This Regulation replaces previous directives and decisions concerning food additives permitted for use in foods. Its aim is to harmonise the use of food additives in foods, or in other additives or food enzymes, at Community level. The new Regulation simplifies the approval procedure for food additives and is an opportunity for the Commission to update and supplement the European food additives list.
Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives.
The Regulation lays down rules on food additives used in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in the food trade.
A food additive may only be approved if it does not pose a safety concern to the health of consumers, if there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means and if its use does not mislead the consumer.
This Regulation shall not apply to the following substances unless they are also used as food additives: processing aids, substances used for the protection of plants and plant products, nutrients added to food, substances used for the treatment of water, flavourings and enzymes.
Community lists of food additives
Annex I defines the different functional classes of food additives: sweeteners, colours, preservatives, antioxidants, carriers, acids, acidity regulators, anti-caking agents, anti-foaming agents, bulking agents, etc.
Additives are included in a list of additives which are authorised at Community level giving details of their conditions of use (Annex II).
Moreover, this Regulation creates a list of food additives for use in other additives and in food enzymes, as well as their conditions of use (Annex III).
Before incorporating all food additives in the lists in Annexes II and III of this Regulation, the Commission must examine all existing authorisations with regard to criteria such as quantities absorbed, technological need and the potential to mislead the consumer. Whilst these lists are being drawn up, the Annexes of Directives 94/35/EC, 94/36/EC and 95/2/EC will be regularly updated and remain in force.
If the production methods or raw materials used in a food additive already included in a Community list are altered considerably, the additive produced in this way shall be considered as a different additive. Before being placed on the market, this new additive shall be submitted to the European Food Safety Authority (EFSA) for an assessment of health risks.
Labelling of food additives must comply with the general labelling conditions defined in Directive 2000/13/EC. It must include, in particular, the information necessary for their identification (name, batch, manufacturer, etc.).
Common authorisation procedure and risk assessment
11.Risk assessment and the authorisation of food additives are integrated into a common authorisation procedure for food additives, enzymes and flavourings, established by Regulation (EC) No 1331/2008.
The Commission will re-examine all additives that have already been authorised with the assistance of the Standing Committee on the Food Chain and Animal Health.
At the same time, all food additives which were permitted before 20 January 2009 shall be subject to a new assessment carried out by the EFSA. After consulting the Authority, the Commission will prepare an assessment programme by 20 January 2010 with a view to defining the needs and order of priorities for risk assessment.
This Regulation shall apply from 20 January 2010.
Nevertheless, the reassessments of the Community food additives list (Annex II) and the list of food additives for use in food additives and enzymes (Annex III) should be completed by 1 January 2011.
This Regulation is part of extensive reforms launched by the European Commission on 18 July 2006 to modernise existing legislation concerning food additives, flavourings and enzymes. These reforms have led to the development of new legislation based on:
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 1333/2008
OJ L 354 of 31.12.2008
The successive amendments and corrections to Regulation (C) No 1333/2008 have been incorporated in the original text. This consolidated version is of documentary value only.