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Final decisions and reasons for NCEs, medicines and chemicals, November 2018

Scheduling medicines and poisons

26 April 2019

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2.1. Salts of boric acid

Part A - Final decisions on matters referred to an expert advisory committee (November 2018)

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

2.1. Salts of boric acid

Note

New text is shown as green, larger font, with a horizontal line above it.

Deleted text is shown as red, smaller font, with a strikethrough.

Delegate's final decision
Final decision

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

First aid instructions: A.

Appendix F, Part 3 - New Entry

BORIC ACID when included in Schedule 5

Warning statements: 25, 26.

Index - Amend Entry

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

Schedule 5

Schedule 4

Appendix E, Part 2

Appendix F, Part 3

Implementation date

1 February 2021

Reasons

The delegate has confirmed that the reasons for the final decision align with those for the interim decision.

Additional reasons, including consideration of the public submission on the interim decision:

Having considered the public submission on the interim decision, to further clarify which substances are captured by the boric acid entry and to facilitate compliance, the index entry will be further amended to include cross references to the additional compounds, sodium borate, potassium borate, meta-borate and mipa-borate.

Public submissions on the interim decision

One (1) public submission was received before the second closing date in response to an invitation published on 7 February 2019 under regulation 42ZCZP of the Regulations. While the submission was generally supportive, it did request minor changes to the interim decision to provide clarity and reduce the regulatory burden on industry.

The main points raised in the submission were:

  • It was previously indicated that there was a preference for the scheduling of the four salts specifically (i.e. by CAS number). If separate entries by CAS number are not supported in this case, other ways of easily identifying the substances intended to be captured by the Schedule entry should be considered i.e. by adding the four borate salts (sodium borate, potassium borate, MEA-borate, MIPA-borate) to the index with cross-references to the boric acid entry.
  • The concentration cut-off for the exemption for non-cosmetic preparations (other than insect baits) is now expressed as a percentage of boric acid instead of boron, though the effective concentration remains the same. This change provides consistency with the exemptions for cosmetic products, based on the European Union Cosmetics Regulation.
  • An adequate transition period of at least 12 months, preferably 24 months, is necessary to accommodate these changes as there is no evidence that would suggest immediate action is required for the risk management of these substances.
Interim decision

The interim decision was published on the TGA website on 7 February 2019 at Scheduling delegates' interim decisions and invitation for further comment: ACMS #25, November 2018 - 2.1 Salts of boric acid.

Scheduling proposal

The pre-meeting scheduling proposal 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.

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