Activites

• 2003/10/18 Final act published in Official Journal
  • Regulation 2003/1830
  • OJ L 268 18.10.2003, p. 0024-0028
• 2003/09/22 Final act signed
• 2003/09/22 End of procedure in Parliament
• #2524
• 2003/07/22 Council Meeting
• 2003/07/02 Decision by Parliament, 2nd reading
  • T5-0315/2003 summary

    The European Parliament adopted a resolution which approved some of the amendments in the report drafted by Antonios TRAKATELLIS (EPP-ED, Greece). The amendments adopted include the following: - a central register should be set up containing sequencing information and reference material for authorised GMOs as well as relevant information concerning GMOs not authorised in the EU. The competent authorities in the Member States will have access to the register; - a new recital states that the Commission must submit a report on the implementation of the Regulation and the effectiveness of the rules on traceability and labelling.�

• 2003/07/01 Debate in Parliament
  • Debate in Parliament
• 2003/05/22 Vote in committee, 2nd reading
  • A5-0204/2003
• 2003/03/27 Committee referral announced in Parliament, 2nd reading
• #2494
• 2003/03/17 Council Meeting
  • 15798/1/2002 summary

    The Council adopted the common position by qualified majority without the support of Danish, Luxembourg, Netherlands and the UK delegations. It accepts 15 out of the 30 amendments adopted by the European Parliament at first reading. With regard to the scope of the Regulation, the Council fully accepts the Commission proposal. Exemptions from the traceability and labelling scheme shall be allowed for the adventitious or technically unavoidable presence of traces of GMOs. The thresholds for these exemptions are introduced in this Regulation by way of reference to the respective Articles of the Regulation on genetically modified food and feed (as discussed in parallel with this Regulation - refer to COD/2001/0173), where the threshold level has been set at 0,9% and can be lowered via a regulatory committee procedure, as well as by way of reference to Directive 2001/18/EC. While the exemptions generally cover only GMOs that have been authorised in the EU, the adventitious or technically unavoidable presence of such GMOs that have not been authorised but have benefited from a favourable risk evaluation will be permitted below a threshold level of 0,5%, or lower as set by a regulatory committee procedure, for a transitional period of three years. The Council has tightened the Commission proposal with regard to the information that has to accompany bulk shipments of products containing mixtures of GMOs by allowing only for "a list of the unique identifiers for all those GMOs that have been used to constitute the mixture", instead of " unique codes for the GMOs that the product may contain" as originally proposed by the Commission. Complementary to this provision, the Council has introduced a review clause in order to call on the Commission - to present a report after the first experiences with the provision of Article 4(3) have been gained in practice and - where appropriate, to make proposals for changes to the Regulation. While the Regulation generally covers all stages of placing on the market of the products, the Council has filled a gap by introducing that inspection and control measures can also target the holding of a product. The Council has introduced the following main innovations in the text of the Regulation: - new Recital addressing feed for animals not destined for food production (pets); - further detailing of Recital 10, addressing the need for thresholds for the exemption of the adventitious or technically unavoidable presence of GMOs from the traceability and labelling rules; - revision of the definitions: elimination of the definitions of food/feed additives, (compound) feedingstuff, flavourings and feed materials and the inclusion of the definitions of "Final consumer" and "Ingredient". - re-structuring of the Articles that describe the traceability and labelling rules and the exemptions thereof; - amendment of Directive 2001/18/EC by way of inclusion of a new Article which provides for an exemption from labelling for GMOs intended for direct processing.�

• #2481
• 2003/01/27 Council Meeting
  • 2481 summary

    The Danish delegation, supported by the French, Italian, Austrian, Portuguese and Luxembourg delegations, drew the attention of the Council and the Commission to the conditions for further approval of Genetically Modified Organisms (GMO) since a political agreement had been reached at the Council on 28 November 2002 (refer to the previous summary). Some of these delegations supported in particular the view that no new procedure of authorisation for placing on the market new GMOs should be granted as long as this Regulation had not yet entered into force. Commissioner BYRNE recalled that political agreements had been reached on a proposal for a Regulation on genetically modified food and feed at the Agriculture and Fisheries Council on 28 November 2002 and on a proposal for a Regulation concerning the traceability and labelling of GMOs and of food and feed products produced from GMOs at the Environment Council on 9 December 2002. He noted that the application for an authorisation regarding a GM product would be managed under either of these two Regulations. He mentioned that current application were managed under current EC rules prior to the approval of these two texts by the European Parliament in second reading.�

• #2473
• 2002/12/09 Council Meeting
• #2457
• 2002/10/17 Council Meeting
  • 2457
• 2002/09/13 Modified legislative proposal published
  • COM(2002)0515 summary

