Source: EURLEX
Language: en
Format: md

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 14.6.2006
COM(2006) 286 final

2006/0100 (COD)

Proposal for a

**DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

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

(Codified version)

(presented by the Commission)

# **EN EN**

**EXPLANATORY MEMORANDUM**

1. In the context of a people’s Europe, the Commission attaches great importance to
simplifying and clarifying Community law so as to make it clearer and more
accessible to the ordinary citizen, thus giving him new opportunities and the chance
to make use of the specific rights it gives him.

This aim cannot be achieved so long as numerous provisions that have been amended
several times, often quite substantially, remain scattered, so that they must be sought
partly in the original instrument and partly in later amending ones. Considerable
research work, comparing many different instruments, is thus needed to identify the
current rules.

For this reason a codification of rules that have frequently been amended is also
essential if Community law is to be clear and transparent.

2. On 1 April 1987 the Commission therefore decided [1] to instruct its staff that all
legislative acts should be codified after no more than ten amendments, stressing that
this is a minimum requirement and that departments should endeavour to codify at
even shorter intervals the texts for which they are responsible, to ensure that the
Community rules are clear and readily understandable.

3. The Conclusions of the Presidency of the Edinburgh European Council
(December 1992) confirmed this [2], stressing the importance of codification as it offers
certainty as to the law applicable to a given matter at a given time.

Codification must be undertaken in full compliance with the normal Community
legislative procedure.

Given that no changes of substance may be made to the instruments affected by
codification, the European Parliament, the Council and the Commission have agreed,
by an interinstitutional agreement dated 20 December 1994, that an accelerated
procedure may be used for the fast-track adoption of codification instruments.

4. The purpose of this proposal is to undertake a codification of Council
Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified
micro-organisms [3] _._ The new Directive will supersede the various acts incorporated in
it [4] ; this proposal fully preserves the content of the acts being codified and hence does
no more than bring them together with only such formal amendments as are required
by the codification exercise itself.

5. The codification proposal was drawn up on the basis of a preliminary consolidation,
in all official languages, of Directive 90/219/EEC and the instruments amending it,
carried out by the Office for Official Publications of the European Communities, by
means of a data-processing system. Where the Articles have been given new

1 COM(87) 868 PV.
2 See Annex 3 to Part A of the Conclusions.
3 Carried out pursuant to the Communication from the Commission to the European Parliament and the
Council – Codification of the Acquis communautaire, COM(2001) 645 final.
4 See Annex VI, Part A of this proposal.

# EN 2 EN

numbers, the correlation between the old and the new numbers is shown in a table
contained in Annex VII to the codified Directive.

# EN 3 EN

� 90/219/EEC (adapted)
2006/0100 (COD)

Proposal for a

**DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

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

**(Text with EEA relevance)**

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular
Article ⌦ 175(1) ⌫ thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee [5],

Having regard to the opinion of the Committee of the Regions [6],

Acting in accordance with the procedure laid down in Article 251 of the Treaty [7],

Whereas:

�

(1) Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically
modified micro-organisms [8] has been substantially amended several times [9] . In the
interests of clarity and rationality the said Directive should be codified.

� 90/219/EEC Recital 1 (adapted)

(2) Under the Treaty, action by the Community relating to the environment shall be based
on the principle that preventive action shall be taken and shall have as its objective

5 OJ C […], […], p. […].
6 OJ C […], […], p. […].
7 OJ C […], […], p. […].
8 OJ L 117, 8.5.1990, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
9 See Annex VI, Part A.

# EN 4 EN

⌦, among other things, ⌫ to preserve, protect and improve the environment and to
protect human health.

� 90/219/EEC Recital 2 (adapted)

(3) Measures concerning the evaluation and best use of biotechnology with regard to the
environment are a priority area on which Community action should concentrate.

� 90/219/EEC Recital 3 (adapted)

(4) The development of biotechnology is such as to contribute to the economic expansion
of the Member States. This implies that genetically modified micro-organisms
⌦ (GMMs) ⌫ will be used in operations of various types and scale.

� 90/219/EEC Recital 4 (adapted)

(5) The contained use of ⌦ GMMs ⌫ should be carried out in such a way as to limit
their possible negative consequences for human health and the environment, due
attention being given to the prevention of accidents and the control of waste.

