Explanatory Memorandum to COM(2007)670 - 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 and Regulation 258/97 (presented by the Commission pursuant to article 250 (2) of the EC Treaty)

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2007)670 - Food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, and ...
source COM(2007)670 EN
date 24-10-2007
I. PROCEDURE

1. On 28th July 2006, the Commission adopted the proposal for a European Parliament and Council Regulation 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 [Document (COM (2006)0425 final)] as part of a package of four proposals on food improvement agents. The proposal was submitted to the Council and the European Parliament on 28th July 2006.

Contents

1.

2. The Economic and Social Committee adopted its opinion on 25th April 2007


3. The Council has agreed a ‘general approach’ on the proposal at the EPSCO meeting on 31st May 2007.

4. The European Parliament has given in first reading a favourable opinion on the proposal on 9 July 2007.

5. The present proposal amends the original proposal [COM (2006)0425 – 2006/0144(COD)] so as to take into account the amendments of the European Parliament that were accepted by the Commission.

With regard to the original proposal, the European Parliament adopted 33 amendments. Commissioner Kyprianou had indicated to the plenary meeting on 9 July 2007 that the Commission could accept most of the amendments, wholly or in part, and subject to rewording. From the adopted amendments the following cannot be accepted by the Commission: 6, 9, 13, 16, 32, 37, 38.

The amendments in the revised proposal are in bold and underlined . A number of amendments have been reformulated so as to ensure consistency of the terminology used throughout the proposal and the other proposals of the package, or to bring the text in line with the approach of the Council with regard to similar amendments.

The numbering of the Articles has been adapted to take into account a number of amendments. Within certain Articles, the numbering of the paragraphs has been adapted in order to take into account the addition or deletion of elements in the Commission proposal.

2.

II. OBJECTIVES OF THE PROPOSAL


6. 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.

7. Currently the scope of Directive 89/107/EEC only covers enzymes used as food additives. The remaining enzymes are not regulated at all or are regulated as processing aids under the legislation of the Member States, which is diverse. 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. The proposal aims to establish harmonised rules for food enzymes at Community level, in order to promote fair trading and effective functioning of the internal market and to ensure protection of human health and consumers' interest.

3.

III. OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT


4.

8. Technical/editorial amendments


Amendments 2, 8, 10 and 17 aim to improve the proposal from a technical and editorial point of view and have been taken over by the Commission, in some cases subject to some editorial changes. Amendment 19 was partially accepted.

Amendment 31 amends Regulation (EC) No 258/97 on novel foods in order to clarify that food enzymes which are covered by the proposed Regulation on food enzymes will be excluded from the scope of the novel food Regulation.

5.

9. Legal basis


Amendment 35 deletes Article 37 of the Treaty from the legal basis of the proposed Regulation. Since the agricultural aspects of the proposal (amendments to vertical agricultural texts) are only secondary objectives of the proposed Regulation, the deletion of Article 37 has been endorsed in the amended proposal.

6.

10. Scope (Article 2)


Amendments 3, 11 and 12 aim to clarify that the proposal does not apply to food enzymes intended for direct human consumption, such as enzymes for nutritional purposes or enzymes used as digestive aids. The principle of these amendments is in line with the Commission proposal. As these enzymes are not added to food to perform a technological function, they are not covered by the definition of food enzymes. However, the text proposed under amendment 11 is not well placed under Article 2 i and the proposed exclusion is better covered by amendment 12. Therefore, amendment 11 is redundant and not taken on board in the amended proposal.

With regard to amendment 12, the Commission retains the exclusion of cultures that are ‘traditionally’ used in the production of foods such as cheese, wine etc. and which may incidentally produce enzymes. The deletion of the word traditionally would enlarge the scope of the exclusion and could result in cultures, which are added to food for the technological function of the enzyme that they produce (e.g. preservation), not being regulated.

7.

11. Definitions (Article 3)


Amendment 14 introduces some new definitions. The definitions of ‘ enzyme’ and ‘food enzyme preparation’ are incorporated with some editorial changes in the amended proposal.

