Report from the Commission to the Council and the European Parliament on the experience of member states with GMOs placed on the market under Directive 2001/18/EC and incorporating a specific report on the operation of parts B and C of the Directive {SEC(2004) 1063}
Date: 2004-08-31
Institutions: European Commission
Subjects: EU Member State, environmental protection, genetically modified organism, health policy, marketing, report

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 31.8.2004 
COM(2004) 575 final 

. 

REPORT FROM THE COMMISSION TO THE COUNCIL AND 
THE EUROPEAN PARLIAMENT 

on the experience of member states with GMOs placed on the market under 
Directive 2001/18/EC and incorporating a specific report on the operation of 
parts B and C of the Directive 

{SEC(2004) 1063} 

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TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Background .................................................................................................................. 3 

Overview of implementation........................................................................................ 4 

Number of applications for Part B and Part C releases................................................ 4 

Common issues relating to the operation of both Part B and Part C releases.............. 5 

Specific issues relating to Part C releases. ................................................................... 6 

Improving the consistency and efficiency of the legislative framework. .................... 6 

Conclusions .................................................................................................................. 7 

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1. 

BACKGROUND 

On 17 April 2001, Directive 2001/18/EC of the European Parliament and of the Council on 
the  deliberate  release  into  the  environment  of  genetically  modified  organisms  (GMOs)  and 
repealing  Council  Directive  90/220/EEC1  entered  into  force.  This  Directive  became 
applicable as of 17 October 2002.  

According  to  Article  31(6)  of  this  Directive,  ‘the  Commission  shall  send  to  the  European 
Parliament  and  the  Council,  in  2003  and  thereafter  every  three  years,  a  report  on  the 
experience  of  Member  States  with  GMOs  placed  on  the  market  under  this  Directive.’  It 
should be noted that this first report relates only to 15 Member States given that the reporting 
period  in  question  ended  prior  to  the  date  of  entry  for  accession  countries  (1  May  2004). 
Subsequent three-year reports will, however, include these additional Member States. 

According  to  Article  31(7)  of  this  Directive,  “when  submitting  this  report  in  2003,  the 
Commission shall at the same time submit a specific report on the operation of part B and part 
C  including  an  assessment  of:  (a)  all  its  implications,  particularly  to  take  account  of  the 
diversity  of  European  ecosystems  and  the  need  to  complement  the  regulatory  framework  in 
this  field;  (b)  the  feasibility  of  various  options  to  improve  further  the  consistency  and 
efficiency of this framework, including a centralised Community authorisation procedure and 
the  arrangements  for  the  final  decision  making  by  the  Commission;  (c)  whether  sufficient 
experience  has  accumulated  on  the  implementation  of  part  B  differentiated  procedures  to 
justify  a  provision  on  implicit  consent  in  these  procedures  and  on  part  C  to  justify  the 
application of differentiated procedures; and (d) the socioeconomic implications of deliberate 
releases and placing on the market of GMOs”.  

In  July  2003,  the  Commission  funded  a  study2  to  gather  information  from  four  groups  of 
stakeholders  (15  Member  States  (MS),  industry  and  research  organisations,  public  interest 
groups and farmers’ organisations), as a basis for this report. The final report of the study is 
available upon request. 

In the following sections, the overall state of implementation is described, the experience of 
stakeholders in implementing the Directive is summarised and issues requiring further action 
are identified. 

1 
2 

OJ L 106 , 17.4.2001 p. 1 – 39. 
SBC (2004), ‘Means to improve the consistency and efficiency of the legislative framework in the field 
of biotechnology’, study contract number B4-3040/2003/359058/MAR/C4, carried out by Schenkelaars 
Biotechnology  Consultancy  (SBC),  NL,  in  cooperation  with  Risk  and  Policy  Analysts  Ltd,  UK,  on 
behalf of the European Commission, April 2004. 

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2. 

OVERVIEW OF IMPLEMENTATION  

The Commission convenes twice-yearly meetings with the competent authorities (CAs) of the 
MS in order to exchange views on specific implementation issues. Since April 2001, the date 
of  entry  into  force  of  Directive  2001/18/EC,  seven  meetings  have  taken  place.  Working 
groups  were  established  to  develop  the  content  of  six  implementing  measures  which  have 
since  been  adopted  by  either  the  Commission  or  the  Council  in  the  framework  of  Directive 
2001/18/EC.  Two  of  these  measures  are  specific  to  Part  B  of  the  Directive:  (1)  a  standard 
format for summary notifications and (2) a standard format for reports on releases. Three are 
specific  to  Part  C  of  the  Directive:  (1)  a  standard  format  for  summary  notifications;  (2) 
guidelines for monitoring; and (3) the establishment of a register to record information related 
to  genetic  modifications.  The  sixth  measure  provides  guidelines  for  environmental  risk 
assessment concerning both Part B and Part C of the Directive. 

