Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p71
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 193672–197242

general compositional requirements:

     B.1 Data to enable the dietary exposure of the target population to be estimated

This includes information on the dietary exposure of a food additive, processing aid, novel food or novel food ingredient, or dietary intake of a nutritive substance (as indicated elsewhere in these Applications guidelines for the target population.

     B.2 Data on the recommended level of consumption of the special purpose food for the target population

Information relating to the recommended number of serves per day and the size of each recommended serve should be provided for relevant special purpose foods for the target population.

     C Information related to labelling requirements under Part 2.9 of the Code

The application must contain the following information if it relates to a change to labelling requirements:

     C.1 Information related to safety or nutritional impact of the proposed labelling change

This includes information to support the proposed labelling change e.g. the inclusion of (or change to) a warning or advisory statement, directions for use, or claim conditions.

     C.2 Information to demonstrate that the proposed labelling change will be understood and will assist consumers, if applicable

This includes consumer research information to demonstrate the anticipated consumer response to the proposed change, or data obtained from an overseas market where the proposed labelling is in place.

For example, information to demonstrate how the proposed label change will assist consumer understanding of the specific nature of the food, the intended population group or the intended special purpose of the food;

Note:

A proposed labelling change will only be relevant to consumers. for those special purpose foods which are available for retail sale.

     D Information related to internationally recognised codes of practice and guidelines

The application must contain information demonstrating the extent to which the application is consistent with internationally recognised standards and codes of practices. These include Codex and the WHO recommendations and guidelines, relating to the composition and labelling of special purpose foods.

Note:

Examples of relevant standards, codes of practice, recommendations and guidelines are:

Codex Guidelines for Formulated Supplementary Foods for Older Infants and Young Children at http://www.codexalimentarius.org/download/standards/298/CXG_008e.pdf.

Codex Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses Intended for Infants and Young Children
http://www.codexalimentarius.org/download/standards/300/CXG_010e.pdf.

Codex Code of Hygienic Practice for Powdered Formulae for Infants and Young Children
http://www.codexalimentarius.org/download/standards/11026/CXP_066e.pdf.

Codex Standard for Processed Cereal-Based Foods for Infants and Young Children
http://www.codexalimentarius.org/download/standards/290/cxs_074e.pdf.

Codex Standard for Formula Foods for Use in Weight Control Diets
http://www.codexalimentarius.org/download/standards/295/CXS_181e.pdf.

Codex Standard for Labelling of and Claims for Foods for Special Medical Purposes at http://www.codexalimentarius.org/download/standards/294/CXS_180e.pdf.

Codex Standard for the Labelling of and Claims for Pre-packaged Foods for Special Dietary Uses
http://www.codexalimentarius.org/download/standards/292/CXS_146e.pdf.

     Chapter 3.7

     Guidelines for applications for food production

     3.7.1 Food safety standards