    The following are amongst those amendments that have been accepted in part or in principle by the Commission: - the exemption of certain organisms from the definition of "GMO" as per the exemption under Article 3(1) Directive 2001/18/EC; - the definition of "operator" clarifying that a person handling products placed on the market in the Community could be either from a Member State of the EU or from a third country; - on labelling, one amendment retains the wording of Directive 2001/18/EC for products containing GMOs but provides for an alternative in that the name of the crop or GMO can be included on the label; - operators who receive pre-packaged products have to retain certain information; - the close co-operation of Member States in the development of guidance; - an additional recital stating that account should be taken of the registers containing information on genetic modifications in GMOs to be established by the Commission. The Commission does not accept the following amendments: - the reference to the precautionary principle in the context of this proposal. The principle relates to the risk analysis of products and is accounted for as part of the approval process under the authorising legislation (Directive 2001/18/EDC and Regulation 178/2002/EC). Any safety measure to protect human health and the environment arise directly from this authorising legislation. Traceability is not a safety measure per se but can be used to facilitate the application of other measures, such as product withdrawals and monitoring, as a means to ensure safety. The precautionary principle cannot, therefore, be taken into account when implementing traceability requirements. - the removal of the derogation concerning traceability requirements for products intended for direct use as food, feed or processing. The derogation allows operators to state that these products are intended for direct use as food, feed or processing and provide the unique codes of the GMOs that the products 'may contain'. The Commission believes that this derogation is essential for an operational traceability system for such products. - the extension of the period for retention of information by operators from 5 to 10 years - even if traceability were possible after 5 years, the benefits of this information would be minimal with no practical value. - the introduction of additional labelling requirements for pre-packaged products produced from GMOs; - the amendment requiring that the GMOs from which food and feed products are derived have to be precisely identified with provision of their unique codes cannot be accepted. It is not necessary to establish the detailed history and origin of individual GMOs. To provide appropriate information to the consumer, it is sufficient to label that the product is produced from GMOs. Measures for co-existence and segregation cannot be accepted. The objective of this regulation is to trace products and not to avoid adventitious or technically unavoidable presence of GM material in food. - the amendments stating that no new products could be authorised prior to the entry into force of the system to assign uniquecodes under the proposal are not acceptable. The intention of the Commission proposal is to provide that products containing traces of GMOs and GM material below a threshold do not have to traced. This possibility has been deleted by the above amendments. This will not only undermine the feasibility of tracing and labelling requirements but also have major restrictions for trade.�

  • DG [{'url': 'http://ec.europa.eu/dgs/environment/', 'title': 'Environment'}],
• 2002/07/03 Decision by Parliament, 1st reading/single reading
  • T5-0353/2002 summary

    The European Parliament adopted a resolution on GMO labelling, where the rapporteur was Antonios TRAKATELLIS (EPP-ED, Greece). The rapporteur voted against the report. (Please refer to the summary of 04/06/02.) The recitals make a specific reference to the precautionary principle. In exceptional cases, where there is a risk to health or environment, but where scientific data is still uncertain, the precautionary principle may be used to determine which risk management measures or other steps will be taken to ensure the high level of health protection that the Community desires. Parliament stated that, to cover cases of adventitious or technically unavoidable traces of material produced from GMOs, a threshold should be set up. As and when advances in science and technology allow, appropriately lower thresholds should be established. When placing products produced from GMOs on the market, operators must ensure that the words this product is produced from GMOs" or the words "This product contains [ingredient] produced from GMOs" appear on a label and in connection with the display and the advertising of the product.�

• 2002/07/02 Debate in Parliament
  • Debate in Parliament
• #2439
• 2002/06/25 Council Meeting
  • 2439 summary

    The Council took note of the progress made, pending the European Parliament's Opinion, on the proposal for a Regulation concerning traceability and labelling of genetically modified organisms (GMOs) and traceability of food and feed products produced from GMOs. This dossier was the subject of a public debate during the Council meeting on 29 October 2001 and an interim report was submitted to the Council at its meeting on 12 December 2001. Work remains to be done on various issues including the scope of the Regulation, communication of information on the potential presence of GMOs in products, traceability of derived products and threshold values for the adventitious presence of GMOs. A political agreement is expected at the meeting on 17 October 2002 at the earliest.�

• 2002/06/04 Vote in committee, 1st reading/single reading
  • A5-0229/2002
• #2399
• 2001/12/12 Council Meeting
  • 2399
• #2377
• 2001/10/23 Council Meeting
  • 2377
• #2371
• 2001/09/27 Council Meeting
  • 2371
• 2001/09/03 Committee referral announced in Parliament, 1st reading/single reading
• 2001/07/25 Legislative proposal published
  • COM(2001)0182 summary

    PURPOSE : to provide a framework for the traceability of GMOs and food and feed produced from GMOs, with the objective of facilitating accurate labelling, environmental monitoring and withdrawals of products. CONTENT : this proposal concerns the traceability of GMOs, as defined under Directive 2001/18/EC, as or in products including seeds, as well as food and feed product produced from GMOs. It provides for legal certainty as well as a coherent and consistent approach that should contribute to the effective functioning of the internal market. The proposal lays down the following requirements to ensure a harmonised framework for traceability of such products at all stages of their placing on the market: - operators shall have in place systems and procedures to identify to whom and from whom products are made available; - operators shall transmit specified information concerning the identity of a product in terms of the individual GMOs it contains or whether it is produced from GMOs; - operators shall retain specified information for a period of five years and make it available to competent authorities on demand. The proposal does not specify the means to transmit and retain this information given that existing systems to do so are already in place in many organisations. The objectives for traceability of GMOs and products produced from GMOs are not identical and therefore the specified information to be transmitted and retained differs for each. This proposal provides for the traceability of individual GMOs within a product on the basis of authorised transformation events. In addition, the proposal provides that the Commission shall establish a system to develop and assign simple numeric or alphanumeric unique codes to GMOs. Moreover, the proposal provides for the establishment of a system to develop and assign unique codes to GMOs.�

  • DG [{'url': 'http://ec.europa.eu/dgs/environment/', 'title': 'Environment'}],

Documents

• Legislative proposal published: COM(2001)0182
• Debate in Council: 2371
• Debate in Council: 2377
• Debate in Council: 2399
• Committee report tabled for plenary, 1st reading/single reading: A5-0229/2002
• Debate in Council: 2439
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T5-0353/2002
• Modified legislative proposal published: COM(2002)0515
• Debate in Council: 2457
• Debate in Council: 2481
• Council position published: 15798/1/2002
• Committee recommendation tabled for plenary, 2nd reading: A5-0204/2003
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 2nd reading: T5-0315/2003
• : Regulation 2003/1830
• : OJ L 268 18.10.2003, p. 0024-0028

History

(these mark the time of scraping, not the official date of the change)