COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the freedom for Member States to decide on the cultivation  of genetically modified crops
Date: 2010-07-13
Institutions: European Commission
Subjects: consumer protection, crop production, environmental protection, genetically modified organism, health policy, marketing

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EUROPEAN COMMISSION 

Brussels, 13.7.2010 
COM(2010) 380 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE ECONOMIC AND SOCIAL COMMITTEE 
AND THE COMMITTEE OF THE REGIONS 

on the freedom for Member States to decide on the cultivation  
of genetically modified crops 

{COM(2010) 375 final} 

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE ECONOMIC AND SOCIAL COMMITTEE 
AND THE COMMITTEE OF THE REGIONS 

on the freedom for Member States to decide on the cultivation  
of genetically modified crops 

1. 

INTRODUCTION 

The  European  Union  (EU)  has  adopted  a  comprehensive  legal  framework  for  the 
authorisation  of  products  consisting  of  or  derived  from  Genetically  Modified 
Organisms (GMOs). The authorisation procedure covers the use of GMOs and their 
derived products for food and feed, industrial processing and cultivation. 

The EU authorisation system aims at ensuring the safety of authorised GMOs while 
establishing an internal market for those products. Two pieces of legislation, namely 
Directive 2001/18/EC on the environmental release of GMOs1 and Regulation (EC) 
No 1829/2003 on GM food and feed2, provide for the pre-marketing authorisation of 
GMOs. Both set science based standards in terms of human health, animal health and 
environmental risk assessment. In addition, Regulation (EC) No 1830/20033 provides 
rules on the traceability and labelling of GMOs and the traceability of food and feed 
produced from GMOs. 

The  responsibility  for  the  scientific  assessment  is  assigned  to  the  European  Food 
Safety Authority (EFSA), but also to the scientific authorities of the Member States. 
The role of the Member States is particularly important in the authorisation of GMOs 
for  cultivation,  where  they  carry  out  the  initial  risk  assessment  of  environmental 
aspects. 

Since the adoption of the legal framework six years ago, seven Member States have 
prohibited or restricted cultivation on their territories through safeguard measures on 
individual authorized GMOs4 or through general prohibitions of GM seeds5. In four 
different occasions6, the Council has rejected by qualified majority all Commission 
proposals to repeal national safeguard measures on GMO cultivation even though in 

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OJ L 106, 17.4.2001, p. 1. 
OJ L 268, 18.10.2003, p. 1. 
OJ L 268, 18.10.2003, p. 24. 
Maize  MON  810  has  been  prohibited  by  AT,  HU  and  LU  on  the  basis  of  Article  23  of  Directive 
2001/18/EC,  EL  on  the  basis  of  Article  23  of  Directive  2001/18/EC  and  Article  18  of  Directive 
2002/53/EC,  FR  and  DE  on  the  basis  of  Article  23  of  Directive  2001/18/EC  and  Article  34  of 
Regulation  (EC)  No1829/2003.  Maize  T  25  has  been  prohibited  by  AT  on  the  basis  of  Article  23  of 
Directive 2001/18/EC. Amflora Potato has been banned by AT, HU and LU on the basis of Article 23 
of Directive 2001/18/EC. 
PL has also adopted a legislation prohibiting in general the marketing of GM seeds which was not based 
on the safeguard clauses set out in EU legislation. On 16 July 2009 the Court of Justice of the EU issued 
a  judgement  whereby  it  considered  that  legislation  contrary  to  EU  law  and  condemned  Poland  for 
failure to fulfil its obligations (case C-165/08). 
June 2005, December 2006, February 2007 and March 2009. 

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all  cases  EU  scientific  assessments  had  concluded  that  these  measures  were  not 
based  on  new  or  additional  scientific  information  since  the  authorisations  were 
granted and therefore such measures were not justified from a legal point of view.  

The Council Conclusions of December 2008 considered the legislative framework on 
GMOs  comprehensive  and  underlined  the  need  to  better  implement  the  existing 
provisions, notably as concerns cultivation, while noting the necessity of continuing 
processing  applications  without  undue  delays.  The  Council  conclusions  identified 
particular areas for improvement of the implementation of the GMO legislation, on 
which work by the Commission and EFSA, in co-operation with the Member States, 
is currently ongoing.  

