Amended proposal for a Regulation of the European Parliament and of the Council on the transboundary movement of genetically modified organisms (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2002-10-16
Institutions: European Commission
Subjects: biotechnology, cross-border transport, environmental risk prevention, genetically modified organism, information system, public health

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.10.2002
COM(2002) 578 final

2002/0046 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

ON THE TRANSBOUNDARY MOVEMENT OF GENETICALLY MODIFIED
ORGANISMS

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

2002/0046 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

ON THE TRANSBOUNDARY MOVEMENT OF GENETICALLY MODIFIED
ORGANISMS

1.

BACKGROUND

Transmission of the Proposal to the Council and the European
Parliament (COM(2002)85 final – 2002/0046(COD)) in
accordance with Article 175(1) of the Treaty

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Opinion of the Economic and Social Committee

Opinion of the Committee of the Regions

Opinion of the European Parliament – first reading

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-

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18 February 2002

17 July 2002

16 May 2002

24 September 2002

2.

OBJECTIVE OF THE COMMISSION PROPOSAL

In accordance with the precautionary principle, the objective of this Proposal is to establish a
common system of notification  and information for  exports  to  third  countries  of  genetically
modified organisms (GMOs) in order to contribute to ensuring an adequate level of protection
in the field of the safe transfer, handling and use of GMOs that may have adverse effects on
the conservation and the sustainable use of biological diversity, taking also into account risks
to human health.

3.

COMMISSION OPINION ON THE AMENDMENTS ADOPTED BY THE PARLIAMENT

At  the  Plenary  Session  of  24  September  2002,  the  European  Parliament  adopted  48
amendments, out of the 60 amendments that were tabled.

The  Commission  can  accept  15  amendments  fully,  12  in  principle  and  2  partly.  The
Commission cannot accept 19 amendments.

More specifically, the Commission fully agrees to amendments 2, 6, 8, 11, 28, 35, 37, 39, 40,
41, 43, 46, 50, 51 and 56. The Commission agrees in principle to amendments 10, 12, 13, 14,
15,  18,  23,  24,  25,  26,  34  and  36.  Amendments  21  and  60  can  be  accepted  partly.  The
Commission cannot accept amendments 1, 3, 4, 5, 7, 9, 16, 17, 27, 29, 30, 31, 32, 38, 44, 45,
47, 53 and 59.

3.1.

Amendments accepted by the Commission

Amendment  2  recognises  the  fundamental  right  of  citizens  to  a  free  choice  in  regard  to
GMOs,  which  is  in  line  with  the  Commission’s  general  approach  to  biotechnology.  The

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Commission can accept this amendment and therefore proposes to add its text to recital 4 of
the Proposal.

Amendments 6, 8, 39, 40, 41 and 43 improve the editorial quality of the Proposal and are in
line with the Cartagena Protocol. Therefore, the Commission can accept all these amendments
and proposes to modify the following parts of the Proposal in line with these six amendments
respectively: Recitals 8, 13 and Articles 10(1), 10(1)(b), 11 and 11(2)(j).

Amendments 11 and 56 move the exemption of notification for GMOs intended for deliberate
release into the environment, which have been identified as being not likely to have adverse
effects, from the article related to the scope to the article dealing with notification to Parties
and  non-Parties  of  Import.  The  Commission  can  accept  both  amendments,  since  they  only
improve  the  structure  of  the  text,  and  do  not  have  any  impact  on  its  substance.  The
Commission proposes to amend Article 2(3) of the Proposal according to Amendment 11 and
to create a new Article 4, paragraph 2a in the Proposal, in line with amendment 56.

Amendment  28  clarifies  the  objective  of  the  information  procedure  for  GMOs  intended  for
direct use as food, feed, or for processing. The Commission can accept this amendment, and
therefore proposes to amend Article 8(1) of the Proposal accordingly.

