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REPORT     
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28 January 1999
PE 227.836/fin. A4-0024/99
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))
Committee on the Environment, Public Health and Consumer Protection
Rapporteur: David Bowe
By letter of 23 February 1998 the Commission submitted to Parliament, pursuant to Articles 189b(2) and 100A of the EC Treaty, 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.
 A LEGISLATIVE PROPOSAL DRAFT LEGISLATIVE RESOLUTION
 B EXPLANATORY STATEMENT
 OPINION
 OPINION

 By letter of 23 February 1998 the Commission submitted to Parliament, pursuant to Articles 189b(2) and 100A of the EC Treaty, 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.

At the sitting of 9 March 1998 the President of Parliament announced that he had referred this proposal to the Committee on the Environment, Public Health and Consumer Protection as the committee responsible and the Committee on Research, Technological Development and Energy for its opinion, and the documents were also referred to the Committee on Agriculture and Rural Development on 30 March 1998 for its opinion.

At its meeting of 6 January 1998 the Committee on the Environment, Public Health and Consumer Protection had appointed Mr David Bowe rapporteur.

It considered the Commission proposal and the draft report at its meetings of 24 November 1998 and 21 January 1999.

At the latter meeting it adopted the draft legislative resolution by 15 votes, with 11 abstentions.

The following took part in the vote: Collins, president; Lannoye, vice-president; Bowe, rapporteur; Breyer, Eisma, Flemming, Florenz, Gebhardt (for Jensen K.), Graenitz, Grossetête, Hardstaff (for White), Holm (for Tamino), Jackson, Kestelijn-Sierens (for Olsson), Kuhn, Liese (for Schnellhardt), Marinucci, McKenna, Oomen-Ruijten, Pollack, van Putten, Roth-Behrendt, Schleicher, Sjöstedt (for Bertinotti), Trakatellis, Virgin

The opinions of the Committee on Agriculture and Rural Development and the Committee on Research, Technological Development and Energy are attached.

The report was tabled on 28 January 1999.

The deadline for tabling amendments will be indicated in the draft agenda for the relevant partsession.


 A LEGISLATIVE PROPOSAL DRAFT LEGISLATIVE RESOLUTION

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 - C40129/98 - 98/0072(COD))

This proposal is approved with the following amendments:

Text proposed by the Commission(1)

Amendments by Parliament

(Amendment 1)
Recital 4a (new)

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

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;

Deleted.

(Amendment 3)
Recital 5a (new)

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)

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 5)
Recital 7

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.

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

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;

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 either of their views may raise ethical concerns;

(Amendment 7)
Recital 17a (new)

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

(Amendment 8)
Recital 18

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 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 9)
ARTICLE 1(1)
Article 2(1)(Directive 90/220/EEC)

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

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) (Directive 90/220/EEC)

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.

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)

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)

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)

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

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)

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'.

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)

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.

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)
(retention of the former Article 2(7))

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 17)
ARTICLE 1(1)
Article 4(1)(Directive 90/220/EEC)

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.

1. Member States and the European Commission will adopt the precautionary principle and 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.

(Amendment 18)
ARTICLE 1(1)
Article 4(1b)(new)(Directive 90/220/EEC)

1b. All GMOs authorised for release under this Directive shall carry unique genetic tags to assist ease of identification. The competent authorities shall maintain a register of such tags on a publicly accessible database subject to the provisions in Article 19.

(Amendment 19)
ARTICLE 1(1)
Article 4(3a)(new)(Directive 90/220/EEC)

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

(Amendment 20)
ARTICLE 1(1)
Article 4(3c)(new)(Directive 90/220/EEC)

3c. 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)

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 EU - 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)

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.

Delete

(Amendment 23)
ARTICLE 1(2)
Article 6a (3)(Directive 90/220/EEC)

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:

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:

a) indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed, or

a) indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed, or

b) indicating that the release does not fulfil the conditions of this Directive and the notification is therefore rejected.

b) indicating that the release does not fulfil the conditions of this Directive and the notification is therefore rejected.

(Amendment 24)
ARTICLE 1(2)
Article 6a(3a) (new)(Directive 90/220/EEC)

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 25)
ARTICLE 1(2)
Article 6b(2)(e)(Directive 90/220/EEC)

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

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

(Amendment 26)
ARTICLE 1(2)
Article 6b(-3) (Directive 90/220/EEC)

-3. 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)

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,

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

or

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

(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.

shall not be taken into account.

(Amendment 28)
ARTICLE 1(2)
Article 6c(1) (Directive 90/220/EEC)

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.

Delete

(Amendment 29)
ARTICLE 1(2)
Article 6c(6) (Directive 90/220/EEC)

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,

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,

or

or

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

(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.

shall not be taken into account.

(Amendment 30)
ARTICLE 1(2)
Article 6c(6a) (new)

6a. The public inquiry or consultation as referred to in Article 6c(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)

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.

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)

Where a Member State considers it appropriate, it may provide that Groups or the public shall be consulted on any aspect of the proposed deliberate release.

Without prejudice to the provisions of Article 19, the consenting 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(2)a (new)
Article 8 (Directive 90/220/EEC)

After completion of a release, the notifier shall send to the competent authority the result of the release in respect of any risk to human health or the environment, with particular reference to any kind of product that the notifier intends to notify at a later stage.

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 longterm 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)

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.

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)

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 accordancewith Article 6a(3)(b).

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 accordancewith 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 36)
ARTICLE 1(3)
Article 10(1)(Directive 90/220/EEC)

1. 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.

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

(Amendment 37)
ARTICLE 1(3)
Article 11(2)(e) (Directive 90/220/EC)

(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;

(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)

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

(Amendment 39)
ARTICLE 1(3)
Article 12(3)(Directive 90/220/EEC)

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.

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.

The assessment reports shall be established in accordance with the guidelines laid down in Annex VI.

The assessment reports shall be established in accordance with the guidelines laid down in Annex VI.

(Amendment 40)
ARTICLE 1(4)
Article 13a(2)(Directive 90/220/EEC)

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.

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)

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.

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)

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.

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.

