Source: EURLEX
Language: en
Format: md

1990L0219 — EN — 20.11.2003 — 004.001 — 1

**This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents**

**►B** **COUNCIL DIRECTIVE**

**of 23 April 1990**

**on the contained use of genetically modified micro-organisms**

(90/219/EEC)

(OJ L 117, 8.5.1990, p. 1)

Amended by:

Official Journal

No page date

**►M1** Commission Directive 94/51/EC of 7 November 1994 L 297 29 18.11.1994

**►M2** Council Directive 98/81/EC of 26 October 1998 L 330 13 5.12.1998

**►M3** Council Decision 2001/204/EC of 8 March 2001 L 73 32 15.3.2001

**►M4** Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003
Council of 29 September 2003

Corrected by:

**►C1** Corrigendum, OJ L 93, 8.4.1999, p. 27 (98/81/EC)

1990L0219 — EN — 20.11.2003 — 004.001 — 2

- **B**

**COUNCIL DIRECTIVE**

**of 23 April 1990**

**on the contained use of genetically modified micro-organisms**

(90/219/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic
Community, and in particular Article 130s thereof,

Having regard to the proposal from the Commission ( [1] ),

Having regard to the opinion of the European Parliament ( [2] ),

Having regard to the opinion of the Economic and Social
Committee ( [3] ),

Whereas, under the Treaty, action by the Community relating to the
environment shall be based on the principle that preventive action shall
be taken and shall have as its objective to preserve, protect and
improve the environment and to protect human health;

Whereas the Council Resolution of 19 October 1987 ( [4] ) concerning the
Fourth Environmental Action Programme of the European Communities declares that measures concerning the evaluation and best use of
biotechnology with regard to the environment are a priority area on
which Community action should concentrate;

Whereas the development of biotechnology is such as to contribute to
the economic expansion of the Member States; whereas this implies
that genetically modified micro-organisms will be used in operations
of various types and scale;

Whereas the contained use of genetically modified micro-organisms
should be carried out in such way as to limit their possible negative
consequences for human health and the environment, due attention
being given to the prevention of accidents and the control of wastes;

Whereas micro-organisms, if released in the environment in one
Member State in the course of their contained use, may reproduce and
spread, crossing national frontiers and thereby affecting other Member
States;

Whereas, in order to bring about the safe development of biotechnology throughout the Community, it is necessary to establish
common measures for the evaluation and reduction of the potential
risks arising in the course of all operations involving the contained
use of genetically modified micro-organisms and to set appropriate
conditions of use;

Whereas the precise nature and scale of risks associated with genetically modified micro-organisms are not yet fully known and the risk
involved must be assessed case by case; whereas, to evaluate risk for
human health and the environment, it is necessary to lay down requirements for risk assessment;

Whereas genetically modified micro-organisms should be classified in
relation to the risks they present; whereas criteria should be provided
for this purpose; whereas particular attention should be given to operations using the more hazardous genetically modified micro-organisms;

Whereas appropriate containment measures should be applied at the
various stages of an operation to control emissions and to prevent accidents;

( [1] ) OJ No C 198, 28. 7. 1988, p. 9 and
OJ No C 246, 27. 9. 1989, p. 6.
( [2] ) OJ No C 158, 26. 6. 1989, p. 122 and
OJ No C 96, 17. 4. 1990.
( [3] ) OJ No C 23, 30. 1. 1989, p. 45.
( [4] ) OJ No C 328, 7. 12. 1987, p. 1.

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- **B**

Whereas any person, before undertaking for the first time the contained
use of a genetically modified micro-organism in a particular installation, should forward to the competent authority a notification so that
the authority may satisfy itself that the proposed installation is appropriate to carry out the activity in a manner that does not present a
hazard to human health and the environment;

Whereas it is also necessary to establish appropriate procedures for the
case-by-case notification of specific operations involving the contained
use of genetically modified micro-organisms, taking account of the
degree of risk involved;

Whereas, in the case of operations involving high risk, the consent of
the competent authority should be given;

Whereas it may be considered appropriate to consult the public on the
contained use of genetically modified micro-organisms;

Whereas appropriate measures should be taken to inform any person
liable to be affected by an accident on all matters relating to safety;

Whereas emergency plans should be established to deal effectively
with accidents;

Whereas, if an accident occurs, the user should immediately inform the
competent authority and communicate the information necessary for
assessing the impact of that accident and for taking the appropriate
action;

Whereas it is appropriate for the Commission, in consultation with the
Member States, to establish a procedure for the exchange of information on accidents and for the Commission to set up a register of such
accidents;

Whereas the contained use of genetically modified micro-organisms
throughout the Community should be monitored and to this end
Member States should supply certain information to the Commission;

Whereas a committee should be set up to assist the Commission on
matters relating to the implementation of this Directive and to its adaptation to technical progress,

HAS ADOPTED THIS DIRECTIVE:

_Article 1_

This Directive lays down common measures for the contained use of
genetically modified micro-organisms with a view to protecting human
health and the environment.

