Second 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 on the deliberate release into the environment of genetically modified organisms. {SEC(2007) 274}
Date: 2007-03-05
Institutions: European Commission
Subjects: EU Member State, environmental protection, genetically modified organism, health policy, marketing, report

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.3.2007 
COM(2007) 81 final 

. 

SECOND 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 on the deliberate release into the environment of genetically 
modified organisms.  

{SEC(2007) 274} 

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TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

Background and Scope................................................................................................. 3 

Placing on the market of GMOs as or in products (Part C of the Directive ) .............. 4 

Research and development and purposes other than Placing on the market of GMOs 
as or in products (Part B of the Directive) ................................................................... 7 

Conclusions .................................................................................................................. 9 

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1. 

BACKGROUND AND SCOPE 

On 17 October 2002, 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 became fully applicable.  

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.’  

The first report to the European Parliament and the Council was adopted by the Commission 
on 31 August 20042. Subsequently, in accordance with Article 31.4 of Directive 2001/18/EC, 
all Member States (MS) were required to submit three-year reports to the Commission for the 
period  17  October  2002  –  17  October  2005,  on  the  measures  taken  to  implement  the 
provisions  of  the  Directive,  including  a  brief  factual  report  on  their  experience  with  GMOs 
placed on the market in or as products under the Directive. All MS except Portugal submitted 
their  three-year  reports  to  the  Commission  and  a  summary  is  included  in  Annex  1  to  this 
second report to the European Parliament and the Council.  

In order to deliver a comprehensive and balanced report to the European Parliament and to the 
Council, the Commission considers it appropriate  

–  to  include  experience  not  only  with  GMOs  placed  on  the  market  under  the 
Directive (Part C of the Directive) but also  experience with GMOs for purposes 
other  than  placing  on  the  market,  i.e.  research  and  development  (Part  B  of  the 
Directive) as well as  

–  to 

include  contributions  from  other  stakeholders  such  as 

organisations,  farmers'  associations  and  environmental  NGOs.  A 
stakeholders who contributed is included in Annex 2. 

industry/trade 
list  of 

The three-year reports from MS as well as contributions from other stakeholders thus form the 
basis of this second report to the European Parliament and to the Council. 

1 
2 

OJ L 106 , 17.4.2001 p. 1 – 39. 
Available at http://ec.europa.eu/environment/biotechnology/index_en.htm 

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2. 

PLACING  ON  THE  MARKET  OF  GMOS  AS  OR  IN  PRODUCTS  (PART  C  OF  THE 
DIRECTIVE )  

Numbers of applications and authorisations  

A total of 26 Part C notifications for GM plants was submitted under the Directive to eight 
MS  (BE,  DE,  DK,  ES,  FR,  NL,  SE,  UK)  between  17  October  2002  and  17  October  2005. 
However,  as  of  18  April  2004,  Regulation  1829/2003  on  GM  food  and  feed3  became  fully 
applicable. According to transitional arrangements set out in Article 46(3) of this Regulation, 
notifications submitted under Directive 2001/18/EC, which included feed use and for which 
an  assessment  report  had  not  yet  been  provided,  were  transferred  to  the  authorisation 
procedure under the Regulation. As a result of this exercise and following the withdrawal of a 
further three applications by the notifiers, thirteen applications remained under the Directive. 

Out of these 13 applications, 5 products have been authorised under the Directive, as follows:  

•  NK603 maize from Monsanto Europe S.A 4,  

•  MON863 maize from Monsanto Europe S.A5, 

•  GT73 oilseed rape from Monsanto Europe S.A6,  

•  1507 maize from Pioneer Hi-Bred International INC and Mycogen Seeds7, and 

•  MON863 X MON810 maize from Monsanto Europe S.A8.  

