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Document 52000AG0012

Common Position (EC) No 12/2000 of 9 December 1999 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

OJ C 64, 6.3.2000, p. 1–46 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

52000AG0012

Common Position (EC) No 12/2000 of 9 December 1999 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

Official Journal C 064 , 06/03/2000 P. 0001 - 0046


Common position (EC) No 12/2000

adopted by the Council on 9 December 1999

with a view to adopting Directive 2000/.../EC of the European Parliament and of the Council of ... on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

(2000/C 64/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the Economic and Social Committee(2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

(1) The Report of the Commission on the Review of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(4), adopted on 10 December 1996, identified a number of areas where improvement is needed.

(2) There is a need for clarification of the scope of Directive 90/220/EEC and of the definitions therein.

(3) Directive 90/220/EEC has been amended; now that new amendments are being made to the said Directive, it is desirable, for reasons of clarity and rationalisation that the provisions in question should be recast.

(4) Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States; the effects of such releases on the environment may be irreversible.

(5) The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs).

(6) Under the Treaty, action by the Community relating to the environment should be based on the principle that preventive action should be taken.

(7) It is necessary to approximate the laws of the Member States concerning the deliberate release into the environment of GMOs and to ensure the safe development of industrial products utilising GMOs.

(8) The precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it.

(9) Respect for ethical principles recognised in a Member State is particularly important; Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.

(10) For a comprehensive and transparent legislative framework, it is necessary to ensure that the public is consulted by either the Commission or the Member States during the preparation of measures and that they are informed of the measures taken during the implementation of this Directive.

(11) Placing on the market also covers import; products containing and/or consisting of GMOs covered by this Directive cannot be imported into the Community if they do not comply with its provisions.

(12) Making GMOs available to be imported or handled in bulk quantities, such as agricultural commodities, should be regarded as placing on the market for the purpose of this Directive.

(13) The content of this Directive duly takes into account international experience in this field and international trade commitments.

(14) Guidance on the implementation of provisions related to the definition of the placing on the market in this Directive should be provided by the Regulatory Committee.

(15) When defining "genetically modified organism" for the purpose of this Directive human beings should not be considered as organisms.

(16) The provisions of this Directive be without prejudice to national legislation in the field of liability.

(17) This Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record.

(18) It is necessary to establish harmonised procedures and criteria for the case-by-case evaluation of the potential risks arising from the deliberate release of GMOs into the environment.

(19) A case-by-case environmental risk assessment should always the carried out prior to a release.

(20) It is necessary to establish a common methodology to carry out the environmental risk assessment based on independent scientific advice; it is also necessary to establish common objectives for the monitoring of GMOs after their deliberate release or placing on the market as or in products.

(21) The issue of antibiotic-resistance genes should be taken into particular consideration when conducting the risk assessment of GMOs containing such genes.

(22) The deliberate release of GMOs at the research stage is in most cases a necessary step in the development of new products derived form, or containing, GMOs.

(23) The introduction of GMOs into the environment should be carried out according to the "step by step" principle; this means that the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken.

(24) No GMOs, as or in products, and intended for deliberate release are to be considered for placing on the marked without first having been subjected to satisfactory field testing at the research and development stage in ecosystems which could be affected by their use.

(25) The implementation of this Directive should be carried out in close liaison with the implementation of other relevant instruments such as Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(5); in this context the competent authorities concerned with the implementation of this Directive and of those instruments, within the Commission and at national level, should coordinate their action as far as possible.

(26) Concerning the environmental risk assessment for Part C, risk management, labelling, monitoring, information to the public and safeguard clause, this Directive should be a point of reference for GMOs as or in products authorised by other Community legislation which should therefore provide for a specific environmental risk assessment, to be carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements laid down by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive.

(27) It is necessary to establish a Community authorisation procedure for the placing on the market of GMOs, as or in products, where the intended use of the product involves the deliberate release of the organism(s) into the environment.

(28) For sectoral legislation, monitoring requirements may have to be adapted to the product concerned.

(29) Part C of this Directive does not apply to products covered by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of medial Products(6), provided that it includes an environmental risk assessment equivalent to that provided for by this Directive.

(30) Any person, before undertaking a deliberate release into the environment of a GMO, or the placing on the market of GMOs, as or in products, where the intended use of the product involves its deliberate release into the environment, is to submit a notification to the national competent authority.

(31) That notification should contain a technical dossier of information including a full environmental risk assessment, appropriate safety and emergency response, and, in the case of products precise instructions and conditions for use, and proposed labelling and packaging.

(32) After notification, no deliberate release of GMOs should be carried out unless the consent of the competent authority has been obtained.

(33) A notifier should be able to withdraw his dossier at any stage of the administrative procedures laid down in this Directive; the administration procedure should stop when a dossier is withdrawn.

(34) Rejection of a notification for the placing on the market of a GMO as or in products by a competent authority should be without prejudice to the submission of a notification of the same GMO to another competent authority.

(35) An agreement should be reached at the end of the mediation period when no objections remain.

(36) Rejection of a notification following a confirmed negative assessment report should be without prejudice to future decisions based on the notification of the same GMO to another competent authority.

(37) In the interests of the smooth functioning of this Directive, Member States should be able to avail themselves of the various provisions for the exchange of information and experience before having recourse to the safeguard clause of this Directive.

(38) In order to ensure that the presence of GMOs in products containing, or consisting of, genetically modified organisms is appropriately identified, the words "This product contains genetically modified organisms" should appear clearly either on a label or in an accompanying document.

(39) A system should be designed using the appropriate committee procedure, for the assignment of a unique identifier to GMOs, taking into account relevant developments in international fora.

(40) It is necessary to ensure traceability at all stages of the placing on the market of GMOs as or in products authorised under Part C of this Directive.

(41) It is necessary to introduce into this Directive an obligation to implement a monitoring plan in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after they have been placed on the market.

(42) Member States should be able, in accordance with the Treaty, to take further measures for monitoring and inspection, for example by official services, of the GMOs as or in products placed on the market.

(43) Means should be sought for providing possibilities for facilitating the control of GMOs or their retrieval in the event of severe risk.

(44) Comments by the public should be taken into consideration in the drafts of measures submitted to the Regulatory Committee.

(45) The competent authority should give its consent only after it has been satisfied that the release will be safe for human health and the environment.

(46) The administrative procedure for granting consents for the placing on the market of GMOs as or in products should be made more efficient and more transparent and first-time consent should be granted for a fixed period.

(47) For products for which consent has been granted for a fixed period a streamlined procedure should apply as regards the renewal of consent.

(48) The existing consents granted under Directive 90/220/EEC have to be renewed in order to avoid disparities between consents granted under that Directive and those pursuant to this Directive and in order to take full account of the conditions of consent under this Directive.

(49) Such renewal requires a transitional period during which existing consents granted under Directive 90/220/EEC remain unaffected.

(50) When a consent is renewed, it should be possible to revise all the conditions of the original consent, including those related to monitoring and the time limitation of the consent.

(51) Provision should be made for consultation of the relevant scientific committee(s) established by Commission Decision 97/579/EC(7) on matters which are likely to have an impact on human health and/or the environment.

(52) The system of exchange of information contained in notifications, established under Directive 90/220/EEC, has been useful and should be continued.

(53) It is important to follow closely the development and use of GMOs.

(54) When a product containing a GMO, as, or in products, is placed on the market, and where such a product has been properly authorised under this Directive, a Member State may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of the Directive; a safeguard procedure should be provided in case of risk to human health or the environment.

(55) The Commission's European group on ethics in science and new technologies should be consulted with a view to obtaining advice on ethical issues of a general nature regarding the deliberate release or placing on the market of GMOs; such consultations should be without prejudice to the competence of Member States as regards ethical issues.

(56) Member States should be able to consult any committee they have established with a view to obtaining advice on the ethical implications of biotechnology.

(57) The measures necessary for the implementation of this Directive are to be adopted in accordance with Council Directive 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8).

(58) The information exchange set up under this Directive should also cover experience gained with the consideration of ethical aspects.

(59) In order to increase the effective implementation of the provisions adopted under this Directive it is appropriate to provide for penalties to be applied by Member States.

(60) The regulatory framework for biotechnology should be reviewed so as to identify the feasibility of improving further the consistency and efficiency of that framework; procedures may need to be adapted so as to optimise efficiency, and all options which might achieve that should be considered,

HAVE ADOPTED THIS DIRECTIVE:

PART A

GENERAL PROVISIONS

Article 1

Objective

In accordance with the precautionary principle the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:

- carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community

- placing on the market genetically modified organisms as or in products within the Community.

Article 2

Definitions

For the purposes of this Directive:

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

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

Within the terms of this definition:

(a) genetic modification occurs at least through the use of the techniques listed in Annex IA, Part 1,

(b) the techniques listed in Annex IA, Part 2, are not considered to result in genetic modification;

3. "deliberate release" means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment;

4. "placing on the market" means making available to third parties, whether in return for payments or free of charge;

The following operations shall not be regarded as placing on the market:

- making available genetically modified micro-organisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms(9) including culture collections,

- making available GMOs other than micro-organisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment; the measures should be based on the same principles of containment as laid down in Directive 90/219/EEC,

- making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in Part B of this Directive;

5. "notification" means the submission of the information required under this Directive to the competent authority of a Member State;

6. "notifier" means the person submitting the notification;

7. "product" means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market;

8. "environmental risk assessment" means the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II.

Article 3

Exemptions

1. This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex IB.

2. This Directive shall not apply to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air.

Article 4

General obligations

1. Member States, in accordance with the precautionary principle, 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 or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with Part B or Part C respectively.

2. Any person, before submitting a notification under Part B or Part C, shall carry out an environmental risk assessment. The information which may be necessary to carry out the environmental risk assessment is laid down in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment.

3. Member States shall designate the competent authority or authorities responsible for carrying out the requirements of this Directive. The competent authority shall examine notifications under Parts B and C for compliance with the requirements of this Directive and whether the assessment provided for in paragraph 2 is appropriate.

