51999AP0024

A4-0024/99

Proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (COM(98)0085 - C4-0129/98 - 98/0072(COD))

The proposal was approved with the following amendments:

(Amendment 1)

Recital 4a (new)

>Original text>

>Text following EP vote>

Whereas means must be sought of providing GMOs with genetically stable characteristics which make it possible to distinguish them from non-genetically modified organisms, thereby facilitating their retrieval in the event of unwelcome occurrences;

(Amendment 2)

Recital 5

>Original text>

Whereas the provisions of the Directive concerning Part B releases of products shall not apply to products under development covered by Community legislation which provides for a specific environmental risk assessment similar to that laid down in this Directive;

>Text following EP vote>

Deleted.

(Amendment 3)

Recital 5a (new)

>Original text>

>Text following EP vote>

Whereas the provisions of this Directive relating to placing on the market of products should be a point of reference for products containing, or consisting of, GMOs covered by other Community legislation which should therefore provide for a specific environmental risk assessment and other regulatory procedures at least equivalent to those laid down in this Directive;

(Amendment 4)

Recital 5b (new)

>Original text>

>Text following EP vote>

Whereas, for the renewal of a notification of consent, all the terms of the original consent may be revised, including those such as monitoring and/or the fixed period of the consent;

(Amendment 84)

Recital 5c (new)

>Original text>

>Text following EP vote>

Whereas in relation to the risks of deliberate release of GMOs into the environment, science is not able to give clear-cut answers, and whereas the uncertainties should be cleared up through close co-operation between scientists and policy-makers, using any opportunity to gather scientific data on the indirect and direct effects on public health and the environment;

(Amendment 5)

Recital 7

>Original text>

Whereas it is appropriate that the administrative procedure for granting consents to the placing on the market of GMOs as or in products should become more efficient and more transparent and that consent should only be granted for a fixed period;

>Text following EP vote>

Whereas it is appropriate that the administrative procedure for granting consents to the placing on the market of GMOs as or in products should become more efficient and more transparent;

(Amendment 6)

Recital 12

>Original text>

Whereas the Commission may consult any committee it has created with a view to advising it on the ethical implications of biotechnology on general matters which in the view of the Commission may raise ethical concerns;

>Text following EP vote>

Whereas the Commission

or the European Parliament may consult any appropriate committee with a view to obtaining advice on matters relating to the release of GMOs which in the view of either institution may raise ethical concerns;

(Amendment 96)

Recital 13a (new)

>Original text>

>Text following EP vote>

Whereas the long-term aim should be to create a centralised procedure at Community level for the release of GMOs, for instance along the lines of that used for the licensing of medicinal products; whereas the Commission should conduct a study of the possibility of centralised monitoring of the release of genetically modified organisms, for instance by the European Environment Agency in Copenhagen;

(Amendment 7)

Recital 17a (new)

>Original text>

>Text following EP vote>

Whereas there may be a wide range of causes of damage to the environment, not only GMOs; whereas EU-wide environment liability rules should therefore be introduced to provide wide-ranging regulation of possible cases of damage;

(Amendment 8)

Recital 18

>Original text>

Whereas in order to increase the effect of implementation of the provisions adopted under this directive, it is appropriate to provide for sanctions to be applied by Member States;

>Text following EP vote>

Whereas in order to increase the effect of implementation of the provisions adopted under this directive, it is appropriate to provide for sanctions to be applied by Member States;

whereas it is also appropriate to provide for sanctions against the unintentional release of GMOs;

(Amendment 61)

Recital 18a (new)

>Original text>

>Text following EP vote>

Whereas a study should be made of the likely socio-economic costs and benefits of the proposed deliberate release/market authorisation;

(Amendment 9)

ARTICLE 1(1)

Article 2(1) (Directive 90/220/EEC)

>Original text>

1. 'organism' is any biological entity capable of replication or of transferring genetic material;

>Text following EP vote>

1.

'organism' is any biological entity, with the exception of human beings, capable of replication or of transferring genetic material, including human genetic material for donation only.

(Amendment 10)

ARTICLE 1(1)

Article 2(2), 1st subparagraph (Directive 90/220/EEC)

>Original text>

2. 'genetically modified organism (GMO)' means an organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.

