Report from the Commission to the Council and the European Parliament on the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed
Date: 2006-10-25
Institutions: European Commission
Subjects: animal feedingstuffs, application of EU law, food inspection, food safety, genetically modified organism, labelling, market approval, report

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.10.2006 
COM(2006) 626 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

on the implementation of Regulation (EC) No 1829/2003 of the European Parliament 
and of the Council on genetically modified food and feed 

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REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

on the implementation of Regulation (EC) No 1829/2003 of the European Parliament 
and of the Council on genetically modified food and feed 

TABLE OF CONTENTS 

1. 

2. 

Introduction .................................................................................................................. 5 

The placing on the market of genetically modified food and feed since the date of 
application of the Regulation ....................................................................................... 6 

2.1. 

Authorisation procedure under the Regulation ............................................................ 6 

2.1.1.  Presentation of the authorisation procedure................................................................. 6 

2.1.2.  CRL, ENGL and validation of detection methods ....................................................... 8 

2.1.3.  Comments of the public ............................................................................................... 8 

2.1.4.  Public access ................................................................................................................ 9 

2.1.5.  Practical experience of the authorisation procedure .................................................... 9 

2.1.6.  Practical improvements of the authorisation procedure............................................. 10 

2.2. 

2.3. 

3. 

3.1. 

3.2. 

4. 

4.1. 

4.2. 

4.3. 

Authorisation of food and feed according to the transitional measures provided for by 
Article 46 of the Regulation....................................................................................... 12 

Notification of products legally placed on the market before the date of application of 
the Regulation ............................................................................................................ 12 

Labelling of GM food and feed.................................................................................. 13 

Occurrence on the market of food labelled as genetically modified.......................... 13 

Occurrence on the market of feed labelled as genetically modified .......................... 14 

Unauthorised products ............................................................................................... 14 

Unauthorised GM papaya .......................................................................................... 14 

Contamination of GM maize imported from the United States by unauthorised GM 
maize Bt 10 ................................................................................................................ 15 

Contamination of rice imported from the United States by unauthorised GM rice 
LL601......................................................................................................................... 16 

4.4. 

Conclusions ................................................................................................................ 17 

5. 

Food Veterinary Office: outcome of inspections carried out in thirteen Member 
States .......................................................................................................................... 17 

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6. 

7. 

8. 

9. 

Activities of the Standing Committee on the Food Chain and Animal Health 
(SCFCAH) ................................................................................................................. 19 

Adoption of implementing rules and guidelines ........................................................ 19 

Interplay between Directive 2001/18/EC and Regulation (EC) No 1829/2003 relating 
to Existing products and Feed produced from GMO ................................................. 21 

Measures for adventitious or technically unavoidable presence of genetically 
modified material not authorised under Community legislation................................ 22 

10. 

Status of food or feed produced by fermentation using genetically modified micro-
organisms not present in the final product ................................................................. 23 

10.1.  Background ................................................................................................................ 23 

10.2.  Clarification of the status of food or feed produced by fermentation using genetically 
modified micro-organisms not present in the final product ....................................... 24 

10.3.  Application of the clarification to food products and processing aids....................... 24 

10.4.  Application of the clarification to feed products and processing aids ....................... 25 

10.5.  Guidelines on the Safety assessment of food or feed produced by fermentation using 
genetically modified micro-organisms....................................................................... 26 

10.6.  Conclusions ................................................................................................................ 26 

11. 

12. 

Clarifications related to some aspects of the labelling provision of the Regulation.. 26 

Conclusions ................................................................................................................ 28 

ANNEX.................................................................................................................................... 30 

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List of abbreviations 

CA or CAs: Competent authority or Competent authorities 

CRL: Community Reference Laboratory 

DG SANCO: Directorate-General Health and Consumer Protection 

DNA: Deoxyribonucleic acid 

EFSA: European Food Safety Authority 

ENGL: European Network of GMO Laboratories 

FVO: Food and Veterinary Office of the Directorate-General Health and Consumer Protection  

GM: Genetically modified 

GMM: Genetically modified micro-organism 

GMOs: Genetically modified organisms 

ISO: International Organisation for Standardisation 

RASFF: Rapid Alert System for Food and Feed 

SCFCAH: Standing Committee on Food Chain and Animal Health 

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1. 

INTRODUCTION 

Regulation (EC) No 1829/20031 on GM food and feed (“the Regulation”) has applied 
since 18 April 2004. It covers genetically modified organisms (GMOs) for food and 
feed use, food/feed containing or consisting of GMOs and food/feed produced from 
GMOs. This scope of application is large since all GMOs that may be used as food or 
feed  or  as  a  source  material  for  the  production  of  food  or  feed  are  considered  as 
GMOs for food and feed use. It establishes a centralised procedure of authorisation 
by the European Commission based on an independent risk assessment carried out by 
the  European  Food  Safety  Authority  (EFSA),  rules  for  labelling  and  thresholds  for 
presence  of  GM  material  that  is  adventitious  or  technically  unavoidable.  The  risk 
assessment  as  provided  for  in  the  Regulation  includes  in  particular  a  safety 
assessment  of  the  GM  food  and/or  GM  feed  as  well  as,  as  the  case  may  be,  an 
environmental  risk  assessment.  In  the  case  of  GMOs  for  cultivation  falling  in  the 
scope of the Regulation, EFSA shall ask a national competent authority (CA) under 
Directive  2001/18/EC  to  carry  out  the  environmental  risk  assessment.  In  all  cases 
where  an  environmental  safety  assessment  is  required,  EFSA  has  to  consult  the 
national CA under Directive 2001/18/EC of each Member State. 

The  Commission  was  to  adopt  the  necessary  implementing  rules  and  guidelines  as 
well as to establish the Community register of GM food and feed (publicly available 
on the website of the Commission2). 

The Commission is also required to monitor the application of the Regulation and its 
impact on human and animal health, consumer protection, consumer information and 
the functioning of the internal market. 

According  to  Article  48  of  the  Regulation  the  Commission  is  to  forward  to  the 
European  Parliament  and  to  the  Council  a  report  on  the  implementation  of  this 
Regulation and in particular of Article 473. Article 48 states that the report should be 
accompanied, where appropriate, by any suitable proposal. 

In  order  to  gain  more  insight  on  the  implementation  of  the  Regulation,  the 
Commission  compiled  a  questionnaire  comprising  questions  on  its  different 
provisions. The questionnaire was submitted to all CAs under the Regulation, as well 
as to relevant stakeholders from all involved sectors. The responses, as well as other 
information received and retrieved by the Commission from the date of application 
of the Regulation to the current time, have been carefully analysed. 

1 
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3 

OJ L 268, 18.10.2003, p. 1. 
http://europa.eu.int/comm/food/dyna/gm_register/index_en.cfm 
Article 47 of Regulation (EC) No 1829/2003 foresees, under certain conditions, transitional measures 
for  adventitious  or  technically  unavoidable  presence  of  genetically  modified  material  which  has 
benefited from a favourable risk evaluation. 

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The  current  report  is  based  on  the  results  of  this  consultation  as  well  as  on  the 
discussions  which  took  place  in  the  Standing  Committee  on  the  Food  Chain  and 
Animal Health (SCFCAH) and in the Council. It focuses on the main aspects raised 
by  Member  States  and  stakeholders  and  therefore  does  not  reflect  individual 
positions as such. The report contains a first part concerning the experience acquired 
with the practical implementation of the Regulation and a second part which details 
additional  implementing  measures  and  specific  clarifications  which  have  been 
developed  by  the  Commission  to  complement  and  explicit  specific  points  of  the 
Regulation. 

Regulation  (EC)  No  1830/20034  on  the  traceability  and  labelling  of  genetically 
modified  organisms  and  the  traceability  and  labelling  of  food  and  feed  products 
produced from genetically modified organisms and amending Directive 2001/18/EC 
was developed alongside Regulation (EC) No 1829/2003 and was also adopted on 22 
September 2003. The two regulations are intended to operate in tandem and rely on 
each other for certain requirements.  

Also  Regulation  (EC)  No  1830/2003  contains  a  requirement  (Article  12)  for  the 
Commission to produce a report concerning experiences gained with this regulation. 
This report was adopted on 10 May 20065. The Commission has taken account of the 
above interplay between the two regulations and has attempted to avoid duplication 
in the two reports.  

The  legislative  framework  on  GM  products  is  generally  recognised  as  complex  by 
stakeholders. In order to facilitate its implementation, DG SANCO provides support 
to the operators and the general public on the website of the Commission and under 
the  form  of  “questions  and  answers”6.  Similarly,  a  number  of  Member  States  or 
associations  of  stakeholders  also  provided  documents  aiming  to  further  explain  the 
provisions of the legislation. 

Part 1: Implementation of Regulation (EC) No 1829/2003 

2. 

THE PLACING ON THE MARKET OF GENETICALLY MODIFIED FOOD AND FEED SINCE 
THE DATE OF APPLICATION OF THE REGULATION 

2.1. 

Authorisation procedure under the Regulation 

2.1.1.  Presentation of the authorisation procedure 

The authorisation procedure is composed of three major steps. 

