Sub menu

 
 

2.1 Salts of boric acid

Scheduling of medicines and poisons
Last updated

2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #20)

2.1 Salts of boric acid

On this page: Delegate's interim decision | Materials considered | Scheduling proposal | Background information for salts of boric acid

Delegate's interim decision
Interim decision:

The delegate's interim decision under regulation 42ZCZN of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the current Poisons Standard in relation to boric acid and it salts.

The amendments relate to the delegate's final decision (published on 10 April 2018) to amend the Schedule 5 entry for boric acid aligning it with the European Union cut-off concentrations for cosmetics, to create new entries in Schedule 5 for the salts of boric acid (due to be implemented on 1 June 2019) and to create new Appendix F, Part 3 entries, as follows:

Schedule 5

BORIC ACID except

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or c) cosmetic hand cleaning preparations when labelled with a warning to the following effect:

    NOT TO BE USED FOR CHILDREN UNDER 3 YEARS OF AGE; and if the concentration of free soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  3. d)in cosmetic talc preparations containing 5 % per cent or less calculated as boron boric acid when labelled with a warning to the following effect:

    DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR CHILDREN UNDER 3 YEARS OF AGE OR LESS; and if the concentration of free soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. e)in cosmetic oral hygiene preparations containing 0.1% per cent or less calculated as boron boric acid when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR CHILDREN UNDER 3 YEARS OF AGE OR LESS; or

  5. f) in other cosmetic preparations containing 3% per cent or less calculated as boron boric acid when labelled with a warning to the following effect:

    DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR CHILDREN UNDER 3 YEARS OF AGE OR LESS; and if the concentration of free soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  6. in preparations, other than insect baits, containing 6 per cent or less calculated as boric acid.

Schedule 5 - New Entries

SODIUM BORATE (CAS No. 1330-43-4) except:

  1. in talc preparations containing 5% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

POTASSIUM BORATE (CAS No. 1332-77-0) except:

  1. in talc preparations containing 5% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

MEA-borate (CAS No. 26038-87-9) except:

  1. in talc preparations containing 5% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4) except:

  1. in talc preparations containing 5% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

Index - New Entries

SODIUM BORATE (CAS No. 1330-43-4)
Schedule 5

POTASSIUM BORATE (CAS No. 1332-77-0)

Schedule 5

MEA-BORATE (CAS No. 26038-87-9)

Schedule 5

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4)

Schedule 5

Appendix E, Part 2

BORIC ACID

A (For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once)).

Appendix F, Part 3 - New Entry

BORIC ACID when included in Schedule 5

Warning statements:

25 (Do not use on broken skin. Wash hands thoroughly after use); and

26 (powder) (and) (concentrated solutions) are dangerous if swallowed

Index - Amend Entry

BORIC ACID cross reference: BORAX

Schedule 4

Schedule 5

Appendix E, Part 2

Appendix F, Part 3

Proposed date of effect of the proposed amendment: 1 February 2020
Reasons for interim decision:

The reasons for the interim decision are as follows:

  1. the risks and benefits of the use of a substance:

    Salts of boric acid are used as excipients in a range of therapeutic goods, cosmetics and other domestic and industrial products. They are also used as both active ingredients and excipients in a range of veterinary medicines and pesticide products.

    While salts of boric acid are considered to have low to moderate effects in humans with normal use, they can still however cause minor adverse effects.

  2. the purposes for which a substance is to be used and the extent of use of a substance:

    Boric acid and its salts are used in very low concentrations in cosmetics as buffering/viscosity controlling agents, as enzyme stabilisers in domestic detergent products and as corrosion inhibitors in industrial products. Salts of boric acid are also used in personal care products (e.g. antiseptics, astringents, skin lotions, eyewash solutions).

    Salts of boric acid are also used in a range of professional and domestic animal treatment products (e.g. poultices, ear cleaners, wound ointments), insecticide products and swimming pool products (e.g. bactericides, algaecides).