>Text following EP vote>

2.

'genetically modified organism (GMO)' means an organism, including DNA and plasmid, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination, excluding human beings as recipients of such alterations.

(Amendment 11)

ARTICLE 1(1)

Article 2(3a) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

3a. 'unauthorised release' means any release of GMOs or products for which no authorisation was given.

(Amendment 12)

ARTICLE 1(1)

Article 2(3b) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

3b. 'product' means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market.

(Amendment 13)

ARTICLE 1(1)

Article 2(4) (Directive 90/220/EEC)

>Original text>

4. 'placing on the market' means supplying or making available to third parties.

>Text following EP vote>

4.

'placing on the market' means supplying or making available to third parties with the exception of the handing over for examination purposes to administrative authorities.

(Amendment 14)

ARTICLE 1(1)

Article 2(5) (Directive 90/220/EEC)

>Original text>

5. 'notification' means the presentation of documents containing the requisite information to the competent authority of a Member State. The person making the presentation shall be referred to as 'the notifier'.

>Text following EP vote>

5.

'notification' means the presentation of documents containing the requisite information to, and if appropriate, the lodging of samples of the GMO or its genetic materials with, the competent authorities of a Member State. The person making the presentation shall be referred to as 'the notifier'.

(Amendment 15)

ARTICLE 1(1)

Article 2(6) (Directive 90/220/EEC)

>Original text>

6. 'environmental risk assessment' means the evaluation of the direct and indirect risks to human health and the environment which the deliberate release of GMOs into the environment may pose.

>Text following EP vote>

6.

'environmental risk assessment' means the evaluation of the direct and indirect risks to human health and the environment, including the evaluation of secondary and long-term effects, which the deliberate release of GMOs into the environment may pose.

(Amendment 16)

ARTICLE 1(1)

Article 2(6a)(new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

6a. 'use' means the deliberate release of a product which has been placed on the market. The persons carrying out this use will be referred to as 'users'.

(Amendment 79)

ARTICLE 1(1)

Article 3, 2nd paragraph (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

Nor shall it apply to pharmaceutical products for human use consisting of or containing a GMO or a combination of GMOs, provided that the Community legislation governing them provides for an environmental risk assessment equivalent to that set out in Annexes II and III of this Directive.

(Amendment 17)

ARTICLE 1(1)

Article 4(1) (Directive 90/220/EEC)

>Original text>

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 deliberate release of GMOs. To this end GMOs may only be deliberately released into the environment following an assessment of any potential risks for human health and/or the environment in conformity with Part B or Part C of this Directive. The risk assessment shall take account of the principles laid down in Annex II.

>Text following EP vote>

1.

Member States and the Commissionshall adopt the precautionary principle andshall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release of GMOs. To this end GMOs may only be deliberately released into the environment following an assessment of any potential risks for human health and/or the environment in conformity with Part B or Part C of this Directive. The risk assessment shall take account of the principles laid down in Annex II.

(Amendment 92)

ARTICLE 1(1)

Article 4(1a) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

1a. For all GMOs authorised for release under this Directive the notifier shall submit to the competent authority a description of identification methods of the GMO to ensure its traceability. The lodging of samples of the GMO or its genetic materials, including accompanying documents and labelling, shall be compulsory.

A register and a publicly accessible database subject to the provisions in Article 19 shall be maintained.

(Amendment 90)

ARTICLE 1(1)

Article 4(1b)(new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

1b. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are not released into the environment.

(Amendment 91)

ARTICLE 1(1)

Article 4(1c) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

1c. When consenting to a deliberate release, Member States and the Commission shall ensure that measures are taken to prevent gene-transfer from GMOs to other organisms in the environment.

(Amendment 73)

ARTICLE 1(1)

Article 4(2a) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

2a. In accordance with Annex II(A), certain categories of GMOs which contain characteristics or specific traits currently recognised as posing unacceptable risks to the environment or to human health or to biological diversity may not be released within the Community. Such list shall be reviewed and revised in the light of future knowledge. The Commission shall, in consultation with the competent authorities, produce supplementary criteria for the maintenance of this list.