The  first  step  is  the  submission  of  an  application  to  obtain  an  authorisation  for  the 
placing on the market of a GM food or feed. 

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6 

OJ L 268, 18.10.2003, p. 24. 
COM(2006) 197 final (http://eur-lex.europa.eu/LexUriServ/site/en/com/2006/com2006_0197en01.pdf) 
http://ec.europa.eu/food/food/biotechnology/gmfood/index_en.htm and; 
http://europa.eu.int/comm/food/food/biotechnology/gmfood/qanda_en.pdf. It should be understood that 
only the Community courts can give an authoritative interpretation of EC legislation. 

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It has to be sent to the national CA under the Regulation of one Member State who 
has  to  acknowledge  the  receipt  of  the  application,  inform  without  delay  EFSA  and 
make the submitted information available to EFSA. 

The  second  step  is  the  preparation  and  the  delivery  of  an  opinion  by  EFSA.  EFSA 
publishes  summaries  of  the  applications  on  the  EFSA  website  and  following  a 
completeness  check,  valid  applications  are  made  available  to  the  Commission  and 
the Member States who are consulted on the application during a 3 month period. In 
case of a GMO to be used as seeds or other plant-propagating material EFSA asks a 
CA  under  Directive  2001/18/EC  to  carry  out  the  environmental  risk  assessment,  as 
required by the Regulation. 

In accordance with the Regulation, EFSA endeavours to comply with a time limit of 
six months to provide its opinion. The procedure is stopped whenever EFSA (or the 
CRL via EFSA) seeks supplementary information from the applicant.  

An overview of the applications received by EFSA is made available to the public on 
its website7. Until 1 July 2006, thirty four applications have been submitted. 

In  order  to  facilitate  the  numerous  exchanges  of  information  between  EFSA,  the 
Member  States  and  the  Commission,  EFSA  has  put  in  place  an  electronic  system 
(called  “GMO  EFSAnet)  providing  a  secure  data  communication  platform.  This 
system  is  recognised  by  all  the  involved  parties  as  contributing  to  the  smooth 
operation of the authorisation procedure. EFSA is continuously working to improve 
this system, especially with regard to putting in place a system allowing the involved 
parties to access data in a more efficient way. 

The  scientific  opinions  adopted  by  the  GMO  Panel  of  EFSA  are  published  on  the 
EFSA  website8.  In  the  case  of  favourable  EFSA  opinions,  the  scientific  opinion  of 
the  GMO  panel  shall  be  complemented  by  other  information  (including,  among 
others,  a  proposal  for  labelling,  any  appropriate  conditions  or  restrictions  which 
should be imposed for the placing on the market, a method for detection validated by 
the CRL, an indication of where the reference material can be accessed, and, when 
the  scope  of  the  applications  cover  the  placing  on  the  market  of  a  GMO,  an 
environmental monitoring plan and information related to the Cartagena protocol) in 
order  to  constitute  the  overall  EFSA  opinion  as  required  by  the  Regulation.  It  is 
therefore important to make a clear distinction between the scientific opinions of the 
GMO Panel and the overall EFSA opinions that are required by the Regulation. 

The  third  step  of  the  procedure  is  the  preparation  and  the  adoption  of  a  decision 
related to the application. 

Within  30  days  after  the  publication  of  the  overall  EFSA  opinion,  the  public  may 
make comments to the Commission. Section 2.1.3 of the current report is specifically 
dedicated  to  the  organisation  of  this  commenting  period  and  to  the  handling  of  the 
received contributions. 

7 
8 

http://www.efsa.eu.int/science/gmo/gm_ff_applications/catindex_en.html 
http://www.efsa.eu.int/science/gmo/gmo_opinions/catindex_en.html 

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The Commission shall submit a draft Decision to the SCFCAH within 3 months after 
receiving the overall EFSA opinion. The adoption is subject to the comitology rules9. 

2.1.2.  CRL, ENGL and validation of detection methods 

The  Commission’s  Joint  Research  Centre  was  designated  as  the  Community 
Reference  Laboratory,  whose  task  is  the  technical  evaluation  and  validation  of 
quantitative detection and identification methods for GM food and feed as part of the 
centralised  authorisation  procedure.  The  agreement  on  the  European  Network  of 
GMO  laboratories  (ENGL)  was  made  in  2002  and  the  network  comprises  over 
seventy National Control Laboratories. 

On 18 April 2004, the CRL published “explanatory notes to applicants” in order to 
provide  the  applicants  with  practical  instructions  concerning  the  method  validation 
task  of  the  CRL  as  described  in  Regulation  (EC)  1829/2003  and  in  the  Regulation 
(EC) 641/200410 (see point 7 of the current report). These notes were complemented 
by  additional  documents  notably  related  to  the  description  of  the  CRL  Validation 
Process  and  the  definition  of  Minimum  Performance  Requirements  for  Analytical 
Methods  of  GMO  Testing.  These  documents  are  available  on  the  website  of  the 
CRL11. 

On 1 July 2006, the CRL had carried out the validation of 16 methods. The reports of 
these  validations  are  published  on  the  website  of  the  CRL12  and  are  part  of  the 
overall opinions of EFSA. 

2.1.3.  Comments of the public 

Articles  6(7)  and  18(7)  of  the  Regulation  provide  that  the  public  may  -  within  30 
days from its publication – make comments on the overall EFSA opinion. Comments 
should be addressed to the Commission. In order to facilitate the addressing of these 
comments,  the  Commission  has  created  a  dedicated  webpage  on  the  section  of  the 
website  dedicated  to  the  Regulation13.  This  page  clearly  indicates  when  a  given 
application is within this commenting period and offers to the public a form in order 
to  structure  the  comments.  It  also  presents  a  link  to  the  concerned  overall  EFSA 
opinion. 

The opportunity to address comments for a given GMO is advertised throughout the 
commenting period on the first page of the website “Food Safety – From the Farm to 
the  Fork”14.  In  addition,  the  start  of  the  commenting  period  is  announced  via  the 
“sanco  news”  e-mail  service  and  a  link  on  DG  SANCO  webpage  is  added  to  the 
EFSA webpage where the overall opinions are published.  

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14 

See Article 35 of Regulation No (EC) 1829/2003 and Decision 1999/468/EC for more details. 
OJ L 102, 7.4.2004, p. 14. 
http://gmo-crl.jrc.it/guidancedocs.htm 
http://gmo-crl.jrc.it/statusofdoss.htm 
http://ec.europa.eu/food/food/biotechnology/authorisation/public_comments_en.htm 
http://ec.europa.eu/food/index_en.htm 

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After  the  commenting  period,  the  comments  received  are  communicated  without 
delay to the CA of the Member States. As a consequence, both the Commission and 
the CA of the Member States can take these comments into consideration for the last 
phase of the authorisation process. 

The comments received are also made available to the public on the same webpage. 
This is subject to the agreement of those making the comments. 

Since  the  application  of  the  Regulation,  six  overall  EFSA  opinions  have  been 
finalised  in  accordance  with  the  provisions  laid  down  in  the  Regulation.  Therefore 
the  experience  related  to  this  opportunity  provided  to  the  public  and  its  further 
handling by the authorities within the framework of the Regulation is limited to these 
cases. 

2.1.4.  Public access 

According  to  Article  29(2)  of  Regulation  (EC)  1829/2003,  EFSA  shall  apply  the 
principles of Regulation (EC) No 1049/200115 of the European Parliament and of the 
Council  regarding  public  access  to  European  Parliament,  Council  and  Commission 
documents  when  handling  applications  for  access  to  documents  held  by  EFSA. 
Consequently, EFSA has implemented the necessary tools and procedures to handle 
requests for access to documents according to the provisions of the Regulation. Up 
until May 2006, EFSA has received 26 individual requests from the public to access 
a total of 73 separate documents or applications submitted to EFSA under Regulation 
(EC) 1829/2003. Of the 26 individual requests 18 have come  from  5  different  Non 
Governmental Organisations (NGOs), mainly environmental NGOs, where 2 NGOs 
account  for  a  majority  of  the  requests.  Furthermore  members  of  National  and 
European Parliaments have submitted 3 requests, National Authorities 2 and 3 have 
come from other stakeholders. 

In  addition,  the  Commission  has  received  3  requests  for  access  to  documents  or 
applications submitted under the Regulation, two coming from NGOs, and the third 
from a Member of the European Parliament. 

2.1.5.  Practical experience of the authorisation procedure 

So  far,  one  authorisation16  (for  the  placing  on  the  market  of  food  containing 
consisting  or  produced  from  1507  maize)  has  been  given  following  this  procedure. 
Other  products  were  authorised  according  to  the  transitional  measures  of  the 
Regulation (see section 2.2. of the current report). Once authorised, the products are 
entered in the Community register of GM food and feed17 that was established by the 
Commission. 

