Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Austria of genetically modified maize (Zea mays L. line T25) pursuant to Directive 2001/18/EC of the European Parliament and of the Council (Only the German text is authentic)
Date: 2006-10-09
Institutions: European Commission
Subjects: Austria, genetically modified organism, maize, market approval, marketing restriction

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 9.10.2006 
COM(2006) 510 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 T25) pursuant to Directive 2001/18/EC of the 
European Parliament and of the Council 

(Only the German text is authentic) 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

1 
2 

3 

EXPLANATORY MEMORANDUM 

A genetically modified variety of Zea mays L. line T25 was authorised for its placing 
on  the  market  pursuant  to  Commission  Decisions  under  Part  C  of  Directive 
90/220/EEC and the French authorities granted consent for the placing on the market 
of this genetically modified organisms (GMO). 

In  accordance  with  Article  16  of  Directive  90/220/EEC  concerning  safeguard 
measures,  Austria  subsequently  informed  the  Commission  of  its  decision  to 
provisionally prohibit or restrict the placing on the market of Zea mays L. line T25 
and provided its reasons for this decision. 

The Scientific Committee on Plants was consulted and concluded in its opinions that 
the  information  submitted  by  Austria  did  not  constitute  new  relevant  scientific 
evidence that had not been taken into account during the original risk assessments for 
those GMOs and which would necessitate a review of its original scientific opinion 
concerning the safety of Zea mays L. line T25. 

Directive  90/220/EEC  was  repealed  by  Directive  2001/18/EC  of  the  European 
Parliament  and  of  the  Council  on  the  deliberate  release  into  the  environment  of 
genetically modified organisms1. 

In  January  2004,  the  Commission  requested  Austria  to  re-consider  its  safeguard 
clause  in  light  of  the  new  regulatory  framework  and  if  appropriate,  to  re-notify  it 
under Directive 2001/18/EC. 

In  accordance  with  Article  23  of  Directive  2001/18/EC,  Austria  submitted  to  the 
Commission further additional information in support of its existing safeguard clause 
measure. 

Article  23  of  Directive  2001/18/EC  requires  the  Commission  to  take  decisions  in 
accordance  with  the  procedures  laid  down  in  Article  30(2)  of  the  Directive  which 
refers to Decision 1999/468/EC. 

In accordance with Article 28(1) of Directive 2001/18/EC, the European Food Safety 
Authority (EFSA) was consulted, as established by Regulation (EC) No 178/2002 of 
the  European  Parliament  and  of  the  Council2,  under  which  it  has  replaced  the 
relevant scientific committees and concluded, in its opinion of 8 July 20043, that the 
information  submitted  by  Austria  did  not  constitute  new  scientific  evidence  which 
would  invalidate  the  environmental  risk  assessment  of  Zea  mays  L.  line  T25  and 
would justify a prohibition of this GMO in Austria. 

A  draft  Commission  Decision  requesting  Austria  to  repeal  its  national  safeguard 
clause  was  therefore  submitted  for  opinion,  under  Article  5(2)  of  Council  Decision 

OJ L 106, 17.4.2001, p. 1 
OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ 
L 100, 8.4.2006, p.3). 
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission 
related to the Austrian invoke of Article 23 of Directive 2001/18/EC, The EFSA Journal (2004) 78, 1-
13. 

EN 

2 

   EN 

 
                                                 
10. 

11. 

12. 

13. 

14. 

15. 

16. 

4 

1999/468/EC,  to  the  Committee  established  under  Article  30  of  Directive 
2001/18/EC. 

The Committee was consulted on 29 November 2004 but delivered no opinion on the 
safeguard clause measure which requires that the Commission, under Article 5(4) of 
Council Decision 1999/468/EC, shall, without delay, submit to the Council proposals 
relating to the measures to be taken and shall inform the European Parliament. 

In accordance with Article 5(6) of Council Decision 1999/468/EC, the Environment 
Council,  on  24  June  2005,  indicated  its  opposition  by  qualified  majority,  to  the 
proposal requesting Austria to repeal its safeguard measure, which requires that the 
Commission re-examines its proposals. 

