Source: EURLEX
Language: en
Format: md

1990L0219 — EN — 08.12.1994 — 001.001 — 1

**This document is meant purely as 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

! **B**

1990L0219 — EN — 08.12.1994 — 001.001 — 2

**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 microorganisms 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;

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;

( [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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1990L0219 — EN — 08.12.1994 — 001.001 — 3

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.

_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;

(b) ‘genetically modified micro-organism’ 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 A, Part 1;

(ii) the techniques listed in Annex I A, Part 2, are not considered to result
in genetic modification;

(c) ‘contained use’ shall mean any operation in which micro-organisms are
genetically modified or in which such genetically modified microorganisms are cultured, stored, used, transported, destroyed or disposed of
and for which physical barriers, or a combination of physical barriers
together with chemical and/or biological barriers, are used to limit their
contact with the general population and the environment;

(d) Type A operation shall mean any operation used for teaching, research,
development, or non-industrial or non-commercial purposes and which is
of a small scale (e.g. 10 litres culture volume or less);

(e) Type B operation shall mean any operation other than a Type A
operation;

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

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(g) ‘user’shall mean any natural or legal person responsible for the contained
use of genetically modified micro-organisms;

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

_Article 3_

This Directive shall not apply where genetic modification is obtained through
the use of the techniques listed in Annex I B.

_Article 4_

1. For the purposes of this Directive, genetically modified micro-organisms
shall be classified as follows:

Group I: those satisfying the criteria of Annex II;
Group II: those other than in Group I.

2. For Type A operations, some of the criteria in Annex II may not be
applicable in determining the classification of a particular genetically
modified micro-organism. In such a case, the classification shall be
provisional and the competent authority shall ensure that relevant criteria
are used with the aim of obtaining equivalence as far as possible.

3. Before this Directive is implemented, the Commission shall draw up
guidelines for classification under the procedures of Article 21.

_Article 5_

Articles 7 to 12 shall not apply to the transport of genetically modified
micro-organisms by road, rail, inland waterway, sea or air. This Directive shall
not apply to the storage, transport, destruction or disposal of genetically
modified micro-organisms which have been placed on the market under
Community legislation, which includes a specific risk assessment similar to
that provided in this Directive.

_Article 6_

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 genetically modified micro-organisms.

2. To this end, the user shall carry out a prior assessment of the contained
uses as regards the risks to human health and the environment that they may
incur.

3. In making such an assessment the user shall, in particular, take due
account of the parameters set out in Annex III, as far as they are relevant, for
any genetically modified micro-organisms he is proposing to use.

4. A record of this assessment shall be kept by the user and made available
in summary form to the competent authority as part of the notification under
Articles 8, 9 and 10 or upon request.

_Article 7_

1. For genetically modified micro-organisms in Group I, 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 physical, chemical
or biological agent 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 training of personnel;

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

! **B**

1990L0219 — EN — 08.12.1994 — 001.001 — 5

(vii) to formulate and implement local codes of practice for the safety of
personnel.

2. In addition to these principles, the containment measures set out in Annex
IV shall be applied, as appropriate, to contained uses of genetically modified
micro-organisms in Group II so as to ensure a high level of safety.

3. The containment measures applied shall be periodically reviewed by the
user to take into account new scientific or technical knowledge relative to risk
management and treatment and disposal of wastes.

_Article 8_

When a particular installation is to be used for the first time for operations
involving the contained use of genetically modified micro-organisms, 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
A.

A separate notification shall be made for first use of genetically modified
micro-organisms in Group I and Group II respectively.

_Article 9_

1. Users of genetically modified micro-organisms classified in Group I in
Type A operations shall be required to keep records of the work carried out
which shall be made available to the competent authority on request.

2. Users of genetically modified micro-organisms classified in Group I in
Type B operations shall, before commencing the contained use, be required to
submit to the competent authorities a notification containing the information
listed in Annex V B.

_Article 10_

1. Users of genetically modified micro-organisms classified in Group II in
Type A operations shall, before commencing the contained use, be required to
submit to the competent authorities a notification containing the information
listed in Annex V C.

2. Users of genetically modified micro-organisms classified in Group II in
Type B operations shall, before commencing the contained use, be required to
submit to the competent authorities a notification containing:

— information on the genetically modified micro-organism(s),

— information on personnel and training,

— information on the installation,

— information on waste management,

— information on accident prevention and emergency response plans,

— the assessment of the risks to human health and the environment referred
to in Article 6,

the details of which are listed in Annex V D.

