Considerations on COM(2007)671 - 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 (presented by the Commission pursuant to Article 250 (2) of the EC Treaty) - Main contents
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| dossier | COM(2007)671 - Flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation ... |
|---|---|
| document | COM(2007)671  |
| date | October 24, 2007 |
2. Council Decision 88/389/EEC of 22 June 1988 on the establishment, by the Commission, of an inventory of the source materials and substances used in the preparation of flavourings[4] provides for the establishment of that inventory within 24 months of its adoption. That Decision is now obsolete and should be repealed.
3. Commission Directive 91/71/EEC of 16 January 1991 completing Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production[5] lays down rules on the labelling of flavourings. These rules are being replaced by the present Regulation and the Directive should now be repealed.
4. The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well being of citizens and to their social and economic interests.
5. In order to protect human health the scope of this Regulation should cover flavourings, source materials for flavourings and foods containing flavourings. It should also cover certain food ingredients with flavouring properties which are added to food for the main purpose of adding flavour and which contribute significantly to the presence in food of certain naturally occurring undesirable substances (‘food ingredients with flavouring properties’), their source material and foods containing them.
6. Flavourings and food ingredients with flavouring properties may only be used if they fulfil the criteria laid down in this Regulation. They must be safe when used, and certain flavourings should, therefore, undergo a risk assessment before they can be permitted in food. They should not mislead the consumer and their presence in food should, therefore, always be indicated by appropriate labelling. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product.
7. Since 1999, the Scientific Committee on Food and subsequently the European Food Safety Authority has expressed opinions on a number of substances occurring naturally in source materials for flavourings and food ingredients with flavouring properties[6] which, according to the Committee of Experts on Flavouring Substances of the Council of Europe, raise toxicological concern. Substances for which the toxicological concern was confirmed by the Scientific Committee on Food should be regarded as undesirable substances which should not be added as such to food.
8. Due to their natural occurrence in plants, undesirable substances might be present in flavouring preparations and food ingredients with flavouring properties. The plants are used traditionally as food or food ingredients. Appropriate maximum levels should be established for the presence of these undesirable substances in foods which contribute most to the human intake of these substances, taking into account both the need to protect human health and their unavoidable presence in traditional foods.
9. Provisions should be established at Community level in order to prohibit or restrict the use of certain plant or animal materials which raise concern for human health in the production of flavourings and food ingredients with flavouring properties and their applications in food production.
10. Risk assessments should be carried out by the European Food Safety Authority, hereinafter referred to as “the Authority”, 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[7].
11. In order to ensure harmonisation, the risk assessment and approval of flavourings and source materials that need to undergo an evaluation should be carried out in accordance with the procedure laid down in Regulation (EC) No […]establishing a common approval procedure for food additives, food enzymes and food flavourings[8].
12. Flavouring substances are chemically defined substances with flavouring properties. An evaluation programme of flavouring substances is ongoing in accordance with 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[9]. Under that Regulation a list of flavouring substances is to be adopted within five years of adoption of that programme. A new deadline should be set for the adoption of that list. That list will be proposed for inclusion in the list referred to in Article 2(1) of Regulation (EC) No […].
13. Flavouring preparations are flavourings other than chemically defined substances obtained from materials of vegetable, animal or mineral origin, by appropriate physical, enzymatic or microbiological processes, either in the raw state of the material or after processing for human consumption. Flavouring preparations produced from food do not need to undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of flavouring preparations produced from non-food material should be evaluated prior to approval.
14. Regulation (EC) No 178/2002 defines food as any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Materials of vegetable, animal or microbiological origin, for which hitherto there is significant evidence of use for the production of flavourings, are considered as food materials for this purpose, even though some of these source materials, such as rose wood, oak wood chips and strawberry leaves, may not have been used for food as such. They do not need to be evaluated.
15. Likewise, thermal process flavourings produced from food under authorised conditions need not undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of thermal process flavourings produced from non-food material or produced under non-authorised conditions should be evaluated prior to approval.