Article 13ca

(Amendment 43)
ARTICLE 1(4)
Article 13ca (new)(Directive 90/220/EEC)

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) (Directive 90/220/EEC)

1. In cases where an objection is raised and maintained in accordance with Article 13(2), 13b(5) or 13c(3), or an additional assessment is required in accordance with Article 12(3), the Commission shall take a decision within three months in accordance with the procedure laid down in Article 21.

1. In cases where an objection is raised and maintained in accordance with Article 13(2), 13b(5) or 13c(3), or an additional assessment is required in accordance with Article 12(3), the Commission shall take a decision within three months in accordance with the procedure laid down in Article 21.

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.

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, but which must draw up this opinion within 120 days, shall not be taken into account.

(Amendment 45)
ARTICLE 1(4)
Article 13d(2)(Directive 90/220/EEC)

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.

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 46)
ARTICLE 1(4)
Article 13e(3)(Directive 90/220/EEC)

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.

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 sentence, shall not apply.

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.

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.

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 47)
ARTICLE 1(4)
Article 13e(5)(Directive 90/220/EEC)

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.

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 may require the notifier to modify the conditions of, suspend or terminate the deliberate release, take any necessary remedial action and it 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)

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)

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)

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.

Article 13ea

(Amendment 51)
ARTICLE 1(4)
Article 13ea (new)(Directive 90/220/EEC)

1. In connection with the export of GMOs and/or products containing GMOs to nonMember 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)

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).

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)

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.

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.

The relevant Scientific Committee(s) shall be consulted by the Commission on any matter which is likely to have an effect on human health and/or the environment before the decision procedure referred to in Articles 13d(1) or 16(2) is initiated.

(Amendment 54)
ARTICLE 1(10)
Article 20a (Directive 90/220/EEC)

The relevant Scientific Committee(s) shall be consulted by the Commission on any matter which is likely to have an effect on human health and/or the environment before the decision procedure referred to in Articles 13d(1) or 16(2) is initiated.

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.

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 (Directive 90/220/EEC)

Where the procedure defined in this Article is to be implemented, the Commission shall be assisted by a Committee composed of the representatives of the Member States and chaired by the representative of the Commission, hereinafter referred to as the 'Committee'.

Where the procedure defined in this Article is to be implemented, the Commission shall be assisted by a Committee composed of the representatives of the Member States and chaired by the representative of the Commission, hereinafter referred to as the 'Committee'.

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.

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.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

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.

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.

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".

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".

Article 22aa

(Amendment 56)
Article 1(12)
Article 22aa (new)(Directive 90/220/EEC)

Those legally responsible for deliberate releases of genetically modified organisms shall have full civil and criminal 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.

Principles for the environmental risk assessment

(Amendment 57)
ANNEX II, title (addition)

Principles for the environmental risk assessment

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 to occur should not be used as a reason for postponing measures to prevent these risks.

(Amendment 58)
ANNEX II (A)(1)

A The environmental risk assessment referred to in Articles 6 and 11 shall take into account the following :

A The environmental risk assessment referred to in Articles 6 and 11 shall take into account the following :

1. Elements which may be considered as potentially harmful effects :

1. Elements which may be considered as potentially harmful effects :

- pathogenicity to humans, animals or plants

- pathogenicity to humans, animals, plants or microorganisms

- compromising of prophylactic or therapeutic treatments

- compromising of prophylactic or therapeutic treatments

- effects on population dynamics within the receiving environment

- effects on population dynamics within the receiving environment

- effects on geochemistry

- effects on geochemistry

- the uncontrolled spread of the GMO(s) in the environment and invasion of unrelated ecosystems

- the uncontrolled spread of the GMO(s) in the environment and invasion of unrelated ecosystems

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

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

- phenotypic and genetic instability.

- phenotypic and genetic instability

(Amendment 59)
ANNEX II (A)(2)

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

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

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

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

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

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

-the characteristics of the intended use,

-the characteristics of the intended use,

-the receiving environment, and

-the receiving environment (physical and socioeconomic), and

-the interaction between these.

-the interaction between these.

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

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)

5. Application of management strategies for risks from the deliberate release of GMO(s)

5. Application of management strategies for risks from the deliberate release of GMO(s)

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.

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.

6a. Socio-economic cost benefit analysis

(Amendment 61)
ANNEX II (B)(6a)(new)

A study shall be made of the likely socioeconomic costs and benefits of the proposed deliberate release/market authorisation.

(Amendment 62)
ANNEX II (C)(new)

C. 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.

C. Title of the project.

(Amendment 63)
ANNEX III A(I)

I. GENERAL INFORMATION

I. GENERAL INFORMATION

A. Name and address of the notifier

A. Name and address of the notifier

(company or institute)

(company or institute)

B. Name, qualifications and experience of the responsible scientist(s)

B. Name, qualifications and experience of the responsible scientist(s)

C. Title of the project.

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

(Amendment 64)
ANNEX III A (V)(D)(5a)(new)

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

(Amendment 65)
ANNEX III B(G)(4)

4. Description of monitoring plans and techniques.

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

(Amendment 66)
ANNEX IV(B)(5a) (new)

Error in DE version

5a. proposed certification system to keep the GMO or products indentified at all stages from non-GMO products. This must include specific detection methods.

(Amendment 67)
ANNEX IV (C) (1) and (2)

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.

A Proposal for a mandatory labelling 'this product contains or consists of genetically modified organisms', either on a label or in 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.

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.

(Amendment 68)
ANNEX V (A)(3)

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.

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.

a. The genetically modified organism should have no wild relatives with which it could hybridise under natural conditions, nor should it have the potential to become established as a weed.

(Amendment 69)
ANNEX V (A)(3a)(new)

b. In particular they must not contain any antibiotic resistant genes or any allergy causing toxic or pathogenic trails and /or any unnecessary or not fully described/characterised DNA sequences.

5. A conclusion on whether the GMO(s) in question should be placed on the market in or as (a) product(s) and under which conditions or whether an additional assessment is required on certain aspects. The aspects which require additional assessment should be specified.