- **M2**

_Article 2_

For the purposes of this Directive:

(a) ‘micro-organism’ shall mean any microbiological entity, cellular
or non-cellular, capable of replication or of transferring genetic
material, including viruses, viroids, animal and plant cells in
culture;

(b) ‘genetically modified micro-organism’ (GMM) shall mean a
micro-organism in which the genetic material has been altered in
a way that does not occur naturally by mating and/or natural
recombination.

Within the terms of this definition:

(i) genetic modification occurs at least through the use of the
techniques listed in Annex I, Part A;
(ii) the techniques listed in Annex I, Part B, are not considered to
result in genetic modification;

(c) ‘contained use’ shall mean any activity in which micro-organisms
are genetically modified or in which such GMMs are cultured,
stored, transported, destroyed, disposed of or used in any other

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- **M2**

way, and for which specific containment measures are used

   - **C1** to limit their contact with, and to provide a high level of
safety for, the general population and the environment; ◄

(d) ‘accident’ shall mean any incident involving a significant and
unintended release of GMMs in the course of their contained use
which could present an immediate or delayed hazard to human
health or the environment;

(e) ‘user’ shall mean any natural or legal person responsible for the
contained use of GMMs;

(f) ‘notification’ shall mean the presentation of the requisite information to the competent authorities of a Member State.

_Article 3_

Without prejudice to Article 5(1) this Directive shall not apply:

— where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, or

— for contained uses involving only types of GMMs meeting the
criteria listed in Annex II, Part B which establish their safety to
human health and the environment. These types of GMMs shall be
listed in Annex II, Part C.

_Article 4_

Article 5(3) and 5(6) and Articles 6 to 12 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air.

This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market
in accordance with Council Directive 90/220/EEC of 23 April 1990 on
the deliberate release into the environment of genetically modified
organisms ( [1] ) or pursuant to other Community legislation, which
provides for a specific environmental risk assessment similar to that
laid down in the said Directive, provided that the contained use is in
accordance with the conditions, if any, of the consent for placing on
the market.

_Article 5_

1. Member States shall ensure that all appropriate measures are
taken to avoid adverse effects on human health and the environment
which might arise from the contained use of GMMs.

2. To this end the user shall carry out an assessment of the
contained uses as regards the risks to human health and the environment that these contained uses may incur, using as a minimum the
elements of assessment and the procedure set out in Annex III, sections
A and B.

3. The assessment referred to in paragraph 2 shall result in the final
classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of
containment levels in accordance with Article 6:

Class 1: activities of no or negligible risk, that is to say activities for
which level 1 containment is appropriate to protect human
health as well as the environment.

Class 2: activities of low risk, that is to say activities for which level
2 containment is appropriate to protect human health as well
as the environment.

Class 3: activities of moderate risk, that is to say activities for which
level 3 containment is appropriate to protect human health as
well as the environment.

( [1] ) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

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Class 4: activities of high risk, that is to say activities for which level
4 containment is appropriate to protect human health as well
as the environment.

4. Where there is doubt as to which class is appropriate for the
proposed contained use, the more stringent protective measures shall
be applied unless sufficient evidence, in agreement with the competent
authority, justifies the application of less stringent measures.

5. The assessment referred to in paragraph (2) shall especially take
into account the question of disposal of waste and effluents. Where
appropriate, the necessary safety measures shall be implemented in
order to protect human health and the environment.

6. A record of the assessment referred to in paragraph (2) shall be
kept by the user and made available in an appropriate form to the
competent authority as part of the notification pursuant to Articles 7,
9 and 10 or on request.

_Article 6_

1. The user shall apply, except to the extent that paragraph 2 of
Annex IV allows other measures to be applied, the general principles
and the appropriate containment and other protective measures set out
in Annex IV corresponding to the class of the contained use, so as to
keep workplace and environmental exposure to any GMMs to the
lowest reasonably practicable level, and so that a high level of safety
is ensured.

2. The assessment referred to in Article 5(2) and the containment
and other protective measures applied shall be reviewed periodically,
and forthwith if:

(a) the containment measures applied are no longer adequate or the
class assigned to the contained uses is no longer correct, or

(b) there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge.

_Article 7_

When premises are to be used for the first time for contained uses, the
user shall be required to submit to the competent authorities, before
commencing such use, a notification containing at least the information
listed in Annex V, Part A.

_Article 8_

Following the notification referred to in Article 7, subsequent class 1
contained use may proceed without further notification. Users of
GMMs in class 1 contained uses shall be required to keep the record
of each assessment referred to in Article 5(6), which shall be made
available to the competent authority on request.

_Article 9_

1. For first and subsequent class 2 contained uses to be carried out
in premises notified in accordance with Article 7, a notification
containing the information listed in Annex V, Part B shall be
submitted.

2. If the premises have been the subject of a previous notification to
carry out class 2 or a higher class of contained uses and any associated
consent requirements have been satisfied, the class 2 contained use
may proceed immediately following the new notification.

