Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
Date: 2010-07-13
Institutions: European Commission
Subjects: approximation of laws, consumer protection, crop production, environmental protection, genetically modified organism, health policy, marketing

EN 

EN 

   EN 

 
EUROPEAN COMMISSION 

Brussels, 13.7.2010 
COM(2010) 375 final 

2010/0208 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directive 2001/18/EC as regards the possibility for the Member States to 
restrict or prohibit the cultivation of GMOs in their territory 

{COM(2010) 380 final} 

EN 

   EN 

 
 
  
EXPLANATORY MEMORANDUM  

1. 

Context of the proposal 

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 for food 
and  feed  purposes,  industrial  processing  and  cultivation,  and  their  derived  products 
for food and feed uses.  

The  European  Union  authorisation  system  is  aimed  at  avoiding  adverse  effects  of 
GMOs  on  human  and  animal  health  and  the  environment  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 establish science based standards for the assessment of potential risks 
for  human  health,  animal  health  and  the  environment  as  well  as  labelling 
requirements.  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  Council  Conclusions  of  December  2008  considered  the  existing  legislative 
framework  on  GMOs  comprehensive  and  underlined  the  need  to  better  implement 
the existing provisions, notably as concerns cultivation. It also noted the necessity of 
continuing  processing  applications  without  undue  delays.  In  March  2009,  the 
Council  rejected  Commission's  proposals  requesting  Austria  and  Hungary  to  repeal 
their  national  safeguard  measures,  as  according  to  the  European  Food  Safety 
Authority (EFSA) they lacked the necessary scientific support needed under the EU 
legislation. Subsequently, a group of 13 Member States4 called on the Commission to 
prepare  proposals  to  give  freedom  to  Member  States  to  decide  on  cultivation  of 
GMOs5.  

In  September  2009  the  political  guidelines  for  the  new  Commission  set  out  by 
President Barroso made reference to the principle of subsidiarity in the GMO area as 
an  example  where  the  balance  may  not  be  always  right  between  an  EU  framework 
and the need to take account of diversity in an EU of 27 Member States. According 
to these guidelines, it should be possible to combine a European Union authorisation 
system  for  GMOs,  based  on  science,  with  freedom  for  Member  States  to  decide 
whether or not they wish to cultivate GM crops on their territory. 

The proposed Regulation aims at implementing these guidelines by providing a legal 
base in the EU legal framework on GMOs to authorise Member States to restrict or 
prohibit the cultivation of GMOs that have been authorised at EU level in all or part 
of their territory. Those prohibitions or restrictions shall be based on grounds other 

1 
2 
3 
4 
5 

OJ L 106, 17.4.2001, p. 1. 
OJ L 268, 18.10.2003, p. 1. 
OJ L 268, 18.10.2003, p. 24. 
AT, BG, IE, EL, CY, LV, LT, HU, LU, MT, NL, PL and SI. 
Respective discussions took place at Council meetings of 2 March, 23 March and 25 June 2009. 

EN 

2 

   EN 

                                                   
than  those  covered  by  the  environmental  and  health  risk  assessment  under  the  EU 
authorisation system. 

2. 

Preferred option and assessment of its impacts 

2.1.  Reasons  for  modification  of  EU  legislative  framework  compared  to  other 

options 

A.  The current legislative framework does not fully address the need to give 
more freedom to Member States on cultivation of GMOs, as it does not 
grant them sufficient flexibility to decide on GMO cultivation after they 
have been authorised at EU level. 

