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.