Explanatory Memorandum to COM(2006)425 - Food enzymes - Main contents
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| dossier | COM(2006)425 - Food enzymes. |
|---|---|
| source | COM(2006)425  |
| date | 28-07-2006 |
The Commission announced in the White Paper on Food Safety a proposal amending the framework Directive 89/107/EEC on food additives to lay down specific provisions in respect of food enzymes. In-depth assessment of the situation has led to the development of a specific proposal for food enzymes.
Currently the scope of Directive 89/107/EEC only covers enzymes used as food additives and only two enzymes are authorised under this Directive. The remaining enzymes are not regulated at all or are regulated as processing aids under the legislation of the Member States, which is diverse. Thus, there is a need for harmonised rules at Community level, in order to promote fair trading and effective functioning of the internal market in food enzymes and ensure protection of human health and consumers' interest. A proposal for a new Regulation on food enzymes, as part of the package on food improvement agents, is included in the Commission Legislative Working Programme of 2005.
The legislation controlling the use of enzymes in food processing is not fully harmonised in the EU. The national regulatory context for enzymes used as processing aids in food production differs significantly among Member States. Only a few Member States have a mandatory or voluntary authorisation procedure, the majority have none at all. Moreover, there are divided opinions among Member States in relation to the categorisation of enzymes into food additives or processing aids according to their function in the food process or in the final food. This lack of harmonised rules in the Community created barriers to the trade of food enzymes and has hindered growth in this field.
With respect to safety, there is neither safety evaluation nor authorisation of food enzymes at European level, except for those that are considered as food additives. Historically, food enzymes were considered to be non-toxic. However, the food enzyme industry is continually striving to develop improved technology resulting in the development of food enzymes which became through the years more complex and sophisticated. There could be some potential hazards arising from their chemical nature and source such as allergenicity, activity-related toxicity, residual microbiological activity, and chemical toxicity. Therefore safety evaluation of all food enzymes, including those produced by genetically modified micro-organisms (GMOs), is essential in order to ensure consumer safety.
Directive 95/2/EC on food additives other than colours and sweeteners allows for the use of two enzymes as food additives: E 1103 Invertase and E1105 Lysozyme.
In addition, Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption, Council Directive 83/417/EEC relating to certain lactoproteins (caseins and caseinates) intended for human consumption and Council Regulation (EC) No 1493/1999 on the common organisation of the market in wine, regulate the use of certain food enzymes in these specific foods.
The policy objectives to be met are:
– the promotion of fair trading in food enzymes in order to ensure an efficient and internationally competitive food industry;
– the protection of human health and consumers' interest.
These objectives will contribute to the strategic objectives of the Commission as set out in the Lisbon Strategy, the Commission five year plan and the Commission's White paper of Food Safety published in 2000.
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. Some of the stakeholders consulted were:
CIAA (Confederation of the food and drink industries of the EU)
CEFIC (European Chemical Industry Council)
AMFEP (Association of Manufacturers and Formulators of Enzyme products)
ELC (Federation of European Food Additives and Food Enzymes Industries)
ISA (International Sweeteners Association)
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.
After each consultation, comments have been considered and texts have been adapted. General consensus exists on the proposal. The following points were specifically raised and comments considered as follows:
1. Harmonisation and scope of legislation:
The introduction of specific harmonising legislation on food enzymes was generally welcomed.
2. Harmonisation of safety evaluation and authorisation:
All stakeholders were generally positive to the introduction of a European wide safety evaluation and authorisation of food enzymes.
3. Labelling of enzymes on food:
Initially proposed labelling of enzymes which have no function in food raised concerns among the food industry. On the other hand some Member States and consumer's association supported more specific labelling for enzymes present in food. Revised labelling rules require specific and informative labelling for enzymes which have a technological function in the final food, but exclude from labelling enzymes which are used as processing aids.
4. Time limited authorisation:
There was a strong indication from industry that a time limited authorisation could be a barrier to innovation. On the other hand Member States and consumer organisations considered that enzyme approvals should be kept under review to ensure that they remain current. An intermediate solution is proposed where producers or users of enzymes should provide to the Commission on its request information on actual uses.
5. Transitional periods:
The proposal sets out a procedure for a smooth transition to a Community positive list. The consultation pointed out that during this transition period, industry should continue to be able to develop and market new enzymes. In order to avoid hindering innovation in this sector, the proposal now provides for additional transitional measures.