The  replacement  of  the  Recommendation  for  co-existence6  by  a 
Recommendation on guidelines for the development of national measures 
to avoid the unintended presence of  GMOs in conventional and organic 
crops  complements  the  steps  towards  recognising  Member  States'  need 
for  flexibility  to  take  into  consideration  the  particular  conditions  of 
the  new 
agriculture 
Recommendation,  which  mirrors  Article  26a  of  Directive  2001/18/EC7, 
can only refer to measures aimed at avoiding the unintended presence of 
GMOs  in  other  crops,  which  offer  fewer  margins  for  Member  States  to 
decide than under a comprehensive legal amendment.  

territory.  However 

the  scope  of 

their 

in 

the 

linked 

Some  further  elements 
the  EU  framework  of  GMO 
to 
authorisations  could  give  margin  to  consideration  of  specific  conditions 
of cultivation in Member States. Those could be (i) the consideration of 
regional  aspects  under 
risk  assessment  and  conditions  of 
authorisations  or  (ii)  the  consideration  of  other  legitimate  factors  under 
the Regulation. However those options would only have an impact on the 
way  in  which  authorisations  are  adopted  at  EU  level.  Moreover  the 
framework  within  which  those  elements  may  be  applied  appears  too 
restrictive. Therefore they would not fulfil the central notion of allowing 
Member  States  to  decide  on  GMO  cultivation  taking  into  consideration 
their specific conditions. 

The fact that Member States have currently no margin of appreciation on 
cultivation  of  authorised  GMOs  has  led  in  several  cases  some  Member 
States to vote on the basis of non-scientific grounds. Some of them have 
also  invoked  the  available  safeguard  clauses,  or  used  the  special 
notification procedures of the Treaty under the internal market, as ways 
to prohibit the cultivation of GMOs at national level. 

6 

7 

Commission Recommendation of 23 July 2003 on guidelines for the development of national strategies 
and best practices to ensure the coexistence of genetically modified crops with conventional and organic 
farming . 
According to Article 26a(1) of Directive 2001/18/EC, "Member States may take appropriate measures 
to avoid the unintended presence of GMOs in other products". 

EN 

3 

   EN 

 
 
 
                                                   
B.  Therefore an amendment to the existing EU legislative framework would 
be  necessary  to  facilitate  decision  making  and  take  into  account  all 
relevant  factors.  It  is  also  expected  to  reduce  the  recourse  of  Member 
States  to  safeguard  measures,  which  according  to  the  legislation  must 
only be based on new or additional scientific evidence with regards to the 
health  and  environment  safety  of  the  GMO.  This  would  reduce  the 
institutional burdens on the Commission as well as on EFSA. Moreover 
Member States would not invoke the procedure of Article 114(5) of the 
Treaty  on  the  Functioning  of  the  European  Union  (TFEU)  in  order  to 
prohibit  or  restrict  the  cultivation  of  GMOs  in  their  territories  on  the 
basis  of  considerations  other  than  health  and  environmental  protection. 
Moreover, the proposed amendment is expected to provide legal certainty 
to  Member  States  that  wish  to  restrict  or  prohibit  GMO  cultivation. 
Finally  it  will  offer  greater  clarity  to  affected  stakeholders  (e.g.  GMO 
farmers, 
seed 
producers/exporters/importers,  livestock  breeders,  feed  processors  and 
consumers and biotechnology companies,) about cultivation of GMOs in 
the  EU  and  will  possibly  increase  the  predictability  of  the  decision-
making process. 

conventional 

farmers, 

farmers, 

organic 

2.2.  Economic, social and environmental impacts of the proposal 

GMO  cultivation  in  the  EU  has  been  very  limited  up  to  date.  Therefore  it  is 
difficult  to  make  ex  ante  a  precise  quantification  of  the  possible  economic, 
social and environmental impacts in case Member States are allowed to decide 
to prohibit/restrict cultivation.  

2.2.1. Economic impacts 

The proposal does not affect the EU authorisation process for GMOs and 
the  Commission  will  continue  to  process  applications  for  cultivation  in 
accordance with existing rules. Therefore the proposal will not entail any 
direct  impacts  for  applicants.  This  concerns  17  applications  currently 
pending for authorisation or re-authorisation (mainly maize)8. 

