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Progress Report
I. INTRODUCTION
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1.On 15 January 2008, the Commission submitted to the Council and the European Parliament 1
the above-mentioned proposal, based on Article 95 of the Treaty . The proposed Regulation will replace current Regulation (EC) No 258/97, on novel foods and novel food ingredients,
in force since 15 May 1997.
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Doc. 5431/08 (COM(2007) 872 final)
The objectives of the proposal are to ensure food safety, protection of human health and
consumer interests and the effective functioning of the internal market. To meet these
objectives, the Commission proposed to update and clarify the scope of Regulation(EC)
No 258/97. The first step in this direction was taken with the adoption of Regulation (EC)
1829/2003 on genetically modified food and feed, which excluded genetically modified food
from the scope of the current Regulation on novel food.
The Commission proposed to keep 15 May 1997 as the threshold date for determination of the
novelty of the food.
The Commission included in the scope of its proposed Regulation food of animal origin,
when a non-traditional breeding technique is applied to the animal. The Commission's
intention was to keep the current status of Regulation (EC) No 258/97 i.e. to include food
from cloned animal origin, but not to include food from their offspring.
The placing on the market of novel foods, other than traditional foods from third countries,
would be subject to a centralised procedure at the Community level in accordance with the
Regulation (EC) No XXX/XXX [common authorisation procedure].
In addition, the Commission introduced the concept of "traditional food from a third country"
as a category of novel food which can be placed on the EU market at the end of a notification
procedure in the absence of evidence-based safety objections from the Member States and/or
the European Food Safety Authority (EFSA).
Both procedures would replace the existing procedure whereby the risk assessment is initially
carried out at national level.
Applicant-linked authorisations would be abolished as a general rule. However, in specific
cases, applicants may request the protection of proprietary data and/or newly developed
scientific evidence provided in support of applications for authorisation.
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2.The proposal has been examined by the Working Party on Foodstuffs (hereinafter "Working Party") since January 2008. The results achieved during the Slovenian Presidency are
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summed up in the progress report submitted to the EPSCO Council of 10 June 2008 . Under the French Presidency, the Working Party met on 4 July, 24 September, 10 October,
24 October, 19 November and 3 December.
Some Member States maintain general or parliamentary scrutiny reservations. At this stage,
the Commission maintains a general scrutiny reservation regarding all the amendments to its
original proposal.
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3.The European Parliament appointed Mrs Kartika Liotard (GUE/NGL - Netherlands) as rapporteur. In the context of the first-reading opinion, the ENVI Committee adopted its report
on 2 December 2008.
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4.The Economic and Social Committee delivered its opinion on 29 May 2008.
II. STATE OF PLAY
The main issues dealt with during the French Presidency relate to:
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1)Food produced from cloned animals
According to the definition of novel food included in the Commission's proposal, food
produced from cloned animals is covered within the scope of the proposed Regulation.
The Member States are of the opinion that the proposed Regulation is probably not the
adequate legal framework to deal with the general aspects of cloned animals (with regard, for
instance to animal welfare) related to the use of cloning techniques on animals for food
production and that a specific EU legislation should therefore be considered.
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9689/08.
The related questions raised were: should cloned animals be immediately excluded from the
scope of this proposed Regulation and fall into a legal vacuum or should they be kept within
the scope of this proposed Regulation and be made subject to food safety assessment, until a
specific legislation on cloning will have been adopted?
A large majority of the Member States and the Commission considered that it was preferable
to keep food produced from cloned animals within the scope of the proposed Regulation until
specific legislation was adopted, assuming that this specific legislation would regulate all the
problems relating to cloning.
Nonetheless, some other Member States proposed that the proposed Regulation should
continue to cover the aspects related to food safety, co-existing with the new legislation on
cloned animals that would regulate more general matters, as animal welfare.
Two Member states asked for a ban of food produced from cloned animals.
A few Member States have not yet defined their position. For the Commission, food produced
from animals to which a breeding technique not used before 15 May 1997 was aplied must be
authorised as novel food.
Concerning the offspring of cloned animals, some Member States think that the food
produced from the offspring would share the same problematic as food produced from cloned
animals, and should therefore be included within the scope of this legislation, pending a
specific legislation, while other Member States and the Commission take the view that the
food produced from the offspring do not share the same problematic, and are therefore not
included within the scope of the present Regulation on novel foods and of the proposal.
Some other Member States have not yet formed an opinion.
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2)Clarification of definitions:
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a)It has been made clear that the rule of non-consumption to a significant degree before 15 May 1997 applies to all kinds of novel food.
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b)Concerning non-traditional breeding techniques, a distinction has been proposed between animals and plants. For plants to which a non-traditional breeding technique is
applied, there is a further condition for their inclusion in the scope of this Regulation:
they must give rise to significant changes in the composition or structure of the food.
A few Member States and the Commission maintain reservations regarding this
distinction.
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c)It was considered that, if appropriate, the definitions would be clarified through further criteria to be adopted by the Commission in accordance with the comitology procedure.
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3)Determination of novel food status:
It has been made clear that the food operator is the entity responsible for providing
information on food to be placed on the market, in particular concerning its consumption to a
significant degree before 15 May 1997.
The role of the national competent authorities and of the Commission, as well as the
connections between them, in determining if a food was used for human consumption before
15 May 1997 have been clarified.
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4)Traditional foods from third countries:
At present, traditional foods from third countries are subject to the same authorisation procedure as other kinds of novel foods. The Commission proposed to simplify the procedure
for those traditional foods from third countries where there is sufficient data concerning the
history of their safe food use in the country of origin.
According to the proposed Regulation now on the table, the procedure for the authorisation of
foods from third countries is always based on an opinion of the European Food Safety
Authority (EFSA), concerning the history of safe food use of the product. The comitology
procedure is applied only in case of objections by the Member States. The food approved in
accordance with this procedure will only be put on the market under the conditions that
correspond to those for which the history of safe use has been demonstrated. The food will be
added to a list which would include the conditions of use as well as, where appropriate,
specific labelling requirements.
The whole structure of the procedure has been redesigned and the role of the Member States
and the Commission has been detailed.
A few Member States and the Commission maintain reservations on this procedure. Some of
them prefer to apply the common procedure to all novel foods, others prefer a kind of
notification procedure with no systematic EFSA opinion.
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5)Data protection
In order to promote innovation in industry, the need for the protection of new scientific evidence and/or proprietary scientific data was accepted by the Member States. In addition, it
was agreed to specify that new scientific evidence or data could not be used for the benefit of
another application during 5 years without the agreement of the applicant where:
new scientific evidence or data has been designated as proprietary; the applicant had exclusive right of reference;
the novel food could not have been authorised without the submission of the data.
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6)Transparency
Provisions have been laid down requiring the publication, by the Commission, of the
summaries of the applications/notifications, of the results of the consultations between the
competent authorities, of the contents of the lists of the novel foods, etc.
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