The applicant can, however, himself request a decision on a formal
authorisation from the competent authority. The decision must be
made within a maximum of 45 days from the notification.

3. If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2
contained use may, in the absence of any indication to the contrary

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from the competent authority, proceed 45 days after submission of the
notification referred to in paragraph 1, or earlier with the agreement of
the competent authority.

_Article 10_

1. For first and subsequent class 3 or class 4 contained uses to be
carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part C shall be
submitted.

2. A class 3 or higher class of contained use may not proceed
without the prior consent of the competent authority which shall
communicate its decision in writing:

(a) at the latest 45 days after submission of the new notification, in the
case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and
where any associated consent requirements have been satisfied for
the same or a higher class than the contained use with which it is
intended to proceed;

(b) at the latest 90 days after submission of the notification, in other

cases.

_Article 11_

1. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this
Directive and to receive and acknowledge the notifications referred to
in Articles 7, 9 and 10.

2. The competent authorities shall examine the conformity of the
notifications with the requirements of this Directive, the accuracy and
completeness of the information given, the correctness of the assessment referred to in Article 5(2) and the class of contained uses and,
where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response

measures.

3. If necessary, the competent authority may:

(a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned
to the contained use(s). In this case the competent authority may
require that the contained use, if proposed, does not begin, or, if
in progress, is suspended or terminated, until the competent
authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use;

(b) limit the time for which the contained use should be permitted or
subject it to certain specific conditions.

4. For the purpose of calculating the periods referred to in Articles 9
and 10, any period of time during which the competent authority:

— is awaiting any further information which it may have requested
from the notifier in accordance with paragraph 3(a), or

— is carrying out a public inquiry or consultation in accordance with
Article 13

shall not be taken into account.

_Article 12_

If the user becomes aware of relevant new information or modifies the
contained use in a way which could have significant consequences for
the risks posed by it, the competent authority shall be informed as soon
as possible and the notification pursuant to Articles 7, 9 and 10 shall be
modified.

If information subsequently becomes available to the competent
authority which could have significant consequences for the risks posed

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by the contained use, the competent authority may require the user to
modify the conditions of, or suspend or terminate, the contained use.

_Article 13_

Where a Member State considers it appropriate, it may provide that the
public shall be consulted on aspects of the proposed contained use,
without prejudice to Article 19.

_Article 14_

The competent authorities shall ensure that before a contained use

commences:

(a) an emergency plan is drawn up for contained uses where failure of
the containment measures could lead to serious danger, whether
immediate or delayed, to humans outside the premises and/or to
the environment, except where such an emergency plan has been
drawn up under other Community legislation;

(b) information on such emergency plans, including the relevant safety
measures to be applied, is supplied in an appropriate manner, and
without their having to request it, to bodies and authorities liable to
be affected by the accident. The information shall be updated at
appropriate intervals. It shall also be made publicly available.

The Member States concerned shall at the same time make available to
other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same
information as that which is disseminated to their nationals.

_Article 15_

1. Member States shall take the necessary measures to ensure that,
in the event of an accident, the user shall be required to inform immediately the competent authority specified in Article 11 and provide the
following information:

— the circumstances of the accident,

— the identity and quantities of the GMMs concerned,

— any information necessary to assess the effects of the accident on
the health of the general population and the environment,

— the measures taken.

2. Where information is given pursuant to paragraph 1, the Member
States shall be required to:

— ensure that any measures necessary are taken, and immediately alert
any Member States which could be affected by the accident,

— collect, where possible, the information necessary for a full analysis
of the accident and, where appropriate, make recommendations to
avoid similar accidents in the future and to limit the effects thereof.

_Article 16_

1. Member States shall be required to:

(a) consult with other Member States, likely to be affected in the event
of an accident, on the proposed implementation of emergency
plans;

(b) inform the Commission as soon as possible of any accident within
the scope of this Directive, giving details of the circumstances of
the accident, the identity and quantities of the GMMs concerned,
the response measures taken and their effectiveness and an analysis
of the accident, including recommendations to limit its effects and
avoid similar accidents in the future.

2. The Commission, in consultation with the Member States, shall
establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member
States a register of accidents within the scope of this Directive,

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including an analysis of the causes of the accidents, experience gained
and measures taken to avoid similar accidents in the future.

- **B**

_Article 17_

Member States shall ensure that the competent authority organizes
inspections and other control measures to ensure user compliance with
this Directive.

- **M2**

_Article 18_

1. Member States shall send to the Commission, at the end of each
year, a summary report on class 3 and class 4 contained uses notified
during that year pursuant to Article 10 including the description,
purpose and risks of the contained use(s).

2. Every three years, Member States shall send the Commission a
summary report on their experience with this Directive, the first time
being on 5 June 2003.

3. Every three years, the Commission shall publish a summary based
on the reports referred to in paragraph 2, the first time being on 5 June
2004.

