Proposal for a Council Decision concerning the provisional prohibition of the use and sale in Hungary of genetically modified maize (Zea mays L. line MON810) expressing the Bt cryIA(b) gene, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (Only the Hungarian text is authentic)
Date: 2006-11-23
Institutions: European Commission
Subjects: Hungary, genetically modified organism, maize, market approval, marketing restriction

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 23.11.2006 
COM(2006) 713 final 

Proposal for a 

COUNCIL DECISION  

concerning the provisional prohibition of the use and sale in Hungary of genetically 
modified maize (Zea mays L. line MON810) expressing the Bt cryIA(b) gene, pursuant 
to Directive 2001/18/EC of the European Parliament and of the Council 

(Only the Hungarian text is authentic) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

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

On  3  August  1998  the  French  authorities  granted  consent  for  the  placing  on  the 
market of that product. Pursuant to Article 13(5) of Directive 90/220/EEC, the product 
may be used throughout the Community. 

In  accordance  with  Article  23(1)  of  Directive  2001/18/EEC,  the  Hungarian 
authorities  informed  the  Commission  on  20  January  2005  of  their  decision  to 
provisionally prohibit the use and sale of the genetically modified maize in question 
and gave reasons therefore. 

On  8  June  2005  the  European  Food  Safety  Authority  (EFSA)  considered  that  the 
information submitted by Hungary did not constitute new scientific evidence which 
would  invalidate  the  environmental  risk  assessment  of  Zea  mays  L.  line  MON810 
and  therefore  would  justify  a  prohibition  of  the  use  and  sale  of  this  product  in 
Hungary. 

On  24  June  2005,  the  Environment  Council  indicated  its  opposition  by  qualified 
majority, to a proposal requesting Austria to repeal its safeguard clause measure on 
Zea mays L. line MON810. 

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  therefore  consulted  as  to  whether  there  was  any 
scientific  reason  to  believe  that  the  continued  placing  on  the  market  of  the  GMOs 
subject to the safeguard clause measures, including 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  opinions 
that assessed the safety of these GMOs. 

It has been considered appropriate to await this new EFSA opinion on Zea mays L. 
line  MON810  before  taking  any  action  on  the  corresponding  safeguard  clause 
notified  by  Hungary,  because  of  its  possible  implication  on  the  previous  opinion 
adopted in June 2005. 

In its opinion of 29 March 2006 (published on 11 April 2006), EFSA 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 respective consent.  

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Under  such  circumstances  Article  23  of  Directive  2001/18/EC  requires  the 
Commission  to  take  a  decision  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. 

Since EFSA considered that the product did not constitute a risk to human health or 
the environment the Commission prepared a draft Decision asking Hungary to repeal 
its measures concerning Zea mays L. line MON810. 

A draft of the measures to be taken was submitted, in accordance with Article 5(2) of 
Decision  1999/468/EC,  for  opinion,  to  the  Committee  set  up  under  Article  30  of 
Directive 2001/18/EC. 

The  Committee,  consulted  on  18  September  2006,  has  not  delivered  an  opinion, 
which  requires  that  the  Commission,  in  accordance  with  Article  5(4)  of  Decision 
1999/468/EC,  shall,  without  delay,  submit  to  the  Council  a  proposal  relating  to  the 
measures  to  be  taken  and  inform  the  European  Parliament  (informed  on  19 
September  2006).  The  European  Parliament  may  consider  appropriate  to  take  a 
position in accordance with Article 8 of the above Decision. 

Article  5(6)  of  Decision  1999/468/EC  provides  that  the  Council  may,  where 
appropriate in view of any such position, act by qualified majority within a period set 
at three months in accordance with Article 30(2) of Directive 2001/18/EC. If within 
that  three-month  period,  the  Council  has  indicated  by  qualified  majority  that  it 
opposes the proposal, the Commission should re-examine it; whereas if, on expiry of 
that  period  the  Council  has  neither  adopted  the  proposed  implementing  act  nor 
indicated  its  opposition,  then  the  proposed  implementing  act  should  be  adopted  by 
the Commission. 