(Amendment 19)

ARTICLE 1(1)

Article 4(3a)(new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

3a. Member States and the Commission shall ensure that no GMO and/or products thereof leave the territory of the European Union without the prior informed consent of the importing party/country.

(Amendment 20)

ARTICLE 1(1)

Article 4(3b)(new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

3b. In the event of an unauthorised or accidental release of a GMO, including importation, the Member State concerned shall take all necessary measures to terminate the release, to initiate remedial action to eliminate any damage caused and to inform other Member States, the Commission and the public.

(Amendment 21)

ARTICLE 1(1)

Article 4(3d)(new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

3d. Member States and the Commission shall ensure that, when GMOs or products made from GMOs are exported to non-Member States, the importing states are informed of the authorisation procedure in the European Union - if appropriate through exchange of data held by the Commission, having regard to Article 19 - to enable them to make an independent decision.

(Amendment 22)

ARTICLE 1(1)

Article 5 (Directive 90/220/EEC)

>Original text>

Article 5

Articles 6 to 9 shall not apply to any products under development covered by Community legislation which provides for a specific environmental risk assessment similar to that laid down in those articles.

>Text following EP vote>

Deleted

(Amendment 23)

ARTICLE 1(2)

Article 6a (3), introduction (Directive 90/220/EEC)

>Original text>

3. The competent authority shall verify the classification into Category I in accordance with the criteria referred to in Article 6(2) and shall examine the dossier for any potential risks to human health and/or the environment. The competent authority shall respond in writing to the notifier within 30 days of receipt of the notification by either:

>Text following EP vote>

3.

The competent authority shall verify the classification into Category I in accordance with the criteria referred to in Article 6(2) and shall examine the dossier for any potential risks to human health and/or the environment. The competent authority shall respond in writing to the notifier within 45 days of receipt of the notification by either:

(Amendment 24)

ARTICLE 1(2)

Article 6a(3a) (new )(Directive 90/220/EEC)

>Original text>

>Text following EP vote>

3a. The notifier may proceed with the release in the absence of any indication to the contrary from the competent authority concerned within 45 days.

(Amendment 86)

ARTICLE 1(2)

Article 6a(3b) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

3b. If the competent authority does not respond within 45 days the notifier may take legal action.

(Amendment 25)

ARTICLE 1(2)

Article 6b(2)(e) (Directive 90/220/EEC)

>Original text>

(e) information on monitoring, control, waste treatment and emergency response plans;

>Text following EP vote>

(e)

information on monitoring, control, remediation, waste treatment and emergency response plans;

(Amendment 26)

ARTICLE 1(2)

Article 6b(2a) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

2a. As part of the notification, in accordance with Annex VII the notifier shall also submit a detailed monitoring plan which indicates how optimum use will be made of the proposed experiments to gather scientific data with a view to determining any direct, indirect or delayed impact the GMO may have on human health and/or the environment.

(Amendment 27)

ARTICLE 1(2)

Article 6b(4) (Directive 90/220/EEC)

>Original text>

4. For the purpose of calculating the 90-day period referred to in paragraph 3, any periods of time during which the competent authority: (a) is awaiting further information which it may have requested from the notifier,

or

(b) is carrying out a public inquiry or consultation in accordance with Article 7

shall not be taken into account.

>Text following EP vote>

4.

For the purpose of calculating the 90-day period referred to in paragraph 3,

(a) any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier,

or

(b) periods of time not exceeding 90 days during which the competent authority is carrying out a public inquiry or consultation in accordance with Article 7

shall not be taken into account.

(Amendment 28)

ARTICLE 1(2)

Article 6c(1) (Directive 90/220/EEC)

>Original text>

1. In the case of part B releases planned to take place in more than one Member State, the applicant may choose to follow the procedure outlined in the following paragraphs.

>Text following EP vote>

Deleted

(Amendment 29)

ARTICLE 1(2)

Article 6c(6) (Directive 90/220/EEC)

>Original text>

6. For the purpose of calculating the 90-day period referred to in paragraph 5, any periods of time during which the competent authorities:

(a) are awaiting further information which it may have requested from the notifier,

>Text following EP vote>

6.

