Advisory Committee on Borderline Substances (ACBS)
Advisory Committee on Borderline Substances (ACBS)
The ACBS was established in 1971 and is the committee responsible for advising approved prescribers on the prescribing of certain foodstuffs and toiletries.
Borderline substances are mainly foodstuffs, such as enteral feeds and foods that are specially formulated for people with medical conditions, but also include some toiletries, such as sun blocks for use by people with conditions such as photodermatosis.
Following the recent review of the Department of Health’s Advisory Non-Departmental Public Bodies (ANDPBs), the organisational form of the ACBS has changed. The ACBS is no longer classified by the Cabinet Office as an advisory non-departmental public body (NDPB), non-statutory and UK-wide and is now constituted by the Department of Health (DH) as a Departmental Expert Committee.
The remit of the ACBS remains unaltered.
Notes for applicants wishing to make Nutritional or Dermatological submissions to the ACBS
The ACBS has reviewed this information and the updated ‘Information Notes/Application for both Nutritional and Dermatological products being considered for ACBS approval.
Applicants wishing to make a nutritional or dermatological application to the ACBS should note the following:
- When making a Type 1 or Type 2 application, the Information Notes / Application must be downloaded in its entirety and used as a template with the statements supporting an application appearing under the relevant paragraph.
- Applicants must respond to each and every requirement as indicated and provide a statement that the requirement either can or cannot be met along with brief supporting evidence
- Applicants must conform to this format and layout
- All information must be provided in English
- Each application must be accompanied by an Application Summary Form.
- Applications which do not conform to the above requirements, will not be accepted
- Responses should be made in blue (black may be used as an alternative).
- No information other than that which has been requested should be attached.
- Applications for Pharma Form Products (Type 1 and Type 2 only) must be accompanied by an exemption form from the Medicines and Healthcare Products Regulatory Agency (MHRA).
- Details for Pharma Form Products (Type 3 changes), as listed below, must also be sent to the MHRA via their on-line ACBS form. A copy of the resulting MHRA response must be included with the Type 3 application.
- alterations in product formulation / data sheets
- product name change
- changes to packaging / labelling
- For Type 3 applications only, the relevant paragraphs of the Information Notes / Application that are applicable to the nature of the change must be attached to the Application Summary Form. See Appendix 2.1 for further details.
Note: The following have been classed as ‘Pharma Form’ products:
- Sterile Liquids
- Sterile Powders
- Powers (this does not include powder that are made into liquids for drinks, e.g. Infant formula, meal replacement drinks or breads)
- Bath Oils
Note: specialist nutritional products, which include enteral tube feeds and oral nutritional supplements, are classed by the MHRA as non ‘Pharma Form’ Products
Please refer to Appendix 2 and Appendix 2.1 for further information about any of the above.
Applicants must confirm that the product is not registered / nor in the process of being registered in line with the Medical Devices Directive.
With regards to Pharma Form products, any information sent to the MHRA (i.e. information on the ingredients, copies of the packaging, information leaflets and promotional material) must be exactly the same as the information submitted to the ACBS, otherwise the MHRA certificate will not be valid. If any discrepancy between the two submissions is found, the ACBS will advise the MHRA who may then require a complete re-submission to confirm the original certification. It has been agreed that for future ACBS meetings, should there be any difference including packaging and product formulation between these two submissions, the application will not be considered at that forthcoming ACBS meeting.
- Applications must be accompanied by an ‘Application summary form’ for nutritional products to be considered by the ACBS.
- Applications must be accompanied by an ‘Application summary form for dermatological products to be considered by the ACBS’.
Gluten Free Foods
The range of foods suitable for people with Established Gluten Sensitive Enteropathy including Coeliac Disease has increased significantly. Many foods are now available which enhance a gluten free diet as well as those foods that provide the basics of such a regimen.
The Advisory Committee on Borderline Substances (ACBS) would like to inform manufacturers that it will only approve items that are considered to be “dietary staples”. These foods, typically, form the basis of a nutritionally balanced diet and are usually derived from grains or complex starches:
– plain breakfast cereals containing no added sugar
– breads and rolls
– crackers and crispbreads
– flours and bread mixes
– pastry mixes
– pizza bases
– xanthan gum
All these products may be based on white, brown or wholemeal grains and should not contain any additional products such as fruit, chocolate, nuts, seeds or cheese. Products should not be sugar coated or contain additional sugar in forms including sugar cream fillings and icings. Foods containing these additions will not be classed as ‘dietary staples’ and will therefore not be considered by the ACBS.
Applicants are reminded that the wording outlined on the labels / packaging must reflect the condition for which the product has been approved and the ACBS indication accurately. It must not imply that the product has other characteristics or is free from substances other than gluten.
Notes for applicants wishing to make price changes to ACBS approved products
This pricing document forms part of a series of related Information Notes which the ACBS will use when considering applications. The aim of this document is to ensure consistency and transparency in the pricing of ACBS products. The issue date for this document is April 2014
Submitting to the ACBS
Seventeen copies of the completed application should be sent to Commercial Medicines Unit at the address below:The Secretariat Advisory Committee on Borderline Substances
Department of Health
Cheshire WA7 2ES Note: The changes identified in a Type 3 Application are normally considered by the ACBS to be ‘minor changes’ and, as such, will not require 17 copies of the completed Application. Three copies of the Application should be submitted initially. However, if the Chairman decides that the Application should go before the full Committee for discussion, further copies will be required. The exception to the above procedure is a Type 3 application for price changes. For this type of application a covering letter detailing the product, presentation, current price, proposed price and the percentage change based on the current RPI (excluding mortgages) will suffice.
Samples of the product, if available, preferably in the draft packaging may be provided for the ACBS’s inspection (one sample of each product being submitted will suffice).
The deadline for fully completed applications is normally eight weeks prior to the committee meeting date.
Late or incomplete applications will not be accepted.
Applicants are advised that they must not contact members of the ACBS directly regarding their applications or to seek advice on potential applications. All correspondence with regards to ACBS matters must be made through the ACBS Secretariat.
The Advisory Committee on Borderline Substances will meet on the following dates during 2014 – submission deadlines as stated
18 March 2014 – submission deadline 28 January 2014
8 July 2014 – submission deadline 13 May 2014
11 November 2014 – submission deadline 16 September 2014
Chair: Dr Pamela Mason – Pharmacist and Consultant Nutritionist
Dr James R Courtney – General Practitioner
Dr Andrea Hilton – Pharmacist
Professor Stephen Jackson – Professor of Clinical Gerontology
Ms Una Cuthbert – Prescribing Support Dietitian
Ms Vanessa Shaw – Head of Dietetics
Professor David Silk – Consultant Gastroenterologist and Director of the Department of Gastroenterology and Nutrition
Ms Clare Soulsby – Principal Dietitian
Ms Vera Todorovic – Consultant Dietitian in Clinical Nutrition
Dr Ian R White – Consultant Dermatologist
Mr Richard Wilson – Director of Nutrition and Dietetics