1998L0081 — EN — 05.12.1998 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 98/81/EC
of 26 October 1998
amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
(OJ L 330, 5.12.1998, p. 13)
Corrected by:
►C1 Corrigendum, OJ L 3, 7.1.1999, p. 23 (98/81)
►C2 Corrigendum, OJ L 93, 8.4.1999, p. 27 (98/81)
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COUNCIL DIRECTIVE 98/81/EC
of 26 October 1998
amending Directive 90/219/EEC on the contained use of genetically
modified micro-organisms
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,►
C1and in particular Article 130s(1) thereof, ◄
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 189c of
the Treaty (3),
(1) Whereas, within the meaning of the Treaty, action by theCommunity relating to the environment should be based on theprinciple that preventive action is to be taken and shall have as itsobjective to preserve, protect and improve the environment and toprotect human health;
(2) Whereas contained uses of genetically modified micro-organisms(GMMs) should be classified in relation to the risks they presentfor human health and the environment; whereas such classi-fication should be in line with international practice and based onan assessment of the risk;
(3) Whereas in order to ensure a high level of protection the contain-ment and other protective measures applied to a contained usemust correspond to the classification of the contained use;whereas in case of uncertainty the appropriate containment andother protective measures for the higher classification should beapplied until less stringent measures are justified by appropriatedata;
(4) Whereas appropriate measures should be adopted and used forthe control of the disposal of material from contained uses ofGMMs;
(5) Whereas GMMs which are disposed of without appropriateprovisions for specific containment measures to limit theircontact with the general population and the environment do notfall within the scope of the present Directive; other Communitylegislation such as Council Directive 90/220/EEC of 23 April1990 on the deliberate release into the environment of geneticallymodified organisms (
4) may apply;
(6) Whereas exemptions pursuant to this Directive do not entailexemptions pursuant to any other Community legislation thatmay apply, such as Directive 90/220/EEC;
(7) Whereas for all activities involving GMMs the principles of goodmicrobiological practice and good occupational safety andhygiene should apply in accordance with relevant Communitylegislation;
(8) Whereas the containment and other protective measures appliedto contained uses should be reviewed periodically;
(1) OJ C 356, 22.11.1997, p. 14 and OJ C 369, 6.12.1997, p. 12.
(2) OJ C 295, 7.10.1996, p. 52.
(3) Opinion of the European Parliament of 12 March 1997 (OJ C 115,
14.4.1997, p. 59), Council common position of 16 December 1997 (OJ C62, 26.2.1998, p. 1) and Decision of the European Parliament of 16 June1998 (OJ C 210, 6.7.1998).
(
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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(9) Whereas people employed in contained uses should be consulted
in accordance with the requirements of relevant Communitylegislation, in particular Council Directive 90/679/EEC of 26November 1990 on the protection of workers from risks relatedto exposure to biological agents at work (seventh individualDirective within the meaning of Article 16(1) of Directive 89/391/EEC) (
1);
(10) Whereas weaknesses have been identified in Directive 90/219/EEC (
2); whereas the administrative procedures and noti-
fication requirements should be linked to the risk of the containeduses;
(11) Whereas Directive 90/219/EEC did not permit sufficient adapta-tion to technical progress; whereas the technical parts of thatDirective need to be adapted to technical progress;
(12) Whereas the implementation of Directive 90/219/EEC couldbenefit from the addition of a list of GMMs that are safe forhuman health and the environment; whereas these GMMs shouldmeet certain criteria in order to establish their safety;
(13) Whereas, to take account of the pace at which biotechnology isadvancing, the nature of the criteria to be developed and thelimited scope of this list, it is appropriate for the Council todefine and revise these criteria;
(14) Whereas there is now considerable experience and knowledge ofthe risks associated with the contained use of GMMs;
(15) Whereas Directive 90/219/EEC should therefore be amendedaccordingly,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 90/219/EEC is hereby amended as follows:
1. Articles 2 to 16 shall be replaced by the following:
‘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 transferringgenetic material, including viruses, viroids, animal and plantcells in culture;
(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 naturalrecombination.
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-organ-
isms are genetically modified or in which such GMMs arecultured, stored, transported, destroyed, disposed of or used inany other way, and for which specific containment measures areused►
C2to limit their contact with, and to provide a high
(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).
