EFSA publishes guidance documents for feed additives
Guidance for the preparation of dossiers for zootechnical additives
A zootechnical additive is any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment. The category „zootechnical additives? is further divided into four functional groups (Annex I of Regulation (EC) No 1831/2003).
Guidance for the preparation of dossiers for nutritional additives
A nutritional additive is any substance added to feed to satisfy the nutritional needs of animals.
The category „nutritional additives? is further grouped into four functional groups (Annex I of Regulation (EC) No 1831/2003).
Guidance for the preparation of dossiers for technological additives
A technological additive is any substance added to feed for a technological purpose and which favourably affects the characteristics of feed. The category „technological additives? is further divided into 13 functional groups such as among others preservatives, antioxidants, emulsifiers, stabilisers, gelling agents, binders, substances for control of radionuclide contamination, anticaking agents.
Guidance for the preparation of dossiers for sensory additives
A sensory additive is any substance, the addition of which to feed improves or changes the organoleptic properties of the feed, or the visual characteristics of the food derived from animals. The category „sensory additives? is further grouped into two functional groups: clourants and flavouring compounds.
The above guidance documents follow the structure and definitions of Regulation (EC) No 1831/2003 and its implementing rules (Regulation (EC) No 429/2008). It is intended to assist the applicant in the preparation and the presentation of its application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003.
Guidance for establishing the safety of additives for the consumer
The assessment of the safety of the use of the additives, related to consumer exposure to food products derived from animals given feed or water containing or treated with the additive and containing residues of the additive or its metabolites.
Guidance for the preparation of dossiers for additives already authorised for use in food
Dossiers for additives already authorised as food additives or approved as components of foodstuffs in the European Union and intended for use as a feed additive should follow the respective guidance documents for the feed additive categories to which they are assigned (technological, sensory, nutritional and zootechnical additives).
However, the “simplified procedure” foreseen in Article 7 of Regulation (EC) No 1831/2003 for additives already authorised for use in food allows some extrapolations and consequently exemptions from the requirements laid out in the EFSA guidance documents. These exemptions are detailed in the document.
Guidance on studies concerning the safety of use of the additive for users/workers
An assessment of risk to users/workers should be included based on toxicological studies relevant to the nature of the additive. Experience in the manufacturing plant may be an important source of information in evaluating the risks to workers from exposure to the additive itself by both airborne and topical routes.
This document provides guidance on how to conduct studies concerning safety for the user/workers; persons who may be exposed to the additive while handling it, when incorporating it into premixtures or feedingstuffs or using a feedingstuff supplemented with the additive.
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