Evaluation of Feed Additives Regulation and launch of online EU Register of Feed Additives

Evaluation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition

Online EU Register of Feed Additives

Update

The European Commission has carried out an Evaluation of the Feed Additives Regulation. This Regulation (1831/2003) establishes the EU procedure for authorising feed additives, and lays down rules for placing them on the market and for their labelling and use. Only authorised additives may be placed on the market and used. The Regulation also imposed an EU-wide ban from 2006 on the use of antibiotics as growth promoters in feed. As of 5 April 2023, the EU Register of Feed Additives is now available online.

Impacted Products

feed additives, compound feed, feed materials

What is changing?

The European Commission has carried out an Evaluation of the Feed Additives Regulation.

Why?

The Commission aimed to assess if the legislation has performed as expected, and whether it still meets the needs of citizens, businesses and public authorities. It also aimed to identify possible burdens the Regulation may have created, as well as any inconsistencies or gaps in the legislative framework.

Timeline

A proposal for revised feed additive rules is expected in 2025.

Recommended Actions

Authorisations of feed additives are granted for a limited time period, and a transitional period applies.

Non-EU countries producing feed additives, compound feed and feed materials should check the EU Register of Feed Additives regularly to ensure that they respect the conditions of use and the timelines.

Background

Feed additives

Feed additives are substances, microorganisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to:

• favourably affect the characteristics of feed
• favourably affect the characteristics of animal products
• satisfy the nutritional needs of animals
• favourably affect the environmental consequences of animal production
• favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedstuffs, or
• have a coccidiostatic or histomonostatic effect.

Premixtures are mixtures of one or more feed additives not intended for direct feeding to animals. They are added to feed materials or water used as carriers.

Coccidiostats and histomonostats are legally classified as feed additives. They are pharmacologically active substances authorised for use in food-producing animals to inhibit or destroy protozoan parasites in farmed animals. Therefore their residues in animal products must be checked (see Official controls of veterinary drug residues).

Feed additives are also used to favourably affect the colour of ornamental fish and birds. Specific provisions also exist for additives in pet food. As these applications are not part of the human food chain, they are outside the scope of this summary.

Additives are categorised as:

• technological (e.g. preservatives, antioxidants, emulsifiers, stabilising agents, acidity regulators, silage additives – grass or other green fodder compacted and stored in airtight conditions, typically in a silo)
• sensory (e.g. flavourings, colourants)
• nutritional (e.g. vitamins, minerals, amino acids, trace elements)
• zootechnical (e.g. digestibility enhancers, gut flora stabilisers)
• coccidiostats and histomonostats (antibiotics used to control protozoan infections in food-producing animals).

Authorisations

The Feed Additives Regulation lays out procedures for renewing, modifying, suspending and revoking authorisations for the use of feed additives and their placement on the market. Authorisation is only granted after scientific evaluation has demonstrated that the additive has no harmful effects on human and animal health and on the environment. Authorisations are valid for 10 years throughout the European Economic Area (EEA). They are renewable for a further 10-year period.

EFSA (2021) has updated its guidance on the renewal of authorisations. Authorisations of feed additives that have already been placed on the market must be revised regularly. An application for renewal must be sent to the European Commission at least 1 year before the authorisation expires.

The Feed Additives Regulation is part of the wider EU legal framework governing food and feed safety. It was adopted following the General Food Law (Regulation ) which lays down the requirements of food law and food safety procedures, and established the European Food Safety Authority (EFSA).

EFSA has responsibility for food and feed safety assessment and scientific advice. Additives intended for use in animal nutrition must receive a favourable opinion from EFSA before their use and placing on the market is authorised. Within 6 months of receiving an application, EFSA gives an opinion. If favourable, the opinion sets out:

• specific conditions or restrictions relating to handling, monitoring requirements, animal species and categories of animals for which the additive is to be used
• specific requirements for labelling of the additive and, where appropriate, maximum residue limits in the relevant foodstuffs of animal origin.

For more information see EFSA (2023).

Related legislation

Implementing Regulation 429/2008 sets out detailed rules for preparation of applications, assessment and authorisation under the Feed Additives Regulation. Those rules set out the:

• scientific data to be submitted for identification and characterisation of an additive
• studies to be submitted to demonstrate its efficacy and safety for humans, animals and the environment.

The applicant must also send samples of the additive to the European Union Reference Laboratory for Feed Additives (EURL-FA) for analysis. EURL prepares an evaluation report that is included in the opinion, and provides Guidance for Applicants.

Regulation 378/2005 lays down detailed rules for the duties and tasks of the EURL concerning applications for authorisations of feed additives. Regulation 885/2009 amends that Regulation regarding reference samples, fees and the listed laboratories.

As of 5 April 2023, the EU Register of Feed Additives is now available online.

Resources

Sources