For the purpose of calculating the 90-day period referred to in paragraph 5,

(a) any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier,

>Original text>

or

(b) are carrying out a public inquiry or consultation in accordance with Article 7

shall not be taken into account.

>Text following EP vote>

or

(b) periods of time not exceeding 90 days during which the competent authority is carrying out a public inquiry or consultation in accordance with Article 7

shall not be taken into account.

(Amendment 30)

ARTICLE 1(2)

Article 6c(6a) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

6a. The public inquiry or consultation as referred to in paragraph 6(b) must be carried out within a period of no more than 90 days.

(Amendment 31)

ARTICLE 1(2)

Article 6d(2) (Directive 90/220/EEC)

>Original text>

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

>Text following EP vote>

2.

If information becomes available subsequently to the competent authority which could have significant consequences for the risks posed by the release, the competent authority must evaluate such information and may require the notifier to modify the conditions of, suspend or terminate the deliberate release.

(Amendment 32)

ARTICLE 1(2a) (new)

Article 7 (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

2a. Article 7 is replaced by the following text:

'Article 7

Without prejudice to the provisions of Article 19, the competent authority shall make available to the public information on all Part B releases of GMOs. Where necessary, public consultation may take place, though this must be completed within a period of not more than 90 days. The Commission shall lay down, pursuant to Article 21, the manner in which this consultation shall take place, prior to the implementation of the Directive.¨

(Amendment 33)

ARTICLE 1(2b) (new)

Article 8 (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

2b. Article 8 is replaced by the following text:

'Article 8

After completion of a release and, thereafter, at the intervals laid down in the release authorisation, the notifier shall inform the competent authority of the result and long-term consequences of the release in respect of any risk to human health or the environment.¨

(Amendment 34)

ARTICLE 1(3)

Article 9(2) (Directive 90/220/EEC)

>Original text>

2. The Commission shall immediately forward these summaries to the other Member States, which may, within 30 days, present observations through the Commission or directly.

>Text following EP vote>

2.

The Commission shall immediately forward these summaries to the other Member States, which may, within 30 days, present observations through the Commission or directly. At their request, Member States shall be permitted to receive a copy of the full notification and may request further information. For the purposes of calculating the 30-day period, any periods of time during which the competent authority is awaiting further information shall not be taken into account.

(Amendment 35)

ARTICLE 1(3)

Article 9(4) (Directive 90/220/EEC)

>Original text>

4. Once a year Member States shall send to the Commission and the competent authorities of the other Member States a list of GMOs which have been released on their territory in accordance with Article 6a(3)(a) and a list of notifications that were rejected in accordance

with Article 6a(3)(b).

>Text following EP vote>

4.

Once a year Member States shall send to the Commission and the competent authorities of the other Member States a list of GMOs which have been released on their territory in accordance with Article 6a(3)(a) and a list of notifications that were rejected in accordance

with Article 6a(3)(b). The summaries of the results of all deliberate releases, including any data resulting from monitoring, should also be circulated amongst Member States in order to promote knowledge and as a contribution towards harmonisation.

(Amendment 94)

ARTICLE 1(3)

Article 10 (Directive 90/220/EEC)

>Original text>

Articles 11 to 18 shall not apply to any products covered by Community legislation which provides for a specific environmental risk assessment similar to that laid down in this Directive.

>Text following EP vote>

Articles 11 to 18 shall not apply to any products covered by Community legislation which provides for a specific environmental risk assessment

conforming to that laid down in Annex II and Annex III of this Directive.

(Amendment 75)

ARTICLE 1(3)

Article 10, 2nd paragraph (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

Consent to the placing on the market of GMOs in or as a product shall be granted for a maximum initial period of twelve years.

(Amendment 37)

ARTICLE 1(3)

Article 11(2)(e) (Directive 90/220/EEC)

>Original text>

(e) a proposal for labelling which shall comply with the requirements laid down in Annex IV and which shall inform the consumer of the presence of GMOs in the product(s) whenever there is evidence that the product(s) contain(s) GMOs;

>Text following EP vote>

(e)

a proposal for labelling which shall comply with the requirements laid down in Annex IV and which shall inform the consumer of the presence of GMOs in the product(s) or that it (they) consist(s) of GMOs;

(Amendment 38)

ARTICLE 1(3)

Article 11(2)(fa) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

(fa) a certification system to ensure traceability of the GMO.

