Legal provisions of COM(2002)85 - Transboundary movement of genetically modified organisms - Main contents
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dossier | COM(2002)85 - Transboundary movement of genetically modified organisms. |
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document | COM(2002)85 ![]() |
date | July 15, 2003 |
Contents
- CHAPTER I - OBJECTIVES, SCOPE AND DEFINITIONS
- Article 1 - Objectives
- Article 2 - Scope
- Article 3 - Definitions
- CHAPTER II - EXPORTS OF GMOs TO THIRD COUNTRIES
- Section 1 - GMOs intended for deliberate release into the environment
- Article 4 - Notification to Parties and non-Parties of import
- Article 5 - Cases of non-decision
- Article 6 - Informing the Party of export
- Article 7 - Review of decisions
- Article 8 - Exceptions to Section 1 of this Chapter
- Section 2 - GMOs intended for direct use as food or feed, or for processing
- Article 9 - Information to the BCH
- Article 10 - Parties' and non-Parties' national decisions on import
- Section 3 - GMOs intended for contained use
- Article 11
- Section 4 - Common provisions
- Article 12 - Identification and accompanying documentation
- Article 13 - Transit
- CHAPTER III - UNINTENTIONAL TRANSBOUNDARY MOVEMENT OF GMOs
- Article 14
- CHAPTER IV - COMMON PROVISIONS
- Article 15 - Participation in the international information procedure
- Article 16 - Confidentiality
- Article 17 - Competent authorities and focal points
- Article 18 - Penalties
- Article 19 - Monitoring and reporting
- Article 20 - Entry into force
CHAPTER I - OBJECTIVES, SCOPE AND DEFINITIONS
Article 1 - Objectives
Article 2 - Scope
2. Pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from the scope of this Regulation.
Article 3 - Definitions
1. 'organism' means organism as defined in Article 2(1) of Directive 2001/18/EC;
2. 'genetically modified organism', or 'GMO', means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex IB to Directive 2001/18/EC;
3. 'deliberate release' means deliberate release as defined in Article 2(3) of Directive 2001/18/EC;
4. 'placing on the market' means placing on the market as defined in Article 2(4) of Directive 2001/18/EC;
5. 'contained use' means:
(a) activities defined in Article 2(c) of Directive 90/219/EEC(9);
(b) activities in which organisms other than micro-organisms are genetically modified or in which such GMOs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures, based on the same principles of containment as in Directive 90/219/EEC, are used appropriately to limit their contact with the general population and the environment;
6. 'food' means food as defined in Article 2 of Regulation (EC) No 178/2002(10);
7. 'feed' means feed as defined in Article 3(4) of Regulation (EC) No 178/2002;
8. 'notification' means the submission of the information required from the exporter under this Regulation to the competent authority of a Party to the Protocol or to the competent authority of a non-Party;
9. 'the Biosafety Clearing-House' or 'the BCH' means the Biosafety Clearing-House established under Article 20 of the Protocol;
10. 'export' means:
(a) the permanent or temporary leaving of the customs territory of the Community of GMOs meeting the conditions of Article 23(2) of the Treaty;
(b) the re-export of GMOs not meeting the conditions referred to in (a) which are placed under a customs procedure other than transit procedure;
11. 'import' means the placing under a customs procedure, other than transit procedure, of GMOs introduced into the customs territory of a Party or non-Party outside the Community from a Party within the Community;
12. 'exporter' means any natural or legal person by whom or on whose behalf a notification is made, that is to say the person who, at the time when the notification is sent, holds the contract with the consignee in the third country and has the power to determine that the GMO is to be sent out of the customs territory of the Community. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the power to determine that the GMO is to be sent out of the customs territory of the Community shall be decisive;
13. 'importer' means any natural or legal person, under the jurisdiction of the Party or non-Party of Import, who arranges for a GMO to be imported;
14. 'transboundary movement' means the intentional or unintentional movement of a GMO between one Party or non-Party and another Party or non-Party, excluding intentional movements between Parties within the Community;
15. 'Party' means any country or regional economic integration organisation being a Party to the Protocol;
16. 'non-Party' means any country or regional economic integration organisation not being a Party to the Protocol;
17. 'the Protocol' means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Convention);
18. 'biological diversity' means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems;
19. 'competent authority' means a competent authority designated by a Party to the Protocol, or the relevant equivalent body of a non-Party, which is responsible for performing the administrative functions required by the Protocol, or equivalent functions in the case of a non-Party, and is authorised to act on its behalf with respect to those functions;
20. 'focal point' means the entity designated by a Party to be responsible on its behalf for liaising with the Secretariat;
21. 'Secretariat' means the Secretariat to the Protocol.
CHAPTER II - EXPORTS OF GMOs TO THIRD COUNTRIES
Section 1 - GMOs intended for deliberate release into the environment
Article 4 - Notification to Parties and non-Parties of import
Article 5 - Cases of non-decision
2. In cases where the Party of import does not communicate its decisions in response to a notification within 270 days from the date of receiving the notification, the exporter shall send a written reminder, with a deadline for response of 60 days from receipt of this reminder, to the competent authority of that Party of import, with a copy to the Secretariat, to the Member State of export, and to the Commission. In calculating the time within which a Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account.