A.  Continuation of existing trends - GM crop and seed production in 

the EU 

On the basis of the current limited experience of cultivation in the 
EU, it is expected that the production of GM seeds and cultivation 
of  GMOs  in  the  EU  will  mainly  take  place  in  the  Member  States 
which have already experienced cultivation on their territories. The 
overall  pace  at  which  GM  cultivation  could  proceed  in  the  EU  is 
alreadyunclear under different scenarios established on the basis of 
the  existing  legislative  framework9.  Farmers'  adoption  will  be  the 
result  of  a  trade-off  between,  on  the  one  hand,  expected 
productivity  gain  or  market  opportunities  and,  on  the  other  hand, 

8 
9 

14 for maize, one for soybean, one for sugar beet and one for potato. 
"The  economics  of  adventitious  presence  thresholds  in  the  EU  seed  market",  Kalaitzandonakes, 
Magnier; working paper, June 2007. 

EN 

4 

   EN 

 
 
 
                                                   
possible constraints such as higher prices for GM seeds, premium 
for  non-GM  products,  possible  market  rejection10  and  cost  of 
national co-existence and liability measures. Managing segregation 
will  be  more  demanding  in  regions  where  conventional  seed 
production  overlaps  with  high  shares  of  GM  seed  or  GM  crop 
production. 

B.  Marketing of GM seeds 

This  proposal  concerns  the  freedom  of  Member  States  to 
prohibit/restrict the act of cultivation of GM varieties only, but not 
the  free  marketing  of  authorised  GM  seeds  throughout  the  EU  or 
imports  of  such  seeds  from  third  countries  once  they  have  been 
authorised at EU level.  

C.  Effects  on  other  types  of  production  and  downstream  operators  / 

users 

With regards to other types of production, the possibility to exclude 
GMOs  from  specific  areas  and 
the  clustering  of  different 
production chains may benefit operators and consumers of organic 
or  conventional  products  and  reduce  the  segregation  costs.  It  is 
difficult to assess the effect on final consumer prices. However it is 
expected  that  consumers'  and  operators'  choice  between  three 
different  types  products  -  organic,  conventional  and  GM  -  would 
increase.  

D.  Effects on administrative costs 

This option is expected to reduce the number of national safeguard 
measures, therefore reducing the administrative burden for Member 
States,  EFSA  or  the  Commission  and  the  procedures  linked  to 
them. On the other hand, it might increase the administrative costs 
for  Member  States  in  their  endeavours  to  enforce  potential 
restrictions  or  prohibitions  of  GMO  cultivation.  As  under  the 
current  situation,  in  Member  States,  where  cultivation  would  take 
place, resources for inspections, controls and monitoring, especially 
at  field  level,  will  be  required  to  ensure  that  post-market 
requirements are properly implemented. 

2.2.2. Social impacts 

As  the  overall  cultivation  surface  is  not  expected  to  change  under  the 
current proposal, it is expected that the proposal will have no significant 
impact on jobs.  

10 

According to the 2006 Commission implementation report of Regulation (EC) No 1829/2003, the EU 
market  shares  of  labelled  GM  food  and  feed  products  appear  to  be  contrasted.  Labelled  GM  feed 
products  are  much  more  placed  on  the  market  than  GM  food.  This  situation  is  mainly  governed  by 
factors  that  are  not  related  to  the  legislative  framework  as  such  but  by  other  elements  including 
consumer demand, relative availability and costs of different commodities on the world market, and the 
policies of food producers and retailers.  

EN 

5 

   EN 

 
 
 
 
                                                   
Given the more national or regional approach towards GMO cultivation, 
it is also expected that the level of public involvement in the national and 
regional  decision  making  will  increase  and  Member  States  will  allocate 
more  resources  and  time  to  involve  their  public  with  regards  to  their 
decisions. Social, economic and ethical aspects are expected to be put on 
the table and provide the platform for the respective decisions at national, 
regional or local level. 

