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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, February 2016

Scheduling medicines and poisons

3 February 2016

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2.1 Bismuth oxychloride

Part A - Interim decisions on matters referred to an expert advisory committee

2. Scheduling proposals referred to the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#16)

2.1 Bismuth oxychloride

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):

  • To exempt bismuth oxychloride for human therapeutic use from Schedule 4.
Substance summary

The applicant has provided the following information regarding Bismuth Oxychloride:

Bismuth oxychloride is a synthetically prepared white or nearly white amorphous or finely crystalline powder. Bismuth oxychloride is used in formulations of many cosmetic and personal care products, including make-up, nail products, cleansing products, fragrances and hair colouring products. Bismuth oxychloride imparts a white colour to cosmetics and personal care products.

The United States Food and Drug Administration (FDA) lists bismuth oxychloride as a colour additive exempt from certification. The FDA requires that bismuth oxychloride conforms to the following specifications and shall be free from impurities other than those named (to the extent that such other impurities may be avoided by good manufacturing practice): Volatile matter, not more than 0.5%; Lead (as Pb), not more than 20 ppm; Arsenic (as As), not more than 3 ppm; Mercury (as Hg), not more than 1 ppm; Bismuth oxychloride, not less than 98%. Bismuth oxychloride is permitted to be used to colour externally applied drugs, including those intended for use in the area of the eye. Use in lipsticks is permitted. The FDA considers that certification of bismuth oxychloride is not necessary for protection of public health.

Toxicological data presented in a journal article in 1975 provided the following summary: The pearlescent white pigment, bismuth oxychloride, which is used as a colouring agent for decorative cosmetics, was administered to BD rats in the diet in a concentration of 1, 2 or 5% for two years. Neither carcinogenic activity nor other toxic effect attributable to the test compound was detected in the animals, which were maintained on a control diet from the termination of treatment until their death.

Bismuth oxychloride was included on the Australian Register of therapeutic Goods (ARTG) in July 2002. TGA currently permits its use as an active ingredient in biologicals, and as an excipient in biologicals or medical devices. The ARTG states that bismuth oxychloride "will not be available as a starting material for OTC (products)" - this is consistent with the current scheduling of bismuth oxychloride (Schedule 4 for human therapeutic use).

The TGA regulates some sunscreens as therapeutic goods. These include primary sunscreens with SPF 4 or more, secondary sunscreens (except those regulated as cosmetics), and primary or secondary sunscreens with SPF 4 or more that contain an insect repellent. Products that contain an ingredient with sunscreening properties where the primary purpose of the product is neither sunscreening nor therapeutic ('cosmetic sunscreens') are regulated as cosmetics by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Bismuth oxychloride is not used as a UV filter, but may be included as an excipient in cosmetic products (e.g. to give makeup a shimmering effect), including cosmetic sunscreens.

In Australia, the NICNAS Inventory multi-tiered assessment and prioritisation (IMAP) framework lists the status of bismuth oxychloride (bismuthine, chlorooxo-) for cosmetic use as Tier I Final (chemicals that are not considered to pose an unreasonable risk to the health of workers and public health on the basis of the Tier I assessment).

Scheduling status

Bismuth Oxychloride is currently covered under entries for 'BISMUTH COMPOUNDS' in Schedule 4.

Schedule 4

BISMUTH COMPOUNDS for cosmetic use, except:

  1. bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5 per cent or less; or
  2. bismuth oxychloride.

BISMUTH COMPOUNDS for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth.

Scheduling history
Bismuth compounds

Poisons Standard (Standing) Committee: May 1979

The PSSC considered concerns that had been raised by the Australian Drug Evaluation Committee (ADEC) regarding the unrestricted availability of bismuth compounds (particularly the subnitrate and tripotassium dicitrata-bismuthate) and their potential to cause neurotoxicity.

The PSSC considered Schedule 4 appropriate, in view of limited published data on mechanism of action of bismuth compounds. The PSSC recommended that bismuth subgallate should be deleted from Schedule 4, and that 'Bismuth compounds for human oral use' should be inserted as a new entry in Schedule 4.

