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Division 4.2.3.2 Studies concerning the safety of the additive use for consumer

United Kingdom

Original text. Later amendments are not shown.

  1. (1)

    Metabolic and residue studies are not required.

  2. (2)

    Toxicological studies, according to subsection 3.2.2 of Annex II.

Enzymes and micro-organisms form only a part of the whole additive which, in most cases, can include other components originated from the fermentation process. Consequently, it is necessary to test the additive to ensure it does not contain mutagenic or otherwise materials that can harm human consumers of food derived from animals feed with feedingstuffs or water treated with these additives.

However, most viable bacteria intended for direct or indirect ingestion by mammals (including humans) are selected from groups of organisms with a history of apparent safe use or from groups where the toxic hazards are well defined. Similarly, the hazards associated with micro-organisms currently used for the production of enzymes generally are well recognised and substantially reduced by modern production methods. Therefore, for enzymes from microbial sources and for micro-organisms with a history of apparent safe use and where the components of fermentation process are well defined and know, toxicity tests (e.g. oral toxicity or genotoxicity testing) are not considered necessary. However, for both live organisms and those used for the production of enzymes, the specific concerns in section 2.2.2.2 of Annex II shall always be addressed.

When the organism or its application is novel and insufficient is known about the biology of the (production) organism to exclude a potential for the production of toxic metabolites, genotoxicity and oral toxicity studies made with additives containing viable micro-organisms or enzymes shall be introduced. In this case, they shall take the form of genotoxicity studies including mutagenicity and a subchronic oral toxicity study. It is recommended that such studies are performed with the cell-free fermentation broth or in the case of a solid state fermentation, an appropriate extract.