1990L0219 — EN — 15.03.2001 — 003.001 — 1
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►B COUNCIL DIRECTIVE
of 23April 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
►M1Commission Directive 94/51/EC of 7 November 1994 L 297 29 18.11.1994
►M2Council Directive 98/81/EC of 26 October 1998 L 330 13 5.12.1998
►M3Council Decision 2001/204/EC of 8 March 2001 L 73 32 15.3.2001
Corrected by:
►C1Corrigendum, OJ L 93, 8.4.1999, p. 27 (98/81/EC)
▼B
COUNCIL DIRECTIVE
of 23April 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 Commit-
tee(3),
Whereas, under the Treaty, action by the Community relating to the
environment shall be based on the principle that preventive actionshall be taken and shall have as its objective to preserve, protect andimprove 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 Commu-nities declares that measures concerning the evaluation and best use ofbiotechnology with regard to the environment are a priority area onwhich Community action should concentrate;
Whereas the development of biotechnology is such as to contribute to
the economic expansion of the Member States; whereas this impliesthat genetically modified micro-organisms will be used in operationsof 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 negativeconsequences 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 Mem-
ber State in the course of their contained use, may reproduce andspread, crossing national frontiers and thereby affecting other Member
States;
Whereas, in order to bring about the safe development of biotechnol-
ogy throughout the Community, it is necessary to establish commonmeasures for the evaluation and reduction of the potential risks arising
in the course of all operations involving the contained use of geneti-
cally modified micro-organisms and to set appropriate conditions ofuse;
Whereas the precise nature and scale of risks associated with geneti-
cally modified micro-organisms are not yet fully known and the risk
involved must be assessed case by case; whereas, to evaluate risk forhuman health and the environment, it is necessary to lay downrequirements for risk assessment;
Whereas genetically modified micro-organisms should be classified in
relation to the risks they present; whereas criteria should be providedfor this purpose; whereas particular attention should be given to opera-tions 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 preventaccidents;1990L0219 — EN — 15.03.2001 — 003.001 — 2
(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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Whereas any person, before undertaking for the first time the con-
tained use of a genetically modified micro-organism in a particularinstallation, 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 presenta 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 con-
tained 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 necessaryfor assessing the impact of that accident and for taking the appropriateaction;
Whereas it is appropriate for the Commission, in consultation with the
Member States, to establish a procedure for the exchange of informa-tion on accidents and for the Commission to set up a register of suchaccidents;
Whereas the contained use of genetically modified micro-organisms
throughout the Community should be monitored and to this end Mem-
ber 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 itsadaptation 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 geneticmaterial, including viruses, viroids, animal and plant cells in cul-
ture;
(b) ‘genetically modified micro-organism’ (GMM) shall mean a
micro-organism in which the genetic material has been altered ina 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 geneticmodific ation;
(c) ‘contained use’ shall mean any activity in which micro-organ-
isms are genetically modified or in which such GMMs are cul-tured, stored, transported, destroyed, disposed of or used in anyother way, and for which specific containment measures are used1990L0219 — EN — 15.03.2001 — 003.001 — 3
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►C1to 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 infor-
mation 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 tech-
niques/methods listed in Annex II, Part A, or
— for contained uses involving only types of GMMs meeting the cri-
teria listed in Annex II, Part B which establish their safety tohuman health and the environment. These types of GMMs shall belisted in Annex II, Part C.
Article 4
Article 5(3) and 5(6) and Articles 6 to 12 shall not apply to the trans-
port 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 themarket in accordance with Council Directive 90/220/EEC of 23 April1990 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 tothat laid down in the said Directive, provided that the contained use isin accordance with the conditions, if any, of the consent for placingon the market.
Article 5
1. Member States shall ensure that all appropriate measures are
taken to avoid adverse effects on human health and the environmentwhich might arise from the contained use of GMMs.
2. To this end the user shall carry out an assessment of the con-
tained uses as regards the risks to human health and the environmentthat these contained uses may incur, using as a minimum the elementsof 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 proce-dure set out in Annex III, which will result in the assignment of con-
tainment 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 healthas well as the environment.1990L0219 — EN — 15.03.2001 — 003.001 — 4
(*) 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 wellas the environment.
