Council's progress report (December 2001) on proposal for traceability and labelling of GMOs

February 15, 2002

Brussels, 14 February 2002

Proposal for a regulation of the European Parliament and of the Council 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 - Progress report. Report from Permanent Representatives Committee to Council. Brussels, 5 December 2001 (document 14878/01 LIMITE 2001/0180 (COD) ENV 633 AGRI 244 WTO 138 CONSOM 112 MI 201 CODEC 1307; No. prev. doc.: 14107/01 ENV 576 AGRI 233 WTO 133 CONSOM 101 MI 179 CODEC 1202 + COR 1 + ADD 1 REV 1; No. Cion prop.: 11496/01 ENV 418 AGRI 170 WTO 84 CONSOM 59 MI 199 CODEC 825). Full text

.... II. POINTS ON WHICH SUBSTANTIAL PROGRESS HAS BEEN MADE

While a certain number of reservations still exist, the Presidency considers that substantial progress has been reached on the following points:
- Article 1 on the objectives of the proposal;
- Article 3 on definitions, save for the definition of "placing on the market" in Article 3(8);
- Article 8 on unique identifiers;
- Articles 9 and 11 respectively on inspection and control measures and on penalties.

III. MAIN QUESTIONS OUTSTANDING

1. Article 2(1) - scope of the proposal

The proposal concerns, at all stages of placing on the market, products consisting of, or containing GMOs. In addition, the proposal also covers products derived from GMOs, if they are placed on the market as food or feed. The proposal does not cover food products of animal origin produced from animals fed with genetically modified feed or feed derived therefrom.

While several delegations can agree with the present scope:

- Two delegations (DK/L) consider that the scope should be extended to food products originating from animals fed with GMO-feed. Two delegations (B/EL) can accept the present scope while considering that this issue should be addressed at a later stage. Some other delegations and the Commission consider that the scope should be limited to food and feed products that are directly derived from GMOs. A wider scope would be impracticable, especially for implementation of controls.

- The UK delegation considers that food and feed products derived from GMOs should not be covered by the present proposal because of doubts on the effectiveness of controls for GMO-derived products where the modification in question is not detectable. Several delegations disagree with this point of view.

2. Articles 4 and 5 - traceability

(a) for GMOs directly used in food, feed or for processing (Article 4(3))
The proposal foresees that, in case of GMOs as or in products to be used directly as food, feed or for processing (GMOs-FFP), operators may transmit to the next operator a list of the unique codes for the GMOs that the product potentially contains, instead of transmitting information on the unique codes for the GMOs contained, as foreseen for other GMOs as or in products. This derogation is to be applied to both GMO-products imported in bulk as well as to products originating within the Community.

Six delegations (A/B/DK/EL/E/F) are not satisfied with this provision, and consider that for GMOs-FFP stricter conditions should apply. The Commission considers this unnecessary as GMOs intended to be used only for food or feed products or processing will not enter directly into the environment. Moreover, the traceability objectives (facilitation of labelling) and ensuing requirements for food and feed derived from GMOs do not justify any stricter requirements.

(b) for food and feed products derived from GMOs (Article 5(1))
The proposal foresees that in the case of food and feed produced from GMOs, an indication is to be transmitted to operators receiving the product on whether the food or the feed is produced from GMOs. The transmission of information on the "unique identifier" is therefore not foreseen.

Two delegations (A/NL) are concerned that this provision might be insufficient. In particular, NL considers that the "unique identifier" might need to be transmitted throughout the production chain in some cases. The Commission considers this unnecessary and potentially very expensive for the operator.

3. Article 4 (chapeau) and Article 7(2) - adventitious presence of GMOs

The Commission has foreseen a derogation from the labelling and traceability provisions for products to be used as food, feed or for processing when GMOs are present as traces in a proportion not higher than 1% (to be established case by case) provided that these GMO-traces are adventitious or technically unavoidable and that the GMOs in such traces have been subject to a scientific risk assessment, made by the relevant Scientific Committee or the European Food Authority, which concludes that the GMOs do not present a risk for human health or the environment.

Such a derogation would require an amendment to Directive 2001/18/EC on the deliberate release in the environment of genetically modified organisms. This Directive at present already envisages an exemption from labelling requirements for traces of GMOs. However, the thresholds for such exemptions must be established on a case by case basis through a Comitology procedure and only apply to authorised GMOs.

The Commission had originally placed such a derogation in Article 42 of the proposed regulation on genetically modified food and feed. Following the Council's open debate, the Presidency has foreseen to transfer this provision to Article 7 of the present text (already amending Directive 2001/18/EC ) given that its scope does not concern only genetically modified food or feed but also GMOs for processing. Two delegations (FIN/P) and the Commission maintain a reservation on this transfer.

Concerning the substance of this derogation:
- E/DK/UK/B maintain a scrutiny reservation.
- EL/F/S do not consider that such an amendment to Directive 2001/18/EC is needed while A has a reservation on the coverage of non-authorised GMOs.

Other delegations could envisage such an amendment:
- for GMOs already authorised for placing on the market and
- for non-authorised GMOs as long as a positive risk assessment has been concluded and/or more stringent conditions apply, to be developed case by case (FIN/NL/I/P/IRL).

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