Statement of the Council's Reasons on the common position for a Regulation on genetically modified food and feed

March 31, 2003

Brussels, 28 Mar 2003

Full text of Document 5204/3/03 Addendum 01 Revision 03

[...] III. Analysis of the common position

A. General comments

The common position is substantially in accordance with the positions taken by the Commission and the Parliament, insofar as it

- confirms all the objectives and essential elements of the Commission's proposal which were also supported by the European Parliament;

- takes the greatest possible account of the opinion of the European Parliament by taking on, in letter or in spirit, a great number of its amendments.

On its own initiative, the Council also felt it appropriate to introduce a range of amendments in its common position, either to clarify the scope of certain provisions, or to make the wording of the Regulation more explicit and thus ensure legal certainty, or to increase its consistency with other Community acts.

B. Specific comments

1. Main provisions of the common position

(a) Authorisation procedure established for genetically modified food and feed (Articles 5, 6, 7, 17, 18 and 19)

The Council has entirely followed the solutions proposed on this subject by the Commission, and supported by the Parliament.

The new authorisation procedures for genetically modified food will reproduce the new principles introduced in Directive 2001/18/EC and will make use of the new framework for the food safety risk assessment set by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002.

The placing on the market of genetically modified food and feed will therefore only be authorised after an independent and rigorous assessment of the risks which they might carry for human and animal health and, where appropriate, the environment. This assessment, which will be carried out under the responsibility of the European Food Safety Authority, will be followed by a risk management decision taken by the Community, in the framework of a regulatory procedure which will ensure close cooperation between the Commission and the Member States.

However, two significant amendments have been introduced to this procedure by the Council:

- the request for authorisation must be addressed to the Authority not directly, but through the intermediary of a Member State,

- regarding environmental risk assessment, when the request relates to GMOs to be used as seed or other plant propagating material, the Authority will ask a competent national authority to carry out the assessment itself.

(b) Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (Article 47)

To ensure that the Regulation is applicable and feasible, the Council felt it appropriate to consider that below a certain threshold the presence of such traces in a food or feedingstuff should not be considered as a violation of the obligation to hold a marketing authorisation, if strict conditions were otherwise met.

The Council has therefore set a threshold which it has fixed at 0,5%, subject to compliance with the following strict conditions:

- the GMOs concerned must have received a favourable opinion from a Community scientific authority before the date of application of the Regulation,

- this tolerance will apply only during the three years following the entry into force of this Regulation,

- the threshold may if necessary be lowered in accordance with the committee procedure.

The Council also noted that, in the context of the review clause in Article 48 of the Regulation, the Commission undertook to monitor whether the application of the measures was giving rise to any difficulties.

It should be noted that the Council here chose a much stricter and more consistent approach than that initially proposed by the Commission (since the threshold has been significantly lowered, and the measures provided for are now only temporary), and that it has therefore come considerably closer to the position expressed by the European Parliament.

(c) Labelling threshold concerning the adventitious presence of GMOs (Articles 12 and 24)

The Council took into account the fact that, despite operators' wishes to the contrary, GMO material might nonetheless be present in the form of traces in the food or feed which they produced, as a result of presence which was adventitious or technically unavoidable during the production of seed, cultivation, transport or processing. It therefore judged, like the Commission, that in such cases the food or feed should not be subject to the obligation to indicate the presence of GMOs on the labelling, if that presence was below a certain threshold.

The Council set the proportion of adventitious or technically unavoidable presence at a maximum of 0,9% for each ingredient.

However, the possibility is also allowed of setting lower thresholds in accordance with the committee procedure, particularly as regards food and feed containing GMOs or consisting of such organisms or to take account of progress in science and technology.

It should be noted that the threshold was fixed following careful examination of all the points raised by this issue, and that the Council considers it to represent a good balance enabling the objectives pursued to be attained, while ensuring the applicability of the future Regulation.

(d) Status of existing products (Articles 8 and 20)

The common position extends the scope of the rules applicable to existing products, not limiting these only to GMO products which have already been authorised on the basis of existing legislation but also including GMO products put legally onto the Community market before the Regulation was applied.

Thus the Council intends to establish improved monitoring of all existing genetically modified food and feed on the Community market.

2. Council's position on the European Parliament's amendments

(a) The following amendments have been either accepted or taken into account in the common position:

* Authorisation procedure
37, 39, 81, 84, 87, 93 and 165 (see Article 5(2), Articles 6(3)(c) and 6(4),
Article 17(2), Articles 18(3)(c) and 18(4), and recitals 33 and 34).

* Transparency and public information
30, 38, 45, 47, 52, 55, 56, 57, 77, 82, 90, 92, 98, 101, 102, and 103 (see Article 5(3)(j), Articles 6(5)(f) and 6(6), Article 17(3)(j), Articles 18(5)(f) and 18(6), and more particularly Article 29 which lists the documents and information to be made accessible to the public).

* Community reference laboratory
41, 44, 86 and 89 (see Articles 6(3)(d) and 5(f), 18(3)(d) and 5(f)).

* Labelling
70, 71, 110, 112, 123, 145, 146, 147, 162, 163, 164 (see Articles 12, 13, 24, 25 and 46(2)).

* Precautionary principle
1 and 13 (see Article 1 which refers to the general principles laid down in Regulation (EC) No 178/2002 ).

* Concept of risk
23 (see Articles 4(1)(a) and 16(1)(a) which introduce the concept of an unacceptable risk for health).

* Emergency measures
117 and 118 (see Article 34).

(b) Various editorial amendments

Many of the editorial improvements which have been made to the text of the common position on points of detail are consistent with the spirit of many of the amendments proposed by the European Parliament.

(c) However, the Council has aligned itself with the Commission's position by not taking into account the following amendments:

8, 14, 22, 25, 26, 29, 33, 35, 43, 46, 48, 49, 50, 51, 53, 54, 58, 59, 60, 61, 72, 73, 74, 76, 79, 83, 88, 91, 95, 96, 97, 99, 100, 104, 105, 109, 111, 113, 116, 120, 122, 142, 156, 159, 161, 167.

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