    Borax can be purchased from Australian supermarkets and from online retailers.

    Boric acid is also an ingredient in a range of therapeutic products including eye drops, antifungal treatments, contact lens solution, detergents and vitamins.

  3. the toxicity of a substance:

    The main toxicological concern for boric acid and its salts in animal studies is the potential to cause reproductive and developmental effects. Testes and the developing fetus have been identified as the most sensitive targets of boron toxicity in animal studies.

    The data for oral, dermal and inhalation toxicity and genotoxicity or carcinogenicity in humans are limited or non-existent and overall, toxicity was considered to be low. No appropriate toxicological data are available for analogues boric acid and borax.

    Although no information is available on the skin sensitisation potential of chemicals in this group, based on the available information on the analogue chemicals, the chemicals in this group are not likely to be skin sensitisers.

    The limited data indicate that the chemicals in this group are unlikely to be specific respiratory irritants.

    The compounds in this group (including, tetraborates, and octaborates as well as the other boric acid salts/esters (MEA-borate, MIPA-borate, potassium borate, trioctyldodecyl borate and zinc borate) produce boric acid following contact with water.

  4. the dosage, formulation, labelling, packaging and presentation of a substance:

    All products captured by the Schedule 5 entry for boric acid should be labelled with appropriate warning statements as dictated by the toxicological profile for boric acid (specifically warnings against use in young children due to potential for developmental and reproductive toxicity, and warnings not to use on broken, peeling or irritated skin).

  5. the potential for abuse of a substance:

    Nil.

  6. any other matters that the Secretary considers necessary to protect public health:

    Nil.

Overall conclusions

In November 2017, the Joint ACMS-ACCS considered an application to amend the current entry for boric acid in Schedule 5, to remove 'excluding its salts', so that salts of boric acid are captured by the Poisons Standard. On the 10 April 2018 the delegate published a final decision to amend the Schedule 5 entry for boric acid to align it with European Union concentrations for cosmetics, and to create new entries in Schedule 5 for salts to address risks identified by the NICNAS IMAP assessment, with an implementation date of 1 June 2019. However, the amended entry contained inconsistencies with overseas requirements for cosmetics which may have unintentionally affected non-cosmetic products. In addition, the entry did not address the need to restrict access in children, or include appropriate warnings for repeated use, ingestion and developmental and reproductive toxicity.

This interim decision to amend the Poisons Standard with respect to salts of boric acid is to clarify the nature of the amendments to the entry to ensure that it is clear and unambiguous, is consistent with overseas requirements and does not inadvertently disadvantage legitimate safe use of boric acid and its salts and related products.

Materials considered

In making this interim decision, I have considered the following material:

  • The Delegate's final decision, published on 10 April 2018 to amend the current Poisons Standard with respect to salts of boric acid;
  • The public submissions received before the first closing date;
  • The advice received from the Joint Advisory Committees on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #20);
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • Section 52E of the Therapeutic Goods Act 1989, in particular (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.
Scheduling proposal

The pre-meeting scheduling proposal for salts of boric acid was published on the TGA website on 31 August 2018 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2018.

Background information for salts of boric acid

The delegate of the Secretary sought advice from the Joint Advisory Committees on Chemicals Scheduling (ACCS) and Advisory Committee on Medicines Scheduling (ACMS) on a proposal to amend the Poisons Standard with respect to boric acid and its salts. The proposed amendments relate to the final decision (published on 10 April 2018) to amend the Schedule 5 entries for boric acid and its salts (due to be implemented on 1 June 2019) and to create new Appendix F, Part 3 entries.

Purpose: to clarify the nature of the amendments to the entries to ensure that they are clear and unambiguous and do not inadvertently disadvantage legitimate safe use of Boric Acid and related products.