(Amendment 39)

ARTICLE 1(3)

Article 12(3), 1st subparagraph (Directive 90/220/EEC)

>Original text>

3. The assessment report shall indicate whether the GMO(s) in question should be placed on the market and under which conditions, if any, or whether additional assessment is required.

>Text following EP vote>

3.

The assessment report shall indicate whether the GMO(s) in question should be placed on the market and under what conditions, if any, or whether the GMO(s) in question shall not be placed on the market or whether additional assessment is required.

(Amendment 40)

ARTICLE 1(4)

Article 13a(2) (Directive 90/220/EEC)

>Original text>

2. The Commission, on its own initiative or on the proposal of a competent authority, may adopt criteria and information requirements to be met for the notification of deliberate releases for placing on the market of certain types of GMOs as or in products under the simplified procedure laid down in Article 13b, after consultation of the relevant Scientific Committee(s), in accordance with the procedure laid down in Article 21. The criteria and the information requirements shall be based on safety to human health and/or the environment and on the scientific evidence available on such safety and on the experience gained with the release of comparable GMOs.

>Text following EP vote>

2.

The Commission, on its own initiative or on the proposal of a competent authority, may adopt criteria and information requirements to be met for the notification for placing on the market of certain types of GMOs as or in products under the simplified procedure laid down in Article 13b, after consultation of the relevant Scientific Committee(s), in accordance with the procedure laid down in Article 21. The criteria and the information requirements shall be based on safety to human health and/or the environment and on the scientific evidence available on such safety and on the experience gained with the release of comparable GMOs.

(Amendment 41)

ARTICLE 1(4)

Article 13b(6) (Directive 90/220/EEC)

>Original text>

6. In the absence of any reasoned objection from a competent authority of a Member State or the Commission within 30 days following the date of circulation of the notification dossier or if possible outstanding issues are resolved within the 45 day period referred to in paragraph 5, the competent authority that received the original notification shall give its consent in writing within 15 days so that the product can be placed on the market and shall inform the Commission and the competent authorities of the other Member States thereof. The consent shall be granted for a fixed period of seven years.

>Text following EP vote>

6.

In the absence of any reasoned objection from a competent authority of a Member State or the Commission within 30 days following the date of circulation of the notification dossier or if possible outstanding issues are resolved within the 45 day period referred to in paragraph 5, the competent authority that received the original notification shall give its consent in writing within 15 days so that the product can be placed on the market and shall inform the Commission and the competent authorities of the other Member States thereof. The consent can, pursuant to Article 13e(3), be restricted to a period of 12 years after the placing on the market, where there is not adequate monitoring experience concerning the placing on the market of comparable GMOs.

(Amendment 42)

ARTICLE 1(4)

Article 13c(4) (Directive 90/220/EEC)

>Original text>

4. In the absence of any reasoned objection from a Member State or the Commission within 30 days following the date of submission referred to in paragraph 3, the competent authority that received the original notification shall give its consent in writing for the renewal of the original consent and shall inform the other Member States and the Commission thereof. The consent shall be granted for a fixed period of seven years.

>Text following EP vote>

4.

In the absence of any reasoned objection from a Member State or the Commission within 30 days following the date of submission referred to in paragraph 3, the competent authority that received the original notification shall give its consent in writing for the renewal of the original consent and shall inform the other Member States and the Commission thereof.

(Amendment 43)

ARTICLE 1(4)

Article 13ca (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

Article 13ca

In the event of an acute risk, the placing on the market must be halted and, as far as possible, the GMOs placed on the market must be recovered. In addition, the public must be informed of the risk posed by the GMOs placed on the market.

(Amendment 44)

ARTICLE 1(4)

Article 13d(1), 2nd subparagraph (Directive 90/220/EEC)

>Original text>

For the purpose of calculating the three month period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of a Scientific Committee which has been consulted shall not be taken into account.

