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"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
Corrected by:
"C1 Corrigendum, OJ L 93, 8.4.1999, p. 27 (98/81/EC)1990L0219 — EN — 05.12.1998 — 002.001 — 1
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;!B
(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. 1.1990L0219 — EN — 05.12.1998 — 002.001 — 2
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.
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,!B
!M21990L0219 — EN — 05.12.1998 — 002.001 — 3
stored, transported, destroyed, disposed of or used in any other way,
and for which specific containment measures are used "C1to limit
their contact with, and to provide a high level of safety for, the
general population and the environment; 3
(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 in-
formation 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 (*) 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.!M2
(*) 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).1990L0219 — EN — 05.12.1998 — 002.001 — 4
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.!M21990L0219 — EN — 05.12.1998 — 002.001 — 5
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 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.!M21990L0219 — EN — 05.12.1998 — 002.001 — 6
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
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;!M21990L0219 — EN — 05.12.1998 — 002.001 — 7
(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, 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 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 (*), 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.!M2
(*) OJ L 158, 23.6.1990, p. 56.!B
!M21990L0219 — EN — 05.12.1998 — 002.001 — 8
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.
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 Commis-
sion.
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.!M2
!B1990L0219 — EN — 05.12.1998 — 002.001 — 9
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, bacterialplasmid or other vector system and their incorporation into a host organism inwhich 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 micro-
injection, 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 oftwo 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 ofrecombinant-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.!
M21990L0219 — EN — 05.12.1998 — 002.001 — 10
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 ofrecombinant-nucleic acid molecules or GMMs other than those produced by oneor 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 partof 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 materialby natural physiological processes where the resulting micro-organism isunlikely 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.
PART B
Criteria establishing the safety of GMMs to human health and the environment:
… (to be completed in accordance with the procedures in Article 20a)
PART C
Types of GMMs which meet the criteria listed in Part B:
… (to be completed in accordance with the procedure in Article 21)!
M21990L0219 — EN — 05.12.1998 — 002.001 — 11
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). Itwill be supplemented, as regards in particular section B, by guidance notes to bedeveloped 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
environment,
— 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 insertedmaterial, 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.!M2
(1) This would only apply to animals and plants in the environment likely to be exposed.1990L0219 — EN — 05.12.1998 — 002.001 — 12
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 (1)). International or national
classification schemes (e.g. WHO, NIH, etc.) and their revisions due tonew 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 diseaselikely to be caused. Directive 90/679/EEC classifies micro-organisms, asbiological 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 categorisation of the contained use activities in the four classes of riskreferred to in Article 5(3). The user may also take into considerationclassification 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 activityand 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 riskassociated 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).!
M2
(1) 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 — 05.12.1998 — 002.001 — 13
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 practiceand the following principles of good occupational safety and hygiene, shallapply:
(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 equipmentwhen 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. 3. Member states may, in implementing this Annex, incorporate in addition
the general principles in paragraphs 1 and 2 in the following tables for thesake of clarity of the requirements.!
M21990L0219 — EN — 05.12.1998 — 002.001 — 14
Table I A
Containment and other protective measures for laboratory activities
SpecificationsContainment levels
123 4
1 Laboratory suite: isolation (1) Not required Not required Required Required
2 Laboratory: sealable for fumigation Not required Not required Required Required
Equipment
3 Surfaces resistant to water, acids, alkalis,
solvents, disinfectants, decontamination agents
and easy to cleanRequired
(bench)Required
(bench)Required
(bench, floor)Required
(bench, floor,
ceiling, walls)
4 Entry to lab via airlock (2) Not required Not required Optional Required
5 Negative pressure relative to the pressure of the
immediate environmentNot required Not required Required ex-
cept for (3)Required
6 Extract and input air from the laboratory should
be HEPA-filteredNot required Not required Required
(HEPA) (4)—
extract air ex-cept for (
3)Required
(HEPA) (5)—
input and ex-tract air
7 Microbiological safety post Not required Optional Required Required8 Autoclave On site In the building En suite (
6) In lab = dou-
ble-ended
System of work
9 Restricted access Not required Required Required Required
10 Biohazard sign on the door Not required Required Required Required11 Specific measures to control aerosol dissemina-
tionNot required Required
minimiseRequired pre-
ventRequired pre-
vent
13 Shower Not required Not required Optional Required
14 Protective clothing Suitable pro-
tective cloth-ingSuitable pro-
tective cloth-ingSuitable pro-
tective cloth-ing and (op-
tional) foot-
wearComplete
change ofclothing and
footwear before
entry and exit
15 Gloves Not required Optional Required Required
18 Efficient vector control (e.g. for rodents and
insects)Optional Required Required Required
Waste
19 Inactivation of GMMs in effluent from hand-
washing sinks or drains and showers and similareffluentsNot required Not required Optional Required
20 Inactivation of GMMs in contamined material
and wasteOptional Required Required Required!
