Controls on animal feed additives: Your questions answered

EU Regulation 1831/2003 controls the use of additives in animal nutrition within the European Union. Essentially, new feed additives can only be granted an authorisation following a scientific evaluation by the European Food Safety Authority (EFSA). Additives may be put on the market and used only for the specific purposes provided for by the authorisation. The Regulation covers the following feed additive categories:

• technological additives e.g. preservatives
• sensory additives e.g. flavourings and colourings
• nutritional additives e.g. vitamins and minerals
• zootechnical additives (additives used to affect favourably the performance of animals in good health , e.g. enzymes and micro-organisms)
• coccidiostats and histomonostats

Additionally, Regulation 1831/2003 sets out conditions of use for additives and provisions on the labelling of feed additives or premixtures of additives. The provisions on the labelling of additives and premixtures are set out in Article 16 of Regulation 1831/2003. It should be noted that Article 16 of Regulation 1831/2003 has been amended by Article 29 of EU Regulation 767/2009. Feed additive authorising measures may also include additional labelling requirements.
EU Regulations are directly applicable and do not require transposition (implementation) into national law.

Authorised feed additives are listed in the European Union’s Register of Feed Additives. You can use the Register to check whether or not an additive has been authorised in the EU. Feed additives that are permitted in the EU are logged in the Register by the European Commission. Sometimes you can find out details of a product’s authorisation (including when the authorisation expires) via hyperlinks within the Register. The Register of Feed Additives is a source of information about the status of feed additives, giving information, such as for which animals the additive has been authorised and the relevant conditions for use. We expect all authorised additives to have such a link in the future.

The Register can be accessed on the EU website (pdf file)

In some cases, the Register has a link to the legislation that granted the authorisations for an additive. When you click on this link, you can see the conditions of use for an additive, e.g. type of additive, animal species, doses and how and where it can be used. In some cases, the link will not provide the conditions of use.

If you are unable to find out the conditions of use for an additive, please contact Dr Ray Smith on telephone number 0207 276 8474 or email ray.smith@foodstandards.gsi.gov.uk.

The European Commission has the task of maintaining the Register. Updates are made when new authorisations are granted, or other changes are made.

You need to submit an application for authorisation and a dossier to the European Food Safety Authority (EFSA). The application must meet requirements set down in Article 7 of Regulation (EC) 1831/2003, and should be devised according to new and revised guidelines for the preparation and presentation of applications set down in EU Regulation 429/2008.

EFSA has guidance and technical guidance documents for preparation of dossiers, which can be found on the EFSA website. Administrative guidance for applicants on the preparation and presentation of applications for authorisation of additives can also be found on the EFSA website.

EFSA is responsible for evaluating all dossiers submitted. For further details see the EFSA website.

Experts from EFSA evaluate the dossier and assess the additive in terms of safety, quality and efficacy. EFSA then publishes its Opinion on the additive. This Opinion is considered by the Commission and Member States when deciding whether or not an additive should be authorised. If EFSA's Opinion on a dossier is positive, the Commission will normally prepare a proposal to grant authorisation. The proposal is then presented to the Standing Committee on the Food Chain and Animal Health (SCoFCAH). Essentially, Member States vote on the European Commission’s proposal for authorisation of an additive. If a Qualified Majority Vote in favour is achieved, the proposal is adopted as a Regulation. Agendas and minutes of meetings of SCoFCAH may be viewed at the SCoFCAH website. The Agency also provides regular updates on the outcomes of SCoFCAH animal nutrition meetings.

Most authorisations are granted on a generic basis; in these cases once an authorisation has been made, any person or company could (in theory) produce and market the product. Of course, such a person or company would have to ensure that they kept within the terms of the authorisation and complied with other legislation (e.g. the EU Feed Hygiene Regulation 183/2005).

Specific authorisation is granted if the additive is a zootechnical additive, or a coccidiostat or histomonostat. In these cases, any other person or company who wishes to manufacture and sell an additive that has the same active ingredient should apply for their own product's authorisation as outlined above.