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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. 
Commission  Decision  2004/643/EC  of  19  July  2004  concerning  the  placing  on  the  market,  in 
accordance  with  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council,  of  a  maize 
product (Zea mays L. line NK603) genetically modified for glyphosate tolerance. OJ L 295, 18/9/2004, 
p. 35-37. Final consent issued by Spain on 18/10/2004. 
Commission  Decision  2005/608/EC  of  8  August  2005  concerning  the  placing  on  the  market,  in 
accordance  with  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council,  of  a  maize 
product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm. OJ L 207, 
10/8/2005, p. 17-19. Final consent issued by Germany, 9/2/2005. 
Commission  Decision  2005/635/EC  of  31  August  2005  concerning  the  placing  on  the  market,  in 
accordance  with  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council,  of  an  oilseed 
rape  product  (Brassica  napus  L.,  GT73  line)  genetically  modified  for  tolerance  to  the  herbicide 
glyphosate.  OJ  L  228,  3/9/2005,  p.  11-13.  This  Decision  was  accompanied  by  Commission 
Recommendation 2005/637/EC of 16 August 2005 concerning the measures to be taken by the consent 
holder to prevent any damage to health and the environment in the event of the accidental spillage of an 
oilseed rape (Brassica napus L., GT73 line — MON-00073-7) genetically modified for tolerance to the 
herbicide glyphosate. OJ L 228, 3/9/2005, p. 19-20.  
Commission  Decision  2005/772/EC  of  3  November  2005  concerning  the  placing  on  the  market,  in 
accordance  with  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council,  of  a  maize 
product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and 
for  tolerance  to  the  herbicide  glufosinate-ammonium.  OJ  L  291,  5/11/2005,  p.  42-44.  Final  consent 
issued by the Netherlands, 16/3/2006. 
Commission  Decision  2006/47/EC  of  16  January  2006  concerning  the  placing  on  the  market,  in 
accordance  with  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council,  of  a  maize 
product  (Zea  mays  L.,  hybrid  MON  863 × MON  810)  genetically  modified  for  resistance  to  corn 
rootworm and certain lepidopteran pests of maize. OJ L 26, 31/1/2006, p.17-19. 

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Based  on  the  three-year  reports,  the  majority  of  MS  concur  that  the  implementation  of  the 
Directive has helped to restore confidence in the authorisation process for the placing on the 
market of GM products. Some MS also referred to the authorisation process under Regulation 
1829/2003  on  GM  Food  and  Feed9  and  enquired  about  the  specific  role  of  the  competent 
authorities under Directive 2001/18/EC in this context. A number of MS have commented on 
the largely negative attitude of non-industry stakeholders towards new authorisations.  

Industry reported that, in its experience, the implementation of Directive 2001/18/EC has not 
helped to restore confidence in the EU decision making process for Part  C applications  and 
points in  particular to the fact that no consents for cultivation have been  issued since 1998. 
The  fees  for  notifications  for  placing  on  the  market  differ  among  MS  and  range  from  0-
50,000€  per  application.  Industry  noted  that  this  could  influence  the  selection  of  the  MS  to 
which  a  company  submits  an  application,  especially  in  the  case  of  small  and  medium 
enterprises. Farmers' organisations asserted the right of farmers to be able to choose whether 
or not to grow GM crops. 

NGOs  highlighted  the  current  challenges  of  ensuring  transparency  and  stakeholder 
involvement in the implementation of the Directive. 

Details of all Part C releases are available at http://gmoinfo.jrc.it. 

Traceability, Labelling and Thresholds 

The  general  requirements  for  the  labelling  and  traceability  of  GMOs  under  Directive 
2001/18/EC  (as  well  as  for  food  and  feed  products  produced  from  GMOs)  have  been 
elaborated  in  Regulation  1830/200310.  A  specific  report  on  the  implementation  of  this 
Regulation was submitted by the Commission to the Council and to the European Parliament 
in May 200611. 