4. Member States shall ensure that the competent authority organises inspections and other control measures as appropriate, to ensure compliance with this Directive. In the event of a release of GMO(s) or placing on the market as or in products for which no authorisation was given the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States.

5. Member States shall take measures to ensure, in line with the requirements laid down in Annex IV, traceability, at all stages of the placing on the market of GMOs authorised under Part C.

PART B

DELIBERATE RELEASE OF GMOS FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

Article 5

Standard authorisation procedure

1. Any person before undertaking a deliberate release of a GMO or of a combination of GMOs, must submit a notification to the competent authority of the Member State within whose territory the release is to take place.

2. The notification referred to in paragraph 1 shall include:

(a) a technical dossier supplying the information specified in Annex III necessary for carrying out the environmental risk assessment of the deliberate release of a GMO or combination of GMOs, in particular:

(i) general information including information on personnel and training,

(ii) information relating to the GMO(s),

(iii) information relating to the conditions of release and the potential receiving environment,

(iv) information on the interactions between the GMO(s) and the environment,

(v) a plan for monitoring in accordance with the relevant parts of Annex III in order to identify effects of the GMO(s) on human health or the environment,

(vi) information on control, remedial methods, waste treatment and emergency response plans,

(vii) a summary of the dossier;

(b) the environmental risk assessment and the conclusions required in Annex II, Section D, together with any bibliographic reference and indications of the methods used.

3. The notifier may refer to data or results from notifications previously submitted by other notifiers, provided that the information, data and results are non-confidential or these notifiers have given their agreement in writing, or may submit additional information he considers relevant.

4. The competent authority may accept that releases of the same GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.

5. The competent authority shall acknowledge the date of receipt of the notification and, having considered, where appropriate, any observations by other Member States made in accordance with Article 10, shall respond in writing to the notifier within 90 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

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

6. For the purpose of calculating the 90-day period referred to in paragraph 5, no account shall be taken of any periods of time during which the competent authority:

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

(b) is carrying out a public inquiry or consultation in accordance with Article 8; this public inquiry or consultation shall not prolong the 90-day period referred to in paragraph 5 by more than 30 days.

7. The notifier may proceed with the release only when he has received the written consent of the competent authority, and in conformity with any conditions required in this consent.

8. Member States shall ensure that no material derived from GMOs which are deliberately released in accordance with Part B is placed on the market, unless in accordance with Part C.

Article 6

Differentiated procedures

1. If sufficient experience has been obtained of releases of certain GMOs in certain ecosystems and the GMOs concerned meet the criteria set out in Annex V, a competent authority may submit to the Commission a reasoned proposal for the application of differentiated procedures to such types of GMOs.

2. Following its own initiative or at the latest 30 days following the receipt of a competent authority's proposal, the Commission shall:

(a) forward the proposal to the competent authorities, which may, within 60 days, present observations and at the same time:

(b) make available the proposal to the public which may, within 60 days, make comments; and

(c) consult the relevant Scientific Committee(s) which may, within 60 days, give an opinion.

3. A decision shall be taken on each proposal in accordance with the procedure laid down in Article 29(2). This decision shall establish the minimum amount of technical information from Annex III necessary for evaluating any foreseeable risks from the release, in particular:

(a) information relating to the GMO(s);

(b) information relating to the conditions of release and the potential receiving environment;

(c) information on the interactions between the GMO(s) and the environment;

(d) the environmental risk assessment.

4. This decision shall be taken within 90 days of the date of the Commission's proposal or of receipt of the competent authority's proposal. This 90-day period shall not take into account the period of time during which the Commission is awaiting the observations of competent authorities, the comments of the public or the opinion of Scientific Committees, as provided for in paragraph 2.

5. The decision taken under paragraphs 3 and 4 shall provide that the notifier may proceed with the release only when he has received the written consent of the competent authority. The notifier shall proceed with the release in conformity with any conditions required in this consent.

The decision taken under paragraphs 3 and 4 may provide that releases of a GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.

6. Without prejudice to paragraphs 1 to 5, Commission Decision 94/730/EC of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC(10) shall continue to apply.

7. Where a Member State decides to make use or not of a procedure established in a decision taken in accordance with paragraphs 3 and 4 for releases of GMOs within its territory it shall inform the Commission thereof.

Article 7

Handling of modifications and new information

1. In the event of any modification of, or unintended change to, the deliberate release of a GMO or of a combination of GMOs which could have consequences with regards to risks for human health and the environment after the competent authority has given its written consent, or if new information has become available on such risks, either while the notification is being examined by the competent authority of a Member State or after that authority has given its written consent, the notifier shall immediately:

(a) take the measures necessary to protect human health and the environment;

(b) inform the competent authority in advance of any modification or as soon as the unintended change is known or the new information is available;

(c) revise the measures specified in the notification.

2. If information becomes available to the competent authority referred to in paragraph 1 which could have significant consequences with regard to risks for human health and the environment or under the circumstances described in paragraph 1, the competent authority shall evaluate such information and may require the notifier to modify the conditions of, suspend or terminate the deliberate release.

Article 8

Consultation of and information to the public

1. Member States shall, without prejudice to the provisions of Articles 6 and 24, consult the public and, where appropriate, groups on the proposed deliberate release. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time period, in order to give the public or groups the opportunity to express an opinion.

2. Without prejudice to the provisions of Article 24:

- Member States shall make available to the public information on all Part B releases of GMOs in their territory,

- the Commission shall make available to the public the information contained in the system of exchange of information pursuant to Article 10.

Article 9

Reporting by notifiers on releases

After completion of a release, and, thereafter, at any intervals laid down in the consent on the basis of the results of the environmental risk assessment, 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, where appropriate, particular reference to any kind of product that the notifier intends to notify at a later stage. The format for the presentation of this result shall be established in accordance with the procedure laid down in Article 29(2).

Article 10

Exchange of information between competent authorities and the Commission

1. The Commission shall set up a system of exchange of the information contained in the notifications. The competent authorities shall send to the Commission, within 30 days of its receipt, a summary of each notification received under Article 5. The format of this summary shall be established and modified if appropriate in accordance with the procedure laid down in Article 29(2).

2. The Commission shall, at the latest 30 days following their receipt, forward these summaries to the other Member States, which may, within 30 days, present observations through the Commission or directly. At its request, a Member State shall be permitted to receive a copy of the full notification from the competent authority of the relevant Member State.

3. The competent authorities shall inform the Commission of the final decisions taken in compliance with Article 5(5), including where relevant the reasons for rejecting a notification, and of the results of the releases received in accordance with Article 9.

4. For the releases of GMOs referred to in Article 6, once a year Member States shall send a list of GMOs which have been released on their territory and a list of notifications that were rejected to the Commission, which shall forward them to the competent authorities of the other Member States.

PART C

PLACING ON THE MARKET OF GMOS AS OR IN PRODUCTS

Article 11

Sectoral legislation

1. Articles 12 to 23 shall not apply to any GMO as or in products as far as they are authorised by Community legislation which provides for a specific environmental risk assessment carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements provided for by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive.

2. As far as Council Regulation (EEC) No 2309/93 is concerned, Articles 12 to 23 of this Directive shall not apply to any GMO as or in products as far as they are authorised by that Regulation provided that a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II to this Directive and on the basis of information specified in Annex III to this Directive without prejudice to additional requirements provided for in Regulation (EEC) No 2309/93.

3. Procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in this Directive shall be introduced, in a regulation of the European Parliament and of the Council. Until that regulation enters into force any GMO as or in products as far as they are authorised by other Community legislation shall only be placed on the market after having been accepted for placing on the market in accordance with this Directive.

4. During evaluation of the requests for the placing on the market of the GMOs referred to in paragraph 1, the bodies established by the Community under this Directive and by Member States for the purpose of implementing this Directive shall be consulted.

Article 12

Notification procedure

1. Before a GMO or a combination of GMOs as or in products is placed on the market, a notification shall be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time. The competent authority shall acknowledge the date of receipt of the notification and immediately forward the summary of the dossier referred to in paragraph 2(h) to the competent authorities of the other Member States and the Commission.

The competent authority shall without delay examine whether the notification is in accordance with paragraph 2 and shall, if necessary, ask the notifier for additional information.

When the notification is in accordance with paragraph 2, and at the latest when it sends its assessment report in accordance with Article 13(2), the competent authority shall forward a copy of the notification to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

2. The notification shall contain:

(a) the information required in Annexes III and IV. This information shall take into account the diversity of sites of use of the GMO as or in a product and shall include information on data and results obtained from research and developmental releases concerning the impact of the release on human health and the environment;

(b) the environmental risk assessment and the conclusions required in Annex II, section D;

(c) the conditions for the placing on the market of the product, including specific conditions of use and handling;

(d) a proposed period for the consent which should not exceed 10 years;

(e) a plan for monitoring in accordance with Annex VII, including a proposal for the time period of the monitoring plan; this time period may be different from the proposed period for the consent;

(f) a proposal for labelling which shall comply with the requirements laid down in Annex IV. The labelling shall clearly state that a GMO is present. The words "This product contains genetically modified organisms" shall appear either on a label or in an accompanying document;

(g) a proposal for packaging which shall comprise the requirements laid down in Annex IV;

(h) a summary of the dossier. The format of the summary shall be established in accordance with the procedure laid down in Article 29(2).

If on the basis of the results of any release notified under Part B, or on other substantive, reasoned scientific grounds, a notifier considers that the placing on the market and use of a GMO as or in a product do not pose a risk to human health and the environment, he may propose to the competent authority not to provide part or all of the information required in Annex IV, Section B.

3. The notifier shall include in this notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community.

4. The notifier may also refer to data or results from notifications previously submitted by other notifiers or submit additional information he considers relevant, provided that the information, data and results are non-confidential or these notifiers have given their agreement in writing.

5. In order for a GMO or combination of GMOs to be used for a use different from that already specified in a notification, a separate notification shall be submitted.

