Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS

Invitation to comment

12 April 2018

Scheduling amendments referred to expert advisory committee

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on scheduling proposals referred to the June 2018 meetings of the Advisory Committee on Medicines Scheduling (ACMS #24), the Advisory Committee on Chemicals Scheduling (ACCS #23), and the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #19).

Submissions must be received by close of business Thursday 10 May 2018. See How to respond

Proposed amendments referred for scheduling advice to ACMS #24

Substance Proposal
Budesonide CAS number 51333-22-3
Alternative names (11-beta,16-alpha)-16,17-(Butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione
Applicant Private applicant.
Current scheduling

Budesonide is currently in Schedules 2 and 4 of the Poisons Standard as follows:

Schedule 2

BUDESONIDE in aqueous nasal sprays delivering 50 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

Schedule 4

BUDESONIDE except when included in Schedule 2.

Proposed scheduling

A request has been made to:

  • Amend the Schedule 2 entry for budesonide to increase the dose per actuation from 50 to 64 micrograms; and
  • Remove the limit of 200 actuations.

Schedule 2 - Amend Entry

BUDESONIDE in aqueous nasal sprays delivering 5064 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

Key uses/expected use Medicines.
Reasons for proposal
  • Allergic rhinitis (AR) it is of substantial public health significance and is widely considered as the most common chronic respiratory disorder.
  • Symptoms of AR can have a significant impact on the quality of life.
  • AR is a condition that has been well established as suitable for both self-diagnosis and self-treatment.
  • People who need to continue with the maximum dose of budesonide to maintain symptom control will benefit from the proposed Schedule 2 64 ?g strength, which requires only 4 sprays per day compared to the current 8 sprays per day.
  • The proposed amendment to the Schedule 2 entry for budesonide is likely to have a potentially broad positive healthcare impact by improving AR compliance and treatment outcomes.
Ibuprofen combined with paracetamol Substance Ibuprofen Paracetamol
CAS number 15687-27-1 103-90-2
Alternative names (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid (IUPAC); α-Methyl-4-(isobutyl)phenylacetic acid, (±)-2-(4-Isobutylphenyl)propanoic acid; isobutylphenylpropionic acid. N-(4-hydroxyphenyl)acetamide (IUPAC); 4'-Hydroxyacetanilide; 4-Acetamidophenol, N-Acetyl-4-aminophenol; N-acetyl-p-aminophenol (APAP); Acetaminophen.
Applicant Private applicant.
Current scheduling

Paracetamol is currently in Schedules 2, 3 and 4 of the Poisons Standard.

Ibuprofen is currently in Schedules 2, 3 and 4 of the Poisons Standard.

Proposed scheduling

A request has been made to:

  • Amend the Schedule 3 entry for paracetamol to allow the Schedule 3 primary pack size, when combined with ibuprofen, to be increased from 30 to 50 dosage units; and
  • Amend the Schedule 4 entry to reflect this change.

Schedule 3 - Amend Entry

PARACETAMOL when combined with ibuprofen in a primary pack containing 3050 dosage units or less except when included in Schedule 2.

Schedule 4 - Amend Entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 3050 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection.
Key uses/expected use Medicines.
Reasons for proposal
  • Paracetamol and ibuprofen have been available for many years without a prescription in Australia.
  • Fixed dose combinations of paracetamol and ibuprofen offer greater analgesic efficacy at a lower dose while maintaining the acceptable safety profile of each active alone.
  • The availability of larger pack sizes of ibuprofen/paracetamol combinations will allow pharmacists to exercise greater discretion in assisting clients with acute intermittent strong pain.
  • The proposed amendment will allow pharmacists to offer a safer, more economical and convenient alternative to the stronger analgesics available through medical practitioners.
  • The total amount of paracetamol and ibuprofen in the proposed 50 pack is less than half the amounts present in the existing Schedule 2 packs of the separate ingredients.
Codeine CAS number 76-57-3
Alternative names Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5-alpha,6-alpha)- (9CI); methylmorphine; codeine phosphate; codeine anhydrous; morphine monomethyl ether.
Applicant Private applicant.
Current scheduling Codeine is currently in Schedules 4 and 8 and Appendix K of the Poisons Standard.