15 
16 
17 

OJ L 145, 31.5.2001, p. 43. 
OJ L 70, 9.3.2006, p. 82. 
http://europa.eu.int/comm/food/dyna/gm_register/index_en.cfm 

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Some  remarks  from  the  applicants  have  been  made  about  the  time  used  by  EFSA 
prior to recognise an application as valid. This may be due to the lack of information 
in  the  data  submitted.  EFSA  therefore  requests  and  waits  for  this  additional 
information  before  considering  an  application  as  valid.  It  is  the  opinion  of  the 
Commission that the period of time before declaring an application as valid should 
be as short as possible on the condition that all the requested data are provided. The 
Commission would like to stress the need for applicants to submit applications that 
fulfil the requirements of the Regulation and of the guidelines of EFSA. The request 
of additional information enabling EFSA to consider an application as valid should 
normally not be necessary. 

According to the provisions of the Regulation EFSA should endeavour to finalise its 
overall  opinions  within  six  months.  However,  when  additional  data  are  requested 
during  the  scientific  assessment  or  the  validation  of  the  detection  method,  the  time 
period  of  6  months  may  be  extended.  For  most  of  the  applications,  additional 
information/clarification has to be requested from the applicant before specific issues 
raised by the GMO Panel or the Member States can be addressed and the GMO Panel 
can conclude its risk assessment. In case the scientific opinion of the GMO Panel or 
the validation method are finalised while the other particulars of the overall opinion 
are  not  yet  available,  EFSA,  as  a  matter  of  transparency,  publishes  the  scientific 
opinion  or  the  validation  method  on  its  website.  The  validation  methods  are  also 
published  on  the  JRC  website  as  soon  as  finalised.  The  overall  opinion  is  then 
published  later  on  with  all  particulars  included.  This  has  created  some  confusion 
regarding  the  stage  of  the  authorisation  process.  Appropriate  measures  have  been 
taken in order to clarify in the presentation of the GMO Panel scientific opinion that 
it needs to be complemented by other particulars prior to finalisation of the overall 
opinion of EFSA. 

In  the  framework  of  the  environmental  safety  assessment,  EFSA  has  to  consult  the 
CA under Directive 2001/18/EC of each Member State upon receipt of an application 
with  environmental  safety  requirements.  EFSA  took  the  initiative  to  expand  this 
consultation to all members of the GMO EFSAnet, independently of the scope of the 
application  (CA  under  Directive  2001/18/EC,  CA  under  the  Regulation  as  well  as 
scientific  bodies  nominated  by  their  Member  States).  This  consultation  process 
allows  for  EFSA  to  take  into  consideration  all  the  scientific  comments  from  the 
Member States prior to finalising the scientific opinion of the GMO Panel. 

According to Articles 6(3)(c) and 18(3)(c) of the Regulation, EFSA shall ask a CA 
under Directive 2001/18/EC to carry out the environmental risk assessment when an 
application  concerns  GM  seeds  or  other  GM  plant-propagating  material  for  food 
and/or feed use. To this end EFSA launches a call for expression of interest among 
the  Member  States  to  select  a  CA  under  Directive  2001/18/EC  to  carry  out  the 
environmental risk assessment based on the particular crop and trait, the availability 
of the CA and experience in GMO risk assessment. EFSA experiences difficulties to 
find CA willing to carry out the initial risk assessment for such applications. 

2.1.6.  Practical improvements of the authorisation procedure 

In  light  of  recent  practical  experience  acquired  with  the  placing  on  the  market  of 
GMOs  and  of  Member  State’s  demands  for  more  streamlined  decision  making 

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in  April  2006 

the  Commission  has  concluded 

procedures, 
that  practical 
improvements could be made to the system regarding the scientific consistency and 
transparency  for  Decisions  on  GMOs  taken  under  Directive  2001/18/EC  and  the 
Regulation  and  to  develop  consensus  between  all  interested  parties.  These 
improvements will be made within the existing legal framework taking due account 
of the need to preserve an efficient decision making procedure, in compliance with 
EC law. In particular any undue delays in the adoption of the final decision shall be 
avoided. 

With  the  objective  of  building  greater  consensus  and  transparency  and  recognising 
the importance of maintaining the scientific credibility, excellence and independence 
of EFSA, the Commission proposed that the following practices be implemented.  

In the scientific evaluation phase: 

• 

• 

• 

• 

• 

to invite EFSA to liaise more fully with national scientific bodies, with a view 
to resolving possible diverging scientific opinions with Member States; 

to  invite  EFSA  to  provide  more  detailed  justification,  in  its  opinions  on 
individual  applications,  for  not  accepting  scientific  objections  raised  by  the 
national competent authorities; 

the Commission will fully exercise its regulatory competences foreseen in the 
basic legislation to specify the legal framework in which EFSA assessment is 
to be carried out; 

to invite EFSA to clarify which specific protocols should be used by applicants 
to carry out scientific studies (for example regarding toxicology) demonstrating 
safety; 

applicants  and  EFSA  will  also  be  asked  to  address  more  explicitly  potential 
long-term  effects  and  bio-diversity  issues  in  their  risk  assessments  for  the 
placing on the market of GMOs; 

In the decision-making phase: 

• 

• 

the  Commission  will  also  address  specific  risks  identified  in  the  risk 
assessment or substantiated by Member States by introducing on a case by case 
basis additional proportionate risk management measures in draft decisions to 
place GMO products on the market, as appropriate; 

where in the opinion of the Commission a Member State’s observation raises 
important new scientific questions not properly or completely addressed by the 
EFSA opinion, the Commission may suspend the procedure and refer back the 
question for further consideration. 

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In  June  2006,  EFSA  outlined  its  ongoing  strategy  in  relation  to  the  assessment  of 
GMOs and its initiatives to build closer collaboration with Member States18. 

2.2. 

Authorisation of food and feed according to the transitional measures provided 
for by Article 46 of the Regulation 

Prior to the entry into force of the Regulation, authorisation processes for GM food 
and  feed  were  carried  out  under  Regulation  (EC)  No  258/97  and  Directive 
2001/18/EC. In order to ensure a smooth transition to the new authorisation regime, 
Article 46 of the Regulation provides for transitional measures allowing applications 
that  were  in  an  advanced  stage  of  the  authorisation  procedure  to  continue  to  be 
considered and authorised under the relevant legislation. 

Before  1  July  2006,  4  decisions  authorising  the  placing  on  the  market  of  GM  food 
were  adopted  under  Regulation  (EC)  No  258/97  and  4  decisions  authorising  the 
placing on the market of feed containing or consisting of a GMO were adopted under 
Directive 2001/18/EC. 

These  authorisation  decisions  -  while  adopted  under  the  previous  legislative 
framework for GM food and feed - take into account the provisions of the Regulation 
in terms of coordination of authorisation for food and feed related to the same GMO, 
availability of a validated method of detection and of the reference material. 

An  overview  of  the  products  that  have  been  authorised  in  the  framework  of  these 
transitional measures is provided in the annex. 

2.3. 

Notification  of  products  legally  placed  on  the  market  before  the  date  of 
application of the Regulation 

Certain GM food and feed products have been legally sold in the EU since as early as 
1997  as  they  were  approved  under  other  legislation  or  did  not  require  specific 
approval  procedures.  In  order  to  cover  these  GM  products,  articles  8  and  20  of  the 
Regulation  stipulate  that  operators  who  wished  to  continue  marketing  an  “existing 
product” had to notify the Commission and submit detailed information on the GM 
products before 18 October, 2004.  

Regulation  (EC)  No  641/2004  has  laid  down  detailed  implementing  rules  for  the 
notification of existing products.  

The Commission has then examined the validity of these notifications and agreed to 
enter  26  GMOs  into  a  specific  section  of  the  Community  register  of  GM  food  and 
feed. Once one of these “existing products” is on this register, it can remain on the 
market for a set period of between 3-9 years, after which the operator has to resubmit 
an  application  for  the  renewal  of  the  authorisation.  Specific  aspects  related  to  this 
procedure  for  GMOs  that  were  authorised  under  previously  existing  legislation  are 
provided in point 8 of the current report. 

18 

For more details, see: http://www.efsa.europa.eu/science/gmo/109/gmo_actionplan1.pdf 

EN 

12 

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In this respect the Commission wishes to take this occasion to further clarify that the 
notification exercise was intended to cover also GM seeds for food or feed use which 
were previously authorised. Indeed articles 8 and 20 apply by derogation to articles 
4(2) and 16(2) of the Regulation that cover GM seeds or other GM plant propagating 
material for the production of food or feed. GM seeds are therefore covered by the 
scope  of  articles  8  and  20.  Although  the  notification  form  prepared  by  the 
Commission  services  has  created  some  confusion  among  notifiers  by  not  explicitly 
mentioning  the  seeds  in  the  list  of  products  which  could  be  notified  and  referring 
only  to  food  and  feed  products,  on  the  basis  of  the  indication  provided  by  the 
companies  and  of  the  analysis  of  the  actual  content  of  the  notification,  the 
Commission concluded that seeds were correctly notified. This has been reflected in 
the Community Register via a specific footnote added on 11 July 2005. 