� 98/81/EC Recital 5 (adapted)

(6) GMMs which are disposed of without appropriate provisions for specific containment
measures to limit their contact with the general population and the environment do not
fall within the scope of the present Directive. Other Community legislation such as
⌦ Directive 2001/18/EC of the European Parliament and of the Council of 12 March
2001 ⌫ on the deliberate release into the environment of genetically modified
organisms [10] may apply.

� 90/219/EEC Recital 5

(7) Micro-organisms, if released into the environment in one Member State in the course
of their contained use, may reproduce and spread, crossing national frontiers and
thereby affecting other Member States.

� 90/219/EEC Recital 6 (adapted)

(8) In order to bring about the safe development of biotechnology throughout the
Community, it is necessary to establish common measures for the evaluation and

10 OJ L ⌦ 106, 17.4.2001, p. 1 ⌫. Directive as last amended by ⌦ Regulation (EC) No 1830/2003 of
the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 24) ⌫.

# EN 5 EN

reduction of the potential risks arising in the course of all operations involving the
contained use of ⌦ GMMs ⌫ and to set appropriate conditions of use.

� 90/219/EEC Recital 7 (adapted)

(9) The precise nature and scale of risks associated with ⌦ the contained use of
GMMs ⌫ are not yet fully known and the risk involved must be assessed case by
case. To evaluate the risk to human health and the environment, it is necessary to lay
down requirements for risk assessment.

� 98/81/EC Recital 2 (adapted)

(10) Contained uses of GMMs should be classified in relation to the risks they present to
human health and the environment. Such classification should be in line with
international practice and based on an assessment of the risk.

� 98/81/EC Recital 3

(11) In order to ensure a high level of protection, the containment and other protective
measures applied to a contained use must correspond to the classification of the
contained use. In case of uncertainty, the appropriate containment and other protective
measures for the higher classification should be applied until less stringent measures
are justified by appropriate data.

� 98/81/EC Recital 7

(12) For all activities involving GMMs the principles of good microbiological practice and
good occupational safety and hygiene should apply in accordance with relevant
Community legislation.

� 90/219/EEC Recital 9 and
98/81/EC Recital 4 (adapted)

(13) Appropriate containment measures should be applied at the various stages of an
operation to control emissions ⌦ and the disposal of material from contained uses of
GMMs, ⌫ and to prevent accidents.

� 90/219/EEC Recital 10
(adapted)

(14) Any person, before undertaking for the first time the contained use of a ⌦ GMM ⌫
in a particular installation, should forward to the competent authority a notification so
that the authority may satisfy itself that the proposed installation is appropriate to carry

# EN 6 EN

out the activity in a manner that does not present a hazard to human health and the
environment.

� 90/219/EEC Recital 11
(adapted)

(15) It is also necessary to establish appropriate procedures for the case-by-case
notification of specific operations involving the contained use of ⌦ GMMs ⌫,
taking account of the degree of risk involved.

� 90/219/EEC Recital 12

(16) In the case of operations involving high risk, the consent of the competent authority
should be given.

� 98/81/EC Recital 8

(17) The containment and other protective measures applied to contained uses should be
reviewed periodically.

� 90/219/EEC Recital 13
(adapted)

(18) It may be considered appropriate to consult the public on the contained use of
⌦ GMMs ⌫.

� 98/81/EC Recital 9 (adapted)

(19) People employed in contained uses should be consulted in accordance with the
requirements of relevant Community legislation, in particular ⌦ Directive
2000/54/EC of the European Parliament and of the Council of 18 September 2000 ⌫
on the protection of workers from risks related to exposure to biological agents at
work (seventh individual Directive within the meaning of Article 16(1) of Directive
89/391/EEC) [11] .

� 90/219/EEC Recital 14

(20) Appropriate measures should be taken to inform any person liable to be affected by an
accident on all matters relating to safety.

11 OJ L ⌦ 262, 17.10.2000, p. 21 ⌫.

# EN 7 EN

� 90/219/EEC Recital 15

(21) Emergency plans should be established to deal effectively with accidents.

� 90/219/EEC Recital 16

(22) If an accident occurs, the user should immediately inform the competent authority and
communicate the information necessary for assessing the impact of that accident and
for taking the appropriate action.

� 90/219/EEC Recital 17

(23) It is appropriate for the Commission, in consultation with the Member States, to
establish a procedure for the exchange of information on accidents and for the
Commission to set up a register of such accidents.

� 90/219/EEC Recital 18
(adapted)

(24) The contained use of ⌦ GMMs ⌫ throughout the Community should be monitored,
and to this end Member States should supply certain information to the Commission.