16. Regulation (EC) No 2065/2003/EC of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods[10], lays down a procedure for the safety assessment and approval of smoke flavourings and aims to establish a list of primary smoke condensates and primary tar fractions the use of which is authorised to the exclusion of all others.
17. Flavour precursors impart flavour to food by chemical reactions occurring during food processing. Flavour precursors produced from food do not need to undergo an evaluation or an approval procedure for use in and on foods unless there is doubt about their safety. However, the safety of flavour precursors produced from non-food material should be evaluated prior to approval.
18. Other flavourings which do not fall under the definitions of the previously mentioned flavourings may be used in and on foods after they have undergone an evaluation and approval procedure.
19. Material of vegetable, animal, microbiological or mineral origin other than food may only be authorised for the production of flavourings after its safety has been evaluated scientifically. It might be necessary to authorise the use of only certain parts of the material or to set conditions of use.
20. A flavouring or a source material which falls under the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed[11] should be subject to the authorization procedure under that Regulation with regard to the safety assessment of the genetic modification, while the final authorization should be granted under this Regulation. authorised according to that Regulation, prior to its approval under this Regulation.
21. Flavouring substances or flavouring preparations should only be labelled as ‘natural’ if they comply with certain criteria which ensure that consumers are not misled.
22. Specific information requirements should ensure that consumers are not misled concerning the source material used for the production of natural flavourings. The source of vanillin obtained from wood will, for example, have to be mentioned.
23. Flavourings should remain subject to the general labelling obligations as provided for in Directive 2000/13/EC and, where appropriate, in Regulation (EC) No 1829/2003. In addition, specific provisions on labelling of flavourings sold as such to the manufacturer or to the final consumer should be included in this Regulation.
24. Consumers should be informed if the smoky taste of a particular food is due to the addition of smoke flavourings. In accordance with Article 5 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs[12], the name under which the product is sold should not confuse the consumer as to whether the product is smoked conventionally with fresh smoke or treated with smoke flavourings. This Directive needs to be adapted to the definitions of flavourings, smoke flavourings and the term ‘natural’ for the description of flavourings laid down in the present Regulation.
25. For the evaluation of the safety of flavouring substances for human health, information on the consumption and use of flavouring substances is crucial. The amounts of flavouring substances added to food should therefore be checked on a regular basis.
26. The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[13].
27. In particular power should be conferred on the Commission to amend the Annexes to this Regulation and to adopt appropriate transitional measures regarding the establishment of the Community list . Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, and/or to supplement it by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
28. Annexes II to V to this Regulation should be adapted to scientific and technical progress.
29. In order to develop and update Community legislation on flavourings in a proportionate and effective way, it is necessary to collect data, share information and coordinate work between Member States. For that purpose, it may be useful to undertake studies to address specific issues with a view to facilitating the decision-making process. It is appropriate that the Community finance such studies as part of its budgetary procedure. The financing of such measures is covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules[14] and consequently the legal basis for the financing of the above measures will be Regulation (EC) No 882/2004.
30. Pending the establishment of the Community list, provision should be made for the evaluation and approval of flavouring substances which are not covered by the evaluation programme provided for in Regulation (EC) No 2232/96. A transitional regime should therefore be laid down. Under that regime such flavouring substances should be evaluated and approved in accordance with the procedure laid down in Regulation (EC) No [procedural Regulation]. However the time periods provided for in that Regulation for the Authority to adopt its opinion and for the Commission to submit a draft Regulation updating the Community list to the Standing Committee on the Food Chain and Animal Health should not apply, because priority should be given to the ongoing evaluation programme.
31. Since the objective of the action to be taken, namely to lay down Community rules on the use of flavourings and certain food ingredients with flavouring properties in and on foods, cannot be sufficiently achieved by the Member States and can therefore, by reason of market unity and high level of consumer protection, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
32. Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks[15] and Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails[16] need to be adapted to certain new definitions laid down in the present Regulation.
33. Regulations (EEC) No 1576/89, (EEC) No 1601/91 and (EC) No 2232/96 and Directive 2000/13/EC should be amended accordingly.