COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council at first reading with a view to the adoption of a Directive 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: 2014-09-10
Institutions: European Commission
Subjects: approximation of laws, consumer protection, crop production, environmental protection, genetically modified organism, health policy, marketing standard

EUROPEAN 
COMMISSION 

Brussels, 10.9.2014  
COM(2014) 570 final 

2010/0208 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council at first reading with a view to the adoption of a Directive 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 

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2010/0208 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council at first reading with a view to the adoption of a Directive 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 

1. 

BACKGROUND 

Date of transmission of the proposal to the European 
Parliament and to the Council 
(document 2010/0208 COD): 

14 July 2010 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

9 December 2010 

Date  of  the  position  of  the  European  Parliament,  first 
reading: 

5 July 2011 

Date of transmission of the amended proposal: 

[*] 

Date of adoption of the position of the Council: 

23 July 2014 

* 

The Commission did not prepare an amended proposal but expressed its views 
on  the  Parliament  amendments  in  the  "Commission  Communication  on  the 
action  taken  on  opinions  and  resolutions  adopted  by  Parliament  at  the  July 
2011 part-session" (document SP (2011)8072) sent to the European Parliament 
on 8 September 2011. 

2. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

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  EU  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 

1 
2 

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

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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. 

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 reflects these political guidelines by providing a legal base 
in the EU legal framework on GMOs for Member States to restrict or prohibit in all 
or  part  of  their  territory  the  cultivation  of  GMOs  that  have  been  authorised  at  EU 
level.  Those  prohibitions  or  restrictions  shall  be  based  on  grounds  other  than  those 
covered by the environmental and health risk assessment under the EU authorisation 
system. 

3. 

COMMENTS ON THE POSITION OF THE COUNCIL 

3.1. 

General comments 

The  Commission's  proposal  was  transmitted  to  the  European  Parliament  and  to  the 
Council  on  14  July  2010.  The  European  Parliament  adopted  its  position  at  first 
reading on 5 July 2011 and supported the main goals of the Commission's proposal, 
subject to 28 amendments.  

No modified Commission's proposal was issued. In the "Commission Communication 
on  the  action  taken  on  opinions  and  resolutions  adopted  by  Parliament  at  the  July 
2011  part-session"  (document  SP  (2011)8072)  sent  to  the  European  Parliament  on 
8 September 2011, the Commission indicated that it could accept in full, in part, in 
principle or subject to rewriting 21 of the 28 amendments, as it considered that these 
amendments could clarify or improve the Commission's proposal and were consistent 
with its general aims. 

Prior  and  following  adoption  of  the  European  Parliament's  first  reading  position, 
discussions took place in Council with a view to finding a common position. These 
discussions  were  finalised  by  the  adoption  with  qualified  majority  of  a  political 
agreement at the Environment Council of 12 June 2014, which was translated into a 
common position of the Council at the Council of 23 July 2014. 

The Commission considers that the Council's common position reflects the original 
goals  of  the  Commission's  proposal.  Although  on  certain  elements,  the  common 

3 
4 
5 

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. 

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position differs from the Commission's proposal, the Commission is satisfied that it 
covers all issues considered essential by the Commission when adopting its proposal.  

3.2. 

Amendments  of  the  European  Parliament  accepted  by  the  Commission  and 
incorporated in full, in part or in principle in the position of the Council at first 
reading 

• 

Recitals 

Amendment  2,  which  explains  particular  aspects  of  the  EU  harmonised 
environmental  risk  assessment  required  under  Directive  2001/18/EC,  is 
accepted by the Commission. The Council's common position incorporates in 
part this amendment in the amended recital (2), by making a general reference 
to the Annex II of Directive 2001/18/EC. 

Amendment  11,  referring  to  the  importance  of  avoiding  that  national 
measures  restricting  or  banning  GMO  cultivation  prevent  biotechnology 
research  from  being  carried  out,  is  accepted  by  the  Commission.  This 
amendment  has  been  incorporated  in  full  in  the  new  recital  (15)  of  the 
Council's common position.  