Proposed scheduling

A request has been made to amend the Schedule 4 and 8 entries for codeine to:

  • Up-schedule codeine from Schedule 4 to Schedule 8 when in divided preparations containing more than 12 mg of codeine per dosage unit;
  • Up-schedule codeine from Schedule 4 to Schedule 8 when in undivided preparations containing more than 0.25 per cent of codeine; and
  • Amend both Schedule 4 and 8 entries for codeine to reflect these changes.

Schedule 4 - Amend Entry

CODEINE when compounded with one or more other therapeutically active substances:

  1. in divided preparations containing 3012 mg or less of codeine per dosage unit; or
  2. in undivided preparations containing 10.25 per cent or less of codeine.

Schedule 8 - Amend Entry

CODEINE alone or when compounded with one or more other therapeutically active substances:

  1. in divided preparations containing more than 12 mg of codeine per dosage unit; or
  2. in undivided preparations containing more than 0.25 per cent of codeine

except when included in Schedule 4.

Key uses/expected use Medicines.
Reasons for proposal
  • The proposal seeks to address scheduling inconsistencies highlighted in the Regulation Impact Statement (RIS). This will be achieved by moving high dose codeine-containing medicines and single ingredient 30 mg codeine into Schedule 8 where, as suggested by the RIS, these products belong.
  • By up-scheduling high dose codeine-containing medicines to Schedule 8, they will be monitored by State and Territory Real Time Monitoring systems.
Sildenafil CAS number 171599-83-0 (as citrate)
Alternative names 5-[2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-D-]pyrimidin-7-one dihydrogen 2-hydroxypropane-1,2,3- tricarboxylic acid.
Applicant Private applicant.
Current scheduling

Sildenafil is currently in Schedule 4 of the Poisons Standard as follows:

Schedule 4

SILDENAFIL.

Proposed scheduling

A request has been made to:

  • Create a new Schedule 3 entry for sildenafil in oral preparations containing 50 mg of sildenafil per dosage unit in packs containing not more than 8 dosage units;
  • To include sildenafil in Appendix H to permit advertising; and
  • To include sildenafil in Appendix M to provide additional controls or supply requirements to allow sildenafil to be supplied by a pharmacist.

Schedule 3 - New Entry

SILDENAFIL in divided preparations for oral use containing 50 mg of sildenafil per dosage unit in packs of not more than 8 dosage units when compliant with the requirements of Appendix M.

Schedule 4 - Amend Entry

SILDENAFIL except when included in Schedule 3.

Appendix M - New Entry

Supply of Schedule 3 sildenafil will be contingent on:

  • the sponsor making Continuing Professional Development (CPD) accredited training available to pharmacists; and
  • the sponsor providing a patient assessment tool to facilitate screening and counselling by the pharmacist.

Appendix H - New Entry

SILDENAFIL.

Key uses / expected use Medicines.
Reasons for proposal
  • Non-prescription availability of sildenafil 50 mg with appropriate informative consumer and pharmacist educational programmes, and advertising of Schedule 3 sildenafil 50 mg, will help to reach many men with erectile dysfunction (ED) who currently do not seek help from their doctor about their condition. It will also direct men away from the unregulated supply of purported ED medications.
  • The proposed re-scheduling will help destigmatise ED, raise awareness of the causes of ED and its association with more chronic conditions such as cardiovascular disease (CVD) and diabetes, encourage treatment seeking behaviour, and will offer the potential for earlier and more frequent interaction with the primary healthcare system.
  • The important risks for non-prescription sildenafil 50 mg are consistent with those that have been established for sildenafil in the prescription setting. These risks can be effectively managed in the pharmacy setting through routine risk minimisation measures that have been specifically tailored for non-prescription use. Benefits outweigh the risks, and all risks can be appropriately managed through Schedule 3 availability. Any incremental risks associated with non-prescription availability and advertising of sildenafil 50 mg can be effectively managed in the pharmacy setting through key measures such as pharmacist intervention at the point of sale, pharmacist training and consumer education.
Cannabidiol and tetrahydrocannabinols (THC) Substance Cannabidiol THC
CAS number 13956-29-1 1972-08-03
Alternative names 2-[(1R,6R)-3-methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol (IUPAC). Dronabinol (INN); (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo(b,d)pyran-1-ol (USPDDN); (-)-(6aR,10aR)-6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol (IUPAC).
Applicant Private applicant.
Current scheduling

Cannabidiol is in Schedules 4 and 8 of the Poisons Standard.

THC is in Schedules 8 and 9 and Appendices D and K of the Poisons Standard.