� 98/81/EC Recitals 12 and 13
(adapted) and 2001/204/EC
Recital 2 (adapted)

(25) ⌦ In order to be considered safe for human health and the environment, GMMs
should meet the list of criteria as defined in Annex II, Part B. To take account of the
pace at which biotechnology is advancing, the nature of the criteria to be developed
and the limited scope of this list, it is appropriate for the Council to revise those
criteria, which should, where necessary, be supplemented by guidance notes to
facilitate their application. ⌫

�

(26) The measures necessary for the implementation and for the adaptation to technical
progress of this Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of
implementing powers conferred on the Commission [12] .

12 OJ L 184, 17.7.1999, p. 23.

# EN 8 EN

(27) This Directive should be without prejudice to the obligations of the Member States
relating to the time-limits for transposition into national law of the Directives set out in
Annex VI, Part B,

� 90/219/EEC (adapted)

⌦ HAVE ⌫ ADOPTED THIS DIRECTIVE:

� 90/219/EEC

_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.

� 98/81/EC Art. 1 pt. 1 (adapted)
� 1 Corrigendum, 98/81/EC
(OJ L 93, 8.4.1999, p. 27)
(adapted)

_Article 2_

For the purposes of this Directive ⌦ the following definitions shall apply ⌫:

(a) “micro-organism” ⌦ means ⌫ any microbiological entity, cellular or non-cellular,
capable of replication or of transferring genetic material, including viruses, viroids,
animal and plant cells in culture;

(b) “genetically modified micro-organism” (GMM) ⌦ means ⌫ a micro-organism in
which the genetic material has been altered in a way that does not occur naturally by
mating and/or natural recombination; within the terms of this definition:

(i) genetic modification occurs at least through the use of the techniques listed in
Annex I, Part A;

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

(c) “contained use” ⌦ means ⌫ any activity in which micro-organisms are genetically
modified or in which such GMMs are cultured, stored, transported, destroyed,
disposed of or used in any other way, and for which specific containment measures
are used � 1 to limit their contact with, and to provide a high level of safety for, the
general population and the environment; �

# EN 9 EN

(d) “accident” ⌦ means ⌫ 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” ⌦ means ⌫ any natural or legal person responsible for the contained use of
GMMs;

(f) “notification” ⌦ means ⌫ the presentation of the requisite information to the
competent authorities of a Member State.

_Article 3_

1. Without prejudice to Article 4(1) this Directive shall not apply:

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

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

2. Article 4(3) and (6) and Articles 5 to 11 shall not apply to the transport of GMMs by road,
rail, inland waterway, sea or air.

� 98/81/EC, Art. 1 pt. 1 (adapted)

3. This Directive shall not apply to the storage, culture, transport, destruction, disposal or use
of GMMs which have been placed on the market in accordance with
Directive ⌦ 2001/18/EC ⌫ or pursuant to other Community legislation, which provides for
a specific environmental risk assessment similar to that laid down in the said Directive,
provided that the contained use is in accordance with the conditions, if any, of the consent for
placing on the market.

� 98/81/EC, Art. 1 pt. 1

_Article 4_

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

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

3. The assessment referred to in paragraph 2 shall result in the final classification of the
contained uses in four classes applying the procedure set out in Annex III, which will result in
the assignment of containment levels in accordance with Article 5:

# EN 10 EN

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

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

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

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

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

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

6. A record of the assessment referred to in paragraph 2 shall be kept by the user and made
available in an appropriate form to the competent authority as part of the notification pursuant
to Articles 6, 8 and 9 or on request.

_Article 5_

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

2. The assessment referred to in Article 4(2) and the containment and other protective
measures applied shall be reviewed periodically, and forthwith if:

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

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

_Article 6_

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

# EN 11 EN

_Article 7_

Following the notification referred to in Article 6, subsequent class 1 contained use may
proceed without further notification. Users of GMMs in class 1 contained uses shall be
required to keep the record of each assessment referred to in Article 4(6), which shall be made
available to the competent authority on request.

_Article 8_

1. For first and subsequent class 2 contained uses to be carried out in premises notified in
accordance with Article 6, a notification containing the information listed in Annex V, Part B
shall be submitted.

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

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

3. If the premises have not been the subject of a previous notification to carry out class 2 or a
higher class of contained uses, the class 2 contained use may, in the absence of any indication
to the contrary from the competent authority, proceed 45 days after submission of the
notification referred to in paragraph 1, or earlier with the agreement of the competent
authority.