On  thresholds,  MS  reported  difficulties  with  managing  conventional  seed  lots  which  may 
contain  adventitious  presence  of  authorised  GMOs,  in  the  absence  of  seeds'  thresholds  for 
adventitious  presence.  Industry  reported  on  the  need  to  establish  thresholds  for  authorised 
GMOs  as  well  as  for  those  not  yet  authorized  in  the  EU,  but  which  have  already  been 
approved for deliberate release in  third  countries.  NGOs  and  some  MS  have  demanded  that 
thresholds  be  set  at  the  level  of  detection  of  GM  traces.  One  MS  highlighted  the  need  for 
thresholds for GMOs authorised under Part B of the Directive. 

Industry noted that many EU farmers are reluctant to grow GM varieties in many MS where 
large food processors, traders and retailers remain cautious about the use of GM material in 
the light of increasingly negative public opinion and of the costs associated with traceability. 
In  addition,  as  first  generation  GMO  products  become  obsolete  and  are  no  longer 
commercially marketed, industry has requested appropriate, proportionate renewal procedures 
to cover any remaining adventitious traces of these GMOs in order to ensure legal certainty 
following the expiry of consents. 

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c.f. Articles 6 and 18 of the Regulation. 
OJ 268, 18/10/2003, p.24-28 
COM(2006)197 final, 10.5.2006 

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Post-market monitoring 

A majority of MS reported that there is a need for a more consistent approach to post-market 
monitoring  while  retaining  the  possibility  for  specific  monitoring  depending  on  the  specific 
climate  and  natural  environment  in  a  MS.  Several  MS  considered  that  monitoring  plans 
submitted to date had tended to lack detail and a clear allocation of responsibilities. Most MS 
supported the Working Group on Monitoring established by the competent authorities as the 
appropriate forum in which to address these issues. 

NGOs  reported  that,  as  more  GMOs  are  marketed,  there  would  be  a  need  for  a  more  co-
ordinated approach with allocation of responsibility to an independent body rather than to the 
consent-holder alone, to carry out assessment of all monitoring and surveillance data relating 
to deliberate releases. 

Sampling and detection 

Commission  Recommendation  2004/787/EC12,  on  technical  guidance  for  sampling  and 
detection  of  genetically  modified  organisms,  was  developed  to  aid  the  implementation  of 
Regulation  (EC)  No 1830/2003  on  traceability  and  labelling.  However,  many  MS  have 
reported  that  the  protocols  included  in  this  Recommendation  are  complex,  time-consuming 
and expensive and that results are not in proportion to the time and expense involved. 

Overall, MS expressed a clear wish for protocols that would reconcile the need for adequate 
sampling and detection with reasonable costs. 

Industry  reported  that  standard  protocols  to  be  developed  should  be  harmonised  with 
international  testing  methods,  to  be  flexible  and  consistent  with  the  practices  currently  used 
routinely by the seed, food and feed industries. 

Farmers' organisations supported the use of GM DNA as the unit of measure for adventitious 
presence throughout the agricultural chain from seed to food and feed, to ensure consistency 
and to avoid litigation among stakeholders. 

Antibiotic Resistance Marker Genes 

Concerning  the  presence  of  antibiotic  resistance  marker  genes,  the  majority  of  MS  reported 
that the Opinion of the GMO Panel of the European Food Safety Authority (EFSA) dated 2 
April 2004 has proven useful for the phasing-out of such genes. NGOs however have called 
for  a  new  assessment  of  ARM  genes  to  look  solely  at  potential  adverse  effects  on  human 
health and the environment, without reference to their use by industry as a means to ensure 
the efficient selection of transgenic events in plants.  

Further  details  from  the  individual  MS  three-year  reports  are  available  in  Annex  1  of  this 
report. 

National safeguard clauses 

Although  not  explicitly  addressed  by  MS  in  their  three-year  reports,  it  is  worth  noting  that, 
since the entry into force of the Directive, 6 MS (AT, DE, EL, FR, HU, LU) have maintained 

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OJ L 348, 24/11/2004, p.18-26 

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provisional bans on 5 authorised GMOs under the provisions of Article 23 of the Directive. In 
each case, EFSA has found no reason to believe that the continued placing on the market of 
these  GMOs  would  be  likely  to  result  in  adverse  effects  to  human  and  animal  health  or  the 
environment under the conditions of their respective consents. Three of these GMOs are no 
longer commercialised by the companies concerned. 

