Explanatory Memorandum to COM(2006)428 - Food additives - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2006)428 - Food additives. |
|---|---|
| source | COM(2006)428  |
| date | 28-07-2006 |
Grounds for and objectives of the proposal
The Commission announced in the White Paper on Food Safety (COM (1999) 719 final) that it would up-date and simplify existing Community legislation with regard to food additives (Action 11 in the White Paper).The objectives of this proposal are:
- To simplify food additive legislation by creating a single instrument for principles, procedures and approvals;
- To confer the implementing powers on the Commission to update the Community list of authorised food additives;
- To consult the European Food Safety Authority (EFSA) for the safety evaluation of food additives;
- To set up a re-evaluation programme for existing food additives;
- To require the authorisation of additives that consist of, contain or are produced from genetically modified organism under Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.
General context
Authorisation and use of food additives in foodstuffs has been harmonised in the European Union since 1995 when the last of the specific directives on food additives (95/2/EC) was adopted. The current legislation consists of 4 co-decision directives (framework and 3 specific directives) and 3 Commission Directives (specifications).
Food additives legislation is the only technical area where the approval for use of a substance requires a co-decision procedure, which makes managing the approvals cumbersome and slow.
Two related proposals are proposed simultaneously:
1. Proposal on Regulation (EC) No […] establishing a common authorisation procedure for food additives, food enzymes and food flavourings
2. Proposal on Regulation for food enzymes.
Existing provisions in the area of the proposal
Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption lays down the general principles for authorisation of food additives in the European Union.
This Directive is complemented with the European Parliament and the Council Directives 94/35/EC on sweeteners for use in foodstuffs, 94/36/EC on colours for use in foodstuffs and 95/2/EC on food additives other than colours and sweeteners. These 3 directives lay down the list of authorised food additives and their conditions of use to the exclusion of all others.
In addition, the European Parliament and the Council have adopted a Decision No 292/97/EC on the maintenance of national laws prohibiting the use of certain additives in the production of certain specific foodstuffs.
The proposal brings together all the above mentioned provisions.
Consistency with the other policies and objectives of the Union
Not applicable.
Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondents
The opinion of Member States and stakeholders has been sought through consultations at several working groups and during bilateral contacts with stakeholders since 2000. Among the stakeholders consulted were:
CIAA (Confederation of the food and drink industries of the EU)
ISA (International Sweeteners Association)
CEFIC (European Chemical Industry Council)
AMFEP (Association of Manufacturers and Formulations of Enzyme products)
ELC (Federation of European Food Additives and Food Enzymes Industries)
FEDIMA (Federation of the Intermediate products Industries for the Bakery and Confectionery trades in the EEA)
CAOBISCO (Association of the Chocolate, Biscuit and Confectionery Industries of the EU)
Moreover, a questionnaire on the impacts of the proposal was circulated to the different stakeholders on 22.2.2005 to which 70 replies were received by the end of the consultation
Summary of responses and how they have been taken into account
After each consultation, the comments have been considered and the texts have been adapted. The following points were specifically raised and comments considered as follows:
1. Harmonisation and scope of legislation:
During the development of this proposal it was considered whether the definition of processing aid could be revised to reduce interpretation difficulties. However the food industry considered that such a change would cause a considerable impact, it was therefore decided not to progress such a change at this stage but to consider other approaches such as development of agreed interpretive guidelines based upon the current definition.
2. Time limited authorisation:
There was a strong indication from industry that a time limited authorisation could be a barrier to innovation and would introduce uncertainty in the food additives market. On the other hand Member States and Consumer organisations considered that additive approvals should be kept under some form of review to ensure that the Regulation remains current. A compromise solution has therefore been proposed where producers or users of additives should provide to the Commission on its request information on their actual uses.
3. Transitional periods:
As part of the harmonisation and development of the scope of this Regulation it is proposed to additionally regulate the use of additives in additives and enzymes as is already the situation for additives used in flavourings. Although this will have some impact on the food industry this move has been generally welcomed by all stakeholders. The food industry did however suggest that an appropriate time period be included to allow for this change. This proposal therefore foresees a transitional period of 5 years to reduce the impact of this measure.
Collection and use of expertise
There was no need for external expertise.
Impact assessment
There would be no environmental impacts from any of the policy options considered, since the industry concerned is involved in secondary or tertiary processing of food products. Additives are already widely available and widely used.
Economic impact
The process of amending additive authorisations would still require the lengthy co-decision procedure including the time spent by the Member States on implementing the authorisation. This would continue to act as a barrier to innovation by industry, and as a consequence technological developments would not be encouraged.
EFSA would not be required to carry out a review reassessing all currently approved additives and consumers would not benefit from the additional controls on the use of additives used in food additives and enzymes.