(Amendment 70)
ANNEX VI

GUIDELINES FOR THE ASSESSMENT REPORTS FORESEEN BY ARTICLE 12

MINIMUM REQUIREMENTS FOR THE ASSESSMENT REPORTS FORESEEN BY ARTICLE 12

The assessment report foreseen by Article 12 should include in particular the following:

The assessment report foreseen by Article 12 should include in particular the following:

1. Identification of the characteristics of the recipient organism which are relevant to the assessment of the GMO(s) in question. Identification of any known risks to human health and/or the environment resulting from the release into the environment of the recipient non-modified organism;

1. Identification of the characteristics of the recipient organism which are relevant to the assessment of the GMO(s) in question. Identification of any known risks to human health and/or the environment resulting from the release into the environment of the recipient non-modified organism;

2. Assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and/or the environment;

2. The full risk assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and/or the environment;

3. Detailed description of the results of the genetic modification in the modified organism;

3. Detailed description of the results of the genetic modification in the modified organism;

4. Identification of any new risks to human health and/or the environment that may arise from the release of the GMO(s) in question as compared to the release of the corresponding non-modified organism(s) based on the risk assessment as described in Annex II;

4. Identification of any new risks to human health and/or the environment that may arise from the release of the GMO(s) in question as compared to the release of the corresponding non-modified organism(s) based on the risk assessment as described in Annex II;

5. A conclusion on whether the GMO(s) in question should be placed on the market in or as (a) product(s) and under which conditions or whether an additional assessment is required on certain aspects. The aspects which require additional assessment should be specified.

In the event of a ban on the placing on the market the key reasons for the ban shall be specified.

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))(2)

- having regard to Articles 189b(2) and 100Aof 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 (A40024/99),

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.

(1)() OJ C 139, 4.5.1998, p. 1.
(2)() OJ C 139, 4.5.1998, p. 1.


 B EXPLANATORY STATEMENT

Background and Introduction

The present Commission proposal is a revision of Directive 90/220/EEC, which covers both deliberate releases for experimental purposes, and deliberate releases for placing on the market of products. It also secures human and environmental safety for releases and marketing of genetically modified organisms (GMOs) and introduces a single entry point to the Community for GMO products.

The Commission recognised the importance of biotechnology as a growth industry with considerable employment potential when it published its communication on Biotechnology and the White Paper on Growth, Competitiveness and Employment (June 1994). At that point, the Commission confirmed that "in the future the whole network of interrelated biotechnological regulations needs to ensure that regulation is always appropriate to the risks involved, the building of public confidence and to the competitive development of the industries involved while guaranteeing the protection of human health and the environment".

It was in this context that the Commission adopted a Report on the review of Directive 90/220 (COM(96)0630 Final), to which the European Parliament responded in a resolution adopted in plenary on 16 July 1997. The resolution broadly welcomed the Commission"s proposals, but went further by calling, for example, for a civil liability provision; for an ethical dimension in decisionmaking procedures; and for a clear, harmonised definition of risk assessment, including impact on the environment.

Genetically modified organisms and in particular their use in food crops, have been the focus of intense public debate throughout the European Union. In the UK, groups of environmental activists have torn up fields of experimental releases, whilst in Austria, there was a mass public petition against GMO crops. On the one hand, industry argues that GM crops pose little risk and present enormous potential benefits. On the other hand, environmentalists point to a perceived lack of knowledge and understanding of the risks, and to possible developments such as the creation of "super weeds” and the passing of antibiotic resistance through the food chain. Furthermore, consumers have complained that GM products have been forced upon them and that the labelling system is not transparent and hampers choice.

The rapporteur welcomes the public debate that biotechnology has engendered and believes that public participation is essential to the acceptance of biotechnology. The aim of this revision must be to guarantee the highest level of protection for human health and the environment possible and it is essential that measures be taken in order to build consumer confidence in the technology.

The Commission proposal

Part A - General Provisions

This covers the definitions used for the purposes of the directive. It reaffirms the Precautionary Principle as the basis upon which the approval process is constructed. The development of the general provisions of the proposal, in particular the improvement of certain definitions is welcomed. However, the rapporteur believes that some of the definitions need to be made more precise in order to clarify the scope of the directive and in order to avoid conflicting implementation of the directive in the Member States. For example, the definition of environmental risk assessment is further elaborated, by ensuring the principles of risk assessment are incorporated into the directive in a truly comprehensive and satisfactory way.

Concerns have also been raised that, without a requirement for prior informed consent, exports of GMOs could take place to third countries that might not have the scientific knowledge or the technology to deal with them. The rapporteur has therefore introduced a new paragraph to Article 4 of the directive to ensure that such a consent is required.

Part B - Deliberate release for research and development

The rapporteur believes that it is necessary to reinforce this part of the directive in order to provide safeguards for public health and the environment.

One of the principal concerns raised by the Commission"s proposal is the verticalisation or 'hollowing out" of the directive which would be introduced by Article 5. This article excludes from part B (articles 6-9) of the directive, products which undergo a risk assessment that is only "similar" rather than as a minimum, equivalent or identical to that laid down in part B of the new proposal. The rapporteur believes that this is not acceptable and reflects the often piecemeal and incoherent approach to European Union legislation covering genetically modified products. The rapporteur therefore proposes deletion of Article 5.

The Commission has sought, in the remainder of part B, to introduce a streamlining of the administrative procedures, including the creation of two categories of releases. This principle has been accepted in the new revised proposal for Directive 90/219 (contained use of genetically modified micro-organisms) and would seem appropriate in this directive. Experience indicates that it is necessary to establish a classification commensurate with the identified risks involved with the release. It will then be possible to put category I GMOs, for which information is available, through a streamlined procedure, which replaces the simplified procedures in the original directive

The Commission has also increased the requirements of public consultation and exchange of information. However, the rapporteur does not feel that the Commission has gone far enough. Much more information will need to be published and made available to the public. Public participation is to be welcomed and extended, but reasonable time limits should be set to avoid unnecessary delays to the notification process. This will allow industry to plan ahead within a stable legal framework. It is also the rapporteur"s opinion that the quality of decision-making is not necessarily improved by the length of time spent in discussion. However, in some cases, it has been necessary to increase the time limits set by the Commission, for example in Article 6, which were unreasonably short.

The requirement for information gathering and monitoring are important to ensure long-term safety and the development of experience among Member States. The information from the experience of experimental releases is particularly important and must be available to all member states, as soon as possible. Provisions for long-term monitoring are to be especially welcomed and will be very important in the renewal of time limited consents.