4. The Commission may publish general statistical information on
the implementation of this Directive and related matters, as long as it
contains no information likely to cause harm to the competitive position of a user.

_Article 19_

1. Where its disclosure affects one or more of the items mentioned
in Article 3(2) of Council Directive 90/313/EEC of 7 June 1990 on the
freedom of access to information on the environment ( [1] ), the notifier
may indicate the information in the notifications submitted pursuant to
this Directive that should be treated as confidential. Verifiable justification must be given in such cases.

2. The competent authority shall decide, after consultation with the
notifier, which information will be kept confidential and shall inform
the notifier of its decision.

3. In no case may the following information, when submitted
according to Articles 7, 9 or 10, be kept confidential:

— the general characteristics of the GMMs, name and address of the
notifier, and location of use,

— class of contained use and measures of containment,

— the evaluation of foreseeable effects, in particular any harmful
effects on human health and the environment.

4. The Commission and the competent authorities shall not divulge
to third parties any information decided to be confidential according to
paragraph 2 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data
received.

5. If, for whatever reasons, the notifier withdraws the notification,
the competent authority must respect the confidentiality of the information supplied.

_Article 20_

Amendments necessary to adapt Annex II, Part A, and Annexes III to
V to technical progress and to adapt Annex II, Part C, shall be decided
in accordance with the procedure laid down in Article 21.

( [1] ) OJ L 158, 23.6.1990, p. 56.

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_Article 20a_

Before 5 December 2000 Annex II, Part B, listing the criteria for inclusion of types of GMMs into Annex II, Part C, shall be adopted by the
Council acting by qualified majority on a proposal from the Commission. Amendments to Annex II, Part B, shall be adopted by the Council
acting by qualified majority on a proposal from the Commission.

- **M4**

_Article 21_

1. The Commission shall be assisted by a committee.

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC ( [1] ) shall apply, having regard to the provisions of
Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.

3. The Committee shall adopt its rules of procedure.

- **B**

_Article 22_

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later
than 23 October 1991. They shall forthwith inform the Commission
thereof.

_Article 23_

This Directive is addressed to the Member States.

( [1] ) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).

- **M2**

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_ANNEX I_

PART A

Techniques of genetic modification referred to in Article 2(b)(i) are, _inter alia_ :

1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules
produced by whatever means outside an organism, into any virus, bacterial
plasmid or other vector system and their incorporation into a host organism
in which they do not naturally occur but in which they are capable of
continued propagation.

2. Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism including microinjection, macro-injection and micro-encapsulation.

3. Cell fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or
more cells by means of methods that do not occur naturally.

PART B

Techniques referred to in Article 2(b)(ii) which are not considered to result in
genetic modification, on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs made by techniques/methods other than
techniques/methods excluded by Annex II, PART A:

(1) _in vitro_ fertilisation;

(2) natural processes such as: conjugation, transduction, transformation;

(3) polyploidy induction.

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_ANNEX II_

PART A

Techniques or methods of genetic modification yielding micro-organisms to be
excluded from the Directive on the condition that they do not involve the use of
recombinant-nucleic acid molecules or GMMs other than those produced by one
or more of the techniques/methods listed below:

1. Mutagenesis.

2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange
genetic material by known physiological processes.

3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species,
including production of hybridomas and plant cell fusions.

4. Self-cloning consisting in the removal of nucleic acid sequences from a cell
of an organism which may or may not be followed by reinsertion of all or
part of that nucleic acid (or a synthetic equivalent) with or without prior
enzymic or mechanical steps, into cells of the same species or into cells of
phylogenetically closely related species which can exchange genetic material
by natural physiological processes where the resulting micro-organism is
unlikely to cause disease to humans, animals or plants.

Self-cloning may include the use of recombinant vectors with an extended
history of safe use in the particular micro-organisms.

- **M3**

PART B

**Criteria establishing the safety of GMMs for human health and the envir-**
**onment**

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

1. INTRODUCTION

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

2. GENERAL CRITERIA

2.1. **Strain verification/authentication**

Identity of the strain must be precisely established. Modification must be
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. SPECIFIC CRITERIA

3.1. **Non-pathogenic**

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

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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.

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 in particular with that of the micro-organisms
identified in Council Directive 93/88/EEC of 12 October 1993 amending
Directive 90/679/EEC on the protection of workers from risks related to
exposure to biological agents at work ( [1] ).

3.2. **No harmful adventitious agents**

The GMM should not harbour known harmful adventitious agents such
as other micro-organisms, active or latent, existing alongside or 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 a significant and unin-**
**tended release**

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 may not be included in Part
C.

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PART C

Types of GMMs which meet the criteria listed in Part B:

… (to be completed in accordance with the procedure in Article 21)

( [1] ) OJ L 268, 29.10.1993, p. 71.