Economic impact
The process of amending additive authorisations would still require the lengthy codecision procedure including the time spent by the Member States on implementing the authorisation. This would continue to act as a barrier to innovation by industry, whereby technological developments would not be encouraged. Member States and stakeholders would have to elaborate and agree a code of practice on the use of additives in additives and in enzymes.
Consumers would not benefit from increased assurance on the safety of food.
Additive legislation is already harmonised across the European Community, and therefore many aspects of the proposed legislative action will have a limited impact. This action will however affect all food additive manufacturers and will have some consequential impacts on the food industry.
The introduction of comitology for additive approvals will have a positive impact on industry as the procedures for permitting new additives will be faster. This has the potential to stimulate investment in developing new additives by removing many of the delays currently associated with realising the benefits of new developments. There will be an economic impact of the extension of the scope to cover additives in additives and enzymes, where some new substances may require authorisation, however the number of such substances is thought to be low. There will also be a small impact as a result of updating technical data sheets and also from minor changes in labelling as a result of enzymes being removed from the scope. However, these will be one off costs and the effect should be dissipated by the use of suitable transition periods included to allow time to adapt to these changes. Such changes are unlikely to affect the cost of goods sold to consumers.
Consumers will benefit from increased assurances on the composition and safety of the food which they purchase. Consumer organisations, however, have voiced some concern that the introduction of comitology may reduce the overall transparency of the process, where authorisations will no longer be scrutinised and debated to the same extent by the European Parliament. The use of comitology is however appropriate as food additive legislation is one of the few areas in food law where co-decision is still required for largely technical amendments. Consumer need and technological benefit will remain as important parameters to be considered by Member States representatives when authorisations are debated under the comitology procedure. In addition to formal comitology procedures and the routine publishing of agendas for standing committee meetings on the internet, other methods of consultation will continue. These will include discussing amendments to legislation in expert working groups or other fora to which consumer groups and other stakeholders are routinely invited.
Economic impact
Deregulation could result in different risk assessments being undertaken for additives between Member States. Member States could also stipulate different procedures for authorisation. Such a move would therefore have an impact on the administrative burden for the competent authorities of Member States in undertaking this additional work. As a consequence this would also present a considerable administrative burden on food additive manufacturers whereby it would be necessary to apply for authorisation individually in all the Member States in which they wish to use the additive. This would also have an effect on the food industry and international trade.
Although the general principles of food law apply, the deregulation of additives legislation could still lead to a deterioration of consumer protection relating to food additives. This could arise due to different degrees of risk assessment being carried out in Member States combined with potential differences in interpretation of such assessments. The resulting divergence in additive authorisations would also complicate procedures for estimating and comparing the intake of authorised food additives across the European Union and within individual Member States where imported foods would be subject to different additive authorisations.
The Commission carried out an impact assessment listed in the Work Programme, whose report is accessible on ec.europa.eu/food/food/chemicalsafety/additives
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- 2. CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT
- BEUC (The European Consumers' Organisation)
- Environmental impact
- No action
- Social impact
- Non legislative action
- Social impact
- Legislative option
- Economic impact
- Social impact
- Deregulation of additive legislation
- Social impact
- Article 95
- 5. ADDITIONAL INFORMATION
- Chapter I - Subject matter, scope and definitions
- Chapter II - Community lists of approved food additives
- Chapter III - Use of food additives in foods
- Chapter IV - Labelling
- Chapter V - Procedural provisions and implementation
- Chapter VI - Transitional and final provisions
Summary of the proposed action
Creation of a Regulation of the European Parliament and of the Council on food additives that lays down the principles for the use of food additives and lays down the positive list of substances that may be used as food additives.
Repeal of Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption, European Parliament and Council Directives 94/35/EC on sweeteners for use in foodstuffs, 94/36/EC on colours for use in foodstuffs and 95/2/EC on food additives other than colours and sweeteners and the European Parliament and the Council Decision No. 292/97/EC on the maintenance of national laws prohibiting the use of certain additives in the production of certain specific foodstuffs.
Legal basis
Subsidiarity principle
The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Community.
The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reason(s).
Action by Member States only could lead to a confusing situation for the consumers, with different levels of protection, and a loss of confidence in certain Member States and in the internal market.
Community action will better achieve the objectives of the proposal for the following reason(s).
A positive list with about 300 food additives needs to be managed. This requires a harmonised and centralised approach.
Efficiency of the authorisation procedure and effective functioning of the internal market will indicate that the objectives are best met by the European Union.
Effective functioning of the internal market in relation to food additives used in and on food while protecting the health and the interest of the European consumers can best be met via a centralised procedure for authorisation.
