Sunday 5 July 2009

Controls on animal feed additives: Your questions answered

Tuesday 7 October 2008

The information below outlines the legislation that applies to the marketing and use of feed additives, and describes the authorisation process.

This document is an introductory guide. It is neither comprehensive nor definitive and should be read in conjunction with the relevant legislation. Interpretation of legislation in this document is only in the form of opinions; ultimately, it is for the courts to decide such matters.

The assessment process involves a scientific evaluation that assesses first and foremost whether an additive represents significant risks to human or animal health or the environment. Applicants must also demonstrate that products are effective for their intended purpose.

What is the legislation under which feed additives are authorised?

EC 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.;and

Additionally, Regulation 1831/2003 sets out conditions of use of additives and provisions on the labelling of feed additives or premixtures of additives. Transitional measures are in place for additives authorised by previous legislation.

EC Regulations are directly applicable and do not require transposition (implementation) into national law. However, the Feeding Stuffs Regulations 2005 contain enforcement provisions (offences and penalties) relating to 1831/2003. There are separate but parallel Regulations for England, Scotland, Wales and Northern Ireland. These regulations can be found at the following links:

(External) EC Regulation No 1831/2003 on additives for use in animal nutrition

(External) The Feeding Stuffs (England) Regulations 2005

(External) The Feeding Stuffs (Scotland) Regulations 2005

(External) The Feeding Stuffs (Wales) Regulations 2006

(External) The Feeding Stuffs (Northern Ireland) Regulations 2005

Where can I find a list of authorised feed additives?

Authorised feed additives are listed in the European Commission’s Register of Feed Additives. You can use the Register to check if an additive has been authorised in the EU. Feed additives that are permitted in the EC 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.

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

Where can I find out about the conditions of use for an additive?

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 to be used. In other 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 .

Who can modify the entries to the register?

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

What must I do in order to get an additive authorised?

You need to submit an application 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 Regulation (EC) 429/2008.

(External) EC Regulation No 1831/2003 on additives for use in animal nutrition
(External) EC Regulation 429/2008 on rules of the preparation and presentation of dossiers

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

EFSA is responsible for evaluating all dossiers submitted. If EFSA's Opinion on a dossier is positive, the Commission will normally prepare a draft regulation to grant authorisation.For further details see the (External) EFSA website .

What happens once I submit a dossier to EFSA?

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. The process of authorisation is undertaken at meetings of 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. Agendas and minutes of meetings of SCoFCAH may be viewed at the (External) SCoFCAH website .

Are there 'generic authorisations' for feed additives?

Most authorisations are granted on a generic basis. That is, 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 EC Feed Hygiene Regulation 183/2005).

Are any authorisations specific to the applicant?

Specific authorisation is granted if the additive is a zootechnical additive, or a coccidiostat or histomonostat. In these cases this means that 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.

How long can products be kept on the Register?

Under Regulation 1831/2003, feed additives are generally authorised for a period of ten years. A transitional period of authorisation exists for additives where applications were submitted under the previous legislation (Directive 70/524/EC), before 1831/2003 came into force in October 2004.
All additives that have been authorised without a time limit under Directive 70/524/EEC need to have new application submitted by 8 November 2010.

I am told I need to resubmit a dossier for my additive by November 2010. Why?

Regulation (EC) 1831/2003 replaced Directive 70/524/EEC in providing a framework for the assessment and authorisation of additives for use in animal nutrition. Article 10 of Regulation (EC) 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 currently authorised without a time limit need an application for authorisation and a dossier to be submitted for re-assessment by 8 November 2010. Applications are also required for silage additives, which are now included in the scope of Regulation (EC) 1831/2003.

What happens if an application for an additive is not submitted by 8 November 2010?

Article 10 of Regulation 1831/2003 states that if an application is not submitted by 8 November 2010, the authorisation for use in the EC market will lapse.

Provided an application and a dossier have been submitted conforming with Regulation 1831/2003, the additive concerned will continue to be authorised until the Commission takes a decision.

Who has responsibility for submitting applications for generic additives?

Any company can provide the application to maintain the authorisation of a feed additive in the EU, and no one applicant has responsibility for any generic additive. As a result, there is the possibility that some additives will not be covered by an application for authorisation.

The EU Feed Additives and Premixtures Association (FEFANA) have set up several consortia aimed at coordinating, preparing, submitting and following up applications for re-authorisation of feed additives. More information can be found at the (External) FEFANA website.

If I have permission to sell an additive for one animal category, can I sell it for other species?

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.

Are additives authorised outside the EU permitted for use in the UK?

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 an application must be submitted according to procedures in EC Regulation 1831/2003.

Where can I get more information

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

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