Amendment  44  includes  a  call  for  adoption  of  updated  guidelines  on 
environmental  risk  assessment,  as  a  follow  up  to  conclusions  of  the 
Environment  Council  of  4  December  2008.  It  specifies  that  these  guidelines 
should not be based only on the principle of substantial equivalence or on the 
concept of a comparative safety assessment. This part of the amendment can be 
accepted  subject  to  rewording  to  clarify  that  the  legal  reference  for  the 
environmental  risk  assessment  remains  Annex  II  to  Directive  2001/18/EC, 
which reads "a comparison of the characteristics of the GMO(s) with those of 
the  non-modified  organism  under  corresponding  conditions  of  the  release  or 
use  will  assist  in  identifying  the  particular  potential  adverse  effects  arising 
from  the  genetic  modification".  In  the  environmental  risk  assessment,  it  is 
appropriate  to  draw  on  previous  knowledge  and  experience  and  to  use  the 
appropriate  comparator  in  order  to  highlight  differences  associated  with  the 
GM  plant  in  the  receiving  environment(s).  Furthermore,  the  risk  assessment 
guidance developed under the Cartagena Protocol on Biosafety in 2012 follows 
an  approach  that  is  consistent  with  that  of  EFSA  i.e.  step-wise  and  case-by-
case, using a comparative analysis and covering the same seven areas of risk. 
The Council’s common position incorporates in part this section of amendment 
44  in  the  new  Article  2  of  the  amending  Directive,  which  requires  the 
Commission  to  report  on  the  progress  towards  giving  normative  status  to  the 
strengthened  2010  EFSA  guidance  on  the  environmental  risk  assessment  of 
GM plants. 

• 

Enclosure of an indicative list of grounds for justifying opt-out measures 

The  assessment  of  potential  risks  on  human  and  animal  health  and  on  the 
environment  of  the  deliberate  release  of  GMOs  is  fully  harmonised  through 
Annex II to Directive 2001/18/EC. The scope of the assessment of GMOs for 
cultivation  covers  all  possible  areas  of  environmental  risks  on  the  whole  EU 
territory,  including  at  regional  or  local  levels.  It  considers  for  instance  the 
assessment of invasiveness or persistence of a GM event, possibility of cross-
breeding  with  domestic  cultivated  or  wild  plants,  preservation  of  biodiversity 
and persistent scientific uncertainty. A GMO can be authorised only if the risk 

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assessment  concludes,  in  particular  after  examination  of  the  above  elements, 
that the GMO is safe for human and animal health and for the environment. 

The Commission’s proposal provides that Member States’ measures restricting 
or  banning  the  cultivation  of  GMOs  on  the  basis  of  that  proposal  (so  called 
“opt out measures”) have to be based on grounds other than those related to the 
assessment of the adverse effects on health and the environment which might 
arise  from  the  deliberate  release  or  the  placing  on  the  market  of  GMOs. 
Therefore  amendments  5,  8,  10,  41,  47  can  be  accepted  by  the  Commission 
subject to rewording to make clear that grounds invoked by Member States to 
justify opt  out measures  do not conflict with the EU wide  environmental risk 
assessment.  The  Council's  common  position  introduces  in  amended  recitals 
(10)  and  (11),  and  in  the  new  Article  26b(3)  of  the  amended  Directive,  a 
different definition of the environment related ground which ensures that there 
is  no  interference  with  the  EU  wide  risk  assessment  at  Member  State  level: 
“environmental policy objectives distinct from the elements assessed according 
to  Directive  2001/18/EC  and  Regulation  (EC)  1829/2003”.  The  Commission 
considers that the wording proposed by the Council is in line with the objective 
of the proposal. Otherwise, the Commission can accept the grounds not related 
to  environmental  dimensions  proposed  either  by  the  European  Parliament  or 
the Council, as these are broadly similar in substance. 

• 

Other  modifications  of  the  proposed  new  Article  26b  of  the  amended 
Directive  

The Commission agrees with the European Parliament about the importance of 
making  available  to  operators  (including  growers),  in  a  timely  manner, 
necessary  information  about  any  restriction  or  prohibition  of  GMO 
cultivation in the territory of a Member State, and to give them sufficient time 
to  adapt  and  finish  the  current  cultivation  season  when  the  measures  concern 
GMOs  already  authorized  at  Union  level  (amendments  7,  17,  43).  The 
Council's common position incorporates the provisions of these amendments in 
the new recital (21), and the new Articles 26b(4), 26b(5), 26c(3) and 26c(5) 
of  the  amended  Directive  (with  the  exception  of  information  obligations 
towards growers).  

