A4-0192/98

Decision on the common position adopted by the Council with a view to adopting a Council Directive amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (C4-0031/98 - 95/0340(SYN))(Cooperation procedure: second reading)

The European Parliament,

- having regard to the common position of the Council (C4-0031/98 - 95/0340(SYN)) ((OJ C 62, 26.2.1998, p. 1.)),

- having regard to its opinion at first reading ((OJ C 115, 14.4.1997, p. 59.)) on the Commission proposal to the Council (COM(95)0640 ((OJ C 356, 22.11.1997, p. 14.)),

- having been consulted by the Council pursuant to Article 189c of the EC Treaty,

- whereas the legal basis proposed is not appropriate; whereas reference should instead be made to Article 100a of the EC Treaty,

- having regard to Rule 67 of the Rules of Procedure,

- having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Protection (A4-0192/98),

1. Amends the common position as follows;

2. Instructs its President to forward this decision to the Council and the Commission.

(Amendment 1)

Preamble

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THE COUNCIL OF THE EUROPEAN UNION,

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THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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Having regard to the Treaty establishing the European Community, and in particular Article 130s(1) thereof,

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Having regard to the Treaty establishing the European Community, and in particular Article

100a thereof,

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Having regard to the proposal from the Commission,

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Having regard to the proposal from the Commission,

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Having regard to the opinion of the Economic and Social Committee,

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Having regard to the opinion of the Economic and Social Committee,

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Acting in accordance with the procedure laid down in Article 189c of the Treaty,

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Acting in accordance with the procedure laid down in Article

189b of the Treaty,

(Amendment 2)

ARTICLE 1(1)

Article 2(c) (Directive 90/219/EEC)

>Original text>

(c) 'contained use¨ shall mean 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 to limit their contact with the general population and the environment;

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(c)

'contained use¨ shall mean 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 physical barriers, or a combination of physical barriers together with chemical and /or biological barriers, are used to avoid their contact with the general population and the environment;

(Amendment 3)

ARTICLE 1(1)

Article 6(2)(b) (Directive 90/219/EEC)

>Original text>

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

>Text following EP vote>

(b)

there is reason to suspect or the competent authority is made aware that the assessment is no longer adequate as judged in the light of new scientific or technical knowledge.

(Amendment 5)

ARTICLE 1(1)

Article 9(2a) (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

2a. The applicant can, however, himself request a decision on a formal authorization from the competent authority. This decision must be made within a maximum of 45 days from the notification.

(Amendment 6)

ARTICLE 1(1)

Article 10(2), introduction (Directive 90/219/EEC)

>Original text>

2. A class 3 or higher class of contained use may not proceed without the prior written consent of the competent authority:

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2.

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

(Amendment 7)

ARTICLE 1(1)

Article 13 (Directive 90/219/EEC)

>Original text>

Where a Member State considers it appropriate, it may provide that the public shall be consulted on aspects of the proposed contained use, without prejudice to Article 19.

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Where a Member State considers it appropriate, it may provide that the public shall be consulted on aspects of the proposed contained use

and on the related health and environmental safety measures or emergency plans, without prejudice to Article 19.

(Amendment 8)

ARTICLE 1(1)

Article 14(b) (Directive 90/219/EEC)

>Original text>

(b) information on such emergency plans 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.

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(b)

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

(Amendment 9)

ARTICLE 1(1)

Article 14a (new) (Directive 90/219/EEC)

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Article 14a

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Legally responsible users of genetically modified micro-organisms shall have full civil liability for any damage to human health and the environment caused by the uses in question. Before the activities begin, they shall take out sufficient liability insurance to cover such losses as might be occasioned thereby.

(Amendment 10)

ARTICLE 1(1a) (new)

Article 17 (Directive 90/219/EEC)

>Text following EP vote>

1a. Article 17 shall be replaced by the following:

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'Article 17

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Member States shall ensure that the competent authority organizes inspections and other control measures to ensure user compliance with this Directive. Users shall be required to keep appropriate records.¨

(Amendment 11)

ARTICLE 1(2)

Article 20 (Directive 90/219/EEC)

>Original text>

Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress and to adapt Annex II, Part C, shall be decided in accordance with the procedure laid down in Article 21.