2.2.3. Environmental impacts 

Potential  health  and  environmental  risks  of  each  GMO  will  continue 
being assessed by EFSA at EU level and on a case-by-case basis. EFSA 
will adopt the respective opinions after taking into account the scientific 
contributions  of  the  national  competent  authorities,  especially  with 
respect to regional aspects.  

As under the current situation, in the areas where GMO cultivation will 
take  place,  risk  management  and  monitoring  of  potential  environmental 
effects  may  be  needed  on  the  basis  of  the  respective  risk  assessments. 
This might require the active involvement of national/regional authorities 
and  other  networks  (e.g.  farmers  or  scientists)  to  provide  the  most 
effective possible results. 

2.3.  Conclusion 

The Commission considers that the amendment of the legislation is necessary 
to get the right balance between maintaining the EU  system of authorisations 
based  on  the  scientific  assessment  of  health  and  environmental  risks  and  the 
need  to  grant  freedom  to  Member  States  to  address  specific  national  or  local 
aspects raised by the cultivation of GMOs. This approach, while preserving the 
EU authorisation system of GMOs 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 public support. It is also estimated that the potential 
economic  and  social  benefits  of  this  proposal  are  likely  to  outweigh  the 
potential disadvantages. 

Member  States  may  be  in  a  more  appropriate  position  to  carry  out  their  own 
impact assessments to justify their decisions about cultivation of GMOs in their 
territories at national/regional/local levels. 

3. 

Legal elements of the proposal  

3.1.  Content of the proposal 

The  proposal  amends  Directive  2001/18/EC  by  introducing  a  new  Article 
which allows Member States to restrict or prohibit the cultivation of authorised 
GMOs in part or all of their territories on grounds other than those covered by 
the environmental risk assessment under the EU authorisation system and those 
related to avoiding the unintended presence of GMOs in other products.  

EN 

6 

   EN 

 
 
 
 
 
 
This  amendment  will  apply  to  GMOs  authorised  for  cultivation  either  under 
Directive  2001/18/EC  or  Regulation  (EC)  No  1829/2003  which  also  covers 
applications for cultivation if they concern GMOs that are intended as source 
materials  for  the  further  production  of  food  and  feed.  It  will  equally  apply  to 
cultivation of all varieties of seed and plant propagating material placed on the 
market in accordance with relevant EU legislation11. 

The  freedom  which  Member  States  will  obtain  will  only  concern  the  act  of 
GMO cultivation,  but not the placing on the market and import of authorised 
GM  seeds  which  must  continue  unimpeded  within  the  framework  of  the 
internal market and the respective international obligations of the Union. The 
proposal sets out two series of conditions under which Member States can take 
measures: 

1.  As  the  assessment  of  the  safety  of  GMOs  for  human/animal  health  and 
the  environment  is  carried  out  at  EU  level,  Member  States  have  the 
possibility  under  the  existing  legal  framework  to  invoke  the  special 
procedures of the safeguard clause of Directive 2001/18/EC (Article 23) 
or the emergency measure of Regulation (EC) No 1829/2003 (Article 34) 
in case they have serious grounds to consider that the authorised product 
is  likely  to  constitute  a  serious  risk  to  health  and  environment. 
Consequently, the proposal stipulates that Member States cannot invoke 
protection  of  health  and  environment  to  justify  a  national  ban  of 
cultivation  of  GMOs  outside  these  special  procedures.  This  condition 
aims  at  preserving  the  authorisation  system  based  on  science  set  out  in 
EU legislation. 

2.  Member States can thus invoke grounds (other than those covered by the 
environmental  risk  assessment  under  the  EU  authorisation  system)  to 
restrict or prohibit cultivation of GMOs in their territories. The measures 
taken by the Member States have to be in conformity with the Treaty on 
European  Union  (TEU)  and  the  Treaty  on  the  Functioning  of  the 
European  Union  (TFEU),  in  particular  as  regards  the  principle  of  non-
discrimination  between  national  and  non-national  products  and  the 
provisions  on  quantitative  restrictions  of  trade  between  Member  States 
(Articles  34  and  36  TFEU).  They  should  finally  be  consistent  with  the 
international  obligations  of  the  EU,  and  in  particular  with  the  ones 
established under the World Trade Organisation (WTO). 

