Opinion of the Commission pursuant to Article 251(2) (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, amending the proposal of the Commission pursuant to Article 250(2) of the EC Treaty
Date: 2000-05-16
Institutions: European Commission
Subjects: EC Directive, environmental impact, environmental protection, genetically modified organism, public health

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 16.05.2000
COM(2000)293 final

1998/0072 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2) (c) of the EC Treaty,
on the European Parliament's amendments
to the Council's common position regarding the
proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the deliberate release into the environment of genetically modified organisms and
repealing Council Directive 90/220/EEC

AMENDING THE PROPOSAL OF THE COMMISSION
pursuant to Article 250 (2) of the EC Treaty

EXPLANATORY MEMORANDUM

Article 251, paragraph 2, letter c) of the Treaty establishing the European Community
establishes that the Commission gives an opinion on the amendments proposed by the
European Parliament in the second reading.

The Commission hereafter gives its opinion on the twenty-nine amendments proposed by the
European Parliament.

1.

Background

Transmission of the Proposal
to the Council and the European
Parliament (COM(1998) 85 final) (based on Article 95 of the Treaty)

23 February 1998

Opinion of the Economic and Social Committee

9 September 1998

Opinion of the European Parliament – first reading

11 February 1999

Amended Proposal of the Commission (COM(1999)139 final)

26 March 1999

Adoption of the Common Position

Opinion of the Commission on the Common Position
(SEC(1999)2180 final)

9 December 1999

13 January 2000

The Common Position maintains in principle the basic structure of the Commission Proposal.
The Commission supports the Common Position and is satisfied it will provide for an
efficient, effective as well as transparent regulatory framework for genetically modified
organisms.

2.

Objective of the Commission Proposal

The Directive aims to replace Directive 90/220/EEC of 23 April 1990 on the deliberate
release into the environment of genetically modified organisms (GMOs). It seeks to increase
the efficiency and the transparency of the decision-making process whilst ensuring a high
level of protection for human health and the environment.

The Directive clarifies a number of operational aspects, in particular the scope, the definitions
and the administrative procedures of the current Directive 90/220/EEC. It also promotes a
harmonisation of the risk assessment and introduces clear labelling requirements for all
GMOs which are placed on the market in accordance with this Directive. In addition it
improves transparency of the decision-making and the involvement of the public in the
authorisation process.

The key objectives therefore are to:

– clarify the scope and the definitions and to define common principles for the risk

assessment conducted on a case by case basis

– improve the administrative procedures and the approval system by introducing stricter

administrative delays

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– introduce mandatory post-marketing monitoring and a mandatory time limitation of

maximum ten years for first-time consent

– increase the transparency of the decision-making process and provide for consultation of

the public

– broaden the labelling requirements

3.

Commission opinion on the amendments adopted by the Parliament

Twenty-nine amendments have been adopted by the Parliament. The Commission can accept
fully four amendments (9, 17, 19 and 47) and nine in principle (1, 3, 4, 8, 24, 35, 36, 38 and
48). The remaining amendments (5, 6, 10, 16, 20, 21, 22, 23, 25, 26, 27, 28, 31, 32, 34, and
39) are not acceptable.

The Commission position with regard to the amendments adopted by the European Parliament
is as follows.

3.1.

Amendments accepted by the Commission

Amendment 9 which reintroduces the definition of the term ‘use’ in the text as defined by the
existing Directive is acceptable to the Commission. Although the legal text is self-explanatory
regarding this term, the Commission accepts to introduce this definition into the Common
Position, since it stresses the legal difference between ‘user’ and ‘notifier’ as referred to in the
Directive.

Amendment 17 adds an obligation for the competent authorities of Member States to state the
reasons when demanding further information from the notifier under Part B of the Directive.
This requirement
for the assessment of Part C
notifications and it is appropriate to include it also for Part B notifications. This amendment is
therefore acceptable to the Commission.

is already included in Article 13(4)

The Commission also accepts Amendment 19 which clarifies that Member States are to
inform the public when information becomes available which could have significant
consequences as regards risks for human health and the environment. This amendment
strengthens transparency and ensures that the public is informed about relevant additional
information as regards risks to human health and the environment after consent has been
granted to a Part B release.

Amendment 47 states in the recital regarding sanctions that these should include penalties for
the negligent release of GMOs. This is a useful clarification and is therefore acceptable to the
Commission.

3.2.