6. If new information has become available with regard to the risks of the GMO to human health or the environment, before the written consent is granted, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof. In addition, the notifier shall revise the information and conditions specified in the notification.

Article 13

Assessment report

1. On receipt and after acknowledgement of the notification in accordance with Article 12(2), the competent authority shall examine it for compliance with this Directive.

2. Within 90 days after receipt of the notification the competent authority shall:

- prepare an assessment report and send it to the notifier. A subsequent withdrawal by the notifier shall be without prejudice to any further submission of the notification to another competent authority,

- in the case referred to in paragraph 3(a), send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

In the case referred to paragraph 3(b) the competent authority shall send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission no earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification. The Commission shall, within 30 days of its receipt, forward the report to the competent authorities of the other Member States.

3. The assessment report shall indicate whether:

(a) the GMO(s) in question should be placed on the market and under which conditions, or

(b) the GMO(s) in question should not be placed on the market.

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

4. For the purpose of calculating the 90-day period referred to in paragraph 2, any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier, shall not be taken into account. The competent authority shall state the reasons in any request for further information.

Article 14

Standard procedure

1. In the cases referred to in Article 13(3), a competent authority or the Commission may ask for further information, make comments or present reasoned objections to the placing on the market of the GMO(s) in question within a period of 60 days from the date of circulation of the assessment report.

Comments or reasoned objections and replies shall be forwarded to the Commission which shall, immediately circulate them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 105 days from the date of circulation of the assessment report.

Any periods of time during which further information from the notifier is awaited shall not be taken into account for the purpose of calculating the final 45-day period to arrive at an agreement. Reasons shall be stated in any request for further information.

2. In the case referred to in Article 13(3)(b), if the competent authority which prepared the report decides that the GMO(s) should not be placed on the market, the notification shall be rejected. This decision shall state the reasons.

3. If the competent authority which prepared the report decides that the product may be placed on the market, in the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the assessment report referred to in Article 13(3)(a) or if outstanding issues are resolved within the 105-day period referred to in paragraph 1, the competent authority which prepared the report shall give consent in writing for placing on the market, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

4. The consent shall be given for a maximum period of 10 years.

Article 15

Criteria and information for specified GMOs

1. A competent authority, or the Commission on its own initiative, may make a proposal on criteria and information requirements to be met for the notification, by way of derogation from Article 12 for placing on the market of certain types of GMOs as or in products.

2. These criteria and information requirements as well as any appropriate requirements for a summary shall be adopted, after consultation of the relevant scientific committee(s), in accordance with the procedure laid down in Article 29(2). The criteria and the information requirements shall be such as to ensure a high level of safety to human health and the environment and be based on the scientific evidence available on such safety and on the experience gained with the release of comparable GMOs.

The requirements set out in Article 12(2) shall be replaced by those adopted above, and the procedure set out in Article 12(3), (4), (5) and (6) and Articles 13 and 14 shall apply.

3. Before the procedure laid down in Article 29(2) on a decision for criteria and information requirements referred to in paragraph 1 is initiated, the Commission shall make the proposal available to the public. The public may make comments to the Commission within 60 days.

Article 16

Renewal of consent

1. By way of derogation from Articles 12, 13 and 14, the procedure set out in paragraphs 2 to 9 shall be applied to the renewal of:

(a) consents granted under Part C, and

(b) before ...(11) of consents granted under Directive 90/220/EEC for placing on the market of GMOs as or in products before ...(12).

2. At the latest nine months before the expiry of the consent, for the consents referred to in paragraph 1(a), and before ...(13), for the consents referred to in paragraph 1(b), the notifier under this Article shall submit a notification, to the competent authority which received the original notification, which shall contain:

(a) a copy of the consent to the placing on the market of the GMOs;

(b) a report on the results of the monitoring which was carried out according to Article 19. In the case of consents referred to in paragraph 1(b) this report shall be submitted when the monitoring was carried out;

(c) any other new information which has become available with regard to the risks of the product to human health and/or the environment; and,

(d) as appropriate, a proposal for amending or complementing the conditions of the original consent, inter alia, the conditions concerning future monitoring and the time limitation of the consent.

The competent authority shall acknowledge the date of receipt of the notification and when the notification is in accordance with this paragraph it shall without delay forward a copy of the notification and its assessment report to the Commission, which shall, within 30 days of their receipt, forward them to the competent authorities of the other Member States. It shall also send its assessment report to the notifier.

3. The assessment report shall indicate whether:

(a) the GMO(s) should remain on the market and under which conditions; or

(b) the GMO(s) should not remain on the market.

4. The other competent authorities or the Commission may ask for further information, make comments, or present reasoned objections within a period of 60 days from the date of circulation of the assessment report.

5. All comments, reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.

6. In the case of paragraph 3(a) and in the absence of any reasoned objection from a Member State or the Commission within 60 days from the date of circulation of the assessment report, the competent authority which prepared the report shall transmit to the notifier the final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate.

7. The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

8. If outstanding issues are resolved within the 75-day period referred to in paragraph 7, the competent authority which prepared the report shall transmit to the notifier its final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate.

9. Following a notification for the renewal of a consent in accordance with paragraph 2, the notifier may continue to place the GMOs on the market under the conditions specified in that consent until a final decision has been taken on the notification.

Article 17

Community procedure in case of objections

1. In cases where an objection is raised and maintained by a competent authority or the Commission in accordance with Articles 14, 16 and 19 a decision shall be adopted and published within 120 days in accordance with the procedure laid down in Article 29(2). This decision shall contain the same information as in Article 18(3).

For the purpose of calculating the 120-day 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 in accordance with Article 27 shall not be taken into account. The Commission shall state reasons in any request for further information and inform the competent authorities of its requests to the notifier. The period of time during which the Commission is awaiting the opinion of the scientific committee shall not exceed 90 days.

The period of time that the Council takes to act in accordance with the procedure laid down in Article 29(2) shall not be taken into account.

2. Where a favourable decision has been taken, the competent authority which prepared the report shall give consent in writing to the placing on the market or to the renewal of the consent, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days following the publication or notification of the decision.

Article 18

Consent

1. Without prejudice to requirements under other Community legislation, only if a written consent has been given for the placing on the market of a GMO as or in a product may that product be used without further notification throughout the Community in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to.

2. 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 14, 16 and 17, and in conformity with any conditions required in that consent.

3. The written consent referred to in Articles 14, 16 and 17 shall, in all cases, explicitly specify:

(a) the scope of the consent, including the identity of the GMO(s) to be placed on the market as or in products, and their unique identifier;

(b) the period of validity of the consent;

(c) the conditions for the placing on the market of the product, including any specific condition of use, handling and packaging of the GMO(s) as or in products, and conditions for the protection of particular ecosystems/environments and/or geographical areas;

(d) that, without prejudice to Article 24, the notifier shall make control samples available to the competent authority on request;

(e) the labelling requirements, in compliance with the requirements laid down in Annex IV. The labelling shall clearly state that a GMO is present. The words "This product contains genetically modified organisms" shall appear either on a label or in a document accompanying the product or other products containing the GMO(s);

(f) monitoring requirements in accordance with Annex VII, including obligations to report to the Commission and competent authorities, the time period of the monitoring plan and, where appropriate, any obligations on any person selling the product or any user of it.

4. Member States shall take all necessary measures to ensure that the written consent and the decision referred to in Article 17, where applicable, are made accessible to the public and that the conditions specified in the written consent and the decision, where applicable, are complied with.

Article 19

Monitoring and handling of new information

1. Following the placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent. The reports of this monitoring shall be submitted to the Commission and the competent authorities of the Member States. On the basis of these reports, in accordance with the consent and within the framework for the monitoring plan specified in the consent, the competent authority which received the original notification may adapt the monitoring plan after the first monitoring period.

2. If new information has become available, from the users or other sources, with regards to the risks of the GMO(s) to human health or the environment after the written consent, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof.

In addition, the notifier shall revise the information and conditions specified in the notification.

3. If information becomes available to the competent authority which could have consequences for the risks of the GMO(s) to the human health or the environment, or under the circumstances described in paragraph 2, it shall immediately forward the information to the Commission and the competent authorities of the other Member States and may avail itself of the provisions provided for in Articles 14(1) and 16(7) where appropriate, when the information has become available before the written consent.

When the information has become available after the consent has been given, the competent authority shall, within 60 days after receipt of the new information, forward its assessment report indicating whether and how the conditions of the consent should be amended or the consent should be terminated to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Comments or reasoned objections to further placing on the market of the GMO or on the proposal for amending the conditions of the consent shall be forwarded, within 60 days following the circulation of the assessment report, to the Commission which shall immediately forward them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

In the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the new information or if outstanding issues are resolved within 75 days, the competent authority which prepared the report shall amend the consent as proposed, shall transmit the amended consent to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

Article 20

Labelling

1. Member States shall take all necessary measures to ensure that at all stages of the placing on the market, the labelling and packaging of GMOs placed on the market as or in products comply with the relevant requirements specified in the written consent referred to in Articles 14(3), 16(5) and (8), 17(2) and 18(3).

2. For products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded a minimum threshold may be established below which these products shall not have to be labelled according to the provision in paragraph 1. The threshold levels shall be established according to the product concerned, under the procedure laid down in Article 29(2).

Article 21

Free circulation

Without prejudice to Article 22 Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive.

Article 22

Safeguard clause

1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in 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 GMO as or in a product on its territory.

The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.

The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its reassessment of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.

2. A decision shall be taken on the matter within 60 days in accordance with the procedure laid down in Article 29(2). For the purpose of calculating the 60-day 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 scientific committee(s) which have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the scientific committee(s) consulted shall not exceed 60 days.

Likewise, the period of time the Council takes to act in accordance with the procedure laid down in Article 29(2) shall not be taken into account.

Article 23

Information to the public

1. Without prejudice to Article 24, upon receipt of a notification in accordance with Article 12(1), the Commission shall immediately make available to the public the summary referred to in Article 12(2)(h). The Commission shall also make available to the public assessment reports in the case referred to in Article 13(3)(a). The public may make comments to the Commission within 30 days. The Commission shall immediately forward the comments to the competent authorities.