>Text following EP vote>

For the purpose of calculating the three month period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or

, in cases where there is no comprehensive experience, is seeking the opinion of a Scientific Committee which has been consulted shall not be taken into account. The Committee must draw up its opinion within 120 days.

(Amendment 45)

ARTICLE 1(4)

Article 13d(2) (Directive 90/220/EEC)

>Original text>

2. Where the Commission has taken a favourable decision, the competent authority that received the original notification shall give, within 30 days following the publication of the Commission decision, consent in writing to the notification so that the product may be placed on the market for the period of seven years and shall inform the other Member States and the Commission thereof.

>Text following EP vote>

2.

Where the Commission has taken a favourable decision, the competent authority that received the original notification shall give, within 30 days following the publication of the Commission decision, consent in writing to the notification so that the product may be placed on the market and shall inform the other Member States and the Commission thereof.

(Amendment 87)

ARTICLE 1(4)

Article 13d(2a) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

2a. The competent authority, when granting consent, can impose additional conditions for the protection of environmentally sensitive areas. It shall inform the Commission and the other Member States of this immediately, stating the reasons.

(Amendment 46)

ARTICLE 1(4)

Article 13e(3) (Directive 90/220/EEC)

>Original text>

3. Consent to the placing on the market of GMOs in or as a product shall be granted for a fixed period of seven years. The notifier may proceed with the placing on the market only when he has received the written consent of the competent authority in accordance with Articles 13, 13b, 13c and 13d, and in conformity with any conditions, including reference to particular ecosystems/environments, required in that consent.

>Text following EP vote>

3.

Consent to the placing on the market of GMOs in or as a product shall be granted for a fixed period of twelve years after the start of marketing. In such a case the notifier must gather his own experiences and any objections brought to his attention in connection with the aspects listed in Annex VII, assess them and forward them to the competent authorities which shall then act in accordance with the procedure set out in Article 13c. Article 13d(1), second subparagraph, shall not apply.

>Original text>

>Text following EP vote>

If during this process the competent authorities reach the view that new information has become available which could have a significant impact on the risks associated with marketing, they can call on the notifier to cease marketing activities either temporarily or permanently.

>Original text>

>Text following EP vote>

The notifier may proceed with the placing on the market only when he has received the written consent of the competent authority in accordance with Articles 13, 13b, 13c and 13d, and in conformity with any conditions, including reference to particular ecosystems/environments, required in that consent.

(Amendment 89)

ARTICLE 1(4)

Article 13e(5) (Directive 90/220/EEC)

>Original text>

5. If the competent authority receives additional information pursuant to paragraph 4, it shall immediately inform the Commission and the competent authorities of the other Member States.

>Text following EP vote>

5.

If the competent authority receives additional information pursuant to paragraph 4, or otherwise, which could have significant consequences for the risks posed by the release, the competent authority or the Commission may require the notifier to modify the conditions of, suspend or terminate the deliberate release, take any necessary remedial action and shall immediately inform the Commission and the competent authorities of the other Member States of the action taken.

(Amendment 48)

ARTICLE 1(4)

Article 13e(5a) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

5a. Should cases of unauthorised release and unauthorised placing on the market come to light, the authority shall immediately call on the notifier to halt the release/placing on the market and take all the steps required to deal with any consequences.

(Amendment 49)

ARTICLE 1(4)

Article 13e(5b) (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

5b. In the event of an acute risk, the placing on the market must be halted and, as far as possible, the GMOs placed on the market must be recovered. In addition, the public must be informed of the risk posed by the GMOs placed on the market.

(Amendment 50)

ARTICLE 1(4)

Article 13e(5c)(new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

5c. The competent authority, when granting consent, can impose additional conditions for the protection of environmentally sensitive areas. It shall inform the Commission and the other Member States of this immediately, stating the reasons.

(Amendment 51)

ARTICLE 1(4)

Article 13ea (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

Article 13ea

1. In connection with the export of GMOs and/or products containing GMOs to non-Member States, the exporter or importer must obtain

- consent to the import from the country of destination and

- export authorisation from the authority of the competent Member State

2. The country of destination must give its consent to the import before the authority of the competent Member State can issue its authorization.