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_ANNEX III_

**PRINCIPLES** **TO** **BE** **FOLLOWED** **FOR** **THE** **ASSESSMENT**
**REFERRED TO IN ARTICLE 5(2)**

This Annex describes in general terms the elements to be considered and the
procedure to be followed to perform the assessment referred to in Article 5(2).
It will be supplemented, as regards in particular section B, by guidance notes to
be developed by the Commission in accordance with the procedure set out in
Article 21.

These guidance notes shall be completed no later than 5 June 2000.

A. ELEMENTS OF ASSESSMENT

1. The following should be considered as potentially harmful effects:

— disease to humans including allergenic or toxic effects,
— disease to animals or plants,
— deleterious effects due to the impossibility of treating a disease or
providing an effective prophylaxis,

— deleterious effects due to establishment or dissemination in the environ
ment,

— deleterious effects due to the natural transfer of inserted genetic material
to other organisms.

2. The assessment referred to in Article 5(2) should be based on the following:

(a) the identification of any potentially harmful effects, in particular those
associated with:

(i) the recipient micro-organism;
(ii) the genetic material inserted (originating from the donor organism);
(iii) the vector;
(iv) the donor micro-organism (as long as the donor micro-organism is
used during the operation);
(v) the resulting GMM;

(b) the characteristics of the activity;

(c) the severity of the potentially harmful effects;

(d) the likelihood of the potentially harmful effects being realised.

B. PROCEDURE

3. The first stage in the assessment process should be to identify the harmful
properties of the recipient and, where appropriate, the donor micro-organism,
any harmful properties associated with the vector or inserted material,
including any alteration in the recipient's existing properties.

4. In general, only GMMs which show the following characteristics would be
considered appropriate for inclusion in class 1 as defined in Article 5:

(i) the recipient or parental micro-organism is unlikely to cause disease to
humans, animals or plants ( [1] );
(ii) the nature of the vector and the insert is such that they do not endow the
GMM with a phenotype likely to cause disease to humans, animals or
plants ( [1] ), or likely to cause deleterious effects in the environment;
(iii) the GMM is unlikely to cause disease to humans, animals or plants ( [1] )
and is unlikely to have deleterious effects on the environment.

5. In order to obtain the necessary information to implement this process the
user may firstly take into account relevant Community legislation (in particular Council Directive 90/679/EEC ( [2] )). International or national
classification schemes (e.g. WHO, NIH, etc.) and their revisions due to new
scientific knowledge and technical progress may also be considered.

These schemes concern natural micro-organisms and as such are usually
based on the ability of micro-organisms to cause disease to humans, animals
or plants and on the severity and transmissibility of the disease likely to be
caused. Directive 90/679/EEC classifies micro-organisms, as biological
agents, into four classes of risk on the basis of potential effects on a healthy
human adult. These classes of risk can be used as guidance to the categorisa

( [1] ) This would only apply to animals and plants in the environment likely to be exposed.
( [2] ) OJ L 374, 31.12.1990, p. 1. Directive as last amended by Commission Directive 97/59/
EC (OJ L 282, 15.10.1997, p. 33).

1990L0219 — EN — 20.11.2003 — 004.001 — 14

- **M2**

tion of the contained use activities in the four classes of risk referred to in
Article 5(3). The user may also take into consideration classification schemes
referring to plant and animal pathogens (which are usually established on a
national basis). The abovementioned classification schemes give only a
provisional indication of the risk class of the activity and the corresponding
set of containment and control measures.

6. The hazard identification process carried out in accordance with paragraphs
3 to 5, should lead to the identification of the level of risk associated with
the GMM.

7. Selection of the containment and other protective measures should then be
made on the basis of the level or risk associated with the GMMs together
with consideration of:

(i) the characteristics of the environment likely to be exposed (e.g. whether
in the environment likely to be exposed to the GMMs there are known
biota which can be adversely affected by the micro-organisms used in
the contained use activity);
(ii) the characteristics of the activity (e.g. its scale; nature);
(iii) any non-standard operations (e.g. the inoculation of animals with
GMMs; equipment likely to generate aerosols).

Consideration of items (i) to (iii) for the particular activity may increase,
reduce or leave unaltered the level of risk associated with the GMM as identified under paragraph 6.

8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 5(3).

9. The final classification of the contained use should be confirmed by
reviewing the completed assessment referred to in Article 5(2).

1990L0219 — EN — 20.11.2003 — 004.001 — 15

- **M2**

_ANNEX IV_

**CONTAINMENT AND OTHER PROTECTIVE MEASURES**

_General principles_

1. These tables present the normal minimum requirements and measures necessary for each level of containment.

Containment is also achieved through the use of good work practices,
training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the
following principles of good occupational safety and hygiene, shall apply:

(i) to keep workplace and environmental exposure to any GMM to the
lowest practicable level;

(ii) to exercise engineering control measures at source and to supplement
these with appropriate personal protective clothing and equipment
when necessary;

(iii) to test adequately and maintain control measures and equipment;

(iv) to test, when necessary, for the presence of viable process organisms
outside the primary physical containment;

(v) to provide appropriate training of personnel;

(vi) to establish biological safety committees or subcommittees, if required;

(vii) to formulate and implement local codes of practice for the safety of
personnel, as required;

(viii) where appropriate to display biohazard signs;

(ix) to provide washing and decontamination facilities for personnel;

(x) to keep adequate records;

(xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing
of food for human consumption in the work area;

(xii) to prohibit mouth pipetting;

(xiii) to provide written standard operating procedures where appropriate to
ensure safety;

(xiv) to have effective disinfectants and specified disinfection procedures
available in case of spillage of GMMs;

(xv) to provide safe storage for contaminated laboratory equipment and
materials, when appropriate.

