Amended proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed (presented by the Commission pursuant to Article 250 (2) of the EC-Treaty)
Date: 2002-10-08
Institutions: European Commission
Subjects: animal nutrition, consumer information, food safety, foodstuff, genetically modified organism, health policy, labelling

EN

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 08.10.2002
COM(2002) 559 final

2001/0173 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

ON GENETICALLY MODIFIED FOOD AND FEED

(presented by the Commission pursuant to Article 250 (2) of the EC-Treaty)

 
EXPLANATORY MEMORANDUM

AMENDED PROPOSAL FOR A REGULATION OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL 
ON GENETICALLY MODIFIED FOOD AND FEED

1. 

BACKGROUND

–  Adoption  of  the  proposal  by  the  Commission  on  25  July  2001  and  transmission  to  the
Parliament and the Council on 30 July 2001 (COM(2001) 425 final – 2001/0173(COD)),
on the basis of Articles 37, 95 and 152 (4) (b) of the EC-Treaty.

–  Opinion of the Committee of the Regions adopted on 16 May 2002.

–  Opinion of the Economic and Social Committee adopted on 30 May 2002.

–  Opinion of the European Parliament at first reading adopted on 3 July 2002.

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL

The objective of the proposal is to provide the basis for ensuring a high level of protection of
human  life  and  health,  animal  health,  environment  and  consumers’  interest  in  relation  to
genetically modified food and  feed, whilst  ensuring the effective  functioning of  the  internal
market. 
The proposal lays down centralised Community procedures for the assessment, authorisation
and supervision of genetically modified food and feed, as well as labelling requirements for
these products.

3. 

COMMISSION POSITION ON THE 111 AMENDMENTS ADOPTED BY THE PARLIAMENT

3.1. 

Amendments accepted by the Commission

The Commission can accept amendments 13, 16, 17, 18, 19, 31, 70, 78, 110, 115, 119, 123,
124,  145,  146  and  147,  as  these  amendments  improve  or  bring  clarification  to  the
Commission’s initial proposal.

Amendment  13  makes  explicit  reference  in  Article  1  of  the  proposal  to  the  precautionary
principle, which is taken into account by the regime provided for by the proposal.

Amendment  16  aims  at  splitting  the  definition  of  “genetically  modified  food”  from
“genetically modified feed”, which is consistent with the structure of the text of the proposal.

Amendments  17  and  18  refer  to  the  definition  of  “genetically  modified  organisms  for  food
and feed use” and suppress the reference to the exemption of genetically modified organisms
not  covered  by  the  scope  of  Directive  2001/18/EC.  This  is  accepted  by  the  Commission
because such exemption should rather be included in the definition of “genetically modified
organism” (see also amendment 9 on the “Traceability and Labelling” proposal). For the sake
of  legal  consistency,  the  exclusion  provided  for  in  Article  3  (1)  of  Directive  2001/18/EC,
which refers to specific techniques of genetic modification, has to be taken into account in the
present proposal.

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Amendment 19 clarifies the wording of the definition of “control sample” in order to make a
clear distinction between positive and negative control samples.

Amendments 31 and 78 require that the summary of the dossier submitted by the applicant be
presented  in  a  standardised  form,  which  will  make  the  handling  and  the  access  to  the
application easier. This is also in line with Directive 2001/18/EC.

Amendment  70  clarifies  how  the  labelling  of  genetically  modified  food  without  pre-
packaging has to be made in order to offer a better information to the consumer. It also adds
reference  to  small  pre-packagings,  as  the  particularity  of  these  items  should  be  taken  into
account.

Amendments 110, 145, 146 and 147 suppress the mention of “but not containing a genetically
modified  organism”  within  the  labelling  requirements  of  food  and  feed  produced  from
genetically  modified  organisms.  This  brings  clarification  to  the  labelling  and  suppresses
unnecessary and possibly misleading information on the label.

Amendment 115 makes legally clear in Article 29 of the proposal that the Authority has the
obligation - and not only the possibility - to examine whether the application for authorisation
should be submitted both as food and feed.

Amendment  119  aims  at  deleting  the  proposed  amendment  to  Article  12  (1)  of  Regulation
(EC) No 258/97, in order to maintain the possible application of the emergency clause of this
Regulation to non-genetically modified novel foods in case of danger to the environment. It
cannot  be  excluded  indeed  that  new  production  processes  could  have  effects  on  the
environment.

Amendment 123 imposes a time  limit  of  twelve  months  from  the  date  of  application  of  the
proposed Regulation to the transitional measure laid down in Article 45 (2) of the proposal, so
that  the  labelling  requirements  would  fully  apply  to  all  genetically  modified  food  and  feed
after this time limit.

Amendment  124  provides  for  the  publication  of  the  report  on  the  implementation  of  the
proposed Regulation and of any accompanying proposal. It is appropriate to refer explicitly to
the public availability of these documents in Article 46 (1) of the proposal.

3.2. 

Amendments accepted in principle, in part and/or subject to re-wording

The Commission can accept amendments 10, 36, 64 and 144 in principle.

Amendments 10 and 36 refer to the contribution by the Member States to the drawing up of
guides  to  good  segregation  practice  to  be  applied  by  food  operators  in  order  to  avoid
adventitious  contamination  by  genetically  modified  organisms.  The  Commission  can  accept
the  principle  laid  down  in  these  amendments  and  would  refer  to  its  Communication  on  life
sciences and biotechnology adopted in January 2002, where an action concerning the issue of
co-existence has been put forward. However, this specific issue is basically not the subject of
the proposal and should therefore not be expressly mentioned in the proposed Regulation. The
Commission  accepts  to  make  reference  to  this  issue  in  another  appropriate  document  in
relation to the proposed Regulation.

Amendments  64  and  144  explicitly  mention  in  Article  13  of  the  proposal  the  exclusion  of
processing  aids  (amendment  64)  and  of  foods  produced  from  animals  fed  with  genetically
modified  organisms  or  products  thereof  (amendment  144)  from  the  scope  of  the  labelling

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section  for  genetically  modified  food.  The  Commission  agrees  with  the  principle  of  these
exclusions, but these should not be explicitly mentioned in the enacting terms of the proposed
Regulation  as  Article  13  of  the  proposal  already  defines  the  scope  in  a  positive  way  and
includes “food produced from genetically modified organisms” and not “foods produced with
genetically  modified  organisms”.  The  Commission  accepts  however  that  mention  of  the
exclusion of these specific products from the scope of the labelling but also the authorisation
sections be explicitly made in the recitals of the proposal, which is the purpose of recital 15.

The Commission can accept the following amendments subject to re-wording: 1, 3, 12, 20,
23, 28, 30, 34, 38, 45, 55, 56, 71, 75, 77, 82, 89, 90, 101, 112, 114, 117, 118 and 121. The
following  amendments  can  be  accepted  in  part:  37,  41,  44,  57,  81,  86,  102,  103,  165  and
166.

Amendment  1  adds  reference  to  the  precautionary  principle  in  the  recitals  of  the  proposal.
This reference should be included in recital 3 of the proposal related to safety assessment and
should be re-worded in order to be in line with the wording of Directive 2001/18/EC and to
mention that the precautionary principle has also been taken into account in the drafting of the
proposed Regulation.

Amendments 3 and 114 mention that the Community requirements for food and feed should
apply similarly to imported products to avoid the creation of unfair conditions of competition.
This is a general principle already laid down in Regulation (EC) No 178/2002 and which can
be  reminded  in  a  recital  of  the  proposal,  but  not  in  the  enacting  terms  as  it  is  not  a  new
specific  requirement  laid  down  by  the  proposal.  It  is  proposed  to  include  mention  of  this
principle in recital 38, related to international trade, with a reference to the basic objectives of
the proposal.

Amendments  12,  28  and  75  add  reference  to  independent  and  peer-reviewed  studies  on  the
safety  of  the  product  to  be  included  in  the  Register  and  the  application  dossier.  As  these
independent studies may  not always  exist,  it  is  proposed  to  specify  that  this  applies  “where
available”.

Amendment 20 adds a definition of “final consumer”. The Commission proposes to refer to
the definition included in Regulation (EC) No 178/2002. I should be noted that the concept of
“final consumer” is not used in the feed sector. The wording of Article 14 (1) (d) (“ultimate
consumer”) should be adapted accordingly.

Amendment 23 refers to Article 4 (1) of the proposal laying down the basic requirements for
genetically modified food and replaces the concept of “risk” with “danger”. The Commission
agrees  that  a  zero  risk  level  can  generally  not  be  guaranteed  and,  taking  into  account  the
definitions  of  “risk”  and  “danger”  included  in  Regulation  (EC)  No  178/2002,  would  rather
propose to qualify the risk as “unacceptable”. Risk management requires a risk analysis on the
basis of the results of the scientific risk assessment and other factors legitimate to the matter
under  consideration,  in  order  to  decide  whether  the  risk  is  “acceptable”  with  regard  to  the
achievement  of  the  general  objectives  of  the  proposed  Regulation.  This  amendment  should
also apply to genetically modified feed in Article 17 (1) (a) of the proposal.

In  addition  to  amendment  124  supra,  the  Commission  can  accept  a  series  of  amendments
which  aim  at  strengthening  information  requirements  and  public  involvement  within  the
authorisation  and  supervision  process  of  genetically  modified  food  and  feed.  All  provisions
on  public  access  should  however  be  without  prejudice  to  the  protection  of  intellectual
property rights relating to the data concerned. Also, account should be taken of the provisions

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of  Regulation  (EC)  No  178/2002  on  transparency,  confidentiality  and  access  to  documents
related to  the activities of  the  European  Food  Safety  Authority,  and  of  Regulation  (EC)  No
1049/2001  regarding  public  access  to  European  Parliament,  Council  and  Commission
documents. The Commission proposes therefore to refer to these general provisions in a new
first  paragraph  of  Article  31  of  the  proposal,  which  would  be  re-titled  “Disclosure  and
confidentiality”.  Specific  information  requirements  would  still  be  stated  in  the  relevant
provisions of the proposal, “in accordance with Article 31”. Amendments accepted (subject to
re-wording) are the following:

– 

– 

– 

– 

– 

amendments  30,  45,  77  and  90  provide  for  mention  of  the  place  where  the
reference  material  can  be  accessed.  This  can  be  necessary  information  for
example for authorities for inspection purpose or for operators for self-check of
supplies;

amendments  38  and  82  provide  that  the  publication  of  the  summary  of  the
dossier shall refer to the possibility for the public to have access to the entire
application on request;

amendments  55  and  101  require  the  public  accessibility  of  the  monitoring
reports. This public access requirement implies an adaptation of Article 31 (3)
(f) accordingly. It should be noted that these amendments also provide that all
parties concerned, and not only the authorisation-holder, have to comply with
the conditions and restrictions imposed in the authorisation. This is in line with
Articles 4 (2) and 17 (2) of the proposal, which refer to “relevant” conditions
and restrictions;

amendments  56  and  102  refer  to  new  information  forwarded  by  the
authorisation-holder in the frame of the supervision of the genetically modified
food and feed, and require that this information be notified to the Commission
and the Member States and be made available to the public. The Commission
believes that  this  information  should  first  be  validated  by  the  European  Food
Safety Authority and then be made available to the Commission, the Member
States and the public. Amendment 102 (for supervision of genetically modified
feed)  also  requires  that  the  local  authorities  be  informed,  but  this  cannot  be
accepted  by  the  Commission  because  these  entities  are  not  involved  as  such
within the centralised procedures laid down by the proposed Regulation;

amendments 57 and 103 provide that the opinion of the European Food Safety
Authority be transmitted to the authorisation-holder, the Member States and be
made  publicly  available,  which  is  in  line  with  the  basic  authorisation
procedure. However, this opinion should not be transmitted to local authorities
(see amendment 102 supra).

Amendments 34, 165 and 166 relate to the role of the competent authorities under Directive
2001/18/EC.  The  Commission  can  accept  to  consult  these  authorities  for  the  adoption  of
implementing  rules  on  the  submission  of  application  dossiers,  but  only  for  matters  falling
within their remit. Local authorities should not be consulted in this process (see amendment
102  supra).  The  Commission  accepts  also  that  the  adoption  of  implementing  rules  on  the
application dossiers be mandatory in order to avoid a risk of legal vacuum. The Commission
can accept to bring minor editorial amendments to Article 7 (4) of the proposal as regards the
application  of  the  environmental  safety  requirements  laid  down  in  Directive  2001/18/EC
(which should also be taken into account under the Feed chapter). However, involvement of

5

the Commission, national and local authorities in the evaluation process cannot be accepted as
such: the evaluation is to be undertaken under the responsibility of the European Food Safety
Authority, who shall consult with the bodies set up under Directive 2001/18/EC, as provided
for by Article 12 (4) of this Directive.

Amendments 37 and 81 provide for more involvement of the authorities of the Member States
in  the  evaluation  of  the  application  dossiers.  The  Commission  can  accept  that  the  Member
States  and  the  Commission  be  informed  without  delay  of  new  applications  and  any
supplementary  information  received  from  the  applicant.  However,  the  Commission  cannot
accept to give such an active role to the  national authorities in this process so  that it  would
suppress the centralised risk assessment procedure.

Amendments 41, 44, 86 and 89 make clear that the Community reference laboratory should in
all cases test and validate the method of detection and identification proposed by the applicant
before the European Food Safety Authority gives an opinion. However, the validated method
should  not  be  published  by  the  laboratory  at  this  stage:  in  the  context  of  the  centralised
procedure,  the  European  Food  Safety  Authority  should  receive  reports  from  the  laboratory
and then include the validated method in its opinion, which should be published. Reference to
“access to appropriate reference material” and to “the sequence of” the transformation event
in Article 7 (5) (f) are not necessary to make as these elements are already covered by the text
of the proposal (in particular, see amendment 45 supra). The last part of amendment 44 (“or
with  it”)  is  not  acceptable  because  foods  produced  with  genetically  modified  organisms  are
not included in the scope of the proposal.

Amendment 71 brings editorial improvement to Article 14 (2) of the proposal on the labelling
of characteristics not equivalent to the conventional counterpart.

