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Part 3 · Presentation of oral dental gums

6. List of ingredients

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(1)

For the purposes of regulation 5(b), every ingredient of an oral dental gum must, subject to paragraphs (2) to (5), be listed by volume or by mass in descending order using nomenclature from the latest edition of any of the following publications: (a)the British Pharmacopoeia;

(b)

the Chemical Abstracts Service;

(c)

the Codex Alimentarius; (d)the Food Chemicals Codex;

(e)

the United States Pharmacopoeia.

(2)

Where an oral dental gum contains tartrazine, it must be specified in the list of ingredients as —

(a)

tartrazine;

(b)

colour (102); or

(c)

colour (FD and C Yellow No. 5).

(3)

Any flavour used as an ingredient of an oral dental gum must be specified in the list of ingredients by the word “flavour” or the ingredients of the flavour.

(4)

A substance need not be specified in the list of ingredients if it is only present as a trace which could not reasonably have been removed during or after the manufacture of the oral dental gum. (5) The Authority may, on the application of a person who intends to supply an oral dental gum, allow any ingredient of the oral dental gum to be specified as “other ingredient” in the list of ingredients if the Authority is satisfied that —

(a)

revealing the ingredient in the list of ingredients would prejudice a trade secret; and

(b)

including the ingredient in the oral dental gum is unlikely to be harmful to any consumer.

(6)

In this regulation, “flavour” means a substance used as an ingredient of any oral dental gum solely to impart a taste to the oral dental gum.

Subregulation 1

For the purposes of regulation 5(b), every ingredient of an oral dental gum must, subject to paragraphs (2) to (5), be listed by volume or by mass in descending order using nomenclature from the latest edition of any of the following publications: (a)the British Pharmacopoeia;

(b)

the Chemical Abstracts Service;

(c)

the Codex Alimentarius; (d)the Food Chemicals Codex;

(e)

the United States Pharmacopoeia.

Subregulation 2

Where an oral dental gum contains tartrazine, it must be specified in the list of ingredients as —

(a)

tartrazine;

(b)

colour (102); or

(c)

colour (FD and C Yellow No. 5).

Subregulation 3

Any flavour used as an ingredient of an oral dental gum must be specified in the list of ingredients by the word “flavour” or the ingredients of the flavour.

Subregulation 4

A substance need not be specified in the list of ingredients if it is only present as a trace which could not reasonably have been removed during or after the manufacture of the oral dental gum.

Subregulation 5

The Authority may, on the application of a person who intends to supply an oral dental gum, allow any ingredient of the oral dental gum to be specified as “other ingredient” in the list of ingredients if the Authority is satisfied that —

(a)

revealing the ingredient in the list of ingredients would prejudice a trade secret; and

(b)

including the ingredient in the oral dental gum is unlikely to be harmful to any consumer.

Subregulation 6

In this regulation, “flavour” means a substance used as an ingredient of any oral dental gum solely to impart a taste to the oral dental gum.

Report

Part 4

Advertisement of oral dental gums

Part 5

Matters relating to licences and registration

Part 6

Duties of manufacturers, importers, etc., of oral dental gums

Part 7