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1. Amendments necessary to adapt Annex II, Part A, Annex III, Part A, and Annexes IV and V to technical progress and to adapt Annex II, Part C, shall be decided in accordance with the procedure laid down in Article 21.

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2. Amendments necessary to adapt Annex III, Part B, to new scientific knowledge shall be laid down on a proposal from the Commission in accordance with Article 100a of the EC Treaty.

(Amendment 12)

ARTICLE 1(3)

Article 20a (Directive 90/219/EEC)

>Original text>

Before the .... () Annex II, Part B, listing the criteria for inclusion of types of GMMs into Annex II, Part C, shall be adopted by the Council acting by qualified majority on a proposal from the Commission. Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority on a proposal from the Commission.

__________

(*) 24 months after the entry into force of this Directive.

>Text following EP vote>

Within six months of the implementation date of this Directive specified in Article 2, the criteria for the inclusion of certain types of genetically modified micro-organisms in Annex II, Part B, shall be laid down on a proposal from the Commission in accordance with Article 100a of the EC Treaty.

(Amendment 13)

ARTICLE 1(3a) (new)

Article 21 (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

3a. Article 21 shall be replaced by the following

'Article 21

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

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

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3. The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event the Commission may defer application of the measures which it has decided for a period of not more than three months from the date of such communication.

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The Council, acting by a qualified majority, may take a different decision within the time-limit referred to in the previous subparagraph.

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4. The reasons for the decision and the minutes of this committee shall be made available to the public.

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5. The Commission shall submit to the European Parliament every three years and for the first time ...... a summary report on the implementation of the Directive, and in particular the measures it has adopted and the implemented and planned changes to the technical annexes.¨

(Amendment 14)

ANNEX

Annex III (Directive 90/219/EEC)

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PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 5(2)

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PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 5(2)

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This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 5(2). It will be supplemented, as regards in particular section B below, by guidance notes to be developed by the Commission in accordance with the procedure set out in Article 21.

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This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 5(2).

Amendments necessary to adapt to new scientific knowledge shall be decided in accordance with the procedure set out in Article 20.

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These guidance notes shall be completed no later than the ....(*).

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A. ELEMENTS OF ASSESSMENT

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A.

ELEMENTS OF ASSESSMENT

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

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1.

The following should be considered as potentially harmful effects:

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- disease to humans including allergenic or toxic effects;

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-

disease to humans including allergenic or toxic effects;

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- diseases to animals or plants;

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-

diseases to animals or plants;

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- adverse effects resulting from the inability to treat disease or offer effective prophylaxis;

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-

adverse effects resulting from the inability to treat disease or offer effective prophylaxis;

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- adverse effects resulting from establishment or dissemination in the environment;

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-

adverse effects resulting from establishment or dissemination in the environment;

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- adverse effects resulting from the natural transfer of inserted genetic material to other organisms.

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-

adverse effects resulting from the natural transfer of inserted genetic material to other organisms.

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2. The assessment referred to in Article 5(2) should be based on the following:

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2.

The assessment referred to in Article 5(2) should be based on the following:

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(a) the identification of any potentially harmful effects, in particular those associated with:

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(a)

the identification of any potentially harmful effects, in particular those associated with:

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(i) the recipient micro-organism;

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(i) the recipient micro-organism;

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(ii) the inserted (donated) genetic material;

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(ii) the inserted (donated) genetic material;

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(iii) the vector;

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(iii) the vector;

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(iv) the donor micro-organism (as long as the donor micro-organism is used during the operation);

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(iv) the donor micro-organism (as long as the donor micro-organism is used during the operation);

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(v) the resulting GMM;

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(v) the resulting GMM;

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(b) the characteristics of the activity;

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(b)

the characteristics of the activity;

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(c) the severity of the potentially harmful effects;

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(c)

the severity of the potentially harmful effects;

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(d) the likelihood of the potentially harmful effects being realised.

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(d)

the likelihood of the potentially harmful effects being realised.

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B. PROCEDURE

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B.

PROCEDURE

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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.