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Proposal for a 

COUNCIL DECISION  

concerning the provisional prohibition of the use and sale in Hungary of genetically 
modified maize (Zea mays L. line MON810) expressing the Bt cryIA(b) gene, pursuant to 
Directive 2001/18/EC of the European Parliament and of the Council 

(Only the Hungarian 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) 

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. 

(2) 

On 3 August 1998 the competent authorities of France granted such consent. 

(3) 

(4) 

On  20  January  2005  Hungary  informed  the  Commission  that,  pursuant  to  the  first 
subparagraph of Article 23(1) of Directive 2001/18/EC, it had introduced a provisional 
prohibition on the use and sale of Zea mays L. line MON810 and gave reasons for its 
decision. 

The Commission sought the opinion of the European Food Safety Authority (EFSA), 
as established by Regulation (EC) No 178/2002 of the European Parliament and of the 
Council  of  28  January  2002  laying  down  the  general  principles  and  requirements  of 
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures  in  matters  of  food  safety3,  regarding  the  information  submitted  by 
Hungary. 

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OJ L 106, 17.4.2001, p. 1. 
OJ No L 131, 5.5.1998, p.32. 
OJ  L  31,  1.2.2002,  p.1.  Regulation  as  last  amended  by  Regulation  (EC)  No  575/2006  (OJ  L  100, 
8.4.2006, p. 3). 

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(9) 

On  8  June  2005,  and  following  investigation  of  the  evidence  presented  in  the 
Hungarian  submission,  the  EFSA  concluded  that  the  scientific  evidence  currently 
available does not sustain the arguments provided by Hungary and that the information 
submitted  by  Hungary  did  not  constitute  new  scientific  evidence  sufficient  to 
invalidate  the  environmental  risk  assessment  of  Zea  mays  L.  line  MON810 
established  under  Directive  90/220/EEC,  justifying  a  prohibition  of  the  use  and 
sale of that product in Hungary. 

On  24  June  2005,  the  Environment  Council  indicated  its  opposition  by  qualified 
majority, to the proposal requesting Austria to repeal its safeguard clause measure on 
MON810;  

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,  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 
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 
opinions that assessed the safety of these GMOs. 

In  its  opinion  of  29  March  2006,  the  EFSA,  supported  by  the  assessment  of  several 
applications on hybrids containing MON810 maize, 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 consent. 

(10)  Consequently,  there  is  no  reason  to  consider  that  the  product  constitutes  a  risk  to 

human or animal health or to the environment. 

(11)  Hungary should therefore repeal the safeguard clause measures concerning Zea mays 

L. line MON810.  

(12)  The  Committee  established  under  Article  30  of  Directive  2001/18/EC  has  not 
delivered  an  opinion  on  the  measures  laid  down  in  a  draft  Commission  Decision, 
following  its  consultation,  on  18  September  2006,  in  accordance  with  the  procedure 
laid down in Article 30(2) of that Directive 

(13)  The  Commission,  under  Article  5(4)  of  Council  Decision  1999/468/EC,  should, 
without delay, submit to the Council proposals relating to the measures to be taken and 
should inform the European Parliament (informed on 19 September 2006). 

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HAS ADOPTED THIS DECISION:  

Article 1 

The measures taken by Hungary to prohibit the use and sale of the genetically modified maize 
product, Zea mays L. line MON810, expressing the Bt cryIA(b) gene, authorised for placing 
on the market by Decision 98/294/EC are not justified under Directive 2001/18/EC. 

Hungary shall take the necessary steps to comply with this Decision by no later than 20 days 
after its notification. 

Article 2 

Article 3 

This Decision is addressed to the Republic of Hungary. 

Done at Brussels,  

For the Council 
The President 

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