Commission  and  EFSA,  together  with  the  Member  States,  are  working  on  the 
particular  areas  for  improvement  of  the  implementation  of  the  GMO  legislation, 
identified  by  the  2008  Environment  Council  conclusions.  The  update  of  the  EFSA 
guidelines for the environmental risk assessment is ongoing and covers the specific 
areas requested by the Council. EFSA is expected to finish the guidelines in the last 
quarter  of  2010.  The  Commission  will  then  discuss  these  updated  guidelines  with 
Member States to give them normative value with the Member States' endorsement. 

Furthermore, the Commission is analysing how to further reinforce the post-market 
environmental monitoring of GMO crops, in line with the provisions of the current 
legislation and the 2008 Environment Council conclusions.  

In December 2008, the Council requested the Commission as well to provide a report 
on  the  socio-economic  implications  of  GMOs.  This  report  should  be  based  on 
information  provided  by  Member  States,  which  have  made  an  important  effort  to 
compile information on the socio-economic implications of GMOs and, notably, of 
their  cultivation.  The  Commission  will  finalize  its  report  by  the  end  of  2010.  This 
report  will  then  be  submitted  to  the  European  Parliament  and  to  the  Council  for 
consideration and further discussion. 

As  part  of  broader  regular  exercises  of  revision  of  EU  legislation,  the  Commission 
has  launched  two  evaluations  in  order  to  assess  the  EU  legislative  framework  on 
GMOs: one on GM food and feed, the other on the cultivation of GMOs. The scope 
of these evaluations covers the major aspects of the legislative framework. The two 
evaluations will be finalised in the last quarter of 2010 and will be followed by an 
analysis of possible policy changes by mid-2012. 

The  2008  Conclusions  discussed  as  well  at  some  length  regional  aspects  of  GMO 
cultivation,  both  in  the  context  of  the  scientific  risk  assessment  and  of  particular 
socio-economic  implications.  Some  Member  States  have  since  called  on  the 
Commission  to  prepare  proposals  to  give  freedom  to  Member  States  to  decide  on 
cultivation of GMOs. 

Against this background, the political guidelines for the new Commission set out by 
President  Barroso  in  September  2009  and  endorsed  by  the  Commission  in  March 
2010, indicated that it should be possible to combine a European Union authorisation 
system, based on science, with freedom for Member States to decide whether or not 
they wish to cultivate GM crops on their territory. 

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The objective of this Communication is to clarify how to implement the freedom for 
Member  States  through  an  approach  that  combines  a  revision  of  the  existing 
recommendation  on  coexistence,  recognising  that  Member  States  need  more 
flexibility, with a modification of the existing legislative framework. 

2. 

A MORE FLEXIBLE APPROACH UNDER THE EXISTING LEGISLATION  

2.1. 

The way forward: increase of flexibility for Member States on GMO cultivation 

In line with Article 26a of Directive 2001/18/EC, Member States are entitled to take 
appropriate measures to avoid the unintended presence of GMOs in other products. 
Given the diversity of national, regional and local conditions under which European 
farmers  work,  the  Commission  has  always  considered  that  measures  to  avoid  the 
unintended  presence  of  GMOs  in  conventional  and  organic  crops  should  be 
developed and implemented by the Member States. 

to  avoid 

that  presence, 

In  an  attempt  to  support  Member  States  in  the  process  of  developing  national 
measures 
in  2003 
Recommendation  2003/556/EC  on  guidelines  for  the  development  of  national 
strategies and best practices to ensure the co-existence of genetically modified crops 
with conventional and organic farming7. The purpose of such national measures is to 
avoid  the  potential  economic  impact  of  the  admixture  of  GM  and  non-GM  crops 
(conventional and organic).  