Under Regulation 1831/2003, feed additives are generally authorised for a period of 10 years. A transitional period of authorisation exists for additives where applications were submitted under the previous legislation (Directive 70/524/EC), before 1831/2003 became applicable in October 2004.

No. Authorisations are specific. They specify the animal category in question. You will need to submit a new dossier to extend the use to other categories.

Additives that are authorised outside the EU are not automatically authorised for use in the UK. If they have not been through the process of authorisation as outlined above, and are not on the Register, then to gain authorisation an application must be submitted according to procedures set out in EC Regulation 1831/2003.

EU Regulation 1831/2003 replaced Directive 70/524/EEC and provides a framework for the assessment and authorisation of additives for use in animal nutrition. Article 10 of EU Regulation 1831/2003 provides a requirement for re-evaluation of additives that have been authorised under Directive 70/524/EEC without a time limit. Article 10 states that ‘an application shall be submitted in accordance with Article 7 within a maximum of seven years after the entry into force of this Regulation for additives authorised without a time limit or pursuant to Directive 82/471/EEC’.

This means that all additives authorised under the previous legislation required an application for authorisation and a dossier for re-assessment to be submitted by 8 November 2010.

Provided an application and a dossier have been submitted conforming to Regulation 1831/2003, the additive concerned will continue to be authorised until the Commission takes a decision on whether to re-authorise or not.

Article 10 of Regulation 1831/2003 states that if an application is not submitted by 8 November 2010, the authorisation for placing on the market, processing or use in the EU will be revoked.

The European Commission has published a list of additives that have and have not been supported by an application for authorisation. This can be found as an appendix to the EU Register of Feed Additives, formerly known as the Community Register of Feed Additives.

The Commission will draft a proposal for a Regulation that will revoke the authorisations for the additives that have not been supported by an application (also known informally as orphan additives). The proposal will be voted on at a meeting of the Animal Nutrition Section of the Standing Committee on the Food Chain and Animal Health (SCoFCAH). The Agency will consult stakeholders on the proposal and inform them of the outcome of the vote. Stakeholders can read the outcomes of SCoFCAH meetings here.

If an additive was not supported with an application under the re-assessment procedure the authorisation for its marketing and use in the EU will be revoked and the additive will be removed from the Community Register of Feed Additives.

However, a company or person may submit a new application for authorisation in accordance with Article 4 of Regulation 1831/2003. Unlike applications for re-authorisation submitted under Article 10, the marketing or use of the additive within the EU will not be permitted until a Regulation authorising that use has been published in the Official Journal. However, EFSA must give an Opinion within six months of receipt of a valid application, in line with Article 8; in some cases, this may mean the authorisation will be processed more quickly than under the re-assessment procedure.

It is estimated that EFSA will have received over 1,000 applications for re-authorisation under Article 10 of Regulation 1831/2003 and it is likely that it will take EFSA several years to complete the assessment of all these dossiers. In view of this, EFSA and the European Commission have agreed a list for prioritising applications based on consumer safety. Substances have been divided into groups to improve efficiency. High priority has been given to:

• substances that have not been evaluated by EFSA or its predecessor, the Scientific Committee on Animal Nutrition (SCAN)
• to those not authorised in food
• to those for which EFSA or SCAN have expressed the need for additional information, as well as to substances with higher levels of concern (e.g. substances with a tendency to bioaccumulate)

Lower priority has been given to additives that have been recently evaluated by EFSA/SCAN and/or those currently authorised for use in human food.

The Agency cannot predict the outcome of the re-assessments, but it is likely that there will be significant changes to the additives that are currently authorised. It is possible that some generic additives that were previously authorised may not be supported for re-authorisation if there are safety concerns. There may also be amendments to conditions of use, such as species or category restrictions, age restrictions, production techniques, minimum or maximum permitted levels, etc.

If the re-authorisation does not cover your intended use (e.g. species or category of animal, or production technique), a new application for authorisation in accordance with Article 4 as read with Article 7 of Regulation 1831/2003 would have to be submitted. The marketing or use of the additive within the EU for the new use will not be permitted until it has been specifically authorised.

Further information may be obtained from Dr Ray Smith on telephone number 0207 276 8474 or email ray.smith@foodstandards.gsi.gov.uk