More generally the notification of existing products represented an important step in 
the  implementation  of  the  legislative  framework  introduced  by  the  Regulation,  by 
allowing  clarification  of  the  situation  of  food  and  feed  products  produced  from 
GMOs on the Community market. 

3. 

LABELLING OF GM FOOD AND FEED 

Under Article 13 of the Regulation, food must carry a label referring to the presence 
of GM in defined circumstances. However, Articles 12 provides that these labelling 
requirements shall not apply to food containing material, which contains, consists of 
or  is  produced  from  GMOs  in  a  proportion  no  higher  than  0.9  %  of  the  food 
ingredients  considered  individually  or  food  consisting  of  a  single  ingredient, 
provided that this presence is adventitious or technically unavoidable. Similar rules 
are laid down for feed in Articles 24 and 25  

The  range  of  products  that  should  be  subject  to  compulsory  GM  labelling  was  the 
result of an extensive exchange of views during the legislative process that led to the 
adoption  of  the  Regulation.  Even  though  the  majority  of  replies  does  not  question 
this range, it is for some stakeholders still considered to be either too extended (i.e. 
products that do not contain DNA or proteins should not be labelled as GM) or too 
restricted (i.e. products of animal origin fed with GM feed such as meat, milk or eggs 
should be labelled as genetically modified). 

3.1. 

Occurrence on the market of food labelled as genetically modified 

According to different reports, few food products labelled as genetically modified are 
at the present time on the Community market. The situation is however not uniform 
throughout  the  EU  since  in  some  Member  States  the  number  of  GM  products  is 
negligible while in others their number is more significant. 

The  Regulation  as  such  did  not  have  an  impact  on  the  sale  of  food  labelled  as 
genetically modified. The sale of this type of products is mainly governed by factors 
that are not related to the legislative framework, such as consumer demand and the 
policies of food producers and retailers. 

EN 

13 

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According  to  the  results  of  the  sample  analysis  reported  by  Member  States,  the 
frequency  of  non  compliance  to  the  food  labelling  requirements  of  the  Regulation 
across  the  EU  may  be  estimated  below  2%  (113  out  of  7129  analysed  samples).  It 
must be further stressed that this figure is related to controls that often are targeted to 
products that are likely to contain GMOs or their derivatives and that the number of 
reported tests as well as the percentage of non compliance varied significantly from 
one Member State to another. 

3.2. 

Occurrence on the market of feed labelled as genetically modified 

By contrast with food, compound feed labelled as genetically modified is much more 
present  on  the  Community  market  and  is  even  reported  to  be  predominant  at  EU 
level.  This  can  be  largely  explained  by  the  predominance  of  GM  soy  in  the 
production of soy at world-scale level and the difference of costs between non-GM 
soy and GM soy. 

Practices consisting in systematic labelling with a statement of the type “may contain 
GMO” have been reported. These practices are not compatible with Regulation (EC) 
No 1829/2003 and Regulation (EC) No 1830/2003 which prescribe explicit wording 
to  be used for food and feed containing GM. The required wording does not allow 
ambiguous statements like "may contain GMOs”. In addition, practices consisting in 
systematic  labelling  of  feed  products  as  genetically  modified  irrespective  of  the 
information  provided  regarding  the  origin  of  the  products  have  been  reported  in 
several  Member  States.  On  the  basis  of  Regulation  (EC)  No  1830/2003,  operators 
have to be systematically informed of the GM nature of the feed materials that they 
buy.  Regulation  (EC)  No  1830/2003  also  provides  that  operators  must  take 
appropriate  steps  to  avoid  the  presence  of  GM  feed  if  they  want  to  avoid  their 
products to be labelled as GM in case of adventitious or technical presence of GMO 
products.  However,  the  Commission  does  not  consider  that  this  provision  implies 
that operators are entitled to label products as GM without appropriate justification. 

According  to  the  results  of  the  sample  analysis  reported  by  Member  States,  the 
frequency of non compliance to the feed labelling requirements of Regulation (EC) 
No  1829/2003  across  the  EU  may  be  estimated  to  be  around  6%  (153  out  of  2478 
analysed  samples).  It  must  be  further  stressed  that  this  figure  is  related  to  controls 
that often are targeted to products that are likely to contain GMOs or their derivatives 
and  that  the  number  of  reported  tests  as  well  as  the  percentage  of  non  compliance 
varied significantly from one Member State to another. 

4. 

UNAUTHORISED PRODUCTS 

Three  cases  of  unauthorised  GM  products  that  entered  the  EU  deserve  a  specific 
analysis. 

4.1. 

Unauthorised GM papaya 

The presence of unauthorised GM papaya from the US (Hawaii) was detected by 
the authorities of one Member State on seven occasions, three of which after the date 
of application of the Regulation.  

EN 

14 

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Such cases were notified to the other Member States via the Rapid Alert System for 
Food  and  Feed  (RASFF)  and  a  specific  detection  method  has  been  made  available 
via the Joint Research Centre. 

The measures taken by customs administrations to ensure that papaya imports from 
Hawaii  were  tested  for  genetic  modification  at  border  controls  posts  in  view  to 
communicate positive results to other Member States and reject the concerned import 
proved  to  be  effective.  Since  July  2005  no  further  discovery  of  unauthorised  GM 
papaya has been notified to the RASFF. 

4.2. 

Contamination of GM maize imported from the United States by unauthorised 
GM maize Bt 10 

The Commission was informed on 22 March 2005 by the US mission to the EU of 
the accidental release in the US of the unauthorised GM maize Bt10, erroneously 
commercialised  as  the  approved  line  Bt1119.  This  was  three  months  after  the 
company  responsible  for  the  commercialization  of  the  product  had  notified  the 
accident to the US governmental authorities. According to the US authorities, maize 
products contaminated with Bt10 were likely to have been exported to the EU since 
2001 and it was likely that such exports were still continuing. 

After  the  communication of  the accidental release the Commission took a series of 
actions to prevent the unauthorised product from entering the Community market.  

In  particular,  the  Commission,  with  the  support  of  Member  States,  adopted  on 
18 April  2005  Decision  2005/317/EC20.  This  Decision  lays  down  that  each 
consignment of products likely to be contaminated by Bt10, i.e. GM corn gluten feed 
and  brewers  grains  originating  from  the  US,  has  to  be  accompanied  by  a  report  of 
analysis  demonstrating  the  absence  of  the  unauthorised  GM  maize,  before  being 
placed on the Community market. It further provides that Member States shall take 
the  appropriate  control  measures  for  products  that  are  already  on  the  Community 
market.  

Between  April  and  September  2005  1600  analytical  tests  have  been  reportedly 
carried out in the US on corn gluten feed intended to be exported to the EU. At the 
same time more than 1400 controls were carried out by Member States at the import 
stage or on food and feed products already on the market. No positive results were 
recorded. 

There  is  no  evidence  that  the  emergency  measures  did  negatively  impact  the  US 
exports  of  maize  products  to  the  EU.  More  generally  the  approach  taken  by  the 
Commission  received  broad  support  by  Member  States  and  the  public  at  large  as 
effective and proportionate. No difficulty has been reported by Member States in the 
implementation of the Decision.  

19 

20 

Bt10 is a GM maize line, resistant to the European corn borer developed in the 90ies by the company 
Syngenta together with Bt 11  maize. Further development of Bt10 has then been discontinued before 
reaching the stage of regulatory approval. The accidental release has occurred because some batches of 
Bt 10 were erroneously labelled as Bt11 
OJ L 101, 21.4.2005, p. 14. 

EN 

15 

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The appropriateness of the measures provided in the Decision is regularly reviewed. 

4.3. 

Contamination  of  rice  imported  from  the  United  States  by  unauthorised  GM 
rice LL601 

The  Commission  was  informed  on  18  August  2006  by  the  US  authorities  of  the 
accidental release in the US of the unauthorised GM rice LL60121. This was three 
weeks  after  the  company  responsible  for  the  GMO  had  officially  notified  the 
contamination to the US governmental authorities. According to the US authorities, 
at that time, it was not known to what extent the supply chain had been contaminated 
and information on possible contamination of exports to the Community could not be 
provided. 

After  the  communication of  the accidental release the Commission took a series of 
actions to prevent the unauthorised product from entering the Community market.  

In  particular,  the  Commission  adopted  on  23  August  Decision  2006/578/EC  on 
emergency measures regarding the non-authorised genetically modified organism LL 
RICE  601  in  rice  products22  to  prevent  the  placing  on  the  market  of  these 
contaminated products. This Decision lays down that each consignment of products 
likely to be contaminated by LL601 rice, i.e. US long grain rice originating from the 
US, has to be accompanied by a report of analysis demonstrating the absence of the 
unauthorised  GM  rice,  before  being  placed  on  the  Community  market.  It  further 
provides that Member States shall take the appropriate control measures for products 
that are already on the Community market. These measures were further confirmed 
by  Decision  2006/601/EC23.  On  the  top  of  that,  the  Commission  requested  the 
European  Food  Safety  Authority  to  provide  scientific  support  on  the  issue.  The 
Authority adopted a statement on 14 September. Whilst the Authority concluded that 
the  available  information  was  not  sufficient  to  complete  a  comprehensive  risk 
assessment,  on  the  basis  of  the  information  available,  it  has  been  in  a  position  to 
conclude that the consumption of imported long grain rice containing trace levels of 
LLRICE601 is not likely to pose an imminent safety concern to humans or animals. 

