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Consultation: Referral of proposed amendments to the current Poisons Standard to the ACMS, Joint ACCS-ACMS or ACCS meeting, November 2018

Invitation to comment

31 August 2018

This consultation closed on 28 September 2018.

Invitation for public submissions

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary decides to refer a proposed amendment to the current Poisons Standard to an expert advisory committee pursuant to regulation 42ZCZJ of the Regulations.

Details of the proposed amendment which a delegate of the Secretary has referred to the November 2018 meetings of the Advisory Committee on Medicines Scheduling (ACMS #25), the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #20), or the Advisory Committee on Chemicals Scheduling (ACCS #23) are set out below.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions to be made in relation to the proposed amendment on or before close of business on 28 September 2018 (first closing date). See the section below titled: How to make a submission.

1. Details of proposed amendments referred for scheduling advice to ACMS #25

Substance Proposal
Nabiximols CAS numbers

Nabiximols

56575-23-6

Cannabidiol

13956-29-1

Tetrahydrocannabinol

1972-08-3

Alternative name Sativex
Applicant Private applicant
Current scheduling

Nabiximols is currently in Schedule 8 and Appendices D and K of the Poisons Standard as follows:

Schedule 8

# NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinols, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acids, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinols and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use.

Appendix D, Item 1

NABIXIMOLS

Appendix K

NABIXIMOLS

Index

NABIXIMOLS

cross reference: CANNABICHROMENE, CANNABIDIOL, CANNABIDIOLIC ACID, CANNABIDIVAROL, CANNABIGEROL, CANNABINOIDS, CANNABINOL, CANNABIS SATIVA, TETRAHYDROCANNABINOLIC ACID, TETRAHYDROCANNABINOLS, TETRAHYDROCANNABIVAROL

Schedule 8
Appendix D, Item 1
Appendix K

Proposed scheduling

A request has been made to down-schedule nabiximols from Schedule 8 to Schedule 4 (with revised wording) and delete the Appendix D, Item 1 entry for nabiximols as follows:

Schedule 84 - Proposed Amended Entry (Schedule 8 to Schedule 4)

# NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinols, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acids, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinols delta-9-tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray with a concentration of not more than 30 milligrams of cannabidiol per millilitre, and not more than 30 milligrams of tetrahydrocannabinols per millilitre, and registered on the Australian Register of Therapeutic Goods for human therapeutic use.

Appendix D, Item 1 - Delete Entry

NABIXIMOLS

Appendix K - Current Entry (No change proposed)

NABIXIMOLS

Index
NABIXIMOLS

cross reference: CANNABICHROMENE, CANNABIDIOL, CANNABIDIOLIC ACID, CANNABIDIVAROL, CANNABIGEROL, CANNABINOIDS, CANNABINOL, CANNABIS SATIVA, TETRAHYDROCANNABINOLIC ACID, TETRAHYDROCANNABINOLS, TETRAHYDROCANNABIVAROL

Schedule 84
Appendix D, Item 1
Appendix K

Key uses / expected use Medicines
Applicant reasons for proposal
  • Nabiximols is regulated as an approved medicine and controlled under a Risk Management Plan in Australia by the TGA.
  • Nabiximols at established therapeutic dosage levels does not produce dependency or have a high propensity for misuse, abuse, or illicit use.
  • Nabiximols is currently available as a prescription medicine in 26 other countries with scheduling that is similar to Schedule 4 in Australia. This level of control has not led to abuse, diversion, dependence or use for illegal purposes of nabiximols.
  • As of 26th June 2018 there have been no post-marketing reports of abuse or diversion reported spontaneously from healthcare professionals in the global safety database.
  • Nabiximols meet the Scheduling Policy Framework criteria for Schedule 4.
  • It is estimated that there have been 82060 patient years of exposure to nabiximols from post-marketing and compassionate use. There are no important interactions considered to be a safety concern, or emergent in the post-market data. The potential for interactions is managed in the current wording of the PI and monitored as part of the RMP and ASA through Pharmacovigilance.
  • The risk profile of the nabiximols product is considered to be well defined.
Racetams and nootropics CAS numbers 72432-10-1, 135463-81-9, 126100-97-8, 110958-19-5, 97205-34-0, 77191-36-7, 157115-85-0, 62613-82-5, 77472-70-9, 68497-62-1, 18356-28-0, 357336-74-4, 314728-85-3, 272786-64-8
Alternative names aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram
Applicant This proposed amendment has been initiated by a delegate of the Secretary of the Department of Health.
Current scheduling The racetams, brivaracetam, levetiracetam and piracetam, are in Schedule 4 (Prescription Only Medicine) of the Poison Standard. Brivaracetam and levetiracetam are also in Appendix K. Aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram are not specifically scheduled but are all captured as derivatives of the Schedule 4 entries for brivaracetam, levetiracetam and piracetam as above
Proposed scheduling

A new Schedule 4 group entry for racetams is proposed, in addition to new specific Schedule 4 entries for aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram as follows:

Schedule 4 - New Entries

RACETAMS except when separately specified in these Schedules

ANIRACETAM.