the  Commission  published 

Experience gained over the last years shows that the approach applied on the basis of 
Recommendation  2003/556/EC  does  not  exhaust  the  provisions  of  Article  26a  of 
Directive  2001/18/EC,  notably  as  concerns  the  Member  States'  entitlement  to  set 
measures  to  avoid  the  unintended  presence  of  GMOs  in  other  products.  This  is 
supported by the observation of the developments regarding GMO cultivation in the 
Member States. At present some Member States have adopted national co-existence 
measures that aim at reaching levels of presence of GMOs in other crops lower than 
0.9%.  Other  Member  States  have  provided  different  isolation  requirements  for 
organic  production.  In  concrete  terms,  experience  with  the  implementation  of  the 
2003  Recommendation  shows  that  the  potential  loss  of  income  for  organic  and 
(sometimes) conventional producers is not limited to exceeding 0.9%.  

Since  certain  types  of  agriculture  production  such  as  organic  production8  are  often 
more costly, the possibility of losing the associated price premium due to unintended 
presence  of  GMOs  may  entail  important  economic  damages  to  these  types  of 
production.  Therefore  such  production  may  require  stricter  segregation  efforts.  In 
addition, local constraints and characteristics may render these particular segregation 
needs very difficult and costly to be met efficiently in some regions.  

Furthermore,  in  certain  cases,  and  depending  on  market  demand  and  on  the 
respective  provisions  of  national  legislations  (e.g.  some  Member  States  have 

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OJ L 189, 29.07.2003, p. 36. 
In  accordance  with  Regulation  (EC)  No  834/2007  on  organic  production  and  labelling  of  organic 
products, GMOs shall not be used in organic production, including as seeds, food or feed (Article 9(1)). 
The aim is to have the lowest possible presence of GMOs in organic products (see Recital 10). 

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developed  national  standards  for  different  types  of  "GM-free"  labelling),  the 
presence  of  traces  of  GMOs  in  particular  food  products  –even  at  a  level  close  to 
0.9%- may cause economic damages to operators who would wish to market them as 
non containing GMOs. 

From the above, it appears that it is appropriate to revise the 2003 Recommendation 
on co-existence and replace it with a new one to reflect the experience gained with 
national measures on GMO cultivation so far and make it more flexible.  

The  new  Recommendation  further  refers  to  the  possibility  for  Member  States  to 
restrict  GMO  cultivation  from  large  areas  of  their  territory  to  avoid  the  unintended 
presence of GMOs on conventional and organic crops ("GM-free areas"). However, 
this possibility has to rest on the demonstration by Member States that for those areas 
other  measures  are  not  sufficient  to  prevent  the  unintended  presence  of  GMOs  in 
conventional  or  organic  crops.  Moreover,  the  restriction  measures  need  to  be 
proportionate  to  the  objective  pursued  (i.e.  protection  of  particular  needs  of 
conventional or organic farming).  

To  these  ends,  the  new  Recommendation  on  guidelines  for  the  development  of 
national  co-existence  measures  (annexed)  limits  its  content  to  the  main  general 
principles  for  the  development  of  measures  to  avoid  GMO  admixture  thereby 
recognising the flexibility for Member States to take into account their regional and 
national specificities and the particular local needs of organic, conventional and other 
types  of  crops.  This  Recommendation  is  adopted  by  the  Commission  together  with 
this  Communication.  The  Commission  will  continue  to  develop  together  with 
Member  States  best  practices  for  co-existence  (work  of  the  European  Coexistence 
Bureau).  

2.2. 

Other elements linked to the EU framework of GMO authorisation 

It should also be noted that the existing legislative framework on GMOs consists of a 
clear  European  Union  wide  authorisation  system,  based  on  a  scientific  risk 
assessment.  It  is  possible  in  principle  to  differentiate  between  regions  in  the  risk 
assessment,  on  the  basis  of  scientific  arguments9.  If  the  risk  assessment  concludes 
that  the  cultivation  of  a  GMO  raises  particular  regional  concerns,  these  concerns 
must  be  addressed  in  the  EU  authorisation  through  specific  conditions  or  risk 
management  measures.  Such  measures  may  include  restriction  or  prohibition 
measures, if scientifically justified.  