Amendments accepted in principle by the Commission

Amendment 1 is acceptable to the extent that it refers to the need to submit the appropriate
Proposals for the implementation of the recently agreed Protocol on Biosafety in the context
of ratification. However, the Commission cannot accept to include provisions in the text of
the Directive on export obligations in the present revision and therefore rejects the first part of
the
the amendment. Prior to implementation of the Cartagena Protocol on Biosafety,
implications of the Protocol on the overall Community legislative framework have to be fully
assessed in order to avoid inconsistent piecemeal legislation.

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The Commission accepts Amendment 3 in substance. However, in order to make it consistent
with the text of the Directive, in particular with Annexes II and VII, the Commission proposes
to split and reword the text as follows. At the end of recital 19, the following new paragraph
should be added: “it should also take due account of potential cumulative long-term effects
associated with the interaction between different GMOs in the environment.”. Recital 20
should be supplemented by the following: “; potential cumulative long-term effects should be
considered as a compulsory part of the monitoring plan.”.

Amendment 4 introduces a new recital which stresses the need for independent, systematic
research on potential risks associated with the release of GMOs and that researchers should be
given access to all relevant material. Research concerning potential risks associated with
genetic engineering is a significant part of the Fifth Framework Programme of Research and
Technological Development. The Commission therefore accepts this amendment provided
that it is clarified that intellectual property rights are respected.

The Commission can agree to a recital concerning studies of the likely socio-economic
implications associated with the release or placing on the market of GMOs which refers to the
regular three-year report of the Commission as laid down in Article 30(5). Amendment 8 is
therefore acceptable in principle and the following wording is suggested: “The three-year
reports of the Commission should include a study of the likely socio-economic implications
of the deliberate release or the placing on the market of GMOs, which will take due account
of the interests of farmers and consumers.”.

Amendment 24 which requires that any comments received from the public on a proposal for
establishing criteria and information requirements for specified GMOs under Part C of the
Directive be forwarded to the Regulatory Committee is acceptable to the Commission. It
should however be clarified that an analysis should be done only where it is deemed to be
appropriate.

The Commission can accept Amendment 35. It adds a requirement in Annex IV concerning
additional information for Part C notification dossiers to include a statement on the wording
of the proposed labelling. However, the text has to be aligned with the corresponding Article
12(2)(f).

Amendment 36 introduces a new recital which refers to the need for Community wide
environmental liability rules and that the Commission is to submit a proposal which includes
the impact of biotechnology on all areas of the European Union before the end of 2001. The
Commission can accept this amendment in principle, but indicates that it has to be reworded
in order to align it to the objective of the Directive. The last part of the text of the recital must
apply to “the impact of GMOs on the environment”. The amendment should also refer to the
discussions in the institutions on the Commission White Paper on environmental liability.

Amendment 38 requires that Member States and the Commission ensure that the implications
of gene transfer are accurately assessed on a case by case basis. This provision constitutes a
balanced approach between a total prevention of gene transfer and a permissive approach and
is therefore acceptable in principle. However, the wording has to be aligned with the legal text
of the Directive. In addition, the reference to the Commission should be deleted, since the
Commission does not regularly play a role when risk assessments are conducted under
Member States competence. This is in particular the case when granting consents for Part B
releases.

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Amendment 48 introduces in Article 4(2) the year 2005 as the deadline for the phasing out of
antibiotic resistance marker genes. The Commission is of the opinion that antibiotic resistance
marker genes need to be phased out and be replaced with alternatives as soon as practically
possible. A phasing out is foreseen in the Common Position and the Commission can agree to
strengthen this political message. A fixed deadline for the phasing out of the use of these
markers seems, however, not to be advisable. In that context the Commission would also
prefer a differentiation between research activities and the placing on the market of GMOs.
Within these limits Amendment 48 is therefore acceptable in principle.

3.3.

Amendments not accepted by the Commission

Amendment 5 is not acceptable as a matter of principle. The text of the proposed recital is not
consistent with the corresponding provision in the legal text and would therefore introduce
legal uncertainty.

