20.7.2007   

EN

Official Journal of the European Union

C 168/34

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Proposal for a Regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings

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Proposal for a Regulation of the European Parliament and of the Council on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, and Council Directive 2001/112/EC

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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 and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC

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Proposal for a Regulation of the European Parliament and of the Council on food additives

1.1

The Committee welcomes the package of proposals on additives, enzymes and flavourings and on common authorisation procedures, in the context of an effective and competitive internal market that ensures a high level of protection for human life and health.

1.2

The Committee believes that a series of clear and harmonised rules on the way safety assessments are carried out, with definite timeframes and reasonable costs, is of benefit to consumers and producers alike, particularly small-scale producers.

1.3

The Committee welcomes the Commission's plan to simplify and harmonise the additives, flavourings and enzymes sectors and to promote consistency between them by adopting a single common procedure for their approval.

1.4

In the Committee's view, while the possibility of a single authorisation procedure for the entire EU may be of great benefit to the single market in the medium to long term, consideration must nevertheless be given to the impact of the new regulations on imported products.

1.4.1

Europe is in constant competition on the global market in terms both of exports and imports, and the rules proposed are in many cases more burdensome than those laid down by the Codex Alimentarius, potentially distorting competition to the detriment of European companies, small ones in particular.

1.5

The Committee welcomes the choice of procedure, namely that of submitting changes to the Community list to the comitology process, providing that there are high levels of transparency, constant dialogue with producers and consumers and swift mechanisms for innovation and product development.

1.6

The Committee supports the bolstering of the work of the EFSA (European Food Safety Authority), in order to promote transparent risk assessment based on scientific data and objective reasoning, with a view to protecting consumers.

1.7

The Committee recommends fleshing out the procedures and human and financial resources available to the EFSA, with a view to ensuring high quality, transparent and independent assessments, with full respect for confidentiality.

1.8

The Committee also believes it would be worthwhile stepping up the monitoring done by Member States on the consumption and use of additives, enzymes and flavourings, by means of effective methodologies incorporating data supplied by industry.

1.9

The Committee is in favour of a periodical review of the positive lists of additives, enzymes and flavourings, providing this is based on an ongoing structured dialogue with consumers and producers and does not generate an additional burden in terms of time and money.

2.1

Scientific and technological advances offer better quality food products thanks, not least, to the use of small quantities of enzymes, flavouring and additives. These advances also provide means of ensuring that such substances are not used inappropriately.

2.2

In its White Paper on Food Safety, on which the Committee issued an opinion (1), the Commission announced its intention to update and flesh out existing legislation on additives and flavourings and to prepare specific provisions on enzymes (White Paper — actions 11 and 13), in the context of work to improve Community legislation on the basis of the ‘farm to table’ principle.

2.3

The Committee has always supported the objective of securing the smooth running of the internal market, while also ensuring a high level of protection for human life and health, and has repeatedly supported the need to adopt a global and integrated approach to food safety in the EU.

2.4

In the Committee's view, ‘The European food chain must be legislated in its entirety — from “farm to table”. Each link in the food chain must be as strong as the next and the Commission should assure reliable enforcement of Community legislation’ (2).

2.5

The adoption of a common procedure for the approval of enzymes, flavourings and additives is a key innovation in the Commission's package of proposals and the Committee welcomes the plan to simplify and harmonise these sectors. This will do away with multiple authorisation procedures by individual Member States, remove parallel authorisation systems and considerably reduce administrative burdens and red tape.

2.6

Legislation on food additives has already been harmonised at European level. Presently, there are around 330 food additives permitted under the legislation, and requests to allow additional additives or new uses of additives continue to abound.

2.6.1

Sufficiently detailed information on the use and properties of the substances concerned is required when evaluating these requests, particularly for decisions that relate to risk management.

2.7

Harmonising procedures for flavourings and enzymes will make for more streamline authorisation procedures, cutting the cost of updating technical data sheets and of changing labelling.

2.8

The current legal uncertainty resulting from differences in national legislation on food enzymes is threatening to distort the market for food enzymes and increase the administrative and financial burden in the various Member States. Furthermore, in the absence of a harmonisation initiative, there will continue to be differences in protection levels, owing to the differences between the Member States when it comes to risk perception, safety assessment and legislation on food enzymes.

2.8.1

It should be noted that while the absence of EU-level harmonised rules threatens to pose obstacles to the free movement of goods and to trade in the industry, harmonisation — both of safety assessments and of the authorisation of food enzyme use — could entail a major investment, owing mainly to the cost of authorisations, estimated to be in the order of EUR 150-250 000 (3) per enzyme.

2.8.2

The food enzymes industry is continually developing technologies and processes to innovate and improve food production. It should not, however, underestimate the possible chemical risks in terms of allergies, toxicity and residual microbiological activity. These potential risks require ongoing consumer safety assessments, in particular regarding enzymes from genetically modified organisms.

2.9

As regards legislation on flavourings and certain food ingredients with flavouring properties destined for use in and on food products, a more efficient authorisation procedure is needed for the management of a ‘positive list’ containing approximately 2 600 flavouring products.

2.9.1

Harmonisation of the legislation on flavourings will clearly put the European Union in a stronger position in negotiations with third countries, as the flavourings will have to be entered into the Codex Alimentarius system, not least in order to prevent European companies, SMEs in particular, from being penalised.

2.9.2

By creating a uniform and integrated market for flavourings in the EU, the European industry will be able to maintain its leading position as a producer and developer of flavourings.

2.9.3

On the other hand, the additional work that will be required to meet the new standards on flavouring labelling should not be underestimated.

2.10

The Committee believes that the European Food Safety Authority should be given more resources and means and that new procedures should be devised to ensure an independent, transparent and high quality assessment of the safety of additives, enzymes and flavourings.