(2) OJ L 117, 8.5.1990, p. 1. Directive as amended by Commission Directive
94/51/EC (OJ L 297, 18.11.1994, p. 29).
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level of safety for, the general population and the environ-
ment;◄
(d) “accident” shall mean any incident involving a significant and
unintended release of GMMs in the course of their contained usewhich could present an immediate or delayed hazard to humanhealth 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
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 tohuman health and the environment. These types of GMMs shallbe 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 themarket in accordance with Council Directive 90/220/EEC of 23April 1990 on the deliberate release into the environment of geneti-cally modified organisms (*) or pursuant to other Community legis-lation, which provides for a specific environmental risk assessmentsimilar to that laid down in the said Directive, provided that thecontained use is in accordance with the conditions, if any, of theconsent for placing on the market.
(*) 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).
Article 5
1. Member States shall ensure that all appropriate measures are
taken to avoid adverse effects on human health and the environ-ment 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 envir-onment that these contained uses may incur, using as a minimumthe elements of assessment and the procedure set out in AnnexIII, 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 applyingthe procedure set out in Annex III, which will result in theassignment 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 protecthuman 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 humanhealth as well as the environment.
Class 3: activities of moderate risk, that is to say activities for
which level 3 containment is appropriate to protecthuman health as well as the environment.
Class 4: activities of high risk, that is to say activities for which
level 4 containment is appropriate to protect humanhealth as well as the environment.
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4. Where there is doubt as to which class is appropriate for theproposed contained use, the more stringent protective measuresshall be applied unless sufficient evidence, in agreement with thecompetent authority, justifies the application of less stringentmeasures.
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 imple-mented 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 tothe competent authority as part of the notification pursuant toArticles 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 generalprinciples and the appropriate containment and other protectivemeasures set out in Annex IV corresponding to the class of thecontained use, so as to keep workplace and environmentalexposure 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 contain-
ment and other protective measures applied shall be reviewedperiodically, 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 technicalknowledge.
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 author-ities, before commencing such use, a notification containing atleast 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 tokeep the record of each assessment referred to in Article 5(6),which shall be made available to the competent authority onrequest.
Article 9
1. For first and subsequent class 2 contained uses to be carried
out in premises notified in accordance with Article 7, a noti-fication containing the information listed in Annex V, Part B shallbe submitted.
2. If the premises have been the subject of a previous noti-
fication to carry out class 2 or a higher class of contained usesand any associated consent requirements have been satisfied, theclass 2 contained use may proceed immediately following the newnotification.
The applicant can, however, himself request a decision on a
formal authorisation from the competent authority. The decisionmust be made within a maximum of 45 days from the noti-fication.
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3. If the premises have not been the subject of a previous noti-fication to carry out class 2 or a higher class of contained uses,the class 2 contained use may, in the absence of any indication tothe contrary from the competent authority, proceed 45 days aftersubmission of the notification referred to in paragraph 1, orearlier 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, anotification containing the information listed in Annex V, Part Cshall be submitted.
2. A class 3 or higher class of contained use may not proceed
without the prior consent of the competent authority which shallcommunicate 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 aprevious notification to carry out class 3 or a higher class ofcontained uses and where any associated consent requirementshave been satisfied for the same or a higher class than thecontained 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 inapplication of this Directive and to receive and acknowledge thenotifications 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 accu-racy and completeness of the information given, the correctness ofthe assessment referred to in Article 5(2) and the class ofcontained uses and, where appropriate, the suitability of thecontainment and other protective measures, the waste manage-ment, 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 theclass assigned to the contained use(s). In this case thecompetent authority may require that the contained use, ifproposed, does not begin, or, if in progress, is suspended orterminated, until the competent authority has given itsapproval on the basis of the further information obtained or ofthe 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 competentauthority:
— 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 modi-
fies the contained use in a way which could have significantconsequences for the risks posed by it, the competent authority
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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 risksposed by the contained use, the competent authority may requirethe user to modify the conditions of, or suspend or terminate, thecontained use.
Article 13
Where a Member State considers it appropriate, it may provide
that the public shall be consulted on aspects of the proposedcontained 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 seriousdanger, whether immediate or delayed, to humans outside thepremises and/or to the environment, except where such anemergency plan has been drawn up under other Communitylegislation;
(b) information on such emergency plans, including the relevant
safety measures to be applied, is supplied in an appropriatemanner, and without their having to request it, to bodies andauthorities liable to be affected by the accident. The informa-tion shall be updated at appropriate intervals. It shall also bemade publicly available.
