Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p31
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 82807–85843

are consistent with achieving the technological purpose.

     A.3 Information on the chemical and physical properties of the processing aid

This includes details of the chemical and physical properties that make it suitable as a food processing aid.
Information on how the food additive is incorporated homogenously and stably into the different food matrices to which it is proposed to be added should be provided. Data should also be provided to address losses of the substance from the foods during normal shelf life conditions.

The application must include information on possible interactions of the processing aid with different foods. If the processing aid is an enzyme, the application must include information on its technological purpose, including enzymatic properties.

Where the substance, in the form in which it will be present in food, is particulate in nature, the application must include information on particle size, size distribution and morphology in cases where the referenced specification does not include this information.

     A.4 Manufacturing process

This includes a description of the method of manufacture of the processing aid.

Information is required to address whether the manufacture of the processing aid results in carry-over of allergens or gives rise to any food safety issues. This should cover both the processing aid and, if relevant, other substances that are inherently part of the commercial product (for example, preservatives in a processing aid preparation).

For enzymes, detailed information on the manufacturing process must be provided, including any recombinant DNA techniques used to prepare genetically modified organisms used as an enzyme source.

     A.5 Specification for identity and purity

This includes a specification from one of the published sources identified in Schedule 3 – Identity and purity. If a published specification is not available, a detailed specification must be provided. Specifications should include information on the name of the processing aid, its chemical and physical properties, its purity, acceptable levels of impurities, the method of preparation, and analytical methods for determining purity.

The presence of known allergens (see section 1.2.3—4 in the Code) in processing aid preparations must be identified

     A.6 Analytical method for detection

Where a processing aid or breakdown or by-products of a processing aid are likely to be present in the final food, an analytical method must be provided to detect and quantify the amount(s). Such an analytical method should be robust and applicable for analytical laboratories to determine compliance of any limits prescribed in the Code. This information is not required in the case of an enzymatic processing aid.

     B Information related to the safety of a chemical processing aid

The application must contain the following information:

     B.1 General information on the industrial use of the chemical

This includes any information on non-food industrial uses