11 

Directives 2002/53/EC and 2002/55/EC. 

EN 

7 

   EN 

 
 
                                                   
3.2.  Choice of the instrument 

The  proposal  is  under  the  form  of  a  Regulation,  even  though  it  amends  a 
Directive. 

The reason of this choice is that the proposal has general application, is binding 
in  its  entirety  and  is  directly  applicable  in  all  Member  States.  In  addition,  it 
does not contain in substance any provision that would require transposition as 
it only provides to the Member States a legal base to adopt measures.  

3.3.  Subsidiarity and proportionality principle 

3.3.1. Conformity of the proposal with the principle of subsidiarity. 

According  to  Article  5(3)  TEU,  under  the  principle  of  subsidiarity,  in 
areas which do not fall within its exclusive competence, the Union shall 
act only if and in so far as the objectives of the proposed action cannot be 
sufficiently  achieved  by  the  Member  States,  either  at  central  level  or  at 
regional and local level, but rather, by reason of the scale of effects of the 
proposed action, be better achieved at Union level.  

Following  Article  2(2)  TFEU,  when  the  Treaties  confer  on  the  Union  a 
competence shared with the Member States in a specific area, the Union 
and  the  Member  States  may  legislate  and  adopt  legally  binding  acts  in 
that area. In accordance with the last sentence of this provision, Member 
States shall again exercise their competence to the extent that the Union 
decides to cease its competence. 

The current EU legal framework fully harmonises cultivation of GMOs. 
Member States are thus allowed to adopt reasoned measures restricting or 
prohibiting the cultivation of GMOs only under the conditions set out in 
that  legal  framework  (essentially  the  safeguard  clauses  and  emergency 
measures  provisions  when  a  serious  risk  to  health  and  environment  is 
identified, and Article 26a of Directive 2001/18/EC to avoid the presence 
of authorised GMOs in other products). 

Experience  however  has  shown  that  cultivation  of  GMOs  is  an  issue 
which is more thoroughly addressed by Member States, either at central 
level or at regional and local level. It is closely linked to land use and the 
requirements  of  local  agricultural  structures,  separate  production  chains 
and  consumers'  demands.  Contrary  to  the  safety  assessment  of  GMOs, 
whose principles are common throughout the EU, or to issues related to 
the  imports  and  marketing  of  GMOs,  which  should  remain  regulated  at 
EU  level,  GMO  cultivation  has  been  acknowledged  as  an  issue  with  a 
strong  local/regional  dimension.  As  such,  national,  regional  or  local 
levels  of  decision  making  are  considered  to  be  the  most  appropriate 
frameworks to address the particularities linked to GMO cultivation. 

In  line  with  the  principle  of  subsidiarity  and  by  application  of 
Article 5(3) last sentence of the TEU, Member States should therefore be 
entitled to conserve a possibility to adopt rules concerning cultivation of 
GMOs in their territories after the GMO has been legally placed on the 

EN 

8 

   EN 

 
 
 
 
 
 
 
EU  market,  provided  that  these  measures  do  not  affect  their  placing  on 
the market and import and that they are in conformity with the Treaties 
and  with  the  EU  international  commitments,  and  more  particularly  the 
obligations under the World Trade Organisation (WTO).  

3.3.2. Conformity of the proposal with the principle of proportionality 

According to Article 5(4) TEU, under the principle of proportionality, the 
content and form of Union action shall not exceed what is necessary to 
achieve the objectives of the Treaties. 