_Article 9_

1. For first and subsequent class 3 or class 4 contained uses to be carried out in premises
notified in accordance with Article 6, a notification containing the information listed in Annex
V, Part C shall be submitted.

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

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

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

# EN 12 EN

� 98/81/EC, Art. 1 pt. 1

_Article 10_

1. Member States shall designate the authority or authorities competent to implement the
measures which they adopt in application of this Directive and to receive and acknowledge
the notifications referred to in Articles 6, 8 and 9.

2. The competent authorities shall examine the conformity of the notifications with the
requirements of this Directive, the accuracy and completeness of the information given, the
correctness of the assessment referred to in Article 4(2) and the class of contained uses and,
where appropriate, the suitability of the containment and other protective measures, the waste
management, and emergency response measures.

3. If necessary, the competent authority may:

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

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

4. For the purpose of calculating the periods referred to in Articles 8 and 9, any period of time
during which the competent authority:

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

(b) is carrying out a public inquiry or consultation in accordance with Article 12

shall not be taken into account.

_Article 11_

1. If the user becomes aware of relevant new information or modifies the contained use in a
way which could have significant consequences for the risks posed by it, the competent
authority shall be informed as soon as possible and the notification pursuant to Articles 6, 8
and 9 shall be modified.

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

# EN 13 EN

_Article 12_

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 18.

_Article 13_

1. The competent authorities shall ensure that before a contained use commences:

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

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

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

_Article 14_

1. Member States shall take the necessary measures to ensure that, in the event of an accident,
the user shall be required to inform immediately the competent authority specified in
Article 10 and provide the following information:

(a) the circumstances of the accident;

(b) the identity and quantities of the GMMs concerned;

(c) any information necessary to assess the effects of the accident on the health of the
general population and the environment;

(d) the measures taken.

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

to:

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

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

# EN 14 EN

_Article 15_

1. Member States shall be required to:

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

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

2. The Commission, in consultation with the Member States, shall establish a procedure for
the exchange of information pursuant to paragraph 1. It shall also set up and keep at the
disposal of the Member States a register of accidents within the scope of this Directive,
including an analysis of the causes of the accidents, experience gained and measures taken to
avoid similar accidents in the future.

� 90/219/EEC

_Article 16_

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

� 98/81/EC, Art. 1 pt. 2

_Article 17_

1. Member States shall send to the Commission, at the end of each year, a summary report on
class 3 and class 4 contained uses notified during that year pursuant to Article 9 including the
description, purpose and risks of the contained use(s).

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

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

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

# EN 15 EN

_Article 18_

� 98/81/EC, Art. 1 pt. 2 (adapted)

1. Where its disclosure affects one or more of the items mentioned in Article 4(2) of Directive
⌦ 2003/4/EC of the European Parliament and of the Council ⌫ [13], the notifier may indicate
the information in the notifications submitted pursuant to this Directive that should be treated
as confidential. Verifiable justification should be given in such cases.

� 98/81/EC, Art. 1 pt. 2

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

2. In no case may the following information, when submitted according to Articles 6, 8 or 9,
be kept confidential:

(a) the general characteristics of the GMMs, name and address of the notifier, and
location of use;

(b) the class of contained use and the containment measures ;

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

� 98/81/EC Art. 1 pt. 2 (adapted)

3. The Commission and the competent authorities shall not divulge to third parties any
information ⌦ deemed ⌫ to be confidential according to ⌦ the second subparagraph of ⌫
paragraph 1 and notified or otherwise provided pursuant to this Directive, and shall protect
intellectual property rights relating to the data received.

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

_Article 19_

Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress
and to adapt Annex II, Part C, shall be decided in accordance with the procedure ⌦ referred
to ⌫ in Article 21 ⌦ (2) ⌫.

13 OJ L ⌦ 41, 14.2.2003, p. 26 ⌫.

# EN 16 EN

� 98/81/EC Art. 1 pt. 3 (adapted)

_Article 20_

Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority
on a proposal from the Commission.

� 1882/2003, Art. 3, Annex III,
pt. 19

_Article 21_

1. The Commission shall be assisted by a committee.

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

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

3. The Committee shall adopt its rules of procedure.

�

_Article 22_

Directive 90/219/EEC, as amended by the acts listed in Annex VI, Part A, is repealed, without
prejudice to the obligations of the Member States relating to the time-limits for transposition
into national law of the Directives set out in Annex VI, Part B.

References to the repealed Directive shall be construed as references to this Directive and
shall be read in accordance with the correlation table in Annex VII.