The  findings  of  products  contaminated  with  LLRice601  were  notified  to  the  other 
Member States via the Rapid Alert System for Food and Feed (RASFF) allowing, in 
particular,  the  withdrawal  from  the  market  of  products  that  had  been  dispatched  to 
several Member States. 

In accordance with the decision, the effectiveness of the measures is being monitored 
by the Member States. The measures shall be reviewed by 28 February 2007 at the 
latest. 

21 

22 
23 

LLRICE601 is a GM rice that has been developed for tolerance to the Liberty® herbicide. It is similar 
to  the  GM  rice  LLRICE62  for  which  an  application  is  currently  pending  under  Regulation  (EC)  No 
1829/2003. Further development of LL601 has been discontinued in 2001 before reaching the stage of 
regulatory approval. 
OJ L 230, 24.8.2006, p. 8. 
OJ L 244, 7.9.2006, p. 27. 

EN 

16 

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4.4. 

Conclusions 

From  the  experience  of  the  GM  papaya,  Bt10  maize,  and  LL601  rice  some 
conclusions can be drawn.  

The three cases prove that the possibility of unauthorised GM products arriving at the 
doors of the EU can not be excluded.  

The reaction of the Commission in these cases was and will be targeted to guarantee 
full respect of the EU legislation especially as regards the protection of human and 
animal health and the environment. A prompt evaluation on a case-by-case basis and 
close  co-operation  between  the  Commission  and  the  Member  States  that  are 
responsible for the implementation of official controls are necessary. In this respect 
the RASFF worked as an effective communication tool allowing a timely reaction.  

It is also important to acknowledge the relevant role played in the Bt10 and LL601 
cases, by both EFSA in its quality of scientific evaluator for safety aspects and the 
Joint Research Centre as Community Reference Laboratory (CRL) for GMOs for the 
validation of the required detection methods. It is nevertheless to be noted that it is 
unlikely that, in this type of situations where the GMOs in question are not intended 
to be commercialised, the available data will be sufficient to complete a full safety 
assessment  in  accordance  with  EU  standards.  In  the  same  way,  it  is  unlikely  that  a 
robust specific detection method will always be readily available. When such method 
is  available,  the  capacity  of  the  CRL  to  validate  detection  methods  rapidly  is  of 
strategic importance to identify contaminated products. In all cases, the rapid sharing 
of  relevant  information,  data  and  material  in  a  transparent  and  efficient  manner  is 
crucial to allow an efficient and proportionate response to the issue.  

Of  equal  importance  is  the  readiness  of  GMO  producers  and  exporting  countries 
authorities, when it is the case, to quickly communicate possible problems and to co-
operate with the EU authorities in order to find effective solutions.  

Finally  preventing  the  import  of  unauthorised  GM  products  into  the  EU  market 
implies  a  high  degree  of  vigilance  from  operators  and  Member  States  in  order  to 
detect  at  an  early  stage  any  unauthorised  product  that  might  be  placed  on  the  EU 
market. It also requires prompt information from the companies responsible for the 
concerned GMO and, from the exporting country where the contamination is firstly 
reported. Overall, better international cooperation is urgently needed. 

Based on the lessons from these three cases, the Commission will consider whether 
specific actions are needed. 

5. 

FOOD  VETERINARY  OFFICE:  OUTCOME  OF  INSPECTIONS  CARRIED  OUT  IN 
THIRTEEN MEMBER STATES  

With the entry into force of the Regulations (EC) No 1829/2003 and 1830/2003 the 
Food and Veterinary Office of DG SANCO (FVO) planned a series of inspections to 
Member  States  with  the  objective  of  evaluating  on  the  spot  the  official  control 
systems  implementing  the  above  Regulations.  In  pursuit  of  these  objectives  the 
inspection teams evaluated controls at central and regional levels, those steps relating 

EN 

17 

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to  import,  processing  and  retailing  of  products  consisting  of  or  produced  from 
GMOs, including food, feed and seed.  

To  date  there  have  been  13  inspections  to  Member  States,  preliminary  findings  of 
which are detailed below: 

• 

• 

• 

• 

• 

• 

• 

All  have  designated  responsibility  for  GMO  controls  for  both  food  and  feed. 
Different authorities are normally responsible for food and feed.  

All  Member  States  had  adequate  controls  regarding  Commission  Decision 
2005/317/EC on BT10. 

The  majority  of  infringements  found  by  Member  Sates  related  to  the 
mislabelling of food and feed products. 

As with other FVO inspections the findings indicated that those Member States 
having a high degree of regional autonomy, had weaker co-ordination between 
the  regions  and  central  level  as  evidenced  by  a  lack  of  overall  results  for 
controls. 

The level of sampling reported by MSs varied considerably for food, feed and 
seed.  Specifically,  6  MSs  did  not  perform  sampling  controls  at  the  point  of 
entry  for  food,  and  feed.  Based  on  data  provided  for  2004/2005,  3  MSs 
performed  no  sampling  controls  on  seed  consignments  for  the  adventitious 
presence of GMO.  

Commission  Recommendation  2004/787/EC  on 
technical  guidance  for 
sampling and detection of GMOs and material produced from GMOs as or in 
products  in  the  context  of  Regulation  (EC)  No.  1830/2003  was  not  being 
routinely  complied  with  in  the  Member  States  visited.  In  a  number  of  cases 
Member  States  used  alternative  sampling  strategies  such  as  international 
standards ISO 2859, or Community legislation (Directive 76/371/EEC for feed 
control, or Directive 98/53/EC on mycotoxin sampling). Competent authorities 
indicated  a  difficulty 
the 
recommendation in particular to large consignments of food and feed.  

the  sampling  provisions  of 

in  applying 

Official  control  laboratories  dealing  with  GMOs  analysis  were  usually 
accredited  to  ISO  standards  (either  ISO  17025  or  ISO  45000)  although  there 
were  still  some  laboratories  lacking  the  necessary  accreditation.  Most 
laboratories  could  analyse  qualitatively  and  quantitatively  those  GMOs  for 
which certified reference material was available, although the number of events 
which were analysed for varied between MSs. 

EN 

18 

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• 

• 

However, four MSs had limited or no capabilities regarding the quantification 
of  GMOs  in  food  or  feed.  This  means  that  they  were  unable  to  determine  if 
food or feed samples which were positive for the presence of GMO were above 
the threshold level of 0.9% and thus they were unable to enforce the labelling 
requirements set down in Art 12 of the Regulation.  

Six  MSs  did  not  take  action  in  all  cases  with  regard  to  positive  results  (trace 
amounts) for seed consignments.  

Part 2: Development of implementing measures and specific 
clarifications 

6. 

ACTIVITIES  OF  THE  STANDING  COMMITTEE  ON  THE  FOOD  CHAIN  AND  ANIMAL 
HEALTH (SCFCAH) 

Since the entry into force of the Regulation on 7 November 2004, the section on GM 
Food and Feed and environmental risk of the SCFCAH held 8 meetings. The agendas 
and the minutes of its meetings are published on the “Food and Feed safety”section 
of the website of the Commission24. 

In addition to Regulation (EC) No 641/2004 (see point 7 of the current report), the 
Committee  provided  a  positive  opinion  on  the  draft  Commission  Decision  on 
emergency measures regarding the non-authorised GMO Bt10 in maize products that 
was  adopted  as  Decision  2005/317/EC25  (see  point  4.2  of  the  current  report  for 
further details). By contrast, it provided no opinion on a draft Decision related to the 
authorisation of food containing, consisting of, or produced from maize 1507. 

During  the  meetings  of  this  committee,  different  exchange  of  views  took  place 
regarding some aspects of the Regulation that should be clarified. The Commission is 
providing  clarifications  for  some  of  these  aspects  in  the  following  sections  of  the 
current report. 

7. 

ADOPTION OF IMPLEMENTING RULES AND GUIDELINES 

On  6  April  2004  the  Commission  adopted  Regulation  (EC)  No  641/200426  on 
detailed  rules  for  the  implementation  of  Regulation  (EC)  No  1829/2003  of  the 
European  Parliament  and  of  the  Council  as  regards  the  application  for  the 
authorisation  of  new  GM  food  and  feed,  the  notification  of  existing  products  and 
adventitious or technically unavoidable presence of GM material which has benefited 
from a favourable risk evaluation. 

24 
25 
26 

http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/index_en.htm 
OJ L 101, 21.4.2005, p. 14. 
OJ L 102, 7.4.2004, p.14. 