Amendment 112 refers to the labelling of genetically modified feed and takes into account the
case  of  feed  consisting  of  more  than  one  ingredient.  It  proposes  a  wording  similar  to  the
corresponding  labelling  requirements  of  genetically  modified  food.  The  Commission  agrees
that the proposal should make clearer that genetically modified feed components have to be
labelled,  in  consideration  of  the  definition  of  “feed”  provided  for  in  Regulation  (EC)  No
178/2002, which  covers  also  additives.  The  concept  of  “ingredient”  in  the  Community  feed
legislation does however not refer to additives and therefore the Commission proposes to re-
word Article 27 (3) (a) in specifying that “each feed material or additive of which a particular
feed is composed of” has to be labelled. The Commission can accept that the wording related
to  the  form  of  the  labelling  (place  on  the  label,  font)  be  consistent  with  the  corresponding
labelling rules  of  genetically modified  food. Reference to  Directive 79/373/EEC is  however
not  necessary  as  Article  27  (1)  of  the  proposal  already  states  that  these  rules  are  without
prejudice to the other requirements of Community law concerning the labelling of feed.

Amendments 117 and 118 relate to the provision on emergency measures. The Commission
can  accept  to  amend  Article  35  of  the  proposal,  subject  to  the  application  of  the  general
“emergency  measures”  clause  laid  down  in  Regulation  (EC)  No  178/2002,  for  consistency
purpose in matters of food and feed safety. The Commission proposes therefore to refer to the
application of Articles 53 and 54 of Regulation (EC) No 178/2002, including where the need
of emergency measures arises further to an opinion of the European  Food Safety  Authority.
This amendment makes paragraph  3  of  Article  36  of  the  proposal  (implementing  powers  of
the Commission in case of emergency) useless.

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The  Commission  can  accept  amendment  121  referring  to  the  adaptation  of  Article  7  (5)  of
Directive  70/457/EEC,  in  order  to  simplify  its  wording  and  make  reference  to  “relevant
legislation” instead of enumerating relevant acts.

3.3. 

Amendments not accepted by the Commission

The Commission cannot accept the following amendments: 8, 14, 22, 25, 26, 29, 33, 35, 39,
43, 46, 47, 48, 49, 50, 51, 52, 53, 54, 58, 59, 60, 61, 72, 73, 74, 76, 79, 83, 84, 87, 88, 91, 92,
93, 95, 96, 97, 98, 99, 100, 104, 105, 109, 111, 113, 116, 120, 122, 142, 156, 159, 161, 162,
163,  164  and  167.  The  Commission  considers  that  many  of  these  amendments  would
undermine  the  attempts  to  sustain  the  overall  Community  regime  as  proportionate  and
efficient.

(cid:1)  Status of sectoral legislation and application of centralised procedure

Amendments 33, 39, 49, 73, 79, 83, 84, 87, 95 and 120 deny the future Regulation the status
of  sectoral  legislation,  implying  that  the  non-centralised  assessment  procedure  and  the
authorisation  procedure  laid  down  in  Directive  2001/18/EC  should  apply  before  getting  an
authorisation  under  the  proposed  Regulation  (no  “one  door-one  key”  procedure).  The
Commission considers that the proposed Regulation will have the status of sectoral legislation
in accordance with the conditions of Article 12 of Directive 2001/18/EC: the proposal makes
explicit  reference  to  the  relevant  requirements  laid  down  in  this  Directive  as  regards
genetically  modified  organisms  as  or  in  products  to  be  approved  under  the  proposed
labelling,  monitoring,
Regulation.  Environmental  risk  assessment,  risk  management, 
information  to  the  public  and  safeguard  clause  provisions  are  at  least  equivalent  and  even
stricter to those laid down in Directive 2001/18/EC. Furthermore, the proposal  consists of a
Regulation of the European Parliament and of the Council, as referred to in Article 12 (3) of
Directive 2001/18/EC, which is the same legislator in both cases.

Authorisations of  genetically  modified  food  and  feed  should  be  granted  under  the  proposed
Regulation subject to a single risk assessment process under the central responsibility of the
European  Food  Safety  Authority,  who  shall  apply  the  relevant  above-mentioned  conditions
and consult the bodies set up under Directive 2001/18/EC, in accordance with Article 12 (4)
of this Directive. It should also be noted that the Authority may ask a food or feed assessment
body of a Member State to carry out a safety assessment or ask a competent authority under
Directive  2001/18/EC  to  perform  an  environmental  risk  assessment  of  the  genetically
modified food or feed. This is also in line with Article 36 of Regulation (EC) No 178/2002
regarding co-operation of the Authority with national bodies.

(cid:1)  Information requirements and public involvement

Amendments 47, 48, 50, 52, 53, 58, 59, 92, 96, 98, 99, 104, 105, 116 and 167 require more
information or involvement of the public or local bodies in the assessment and authorisation
procedure. However, the proposed Regulation is already to be considered as providing a very
transparent system, taking also into account other amendments accepted by the Commission
in  order  to  strengthen  public  information  and  involvement  (see  under  points  3.1  and  3.2
above).  Amendments  considered  as  not  reasonable  or  going  too  far  with  regard  to  usual
Community rules cannot be accepted: period of three months for public consultation (this is
far more than provided for by Directive 2001/18/EC and would undermine the adoption of a
decision  within  a  reasonable  time  limit),  publication  of  draft  Commission  decision,  public
access to the issues discussed in connection with the risk management decision and the result
of  the  vote.  Comitology  rules  should  not  be  amended  through  the  proposed  Regulation  and
the  institution’s  decision-making  process  should  not  be  undermined.  Also,  amendments

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requiring specific involvement of local authorities cannot be accepted as the European Food
Safety  Authority  already  takes  into  account  the  consultation  requirements  of  Directive
2001/18/EC. Amendment 116 requires that detection methods used by the national reference
laboratories  be  also  included  in  the  Register,  but  this  would  not  be  useful  as  the  method
validated  by  the  Community  reference  laboratory,  which  will  be  assisted  by  the  national
reference  laboratories,  will  be  already  included  in  the  Register  for  the  genetically  modified
product concerned.

(cid:1)  Derogation in case of adventitious presence of genetically modified organisms

– 

– 

Amendments  25,  74  and  122  aim  at  suppressing  the  derogation  for  adventitious
presence of unauthorised genetically modified organisms in food and feed and thus
refuse to amend Directive 2001/18/EC in this regard, which is not acceptable by the
Commission. More than 50 million hectares of genetically modified crops are grown
in  the  world  and  adventitious  or  technically  unavoidable  presence  of  traces  of
genetically  modified  organisms  or  materials  in  conventional  food  and  feed  is
inevitable. The proposed Regulation would not be feasible if it does not provide for
any  tolerance,  under  certain  conditions,  of  traces  of  genetically  modified  materials
which  are  not  authorised  in  the  Community.  The  Commission  believes  that  the
objective of protection of health and the environment is safeguarded by the proposal
on  the  basis  of  the  strict  conditions  laid  down  therein:  only  adventitious  or
technically  unavoidable  presence  of  genetically  modified  organisms  which  were
positively  assessed  by  a  European  scientific  committee  would  be  tolerated  under  a
threshold of maximum 1%, which can be lowered by comitology in order to take into
account scientific developments and products particularities.

Amendments 162, 163 and 164 relate to the derogation to the labelling requirements
in  case  of  adventitious  presence  of  material  produced  from  genetically  modified
organisms and provide for a threshold of maximum 0,5 %. The Commission believes
that  the  derogation  should  also  apply  to  material  containing  or  consisting  of
genetically  modified  organisms  and  that  the  threshold  should  be  established  by
comitology,  as  also  laid  down  in  Article  21  (2)  of  Directive  2001/18/EC.  Explicit
reference  to  “appropriate  measures  to  avoid  contamination”  is  not  necessary  as
Articles 15 and 28 of the proposal already provide for the adoption of implementing
rules for the labelling requirements. In addition, these measures should not be mixed
with  the  adoption  of  actions  to  prevent  the  unintended  presence  of  genetically
modified material in non-genetically modified products, which are not the subject of
the  proposed  Regulation  (see  below).  Amendment  8  is  not  acceptable  as  operators
should be in a position to demonstrate to authorities that they have taken appropriate
steps,  i.e.  on  request  and  not  automatically  at  each  operation  of  placing  on  the
market.

(cid:1)  Objectives and scope of the proposal

Amendments 14, 43 and 88 include the objective of prevention of the unintended presence of
genetically modified material in food and feed. Reference to this objective and to measures to
this  effect  cannot  be  accepted  as  it  is  basically  not  the  subject  nor  the  objective  of  the
proposal. This is related to the issue  of  co-existence between  genetically modified and non-
genetically  modified  production,  which  has  been  addressed  in  the  Communication  on  life
sciences and biotechnology adopted in January 2002.

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Amendments  22  and  72  refer  to  Articles  3  (2)  and  16  (2)  of  the  proposal  and  provide  that
“further  types”  of  food  and  feed  may  be  determined  as  falling  within  the  scope  of  the
Authorisation sections of the proposal. The Commission cannot accept these amendments, as
the intention is to possibly implement the provisions of paragraph 1 of Articles 3  and  16  of
the proposal, and not to add new categories of products in the scope of the section.

(cid:1)  Specific issues related to the assessment and authorisation procedure

Amendment  26  provides  for  the  acknowledgement  of  receipt  of  the  application  within  15
working days of its  receipt.  The Commission believes that a period of 15 “days” (including
public holidays, Sundays and Saturdays – cfr. Regulation (EEC, Euratom) No 1182/71)  is a
reasonable  time  limit  for  this  matter.  In  addition,  “days”  periods  should  be  referred  to  with
consistency:  all  references  within  the  proposal,  but  also  in  Directive  2001/18/EC,  in
Regulation (EC) No 258/97 and in the Cartagena Biosafety Protocol are made in “days” and
not “working days”.

Amendments 29 and 76 require that the application include a proposal for the labelling of the
product concerned in accordance with Article 14 (1) for genetically modified food and Article
27 (3) (a) for genetically modified feed. This is not acceptable as these provisions lay down
general  mandatory  labelling  requirements  which  apply  in  all  cases,  irrespective  of  the  risk
assessment and of the conditions of the authorisation.

Amendment 35 provides that guidance on the presentation of applications should be published
by  the  European  Food  Safety  Authority  “before  the  entry  into  force”  of  the  proposed
Regulation. This cannot be accepted because there would be no legal basis for such action at
this time and because such guidance should be flexible and adapted regularly.

Amendment  93  deletes  the  provision  related  to  the  adoption  of  a  recommendation  by  the
Commission  on  the  nature  of  the  risk  assessment  of  genetically  modified  feed.  The
Commission  believes  that  this  provision  should  be  maintained,  as  it  is  for  genetically
modified  food  and  as  also  laid  down  in  Regulation  (EC)  No  258/97,  in  order  to  give
orientations  on  the  risk  assessment,  such  as  the  basic  elements  to  be  included  in  the  risk
assessment reports.

Amendments 46 and 91 require the transmission of the opinion of the European Food Safety
Authority  to  national  food/feed  safety  and  environmental  risk  assessment  bodies,  but  the
Commission  considers  that  this  is  not  necessary  as  the  opinion  is  already  published  and
forwarded to the Commission, the Member States and the applicant.

Amendments 51 and 97 require the notification of the authorisation decision to the European
Parliament, the Member States and various national bodies, but the Commission would refer
to the application of usual Community (including comitology) rules as regards the adoption,
notification and publication of Community acts.

Amendments  54,  100  and  156  delete  the  possibility,  in  case  of  withdrawal  of  an  existing
product, to provide for a limited period of time within which existing stocks would be allowed
to  be  used  up.  The  Commission  would  point  out  that  this  rule,  which  exists  also  in  other
Community legislation, applies where there is no safety concern. In this case, the principle of
proportionality  should  be  respected  and  flexibility  should  be  left  to  the  risk  manager  as
regards the using up of existing stocks of the product concerned, on a case-by-case basis.

9

Amendment 60, related to the renewal of authorisations, cannot be accepted as it restricts the
scope of the reports to be submitted to “post-market” monitoring. Monitoring reports within
the meaning of Directive 2001/18/EC should also be covered.

Amendments  159  and  161  stipulate  that  where  no  renewal  decision  is  adopted  before  the
authorisation  expiry  date,  the  authorisation  is  extended  “once  by  one  year”  or  until  the
Commission  takes  a  decision  “within  that  year”.  The  Commission  believes  that  it  is  not
necessary  to  inflict  injury  on  the  authorisation-holder  in  case  of  delay  in  the  authorisation
renewal which is not due to the authorisation-holder’s fault. This is also in line with Directive
2001/18/EC. Articles 11 or 35 of the proposal may always apply if necessary. 

Amendments  52  (1st  part),  98  (1st  part)  and  61  bring  editorial  amendments  which  are  not
considered appropriate with regard to legislative drafting and considering that the text of the
proposal should be read as a whole.

Amendment 142 includes new transitional measures for pending applications submitted under
Directive  2001/18/EC  and  Regulation  (EC)  No  258/97  before  the  entry  into  force  of  the
proposed Regulation. However, Article 45 of the proposal already provides in a precise and
comprehensive way the transitional measures applicable to the products concerned. 

(cid:1)  Labelling

Amendments 109, 111 and 113 relate to the labelling of genetically modified feed and are not
acceptable because they do not take into account the wording of Community legislation on the
labelling  of  feed,  in  particular  Directive  96/25/EC.  Unlike  the  provisions  on  food  labelling,
feed labelling rules cover each stage of the placing on the market and not only the final stage,
justifying that information for the users is in many cases made through the documents (such
as  invoices  or  waybills)  accompanying  bulk  consignments,  where  there  is  no  packaging,
container  or  label.  Amendment  111  should  not  repeat  what  is  already  mentioned  in  the
introductory part of paragraph 3 of Article 27 of the proposal.

Taking  into  account  the  above-mentioned  positions,  the  Commission  amends  its  proposal
pursuant to Article 250 (2) of the EC-Treaty.