The Commission accepts the particular reference to the importance of national 
measures  being 
the  principle  of  proportionality 
(amendment  20).  This  amendment  has  been  incorporated  in  full  by  the 
Council, in the new recital (13) and in the new Article 26b(3) of the amended 
Directive. 

in  conformity  with 

•  Modification of other articles of Directive 2001/18/EC  

Amendment 26 relating to the entry into force of the Regulation is accepted 
by  the  Commission.  The  Council's  common  Position  incorporates  in  full  this 
amendment in the new Article 3 of the amending Directive. 

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3.3. 

Amendments  of  the  European  Parliament  rejected  by  the  Commission  and 
incorporated in full, in part or in principle in the position of the Council at first 
reading 

•  Modification of other articles of Directive 2001/18/EC  

The  Commission  does  not  accept  amendment  12  modifying  Article  22  of 
Directive  2001/18/EC  on  free  circulation,  because  the  proposal  will  allow 
Member States to restrict exclusively the cultivation of GMOs on their territory 
and  not  the  trade  or  import  of  GM  or  conventional  seeds,  food  and  feed. 
However, the Commission acknowledges the usefulness of stating clearly that 
the proposal is not affecting the functioning of the internal market. Therefore it 
accepts the Council’s modified wording of recitals (13) and (18) and the new 
Articles  26b(9)  and  26c(6)  of  the  amended  Directive  on  free  circulation  and 
import  of  authorised  GMOs  in  all  Member  States  and  their  use  in  Member 
States  which  do  neither  restrict  nor  prohibit  GMO  cultivation,  and  the  new 
recital  (20)  as  regards  the  free  movement  of  conventional  seeds,  plant 
propagating material and of the product of the harvest.  

3.4. 

Amendments of  the European Parliament accepted  by the Commission  in full, 
in  part  or  in  principle,  but  not  incorporated  in  the  position  of  the  Council  at 
first reading 

• 

Recitals 

Amendment  4  referring  to  the  importance  of  collecting  the  results  of 
research, is accepted. 

The  Commission  accepts  the  provisions  of  amendment  44  referring  to 
establishment  of  an  extensive  network  of  scientific  organisations,  and  to 
independent research on the potential risks arising from the deliberate release 
or the placing on the market of GMOs. 

•  Modifications of the proposed new Article 26b of the amended Directive 

Amendment 40,  clarifying the need  for a case by  case  examination prior to 
the adoption of national measures, can be accepted. 

Amendment  42,  asking  for  a  prior  independent  cost-benefit  analysis  of 
national measures taking into account alternatives, can be accepted.  

Amendment  19,  which  requires  national  measures  to  be  subject  to  a  prior 
public consultation of at least 30 days, can be accepted.  

the  Commission  considers 

However, 
three 
abovementioned  amendments  should  be  reviewed  in  light  of  the  Council’s 
common position which proposes to transform the Regulation into a Directive, 
which leaves to the Member States the choice of forms and methods. 

the  relevance  of 

that 

the 

•  Modification of other articles of Directive 2001/18/EC  

The  Commission  accepts  in  principle  the  modification  of  Article  26a  of  the 
Directive  (amendments  6,  14)  to  oblige  Member  States  to  establish  co-
existence  measures  to  avoid  the  unintended  presence  of  GMOs  on  their 
territory  and  in  border  areas  of  neighbouring  Member  States,  although  the 
current  legislation  does  not  set  obligations  in  this  field.  Amendment  9, 
underlining  the  importance  of  effective  measures  to  prevent  cross-border 
contamination,  can  also  be  accepted.  The  Council's  common  Position  also 

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addresses coexistence measures by making a reference, in new recital (22), to 
the  Commission  Recommendation  of  13  July  2010  which  provides  non-
compulsory  guidance  to  Member  States  for  the  development  of  coexistence 
measures,  including  in  border  areas.  The  Commission  accepts  this  wording, 
which  mirrors  the  existing  legislation  and  reflects  the  diversity  of  Member 
States’ positions on this matter.The Commission would like to observe that the 
modification  of  Article  25  of  the  Directive  referring  to  the  importance  of 
making seed material available for independent research is not related to the 
objectives of the proposal (amendment 13). However the Commission accepts 
in principle this amendment provided that it is compatible with the legal basis 
of the act.  