_Article 23_

This Directive shall enter into force on the twentieth day following that of its publication in
the _Official Journal of the European Union_ .

� 90/219/EEC

_Article 24_

This Directive is addressed to the Member States.

# EN 17 EN

Done at Brussels,

_For the European Parliament_ _For the Council_
_The President_ _The President_

# EN 18 EN

� 98/81/EC Art. 1 pt. 4

**ANNEX I**

PART A

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

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

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

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

PART B

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

(1) _in vitro_ fertilisation;

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

(3) polyploidy induction.

_______________

# EN 19 EN

**ANNEX II**

PART A

Techniques or methods of genetic modification yielding micro-organisms to be excluded from
the Directive on 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.

� 2001/204/EC Art. 1 (adapted)

PART B

**Criteria establishing the safety of GMMs for human health and the environment**

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 ⌦ (2) ⌫.

**1.** **INTRODUCTION**

Types of GMMs listed in Part C in accordance with the procedure referred to in
Article 21 ⌦ (2) ⌫ 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.

# EN 20 EN

� 2001/204/EC Art. 1

**2.** **GENERAL** **CRITERIA**

**2.1.** **Strain verification/authentication**

Identity of the strain must be precisely established. Modification must be known and
verified.

**2.2.** **Documented and established evidence of safety**

Documented evidence of the safety of the organism must be provided.

**2.3.** **Genetic stability**

Where any instability could adversely affect safety, evidence of stability is required.

**3.** **SPECIFIC** **CRITERIA**

**3.1.** **Non-pathogenic**

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

_3.1.1._ _Non-toxigenic_

The GMM should not produce increased toxigenicity as a result of the genetic
modification nor be noted for its toxigenic properties.

� 2001/204/EC Art. 1 (adapted)

_3.1.2._ _Non-allergenic_

The GMM should not produce increased allergenicity as a result of the genetic
modification nor be a noted allergen, having, for example, allergenicity comparable
in particular with that of the micro-organisms identified in Directive
⌦ 2000/54/EC ⌫.

� 2001/204/EC Art. 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.

# EN 21 EN

**3.3.** **Transfer of genetic material**

The modified genetic material must not give rise to harm if transferred nor should it
be self transmissible or transferable at a frequency greater than other genes of the
recipient or parental micro-organism.

**3.4.** **Safety for the environment in the event of a significant and unintended 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.

� 98/81/EC, Art. 1 pt. 4 (adapted)

PART C

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

… (to be completed in accordance with the procedure ⌦ referred to ⌫ in Article 21
⌦ (2) ⌫)

_______________

# EN 22 EN

**ANNEX III**

**PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN**

**ARTICLE 4(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 4(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 ⌦ referred to ⌫ in Article 21 ⌦ (2) ⌫.

� 98/81/EC, Art. 1 pt. 4

**A.** **ELEMENTS** **OF** **ASSESSMENT**

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

–
disease to humans including allergenic or toxic effects,

–
disease to animals or plants,

–
deleterious effects due to the impossibility of treating a disease or providing an
effective prophylaxis,

–
deleterious effects due to establishment or dissemination in the environment,

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

2. The assessment referred to in Article 4(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.

# EN 23 EN

**B.** **PROCEDURE**

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

4. In general, only GMMs which show the following characteristics would be
considered appropriate for inclusion in class 1 as defined in Article 4(3):

(i) the recipient or parental micro-organism is unlikely to cause disease to humans,
animals or plants [14] ;

(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 [15], or
likely to cause deleterious effects in the environment;

(iii) the GMM is unlikely to cause disease to humans, animals or plants [16] and is
unlikely to have deleterious effects on the environment.

� 98/81/EC, Art. 1 pt. 4 (adapted)

5. In order to obtain the necessary information to implement this process the user may
firstly take into account relevant Community legislation (in particular Directive
⌦ 2000/54/EC ⌫). International or national classification schemes (e.g. WHO,
NIH, etc.) and their revisions due to new scientific knowledge and technical progress
may also be considered.

These schemes concern natural micro-organisms and as such are usually based on the
ability of micro-organisms to cause disease to humans, animals or plants and on the
severity and transmissibility of the disease likely to be caused. Directive
⌦ 2000/54/EC ⌫ 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 categorisation of the contained use activities in
the four classes of risk referred to in Article 4(3). The user may also take into
consideration classification schemes referring to plant and animal pathogens (which
are usually established on a national basis). The abovementioned classification
schemes give only a provisional indication of the risk class of the activity and the
corresponding set of containment and control measures.