Part C - Placing on the market of products containing GMOs

This part of the directive defines the procedure to be followed in the case of the placing on the market of products containing or consisting of GMOs. It has proved unsatisfactory and has led to considerable delays in receiving product approval.

The Commission attributed the delays to the cumbersome decision-making procedures in the 1990 directive. It has therefore proposed a procedure that involves all Member States from the very beginning and that should ensure greater transparency than was previously the case.

A clear and coherent labelling policy is vital to establish consumer confidence in this new technology. There needs to be a clear link between the labelling provision in this directive and the Novel Foods Regulation. The rapporteur has introduced a means by which an organism can be identified. The importance of this issue and achieving a satisfactory outcome should not be underestimated in gaining the necessary public confidence for the legislation to function effectively.

The rapporteur welcomes the provision to consult the relevant Scientific Committee(s) on any issue likely to have an effect on human health and/or the environment. However, the committee should be constructed and should function in such a way that it engenders public trust and confidence. Therefore it is necessary that the Commission introduce new rules for these committees, which ensure openness, transparency and public accessibility to their deliberations. Furthermore, the rapporteur believes that given the ethical questions that the use of biotechnology can raise, the directive should also include the possibility to refer certain issues to the Commission"s Ethical Committee. It should be clear, however, that the scientific and ethical committees are there to give advice and should not be expected to take political decisions.

The comitolgy has given rise to considerable difficulties, as the Austrian and Luxembourg bans of GM maize have shown. The Commission has proposed giving more influence over decision-making to the Member States, by changing the committee procedure from IIIa) to IIIb). Although this cannot be a long-term solution, the rapporteur welcomes this change for the time being. However, he believes that this problem cannot be solved properly until the revision of the comitology procedure, as foreseen by the Amsterdam European Council, is incorporated into the proposal. In the meantime, the rapporteur proposes to accept the amendments from the Energy Committee, which embody the view that the European Parliament must be involved in the decision-making process.

The Commission proposal did not include a liability clause, mainly on the justification that a general liability proposal should be issued by the Commission in the near future. This was the argument used when the original directive was first discussed and nothing has been forthcoming since. The rapporteur believes that this is an important issue, as it will be an incentive for industry to ensure the safety of their releases.

The Annexes

In general, the rapporteur feels that the annexes are adequate. However, amendments have been tabled to certain important areas. In particular, it is necessary to clarify the principles of risk assessment to establish more clearly what is and what is not within the scope of the risk assessment.

Annex II deals with the environmental risk assessment. The rapporteur believes that it is necessary to increase the amount of information that should be used to assist the risk assessment. He also supports a strengthening of the Precautionary Principle, by highlighting that a lack of full scientific certainty should not lead to a postponement of risk prevention measures and by calling for any release with a risk that is higher than an acceptable level to be banned, halted, or, if possible, reversed.

One of the criticisms of policy-making in the biotechnology field is that little reference is made to its impact on society as a whole. The rapporteur is of the opinion that legislation regarding biotechnology and, for that matter, other areas, can be improved, if it is accepted that scientific and technological progress does not take place in a vacuum, apart from society, but is an integral part of it. He therefore believes that socio-economic factors should be taken into account. This should include an analysis of the likely socio-economic costs and benefits.

The rapporteur has also introduced amendments to annex III, which deals with the information required in notifications for releases. He calls for a procedure to allow the presence of GMOs to be demonstrated. This is linked to the amendments to Annex IV regarding a certification system which would allow the identification of GMOs and GMO products.

There have been many criticisms relating to the dangers of the creation of "superweeds”, to the transferral of antibiotic resistant and to the potential for inserting an allergy-causing gene into a crop which did not previously contain it. The rapporteur believes that enough research exists to show that these fears are justified. An amendment has therefore been tabled to Annex V to ensure that a GMO should have no wild relatives with which it could hybridise under natural conditions, nor should it contain antibiotic resistant genes or allergy causing toxic or pathogenic trails.

26 November 1998


 OPINION

(Rule 147)

for the Committee on the Environment, Public Health and Consumer Protection

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)) (Bowe report)

Committee on Agriculture and Rural Development

Draftsman: Mr José Happart

PROCEDURE

At its meeting of 16 April 1998 the Committee on Agriculture and Rural Development appointed Mr José Happart draftsman.

It considered the draft opinion at its meeting of 24, 25 and 26 November 1998.

At that meeting it adopted the following conclusions unanimously.

The following took part in the vote: Happart, vice-chairman, and acting chairman and draftsman; Graefe zu Baringdorf, vice-chairman; Anttila, Botz (for Rehder), Fantuzzi, Filippi, Funk, Garot, Görlach, Iversen, Keppelhoff-Wiechert, Kofoed, Lulling (for Ebner), Mayer, Otila (for Sturdy), and Rosado Fernandes.

1. Introduction

Genetic modification of organisms in the agricultural sector involves the selection of plants for the purpose of improving quality and resistance to disease and parasites, as well as increasing yield by withdrawing genes or adding genes that are not part of the original genetic structure.

It is now possible, using genetic manipulation techniques recombining DNA, to modify or create new varieties of transgenic plants, such as slow-ripening tomatoes.

In the EU Member States a number of experiments have been carried out on plants from genetically modified organisms. These plants include colza, maize, beet, potatoes, bean sprouts, tobacco, tomatoes, cereals and rice.

Given that any new technology may entail direct or indirect risks, it is important to be aware of such risks and to keep them under control. A genuine dialogue on biotechnology and its applications must be established between industrialists, researchers, producers and consumers.

It should be made clear from the outset that your rapporteur under no circumstances feels capable of siding with a particular scientific position. He has in fact endeavoured, in the preparatory meetings with a view to drafting this document, to hear the widest possible range of views.

However, the greatest possible care must be taken in this area to avoid misuse of the techniques whose consequences are difficult to foresee. This biotechnology is still extremely technical and experiencing rapid growth. It must be governed by the principle of caution with regard to both food security and the release of such organisms in the environment.

2. GMOs in the agricultural sector and protection of crops

(a) Gene flow and dissemination of herbicide-tolerant genes

Through genetic engineering it is possible to produce useful plants which are resistant to herbicides. The growing of transgenic plants may lead to the dissemination of genes introduced by transgenesis to non-modified varieties of the same species or related species. This dissemination of genes, which incidentally also takes place naturally between plants is called 'gene flow'. Gene flows are common between plants of the same species: pollen is generally the main vector of dissemination of genes, and hence potentially of a transgene, in the case of a genetically modified species, via the wind or pollinating insects. Gene flow probability varies according to the species and ecosystem concerned.

