Guidance

Guidelines for submitting a nutritional product to the ACBS

Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).

From:
Department of Health and Social Care
Published
12 April 2019
Last updated
4 May 2022 — See all updates

Applies to England

Documents

Appendix 1: categorisation of nutritional products

PDF, 199 KB, 5 pages

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Appendix 2: types of application

PDF, 127 KB, 3 pages

Appendix 2.1: evidence required for type 3 applications

PDF, 104 KB, 4 pages

Appendix 3: nutritional legislation

PDF, 160 KB, 5 pages

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Appendix 4: clinical trial information to be applied for type 1 products

PDF, 157 KB, 3 pages

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Appendix 5: acceptability studies

PDF, 144 KB, 3 pages

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Appendix 6: products which will not be considered

PDF, 89 KB, 4 pages

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Appendix 7: the mechanism to ensure patients will be protected

PDF, 137 KB, 2 pages

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Details

This set of documents contains supporting information for use in submitting a nutritional product for consideration by the Advisory Committee for Borderline Substances (ACBS). This includes:

  • how nutritional products are categorised by the ACBS
  • evidence required for applications
  • relevant nutritional legislation

The documents can be used when filling out the nutritional products application form.

Published 12 April 2019
Last updated 4 May 2022 + show all updates

  1. Updated the definitions for type 2 and type 3 applications, in the attachment 'Appendix 2: types of application'.

  2. Updated to remove the requirement to submit a type 3 application for changes to (i) a product’s shelf life and (ii) the location of manufacture.

  3. First published.

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