The Member States concerned shall at the same time make avail-
able to other Member States concerned, as a basis for all neces-sary consultation within the framework of their bilateral relations,the same information as that which is disseminated to theirnationals.
Article 15
1. Member States shall take the necessary measures to ensure
that, in the event of an accident, the user shall be required toinform immediately the competent authority specified in Article11 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 acci-dent,
— collect, where possible, the information necessary for a full
analysis of the accident and, where appropriate, make recom-mendations to avoid similar accidents in the future and tolimit 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 ofemergency plans;
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(b) inform the Commission as soon as possible of any accident
within the scope of this Directive, giving details of thecircumstances of the accident, the identity and quantities ofthe GMMs concerned, the response measures taken and theireffectiveness and an analysis of the accident, including recom-mendations to limit its effects and avoid similar accidents inthe future.
2. The Commission, in consultation with the Member States,
shall establish a procedure for the exchange of informationpursuant to paragraph 1. It shall also set up and keep at thedisposal of the Member States a register of accidents within thescope of this Directive, including an analysis of the causes of theaccidents, experience gained and measures taken to avoid similaraccidents in the future.'
2. Articles 18, 19 and 20 shall be replaced by the following:
‘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 containeduses notified during that year pursuant to Article 10 including thedescription, 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 firsttime 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 timebeing on 5 June 2004.
4. The Commission may publish general statistical information
on the implementation of this Directive and related matters, aslong as it contains no information likely to cause harm to thecompetitive 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 7June 1990 on the freedom of access to information on the envir-onment (*), the notifier may indicate the information in the notifi-cations submitted pursuant to this Directive that should be treatedas confidential. Verifiable justification must be given in suchcases.
2. The competent authority shall decide, after consultation with
the notifier, which information will be kept confidential and shallinform 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 confidentialaccording to paragraph 2 and notified or otherwise providedpursuant to this Directive, and shall protect intellectual propertyrights relating to the data received.
5. If, for whatever reasons, the notifier withdraws the noti-
fication, the competent authority must respect the confidentialityof the information supplied.
(*) OJ L 158, 23.6.1990, p. 56.
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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, shallbe decided in accordance with the procedure laid down in Article21.'
3. The following Article shall be inserted:
‘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 beadopted by the Council acting by qualified majority on a proposalfrom the Commission. Amendments to Annex II, Part B, shall beadopted by the Council acting by qualified majority on a proposalfrom the Commission.'
4. The Annexes are replaced by the Annexes shown in the Annex
hereto.
Article 2
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive notlater than 18 months after the date of its entry into force. They shallforthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a
reference to this Directive or shall be accompanied by such referenceon the occasion of their official publication. The methods of makingsuch reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text
of the main provisions of national law which they adopt in the fieldcovered by this Directive.
Article 3
This Directive enters into force on the day of its publication in the
Official Journal of the European Communities .
Article 4
This Directive is addressed to the Member States.
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ANNEX I
‘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 moleculesproduced by whatever means outside an organism, into any virus, bacterialplasmid or other vector system and their incorporation into a hostorganism in which they do not naturally occur but in which they arecapable 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 combina-
tions of heritable genetic material are formed through the fusion of two ormore 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 recom-binant-nucleic acid molecules or GMMs made by techniques/methods otherthan techniques/methods excluded by Annex II, PART A:
(1)in vitro fertilisation;
(2) natural processes such as: conjugation, transduction, transformation;(3) polyploidy induction.
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ANNEX II
PART A
Techniques or methods of genetic modification yielding micro-organisms to
be excluded from the Directive on the condition that they do not involve theuse of recombinant-nucleic acid molecules or GMMs other than thoseproduced 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 ofall or part of that nucleic acid (or a synthetic equivalent) with or withoutprior enzymic or mechanical steps, into cells of the same species or intocells of phylogenetically closely related species which can exchangegenetic material by natural physiological processes where the resultingmicro-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 to human health and the environ-
ment:
… (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)
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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 Article5(2). It will be supplemented, as regards in particular section B, by guidancenotes to be developed by the Commission in accordance with the procedureset out in Article 21.