Formal adaptations to  the wording  of  the  proposal  have  also  been  included  in  order  to  take
into account the adoption of Regulation (EC) No 178/2002 and a new amendment to Directive
70/524/EEC.

The  modifications  to  the  initial  proposal  of  the  Commission  are  highlighted  as  follows:
underlining of additions and/or modifications and strikethrough of the deletions.

10

2001/0173 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

ON GENETICALLY MODIFIED FOOD AND FEED

(Text with EEA relevance)

THE  EUROPEAN  PARLIAMENT  AND  THE  COUNCIL  OF  THE  EUROPEAN
UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Articles 37, 95 and 152 (4) (b) thereof,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3,

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1) 

(2) 

(3) 

(4) 

The free movement of safe and wholesome food and feed is an essential aspect of
the  internal  market  and  contributes  significantly  to  the  health  and  well-being  of
citizens, and to their social and economic interests.

A  high  level  of  protection  of  human  life  and  health  should  be  assured  in  the
pursuit of Community policies.

In  order  to  protect  human  and  animal  health,  food  and  feed  consisting  of,
containing  or  produced  from  genetically  modified  organisms  (hereunder  called
“genetically  modified  food  and  feed”)  should  undergo  a  safety  assessment
through  a  Community  procedure  before  being  placed  on  the  market  within  the
Community. The precautionary principle has been taken into account in the
drafting  of  this  Regulation  and  must  be  taken  into  account  when
implementing it.

Differences  between  national  laws,  regulations  and  administrative  provisions
concerning  the  assessment  and  authorisation  of  genetically  modified  food  and
feed  may hinder their free movement,  creating conditions  of  unequal  and  unfair
competition.

1

2

3

OJ C 304 E, 30.10.2001, p. 221. 
OJ C [x], [x], p. [x] 
OJ C [x], [x, p. [x] 

11

                                                
(5) 

(6) 

(7) 

(8) 

An  authorisation  procedure  involving  Member  States  and  the  Commission  has
been established for genetically modified foods in Regulation (EC) No 258/97 on
novel  foods  and  novel  food  ingredients4.  This  procedure  should  be  streamlined
and made more transparent. 

Regulation  (EC)  No  258/97  also  provides  for  a  notification  procedure  for  novel
foods  which  are  substantially  equivalent  to  existing  foods.  Whilst  substantial
equivalence is a key step in the safety assessment process of genetically modified
foods,  it  is  not  a  safety  assessment  in  itself.  In  order  to  ensure  clarity,
transparency  and  a  harmonised  framework  for  authorisation  of  genetically
modified  food,  this  notification  procedure  should  be  abandoned  in  respect  of
genetically modified foods. 

Feed consisting of or containing genetically modified organisms (GMOs) have so
far  been  authorised  in  accordance  with  Directive  90/220/EEC  on  the  deliberate
release into the environment of genetically modified organisms5; no authorisation
procedure exists for feed produced from GMOs; a single, efficient and transparent
Community  authorisation  procedure  for  feed  consisting  of,  containing  or
produced from GMOs should be established.

The new authorisation procedures for genetically modified food and feed should
include the new principles introduced in Directive 2001/18/EC on the deliberate
release  into  the  environment  of  genetically  modified  organisms  and  repealing
Council  Directive  90/220/EEC6.  They  should  further  make  use  of  the  new
framework  for  risk  assessment  in  matters  of  food  safety  set  up  by  European
Parliament and Council Regulation (EC) No ../… 178/2002… laying down the
general principles and requirements of food law, establishing the European Food
Safety  Authority,  and  laying  down  procedures  in  matters  of  food  safety7.  Thus,
genetically modified food and  feed should only be authorised for placing on the
Community market after a scientific evaluation of the highest  possible  standard,
to be undertaken under the responsibility of the European Food Safety Authority,
of any risks which they present for human and animal health and, as the case may
be,  for  the  environment.  This  scientific  evaluation  should  be  followed  by  a  risk
management decision by the Community, under a regulatory procedure  ensuring
close co-operation between the Commission and the Member States.

(9) 

Experience  has  shown  that  authorisation  should  not  be  granted  for  a  single  use,
when  a  product  is  likely  to  be  used  both  for  food  and  feed  purposes;  therefore
such products should only be authorised when fulfilling authorisation criteria for
both food and feed.

(10)  Under  this  Regulation,  authorisation  may  be  granted  either  to  a  GMO  and
products for food and/or feed use which contain, consist of or are produced from
it,  or  to  foods  or  feed  produced  from  a  GMO.  Thus,  where  a  GMO  used  in  the
production of food and/or feed has been authorised under this Regulation, foods
and/or feed containing, consisting of or produced from that GMO do not need an

4

5

6

7

OJ L 43, 14.2.1997, p. 1. 
OJ L 117, 8.5.1990, p. 15. 
OJ L 106, 17.4.2001, p. 1. 
OJ L 31, 1.2.2002, p. 1.

12

                                                
authorisation under this Regulation, but are subject to the requirements laid down
in the authorisation granted  in respect of the  GMO. Furthermore, foods  covered
by  an  authorisation  granted  under  this  Regulation  are  exempted  from  the
requirements  of  Regulation  (EC)  No  258/97  concerning  novel  foods  and  novel
food ingredients, except where they fall under one or more of the categories laid
down  in  Article  1  (2)  (a)  of  Regulation  (EC)  No  258/97  in  respect  of  a
characteristic which has not been considered for the purpose of the authorisation
granted under this Regulation.

(11)  Council  Directive  89/107/EEC  of  21  December  1988  concerning  food  additives
authorised  for  use  in  foodstuffs  intended  for  human  consumption8,  as  last
amended  by Directive  94/34/EC  of  30  June 19949, provides  for  authorisation  of
additives  used  in  foodstuffs.  In  addition  to  this  authorisation  procedure,  food
additives containing, consisting of or produced from GMOs should fall also under
the scope of this Regulation for the safety assessment of the genetic modification,
while the final authorisation should be granted under the procedure laid down in
Directive 89/107/EEC.

(12)  Flavourings falling under the scope of Council Directive 88/388/EEC of 22 June
1988 relating to flavourings for use in foodstuffs, which contain, consist of or are
produced from GMOs should fall also under the scope of this Regulation for the
safety assessment of the genetic modification. 

(13)  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used
in  animal  nutrition10,  as  last  amended  by  Council  Directive  1999/20/EC11,
provides  for  an  approval  procedure  for  feed  materials  produced  using  different
technologies that may pose risk to human or animal health and the environment;
these feed materials containing, consisting of or produced from GMOs should fall
instead under the scope of this Regulation.

(14)  Council  Directive  70/524/EEC  of  23  November  1970  concerning  additives  in
feedingstuffs12,  as  last  amended  by  Council  Directive  1999/20/EC  Regulation
(EC) No 2205/200113, provides for an authorisation procedure for placing on the
market additives used in feedingstuffs. In addition to this authorisation procedure,
feed additives containing, consisting of or produced from GMOs should also fall
under  the  scope  of  this  Regulation  for  the  safety  assessment  of  the  genetic
modification, while the final authorisation should be granted under the procedure
laid down in Directive 70/524/EEC.

(15)  This Regulation covers food and feed produced “from” a GMO but not food and
feed “with” a GMO. The determining criterion is whether or not material derived
from  the  genetically  modified  starting  material  is  present  in  the  food  or  in  the
feed. Processing aids as defined in Council Directive 89/107/EEC, which are only
used during the food or feed production process, are not covered by the definition

8

9

10

11

12

13

OJ L 40, 11.2.1989, p. 27. 
OJ L 237, 10.9.1994, p. 1. 
OJ L 213, 21.7.1982, p. 8.
OJ L 80, 25.3.1999, p. 20.
OJ L 270, 14.12.1970, p. 1.
OJ L 297, 15.11.2001, p. 3.80,25.3.1999, p. 20.

13

                                                
of  food  or  feed  and,  therefore,  are  not  included  in  the  scope  of  this  Regulation.
Nor  are  food  and  feed  which  are  manufactured  with  the  help  of  a  genetically
modified  processing  aid.  Thus,  food  and  feed  produced  with  a  genetically
modified enzyme that does not remain in the final product and products obtained
from  animals  fed  with  genetically  modified  feed  or  treated  with  genetically
modifed  medicinal  products  will  be  subject  neither  to  the  authorisation
requirements, nor to the labelling requirements laid down in this Regulation.

(16) 

In accordance with Article 153 of the Treaty, the Community shall contribute to
promote  the  right  of  consumers  to  information.  Additional  to  other  types  of
information to the public established in this Regulation, labelling of products is a
means  that  enables  the  consumer  to  make  an  informed  choice  and  facilitates
fairness of transactions between seller and purchaser.

(17)  Article 2 of Directive 2000/13/EC of 20 March 2000 on the approximation of the
laws of the Member States relating to the labelling, presentation and advertising
of foodstuffs14 requires that the labelling must not mislead the purchaser, as to the
characteristics  of  the  foodstuff  and  among  others,  in  particular,  as  to  its  nature,
identity, properties, composition, method of manufacture or production.

(18)  Additional  requirements  for  the  labelling  of  genetically  modified  foods  are  laid
down in Regulation (EC) No 258/97 on novel foods and novel foods ingredients,
in  Regulation  (EC)  No  1139/9815  concerning  the  compulsory  indication,  on  the
labelling of certain foodstuffs produced from genetically modified organisms, of
particulars other than those provided for in Directive 79/112/EEC, as amended by
Regulation  (EC)  No  49/200016  and  in  Regulation  (EC)  No  50/2000  on  the
ingredients  containing  additives  and
labelling  of 
flavourings17.

foodstuffs  and 

food 

(19)  Harmonised labelling requirements should be laid down for genetically modified
feed  to  provide  final  users,  in  particular  livestock  farmers,  with  accurate
information on the composition and properties of  feed, which enable the user  to
make an informed choice. 

(20)  The labelling should include objective information that a food or feed consists of,
contains  or  is  produced  from  GMOs;  clear  labelling,  irrespective  of  the
detectability  of  DNA  or  protein  resulting  from  the  genetic  modification  in  the
final  product,  meets  the  demands  expressed  in  numerous  surveys  by  a  large
majority  of  consumers,  facilitates  informed  choice  and  precludes  potential
misleading of consumers as regards method of manufacture or production.

(21)  Additionally,  the  labelling  should  inform  about  any  characteristic  or  property
which  renders  a  food  or  feed  not  equivalent  to  its  conventional  counterpart  in
respect to composition, nutritional value or nutritional effects, intended use of the
food or feed and health implications on certain sections of the population, as well
as any characteristic or property which gives rise to ethical or religious concerns.

14

15

16

17

OJ L 109, 6.3.2000, p. 29 
OJ L 159, 3.6.1998, p. 4.
OJ L 6, 11.1.2000, p. 13. 
OJ L 6, 11.1.2000, p. 15.

14

                                                
(22)  Regulation  (EC)  No  …/…  of  the  European  Parliament  and  of  the  Council
concerning  traceability  and  labelling  of  genetically  modified  organisms  and
traceability  of  food  and  feed  products  produced  from  genetically  modified
organisms18  ensures  that  the  specific  information  concerning  the  genetic
modification is available at each stage of the placing on the market of GMOs and
food and feed produced thereof and should thereby facilitate accurate labelling.

(23)  Despite  the  fact  that  some  operators  avoid  using  genetically  modified  food  and
feed, such material may be present in minute traces in conventional food and feed
as  a  result  of  adventitious  or  technically  unavoidable  contamination  during
cultivation,  harvest,  transport  and  processing;  in  such  cases,  this  food  or  feed
should not be subject to the labelling requirements of this Regulation; in order to
achieve this objective, it is necessary to establish thresholds for  the  adventitious
or technically unavoidable presence of genetically modified material in foods  or
feed.

(24) 

(25) 

(26) 

(27) 

(28) 

In  order  to  establish  that  the  presence  of  this  material  is  adventitious  or
technically  unavoidable,  operators  must  be  in  a  position  to  demonstrate  to  the
competent authorities that they have taken appropriate steps to avoid the presence
of the genetically modified food or feed.

In order to ensure the practicability and feasibility of this Regulation, a threshold
of 1 %, with the possibility of establishing lower levels, should be established for
minute  traces  in  food  or  feed  of  genetically  modified  material  not  authorised
under Community legislation, where the presence of such material is adventitious
or 
technically  unavoidable;  Directive  2001/18/EC  should  be  amended
accordingly.

It  is  necessary  to  establish  harmonised  procedures  for  risk  assessment  and
authorisation,  that  are  efficient,  time  limited  and  transparent,  and  criteria  for
evaluation of the potential risks arising from genetically modified foods and feed.

In  order  to  ensure  a  harmonised  scientific  assessment  of  genetically  modified
foods  and  feed,  such  assessments  should  be  carried  out  by  the  European  Food
Safety Authority.

It  is  recognised  that  scientific  risk  assessment  alone  cannot,  in  some  cases,
provide  all  the  information  on  which  a  risk  management  decision  should  be
based, and that other legitimate factors relevant to the matter under consideration
may be taken into account.

(29)  Risks to the environment may be associated with foods and feed which contain or
consist  of  GMOs.  Part  C  of  Directive  2001/18/EC  provides  that  no  product
consisting  of  or  containing  a  GMO  may  be  placed  on  the  market  without  inter
alia a risk assessment having been carried out in accordance with that part of the
Directive. However, that requirement is waived in respect of any product covered
by sectoral Community legislation that provides for a specific environmental risk
assessment at least equivalent to the environmental risk assessment carried out in

18

OJ L [x], [x], p. [x]

15

                                                
accordance  with  Annexes  II  and  III  to  that  Directive.  This  Regulation  should
satisfy the conditions for the waiver to apply the requirements of that Directive. It
is  therefore  also  necessary  that  its  provisions  in  regard  to  risk  management,
labelling, monitoring, information to the public and safeguard clause, must be at
least equivalent to those laid down in Directive 2001/18/EC.

