Food additives

PURPOSE: to regulate food additives.

PROPOSED ACT: Regulation of the European Parliament and of the Council

CONTENT: currently, food additives are regulated through four co-decision framework Directives; three specific Directives and three Commission Directives. For the sake of improved efficiency and greater simplicity, the Commission is proposing to repeal the existing legislative acts and replace them with a new single Regulation in which all existing food additives are brought under one umbrella. The stated objectives of this proposed Regulation are:

-         to simplify food additive legislation by creating a single instrument for procedures and approvals;

-         to confer the right of updating and implementing the Community list of authorised food additives to the Commission;

-         to consult the European Food Safety Authority (EFSA) for the safety evaluation of food additives;

-         to set up a re-evaluation programme for existing food additives; and

-         to require authorisation from additives containing GMOs, as defined by Regulation 1829/2003.

This proposal is being forwarded to the Parliament and Council alongside three related proposed Regulations on:

-         Establishing a common authorisation procedure for food additives, food enzymes and food flavourings. (For a summary refer to COD/2006/0143)

-         Food enzymes; (For a summary refer to COD/2006/0144)

-         Certain food ingredients with flavouring properties for use in and on food. (For a summary refer to COD/2006/0147).

The Commission notes that food additives are fully harmonised in the EU albeit through a number of legislative acts. This Regulation, however, would combine current provisions into a single instrument and thereby facilitate the use of food additives across the EU. In a further development, the Commission is proposing to replace the current practice of using the “co-decision” procedure for the authorisation of an additive (which is lengthy and cumbersome) with the “regulatory” procedure. Such a move would speed up considerably the approval procedure for food additives.

In summary, the provisions proposed would state that food additives used in foods, in food additives and in food enzymes would be subject to safety evaluation and approval via a Community-approved positive list. Their use in food will be evaluated according to their safety, technological need, benefit to the consumer and that the consumer is not being misled. All applications for the approval of new food additives will be directed to the EFSA, which will be responsible for carrying out the safety evaluations. The inclusion of a food additive to the list will be considered by the Commission on the basis of the EFSA opinion. The more general criteria such as technological need and consumer interest will be examined by the Standing Committee on the Food Chain and Animal Health (SCFSAH). Final inclusion on the list will be done by the Commission.

A food additive which consists, contains, or is produced from a genetically modified organism, should be authorised in accordance with Regulation 1829/2003/EC on genetically modified food and feed – prior to its inclusion in the positive list established by the new Regulation.

In other provisions, the Regulation lays down the general rules on placing food additives on the market, the labelling of additives sold to the manufacturer or directly to the consumer and the need to keep the Commission abreast of any new information pertaining to food additives. Implementation of the measures proposed in the Regulation will be adopted by the Commission in accordance with the regulatory procedure. This consists of including the use of a food additive and laying down he conditions of use in the positive list as well as laying down criteria on origin and purity. Given that these are matters of high technicality, and given that they are adopted on the basis of commonly agreed principles, the Commission argues that it should be entrusted with these tasks.

Lastly, food additives listed under current legislation will be entered into Annex II of this proposal following a review by the SCFCAH.  Until its review has been notified the existing legislation will continue to apply. In addition, the Authority will be required to carry out a risk assessment on all currently approved food additives.

The proposal has some implication for the Community budget. The Commission is seeking funding for the development of a database capable of gathering and storing all Community legislation on food additives; undertaking studies on the preparation and development of food additive legislation and to undertake studies on harmonising procedures, decision-making criteria and data requirements and how to facilitate work-sharing between the Member States. This kind of support expenditure is covered by Regulation 882/2004 on official feed and food controls and is in line with its 2007-2013 implementation period.