Proposal for a Council Decision concerning the provisional prohibition of the sale in Austria 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: Austria, genetically modified organism, maize, plant health product, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 02.06.1998 
COM(1998) 339  final 

Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the sale in 
Austria of genetically modified maize (ZeamaysL.) 
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 

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 February  1997 Austria  informed  the Commission  that  it had banned the 
sale of the Bt-maize in its territory with a Decree signed on  14 February. 

On  28  February  1997  the  arguments  of  the  Austrian  Authorities  which 
concerned  potential  adverse effects  for human  health  and  the environment from 
transfer  of the antibiotic  resistance  gene as well  as the possible development  of 
insect  resistance  to  Bt-toxin  were  submitted  to  the  three  relevant  Scientific 
Committees  which  had  originally  examined  the  dossier  with  the  following 
questions: 
a) 

Does  the  information  submitted  by  Austria  constitute  new  relevant 
the 
scientific  evidence  which  was  not 
Committees at the time their Opinions were delivered? 

into  account  by 

taken 

b)  Would this information  thus cause the Committees  to consider that  this 
product constitutes a risk to human health or the environment? 

The  three  Scientific  Committees  gave  their  Opinions  on  the  information 
submitted  on 21 March  1997 (SCF),  10 April  1997 (SCAN)  and  12 May  1997 
(SCP).  According  to  these  Opinions,  the  information  submitted  by  Austria 
does  not  constitute  new  evidence  which  would  occasion  a  review  of  the 
Opinions of the Scientific  Committees. 

e_ 

6. 

7. 

8. 

9^ 

10. 

As  a  consequence,  on  10  September  1997  the  Commission  adopted  a  draft 
Decision requesting Austria to repeal its national provision prohibiting the sale 
of the Bt-maize  in  its territory. 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 shall 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. 

3 

Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the sale in 
Austria 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) 

Is  Vj^o 

THE COUNCIL OF THE E U R O » ** UNION, 

Having regardto the Treaty eitablishmg the Europtan Coow»mity, 

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^, 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 Austria provisionally prohibited the sale of genetically modified  maize in question by 
a measure which entered into force on 14 February 1997; 

Whereas, on  17 February  1997 Austria informed the Commission and the other Member States 
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 Commission sought the opinions of the Scientific Committee for Animal Nutrition 
established  by  Commission  Decision  76/791/EEC(4),  of  the  Scientific  Committee  for  Food 
established  by  Commission  Decision  95/273/EEC(5),  and  of  the  Scientific  Committee  for 
Pesticides established by Commission Decision 78/436/EEC(6) on the information  submitted by 
Austria; 

Whereas the Scientific  Committees did not consider that the information  submitted by Austria 
constituted  new  relevant  scientific  evidence  which  was  not  taken  into  account  during  the 

(,) 
(2) 
<3) 
(4) 
(5) 
(6) 

OJN° LI 17, 8.5.1990, p.15. 
OJ N° L169,27.6.1997, p.72. 
OJN°L31,1.2.1997,p.69. 
OJN° L279, 9.10.1976, p.35. 
OJN°L167,18.7.1995, p.22. 
OJN°L124,12.5.1978, p.16 

original evaluation of the dossier and which would occasion a review of their original opinions 
on this product; 

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

Whereas 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; 

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

Whereas-the Austrian  measures 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, 

HAS ADOPTED THIS DECISION: 

Article 1 

Austria shall repeal at the latest 20 days after notification of this Decision its national provisions 
which  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 Austria. 

Article 2 

Done at Brussels, 

For the Council 

ISSN 0254-1475 

COM(98) 339  final 

DOCUMENTS 

EN 

15  03  14 

Catalogue number  :  CB-C0-98-347-EN-C 

ISBN 92-78-36553-X 

Office  for Official  Publications of the European Communities 

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i