EU Feed Additive Application

What is feed additive in the EU?

Regulation (EC) No 1831/2003 defines feed additives as 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.

Additives may be classified as follows:

• technological (e.g. preservatives, antioxidants, emulsifiers, stabilising agents, acidity regulators, silage 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.

Why apply for feed additive?

According to Regulation (EC) No 1831/2003, no person shall place on the market, process or use a feed additive unless:

• it is covered by an authorisation granted in accordance with this Regulation;
• the conditions for use set out in this Regulation, including the general conditions set out in Annex IV, unless otherwise provided for in the authorisation, and in the authorisation of the substance are met; and
• the conditions on labelling set out in this Regulation are met.

The EU has currently established a positive list of authorised feed additives, which specifies the permitted uses and use levels for each additive. To market a new feed additive not listed in the EU positive list, an authorization application must first be submitted to the EU authorities.

Who can apply for feed additive?

As regulated in Regulation (EC) No 1831/2003, the applicant for an authorisation or his representative shall be established in the Community.

Validity period

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.

Authorisation procedure

Applications for authorisation are submitted to the Commission and evaluated by the European Food Safety Authority (EFSA). The procedures are as follows:

Pre-submission phase

• Potential applicant requests general pre-submission advice (optional)
• Potential applicant notifies studies commissioned or carried out as of 27 March 2021

Submission phase & completeness check

• Applicant submits application via e-submission system to the EC
• The EC check the application and forwards it to EFSA for the risk assessment procedure
• Receipt of the application by EFSA and completeness check (30 working days)

Risk assessment phase (6 months + Request of additional information)

• EFSA validates the application
• EFSA launches public consultation on the application dossier
• EFSA performs thorough risk assessment
• EFSA Panel adopts the scientific output

Post-adoption phase

• EFSA publishes the scientific output
• Based on EFSA’s opinion, the EC prepares a draft specific Regulation granting the authorisation

Materials required for application

According to the Administrative guidance for the preparation of applications on additives for use in animal nutrition, the information on the specific requirements for application dossiers are summarized below.

Administrative data

• Applicant’s contact details;
• Applicant’s EU representative contact details;
• Person responsible for the dossier contact details;
• Subject of the request;
• Existing authorisation in EU feed and/or food legislation;
• Existing authorisation under GMO legislation;
• Existing authorisations in non-EU countries;
• Information on data sharing agreement in place, if any;
• Confirmation/written statement that the three samples have been sent directly to the EURL as well as other documents relevant to EURL submission;
• Application form

Public summary of the dossier

A short summary of the dossier should be provided. This document will be made available to the public through the OpenEFSA portal once the application is considered valid, along with the non-confidential version of the application dossier. It should not contain any confidential information.

Technical dossier

1. Pre-application information;
2. Scientific summary;
3. Identity, characterisation and conditions of use of the additive; methods of analysis;
4. Safety of the additive, including safety of use of the additive for the target animals, for consumers, for users, and for the environment;
5. Efficacy of the additive
6. Post-market monitoring plan
7. List of annexes, references and checklist

Oue services

CIRS Europe can serve as the EU representative for applications

• EU feed additive application feasibility analysis;
• EU feed additive application service; and
• Other customized compliance services

About CIRS

The Food Business Division of CIRS Group, established in 2012, has successfully assisted over 1,000 domestic and international food and feed companies in achieving "one-stop" regulatory compliance. Leveraging our extensive expertise and resources across multiple jurisdictions, we provide comprehensive compliance solutions including:

• China - “Three New” Food Registration: new food material, new food additives, and new food contact materials (including synthetic biology-derived products)
• China - New Feed and New Feed Additive Application
• U.S. - FDA GRAS Notice
• U.S. - Animal Food GRAS Conclusions
• EU - Novel Food Application
• EU - Feed Additive Application