Regulation (EC) No 1829/2003 also provides for the possibility for the Commission 
to  take  into  account  legitimate  factors  other  than  science  in  the  context  of  the 
procedure of authorisation of GMOs to restrict or prohibit their placing on the market 
However,  justifications  for  such  restrictions  need  to  be  specific  to  each  GMO  and 
can  only  be  taken  into  account  at  the  moment  of  the  adoption  of  the  decision  of 
authorisation  of  the  GMO  in  question.  In  addition  this  possibility  does  not  exist 
under Directive 2001/18/EC and would thus not be applicable to GMOs authorised 
under this Directive. 

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In  line  with  Article  19(3)(c)  and  Annex  II  of  Directive  2001/18/EC  and  Article  6  and  Article  18  of 
Regulation (EC) No 1829/2003. 

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Therefore, it appears that the existing framework within which scientific arguments 
or  other  legitimate  factors  may  be  applied  to  justify  restrictions  or  prohibitions  of 
GMO  cultivation,  does  not  provide  the  necessary  freedom  for  Member  States  to 
decide whether or not they wish to cultivate GMOs in their territory on the basis of 
their specific conditions.  

3. 

LEGISLATIVE AMENDMENT TO INTRODUCE AN "OPT-OUT CLAUSE" 

A certain number of Member States want to have the possibility to opt-out from GM 
cultivation.  So  far,  several  of  these  Member  States  have  banned  the  cultivation  of 
GMOs  on  the  basis  of  the  safeguard  clause  set  out  in  Article  23  of  Directive 
2001/18/EC or the emergency measures referred to in Article 34 of Regulation (EC) 
No  1829/2003,  which  are  solely  intended  to  address  new  risks  emerging  after  an 
authorisation has been granted. As a result, these measures were not considered to be 
scientifically  justified  by  the  European  Food  Safety  Authority  (EFSA).  Similarly  a 
certain number of regions have declared themselves to be “GM-free”.  

The reasons for banning GMOs in a country or declaring a region GM-free appears 
to be diverse. These reasons vary from agronomic justifications related to difficulties 
of  ensuring  co-existence  to  political  or  economic  motivations  such  as  meeting  the 
demand of GM-free markets. In other cases, Member States want to preserve certain 
areas in line with national policies on biodiversity or other broad nature conservation 
goals.  

The  Netherlands  submitted  a  declaration  to  the  23  March  2009  Agriculture  and 
Environment Councils10 asking the Commission to come forward with a solution on 
cultivation  while  taking  into  account  the  socio-economic  dimension  of  GMO 
cultivation and keeping the internal market for GM food and feed products. Austria, 
supported  by  twelve  Member  States11,  presented  in  the  Environment  Council  of 
25 June 2009 a paper12 that underlined the subsidiarity issue linked to cultivation and 
suggested an opt-out clause for cultivation to be introduced in the legislation.  

In this context it appears appropriate to amend EU legislation in order to provide in 
the EU legislative framework on GMOs an explicit legal base to authorise Member 
States  to  restrict  or  prohibit  the  cultivation  of  all  or  particular  authorised  GMO  in 
part  or  all  of  their  territories  on  the  basis  of  their  specific  conditions.  This 
amendment  can  be  done  through  the  inclusion  of  a  new  Article  26b  in  Directive 
2001/18/EC  and  would  be  applicable  to  all  GMOs  which  have  been  authorised  for 
cultivation  in  the  EU,  being  under  Directive  2001/18/EC  or  under  Regulation  (EC) 
No 1829/2003. 

According  to  the  legal  framework  for  the  authorisation  of  GMOs,  the  level  of 
protection of human/animal health and of the environment chosen in the EU cannot 
be revised by a Member State and this situation must not be altered. However, with 
the  new  legal  base,  Member  States  will  be  able  to  adopt  measures  restricting  or 
prohibiting the cultivation of all or particular GMOs in all or part of their territory on 

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Note with ref. 7581/09 of the Council of the European Union. 
BG, IE, EL, CY, LV, LT, HU, LU, MT, NL, PL and SI. 
Note with ref. 11226/2/09 REV 2 of the Council of the European Union. 

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the basis of grounds other than those already addressed by the harmonised set of EU 
rules which already provide for procedures to take into account the risks that a GMO 
for cultivation may pose on health and the environment.  