The proposal therefore complies with the subsidiarity principle.
Proportionality principle
The proposal complies with the proportionality principle for the following reason(s).
The proposed measure simplifies current provisions by combining four co-decision Directives and one Decision and confers the implementing powers to the Commission to create and update the Community list of food additives. The proposed measure is a Regulation to accelerate the entry into force of approvals and to avoid misinterpretation of provisions.
Administrative burden will be minimised as the Regulation will be directly applicable. Financial burden is minimised as the current provisions exist already, they are only simplified.
Choice of instruments
Proposed instruments: regulation.
Other means would not be adequate for the following reason(s).
The area of food additives is fully harmonised in the EU. The safe use of food additives depends on the safety evaluations and permitted conditions of use of these substances, therefore recommendations or self-regulations would not guarantee the protection of consumer's health. This proposal combines current framework Directive and specific Directives to a single instrument to facilitate the use of food additives in the EU.
The Community may finance the establishment of a harmonised policy and system in the field of food additives including:
- development of an appropriate database for gathering and storing all information relating to Community legislation on food additives,
- undertaking studies necessary for the preparation and development of legislation on food additives,
- undertaking studies necessary to harmonise procedures, decision-making criteria and data requirements, to facilitate work sharing between Member States and to develop guidance in these areas.
Simulation, pilot phase and transitory period
There was or there will be a transitory period for the proposal.
Simplification
The proposal provides for simplification of legislation.
There will be only one co-decision Regulation to manage instead of the current four. The positive list can be created and updated by comitology procedure. In addition as the measure is a Regulation this will accelerate considerably the approval procedure for food additives.
The proposal is included in the Commission's Work and Legislative Programme under the reference 2005/SANCO/034.
Repeal of existing legislation
The adoption of the proposal will lead to the repeal of existing legislation.
European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.
Detailed explanation of the proposal
Food additives used in foods, in food additives and in food enzymes shall be subject to safety evaluation and approval via community positive lists.
All food additives and their use in food will be evaluated for the following criteria: safety, technological need, benefit to the consumer and that the consumer is not being misled by the use.
In line with the decision to separate risk management and risk assessment, all applications for the approval of new food additives will be directed to EFSA which will carry out the safety evaluations. The inclusion of a food additive in the Community positive list will be considered by the Commission on the basis of the opinion from EFSA. In addition to the safety of the substance, the other general criteria (technological need, consumer aspects) have to be examined before a food additive may be included in the Community positive list. This will be done by the Standing Committee on the Food Chain and Animal Health (SCFCAH).
The final inclusion in the positive list will be done by the Commission by entering the food additive and its conditions of use in Annexes II and III of this Regulation.
A food additive which consists, contains or is produced from a genetically modified organism, should be authorised in respect of the genetic modification according to Regulation (EC) No 1829/2003 on genetically modified food and feed, prior to its inclusion in the positive list under this Regulation.
For every authorised food additive included in the positive list a specification must be laid down. This contains the criteria on purity and defines the origin of a food additive.
General rules on placing on the market of foods containing food additives are laid down.
Labelling of food additives sold to the manufacturer or directly to the consumer is regulated by Directive 89/107/EC. This proposal up-dates these rules.
To ensure that food additives once permitted are kept under continuous observation and re-evaluated wherever necessary producers or users of food additives will be obliged to inform the Commission of any new information which may affect the safety assessment of the food additive. They shall also provide data on the usage of food additives to enable assessments of dietary intake to be undertaken.
Implementation of the measures proposed in the Regulation will be adopted by the Commission in accordance with the regulatory procedure laid down in Council Decision 1999/468/EC. This consists of including the use of a food additive and laying down the conditions of use in the positive list as well as laying down specifications, including criteria on origin and purity criteria and the verification of such criteria. As these are matters of high technicality that are adopted on the basis of commonly agreed principles, they should be trusted to the Commission for the sake of efficiency and simplification.
Food additives currently included in Directives 94/35/EC, 94/36/EC and 95/2/EC shall be entered in Annex II of this proposal after a review carried out by the SCFCAH. The Standing Committee will evaluate the compliance of existing authorisations for food additives and their conditions of use with the general criteria laid down in the Regulation taking into account the latest scientific opinion on the safety of the food additive. Until the Committee has completed the review of existing authorisations, the above-mentioned Directives shall remain applicable.
The Authority shall carry out a risk assessment on all currently approved food additives. In consultation with the Authority, the Commission should set up an evaluation programme in order to define the need and the order of priorities for the risk assessment. Time limits for the evaluation should be laid down in the programme.
Provisions on additives in food additives (other than carriers) and in food enzymes will apply after an appropriate interval to provide time for safety assessments to be undertaken.