Scientific/expertise domains concerned
A 'study of the enzymes used in foodstuffs and collation of data on their safety', was generated under the scientific co-operation procedure within the legal frame of Council Directive 93/5/EEC on the assistance to the Commission and co-operation by the Member States in the scientific examination of questions relating to food (SCOOP).
Data was collected from 9 Member States on the approval systems, safety evaluation procedures and uses of enzymes in the EU.
Experts from 9 Member States and AMFEP.
The existence of potentially serious risks with irreversible consequences has not been mentioned.
The SCOOP Task Force concluded that 'A consensus was obtained to assert that, in all cases, whatever the status or the categorisation of the enzyme, a rationale for safety evaluation is necessary'.
The report was published on: europa.eu.int/comm/food/fs/scoop/7.4.1_en.pdf
The impacts expected on the different options concern economic and social aspects. Environmental impacts are not expected from the different options considered, since the industry concerned - the food industry - is involved in secondary or tertiary processing of food products. Enzymes are already widely used.
The current legal uncertainty due to the differing regulatory approaches among Member States would remain, along with the current market distortions in the trade of food enzymes. Enzyme producers would continue to seek authorisation for the same enzyme in more than one Member States which is an administrative and financial burden for industry.
Differences in risk perception, safety assessment and regulation of food enzymes among Member States would lead to different levels of consumer protection. GMO produced enzymes not covered by Regulation 1829/2003, such as microbial enzymes, would not be assessed for their safety.
Self-regulation would provide flexibility; on the other hand, food enzymes are already regulated when used as food additives by Community law and as processing aids by national legislation. This could lead to contradictory and confusing situation for the industry and negative economic impact.
A safety assessment, which is not carried out by an independent body, would not get the same level of acceptance from the public. The transparency of the procedures built in a self-regulatory system would be limited. An unclear legal situation would result in loss of consumer confidence, especially with regard to enzymes obtained from GMOs.
The harmonisation of the safety evaluation and authorisation of food enzymes, may result in higher upfront investments before market introduction of food enzymes due to the authorisation cost, estimated to be in the range of 150-250k € per enzyme. However, some Member States already have authorisation procedures in place entailing similar costs for companies that market their products in those Member States. With this proposal industry will benefit from a harmonised Community procedure with defined deadlines, instead of multiple national ones.
The proposal exempts from labelling those food enzymes used as processing aids. Food enzymes used in the same way as food additives, to exert a technological function in the final food should be labelled with their function (e.g. stabiliser etc) and specific name. This provision is unlikely to have an economic impact on businesses as only a limited number of enzymes (currently only 2 and in the future not more than a dozen) would need to be labelled. This implies no major change to the current situation.
This proposal will have a very limited impact on households. Although the costs of evaluation seem high it is unlikely that these costs will result in any significant increases in the cost which consumers pay for food.
It can be expected that the proposed comprehensive system of safety evaluation of food enzymes will have positive impacts on public health and consumer confidence.
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
- Grounds for and objectives of the proposal
- General context
- Existing provisions in the area of the proposal
- Consistency with other policies and objectives of the Union
- 2. Consultation of interested parties and impact assessment
- BEUC (The European Consumers' Organisation)
- Summary of responses and how they have been taken into account
- Collection and use of expertise
- Methodology used
- Main organisations/experts consulted
- Summary of advice received and used
- Means used to make the expert advice publicly available
- Impact assessment
- 1. No action
- 1.1 Economic impact
- 1.2 Social impact
- 2. Non-Regulatory instrument
- 2.1 Economic impact
- 2.2 Social impact
- 3. Regulatory approach
- 3.1 Economic impacts
- 3.2 Social impact
- Summary of the proposed action
- Legal basis
- Proportionality principle
- Choice of instruments
- 5. Additional information
- Simplification
- European Economic Area
- Detailed explanation of the proposal
- Chapter II - Community list of approved food enzymes
- Chapter III - Labelling
- Chapter IV - Procedural provisions and implementation
- Chapter V -Transitional and final provisions
The proposed Regulation sets the conditions of use of food enzymes, provides for the establishment of a Community list of approved food enzymes and lays down labelling rules for those enzymes. The proposal will complete the framework of GM food and feed legislation.
Article 95 of the EC Treaty
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).
In the absence of harmonisation and to the extent that there is still uncertainty in the current state of scientific research, which is particularly the case in new technology sectors such as food enzymes, it is for the Member States to decide on the level of protection of human health they wish to ensure and whether to require prior authorisation for the marketing of foodstuffs, taking into account the requirements of the free movement of goods within the Community. In terms of risk assessment, Member States often start with different scientific assumptions and may require different scientific data. Therefore, if Member States were to introduce their own legislation, that would risk creating barriers to trade and possible burdens to industry from different requirements which might arise, as well as different levels of consumer protection among Member States.