EN 

19 

   EN 

 
                                                 
The  detailed  requirements  concerning  applications  submitted  in  accordance  with 
Articles 5 and 17 of the Regulation are provided for in Chapter I of Regulation (EC) 
No  641/2004.  Those  have  been  complemented  by  guidance  documents  issued  by 
EFSA  (see  hereunder).  Chapter  II  of  Regulation  (EC)  No  641/2004  provides  the 
requirements  for  the  notification  of  existing  products.  In  addition  to  indicating  the 
compulsory  pieces  of  information  to  be  included  in  the  notification  dossiers,  this 
Chapter also clarifies the interplay of the Regulation with previous Community legal 
acts under which GM products could already be authorised, and defines the rules for 
establishing the date on which a product was first placed on the market. 

Chapter III of Regulation (EC) No 641/2004 contains the implementing rules related 
to Article 47 of the Regulation providing for transitional measures for adventitious or 
technically  unavoidable  presence  of  GM  material  which  has  benefited  from  a 
favourable risk evaluation. These measures remain applicable until 18 April 2007. In 
accordance  with  this  Chapter,  the  Commission  published  a  list  that  distinguishes 
between material fulfilling all the requirements of Article 47 and material for which a 
method  of  detection  is  not  publicly  available.  The  Commission  will  continue  to 
update this list until 18 April 2007. 

Annexes I and II of Regulation (EC) No 641/2004 define the technical requirements 
related to the validation of the detection method and to the reference material. 

In addition, Commission Regulation (EC) No 65/200427 establishing a system for the 
development and assignment of unique identifiers for genetically modified organisms 
and  Commission  Recommendation  2004/787/EC28  on  technical  guidance  for 
sampling  and  detection  of  genetically  modified  organisms  and  material  produced 
from genetically modified organisms as or in products in the context of Regulation 
(EC)  No  1830/2003  were  adopted  on  14  January  2004  and  4  October  2004, 
respectively. 

These texts further complement the Regulation with regard to the designation of the 
GMO by a defined unique identifier and to the testing of GMOs and GM products in 
the  context  of  official  controls.  Their  implementation  is  further  developed  in  the 
report on the implementation of Regulation (EC) No 1830/2003. 

In  accordance  with  Articles  5(8)  and  17(8)  of  the  Regulation,  the  European 
Commission has requested EFSA to publish detailed guidance to assist the applicant 
in  the  preparation  and  the  presentation  of  the  application  for  authorisation  of  GM 
food and/or feed.  

27 
28 

OJ L 10, 16.1.2004, p. 5. 
OJ L 348, 24.11.2004, p. 18. 

EN 

20 

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On 8 November 2004, the Scientific Panel on genetically modified organisms (GMO 
Panel) finalised, after extensive consultation, the first guidance document for the risk 
assessment  of  GM  plants  and  derived  food  and  feed  to  assist  the  applicant  in  the 
preparation  and  presentation  of  applications29.  The  EFSA  guidance  document  has 
been  updated,  on  December  2005,  with  a  section  on  general  surveillance  of 
unanticipated  effects  of  GM  plants  as  part  of  the  post  market  environmental 
monitoring30. 

A  second  guidance  document  for  the  risk  assessment  of  genetically  modified 
microorganisms and their derived products intended for food and feed use has been 
adopted by the GMO Panel on 17 May 200631.  

8. 

INTERPLAY  BETWEEN  DIRECTIVE  2001/18/EC  AND  REGULATION 
(EC) 
NO 1829/2003  RELATING  TO  EXISTING  PRODUCTS  AND  FEED  PRODUCED  FROM 
GMO 

The Regulation provides for several transitory measures related to the authorisation 
for  the  placing  on  the  market  of  GM  food  and  feed,  e.g.  for  so-called  “existing 
products”. 

Existing  products  are  products  that  were  lawfully  placed  on  the  market  prior  to 
18 April 2004, either on the basis of a Decision taken under Directive 90/220/EEC, 
Directive  2001/18/EC,  Regulation  (EC)  No  258/97,  Directive  70/524/EEC  or 
Directive 82/471/EEC or on the basis that the products did not require any specific 
authorisation.  Such  products  can  continue  to  be  used,  on  condition  that  they  were 
notified under the Regulation as "existing products" within 6 months of the date of 
application of the Regulation (i.e. October 2004). 

According to Articles 8(4) and 20(4) of the Regulation, the placing on the market of 
existing products is subject to the procedure for the renewal of authorisations, which 
applies mutatis mutandis.  

• 

Applicants  who  wish  to  apply  for  a  renewal  of  authorisations  for  existing 
products  falling  under  Articles  8(1)(a)  and  20(1)(a)  of  the  Regulation  (in 
particular,  products  that  were  already  covered  by  an  authorisation  for  placing 
on  the  market  before  the  application  of  the  Regulation,  including  GMOs  that 
were  authorised  under  Directive  90/220/EC  or  Directive  2001/18/EC)  should 
not  submit  their  applications  before  18  April  2007,  which  is  the  earliest 
possible date, three years after the date of application of the Regulation.  

– 

For the products for which the period of 9 years of placing on the market 
elapses  before  this  date,  the  applications  have  to  be  submitted  on 
18 April 2007.  

29 
30 
31 

http://www.efsa.eu.int/science/gmo/gmo_guidance/660_en.html 
http://www.efsa.eu.int/science/gmo/gmo_guidance/1275_en.html 
To be published on the website of EFTA. 

EN 

21 

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– 

For the other products, the time limit can be later on condition that it is 
within 9 years from their first placing on the market.  

• 

Applicants  who  wish  to  apply  for  a  renewal  of  authorisations  for  existing 
products  falling  under  Articles  8(1)(b)  and  20(1)(b)  (products  for  which  an 
authorisation was not required before the application of the Regulation) should 
submit their applications before 18 April 2007. 

The  Community  register  of  GM  Food  and  Feed  clearly  indicates  whether  a  given 
product has been notified in accordance with, respectively, Articles 8(1)(a), 8(1)(b), 
20(1)(a) or 20(1)(b). 

If  these  rules  are  respected,  the  products  in  question  may  remain  legally  on  the 
market  until  a  decision  on  the  basis  of  the  Regulation  has  been  taken  (see 
Articles 11(4)  and  23(4)),  without  regard  to  the  expiry  date  laid  down  in  the 
authorisation that was granted under a different legislation. 

It also appears useful to clarify the situation for several GMOs (e.g. NK603, GT73, 
1507  and  MON  863)  that  have  been  recently  authorised  on  the  basis  of  a  positive 
assessment  in  terms  of  safety  to  human  health  and  the  environment  as  part  of  the 
approval under Directive 2001/18/EC, including feed use according to the transitory 
measures of the Regulation. Since the need for an authorisation for the placing on the 
market of feed produced from GMOs is a new requirement in Community law that 
has been introduced by the Regulation (see Recital 7 of the Regulation which reflects 
this state of affairs), a further authorisation for feed produced from these GMOs will 
be required under the Regulation. 

The feed produced from the aforementioned GMOs have all been notified as existing 
products indicating that notifiers are aware of the situation. The notifications cover 
food/feed additives and feed materials produced from the GMOs. These products are 
therefore allowed to remain on the market as existing products and they will have to 
go  through  a  renewal  procedure  within  the  timeframe  indicated  in  Article  20(4)  of 
the Regulation. 

9. 

MEASURES  FOR  ADVENTITIOUS  OR  TECHNICALLY  UNAVOIDABLE  PRESENCE  OF 
GENETICALLY  MODIFIED  MATERIAL  NOT  AUTHORISED  UNDER  COMMUNITY 
LEGISLATION 

Article 47 of the Regulation states that the presence in food or feed of material which 
contains, consists of or is produced from GMOs in a proportion no higher than 0.5 % 
shall not be considered to be in breach of Article 4(2) or Article 16 (2) which require 
an  authorisation  prior  to  the  placing  on  the  market  of  GM  food  or  feed.  This 
threshold  is  only  valid  for  the  adventitious  or  technically  unavoidable  presence  of 
products that have benefited from the favourable opinion of a Community Scientific 
Committee or of EFSA before 18 April 2004, and provided that the application for its 
authorisation  has  not  been  rejected  in  accordance  with  the  relevant  Community 
legislation and that a detection method is publicly available. The thresholds may be 
lowered in accordance with the Committee procedure referred to in Article 35(2), in 
particular for GMOs sold directly to the final consumer. This later possibility has not 
been used so far. 

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The  Commission  has  adopted  Regulation  (EC)  No  641/2004  that  includes  detailed 
rules  for  the  implementation  of  Article  47.  On  that  basis  the  Commission  has 
published on 18 April 2004 a list including 4 GM foods and 9 GM feed products that 
fulfilled  all  the  above-mentioned  requirements  as  well  as  3  GM  feed  products  for 
which  no  detection  method  was  publicly  available.  An  updated  list  is  currently 
available on the website of the Commission32.  

Since the publication of this list, 4 Decisions authorising the placing on the market of 
GM foods have been adopted (cfr. Annex). As a consequence, Article 47 now only 
covers one food product: food containing or consisting of GM maize GA21. The list 
of  GM  feed  was  also  amended  following  the  authorisation  for  the  placing  on  the 
market of 2 GM feed products. 

Article  47  will  remain  applicable  until  three  years  after  the  entry  into  force  of  the 
Regulation, i.e. 18 April 2007. 