3.5. 

Amendments of the European Parliament rejected by the Commission and not 
incorporated in the position of the Council at first reading 

• 

Legal basis 

The  Commission  considers  that  the  proposal  should  be  based  on  Article  114 
TFUE,  since  it  amends  Directive  2001/18/EC,  which  is  itself  based  on 
Article 114 TFUE, and  because it aims at ensuring a smoother functioning of 
the  internal  market  while  guaranteeing  protection  of  the  environment,  in  line 
with  Art.  114(2)  TFUE.  Even  if  amendments  8  and  47  of  the  European 
Parliament,  which  introduce  the  possibility  to  ban  cultivation  based  on 
environment  related grounds, were to be adopted, the centre of gravity of the 
proposal  and  of  the  Directive  as  amended  would  still  remain  the  smooth 
functioning  of  the  internal  market.  Therefore  the  Commission  does  not  accept 
amendment 1. 

• 

Recitals  

The objective of the Commission proposal is to allow national restrictions or 
prohibitions  on  the  basis  of  grounds  other  than  risks,  which  are  addressed 
under the EU-wide environmental risk assessment. The precautionary principle 
should  be  taken  into  account  in  the  implementation  of  Directive  2001/18/EC 
(in  line  with  its  recital  8),  but  it  is  not  relevant  for  the  proposed  Regulation. 
Therefore, the Commission does not accept amendment 46. 

•  Modifications of the proposed new Article 26b of the amended Directive  

Amendment  51  refers  to  the  possibility  of  regions  within  Member  States  to 
adopt  restrictions  or  prohibitions  on  their  territory.  This  is  an  aspect  that 
concerns  the  distribution  of  competences  between  central  governments  and 
regional/local  entities  within  Member  States,  which  is  a  matter  belonging  to 
their  constitutional  law  and  in  which  EU  law  cannot  interfere.  Therefore,  the 
Commission does not accept this amendment. 

Amendment  22  limiting  the  duration  of  Member  States'  measures  to  five 
years  –  whereas  the  duration  of  the  authorization  granted  to  a  given  GMO 
under EU law is of 10 years - is inconsistent with the objectives of the proposal 
–  which  is  to  offer  to  Member  States  the  widest  margin  of  legally  sound 
solutions  to  restrict  or  ban  GMO  cultivation  -  and  with  the  fact  that  these 
measures  are  justified  by  reasons  of  public  interest,  which  may  remain 
unchanged  over  the  five  year  period.  Therefore,  the  Commission  does  not 
accept this amendment.  

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Amendment  23  deletes  the  word  "reasoned"  when  referring  to  measures 
adopted  by  Member  States.  The  Commission  does  not  accept  this  deletion 
because  restrictions  or  prohibitions  need  to  be  well  reasoned  and  justified  in 
line with national conditions. 

• 

Addition of a new article to Directive 2001/18/EC  

Amendment 24 introducing in Directive 2001/18/EC a new article on liability 
requirements  is  not  directly  linked  with  the  objective  of  the  proposal.  The 
Commission  would  like  to  recall  that  GMOs  are  covered  by  Directive 
2004/35/EC  on  environmental  liability  with  regard  to  the  prevention  and 
remedying of environmental damages6. This Directive takes due account of the 
polluter pays principle as indicated in the Treaty and in line with the principle 
of sustainable development. Under current EU legislation, questions of liability 
and  compensation  due  to  situations  covered  by  Article  26a  of  Directive 
2001/18/EC  (i.e.  economic  losses  of  farmers/operators  due  to  unintended 
presence of authorized GMOs in other products) are let to the competence of 
Member States, as acknowledged in the Recommendation of the Commission 
of  13  July  2010  on  guidelines  for  the  development  of  national  co-existence 
measures  to  avoid  the  unintended  presence  of  GMOs.  Indeed,  although  there 
are  examples  of  EU  legislation  setting  provisions  on  financial  liability  and 
financial  compensations  in  certain  areas  falling  within  the  scope  of  the 
Treaties,  these  matters  are  usually  not  addressed  in  EU  law,  in  view  of  the 
principle of subsidiarity and due to large differences between Member States’ 
civil and penal laws. The Commission supports the setting by Member States 
of  rules  establishing  systems  of  compensation  for  economic  losses  due  to 
adventitious presence  of authorized GMOs. However,  the  current formulation 
of the amendment needs to be clarified as it mixes issues related to liability and 
compensation and can hence not be accepted in this form. 

