Explanatory Memorandum to COM(2006)423 - Common authorisation procedure for food additives, food enzymes and food flavourings - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2006)423 - Common authorisation procedure for food additives, food enzymes and food flavourings. |
|---|---|
| source | COM(2006)423  |
| date | 28-07-2006 |
( Grounds for and objectives of the proposal As part of the efforts undertaken to improve Community legislation on the basis of the “farm to table” concept, in the White Paper on Food Safety, the Commission announced its intention to update and complete existing legislation with regard to additives and flavourings and to lay down specific provisions in respect of enzymes. (Actions 11 and 13 of the White Paper). This proposal aims to ensure the proper functioning of the internal market, while also ensuring a high level of protection of human life and health as regards food additives, food enzymes and food flavourings. In order to do this, it aims to establish a common authorisation procedure that is centralised, effective, expedient and transparent and that is based on risk assessment carried out by the European Food Safety Authority (hereinafter referred to as “the Authority”) and a risk management system in which the Commission and the Member States take action within the framework of a regulatory committee procedure. It assigns to the Commission, on the basis of the Authority’s scientific assessments, the task of creating, maintaining and updating a general positive list for each category of substances concerned. The inclusion of a substance on one of these lists means that its use is authorised in general for all operators on the Community market.
( General context So as to meet the objectives set in the White Paper, and for reasons of efficiency in the areas of food safety, human health protection and the free movement of the products concerned, the Commission has developed, in parallel, three other proposals for Regulations that make the placing on the Community market of these substances subject to compliance with harmonised criteria and the granting of authorisation: 1. Proposal for a Regulation of the European Parliament and of the Council on food additives; 2. Proposal for a Regulation of the European Parliament and of the Council on food enzymes; 3. Proposal for a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods. The new regulatory framework proposed for the substances in question must be completed by the establishment of a common authorisation procedure, insofar as the existence of different national authorisation procedures could potentially lead to different results and, in consequence, hinder the free movement of the substances concerned and distort free competition.
( Existing provisions in the area of the proposal 1. Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. The procedure laid down in the above Directive is close to the procedure established by this proposal in that it provides for the creation of a positive list of authorised additives at Community level. It differs from the procedure envisaged in this proposal as regards the following aspects in particular: the existing procedure is out of date insofar as it does not use the new 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; an additive is included on the positive list following the adoption of a directive under the codecision procedure, rather than by means of a regulation and the comitology procedure as envisaged by this proposal. 2. Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs. The procedure laid down in the above Regulation is close to the procedure established by this proposal in that it assigns the Commission the task of creating a positive list of flavouring substances and lays down that this list be adopted in accordance with the comitology procedure. It differs from the procedure envisaged in this proposal on several points, and on the following aspects in particular: the existing procedure is out of date insofar as it does not use the new framework for risk assessment in matters of food safety established by Regulation (EC) No 178/2002; it is a procedure that is limited to notification of the Commission by the Member States of all the flavouring substances that may, in accordance with Directive 88/388/EEC, be used in or on foodstuffs marketed in their territory. Unlike the current proposal, it does not make provision for private operators to submit authorisation requests; it involves the creation of a positive list of flavouring substances without making provision for the list to be updated; the existing procedure lacks clarity in relation to new substances and the deadlines for the various stages of the procedure.
( Consistency with the other policies and objectives of the Union The proposed Regulation not only falls within the general framework of the Lisbon Strategy but also fulfils the Commission’s objectives as regards simplification and “Better Regulation”.
Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondents The consultation methods and the organisations consulted are described in detail in the explanatory memorandums of the proposals for regulations on additives, enzymes and flavourings.
Summary of responses and how they have been taken into account The parties consulted welcomed the idea of a simplified, transparent and expedient common authorisation procedure. The involvement of the Member States in the authorisation procedure as compulsory relays between applicants and the Commission was criticised by the Member States. This “extra-step procedure” seems to be regarded as a bureaucratic complication that needlessly slows down the procedure. In consequence, this proposal abolishes the “letter-box” role of the national authorities in the common procedure. Some consumer organisations expressed the fear that replacing codecision with the comitology procedure in the authorisation procedure for additives would reduce the current transparency. Nevertheless, use of the comitology procedure is desirable, as it establishes a common procedure for the three types of substance. Moreover, the codecision procedure currently applicable in relation to additives is an isolated case in food legislation as a whole, despite its use not being justified by a higher level of risk posed by additives.