The only reasonable way of approaching the subject is on a case-by-case basis.

It is believed that maize, potatoes, tobacco and soya, which are not originally European plants, do not generally give rise to problems of transmission to related wild species because there is no wild species in the European ecosystem with which these plants could cross-breed. Maize, for example, has been domesticated to such an extent that it cannot survive without human intervention.

It is unlikely that grains derived from cross-fertilisation can breed. In the case of such plants, the probability of a gene flow towards a spontaneous variety is minimal. However, it would appear that, in the case of other species such as colza, beet or endive, the probability of a gene flow between the species and closely related species is not insignificant.

The implications of the gene flow issue may be fully measured by considering that the main application of transgenesis at present consists in introducing herbicide tolerance in certain plants. The usefulness of such plants would thus be significantly lessened since there would no longer be effective self-projection. Any transfer of this resistance transgene to weeds could thus mean that herbicides would no longer be as effective in combating these unwanted plants.

As far as the environment is concerned, biotechnologies are a powerful means of reducing the use of pesticides and herbicides, whose harmful effects no longer need proving. The area of application of broad-spectrum herbicides which pollute the environment may be extended.

Your rapporteur considers that this is an environmental issue since lower efficiency would deprive agriculture of total herbicides which are considered as the least harmful to the environment on the market and would cause a return to the use of selective, highly toxic products.

(b) The appearance of insects resistant to transgenic plants

Plants which have become genetically modified to protect themselves against an insect (e.g. meal moth-resistant maize) could lead to the appearance of insects which are resistant to such transgenic plants following a 'natural' genetic mutation of the said insects. The environmental dimension of this issue is therefore not insignificant since the possible appearance of such forms of resistance could build up insect populations.

The usefulness of such plants would thus be considerably lessened since self-protection would not work. The probability of this risk materialising has actually been calculated, not however in respect of genetically modified plants but with regard to conventional farming methods.

The toxin produced by the Bacillus thunigensis bacterium is used in organic farming in various countries in the form of a bio-pesticide. Its repeated use has led to the emergence of a process of selection of pests which are now resistant to this product. It is not unthinkable that a similar process may take place with regard to transgenic plants and therefore that meal moths, for example, may one day become resistant to herbicide BT maize.

(c) Possible impact on useful insects, such as bees

Are useful insects, such as pollinating bees, likely to be affected by the development of transgenic plants. A firm which is developing a 'BT maize' has stated that it has studied the consequences of this maize mutation, in particular among bees, worms and ladybirds. The results of these tests have shown no impact on 'non-targeted insects' although the current use of insecticides is considerably reducing their numbers.

(d) The risk of biodiversity reduction

Some believe that the development of biotechnology could further contribute to the impoverishment of genetic diversity, an already recognisable tendency in agriculture, by making it possible to confer the same gene to a whole range of species. This impoverishment of diversity is likely to make crops more vulnerable.

(e) Impact on the rhizosphere

The rhizosphere is the region of the soil in direct contact with plant roots. It contains many microorganisms and biological substances. To date there is no evidence of any impact of transgenic plants on this subsoil.

The mushroom which transmits the rhizomania virus to sugarbeet cannot be combated chemically. The use of transgene methods has shown that it is permissible to produce sugarbeet that is resistant to rhizomania.

It should be pointed out that any use of GMOs, even solely for the purposes of research or development, is subject to prior authorisation by an administrative authority following consultation of the European Union Scientific Committee.

3. Scope

Directive 90/219/EEC established a common framework for the development of this new technology at EU level. In view of the new scientific knowledge and applications available with regard to genetically modified microorganisms, it was felt that this directive should be amended by incorporating the Community provisions of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, drawn up on the basis of Article 100a of the EC Treaty.

The two horizontal European directives 90/219/EEC and 90/220/EEC, as opposed to the 'sectoral' legislative provisions which refer more specifically to particular biotechnology-derived sectors, have been introduced as a response to a desire to market transgenic products. To meet immediate needs, the Commission on 18 June 1997 adopted a directive (97/35/EC) amending an annex to Directive 90/220/EEC to introduce a labelling requirement for products composed of or containing GMOs.

4. Regulatory framework

Directive 90/220/EEC applies to organisms whose genetic material has been altered in a way that does not occur naturally by mating or natural recombination. It provides a horizontal-type legislative framework whose purpose is to guarantee market conditions and the protection of human health and the environment for 'living' GMOs. It does not apply to processed or derivative products, but does apply to products not covered by any sectoral legislation.

In order to provide a more comprehensive framework, the Commission submitted a proposal to amend this directive on 26 November 1997. The proposal seeks to bring the directive into line with technological progress, clarify its scope and fill certain loopholes detected during implementation, both in terms of procedures for authorising the marketing of GMOs and labelling rules. It lays down specific labelling measures, including those advocated in the European Parliament's guidelines of July 1997.

The rules contained in this directive seek to adjust the authorisation provisions in respect of the release of GMOs for research and development purposes - Part B of the directive - by stipulating that applications should be referred to the national authority for assessment and, where appropriate, authorisation. The rules on authorisation for the placing on the market of products, contained in Part C of the directive, provide for broader discussion of a technical dossier by the Commission and the competent authorities of the other Member States.

5. Labelling

Originally, Directive 90/200/EEC made virtually no reference to labelling. It became necessary for the Commission to make up for this shortcoming because a variety of genetically modified soya and another of maize had been authorised by Directive 90/220/EEC before its amendment of 18 June 1997 which made labelling compulsory and before the entry into force of the 'novel food' regulation. Specific labelling rules were required for these two varieties and their derivatives, which had not initially been subject to any labelling requirement. In both cases, the Commission negotiated the possibility of voluntary labelling with the producers concerned.

Annex III also needs amending. Additional information must be provided by the applicant when requesting authorisation for the placing on the market of a transgenic plant, including a requirement to provide information on labelling. The national authority is responsible for assessing the risk to human beings and the environment and for adopting an opinion within 90 days of receipt of the application.