>Text following EP vote>

3. In order to arrive at the categorization of the class of risk for human health and environment the user should take into account the classification schemes of the recipient micro-organisms as given in other Community legislation or international schemes (e.g. the catalogues of bacteria, fungi, parasites, virus and other biological agents with their risk classification in Council Directives 90/679/EEC and 93/88/EEC(1), and classification schemes of the WHO and NIH etc) and their updated versions due to new scientific knowledge and technical progress.

>Original text>

>Text following EP vote>

3a. These classification schemes concern natural micro-organisms and are usually based on the ability of micro-organisms to cause disease to humans or animals, and on the severity and transmissibility of the disease likely to be caused. The user may also take into consideration classification schemes referring to plant 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 required.

>Original text>

4. In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Article 5:

>Text following EP vote>

4.

In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Article 5:

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

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(i)

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

>Original text>

(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, or likely to cause adverse effects in the environment;

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(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, or likely to cause adverse effects in the environment;

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

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(iii)

the GMM is unlikely to cause disease to humans, animals or plants and is unlikely to have adverse effects on the environment.

>Original text>

5. In order to be informed on this process the user may firstly take into account relevant Community legislation (for example Council Directive 90/679/EEC and classification schemes referring to plant and animal pathogens) and other international and national classification schemes. 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.

>Text following EP vote>

5. Risk assessment for human health

(a) The first stage in the risk assessment for human health should be to identify the risk class of the recipient micro-organism involved in the operation. Recipient micro-organisms are classified into four classes of risk on the basis of potential effects on a healthy human adult (Table 1). These classes of risk correspond exactly to the categorization of the contained use activities in the four classes of risk referred to in Article 5(3). The identification (or categorization) of the class of risk for human health gives only a provisional indication of the class of risk of the activity and the corresponding set of containment and control measures required.

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Table 1: 'The four classes of risk for human health¨

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Recipient micro-organism Class of risk

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Not associated with disease 1

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Associated with human 2

disease which is rarely

serious and for which

preventive or therapeutic

interventions are often

available

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Associated with serious or 3

lethal human disease for

which preventive or therapeutic

interventions may

be available (high individual

risk but low community

risk)

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>Text following EP vote>

Associated with serious or4

lethal human disease for

which preventive or therapeutic

interventions are

not usually available (high

individual risk

and high community risk)

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>Text following EP vote>

(b) The following aspects should be considered for the allocation of the recipient micro-organism to classes of risk 1 to 4 for human health:

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

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- nature of indigenous vectors, where they could mobilize the inserted DNA, and the frequency of mobilization;

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- nature and stability of disabling mutations;

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- host range (if relevant);

>Original text>

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- any significant physiological traits which may be altered in the final GMM and if relevant their stability;

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

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

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

>Text following EP vote>

6. The final classification and selection of control measures must be made in the light of:

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>Text following EP vote>

(i) any harmful properties (see above) which the vector or inserted material might confer on the recipient, or any alteration of the recipient's existing properties;

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

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

>Original text>

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:

>Text following EP vote>

7. Final risk assessment

The risk assessment for human health and the risk assessment for the environment should be considered together in order to arrive at and allocate the final risk assessment of categorization of the activities involved in the production of the given genetically modified micro-organism in the given facilities. This final assessment will be at least the higher of the two classes of risk assigned for the protection of human health and the environment.

>Original text>

(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);

>Text following EP vote>

>Original text>

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

>Text following EP vote>

>Original text>

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

>Text following EP vote>

>Original text>

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

>Text following EP vote>

>Original text>

8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 5(3).

>Text following EP vote>

8.

The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 5(3).

>Original text>

9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 5(2).

>Text following EP vote>

Deleted

>Original text>

________

(*) 18 months after the entry into force of the Directive.

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________

(1) OJ L 68, 29.10.1993, p. 71.

(Amendment 15)

ANNEX

Annex IV, Table Ia, line 3 (Directive 90/219/EEC)

>Original text>

3 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean.

