ZITTING VAN DE RAAD WERKGELEGENHEID, SOCIAAL BELEID, VOLKSGEZONDHEID EN CONSUMENTENZAKEN OP 9 EN 10 JUNI 2008

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  1. Tekst
  2. Originele weergave
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1.

Tekst

I. INTRODUCTION

  • 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 the current Regulation (EC) No 258/97, on novel foods and novel food

ingredients which has been in force since 15 May 1997.

1

Doc. 5431/08 (COM(2007) 872 final)

The objective of the proposal is to ensure food safety, protection of human health and

consumer interests and the effective functioning of the internal market. To meet this objective,

the Commission proposed to update and clarify the scope of the Regulation. The first step in

this respect was taken with the adoption of the Regulation (EC) 1829/2003 on genetically

modified food and feed, which excluded genetically modified food from the scope of the

current Regulation (EC) No 258/97 on novel food. The Commission proposed to maintain

15 May 1997 as a threshold date for determination of the novelty of the food.

The placing on the market of novel foods, other than traditional foods from third countries,

would be subject to a centralized procedure at the Community level according to the

Regulation (EC) No XXX/XXX [common authorisation procedure] (hereinafter referred to as

"future Regulation on 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 within the framework of the notification procedure in

the absence of evidence based safety objections from 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.

The applicant linked authorisations should 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.

  • 2. 
    The proposal and its accompanying impact assessment have been examined by the Working Party on Foodstuffs (hereinafter "Working Party") at seven meetings since being presented by

the Commission.

The Working Party welcomed the proposed Regulation and supported its main objectives.

Nevertheless, 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.

  • 3. 
    The European Parliament has appointed Mrs Kartika Liotard as rapporteur and expects to adopt the draft first reading opinion in the ENVI Committee in December 2008 with a vote in

the EP Plenary in January 2009.

II. CURRENT STATE OF PLAY

During the examination of the text by the Working Party, a number of changes have been suggested

to the proposal of the Commission with the immediate objective of making it clearer.

  • A) 
    Concerning the substantive issues, it is possible at this stage to consider that there is broad agreement on the following issues:
  • 1) 
    Centralized risk assessment procedure

One of the main changes introduced by the proposal with respect to the present system, is the replacement of the current procedure ­ i.e. initial risk assessment carried out at national level

and, if necessary, the additional risk assessment by EFSA - by a single centralized risk

assessment procedure carried out by EFSA, which will be used in the case of all novel food

other than traditional foods from third countries. This approach was accepted by Member

States.

  • 2) 
    Scope

It should be ensured that all foods that require an authorisation are covered by the respective sectoral food laws. In this respect the Working Party clarified that, novel foods which are

vitamins and minerals falling under the scope of specific legislation on vitamins and minerals

should not be regulated under the proposed Regulation on novel food unless they are obtained

from new sources or using a production process, which was not taken into account when they

were authorised under the respective legislation.

  • 3) 
    Clarification of definitions

Given the recurring difficulties encountered as regards the interpretations of the definitions, there was consensus among Member States that the definitions included in the proposal (e.g.

of "novel food" in general and " traditional food from a third country") needed further

clarification.

Therefore, the Working Party agreed that further criteria for assessing if a food has been used for human consumption to a significant degree within the Community before 15 May 1997

must be developed. The question whether this should be done before the application of the

proposed Regulation remains open at this stage. Similarly, the other concepts, such as

"significant change", "normal diet" and "large part of the population", might need to be based

on agreed criteria.

  • 4) 
    Determination of the novel food status

Food business operators are in general responsible for providing information about use of a

product as food to a significant degree within the Community before 15 May 1997. However,

if necessary, Member States' competent authorities for novel foods are the ones responsible

for verifying the evidence on the status of foods presented by food business operators. In case

of doubt about the novelty of a food, the decision should be taken by the regulatory

comitology procedure. To support this decision process, the possibility would exist for the

Commission to collect information from Member States and/or business operators to

determine to what extent a food has been used for human consumption before 15 May 1997 as

well as to confirm any such information submitted by the business operator with Member

States. In addition, implementing measures could be adopted (e.g. on the outcome of

enquiries).