6. Conclusions

The Committee on Agriculture and Rural Development therefore calls on the Committee on the Environment, Public Health and Consumer Protection, as the committee responsible, to take due account of the following conclusions:

1. Accepts that, in the present circumstances, GMOs can be of benefit to agriculture as they can allow integrated agricultural development at local level, in particular with regard to plants which, in the absence of GMOs, could not be grown in certain areas owing to climatic or soil conditions;

2. Stresses that the precise nature of GMOs is still unclear and that the use of genetically modified plants therefore entails risks;

3. Considers that, in view of the current insufficient scientific knowledge on the matter, the principle of caution with regard to possible gene mutations should be linked to a risk assessment accompanied by a GMO registration and approval procedure as rigorous as in the case of medicinal products. In the event of a risk appearing, technical measures should be ready to ensure that the authorisation for crops intended for marketing is withdrawn;

4. Stresses the need for a clear, reliable and responsible labelling policy. Community legislative provisions should be harmonised with regard to international distribution circuits and the traceability of all transgenic plants to be placed on the market;

5. Considers that public information should be transparent prior to distribution of GMOs for limited use. All consumer safety measures should be totally reliable and unambiguous;

6. Advocates the establishment of an International Advisory Committee prior to any cultivation or marketing authorisation;

7. Welcomes the Commission's announcement that it intends, in its proposal for amending Directive 90/220/EEC, to provide for a wider ranging assessment of the direct and indirect risks to human health and the environment, and calls on the Commission, to contribute by way of its proposal to reducing assessment deadlines generally and increasing transparency in assessment and approvals procedures, without thereby compromising the quality and credibility of the assessment;

8. Believes that the concept of protection should be present at all stages and that applicants responsible for deliberately releasing GMOs, in accordance with Part B, or placing products containing GMOs on the market, in accordance with Part C, must assume liability for damage to persons or property.

16 October 1998


 OPINION

(Rule 147)

for the Committee on the Environment, Public Health and Consumer Protection

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)), report by Mr Bowe)

Committee on Research, Technological Development and Energy

Draftsman: Mrs Marjo Matikainen-Kallström

PROCEDURE

At its meeting of 17 March 1998 the Committee on Research, Technological Development and Energy appointed Mrs Marjo Matikainen-Kallström draftsman.

It considered the draft opinion at its meetings of 23 June, 2 September, 28 and 29 September 1998.

At the/last meeting it adopted the following conclusions by 16 votes to 2.

The following were present for the vote: Scapagnini, chairman; Adam and Lange vice-chairmen; Matikainen-Kallström, draftsman; Argyros, Breyer (for Ahern), Bloch von Blottnitz, Chichester, Desama, Estevan Bolea, Ferber, Heinisch (for Quisthoudt-Rowohl), Izquierdo Collado (for McNally), Mombaur, Plooij-van Gorsel, Pompidou, Tannert, W.G. van Velzen.

INTRODUCTION

The Commission has introduced this proposal to amend directive 90/220/EEC because it believes it needs updating in the light of improved scientific understanding, experience with the sometimes cumbersome administrative procedures, the (current) lack of harmonised risk assessment criteria, the need to increase flexibility, and the need to facilitate the links with product legislation. The main elements in the proposed modification to the Deliberate Release Directive 90/220/EEC are:

- a clarification of the scope of the Directive, and the definitions contained therein;

- the introduction of a post-marketing mandatory monitoring system for GMO products;

- the introduction of harmonised risk assessment criteria for GMO releases;

- the introduction of different risk categories for organisms, as well as a multi-state procedure;

- the introduction of a simplified procedure in some cases;

- obligatory consultation of an advisory Scientific Committee in certain circumstances;

- some increased transparency concerning notifications to place GMO products on the market;

- a change in the 'commitology' procedure from type IIIa to type IIIb;

- broader and more detailed labelling requirements.

This Opinion will concentrate on specific issues, some of which were raised in our previous opinion on last year's Commission Communication on the same subject.(1)

Can we agree harmonised criteria for risk assessment?

In recent years we have witnessed a gradual loss of faith both in technical expertise and in the social and political institutions involved in the resolution of environmental conflict, not least because scientific uncertainty is endemic in nearly all environmental policy issues which attract public interest. When scientific knowledge is used in policy making, there are usually uncertainties not just about the intrinsic accuracy of particular measurements, or data concerning environmental damage, but even uncertainties about the applicability of theoretical models to the physical phenomena under investigation.

Risk assessment should therefore not be seen as narrowly defined reductionist science, which ignores the more difficult to handle variables, or, worse still, imagines them to be non-existent or 'irrational' - or 'based on ignorance'. A case can be made for broadening its scope, as some Member States have tried to do, to try to take account of the diverse views which are legitimately held on the subject, and, more particularly, to include an assessment of likely impacts on socio-economic systems. An amendment tabled in 1989 by Parliament's rapporteur on the Deliberate Release Directive required that the notification to be supplied by the applicant to the competent authority must include "Justification of the social desirability of the objective of the proposed deliberate release and assessment of possible alternatives to attain the same objective."(2) A further amendment, required any national competent authority, before granting authorisation to place GMOs on the market, to 'carry out a full risk assessment of the proposed deliberate release as well as an evaluation of the social costs and benefits of the marketing of the product' This, of course, recognised the political limits of scientific risk assessment.

It is entirely possible that any attempt to define a legally binding and watertight set of 'scientific' criteria, to be deployed in the assessment of risks of deliberate releases of GMOs to human health and to the environment, will almost certainly be doomed to failure, and will be unenforceable in the courts.

A more sensible approach would maintain the flexibility and adaptability which characterises the essentially procedural approach embodied in the original Directive, whilst at the same time instituting procedures for the appraisal of scientific uncertainty which have at their core an approach centred on openness and transparency.

The problem of 'commitology' in the Deliberate Release Directive

There are considerable difficulties in differentiating between basic EC legislation and implementing measures in the area of biotechnology regulation. The complex procedures required for the treatment of the application by a firm to place on the EU market a genetically modified product are a case in point, and often have political ramifications, features splendidly illustrated by the case of the CibaGeigy Bt-maize.