However the definition of produced by GMOs is not necessary for the scope of the proposed Regulation which covers all food enzymes regardless of falling or not within the scope of Regulation (EC) No 1829/2003. Such definition relates to genetically modified (GM) food in general and it is therefore not appropriate to add this definition in the proposed sector specific Regulation on food enzymes.

The definition of ‘ quantum satis ’ is laid down in the definitions of the proposal on food additives. Since all definitions of food additives apply also for food enzymes, its repetition in the proposal on food enzymes is not necessary.

8.

12. Prohibition of non-compliant food enzymes (Article 5)


Amendment 15 aims to clarify that a food enzyme or a food in which an enzyme is used should not be placed on the market, if the enzyme or its use do not comply with the proposed regulation. This clarification is endorsed in the amended proposal.

9.

13. General criteria for inclusion and use of food enzymes in the Community list (Article 6)


The Commission proposal sets criteria for the authorisation of food enzymes. Enzymes must be safe; there must be a technological need for their use; and their use must not mislead the consumer.

Amendment 4, second part introduces clarification of what is meant by misleading the consumer. This part of amendment 4 is included in the amended proposal.

Amendments 6 and 16 require the authorisation of food enzymes to be based on the precautionary principle. The precautionary principle and the conditions for its application are already laid down in the General Food Law (Regulation (EC) No 178/2002) and it should not be repeated here.

Amendments 4 and 16 also require food enzymes to bring a clear benefit to the consumer in order to be authorised. Most enzymes are used as processing aids. Such uses can improve the environmental performance of production processes, through lower energy consumption, less raw materials, fewer waste and better biodegradability. This cannot always be translated into a direct benefit to the consumer, although there is an indirect benefit from the environmental advantage. These provisions have not been taken over by the Commission.

10.

14. Relation with Regulation (EC) No 1829/2003 on GM food and feed (Article 9) and Regulation (EC) No 1830/2003 (Article 7)


The Commission proposal aimed to cover all food enzymes including those produced from genetically modified organisms (GMOs) or by fermentation using genetically modified micro-organisms (GMMs). Food enzymes which fall within the scope of Regulation (EC) No 1829/2003, i.e. enzymes produced from GMOs, will be also subject to that Regulation with regard to the safety assessment of the genetic modification, while the other aspects of safety and the final authorisation will be dealt with under the enzymes Regulation. The two evaluations and authorisations can run in parallel.

Amendments 7 and 34 clarify that the two procedures can run simultaneously in accordance with good administrative practice. The proposed clarification is endorsed by the Commission, subject to some drafting changes in order to make the provision more compatible with Regulation (EC) No1829/2003.

The Commission proposal also aimed to ensure that the unique identifier attributed to a GMO in accordance with Regulation (EC) No 1830/2003 should be included in the specifications of the enzyme produced from the GMO.

Amendments 18 and 38 aim to clarify this provision, however the proposed wording is not compatible with Regulation (EC) No 1830/2003. The Commission accepted in principle the proposed clarification, however the wording was changed in order to make it consistent with that Regulation.

15. Comitology (Article 2§5, Article 15 and Article 17)

Since the proposal was adopted around the time that Decision 2006/512/EC amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission was adopted, the Commission proposal referred to the normal regulatory procedure. Therefore the alignment of the amended proposal with Decision 2006/512/EC is generally endorsed by the Commission. Amendments 10, 28 and 30 are acceptable.

However amendment 13 introduces the regulatory procedure with scrutiny for deciding whether or not a given substance falls within the scope of the Regulation. The application of this provision is an implementation of the rules contained in the basic act ('food enzyme' definition) and therefore does not fall within the regulatory procedure with scrutiny. The normal regulatory procedure should therefore apply.

11.

16. 10-year review


Amendment 9 introduces a regular review of the evaluation and authorisation of all food enzymes every 10 years. Such requirement would impose a significant administrative burden. For reasons of proportionality and since the proposal already provides that substances will be under continuous observation and be evaluated whenever necessary in the light of new scientific or technological information, this amendment was not taken up in the amended proposal.

12.

17. Fast track authorisation (Article 17)


Amendment 29 provides for enzymes which are currently on the market to be transferred directly to the Community list, if the European Food Safety Authority (EFSA) is satisfied with the previous safety assessment carried out at Community or national level.

