| Published date | 31 December 2008 |
| Subject Matter | Internal market - Principles,Foodstuffs,Approximation of laws |
| Official Gazette Publication | Official Journal of the European Union, L 354, 31 December 2008 |
Consolidated TEXT: 32008R1332 — EN — 03.12.2012
2008R1332 — EN — 03.12.2012 — 001.001
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
Amended by:
| | | Official Journal |
| No | page | date |
| ►M1 | COMMISSION REGULATION (EU) No 1056/2012 of 12 November 2012 | L 313 | 9 | 13.11.2012 |
▼B
REGULATION (EC) No 1332/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 December 2008
on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee ( 1 ),
Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 2 ),
Whereas:
| (1) | 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. |
| (2) | A high level of protection of human life and health should be assured in the pursuit of Community policies. |
| (3) | Food enzymes other than those used as food additives are not currently regulated or are regulated as processing aids under the legislation of the Member States. Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of food enzymes may hinder their free movement, creating conditions for unequal and unfair competition. It is therefore necessary to adopt Community rules harmonising national provisions relating to the use of enzymes in foods. |
| (4) | This Regulation should only cover enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids (hereinafter referred to as food enzymes). The scope of this Regulation should therefore not extend to enzymes that are not added to food to perform a technological function but are intended for human consumption, such as enzymes for nutritional or digestive purposes. Microbial cultures traditionally used in the production of food such as cheese and wine, and which may incidentally produce enzymes but are not specifically used to produce them, should not be considered food enzymes. |
| (5) | Food enzymes used exclusively in the production of food additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ( 3 ) should be excluded from the scope of this Regulation, since the safety of these foods is already assessed and regulated. However, when these food enzymes are used as such in food, they are covered by this Regulation. |
| (6) | Food enzymes should be approved and used only if they fulfil the criteria laid down in this Regulation. Food enzymes must be safe when used, there must be a technological need for their use and their use must not mislead the consumer. 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. The approval of food enzymes should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary principle and the feasibility of controls. |
| (7) | Some food enzymes are permitted for specific uses, such as in fruit juices and certain similar products and certain lactoproteins intended for human consumption, and for certain authorised oenological practices and processes. The use of such food enzymes should comply with this Regulation and with the specific provisions laid down in the relevant Community legislation. Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption ( 4 ), Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) intended for human consumption ( 5 ) and Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine ( 6 ) should therefore be amended accordingly. Since all food enzymes should be covered by this Regulation, Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients ( 7 ) should be amended accordingly. |
| (8) | Food enzymes the use of which is permitted within the Community should appear in a Community list that should clearly describe the enzymes and specify any conditions governing their use, including where necessary information on their function in the final food. This list should be supplemented by specifications, in particular on their origin, including where relevant information about allergenic properties, and purity criteria. |
| (9) | In order to ensure harmonisation, the risk assessment of food enzymes and their inclusion in the Community list should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings ( 8 ). |
| (10) | Under 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 ( 9 ), the European Food Safety Authority (hereinafter referred to as the Authority) is to be consulted on matters likely to affect public health. |
| (11) | A food enzyme which falls within 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 ( 10 ) should be authorised in accordance with that Regulation as well as under this Regulation. |
| (12) | A food enzyme already included in the Community list under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the Authority, or different from those covered by the authorisation and the specifications under this Regulation, should be submitted for evaluation by the Authority. ‘Significantly different’ could mean inter alia a change of the production method from extraction from a plant to production by fermentation using a micro-organism or a genetic modification of the original micro-organism, a change in starting materials, or a change in particle size. |
| (13) | Since many food enzymes are already on the Community market, provision should be made to ensure that the switchover to a Community list of food enzymes takes place smoothly and does not disturb the existing food enzyme market. Sufficient time should be allowed for applicants to make available the information necessary for the risk assessment of these products. An initial two-year period should therefore be allowed following the date of application of the implementing measures to be laid down in accordance with Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], in order to give applicants sufficient time to submit the information on existing enzymes which may be included in the Community list to be drawn up under this Regulation. It should also be possible to submit applications for the authorisation of new enzymes during the initial two-year period. The Authority should evaluate without delay all applications for food enzymes for which sufficient information has been submitted during that period. |
| (14) | In order to ensure fair and equal conditions for all applicants, the Community list should be drawn up in a single step. That list should be established after completion of the risk assessment of all food enzymes for which sufficient information has been submitted during the initial two-year period. However, the risk assessments of the Authority for individual enzymes should be published as soon as they are completed. |
| (15) | A significant number of applications is expected to be submitted during the initial two-year period. A lengthy period may therefore be needed before the risk assessment of these has been completed and the Community list is drawn up. In order to ensure equal access to the market for new food enzymes after the initial two-year period, a transitional period should be provided for during which food enzymes and food using food enzymes may be placed on the market and used, in accordance with the existing national rules in the Member States, until the Community list has been drawn up. |
| (16) | The food enzymes E 1103 Invertase and E 1105 Lysozyme, that have been authorised as food additives under Directive 95/2/EC of the European Parliament and of the |
...
Get this document and AI-powered insights with a free trial of vLex and Vincent AI