3.6. 

New provisions introduced by the Council 

• 

Directive instead of a Regulation 

The  Council's  common  position  transforms  the  proposed  Regulation  into  a 
Directive,  by  application  of  the  legal  principle  of  formal  parallelism.  The 
Commission notes that the  proposal is an atypical act which does not impose 
direct obligations to third parties (as a Regulation would normally do) and does 
not set either a result that Member States would have to reach (as a Directive 
would normally do); it only provides to Member States a faculty to act if they 
wish  so.  Under  these  circumstances,  the  Commission  considers  that  applying 
the  principle  of  formal  parallelism,  i.e.  modifying  Directive  2001/18/EC  by  a 
Directive, is acceptable.  

• 

Restriction of the geographical scope of the application (step 1) 

The Council's common position establishes a two consecutive steps procedure 
to allow Member States to restrict or prohibit cultivation of a GMO: 

First  the  Council's  common  position  foresees  in  new  Articles  26b(1)  and 
26b(2)  of  the  amended  Directive  that  Member  States,  should  they  wish  to 
restrict  or  ban  cultivation  of  a  GMO  on  part  of  or  all  their  territory,  have  to 
request  the  applicant,  via  the  Commission,  to  exclude  their  territory  from  the 

6 

see point 11 of Annex III to Directive 2004/35/EC. 

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scope  of  the  application  with  respect  to  cultivation  (so-called  “step  1”). 
Secondly, the Council's common position foresees in the new Article 26b(3) of 
the amended Directive that in the case of an explicit refusal of the applicant in 
step  1,  Member  States  would  be  allowed  to  adopt  measures  restricting  or 
banning the cultivation of a given GMO after it has been authorized (so-called 
“step 2” or “opt out measures”) on the basis of a list of grounds distincts from 
the environmental risk assessment, in line with the original proposal. 

The  Commission  accepts  the  Council’s  common  position  establishing  a  two 
consecutive  steps  procedure  (at  the  time  of  the  definition  of  the  scope  of  the 
application by the applicant and after the GMO has been authorized) to allow 
Member States to restrict or ban GMO cultivation since it enlarges the range of 
tools  to  restrict  or  ban  GMO  cultivation  and  preserves  the  right  of  Member 
States  to  decide  on  GMO  cultivation  based  on  grounds  of  public  interest 
independently  of 
the  applicant/authorisation  holder. 
Furthermore,  the  deadline  for  introducing  a  step  1  geographical  scope 
restriction request (no later than 30 days after the scientific opinion of EFSA) 
leaves  sufficient  time  to  Member  States  to  decide  on  whether  they  want  to 
make use of this possibility, since they can introduce a request at any moment 
during  the  risk  assessment  by  EFSA,  which  is  a  process  that  can  last  several 
months/years.  

the  position  of 

• 

Opt out measures – procedures to follow prior to adoption 

The  Council’s  common  position  foresees  in  the  new  Article  26b(4)  of  the 
amended  Directive  that  Member  States  that  intend  to  adopt  (a)  post 
authorisation  opt  out  measure(s)  (step  2)  shall  first  communicate  a  draft  of 
this(ese) measure(s) to the Commission, which will have 75 days to make any 
comment  if  deemed  appropriate.  During  that  period,  the  Member  State  shall 
refrain from adopting and implementing this(ose) measure(s). At the expiry of 
the  75  days  standstill  period  the  Member  State  concerned  may  adopt  the 
measure(s)  either  in  the  form  originally  proposed,  or  as  amended  to  take 
account  of  any  comments  received  from  the  Commission.  The  Commission 
accepts this amendment in the Council’s common position which is in line with 
the Commission's proposed approach.  