3. Without prejudice to paragraph 1, the exporter shall not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or, where appropriate, equivalent procedures required by a non-Party of import have been followed.
4. Paragraphs 1, 2 and 3 shall not apply to cases of transboundary movements covered by simplified procedures or bilateral, regional and multilateral agreements or arrangements entered into in accordance with Article 13 and 14 of the Protocol.
5. The Commission and the Member States shall, in consultation with the Secretariat, take appropriate action in accordance with any appropriate procedures and mechanisms to facilitate decision-making or to promote compliance with the provisions of the Protocol by the Parties of import as decided by the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol.
Article 6 - Informing the Party of export
Without prejudice to Article 16, the Commission shall make these documents available to the public in accordance with the Community rules on access to environmental information.
Article 7 - Review of decisions
2. Where a Party or non-Party of import does not respond to such a request within 90 days, the exporter shall send a written reminder to the competent authority of that Party or, where appropriate, non-Party of import, with a copy to the Secretariat, requesting a response within a set period following receipt of the reminder.
Article 8 - Exceptions to Section 1 of this Chapter
2. Section 1 of this Chapter shall not apply to GMOs intended for direct use as food or feed, or for processing.
3. The obligations referred to in section 1 of this Chapter shall not apply if the Party of import has specified in advance to the BCH, in accordance with Article 13(1)(b) and Article 14(3) of the Protocol, that such imports of GMOs are to be exempted from the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Protocol, provided that adequate measures are applied to ensure their safe intentional transboundary movement in accordance with the objective of the Protocol.
Section 2 - GMOs intended for direct use as food or feed, or for processing
Article 9 - Information to the BCH
This paragraph shall not apply to decisions regarding the deliberate release in accordance with Part B of Directive 2001/18/EC of a GMO which is not intended for direct use as food or feed or for processing in a third country without a subsequent decision.
2. The information referred to in paragraph 1 and sent to the BCH shall contain as a minimum the information specified in Annex II.
3. The Commission or the Member State referred to in paragraph 1 shall process requests submitted to them by any Party or non-Party for additional information regarding the decisions referred to in paragraph 1.
4. A copy of the information referred to in paragraphs 1, 2 and 3 shall be sent by the Commission or the Member State referred to in paragraph 1, in writing, to the focal point of each Party that informs the Secretariat in advance that it does not have access to the BCH.
Article 10 - Parties' and non-Parties' national decisions on import
2. If a developing country Party or non-Party of import or a Party or non-Party of import with an economy in transition has declared through the BCH that it will take a decision prior to an import of a specific GMO intended for direct use as food or feed, or for processing, in accordance with Article 11(6) of the Protocol, the exporter shall not proceed with the first export of such GMO unless the procedure provided for under that provision has been followed.
3. Failure by the Party or non-Party of import to acknowledge receipt of a notification or to communicate its decision in accordance with paragraph 2 shall not imply its consent or refusal to the import of a GMO intended for direct use as food or feed, or for processing. No GMO that may be subject to transboundary movements for direct use as food or feed or for processing may be exported, unless it is authorised within the Community or the competent authority of a third country has expressly agreed to the import as required under Article 12 of Regulation (EC) No 178/2002.
Section 3 - GMOs intended for contained use
Article 11
2. Paragraph 1 shall be without prejudice to any right of a Party or non-Party to subject all GMOs to risk assessment prior to decisions on import and to set standards for contained use within their jurisdiction.
Section 4 - Common provisions
Article 12 - Identification and accompanying documentation
(a) that it contains or consists of GMOs;
(b) the unique identification code(s) assigned to those GMOs if such codes exist.
2. For GMOs intended for direct use as food or feed, or for processing, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter:
(a) stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and
(b) giving details of the contact point for further information.
Paragraph 1(b) shall not apply to products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing. These products shall be subject to the traceability requirements of Directive 2001/18/EC and, when applicable, future Community legislation covering traceability, labelling and identification of such GMOs.
3. For GMOs intended for contained use, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall specify:
(a) any requirements for the safe handling, storage, transport and use of these GMOs;
(b) the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned.
4. For GMOs intended for deliberate release into the environment and any other GMO to which this Regulation applies, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall set out:
(a) the identity and relevant traits and characteristics of the GMOs;
(b) any requirements for the safe handling, storage, transport and use of these GMOs;
(c) the contact point for further information and, as appropriate, the name and address of the importer and exporter;
(d) a declaration that the movement is in conformity with the requirements of the Protocol applicable to the exporter.
5. Paragraph 1 to 4 shall be without prejudice to other specific requirements imposed by Community legislation and to international identification requirements to be developed in accordance with Article 18 of the Protocol.