Amendment 6 concerning the creation of a centralised procedure at Community level for the
release of GMOs is not acceptable. The second part of the recital is already appropriately
covered by recital 60 and the corresponding Art 30(6)(b), which states that in 2003 the
Commission shall report on the feasibility of various options to improve further the
including a centralised Community
framework,
consistency and efficiency of
authorisation procedure. The first part of the proposed recital is a political statement which
prejudges the outcome of that report.

this

For pharmaceuticals, the Common Position maintains the current state of play under the
In certain
existing Directive regarding the verticalisation into product
circumstances these products may have environmental
is therefore
appropriate that at least the general obligations of the Directive apply to these products.
the Commission cannot accept Amendment 10 which seeks to exclude
Therefore,
pharmaceuticals for human use from the scope of the Directive at all. Amendment 20 is also
not acceptable. The Commission is of the opinion that the text of Article 11(2) of the
Common Position represents the appropriate flexible requirements for the verticalisation of
Part C of the Directive as far as pharmaceuticals are concerned.

legislation.
implications and it

The Commission cannot accept Amendment 16. It is necessary that public consultation under
Part B of the Directive can be properly prepared and carried out. Therefore, the prolongation
of the 90-day assessment period by a maximum of 30 days for the carrying out of a public
inquiry or consultation is appropriate and may in certain cases even be too short.

Amendment 21 is not acceptable as a matter of principle. The legal basis of future legislation
has to be chosen in accordance with the content of the measure. The Commission will propose
the appropriate legal basis when submitting the Proposals for Regulations ensuring
equivalence of product legislation and this Directive as referred to in Article 11(3).

The Commission cannot accept Amendments 22 and 23 as they stand. The provisions
foreseen in these amendments would not be workable within the authorisation system
the
established by the Directive, both for administrative and legal reasons. However,
Commission acknowledges that these amendments aim at addressing the possible problems
that certain industries, in particular the plant breeding industry, might face with the strict time
limited consents. The Commission will therefore consider how due account can be taken of
these concerns, while ensuring political, legal and administrative consistency.

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Amendment 25 seeks to introduce a provision, which allows for establishing differentiated
procedures under Part C of the Directive for the placing on the market of GMOs. This builds
on the original Commission Proposal as presented in the first reading in the European
Parliament. However, this amendment goes beyond the original Commission Proposal and is
therefore not acceptable to the Commission as it stands. The Commission is, however, willing
to reconsider this amendment in the light of its original Proposal and in the framework of an
overall compromise.

Amendment 26 requires that in the case of renewal the consent granted may not exceed 10
years and may be limited as appropriate for other reasons. This amendment is not acceptable
to the Commission, since it would limit the flexibility of the optional time limitation of
consents for the renewal as foreseen in the Common Position.

The deletion of the provisions that the periods of time that the Council takes to act shall not be
taken into account in the deadline for adopting a decision by comitology procedure is not
acceptable (Amendments 27 and 31). This puts into question the administrative feasibility of
the procedure because it would mean that this period, which is set at three months by Article
29(2) of the Directive, is included in the 120-day period within which the Commission shall
adopt and publish a decision in accordance with the comitology procedure.

Amendment 28 which seeks to introduce obligations for the exporter to apply for an export
authorisation and for the Commission to submit a legislative Proposal for the implementation
of the Cartagena Protocol on Biosafety within six months of signature is not acceptable. The
legislation for the implementation of the
Commission cannot agree to any piecemeal
Cartagena Protocol on Biosafety. On 30 March, the Commission adopted a Draft Council
Decision for the signature of the Protocol as soon as possible in order to give a political signal
stressing the importance of the Protocol as a multilateral environmental agreement. Prior to
ratification, it will be necessary to ascertain the implications on all relevant existing EU
legislation.

The Commission agrees that access to the work of the European Group on Ethics and their
opinions are an important part of the general evaluation. However, the remit of the European
Group on Ethics is much wider than genetic engineering and it works already on the basis of
specific rules of procedure, which ensure openness and transparency. These rules of
procedure include the possibility for holding public hearings and round table discussions, to
which representatives of the institutions are invited. These rules as well as the composition,
opinions and reports of the Committee are publicly available on its website. It is inappropriate
to establish rules concerning transparency of the European Group on Ethics within this
specific Directive and Amendment 32 is therefore not acceptable.

The proposed provision of Amendment 34 is in substance already covered in a more general
way by Annex II. In addition, it would be counterproductive to provide a specific list of
aspects to be taken into account in case of the assessment of cumulative aspects which is
different from the general requirements in the text of the Directive. An extensive list like the
proposed one is not flexible enough and might turn out to be too limited in relation to certain
cases. This amendment is therefore not acceptable.

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Amendment 39 requires that in order to facilitate monitoring, the location of where GMOs are
grown shall be recorded in public registers. This provision does not improve the quality and
clarity of the text. Article 30(2), in connection with Annex IV(A)(7), already lays down in
detail the requirements for the establishing of publicly accessible registers for the purpose of
recording the information on genetic modifications in GMOs in order to facilitate post-
marketing control and inspection. Further aspects should be considered in the framework of
the discussions concerning the implementation of a traceability system.

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