EFSA is the risk assessment body in the Community. An automatic transfer of food enzymes into the Community list, without a previous evaluation by EFSA is not appropriate. As part of usual practice, when EFSA evaluates substances they consider any relevant scientific assessments undertaken by other bodies. The Commission has introduced in the amended proposal wording to clarify that EFSA could consider existing opinions as part of their evaluation.

13.

18. Labelling (Articles 10 to 13 and Article 22)


Labelling of food enzymes sold from business to business or to the final consumer

Amendments 21-27 aim to ensure a new presentation and simplification of the labelling provisions for food enzymes sold from business to business or to the final consumer. The Commission has taken over the main ideas of these amendments but re-drafted the text so as to take into account similar amendments of the Council and to ensure coherence with the other proposals of the Food Improvement Agents package.

However, the provision of amendment 21 requiring information on the “side-effects of their use in excessive quantities” is not relevant, as food enzymes will be evaluated for their safety by EFSA and any side effects would be taken into account when authorising the food enzyme, if necessary, with appropriate conditions of use that should be respected by all operators. This provision is therefore not accepted.

In addition, amendment 21 requires that food enzymes should be added to foods only in a dose which is strictly necessary in order to achieve the purpose for which they are used. This is the quantum satis principle which is in line with the Commission proposal. It was therefore introduced in the amended proposal, subject to redrafting and under Article 7 relating to the content of the Community list of food enzymes .

With regard to the labelling of food enzymes intended for sale to the final consumer, these are considered food and must comply with the relevant labelling provisions of Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs. Therefore, Article 12 was further simplified so as not to repeat the provisions of Directive 2000/13/EC.

Amendment 37 requires labelling of the technological function of food enzymes sold directly to the final consumer. Directive 2000/13/EC already provides that on the label of a food, including a food enzyme, instructions for use should be included. This information will be more useful for the consumer than a technical description of the function of the enzyme which could lead to confusion and misunderstanding. Therefore, this amendment is not accepted.

14.

Labelling of food enzymes in food


Most food enzymes are used as processing aids in the production of food and they are present in food in the form of a residue, if at all, and have no technological function on the finished product. Taking into account that all food enzymes will be assessed for their safety, the Commission proposal provided for an exception from labelling of food enzymes which are used as processing aids. Food enzymes used to exert a technological function in the final food would be labelled with their function (e.g. stabiliser etc.) and specific name.

Amendment 32 introduces labelling of all food enzymes present in the final food, irrespective of the level of residues and whether they continue to function or not. The labelling should also indicate whether the enzymes are still active or not in the final product.

Amendment 37 requires information about all food enzymes used in the production process to be made available to consumers, if not on the label at least through other information channels. Both amendments are not compatible with Directive 2000/13/EC which excludes from labelling processing aids, i.e. substances which are present in the final product only as technically unavoidable residues and do not have any technological effect on the finished product. Labelling of food enzymes used as processing aids would be therefore disproportionate. In addition labelling of food enzymes on food as active or inactive, may give misleading information to the consumer as to what is meant by active or inactive, e.g. it could be associated with a nutritional effect.

With regard to labelling of GMOs, Article 12 of Regulation 1829/2003 already provides for labelling of food, including food enzymes, produced from GMOs. Therefore the inclusion here is redundant.

Therefore, amendments 32 and 37 are not accepted by the Commission.

15.

19. Transitional measures (Article 18)


Amendment 36 introduces transitional measures for food enzymes, food enzyme preparations and food containing food enzymes which were put on the market or labelled before the date of application of the proposed Regulation. Such provision is appropriate and the amendment has been endorsed in the Commission amended proposal.

16.

20. Changes in production process or starting materials of a food enzyme (Article 8)


The amended Commission proposal includes a new Article 8 introducing requirements for food enzymes already included in the Community list which are prepared by production methods or starting materials significantly different from those included in the risk assessment of the Authority. This Article reflects the principle in recital i of the Commission proposal and keeps consistency with the proposal on food additives, where the same text has been introduced in order to address an amendment concerning nano substances.

21. Pursuant to Article 250 i of the EC-Treaty, the Commission amends it proposal in accordance with the lines set out above.