Community action will better achieve the objectives of the proposal for the following reason(s).
As food enzymes and food containing those enzymes are traded across borders, Member States cannot by themselves achieve the objectives of the proposal sufficiently. 300 food enzymes need to be managed. This requires a harmonised and centralised approach.
Efficiency of the authorisation procedure and effective functioning of the internal market with a level playing field for all economic operators will indicate that the objectives are best met by the Community action.
The proposal achieves its objectives by limiting its scope to general conditions for the safe use of food enzymes, provisions for the establishment of a Community list of food enzymes and common labelling provisions.
The proposal therefore complies with the subsidiarity principle.
The proposal complies with the proportionality principle for the following reason(s).
The proposal is a framework Regulation that sets the general rules for the safe use and authorisation of food enzymes via a Community list. In terms of consumer information, the proposal provides for a proportionate labelling of food enzymes with a limited cost for industry while at the same time offers, where necessary, sufficient information to the consumer.
The Community procedure for the safety assessment of food enzymes will have a financial and administrative impact upon the European Food Safety Authority. However, it will move the burden of safety assessment from those Member States that have currently legislation on food enzymes, and will allow them to direct their resources more towards the implementation of legislation and control activities. The financial and in particular administrative impact on economic operators will be decreased as they will have to apply for a single Community authorisation instead of multiple national ones.
Proposed instruments: regulation.
Other means would not be adequate for the following reason(s).
The provisions of this proposal are of technical nature. The use of regulation as the legal instrument for the proposal will ensure uniform and direct application of the rules for the benefit both of the consumers and of the competitiveness of the industry.
The Community may finance the establishment of a harmonised policy and system in the field of food enzymes including:
development of an appropriate database for gathering and storing all information relating to Community legislation on enzymes, undertaking of studies necessary for the preparation of legislation, for the harmonisation of procedures, for 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.
The proposal provides for simplification of administrative procedures for public authorities (EU or national), simplification of administrative procedures for private parties.
The evaluation and authorisation of food enzymes by national authorities will be replaced by a Community procedure.
Administrative burden will be decreased for private parties as they will have to apply for a single Community authorisation instead of multiple national ones.
The proposal is included in the Commission's rolling programme for up-date and simplification of the acquis communautaire and its Work and Legislative Programme under the reference 2005/SANCO/034.
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.
Chapter I - Subject matter, scope and definitions.
The proposed Regulation will apply to enzymes used for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of food, including those used as processing aids ('food enzymes'). Food enzymes shall be subject to safety evaluation and approval via a community list.
All food enzymes and their use in food will be evaluated for 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, the European Food Safety Authority (EFSA) will carry out the safety evaluations. The inclusion of a food enzyme in the Community list will be considered by the Commission on the basis of the opinion from EFSA, taking into account the other general criteria (technological need, consumer aspects). For every food enzyme included in the positive list specifications, including the criteria on purity and the origin of the food enzyme shall be laid down.
The proposed Regulation will introduce labelling requirements for food enzymes sold to the manufacturer or directly to the consumer. For the purpose of labelling, enzymes used in food should be considered as ingredients similarly to additives according to Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs. In most cases food enzymes will be used as processing aids i.e. will be present in food in the form of a residue, if at all and will have no technological effect on the finished product. Taking into account that all food enzymes will be assessed for their safety, it is proposed that food enzymes which are used as processing aids are exempted from labelling. Food enzymes used to exert a technological function in the final food, will be labelled with their function (e.g. stabiliser etc) and specific name.
Wherever necessary, producers or users of food enzymes will be obliged to inform the Commission of any new information which may affect the safety assessment of the food enzyme.
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.
Since many food enzymes are already on the market in the Community, the transition to a Community positive list should be smooth and should not lead to unfair conditions for enzyme producers. Therefore, the proposal provides for an initial period of 24 months, after the date of application of the implementing measures foreseen in the common procedure Regulation, during which applications can be submitted. The establishment of the Community list will take place in a single step procedure after the Authority has expressed opinions on all products for which sufficient information has been submitted during the 24-month period. Until the establishment of the Community list, food enzymes and food produced with food enzymes may be placed on the market and used, according to the existing national rules. A transitional period is also foreseen for the proposed labelling requirements.