The  content  of  the  Union  action  in  the  proposal  is  limited  to  allow 
Member  States  to  adopt  reasoned  measures  on  cultivation  of  GMOs. 
Within  the  limits  foreseen  by  the  proposal  (namely  that  national 
measures taken by Member States shall not be based on grounds covered 
by  the  environmental  risk  assessment  under  the  EU  authorisation  and 
shall respect the Treaties and relevant international obligations) it should 
not  prevent  the  EU  to  achieve  the  objectives  of  the  Treaties.  Measures 
adopted by Member States could  refer  to  the  cultivation  of GMOs  only 
and  not  to  the  free  circulation  and  import  of  genetically  modified  seeds 
and  plant  propagating  material,  as  or  in  products,  and  the  products  of 
their harvest. 

In addition, it is expected to bring about no additional costs to involved 
stakeholders  (such  as  biotech  companies  or  farmers)  and  consumers 
compared  to  the  current  situation.  Some  Member  States  might  need  to 
allocate  some  more  administrative  resources  to  address  potentially 
increased needs for inspections and controls; however those costs are not 
expected  to  be  excessive  or  unjustifiable.  The  further  economic,  social 
and  environmental  impacts  indicated  above  indicate  that  no  excessive 
burdens,  costs  or  disadvantages  are  going  to  be  caused  to  operators, 
consumers or any other side in comparison to the current situation. 

4. 

Budgetary implications 

This  proposal  for  a  European  Parliament  and  Council  Regulation  has  no  financial 
implications for the Union budget. 

This proposal will have no impact on small or medium-sized undertakings different 
than the impact of the current situation. 

EN 

9 

   EN 

 
 
 
2010/0208 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directive 2001/18/EC as regards the possibility for the Member States to 
restrict or prohibit the cultivation of GMOs in their territory 

(Text with EEA relevance)  

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 […] thereof, 

Having regard to the proposal from the European Commission, 

Having regard to the opinion of the European Economic and Social Committee12, 

Having regard to the opinion of the Committee of the Regions13, 

After transmission of the proposal to the national Parliaments, 

Acting in accordance with the ordinary legislative procedure14, 

Whereas:  

(1) 

(2) 

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/EEC15 and Regulation (EC) No 1829/2003 of 
the  European  Parliament  and  of  the  Council  of  22  September  2003  on  genetically 
modified  food  and  feed16  establish  a  comprehensive  legal  framework  for  the 
authorisation of genetically modified organisms (GMOs), which is fully applicable to 
GMOs to be used for cultivation purposes throughout the EU as seeds or other plant-
propagating material (hereinafter 'GMOs for cultivation'). 

Under  this  set  of  legislation,  GMOs  for  cultivation  shall  undergo  an  individual  risk 
assessment before being authorised to be placed on the Union market. The aim of this 
authorisation  procedure  is  to  ensure  a  high  level  of  protection  of  human  life  and 
health,  animal  health  and  welfare,  the  environment  and  consumer  interests,  whilst 
ensuring the effective functioning of the internal market.  

12 
13 
14 
15 
16 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ L 106, 17.4.2001, p. 1. 
OJ L 268, 18.10.2003, p. 1. 

EN 

10 

   EN 

                                                   
(3) 

(4) 

(5) 

In  addition  to  the  authorisation  for  placing  on  the  market,  genetically  modified 
varieties also need to comply with the requirements of EU legislation on the marketing 
of  seed  and  plant  propagating  material,  as  set  out  in  particular  in  Council  Directive 
66/401/EEC  of  14 June  1966  on  the  marketing  of  fodder  plant  seed17,  Council 
Directive  66/402/EEC  of  14 June  1966  on  the  marketing  of  cereal  seed,  Council 
Directive  2002/53/EC  of  13  June  2002  on  the  common  catalogue  of  varieties  of 
agricultural  plant  species18,  Council  Directive  2002/54/EC  of  13  June  2002  on  the 
marketing  of  beet  seed19,  Council  Directive  2002/55/EC  of  13  June  2002  on  the 
marketing of vegetable seed20, Council Directive 2002/56/EC of 13 June 2002 on the 
marketing  of  seed  potatoes21,  Council  Directive  2002/57/EC  of  13  June  2002  on  the 
marketing of seed of oil and fibre plants22, Council Directive 68/193/EEC of 9 April 
1968 on the marketing of material for the vegetative propagation of the vine23, Council 
Directive  98/56/EC  of  20  July  1998  on  the  marketing  of  fruit  plant  propagating 
material of ornamental plants24, Council Directive 99/105/EC of 22 December 1999 on 
the marketing of forest reproductive material25 and Council Directive 2008/90/EC of 
29 September  2008  on  the  marketing  of  fruit  plant  propagating  material  and  fruit 
plants  intended  for  fruit  production26.  Among  them  Directives  2002/53/EC  and 
2002/55/EC  contain  provisions  which  allow  the  Member  States  to  prohibit,  under 
certain well defined conditions, the use of a variety in all or in parts of its territory or 
to lay down appropriate conditions for the cultivation of a variety. 