Amendment 35 improves the provisions of the Proposal on the identification of GMOs, in line
with article 18 of the Biosafety Protocol and in coherence with the Commission’s Proposal for
a  Regulation  on  the  Labelling  and  Traceability  of  GMOs.  The  Commission  can  accept  this
amendment, and therefore proposes to create a new Article 9(1) subparagraph 1 point (ba) in
the Proposal.

Amendment 37 ensures a better transposition of article 11(4) of the  Biosafety Protocol. The
Commission can accept this amendment, and therefore proposes to create a new Article 9(a)
in the Proposal.

Amendment 46 adjusts the deadlines for monitoring and reporting obligations of the Proposal
so that they conform to Art. 31 (4) of Directive 2001/18/EC on the deliberate release into the
environment of GMOs1. The Commission can accept this amendment, and therefore proposes
to modify Article 14(1) of the Proposal accordingly.

Amendment 50 clearly rules out re-notification of subsequent movements of a specific GMO
that  has  already  been  approved  in  a  given  country,  in  line  with  the  Biosafety  Protocol  and
Community practices. The Commission can accept this amendment, and therefore proposes to
add the text of this amendment to Article 4(2) of the Proposal

Amendment  51  is  acceptable  for  the  Commission,  in  line  with  Article  7  of  the  original
Proposal. The Commission therefore proposes to create a new Article 4(2)(a) in the Proposal.

3.2.

Amendments accepted in part or principle by the Commission

Amendment 10 improves the consistency of the Proposal with the Protocol for GMOs that are
pharmaceuticals for human use. The Commission can accept it in principle, but would prefer a
simpler  wording  for  Article  2(2)  of  the  Proposal:  “Pharmaceuticals  for  humans  that  are
addressed  by  other  relevant  international  agreements  or  organisations  are  excluded  from
the scope of this Regulation”.

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OJ L 106, 17.4.2001, p. 1-39

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Amendments  12  and  13  update  the  Proposal,  in  line  with  the  adoption  of  Regulation  (EC)
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 safety2. The
Commission can accept these amendments in principle, but sees no need to quote the full title
of the legislation in the text. This should be done in footnotes to Articles 3(7) and 3(8) of the
Proposal.

Amendment  14  deletes  the  definition  of  “notifier”  in  Article  3(11)  of  the  Proposal.  In  the
original  Proposal,  the  Commission  wished  to  reflect  the  practical  situation  where  the
“notifier”  and the  “exporter”  are  different  legal  entities.  However,  this  question  can  also  be
dealt with under general civil law and the Proposal can refer solely to the “exporter”, in line
with the Biosafety Protocol. The Commission can therefore accept, in principle, the deletion
of  Article  3(11)  of  the  Proposal,  but  only  if  the  reference  to  “notifier”  is  suppressed  in  all
linguistic  versions,  not  just  Swedish,  as  it  might  be  understood  from  the  wording  of
Amendment 43.

Amendment  15  aims  at  simplifying  the  definition  of  “exporter”.  The  definition  within  the
actual Proposal is taken out of the Community’s Customs Code. The Commission shares the
objective  of  the  Parliament  to  simplify  the  wording  of  the  Proposal,  but  the  proposed
definition  is  not  necessarily  in  line  with  customs  procedures.  The  Commission  can  accept
amendment 15 in principle, provided that  a reference to the relevant Article of the Customs
Code is inserted in Article 3(14) of the Proposal, instead of the original text, as for technical
definitions  under  Directive  2001/18/EC.  This  could  read  as  follows:  “Exporter”  means
exporter  as  defined  in  Article  788  of  Commission  Regulation  (EEC)  n°2454/93  of  2  July
1993  laying  down  provisions  for  the  implementation  of  Council  Regulation  (EEC)
n°2913/92 establishing the Community’s Customs Code”.