_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 Article 8, Article 9
(2) and Article 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 classification
and, where appropriate, the adequacy of the waste management, safety, 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. In this case the proposed contained use
cannot proceed until the competent authority has given its approval on the

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1990L0219 — EN — 08.12.1994 — 001.001 — 6

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. In the case of first-time use in an installation as referred to in Article 8:

— where such use involves genetically modified micro-organisms in Group
I, the contained use may, in the absence of any indication to the contrary
from the competent authority, proceed 90 days after submission of the
notification, or earlier with the agreement of the competent authority;

— where such use involves genetically modified micro-organisms in Group
II, the contained use may not proceed without the consent of the
competent authority. The competent authority shall communicate its
decision in writing at the latest 90 days after submission of the
notification.

5. (a) Operations notified under Article 9 (2) and Article 10 (1), may, in the
absence of any indication to the contrary from the competent
authority, proceed 60 days after submission of the notification, or
earlier with the agreement of the competent authority.

(b) Operations notified under Article 10 (2) may not proceed without the
consent of the competent authority. The competent authority shall
communicate its decision in writing at the latest 90 days after
submission of the notification.

6. For the purpose of calculating the periods referred to in paragraphs 4 and
5, any periods 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_

1. 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 the contained use, or if the category of genetically modified
micro-organisms used is changed, the competent authority shall be informed
as soon as possible and the notification under Articles 8, 9 and 10 modified.

2. If information becomes available subsequently to the competent authority
which could have significant consequences for the risks posed by the
contained use, the competent authority may require the user to modify the
conditions of, suspend or terminate the contained use.

_Article 13_

Where a Member State considers it appropriate, it may provide that groups or
the public shall be consulted on any aspect of the proposed contained use.

_Article 14_

The competent authorities shall ensure that, where necessary, before an
operation commences:

(a) an emergency plan is drawn up for the protection of human health and the
environment outside the installation in the event of an accident and the
emergency services are aware of the hazards and informed thereof in
writing;

(b) information on safety measures and on the correct behaviour to adopt in
the case of an accident is supplied in an appropriate manner, and without
their having to request it, to persons liable to be affected by the accident.
The information shall be repeated and updated at appropriate intervals. It
shall also be made publicly available.

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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 immediately to inform the
competent authority specified in Article 11 and provide the following
information:

— the circumstances of the accident,

— the identity and quantities of the genetically modified micro-organisms
released,

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

— the emergency measures taken.

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

— ensure that any emergency, medium and long-term measures necessary
are taken, and immediately alert any Member State 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 liable to be affected in the event of an
accident in the drawing up and 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 genetically modified
micro-organisms released, the emergency response measures employed
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 under 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 which have occurred, including an analysis
of the causes of the accidents, experience gained and measures taken to avoid
similar accidents in the future.

_Article 17_

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

_Article 18_

1. Member States shall send to the Commission, at the end of each year, a
summary report on the contained uses notified under Article 10 (2) including
the description, proposed uses and risks of the genetically modified
micro-organisms.

2. Every three years, Member States shall send the Commission a summary
report on their experience with this Directive, the first time being on 1
September 1992.

3. Every three years, the Commission shall publish a summary based on the
reports referred to in paragraph 2, the first time being in 1993.

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.

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_Article 19_

1. The Commission and the competent authorities shall not divulge to third
parties any confidential information notified or otherwise provided under this
Directive and shall protect intellectual property rights relating to the data
received.

2. The notifier may indicate the information in the notifications submitted
under this Directive, the disclosure of which might harm his competitive
position, that should be treated as confidential. Verifiable justification must
be given in such cases.

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

4. In no case may the following information, when submitted according to
Articles 8, 9 or 10, be kept confidential:

— description of the genetically modified micro-organisms, name and
address of the notifier, purpose of the contained use, and location of use;

— methods and plans for monitoring of the genetically modified microorganisms and for emergency response;

— the evaluation of foreseeable effects, in particular any pathogenic and/or
ecologically disruptive effects.

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 Annexes II to V to technical progress shall be
decided in accordance with the procedure defined in Article 21.

_Article 21_

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

2. The representative of the Commission shall submit to the committee a
draft of the measures to be taken. The committee shall deliver its opinion on
the draft within a time limit which the chairman may lay down according to
the urgency of the matter. The opinion shall be delivered by the majority laid
down in Article 148 (2) of the Treaty in the case of decisions which the
Council is required to adopt on a proposal from the Commission. The votes of
the representatives of the Member States within the committee shall be
weighted in the manner set out in that Article. The chairman shall not vote.