These guidance notes shall be completed no later than 5 June 2000.A. ELEMENTS OF ASSESSMENT1. 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 envir-
onment,
— 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 environ-
ment.
5. In order to obtain the necessary information to implement this process the
user may firstly take into account relevant Community legislation (inparticular Council Directive 90/679/EEC (
2)). 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, as
(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).
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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 guidanceto the categorisation of the contained use activities in the four classes ofrisk referred to in Article 5(3). The user may also take into considerationclassification schemes referring to plant and animal pathogens (which areusually established on a national basis). The abovementioned classificationschemes 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 para-
graphs 3 to 5, should lead to the identification of the level of risk asso-ciated 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 togetherwith 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 thereare 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 asidentified 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
reviewing the completed assessment referred to in Article 5(2).
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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 allactivities 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 Tabl e I A for glass-
house/growth-room activities involving GMMs.
Table I C presents additions to and modifications of Tabl e I A for activi-
ties 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 Tabl e 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 combinespecifications 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 Article5(2).
3. Member states may, in implementing this Annex, incorporate in addition
the general principles in paragraphs 1 and 2 in the following tables for thesake of clarity of the requirements.
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Containment levels
Specifications
1 2 3 4Table I A
Containment and other protective measures for laboratory activities
1 Laboratory suite: isola-
tion (1)Not required Not required Required Required
2 Laboratory: sealable forfumigation Not required Not required Required Required
Equipment
3 Surfaces resistant towater, acids, alkalis,solvents, disinfectants,decontamination agentsand easy to cleanRequired(bench) Required(bench) Required(bench,floor) Required(bench, floor,ceiling, walls)
4 Entry to lab viaairlock (
2)Not required Not required Optional Required
5 Negative pressure rela-tive to the pressure of theimmediate environment Not required Not required Requiredexcept for (
3)Required
6 Extract and input airfrom the laboratoryshould be HEPA-filtered Not required Not required Required(HEPA) (
4)
— extract airexcept for (
3)Required(HEPA) (
5)—
input andextract air
7 Microbiological safetypost Not required Optional Required Required
8 Autoclave On site In thebuilding En suite (6) In lab =double-ended
System of work
9 Restricted access Not required Required Required Required
10 Biohazard sign on thedoor Not required Required Required Required
11 Specific measures tocontrol aerosol dissemi-nation Not required Requiredminimise Requiredprevent Requiredprevent
13 Shower Not required Not required Optional Required
▼C2
14Protective clothing Suitableprotectiveclothing Suitableprotectiveclothing Suitableprotectiveclothing and(optional)footwearCompletechange ofclothing andfootwearbefore entryand exit
▼B
15Gloves Not required Optional Required Required
18 Efficient vector control(e.g. for rodents andinsects) Optional Required Required Required
1998L0081 — EN — 05.12.1998 — 000.001 — 16
▼B
Containment levels
Specifications
1 2 3 4
Containment levels
Specifications
1 2 3 4Waste
19 Inactivation of GMMs ineffluent from hand-washing sinks or drainsand showers and similareffluentsNot required Not required Optional Required
20 Inactivation of GMMs incontamined material andwaste Optional Required Required Required
Other measures
21 Laboratory to contain itsown equipment Not required Not required Optional Required
23 An observation windowor alternative is to bepresent so that occupantscan 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 providing
an equivalent level of protection.
Table I B
Containment and other protective measures for glasshouses and growth-rooms
The terms “glasshouse” and “growth-room” refer to a structure with walls, a roof and a floor designed
and used principally for growing plants in a controlled and protected environment.
