The Council adopted its common position by qualified majority - the Luxembourg, Austrian and UK voting against -
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.
As regards the main provisions of the common position
1) Authorisation procedure established for genetically modified food and feed : 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 178/2002/EC 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.
3) Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation : 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 applicationof 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.
4) 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.
5) Status of existing products : 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.