(Amendment 52)

ARTICLE 1(5)

Article 14 (Directive 90/220/EEC)

>Original text>

Member States shall take all necessary measures to ensure that the labelling and packaging of products containing, or consisting of, GMOs comply with relevant proposal in the dossier and with the relevant requirements specified in the written consent referred to in Articles 13(3), 13b(6), 13c(4) or 13d(2).

>Text following EP vote>

Member States shall take all necessary measures to ensure that the labelling

, the certification system to ensure traceability and packaging of products containing, or consisting of, GMOs comply with relevant proposal in the dossier and with the relevant requirements specified in the written consent referred to in Articles 13(3), 13b(6), 13c(4) or 13d(2).

(Amendment 53)

ARTICLE 1(7)

Article 16(1) (Directive 90/220/EEC)

>Original text>

1. Where a Member State, as a result of new information or reassessment of existing information, has detailed grounds for considering that a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that product on its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.

>Text following EP vote>

1.

Where a Member State, as a result of additional information or reassessment of existing information, has detailed grounds for considering that a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that product on its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.

(Amendment 54)

ARTICLE 1(10)

Article 20a, 2nd and 3rd paragraphs (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

The Commission or the Member States or the European Parliament may consult any committee, created by the Commission with a view to advising it on the ethical implications of biotechnology, on issues which, in the view of the Commission or the Member States or the European Parliament, may raise ethical concerns.

>Original text>

>Text following EP vote>

The Commission shall take the necessary measures to ensure that these consultation processes are conducted under clear rules of openness and transparency with full public accessibility and do not unduly delay the decision procedures of this Directive and, in any case, do not exceed three months.

(Amendment 55)

ARTICLE 1(11)

Article 21, 4th and 5th paragraphs (Directive 90/220/EEC)

>Original text>

If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

>Text following EP vote>

If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council

and to the European Parliament a proposal relating to the measures to be taken. The Council shall act by a qualified majority. The European Parliament shall act by an absolute majority of its members.

>Original text>

If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority¨.

>Text following EP vote>

If, on the expiry of a period of three months from the date of referral to the Council

and the European Parliament, neither the Council nor the European Parliament has acted, the proposed measures shall be adopted by the Commission, save where the Council or the European Parliament has decided against the said measures by a simple majority¨.

(Amendment 95)

ARTICLE 1(12)

Article 22aa (new) (Directive 90/220/EEC)

>Original text>

>Text following EP vote>

Article 22 aa

Those legally responsible for deliberate releases of genetically modified organisms shall have strict civil liability for any damage to human health and the environment caused by the releases in question. Before the activities begin, they shall take out sufficient liability insurance to cover such losses as might be occasioned thereby.

(Amendment 57)

ANNEX II, after title

>Original text>

>Text following EP vote>

The rationale of any risk assessment should be precautionary approach. The lack of full scientific certainty or consensus regarding the levels of risks or the likelihood of unwanted effects should not be used as a reason for postponing measures to prevent these risks.

(Amendment 58)

ANNEX II (A)(1), 1st indent

>Original text>

- pathogenicity to humans, animals or plants

>Text following EP vote>

-

pathogenicity to humans, animals, plants or microorganisms

(Amendment 59)

ANNEX II (A)(2)

>Original text>

2. Elements which form the basis of the risk assessment:

- the characteristics of the non-modified organism(s), and of the

- introduced trait(s) which give rise to the GMO(s),

- the characteristics of the intended use,

- the receiving environment, and

- the interaction between these.

>Text following EP vote>

2. Elements which form the basis of the risk assessment:

- the characteristics of the non-modified organism(s), and of the

- introduced trait(s) which give rise to the GMO(s),

- the characteristics of the intended use,

- the receiving environment (physical and socio-economic), and

- the interaction between these.

>Original text>

Information from releases of similar organisms and similar traits and their interaction with similar environments can assist the risk assessment.

>Text following EP vote>

Available information from releases of similar organisms and similar traits and their interaction with similar environments must be used to assist the risk assessment.

