Amended proposed regulation concerning traceability and labelling of genetically modified organisms

September 18, 2002

Brussels, 17 Sep 2002

Amended proposal for a
concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending directive 2001/18/EC
Full Text

[...] 3.3. Amendments not accepted by the Commission

Amendments 2 and 6 make reference to the precautionary principle in the context of this Proposal, which cannot be accepted. The precautionary 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/EC and Regulation 178/2002/EC ). Any safety measures 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.

Amendment 16 is not acceptable as it removes 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 product `may contain'. The Commission believes that this derogation is essential for an operational traceability system for such products. Imposing further requirements for these products would be very difficult and burdensome for operators to implement. Whilst the identity (unique codes) of specific GMOs to be released into the environment for cultivation is essential given that they are capable of establishing and reproducing, this is not the case for GMOs intended for food, feed or processing, where any potential environmental risk is extremely limited. The Biosafety Protocol, similarly, does not include a requirement for full listing of GMOs intended for food, feed, or processing in bulk consignments for trans-boundary movement.

Amendments 17 and 22 extend the period for retention of information by operators from 5 to 10 years and cannot be accepted. Even if traceability were possible after 5 years, the benefits of this information would be minimal with no practical value. Extension of the time limit would also place an unnecessary burden both on operators and inspection authorities.

Amendment 20 includes additional labelling requirements for pre-packaged products produced from GMOs under a new Article 5(1)(a) and cannot be accepted. Article 5(1) already requires that this information is transmitted to the next operator in the chain and it is not necessary to impose labelling with the same information to meet the objectives of the Proposal.

Amendment 21 requires that the GMOs from which food and feed products are derived have to be precisely identified with provision of their unique codes and this cannot be accepted. The main objective of the Proposal as regards products produced from GMOs is to ensure accurate labelling (recital no. 4). It is not necessary to establish the detailed history and origin of individual GMOs, through a traceability system including the unique codes to provide for comprehensive labelling. For the purpose of providing appropriate information to the purchaser or consumer it is sufficient that the label documents that the product is produced from GMOs.

Amendment refers to measures for co-existence and segregation, which cannot be accepted given that the objective of this Regulation is to trace products and not to avoid adventitious or technically unavoidable presence of GM material in food. The Commission has put forward an action concerning the issue of co-existence between different types of crops, including GM crops in the Communication on life sciences and biotechnology adopted in January 2002.

The Commission cannot accept amendment 28, which requires that the traceability provisions under Article 4(6) of Directive/ 2001/18/EC would remain in place rather than repealed when the Proposal enters into force. This would mean that national measures for traceability could proceed alongside the Community system for traceability under this Proposal, creating possible disruption of the internal market. Recital 2 specifically refers to the fact that a harmonised Community framework for traceability and labelling of GMOs should contribute to the effective functioning of the internal market and that Directive/ 2001/18/EC should be amended accordingly. The Commission cannot accept amendment 51 removing the wording `and amending Directive 2001/18/EC ' from the title in order to maintain the legal consistency of the Proposal.

Amendments 32 & 33 mean that no new products could be authorised prior to the entry into force of the system to assign unique codes under the Proposal and are not acceptable. The authorising legislation for new products provides for a comprehensive pre-market risk assessment. Products are only granted authorisation on the basis that they will not present a risk to human health or the environment. The requirement to assign unique codes to GMOs under this Proposal does not impinge on the approval procedure under the authorising legislation. The Commission is firmly against extending the conditions of authorisation to include formal adoption of the provisions of this Proposal.

Amendment 39, which removes part of the wording for the definition of `produced from GMOs' is not acceptable. The Commission considers that the definition of `produced from GMOs' needs to be the same in the GM food and feed proposal and in this proposal. Furthermore, the wording `but not containing GMOs' is already enshrined in the Novel Foods Regulation (EC) 258/97, which has been in force for more than 5 years.

Amendment 48, which shifts assistance for the development of unique codes from the committee under Directive 2001/18/EC to that under Regulation (EC) No. 178/2002, cannot be accepted. The Proposal requires that unique codes shall be assigned to all GMOs, including seeds for cultivation, and not merely those intended for food, feed and processing. The Commission considers that the committee under the `horizontal' Directive 2001/18/EC , which contains the foundations for environmental risk assessment, is most appropriate for this purpose.

Amendment 50 introduces the word `standardised' with regard to procedures for transmitting and retaining information to ensure traceability and is not acceptable. The Proposal specifically does not require standardised procedures to be used as a means to accommodate use of existing systems, where appropriate. Operators must be in a position to identify to whom and from whom products have been made available. The Commission considers that this does not hinge on use of standardised procedures.

Amendments 26, 52 and 55 either remove or restrict the possibility to establish thresholds to address the issue of adventitious presence and are not acceptable.

More than 50 million hectares of GM crops are grown in the world and adventitious or technically unavoidable presence of traces GMOs or GM materials in conventional products is inevitable and largely unavoidable. The Commission therefore agrees with the Parliament that a threshold should apply to traces of authorised GMOs and GM materials below which such products do not have to be labelled or traced. The possibility of establishing labelling thresholds for such traces of GMOs is already provided for in Directive 2001/18/EC and under the Novel Foods Regulation. It is, therefore, logical and consistent to provide for such traces of GMOs and GM material to be exempted from the labelling and traceability requirements of this Proposal.

However, the Commission also considers it necessary to provide thresholds for GMOs that have been scientifically assessed as without risk to human health or the environment but are pending approval under Community legislation. This is necessary because these GMOs have been approved in third countries and traces of such GMOs in imported commodities will be largely unavoidable. This issue will have to be addressed in order to avoid trade grinding to a halt. However, we need to acknowledge the fact that authorisation processes can take some time. On this basis, the Commission has suggested that a tolerance level should be introduced for such materials BUT only under certain stringent conditions that do not compromise safety. These thresholds would be limited to adventitious or technically unavoidable traces of GMOs or GM material that have been positively assessed by a Community scientific committee as without risk to human health or the environment and which is pending administrative approval under Community legislation.

The intention of the Commission proposal is to provide that products containing or consisting of traces of such GMOs and GM material below a threshold do not have to be traced. This possibility has been deleted by the above amendments. This will not only undermine the feasibility and practicability of the traceability and labelling requirements under the Proposal but also have major implications and restrictions for trade.


Brussels, 13.09.2002 COM(2002) 515 final 2001/0180 (COD)

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