Since  there  are  no  scientific  elements  to  justify  national  safeguard  clauses  on  any  of  these 
products,  the  Commission,  in  accordance  with  its  obligation  under  the  EC  Treaty,  is  in  the 
process of requesting the MS concerned to withdraw their national measures prohibiting the 
sale of these products. In addition, the Commission intends to take the necessary measures to 
formalise  the  withdrawal  from  the  market  of  the  three  GMOs  that  are  no  longer 
commercialised. 

Scientific consistency and transparency of authorising Decisions 

At the Environment Council of 26 June 2006, MS welcomed a series of measures proposed by 
the  Commission  to  bring  about  practical  improvements  with  a  view  to  reassuring  MS, 
stakeholders  and  the  general  public  that  Community  decisions  are  based  on  high  quality 
scientific  assessments  which  deliver  a  high  level  of  protection  of  human  health  and  the 
environment.  These  measures  aim  at  improving  the  scientific  consistency  and  transparency 
for risk assessment and decision making procedures under the current legislative framework 
and are outlined in Annex 3 to this report. 

3. 

RESEARCH  AND  DEVELOPMENT  AND  PURPOSES  OTHER  THAN  PLACING  ON  THE 
MARKET OF GMOS AS OR IN PRODUCTS (PART B OF THE DIRECTIVE) 

On numbers of applications 

245 applications for the release of GMOs for purposes other than for placing on the market 
were submitted to 13 MS during the reporting period of 17 October 2002 – 17 October 2005. 
The  highest  numbers  of  applications  were  submitted  in  Spain  (89),  France  (54),  Germany 
(25),  Hungary  (21),  Sweden  (18)  and  Netherlands  (13).  Twelve  MS  did  not  receive  any 
applications. 

Of  the  total  of  245  applications,  4  applications  were  withdrawn,  23  applications  were  still 
pending  as  of  October  200513,  191  consents  were  issued,  and  27  applications  were  refused. 
The highest percentage of refusals was in Hungary where 14 out of a total of 21 applications 
were refused. 

Details of all Part B releases are available at http://gmoinfo.jrc.it. 

DE,  FR  and  NL  reported  the  destruction  of  field  trials  –  in  NL,  2  trials  were  partially 
destroyed; in FR, 19 of 56 planted trials were destroyed in 2003; and in DE, several cases of 
destruction were reported although the exact number  is not known since, legally, applicants 
do not have to report destructions unless the authorisation requirements have been affected. 

13 

The end of the reporting period for the Member State three-year reports (17 October 2002-2005) 

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The fees for Part B notifications differ among MS and range from 0-17,000€ per application. 
Industry noted that this could influence the selection of the MS to which a company submits 
an application, especially in the case of small and medium enterprises. 

Farmers' organisations said that field trials were one of the means to maintain competitiveness 
in European research and agriculture. 

Overall authorisation procedure 

A majority of MS consider that the Directive has provided a more transparent and predictable 
regime  within  the  EU.  Concerns  were  expressed,  however,  about  the  lack  of  consistency 
among MS, given that the authorisation process is largely at the national level, and about the 
possibility of contamination of neighbouring crops from Part B trials. A number of MS also 
highlighted the specific issue of clinical trials on gene therapy, given that some MS currently 
apply the provisions of Directive 90/219/EC14 on contained use whilst others apply Directive 
2001/18/EC  on  deliberate  release  into  the  environment.  Following  a  recent  study, 
commissioned by the Commission, this issue will be discussed with the competent authorities 
appointed under both pieces of legislation in 2007. 