Amendment  18  aims  at  providing  a  definition  of  “transboundary  movements“.  The
Commission  can  accept  this  amendment  in  principle.  However,  it  needs  to  be  reworded  in
order to ensure that: (i) intentional transboundary movements do not cover imports of GMOs
into the European Union and movements of GMOs between Member States of the European
Union; (ii) unintentional transboundary movements do cover the above-mentioned situations.
This has to be done in order to reflect the provisions of Article 14 of the Biosafety Protocol.
The new Article 3(16)(a) of the Proposal could read as follows: 'Transboundary movement'
means  the  intentional  or  unintentional  movement  of  a  genetically  modified  organism
between  one  Party  or  non-Party  and  another  Party  or  non-Party,  excluding  intentional
movements into and between Parties, or non-Parties, within the Community."

Amendment  23  is  intended  to  develop  the  information  obligation  of  exporters  towards
Member  States  and  the  European  Commission  regarding  transboundary  movements  of
GMOs. It also intends to make this information available to the public through the European
Commission. The Commission can accept this amendment in principle, but proposes to split it
into two sentences and introduce the following modifications. The deletion of the reference to
“notifier”  in  the  first  sentence  of  Article  6  of  the  Proposal  can  be  accepted,  in  line  with
amendments  14  (Art  3(11))  and  60  (Art  4(1)).  However,  this  must  concern  all  linguistic
versions, not just Swedish, as might be understood from the wording of Amendment 4. The
second sentence of amendment 23 cannot be accepted since the notification is addressed to a
Third country, not to the Commission, and it should be for this country to decide how to deal

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3

OJ L 31, 1.2.2002, p. 1–24
Which the Commission cannot accept, partly for this reason. See also amendments 23 and 60.

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with this document. It is therefore not for the Commission to make the notification available
to the public.

Amendments  24  and  25  reflect  the  provisions  of  Article  21  of  the  Biosafety  Protocol  that
deals with confidential information. The original Proposal did not deal with this issue, leaving
it  to  existing  Community  legislation,  namely  Article  25  of  Directive  2001/18/EC.  The
Commission  can  accept  both  amendments  in  principle,  since  they  clarify  the  original
Proposal.  However,  the  Commission  would  like  to  introduce  a  reference  to  Directive
2001/18/CE to ensure coherence with this piece of legislation. The Commission proposes to
draft  the  new  Article  6(1)(a)  of  the  Proposal  as  follows:  “In  accordance  with  Directive
2001/18/EC, the Commission and the competent authorities shall not divulge to third parties
any  confidential  information  notified  under  this  Regulation  and  shall  protect  intellectual
property  rights  relating  to  the  data  received.  The  exporter  may  indicate  the  information,  in
the  notification  submitted  under  this  Regulation4,  […]”.  For  the  same  reason,  the
Commission  proposes  to  introduce  the  following  modification  in  the  new  Article  6a:  “In
accordance with Directive 2001/18/EC, in no case may any of the following information be
considered confidential […]” should be added at the beginning of the new Article 6(a).

Amendment 26 is an editorial change that the Commission can accept in principle. However,
the Commission proposes to replace “must ensure notification” in the original Article 7 of the
Proposal by “shall notify”, in line with the original wording of the Protocol5.

Amendment 34 is in line with the identification requirements of the Protocol, as well as with
those  of  the  Commission  Proposal  on  Labelling  and  Traceability  of  GMOs.  Therefore,  the
Commission  can  accept  it  in  principle.  However,  information  under  Annex  1  (e)  –  (i)  is
already available via the unique code(s). Therefore, the Commission proposes to add the text
of the amendment to Article 9(1) subparagraph 1 point (b) of the Proposal, with the exception
of points (e) – (i), for which a reference is not needed.

The Commission can accept Amendment 36 in principle, since it is in line with Article 18 of
the Biosafety Protocol. However, as worded now, this is too general and disproportionate for
the operator given the broad scope of the Protocol. If such a provision were to be introduced,
it  should  only  impose  a  declaration  on  the  conformity  of  the  movements  with  the
requirements  of  this  Proposal  applicable  to  the  exporters.  The  Commission  proposes  to
reword Article 9(1) subparagraph 1 point (bb) of the Proposal as follow: “(d) a statement that
the movement is in conformity with the relevant provisions of this Regulation.”

