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This Regulation harmonises at Community level the national provisions relating to the use of enzymes in foodstuffs. Its objective is to ensure the smooth operation of the internal market while guaranteeing a high level of protection for human health and consumers. This Regulation aims to create a list of authorised enzymes, to lay down the conditions for the use of food enzymes and to define rules for their labelling.
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.
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 concerning the assessment and authorisation of food enzymes may hinder their free movement within the internal market by distorting the rules of competition.
This Regulation lays down the rules on food enzymes used in foods, including such enzymes used as processing aids. It does not cover food enzymes used in the production of food additives falling within the scope of Regulation (EC) No 1333/2008, or those used in the production of processing aids.
Community list of food enzymes
The creation of a list of authorised enzymes will make it possible to harmonise at European level all enzymes used as food additives. This list shall include all enzymes which perform a technological function in foods such as invertase (E 1103), lysozyme (E 1105), urease and betaglucanase.
The establishment of the positive list of food enzymes will benefit the consumer because the list will lay down common rules for the assessment and authorisation of these products.
The list shall be established on the basis of the applications for authorisation submitted to the Commission. A period of 24 months shall be allowed for the submission of applications with effect from the entry into force of the implementing measures for Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. These applications shall be forwarded to the European Food Safety Authority (EFSA).
Only the enzymes mentioned in the Community list may be placed on the market and added to food.
The list of enzymes should include:
- the name of the enzyme;
- its specifications (including its origin, purity criteria, etc.);
- the foods to which it may be added;
- the conditions under which it may be used;
- restrictions on its sale;
- specific labelling requirements.
Conditions for the inclusion of food enzymes in the Community list
An enzyme may be included in the Community list if and only if:
- it does not pose a concern to the health of the consumer, in the concentration used and on the basis of the existing scientific information;
- its use is justified by a technological need;
- its use does not mislead the consumer.
Labelling of food enzymes intended for sale to the final consumer
The labelling of food enzymes intended for sale to the final consumer should comply with the general conditions for labelling laid down in Directive 2000/13/EC. It should also include:
- the name of the food enzyme or the accepted name laid down in the nomenclature of the International Union of Biochemistry and Molecular Biology (IUBMB);
- the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its intended food use.
The information should be easily visible, clearly legible, indelible and written in a language easily understood by the consumer.
Entry into force
This Regulation shall enter into force on 20 January 2009.
Article 4 shall apply with effect from the date of application of the Community list. Until that date, national provisions in force concerning the placing on the market and use of food enzymes and food produced with food enzymes shall continue to apply in the Member States.
Articles 10 to 13 shall apply with effect from 20 January 2010.
This Regulation is part of the reform launched by the European Commission in order to simplify the existing legislation on food additives, food flavourings and food enzymes. This reform has led to the drafting of new legislation based on four Regulations:
Key terms of the Act
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1332/2008||
OJ L 354 of 31.12.2008
Further information is available on the website of the Directorate-General for Health and Consumers.