COLURACETAM.

DIMIRACETAM.

FASORACETAM.

METHYLPHENYLPIRACETAM.

NEBRACETAM.

NEFIRACETAM.

OMBERACETAM.

OXIRACETAM.

PHENYLPIRACETAM.

PRAMIRACETAM.

ROLZIRACETAM.

SELETRACETAM.

SUNIFIRAM.

UNIFIRAM.

Key uses / expected use Medicines
Reasons for proposal
  • Aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram are not specifically scheduled. Although captured as derivatives by the Schedule 4 entries for the racetams, brivaracetam, levetiracetam and piracetam, specifically scheduling these racetams will clarify their scheduling status as Schedule 4 substances.
  • Due to their potential use and adverse events the proposal recommends that these should be prescription only medicines.

2. Details of proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #20

Substance Proposal
Naphthalene CAS number 91-20-3
Alternative name Bicyclo[4.4.0]deca-1,3,5,7,9-pentaene
Applicant Private applicant
Current scheduling

Naphthalene is currently listed in Schedules 6, and Appendices E, F and G of the Poisons Standard as follows:

Schedule 6

NAPHTHALENE (excluding its derivatives) except in liquid hydrocarbons as an impurity.

Appendix E, Part 2

Standard statements: 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), G1 (Urgent hospital treatment is likely to be needed), G3 (If swallowed, do NOT induce vomiting)

Schedule F, Part 3

Naphthalene Warning statements Safety direction
  1. in block, ball, disc, pellet or flake form, enclosed in a device which, in normal use, prevents removal or ingestion of its contents.

9 (Can be fatal to children if sucked or swallowed);

105 (Do not use on the bedding or clothing of infants or in the bedrooms of children 3 years of age or less)

 
  1. in other forms.

9 (Can be fatal to children if sucked or swallowed);

105 (Do not use on the bedding or clothing of infants or in the bedrooms of children 3 years of age or less)

1 (Avoid contact with eyes)

Appendix G

NAPHTHALENE

Concentration (quantity per litre or kilogram): 1 mg

Naphthalene is also subject to additional labelling and container requirements as outlined in Part 2 of the Poisons Standard.

Proposed scheduling

A request has been made to reschedule naphthalene from Schedule 6 to Schedule 7 as follows:

Schedule 6

NAPHTHALENE (excluding its derivatives) except in liquid hydrocarbons as an impurity.

Schedule 7 - New Entry

NAPHTHALENE (excluding its derivatives) except in liquid hydrocarbons as an impurity.

Key uses / expected use Industrial, research, domestic
Applicant reasons for proposal
  • The sale of naphthalene to the public in the form of mothballs is an unacceptable risk. Reports of poisonings in Australia continue and there are regular enquiries to state Poisons Information Centres regarding mothball exposure.
  • Sale of naphthalene has been banned in the EU and New Zealand.
  • Inhalation of naphthalene vapours can cause toxic reactions and containment in a device that prevents ingestion will not prevent this.
  • There are safer alternatives to naphthalene including camphor and 1,4-dichlorobenzene.
Salts of boric acid CAS numbers

Boric acid: 1330-43-4

Sodium borate: 1330-43-4

Potassium borate: 1332-77-0

MEA-borate: 26038-87-9

MIPA-borate: 26038-90-4 and 68003-13-4

Applicant This proposed amendment has been initiated by a delegate of the Secretary of the Department of Health.
Scheduling entry as of 1 June 2019

Current scheduling decision (effective from 1 June 2019).