Article 13 - Transit
CHAPTER III - UNINTENTIONAL TRANSBOUNDARY MOVEMENT OF GMOs
Article 14
2. As soon as a Member State becomes aware of an occurrence, under its jurisdiction, resulting in a release of GMOs that leads, or may lead, to an unintentional transboundary movement that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, that Member State shall:
(a) take the appropriate measures to inform the public and inform without delay the Commission, all other Member States, affected or potentially affected States, the BCH, and, where appropriate, relevant international organisations;
(b) without delay consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures in order to minimise any significant adverse effects.
3. Any information arising from paragraph 2 shall include the information specified in Annex III.
CHAPTER IV - COMMON PROVISIONS
Article 15 - Participation in the international information procedure
(a) national legislation and guidelines relevant to the implementation of the Protocol, in accordance with Article 11(5) and Article 20(3)(a) of the Protocol;
(b) national contact points for notification of unintentional transboundary movements, in accordance with Article 17 of the Protocol;
(c) any bilateral, regional and multilateral agreement and arrangements entered into by the Member State regarding intentional transboundary movements of GMOs, in accordance with Article 20(3)(b) of the Protocol;
(d) any information concerning cases of unintentional or illegal transboundary movements pertaining to them, in accordance with Articles 17 and 25 of the Protocol;
(e) any final decision taken by a Member State, on the use of GMOs within that Member State, including decisions:
- on contained use classified in risk class 3 or 4 of GMOs which are likely to be subject to transboundary movements,
- on the deliberate release of GMOs in accordance with part B of Directive 2001/18/EC, or
- on import into the Community of GMOs,
in accordance with Article 11 and Article 20(3)(d) of the Protocol, within 15 days of the adoption of that decision;
(f) any summary of risk assessments or environmental reviews of GMOs generated by the Community's regulatory process and carried out in accordance with Article 15 of the Protocol, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, in accordance with Article 20(3)(c) of the Protocol;
(g) any review of national decisions regarding an intentional transboundary movement, in accordance with Article 12 of the Protocol;
(h) any decision taken by a Member State on safeguard measures under Article 23 of Directive 2001/18/EC or emergency measures taken by a Member State under Community legislation on genetically modified food and feed.
2. The Commission shall in accordance with the provisions of the Protocol inform, on behalf of the Community, the BCH of:
(a) Community legislation and guidelines relevant for the implementation of the Protocol, in accordance with Article 11(5) and Article 20(3)(a) of the Protocol;
(b) any bilateral, regional and multilateral agreement and arrangements at Community level regarding intentional transboundary movements of GMOs, in accordance with Article 20(3)(b) of the Protocol;
(c) any final decision taken at Community level regarding the use of a GMO within the Community, including decisions on the placing on the market or the importation of a GMO, in accordance with Article 11 and Article 20(3)(d) of the Protocol;
(d) any summary of risk assessments or environmental review of GMOs generated by the Community regulatory process and carried out in accordance with procedures similar to those laid down in Annex II to Directive 2001/18/EC, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of GMO origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, in accordance with Article 20(3)(c) of the Protocol;
(e) any review of decisions at Community level regarding an intentional transboundary movement, in accordance with Article 12 of the Protocol;
(f) any application of Community legislation instead of the procedures of the Protocol for intentional movements of GMOs within the Community and imports of GMOs into the Community in accordance with Article 14(3) and (4) of the Protocol;
(g) reports submitted pursuant to Article 19 of this Regulation, including those on implementation of the advanced informed agreement procedure, in accordance with Article 20(3)(e) of the Protocol.
Article 16 - Confidentiality
2. The exporter may indicate the information in the notification submitted under Article 4 which should be treated as confidential. Justification shall be given in such cases upon request.
3. In no case may the following information when submitted according to Articles 4, 9 or 12 be kept confidential:
(a) name and address of the exporter and importer,
(b) general description of the GMO or GMOs,
(c) a summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and
(d) any methods and plans for emergency response.
4. If, for whatever reasons, the exporter withdraws the notification, the Member States and the Commission must respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the Party or non-Party of import and the exporter disagree as to its confidentiality.
Article 17 - Competent authorities and focal points
2. Each Member State shall designate one focal point, as well as one or more competent authorities. A single entity may fulfil the functions of both focal point and competent authority.
3. The Commission, on behalf of the Community, and each Member State respectively shall, no later than the date of entry into force of the Protocol for them, inform the Secretariat of the names and addresses of their focal points and their competent authorities. Where a Member State or the Commission designates more than one competent authority, it shall, when conveying this to the Secretariat, include relevant information on the respective responsibilities of those authorities. Where applicable, such information shall, as a minimum, specify which competent authority is responsible for which type of GMO. The Commission and the Member States shall forthwith inform the Secretariat of any changes in the designation of their focal points or in the name and address or responsibilities of their competent authority or authorities.
Article 18 - Penalties
Article 19 - Monitoring and reporting
2. The Commission shall, at intervals to be determined by the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol, compile a report on the basis of the information provided by the Member States and present it to the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol.
Article 20 - Entry into force
2. This Regulation shall apply from the date of entry into force of the Protocol, in accordance with Article 37(1) of the Protocol, or from the date of entry into force of this Regulation, whichever shall be the later.
This Regulation shall be binding in its entirety and directly applicable in all Member States.