Amendment 21 clarifies the procedure to be followed in cases of non-decision by a Party of
Import on a notification of a GMO. The Commission can accept this amendment in part. The
new heading of Article 5 of the Proposal, as well as its first sentence, can be accepted, since
they are in line with the original Proposal and the Biosafety  Protocol. The  second  and third
sentences  can also be  accepted  since  they improve  the  consistency  of  the  Proposal  with  the
Protocol. The fourth sentence cannot be accepted since it goes beyond the provisions  of  the
Protocol and prejudges future international discussions and practices. The Protocol only says
that the absence of reply/decision does not imply consent. It does not “per se” forbid exports
in such a situation6.

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5

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Editorial change.
And not by “must notify” as suggested.
For the same reason, the Commission cannot accept the first sentence of Amendment 60.

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Amendment 60 aims at clarifying the notification procedure for GMOs intended for deliberate
release  into  the  environment.  The  Commission  can  accept  this  amendment  in  part  and
proposes to reword Article 4(1) the following way: the first sentence cannot be accepted since
it  goes  beyond  the  provisions  of  the  Protocol  and  prejudge  future  international  discussions
and practices7. The second sentence could be accepted but without using the terms "directly or
indirectly", since it will in any case be impossible to monitor from the EU subsequent use of a
GMO in the Party of Import. The third sentence was not amended. The fourth sentence can be
accepted, in line with amendments 14 and 23.

3.3.

Amendments not accepted by the Commission

The Commission cannot accept Amendment 1, which deletes in Recital 3 of the Proposal the
reference to an eventual amendment of Directive 2001/18/EC by the upcoming Regulation on
the Labelling and Traceability of GMOs. The Commission’s amended proposal on Labelling
and  Traceability  still  mentions  an  amendment  of  Directive  2001/18/EC.  Therefore,  the
Commission cannot accept this amendment.

Amendments 3 and 4 raise problems of redaction and of substance:

– 

– 

On a linguistic point of view, in both amendments, the modification, in the Swedish
text of Recital 6 and 7 of the Proposal, from 'should' to 'shall' (in Swedish) could be
seen  as  inconsistent  with  the  inter-institutional  rules  on  the  wording  of  recitals  (Le
considérant est formulé dans un langage non-impératif,  ne devant pas pouvoir être
confondu avec celui du dispositif).

On the substance, Amendment  3 adds  in  Recital  6  a  reference  to  the  precautionary
principle,  which  should  not  be  a  problem  as  such,  but  shall  be  reflected  in  all
languages,  and  not  just  Swedish.  The  same  applies  to  Amendment  4  where  an
important  question  of  substance  (suppression  of  the  reference  to  "notifier"  and
replacement by a single reference to exporter) is introduced in Recital 7 and would
need to be reflected in all languages, not just Swedish.

For these reasons, the Commission cannot accept amendments 3 and 4 as they stand now.

Amendments 5 and 47 raise the important issue of capacity building in developing countries,
but  do  not  provide  for  operational  mechanisms.  The  Commission  believes  that  this  issue
would  be better  addressed  in  a  more appropriate  framework,  like for example the  European
Development Fund. Therefore, these amendments cannot be accepted.

Amendments  7  and  45  raise  the  issue  of  environmental  liability.  The  Commission  believes
that this Proposal is not the right instrument to tackle this issue. This should be addressed in
the horizontal instrument on environmental  liability  currently  discussed  at  Community  level
and, in parallel, in international negotiations in this field. Therefore, the Commission cannot
accept these amendments.

Amendment 9 recognises the need for exporters to respect the importing country's regulatory
framework for GMOs. The Commission believes that such an obligation is implicit and that
this addition is not necessary. It may also give an “a priori” legitimacy to legislation of third
countries, which are not in line with the Biosafety Protocol (i.e. authorisation procedures that

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See also Amendment 21.

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do not rely on scientific risks assessment). For these reasons, the Commission cannot accept
this amendment.