� 98/81/EC, Art. 1 pt. 4

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

14 This would only apply to animals and plants in the environment likely to be exposed.
15 This would only apply to animals and plants in the environment likely to be exposed.
16 This would only apply to animals and plants in the environment likely to be exposed.

# EN 24 EN

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

(i) the characteristics of the environment likely to be exposed (e.g. whether in the
environment likely to be exposed to the GMMs there are known biota which
can be adversely affected by the micro-organisms used in the contained use
activity);

(ii) the characteristics of the activity (e.g. its scale; nature);

(iii) any non-standard operations (e.g. the inoculation of animals with GMMs;
equipment likely to generate aerosols).

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

8. The analysis carried out as described above will finally lead to the assignment of the
activity to one of the classes described in Article 4(3).

9. The final classification of the contained use should be confirmed by reviewing the
completed assessment referred to in Article 4(2).

_______________

# EN 25 EN

**ANNEX IV**

**CONTAINMENT AND OTHER PROTECTIVE MEASURES**

_General principles_

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

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

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

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

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

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

(v) to provide appropriate training of personnel;

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

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

(viii) where appropriate to display biohazard signs;

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

(x) to keep adequate records;

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

(xii) to prohibit mouth pipetting;

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

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

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

# EN 26 EN

2. The titles of the tables are indicative:

Table I A presents minimum requirements for laboratory activities.

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

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

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

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

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

In these tables “optional” means that the user may apply these measures on a caseby-case basis, subject to the assessment referred to in Article 4(2).

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

_Table I A_

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

|Specifications|Col2|Containment levels|Col4|Col5|Col6|
|---|---|---|---|---|---|
|Specifications|Specifications|1|2|3|4|
|1|Laboratory suite:<br>isolation1|Not<br>required|Not<br>required|Required|Required|
|2|Laboratory: sealable<br>for fumigation|Not<br>required|Not<br>required|Required|Required|

**Equipment**

# EN 27 EN

|4|Entry to lab via<br>airlock2|Not<br>required|Not<br>required|Optional|Required|
|---|---|---|---|---|---|
|5|Negative pressure<br>relative to the pressure<br>of the immediate<br>environment|Not<br>required|Not<br>required|Required<br>except for3|Required|
|6|Extract and input air<br>from the laboratory<br>should be HEPA-<br>filtered|Not<br>required|Not<br>required|Required<br>(HEPA)4 —<br>extract air<br>except for3|Required<br>(HEPA)5 —<br>input and<br>extract air|
|7|Microbiological safety<br>post|Not<br>required|Optional|Required|Required|
|8|Autoclave|On site|In the<br>building|En suite6|In lab =<br>double-ended|

**System of work**

|9|Restricted access|Not<br>required|Required|Required|Required|
|---|---|---|---|---|---|
|10|Biohazard sign on the<br>door|Not<br>required|Required|Required|Required|
|11|Specific measures to<br>control aerosol<br>dissemination|Not<br>required|Required<br>minimise|Required<br>prevent|Required<br>prevent|
|13|Shower|Not<br>required|Not<br>required|Optional|Required|

|Col1|Col2|Col3|Col4|Ð Corrigendum, 98/81/EC<br>(OJ L 93, 8.4.1999, p. 27)|Col6|Col7|Col8|
|---|---|---|---|---|---|---|---|
|14|Protective clothing|Suitable<br>protective<br>clothing|Suitable<br>protective<br>clothing|Suitable<br>protective<br>clothing|Suitable<br>protective<br>clothing and<br>(optional)<br>footwear|Complete<br>change of<br>clothing and<br>footwear<br>before entry<br>and exit|Complete<br>change of<br>clothing and<br>footwear<br>before entry<br>and exit|

# EN 28 EN

|Col1|Col2|Col3|Col4|Ð 98/81/EC Art. 1 pt. 4|Col6|Col7|Col8|
|---|---|---|---|---|---|---|---|
|15|Gloves|Not<br>required|Optional|Optional|Required|Required|Required|
|18|Efficient vector<br>control (e.g. for<br>rodents and insects)|Optional|Required|Required|Required|Required|Required|

|Waste|Col2|Col3|Col4|Col5|Col6|
|---|---|---|---|---|---|
|19|Inactivation of GMMs<br>in effluent from hand-<br>washing sinks or<br>drains and showers<br>and similar effluents|Not<br>required|Not<br>required|Optional|Required|
|20|Inactivation of GMMs<br>in contamined<br>material and waste|Optional|Required|Required|Required|

**Other measures**

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

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

# EN 29 EN

_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.

