Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Austria of genetically modified maize (Zea mays L. line MON810) pursuant to Directive 2001/18/EC of the European Parliament and of the Council (Only the German text is authentic)
Date: 2007-10-09
Institutions: European Commission
Subjects: Austria, genetically modified organism, maize, market approval

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 9.10.2007 
COM(2007) 586 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 MON810) 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 MON810 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).  The  consent  covers  all  uses  of  the 
product, namely import, processing into food and feed products and cultivation. 

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 MON810 for all uses covered 
by the consent granted under Directive 90/220/EEC and provided its reasons for this 
decision. 

Products  derived  from  Zea  mays  L.  line  MON810  (food  and  food  ingredients 
produced from maize flour, maize gluten, maize semolina, maize starch, maize glucose 
and  maize  oil  produced  from  Zea  mays  L.  line  MON810)  are  authorised  under 
Regulation (EC) N° 258/971 and Regulation (EC) N° 1829/20032. These uses are not 
subject to the safeguard clause notified by Austria. 

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 MON810. 

Directive  90/220/EEC  was  repealed  by  Directive  2001/18/EC  of  the  European 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 organisms3. 

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 

OJ L 43, 14.2.1997, p. 1 
OJ L 106, 18.10.2003, p. 1 
OJ L 106, 17.4.2001, p. 1 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

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the  European  Parliament  and  of  the  Council4,  under  which  it  has  replaced  the 
relevant scientific committees and concluded, in its opinion of 8 July 20045, that the 
information  submitted  by  Austria  did  not  constitute  new  scientific  evidence  which 
would  invalidate  the  environmental  risk  assessment  of  Zea  mays  L.  line  MON810 
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 
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]  […]  MON810  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 
MON810 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)6,  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 MON810 is likely to cause any adverse effects for 
human and animal health or the environment under the conditions of its consents. 

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.  
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.  

10. 

11. 

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16. 

17. 

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21. 

22. 

23. 

24. 

In accordance with Article 5(6) of Council Decision 1999/468/EC, the Commission 
submitted  a  proposal  to  the  Council  requesting  Austria  to  repeal  its  safeguard 
measure. 

The  Environment  Council,  on  18  December  2006,  indicated  its  opposition  to  the 
proposal by qualified majority. 

In its Decision, the Council referred to the environmental risk assessment as provided 
in  the  Directive  2001/18/EC  and  indicated  that  'the  different  agricultural  structures 
and regional ecological characteristics in the European Union need to be taken into 
account in a more systematic manner in the environmental risk assessment'. 

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

The Council decision of 18 December 2006 refers only to the environmental aspects 
of the safeguard clause, namely cultivation. 

Austria has initiated work to collect any relevant scientific evidence on these aspects, 
which in the view of Austria justifies provisionally the maintenance of the safeguard 
clause, in particular in reference to 'the different agricultural structures and regional 
ecological  characteristics'  as  indicated  in  recital  3  of  the  abovementioned  Council 
decision. In accordance with Article 23 of Directive 2001/18/EC, Austria is invited 
to  provide  the  Commission  with  all  the  scientific  evidence  that  it  has  collected  as 
well as any new risk assessment as soon as it is completed and inform all Member 
States thereof. 

On  the  basis  of  Austria's  submission  and  its  scientific  assessment,  the  Commission 
will act  in accordance with Article 23 of Directive 2001/18/EC on these aspects of 
the Austrian measure. 

The  food  and  feed  safety  aspects  of  Zea  mays  L.  line  MON810  covered  by  the 
consent  granted  under  Directive  90/220/EEC  (including  import  and  processing)  are 
identical throughout Europe and have been assessed by the EFSA, which concluded 
that  this  product  is  unlikely  to  cause  any  adverse  effects  for  human  and  animal 
health.  

Under  these  circumstances,  the  Commission  considers  that  the  proposal  should  be 
amended  in  order  to  take  into  account  only  food  and  feed  aspects  of  the  Austrian 
prohibition namely the prohibition on import and processing of unprocessed kernels 
as source materials for further processing or for direct food or feed use. 

25. 

In accordance with Article 5(6) of Council Decision 1999/468/EC, the Commission 
therefore submits an amended proposal to the Council. 

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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 MON810) 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/EEC1, and in particular Article 23(2) thereof, 

Having regard to the proposal from the Commission,  

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

By Commission Decision 98/294/EC of 22 April 1998 concerning the placing on the 
market of genetically modified maize (Zea mays L. line MON810), pursuant to Council 
Directive 90/220/EEC2 it was decided that consent was to be given for the placing on the 
market of that product.  

On 3 August 1998 the French authorities granted such consent. The consent covers all 
uses  of  the  product,  namely  import,  processing  into  food  and  feed  products  and 
cultivation. 