In this section: Scheduling proposal and reasons | Current scheduling status | Scheduling history | Australian regulations | International regulations | Substance summary | Pre-meeting public submissions | Joint ACMS-ACCS advice

Scheduling proposal and reasons

The delegate's proposed amendments to the Poison Standard[17] are:

Schedule 5 - Amend Entry

BORIC ACID except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in talc preparations containing 5% or less calculated as boron when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in oral hygiene preparations containing 0.1% or less calculated as boron when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other preparations, other than insect baits, containing 3% or less calculated as boron when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

Index - Amend Entry

BORIC ACID
cross reference: BORAX, BORON, SODIUM BORATE, POTASSIUM BORATE, MEA-BORATE AND MIPA-BORATE

Schedule 5 - New Entries

SODIUM BORATE (CAS No. 1330-43-4) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in talc preparations containing 5% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in oral hygiene preparations containing 0.1% or less of sodium borate when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other preparations containing 3% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

POTASSIUM BORATE (CAS No. 1332-77-0) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in talc preparations containing 5% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in oral hygiene preparations containing 0.1% or less of sodium borate when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other preparations containing 3% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

MEA-borate (CAS No. 26038-89-9) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in talc preparations containing 5% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in oral hygiene preparations containing 0.1% or less of sodium borate when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other preparations containing 3% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in talc preparations containing 5% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in oral hygiene preparations containing 0.1% or less of sodium borate when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other preparations containing 3% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

Index - New Entries

SODIUM BORATE (CAS No. 1330-43-4)

Schedule 5

POTASSIUM BORATE (CAS No. 1332-77-0)

Schedule 5

MEA-BORATE (CAS No. 26038-89-9)

Schedule 5

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4)

Schedule 5

Appendix F, Part 3 - New Entry

BORIC ACID, SODIUM BORATE, POTASSIUM BORATE, MEA-BORATE AND MIPA-BORATE when included in Schedule 5

Warning statements:

  • 25 (Do not use on broken skin. Wash hands thoroughly after use); and
  • 26 (powder) (and) (concentrated solutions) are dangerous if swallowed; and
  • 38 (CAUTION - Do not use for children under 2 years unless a doctor has told you to; and
  • 77 (may cause birth defects) or 46 (WARNING - contains boric acid which causes birth defects in laboratory animals. Women of child bearing age should avoid contact with boric acid).
Current scheduling status

On the 10 April 2018 the delegate published a final decision to amend the Schedule 5 entry for boric acid aligning it with European Union cut-off concentrations for cosmetics and to create new entries in Schedule 5 for salts to address risks identified by IMAP assessment as follows:

Schedule 5 - Amend Entry

BORIC ACID except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations; or
  4. in talc preparations containing 5% or less calculated as boron when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  5. in oral preparations containing 0.1% or less calculated as boron when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  6. in other preparations containing 3% or less calculated as boron when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

Index - Amend Entry

BORIC ACID
cross reference: BORAX, BORON

Schedule 5

Schedule 5 - New Entries

SODIUM BORATE (CAS No. 1330-43-4) except:

  1. in talc preparations containing 5% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

POTASSIUM BORATE (CAS No. 1332-77-0) except:

  1. in talc preparations containing 5% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

MEA-borate (CAS No. 26038-87-9) except:

  1. in talc preparations containing 5% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4) except:

  1. in talc preparations containing 5% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

Index - New Entries

SODIUM BORATE (CAS No. 1330-43-4)

Schedule 5

POTASSIUM BORATE (CAS No. 1332-77-0)

Schedule 5

MEA-BORATE (CAS No. 26038-87-9)

Schedule 5

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4)

Scheduling history

The scheduling history for boron compounds dates back to July 1968. The most recent scheduling considerations are as follows:

May and August 2001 National Drugs and Poisons Schedule Committee (NDPSC)

The May and August 2001 NDPSC Meetings agreed to revise the boron Schedule 4 entry to exempt a daily oral dose of 3 mg and to exempt dermal preparations containing 0.35 per cent or less to harmonise with the New Zealand (NZ) classification for dermal use. However, the committee did not agree to harmonise on other use patterns. This outcome was referred to NZ's Medicines Classification Committee (MCC) for consideration.