2.11

The shift from decision-making based on co-decision with the European Parliament to the comitology procedure, using committees for authorisations, will demand clear and transparent criteria for the safety assessment of claimed benefits to consumers.

2.12

As the Committee has already stressed in previous opinions (4), in order to be able to evaluate progress on food safety matters and to judge whether the new system is living up to its expectations, there is a need for assessment criteria, such as increased/decreased consumer confidence, the occurrence and handling of food crises, closer cooperation between stakeholders, etc.

3.1

The package of proposals put forward by the Commission is designed to clarify existing legislation on food additives and food flavourings and introduces new rules on enzymes. A further proposal aims to establish common procedures for authorisations in all three sectors on the basis of scientific opinions given by the European Food Safety Authority (EFSA).

3.2

Additives The new rules are designed to simplify and pare down the authorisation system for food additives, currently governed by Directive 89/107/EEC. Authorisations for the inclusion of additives in the new positive list would be based on a food safety risk assessment by the EFSA, in accordance with Regulation 178/2002/EC. There is also a proposal for a review of the technical aspects of the current authorisation system and new harmonised Community provisions are set out for additives used in other additives.

3.3

Enzymes A new legislative framework is proposed for the assessment, approval and monitoring of food enzymes and for the establishment of a positive list of all enzymes with a technological function in the final food, on the basis of a favourable scientific opinion from the EFSA. There are also provisions for the labelling of food enzymes, with the exception of those used as processing aids.

3.4

Flavourings Provision is made for a review of the general rules established by Directive 88/388/EEC, bringing them up to date with technological and scientific developments. The directive will be replaced by a new regulation, setting out clearer rules on:

3.5

Common authorisation procedure The proposal suggests introducing a common authorisation procedure for food additives, food flavourings and food enzymes, based on risk assessments conducted by the European Food Safety Authority and a risk management system. The authorisation stages involve the Member States and the Commission within the framework of a regulatory committee procedure. The proposal gives the Commission the task of drafting and updating various ‘positive lists’, one for each category of substance concerned, on the basis of the EFSA's scientific assessments. The inclusion of a substance on one of these lists means that its use has been authorised on a general level and for all operators on the Community market.

4.1

For the most part, the Committee welcomes the Commission's proposals, providing there are safeguards for the efficiency and competitiveness of the internal market and a guaranteed high level of protection for human life and health.

4.2

The Committee considers that the proposed instrument — a regulation — will provide a better guarantee than would a directive, as the latter would allow for differing interpretations regarding the implementation of the rules.

4.3

The possibility of obtaining a single authorisation valid for the entire European Union may, in the Committee's view, be highly advantageous to the internal market in the medium to long term.

4.3.1

Consideration must, however, be given to the impact of the new regulations on imported products and to the fact that Europe is a major importer competing on the global market, as the Community rules are more burdensome than those currently set out in the Codex Alimentarius. The Codex should therefore be amended, to prevent European companies from being penalised.

4.4

The Commission's choice of the comitology procedure for amending the Community list may prove to be a positive step, both for industry and for civil society, on condition that high levels of transparency are ensured and it remains possible to keep step with innovation and the development of new and improved products, not least in the fight against allergies.

4.5

The Committee welcomes the fact that the EFSA's risk assessments are to be based on transparent procedures, scientific data and objective reasoning.

4.6

The new responsibilities entrusted to the EFSA should be matched by more robust procedures and human and financial resources, with a view to ensuring high quality, transparent and independent assessments, with full respect for confidentiality.

5.1.1

The Committee believes that the implementing measures, including the content, drafting and presentation of the application, arrangements for checking the validity of applications and the type of information, as set out in Article 9, should be included in the EFSA's opinion.

5.1.2

As regards updating the Community list, the deadlines for the authorisation system should be shorter, cutting the time taken by the Commission to issue its draft regulation from nine to three months, so as to enable the entire examination and approval cycle to be completed within 12 months.

5.1.3

Similarly, the possibility offered by Article 10 for the EFSA or the Commission to extend the assessment period in certain cases should not be open-ended. A maximum period should be specified in the regulation.

5.1.4

The Committee believes that the common authorisation procedure should provide for a periodical review and update of the lists, at a limited cost and effort and on the basis of an ongoing structured dialogue with producers and consumers.

5.1.5

Under no circumstances should the Community authorisation system be used to justify the creation of technical barriers to trade. Costly tests and certification procedures for imports and exports should not therefore be allowed.

5.2.1

The criteria of ‘reasonable technological need’ and ‘advantages and benefits for the consumer’ (Article 5) need further clarification.

5.2.2

The information provided in the labelling mentioned in Article 20 must be clearly comprehensible and recognisable to the general public and uniform throughout the Community.

5.3.1

The Committee welcomes the fact that all food enzymes with a technological function are covered by the regulation and will be subject to approval before being added to the Community's positive list.

5.3.2

The Committee believes that the assessment criteria for enzymes should include ‘advantages and benefits for the consumer’ in the same way as for additives.

5.3.3

With regard to labelling, the Committee would stress the need for clarity and uniformity at Community level, without unnecessary complexities, for the benefit of producers and consumers alike.

5.3.4

The Committee believes that use of positive lists in vertical legislation should be avoided as that would create a double authorisation system for the same enzymes. Previous directives and regulations must be modified as soon as possible in order to make uniform reference to the new regulation.

5.4.1

In the Committee's view, the assessment criteria should mirror those set out for additives, including ‘advantages and benefits for the consumer’.

5.4.2

The Committee would underline the need for clearer information for consumers, as set out in Article 14 regarding the nature and origin of food flavourings.