M2
!C1
!M21990L0219 — EN — 05.12.1998 — 002.001 — 15
SpecificationsContainment levels
123 4
Other measures
21 Laboratory to contain its own equipment Not required Not required Optional Required
23 An observation window or alternative is to be
present so that occupants can be seenOptional 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 levelof protection.!M21990L0219 — EN — 05.12.1998 — 002.001 — 16
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:
SpecificationsContainment levels
123 4
Building
1 Greenhouse: permanent structure (1) Not required Required Required Required
Equipment
3 Entry via a separated room with two interlock-
ing doorsNot required Optional Optional Required
4 Control of contaminated run-off water Optional Minimise (2)
run-offPrevent run-off Prevent run-off
System of work
6 Measures to control undesired species such as
insects, rodents, arthropodsRequired Required Required Required
7 Procedures for transfer of living material
between the glasshouse/growth-room, protectivestructure and laboratory shall control dissemina-tion of genetically modified micro-organismsMinimise dis-
seminationMinimise dis-
seminationPrevent disse-
minationPrevent disse-
mination
(
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.!M21990L0219 — EN — 05.12.1998 — 002.001 — 17
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:
SpecificationsContainment levels
123 4
Facilities
1 Isolation of animal unit (1) Optional Required Required Required
2 Animal facilities (2) separated by lockable doors Optional Required Required Required
3 Animal facilities designed to facilitate deconta-
mination (waterproof and easily washable ma-
terial (cages, etc.))Optional Optional Required Required
4 Floor and/or walls easily washable Optional Required
(floor)Required
(floor and
walls)Required (floor
and walls)
5 Animals kept in appropriate containment facil-
ities such as cages, pens or tanksOptional Optional Optional Optional
6 Filters on isolators or isolated room (3) Not 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 performanceof minor surgical procedures.
(3)Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may bemore appropriate.!M21990L0219 — EN — 05.12.1998 — 002.001 — 18
Table II
Containment and other protective measures for other activities
SpecificationsContainment levels
123 4
General
1 Viable micro-organisms should be contained in
a system which separates the process from theenvironment (closed system)Optional Required Required Required
2 Control of exhaust gases from the closed system Not required Required,
minimise dis-seminationRequired, pre-
vent dissemi-nationRequired, pre-
vent dissemina-tion
3 Control of aerosols during sample collection,
addition of material to a closed system or
transfer of material to another closed systemOptional Required,
minimise dis-
seminationRequired, pre-
vent dissemi-
nationRequired, pre-
vent dissemina-
tion
4 Inactivation of bulk culture fluids before
removal from the closed systemOptional Required, by
validatedmeansRequired, by
validatedmeansRequired, by
validatedmeans
5 Seals should be designed so as to minimise or
prevent releaseNo sepecific
requirementMinimise dis-
seminationPrevent disse-
minationPrevent disse-
mination
6 The controlled area should be designed to
contain spillage of the entire contents of theclosed systemOptional Optional Required Required
7 The controlled area should be sealable to permit
fumigationNot required Optional Optional Required
Equipment
8 Entry via airlock Not required Not required Optional Required
9 Surfaces resistant to water, acids, alkalis,
solvents, disinfectants, decontamination agents
and easy to cleanRequired
(bench if any)Required
(bench if any)Required
(bench if any,
floor)Required
(bench, floor,
ceiling, walls)
10 Specific measures to adequately ventilate the
controlled area in order to minimise aircontaminationOptional Optional Optional Required
11 The controlled area should be maintained at an
air pressure negative to the immediate surround-
ingsNot required Not required Optional Required
12 Extract and input air from the controlled area
should be HEPA filteredNot required Not required Required (ex-
tract air, op-tional for input
air)Required (input
and extract air)
System of work
13 Closed systems should be located within a
controlled areaNot required Optional Required Required
14 Access should be restricted to nominated
personnel onlyNot required Required Required Required
15 Biohazard signs should be posted Not required Required Required Required!
M21990L0219 — EN — 05.12.1998 — 002.001 — 19
SpecificationsContainment levels
123 4
17 Personnel should shower before leaving the
controlled areaNot required Not required Optional Required
18 Personnel should wear protective clothing Required
(work cloth-
ing)Required
(work cloth-
ing)Required Complete
change before
exit and entry
Waste
22 Inactivation of GMMs in effluent from hand-
washing sinks and showers or similar effluentsNot required Not required Optional Required
23 Inactivation of GMMs in contaminated material
and waste including those in process effluentbefore final dischargeOptional Required, by
validatedmeansRequired, by
validatedmeansRequired, by
validatedmeans!
M21990L0219 — EN — 05.12.1998 — 002.001 — 20
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 begenerated, 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;!
M21990L0219 — EN — 05.12.1998 — 002.001 — 21
(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).!
M21990L0219 — EN — 05.12.1998 — 002.001 — 22