2. Without prejudice to Article 24, for all GMOs which have received written consent for the placing on the market or whose placing on the market was rejected as or in products under this Directive, the assessment reports carried out for these GMOs and the opinion(s) of the scientific committees consulted shall be made available to the public. For each product, the GMO or GMOs contained therein and the use or uses shall be clearly specified.

PART D

FINAL PROVISIONS

Article 24

Confidentiality

1. The Commission and the competent authorities shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.

2. The notifier may indicate the information in the notification submitted under this Directive, the disclosure of which might harm his competitive position, that should therefore be treated as confidential. Verifiable justification must be given in such cases.

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

4. In no case may the following information when submitted according to Articles 5, 6, 7, 12, 16, 19 or 22 be kept confidential:

- general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses,

- methods and plans for monitoring of the GMO or GMOs and for emergency response,

- the environmental risk assessment.

5. If, for whatever reasons, the notifier withdraws the notification, the competent authorities and the Commission must respect the confidentiality of the information supplied.

Article 25

Labelling of GMOs referred to in Article 2(4), second subparagraph

1. The GMOs to be made available for operations referred to under Article 2(4), second subparagraph shall be subject to adequate labelling requirements in accordance with the relevant sections of Annex IV in order to provide for clear information, on a label or in accompanying document, on the presence of genetically modified organisms. To that effect the words "This product contains genetically modified organisms" shall appear either on a label or in an accompanying document.

2. The conditions for the implementation of paragraph 1, without duplicating or creating inconsistencies with existing labelling provisions laid down in existing Community legislation, shall be determined in accordance with the procedure laid down in Article 29(2). In doing so, account should be taken, as appropriate, of labelling provisions established by Member States in accordance with Community legislation.

Article 26

Adaptation of Annexes to technical progress

Sections C and D of Annex II, Annexes III to VI, and section C of Annex VII shall be adapted to technical progress in accordance with the procedure laid down in Article 29(2).

Article 27

Consultation of scientific committee(s)

1. In cases where an objection as regards the risk of GMOs to human health or to the environment is raised by a competent authority or the Commission and maintained in accordance with Articles 14(1), 16(4), 19(3) or 22, or where the assessment report referred to in Article 13 indicates that the GMO should not be placed on the market, the relevant scientific committee(s) shall be consulted by the Commission, on its own initiative or at the request of a Member State, on the objection.

2. The relevant scientific committee(s) may also be consulted by the Commission, on its own initiative or at the request of a Member State on any matter under this Directive that may have an adverse effect on human health and the environment.

3. The administrative procedures laid down in this Directive shall not be affected by paragraph 2.

Article 28

Consultation of Committee(s) on Ethics

1. Without prejudice to the competence of Member States as regards ethical issues, the Commission, on its own initiative or at the request of the European Parliament or the Council, shall consult any committee it has created with a view to obtaining its advice on the ethical implications of biotechnology, such as the European Group on ethics in science and new technologies, on ethical issues of a general nature.

This consultation may also take place at the request of a Member State.

2. The administrative procedures provided for in this Directive shall not be affected by paragraph 1.

Article 29

Committee procedure

1. The Commission shall be assisted by a committee, hereinafter referred to as the "committee".

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

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

3. The committee shall adopt its own rules of procedure.

Article 30

Exchange of information and reporting

1. Member States and the Commission shall meet regularly and exchange information on the experience acquired with regard to the prevention of risks related to the release and the placing on the market of GMOs. This information exchange shall also cover experience gained with the implementation of Article 2(4), second subparagraph, environmental risk assessment, monitoring and the issue of consultation and information of the public.

Where necessary, guidance on the implementation of Article 2(4), second subparagraph may be provided by the committee established under Article 29(1).

2. The Commission shall establish one or several register(s) for the purpose of recording the information on genetic modifications in GMOs mentioned in point A.7 of Annex IV. Without prejudice to Article 24 the register(s) shall include a part which is accessible to the public. The detailed arrangements for the operation of the register(s) shall be decided in accordance with the procedure laid down in Article 29(2).

3. Every three years. Member States shall send the Commission a report on the measures taken to implement the provisions of this Directive. This report shall include a brief factual report on their experience with GMOs placed on the market in or as products under this Directive.

4. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 3.

5. The Commission shall send to the European Parliament and the Council, in 2003 and thereafter every three years, a report on the experience of Member States with GMOs placed on the market under this Directive.

6. When submitting this report in 2003 the Commission shall at the same time submit a specific report on the operation of Part B and Part C including an assessment of:

(a) all its implications, particularly to take account of the diversity of European ecosystems and the need to complement the regulatory framework in this field;

(b) the feasibility of various options to improve further the consistency and efficiency of this framework, including a centralised Community authorisation procedure and the arrangements for the final decision-making by the Commission;

(c) whether sufficient experience has accumulated on the implementation of Part B differentiated procedures to justify a provision on implicit consent in these procedures and on Part C to justify the application of differentiated procedures; and

(d) socioeconomic implications of deliberate releases and placing on the market of GMOs.

7. The Commission shall send to the European Parliament and the Council, every year, a report on the ethical issues referred to in Article 28(1); this report may be accompanied, if appropriate, by a proposal with a view to amending this Directive.

Article 31

Penalties

Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. Those penalties shall be effective, proportionate and dissuasive.

Article 32

Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ...(14). They shall forthwith inform the Commission thereof.

When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field covered by this Directive.

Article 33

Pending notifications

1. Notifications concerning placing on the market of GMOs as or in products received pursuant to Directive 90/220/EEC and in respect of which the procedures of that Directive have not been completed by ...(15) shall be subject to the provisions of this Directive.

2. By ...(16) notifiers shall have completed their notification in accordance with this Directive.

Article 34

Repeal

1. Directive 90/220/EEC shall be repealed on ...(17).

2. References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex VIII.

Article 35

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

Article 36

This Directive is addressed to the Member States.

Done at ...,

For the European Parliament

The President

For the Council

The President

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

(2) OJ C 407, 28.12.1998, p. 1.

(3) Opinion of the European Parliament of 11 February 1999 (OJ C 150, 28.5.1999, p. 363), Council Common Position of 9 December 1999 and Decision of the European Parliament of ... (not yet published in the Official Journal).

(4) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

(5) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 1999/80/EC (OJ L 210, 10.8.1999, p. 13).

(6) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

(7) OJ L 237, 28.8.1997, p. 18.

(8) OJ L 184, 17.7.1999, p. 23.

(9) OJ L 117, 8.5.1990, p. 1. Directive as amended by Directive 98/81/EC (OJ L 330, 5.12.1998, p. 13).

(10) OJ L 292, 12.11.1994, p. 31.

(11) Four years after the date referred to in Article 32.

(12) Date referred to in Article 32.

(13) 4 years after the date referred to in Article 32.

(14) 18 months after the entry into force of this Directive.

(15) 18 months after the entry into force of this Directive.

(16) 21 months after the entry into force of this Directive.

(17) Date referred to in Article 32.

ANNEX I A

TECHNIQUES REFERRED TO IN ARTICLE 2(2)

PART 1

Techniques of genetic modification referred to in Article 2(2)(a) are, inter alia:

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

2. techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;

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

PART 2

Techniques referred to in Article 2(2)(b) which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques/methods other than those excluded by Annexe IB:

1. in-vitro fertilisation;

2. natural processes such as: conjugation, transduction, transformation;

3. polyploidy induction.

ANNEX I B

TECHNIQUES REFERRED TO IN ARTICLE 3

Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are:

1. mutagenesis;

2. cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.

ANNEX II

PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

This Annex describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment (ERA) referred to in Articles 4 and 12. It will be supplemented by guidance notes to be developed in accordance with the procedure laid down in Article 29(2). These guidance notes shall be completed by ...(1).

With a view to contributing to a common understanding of the terms "direct, indirect, immediate and delayed" when implementing this Annex, without prejudice to further guidance in this respect and in particular as regards the extent to which indirect effects can and should be taken into account, these terms are described as follows:

- "direct effects" refers to primary effects on human health or the environment which are a result of the GMO itself and which do not occur through a causal chain of events,

- "indirect effects" refers to effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interaction with other organisms, transfer of genetic material, or changes in use or management. Observations of indirect effects are likely to be delayed,

- "immediate effects" refers to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect,

- "delayed effects" refers to effects on human health or the environment which may not be observed during the period of the release of the GMO but become apparent as a direct or indirect effect either at a later stage or after termination of the release.

A. OBJECTIVE

The objective of an ERA is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The ERA should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used.

B. GENERAL PRINCIPLES

In accordance with the precautionary principle, the following general principles should be followed when performing the ERA:

- identified characteristics of the GMO and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations,

- the ERA should be carried out in a scientifically sound and transparent manner based on available scientific and technical data,

- the ERA should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the GMO's concerned, their intended use and the potential receiving environment, taking into account, inter alia, GMOs already in the environment,

- if new information on the GMO and its effects on human health or the environment becomes available, the ERA may need to be re-addressed in order to:

- determine whether the risk has changed,

- determine whether there is a need for amending the risk management accordingly.

C. METHODOLOGY

C.1. Characteristics of GMOs and releases

Depending on the case the ERA has to take into account the relevant technical and scientific details regarding characteristics of:

- the recipient or parental organism(s),

- the genetic modification(s), be it inclusion or deletion of genetic material, and relevant information on the vector and the donor,

- the GMO,

- the intended release or use including its scale,

- the potential receiving environment, and

- the interaction between these.

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

C.2. Steps in the ERA

In drawing conclusions for the ERA referred to in Articles 4, 5, 6 and 12 the following points should be addressed:

1. Identification of characteristics which may cause adverse effects:

Any characteristics of the GMOs linked to the genetic modification that may result in adverse effects on human health or the environment shall be identified. A comparison of the characteristics of the GMO(s) with those of the non-modified organism under corresponding conditions of the release or use, will assist in identifying the particular potential adverse effects arising from the genetic modification. It is important not to discount any potential adverse effect on the basis that it is unlikely to occur.