In spite of opportunities to discuss the applications prior to submission, almost all competent 
authorities were required to seek additional information following submission, particularly in 
cases  of  new  applications  or  applications  for  significantly  larger  field  trials  than  previously 
authorised. This was cited as the biggest cause of delays in the process. 

Industry  also  called  for  greater  harmonisation  of  Part  B  applications  across  the  EU,  citing 
differences amongst MS regarding data requirements, timelines and information to the public 
which  decreased  the  predictability  of  the  current  system.  Industry  expressed  particular 
concern about the timing of consents which were sometimes issued after the planting season. 

Environmental risk assessment 

A  majority  of  MS  considered  that  the  Commission  had  provided  clear  guidance  on  what  is 
required  in  the  environmental  risk  assessment.  Nevertheless  a  number  of  MS  would 
appreciate additional guidance on what are considered to be acceptable and unacceptable risks 
and  on  long-term  cumulative  effects.  Industry  also  called  for  more  harmonisation  of  the 
environmental  risk  assessment  requirements.  NGOs  pointed  to  the  need  for  stronger 
guidelines for allergenicity testing. 

Public Consultation  

A  majority  of  MS  provide  a  minimum  of  30  days  for  public  comments,  using  national  and 
local  newspapers,  mailing  lists,  websites,  registers  and  public  hearings  to  provide  access  to 
applications by the public. Most MS provide the location of the field trial at the level of the 
municipality or townland rather than the exact location, in order to reduce the possibility of 
destruction of sites. 

Public comments are forwarded to the scientific advisory committees set up by a majority of 
MS.  The  comments  are  also  provided  in  the  decision-making  file  forwarded  to  the  relevant 

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OJ L 117, 8/5/1990, p. 1-6 

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Ministers. A number of MS have found that public comments, when given, are too general in 
most cases to apply to specific cases. 

Industry expressed concern about the release of the exact location of field trials which often 
resulted in the harassment of farmers and ultimately in the destruction of the trials by anti-GM 
activists. This had clear adverse effects  on biosafety  research  and  on biotechnology product 
development  in  the  EU.  NGOs  called  for  information  of  public  interest  to  be  easily  and 
quickly accessible.  

Further  details  from  the  individual  MS  three-year  reports  are  available  in  Annex  1  of  this 
report. 

4. 

CONCLUSIONS 

This report is specifically concerned with Directive 2001/18/EC and the deliberate release of 
GMOs  into  the  environment.  Eight  Member  States  received  applications  for  placing  on  the 
market of GMOs, and thirteen Member States received applications to conduct field trials for 
R&D purposes during the period October 2002-2005. 

Those  Member  States  which  have  handled  applications  are  generally  positive  about  their 
experience  with  the  implementation  of  the  Directive,  despite  a  number  of  technical  issues 
which have yet to be adequately addressed such as a cost-effective and practical sampling and 
detection  system,  as  well  as  greater  consistency,  more  detail  and  better  allocation  of 
responsibilities  in  post-market  monitoring  measures.  Other  stakeholders  have  tended  to  be 
less positive in their assessment of the Directive.  

Some Member States have called for more guidance on specific aspects of environmental risk 
assessment.  The  Commission  is  committed  to  working  with  EFSA  to  further  develop 
guidelines as part of an overall framework for risk assessment with a view to increasing the 
overall transparency of, and confidence in, the evaluation process. 

The majority of Member States would also welcome increased harmonisation on the process 
for  Part  B  releases,  including  gene  therapy  trials,  the  definition  of  “location”  of  field  trials, 
additional guidance on environmental risk assessment and management measures to prevent 
contamination of neighbouring crops. 

Finally,  the  majority  of  Member  States  has  emphasised  the  need  for  a  legal  instrument 
establishing  seeds’  thresholds,  based  on  the  difficulties  they  have  experienced  in  managing 
the  labelling  and  traceability  of  conventional  seed  lots  without  such  thresholds  for 
adventitious  presence.  The  Commission  is  currently  exploring  various  options  in  relation  to 
this issue. 

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