The possibility to apply a similar approach to other products that have been similarly 
risk assessed should also be considered. Authorisations for the placing on the market 
of GM products are granted for a time period of 10 years and may not be requested to 
be renewed.. At the end of the authorisation period, these legally marketed products 
may be present at different levels of the food and feed chain. It should, therefore, be 
ensured that the phasing out of the products concerned does not lead to production or 
use,  which  might  unavoidably  include  these  products  or  traces  of  these  products, 
being rendered illegal. 

Another type of product that should be considered relates to products that have been 
authorised in third countries after a safety assessment equivalent to the one required 
for EU authorisation. The establishment of such a tolerance would certainly require a 
dedicated  procedure  as  well  as  extensive  exchange  of  information  between  the  EU 
and  third  countries.  Preliminary  international  discussions  on  this  matter  were  held 
during the fifth session of the Codex Ad Hoc Intergovernmental Task Force on Foods 
Derived from Biotechnology that took place in January 200533. 

These measures, as it is the case at the present time, would only apply under specific 
conditions ensuring that this adventitious presence is compatible with a high level of 
protection of human life and health, animal health and welfare, and environment and 
that management measures are in place to enforce such measures. 

10. 

STATUS  OF  FOOD  OR  FEED  PRODUCED  BY  FERMENTATION  USING  GENETICALLY 
MODIFIED MICRO-ORGANISMS NOT PRESENT IN THE FINAL PRODUCT 

10.1.  Background 

Upon  the  adoption  of  the  Common  Position  regarding  the  proposal  for  the 
Regulation on GM food and feed, the following declaration was made “The Council 
and  the  Commission  agree  that  the  status  of  food  produced  by  fermentation  using 

32 
33 

http://europa.eu.int/comm/food/food/biotechnology/gmfood/events_en.pdf 
The report of this session is available at: http://www.codexalimentarius.net/web/archives.jsp?lang=EN 

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genetically  modified  micro-organisms  not  present  in  the  final  product,  needs  to  be 
clarified, at the latest in the context of the report to be presented by the Commission 
as foreseen in Article [48] of the Regulation.” 

From  the  answers  received  from  the  Member  States  and  stakeholders,  one  may 
conclude  that  there  is  a  general  opinion  that  a  safety  assessment  of  this  type  of 
products  should  be  mandatory  prior  to  their  placing  on  the  market.  It  is  also 
mentioned that a great part of these products (for example food and feed additives) 
have already undergone an authorisation procedure that includes a safety assessment. 
All  stakeholders  were  opposed  to  the  GM  labelling  of  this  type  of  products.  Few 
Member States are in favour while others are directly opposed to such a labelling.  

10.2.  Clarification  of  the  status  of  food  or  feed  produced  by  fermentation  using 

genetically modified micro-organisms not present in the final product 

The  status  of  food  or  feed  produced  by  fermentation  using  genetically  modified 
micro-organisms has to be clarified in the light of the recital n° 16 of the Regulation. 
When  the  GM  micro-organism  is  used  as  a  processing  aid,  the  food  and  the  feed 
resulting from such production process are not to be considered as falling under the 
scope of the Regulation. 

10.3.  Application of the clarification to food products and processing aids 

Article  1  of  Directive  89/107/EC34  defines  food  processing  aids  as  “any  substance 
not  consumed  as  a  food  by  itself,  intentionally  used  in  the  processing  of  raw 
materials, foods or their ingredients, to fulfil a certain technological purpose during 
treatment  or  processing  and  which  may  result  in  the  unintentional  but  technically 
unavoidable  presence  of  residues  of  the  substance  or  its  derivatives  in  the  final 
product, provided that these residues do not present any health risk and do not have 
any technological effect in the finished product”. 

This may be the case, for example, when the micro-organisms are removed after the 
fermentation and that the produced food is further purified in the production process 
or  when  the  micro-organisms  are  attached/fixed  to  a  support/matrix  in  such  a  way 
that it is used during the treatment or processing of the food but it is not transferred 
into the final product as such or under an altered form. 

34 

OJ L 40, 11.2.1989, p. 27. 

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When the GM micro-organisms are not removed during the production process, they 
are  not  used  as  processing  aids.  In  these  cases,  the  produced  foods  and  food 
ingredients  fall  under  the  scope  of  the  Regulation  and  have  to  be  authorised  and 
labelled accordingly. 

It  is  to  be  underlined  that  an  extended  range  of  food  produced  using  GM  micro-
organisms  as  processing  aids  are  already  subject  to  requirements  consisting  in  a 
safety assessment and a pre-market approval, or will be subject to such requirements 
by  the  way  of  new  proposed  legislation  in  the  near  future.  It  is  the  case  for  food 
additives  (subject  to  Directive  89/107/EC  as  amended),  flavourings  (subject  to 
Directive  88/388/EC35),  and  food  enzymes.  For  these  3  types  of  substances,  the 
Commission  is  finalising  proposals  to  the  European  Parliament  and  the  Council.  It 
may  also  be  the  case  for  the  placing  on  the  market  of  food  and  food  ingredients 
produced with new GM micro-organisms if they fall within the scope of Regulation 
(EC) No 258/9736, and in particular art.1(2)(f) thereof: “foods and food ingredients to 
which has been applied a production process not currently used, where that process 
gives rise to significant changes in the composition or structure of the foods or food 
ingredients  which  affect  their  nutritional  value,  metabolism  or  level  of  undesirable 
substances”. 

10.4.  Application of the clarification to feed products and processing aids 

Article 2(2)(h) of Regulation (EC) No 1831/2003 of the European Parliament and of 
the  Council  of  22  September  2003  on  additives  for  use  in  animal  nutrition  defines 
feed  processing  aids  as  “any  substance  not  consumed  as  a  feedingstuff  by  itself, 
intentionally  used  in  the  processing  of  feedingstuffs  or  feed  materials  to  fulfil  a 
technological  purpose  during  treatment  or  processing  which  may  result  in  the 
unintentional but technologically unavoidable presence of residues of the substance 
or  its  derivatives  in  the  final  product,  provided  that  these  residues  do  not  have  an 
adverse  effect  on  animal  health,  human  health  or  the  environment  and  do  not  have 
any technological effects on the finished feed”. 

Article 2(2)(a) of the same Regulation provides that feed additives mean “substances, 
micro-organisms or preparations, other than feed material and premixtures, which are 
intentionally added to feed or water in order to perform, in particular, one or more of 
the functions mentioned in Article 5(3) [of Regulation (EC) No 1831/2003]”. 

When the GM micro-organisms are present in the feed or when they are not removed 
during the production process, they are not used  as processing aids.  In these cases, 
the produced feeds fall under the scope of the Regulation and have to be authorised 
and labelled accordingly. When the GM micro-organisms are present as such in the 
feed,  whether  as  or  in  a  product  that  fall  within  the  definition  of  feed  additives 
provided  by  Regulation  (EC)  No  1831/2003,  that  product  must  also  be  approved 
under that Regulation before it may be placed on the market and used.  

35 
36 

OJ L 184, 15.7.1988, p. 61. 
OJ L 43, 14.2.1997, p. 1. 

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Certain  categories  of  feed  materials  which  are  produced  by  fermentation  with 
bacteria,  algae,  yeasts  or  lower  fungi  and  used  as  source  of  protein  require  pre-
market assessment and approval before being placed on the market and used. Council 
Directive 82/471/EEC37 of 30 June 1982 concerning certain products used in animal 
nutrition lay down the conditions for authorisation of such products as amended. 

Consequently,  an  extended  range  of  feed  produced  using  GM  micro-organisms  as 
processing aids are, due to the fact that the produced feeds are used as additives or 
source of protein and manufactured by certain technical processes, subject to specific 
legal  requirements  laid  down  in  Regulation  (EC)  No  1831/2003  or  Directive 
82/471/EEC regarding their safety in order to be lawfully placed on the market. 

10.5.  Guidelines  on the Safety assessment of food  or  feed  produced  by  fermentation 

using genetically modified micro-organisms 

The  GMO  Panel  of EFSA has adopted on 17 May 2006 its guidance document for 
the  risk  assessment  of  genetically  modified  micro-organism  and  their  derived 
products  intended  for  food  and  feed  use38.  The  guidance  was  subject  to  public 
consultation  between  15  July  and  30  September  2005.  The  current  document 
addresses  all  the  uses  of  the  GM  micro-organisms  and  their  derived  products 
intended  for  food  and  feed  use,  irrespective  of  the  fact  that  they  are  used  as 
processing  aids  or  not.  The  outcome  of  this  work  will  be  relevant  for  the  safety 
assessment of all the uses of GM micro-organisms and their derived food and feed, 
irrespective of the fact that they fall under the scope of the Regulation or one of the 
other legislative framework presented above. 

10.6.  Conclusions 

Food  or  feed  produced  using  genetically  modified  micro-organisms  as  processing 
aids are not falling under the scope of the Regulation. However, an extended range of 
these  products  are  already  subject  to  an  equivalent  authorisation  procedure  under 
Community law and thus to equivalent requirements in terms of food and feed safety. 