Potential adverse effects of GMOs will vary from case to case and may include:

- disease to humans including allergenic or toxic effects (see e.g. points II.A.11 and II.C.2(i) in Annex IIIA, and B.7 in Annex IIIB),

- disease to animals and plants including toxic, and where appropriate, allergenic effects (see e.g. points II.A.11 and II.C.2(i) in Annex IIIA, and B.7 and D.8 in Annex IIIB),

- effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations (see e.g. points IV.B.8, 9 and 12 in Annex IIIA),

- altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or creating new reservoirs or vectors,

- compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, e.g. by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine (see e.g. points III.A.11(e) and II.C.2(i)(iv) in Annex IIIA),

- effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material (see e.g. points II.A.11(f) and IV.B.15 in Annex IIIA, and D.11 in Annex IIIB).

Adverse effects may occur directly or indirectly through mechanisms which may include:

- the spread of the GMO(s) in the environment,

- the transfer of the inserted genetic material to other organisms, or the same organism whether genetically modified or not,

- phenotypic and genetic instability,

- interactions with other organisms,

- changes in management, including, where applicable, in agricultural practices.

2. Evaluation of the potential consequences of each adverse effect, if it occurs

The magnitude of the consequences of each potential adverse effect should be evaluated. This evaluation should assume that such an adverse effect will occur. The magnitude of the consequences is likely o be influenced by the environment into which the GMO(s) is (are) intended to be released and the manner of the release.

3. Evaluation of the likelihood of the occurrence of each identified potential adverse effect

A major factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment into which the GMO(s) is intended to be released, and the manner of the release.

4. Estimation of the risk posed by each identified characteristic of the GMO(s)

An estimation of the risk to human health or the environment posed by each identified characteristic of the GMO which has the potential to cause adverse effects should be made as far as possible, given the state of the art, by combining the likelihood of the adverse effect occurring and the magnitude of the consequences, if it occurs.

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

The risk assessment may identify risks that require management and how best to manage them, and a risk management strategy should be defined.

6. Determination of the overall risk of the GMO(s)

An evaluation of the overall risk of the GMO(s) should be made taking into account any risk management strategies which are proposed.

D. CONCLUSIONS ON THE POTENTIAL ENVIRONMENTAL IMPACT FROM THE RELEASE OR THE PLACING ON THE MARKET OF GMOS

On the basis of an ERA carried out in accordance with the principles and methodology outlined in sections B and C, information on the points listed in sections D.1 or D.2 should be included, as appropriate, in notifications with a view to assisting in drawing conclusions on the potential environmental impact from the release or the placing on the market of GMOs:

D.1. In the case of GMOs other than higher plants

1. Likelihood of the GMO to become persistent and invasive in natural habitats under the conditions of the proposed release(s).

2. Any selective advantage or disadvantage conferred to the GMO and the likelihood of this becoming realised under the conditions of the proposed release(s).

3. Potential for gene transfer to other species under conditions of the proposed release of the GMO and any selective advantage or disadvantage conferred to those species.

4. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the GMO and target organisms (if applicable)

5. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the GMO with non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.

6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMO and persons working with, coming into contact with or in the vicinity of the GMO releases(s).

7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the GMO and any products derived from it if it is intended to be used as animal feed.

8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the GMO and target and non-target organisms in the vicinity of the GMO release(s).

9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the GMO where these are different from those used for non-GMOs.

D.2. In the case of genetically modified higher plants (GMHP)

1. Likelihood of the GMHP becoming more persistent than the recipient or parental plants in agricultural habitats or more invasive in natural habitats.

2. Any selective advantage or disadvantage conferred to the GMHP.

3. Potential for gene transfer to the same or other sexually compatible plant species under conditions of planting the GMHP and any selective advantage or disadvantage conferred to those plant species

4. Potential immediate and/or delayed environmental impact resulting from direct and indirect interactions between the GMHP and target organisms, such as predators, parasitoids, and pathogens (if applicable).

5. Possible immediate and/or delayed environmental impact resulting from direct and indirect interactions of the GMHP with non-target organisms, (also taking into account organisms which interact with target organisms), including impact on population levels of competitors, herbivores, symbionts (where applicable), parasites and pathogens.

6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMHP and persons working with, coming into contact with or in the vicinity of the GMHP release(s).

7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the GMO and any products derived from it if it is intended to be used as animal feed.

8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the GMO and target and non-target organisms in the vinicity of the GMO release(s).

9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific cultivation, management and harvesting techniques used for the GMHP where these are different from those used for non-GMHPs.

(1) Date referred to in Article 32.

ANNEX III

INFORMATION REQUIRED IN THE NOTIFICATION

A notification referred to in Part B or Part C of the Directive is to include, as appropriate, the information set out below in the sub-Annexes.

Not all the points included will apply to every case. It is to be expected that individual notifications will address only the particular subset of considerations which is appropriate to individual situations.

The level of detail required in response to each subset of considerations is also likely to vary according to the nature and the scale of the proposed release.

Future developments in genetic modification may necessitate adapting this Annex to technical progress or developing guidance notes on this Annex. Further differentiation of information requirements for different types of GMOs, for example single-celled organisms, fish or insects, or for particular use of GMOs like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular GMOs has been gained in the Community.

The description of the methods used or the reference to standardised or internationally recognised methods shall also be mentioned in the dossier, together with the name of the body or bodies responsible for carrying out the studies.

Annex IIIA applies to releases of all types of genetically modified organisms other than higher plants. Annex IIIB applies to release of genetically modified higher plants.

The term "higher plants" means plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).

ANNEX III A

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

I. GENERAL INFORMATION

A. Name and address of the notifier (company or institute)

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

C. Title of the project

II. INFORMATION RELATING TO THE GMO

A. Characteristics of (a) the donor, (b) the recipient or (c) (where appropriate) parental organism(s):

1. scientific name;

2. taxonomy;

3. other names (usual name, strain name, etc.);

4. phenotypic and genetic markers;

5. degree of relatedness between donor and recipient or between parental organisms;

6. description of identification and detection techniques;

7. sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;

8. description of the geographic distribution and of the natural habitat of the organism including information on natural predators, preys, parasites and competitors, symbionts and hosts;

9. organisms with which transfer of genetic material is known to occur under natural conditions;

10. verification of the genetic stability of the organisms and factors affecting it;

11. pathological, ecological and physiological traits:

(a) classification of hazard according to existing Community rules concerning the protection of human health and/or the environment;

(b) generation time in natural ecosystems, sexual and asexual reproductive cycle;

(c) information on survival, including seasonability and the ability to form survival structures;

(d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organism. Possible activation of latent viruses (proviruses). Ability to colonise other organisms;

(e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy;

(f) involvement in environmental process: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.

12. Nature of indigenous vectors:

(a) sequence;

(b) frequency of mobilisation;

(c) specificity;

(d) presence of genes which confer resistance.

13. History of previous genetic modifications.

B. Characteristics of the vector:

1. nature and source of the vector;

2. sequence of transposons, vectors and other non-coding genetic segments used to construct the GMO and to make the introduced vector and insert function in the GMO;

3. frequency of mobilisation of inserted vector and/or genetic transfer capabilities and methods of determination;

4. information on the degree to which the vector is limited to the DNA required to perform the intended function.

C. Characteristics of the modified organism:

1. Information relating to the genetic modification:

(a) methods used for the modification;

(b) methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;

(c) description of the insert and/or vector construction;

(d) purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function;

(e) methods and criteria used for selection;

(f) sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence.

2. Information on the final GMO:

(a) description of genetic trait(s) or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;

(b) structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism;

(c) stability of the organism in terms of genetic traits;

(d) rate and level of expression of the new genetic material; method and sensitivity of measurement;

(e) activity of the expressed protein(s);

(f) description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector;

(g) sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;

(h) history of previous releases or uses of the GMO;

(i) considerations for human health and animal health, as well as plant health:

(i) toxic or allergenic effects of the GMOs and/or their metabolic products;

(ii) comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

(iii) capacity for colonisation;

(iv) if the organism is pathogenic to humans who are immunocompetent:

- diseases caused and mechanism of pathogenicity including invasiveness and virulence,

- communicability,

- infective dose,

- host range, possibility of alteration,

- possibility of survival outside of human host,

- presence of vectors or means of dissemination,

- biological stability,

- antibiotic-resistance patterns,

- allergenicity,

- availability of appropriate therapies.

(v) other product hazards.

III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

A. Information on the release:

1. description of the proposed deliberate release, including the purpose(s) and foreseen products;

2. foreseen dates of the release and time planning of the experiment including frequency and duration of releases;

3. preparation of the site previous to the release;

4. size of the site;

5. method(s) to be used for the release;

6. quantities of GMOs to be released;

7. disturbance on the site (type and method of cultivation, mining, irrigation, or other activities);

8. worker protection measures taken during the release;

9. post-release treatment of the site;

10. techniques foreseen for elimination or inactivation of the GMOs at the end of the experiment;

11. information on, and results of, previous releases of the GMOs, especially at different scales and in different ecosystems.

B. Information on the environment (both on the site and in the wider environment):

1. geographical location and grid reference of the site(s) (in case of notifications under Part C the site(s) of release will be the foreseen areas of use of the product);

2. physical or biological proximity to humans and other significant biota;

3. proximity to significant biotopes, protected areas, or drinking water supplies;

4. climatic characteristics of the region(s) likely to be affected;

5. geographical, geological and pedological characteristics;

6. flora and fauna, including crops, livestock and migratory species;

7. description of target and non-target ecosystems likely to be affected;

8. a comparison of the natural habitat of the recipient organism with the proposed site(s) of release;

9. any known planned developments or changes in land use in the region which could influence the environmental impact of the release.

IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOS AND THE ENVIRONMENT

A. Characteristics affecting survival, multiplication and dissemination:

1. biological features which affect survival, multiplication and dispersal;

2. known or predicted environmental conditions which may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, etc.);

3. sensitivity to specific agents.

B. Interactions with the environment:

1. predicted habitat of the GMOs;

2. studies of the behaviour and characteristics of the GMOs and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms, greenhouses;

3. genetic transfer capability:

(a) post-release transfer of genetic material from GMOs into organisms in affected ecosystems;

(b) post-release transfer of genetic material from indigenous organisms to the GMOs;

4. likelihood of post-release selection leading to the expression of unexpected and/of undesirable traits in the modified organism;

5. measures employed to ensure and to verify genetic stability. Description of genetic traits which may prevent or minimise dispersal of genetic material; methods to verify genetic stability;

6. routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc.;

7. description of ecosystems to which the GMOs could be disseminated;

8. potential for excessive population increase in the environment;

9. competitive advantage of the GMOs in relation to the unmodified recipient or parental organism(s);

10. identification and description of the target organisms if applicable;

11. anticipated mechanism and result of interaction between the released GMOs and the target organism(s) if applicable;

12. identification and description of non-target organisms which may be adversely affected by the release of the GMO, and the anticipated mechanisms of any identified adverse interaction;

13. likelihood of post-release shifts in biological interactions or in host range;

14. known or predicted interactions with non-target organisms in the environment, including competitors, preys, hosts, symbionts, predators, parasites and pathogens;

15. known or predicted involvement in biogeochemical processes;

16. other potential interactions with the environment.

V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS

A. Monitoring techniques:

1. methods for tracing the GMOs, and for monitoring their effects;

2. specificity (to identify the GMOs, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques;

3. techniques for detecting transfer of the donated genetic material to other organisms;

4. duration and frequency of the monitoring.

B. Control of the release:

1. methods and procedures to avoid and/or minimise the spread of the GMOs beyond the site of release or the designated area for use;

2. methods and procedures to protect the site from intrusion by unauthorised individuals;

3. methods and procedures to prevent other organisms from entering the site.

C. Waste treatment:

1. type of waste generated;

2. expected amount of waste;

3. description of treatment envisaged.

D. Emergency response plans:

1. methods and procedures for controlling the GMOs in case of unexpected spread;

2. methods for decontamination of the areas affected, e.g. eradication of the GMOs;

3. methods for disposal or sanitation of plants, animals, soils, etc. that were exposed during or after the spread;

4. methods for the isolation of the area affected by the spread;

5. plans for protecting human health and the environment in case of the occurrence of an undesirable effect.

ANNEX III B

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPS) (GYMNOSPERMAE AND ANGIOSPERMAE)

A. General information

1. Name and address of the notifier (company or institute).

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

3. Title of the project.

B. INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE) PARENTAL PLANTS

1. Complete name:

(a) family name;

(b) genus;

(c) species;

(d) subspecies;

(e) cultivar/breeding line;

(f) common name.

2. (a) Information concerning reproduction:

(i) mode(s) of reproduction;

(ii) specific factors affecting reproduction, if any;

(iii) generation time.

(b) Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species.

3. Survivability:

(a) ability to form structures for survival or dormancy;

(b) specific factors affecting survivability, if any.

4. Dissemination:

(a) ways and extent (e.g. an estimation of how viable pollen and/or seeds decline(s) with distance) of dissemination;

(b) specific factors affecting dissemination, if any.

5. Geographical distribution of the plant.

6. In the case of plant species not normally grown in the Member State(s), description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

7. Other potential interactions, relevant to the GMO, of the plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

C. INFORMATION RELATING TO THE GENETIC MODIFICATION

1. Description of the methods used for the genetic modification.

2. Nature and source of the vector used.

3. Size, source (name) of donor organism(s) and intended function of each constituent fragment of the region intended for insertion.

D. INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT

1. Description of the trait(s) and characteristics which have been introduced or modified.

2. Information on the sequences actually inserted/deleted:

(a) size and structure of the insert and methods used for its characterisation, including information on any parts of the vector introduced in the GMHP or any carrier or foreign DNA remaining in the GMHP;

(b) in case of deletion, size and function of the deleted region(s);

(c) copy number of the insert;

(d) location(s) of the insert(s) in the plant cells (integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its determination.

3. Information on the expression of the insert:

(a) information on the developmental expression of the insert during the lifecycle of the plant and methods used for its characterisation;

(b) parts of the plant where the insert is expressed (e.g. roots, stem, pollen, etc.).

4. Information on how the genetically modified plant differs from the recipient plant in:

(a) mode(s) and/or rate of reproduction;

(b) dissemination;

(c) survivability.

5. Genetic stability of the insert and phenotypic stability of the GMHP.

6. Any change to the ability of the GMHP to transfer genetic material to other organisms.

7. Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification.

8. Information on the safety of the GMHP to animal health, particularity regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the GMHP is intended to be used in animal feedstuffs.

9. Mechanism of interaction between the genetically modified plant and target organisms (if applicable).

10. Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification.

11. Potential interactions with the abiotic environment.

12. Description of detection and identification techniques for the genetically modified plant.

13. Information about previous releases of the genetically modified plant, if applicable.

E. INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 5 AND 6)

1. Location and size of the release site(s).

2. Description of the release site ecosystem, including climate, flora and fauna.

3. Presence of sexually compatible wild relatives or cultivated plant species.

4. Proximity to officially recognised biotopes or protected areas which may be affected.

F. INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 5 AND 6)

1. Purpose of the release.

2. Foreseen date(s) and duration of the release.

3. Method by which the genetically modified plants will be released.

4. Method for preparing and managing the release site, prior to, during and post-release, including cultivation practices and harvesting methods.

5. Approximate number of plants (or plants per m2).

G. INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 5 AND 6)

1. Any precautions taken:

(a) distance(s) from sexually compatible plant species, both wild relatives and crops

(b) any measures to minimise/prevent dispersal of any reproductive organ of the GMHP (e.g. pollen, seeds, tuber).

2. Description of methods for post-release treatment of the site.

3. Description of post-release treatment methods for the genetically modified plant material including wastes.

4. Description of monitoring plans and techniques.

5. Description of any emergency plans.

6. Methods and procedures to protect the site.

ANNEX IV

ADDITIONAL INFORMATION

This Annex describes in general terms the additional information to be provided in the case of notification for placing on the market and information for labelling requirements regarding GMOs as or in product to be placed on the market, and GMO exempted under Article 2(4), second subparagraph. It will be supplemented by guidance notes, as regards, inter alia, the description of how the product is intended to be used, to be developed in accordance with the procedure laid down in Article 29(2). The labelling of exempted organisms as required by Article 25 shall be met by providing appropriate recommendations for, and restrictions on, use:

A. The following information shall be provided in the notification for placing on the market of GMOs as or in product in addition to that of Annex III:

1. proposed commercial names of the products and names of GMOs contained therein, and any specific identification, name or code used by the notifier to identify the GMO. After the consent any new commercial names should be provided to the competent authority;

2. name and full address of the person established in the Community who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor;

3. name and full address of the supplier(s) of control samples;

4. description of how the product and the GMO as or in product are intended to be used. Differences in use or management of the GMO compared to similar non-genetically modified products should be highlighted;

5. description of the geographical area(s) and types of environment where the product is intended to be used within the Community, including where possible, estimated scale of use in each area;

6. intended categories of users of the product e.g. industry, agriculture and skilled trades, consumer use by public at large;

7. information on the genetic modification for the purposes of placing on one or several registers modifications in organisms, which can be used for the detection and identification of particular GMO products to facilitate post-marketing control and inspection. This information should include where appropriate the lodging of samples of the GMO or its genetic material, with the competent authority and details of nucleotide sequences or other type of information which is necessary to identify the GMO product and its progeny, e.g. the methodology for detecting and identifying the GMO product, including experimental data demonstrating the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register should be identified;

8. proposed labelling on a label or in an accompanying document. This must include, at least in summarised form, a commercial name of the product, the name of the GMO and the information referred to in point 2; the labelling should indicate how to access the information in the publicly accessible part of the register.

B. The following information shall be provided in the notification, when relevant, in addition to that of point A, in accordance with Article 12 of this Directive:

1. measures to take in case of unintended release or misuse;

2. specific instructions or recommendations for storage and handling;

3. specific instructions for carrying out monitoring and reporting to the notifier and, if required, the competent authority, so that the competent authorities can be effectively informed of any adverse effect. These instructions should be consistent with Annex VII, Part C;

4. proposed restrictions in the approved use of the GMO, for example where the product may be used and for what purposes;

5. proposed packaging;

6. estimated production in and/or imports to the Community;

7. proposed additional labelling. This may include, at least in summarised form, the information referred to in points A.4, A.5, B.1, B.2, B.3 and B.4.

ANNEX V

CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 6)

The criteria referred to in Article 6(1) are set out below.

1. The taxonomic status and the biology (e. g. mode of reproduction and pollination, ability to cross with related species, pathogenecity) of the non-modified (recipient) organism shall be well-known.

2. There shall be sufficient knowledge about the safety for human health and the environment of the parental, where appropriate, and recipient organisms in the environment of the release.

3. Information shall be available on any interaction of particular relevance for the risk assessment, involving the parental, where appropriate, and recipient organism and other organisms in the experimental release ecosystem.

4. Information shall be available to demonstrate that any inserted genetic material is well characterised. Information on the construction of any vector systems or sequences of genetic material used with the carrier DNA shall be available. Where a genetic modification involves the deletion of genetic material, the extent of the deletion shall be known. Sufficient information on the genetic modification shall also be available to enable identification of the GMO and its progeny during a release.

5. The GMO shall not present additional or increased risks to human health or the environment under the conditions of the experimental release that are not presented by releases of the corresponding parental, where appropriate, and recipient organisms. Any capacity to spread in the environment and invade other unrelated ecosystems and capacity to transfer genetic material to other organisms in the environment shall not result in adverse effects.