� 98/81/EC (adapted)

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

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

**Building**

**Equipment**

|3|Entry via a separate<br>room with two<br>interlocking doors|Not<br>required|Optional|Optional|Required|
|---|---|---|---|---|---|
|4|Control of<br>contaminated run-off<br>water|Optional|Minimise2 run-off|Prevent<br>run-off|Prevent<br>run-off|

**System of work**

# EN 30 EN

~~1~~ The glasshouse shall consist of a permanent structure with a continuous waterproof covering, located
on a site graded to prevent entry of surface-water run-off ⌦, and with ⌫ self-closing lockable
doors.
2 Where transmission can occur through the ground.

# EN 31 EN

� 98/81/EC Art. 1 pt. 4

_Table I C_

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

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

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

**Facilities**

|1|Isolation of animal unit1|Optional|Required|Required|Required|
|---|---|---|---|---|---|
|2|Animal facilities2 <br>separated by lockable<br>doors|Optional|Required|Required|Required|
|3|Animal facilities<br>designed to facilitate<br>decontamination<br>(waterproof and easily<br>washable material<br>(cages, etc.))|Optional|Optional|Required|Required|
|4|Floor and/or walls easily<br>washable|Optional|Required<br>(floor)|Required<br>(floor and<br>walls)|Required<br>(floor and<br>walls)|
|5|Animals kept in<br>appropriate containment<br>facilities such as cages,<br>pens or tanks|Optional|Optional|Optional|Optional|
|6<br>|Filters on isolators or<br>isolated room3|Not<br>required|Optional|Required|Required|

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

# EN 32 EN

_Table II_

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

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

**General**

|1|Viable micro-<br>organisms should be<br>contained in a system<br>which separates the<br>process from the<br>environment (closed<br>system)|Optional|Required|Required|Required|
|---|---|---|---|---|---|
|2|Control of exhaust<br>gases from the closed<br>system|Not<br>required|Required,<br>minimise<br>dissemination|Required,<br>prevent<br>dissemination|Required,<br>prevent<br>dissemination|
|3|Control of aerosols<br>during sample<br>collection, addition of<br>material to a closed<br>system or transfer of<br>material to another<br>closed system|Optional|Required,<br>minimise<br>dissemination|Required,<br>prevent<br>dissemination|Required,<br>prevent<br>dissemination|
|4|Inactivation of bulk<br>culture fluids before<br>removal from the<br>closed system|Optional|Required, by<br>validated<br>means|Required, by<br>validated<br>means|Required, by<br>validated<br>means|
|5|Seals should be<br>designed so as to<br>minimise or prevent<br>release|No<br>sepecific<br>requirement|Minimise<br>dissemination|Prevent<br>dissemination|Prevent<br>dissemination|
|6|The controlled area<br>should be designed to<br>contain spillage of the<br>entire contents of the<br>closed system|Optional|Optional|Required|Required|
|7|The controlled area<br>should be sealable to<br>permit fumigation|Not<br>required|Optional|Optional|Required|

# EN 33 EN

**Equipment**

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

**System of work**

|13|Closed systems should<br>be located within a<br>controlled area|Not<br>required|Optional|Required|Required|
|---|---|---|---|---|---|
|14|Access should be<br>restricted to nominated<br>personnel only|Not<br>required|Required|Required|Required|
|15|Biohazard signs should<br>be posted|Not<br>required|Required|Required|Required|
|17|Personnel should<br>shower before leaving<br>the controlled area|Not<br>required|Not required|Optional|Required|
|18|Personnel should wear<br>protective clothing|Required<br>(work<br>clothing)|Required<br>(work<br>clothing)|Required|Complete<br>change before<br>exit and entry|

# EN 34 EN

|Waste|Col2|Col3|Col4|Col5|Col6|
|---|---|---|---|---|---|
|22|Inactivation of GMMs<br>in effluent from<br>handwashing sinks and<br>showers or similar<br>effluents|Not<br>required|Not required|Optional|Required|
|23|Inactivation of GMMs<br>in contaminated<br>material and waste<br>including those in<br>process effluent before<br>final discharge|Optional|Required, by<br>validated<br>means|Required, by<br>validated<br>means|Required, by<br>validated<br>means|

_______________

# EN 35 EN

**ANNEX V**

� 98/81/EC, Art. 1 pt. 4 (adapted)

⌦ **INFORMATION REQUIRED FOR THE NOTIFICATION REFERRED TO IN**
**ARTICLES 6, 8 AND 9** ⌫

� 98/81/EC Art. 1 pt. 4

PART A

Information required for the notification referred to in Article 6:

–
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 4(2) and information on waste management.