2. The titles of the tables are indicative:

Table I A presents minimum requirements for laboratory activities.

Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs.

Table I C presents additions to and modifications of Table I A for activities
with animals involving GMMs.

Table II presents minimum requirements for activities other than laboratory
activities.

In some particular cases, it might be necessary to apply a combination of
measures, from Table I A and Table II, of the same level.

In some cases users may, with the agreement of the competent authority, not
apply a specification under a particular containment level or combine specifications from two different levels.

In these tables ‘optional’ means that the user may apply these measures on a
case-by-case basis, subject to the assessment referred to in Article 5(2).

3. Member states may, in implementing this Annex, incorporate in addition the
general principles in paragraphs 1 and 2 in the following tables for the sake
of clarity of the requirements.

- **M2**

- **C1**

- **M2**

1990L0219 — EN — 20.11.2003 — 004.001 — 16

_Table I A_

**Containment and other protective measures for laboratory activities**

|Specifications|Col2|Containment levels|Col4|Col5|Col6|
|---|---|---|---|---|---|
|Specifications|Specifications|1|2|3|4|
|1|Laboratory suite: isolation (1)|Not<br>required|Not<br>required|Required|Required|
|2|Laboratory: sealable for fumigation|Not<br>required|Not<br>required|Required|Required|

**Equipment**

|3|Surfaces resistant to water, acids,<br>alkalis, solvents, disinfectants,<br>decontamination agents and easy to<br>clean|Required<br>(bench)|Required<br>(bench)|Required<br>(bench,<br>floor)|Required<br>(bench,<br>floor,<br>ceiling,<br>walls)|
|---|---|---|---|---|---|
|4|Entry to lab via airlock (2)|Not<br>required|Not<br>required|Optional|Required|
|5|Negative pressure relative to the<br>pressure of the immediate environ-<br>ment|Not<br>required|Not<br>required|Required<br>except<br>for (3)|Required|
|6|Extract<br>and<br>input<br>air<br>from<br>the<br>laboratory should be HEPA-filtered|Not<br>required|Not<br>required|Required<br>(HEPA) (4)<br>— extract<br>air except<br>for (3)|Required<br>(HEPA) (5)<br>— input<br>and extract<br>air|
|7|Microbiological safety post|Not<br>required|Optional|Required|Required|
|8|Autoclave|On site|In the<br>building|En suite (6)|In lab =<br>double-<br>ended|

**System of work**

|9|Restricted access|Not<br>required|Required|Required|Required|
|---|---|---|---|---|---|
|10|Biohazard sign on the door|Not<br>required|Required|Required|Required|
|11|Specific<br>measures<br>to<br>control<br>aerosol dissemination|Not<br>required|Required<br>minimise|Required<br>prevent|Required<br>prevent|
|13|Shower|Not<br>required|Not<br>required|Optional|Required|
|14|Protective clothing|Suitable<br>protective<br>clothing|Suitable<br>protective<br>clothing|Suitable<br>protective<br>clothing<br>and<br>(optional)<br>footwear|Complete<br>change of<br>clothing<br>and foot-<br>wear before<br>entry and<br>exit|
|15|Gloves|Not<br>required|Optional|Required|Required|

- **M2**

1990L0219 — EN — 20.11.2003 — 004.001 — 17

|Specifications|Col2|Containment levels|Col4|Col5|Col6|
|---|---|---|---|---|---|
|Specifications|Specifications|1|2|3|4|
|18|Efficient vector control (e.g. for<br>rodents and insects)|Optional|Required|Required|Required|

**Waste**

|19|Inactivation of GMMs in effluent<br>from hand-washing sinks or drains<br>and showers and similar effluents|Not<br>required|Not<br>required|Optional|Required|
|---|---|---|---|---|---|
|20|Inactivation of GMMs in contam-<br>ined material and waste|Optional|Required|Required|Required|

**Other measures**

|21|Laboratory to contain its own<br>equipment|Not<br>required|Not<br>required|Optional|Required|
|---|---|---|---|---|---|
|23|An observation window or alterna-<br>tive<br>is<br>to<br>be<br>present<br>so<br>that<br>occupants can be seen|Optional|Optional|Optional|Required|

( [1] ) Isolation = the laboratory is separated from other areas in the same building or is in a separated building.
( [2] ) Airlock = entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of
the airlock must be separated from the restricted side by changing or showering facilities and preferably by
interlocking doors.
( [3] ) Activities where transmission does not occur via airborne route.
( [4] ) HEPA = High efficiency particulate air.
( [5] ) Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract
air.
( [6] ) With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing
an equivalent level of protection.