On the 10 April 2018 the delegate made a final decision to amend the Schedule 5 entry for boric acid (on 1 June 2019) 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 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. 26038-89-9) 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. 26038-89-9)

Schedule 5

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

Schedule 5

Proposed changes to delegate's final scheduling decision (as published on TGA website 10 April 2018)

The proposed amendments to the Poisons Standard 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).
Key uses / expected use Cosmetic, domestic, veterinary, agriculture, industrial use, pesticide formulations
Reasons for proposal
  • 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 (i.e. specifically warnings for repeated use, ingestion and developmental and reproductive toxicity).
  • Addition of the words 'hygiene' and 'NOT TO BE SWALLOWED' will provide clarification regarding oral preparations containing boric acid.
  • The proposed warning statements, including 'not to be used on peeling or irritated skin,' are intended to be consistent with European labelling requirements for cosmetic and personal hygiene products.
International restrictions
  • 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 and labelling for talc (5%), oral products (0.1%), and other products (3%) (excluding bath products and hair waving products).
Atranol and chloratranol Substance Atranol Chloratranol
CAS number 526-37-4 57074-21-2
Alternative names 2,6-dihydroxy-4-methylbenzaldehyde (IUPAC and INCI); orcal; p-orsellinaldehyde 3-chloro-2,6-dihydroxy-4-methylbenzaldehyde (IUPAC and INCI); Benzaldehyde, 3-chloro-2,6-dihydroxy-4-methyl
Applicant The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Existing Chemicals Program
Current scheduling Atranol and chloroatranol are not scheduled in the current Poisons Standard.
Proposed scheduling

A proposal has been made to create new Schedule 10 entries for atranol and chloroatranol. Please note that the implementation date will align as closely as possible with the final prohibition date in Europe (23 August 2019).

The Schedule 10 entry proposal is as follows:

Schedule 10 - New Entries

ATRANOL.

CHLOROATRANOL.

Key uses / expected use Cosmetic
Reasons for proposal
  • Atranol and chloroatranol are the main allergenic constituents of oak moss extract and tree moss extract, which are used in fine fragrances and a wide range of cosmetic products.
  • Atranol and chloroatranol are extremely potent fragrance allergens that elicit allergic reactions at very low concentrations; and
  • Atranol and chloroatranol are to be prohibited for cosmetic use overseas based on their sensitisation potency.
International restrictions

Atranol and chloroatranol are listed on the following:

  • EU Cosmetics Regulation 2017/1410 Annex II - List of substances prohibited in cosmetic products; and
  • Association of South East Asian Nations (ASEAN) Cosmetic Directive Annex II - List of substances which must not form part of the composition of cosmetic products.
Solvent yellow 33 CAS numbers 8003-22-3 and 6493-58-9
Alternative names

8003-22-3: C.I. Solvent Yellow 33 (CAS); Solvent Yellow 33; C.I. 47000; Yellow 11; Quinoline Yellow SS

6493-58-9: 1H-indene-1,3(2H)-dione, 2-(6-methyl-2-quinolinyl)- (CAS); 2-(6-methyl-2-quinolyl)-1H-indene-1,3(2H)-dione; 1,3-indandione, 2-(6-methyl-2-quinolyl)-

Applicant The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Existing Chemicals Program
Current scheduling Solvent Yellow 33 is not specifically scheduled in the current Poisons Standard.
Proposed scheduling

A proposal has been made to create a new Schedule 10 entry in the Poisons Standard for Solvent Yellow 33 as follows:

Schedule 10 - New Entry

SOLVENT YELLOW 33 for use in products applied to mucous membranes (the oral cavity, on the rim of the eyes and genital region), and in hair dye preparations.

Key uses / expected use Cosmetics and therapeutic goods
Reasons for proposal
  • The chemical have been identified as sensitisers and having carcinogenic potential (GHS category 2).
International restrictions

Solvent Yellow 33 is listed on the following:

  • European Commission (EC) Cosmetics Regulation Annex II (List of substances prohibited in cosmetic products): when used as a substance in hair dye products (CosIng);
  • EC Cosmetics Regulation Annex IV (List of colourants allows in cosmetic products): with a condition 'not to be used in products applied on mucous membranes' (CosIng);
  • US FDA Colour Additive Status List 3 (Colour additives subject to certification and permanently listed for use in externally applied drugs and cosmetic): not to be used in products that are used in the area of the eye; and
  • The Association of Southeast Asian Nations (ASEAN) Cosmetic Directive (2018) and New Zealand Cosmetic Products Group Standard (2017) adopted the cosmetic regulations similar to the EU.

