32003R1831

WHAT IS THE AIM OF THE REGULATION?

It sets out a standardised procedure for authorising feed additives¹ and lays down rules for their labelling, placing on the market and use.

KEY POINTS

Scope

The regulation applies to all feed additives and premixtures². It does not apply to:

• processing aids³; and
• veterinary medicinal products as defined by Directive 2001/82/EC.

General aspects

Only authorised additives may be placed on the market and used. Authorisations are granted for use in feed intended for specific animal species or categories and for specific conditions of use.

Additives may be classified as follows:

• technological (e.g. preservatives, antioxidants, emulsifiers, stabilising agents, acidity regulators, silage (grass or other green fodder compacted and stored in airtight conditions, typically in a silo) additives);
• sensory (e.g. flavourings, colourants);
• nutritional (e.g. vitamins, minerals, aminoacids, trace elements);
• zootechnical (e.g. digestibility enhancers, gut flora stabilisers);
• coccidiostats and histomonostats.

These categories are themselves divided into functional groups according to the additives’ main functions.

Antibiotics, other than coccidiostats or histomonostats, are not feed additives.

Authorisation types

There are 2 types of authorisations:

• Authorisations issued to a holder of authorisation for additives in the ‘zootechnical additives’ and ‘coccidiostats and histomonostats’ categories, as well as additives consisting of, containing or produced from genetically modified organisms.
• Authorisations issued to a holder of authorisation for substances belonging to the categories of additives ‘technological additives’, ‘sensory additives’ and ‘nutritional additives’.

Authorisations are valid for 10 years throughout the European Economic Area (EEA). They are renewable for 10-year period. An application for renewal must be sent to the European Commission at least 1 year before the authorisation expires. The procedure for renewal is set out in the regulation.

The regulation also lays down a procedure for modifying, suspending and revoking the authorisation.

Authorisation procedure

• Applications for authorisation are submitted to the Commission. The applications are notified to EU countries before they are forwarded to the European Food Safety Authority (EFSA).
• The applicant must send to EFSA a copy of the application and the complete dossier:
  • applicant’s name and address,
  • a description of the method of production,
  • manufacturing and intended uses of the additive,
  • proposed conditions for placing the additive on the market,
  • the safety and efficacy studies, etc..
• EFSA is responsible for conducting the risk assessment based on the dossier submitted by the applicant.
• The applicant must also send samples of the additive to the Community Reference Laboratory for analysis.
• EFSA may ask the applicant for further information during the assessment procedure.
• Additives intended for use in animal nutrition must receive a favourable opinion before their use and placing on the market is authorised. Within 6 months of receipt of an application, EFSA gives an opinion based on the information provided by the applicant. The evaluation report prepared by the reference laboratory is included in the opinion. If the opinion is favourable, it must include information on the specific conditions or restrictions relating to handling, monitoring requirements following placing on the market and use of the additive, including the animal species and categories of animals for which the additive is to be used. This includes information on specific additional requirements for labelling of the additive and, where appropriate, a proposal for the establishment of maximum residue limits in the relevant foodstuffs of animal origin.
• Based on the EFSA opinion, the Commission decides whether authorise or reject the authorisation of the additive. The Commission prepares a draft implementing regulation to grant or deny the authorisation. The Commission is assisted in the procedure by the Standing Committee on Plants, Animals, Food and Feed — Animal Nutrition section.
• Feed business operators are responsible for placing on the market and use of feed additives and for ensuring compliance with any conditions or restrictions imposed by the legislation.

EU register

The Commission has established the European Union Register of Feed Additives, which is regularly updated, and it links to the relevant authorisation regulations. Those regulations include the specific requirements for placing the additives on the market.

It is composed of 2 parts:

• First part: Annex I — contains the list of modifications to the register and the current authorisations.
• Second part: Annex II — contains a list of additives that will be withdrawn in the short term. This list also includes those for which a date is indicated in the column ‘Expiry date of authorisation’. Those additives are no longer allowed to be placed on the market if that date has expired.

The register is for information purposes and does not replace EU legal acts.

Labelling

Additives must be labelled in a conspicuous, clearly, legible and indelible manner. The label must include the following information:

• the specific name given to the additives upon authorisation, the functional group and their identification number;
• the name and address or registered place of the person responsible for these particulars;
• the net weight or net volume of the additives;
• where appropriate the approval number of the establishment manufacturing or placing the additive on the market;
• directions for use and any safety recommendations regarding use and, where applicable;
• the specific requirements mentioned in the authorisation;
• the batch reference number and date of manufacture.

The regulation also sets requirements for the labelling of premixtures of feed additives.

From when does the regulation apply?

It has applied since 18 October 2004.

BACKGROUND

For more information, see:

• Feed additives (European Commission).

KEY TERMS

1. Feed additives: substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the following functions:
2. Premixtures: mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals.
3. Processing aids: any substance which is not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing. This may result in the unintentional — but technologically unavoidable — presence of residues of the substance or its derivatives in the final product(provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed).

MAIN DOCUMENT

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, pp. 29-43)

Successive amendments to Regulation (EC) No 1831/2003 have been incorporated into the original document. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, pp. 1-65)

See consolidated version.