3. (a) The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.

(b) If the measures envisaged are not in accordance with the opinion of
the committee, or if no opinion is delivered, the Commission shall,
without delay, submit to the Council a proposal relating to the
measures to be taken. The Council shall act by a qualified majority.

If, on the expiry of a period of three months from the date of referral
to the Council, the Council has not acted, the proposed measures
shall be adopted by the Commission, save where the Council has
decided against the said measures by a simple majority.

_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.

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_ANNEX I A_

PART 1

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

(i) recombinant DNA techniques using vector systems as previously covered by
Recommendation 82/472/EEC ( [1] );

(ii) techniques involving the direct introduction into a micro-organism of heritable
material prepared outside the micro-organism including micro-injection, macroinjection and micro-encapsulation;

(iii) cell fusion or hybridization 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 2

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-DNA
molecules or genetically modified organisms:

(1) _in vitro_ fertilization;

(2) conjugation, transduction, transformation or any other natural process;

(3) polyploidy induction.

( [1] ) OJ No 213, 21. 7. 1982, p. 15.

! **B**

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_ANNEX I B_

Techniques of genetic modification to be excluded from the Directive, on condition that
they do not involve the use of genetically modified micro-organisms as recipient or
parental organisms:

(1) mutagenesis;

(2) the construction and use of somatic animal hybridoma cells (e.g. for the production
of monoclonal antibodies);

(3) cell fusion (including protoplast fusion) of cells from plants which can be produced
by traditional breeding methods;

(4) self-cloning of non-pathogenic naturally occurring micro-organisms which fulfil
the criteria of Group I for recipient micro-organisms.

! **M1**

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_ANNEX II_

**CRITERIA FOR CLASSIFYING GENETICALLY MODIFIED MICRO-OR-**

**GANISMS INTO GROUP I**

A genetically modified micro-organism is classified as falling within Group I when all
the following criteria are fulfilled:

(i) the recipient or parental micro-organism is unlikely to cause disease to humans,
animals or plants;

(ii) the nature of the vector and the insert is such that they do not endow the genetically
modified microorganism with a phenotype likely to cause disease to humans,
animals or plants, or likely to cause adverse effects in the environment;

(iii) the genetically modified micro-organism is unlikely to cause disease to humans,
animals or plants and is unlikely to have adverse effects on the environment.

! **B**

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_ANNEX III_

**SAFETY ASSESSMENT PARAMETERS TO BE TAKEN INTO ACCOUNT, AS**
**FAR AS THEY ARE RELEVANT, IN ACCORDANCE WITH ARTICLE 6 (3)**

A. Characteristics of the donor, recipient or (where appropriate) parental
organism(s)

B. Characteristics of the modified micro-organism

C. Health considerations

D. Environmental considerations

A. **Characteristics of the donor, recipient or (where appropriate) parental**
**organism(s)**

—
names and designation;

—
degree of relatedness;

—
sources of the organism(s);

—
information on reproductive cycles (sexual/asexual) of the parental
organism(s) or, where applicable, of the recipient micro-organism;

—
history of prior genetic manipulations;

—
stability of parental or of recipient organism in terms of relevant genetic
traits;

—
nature of pathogenicity and virulence, infectivity, toxicity and vectors of
disease transmission;

—
nature of indigenous vectors:

sequence,

frequency of mobilization,

specificity,

presence of genes which confer resistance;

—
host range;

—
other potentially significant physiological traits;

—
stability of these traits;

—
natural habitat and geographic distribution. Climatic characteristics of
original habitats;

—
significant involvement in environmental processes (such as nitrogen
fixation or pH regulation);

—
interaction with, and effects on, other organisms in the environment
(including likely competitive or symbiotic properties);

—
ability to form survival structures (such as spores or sclerotia).

B. **Characteristics of the modified micro-organism**

—
the description of the modification including the method for introducing
the vector-insert into the recipient organism or the method used for
achieving the genetic modification involved;

—
the function of the genetic manipulation and/or of the new nucleic acid;

—
nature and source of the vector;

—
structure and amount of any vector and/or donor nucleic acid remaining in
the final construction of the modified micro-organism;

—
stability of the micro-organism in terms of genetic traits;

—
frequency of mobilization of inserted vector and/or genetic transfer
capability;

—
rate and level of expression of the new genetic material. Method and
sensitivity of measurement;

—
activity of the expressed protein.