The  Council,  in  its  declaration,  stated  that  'there  is  still  a  degree  of  uncertainty  in 
relation  to  the  national  safeguard  measures  on  the  market  of  [the]  genetically 
modified  maize  variet[y]  T25'  and  called  on  the  Commission  'to  gather  further 
evidence on the GMO in question and further assess, whether the measure taken by 
[Austria] aimed at suspending as a temporary precautionary measure [its] placing on 
the  market  [is]  justified  and,  whether  the  authorisation  of  such  [an]  organism  still 
meets the safety requirements of Directive 2001/18/EC'. 

In November 2005, the EFSA was consulted as to whether there was any scientific 
reason to believe that the continued placing on the market of Zea mays L. line T25 
was likely to cause any adverse effects to human health or the environment under the 
conditions of consent and in particular, was requested to take account of any further 
scientific  information  that  has  arisen  subsequent  to  the  previous  scientific  opinion 
that assessed the safety of this GMO. 

In its opinion of 29 March 2006 (published on 11 April 2006)4, the EFSA, following 
investigation  of  the  evidence  presented  in  the  Austrian  submission,  considered  that 
the scientific evidence currently available does not sustain the arguments provided by 
Austria and concluded that there is no reason to believe that the continued placing on 
the market of Zea mays L. line T25 is likely to cause any adverse effects for human 
and animal health or the environment under the conditions of its consent. 

In accordance with Article 5(6) of Council Decision 1999/468/EC, the Commission 
may therefore submit an amended proposal to the Council, re-submit its proposals or 
present a legislative proposal on the basis of the Treaty 

After  having  taken  into  account  the  Council  declaration  of  24  June  2005  and  re-
consulted  the  EFSA,  it  appears  that,  for  the  third  time,  the  scientific  assessment  of 
Zea  mays  L.  line  T25  confirms  that  this  product  is  unlikely  to  cause  any  adverse 
effects for human and animal health or the environment. Therefore, the Commission 
considers that the proposal should not be amended and re-submits its proposal to the 
Council in accordance with Article 5(6) of Council Decision 1999/468/EC. 

Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission 
related  to  genetically  modified  crops  (Bt176  maize,  MON810  maize,  T25  maize,  Topas  19/2  oilseed 
rape  and  Ms1xRf1  oilseed  rape)  subject  to  safeguard  clauses  invoked  according  to  Article  16  of 
Directive 90/220/EEC, The EFSA Journal (2006) 338, 1-15.  

EN 

3 

   EN 

 
                                                 
Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in Austria of genetically 
modified maize (Zea mays L. line T25) pursuant to Directive 2001/18/EC of the 
European Parliament and of the Council 

(Only the German text is authentic) 

(Text with EEA relevance) 

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/EEC5, and in particular Article 23(2) thereof, 

Having regard to the proposal from the Commission,  

Whereas: 

(1) 

By Commission Decision 98/293/EC of 22 April 1998 concerning the placing on the 
market  of  genetically  modified  maize  (Zea  mays  L.  T25),  pursuant  to  Council 
Directive 90/220/EEC6, it was decided that consent was to be given for the placing on 
the market of that product. 

(2) 

On 3 August 1998 the French authorities granted such consent.  

(3) 

(4) 

(5) 

Pursuant  to  Article  35(1)  of  Directive  2001/18/EC  which  replaced  Directive 
90/220/EEC7,  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 Directive 2001/18/EC. 

On  8  May  2000  Austria  informed  the  Commission  of  its  decision  to  prohibit 
provisionally the use and sale of Zea mays L. T25 and gave reasons for that decision in 
accordance with Article 16(1) of Directive 90/220/EEC.  

The  Scientific  Committee  on  Plants  concluded  on  20  July  2001  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 that Committee’s original opinion on this product. 

5 
6 
7 

OJ L 106, 17.4.2001, p. 1 
OJ L 131, 5.5.1998, p. 30 
OJ L 117, 8.5.1990, p. 15 

EN 

4 

   EN 

 
 
                                                 
(6) 

(7) 

(8) 

(9) 

On  9  January  2004,  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 T25. 