_Table I B_

**Containment and other protective measures for glasshouses and growth-rooms**

The terms ‘glasshouse’ and ‘growth-room’ refer to a structure with walls, a roof and a floor designed
and used principally for growing plants in a controlled and protected environment.

All provisions of Table I A shall apply with the following additions/modifications:

|Specifications|Containment levels|Col3|Col4|Col5|
|---|---|---|---|---|
|Specifications|1|2|3|4|

**Building**

**Equipment**

|3|Entry via a separated room with<br>two interlocking doors|Not<br>required|Optional|Optional|Required|
|---|---|---|---|---|---|
|4|Control<br>of<br>contaminated<br>run-off<br>water|Optional|Mini-<br>mise (2)<br>run-off|Prevent<br>run-off|Prevent<br>run-off|

**System of work**

- **M2**

1990L0219 — EN — 20.11.2003 — 004.001 — 18

|Specifications|Col2|Containment levels|Col4|Col5|Col6|
|---|---|---|---|---|---|
|Specifications|Specifications|1|2|3|4|
|7|Procedures for transfer of living<br>material between the glasshouse/<br>growth-room,<br>protective<br>structure<br>and laboratory shall control disse-<br>mination of genetically modified<br>micro-organisms|Minimise<br>dissemina-<br>tion|Minimise<br>dissemina-<br>tion|Prevent<br>dissemina-<br>tion|Prevent<br>dissemina-<br>tion|

( [1] ) The glasshouse shall consist of a permanent structure with a continuous waterproofed covering, located on a site
graded to prevent entry of surface-water run-off having self-closing lockable doors.
( [2] ) Where transmission can occur through the ground.

_Table I C_

**Containment and other protective measures for activities in animal units**

All provisions of Table I A shall apply with the following additions/modifications:

|Specifications|Containment levels|Col3|Col4|Col5|
|---|---|---|---|---|
|Specifications|1|2|3|4|

**Facilities**

|1|Isolation of animal unit (1)|Optional|Required|Required|Required|
|---|---|---|---|---|---|
|2|Animal facilities (2) separated by<br>lockable doors|Optional|Required|Required|Required|
|3|Animal facilities designed to facili-<br>tate<br>decontamination<br>(waterproof<br>and<br>easily<br>washable<br>material<br>(cages, etc.))|Optional|Optional|Required|Required|
|4|Floor and/or walls easily washable|Optional|Required<br>(floor)|Required<br>(floor and<br>walls)|Required<br>(floor and<br>walls)|
|5|Animals<br>kept<br>in<br>appropriate<br>containment<br>facilities<br>such<br>as<br>cages, pens or tanks|Optional|Optional|Optional|Optional|
|6|Filters<br>on<br>isolators<br>or<br>isolated<br>room (3)|Not<br>required|Optional|Required|Required|

( [1] ) Animal unit: a building, or separate area within a building containing facilities and other areas such as changing
rooms, showers, autoclaves, food storage areas, etc.
( [2] ) Animal facility: a facility normally used to house stock, breeding or experimental animals or one which is used
for the performance of minor surgical procedures.
( [3] ) Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals,
isolated rooms may be more appropriate.

_Table II_

**Containment and other protective measures for other activities**

|Specifications|Containment levels|Col3|Col4|Col5|
|---|---|---|---|---|
|Specifications|1|2|3|4|

**General**

- **M2**

1990L0219 — EN — 20.11.2003 — 004.001 — 19

|Specifications|Col2|Containment levels|Col4|Col5|Col6|
|---|---|---|---|---|---|
|Specifications|Specifications|1|2|3|4|
|2|Control of exhaust gases from the<br>closed system|Not<br>required|Required,<br>minimise<br>dissemina-<br>tion|Required,<br>prevent<br>dissemina-<br>tion|Required,<br>prevent<br>dissemina-<br>tion|
|3|Control of aerosols during sample<br>collection, addition of material to a<br>closed system or transfer of mate-<br>rial to another closed system|Optional|Required,<br>minimise<br>dissemina-<br>tion|Required,<br>prevent<br>dissemina-<br>tion|Required,<br>prevent<br>dissemina-<br>tion|
|4|Inactivation of bulk culture fluids<br>before removal from the closed<br>system|Optional|Required,<br>by vali-<br>dated<br>means|Required,<br>by vali-<br>dated<br>means|Required,<br>by validated<br>means|
|5|Seals should be designed so as to<br>minimise or prevent release|No sepe-<br>cific<br>requirement|Minimise<br>dissemina-<br>tion|Prevent<br>dissemina-<br>tion|Prevent<br>dissemina-<br>tion|
|6|The<br>controlled<br>area<br>should<br>be<br>designed to contain spillage of the<br>entire contents of the closed system|Optional|Optional|Required|Required|
|7|The controlled area should be seal-<br>able to permit fumigation|Not<br>required|Optional|Optional|Required|

