Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p57
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 154114–157266

in vitro and in vivo toxicity studies conducted in animals or humans to examine the toxicity of the single chemical entity or dietary macro-component and, where necessary, its metabolites or degradation products.

The application should address the following categories of studies:

(a) acute toxicity studies
(b) short-term toxicity
(c) long-term toxicity studies and carcinogenicity studies
(d) reproductive toxicity studies
(e) developmental toxicity studies
(f) genotoxicity studies
(g) special studies such as neurotoxicity or immunotoxicity

Where data are not available or is not considered relevant to the safety assessment of the single chemical entity, an explanatory statement should be provided.

     C.4.3 Safety assessment reports prepared by international agencies or other national government agencies

This includes safety assessment reports prepared by the WHO or by other national or supranational agencies responsible for food safety or public health.

     C.5 Microorganisms (including probiotics)

An application for a novel food which is a microorganism (including probiotics) must contain the following information:

     C.5.1 Information on potential pathogenicity

This includes information related to the potential pathogenicity of the microorganism and related microorganisms.

     C.5.2 Information on the effects of the microorganism on gut microflora

This includes studies to demonstrate that the microorganism does not have adverse effects on the gut microflora.

     C.5.3. Information on the use of this microorganism in food or as a food in other countries

This t includes information on the extent and history of use of this microorganism or related microorganisms in other countries, together with reports of any adverse health effects. The nature of any adverse event reporting system in that country should be detailed, if available.

     C.5.4 Information on human toleration studies

This includes any published or unpublished reports of toleration studies conducted in humans. Clinical evaluation of potential probiotics must use double-blind, placebo-controlled human trials, with detailed reporting of adverse side effects, which can be used to confirm the results observed in animal tests or in vitro studies.

     C.6 Food ingredients derived from a new source

An application for a novel food which is a food ingredient derived from a new source must contain the following information:

     C.6.1 Information on the safety of the source organism

This includes information on whether the source organism of the novel ingredient has a history of safe use as a food. If the source organism is microbial, the application must include information on any potential pathogenicity and toxicity. The application must also include information on potential naturally-occurring toxins, if applicable.

The application must include details on the presence of known allergens (see section 1.2.3—4 in the Code).

     C.6.2 Information on the composition of the novel food ingredient derived from a new source

This includes information on the levels of major components and nutrients in the