Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p34
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 90975–94091

similarity between the amino acid sequence of the enzyme and that of known allergens.

    In the case of an enzyme derived from an allergenic source, or where there is significant similarity between the amino acid sequence of the enzyme and that of a known allergen, the following additional information must be provided:

    (c) information on the stability of the enzyme to degradation in appropriate gastric and, if applicable, intestinal model digestion systems.

    In the case that the enzyme is tested for stability and found to be stable, the following data must be provided:

    (d) specific serum screening.

    Information on whether the enzyme has a role in the elicitation of gluten-sensitive enteropathy must also be provided if the enzyme has been obtained from wheat, rye, barley, oats, or related cereal grains.

    Where data are not considered relevant to the assessment of potential allergenicity of the enzyme, an explanatory statement must be provided.

     C.4  Safety assessment reports prepared by international agencies or other national government agencies, if available

This includes safety assessment reports prepared by JECFA or by other national or supranational agencies responsible for food safety.

     D Additional information related to the safety of an enzyme processing aid derived from a microorganism

The application must contain the following additional information:

     D.1 Information on the source microorganism

The information provided should include the production strain and the strains from which it was originally derived. Information should also be provided on where the wild-type strain is normally found. Any other information on the taxonomy of this strain which would help its characterisation should be provided. It should be stated if the production strain is currently used in food enzyme production.

The information provided should also contain the production method used.

     D.2 Information on the pathogenicity and toxicity of the source microorganism

This includes information to demonstrate that the strain of the source microorganism is non-pathogenic and non-toxigenic. If the enzyme is from a fungal source, the application must include information to demonstrate that the strain does not produce toxicologically significant amounts of mycotoxins.

     D.3 Information on the genetic stability of the source organism

This includes information to demonstrate that the strain of the source microorganism does not undergo strain drift and that the culture conditions can be applied consistently between batches. The steps which are taken to ensure strain stability should be provided, such as tests for morphological, growth and production characteristics of the strain.

     E  Additional information related to the safety of an enzyme processing aid derived from a genetically-modified microorganism

The application must contain the following additional information:

     E.1  Information on the methods used in the genetic modification of the source organism

This includes information on the nature of the genetic