4. Where there is doubt as to which class is appropriate for the pro-
posed contained use, the more stringent protective measures shall beapplied unless sufficient evidence, in agreement with the competentauthority, 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 thecompetent 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 outin Annex IV corresponding to the class of the contained use, so as tokeep workplace and environmental exposure to any GMMs to the low-est 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 appro-
priate 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 theinformation 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 recordof each assessment referred to in Article 5(6), which shall be madeavailable 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 con-
taining 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 asso-ciated consent requirements have been satisfied, the class 2 containeduse may proceed immediately following the new notification.Theapplicant can, however, himself request a decision on a formal author-
isation 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 notifica-
tion to carry out class 2 or a higher class of contained uses, the class2 contained use may, in the absence of any indication to the contraryfrom the competent authority, proceed 45 days after submission of the1990L0219 — EN — 15.03.2001 — 003.001 — 5
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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 notifi-cation containing the information listed in Annex V, Part C shall besubmitted.
2. A class 3 or higher class of contained use may not proceed with-
out the prior consent of the competent authority which shall communi-
cate 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 usesand where any associated consent requirements have been satisfiedfor the same or a higher class than the contained use with whichit 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 com-
petent 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 andcompleteness of the information given, the correctness of the assess-ment referred to in Article 5(2) and the class of contained uses and,where appropriate, the suitability of the containment and other protec-tive measures, the waste management, and emergency response mea-
sures.
3. If necessary, the competent authority may:
(a) ask the user to provide further information or to modify the condi-
tions of the proposed contained use or to amend the class assigned
to the contained use(s). In this case the competent authority mayrequire that the contained use, if proposed, does not begin, or, ifin progress, is suspended or terminated, until the competentauthority has given its approval on the basis of the further infor-mation 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 consequencesfor the risks posed by it, the competent authority shall be informed assoon as possible and the notification pursuant to Articles 7, 9 and 10shall be modified.
If information subsequently becomes available to the competent
authority which could have significant consequences for the risksposed by the contained use, the competent authority may require the1990L0219 — EN — 15.03.2001 — 003.001 — 6
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user to modify the conditions of, or suspend or terminate, the con-
tained 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, whetherimmediate or delayed, to humans outside the premises and/or tothe environment, except where such an emergency plan has beendrawn up under other Community legislation;
(b) information on such emergency plans, including the relevant
safety measures to be applied, is supplied in an appropriate man-
ner, and without their having to request it, to bodies and authori-ties liable to be affected by the accident. The information shall beupdated at appropriate intervals. It shall also be made publiclyavailable.
The Member States concerned shall at the same time make available
to other Member States concerned, as a basis for all necessary consul-tation within the framework of their bilateral relations, the same infor-mation 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 imme-diately the competent authority specified in Article 11 and provide thefollowing 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 analy-
sis of the accident and, where appropriate, make recommendationsto avoid similar accidents in the future and to limit the effectsthereof.
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 emer-gency 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 analy-sis of the accident, including recommendations to limit its effectsand 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 toparagraph 1. It shall also set up and keep at the disposal of the Mem-1990L0219 — EN — 15.03.2001 — 003.001 — 7
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ber States a register of accidents within the scope of this Directive,
including an analysis of the causes of the accidents, experience gainedand 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 notifiedduring that year pursuant to Article 10 including the description, pur-pose 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 timebeing 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 itcontains no information likely to cause harm to the competitive posi-tion 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 onthe freedom of access to information on the environment(*), the noti-fier may indicate the information in the notifications submitted pur-
suant 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 informthe 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 thedata received.
5. If, for whatever reasons, the notifier withdraws the notification,
the competent authority must respect the confidentiality of the infor-mation 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 bedecided in accordance with the procedure laid down in Article 21.1990L0219 — EN — 15.03.2001 — 003.001 — 8
(*) OJ L 158, 23.6.1990, p. 56.▼B
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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 bythe Council acting by qualified majority on a proposal from the Com-mission.
Article 21
1. The Commission shall be assisted by a committee composed of
the representatives of the Member States and chaired by the represen-tative of the Commission.
2. The representative of the Commission shall submit to the com-
mittee a draft of the measures to be taken. The committee shall deli-
ver its opinion on the draft within a time limit which the chairmanmay lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148 (2) of theTreaty 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 themanner 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 opi-
nion of the committee, or if no opinion is delivered, the Com-mission shall, without delay, submit to the Council a proposalrelating to the measures to be taken. The Council shall act by aqualified 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 proposedmeasures shall be adopted by the Commission, save where theCouncil has decided against the said measures by a simplemajority.
Article 22
Member States shall bring into force the laws, regulations and admin-
istrative 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.1990L0219 — EN — 15.03.2001 — 003.001 — 9
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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 combi-
nations of genetic material by the insertion of nucleic acid molecules pro-
duced 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 con-
tinued propagation.