Collection and use of expertise
No recourse to external expertise was necessary.
( Impact assessment This proposal and the options considered have no environmental impact. 1. No action Economic impact The current authorisation mechanisms for additives and flavourings are slow and outdated. The lack of clarity and the shortcomings in the current legislation create a situation of legal uncertainty that could hinder industrial innovation and new technological developments. Social impact The different national approaches to assessing the safety of the substances concerned could lead to different levels of protection. This situation is liable to create confusion among consumers and undermine their confidence in the public authorities, the internal market and the scientific basis of food legislation. 2. No legislative action The nature of the action to be taken in this area is subject to and connected with the nature of the action taken in the sectors concerned. Given that the principle of general Community-level authorisation of the substances is accepted, legislative action is needed to ensure that there is an effective and fast common procedure. Economic impact A coordination-based solution (possible adoption of guidelines for the parties concerned in relation to the procedure to follow or a Community code) would not offer the protection and legal certainty that the industry requires. Furthermore, it would contradict the legislative approach followed for the authorisation of other food substances. This situation could have a negative economic impact insofar as it could discourage industrial innovation. Social impact Legal uncertainty as regards the procedures to be followed could compromise the effectiveness of scientific assessments and the level of human health protection. This situation could undermine consumer confidence. 3. Deregulation Economic impact Deregulation would lead to the introduction of different national authorisation procedures that could create additional administrative burdens for the competent authorities of the Member States. Furthermore, the operators concerned would have to submit separate authorisation applications to each Member State in which they wanted to market their product. Social impact The existence of different procedures for assessing the safety of substances would lead to there being different levels of protection. This could create confusion among consumers and undermine their confidence.
The Commission has carried out an impact assessment under its Legislative and Work Programme, and the report is available at: ec.europa.eu/food/food/chemicalsafety/additives
3)
Contents
( Summary of the proposed action This proposal establishes an effective, expedient and transparent common authorisation procedure for food additives, food enzymes and food flavourings (in the form of a list of substances that is kept up to date). Community authorisation will be granted in a transparent, centralised manner on the basis of the scientific opinion of the Authority, provided that the authorisation criteria set out in the sectoral food laws are met. Such authorisation will take the form of a regulation to be adopted according to the comitology rules.
( Legal basis Article 95 of the EC Treaty This proposal aims to improve the conditions for the functioning of the internal market, since it will be possible for products authorised in accordance with the proposed procedure to be used throughout the Community. The Regulation envisaged will lead to the Member States’ legal provisions concerning the use of food additives, food enzymes and food flavourings being harmonised in the form of a positive list of authorised substances to be created by the Commission pursuant to the Regulation.
( Subsidiarity principle The principle of subsidiarity applies insofar as the proposal does not concern an area in which the Community has exclusive competence.
The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reasons.
This proposal aims to establish a centralised authorisation procedure at Community level. It would not be possible for this to be achieved by national legislators, even if they simultaneously adopted national provisions with the same content as the proposed Regulation. A Community measure on the authorisation procedure complements the other three harmonisation measures proposed in this area.
Putting in place authorisation procedures separately in each Member State would make the authorisation mechanisms considerably more unwieldy and would create needless additional administrative burdens for the competent authorities of the Member States and for operators.
The objectives of the proposal can be better achieved by Community action for the following reasons.
Community action in relation to the authorisation procedure for the substances in question is more effective than action taken by the Member States insofar as it will fully benefit all operators that market the products concerned on the Community market as well as consumers, who will be able to enjoy the same level of protection in all Member States.
Community action in the area envisaged brings added value as regards legal certainty and efficiency for operators in the sector, administrative simplification, the functioning of the internal market and consumer protection.
