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Use of additives in feedingstuffs

The European Union (EU) is harmonising and streamlining the rules on the evaluation and authorisation of feed additives. Moreover, it provides for measures on the labelling of these additives and for stricter rules on certain substances.

ACT

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [See amending act(s)].

SUMMARY

The aim of this Regulation is to establish a standardised procedure for the authorisation and use of feed additives and to lay down rules for the labelling and supervision of these substances.

Scope

This Regulation applies to all feed additives * except:

Conditions for authorization

The applicant must prove that the additive for which it has submitted an application for authorisation for placing on the market complies with certain conditions, i.e.:

  • the additive must have a favourable influence on the characteristics of the feed into which it is incorporated or on animal production;
  • the additive must not have an adverse effect on animal health, human health or the environment;
  • the additive must not harm the consumer by impairing the distinctive features of animal products;
  • the presentation of the additive must not mislead the user.

Antibiotics, other than coccidiostats or histomonostats, may not be used as feed additives.

Authorisation procedure

Additives intended for use in animal feeds must receive a favourable opinion from the (EFSA) before obtaining an authorisation for their use and placing on the market.

Applications for authorisation are submitted to the Commission. The latter then ensures that the applications are notified to Member States before forwarding the applications to the EFSA. The applicant himself must send the EFSA the copy of the application and certain information (the name and address of the applicant, 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.). In addition, he must send samples to the Community Reference Laboratory for analysis. The EFSA may, if necessary, ask for further information.

Within six months of receipt of an application the EFSA gives an opinion based on the information provided by the applicant and on the evaluation report forwarded by the Community Reference Laboratory. If this 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, information on specific additional requirements for labelling of the additive, and, where appropriate, a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin.

Based on the EFSA opinion, the Commission decides whether or not to authorise the additive. An authorisation is valid for ten years and may be renewed. An authorisation may be renewed by means of simplified provisions.

This Regulation contains provisions concerning the use of non-authorised additives for research purposes and provisions concerning the use of certain additives (in particular those produced from genetically modified organisms).

Persons using an authorised additive or placing it on the market are responsible for ensuring compliance with any conditions or restrictions imposed by the Commission.

Based on the opinion given by the EFSA, the Commission may decide to amend, suspend or revoke an authorisation.

Information on additives

The additives are entered in a register made available to the public. They are allocated to one or more of the following categories: technological additives; sensory additives; nutritional additives; zootechnical additives; coccidiostats and histomonostats. These categories are themselves divided into functional groups according to the additives’ principal functions.

Additives must be labelled clearly and indelibly and include certain information, including the specific name given to the additives upon authorisation and their identification number, the name and address of the person responsible for these particulars, the net weight or net volume of the additives, directions for use and any safety recommendations regarding use and, where applicable, the specific requirements mentioned in the authorisation.

Following the applicant’s request, certain information provided by the latter may remain confidential if the Commission considers that its disclosure is likely to compromise the rules on competition.

Background

Directives 70/524/EEC and 87/153/EEC are repealed but some of their provisions remain temporarily in force.

Key terms used in the act
  • Additives for animal feed: 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: satisfy the nutritional needs of animals, favourably affect the characteristics of feed or animal products, the colour of ornamental fish and birds, the environmental consequences of animal production, animal production, performance or welfare, or have a coccidiostatic or histomonostatic effect.
  • Processing aid: a 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 which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal
Regulation (EC) 1831/2003

7.11.2003

-

OJ L 268 of 18.10.2003

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal
Regulation (EC) No 378/2005

25.3.2005

-

OJ L 59 of 5.3.2005

Regulation (EC) No 596/2009

7.8.2009

-

OJ L 188 of 18.7.2009

Regulation (EC) No 767/2009

21.9.2009

-

OJ L 229 of 1.9.2009

Successive amendments and corrections to Regulation (EC) No 1831/2003 have been incorporated into the basic text. This consolidated version is for reference only.

RELATED ACTS

Commission Regulation (EU) No 516/2010 of 15 June 2010 concerning the permanent authorisation of an additive in feedingstuffs [Official Journal L 150 of 16.6.2010].

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 [Official Journal L 133 of 22.5.2008].
Applications for authorisation of a feed additive are presented using the form in Appendix I of the Regulation. They are accompanied by a dossier which should enable the efficacy and safety of the feed additive for humans, animals and the environment to be evaluated. For applications submitted before 21June 2008, the Appendix to Directive 87/153/EEC is still valid.

Last updated: 25.03.2011
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