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 
scientific evidence which was not taken into account by the 
Committees at the time their Opinions were delivered? 
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. 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. 
7. 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. 
8. 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. 
9^ 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. 
10. 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 EURO»** 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 
(,) OJN° LI 17, 8.5.1990, p.15. 
(2) OJ N° L169,27.6.1997, p.72. 
<3) OJN°L31,1.2.1997,p.69. 
(4) OJN° L279, 9.10.1976, p.35. 
(5) OJN°L167,18.7.1995, p.22. 
(6) 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. 
Article 2 
This Decision is addressed to Austria. 
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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