(30) 

It is necessary to introduce, where appropriate and based on the conclusions of the
risk  assessment,  post-market  monitoring  requirements  for  the  use  of  the
genetically  modified  foods  for  human  consumption  and  for  the  use  of  the
genetically  modified  feed  for  animal  consumption.  In  the  case  of  genetically
modified  organisms,  a  monitoring  plan  concerning  environment  effects  is
compulsory in accordance with Directive 2001/18/EC.

(31)  To  facilitate  controls  on  genetically  modified  foods  and  feed,  applicants  for
authorisation should propose appropriate methods of sampling and detection, and
deposit  samples  of  the  genetically  modified  food  and  feed  with  the  European
Food  Safety Authority; methods of sampling  and  detection  should  be  validated,
where appropriate, by the Community reference laboratory.

(32)  Technological progress and scientific developments should be taken into account

when implementing this Regulation.

(33)  Existing  authorisations  and  notifications  for  placing  on  the  market  genetically
modified foods under Regulation (EC) No 258/97 on novel foods and novel food
ingredients  and  existing  authorisations  of  genetically  modified  food  and  feed,
granted under Directives 90/220/EEC and 2001/18/EC, Directive 82/471/EEC or
Directive  70/524/EEC,  should  continue  to  remain  in  force,  subject  to  that  the
European Food Safety Authority is provided with information concerning the risk
assessment, methods for sampling and detection as appropriate, including samples
of the food and feed and their control samples within six months of the entry into
force of this Regulation. 

(34)  A register of genetically modified food and feed authorised under this Regulation
shall  be  established,  including  product  specific  information,  studies  which
demonstrate the safety of the product, including, where available, reference to
independent  and  peer  reviewed  studies,  and  sampling  and  detection  methods;
non-confidential data should be made available to the public.

(35) 

In  order  to  stimulate  research  and  development  into  genetically  modified
organisms  for  food  and/or  feed  use,  it  is  appropriate  to  protect  the  investment
made  by  innovators  in  gathering  the  information  and  data  supporting  an
application  under  this  Regulation.  This  protection  should  however  be  limited  in
time  in  order  to  avoid  the  unnecessary  repetition  of  studies  and  trials  which
should be against the public interest.

(36)  The  measures  necessary  for  the  implementation  of  this  Regulation  are  to  be
adopted  in  accordance  with  Council  Decision  1999/468/EC  of  28  June  1999
laying down the procedures for the exercise of implementing powers conferred on

16

the Commission19. The Commission shall be assisted by the Committee referred
to in Article 57 58 (1) of Regulation (EC) No …/2001 178/2002laying down the
general principles and requirements of food law, establishing the European Food
Authority, and laying down procedures in matters of food safety.

(37)  Provision  should  be  made  for  consultation  of  the  European  Group  on  Ethics  in
Science  and  New  Technologies  established  by  Decision  of  16  December  1997
with  a  view  to  obtaining  advice  on  ethical  issues  regarding  the  placing  on  the
market of genetically modified food or feed. Such consultations should be without
prejudice to the competence of Member States as regards ethical issues.

(38) 

In  order  to  provide  a  high  level  of  protection  of  human  life  and  health,
animal health and welfare, environment and consumers’ interest in relation
to  genetically  modified  food  and  feed,  it  is  necessary  that  requirements
arising  from  this  Regulation  apply  in  a  non-discriminatory  manner  to
products originating  in  the  Community  and  imported  from  third  countries,
in accordance  with  the  general  principles  laid  down  in  Regulation  (EC)  No
178/2002. The content of this Regulation takes account of the international trade
commitments  of  the  European  Communities  and  of  the  requirements  of  the
Cartagena  Protocol  on  Biosafety  to  the  Convention  on  Biological  Diversity  as
regards importer obligations and notification.

(39)  This  Regulation  respects  the  fundamental  rights  and  observes  the  principles
recognised in particular by the Charter of Fundamental Rights of the EU,

HAVE ADOPTED THIS REGULATION:

19

OJ L 184, 17.7.1999, p. 23.

17

                                                
CHAPTER I
OBJECTIVE AND DEFINITIONS

Article 1
Objective

The objective of this Regulation, in accordance with the precautionary principle, is:

(a)

(b)

to provide the basis for the assurance of a high level of protection of human life
and health,  animal health and welfare,  environment  and  consumers’  interest  in
relation  to  genetically  modified  food  and  feed,  whilst  ensuring  the  effective
functioning of the internal market; 

to  lay  down  Community  procedures  for  the  authorisation  and  supervision  of
genetically modified food and feed;

(c)

to lay down provisions for the labelling of genetically modified food and feed. 

Article 2
Definitions

For the purposes of this Regulation:

(1)

(2)

the definitions of ‘food’, ‘feed’, ‘placing on the market’, ‘final consumer’ and
‘traceability’, laid down in Regulation (EC) No …./2001178/2002 laying down
the general principles and  requirements of food law, establishing the European
Food  Authority  and  laying  down  procedures  in  matters  of  food  safety  shall
apply;

the  definitions  of  ‘organism’,  ‘genetically  modified  organism’  (‘GMO’),
‘deliberate release’ and ‘environmental risk assessment’ laid down in Directive
2001/18/EC shall apply;

(3)          ‘genetically  modified  organism’  (‘GMO’)  means  genetically  modified
organism  as  defined  in  Article  2  (2)  of  Directive  2001/18/EC,  excluding
organisms obtained through the techniques of genetic modification listed in
Annex I B of Directive 2001/18/EC;

(43)

‘genetically modified food or feed’ means food or feed containing, consisting of
or produced from genetically modified organisms;

(5)          ‘genetically modified feed’ means feed containing, consisting of or produced

from genetically modified organisms;

(64)

‘genetically  modified  organism  for  food  use’  means  a  genetically  modified
organism which is not exempted from the application of Directive 2001/18/EC
and that may be used as food or as a source material for the production of food;

18

(75)

(86)

(97)

‘genetically  modified  organism  for  feed  use’  means  a  genetically  modified
organism which is not exempted from the application of Directive 2001/18/EC
and that may be used as feed or as a source material for the production of feed;

‘produced from genetically modified organisms’ means derived, in whole or in
part,  from  genetically  modified  organisms,  but  not  containing  or  consisting  of
genetically modified organisms;

‘control sample’ means the genetically modified organism or its genetic material
(positive  sample)  or  and  the  parental  organism  or  its  genetic  material  that  has
been used for the purpose of the genetic modification (negative sample).

19

CHAPTER II
GENETICALLY MODIFIED FOOD

SECTION 1
AUTHORISATION AND MONITORING

Article 3
Scope

1.

This Section shall apply to:

(a)

genetically modified organisms for food use;

(b)

food containing or consisting of genetically modified organisms;

(c)

food  produced  from  or  containing  ingredients  produced  from  genetically
modified organisms.

2.

Where  necessary,  it  may  be  determined  in  accordance  with  the  procedure  laid
down  in  Article  36  (2)  whether  a  type  of  food  falls  within  the  scope  of  this
Section.

Article 4
Requirements

1.

Food falling within the scope of this Section must not:

-

-

-

present an unacceptable risk for human health or the environment;

mislead the consumer;

differ from the food which it is intended to replace to such an extent that
its  normal  consumption  would  be  nutritionally  disadvantageous  for  the
consumer.

2.

3.

No  person  shall  place  on  the  market  a  genetically  modified  organism  for  food
use  or  food  falling  within  the  scope  of  this  Section  unless  it  is  covered  by  an
authorisation granted in accordance with this Section and the relevant conditions
of the authorisation are adhered to. 

No genetically modified organism for food use or food falling within the scope
of this Section shall be authorised unless the applicant for such authorisation has
adequately  and  sufficiently  demonstrated  that  it  satisfies  the  requirements  of
paragraph 1.

4.

The authorisation referred to in paragraph 2 may cover:

20

-

-

a genetically modified organism and foods containing or consisting of that
genetically  modified  organism  as  well  as  foods  produced  from  or
containing ingredients produced from that genetically modified organism,
or

a  food  produced  from  or  containing  an  ingredient  produced  from  a
genetically  modified  organism  as  well  as  foods  produced  from  or
containing that food.

An  authorisation  as  referred  to  in  paragraph  2  shall  not  be  granted,  refused,
renewed, modified, suspended or revoked except on the grounds  and under the
procedures set out in this Regulation.

The  applicant  for  an  authorisation  as  referred  to  in  paragraph  2  and,  after  the
authorisation  is  granted,  the  authorisation-holder,  shall  be  established  in  the
Community.

Authorisation  under 
this  Regulation 
70/457/EEC and Directive 70/458/EEC.

is  without  prejudice 

to  Directive

5.

6.

7.

Article 5
Adventitious or technically unavoidable presence of genetically modified material

The  presence  in  food  of  material  which  contains,  consists  of  or  is  produced  from
genetically modified organisms in a proportion no higher than 1 % or lower thresholds
established  in  accordance  with  the  procedure  laid  down  in  Article  36  (2),  shall  not  be
considered to be in breach of Article 4 (2), provided that this presence is adventitious or
technically unavoidable and that the genetically modified material has been subject to a
scientific risk assessment made by the relevant Scientific Committee(s) or the European
Food  Safety  Authority,  which  concludes  that  this  material  does  not  present  a  risk  for
human health or the environment.

In  order  to  establish  that  the  presence  of  this  material  is  adventitious  or  technically
unavoidable, operators must be in a position to demonstrate to the competent authorities
that they have taken appropriate steps to avoid the presence of the genetically modified
organisms (or produce thereof).

Article 6
Application for authorisation

1.

2.

3.

To  obtain  the  authorisation  referred  to  in  Article  4  (2),  an  application  shall  be
submitted to the European Food Safety Authority, hereinafter referred to as ‘the
Authority’.

The  Authority  shall  acknowledge  receipt  of  the  application,  in  writing,  to  the
applicant within 15 days of its receipt. The acknowledgement shall state the date
of receipt of the application. 

The  application  shall  be  accompanied  by  the  following  particulars  and
documents:

21

(a)

the name and the address of the applicant;

(b)

the  designation  of 
transformation event(s) used;

the  food,  and 

its  specification, 

including 

the

(c) where  appropriate,  the  information  for  the  purpose  of  complying  with
Annex  II  of  the  Cartagena  Protocol  on  Biosafety  to  the  Convention  on
Biological Diversity;

(d) where appropriate, a detailed description of the method of production and

manufacturing; 

(e)

(f)

(g)

a  copy  of  the  studies,  including,  where  available,  reference  to
independent  and  peer-reviewed  studies,  which  have  been  carried  out
and  any  other  material  which  is  available  to  demonstrate  that  the  food
complies with the criteria laid down in Article 4 (1);

either  an  analysis,  supported  by  appropriate  information  and  data,
demonstrating that the food is not different to a conventional food, having
regard  to  the  criteria  specified  in  Article  14(2)(a),  or  a  proposal  for
labelling the food in accordance with Article 14(2)(a) and (3);

either  a  reasoned  statement  that  the  food  does  not  give  rise  to  ethical  or
religious concerns, or a proposal for labelling it in accordance with Article
14(2)(b);

(h) where  appropriate,  the  conditions  for  placing  on  the  market  the  food  or
foods  produced  from  it  ,  including  specific  conditions  for  use  and
handling;

(i)

(j)

a  method  for  detection,  including  sampling  and  identification  of  the
transformation  event  and,  where  applicable,  for  the  detection  and
identification  of  the  transformation  event  in  the  food  and/or  in  foods
produced from it;

samples of the food and their control samples, as well as information as
to  the  place  where  the  reference  material  can  be  accessed  in
accordance with Article 31;

(k) where  appropriate,  a  proposal  for  post-market  monitoring  for  the  use  of

the food for human consumption;

(l)

a summary of the dossier in a standardised form.

4.

5.

In  the  case  of  an  application  relating  to  a  GMO  for  food  use,  references  to
“food”  in  paragraph  3  shall  be  interpreted  as  referring  to  food  containing,
consisting of or produced from the GMO in  respect of  which  an  application is
made.

In the case of genetically modified organisms or foods containing or consisting
of genetically modified organisms, the application shall also be accompanied by:

22

(a)

the  complete  technical  dossier  supplying  the  information  required  by
Annexes  III  and  IV  to  Directive  2001/18/EC  and  information  and
conclusions about the  risk  assessment  carried  out  in  accordance  with  the
principles  set  out  in  Annex  II  to  Directive  2001/18/EC  or,  where  the
placing  on  the  market  of  the  genetically  modified  organism  has  been
authorised  under  part  C  of  Directive  2001/18/EC,  a  copy  of  the
authorisation decision;

(b)

a  monitoring  plan  for  environmental  effects  according  to  Annex  VII  to
Directive  2001/18/EC,  including  a  proposal  for  the  time-period  of  the
monitoring  plan;  this  time-period  may  be  different  from  the  proposed
period for the consent.

In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

6.

7.

8.

1.

2.

Where the application concerns a substance the use and placing on the market of
which is subject under other provisions of Community law to its inclusion on a
list of substances registered or authorised to the exclusion of others, this must be
stated  in  the  application  and  the  status  of  the  substance  under  the  relevant
legislation must be indicated.

The Commission, having first consulted the Authority and, in matters falling
within  their  remit,  the  national  competent  authorities  established  under
Article 4 (4) of Directive 2001/18/EC, may shall establish, in accordance with
the procedure laid down in Article 36 (2), implementing rules for the application
of this Article.

The  Authority  shall  publish  detailed  guidance  concerning  the  preparation  and
the presentation of the application.

Article 7
Opinion of the Authority

Save in exceptionally complex cases, the Authority shall give an opinion within
6 months of the receipt of a valid application.

The Authority may, where appropriate, request the applicant to supplement the
particulars accompanying the application within a specific time limit. Where the
Authority  requests  supplementary  information,  the  time  limit  laid  down  in
paragraph  1  shall  be  suspended  until  such  time  that  this  information  has  been
provided.  Likewise,  this  time  limit  shall  be  suspended  for  the  time  allowed  to
the applicant to prepare oral or written explanations. 

3.

