EU Regulation on Food Additives, Flavors and Enzymes - Overview and Summary of Requirements

  • By: Staff Editor
  • Date: September 23, 2011
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A Food additive is asubstance added intentionally to foodstuffs to perform certain technological functions. For example it can be used to color, sweeten or help preserve foods. All food additives are identified by an ‘E’ number. The food additives used are always furnished in the list of ingredients of the foodstuff concerned. Some of the additives that one is likely to come across on food labels are: antioxidants (to prevent deterioration caused by oxidation), colors, emulsifiers, stabilizers, gelling agents and thickeners, preservatives and sweeteners. When food additives are used in foods in Europe, the product labels must identify the function of the additive in the finished food (like color and preservative) and the specific substance used. This is done either by referring to the appropriate E number (such as E415) or its name. 
A food enzyme is a product obtained from plants, animals or micro-organisms or products thereof including a product obtained by a fermentation process using micro-organisms. It contains one or more enzymes capable of catalyzing a specific biochemical reaction and is added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packing, transport or storage of foods.
EU framework
Under European legislation, food additives must be authorized before they can be used in foods. In December 2008, a new regulatory package on Food Improvement Agents was adopted which includes, among others:
  • Regulation 1331/2008: it lays down a common authorization procedure for additives, enzymes and flavorings
  • Regulation (EC) No 1332/2008: it covers food enzymes
  • Regulation 1333/2008: it covers food additives; it consolidates all food additives legislations previously covered by different Directives.
Features of the EU framework
The features of the foregoing three Regulations are explained in the following paragraphs, Regulation-wise:
Regulation 1331/2008 (common authorization procedure for additives, enzymes and flavorings)
  • The Regulation came into force on Jan 20, 2009.
  • Through this Regulation, the European Commission prescribes a common, effective, fast and transparent procedure for the authorization of food additives, food enzymes and food flavorings in the Community. 
  • This procedure is based on a risk assessment by the European Food Safety Authority (EFSA). It leads to the establishment, management and updating of a Community list for additives, enzymes and food flavorings.  
  • It facilitates the free movement of food while guaranteeing the health and welfare of consumers.
  • It lays down the arrangements for drawing up and updating the Community lists for each category of substances. Only substances included in these lists are authorized on the Community market.
  • The common procedure for updating the Community list may be started either on the initiative of the Commission or on the initiative of a Member State or an interested party.
  • The European Commission (Commission) should forward the applications to the European Food Safety Authority (EFSA) for risk assessment. The EFSA will furnish its opinion within nine months of receipt of the application. The period may extend if the Authority seeks additional information from the applicant.
  • The common procedure will end with the adoption by the Commission of the Regulation updating the list of substances within nine months of receipt of the EFSA’s opinion. That period may extend if the Commission seeks additional information concerning aspects of risk management.
  • The Commission may terminate the common procedure at any time, irrespective of the stage it has reached. In this case, it will inform the applicant and the Member States if necessary, stating the reasons for its decision.
  • The Commission will adopt the implementing measures for the Regulation within two years of the adoption of the sectoral food law (the Regulations on additives, on enzymes and on flavorings).
  • Six months after each sectoral food law is enforced, the EFSA will present a proposal to the Commission concerning the data required for risk assessment of the substances concerned so the implementing measures of the Regulation can be adopted.
  • The manufacturer should indicate which information is confidential while submitting the application. It is for the Commission to determine which information furnished in the application is confidential and notify the applicant accordingly. If the applicant does not agree with the opinion, the applicant can withdraw the application to preserve confidentiality.
  • If an emergency is associated with any of the substances on the authorized lists, the Commission will initiate the procedures relating to food safety.
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Regulation 1332/2008 (applies to food enzymes)
  • This Regulation will come into force on 20 January 2009.
  • Its objective is to ensure the smooth operation of the internal market while guaranteeing a high level of protection for human health and consumers. 
  • It aims to create a list of authorized enzymes, to lay down the conditions for the use of food enzymes and to define rules for their labeling.
  • 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.
  • The creation of a community list of authorized enzymes will make it possible to harmonize at European level all enzymes used as food additives. This list will 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 authorization of these products.
  • The list will be established on the basis of the applications for authorization submitted to the Commission. A period of 24 months will be allowed for the submission of applications from the date of enforcement of the implementing measures for Regulation (EC) No 1331/2008.
  • Only the enzymes figuring in the Community list may be placed on the market and added to food.
  • 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 terms of 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.
  • The labeling of food enzymes intended for sale to the final consumer should comply with the general conditions for labeling laid down in Directive 2000/13/EC.
  • This Regulation will come into force on 20 January 2009. Article 4 will come into force from the date of application of the Community list. Articles 10 to 13 will come into force from 20 January 2010.
Regulation 1333/2008
  • This Regulation comes into force on 20.1.2009.
  • It lays down rules on food additives used in foods with a view to ensuring the effective functioning of the internal market
  • Simultaneously, it ensures 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; there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means; its use does not mislead the consumer.
  • This Regulation will not apply to: processing aids; substances used for the protection of plants and plant products; nutrients added to food; substances used for the treatment of water, flavorings and enzymes unless they are also used as food additives.
EFSA’s role
EFSA has three main activities in the area of food additives:
  • Carry out safety evaluations of new food additives before they can be authorized for use in the EU.
  • Respond to ad-hoc requests from the European Commission to review certain food additives in the light of new scientific information and/or changing conditions.
  • Carry out the re-evaluation of all food additives that were permitted in the European Union before 20 January 2009.


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