All provisions of Tabl e I A shall apply with the following additions/modifications:
Building
1 Greenhouse: permanent
structure (1)Not required Required Required Required
Equipment
3 Entry via a separatedroom with two inter-locking doors Not required Optional Optional Required
4 Control of contaminatedrun-off water Optional Minimise (2)
run-offPreventrun-off Prevent run-off
1998L0081 — EN — 05.12.1998 — 000.001 — 17
▼B
Containment levels
Specifications
1 2 3 4
Containment levels
Specifications
1 2 3 4System of work
6 Measures to controlundesired species such asinsects, rodents, arthro-podsRequired Required Required Required
7 Procedures for transfer ofliving material betweenthe glasshouse/growth-room, protective structureand laboratory shallcontrol dissemination ofgenetically modifiedmicro-organismsMinimisedissemina-tion Minimisedissemina-tion Preventdissemina-tion Preventdissemination
(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 Tabl e I A shall apply with the following additions/modifications:
Facilities
1 Isolation of animal
unit (1)Optional Required Required Required
2 Animal facilities (2)
separated by lockabledoorsOptional Required Required Required
3 Animal facilitiesdesigned to facilitatedecontamination (water-proof and easily wash-able material (cages,etc.))Optional Optional Required Required
4 Floor and/or walls easilywashable Optional Required(floor) Required(floor andwalls) Required(floor andwalls)
5 Animals kept in appro-priate containment facili-ties such as cages, pensor tanksOptional Optional Optional Optional
6 Filters on isolators orisolated 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 performance of minor surgical procedures.
1998L0081 — EN — 05.12.1998 — 000.001 — 18
▼B
Containment levels
Specifications
1 2 3 4(3) Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals,
isolated rooms may be more appropriate.
Table II
Containment and other protective measures for other activities
General
1 Viable micro-organisms
should be contained in asystem which separatesthe process from theenvironment (closedsystem)Optional Required Required Required
2 Control of exhaust gasesfrom the closed system Not required Required,minimisedissemina-tionRequired,preventdissemina-tionRequired,preventdissemination
3 Control of aerosolsduring sample collection,addition of material to aclosed system or transferof material to anotherclosed systemOptional Required,minimisedissemina-tionRequired,preventdissemina-tionRequired,preventdissemination
4 Inactivation of bulkculture fluids beforeremoval from the closedsystemOptional Required, byvalidatedmeans Required, byvalidatedmeans Required, byvalidatedmeans
5 Seals should be designedso as to minimise orprevent release No sepecificrequirement Minimisedissemina-tion Preventdissemina-tion Preventdissemination
6 The controlled areashould be designed tocontain spillage of theentire contents of theclosed systemOptional Optional Required Required
7 The controlled areashould be sealable topermit fumigation Not required Optional Optional Required
Equipment
8 Entry via airlock Not required Not required Optional Required
9 Surfaces resistant towater, acids, alkalis,solvents, disinfectants,decontamination agentsand easy to cleanRequired(bench ifany) Required(bench ifany) Required(bench ifany, floor) Required(bench, floor,ceiling, walls)
10 Specific measures toadequately ventilate thecontrolled area in orderto minimise air contami-nationOptional Optional Optional Required
1998L0081 — EN — 05.12.1998 — 000.001 — 19
▼B
Containment levels
Specifications
1 2 3 4
11 The controlled areashould be maintained atan air pressure negativeto the immediatesurroundingsNot required Not required Optional Required
12 Extract and input airfrom the controlled areashould be HEPA filtered Not required Not required Required(extract air,optional forinput air)Required(input andextract air)
System of work
13 Closed systems should belocated within acontrolled area Not required Optional Required Required
14 Access should berestricted to nominatedpersonnel only Not required Required Required Required
15 Biohazard signs shouldbe posted Not required Required Required Required
17 Personnel should showerbefore leaving thecontrolled area Not required Not required Optional Required
18 Personnel should wearprotective clothing Required(workclothing) Required(workclothing) Required Completechange beforeexit and entry
Waste
22 Inactivation of GMMs ineffluent from hand-washing sinks andshowers or similar efflu-entsNot required Not required Optional Required
23 Inactivation of GMMs incontaminated materialand waste including thosein process effluent beforefinal dischargeOptional Required, byvalidatedmeans Required, byvalidatedmeans Required, byvalidatedmeans
1998L0081 — EN — 05.12.1998 — 000.001 — 20
▼B
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 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 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 thetype and form of wastes to be generated, their treatment, final form anddestination,
— the purpose of the contained use including the expected results,— description of the parts of the installation;
(d) information about accident prevention and emergency response plans, if any:
— any specific hazards arising from the location of the installation,
— the preventive measures applied such as safety equipment, alarm systems
and containment methods,
— procedures and plans for verifying the continuing effectiveness of the
containment measures,
— a description of information provided to workers,— the information necessary for the competent authority to evaluate any
emergency response plans if required under Article 14;
(e) a copy of the assessment referred to in Article 5(2).'