• 

2 year deadline for adoption of opt out measures 

The  Council’s  common  position  provides  in  amended  recital  (14)  and  the 
new  Article  26b(4)  of  the  amended  Directive  that  the  Member  States  shall 
adopt  opt  out  measures  no  later  than  2  years  after  the  date  that  the  GMO 
consent/authorisation has been granted. The Commission accepts this provision 
which  aims  at  providing  increased  visibility/predictability  to  operators 
(including farmers) on opt out measures to be adopted by Member States. 

• 

Transitional measures 

The  Council’s  common  position  provides  in  recital  (21)  and  the  new 
Article 26c  of  the  amended  Directive  for  a  6  months  transitional  measure 
allowing  Member  States  to  apply  the  provisions  of  the  Directive  to  GMOs 
already authorized before its entry into force (maize MON 810), or for which 
an application is already at an advanced stage at that moment. The Commission 
accepts this provision as it is needed in the context of linkage between steps 1 
and 2: 1) it is not possible to apply step 2 without having used first step 1, and 

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2)  step  1  can  only  be  applied  when  the  application  is  pending  for  a  limited 
period of time. 

The Council’s common position also foresees that the transitional measures are 
without  prejudice  to  the  cultivation  of  any  authorized  GMO  seed  and 
propagating materials which were planted lawfully before the cultivation of the 
GMO  is  restricted  or  prohibited.  The  Commission  supports  this  provision, 
which  provides  legal  security  to  farmers  that  planted  and  harvested  the 
concerned  GMOs  before  the  measures  retricting  or  prohibiting  cultivation 
apply. 

• 

Possibility for a Member State to change its position on cultivation of a GMO 
during the term of validity of the authorisation 

The Council’s common position provides in new Article 26b(5) and 26b(7) of 
the amended  Directive  that, after  authorisation  of  a  GMO  and  no  earlier  than 
two years after this date, a Member State is allowed to (re)initiate a step 1-step 
2  procedure  to  implement  or  extend  a  cultivation  ban  on  part  of  or  all  its 
territory, should new objective circumstances justify it. The Council’s common 
position also provides that this possibility given to the Member States shall be 
“without prejudice to the cultivation of any authorised GMOs seeds and plant 
propagating materials which were planted lawfully before the adjustment was 
adopted".  

The  Council’s  common  position  also  provides  in  new  Article  26b(6)  and 
26b(7) of the amended Directive that Member States wishing to have part of or 
all  their  territory  reintegrated  into  the  geographical  scope  of  a  GMO 
authorisation, could do it via a simplified procedure.  

The Commission accepts these new provisions since they contribute to enlarge 
the  range  of  possibilities  offered  to  Member  States  to  restrict  or  ban  GMO 
cultivation, whilst preserving the rights of farmers who lawfully planted GMOs 
before their ban. 

• 

Reporting obligation 

The  Council’s  common  position  foresees  in  new  Article  2  of  the  amending 
Directive  that  “no  later  than  four  years  after  the  entry  into  force  of  the 
Directive,  the  Commission  shall  present  a  report  to  the  European  Parliament 
and to the Council regarding the use made by Member States of this Directive 
including the effectiveness of the provisions enabling Member States to restrict 
or  prohibit  the  cultivation  of  GMOs  in  all  or  part  of  their  territory  and  the 
smooth functioning on the internal market. That report may be accompanied by 
any 
the  Commission  considers  appropriate.  The 
Commission shall also report on the progress towards giving normative status 
to the strengthened 2010 EFSA guidance on the environmental risk assessment 
of  genetically  modified  plants”.  The  Commission  accepts  this  amendment  in 
the Council’s common position. 

legislative  proposals 

EN 

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4. 

CONCLUSION 

The  Commission  considers  that  the  common  position  adopted  by  the  Council  with 
qualified  majority  on  23  July  2014  reflects  the  original  goals  of  the  Commission's 
proposal and takes into account many concerns of the European Parliament. 

For  the  reasons  outlined  above  the  Commission  accepts  the  Council  common 
position. 

EN 

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