C. **Health considerations**

—
toxic or allergenic effects of non-viable organisms and/or their metabolic
products;

—
product hazards;

! **B**

1990L0219 — EN — 08.12.1994 — 001.001 — 13

—
comparison of the modified micro-organism to the donor, recipient or
(where appropriate) parental organism regarding pathogenicity;

—
capacity for colonization;

—
if the micro-organism is pathogenic to humans who are immunocompe
tent:

(a) diseases caused and mechanism of pathogenicity including invasiveness and virulence;

(b) communicability;

(c) infective dose;

(d) host range, possibility of alteration;

(e) possibility of survival outside of human host;

(f) presence of vectors or means of dissemination;

(g) biological stability;

(h) antibiotic-resistance patterns;

(i) allergenicity;

(j) availability of appropriate therapies.

D. **Environmental considerations**

—
factors affecting survival, multiplication and dissemination of the modified
micro-organism in the environment;

—
available techniques for detection, identification and monitoring of the
modified micro-organism;

—
available techniques for detecting transfer of the new genetic material to
other organisms;

—
known and predicted habitats of the modified micro-organism;

—
description of ecosystems to which the micro-organism could be
accidentally disseminated;

—
anticipated mechanism and result of interaction between the modified
micro-organism and the organisms or micro-organisms which might be
exposed in case of release into the environment;

—
known or predicted effects on plants and animals such as pathogenicity,
infectivity, toxicity, virulence, vector of pathogen, allergenicity, colonization;

—
known or predicted involvement in biogeochemical processes;

—
availability of methods for decontamination of the area in case of release to
the environment.

! **B**

1990L0219 — EN — 08.12.1994 — 001.001 — 14

_ANNEX IV_

**CONTAINMENT MEASURES FOR MICRO-ORGANISMS IN GROUP II**

The containment measures for micro-organisms from Group II shall be chosen by the
user from the categories below as appropriate to the micro-organism and the operation
in question in order to ensure the protection of the public health of the general
population and the environment.

Type B operations shall be considered in terms of their unit operations. The
characteristics of each operation will dictate the physical containment to be used at
that stage. This will allow selection and design of process, plant and operating
procedures best fitted to assure adequate and safe containment. Two important factors to
be considered when selecting the equipment needed to implement the containment are
the risk of, and the effects consequent on, equipment failure. Engineering practice may
require increasingly stringent standards to reduce the risk of failure as the consequence
of that failure becomes less tolerable.

Specific containment measures for Type A operations shall be established taking into
account the containment categories below and bearing in mind the specific
circumstances of such operations.

|Specifications|Containment Categories|Col3|Col4|
|---|---|---|---|
|Specifications|1|2|3|
|1.<br>Viable micro-organisms should be contained in a<br>system which physically separates the process from<br>the environment (closed system)<br>2.<br>Exhaust gases from the closed system should be<br>treated so as to:<br>3.<br>Sample collection, addition of materials to a closed<br>system and transfer of viable micro-organisms to<br>another closed system,should be performed so as to:<br>4.<br>Bulk culture fluids should not be removed from the<br>closed system unless the viable micro-organisms have<br>been:<br>5.<br>Seals should be designed so as to:<br>6.<br>Closed systems should be located within a controlled<br>area<br>(a)<br>Biohazard signs should be posted<br>(b)<br>Access should be restricted to nominated<br>personnel only<br>(c)<br>Personnel should wear protective clothing<br>(d)<br>Decontamination and washing facilities should<br>be provided for personnel<br>(e)<br>Personnel should shower before leaving the<br>controlled area<br>(f)<br>Effluent from sinks and showers should be<br>collected and inactivated before release<br>(g)<br>The controlled area should be adequately<br>ventilated to minimize air contamination<br>(h)<br>The controlled areas should be maintained at an<br>air pressure negative to atmosphere<br>(i)<br>Input air and extract air to the controlled area<br>should be HEPA filtered<br>(j)<br>The controlled area should be designed to<br>contain spillage of the entire contents of the<br>dosed system<br>(k)<br>The controlled area should be sealable to permit<br>fumigation|Yes<br>Minimize release<br>Minimize release<br>Inactivated by vali-<br>dated means<br>Minimize release<br>Optional<br>Optional<br>Optional<br>Yes, work clothing<br>Yes<br>No<br>No<br>Optional<br>No<br>No<br>Optional<br>No|Yes<br>Prevent release<br>Prevent release<br>Inactivated by vali-<br>dated chemical or<br>physical means<br>Prevent release<br>Optional<br>Yes<br>Yes<br>Yes<br>Yes<br>Optional<br>Optional<br>Optional<br>Optional<br>Optional<br>Yes<br>Optional|Yes<br>Prevent release<br>Prevent release<br>Inactivated by vali-<br>dated chemical or<br>physical means<br>Prevent release<br>Yes, and purpose-<br>built<br>Yes<br>Yes, via airlock<br>A complete change<br>Yes<br>Yes<br>Yes<br>Yes<br>Yes<br>Yes<br>Yes<br>Yes|