Furthermore, Regulation 1830/20033 concerning the traceability and labelling of GMOs and 
the  traceability  of  food  and  feed  products  produced  from  GMOs  and  amending  Directive 
2001/18/EC was adopted on 22 September 2003 and became fully applicable as of 15 April 
2004.  In  the  framework  of  this  Regulation,  and  in  relation  to  Article  19  of  Directive 
2001/18/EC, an additional implementing measure addressing the development and assignment 
of unique identifiers for GMOs was adopted on 14 January 2004. 

Currently,  additional  working  groups  of  CAs,  chaired  by  the  Commission,  have  been 
established  to  address  specific  issues  such  as  herbicide  resistance,  Bt  toxin,  antibiotic 
resistance  marker  genes,  post-market  monitoring  and  ease  of  access  to  and  exchange  of 
information.  In  addition,  as  a  result  of  the  regular  exchange  of  views  among  MS,  the  CAs 
have  arrived  at  a  common  understanding  on  the  implementation  of  specific  articles  of  the 
Directive. 

A full list of implementing measures and CA meetings is attached in Annex 1. 

Regarding  transposition  of  the  Directive  by  the  MS,  it  should  be  noted  that,  at  the  time  of 
preparing  this  report,  seven  of  the  EU  15  MS  and  eight  of  the  acceding  countries  had 
communicated transposition measures. Details are provided in Annex 2. The Commission has 
taken eight of the EU 15 States to court for non-transposition. 

3. 

NUMBER OF APPLICATIONS FOR PART B AND PART C RELEASES 

The number of Part B applications (by type of GMO) as of 26 February 2004 under Directive 
2001/18/EC  and  its  predecessor  Directive  90/220/EEC4  is  presented  in  Annex  3,  Table  1. 
Since  the  adoption  of  Directive  2001/18/EC,  a  slight  increase  in  the  number  of  summary 
notifications has occurred in France, Germany, Spain and the UK. In all other countries there 
has been a reduction or no change in the number of summary notifications. 

3 
4 

OJ L 268, 18.10.2003, p. 24 - 28. 
OJ L 117 , 8.5.1990, p. 15 – 27. 

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Table 1 also highlights the fact that most experience with Part B applications has been with 
the  authorisation  of  GM  plants.  Although  a  number  of  non-plant  GMOs  were  authorised 
under  Directive  90/220/EEC,  very  few  have  been  authorised  since  Directive  2001/18/EC 
came into force. 

Between January 2003 and March 2004, 24 Part C applications were submitted, as presented 
in  Annex  3,  Table  2.  A  number  of  these  applications  had  originally  been  submitted  under 
Directive  90/220/EEC  (prior  to  17 October  2002)  and  were  complemented  under  Directive 
2001/18/EC  in  accordance  with  Article  35  of  the  Directive.  These  applications  are  now  at 
various stages of the authorisation process. 

Although  Part  C  of  Directive  2001/18/EC  covers  all  commercial  releases,  Regulation 
1829/2003 on GM food and feed5 now defines the procedures for placing GM food and feed 
(including  crops  for  food  or  feed  use)  on  the  market.  As  of  18  April  2004  when  the  new 
Regulation  became  fully  applicable,  notifications  submitted  under  Directive  2001/18/EC, 
concerning products for which feed use was included and for which an assessment report had 
not  yet  been  provided,  were  to  be  transformed  into  applications  under  the  new  Regulation. 
Likewise,  requests  submitted  under  Regulation  258/97  on  novel  foods  and  novel  food 
ingredients6,  for  which  the  initial  assessment  report  had  not  been  forwarded  to  the 
Commission  as  well  as  for  all  cases  in  which  an  additional  assessment  report  had  been 
requested,  were  to  be  transformed  into  applications  under  the  new  Regulation.  Henceforth, 
applications for GMOs for food and feed use will be authorised under this Regulation. Thus, 
in future, the number of applications under Part C of Directive 2001/18/EC may be reduced as 
a consequence of the evolving legislative framework in the field of biotechnology. 

4. 

COMMON  ISSUES  RELATING  TO  THE  OPERATION  OF  BOTH  PART  B  AND  PART  C 
RELEASES. 

A number of issues are common to the operation of both Part B and Part C releases. These 
include: 

•  Pre-application discussions 

•  Environmental risk assessment (ERA) 

•  Public information and consultation 

•  Antibiotic Resistance Marker (ARM) Genes  

•  Implications for the diversity of European ecosystems  

•  Socio-economic implications 

•  Use of simplified and differentiated procedures 

Details of the experience to date with these issues are provided in Annex 4. 

5 

6 

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed, OJ L 268 , 18.10.2003 p. 1 – 23. 
OJ L 43, 14.2.1997, p. 1. 

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5. 

SPECIFIC ISSUES RELATING TO PART C RELEASES. 

Two specific issues relate to Part C releases, as follows: 

•  The decision-making process 

•  Post-market monitoring and guidance 

Details of the experience on these two issues are provided in Annex 5. 

6. 

IMPROVING  THE  CONSISTENCY  AND  EFFICIENCY  OF  THE  LEGISLATIVE 
FRAMEWORK. 

