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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

10 April 2018

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2.2 Salts of Boric Acid

Part A - Final decisions on matters referred to an expert advisory committee (November 2017)

2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #17)

2.2 Salts of Boric Acid

Delegate's final decision
Final decision:

The delegates' final decision is to amend the Schedule 5 entry for boric acid 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 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)

Schedule 5

Implementation date: 1 June 2019

The delegate notes the public submissions on the interim decision and agrees that an implementation date of 1 June 2018 is insufficient time to allow for relabelling and re-formulation of affected products. An implementation of 1 June 2019 will allow for any necessary labelling changes.

Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

  1. the risks and benefits of the use of a substance:
    • Benefits:
      • Salts of boric acid are used as excipients to improve products.
    • Risks:
      • Salts of boric acid are considered to have low to moderate effects in humans with normal use;
      • Salts of boric acid can cause minor human adverse effects with normal use;
      • Salts of boric acid requires caution in handling, storage, or use in alignment with the criteria for Schedule 5
  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 domestic/industrial cleaning products (E.g. dishwashing and laundry liquids), cosmetics, and personal products (E.g. antiseptics, astringents, skin lotions, eyewash solutions), as well as enamels and glazes.
  3. the toxicity of a substance:
    • Studies show reproductive and developmental effects as a result of exposure to boric acid and its salts in sensitive animals.
      • Testes and the developing foetus have been identified as the most sensitive targets of boron toxicity in animal studies.
    • Sodium borate (CAS No. 1330-43-4) and analogues boric acid (CAS No. 10043-35-3), borax (CAS No. 1303-96-4) and zinc borates suggest that the chemicals in this group are likely to have low acute toxicity in animal tests following oral exposure.
    • The median lethal dose (LD50) in rats for the tested chemicals in the group and the analogue chemicals is >2000 mg/kg bw. The boric acid amine salts (MEA-borate and MIPA-borate) are also expected to have low acute oral toxicity (>2000 mg/kg bw).
    • Toxicity in humans:
      • 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.
    • 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 Warning for:
      • Repeated Use;
      • Ingestion; and
      • Developmental and Reproductive toxicity.
    • Labelling and packaging should restrict use in children and child access to products with higher concentrations.
  5. the potential for abuse of a substance:
    • Nil.
  6. any other matters that the Secretary considers necessary to protect public health:
    • Nil.
Public submissions on the interim decision

Two (2) public submissions were received, both of which oppose the interim decision for salts of boric acid. The main points include:

The main points in support were:
  • The interim decision appears to have no impact on the many complementary medicines which include borax below the 6 mg per daily dose cut-off. However, the proposed changes if implemented would affect products currently in the Australian market with an established history of safe use.
  • There is no evidence that suggests immediate action is required for the risk management of these substances. An implementation date of 1 October 2018 is insufficient time for research, re-formulation, testing and relabelling of affected products. An adequate transition period of 12-30 months is requested.
  • Amending the current Schedule 5 entry for boric acid may result in the inadvertent regulation of substances other than the 5 that were identified to be of concern in the IMAP assessment.
  • The generic nature of proposed entry makes it difficult for industry to identify those substances which are intentionally captured, or those inadvertently captured by the proposed schedule entry. This has caused significant problems previously and continues to do so due to the derivatives issue.
  • Scheduling of these 5 substances specifically (i.e. by CAS number) is preferred over an unqualified "all salts" entry and is consistent with addressing the risks identified for these 5 substances in the IMAP assessment.
  • These substances are currently permitted for use in cosmetics in the EU with specific conditions on maximum in-use concentrations for talc (5%), oral products (0.1%) and other products (3%). Other conditions include restrictions and label statements to the effect of "Not to be used in products for children under 3 years of age". Alignment with the EU concentrations for cosmetics is preferred. If the proposed scheduling requirements are not aligned, changes to labelling and/or reformulation of products will be required.
  • Other (non-cosmetic) products containing boric acid salts above 1% (such as metalworking fluids) will also go from being unscheduled to being Schedule 5 poisons.
Interim decision

The interim decision for salts of boric acid was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 2.2. Salts of Boric Acid.

Scheduling proposal

The pre-meeting scheduling proposal for salts of boric acid was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.

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