February 2006 National Drugs and Poisons Schedule Committee (NDPSC)

The February 2006 NDPSC Meeting:

  • noted that NZ had toxicity concerns regarding the use of high strength boron for nappy rash in babies under occlusive conditions.
  • noted that NZ products only contained boric acid and that boron was not listed as an ingredient in medicines. In contrast, registered ingredients for Australian therapeutic products include either boron or boric acid. A Member also noted that the boron scheduling excluded excipients and that this may need to be reviewed on the basis of the substance's toxicity.
  • recommended that NZ consider harmonising with the Australian scheduling of boron and that MCC consider submitting a proposal to the NDPSC regarding appropriate nomenclature for harmonisation.

June 2007 National Drugs and Poisons Schedule Committee (NDPSC)

The June 2007 NDPSC Meeting agreed that consideration of the scheduling of boron should be deferred, pending information from NZ regarding a potential proposal to set a new exemption cut-off, and the reasons for any such recommendation.

December 2007 NZ Medicines Classification Committee (MCC)

At the December 2007 Meeting, the MCC agreed that boron, including boric acid and borax, should be a prescription medicine except when for internal use in medicines containing 6 mg or less per recommended daily dose; for dermal use other than paediatric use, in medicines containing 0.35 per cent or less or when present as an excipient.

February and June 2008 National Drugs and Poisons Schedule Committee (NDPSC)

At the February and June 2008 NDPSC Meetings, following reconsideration of the issues (including the reasons for the adoption by New Zealand of a 6 mg cut-off for internal use), it was agreed to foreshadow the following amendments to the Schedule 4 boron entry (including capturing of all paediatric use as Schedule 4) to allow stakeholders a further opportunity to comment, and to help identify any potential unintended consequences:

  • Broadening the entry, particularly regarding topical use, by amending from an "inclusive to an exclusive form".
  • Increasing the internal use cut-off from 3 mg to 6 mg.
  • Capturing all dermal paediatric use in Schedule 4 (i.e. remove the current allowance for dermal paediatric use, when not a dusting powder and ≤ 0.35 per cent, to be unscheduled).
  • Removing the exemption for antifungal preparations for dermal use (i.e. these will be captured in Schedule 4).
  • Adding the expression "including boric acid and borax" and changing 'milligrams' in part (a) to 'mg'.

"Schedule 4 - Foreshadowed amendment

BORON - Amend entry to read:

BORON, including boric acid and borax, for human therapeutic use except:

  1. in preparations for internal use containing 6 mg or less of boron per recommended daily dose;
  2. in preparations for dermal use containing 0.35 per cent or less of boron, other than preparations other than preparations for paediatric or antifungal use; or
  3. when present as an excipient."

(The above Schedule 4 amendment was implemented in the Poisons Standard on 1 January 2009).

November 2017 Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS)

In November 2017, the Joint ACMS-ACCS considered an application to amend the current entry for boric acid in Schedule 5, to remove "excluding its salts", so that salts of boric acid are captured by the Poisons Standard. On the 10 April 2018 the delegate published a final decision to amend the Schedule 5 entry for boric acid to align it with European Union concentrations for cosmetics, and to create new entries in Schedule 5 for salts to address risks identified by IMAP assessment, with an implementation date of 1 June 2019.

Australian regulations

Boric acid is an ingredient in 80 products on the ARTG including eye drops, antifungal treatments, contact lens solution, detergents and vitamins.

Boric acid is listed in the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2018 as follows:

  Ingredient Name Purpose of the ingredient in the medicine Specific requirements
903 BORIC ACID A, H

Boron is a mandatory component of Boric acid.

The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid.

The maximum recommended daily dose must provide no more than 6 mg of Boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%.