The  previous  sections  identify  areas  in  the  operation  of  Part  B  and  Part  C  of  Directive 
2001/18/EC  where  progress  has  been  made  and  implementation  is  running  smoothly,  and 
where  work  is  already  underway  to  develop  further  guidance  (e.g.  on  antibiotic  resistance 
marker genes and on monitoring) and to address outstanding issues (e.g. transposition). This 
section identifies issues at this stage of implementation of the Directive where further action 
could  be  envisaged  to  improve  the  consistency  and  efficiency  of  the  overall  legislative 
framework. 

The current authorisation process (in terms of forms and guidance) is focused on GM plants. 
GM  medicines  and  GM  animals  are  also  under  development  and  their  authorisation  will 
require consideration of different issues. In order to allow research organisations, industry as 
well as MS CAs to address these issues in a harmonised way, it will be necessary to develop 
specific guidance on the risk assessment of non-plant GMOs.  

Research relating to the safety of field releases has been part of the EU research programmes 
in  biotechnology  for  over  20  years7.  Further  research  sponsored  by  these  programmes 
should be encouraged in areas such as: rates of gene flow and introgression in relation to the 
adventitious presence of GMOs in (non-GM) seeds, food and feed; the efficacy of measures to 
limit pollen flow; and the environmental impact of different methods of conventional farming 
against which to compare the findings from GM crop growing. 

Some  stakeholders  have  requested  further  guidance  on  the  interaction  between  different 
pieces of legislation and how these will work in practice. For example, although Article 12.2 
of Directive 2001/18/EC clearly states that GMOs for medical use are excluded from Part C 
of  Directive  2001/18/EC,  industry  stakeholders  believe  that  it  may  be  necessary  to  submit 
applications  under  both  the  Deliberate  Release  Directive  and  the  medical  authorisation 
procedures, based on their experience for Part B applications.  

7 

“A  Review  of  Results:  EC-sponsored  research  on  safety  of  GMOS  ”,European  Commission,  2001. 
Available at http://europa.eu.int/comm/research/quality-of-life/gmo/ 

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Regarding  the  feasibility  of  a  centralised  Community  authorisation  procedure,  industry 
stakeholders  generally  advocated  this  procedure.  The  experience  of  MS  CAs  with  the 
centralised procedure under Regulation (EEC) No.2309/938 for the authorisation of medicinal 
products suggests that there is a need to clarify the obligations of the European Agency for the 
Evaluation  of  Medicinal  Products  (EMEA)  when  consulting  national  CAs,  particularly  with 
regard to the ERA. Experience has also shown that, for the purpose of cultivation, MS were 
not  ready  to  accept  the  environmental  risk  assessment  carried  out  by  other  MS,  even  if  a 
common  basis  for  such  risks  is  foreseen  in  the  Directive.  As  of  18  April  2004,  Regulation 
1829/2003  provides  for  a  centralised  procedure  with  the  European  Food  Safety  Authority 
(EFSA). In the light of experience to be acquired in the implementation of this Regulation, the 
Commission will consider the need for a centralised procedure under Directive 2001/18/EC. 

7. 

CONCLUSIONS 

This report is specifically concerned with Directive 2001/18/EC and the deliberate release of 
GMOs,  although  the  wider  legislative  framework  is  also  considered.  The  vast  majority  of 
GMOs  that  have  been  developed  to  date  for  deliberate  release  are  transgenic  crop  plants, 
modified to be tolerant to certain herbicides or resistant to certain insect pests. Consequently, 
much of the available information and experience relates to GM crops. 

Given that the Directive became fully applicable as of 17 October 2002, there is still relatively 
little  experience  of  its  implementation.  The  lack  of  transposition  by  a  number  of  Member 
States  also  hinders  implementation.  Nevertheless,  there  is  general  agreement  that  the 
Directive, together  with  the  recent Regulations  on GM Food and Feed and Traceability and 
Labelling,  help  to  increase  confidence  in  the  legislative  framework  and  to  increase  the 
predictability  of  the  decision-making  process.  In  particular,  increased  requirements  for  the 
environmental risk assessment address the possible longer term, direct, indirect, delayed and 
cumulative effects on the environment and wildlife of releasing and using GMOs. 

Currently,  most  concerns  relate  to  the  need  for  guidance  in  interpreting  elements  of  the 
Directive  such  as  post-market  monitoring,  the  phasing  out  of  antibiotic  resistance  marker 
genes which may have adverse effects on human health and the environment, and non-plant 
GMOs. In addition, guidance is required on the interaction of the various pieces of legislation. 
The  Commission  and  Member  States  are  already  working  on  guidance  for  post-market 
monitoring and antibiotic resistance marker genes. 

8 

Council  Regulation  (EEC)  No  2309/93  of  22  July  1993  laying  down  Community  procedures  for  the 
authorization  and  supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a 
European Agency for the Evaluation of Medicinal Products, OJ L 214 , 24.8.1993, p. 1 – 21. 

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