In accordance with Article 28(1) of Directive 2001/18/EC, the Commission consulted 
the  European  Food  Safety  Authority  (EFSA),  as  established  by  Regulation  (EC) 
No 178/2002  of  the  European  Parliament  and  of  the  Council8,  under  which  it  has 
replaced the relevant scientific committees.  

The  EFSA  concluded  on  8  July  20049  that  the  information  submitted  by  Austria  did 
not  constitute  new  scientific  evidence  sufficient  to  invalidate  the  environmental  risk 
assessment  of  maize  line  T25,  justifying  a  prohibition  of  the  use  and  sale  of  that 
product in Austria. 

Since,  under  the  circumstances,  there  was  no  reason  to  consider  that  the  product 
constituted a risk to human health or the environment, the Commission submitted on 
29  November  2004  a  draft  Decision,  requesting  Austria  to  repeal  its  provisional 
safeguard measures, for consideration by the Committee established under Article 30 
of Directive 2001/18/EC, in accordance with the procedure laid down in Article 30(2) 
of that Directive. 

(10)  However, that Committee did not deliver an opinion and, in accordance with Article 
5(4)  of  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the  procedures 
for  the  exercise  of  implementing  powers  conferred  on  the  Commission10,  the 
Commission submitted to the Council a proposal relating to the measures to be taken.  

(11)  On  24  June  2005,  in  accordance  with  Article  5(6)  of  Decision  1999/468/EC,  the 

Council, acting by qualified majority, rejected that proposal. 

(12)  The  Council,  in  its  declaration,  stated  that  'there  is  still  a  degree  of  uncertainty  in 
relation to the national safeguard measures on the market of [the] genetically modified 
maize variet[y] T25' and called on the Commission 'to gather further evidence on the 
GMO in question and further assess, whether the measure taken by [Austria] aimed at 
suspending  as  a  temporary  precautionary  measure  [its]  placing  on  the  market  [is] 
justified  and,  whether  the  authorisation  of  such  [an]  organism  still  meets  the  safety 
requirements of Directive 2001/18/EC'. 

(13) 

In November 2005, the EFSA was consulted again, inter alia on the question whether 
there was any scientific reason to believe that the continued placing on the market of 
T25 maize was likely to cause any adverse effects to human health or the environment 
under  the  conditions  of  consent11.  In  particular,  the  EFSA  was  requested  to  take 

8 

9 

10 
11 

OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ 
L 100, 8.4.2006, p.3). 
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission 
related to the Austrian invoke of Article 23 of Directive 2001/18/EC, The EFSA Journal (2004) 78, 1-
13. 
OJ L 184, 17.7. 1999, p. 23. 
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission 
related  to  genetically  modified  crops  (Bt176  maize,  MON810  maize,  T25  maize,  Topas  19/2  oilseed 
rape  and  Ms1xRf1  oilseed  rape)  subject  to  safeguard  clauses  invoked  according  to  Article  16  of 
Directive 90/220/EEC, The EFSA Journal (2006) 338, 1-15.  

EN 

5 

   EN 

 
                                                 
account of any further scientific information that had arisen subsequent to the previous 
scientific opinion concerning the safety of that GMO. 

(14) 

In its opinion of 29 March 2006, the EFSA concluded that there is no reason to believe 
that the continued placing on the market of T25 maize is likely to cause any adverse 
effects  for  human  and  animal  health  or  the  environment  under  the  conditions  of  its 
consent.  

(15)  Austria should therefore repeal the safeguard clause measures concerning Zea mays L. 

line T25, 

HAS ADOPTED THIS DECISION:  

Article 1 

The measures taken by Austria to prohibit the use and sale of the genetically modified maize, 
Zea  mays  L.  line  T25,  authorised  for  placing  on  the  market  by  Decision  98/293/EC  are  not 
justified under 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 

Article 3 

This Decision is addressed to the Republic of Austria. 

Done at Brussels,  

For the Council 
The President 

EN 

6 

   EN