(Amendment 60)

ANNEX II (B)(5)

>Original text>

If for any release the estimated risk for any identified hazard is not an acceptable level, the GMO(s) or the conditions of the release should be modified to reduce the risk.

>Text following EP vote>

If for any release the estimated risk for any identified hazard is not an acceptable level,

the release must be banned, halted and, as far as possible, reversed. It may be carried out only after the GMO(s) or the conditions of the release have been modified in such a way as to reduce the risk significantly.

(Amendment 62)

ANNEX II (Ba)(new)

>Original text>

>Text following EP vote>

Ba. Where the scientific information that is needed for a risk assessment is inadequate, this should be made clear and any decision based on that assessment should err on the side of safety to the public.

(Amendment 63)

ANNEX III A(I) (Ca) (new)

>Original text>

>Text following EP vote>

Ca. Description of a procedure demonstrating the presence of the GMOs.

(Amendment 64)

ANNEX III A (V)(D)(5a)(new)

>Original text>

>Text following EP vote>

5a. Description of a procedure demonstrating the presence of the GMOs.

(Amendment 65)

ANNEX III B(G)(4)

>Original text>

4. Description of monitoring plans and techniques.

>Text following EP vote>

4.

Description of monitoring plans and techniques and their duration and frequency.

(Amendment 66)

ANNEX IV(B)(5a) (new)

>Original text>

>Text following EP vote>

5a. Proposed certification system to enable the GMO or products to be distinguished at all stages from non-GMO products. This must include specific detection methods.

(Amendment 67)

ANNEX IV (C) (1) and (2)

>Original text>

1. A Proposal for a mandatory labelling 'this product contains GMOs', either on a label or in accompanying document, whenever there is evidence of the presence of GMOs in the product.

2. A proposal for a mandatory labelling 'this product may contain GMOs' where the presence of GMOs in a product cannot be excluded but there is no evidence of any presence of GMOs.

>Text following EP vote>

A Proposal for a mandatory labelling 'this product contains

or consists of genetically modified organisms', either on a label or in an accompanying document. This proposal must be based on a scientific assessment for which at present the presence of genetically modified proteins or DNA is the criterion which best meets these requirements.

(Amendment 68)

ANNEX V (A)(3)

>Original text>

3. The genetically modified organism should not present additional or increased risks to human health and/or the environment under the conditions of the experimental release that are not presented by releases of the corresponding non-modified organism in terms of pathogenicity, allergenicity and toxigenicity. The capacity to spread in the environment and invade other unrelated ecosystems and capacity to transfer genetic material to other organisms in the environment should not create any adverse effect.

>Text following EP vote>

3.

The genetically modified organism should not present additional or increased risks to human health and/or the environment under the conditions of the experimental release that are not presented by releases of the corresponding non-modified organism in terms of pathogenicity, allergenicity and toxigenicity. The capacity to spread uncontrolledly in the environment and capacity to transfer genetic material to other organisms in the environment must be ruled out as far as possible. At all events, it must not create any adverse effect.

(Amendment 101)

ANNEX V (A) (3a) (new)

>Original text>

>Text following EP vote>

3a. The genetically modified organism must not contain any antibiotic-resistant genes or traces of toxic or pathogenic substances.

Legislative resolution embodying Parliament's opinion on the proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (COM(98)0085 - C4-0129/98 - 98/0072(COD))(Codecision procedure: first reading)

The European Parliament,

- having regard to the Commission proposal to Parliament and the Council (COM(98)0085 - 98/0072(COD)) ((OJ C 139, 4.5.1998, p. 1.))

- having regard to Articles 189b(2) and 100a of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C4-0129/98),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection and the opinions of the Committee on Agriculture and Rural Development and the Committee on Research, Technological Development and Energy (A4-0024/99),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to incorporate Parliament's amendments in the common position that it adopts in accordance with Article 189b(2) of the EC Treaty;

4. Should the Council intend to depart from the text approved by Parliament, calls on the Council to notify Parliament and requests that the conciliation procedure be initiated;

5. Points out that the Commission is required to submit to Parliament any modification it may intend to make to its proposal as amended by Parliament;

6. Instructs its President to forward this opinion to the Council and Commission.