  • 5) 
    Validation of application

An application for authorisation of a novel food should only be considered if the food for

which the authorisation is sought meets the definition of a "novel food". The Council

considers that the Commission when receiving an application will carry out the validation of

application. The rules for validation of application will be adopted through the implementing

measures which are foreseen in Article 9 of the future Regulation on common authorisation

procedure, part of this validation will be to verify if the food meets the definition of "novel

food".

  • 6) 
    Lists of novel foods that can be placed on the Community market

It was recognised of the utmost importance that all novel foods which may be placed on the Community market should be listed at a single reference point. Due to the different

procedures (authorisation and notification) established by the proposed Regulation, the

preferable solution to have a single Community list is not possible. The solution is to publish

the list of novel foods authorised under the future Regulation on common authorisation

procedure, as well as the list of notified traditional foods from the third countries, on a single

dedicated page of the Commission's website.

The Working Party decided that, for reasons of legal certainty, each year a summary of

notifications of novel foods from third countries should be published in

the Official Journal of the European Union.

  • 7) 
    General conditions for placing novel food on the market

The Working Party chose to apply the general conditions for placing novel foods on the Community market to all novel foods, including traditional foods from third countries.

  • 8) 
    Articulation of the proposed Regulation with respect to the future Regulation on common authorisation procedure

As the application of the proposed Regulation depends on the date of application of the future Regulation on common authorisation procedure, the solution is to extend the period in which

the proposed Regulation on novel foods will become applicable to 24 months after its entry

into force. This period would cover the maximum period needed for the application of the

future Regulation on common authorisation procedure. Requests for authorisations submitted

during that period should be processed in accordance with the current Regulation on novel

food (i.e. Regulation (EC) 258/97).

  • 9) 
    Additional labelling

Member States agreed that in certain cases, it might be necessary to provide for additional

labelling information on novel foods, in particular: regarding the description of the food, its

source or its conditions of use.

Whether additional labelling, in relation to ethical considerations or other consumer concerns,

should be provided, needs to be discussed further.

  • B) 
    The following issues require further considerations in view of reaching the final agreement by the Council:
  • 1. 
    Traditional foods from third countries

At present, traditional foods from third countries are subject to the same authorisation procedure as other kinds of novel food. The Commission proposed to simplify the procedure

for those traditional foods from third countries where sufficient data of the history of their

safe use in the country of origin exists.

Some Member States raised doubts about the use of this notification procedure. Related doubts have been also expressed about the scope of the definition of such foods and a

question as to whether the definition should not cover only fruits and vegetables has been

raised.

  • 2. 
    Medicinal products

Under the proposed Regulation, authorisation of novel foods is given at Community level. By contrast, in case of borderline products it is up to the Member States to decide if a product is

classified as a medicinal product. The problem might rise when the same product is authorised

as a novel food at the Community level, but would be considered as a medical product in a

Member State. For the time being, it is noted in the text that the level of harmonisation for

medicinal products enables a situation whereby a Member State may, if it establishes in

accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the

placing on the market of such product in accordance with Community law.

  • 3. 
    Committee on Ethics and new Technologies

An additional provision was suggested stating the possibility for the Commission to consult the above Committee on ethical issues relating to science and new technologies of major

ethical importance that may be used in the production of novel foods. Some Member States

proposed that, where appropriate, the advice of the Committee on Ethics and new

Technologies would be taken into account as a criterion for the authorisation of a novel food.

However, this proposal was not supported by other delegations or the Commission.

  • 4. 
    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. However, it is

still under discussion whether criteria similar to those in Article 21 of Regulation (EC)

1924/2006 on health and nutrition claims, should be introduced into the proposed Regulation.

The Council's Working Party will continue the examination of the proposal with a view to reaching

an agreement on the text. The Council would welcome a first reading agreement with the European

Parliament on this legislative proposal, although the adoption of the Council's common position will

depend on the outcome of the first reading examination of the proposal by the European Parliament

and subsequent discussions between the Council and the European Parliament.

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Originele weergave

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