Division 2.2.3.2 Studies concerning the safety of use of the additive for consumers

Evidence that the metabolites of the flavouring do not result in an accumulation in the animal of products of toxicological concern for humans shall be provided. In the case that the use of the requested flavouring product as a consequence of its addition to feedingstuffs results in residues in food of animal origin, detailed calculation of consumer exposure shall be provided.

1. (a)

   Metabolic and residue studies

   1. (1)

      Natural products (either botanically defined or non–plant origin)

      The safety of these products for humans when used as flavourings in feed, as regards its metabolism, may be based on the metabolism (in the target animal) and residues studies of their major and characteristic components and the absence of substances of toxicological concern in the extract.

      If the major or characteristic components are not already authorised as chemically defined flavourings or if the level of intake by the target animals from feed is substantially higher than that by humans from food, the whole of subsection 3.2.1 of Annex II is required.

   2. (2)

      Natural or corresponding synthetic chemically defined flavourings

      If these products are not authorised as flavourings for humans or if the level of intake by the target animal from feed as proposed be the applicant is substantially higher than that by human from food, available data on metabolic fate shall be provided and used to assess the potential accumulation in edible tissues and products according to subsection 3.2.1 of Annex II.

2. (b)

   Toxicological studies

   1. (1)

      Natural products (either botanically defined or non–plant origin)

      The safety of these products for humans when used as flavouring in feed may be based on the toxicological data of their major or characteristic components and the absence of substances of toxicological concern in the extract.

      A toxicological package is required when the metabolic studies of the major or characteristic compounds show that there is accumulation in animal tissues or products and the threshold of toxicological concern for the target animal is exceeded. This toxicological package shall comprise genotoxicity studies, including mutagenicity and a subchronic oral toxicity study, according to subsection 3.2.2 of Annex II.

   2. (2)

      Natural or corresponding synthetic chemically defined flavourings

      A toxicological package comprising genotoxicity studies, including mutagenicity and a subchronic oral toxicity study, according to subsection 3.2.2 of Annex II, is required when the metabolic studies of these products show that there is accumulation in animal tissues or products and the threshold of toxicological concern for the target animal is exceeded.