Moreover, these national measures will have to be in conformity with the Treaties in 
particular  the  principle  of  non  discrimination  between  national  and  non  national 
products  and  Articles  34  and  36  of  the  Treaty  on  the  Functioning  of  the  European 
Union  concerning  the  free  circulation  of  goods.  Measures  should  refer  to  the 
cultivation  of  GMOs  only  and  not  to  the  free  circulation  and  import  of  genetically 
modified  seeds  and  plant  propagating  material  and  the  products  of  their  harvest. 
These  measures  shall  also  be  consistent  with  EU  international  obligations,  notably 
those  in  the  context  of  the  World  Trade  Organisation.  To  ensure  transparency, 
Member  States  which  intend  to  adopt  measures  will  have  to  communicate  them, 
together with their reasons, to the Commission and to the other Member States one 
month prior to their adoption. 

Member  States  would  be  further  free  to  amend  these  measures  as  they  deem 
appropriate  at  all  stages  of  the  authorisation  or  re-authorisation  of  the  concerned 
GMOs.  

In summary, this new legal basis does not change the system of EU authorisations of 
GMOs  but  it  would  allow  Member  States  to  adopt  measures  which  would  be 
applicable to GMOs which have been authorised under the existing legislation. It is 
thus a further option for Member States to adopt measures in relation to authorised 
GMOs,  in  addition  to  the  measures  that  they  are  already  entitled  to  take  by 
application of Article 26a of Directive 2001/18/EC to avoid the unintended presence 
of GMOs in other crops. 

Therefore, and on the basis of the above principles, the Commission has decided to 
submit to the European Parliament and the Council a legislative proposal which takes 
the form of a Regulation amending Directive 2001/18/EC as regards the possibility 
for  the  Member  States  to  restrict  or  prohibit  the  cultivation  of  GMOs  in  their 
territory. 

4. 

CONCLUSIONS 

The Commission considers that this new approach is necessary to achieve the right 
balance  between  maintaining  the  EU  system  of  authorisations  based  on  scientific 
assessment  of  health  and  environmental  risks  and  the  need  to  grant  freedom  to 
Member  States  to  address  specific  national,  regional  or  local  issues  raised  by  the 
cultivation of GMOs. 

As  a  first  step  a  revision  of  the  existing  Recommendation  on  co-existence 
(2003/556/EC) will better reflect the possibilities offered to Member States to adopt 
measures to avoid unintended presence of GMOs in conventional and organic crops 
in accordance with the existing legislative framework.  

In a second step, the adoption of the legislative proposal providing the possibility for 
Member States to restrict or prohibit, under certain conditions, the cultivation of all 
or particular GMOs in part or all their territory by the European Parliament and the 

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Council  will  offer  the  possibility  to  Member  States  to  address  specific  national  or 
local  issues  raised  by  the  cultivation  of  GMOs  independently  of  the  authorisation 
process.  This  approach  on  GMO  cultivation,  while  preserving  the  European  Union 
authorisation  system  of  GMOs,  which  will  continue  to  apply,  as  well  as  the  free 
circulation  and  import  of  GM  food,  feed  and  seeds,  is  expected  to  address  the 
demands of several Member States, and receive stakeholders and public support. It is 
also in line with the observation of the reality of Member States' practice on GMO 
cultivation  so  far  and  the  principle  of  subsidiarity  and  proportionality.  Meanwhile, 
the  Commission  will  continue  to  apply  the  existing  EU  legislative  framework  on 
GMOs.  In  this  context,  and  in  line  with  Article  31  of  Directive  2001/18/EC,  the 
reports  on  the  implementation  of  the  Directive  will  pay  particular  attention  to 
experience acquired with regard to Article 26a and 26b.  

The new Recommendation on guidelines for the development of national cultivation 
measures  to  avoid  the  unintended  presence  of  GMOs  in  conventional  and  organic 
crops  and  a  legislative  proposal  modifying  Directive  2001/18/EC  as  regards  the 
possibility for the Member States to restrict or prohibit the cultivation of GMOs in 
their territory, are annexed to this Communication. 

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