3. Details of proposed amendments referred for scheduling advice to ACCS #23

Substance Proposal
2-chloro-p-phenylenediamine CAS numbers 615-66-7 and 6291-71-2
Alternative names

615-66-7: 1,4-benzenediamine, 2-chloro; 2-chlorobenzene-1,4-diamine;

6291-71-2: 1,4-benzenediamine, 2-chloro-, sulfate; 2-chloro-p-phenylenediamine sulfate; 2-chlorobenzene-1,4-diammonium sulfate

Applicant The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Existing Chemicals Program
Current scheduling 2-chloro-p-phenylenediamine is not specifically scheduled in the current Poisons Standard.
Proposed scheduling

A proposal has been made to amend existing scheduling entries for PHENYLENEDIAMINES in Schedules 6 and 10 in the Poisons Standard to include halogenated derivative of phenylenediamines as follows:

Schedule 6

PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives not elsewhere specified in these Schedules:

  1. in preparations packed and labelled for photographic purposes;
  2. in preparations packed and labelled for testing water except tablets containing 10 mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging provided the directions for use include the statement, "Do not discard testing solutions into the pool";
  3. in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:
    • KEEP OUT OF REACH OF CHILDREN, and
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.
    • written in letters not less than 1.5 mm in height; or
  4. in eyelash and eyebrow tinting products when the immediate container and primary pack are labelled with the following statement:
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals, and when used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.
    • written in letters not less than 1.5 mm in height.

Schedule 10

PHENYLENEDIAMINES, including alkylated, arylated, halogenated and nitro derivatives, in preparations for skin colouration, tattooing and dyeing of eyelashes or eyebrows except when included in Schedule 6.

Key uses / expected use Cosmetics, domestic and industrial
Reasons for proposal
  • These chemicals have been identified as strong skin sensitisers and are acutely toxic following oral exposure.
  • the chemical and its sulfate are reported to have international use in cosmetics for dyeing hair, eyebrows and eyelashes, and in domestic products. It is expected they are used in similar products in Australia; and
  • there is evidence of severe allergic reactions in humans when 2-chloro-p-phenylenediamine is used to dye eyebrows and eyelashes.

How to make a submission

The expert advisory committee must consider all public submissions received by the first closing date which:

  • are relevant to the proposed amendment; and
  • address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 (Act).

Accordingly, to ensure that your submission is considered, your submission should:

  • be relevant to the proposed amendment (and/or address a matter mentioned in section 52E of the Act); and
  • be sent by the first closing date to MedicinesScheduling@health.gov.au for substances referred to the ACMS or Joint ACMS-ACCS, or ChemicalsScheduling@health.gov.au for substances referred to the ACCS. (Please include 'Proposed Amendments to the Poisons Standard (Medicines/Chemicals)' in the subject line of the email);

Ideally, your submission should:

  • be accompanied by a completed TGA Consultation submission coversheet;
  • be no more than 3 pages;
  • include any suggested improvements to the proposed amendment; and/or
  • include an assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

Publication of submissions received on or before the first closing date

Pursuant to regulation 42ZCZL(3) and (4), the Secretary will publish all public submissions received on or before the first closing date on the TGA's webpage titled: Public submissions on scheduling matters.

The Secretary will not, however, publish any information that the Secretary considers to be confidential information.

Accordingly, in order to assist the Secretary to make this assessment, please:

  • complete a TGA Consultation submission coversheet
  • highlight any text within the body of your submission that you want to remain confidential in grey and mark as 'IN CONFIDENCE'.

Further information about how TGA considers information which might be personal or sensitive in nature is set out below in the section titled Privacy and your personal information.

What will happen next

After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment. The Secretary will then, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.

Interim decisions will be published on the TGA website: Scheduling delegate's interim decisions & invitations for further comment

Privacy and your personal information

The Therapeutic Goods Administration (TGA) collects your personal information in this submission in order to:

  • Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
  • Help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).

The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if, when making your submission, you consent to the publication of this information. If at any point in time, you change your mind and wish for your personal information to be redacted then please contact the Scheduling Secretariat at MedicinesScheduling@health.gov.au so that the public submissions can be updated accordingly.

The TGA will not publish information it considers confidential, including yours/other individuals' personal information (unless you/they have consented to publication or it is required by law) or commercially sensitive information. Also, the TGA will not publish information that could be considered advertising or marketing (e.g. logos or slogans associated with products), information about any alleged unlawful activity or that may be defamatory or offensive.

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

For general privacy information, please go to the TGA's webpage on Privacy. The TGA is part of the Department of Health and the link includes a link to the Department's privacy policy and contact information if you have a query or concerns about a privacy matter.

Enquiries

Any questions relating to submissions should be directed by email to MedicinesScheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS) or ChemicalsScheduling@health.gov.au (for substances referred to the ACCS).