Considerations on COM(2007)672 - Common authorisation procedure for food additives, food enzymes and food flavourings (presented by the Commission pursuant to Article 250 (2) of the EC Treaty) - Main contents
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| dossier | COM(2007)672 - Common authorisation procedure for food additives, food enzymes and food flavourings (presented by the Commission pursuant ... |
|---|---|
| document | COM(2007)672  |
| date | October 24, 2007 |
(2) A high level of protection of human life and health and of the environment should be assured in the pursuit of Community policies.
(3) So as to protect human health, the safety of additives, enzymes and flavourings for use in foodstuffs for human consumption must be assessed before they are placed on the Community market.
(4) Regulation (EC) No XXX/2006 of the European Parliament and of the Council of … on food additives[3], Regulation (EC) No YYY/2006 of the European Parliament and of the Council of … on food enzymes[4] and Regulation (EC) No ZZZ/2006 of the European Parliament and of the Council of … on food flavourings and certain food ingredients with flavouring properties[5] lay down harmonised criteria and requirements concerning the assessment and authorisation of these substances.
(5) It is envisaged, in particular, that food additives, food enzymes and food flavourings, to the extent that the safety of the latter must be assessed in accordance with Regulation (EC) No ZZZ/2006, must not be placed on the market or used in foodstuffs for human consumption, in accordance with the conditions laid down in each sectoral food law, unless they are included on the Community list.
(6) Transparency in the production and handling of food is absolutely crucial to achieving consumer confidence.
(7) In this context, it appears appropriate to establish a common Community assessment and authorisation procedure for these three categories of substances that is effective, time-limited and transparent, so as to contribute to their free movement within the Community market.
(8) This common procedure must be founded on the principles of good administration and legal certainty and must be implemented in compliance with these principles.
(9) This Regulation will thus complete the regulatory framework concerning the authorisation of the substances by laying down the various stages of the procedure, the deadlines for these stages, the role of the parties involved and the principles that apply. Nevertheless, for some aspects of the procedure, it is necessary to take the specific characteristics of each sectoral food law into consideration.
(10) In accordance with the framework for risk assessment in matters of food safety established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[6], the placing of substances on the market must be authorised only after an independent scientific assessment, of the highest possible standard, of the risks that they pose to human health. This assessment, which must be carried out under the responsibility of the European Food Safety Authority (hereinafter referred to as “the Authority”), must be followed by a risk management decision taken by the Commission under a regulatory procedure that ensures close cooperation between the Commission and the Member States.
(11) The criteria laid down for authorisation in Regulations (EC) No XXX/2006, (EC) No YYY/2006 and (EC) No ZZZ/2006 should be fulfilled for authorisation pursuant to this Regulation.
(12) It is recognised that , in some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may must be taken into account.
(13) So that both business operators in the sectors concerned and the public are kept informed of the authorisations in force, the authorised substances should be included on a Community list created, maintained and published by the Commission.
( 14 ) Networking between the Authority and the Member States’ organisations operating in the fields within the Authority’s mission is one of the basic principles of the Authority’s operation. In consequence, in preparing its opinion, the Authority may use the network made available to it by Article 36 of Regulation (EC) No 178/2002 and by Commission Regulation (EC) No 2230/2004 laying down detailed rules for the implementation of Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission[7].
( 15 ) The common authorisation procedure for the substances must fulfil transparency and public information requirements while guaranteeing applicants’ right to preserve the confidentiality of certain information, in duly justified cases and for stated reasons in order to protect the competitive position of the applicant .
(16) Pursuant to Article 41 of Regulation (EC) No 178/2002, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents[8] applies to documents held by the Authority.
( 17 ) Articles 53 and 54 of Regulation (EC) No 178/2002 establish procedures for taking emergency measures in relation to foodstuffs of Community origin or imported from third countries. They authorise the Commission to adopt such measures in situations where foodstuffs are likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.
(18 ) In the interests of efficiency and legislative simplification, there should be a medium-term examination , including consultation of stakeholders , as to whether to extend the scope of the common procedure to other legislation in the area of food.
(19 ) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States on account of differences between national laws and provisions and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve these objectives.
(20 ) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [9] . The Commission should, as appropriate, consult stakeholders in preparing the measures to put before the Committee referred to in the above Decision.
(21) In particular, power should be conferred on the Commission to update the Community lists of food additives, food enzymes and food flavourings. Since those measures are of general scope and are designed to amend or supplement non-essential elements of each sectoral food law, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(22) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a (6) of Decision 1999/468/EC for the removal of a substance from the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists.