Proposal for a Council Decision amending Directive 90/219/EEC as regards the criteria for establishing the safety to human health and the environment of types of genetically modified micro-organisms
Date: 2000-10-19
Institutions: European Commission
Subjects: environmental protection, genetic engineering, genetically modified organism, occupational safety, public health

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 19.10.2000
COM(2000) 627 final

Proposal for a

COUNCIL DECISION

amending Directive 90/219/EEC as regards the criteria for establishing the safety to
human health and the environment of types of genetically modified micro-organisms

(presented by the Commission)

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EXPLANATORY MEMORANDUM

Directive 98/81/EC, amending Directive 90/219/EEC on the contained use of
genetically modified micro-organisms, was adopted on 26 October 1998.

The Directive provides the regulatory framework for activities with genetically
modified micro-organisms (GMMs) under appropriate conditions of containment
used to limit their contact with the general population and the environment.

Article 3 of Directive 90/219/EEC provides that types of GMMs may be excluded
from the Directive if criteria establishing their safety to human health and the
environment are met.

This exclusion only applies when the GMM is used under conditions of contained
use as defined in Article 2(c) of the Directive.

The criteria are to be listed in Annex II, Part B, which is to be adopted before
5 December 2000, by the Council acting by a qualified majority on a proposal from
the Commission on the basis of Article 20a of the Directive.

These criteria include both general and specific criteria, which have been considered
in conjunction with the competent authorities, established under the Directive, of
Member States and through consultation of the Scientific Committee(s).

In order to facilitate the application of these criteria the Commission should be able
to adopt detailed guidance notes in accordance with the procedure set out
in
Article 21 of the Directive.

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Proposal for a

COUNCIL DECISION

amending Directive 90/219/EEC as regards the criteria for establishing the safety to
human health and the environment of types of genetically modified micro-organisms

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/219/EEC of 23 April 1990 on the contained use of
genetically modified micro-organisms1, as last amended by Directive 98/81/EC2, and in
particular Article 20a thereof,

Having regard to the proposal from the Commission3,

Whereas:

(1)

(2)

(3)

According to Article 3 of Directive 90/219/EEC, that Directive is not to apply for
contained uses involving only types of genetically modified micro-organisms (GMMs)
meeting the criteria listed in Annex II, Part B, which establish their safety to human
health and the environment.

By virtue of Article 20a of Directive 90/219/EEC, the criteria establishing the safety to
human health and the environment of types of genetically modified mircro-organisms
to that Directive should be adopted before
to be listed in Annex II, Part C,
5 December 2000.
those criteria the
Commission should be able to adopt detailed guidance notes in accordance with the
procedure referred to in Article 21 of that Directive.

to facilitate the application of

In order

The provisions of Directive 90/219/EEC should be adapted to take account of
Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the
exercise of implementing powers conferred on the Commission4.

(4)

Directive 90/219/EEC should be amended accordingly,

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2

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OJ L 117, 8.5.1990, p. 1.
OJ L 330, 5.12.1998, p. 13.
OJ C
OJ L 184, 17.7.1999, p. 23.

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HAS ADOPTED THIS DECISION:

Directive 90/219/EEC is amended as follows:

Article 1

1.

2.

In Article 20, “decided in accordance with the procedure defined in Article 21” is
replaced by “adopted in accordance with the procedure referred to in Article 21(2).”

Article 21 is replaced by the following:

“Article 21

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2.

3.

The Commission shall be assisted by a committee composed of representatives
of the Member States and chaired by the representative of the Commission.

Where reference is made to this paragraph, the regulatory procedure laid down
in Article 5 of Council Decision 1999/468/EC* shall apply, in compliance with
Article 7 thereof.

The period provided for in Article 5(6) of Decision 1999/468/EC shall be
three months.

__________

*

OJ L 184, 17.7.1999, p. 23.”

3.

Annex II, Part B, is replaced by the text in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels,

For the Council

The President

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ANNEX

“PART B

Criteria establishing the safety of GMMs for human health and the environment

This annex describes in general terms the criteria to be met when establishing the safety of
types of GMMs to human health and the environment and their suitability for inclusion in
Part C. It will be supplemented by guidance notes to be developed and, if necessary, amended
by the Commission in accordance with the procedure referred to in Article 21(2).

1.

INTRODUCTION

Types of genetically modified micro-organisms (GMMs)
listed in Part C in
accordance with the procedure referred to in Article 21(2) of the Directive are
excluded from the scope. GMMs will only be added to the list on a case-by-case
basis and the exclusion will only relate to the clearly identified GMM. This exclusion
only applies when the GMM is used under conditions of contained use as defined in
Article 2(c) and does not apply to the deliberate release of GMMs. For a GMM to be
listed in Part C, it must be proven to meet the criteria given below.

2.

2.1

GENERAL CRITERIA

Strain verification/authentication

Identity of the strain must be precisely established and the modification known and
verified.

2.2

Documented and established evidence of safety

Documented evidence of the safety of the organism must be provided.

2.3

Genetic stability

Where any instability could adversely affect safety, evidence of stability is required.

3.

3.1

SPECIFIC CRITERIA

Non-pathogenic

The GMM should not be capable of causing disease or harm to a healthy human,
plant or animal. Pathogenicity includes both toxigenicity and allergenicity,
accordingly the GMM should also be:

3.1.1

Non-toxigenic

The GMM should not produce increased toxigenicity as a result of the genetic
modification nor be noted for its toxigenic properties.

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3.1.2

Non-allergenic

The GMM should not produce increased allergenicity as a result of the genetic
modification nor be a noted allergen, having for example allergenicity comparable
with those micro-organisms identified in Directive 93/88/EEC1.

3.2

No harmful adventitious agents

such as other
The GMM should not harbour known adventitious agents
micro-organisms, active or latent, existing alongside/inside the GMM that could
cause harm to human health and the environment.

3.3

Transfer of genetic material

The modified genetic material must not give rise to harm if transferred nor should it
be self transmissible or transferable at a frequency greater than other genes of the
recipient or parental micro-organism.

3.4

Safety for the environment in the event of an escape from control

GMMs must not produce adverse effects on the environment, immediate or delayed,
should any incident involving a significant and unintended release occur.

GMMs that do not meet the above criteria will not be suitable for inclusion into Part C.

1

OJ L 268, 29.10.1993, p. 71."

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