ANNEX VI

GUIDELINES FOR THE ASSESSMENT REPORTS

The assessment report provided for by Articles 12, 16, 18 and 19 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 the environment resulting from the release into the environment of the recipient non-modified organism.

2. Description of the result of the genetic modification in the modified organism.

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

4. Identification of any new risks to human health and 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 environmental risk assessment carried out in accordance with 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, whether the GMOs in question shall not be placed on the market or whether the views of other competent authorities and the Commission are sought for on specific issues of the ERA. These aspects should be specified. The conclusion should clearly address the use proposed, risk management and the monitoring plan proposed. In the case that it has been concluded that the GMOs should not be placed on the market, the competent authority shall give reasons for its conclusion.

ANNEX VII

MONITORING PLAN

This Annex describes in general terms the objective to be achieved and the general principles to be followed to design the monitoring plan referred to in Articles 12(2), 18(3) and 19. It will be supplemented by guidance notes to be developed in accordance with the procedure laid down in Article 29(2).

These guidance notes shall be completed by ...(1).

A. OBJECTIVE

The objective of a monitoring plan is to:

- confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the ERA are correct, and

- identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were not anticipated in the ERA.

B. GENERAL PRINCIPLES

Monitoring, as referred to in Articles 12, 18 and 19, takes place after the consent to the placing of a GMO on the market.

The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the GMO or its use, as such changes may be the result of environmental factors other than the placing of the GMO on the market.

Experience and data gained through the monitoring of experimental releases of GMOs may assist in designing the post-marketing monitoring regime required for the placing on the market of GMOs as or in products.

C. DESIGN OF THE MONITORING PLAN

The design of the monitoring plan should:

1. be detailed on a case basis by case taking into account the ERA;

2. take into account the characteristics of the GMO, the characteristics and scale of its intended use and the range of relevant environmental conditions where the GMO is expected to be released;

3. incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-) specific monitoring focusing on adverse effects identified in the ERA;

3.1. whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the ERA;

3.2. whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the consent-holder should be provided;

4. facilitate the observation, in a systematic manner, of the release of a GMO in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment;

5. identify who (notifier, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the consent holder and the competent authority will be informed on any observed adverse effects on human health and the environment. (Time points and intervals for reports on the results of the monitoring shall be indicated);

6. give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or the competent authority, where appropriate, to take measures necessary to protect human health and the environment.

(1) Date referred to in Article 32.

ANNEX VIII

CORRELATION TABLE

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 24 February 1998 the Commission submitted to the Council a proposal for a directive based on Article 100a (Article 95 of the Amsterdam Treaty) of the EC Treaty and amending Directive 90/220/EEC.

2. The European Parliament and the Economic and Social Committee delivered their opinions on 11 February 1999 and 9 September 1998 respectively.

3. Following the European Parliament's opinion, the Commission submitted its amended proposal to the Council on 29 March 1999.

4. On 9 December 1999 the Council adopted its common position in accordance with Article 251 of the Treaty.

II. OBJECTIVE

The proposal seeks to revise Directive 90/220/EEC in the light of the experience gained and the evaluation of scientific knowledge so as to ensure the setting up of a suitable regulatory framework to cover the potential environmental and health risks of the release of genetically modified organisms (GMOs) in the environment. The revision would also take account of the need to avoid imposing over-long procedures or excessive administrative formalities on the sector in question.

III. ANALYSIS OF THE COMMON POSITION

In line with the objective described in point II, the Council's common position has adopted, verbatim, partially or in substance, 38 of the 39 European Parliament amendments included by the Commission in its amended proposal, together with a large number of amendments that the Commission did not include.

A. AMENDMENT NOT TAKEN UP BY THE COUNCIL

Amendment 16 which sought to define the term "use" was not accepted in so far as this term was used in its ordinary sense in the common position.

B. CHANGES MADE BY THE COUNCIL TO THE AMENDED PROPOSAL

Given that most of the provisions of Directive 90/220/EEC, including its Annexes, had been substantially amended by the common position, it was thought preferable, for reasons of clarity and transparency vis-à-vis both the general public and the national administrations, to recast that Directive and to put forward a consolidated directive. Annex VIII to the common position shows by way of illustration the correspondence between the provisions of the old and the new Directive.

Apart from the incorporation of most of the recitals of Directive 90/220/EEC, and the structural changes inherent in this presentation in consolidated form, the Council's main changes are described in points 1 to 6 below (unless otherwise indicated, the references in italics are to the common position).

Generally speaking, the procedural time limits in the proposal have been extended so that further information can be supplied and the information itself can be processed more effectively. In most cases information is communicated via the Commission and no longer from a competent authority to the Commission and the other competent authorities.

1. Scope

Although the scope envisaged by the Council and the scope proposed by the Commission are very similar, it was thought necessary:

- to make a clearer distinction between activities regulated by Part B of the Directive (first indent of Article 1) and those covered by Part C (second indent);

- to regroup the exceptions (Article 1(2) and Article 3 of the proposal) in a single Article (Article 3);

- to ensure consistency between this Directive and Directive 90/219/EEC on the contained use of micro-organisms as amended by Directive 98/81/EC: hence the amendment of Article 2(3);

- to clarify the definition of "placing on the market" (Article 2(4)) to ensure that it did not apply to the supplying of GMOs for activities regulated under Directive 90/219/EEC or subject to similar containment measures, or for research and development activities covered by Part B of Directive 90/220/EEC. The definition thus takes account of Amendment 13.

In the interests of transparency, all GMOs supplied in this way will be appropriately labelled (Article 25). It is also specified that placing on the market is not confined to the supply of GMOs in return for payment;

- for the reference to the exception of "human beings" to be included in the definition of GMO (Article 2(2)) rather than in the definition of organism, where it seemed somewhat illogical.

In view of the questions of interpretation that could arise in practice, provision is made (second subparagraph of Article 30(1)) to enable the regulatory committee (Article 29) set up by the Directive to provide guidance on the implementation of these definitions.

2. General obligations

The Council has accepted (Article 4(1)) the reference to the precautionary principle suggested by the European Parliament in Amendment 17 and it has sought to give operational effect to the substance of Amendment 90 concerning genes conferring resistance to antibiotics (see also Annex II point C.2). The Council has also included (Article 4(5)) the obligation to ensure the traceability of GMOs (Amendment 92), with a stipulation that it must be ensured at all stages in the placing of GMOs on the market (see also Article 30(2) and Annex IV).

Regarding Amendments 19 and 21 on GMO exports, the Council intends, at a later stage in the revision of the Directive, to consider the implications for exports of the outcome of the negotiations on the protocol on biosafety.

3. Deliberate release of GMOs for any purpose other than placing them on the market (Part B)

The Council has accepted Amendment 22, taking the view that there was no need to exempt products under development from the requirements of this part. It also thought the distinction between two categories (I and II) of deliberate release as proposed by the Commission complicated the procedures without any gain in terms of health and environmental protection. Likewise, and in line with Amendment 28, the introduction of a third procedure (Article 6c of the proposal) for releases effected in several Member States seemed to add nothing to a notification submitted simultaneously to those Member States under the standard procedure (Article 5). Articles 5, 6 and 6c of the proposal have thus been deleted.

Essentially, Article 5 reproduces Article 6b of the proposal, specifying among other things that (paragraph 2(b)) the environmental risk assessment is to be included in the notification and that (paragraph 4) several releases may be covered by the same notification, and, in the line with the principle of Amendment 27, placing a time limit on public inquiries and consultations (paragraph 6(b)).

With regard to the differentiated procedures, Article 6 combines Article 6a of the proposal and Article 6(5) of Directive 90/220/EEC and reinforces (more information on the genetic modification (paragraph 4), deletion of the criterion based on similarity to other releases (Part B of Annex V to the proposal)) the criteria of Annex V for the application of these procedures. Also, it will be necessary for the public and the relevant scientific committees to be consulted on any proposals for drawing up differentiated procedures (paragraph 2) before the committee set up by Article 29 takes a decision on them. Paragraph 5 stipulates that these procedures must provide that releases may only be made once the competent authority has given its written consent. Decision 94/730/EC, which established such a procedure under Directive 90/220/EEC, will be replaced by a decision based on Article 6 and will have a similar content.

Since each Member State remains free to choose whether or not to use these procedures, it will have to inform the Commission of its intentions in this regard (paragraph 7).

Article 8(1) underlines that it is compulsory (and no longer simply a matter of what is possible) for the public to be consulted, while it is left to the Member States (and no longer to a committee) to lay down the arrangements for such consultation.

4. Placing on the market of GMOs (Part C)

Article 11 (sectoral legislation) has reinforced (paragraph 1) the conditions under which Part C does not apply to GMOs authorised by other Community legislation by imposing a requirement of equivalence not only as regards the environmental risk assessment but also as regards risk management, labelling, monitoring, information to the public and the safeguard clause. As regards medicinal products (paragraph 2), however, it was thought sufficient to restrict this condition to the environmental risk assessment in view of the specific nature of the authorisation and monitoring procedures laid down for such products in Regulation (EEC) No 2309/93. Procedures to ensure equivalence will have to be laid down in a regulation of the European Parliament and the Council (paragraph 3).

The Council considered that, in the light of the available experience, there was no justification for introducing the simplified procedure in Article 13b of the proposal at the risk of undermining the protection of human health and the environment. That Article has therefore been deleted. However, in Article 15 the possibility of introducing different information requirements from those laid down in the notification procedure (Article 12(2)) has been accepted on the understanding that the rest of the standard procedure, in particular Articles 13 and 14, will apply.

As to the period of validity of consents, the Council has followed the approach advocated by the European Parliament in several of its amendments, namely that a time limit should be imposed only in the case of the original consent and that it should be considerably longer than the one proposed by the Commission (seven years). By analogy with the limits laid down in other acts of Community legislation, the Council decided on 10 years. Likewise, in the case of labelling the Council supports the Parliament's position in favour of clear and unambiguous labelling and has used the wording "This product contains genetically modified organisms" in Articles 12(2), 18(3) and 25(1).