On 15 March 1995 the Commission received a notification from Ciba-Geigy concerning market approval for its new maize plant, which had a bacillus thuringiensis (Bt) gene coding for a deltaendotoxin inserted so as to provide resistance to the European corn-borer. The new maize was also resistant to glyphosate herbicides, and it included a 'marker-gene' conferring antibiotic resistance to ampicillin, to enable identification of the successfully modified plants. Ciba-Geigy made their formal proposal for marketing authorisation to the French Competent Authority, which indicated to the Commission that it proposed to approve it. However, seven other national Competent authorities registered their objections to this proposal, which was then referred to the Article 21 'commitology' committee. The Commission failed to obtain qualified majority support for its proposal that the application be approved, with different Member States objecting to different features of the new maize. The matter was therefore referred to the Council, as provided for in the Type IIIa commitology procedure.

In the Environment Council, thirteen Member States opposed the Commission's proposal, yet crucially, the Council was unable to reach a unanimous position, because the French supported the Commission, and unanimity was required in order for the Council to adopt a different decision in the face of opposition from the Commission, pursuant to Article 189a of the EC Treaty. The power of decision thus reverted to the Commission, under the commitology rules. The Commission next sought the advice of three other scientific advisory committees, which, broadly speaking, concurred with the Commission's proposal. The Commission therefore felt confident enough to formally adopt the marketing authorisation on 23 January 1997.(3), provoking a hostile political and media reaction.

Italy, Luxembourg and Austria immediately invoked the provisional derogation clause in Article 16, and banned the use and sale of the Ciba-Geigy maize in their countries. The Commission challenged these decisions, using the commitology procedure, but failed to muster q.m.v. support for its challenge, so once more the question had to be referred to the Council. In the event of defeat; Austria has indicated it will challenge the decision in the ECJ. The latest indication is that the Commission is losing enthusiasm for its challenge to the Austrian decision, which suggests that its high hopes for its much vaunted objective risk assessment criteria may be somewhat misplaced.

It seems reasonably clear that the Council had not thought through the consequences of its choice of a Procedure III(a) Regulatory Committee; since it is only invoked where one national Competent Authority approves an application, and one or more of the others opposes it. It will therefore be logically impossible, to obtain unanimity in the Council to oppose the Commission, irrespective of which national Competent Authority the Commission chooses to support. Unsurprisingly, the Commission has finally bowed to political forces, and has hereby proposed a change of commitology procedure from III(a) to III(b), which will enable a simple majority of Member States to block a final decision by the Commission. Given that the Commission regards the III(b) procedure as anathema, the political pressure on it must have been very considerable.

Giving the Member States a simple majority veto over a product authorisation is all very well, but what about the role of the European Parliament? The so-called "modus vivendi" between Council, Commission and Parliament(4), dealing with implementing measures under 'co-decided' legislation, has not been an obvious success. A strong case exists for a radical overhaul of both legislation and of procedural arrangements for Parliamentary monitoring of implementing measures in this area. An indicative amendment is therefore proposed here.

The labelling of GMO products

The relationship between the GMOs directives, and existing Community legislation concerning novel foods, and conventional agricultural products is extremely complex . The Commission, in parallel with the above provisions, has also adopted a specific Regulation, within the framework of the Novel Foods Regulation, on the labelling of foodstuffs produced from genetically modified soya and maize. This maintains the principle, supported by the biotechnology industry, that the requirement to explicitly acknowledge the presence of a GMO on the label only applies if the GMO product can be scientifically distinguished from the 'conventional' product. Any attempt to oblige the labelling of GMO products per se would probably be challenged by the USA in the World Trade Organisation (WTO) court in Geneva. If the WTO court were to indicate that the Commission had not justified these requirements scientifically, then the Commission would be obliged to do so, if it could. The issue of whether natural science alone can resolve the problem has been sidestepped: a cultural assumption pervades the WTO agreement - an assumption that disputes such as this can be resolved by an appeal to science; and that beyond the authority of science, there is no appeal.

The issue centres on the consumers right to choose, even if the scientists insist that there is no physical difference between the choices offered. The difference, of course, is in the production methods and possible ecological consequences of differing methods - which the consumer feels entitled to differentiate between. Those consumers who wish to express their preference for certain types of agricultural practice, may wish not to buy GMO food products.

Liability for damage to human health and the environment

Despite the efforts of the European Parliament to introduce a liability clause into both GMO Directives, with a concomitant obligation to take out insurance, neither Directive includes such provisions. Nor is there any mention of this subject in the Commission's current proposal. The Commission promised in 1989 that it was developing a general proposal on liability for environmental damage in Europe. It is now 1998, and no such proposal has been tabled, although the Commission did publish a Green Paper on the subject in 1993.(5). The situation at present, then, is that generally national law applies to claims for damages, and the national laws clearly differ.

In its first reading on the proposal to amend the Contained Use Directive, Parliament adopted an amendment which required that: "Legally responsible users of genetically modified micro-organisms shall have full civil and criminal 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."(6)

In its response, the Commission again asserted that "the subject of liability is under consideration by the Commission, which intends to publish a White Paper on environmental liability. The Commission wishes to deal with this matter in a horizontal manner to avoid different liability requirements in different Directives."(7) Perhaps the time has come to lose patience with these interminable delays, and introduce into the Deliberate Release Directive an unambiguous civil liability clause.

Conclusions

The Committee on Research, Technological Development and Energy therefore proposes the following amendments to the Commission's proposal:-

Text proposed by the Commission

Amendments by Parliament

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

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

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

(Amendment 2)
ARTICLE 1(1)
Article 2(4) (Directive 90/220/EEC)

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

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 and the handing over for scientific purposes

(Amendment 3)
ARTICLE 1(1)
Article 2(5) (Directive 90/220/EEC)

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';

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 authority of a Member State. The person making the presentation shall be referred to as 'the notifier';

(Amendment 4)
ARTICLE 1(1)
Article 2(6) (Directive 90/220/EEC)

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.

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

(Amendment 5)
ARTICLE 1(1)
Article 5 (Directive 90/220/EEC)

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.

Articles 6 to 9 shall not apply to any products under development covered by Community legislation which provides for a specific environmental risk assessment which does not fall short of the requirements laid down in those articles.