Poisons Standard (Standing) Committee: February 1984

The PSSC considered the scheduling of bismuth, including a proposal to exempt bismuth oxychloride from Schedule 4 when used as a pearlescent in cosmetics for external use (item 4.36). The PSSC had noted that the Japanese Government Advisory Scientific Medical Committee (the only other country that had imposed restrictions on bismuth oxychloride in cosmetics) had withdrawn its restrictions (see item 3.6). The PSSC supported exempting bismuth oxychloride from scheduling when used in cosmetics, and recommended that the Schedule 4 entry for 'Bismuth' should be amended to 'Bismuth, compounds of, for human therapeutic or cosmetic use, except: (a) bismuth citrate when incorporated in hair colorant preparations in concentrations of 0.5% w/w or less; (b) bismuth oxychloride in cosmetics; (c) bismuth formic iodide in dusting powder containing 3% or less of bismuth.

Poisons Standard (Standing) Committee: May 1979

The PSSC considered concerns that had been raised by the Australian Drug Evaluation Committee (ADEC) regarding the unrestricted availability of bismuth compounds (particularly the subnitrate and tripotassium dicitrata-bismuthate) and their potential to cause neurotoxicity. The PSSC considered Schedule 4 appropriate, in view of limited published data on mechanism of action of bismuth compounds. The PSSC recommended that bismuth subgallate should be deleted from Schedule 4, and that 'Bismuth compounds for human oral use' should be inserted as a new entry in Schedule 4.

Poisons Standard (Standing) Committee: February 1984

The PSSC considered the scheduling of bismuth, including a proposal to exempt bismuth oxychloride from Schedule 4 when used as a pearlescent in cosmetics for external use (item 4.36). The PSSC had noted that the Japanese Government Advisory Scientific Medical Committee (the only other country that had imposed restrictions on bismuth oxychloride in cosmetics) had withdrawn its restrictions (see item 3.6). The PSSC supported exempting bismuth oxychloride from scheduling when used in cosmetics, and recommended that the Schedule 4 entry for 'Bismuth' should be amended to 'Bismuth, compounds of, for human therapeutic or cosmetic use, except: (a) bismuth citrate when incorporated in hair colorant preparations in concentrations of 0.5% w/w or less; (b) bismuth oxychloride in cosmetics; (c) bismuth formic iodide in dusting powder containing 3% or less of bismuth.

National Drugs and Poisons Scheduling Committee: August 1999

The NDPSC considered recommendations from the Trans-Tasman Harmonisation of Scheduling Working Party (June 1999), and agreed that the Schedule 4 entry for Bismuth compounds should be replaced by two separate entries, covering bismuth compounds for cosmetic use and bismuth compounds for therapeutic use (it was noted that the New Zealand schedule only regulates medicines). The NDPSC therefore decided to create the following Schedule 4 new entries: 'Bismuth compounds for cosmetic use except: (a) bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5 per cent or less; or (b) bismuth oxychloride'; and 'Bismuth compounds for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth'.

National Drugs and Poisons Scheduling Committee: November 1999

The NDPSC supported the August 1999 decision regarding the new Schedule 4 entries for bismuth compounds.

Pre-meeting public submissions

Two submissions were received.

The supporting submission made the following main point:

  • The proposed exemption for human therapeutic use should be equivalent to the exemption that is currently in place for other bismuth compounds, namely in dusting powders containing 3 per cent or less of bismuth.

The opposing submission made the following main points:

  • In the absence of further details cannot support the proposed amendment to exempt.
  • Bismuth oxychloride is used safely for cosmetic use; however this cannot easily be transferred for therapeutic use.

The public submissions are available at Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that the current scheduling remains appropriate.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendations comprised the following:

  • No information was provided to the Committee on the type of product intended to be used.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors16;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is that the current scheduling for bismuth oxychloride remains appropriate.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; and c) the toxicity of the substance.

The reasons for the recommendation comprised the following:

  • Lack of information on the type of product intended to be used, safety data when used in therapeutic goods, and the potential of greater exposure to the substance when in a sunscreen.
  • Lack of information on the type of product intended to be used, safety data when used in therapeutic goods, and the potential of greater exposure to the substance when in a sunscreen. If the substance is to be included in a primary sunscreen, then it will be used more widely, in children, over a greater surface area. At present, the safety data is related to cosmetic use only, where this use is limited - primarily by adults only, in small areas and limited usage.
  • Lack of information on the type of product intended to be used, safety data when used in therapeutic goods, and the potential of greater exposure to the substance when in a sunscreen. If the substance is to be included in a primary sunscreen, then it will be used more widely, in children, over a greater surface area. At present, the safety data is related to cosmetic use only, where this use is limited - primarily by adults only, in small areas and limited usage.

Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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