2. Techniques involving the direct introduction into a micro-organism of heri-
table material prepared outside the micro-organism including micro-injec-
tion, macro-injection and micro-encapsulation.
3. Cell fusion or hybridisation techniques where live cells with new combina-
tions of heritable geneticmaterial 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 recombi-
nant-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.1990L0219 — EN — 15.03.2001 — 003.001 — 10
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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.
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 CRITERIA2.1.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 CRITERIA3.1.Non-pathogenic
The GMM should not be capable of causing disease or harm to a
healthy human, plant or animal. Since pathogenicity includes both toxi-
genicity and allergenicity, the GMM should therefore be:1990L0219 — EN — 15.03.2001 — 003.001 — 11
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3.1.1. Non-toxigenic
The GMM should not produce increased toxigenicity as a result of the
geneticmodific ation nor be noted for its toxigenicproperties.
3.1.2. Non-allergenic
The GMM should not produce increased allergenicity as a result of the
geneticmodific ation nor be a noted allergen, having, for example, aller-
genicity comparable in particular with that of the micro-organisms iden-
tified 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 geneticmaterial 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.
PART C
Types of GMMs which meet the criteria listed in Part B:… (to be completed in accordance with the procedure in Article 21)1990L0219 — EN — 15.03.2001 — 003.001 — 12
(1) OJ L 268, 29.10.1993, p. 71.▼M2
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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 pro-
viding 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 geneticmaterial 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-organ-
ism, 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 parti-
cular Council Directive 90/679/EEC(2)). International or national classifica-
tion 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 categori-1990L0219 — EN — 15.03.2001 — 003.001 — 13
(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).
▼M2
sation 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 estab-
lished on a national basis). The abovementioned classification schemes give
only a provisional indication of the risk class of the activity and the corre-
sponding 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-organ-
isms 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 assign-
ment 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 review-
ing the completed assessment referred to in Article 5(2).1990L0219 — EN — 15.03.2001 — 003.001 — 14
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ANNEX IV
CONTAINMENT AND OTHER PROTECTIVE MEASURES
General principles
1. These tables present the normal minimum requirements and measures neces-
sary for each level of containment.
Containment is also achieved through the use of good work practices, train-
ing, 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 stor-
ing 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 glass-
house/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 the
sake of clarity of the requirements.1990L0219 — EN — 15.03.2001 — 003.001 — 15
▼M2
Table I A
Containment and other protective measures for laboratory activities
SpecificationsContainment levels
1234
1 Laboratory suite: isolation (1) Not
requiredNot
requiredRequired Required
2 Laboratory: sealable for fumigation Not
requiredNot
requiredRequired 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, ceil-
ing, walls)
4 Entry to lab via airlock (2) Not
requiredNot
requiredOptional Required
5 Negative pressure relative to the
pressure of the immediate environ-
mentNot
requiredNot
requiredRequired
except
for (3)Required
6 Extract and input air from the
laboratory should be HEPA-filteredNot
requiredNot
requiredRequired
(HEPA) (4)
— extract
air except
for (3)Required
(HEPA) (5)
— input
and extract
air
7 Microbiological safety post Not
requiredOptional Required Required
8 Autoclave On site In the
buildingEn suite (6) In lab =
double-
ended
System of work
9 Restricted access Not
requiredRequired Required Required
10 Biohazard sign on the door Not
requiredRequired Required Required
11 Specific measures to control aero-
sol disseminationNot
requiredRequired
minimiseRequired
preventRequired
prevent
13 Shower Not
requiredNot
requiredOptional Required
14 Protective clothing Suitable
protective
clothingSuitable
protective
clothingSuitable
protective
clothing
and
(optional)
footwearComplete
change of
clothing
and foot-
wear before
entry and
exit
15 Gloves Not
requiredOptional Required Required
18 Efficient vector control (e.g. for
rodents and insects)Optional Required Required Required1990L0219 — EN — 15.03.2001 — 003.001 — 16
▼C1
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SpecificationsContainment levels
1234
Waste
19 Inactivation of GMMs in effluent
from hand-washing sinks or drains
and showers and similar effluentsNot
requiredNot
requiredOptional Required
20 Inactivation of GMMs in contam-
ined material and wasteOptional Required Required Required
Other measures
