Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Austria of genetically modified maize (Zea mays L. line MON 810) 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) 509 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 MON 810) pursuant to Directive 2001/18/EC of the 
European Parliament and of the Council 

(Only the German text is authentic) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

A genetically modified variety of Zea mays L. line MON 810 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  (safeguard  clause)  of  Directive  90/220/EEC,  Austria 
subsequently  informed  the  Commission  of  its  decision  to  provisionally  prohibit  or 
restrict  the  placing  on  the  market  of  Zea  mays  L.  line  MON  810  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 MON 810. 

Directive  90/220/EEC  was  repealed  by  Directive  2001/18/EC  of  the  European 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 to which 
Articles  5  and  7  of  Decision  1999/468/EC  shall  apply,  having  regard  to  the 
provisions of Article 8 thereof. 

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  MON  810 
and would justify a prohibition of this GMO in Austria. 

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.  

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A  draft  Commission  Decision  requesting  Austria  to  repeal  its  national  safeguard 
clause  was  therefore  submitted  for  opinion,  under  Article  5(2)  of  Council  Decision 
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]  […]  MON  810'  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,  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 MON 
810  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,  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 MON 810 is likely to cause any adverse effects for 
human and animal health or the environment under the conditions of its consents. 

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  20  June  2005  and  re-
consulted  the  EFSA,  it  appears  that,  for  the  third  time,  the  scientific  assessment  of 
Zea  mays  L.  line  MON  810  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 

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.  

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proposal  to  the  Council  in  accordance  with  Article  5(6)  of  Council  Decision 
1999/468/EC. 

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Proposal for a 

COUNCIL DECISION 

concerning the provisional prohibition of the use and sale in Austria of genetically 
modified maize (Zea mays L. line MON 810) 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 98/294/EC of 22 April 1998 concerning the placing on the 
market of genetically modified maize (Zea mays L. line MON 810), 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  2  June  1999  Austria  informed  the  Commission  of  its  decision  to  prohibit 
provisionally the use and sale of Zea mays L. line MON 810 and gave reasons for that 
decision in accordance with Article 16(1) of Directive 90/220/EEC. 

The  Scientific  Committee  on  Plants  concluded  on  24  September  1999  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 

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OJ L 106, 17.4.2001, p. 1 
OJ L 131, 5.5.1998, p. 32 
OJ L 117, 8.5.1990, p. 15 

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(6) 

(7) 

(8) 

(9) 

and  which  would  occasion  a  review  of  that  Committee’s  original  opinion  on  this 
product. 

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 MON 810. 

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 MON 810, 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 measure, 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 this 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]  […]  MON  810'  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 by the Commission as to whether 
there was any scientific reason to believe that the continued placing on the market of 
MON  810  maize  was  likely  to  cause  any  adverse  effects  to  human  health  or  the 

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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. 

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environment under the conditions of consent11. In particular, the EFSA was requested 
to take account of any further scientific information that had arisen subsequent to the 
previous scientific opinion concerning the safety of this GMO. 

(14) 

In  its  opinion  of  29  March  2006,  EFSA  concluded that there is no reason to believe 
that  the  continued  placing  on  the  market  of  MON  810  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  measures  concerning  Zea  mays  L.  line 

MON 810, 

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  MON  810,  authorised  for  placing  on  the  market  by  Decision 
98/294/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 

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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. 

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