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)
Date: 2009-02-10
Institutions: European Commission
Subjects: Austria, food safety, genetically modified organism, maize, market approval

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.2.2009 
COM(2009) 56 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) 
(Text with EEA relevance) 

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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/EEC1  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. 

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  replaced  by  Directive  2001/18/EC  of  the  European 
Parliament  and  of  the  Council  on  the  deliberate  release  into  the  environment  of 
genetically modified organisms2. 

5. 
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°  258/973  and  Regulation  (EC)  N°  1829/20034.  These  uses 
are not subject to the safeguard clause notified by Austria. 

In January 2004, the Commission requested Austria to re-consider its safeguard 
6. 
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),  established  by  Regulation  (EC)  No  178/2002  of  the  European 

OJ L 117, 8.5.1990, p. 15 
OJ L 106, 17.4.2001, p. 1 
OJ L 43, 14.2.1997, p. 1 
OJ L 106, 18.10.2003, p. 1 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

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Parliament  and  of  the  Council5,  under  which  it  has  replaced  the  relevant  scientific 
committees,  was  consulted  and  concluded,  in  its  opinion  of  8  July  20046,  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)7,  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.  

8. 

9. 

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11. 

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14. 

15. 

16. 

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19. 

20. 

21. 

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 
submitted an amended proposal requesting Austria to repeal only the prohibition of 
import and the processing into food and feed products.  

On 30 October 2007, the Council voted on the proposal and did not reach a qualified 
majority in favour or against it. The Commission adopted therefore on 7 May 2008 
Decision 2008/495/EC requesting Austria to take all 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  the  notification.  On  27  May  2008  Austria 
complied with this Decision and adopted the respective Regulation. 

For  the  aspects  of  the  safeguard  measure  that  concern  the  sale  and  use  of  seeds 
(cultivation), Austria initiated work to collect any relevant scientific evidence  which 
in its view would justify provisionally the maintenance of the safeguard measure, in 
particular in reference to "the different agricultural structures and regional ecological 
characteristics" as indicated in recital 3 of the Council Decision of 18 December. In 
November 2007, Austria submitted to the Commission the scientific information that 
resulted out of its work. 

On  18  April  2008  the  Commission  requested  EFSA,  under  Article  29(1)  and  in 
accordance  with  Article  22(2)  and  22(5)(c)  of  Regulation(EC)  No  178/2002,  to 
assess whether the information submitted by Austria comprises information affecting 
the  environmental  risk  assessment  of  existing  information  on  the  basis  of  new 
scientific  knowledge  such  that  detailed  grounds  exist  to  consider  that  maize 
MON810, for uses laid down in the corresponding consent, constitutes a risk to the 
environment. 

On 4 December 2008, EFSA adopted its opinion (published on 11 December 2008) 
concluding  that  maize  MON810  is  unlikely  to  have  adverse  effects  on  human  and 
animal health or the environment in the context of its proposed uses and reaffirmed 
its  previous  conclusions  on  the  safety  of  maize  MON810.  Moreover,  having 
considered  the  information  submitted  by  Austria  and  a  broad  range  of  scientific 
literature, EFSA is of the opinion that there is no specific evidence, in terms of risk 
to human and animal health and the environment, that would justify the invocation of 
a  safeguard  clause  under  Article  23  of  Directive  2001/18/EC  for  the  marketing  of 
maize MON810 for its intended uses in Austria. In conclusion, EFSA found that the 
scientific  evidence  currently  available  does  not  sustain  the  arguments  provided  by 
Austria and that cultivation of maize MON810 is unlikely to have an adverse effect 
on human and animal health and the environment in Austria. 

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22. 

23. 

24. 

Under these circumstances, Austria should repeal its safeguard measure with regards 
to the use and sale of seeds of Zea mays L. line MON810. 

Following  the  Council  Decision  of  18  December  2006,  and  in  accordance  with 
Article  5(6)(2)  of  Council  Decision  1999/468/EC,  the  Commission  re-submitted  its 
proposal relating to the measures to be taken and informed the European Parliament. 