In order to prepare its opinion, the Authority:

(a)

shall verify that the particulars and documents submitted by the applicant
are in accordance with Article 6, and examine whether the food complies
with the criteria laid down in Article 4 (1);

(b)

shall inform without delay the Member States and the Commission of
the  application  and  shall  make  the  application  and  any  supplementary

23

information supplied by the applicant available to the Member States and
to the Commissionthem;

(c)

shall  make  the  summary  of  the  dossier  mentioned  in  Article  6  (3)  (l)
available  to  the  public.  The  publication  of  the  summary  shall  refer  to
the  possibility  for  the  public  to  have  access  to  the  application  on
request, in accordance with Article 31;

(d) may ask the appropriate food assessment body of a Member State to carry

out a safety assessment of the food;

(e) may ask a competent authority designated in accordance with Article 4 of
Directive 2001/18/EC to carry out an environmental risk assessment;

(f)

(g)

shall forward to the Community reference laboratory referred to in Article
33  the  particulars  referred  to  in  Article  6  (3)  (h)  and  (i)  and  (j)  with  a
view to testing and validatinge the method of detection and identification
proposed by the applicant;

shall,  in  verifying  the  application  of  Article  14  (2)  (a),  examine  the
information  and  data  submitted  by  the  applicant  showing  that  the
characteristics  of  the  food  are  not  different  in  comparison  with  the
conventional  counterpart,  having  regard  to  the  accepted  limits  of  natural
variations for such characteristics.

In the case of genetically modified organisms or food containing or consisting of
genetically  modified  organismsfalling  within  the  scope  of  this  Section,  the
evaluation  shall  respect  the  environmental  safety  requirements  laid  down  in
Directive  2001/18/EC  shall  apply  to  the  evaluation  to  ensure  that  all
appropriate measures are taken to  prevent the adverse  effects  on human health
and the environment which might arise from the deliberate release of genetically
modified organisms. During evaluation of requests for the placing on the market
of  products  containing  or  consisting  of  genetically  modified  organisms,  the
necessary  consultations  shall  be  held  by  the  Authority  shall  consult  with  the
bodies  set  up  by  the  Community  and/or  the  Member  States  under  Directive
2001/18/EC, in accordance with Article 12 (4) of that Directive 2001/18/EC.

4.

5.

In  the  event  of  an  opinion  in  favour  of  authorising  the  food,  the  opinion  shall
also include the following particulars:

(a)

the name and address of the applicant;

(b)

the designation of the food, and its specification;

(c) where  appropriate,  the  information  required  under  Annex  II  of  the
Cartagena  Protocol  on  Biosafety  to  the  Convention  on  Biological
Diversity;

(d)

the proposal for the labelling of the food and/or foods produced from it;

(e) where appropriate, any conditions or restrictions which should be imposed
on the supply or use of the food and/or foods produced from it, including

24

post-market  monitoring  requirements  based  on  the  outcome  of  the  risk
assessment;

(f)

thea  method,  validated  by  the  Community  reference  laboratory,  for
detection,  including  sampling  and  identification  of  the  transformation
event  and,  where  applicable,  for  the  detection  and  identification  of  the
transformation event in the food and/or in foods produced from it;

(g)     information  as  to  the  place  where  the  reference  material  can  be

accessed in accordance with Article 31;

(hg) where appropriate, the monitoring plan referred to in Article 6 (5) (b).

The Authority shall forward its opinion to the Commission, the Member States
and  the applicant,  including  a  report  describing  its  assessment  of  the  food  and
stating the reasons for its opinion.

The  Authority  shall  make  its  opinion  public,  after  deletion  of  any  information
identified as confidential, in accordance with Article 31. The public may make
comments to the Commission within 30 days from this publication.

Before  the  entry  into  application  of  this  Regulation,  the  Commission  shall
publish a recommendation on the nature of the risk assessment to be undertaken
by the Authority for the purpose of preparing its opinion.

Article 8
Authorisation by the Community

Save  in  exceptionally  complex  cases,  within  three  months  of  receipt  of  the
opinion of the Authority, the Commission shall prepare a draft of the decision to
be taken in respect of the application, taking into account Community law and
other  legitimate  factors  relevant  to  the  matter  under  consideration.  Where  the
draft  decision  is  not  in  accordance  with  the  opinion  of  the  Authority,  the
Commission shall provide an explanation of the reasons for the differences.

In  the  event  of  a  draft  decision  which  envisages  the  granting  of  authorisation,
the  draft  decision  shall  include  the  particulars  mentioned  in  Article  7  (5),  the
name  of  the  authorisation-holder  and,  where  appropriate,  the  unique  code
attributed to the genetically modified organism as referred to in the Regulation
(EC)  No  ../…….  of  the  European  Parliament  and  of  the  Council  concerning
traceability and labelling of  genetically  modified  organisms  and  traceability  of
food and feed products produced from genetically modified organisms20.

A  final  decision  on  the  application  shall  be  adopted  in  accordance  with  the
procedure laid down in Article 36 (2).

6.

7.

8.

1.

2.

3.

20

OJ L [x], [x], p. [x]

25

                                                
4.

5.

6.

7.

1.

The Commission shall without delay inform the applicant of the decision taken.
The  decision  shall  be  published  in  the  Official  Journal  of  the  European
Communities.

The  authorisation  granted  in  accordance  with  the  procedure  laid  down  in  this
Regulation shall be valid throughout the Community for ten  years and shall be
renewable in accordance with Article 12. The authorised food shall be entered in
the Register referred to in Article 30. Each  entry  in the Register shall mention
the  date  of  authorisation  and  shall  include  the  particulars  referred  to  in
paragraph 2.

The  authorisation  under  this  Section  shall  be  without  prejudice  to  other
provisions  of  Community  law  governing  the  use  and  placing  on  the  market  of
substances  which  may  only  be  used  subject  to  their  inclusion  in  a  list  of
substances registered or authorised to the exclusion of others.

The  granting  of  authorisation  shall  not  diminish  the  general  civil  and  criminal
liability of any food operator in respect of the food concerned.

Article 9
Status of existing products

By derogation to Article 4 (2), a product falling within the scope of this Section
which  has  been  placed  on  the  market  under  Directive  90/220/EEC  before  the
entry  into  force  of  Regulation  (EC)  No  258/97  or  in  accordance  with  the
provisions laid down in Regulation (EC) No 258/97 may continue to be placed
on  the  market,  used  and  processed  provided  that  the  following  conditions  are
met:

(a) within  six  months  of  the  entry  into  force  of  this  Regulation,  the  person
responsible  for  placing  on  the  market  the  concerned  product  shall  notify
the Authority of the date at which it was first placed on the market in the
Community.  This  notification  shall  be  accompanied  by  the  particulars
mentioned  in  Article  6  (3)  and  (5),  as  appropriate,  which  the  Authority
shall  forward  to  the  Commission  and  the  Member  States.  The  Authority
shall forward to the Community reference laboratory referred to in Article
33 the particulars referred to in Article 6 (3) (i) and (j) and shall ask it to
test  and  validate  the  method  of  detection  and  identification  proposed  by
the applicant;

(b) within  one  year  of  the  entry  into  force  of  this  Regulation,  the  Authority
shall,  after  verification  that  all  the  information  required  has  been
submitted,  notify  the  Commission  that  it  has  received  the  information
required under this Article. The product concerned shall be entered in the
Register.  Each  entry  in  the  Register  shall  mention  the  date  at  which  the
concerned  product  was  first  placed  on  the  market  and  shall  include  the
particulars referred to in Article 8 (2) as appropriate.

26

2.

3.

4.

5.

1.

2.

3.

1.

Within nine years from the date at which the concerned product was first placed
on the market, the person responsible for placing it on the market shall submit
an application in accordance with Article 12, which shall apply in a like manner.

Products referred to in paragraph 1 and foods containing them or produced from
them shall be subject to the provisions of this Regulation, in particular Articles
10, 11 and 35, which shall apply in a like manner.

Where  the  notification  and  accompanying  particulars  referred  to  in  paragraph
1(a) are not supplied within the period specified or are found to be incorrect, or
where  an  application  is  not  submitted  as  required  by  paragraph  2  within  the
period specifed, the Commission,  acting in  accordance  with  the procedure  laid
down  in  Article  36(2),  shall  adopt  a  measure  requiring  the  product  concerned
and  any  products  derived  from  it  to  be  withdrawn  from  the  market.  Such  a
measure may provide for a limited period of time within which existing stocks
of the product may be used up.

Detailed rules for implementing this Article shall be adopted in accordance with
the procedure laid down in Article 36 (2).

Article 10
Supervision

After  an  authorisation  has  been  issued  in  accordance  with  this  Regulation,  the
authorisation-holder and parties concerned shall comply with the relevantany
conditions or restrictions which have been imposed in the authorisation. Where
post-market  monitoring  as  referred  to in Article 6 (3)  (k)  and Article  6  (5)  (b)
has  been imposed on  the  authorisation-holder,  he shall  ensure  that  it  is  carried
out  and  shall  submit  reports  to  the  Authority  in  accordance  with  the
authorisation. The monitoring reports shall be made accessible to the public
in accordance with Article 31.

If the authorisation-holder proposes to modify the terms of the authorisation, he
shall submit an application to the Authority. 

The  authorisation-holder  shall  forthwith  inform  the  Authority  of  any  new
scientific  or  technical  information  which  might  influence  the  evaluation  of  the
safety in use of the  food. In  particular, the  authorisation-holder  shall  forthwith
inform the Authority of any prohibition or restriction imposed by the competent
authority  of  any  third  country  in  which  the  food  is  placed  on  the  market.  The
Authority shall examine the information forwarded and, if validated, shall
make it available to the Commission, the Member States and the public in
accordance with Article 31.

Article 11
Modification, suspension and revocation of authorisations

Where, on its own initiative or following a request from a Member State or from
the Commission, the Authority is of the opinion that an authorisation granted in
accordance  with  this  Regulation  should  be  modified,  suspended  or  revoked,  it

27

2.

3.

4.

5.

1.

shall  forthwith  transmit  this  opinion  to  the  Commission,  the  Member  States
and the authorisation-holder. The Authority shall make its opinion public,
after  deletion  of  any  information  identified  as  confidential,  in  accordance
with Article 31.

The Commission shall examine the opinion of the Authority as soon as possible
and prepare a draft of the decision to be taken. 

In  the  event  of  a  draft  decision  which  envisages  the  modification  of  the
authorisation,  the  draft  decision  shall  include  any  amendment  needed  to  the
particulars mentioned in Article 8 (2).

A  final  decision  on  the  modification,  the  suspension  or  the  revocation  of  the
authorisation  shall  be  adopted  in  accordance  with  the  procedure  laid  down  in
Article 36 (2).

The  Commission  shall  without  delay  inform  the  authorisation-holder  of  the
decision  taken.  The  decision  shall  be  published  in  the  Official  Journal  of  the
European Communities. The Register shall be amended as appropriate. 

Article 12
Renewal of authorisations

Without  prejudice  to  the  right  of  a  third  party  to  submit  an  application  for
authorisation for a food essentially similar to a food for which an authorisation
has  already  been  granted,  authorisations  under  this  Regulation  shall  be
renewable  for  ten-years  periods,  on  application  to  the  Authority  by  the
authorisation-holder  at  the  latest  one  year  before  the  expiry  date  of  the
authorisation.

The  Authority  shall  acknowledge  receipt  of  the  application,  in  writing,  to  the
authorisation-holder  within  15  days of  its receipt. The  acknowledgement  shall  state  the
date of receipt of the application.

2.

The  application  shall  be  accompanied  by  the  following  particulars  and
documents:

(a)

a copy of the authorisation for placing the food on the market;

(b)

(c)

a  report  on  the  results  of  the  monitoring,  if  so  specified  in  the
authorisation;

any other new information which has become available with regard to the
evaluation of the safety in use of the food and the risks of the food to the
consumer or the environment;

(d) where  appropriate,  a  proposal  for  amending  or  complementing  the
the  conditions

the  original  authorisation, 

inter  alia 

conditions  of 
concerning future monitoring.

3.

Article 7 and Article 8 shall apply in a like manner.

28

4.

5.

6.

Where, for reasons beyond the control of the authorisation-holder, no decision is
taken  on  the  renewal  of  an  authorisation  before  its  expiry  date,  the  period  of
authorisation  of  the  product  shall  automatically  be  extended  until  the
Commission takes a decision. 

The implementing rules for the application of this Article shall be established by
the  Commission  after  consulting  the  Authority,  in  accordance  with  the
procedure laid down in Article 36 (2).

The  Authority  shall  publish  detailed  guidance  concerning  the  preparation  and
the presentation of the application.

29

SECTION 2
LABELLING

Article 13
Scope

1.

2.

This Section shall apply to foods which are to be delivered as such to the final
consumer or mass caterers in the Community and which:

-

-

contain or consist of genetically modified organisms, or

are  produced  from  or  contain  ingredients  produced  from  genetically
modified organisms.

This  Section  shall  not  apply  to  foods  containing  material  which  contains,
consists of or is produced from genetically modified organisms in a proportion
no higher than the thresholds established in accordance with the procedure laid
down in Article 36 (2), provided that this presence is adventitious or technically
unavoidable.

In  order  to  establish  that  the  presence  of  this  material  is  adventitious  or  technically
unavoidable, operators must be in a position to supply evidence to satisfy the competent
authorities that they have taken appropriate steps to avoid the presence of the genetically
modified organisms (or produce thereof).

Article 14
Requirements

1.

Without prejudice to the other requirements of Community law concerning the
labelling  of  foodstuffs,  foods  falling  within  the  scope  of  this  Section  shall  be
subject to the following specific labelling requirements:

(a) Where  the  food  consists  of  more  than  one  ingredient,  the  words
‘genetically  modified’  or  ‘produced  from  genetically  modified  [name  of
organism]  but  not  containing  a  genetically  modified  organism’  shall
appear  in  the  list  of  ingredients  provided  for  in  Article  6  of  Directive
2000/13/EC 
ingredient
concerned. Alternatively, these words may appear in a footnote to the list
of ingredients. It shall be printed in a font of at least the same size as the
list of ingredients. 

in  parentheses 

immediately 

following 

the 

(b) Where the ingredient is designated by the name of a category, the  words
‘contains [name of ingredient] produced from genetically modified [name
of  organism]  but  not  containing  a  genetically  modified  organism’  shall
appear in the list of ingredients.

