEC ; 

Whereas the Commission must take a decision on the matter pursuant to Article  16 (2) of that 
Directive; 

Whereas the reasons  given by Luxembourg  do not constitute new relevant  scientific  evidence 
which was not taken into account during the original evaluation of the dossier and which would 
occasion a review of the Commission Decision concerning this product; 

Whereas under the circumstances there  is no reason to consider that the product  constitutes a 
risk  to human health or the environment; 

Whereas the measures taken by Luxembourg must therefore be repealed; 

Whereas the Committee set up by Article 21  of Directive 90/220/EEC and consulted by written 
procedure on  16 March  1998 has not delivered an opinion on the measures laid down in a draft 
Commission decision, 

(1) 
(2) 
(3) 

OJN°L117, 8.5.1990, p.15. 
OJ N° L169, 27.6.1997, p.72. 
OJN°L31,1.2.1997, p.69. 

HAS ADOPTED THIS DECISION: 

Article 1 

Luxembourg  shall  repeal  at the  latest  20  days  after  notification  of  this  Decision  its  national 
provisions  which rely on Article  16 of Directive  90/220/EEC and prohibit  the placing  on the 
market of the genetically modified  maize covered by Commission Decision 97/98/EC to which 
the French authorities gave their consent on 5 February 1997. 

This Decision is addressed to Luxembourg. 

Article 2 

Done at Brussels, 

For the Council 

ISSN 0254-1475 

COM(98) 340  final 

DOCUMENTS 

EN 

15  03  14 

Catalogue number  :  CB-C0-98-348-EN-C 

ISBN 92-78-36564-5 

Office  for Official  Publications of the European Communities 

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