Article 5(6)(1) of Council Decision 1999/468/EC provides that the Council may act 
by qualified majority within a period set at three months in accordance with Article 
30(2) of Directive 2001/18/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 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/EEC8, 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/EEC9 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/EEC10,  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)  have  been  authorised  under 

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10 

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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Regulation (EC) No 258/9711 and have been subsequently notified as existing products 
in accordance with Article 8 and 20 of Regulation (EC) No 1829/200312. These uses 
are not subject to the safeguard measure notified by Austria, as they do not fall under 
the scope of Directive 2001/18/EC 

(6) 

(7) 

(8) 

(9) 

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. 

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 Council13, under which it has replaced 
the relevant scientific committees.  

The EFSA concluded on 8 July 200414 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  Commission15,  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 

11 
12 
13 

14 

15 

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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[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 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 200616, 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'. 

(14) 

(15) 

(16) 

(17) 

(18) 

(19) 

In  accordance  with  Article  5(6)  of  Council  decision  1999/468/EC  the  Commission 
submitted  an  amended  proposal  requesting  Austria  to  repeal  only  the  prohibition  of 
import and the processing into food and feed products.  

(20)  On 30 October 2007, the Council voted on the proposal and did not reach a qualified 
majority  in  favour  or  against  it.  The  Commission  adopted  therefore  on  7  May  2008 
Decision 2008/495/EC requesting Austria to take all 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  the  notification.  On  27  May  2008  Austria 
complied with this Decision and amended accordingly its national legislation. 

(21)  For  the  aspects  of  the  safeguard  measure  that  concern  the  sale  and  use  of  seeds 
(cultivation), Austria initiated work to collect any relevant scientific evidence which in 
its  view  would  justify  provisionally  the  maintenance  of  the  safeguard  measure,  in 
particular in reference to "the different agricultural structures and regional ecological 
characteristics"  as  indicated  in  recital  3  of  the  Council  Decision  of  18  December.  In 
November 2007, Austria submitted to the Commission the scientific information that 
resulted out of its work. 

16 

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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(22)  On  18  April  2008  the  Commission  requested  EFSA,  under  Article  29(1)  and  in 
accordance with Article 22(2) and 22(5)(c) of Regulation(EC) No 178/2002, to assess 
whether  the  information  submitted  by  Austria  comprises  information  affecting  the 
environmental  risk  assessment  of  existing  information  on  the  basis  of  new  scientific 
knowledge such that detailed grounds exist to consider that maize MON810, for uses 
laid down in the corresponding consent, constitutes a risk to the environment. 

(23)  On  4  December  2008,  EFSA  adopted  its  opinion  (published  on  11  December  2008) 
concluding  that  maize  MON810  is  unlikely  to  have  adverse  effects  on  human  and 
animal health or the environment in the context of its proposed uses and reaffirmed its 
previous  conclusions  on  the  safety  of  maize  MON810.  Moreover,  having  considered 
the information submitted by Austria and a broad range of scientific literature, EFSA 
is  of  the  opinion  that  there  is  no  specific  evidence,  in  terms  of  risk  to  human  and 
animal  health  and  the  environment,  that  would  justify  the  invocation  of  a  safeguard 
clause under Article 23 of Directive 2001/18/EC for the marketing of maize MON810 
for its intended uses in Austria. In conclusion, EFSA found that the scientific evidence 
currently  available  does  not  sustain  the  arguments  provided  by  Austria  and  that 
cultivation  of  maize  MON810  is  unlikely  to  have  an  adverse  effect  on  human  and 
animal health and the environment in Austria. 

(24)  Under these circumstances, Austria should repeal its safeguard measure with regards 

to the use and sale of seeds of Zea mays L. line MON810. 

(25)  Following the Council Decision of 18 December 2006, and in accordance with Article 
5(6)(2)  of Council Decision 1999/468/EC, the Commission  re-submitted its proposal 
relating to the measures to be taken and informed the European Parliament. 

(26)  Article 5(6)(1) of Council Decision 1999/468/EC provides that the Council may act by 
qualified majority within a period set at three months in accordance with Article 30(2) 
of Directive 2001/18/EC. 

HAS ADOPTED THIS DECISION:  

Article 1 

The measures taken by Austria to prohibit the use and sale of seeds 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. 

Article 2 

Austria shall take the necessary steps to terminate the prohibition of use and sale of seeds of the 
Zea mays L. line MON810, on its territory, and shall comply with this Decision by no later than  
20 days after its notification. 

This Decision is addressed to the Republic of Austria. 

Article 3 

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Done at Brussels, […]2009. 

For the Council 
The President 

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