PART B

Information required for the notification referred to in Article 8:

–
the date of submission of the notification referred to in Article 6,

–
the names of the persons responsible for supervision and safety and information on
their 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),

–
the identity and characteristics of the GMM,

–
the purpose of the contained use, including the expected results,

–
the approximate culture volumes to be used,

# EN 36 EN

–
a 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 4(2),

–
the information necessary for the competent authority to evaluate any emergency
response plans, if required under Article 13(1).

PART C

Information required for the notification referred to in Article 9:

(a) – the date of submission of the notification referred to in Article 6,

–
the names of the persons responsible for supervision and safety and
information on their 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 function(s) of the genetic material(s) involved in the
modification(s),

–
the identity and characteristics of the GMM,

–
the culture volumes to be used;

(c) – a 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,

–
a 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,

–
the 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 13(1);

# EN 37 EN

(e) a copy of the assessment referred to in Article 4(2).

_______________

# EN 38 EN

�

**ANNEX VI**

**Part A**

**Repealed Directive with its successive amendments**
(referred to in Article 22)

Council Directive 90/219/EEC
(OJ L 117, 8.5.1990, p. 1)

Commission Directive 94/51/EC
(OJ L 297, 18.11.1994, p. 29)

Council Directive 98/81/EC
(OJ L 330, 5.12.1998, p. 13)

Council Decision 2001/204/EC
(OJ L 73, 15.3.2001, p. 32)

Regulation (EC) No 1882/2003 of the European
Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1)

**Part B**

Annex III, point 19, only

**List of time-limits for transposition into national law**
(referred to in Article 22)

_____________

# EN 39 EN

**ANNEX VII**

|CORRELATI|ION TABLE|
|---|---|
|Directive 90/219/EEC|This Directive|
|Article 1<br>Article 2<br>Article 3, introductory phrase<br>Article 3, first indent<br>Article 3, second indent<br>Article 4, first paragraph<br>Article 4, second paragraph<br>Article 5<br>Article 6<br>Article 7<br>Article 8<br>Article 9<br>Article 10<br>Article 11(1), (2) and (3)<br>Article 11(4), introductory phrase<br>Article 11(4), first indent<br>Article 11(4), second indent<br>Article 12, first paragraph<br>Article 12, second paragraph<br>Article 13<br>Article 14, first paragraph<br>Article 14, second paragraph<br>Article 15(1), introductory phrase|Article 1<br>Article 2<br>Article 3(1), introductory phrase<br>Article 3(1)(a)<br>Article 3(1)(b)<br>Article 3(2)<br>Article 3(3)<br>Article 4<br>Article 5<br>Article 6<br>Article 7<br>Article 8<br>Article 9<br>Article 10(1), (2) and (3)<br>Article 10(4), introductory phrase<br>Article 10(4)(a)<br>Article 10(4)(b)<br>Article 11(1)<br>Article 11(2)<br>Article 12<br>Article 13(1)<br>Article 13(2)<br>Article 14(1), introductory phrase|

# EN 40 EN

Article 15(1), first indent Article 14(1)(a)

Article 15(1), second indent Article 14(1)(b)

Article 15(1), third indent Article 14(1)(c)

Article 15(1), fourth indent Article 14(1)(d)

Article 15(2), introductory phrase Article 14(2), introductory phrase

Article 15(2), first indent Article 14(2)(a)

Article 15(2), second indent Article 14(2)(b)

Article 16 Article 15

Article 17 Article 16

Article 18 Article 17

Article 19(1) Article 18(1), first subparagraph

Article 19(2) Article 18(1), second subparagraph

Article 19(3), introductory phrase Article 18(2), introductory phrase

Article 19(3), first indent Article 18(2)(a)

Article 19(3), second indent Article 18(2)(b)

Article 19(3), third indent Article 18(2)(c)

Article 19(4) Article 18(3)

Article 19(5) Article 18(4)

Article 20 Article 19

Article 20 _a_ Article 20

Article 21 Article 21

Article 22 _________

_________ Article 22

_________ Article 23

Article 23 Article 24

# EN 41 EN

Annexes I-V Annexes I-V

_________ Annex VI

_________ Annex VII

_____________

# EN 42 EN