! **B**

1990L0219 — EN — 08.12.1994 — 001.001 — 15

|Specifications|Containment Categories|Col3|Col4|
|---|---|---|---|
|Specifications|1|2|3|
|7.<br>Effluent treatment before final discharge|Inactivated by vali-<br>dated means|Inactivated by vali-<br>dated chemical or<br>physical means|Inactivated by vali-<br>dated chemical means|

! **B**

1990L0219 — EN — 08.12.1994 — 001.001 — 16

_ANNEX V_

PART A

Information required for the notification referred to in Article 8:

—
name of person(s) responsible for carrying out the contained use including those
responsible for supervision, monitoring and safety and information on their
training and qualifications;

—
address of installation and grid reference; description of the sections of the
installation;

—
a description of the nature of the work which will be undertaken and in particular
the classification of the micro-organism(s) to be used (Group I or Group II) and the
likely scale of the operation;

—
a summary of the risk assessment referred to in Article 6 (2).

PART B

Information required for the notification referred to in Article 9 (2):

—
the date of submission of the notification referred to in Article 8;

—
the parental micro-organism(s) used or, where applicable the host-vector system(s)
used;

—
the source(s) and the intended function(s) of the genetic material(s) involved in the
manipulation(s);

—
identity and characteristics of the genetically modified micro-organism;

—
the purpose of the contained use including the expected results;

—
the culture volumes to be used;

—
a summary of the risk assessment referred to in Article 6 (2).

PART C

Information required for the notification referred to in Article 10 (1):

—
the information required in Part B;

—
description of the sections of the installation and the methods for handling the
micro-organisms;

—
description of the predominant meteorological conditions and of the potential
sources of danger arising from the location of the installation;

—
description of the protective and supervisory measures to be applied throughout the
duration of the contained use;

—
the containment category allocated specifying waste treatment provisions and the
safety precautions to be adopted.

PART D

Information required for the notification referred to in Article 10 (2):

If it is not technically possible, or if it does not appear necessary to give the information
specified below, the reasons shall be stated. The level of detail required in response to
each subset of considerations is likely to vary according to the nature and the scale of
the proposed contained use. In the case of information already submitted to the
competent authority under the requirements of this Directive, reference can be made to
this information by the user:

(a) the date of submission of the notification referred to in Article 8 and the name of
the responsible person(s);

(b) information about the genetically modified micro-organism(s):

—
the identity and characteristics of the genetically modified micro-organism(s),

—
the purpose of the contained use or the nature of the product,

—
the host-vector system to be used (where applicable),

—
the culture volumes to be used,

—
behaviour and characteristics of the micro-organism(s) in the case of changes
in the conditions of containment or of release to the environment,

—
overview of the potential hazards associated with the release of the microorganism(s) to the environment,

! **B**

1990L0219 — EN — 08.12.1994 — 001.001 — 17

—
substances which are or may be produced in the course of the use of the
micro-organism(s) other than the intended product;

(c) information about personnel:

—
the maximum number of persons working in the installation and the number
of persons who work directly with the micro-organism(s);

(d) information about the installation:

—
the activity in which the micro-organism(s) is to be used,

—
the technological processes used,

—
a description of the sections of the installation,

—
the predominant meteorological conditions, and specific hazards arising from
the location of the installation;

(e) information about waste management:

—
types, quantities, and potential hazards of wastes arising from the use of the
micro-organism(s),

—
waste management techniques used, including recovery of liquid or solid
wastes and inactivation methods,

—
ultimate form and destination of inactivated wastes;

(f) information about accident prevention and emergency response plans:

—
the sources of hazards and conditions under which accidents might occur,

—
the preventive measures applied such as safety equipment, alarm systems,
containment methods and procedures and available resources,

—
a description of information provided to workers,

—
the information necessary for the competent authority to enable them to draw
up or establish the necessary emergency response plans for use outside the
installation in accordance with Article 14;

(g) a comprehensive assessment (referred to in Article 6 (2)) of the risks to human
health and the environment which might arise from the proposed contained use;

(h) all other information required under Parts B and C if it is not already specified
above.