The proposal relates exclusively to the intrinsic elements of a centralised authorisation procedure.
The proposal therefore complies with the subsidiarity principle.
Proportionality principle The proposal complies with the principle of proportionality for the following reasons.
The proposed measure is procedural in nature and follows from the principle of pre-marketing authorisation that is established in the sectors concerned. A coordination-based solution would make the authorisation procedure for the substances concerned considerably more unwieldy. The proposed act does not exceed the limits of what is appropriate and necessary in order to achieve the legitimate objective of the legislation in question, namely the proper functioning of the internal market and human health protection.
The procedures put in place by the proposed measure streamline the processing of authorisation files, the majority of which (except for enzymes) have already been scientifically assessed by the Authority and processed by the Commission. Therefore, this has an impact on the procedures currently used by the Commission and the Authority, but one which remains limited. Nevertheless, the proposed measure will considerably reduce the administrative burdens on the Member States by allowing them to devote their resources particularly to implementing the legislation and to control activities. The new rules will enable operators to avail of a clear, transparent, effective and fast procedure by submitting a single authorisation application. The creation and updating of a Community list of authorised substances should also facilitate the movement of the products concerned and increase the level of information in this area.
Choice of instruments
Proposed instrument(s): Regulation.
Other means would not be adequate for the following reasons. The nature of the proposed measure is subject to and connected with the nature of the action taken in the sectors concerned. A different solution (directive, code of conduct, guidelines) would make the authorisation procedure for the substances concerned considerably more unwieldy and would not offer the necessary legal certainty.
4)
The proposal has no implication for the Community budget.
( Simplification
The proposal simplifies the legislative framework, the administrative procedures applicable to (national or European) public authorities and the administrative procedures applicable to bodies and private individuals.
A single regulation will set out the applicable procedure for the authorisation of additives, enzymes and flavourings.
The competent authorities of the Member States will be able to follow all the stages of the authorisation procedure without being burdened with needless administrative tasks.
The operators concerned will benefit fully from the advantages of a centralised, transparent, time-limited procedure. The granting of authorisation by means of a regulation updating a Community list will significantly speed up the authorisation procedure.
The proposal is included in the Commission’s programme for updating and simplifying the Community acquis and in its Work and Legislative Programme under the reference 2005/SANCO/034.
( European Economic Area This draft act concerns an area covered by the EEA Agreement and must therefore be extended to the European Economic Area.
( Detailed explanation of the proposal by chapter or by article Chapter I: General principles A common procedure is established for assessing and authorising additives, enzymes and flavourings. This procedure has been designed to be simple, fast and effective, while respecting the principles of good administration and legal certainty. It is centred around the updating, on the basis of the criteria laid down in the sectoral laws, of a list of authorised substances that must be created and maintained by the Commission. Chapter II: Common procedure Under the proposed procedure, requests for updates must be addressed to the Commission, without first going through a national authority. The Commission shall send the request file to the Authority and to the Member States and shall seek the opinion of the Authority, which must issue such opinion within six months. So as to ensure the binding effect of the updating measures, the proposal provides for their adoption to take the legal form of a regulation adopted in accordance with the comitology procedure. When the list is being updated within the framework of this proposal for a Regulation, any other relevant legitimate factors must be taken into account. Thus, when initiating the decision-making process, the Commission, as risk manager, may propose a measure that is not in line with the outcome of the risk assessment carried out under the responsibility of the Authority. In such cases, the Commission must explain its reasons for such a departure. This is in line with the Codex Alimentarius General Principles on Risk Analysis. Chapter III: Miscellaneous provisions So as to take account of the specific characteristics of each sectoral food law, this proposal gives the Commission the power, following consultation of the Authority, to take decisions on various details of the procedure and provides for a certain degree of flexibility as regards complex and sensitive cases. All non-confidential data should be made available to the public. If the Member States or the Commission consider that a substance that has been authorised in accordance with this proposal poses serious risks to human health, animal health or the environment, emergency measures must be adopted.
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