(c) Where there is no list of ingredients, the words ‘genetically modified’  or
‘produced  from  genetically  modified  [name  of  organism]  but  not

30

containing  a  genetically  modified  organism’  shall  appear  clearly  on  the
labelling.

(d) Where  the  food  is  offered  for  sale  to  the  ultimate  final  consumer  or  to
in  small  pre-packaged
mass  caterers  without  pre-packaging,  or 
containers,  the  information  required  under  this  paragraph  must  be
permanently and  visibly  displayed  either  on  the  food  display  or  right
next to it, or on the packaging material, in a font sufficiently large for
it to be easily identified and read in connection with the display  of the
food.

2.

In addition to the labelling requirements laid down in paragraph 1, the labelling
shall  also  mention  any  characteristic  or  property,  as  specified  in  the
authorisation, in the following cases:

(a) where  a  food  is  not  equivalent  to  its  conventional  counterpart  as  regards

the following characteristics or properties:

-

-

-

-

composition,

nutritional value or nutritional effects,

intended use of the food,

implications for the health of certain sections of the population;

(b) where a food may give rise to ethical or religious concerns.

3.

In  addition  to  the  labelling  requirements  laid  down  in  paragraph  1  and  as
specified in the authorisation, the labelling of foods falling within the scope of
this  Section  which  do  not  have  a  conventional  counterpart  shall  contain
appropriate  information  about  the  nature  and  the  characteristics  of  the  foods
concerned.

Article 15
Implementing measures

Detailed  rules  for  implementing  this  Section  may  be  adopted  in  accordance  with  the
procedure laid down in Article 36 (2).

31

CHAPTER III
GENETICALLY MODIFIED FEED

SECTION 1
AUTHORISATION AND MONITORING

Article 16
Scope

1.

This Section shall apply to: 

(a)

genetically modified organisms for feed use;

(b)

feed containing or consisting of genetically modified organisms;

(c)

feed produced from genetically modified organisms.

2.

Where necessary, it may be determined in accordance with the procedure laid down
in Article 36 (2) whether a type of feed falls within the scope of this Section.

Article 17
Requirements

1.

Feed referred to in Article 16 (1) must not: 

(a)

present  an  unacceptable  risk  for  animal  health,  human  health  or  the
environment;

(b) mislead the user;

(c)

harm the consumer by impairing the distinctive features of the animal products;

(d)

differ from feed which it is intended to replace to such an extent that its normal
consumption would be nutritionally disadvantageous for animals or humans.

No person shall place on the market, use or process a product referred to in Article
16 (1) genetically modified organism for feed use or feed falling  within the scope
of  this  Section  unless  it  is  covered  by  an  authorisation  granted  in  accordance  with
this Section and the relevant conditions of the authorisation are adhered to.

No product referred to in Article 16(1)genetically modified organism for feed use
or  feed  falling  within  the  scope  of  this  Section  shall  be  authorised  unless  the
applicant for such authorisation has adequately and sufficiently demonstrated that it
satisfies the requirements of paragraph 1.

2.

3.

4.

The authorisation referred to in paragraph 2 may cover:

32

-

-

a  genetically  modified  organism  and  feed  containing  or  consisting  of  that
genetically modified  organism as  well as feed  produced from  that  genetically
modified organism, or

a feed produced from a genetically modified organism as well as feed produced
from or containing that feed.

5.

6.

7

An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed,
modified, suspended or revoked except on the grounds and under the procedures set
out in this Regulation.

The  applicant  for  an  authorisation  as  referred  to  in  paragraph  2  and,  after  the
authorisation  is  granted,  the  authorisation-holder,  shall  be  established  in  the
Community.

Authorisation  under  this  Regulation  is  without  prejudice  to  Directive  70/457/EEC
and Directive 70/458/EEC.

Article 18
Adventitious or technically unavoidable presence of genetically modified material

The presence in feed of material which contains, consists of or is produced from genetically
modified  organisms  in  a  proportion  no  higher  than  1  %  or  lower  thresholds  established  in
accordance with  the procedure laid  down  in Article 36 (2),  shall  not  be  considered  to  be  in
breach of Article 17 (2), provided that this presence is adventitious or technically unavoidable
and  that  the  genetically  modified  material  has  been  subject  to  a  scientific  risk  assessment
made by the relevant Scientific Committee(s) or the European Food Safety Authority, which
concludes  that  this  material  does  not  present  a  risk  for  human  health,  animal  health  or  the
environment.

In  order  to  establish  that  the  presence  of  this  material  is  adventitious  or  technically
unavoidable, operators must be in a position to demonstrate to the competent authorities that
they have taken appropriate steps to avoid the presence of the genetically modified organisms
(or produce thereof).

Article 19
Application for authorisation

1.

2.

3.

To  obtain  the  authorisation  referred  to  in  Article  17  (2),  an  application  shall  be
submitted to the Authority. 

The  Authority  shall  acknowledge  receipt  of  the  application,  in  writing,  to  the
applicant within 15 days of its receipt. The acknowledgement shall state the date of
receipt of the application.

The application shall be accompanied by the following:

(a)

the name and the address of the applicant; 

(b)

the designation of the  feed referred to  in  Article  16  (1),  and  its  specification,
including the transformation event(s) used;

33

(c) where appropriate, the information for the purpose of complying with Annex II
of  the  Cartagena  Protocol  on  Biosafety  to  the  Convention  on  Biological
Diversity;

(d) where  appropriate,  a  detailed  description  of  the  method  of  production,
manufacturing and intended uses of the feed referred to in Article 16 (1);

(e)

(f)

a copy of the studies, including, where available, reference  to independent
and  peer-reviewed  studies,  which  have  been  carried  out  and  any  other
material which is available to demonstrate that the feed referred to in Article 16
(1) complies with the criteria laid down in Article 17 (1), and in particular for
feed  falling  within  the  scope  of  Directive  82/471/EEC,  the  information
required  under  Directive  83/228/EEC  on  the  fixing  of  guidelines  for  the
assessment of certain products used in animal nutrition;

either  an  analysis,  supported  by  appropriate 
information  and  data,
demonstrating  that  the  feed  referred  to  in  Article  16  (1)  is  not  different  to  a
conventional feed, having regard to the criteria specified in Article 27(3) (c), or
a proposal for labelling the feed referred to in Article 16 (1) in accordance with
Article 27(3) (c) and (4);

(g)

either a reasoned statement that the feed referred to in Article 16 (1) does not
give  rise  to  ethical  or  religious  concerns,  or  a  proposal  for  labelling  it  in
accordance with Article 27(3)(d);

(h) where appropriate, the conditions for placing the feed referred to in Article 16

(1) on the market, including specific conditions for use and handling;

(i)

(j)

a  method  for  detection,  including  sampling  and  identification  of  the
transformation event and, where applicable, for the detection and identification
of the transformation event in the feed referred to in Article 16 (1);

samples of the feed referred to in Article 16 (1) and their control samples, as
well  as  information  as  to  the  place  where  the  reference  material  can  be
accessed in accordance with Article 31;

(k) where  appropriate,  a  proposal  for  post-market  monitoring  for  the  use  of  the

feed referred to in Article 16 (1) for animal consumption;

(l)

a summary of the dossier in a standardised form.

4.

5.

In the case of an application relating to a GMO for feed use, references to “feed” in
paragraph  3  shall  be  interpreted  as  referring  to  feed  containing,  consisting  of  or
produced from the GMO in respect of which an application is made.

For genetically modified organisms and feed referred to respectively in Article 16 (1)
(a) and (b), the application shall also be accompanied by:

(a)

the complete technical dossier supplying the information required by Annexes
III and IV to Directive 2001/18/EC and information and conclusions about the
risk assessment carried out in accordance with the principles set out in Annex
II  to  Directive  2001/18/EC  or,  where  the  placing  on  the  market  of  the

34

genetically modified organisms has been authorised under Part C of Directive
2001/18/EC, a copy of the authorisation decision;

(b)

a  monitoring  plan  for  environmental  effects  according  to  Annex  VII  to
Directive  2001/18/EC,  including  a  proposal  for  the  time-period  of  the
monitoring  plan;  this  time-period  may  be  different  from  the  proposed  period
for the consent.

In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

Where  the  application  concerns  a  substance  the  use  and  placing  on  the  market  of
which is subject under other provisions of Community law to its inclusion on a list of
substances authorised to the exclusion of others, this must be stated in the application
and the status of the substance under the relevant legislation must be indicated.

The  Commission,  having  first  consulted  the  Authority  and,  in  matters  falling
within their remit, the national competent authorities established under Article
4  (4)  of  Directive  2001/18/EC,  may  shall  establish,  in  accordance  with  the
procedure laid down in Article 36 (2), implementing rules for the application of this
Article. 

The  Authority  shall  publish  detailed  guidance  concerning  the  preparation  and  the
presentation of the application.

Article 20
Opinion of the Authority

Save  in  exceptionally  complex  cases,  the  Authority  shall  give  an  opinion  within  6
months of the receipt of a valid application.

The  Authority  may,  where  appropriate,  request  the  applicant  to  supplement  the
particulars  accompanying  the  application  within  a  specific  time  limit.  Where  the
Authority requests supplementary information, the time limit laid down in paragraph
1  shall  be  suspended  until  such  time  that  this  information  has  been  provided.
Likewise, this time limit shall be suspended for the time allowed to the applicant to
prepare oral or written explanations. 

6.

7.

8.

1.

2.

3.

In order to prepare its opinion, the Authority:

(a)

(b)

(c)

shall verify that the particulars and documents submitted by the applicant are in
accordance with Article 19, and examine whether the feed referred to in Article
16 (1) complies with the criteria laid down in Article 17 (1);

shall inform without delay the Member States and the Commission of the
application  and  shall  make 
the  application  and  any  supplementary
information supplied by the applicant available to the Member States and to the
Commissionthem;

shall make the summary of the dossier mentioned in Article 19 (3) (l) available
to the public. The publication of the summary shall refer to the possibility
for the public to have access to  the application on request, in accordance
with Article 31;

35

(d) may ask the appropriate feed assessment body of a Member State to carry out a

safety assessment of the feed referred to in Article 16 (1);

(e) may  ask  a  competent  authority  designated  in  accordance  with  Article  4  of

Directive 2001/18/EC to carry out an environmental risk assessment;

(f)

(g)

shall forward to the Community  reference laboratory referred to in Article 33
the particulars referred to in Article 19 (3) (i) and (j) with a view and shall ask
it  to  testing  and  validatinge  the  method  of  detection  and  identification
proposed by the applicant;

shall, in verifying the application of Article 27 (3) (c), examine the information
and data submitted by the applicant showing that the characteristics of the feed
referred  to  in  Article  16  (1)  are  not  different  in  comparison  with  the
conventional  counterpart,  having  regard  to  the  accepted  limits  of  natural
variations for such characteristics.

4.

In  the  case  of  genetically  modified  organisms  and  feed  referred  to  respectively  in
Article  16  (1)  (a)  and  (b),  the  evaluation  shall  respect  the  environmental  safety
requirements  laid  down  in  Directive  2001/18/EC  shall  apply  to  the  evaluation  to
ensure  that  all  appropriate  measures  are  taken  to  prevent  the  adverse  effects  on
human and animal health and the environment which might arise from the deliberate
release  of  genetically  modified  organisms.  During  evaluation  of  requests  for  the
placing  on  the  market  of  products  containing  or  consisting  of  genetically  modified
organisms, the necessary consultations shall be held by the  Authority shall consult
with the bodies set up by the Community and/or the Member States under Directive
2001/18/EC, in accordance with Article 12 (4) of that Directive 2001/18/EC.

5.

In the event of an opinion in favour of authorising the feed referred to in Article 16
(1), the opinion shall also include the following particulars:

(a)

the name and address of the applicant;

(b)

the designation of the feed referred to in Article 16 (1), and its specification;

(c) where  appropriate,  the  information  required  under  Annex  II  of  the  Cartagena

Protocol on Biosafety to the Convention on Biological Diversity;

(d)

the proposal for the labelling of the feed referred to in Article 16 (1);

(e) where appropriate, any conditions or restrictions which should be imposed on
the placing on the market, including specific conditions or restrictions for use
and  handling,  including  post-market  monitoring  requirements  based  on  the
outcome of the risk assessment;

(f)

thea  method,  validated  by  the  Community  reference  laboratory,  for
detection,  including  sampling  and  identification  of  the  transformation  event
and, where applicable, for the detection and identification of the transformation
event in the feed referred to in Article 16 (1);

(g)     information as to the place where the reference material can be accessed in

accordance with Article 31;

36

6.

7.

8.

1.

2.

3.

4.

5.

6.

(hg) where appropriate, the monitoring plan as referred to in Article 19 (5) (b).

The Authority shall forward its opinion to the Commission, the Member States and
the applicant, including a report describing its assessment of the  feed referred  to in
Article 16 (1) and stating the reasons for its opinion.

The  Authority  shall  make  its  opinion  public,  after  deletion  of  any  information
identified  as  confidential,  in  accordance  with  Article  31.  The  public  may  make
comments to the Commission within 30 days from this publication.

Before the entry into application of this Regulation, the Commission shall publish a
recommendation  on  the  nature  of  the  risk  assessment  to  be  undertaken  by  the
Authority for the purpose of preparing its opinion.

Article 21
Authorisation by the Community

Save in exceptionally complex cases, within three months of receipt of the opinion of
the  Authority,  the  Commission  shall  prepare  a  draft  of  the  decision  to  be  taken  in
respect of the application, taking into account Community law and other legitimate
factors relevant to the matter under consideration. Where the draft decision is not in
accordance  with  the  opinion  of  the  Authority,  the  Commission  shall  provide  an
explanation of the reasons for the differences.

In  the  event  of  a  draft  decision  which  envisages  the  granting  of  authorisation,  the
draft decision shall include the particulars mentioned in Article 20 (5), the name of
the  authorisation  holder,  and,  where  appropriate,  the  unique  code  attributed  to  the
genetically modified organism as  referred to  in  the  Regulation  (EC)  No  ,,/,,,  of  the
European  Parliament  and  of  the  Council  concerning  traceability  and  labelling  of
genetically modified organisms and traceability of food and feed products produced
from genetically modified organisms21.