(Amendment 6)
ARTICLE 1(2)
Article 6a(3)

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:

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 must respond in writing to the notifier within 30 days of receipt of the notification by indicating that the release does not fulfill the conditions of this Directive and the notification is therefore rejected.

a) indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed, or,

b) indicating that the release does not fulfill the conditions of this Directive and the notification is therefore rejected.

If no such written response is issued by the competent authority within 30 days the notification shall be deemed to be confirmed and the notifier may proceed with the release.

(Amendment 7)
ARTICLE 1(2)
Article 6b(-3) (new)

-3. As part of the notification, in accordance with Annex VII the notifier shall also submit a detailed monitoring plan with a view to determining any direct, indirect or delayed impact the GMO may have on human health and/or the environment.

(Amendment 8)
ARTICLE 1(2)
Article 6b(4)

4. For the purpose of calculating the 90-day period referred to in paragraph 3, any periods of time during which the competent authority:

4. For the purpose of calculating the 90-day period referred to in paragraph 3, periods of time not exceeding 60 days during which the competent authority:

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

(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

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

shall not be taken into account.

shall be taken into account.

(Amendment 9)
ARTICLE 1(2)
Article 6c(6a) (new)

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

(Amendment 10)
ARTICLE 1(3)
Article 9(4) (Directive 90/220/EEC)

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).

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 and a list of notifications that were rejected in accordance with Article 6a(3)(b).

(Amendment 11)
ARTICLE 1(3)
Article 10 (Directive 90/220/EEC)

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.

Articles 11 to 18 shall not apply to any products covered by Community legislation which provides for a specific environmental risk assessment which does not fall short of the requirements laid down in this Directive.

(Amendment 12)
ARTICLE 1(4)
Article 13a(3)

3. Before the decision procedure in accordance with Article 21 on a decision for criteria and information requirements referred to in paragraph 2 is initiated, the Commission shall make available to the public this proposal. The public may make comments within 60 days.

3. Before the decision procedure in accordance with Article 21 on a decision for criteria and information requirements referred to in paragraph 2 is initiated, the Commission shall make available to the public this proposal.

(Amendment 13)
ARTICLE 1(4)
Article 13b(6)

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.

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.

(Amendment 14)
ARTICLE 1(4)
Article 13e(4)(ca) (new)

(ca) 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 15)
ARTICLE 1(4)
Article 13e(d) (new)

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 16)
ARTICLE 1(7)
Article 17(1) (Directive 90/220/EEC)

1. Without prejudice to Article 19, upon receipt of a notification in accordance with Article 11(1) the Commission shall immediately make available to the public the summary referred to in Article 11 (3). The public may make comments within 30 days. The Commission shall immediately forward the comments to all competent authorities of the Member States.

1. Without prejudice to Article 19, upon receipt of a notification in accordance with Article 11(1) the Commission shall immediately make available to the public the summary referred to in Article 11(3).

(Amendment 17)
ARTICLE 1(9)
Article 20 (Directive 90/220/EEC)

According to the procedure laid down in Article 21, the Commission shall adapt Annexes II to VII to technical progress.

According to the procedure laid down in Article 21, the Commission shall adapt Annexes III, IV and VII to technical progress.

(Amendment 18)
ARTICLE 1(11)
Article 21 (Directive No. 90/220/EEC)

11. Article 21 is replaced by the following:"Article 21Where the procedure defined in this Article is to be implemented, the Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission, hereinafter referred to as the "Committee".

11. Article 21 is replaced by the following:"Article 21Where the procedure defined in this Article is to be implemented, the Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission, hereinafter referred to as the "Committee".

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.

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.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

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.

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.

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."

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

Article 22 a(a)(new)

(Amendment 19)
ARTICLE 1(12)

12. The following articles 22a and 22b are inserted:

12. The following articles 22a, 22a(a) and 22b are inserted:

"Article 22a

"Article 22a

Member States shall determine the sanction arrangements applicable to violations of the national provisions made pursuant to this Directive, and take any measure necessary to ensure their implementation. The sanctions thus envisaged must be effective, proportional and dissuasive. Member States must notify these provisions to the Commission at the latest by . . . [the date mentioned in Article 2], and any later modification concerning them as soon as possible.

Member States shall determine the sanction arrangements applicable to violations of the national provisions made pursuant to this Directive, and take any measure necessary to ensure their implementation. The sanctions thus envisaged must be effective, proportional and dissuasive. Member States must notify these provisions to the Commission at the latest by . . . [the date mentioned in Article 2], and any later modification concerning them as soon as possible.

Those legally responsible for deliberate releases of genetically modified microorganisms shall have full civil and criminal 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.

Article 22b

Article 22b

Before . . . [a date seven years after the date forseen for the transposition according to Article 2], the consents granted for placing on the market of products containing or consisting of GMOs before . . . [the date mentioned in Article 2] shall be renewed according to the procedure outlined in Article 13c."

Before . . . [a date seven years after the date forseen for the transposition according to Article 2], the consents granted for placing on the market of products containing or consisting of GMOs before . . . [the date mentioned in Article 2] shall be renewed according to the procedure outlined in Article 13c."

(Amendment 20)
Annex II(A)(2), last sentence

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

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

(Amendment 21)
Annex II(B)(5)

5. Application of management strategies for risks from the deliberate release of GMO(s)

5. Application of management strategies for risks from the deliberate release of GMO(s)

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

If for any release the estimated risk for any identified hazard is not at 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.

6(a)(new)

(Amendment 22)
ANNEX II, point B.6(a)(new)

Socio-economic cost-benefit analysis

A study shall be made of the likely socioeconomic costs and benefits of the proposed deliberate release/market authorisation.

(Amendment 23)
Annex V(A)(3) (new)

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.

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.

(1)() OJ C 286, 22 September 1997, p. 49 (resolution). EP Document A4-0239, 3/7/97 (text)
(2)() EP Document A2-142/89, p. 13
(3)() Decision 97/98/EC, OJ L 31 of 01/02/1997, p.69.
(4)() OJ C 102, 04/04/1996, p.1
(5)() Commission Communication: Green Paper on Remedying Environmental Damage, COM (93)0047.
(6)() Minutes of Proceedings, OJ C 115, 12/03/1997, p 59-75.
(7)() COM (97) 240, op cit, p.5

Last updated: 27 March 1999Legal notice