The  Commission  therefore  considers  that  there  is  no  particular  need  to  review  the 
Regulation for this type of products at the present time. However, the situation will 
be reconsidered when an in-depth review of the Regulation will be carried out on the 
basis of additional experience. In this regard, particular attention will also have to be 
paid  on  the  appropriateness  to  develop  tailored  labelling  rules  for  this  type  of 
product. 

11. 

CLARIFICATIONS  RELATED  TO  SOME  ASPECTS  OF  THE  LABELLING  PROVISION  OF 
THE REGULATION 

Operation of the labelling threshold  

37 
38 

OJ L 213, 21.7.1982, p. 8. 
To be published on the EFSA website. 

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26 

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Articles12  and  24  of  the  Regulation  set  the  conditions  under  which  GM  food  and 
feed are required to be labelled. Articles 12(2) and  24(2) provide an exemption  for 
the  adventitious  or  technically  unavoidable  presence  of  GM  food  and  feed  in  a 
proportion that is no higher than 0.9 %. 

When  the  food/feed  is  composed  of  one  food/feed  (e.g.  a  feed  material  or  an 
ingredient), the threshold must be calculated on the basis of such a food/feed. When 
the  adventitious  or  technically  unavoidable  presence  of  material  consisting  of, 
containing  or  produced  from  GMOs  (hereinafter  referred  to  as  GM  material)  is 
detected in compound feedingstuffs or foods composed of more than one ingredient, 
it is necessary to examine each of the different ingredients/feed components in order 
to establish the origin of such a presence. If the threshold of 0.9% is exceeded in one 
of those components of the food/feed, then the food/compound feed should indicate 
on  the  label  the  presence  of  the  GM  material  in  relation  to  that  specific  food/feed 
component. 

Labelling of alcoholic beverages  

According to Article 6(3) of the general labelling Directive 2000/13/EC, the Council 
shall  adopt  specific  rules  on  the  labelling  of  ingredients  of  alcoholic  beverages 
containing more than 1.2 % by volume of alcohol. Since these specific rules have not 
been adopted by Council, the current interpretation is that labelling of ingredients of 
alcoholic beverages is not compulsory. 

However,  the  Council  and  the  Parliament  have  acted  by  laying  down  specific 
labelling rules for GM food in the Regulation. GM ingredients of alcoholic beverages 
have thus to be labelled according to the labelling requirements of the Regulation. 

Labelling of carriers  

Carriers for food additives that are exempted from labelling should also be exempted 
from  labelling  when  produced  from  a  GMO:  The  reason  is  that  according  to 
Article 13(1) of the Regulation, the labelling requirements of the Regulation apply to 
ingredients as defined in article 6.4 of the General Labelling Directive 2000/13/EC. 
If the requirements of Article 6(4)(c)(iii) of this Directive are met, the carrier is not 
considered  as  an  ingredient  and  therefore  the  labelling  of  the  carriers  is  not 
compulsory, even if they are produced from a GMO. 

Carriers  used  in  premixtures  of  feed  additives  however  are  considered  as  feed 
materials and GM labelling is mandatory if they are produced from a GMO. 

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Labelling requirements for mass caterers  

The labelling requirements of the Regulation are not applicable to food supplied by 
mass caterers to their customers where such foods have been prepared or processed. 
They do, however, apply to food which are supplied to mass caterers and which are 
delivered  as  such  to  the  final  consumer.  This  interpretation  is  consistent  with  the 
interpretation  which  has  traditionally  been  given  to  Article  1(1)  of  Directive 
2000/13/EC, which is written in a similar manner39.  

GM free labelling scheme  

With regard to some practices related to label food or feed products as “GM free”, 
the following elements need to be clarified. 

The  Regulation  is  providing  for  labelling  rules  indicating  the  presence  of  GMO. 
However,  it  does  not  forbid additional  labelling practices  that would  aim  to  inform 
the  consumer  that,  in  addition  to  what  is  prescribed  by  the  EU  legislation,  specific 
measures have been taken to strictly exclude the presence or the use of GMO in some 
food or feed products. 

Two categories of products can be distinguished: 

(1)  Food  categories  that  have  not  been  genetically  modified  hitherto:  labelling 
these foods as GM free is suggesting that they possess a special characteristic 
when  in  fact  all  similar  food  possess  the  same  characteristic,  and  this  is 
misleading within the meaning of Article 2(1)(a)(iii) of Directive 2000/13/EC. 

(2)  Food products that can be genetically modified or not: Such food can be placed 
on the market without a GM label provided that they contain less than 0,9 % of 
GM  material  and  that  the  presence  of  GM  material  is  unintentional  and 
technically  unavoidable.  For  these  foods,  a  GM  free  labelling  can  not  be 
excluded a priori. 

Some Member States have developed national rules regarding this type of labelling 
and the Commission notes that in most of those Member States such national rules 
stipulate that the threshold for adventitious and technically unavoidable presence of 
GM  material  in  GM  free  products  should  be  below  the  level  of  detection  of  the 
current analytical methods.  

12. 

CONCLUSIONS 

The Regulation has only been operational for a limited period of time and experience 
in  terms  of  its  implementation  is  extremely  limited.  Consequently,  this  report  can 
realistically only be viewed as preliminary and further experience and reporting will 
be  required  to  gain  a  true  picture  of  the  implementation  of  the  Regulation.  It  is 
therefore premature to bring forward proposals to amend the current Regulation. 

39 

This  clarification  was  provided  in  answer  to  the  written  question  No  4049/03  of  a  member  of  the 
European Parliament. 

EN 

28 

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The  procedures  established  by  the  Regulation  to  handle  the  submitted  applications 
have been designed to streamline the authorisation process. EFSA is taking a central 
role in this process since it has, after due consultation of the assessment bodies of the 
Member States, to provide the opinions on which the authorisations are based. While 
this  has  been  the  case  for  the  first  authorisation,  the  Commission  agreed  in  April 
2006 on practical improvements with the objective of building greater consensus and 
transparency  regarding  the  authorisation  for  the  placing  on  the  market  of  GM 
products  either  under  the  Regulation  or  under  Directive  2001/18/EC  and  EFSA 
engaged  to  reinforce  collaboration  with  Member  States  on  GMO  risk  assessment. 
The  high  number  of  applications  (more  than  thirty)  is  a  direct  indicator  of  the 
continuous  development  of  new  GM  products  and  of  the  willingness  of  their 
producers to undergo the prescribed thorough safety assessment that is a pre-requisite 
for their commercialisation on the European market. 

In  comparison  to  the  previous  existing  legislation,  the  range  of  products  to  be 
labelled as genetically modified or produced from a GMO was extended to all food 
and  feed  produced  from  GMOs.  This  is  recognised  as  a  major  improvement  in 
responding to European consumers’ requests for the possibility to make an effective 
and informed choice between GM and non GM products. The EU market shares of 
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. 

The Commission will continue, in collaboration with the CA of Member States and 
EFSA, to ensure the appropriate implementation of the Regulation. In this regard, the 
Food  and  Veterinary  Office  of  DG  SANCO  (FVO)  will  pursue  its  missions  in 
Member  States  with  the  objective  of  evaluating  on  the  spot  the  official  control 
systems  implementing  the  legislation  on  GM  food  and  feed.  In  the  case  of 
information  indicating  the  placing  on  the  market  of  non-authorised  GM  products, 
appropriate actions will continue to be decided on a case-by-case basis. 

A  second  report  on  the  Regulation  should  be  prepared  after  a  sufficient  period  of 
time  allowing  more  insight  on  the  different  aspects  of  the  implementation  of  the 
Regulation.  

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ANNEX 

AUTHORISATIONS UNDER DIRECTIVE 2001/18/EC OR REGULATION (EC) NO 258/97 IN 
ACCORDANCE WITH THE TRANSITIONAL MEASURES PROVIDED FOR IN ARTICLE 46. 

COMMISSION  DECISION  2004/657/EC  of  19  May  2004  authorising  the  placing  on  the 
market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food 
ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council 
[OJ L 300, 25.9.2004, p. 48] 

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] 

COMMISSION  DECISION  2005/448/EC  of  3  March  2005  authorising  the  placing  on  the 
market of foods and food ingredients derived from genetically modified maize line NK 603 as 
novel  foods  or  novel  food  ingredients  under  Regulation  (EC)  No  258/97  of  the  European 
Parliament and of the Council [OJ L 158, 21.6.2005, p. 20] 

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] 

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] 

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] 

COMMISSION  DECISION  2006/68/EC  of  13  January  2006  authorising  the  placing  on  the 
market of foods and food ingredients derived from genetically modified maize line MON 863 
as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European 
Parliament and of the Council [OJ, L 34, 7.2.2006, p. 26] 

COMMISSION  DECISION  2006/69/EC  of  13  January  2006  authorising  the  placing  on  the 
market  of  foods  and  food  ingredients  produced  from  genetically  modified  Roundup  Ready 
maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 
of the European Parliament and of the Council [OJ L 34, 7.2.2006, p. 29] 

EN 

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