>Text following EP vote>

3

Surfaces resistant to water and decontamination agents and which are easy to clean

>Original text>

Containment levels

1 required (bench)

2 required (bench)

3 required (bench, floor)

4 required (bench, floor, ceiling, walls)

>Text following EP vote>

Containment levels

1 required (floor)

2 required (floor)

3 required (floor, walls, ceiling)

4 required (floor, walls, ceiling and surfaces resistant to chemicals)

(Amendment 16)

ANNEX

Annex IV, Table Ia, line 3a(new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

3a Bench tops impervious to water and resistant to acids, alkalis, solvents and disinfectants

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 17)

ANNEX

Annex IV, Table Ia, line 10(new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

10 Biohazard signs on the door

>Original text>

>Text following EP vote>

Containment levels

1 not required

2 required

3 required

4 required

(Amendment 18)

ANNEX

Annex IV, Table Ia, line 12 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

12 Handwashing and decontamination provisions for personnel

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 19)

ANNEX

Annex IV, Table Ia, line 14, column 3 (Directive 90/219/EEC)

>Original text>

3 Suitable protective clothing

>Text following EP vote>

3 Suitable protective clothing + footwear

(Amendment 20)

ANNEX

Annex IV, Table Ia, line 16 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

16 Test adequately and maintain control measures and equipment

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 21)

ANNEX

Annex IV, Table Ia, line 17 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

17 Record keeping

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 22)

ANNEX

Annex IV, Table Ia, line 18, column 1 (Directive 90/219/EEC)

>Original text>

1 optional

>Text following EP vote>

1

required

(Amendment 23)

ANNEX

Annex IV, Table Ib, line 3, columns 1 to 3 (Directive 90/219/EEC)

>Original text>

1 not required

2 optional

3 optional

>Text following EP vote>

1 optional

2 optional

3 required

(Amendment 24)

ANNEX

Annex IV, Table Ib, line 5 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

5 Restricted access

>Original text>

>Text following EP vote>

Containment levels

1 required (visitors accepted)

2 required

3 required

4 required

(Amendment 25)

ANNEX

Annex IV, Table Ic, line 2, column 1 (Directive 90/219/EEC)

>Original text>

1 optional

>Text following EP vote>

1

required

(Amendment 26)

ANNEX

Annex IV, Table Ic, line 3, column 2 (Directive 90/219/EEC)

>Original text>

2 optional

>Text following EP vote>

2

required

(Amendment 27)

ANNEX

Annex IV, Table Ic, line 4, columns 1 and 2 (Directive 90/219/EEC)

>Original text>

1 optional

2 required (floor)

>Text following EP vote>

1

required (floor)

2 required (floor and walls)

(Amendment 28)

ANNEX

Annex IV, Table Ic, line 5 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

5 Animal containment in appropriate cages, pens or tanks

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 29)

ANNEX

Annex IV, Table II, line 2, column 1 (Directive 90/219/EEC)

>Original text>

1 not required

>Text following EP vote>

1

required, minimize release

(Amendment 30)

ANNEX

Annex IV,Table II, line 9 (Directive 90/219/EEC)

>Original text>

9 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean

>Text following EP vote>

9

Surfaces resistant to water and decontamination agents and which are easy to clean

>Original text>

Containment levels

1 required (bench if any)

2 required (bench if any)

3 required (bench if any, floor)

4 required (bench, floor, ceiling, walls)

>Text following EP vote>

Containment levels

1 optional(floor)

2 required (floor)

3 required (floor, walls, ceiling)

4 required (floor, walls, ceiling and surfaces resistant to chemicals)

(Amendment 31)

ANNEX

Annex IV, Table II, line 9a (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

9a Bench tops impervious to water and resistant to acids, alkalis, solvents and disinfectants

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 32)

ANNEX

Annex IV, Table II, line 15 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

15 Biohazard signs should be posted.

>Original text>

>Text following EP vote>

Containment levels

1 not required

2 required

3 required

4 required

(Amendment 33)

ANNEX

Annex IV, Table II, line 16 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

16 Handwashing and decontamination provisions for personnel

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 34)

ANNEX

Annex IV, Table II, line 19 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

19 Test adequately and maintain control measures and equipment

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required

(Amendment 35)

ANNEX

Annex IV, Table II, line 20 (new) (Directive 90/219/EEC)

>Original text>

>Text following EP vote>

20 Record keeping

>Original text>

>Text following EP vote>

Containment levels

1 required

2 required

3 required

4 required