Basic Legislation

In its White Paper on Food Safety the European Commission announced its intention to recast and simplify the existing legislation concerning feed additives. The Commission proposal has resulted in the European Parliament and Council Regulation (EC) No 1831/2003.

This Regulation sets out new rules for the authorisation, supervision and labelling of feed additives.

General Aspects

According to Regulation (EC) No 1831/2003, only additives that have been through an authorisation procedure may be placed on the market. Authorisations are granted for specific animal species, specific conditions of use and for ten years periods.

Additives may be classified into the following categories:

• Technological additives (e.g. preservatives, antioxidants, emulsifiers, stabilising agents, acidity regulators, silage additives)
• Sensory additives (e.g. flavours, colorants)
• Nutritional additives (e.g. vitamins, minerals, aminoacids, trace elements)
• Zootechnical additives (e.g. digestibility enhancers, gut flora stabilizers)
• Coccidiostats and histomonostats

The European Food Safety Authority (EFSA) is responsible for conducting the evaluation of the data submitted requesting authorisations. After a favourable opinion of the EFSA, the Commission prepares a draft Regulation to grant authorisation, following the procedure involving Member States within the Standing Committee on the Food Chain and Animal Health - Animal Nutrition.

Maximum residue limits (MRLs) and post market monitoring plan may be established for a feed additive if deemed necessary.

The Regulation contains also additional provisions. For example it lays down provisions phasing out the authorisations of antibiotic feed additives as from 1 January 2006. It also contains certain provisions regarding the labelling and packaging of feed additives and procedures for supervision, modification, suspension, revocation and renewal of authorisations, and about confidentiality and data protection. The Regulation also contains certain provisions regarding transitional measures and about the status of products placed on the market before the entry into force of Regulation (EC) No 1831/2003

Guidelines for submission of applications for authorisations of additives

In accordance with Article 7 paragraph 4 of Council Regulation (EC) No 1831/2003 , the Commission, having first consulted the European Food Safety Authority, has established rules (Commission Regulation (EC) No 429/2008) concerning the preparation and the presentation of applications. See page Guidelines.

Community Register

The Regulation foresees the establishment of a European Union Register of feed addtives.

Status of products placed on the market before the entry into force of Regulation (EC) No 1831/2003

The Regulation also contains certain provisions regarding transitional measures and about the status of existing products on the market at the time of adoption of Regulation (EC) No 1831/2003.

The Regulation foresees transitional provisions to take into account the following products already on the market at the time of adoption of Regulation (EC) No 1831/2003.

• Feed additives already authorised pursuant to Directive 70/524/EEC; (consolidated text-consleg, March 2003)
  
• Urea and derivatives, amino acids & their salts, and analogues of amino acids already authorised and which were listed in points 2.1, 3 and 4 of the Annex to Directive 82/471/EEC;
• Substances, micro-organisms & preparations used in the Community as silage additives, as defined in Annex I 1 (k) of the Regulation, which are on the market before the 18 October 2004.

Re-evaluations of additives

Applications for re-evaluation of the products notified and included in the Register, shall be submitted by specific deadlines following the same procedure than for a new application for authorisation (cf. Article 10 of Regulation (EC) No 1831/2003).

If the application for re-evaluation is not received in due time, the provisions of Article 10 (5) apply. ("…a Regulation shall be adopted […] requiring the additives concerned to be withdrawn from the market. …").

Transitional measures after entry into force of Regulation (EC) No 1831/2003

Only certain limited dispositions of Council Directive 70/524/EEC remain applicable after the 17 October 2004 when the new Regulation (EC) No 1831/2003 started to be applicable.

It is the case for applications for authorisation submitted before the date of application of Regulation (EC) No1831/2003 and for which initial comments were forwarded to the Commission. Those applications continue to be treated following Directive 70/524/EEC ( cf. Article 25 of Regulation (EC) No 1831/2003).

Furthermore, Article 16 of Directive 70/524/EEC shall remain in force until Directive 79/373/EEC on the marketing and labelling of compound feedingstuffs, has been revised to include rules concerning the labelling of feedingstuffs incorporating additives.

Report on the use of coccidiostats and histomonostats as feed additives

The Commission prepared a Report to the European Parliament and the Council on the use of coccidiostats and histomonostats as feed additives (COM (2008) 233) pursant to Article 11 of Regulation 1831/2003. This report has been prepared using information gathered from contributions from Member States authorities and stakeholders.

See also:

• Standing Committee on the Food Chain and Animal Health - Section: Animal Nutrition
• former Scientific Committee for Animal Nutrition (SCAN)
• web site of European Food Safety Authority (EFSA)