A final decision on the application shall be adopted in accordance with the procedure
laid down in Article 36 (2).

The Commission shall without delay inform the applicant of the decision taken. The
decision shall be published in the Official Journal of the European Communities. 

The  authorisation  granted  in  accordance  with  the  procedure  laid  down  in  this
Regulation  shall  be  valid  throughout  the  Community  for  ten  years  and  shall  be
renewable in accordance with Article 25. The authorised feed shall be entered in the
Register referred to in Article 30. Each entry in the Register shall mention the date of
authorisation and shall include the particulars referred to in paragraph 2.

The authorisation under this Section shall be without prejudice to other provisions of
Community  law  governing  the  use  and  placing  on  the  market  of  substances  which
may only be used subject to their inclusion in a list  of  substances  authorised to the
exclusion of others.

21

OJ L [x], [x], p. [x]

37

                                                
7.

1.

2.

3.

4.

The  granting  of  authorisation  shall  not  diminish  the  general  civil  and  criminal
liability of any feed operator in respect of the feed concerned.

Article 22
Status of existing products

By derogation to Article 17 (2), products as referred to in Article 16 (1) which have
been authorised before the date of application of this Regulation 

-

-

-

under Directives 90/220/EEC or 2001/18/EC, including use as feed,

under Directive 82/471/EEC, which are produced from GMOs, or 

under  Directive  70/524/EEC  which  contain,  consist  of  or  are  produced  from
GMOs, 

may  continue  to  be  placed  on  the  market,  used  and  processed  provided  that  the
following conditions are met:

(a) within  six  months  of  the  entry  into  force  of  this  Regulation,  the  person
responsible  for  placing  on  the  market  the  concerned  products  shall  notify  the
Authority  of  the  date  at  which  they  were  first  placed  on  the  market  in  the
Community.  This  notification  shall  be  accompanied  by  the  particulars
mentioned in Article 19 (3) and (5), as appropriate, which the Authority shall
forward  to  the  Commission  and  the  Member  States.  The  Authority  shall
forward  to  the  Community  reference  laboratory  referred  to  in  Article  33  the
particulars  referred  to  in  Article  19  (3)  (i)  and  (j)  and  shall  ask  it  to  test  and
validate the method of detection and identification proposed by the applicant;

(b) within one year of the entry into force of this Regulation, the Authority shall,
after  verification  that  all  the  information  required  has  been  submitted,  notify
the Commission that it has received the information required under this Article.
The  products  concerned  shall  be  entered  in  the  Register.  Each  entry  in  the
Register  shall  mention  the  date  at  which  the  concerned  products  were  first
placed on the market and shall include the particulars referred to in Article 21
(2) as appropriate.

Within nine years from the date at which the concerned products were first placed on
the  market,  the  person  responsible  for  placing  them  on  the  market  shall  submit  an
application in accordance with Article 25, which shall apply in a like manner.

Products referred to in paragraph 1 and feed containing them or produced from them
shall be subject to the provisions of this Regulation, in particular Articles 23, 24 and
35, which shall apply in a like manner.

Where  the  notification  and  accompanying  particulars  referred  to  in  paragraph  1(a)
are not supplied within the period specified or are found to be incorrect, or where an
application is not submitted as required by paragraph 2 within the period specified,
the Commission, acting in accordance with the procedure laid down in Article 36(2),
shall adopt a measure requiring the product concerned and any products derived from
it to be withdrawn from the market. Such a measure may provide for a limited period
of time within which existing stocks of the product may be used up.

38

5.

6.

1.

2.

3.

1.

2.

3.

4.

In  case  of  authorisations  not  issued  to  a  specific  holder,  the  person  who  imports,
produces  or  manufactures  the  products  referred  to  in  this  Article  shall  submit  the
information or the application to the Authority.

Detailed rules for implementing this Article shall be adopted in accordance with the
procedure laid down in Article 36 (2).

Article 23
Supervision

After  an  authorisation  has  been  issued  in  accordance  with  this  Regulation,  the
authorisation-holder  and  parties  concerned  shall  comply  with  any  the  relevant
conditions or restrictions which have been imposed in the authorisation. Where post-
market monitoring as referred to in Article 19 (3) (k) and Article 19 (5) (b) has been
imposed  on  the  authorisation-holder,  he  shall  ensure  that  it  is  carried  out  and  shall
submit  reports  to  the  Authority  in  accordance  with  the  authorisation.  The
monitoring  reports  shall  be  made  accessible  to  the  public  in  accordance  with
Article 31.

If the authorisation-holder proposes to modify the terms of the authorisation, he shall
submit an application to the Authority. 

The  authorisation-holder  shall  forthwith  inform the  Authority  of  any  new  scientific
or technical information which might influence the evaluation of the safety in use of
the  feed  referred  to  in  Article  16  (1).  In  particular,  the  authorisation-holder  shall
forthwith  inform  the  Authority  of  any  prohibition  or  restriction  imposed  by  the
competent authority of any third country in which the feed referred to in Article 16
(1)  is  placed  on  the  market.  The  Authority  shall  examine  the  information
forwarded  and,  if  validated,  shall  make  it  available  to  the  Commission,  the
Member States and the public in accordance with Article 31.

Article 24
Modification, suspension and revocation of authorisations

Where, on its own initiative or following a request from a Member State or from the
Commission,  the  Authority  is  of  the  opinion  that  an  authorisation  granted  in
accordance with this Regulation should be modified, suspended or revoked, it shall
forthwith  transmit  this  opinion  to  the  Commission,  the  Member  States  and  the
authorisation-holder. The Authority shall make its opinion public, after deletion
of any information identified as confidential, in accordance with Article 31.

The Commission shall examine the opinion of the Authority as soon as possible and
prepare a draft of the decision to be taken. 

In the event of a draft decision which envisages the modification of the authorisation,
the draft decision shall include any amendment needed to the particulars mentioned
in Article 21 (2).

A  final  decision  on  the  modification,  the  suspension  or  the  revocation  of  the
authorisation shall be adopted in accordance with Article 36 (2). 

39

5.

1.

The Commission shall without delay inform the authorisation-holder of the decision
taken.  The  decision  shall  be  published  in  the  Official  Journal  of  the  European
Communities. The Register shall be amended as appropriate.

Article 25
Renewal of authorisations

Without  prejudice  to  the  right  of  a  third  party  to  submit  an  application  for
authorisation  for a  feed  essentially  similar  to  a  feed  for  which  an  authorisation  has
already been granted, authorisations under this Regulation shall be renewable for ten-
years periods, on application to the Authority by the authorisation-holder at the latest
one year before the expiry date of the authorisation. 

The Authority shall acknowledge receipt of the  application, in  writing,  to  the  authorisation-
holder within 15 days of its receipt. The acknowledgement shall state the date of receipt of the
application.

2.

The application shall be accompanied by the following particulars and documents:

(a)

a copy of the authorisation for placing the feed on the market;

a  report  on  the  results  of  the  monitoring,  if  so  specified  in  the

(b)
authorisation;

(c)

any  other  new  information  which  has  become  available  with  regard  to  the
evaluation of the safety in use of the feed and the risks of the feed to animals,
humans or the environment;

(d) where  appropriate,  a  proposal for  amending  or  complementing  the  conditions
of  the  original  authorisation,  inter  alia  the  conditions  concerning  future
monitoring.

Article 20 and Article 21 shall apply in a like manner.

Where,  for  reasons  beyond  the  control  of  the  authorisation-holder,  no  decision  is
taken  on  the  renewal  of  an  authorisation  before  its  expiry  date,  the  period  of
authorisation  of  the  product  shall  automatically  be  extended  until  the  Commission
takes a decision. 

The implementing rules for the application of this Article shall be established by the
Commission  after  consulting  the  Authority,  in  accordance  with  the  procedure  laid
down in Article 36 (2).

The  Authority  shall  publish  detailed  guidance  concerning  the  preparation  and  the
presentation of the application.

3.

4.

5.

6.

40

SECTION 2
LABELLING

Article 26
Scope

1.

2.

This Section shall apply to feed referred to in Article 16 (1).

This  Section  shall  not  apply  to  feed  containing,  consisting  of  or  produced  from
genetically  modified  organisms  in  a  proportion  no  higher  than  the  thresholds
established  in accordance  with  the  procedure  laid  down  in  Article  36  (2),  provided
that this presence is adventitious or technically unavoidable.

In order to establish that the presence of this feed is adventitious or technically unavoidable,
operators  must  be  in  a  position  to  supply  evidence  to  satisfy  the  competent  authorities  that
they have taken appropriate steps to avoid the presence of the genetically modified organisms
(or produce thereof).

Article 27
Requirements

1.

2.

3.

Without  prejudice  to  the  other  requirements  of  Community  law  concerning  the
labelling  of  feed,  feed  referred  to  in  Article  16  (1)  shall  be  subject  to  additional
specific labelling requirements laid down in this Article.

By  way  of  derogation  from  the  previous  paragraph  the  exemptions  for  labelling
requirements  provided  for  in  Article  6  (3)  to  Directive  96/25/EC  shall  not  be
applicable for feed referred to in Article 16 (1).

No  person  shall  place  a  feed  referred  to  in  Article  16  (1)  on  the  market  unless  he
ensures  that  the  particulars  specified  below  are  shown,  in  a  clearly  visible,  legible
and indelible manner, on an accompanying document  or,  where appropriate, on  the
packaging, on the container or on a label attached thereto:

(a)

the name of the feed: each feed material or additive of which a particular feed is
composed of shall be subject to the following specific labelling requirements: 

-

-

for  those  referred  to  in  Article  16  (1)  (a)  and  (b),  the  words
genetically modified feed the name shall be: “genetically modified [name
of  the  feedorganism]”  shall  appear  in  parentheses  immediately
following the name of the feed material or additive concerned;

for  those  referred  to  in  Article  16  (1)  (c),  the  words  feed  produced
from  genetically  modified  organisms:  “produced  from  genetically
modified  [name  of  organismthe  feed  from  which  the  feed  is  produced]
but  not  containing  a  genetically  modified  organism”  shall  appear  in
parentheses immediately following the name of the  feed  material  or
additive concerned;

41

alternatively, these words may appear in a footnote to the list of feed materials
and additives. It shall be printed in a font of at least the same size as the list of
feed materials and additives;

(b)

for  feed  referred  to  in  Article  16  (1)  (b)  the  name  of  the  feed  shall  be
accompanied  by  the  relevant  unique  code  as  established  in  Regulation
(EC)…/…  of  the  European  Parliament  and  of  the  Council  concerning
traceability and labelling of genetically modified organisms and traceability of
food and feed products produced from genetically modified organisms;

(c)

as  specified  in  the  authorisation,  any  characteristic  of  the  feed  referred  to  in
Article 16 (1) such as those indicated hereunder, which is not equivalent to its
conventional counterpart:

- composition,

- nutritional properties,

- intended use,

- implications for the health of certain species or categories of animals;

(d)

as  specified  in  the  authorisation,  any  characteristic  or  property  where  a  feed
may give rise to ethical or religious concerns. 

4.

In addition to the requirements laid down in paragraph 3(a) and (b) and as specified
in the authorisation, the labelling or accompanying documents of feed falling within
the scope of this Section which do not have a conventional counterpart shall contain
appropriate  information  about  the  nature  and  the  characteristics  of  the  feed
concerned.

Article 28
Implementing measures

Detailed  rules  for  implementing  this  Section  may  be  adopted  in  accordance  with  the
procedure laid down in Article 36 (2).

42

CHAPTER IV
COMMON PROVISIONS

Article 29
Products likely to be used as food and feed

1.

2.

1.

2.

Where a product is likely to be used both as food and feed, a single application under
Articles 6 and 19 shall be submitted and shall give rise to a single opinion from the
Authority and a single Community decision.

The Authority may shall consider whether the application for authorisation should be
submitted both as food and feed.

Article 30
Community Register

The  Commission shall establish and  maintain a Community  Register  of  Genetically
Modified Food and Feed, referred to in this Regulation as ‘the Register’.

The Register shall be made available to the public.

Article 31
Disclosure and cConfidentiality

1.            Without prejudice to Articles 38, 39 and 41 of Regulation (EC) No 178/2002 and
to  Regulation  (EC)  No  1049/2001  regarding  public  access  to  European
Parliament,  Council  and  Commission  documents22,  the  Authority,  the
Commission  and  the  Member  States  shall  not  divulge  to  third  parties
confidential  information  received  under  this  Regulation  and  shall  protect
intellectual property rights relating to the data received.

2.            The  applicant  may  indicate  which  information  submitted  under  the  present
Regulation  he  wishes  to  be  treated  as  confidential  because  its  disclosure  may
significantly harm its competitive position. Verifiable justification must be given in
such cases.

32.

Without prejudice to paragraph 43, the Authority shall determine, after consultation
with  the  applicant,  which  information  should  be  kept  confidential  and  shall  inform
the applicant of its decision. 

34.

Information relating to the following shall not be considered confidential:

(a)

name  and  composition  of  the  genetically  modified  organism,  food  or  feed
referred to in Articles 3 (1) and 16 (1) and, where appropriate, indication of the
substrate and the micro-organism;

22

OJ L 145, 31.5.2001, p. 43.

43

                                                
(b)

(c)

(d)

(e)

general  description  of  the  genetically  modified  organism  and  the  name  and
address of the authorisation-holder; 

physico-chemical  and  biological  characteristics  of  the  genetically  modified
organism, food or feed referred to in Articles 3 (1) and 16 (1);

effects  of  the  genetically  modified  organism,  food  or  feed  referred  to  in
Articles 3 (1) and 16 (1) on human and animal health and on the environment; 

effects  of  the  genetically  modified  organism,  food  or  feed  referred  to  in
Articles  3  (1)  and  16  (1)  on  the  characteristics  of  animal  products  and  its
nutritional properties;

(f) methods  for  detection, 

including  sampling  and 

the
transformation event and, where applicable, for the detection and identification
of the transformation event in the food or feed referred to in Articles 3 (1) and
16  (1) and,  where  applicable, monitoring requirements  and  a  summary  of  the
results of the monitoring;

identification  of 

(g)

information on waste treatment and emergency response.