Some members of this group (CAS Nos. 1330-43-4, sodium borate; 12267-73-1, tetraboron disodium heptaoxide; 13840-56-7, sodium orthoboric acid) are classified as hazardous for reproductive and developmental toxicity - Category 1B; H360FD (May damage fertility. May damage the unborn child) in the HCIS (Safe Work Australia).

Boric acid (CAS No. 10043-35-3) is classified as hazardous for reproductive and developmental toxicity - Category 1B; H360FD (May damage fertility. May damage the unborn child) in the HCIS (Safe Work Australia).

International regulations

European Union (EU)

EU Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products-Annex III- "List of substances which cosmetic products must not contain except subject to the restrictions laid down" with specific conditions on maximum in-use concentrations for:

  • talc (5%);
  • oral products (0.1%); and
  • other products (3%) (excluding bath products and hair waving products).

Talc products are not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5% (as boric acid), and must be labelled as follows:

  • Not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin.

Oral products are not to be used in products for children under 3 years of age, and must be labelled as follows:

  • Not to be swallowed. Not to be used in products for children under 3 years of age.

Other products are not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceed 1.5% (as boric acid), and must be labelled as follows:

  • Not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin.

The 2013 EU SCCS opinion on "the safety of boron compounds in cosmetic products" recommended further risk management. However this recommendation has not yet been implemented in legislation.

Canada

The chemicals boric acid, disodium salt, MEA-borate and MIPA-borate are listed on the Health Canada List of prohibited and restricted cosmetic ingredients (The Cosmetic Ingredient "Hotlist").

Substance summary

European Union (EU)

EU Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products-Annex III- "List of substances which cosmetic products must not contain except subject to the restrictions laid down" with specific conditions on maximum in-use concentrations for:

  • talc (5%);
  • oral products (0.1%); and
  • other products (3%) (excluding bath products and hair waving products).

Talc products are not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5% (as boric acid), and must be labelled as follows:

  • Not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin.

Oral products are not to be used in products for children under 3 years of age, and must be labelled as follows:

  • Not to be swallowed. Not to be used in products for children under 3 years of age.

Other products are not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceed 1.5% (as boric acid), and must be labelled as follows:

  • Not to be used in products for children under 3 years of age. Not to be used on peeling or irritated skin.

The 2013 EU SCCS opinion on "the safety of boron compounds in cosmetic products" recommended further risk management. However this recommendation has not yet been implemented in legislation.

Canada

The chemicals boric acid, disodium salt, MEA-borate and MIPA-borate are listed on the Health Canada List of prohibited and restricted cosmetic ingredients (The Cosmetic Ingredient "Hotlist").

Pre-meeting public submissions

One public submission was received before the first closing date in response to an invitation published on 31 August 2018 under regulation 42ZCZK of the Regulations.

The submission recommended changes to the scheduling proposal to increase alignment with EU cosmetic regulations while retaining current levels of availability for other uses. The main points of the submission were:

  • Boric acid and the four borate salts are used in very low concentrations in cosmetics as buffering/viscosity controlling agents (sodium borate), as enzyme stabilisers in domestic detergent products and as corrosion inhibitors in industrial products.
  • Inclusion of the word "cosmetic" in the exemptions for talc, oral and other cosmetic preparations, as these align with the EU Cosmetics regulation and should only apply to cosmetic products.
  • Clarification that the cut-off concentrations for the cosmetic exemptions is calculated as that of boric acid (not boron as currently proposed) to align with the EU Cosmetics regulation.
  • Removal of the words "(THIS PRODUCT/INSERT NAME OF PRODUCT)" from the warning statements, as this is unnecessary, does not add any benefit, and is additional to what is required overseas.
  • Correction of substance names in the entries for potassium borate, MEA borate and MIPA borate. (The Secretariat has corrected these typographic errors).
  • There are concerns with the proposed new Appendix F entry for these substances, as the warning statements proposed are not consistent with the schedule entries for these substances e.g.:
    • The warning statement "DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS" is required to meet the exemptions for cosmetic products, but if this statement is not applied, then the preparation is a Schedule 5 poison and the Appendix F statement of "CAUTION - Do not use for children under 2 years unless a doctor has told you to" applies. This is not consistent and does not make sense and should therefore be amended for consistency or removed.
    • The proposed Appendix F warning statements do not seem consistent with the risk profile of a Schedule 5 substance:
      • 77 (may cause birth defects) or
      • 46 (WARNING - contains boric acid which causes birth defects in laboratory animals. Women of child bearing age should avoid contact with boric acid)
  • Currently, these statements only apply to Schedule 4 and Schedule 7 substances. The previous final decision for these substances noted: No or limited data of oral, dermal and inhalation toxicity and genotoxicity or carcinogenicity. Overall, evidence from studies considered shows toxicity in these areas is low in humans. These statements should therefore be reviewed or removed.
  • Depending on the extent of any changes, an adequate transition period will be required to allow for any reformulation and/or labelling changes that would be required for products already in the Australian market.

The following changes to the proposed scheduling entries were proposed:

Schedule 5 - Amended entries

BORIC ACID except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in cosmetic talc preparations containing 5% or less calculated as boric acid when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in cosmetic oral hygiene preparations containing 0.1% or less calculated as boric acid when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other cosmetic preparations, other than insect baits, containing 3% or less calculated as boric acid when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

Schedule 5 - New Entries

SODIUM BORATE (CAS No. 1330-43-4) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in cosmetic talc preparations containing 5% or less of sodium borate (calculated as boric acid) when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in cosmetic oral hygiene preparations containing 0.1% or less of sodium borate (calculated as boric acid) when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other cosmetic preparations containing 3% or less of sodium borate (calculated as boric acid) when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

POTASSIUM BORATE (CAS No. 1332-77-0) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in cosmetic talc preparations containing 5% or less of potassium borate (calculated as boric aci when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in cosmetic oral hygiene preparations containing 0.1% or less of potassium borate (calculated as boric acid) when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other cosmetic preparations containing 3% or less of potassium borate (calculated as boric acid) when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

MEA-borate (CAS No. 26038-87-9) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in cosmetic talc preparations containing 5% or less of MEA-borate (calculated as boric acid) when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in cosmetic oral hygiene preparations containing 0.1% or less of MEA-borate (calculated as boric acid) when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other cosmetic preparations containing 3% or less of MEA-borate (calculated as boric acid) when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4) except:

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or
  3. in hand cleaning preparations when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. in cosmetic talc preparations containing 5% or less of MIPA-borate (calculated as boric acid) when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN); or

  5. in cosmetic oral hygiene preparations containing 0.1% or less of MIPA-borate (calculated as boric acid) when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; or

  6. in other cosmetic preparations containing 3% or less of MIPA-borate (calculated as boric acid) when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN UNDER 3 YEARS; and if the concentration of free soluble borates exceeds 1.5% (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN.

Joint ACMS-ACCS advice

The committee recommended that separate Schedule 5 entries for the salts of boric acid (sodium borate, potassium borate, MEA-borate and MIPA-borate are not necessary as they are captured by the scheduling entry for boric acid (and the words 'excluding its salts' has been removed). Amendments to the delegate's final decision to the Schedule 5 entry for boric acid to align with the cut-offs and wording of warnings in EU Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products-Annex III- 'List of substances which cosmetic products must not contain except subject to the restrictions laid down' are recommended as follows:

Schedule 5

BORIC ACID except

  1. when included in Schedule 4; or
  2. in preparations, other than insect baits, containing 1 per cent or less calculated as boron; or c) cosmetic hand cleaning preparations when labelled with a warning to the following effect:

    NOT TO BE USED FOR CHILDREN UNDER 3 YEARS OF AGE; and if the concentration of free soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  3. d) in cosmetic talc preparations containing 5 % per cent or less calculated as boron boric acid when labelled with a warning to the following effect:

    DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR CHILDREN UNDER 3 YEARS OF AGE OR LESS ; and if the concentration of free soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  4. e) in cosmetic oral hygiene preparations containing 0.1% per cent or less calculated as boron boric acid when labelled with a warning to the following effect:

    NOT TO BE SWALLOWED. DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR CHILDREN UNDER 3 YEARS OF AGE OR LESS; or

  5. f) in other cosmetic preparations containing 3% per cent or less calculated as boron boric acid when labelled with a warning to the following effect:

    DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR CHILDREN UNDER 3 YEARS OF AGE OR LESS; and if the concentration of free soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE USED ON PEELING OR IRRITATED SKIN; or

  6. in preparations, other than insect baits, containing 6 per cent or less calculated as boric acid.

Schedule 5 - New Entries

SODIUM BORATE (CAS No. 1330-43-4) except:

  1. in talc preparations containing 5% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of sodium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

POTASSIUM BORATE (CAS No. 1332-77-0) except:

  1. in talc preparations containing 5% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of potassium borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

MEA-borate (CAS No. 26038-87-9) except:

  1. in talc preparations containing 5% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of MEA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4) except:

  1. in talc preparations containing 5% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  2. in oral preparations containing 0.1% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS; or

  3. in other preparations containing 3% or less of MIPA-borate when labelled with a warning to the following effect:

    DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS OF AGE OR LESS.

Index - New Entries

SODIUM BORATE (CAS No. 1330-43-4)
Schedule 5

POTASSIUM BORATE (CAS No. 1332-77-0)

Schedule 5

MEA-BORATE (CAS No. 26038-87-9)

Schedule 5

MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4)

Schedule 5

Appendix E, Part 2

BORIC ACID

A (For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once)).

Appendix F, Part 3 - New Entry

BORIC ACID when included in Schedule 5

Warning statements:

25 (Do not use on broken skin. Wash hands thoroughly after use); and

26 (powder) (and) (concentrated solutions) are dangerous if swallowed

Index - Amend Entry

BORIC ACID cross reference: BORAX

Schedule 4

Schedule 5

Appendix E, Part 2

Appendix F, Part 3

In addition, the committee recommended an implementation date of 1 February 2020, to allow industry time to comply with any changes in product labelling requirements.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 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 advice included:

  1. the risks and benefits of the use of a substance:

    Risks:

    Data indicates that the hazard is considered:

    • low to moderate effects in humans with normal use
    • can cause only minor adverse effects to the human being in normal use;
    • requires caution in handling, storage, or use (S5)
    • may cause death or severe injury if ingested (S6)

    Benefits:

    • used as an excipient to improve products
  2. the purposes for which a substance is to be used and the extent of use of a substance:
    • Boric Acid and its salts are used in a wide range of cosmetics and personal products (antiseptics/astringents/skin lotions/some eyewash solutions/enamels and glazes)
    • Domestic and industrial cleaning products including dishwashing and laundry liquids.
  3. the toxicity of a substance:
    • The testes and the developing foetus have been identified as the most sensitive targets of boron toxicity in animal studies.
    • Humans: No or limited data of oral, dermal and inhalation toxicity and genotoxicity or carcinogenicity. Overall, evidence from studies considered toxicity in these areas low in humans. No appropriate data available for analogues boric acid and borax.
    • Salts of boric acid are readily converted to boric acid in aqueous solutions
  4. the dosage, formulation, labelling, packaging and presentation of a substance:

    Appropriate warnings to be included for:

    • Repeated Use
    • Ingestion
    • Developmental and Reproductive toxicity
    • Labelling and packaging to restrict use in children and child access to products with higher concentrations.

Footnotes

[17] This proposed amendment refers to the delegate's final decision, published on 10 April 2018

Help us improve the Therapeutic Goods Administration site