**Equipment**

|8|Entry via airlock|Not<br>required|Not<br>required|Optional|Required|
|---|---|---|---|---|---|
|9|Surfaces resistant to water, acids,<br>alkalis,<br>solvents,<br>disinfectants,<br>decontamination agents and easy to<br>clean|Required<br>(bench if<br>any)|Required<br>(bench if<br>any)|Required<br>(bench if<br>any, floor)|Required<br>(bench,<br>floor,<br>ceiling,<br>walls)|
|10|Specific<br>measures<br>to<br>adequately<br>ventilate<br>the<br>controlled<br>area<br>in<br>order to minimise air contamination|Optional|Optional|Optional|Required|
|11|The<br>controlled<br>area<br>should<br>be<br>maintained at an air pressure nega-<br>tive to the immediate surroundings|Not<br>required|Not<br>required|Optional|Required|
|12|Extract<br>and<br>input<br>air<br>from<br>the<br>controlled area should be HEPA<br>filtered|Not<br>required|Not<br>required|Required<br>(extract air,<br>optional for<br>input air)|Required<br>(input and<br>extract air)|

**System of work**

|13|Closed systems should be located<br>within a controlled area|Not<br>required|Optional|Required|Required|
|---|---|---|---|---|---|
|14|Access<br>should<br>be<br>restricted<br>to<br>nominated personnel only|Not<br>required|Required|Required|Required|
|15|Biohazard signs should be posted|Not<br>required|Required|Required|Required|
|17|Personnel<br>should<br>shower<br>before<br>leaving the controlled area|Not<br>required|Not<br>required|Optional|Required|

- **M2**

1990L0219 — EN — 20.11.2003 — 004.001 — 20

|Specifications|Col2|Containment levels|Col4|Col5|Col6|
|---|---|---|---|---|---|
|Specifications|Specifications|1|2|3|4|
|18|Personnel should wear protective<br>clothing|Required<br>(work<br>clothing)|Required<br>(work<br>clothing)|Required|Complete<br>change<br>before exit<br>and entry|

**Waste**

|22|Inactivation of GMMs in effluent<br>from handwashing sinks and<br>showers or similar effluents|Not<br>required|Not<br>required|Optional|Required|
|---|---|---|---|---|---|
|23|Inactivation of GMMs in contami-<br>nated material and waste including<br>those in process effluent before<br>final discharge|Optional|Required,<br>by vali-<br>dated<br>means|Required,<br>by vali-<br>dated<br>means|Required,<br>by validated<br>means|

1990L0219 — EN — 20.11.2003 — 004.001 — 21

- **M2**

_ANNEX V_

PART A

Information required for the notification referred to in Article 7:

— name of user(s) including those responsible for supervision and safety,
— information on the training and qualifications of the persons responsible for
supervision and safety,
— details of any biological committees or subcommittees,
— address and general description of the premises,
— a description of the nature of the work which will be undertaken,

— the class of the contained uses,

— only for class 1 contained uses, a summary of the assessment referred to in
Article 5(2) and information on waste management.

PART B

Information required for the notification referred to in Article 9:

— the date of submission of the notification referred to in Article 7,

— the name of the persons responsible for supervision and safety and information on the training and qualification,
— the recipient, donor and/or parental micro-organism(s) used and, where
applicable, the host-vector system(s) used,
— the source(s) and the intended function(s) of the genetic material(s) involved
in the modification(s),
— identity and characteristics of the GMM,
— the purpose of the contained use including the expected results,
— approximate culture volumes to be used,
— description of the containment and other protective measures to be applied,
including information about waste management including the wastes to be
generated, their treatment, final form and destination,
— a summary of the assessment referred to in Article 5(2),
— the information necessary for the competent authority to evaluate any emergency response plans if required under Article 14.

PART C

Information required for the notification referred to in Article 10:

(a) — the date of submission of the notification referred to in Article 7,
— the name of the persons responsible for supervision and safety and information on the training and qualification;

(b) — the recipient or parental micro-organism(s) to be used,
— the host-vector system(s) to be used (where applicable),
— the source(s) and intended functions(s) of the genetic material(s)
involved in the modification(s),
— identity and characteristics of the GMM,

— the culture volumes to be used;

(c) — description of the containment and other protective measures to be
applied, including information about waste management including the
type and form of wastes to be generated, their treatment, final form and
destination,

— the purpose of the contained use including the expected results,
— description of the parts of the installation;

(d) information about accident prevention and emergency response plans, if

any:

— any specific hazards arising from the location of the installation,
— the preventive measures applied such as safety equipment, alarm
systems and containment methods,
— procedures and plans for verifying the continuing effectiveness of the
containment measures,

— a description of information provided to workers,
— the information necessary for the competent authority to evaluate any
emergency response plans if required under Article 14;

(e) a copy of the assessment referred to in Article 5(2).