54.

65.

76.

Notwithstanding  paragraph  32, 
Commission and Member States with all information in its possession.

the  Authority  shall  on  request  supply 

the

The Commission, the Authority and the Member States shall keep confidential all the
information  identified  as  confidential  under  paragraph  32  except  for  information
which  must  be  made  public  if  circumstances  so  require,  in  order  to  protect  human
health, animal health or the environment.

If  an  applicant  withdraws  or  has  withdrawn  an  application,  the  Authority,  the
Commission and the Member States shall respect the confidentiality  of  commercial
and industrial information, including research and development information as well
as  information  on  which  the  Authority  and  the  applicant  disagree  as  to  its
confidentiality.

Article 32
Data protection

The scientific data and other  information in  the application dossier  required under Article 6
(3) and (5) and Article 19 (3) and (5) may not be used for the benefit of another applicant for
a period of ten years from the date of authorisation, unless the other applicant has agreed with
the authorisation-holder that such data  and  information may be  used.  On  expiry  of  this  ten-
years  period,  the  findings  of  all  or  part  of  the  evaluation  conducted  on  the  basis  of  the
scientific  data  and  information  contained  in  the  application  dossier  may  be  used  by  the
Authority for the benefit of another applicant if he can demonstrate that the food or feed for
which  he  is  seeking  authorisation  is  essentially  similar  to  a  food  or  feed  already  authorised
under this Regulation.

44

Article 33
Community reference laboratory

The Community reference laboratory and its duties and tasks shall be those laid down in the
Annex.

National  reference  laboratories  may  be  established  in  accordance  with  the  procedure  laid
down in Article 36 (2).

Detailed  rules  for  implementing  this  Annex  and  any  changes  to  it  may  be  adopted  in
accordance with the procedure laid down in Article 36 (2).

Article 34
Consultation with the European Group on Ethics in Science and New Technologies

1.

2.

The  Commission,  on  its  own  initiative  or  at  the  request  of  a  Member  State,  may
consult the European Group on Ethics in Science and New Technologies established
by Commission Decision of 16 December 1997, with a view to obtaining its opinion
on ethical issues.

The  Commission  shall  make  available  to  the  public  the  opinions  of  the  European
Group on Ethics in Science and New Technologies.

Article 35
Emergency measures

Where  it  is  evident  that  food  or  feed  placed  on  the  market  in  accordance  with  this
Regulation is likely to constitute a serious risk to human health, animal health
or the environment, or where, in the light of an opinion of the Authority issued
in  pursuance  to  Article  11  or  24,  the  need  to  suspend  or  modify  urgently  an
authorisation arises, measures shall be taken under the procedures provided for
in Articles 53 and 54 of Regulation (EC) No 178/2002.

1.            Where a Member State, as a result of new information or a reassessment of existing
information,  has  detailed  grounds  for  considering  that  the  use  of  a  food  or  feed
authorised in accordance with this Regulation endangers human health, animal health
or the environment, it shall immediately inform the Authority and the Commission.

2.            If the Commission, following information received from a Member State pursuant to
paragraph  1  or  on  its  own  initiative,  considers  that  emergency  measures  are
necessary,  it  may  adopt  them  in  accordance  with  Article  36  (3).  These  emergency
measures  may  remain  in  place  until  a  final  decision  is  taken  in  accordance  with
Article 11 or Article 24, as appropriate.

Article 36
Implementing powers of the Commission

1.

The Commission shall be assisted by the Committee referred to in Article 57 58 (1)
of  Regulation  (EC)  No  178  …./20021  laying  down  the  general  principles  and

45

requirements  of  food  law,  establishing  the  European  Food  Authority,  and  laying
down procedures in matters of food safety.

2.

When  reference  is  made  to  this  paragraph,  the  regulatory  procedure  laid  down  in
Article  5  of  Decision  1999/468/EC  shall  apply,  in  compliance  with  Articles  7  and
Article 8 thereof. The period provided for in Article 5 (6) of Decision 1999/468/EC
shall be three months.

3.            When  reference  is  made  to  this  paragraph,  the  safeguard  procedure  laid  down  in
Article  6  of  Decision  1999/468/EC  shall  apply,  in  compliance  with  Article  7  and
Article  8  thereof.  Any  Member  State  may  refer  the  Commission’s  decision  to  the
Council within 15 days from the receipt of the notification of this decision, in which
case the Council, acting by a qualified majority, may take a different decision within
one month from the date of referral to the Council.

Article 37
Repeals

The  following  Regulations  are  repealed  with  effect  from  the  date  of  application  of  this
Regulation:

–  Regulation (EC) No 1139/98;

–  Regulation (EC) No 49/2000;

–  Regulation (EC) No 50/2000.

Article 38
Amendments to Regulation (EC) No 258/97

Regulation  (EC)  No  258/97  is  amended  with  effect  from  the  date  of  application  of  this

Regulation as follows:

(1) The following provisions are deleted:

–  Article 1 (2) (a) and (b),

–  Article 3 (2) second paragraph and (3),

–  Article 8 (1) (d),

–  Article 9,

(2)

In Article 3, the first sentence of paragraph 4 is replaced by the following:

“By way of derogation from paragraph 2, the procedure laid down in Article 5
shall apply to foods or food ingredients referred to in Article 1 (2) (d) and (e) which,
on  the basis of the  scientific  evidence available and  generally  recognised  or  on  the
basis of an opinion delivered by one of the competent bodies referred to in Article 4
(3), are substantially equivalent to existing foods or food ingredients as regards their
composition, nutritional value, metabolism, intended use and the level of undesirable
substances contained therein.”

46

(3)      In Article 12 (1), the words “or the environment” are deleted.

Article 39
Amendments to Directive 82/471/EEC

Directive 82/471/EEC is amended with effect from the date of application of this Regulation
as follows:

The following paragraph is added to Article 1: 

“3. This Directive does not apply to products which act as direct or indirect protein  sources
that fall within the scope of Regulation ---/---/EC on genetically modified food and feed”.

Article 40
Amendments to Directive 70/457/EEC

Directive 70/457/EEC is amended with effect from the date of application of this Regulation
as follows:

(1)

Article 4 (5) is replaced by the following:

“5. Further, when material derived from a plant variety is intended to be used in food falling
within the scope of Article 3, or feed falling within the scope of Article 16 of Regulation ---/--
-/EC on genetically modified food and feed, the variety shall only be accepted if it has been
approved in accordance with that Regulation”

(2)

Article 7 (5) is replaced by the following:

“5. Member States shall ensure that a variety intended to be used in food or feed as defined in
Articles 2 and 3 of Regulation (EC) No 178 …./20021 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and laying down
procedures  in  matters  of  food  safety,  is  accepted  only  if  it  has  been  authorised  pursuant  to
Regulation (EC) No 258/97 for food or under Directive 90/220/EEC or Directive 2001/18/EC
for  feed  or  Regulation  ---/---/EC  on  genetically  modified  food  and  feedunder  the  relevant
legislation.”

Article 41
Amendments to Directive 70/458/EEC

Directive 70/458/EEC is amended with effect from the date of application of this Regulation
as follows:

(1)

Article 4 (3) is replaced by the following:

“3. Further, when material derived from a plant variety is intended to be used in food falling
within the scope of Article 3, or feed falling within the scope of Article 16 of Regulation ---/--
-/EC on genetically modified food and feed, the variety shall only be accepted if it has been
approved in accordance with that Regulation”

(2)

Article 7 (5) is replaced by the following:

47

“5. Member States shall ensure that a variety intended to be used in food or feed as defined in
Articles 2 and 3 of Regulation (EC) No …./2001178/2002 laying down the general principles
and  requirements  of  food  law,  establishing  the  European  Food  Safety  Authority  and  laying
down procedures in matters of food safety, is accepted only if it has been authorised pursuant
to Regulation (EC) No 258/97 for food or Directive 90/220/EEC or Directive 2001/18/EC for
feed  or  Regulation  ---/---/EC  on  genetically  modified  food  and  feedunder  the  relevant
legislation.”

Article 42
Amendments to Directive 2001/18/EC

Directive  2001/18/EC  is  amended  with  effect  from  the  date  of  entry  into  force  of  this
Regulation as follows:

“The following Article 12a is inserted:

Article 12a
Adventitious presence of GMOs in products

Articles  13  to  21  shall  not  apply  to  the  placing  on  the  market  of  traces  of  a  GMO  or
combination of GMOs in products intended for direct use as food or feed, or for processing, in
a  proportion  no  higher  than  1  %  or  lower  thresholds  established  in  accordance  with  the
procedure laid down in Article 30 (2), provided that these traces of GMOs are adventitious or
technically unavoidable and that the GMOs have been subject to a scientific risk assessment
made by the relevant Scientific Committee(s) or the European Food Safety Authority, which
concludes that the GMOs do not present a risk for human health or the environment. 

In  order  to  establish  that  traces  of  GMOs  are  adventitious  or  technically  unavoidable,
operators  must  be  in  a  position  to  demonstrate  to  the  competent  authorities  that  they  have
taken appropriate steps to avoid them”.

Article 43
Information to be provided in accordance with the Cartagena Protocol on Biosafety

1.

Any authorisation, renewal, modification, suspension or revocation of authorisation
of a genetically modified organism, food or feed referred to in Articles 3 (1) (b)and
16  (1)  (b)  shall  be  notified  by  the  Commission  to  the  Parties  to  the  Cartagena
Protocol  on  Biosafety  through  the  Biosafety  Clearing-House  in  accordance  with
Article 11 (1) or Article 12 (1) of the Cartagena Protocol on  Biosafety,  as  the  case
may be. 

The  Commission  shall  provide  a  copy  of  the  information,  in  writing,  to  the  national  focal
point of each Party that informs the Secretariat in advance that it does not have access to the
Biosafety Clearing-House.

2.

The Commission shall also process requests for additional information made by any
Party  in  accordance  with  Article  11  (3)  and  will  provide  copies  of  the  laws,
regulations  and  guidelines  in  accordance  with  Article  11  (5)  of  the  Cartagena
Protocol on Biosafety.

48

Article 44
Penalties

The Member  States shall  lay down  the rules  on  penalties  applicable to  infringements  of  the
provisions  of  this  Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are
implemented. The penalties provided for must be effective, proportionate and dissuasive. The
Member States shall notify those provisions to the Commission by [six months after the date
of  publication  of  this  Regulation]  at  the  latest  and  shall  notify  it  without  delay  of  any
subsequent amendment affecting them.

1.

2.

3.

4.

5.

1.

2.

Article 45
Transitional measures

Requests submitted under Article 4 of  Regulation (EC) No 258/97  before the  entry
into force of this Regulation shall be transformed into applications under Chapter II,
Section  1 of this  Regulation  where  the  initial  assessment  report  provided  for  under
Article  6  (3)  of  Regulation  (EC)  No  258/97  has  not  yet  been  forwarded  to  the
Commission, as well as in all cases where an additional assessment report is required
in accordance with Article 6 (3) or (4) of Regulation (EC) No 258/97.

For a  period of  not more  than  twelve  months  from  the  date  of  its  application,
tThe labelling requirements laid down in this Regulation shall not apply to products
which  have  been  lawfully  manufactured  and  labelled  in  the  Community,  or  which
have been lawfully imported into the Community and put into circulation, before the
aforementioned date of application of this Regulation.

Notifications concerning products including use as feed submitted under  Article 13
of  Directive  2001/18/EC  before  the  entry  into  force  of  this  Regulation  shall  be
transformed into applications under Chapter III, Section 1 of this Regulation where
the assessment report provided for under Article 14 of Directive 2001/18/EC has not
yet been sent to the Commission.

Requests  submitted  for  products referred  to in Article 16 (1) (c) under  Article  7  of
Directive  82/471/EEC  before  the  entry  into  force  of  this  Regulation  shall  be
transformed into applications under Chapter III, Section 1 of this Regulation.

Requests  submitted  for  products  referred  to  in  Article  16  (1)  under  Article  4  of
Directive  70/524/EEC  before  the  entry  into  force  of  this  Regulation  shall  be
complemented by applications under Chapter III, Section 1 of this Regulation.

Article 46
Review

No later than two years from the date of entry into force of this Regulation and in the
light of experience gained, the Commission shall forward to the European Parliament
and to the Council a report on the implementation of this  Regulation accompanied,
where  appropriate,  by any  suitable proposal.  The  report  and,  where  appropriate,
any suitable proposal shall be made available to the public.

Notwithstanding  the  review  provided  for  in  paragraph  1,  the  Commission  shall
monitor  the  application  of  this  Regulation  and  its  impact  on  human  and  animal

49

health,  consumer  protection,  consumer  information  and  the  functioning  of  the
internal market and, if necessary, will bring forward proposals at the earliest possible
date.

Article 47
Entry into force

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

It shall apply from [six months after the date of publication of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, […]

For the European Parliament
The President
[…]

For the Council
The President
[…]

50

ANNEX 

DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

The  Community  reference laboratory referred  to  in  Article  33  is  the  Commission’s
Joint Research Centre.

For the tasks outlined in this Annex, the Commission’s Joint Research Centre shall
be assisted by a consortium of national reference laboratories, which will be referred
to as the “European Network of GMO laboratories”.

The Community reference laboratory shall be notably responsible for:

1.

2.

3.

-

-

-

-

reception, preparation, storage and maintenance of the appropriate positive and
negative control samples;

testing  and  validation  of  the  method  for  detection,  including  sampling  and
identification of the transformation event and, where applicable, the detection
and identification of the transformation event in the food or feed;

evaluating the data provided by the applicant for  authorisation for placing the
food  or  feed  on  the  market,  for  the  purpose  of  testing  and  validation  of  the
method for sampling and detection;

submitting full evaluation reports to the Authority.

4.

The  Community  reference  laboratory  shall  play  a  role  in  disputes  settlements
between Member States concerning the results of the tasks outlined in this Annex.

51