Also, as regards the standard procedure (Articles 12 to 14):

- the competent authority must first ensure that the notification is in accordance with the requirements concerning the information to be sent to the Commission (Article 12(1)); the sending of such information must in any case occur not later than the submission of the assessment report;

- the notification must propose a period not exceeding 10 years (paragraph 2(d));

- paragraph 6 reproduces paragraph 4 of Article 13e in so far as that paragraph also concerns information available before written consent is granted;

- in Article 13 (assessment report) the common position clarifies (paragraph 2, first indent) the consequences of the notifier's withdrawal of his notification and stipulates (paragraph 2, second subparagraph) that the procedure does not stop at this stage even if the competent authority that prepared the report has issued a negative opinion as to placing on the market. In that case, a GMO cannot be placed on the market if the competent authority confirms its original negative opinion (Article 14(2));

- in Article 13(3) the Council took the view that only two options had to be considered (whether a GMO was to be placed on the market or not) and that it was not necessary to keep the "additional assessment requirement" option, in view of, among other things, the provisions that already require, at several stages in the procedures, consultation with the notifier and with other competent authorities;

- Recitals 34 and 36 clarify the consequences that rejection of a notification has for any subsequent submission or decision concerning the same GMO. Recital 35 explains what is meant by "reaching an agreement" at the end of the mediation period provided for, inter alia, in Article 14(1);

- the consent is valid for a maximum of 10 years.

Article 16 (renewal of consent) incorporates Articles 13c (consents granted under the new Directive) and 22b (consents granted under Directive 90/220/EEC) and makes the following stipulations:

- for "new" consents (paragraph 2) a period of nine months before their expiry should be sufficient for the renewal procedure. For "old" consents granted without time limits, a longer period than the seven years proposed by the Commission could create discrimination in favour of the "old" consents; a shorter period is therefore necessary (four years);

- paragraph 2(d) also requires information on the conditions to be applied for future monitoring and the period of validity of the future consent;

- the renewal procedure (paragraphs 3 to 8) has been based on the one involved in the standard procedure (in particular as regards the assessment report) although the competent authority that drew up the report will not be able to block the consent with a negative report.

The procedure in case of objections (Article 17) will also apply in connection with the monitoring and handling of new information (Article 19). Like the Parliament (Amendment 44), the Council considered that the time required by the scientific committee for drawing up its opinion must not hold up the procedure indefinitely, and it has set a limit of 90 days for this purpose.

For reasons of clarity it is better for Article 13e to be split into an Article 18 (consent) and an Article 19 (monitoring and handling of new information).

Article 18 incorporates paragraphs 1, 3 and 6 of Article 13e, detailing (paragraph 3) the points that must in all cases be specified in the consent (scope, period of validity, conditions for placing on the market, labelling and monitoring arrangements, etc.) and stipulating that the consent and the decision (when Article 17 is applied) are to be made accessible to the public.

Article 19 takes paragraphs 2, 4 (concerning what is applicable after consent is given) and 5 from the proposal and specifies (paragraph 1) the conditions under which the monitoring plan can be adjusted. Paragraph 3 sets out a complete procedure for deciding (in the spirit of Amendment 89) whether a consent should be amended or terminated; this procedure follows mutatis mutandis the one involved in the renewal procedure (Article 16(3) to (8)).

Article 20 (labelling) states (paragraph 1) that the labelling and packaging requirements must apply at all stages of the placing on the market. To take account of the fact that some products contain GMOs only accidentally or because it is technically unavoidable, paragraph 2 provides that, below a certain threshold (to be determined for the product concerned), such products will not have to be labelled in accordance with paragraph 1.

In Article 21 (free circulation) the Council considered that the text would be more coherent if it were specified that this Article applied without prejudice to the safeguard clause (Article 22).

Article 22(1) makes clear that new and additional information is information received by the Member State after consent was given and that existing information is to be reassessed on the basis of new or additional knowledge. It was not considered appropriate to confine the list of emergency measures to the two measures (terminating the placing on the market, recovering (sic) the GMO) envisaged by the Commission. Paragraph 1, third subparagraph, and paragraph 2 specify the information to be supplied by the Member State concerned (revised version of the assessment report, amendments to the consent, etc.) and the method for calculating the procedural time limits, which the Council wanted to reduce to 60 days.

Paragraph 1 of Article 23 (information to the public) takes over Article 17(1) of the proposal by requiring assessment reports (where favourable to placing on the market) to be supplied to the public for its comments. Recital 44 indicates what should be done with the public's comments. Article 17(3) is already covered by Article 8(2) and has therefore not been incorporated.

5. Final provisions (Part D)

Article 24 takes over Article 19 of the proposal, extending the application of paragraph 4 (non-confidential information) to Article 19 (new information) and Article 22, and adds to this information the intended uses and, explicitly, the environmental risk assessment.

As already indicated in the fourth indent of point 1 above, the Council inserted Article 25 to provide for the labelling of GMOs supplied in connection with the operations referred to in Article 2(4). Article 25(2) specifies the conditions under which such labelling will be done.

Regarding the adaptation of Annexes to technical progress (Article 26), the Council took the view that the introduction, the objective and the general principles of Annexes II (risk assessment) and VII (monitoring plan) play a vital role in the implementation of the Directive and should therefore be adapted by means of a full procedure (Parliament/Council).

For reasons of clarity, Article 20a of the proposal has been split into an Article 27 (scientific committee) and an Article 28 (committee on ethics). Article 27(1) makes it compulsory for a scientific committee also to be consulted when Article 16 (renewal) and Article 19 (new information) are applied, and it allows for the possibility of doing this (paragraph 2), including at the request of a Member State, with regard to more general questions. In line with a number of recitals (9, 55, 56 and 58) that acknowledge the importance of the ethical aspects and of the possibility of consulting the relevant committees, Article 28 makes it compulsory to consult such committees on matters of a general nature at the request of the European Parliament, the Council and the Commission and it allows for the possibility of doing this at the request of a Member State. Although there is no explicit time limit on these consultations, as was envisaged by the European Parliament (Amendment 54), they must not be allowed to affect the Directive's administrative procedures.

Article 30 incorporates Articles 18 and 22(2) of the proposal and supplements them as regards:

- the exchange of information between the Member States and the Commission on the experience acquired (paragraph 1) by including within it the implementation of Article 2(4);

- the collection of information on genetic modifications (paragraph 2): in the spirit of Amendment 92 and in conjunction with Annex IV, one or more registers, partly accessible to the public, will be established to store this information;

- the assessments to be made by the Commission (paragraph 6) in the context of a report on the operation of Parts B and C, to be submitted in 2003. These will cover, inter alia, the feasibility of a centralised Community authorisation procedure (see Amendment 96 in this connection) and the arrangements for the final decision-making by the Commission, the possible justification for implicit consent in the case of Part B (see Amendment 24) and a differentiated procedure in Part C (see second paragraph of point 3 above), and the socioeconomic implications (Amendment 61) of releases and placing on the market of GMOs;

- (paragraph 7) a report on the ethical issues referred to in Article 28.

In Article 31 (penalties) the Council did not accept the provision on notification of penalties because it duplicated Article 32(2) (transposition).

The Council considered that the new rules established by the Directive should be implemented as soon as possible. Accordingly, Article 32 limits the transposition period to 18 months (this period was not specified in the proposal) and Article 33 provides that notifications submitted under Directive 90/220/EEC for which the procedures are not yet completed by the date of transposition will be subject to the provisions of the Directive under consideration.

To avoid any legal hiatus, the date on which Directive 90/220/EEC is to be repealed has been set at the end of the Directive's transposition period (Article 34(1)).

6. Annexes

Apart from an updating and clarification of the wording where appropriate in the light of scientific and technical developments since the proposal was drafted, the adjustments necessitated by the changes made to the enacting terms of the Directive and a clarification of the structure (objectives, general principles, operational provisions) of Annexes II and VII, the main amendments are as follows:

- in Annex II definitions have been inserted for "direct effects", "indirect effects", "immediate effects" and "delayed effects" and clarification has been given of the link (Section A) between risk assessment and risk management. The link between the precautionary principle and the general principles for assessment has been underlined (Section B) and the general principles themselves have been clarified (scientific basis of the assessment, case-by-case assessment, revision in the light of new information, etc.).

Section C (methodology): point C.1 incorporates point A2 of the proposal; point C.2 incorporates points B and A1 (in illustration of the negative effects referred to in point C2.1); this section adds, inter alia, allergenic effects and the reference to genes conferring resistance to antibiotics).

Points D.1 and D.2 are based on, and provide a clarification of, point IV.C of Annex IIIA and point H of Annex IIIB, the aim being to clarify the detailed conclusions to be drawn at the end of the assessment;

- the insertion of Annex III indicates the directions in which this Annex may have to be adapted in the future, and additional information is required particularly as regards human health and the health of animals and plants (see, for example, Part IIIB, point D.8);

- Annex IV (point A.2) requires the name and full address of the person responsible for the placing on the market, whatever his function (importer, distributor, etc.), and of the supplier of control samples (point A.3). It includes the supply of samples (point A.7, Amendment 92) in the information to be provided and specifies the details that must appear on the label, including how to access information in the part of the register that is accessible to the public;

- Annex V (see third paragraph of point 3 above);

- Annex VI.5 stipulates that the conclusions of the assessment report must deal with the use proposed, risk management and the monitoring plan proposed;

- Annex VII distinguishes (point A) between confirmation of any assumptions made during the risk assessment and the identification of adverse effects that were not anticipated in the assessment, and it sets out (point C) the principles underlying the design of the monitoring plan (case-by-case formulation, differentiation between general monitoring and case-specific, communication of information on adverse effects to the competent authority and the notifier, etc.)

(1) The Commission did not propose any amendment to Article 7 or Article 8 of Directive 90/220/EEC. These Articles were, however, the subject of European Parliament Amendments 32 and 33, which were incorporated into the amended proposal and the common position.

(2) The Commission proposal does not contain any amendment of Article 22.

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