Pursuant  to  Article  35(1)  of  Directive  2001/18/EC  which  replaced  Directive 
90/220/EEC3,  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  MON810  for  all  uses  and  gave 
reasons for that decision in accordance with Article 16(1) of Directive 90/220/EEC. 

Products derived from Zea mays L. line MON810 (food and food ingredients produced 
from maize flour, maize gluten, maize semolina, maize starch, maize glucose and maize 
oil produced from  Zea  mays  L.  line  MON810)  are  authorised  under  Regulation  (EC) 

1 
2 
3 

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) 

No  258/974  and  Regulation  (EC)  No  1829/20035.  These  uses  are  not  subject  to  the 
safeguard clause notified by Austria. 

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 
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 MON810. 

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 Council6, under which it has replaced 
the relevant scientific committees.  

The EFSA concluded on 8 July 20047 that the information submitted by Austria did 
not  constitute  new  scientific  evidence  sufficient  to  invalidate  the  environmental 
risk assessment of maize line MON810, justifying a prohibition of the use and sale 
of that product in Austria. 

(10)  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. 

(11)  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  Commission8,  the 
Commission submitted to the Council a proposal relating to the measures to be taken.  

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

Council, acting by qualified majority, rejected this proposal. 

(13)  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]  […]  MON810'  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 

4 
5 
6 

7 

8 

OJ L 43, 14.2.1997, p. 1 
OJ L 106, 18.10.2003, 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. 
OJ L 184, 17.7. 1999, p. 23. 

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(14) 

(15) 

(16) 

(17) 

(18) 

(19) 

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 again by the Commission as to whether 
there was any scientific reason to believe that the continued placing on the market of 
MON810  maize  was  likely  to  cause  any  adverse  effects  to  human  health  or  the 
environment under the conditions of consent. 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. 

In its opinion of 29 March 20069, EFSA concluded that there is no reason to believe 
that  the  continued  placing  on  the  market  of  MON810  maize  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 
submitted a proposal to the Council requesting Austria to repeal its safeguard measure. 

In  accordance  with  Article  5(6)  of  Council  Decision  1999/468/EC,  the  Environment 
Council, on 18 December 2006, indicated its opposition by qualified majority, to the 
proposal. 

In its Decision, the Council referred to the environmental risk assessment as provided 
in the Directive 2001/18/EC and indicated that 'the different agricultural structures and 
regional  ecological  characteristics  in  the  European  Union  need  to  be  taken  into 
account in a more systematic manner in the environmental risk assessment'. 

In  accordance  with  Article  5(6)  of  Council  decision  1999/468/EC  the  Commission 
submitted an amended proposal in order to take into account the Council Decision of 
18  December  2006  which  refers  only  to  the  environmental  aspects  of  the  Austrian 
safeguard clause, namely cultivation aspects. 

(20)  Austria has initiated work to collect any relevant scientific evidence on these aspects, 
which in the view of Austria justifies provisionally the maintenance of the safeguard 
clause,  in  particular  in  reference  to  'the  different  agricultural  structures  and  regional 
ecological  characteristics'  as  indicated  in  recital  3  of  the  abovementioned  Council 
decision. In accordance with Article 23 of Directive 2001/18/EC, Austria is invited to 
provide the Commission with all the scientific evidence that it has collected as well as 
any  new  risk  assessment  as  soon  as  it  is  completed  and  inform  all  Member  States 
thereof. 

(21)  On  the  basis  of  Austria's  submission  and  its  scientific  assessment,  the  Commission 
will act in accordance with Article 23 of Directive 2001/18/EC on these aspects of the 
Austrian measure. 

9 

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 

7 

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(22)  The food and feed safety aspects of Zea mays L. line MON810 covered by the consent 
granted  under  Directive  90/220/EEC  (including  import  and  processing)  are  identical 
throughout  Europe  and  have  been  assessed  by  the  EFSA,  which  concluded  that  this 
product is unlikely to cause any adverse effects for human and animal health.  

(23)  The  Commission  proposal  takes  into  account  only  food  and  feed  aspects  of  the 
Austrian prohibition namely the prohibition on import and processing of unprocessed 
kernels as source materials for further processing or for direct food or feed use.  

(24)  Under these circumstances Austria should repeal its safeguard measures at least with 
regard to import and processing into food and feed of Zea mays L. line MON810. 

HAS ADOPTED THIS DECISION:  

Article 1 

The  measures  taken  by  Austria  to  prohibit  the  import  and  the  processing  into  food  and 
feed products of the Zea mays L. line MON810, 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 terminate the prohibition of import and processing into 
food and feed products of Zea mays L. line MON810 at the latest 20 days after its notification. 

Article 2 

Article 3 

This Decision is addressed to the Republic of Austria. 

Done at Brussels, […] 2007. 

For the Council 
The President 

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