Once  a  GMO  is  authorised  for  cultivation  purposes  in  accordance  with  the  EU 
legislative  framework  on  GMOs  and  complies,  as  regards  the  variety  that  is  to  be 
placed on the market, with the requirements of EU legislation on the marketing of seed 
and plant propagating material, Member States are not authorised to prohibit, restrict, 
or impede its free circulation within their territory, except under the conditions defined 
by EU legislation. 

Experience has shown that cultivation of GMOs is an issue which is more thoroughly 
addressed by Member States, either at central or at regional and local level. Contrary 
to issues related to the placing on the market and the import of GMOs, which should 
remain  regulated  at  EU  level  to  preserve  the  internal  market,  cultivation  has  been 
acknowledged as an issue with a strong local/regional dimension. In accordance with 
Article 2(2) TFEU Member States should therefore be entitled to have a possibility to 
adopt  rules  concerning  the  effective  cultivation  of  GMOs  in  their  territory  after  the 
GMO has been legally authorised to be placed on the EU market. 

(6) 

In this context, it appears appropriate to grant to Member States, in accordance with 
the  principle  of  subsidiarity,  more  freedom  to  decide  whether  or  not  they  wish  to 
cultivate  GMO  crops  on  their  territory  without  changing  the  system  of  Union 
authorisations  of  GMOs  and  independently  of  the  measures  that  Member  States  are 

17 
18 
19 
20 
21 
22 
23 
24 
25 
26 

OJ L 125, 11.7.1966, p. 2298. 
OJ L 268, 18.10.2003, p. 1. 
OJ L 193, 20.7.2002, p. 12. 
OJ L 193, 20.7.2002, p. 33. 
OJ L 193, 20.7.2002, p. 60. 
OJ L 193, 20.7.2002, p. 74. 
OJ L 93, 17.4.1968, p. 15. 
OJ L 226, 13.8.1998, p. 16. 
OJ L 11, 15.1.2000, p. 17. 
OJ L 267, 8.1.2008, p. 8. 

EN 

11 

   EN 

                                                   
entitled  to  take  by  application  of  Article  26a  of  Directive  2001/18/EC  to  avoid  the 
unintended presence of GMOs in other products. 

(7)  Member  States  should  therefore  be  authorised  to  adopt  measures  restricting  or 
prohibiting the cultivation of all or particular GMOs in all or part of their territory, and 
respectively  amend  those  measures  as  they  deem  appropriate,  at  all  stages  of  the 
authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. 
This  should  apply  as  well  to  genetically  modified  varieties  of  seed  and  plant 
propagating  material  which  are  placed  on  the  market  in  accordance  with  relevant 
legislation on the marketing of seeds and plant propagating material and, in particular, 
in accordance with Directives 2002/53/EC and 2002/55/EC. 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, as or in products, and of the products 
of  their  harvest.  Similarly  they  should  not  affect  the  cultivation  of  non  genetically 
modified  varieties  of  seed  and  plant  propagating  material  in  which  adventitious  or 
technically unavoidable traces of EU authorised GMOs are found. 