Amendments  16  and  17  raise  drafting  problems.  “Conclusion”  is  the  appropriate  general
terminology,  even  if  “ratification”  is  more  used  in  common  language.  “Conclusion”  allows
encompassing  different  terminology  amongst  Member  States  and  at  international  level.
Therefore, the Commission cannot accept these amendments.

Amendment 27 imposes on the Commission an obligation to notify to the Biosafety Clearing
House, on behalf of the Community, any final decision regarding Community use, including
placing on the market, of a GMO that may be subject to transboundary movements for release
into the environment. This is not in line with the procedures foreseen in Articles 8, 9, 10 and
12 of  the  Biosafety Protocol  for  GMOs for deliberate  release and in  Article  11  of  the  same
agreement for GMOs to be used as food or feed, or for processing. This risks creating legal
uncertainty. Therefore, the Commission cannot accept this amendment.

Amendment  29  raises  a  fundamental  problem.  It,  first  of  all,  sets  up  procedures  for  GMOs
intended for direct use as food or feed, or for processing, that does not fully reflect Article 11
of the Biosafety Protocol.  More  importantly,  by  limiting  Community  exports  to  GMOs  that
have been approved into the EU for direct use as food or feed, or for processing, it contradicts
Article 12 of Regulation 178/2002/EC laying down the general principles and requirements of
food law. Therefore, the Commission cannot accept this amendment.

Amendment 30 is not in line with the scope of both the Biosafety Protocol and the Labelling
and  Traceability  Proposal,  mainly  by  enlarging  the  scope  of  the  Proposal  to  food  and  feed
produced with the aid of GMOs. The Commission insists on maintaining coherence between
different pieces of legislation on biotechnology, and therefore cannot accept this amendment.

Amendment 31 on transit of GMOs is not entirely in line with Article 6 (1) of the Biosafety
Protocol,  notably  by  confusing  transport  and  transit  and  not  mentioning  the  role  of  the
Biosafety  Clearing  House.  Article  7  of  Commission’s  Proposal  is  clearer  and  more  in  line
with Protocol. For these reasons, the Commission cannot accept amendment 31.

Amendment  32  aims  at  detailing  the  obligation  to  transmit  accompanying  documentation
throughout all the different steps of the transboundary movement of a GMO (notably transit
and storage). However, the wording of the amendment is rather cumbersome, and the added
value  limited  since  the  original  provisions  already  encompass  the  practical  situations  the
Parliament  wishes  to  cover.  Therefore,  the  Commission  cannot  accept  this  amendment  and
wishes  to  retain  the  original  wording,  which  is  more  clear  and  general,  avoiding  potential
practical problems and gaps.

Amendments 38 and 59 put an obligation on Member States to take appropriate measures to
living  modified  organisms.  The
prevent  unintentional 
Commission  believes  that  the  concept  of  unintentional  transboundary  movements  mainly
covers cases of accident. This aspect is already adequately covered by Community legislation,
namely Directive 2001/18/EC. Therefore, the Commission cannot accept these amendments.

transboundary  movements  of 

Amendment  44  puts  an  obligation  on  Member  States  to  lay  down,  after  joint  consultation,
rules on uniform penalties applicable to infringements of the provisions of this Proposal for a
Regulation. This aspect is of  Member  State  competence.  If  there  is  certainly  a  need  for  co-
ordination and harmonisation of sanctions is to be encouraged, this goes legally beyond what

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can  be  inserted  into  a  Community  Regulation.  For  these  reasons,  the  Commission  cannot
accept this amendment.

Amendment 53 introduces transit in the scope of the Proposal. The Commission believes that
transit  is  already  covered  by  the  notification  and  information  procedures  foreseen  under  its
Proposal. For this reason, the Commission cannot accept this amendment.

4.

AMENDED PROPOSAL

Having  regard  to  Article  250,  paragraph  2  of  the  EC  Treaty,  the  Commission  modifies  its
Proposal as indicated above.

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