21 Laboratory to contain its own
equipmentNot
requiredNot
requiredOptional Required
23 An observation window or alterna-
tive is to be present so that occu-
pants 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 byinterlocking 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 provid-
ing 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/modifica-
tions:
SpecificationsContainment levels
1234
Building
1 Greenhouse: permanent struc-
ture (1)Not
requiredRequired Required Required
Equipment
3 Entry via a separated room with
two interlocking doorsNot
requiredOptional Optional Required
4 Control of contaminated run-off
waterOptional Mini-
mise (2)
run-offPrevent
run-offPrevent
run-off
System of work
6 Measures to control undesired spe-
cies such as insects, rodents,
arthropodsRequired Required Required Required1990L0219 — EN — 15.03.2001 — 003.001 — 17
▼M2
SpecificationsContainment levels
1234
7 Procedures for transfer of living
material between the glasshouse/
growth-room, protective structure
and laboratory shall control disse-
mination of genetically modified
micro-organismsMinimise
dissemina-
tionMinimise
dissemina-
tionPrevent dis-
seminationPrevent dis-
semination
(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/modifica-
tions:
SpecificationsContainment levels
1234
Facilities
1 Isolation of animal unit (1) Optional Required Required Required
2 Animal facilities (2) separated by
lockable doorsOptional Required Required Required
3 Animal facilities designed to facili-
tate decontamination (waterproof
and easily washable material
(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 con-
tainment facilities such as cages,
pens or tanksOptional Optional Optional Optional
6 Filters on isolators or isolated
room (3)Not
requiredOptional Required Required
(1) Animal unit: a building, or separate area within a building containing facilities and other areas such as chan-
ging 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, iso-
lated rooms may be more appropriate.
Table II
Containment and other protective measures for other activities
SpecificationsContainment levels
1234
General
1 Viable micro-organisms should be
contained in a system which sepa-
rates the process from the environ-
ment (closed system)Optional Required Required Required1990L0219 — EN — 15.03.2001 — 003.001 — 18
▼M2
SpecificationsContainment levels
1234
2 Control of exhaust gases from the
closed systemNot
requiredRequired,
minimise
dissemina-
tionRequired,
prevent dis-
seminationRequired,
prevent dis-
semination
3 Control of aerosols during sample
collection, addition of material to a
closed system or transfer of mate-
rial to another closed systemOptional Required,
minimise
dissemina-
tionRequired,
prevent dis-
seminationRequired,
prevent dis-
semination
4 Inactivation of bulk culture fluids
before removal from the closed
systemOptional Required,
by vali-
dated
meansRequired,
by vali-
dated
meansRequired,
by vali-
dated
means
5 Seals should be designed so as to
minimise or prevent releaseNo sepeci-
ficrequire-
mentMinimise
dissemina-
tionPrevent dis-
seminationPrevent dis-
semination
6 The controlled area should be
designed to contain spillage of the
entire contents of the closed sys-
temOptional Optional Required Required
7 The controlled area should be seal-
able to permit fumigationNot
requiredOptional Optional Required
Equipment
8 Entry via airlock Not
requiredNot
requiredOptional 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, ceil-
ing, walls)
10 Specific measures to adequately
ventilate the controlled area in
order to minimise air contamina-
tionOptional Optional Optional Required
11 The controlled area should be
maintained at an air pressure nega-
tive to the immediate surroundingsNot
requiredNot
requiredOptional Required
12 Extract and input air from the con-
trolled area should be HEPA fil-
teredNot
requiredNot
requiredRequired
(extract air,
optional for
input air)Required
(input and
extract air)
System of work
13 Closed systems should be located
within a controlled areaNot
requiredOptional Required Required
14 Access should be restricted to
nominated personnel onlyNot
requiredRequired Required Required
15 Biohazard signs should be posted Not
requiredRequired Required Required
17 Personnel should shower before
leaving the controlled areaNot
requiredNot
requiredOptional Required1990L0219 — EN — 15.03.2001 — 003.001 — 19
▼M2
SpecificationsContainment levels
1234
18 Personnel should wear protective
clothingRequired
(work
clothing)Required
(work
clothing)Required Complete
change
before exit
and entry
Waste
22 Inactivation of GMMs in effluent
from handwashing sinks and
showers or similar effluentsNot
requiredNot
requiredOptional Required
23 Inactivation of GMMs in contami-
nated material and waste including
those in process effluent before
final dischargeOptional Required,
by vali-
dated
meansRequired,
by vali-
dated
meansRequired,
by vali-
dated
means1990L0219 — EN — 15.03.2001 — 003.001 — 20
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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 informa-
tion 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 emer-
gency 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 sys-
tems 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).1990L0219 — EN — 15.03.2001 — 003.001 — 21