(8) 

(9) 

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  Member 
States may adopt measures restricting or prohibiting the cultivation of all or particular 
GMOs  in  all  or  part  of  their  territory  on  the  basis  of  grounds  relating  to  the  public 
interest  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.  Those  measures  should 
furthermore be in conformity with the Treaties, in particular as regards 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, as well as with the relevant 
international  obligations  of  the  Union,  notably  in  the  context  of  the  World  Trade 
Organisation.  

On  the  basis  of  the  subsidiarity  principle,  the  purpose  of  this  Regulation  is  not  to 
harmonize  the  conditions  of  cultivation  in  Member  States  but  to  grant  freedom  to 
Member  States  to  invoke  other  grounds  than  scientific  assessment  of  health  and 
environmental  risks  to  ban  cultivation  of  GMOs  on  their  territory.  In  additionone  of 
the purposes of Directive 98/34/EC of the European Parliament and of the Council of 
22 June 1998 laying down a procedure for the provision of information in the field of 
technical standards and regulations27 which is to allow the Commission to consider the 
adoption of binding acts at EU level would not be served by the systematic notification 
of  Member  States'  measures  under  that  Directive..  Moreover,  since  measures  which 
Member States can adopt under this Regulation cannot have as a subject the placing of 
the market of GMOs and thus does not modify the conditions of placing on the market 
of  GMOs  authorised  under  the  existing  legislation,  the  notification  procedure  under 
Directive 98/34/EC does not appear the most appropriate information channel for the 
Commission. Therefore, by derogation, Directive 98/34/EC should not be applicable. 
A simpler notification system of the national measures prior to their adoption appears 
to  be  a  more  proportionate  tool  for  the  Commission  to  be  aware  of  these  measures. 
Measures which Member States intend to adopt should thus be communicated together 

27 

OJ L 204, 21.7.1998, p. 37. 

EN 

12 

   EN 

                                                   
with their reasons to the Commission and to the other Member States one month prior 
to their adoption for information purposes. 

(10)  Articles  7(8)  and  19(8)  of  Regulation  (EC)  No  1829/2003  provide  that  references 
made in parts A and D of Directive 2001/18/EC to GMOs authorised under part C of 
that Directive are to be considered as applying equally to GMOs authorised under that 
Regulation. Accordingly, measures adopted by the Member States in accordance with 
this  Regulation  should  apply  as  well  to  GMOs  authorised  in  accordance  with 
Regulation (EC) No 1829/2003. 

(11)  Directive 2001/18/EC, should therefore be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Article 1 
Modification of Directive 2001/18/EC 

In Directive 2001/18/EC, the following Article shall be inserted with effect from the date of 
entry into force of this Regulation: 

'Article 26b 
Cultivation 

Member  States  may  adopt  measures  restricting  or  prohibiting  the  cultivation  of  all  or 
particular  GMOs  authorised  in  accordance  with Part  C  of  this  Directive  or  Regulation  (EC) 
No  1829/2003,  and  consisting  of  genetically  modified  varieties  placed  on  the  market  in 
accordance  with  relevant  EU  legislation  on  the  marketing  of  seed  and  plant  propagating 
material, in all or part of their territory, provided that: 

those measures are based on grounds other than those related to the assessment of the 
adverse  effect  on  health  and  environment  which  might  arise  from  the  deliberate 
release or the placing on the market of GMOs; 

(a) 

and, 

(b) 

that they are in conformity with the Treaties. 

By  way  of  derogation  to  Directive  98/34/EC,  Member  States  that  intend  to  adopt  reasoned 
measures  under  this  Article  shall  communicate  them  to  the  other  Member  States  and  to  the 
Commission, one month prior to their adoption for information purposes'. 

Article 2 
Entry into force 

This Regulation shall enter into force on the […] day following that of its publication in the 
Official Journal of the European Union. 

This Regulation shall be binding in its entirety and directly applicable in the Member States in 
accordance with the Treaties. 

EN 

13 

   EN 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

14 

   EN