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 cry1Ab gene, pursuant to Directive 2001/18/EC of the European Parliament and of the Council
Date: 2009-01-21
Institutions: European Commission
Subjects: Hungary, food safety, genetically modified organism, maize, market approval

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 21.1.2009 
COM(2009) 12 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 cry1Ab gene, pursuant to 
Directive 2001/18/EC of the European Parliament and of the Council 

(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.  

The Commission took note of the declaration of the Environment Council on 24 June 
2005,  which,  in  order  to  indicate  its  opposition  to  a  proposal  requesting  another 
Member State to repeal its safeguard clause measure on the same GMO, stated that 
there was still a degree of uncertainty in relation to the safeguard measure associated 
with the placing on the market of MON810 maize and called on the Commission to 
gather further scientific evidence and to further assess whether the national measure 
was justified and whether the authorisation of the GMO under Directive 90/220/EEC 
still met the safety requirements of Directive 2001/18/EC. 

Therefore  the  Commission  consulted  EFSA  in  November  2005  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 requested EFSA 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  measure 
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 their respective consents.  

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 

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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, did not deliver an opinion, which 
required  that  the  Commission,  in  accordance  with  Article  5(4)  of  Decision 
1999/468/EC,  submitted  to  the  Council  a  proposal  relating  to  the  measures  to  be 
taken and informed the European Parliament .  

The  Environment  Council,  on  20  February  2007,  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'. 

Hungary submitted to the Commission on 30 November 2007 additional information 
regarding the cultivation of Zea mays L. line MON810 to support its measure.  

submitted  by  Hungary  comprises 

Consequently  EFSA  was  requested  on  18  April  2008  to  assess  whether  the 
information 
the 
environmental risk assessment such that detailed grounds exist to consider the above 
maize,  for  the  uses  laid  down  in  the  corresponding  consent,  constitute  a  risk  to  the 
environment.  

information  affecting 

In  its  opinion  of  2  July  2008  (published  on  11  July  2008),  EFSA  reaffirmed  its 
previous conclusions on the safety of Zea mays L. line MON810 and stated that it did 
not identify any new data subject to scientific scrutiny or scientific information that 
would  change  the  previous  risk  assessments  conducted  on  this  product.  EFSA  also 
concluded that the Hungarian submission did not supply scientific evidence that the 
environment  of  Hungary  was  different  from  other  regions  of  the  EU  sufficient  to 
merit separate risk assessments from those conducted for other regions in the EU.  

Under these circumstances Hungary should repeal its safeguard measure with regard 
to the use and sale of Zea mays L.  line MON810. Therefore, following the Council 
Decision  of  February  2007,  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. 

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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 cry1Ab gene, pursuant to 
Directive 2001/18/EC of the European Parliament and of the Council 

(Only the Hungarian text is authentic) 

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, 

After consulting the European Food Safety Authority, 

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. 

(5) 

On  8  June  2005,  and  following  investigation  of  the  evidence  presented  in  the 
Hungarian  submission,  the  EFSA  concluded  that  the  scientific  evidence  currently 

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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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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.  

The Commission took note of the declaration of the Environment Council on 24 June 
2005,  which,  in  order  to  indicate  its  opposition  to  a  proposal  requesting  another 
Member State to repeal its safeguard measure on the same GMO, stated that there was 
still  a  degree  of  uncertainty  in  relation  to  the  safeguard  measure  associated  with  the 
placing  on  the  market  of  MON810  maize  and  called  on  the  Commission  to  gather 
further  scientific  evidence  and  to  further  assess  whether  the  national  measure  was 
justified and whether the authorisation of the GMO under Directive 90/220/EEC still 
met the safety requirements of Directive 2001/18/EC. 

Therefore  the  Commission  consulted  EFSA  in  November  2005  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, and requested EFSA 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,  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. 

(6) 

(7) 

(8) 

(9) 

Consequently,  there  was  no  reason  to  consider  that  the  product  constitutes  a  risk  to 
human or animal health or to the environment. 

(10)  Hungary had therefore to repeal the safeguard clause measures concerning Zea mays 

L. line MON810.  

(11)  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 

(12)  The  Commission,  under  Article  5(4)  of  Council  Decision  1999/468/EC  submitted  to 
the Council proposals relating to the measures to be taken and informed the European 
Parliament. 

(13)  The  Environment  Council,  on  20  February  2007,  indicated  its  opposition  to  the 

proposal by qualified majority.  

(14) 

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'. 

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(15)  Hungary submitted to the Commission on 30 November 2007 additional information 
regarding  the  cultivation  of  Zea  mays  L.  line  MON810  to  support  its  safeguard 
measure.  

(16)  Consequently EFSA was requested on 18 April 2008 to assess whether the information 
submitted  by  Hungary  comprises  information  affecting  the  environmental  risk 
assessment such that detailed grounds exist to consider that the above maize, for the 
uses laid down in the corresponding consent, constitutes a risk to the environment.  

(17) 

In its opinion of 2 July 2008 (published 11 July 2008), EFSA reaffirmed its previous 
conclusions  on  the  safety  of  Zea  mays  L.  line  MON810  and  stated  that  it  did  not 
identify any new data subject to scientific scrutiny or scientific information that would 
change the previous risk assessments conducted on this product. EFSA also concluded 
that the Hungarian submission did not supply scientific evidence that the environment 
of Hungary was different from other regions of the EU sufficient to merit separate risk 
assessments from those conducted for other regions in the EU.  

(18)  Under these circumstances Hungary should repeal its safeguard measure with regard to 

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

(19)  Following  the  Council  Decision  of  February  2007,  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.  

(20)  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 the Republic of Hungary to prohibit the use and sale of the genetically 
modified  maize, Zea mays L.  line MON810, expressing the Bt cry1Ab  gene, authorised  for 
placing on the market by Decision 98/294/EC are not justified under Directive 2001/18/EC. 

Article 2 

The  Republic  of  Hungary  shall  take  the  necessary  steps  to  repeal  the  measures  adopted  to 
prohibit the use and sale of the genetically modified maize, Zea mays L. line MON810, on its 
territory, and comply with this Decision by no later than 20 days after its notification. 

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Article 3 

This Decision is addressed to the Republic of Hungary. 

Done at Brussels, 

For the Council 
The President 

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