Proposed scheduling

A request has been made to amend the wording of the Schedule 4 entry for cannabidiol to reflect absolute weight per volume of no more than 1% w/v of the product rather than relative to the cannabidiol content.

Schedule 4 - Amend Entry

CANNABIDIOL in preparations for therapeutic use containing 2 per cent or less ofwhere other cannabinoids found in cannabis comprise no more than 1% w/v of the product.

Key uses / expected use Medicines.
Reasons for proposal

According to Therapeutic Goods Order No. 93 (TGO 93), Standard for Medicinal Cannabis) 4 (2):

"...are taken to be active ingredients for the purposes of this order (whether or not those ingredients are specified, disclosed, purported or notified to the Secretary to be active ingredients):

  1. any tetrahydrocannabinol present in a medicinal cannabis product, the quantity or proportion of which (together with any corresponding acid) is greater than or equal to 1.0% w/w or w/v of the product"
Alkyl nitrites CAS number

N/A (group entry).

Examples of volatile alkyl nitrites not listed in the Poisons Standard include:

  • 110-46-3, isopentyl nitrite (nitrous acid, 3-methylbutyl ester, isoamyl nitrite);
  • 541-42-4, 2-propyl nitrite (IUPAC) synonyms: isopropyl nitrite, isopropyl alcohol nitrite, nitrous acid, isopropyl ester, 1-methylethyl nitrite, 2-propyl nitrite;
  • 543-67-9, N-propyl nitrite, Propyl nitrite; Propanol nitrite; Nitrous acid, propyl ester; N-Propyl-nitrite; and
  • 5156-40-1, cyclohexyl nitrite (IUPAC) (nitrous acid, cyclohexyl ester; N-cyclohexyl nitrite; cyclohexyl alcohol nitrite; C-hexyl nitrite; O-nitrosocyclohexanol).
Applicant Delegate initiated
Current scheduling Five (5) alkyl nitrites (amyl nitrite, butyl nitrite, isoamyl nitrite, isobutyl nitrite and octyl nitrite) are in Schedule 4 of the Poisons Standard.

Proposed scheduling

The proposed scheduling is aimed to reduce the misuse and abuse of alkyl nitrites in lubricants and inhalants/'poppers' for recreational use by:

  • Amending the Appendix A entry for lubricants to clarify use for 'preparations that provide a lubricating action between machinery parts'; and
  • Including a group entry for volatile alkyl nitrites in Schedule 4.

Schedule 4 - New Entry

ALKYL NITRITES except those specifically listed elsewhere in these Schedules.

Appendix A - Amend Entry

LUBRICANTS in preparations that provide a lubricating action between machinery parts, except soluble oils and solvent-deposited lubricating agents.

Key uses / expected use Medicines and industrial use.
Reasons for proposal
  • There are increasing reports of misuse and abuse of 'poppers' containing short chain volatile alkyl nitrites for purposes of recreational use alongside narcotics in the clubbing/dance scene in Australia and globally.
  • Some suppliers of products containing alkyl nitrites for illicit use are claiming that these substances are used for their lubricant properties and are therefore exempt from scheduling.
  • Ophthalmologists in Australia are reporting an increase in the number of cases of maculopathies (retinal damage) caused by recreational use of poppers/'lubricants' containing alkyl nitrites. These reports have also been observed internationally.

Proposed amendments referred for scheduling advice to ACCS #23

Substance Proposal
Carbendazim CAS number 10605-21-7
Alternative names Methyl N-(1H-benzimidazol-2-yl)carbamate (IUPAC); Carbendazole; Mecarzole; Bavistin; Carbendazim/e; 1h-benzimidazole-2-carbamic acid, methyl ester; 2-(methoxycarbonylamino)benzimidazole; carbendazyme; carbendazim/e.
Applicant Private applicant.
Current scheduling

Carbendazim is in Schedule 7 of the Poisons Standard as follows:

Schedule 7

CARBENDAZIM except in paints, jointing compounds and sealants containing 0.1 per cent or less of carbendazim.

Proposed scheduling

To reschedule carbendazim when used for industrial purposes from Schedule 7 to Schedule 5, as follows:

Schedule 7 - Amend Entry

CARBENDAZIM except when in Schedule 5 in paints, jointing compounds and sealants containing 0.1 per cent or less of carbendazim.

Schedule 5 - New Entry

CARBENDAZIM when 99.5%, or greater purity, for use in paints, jointing compounds, plaster boards and sealants except when they contain 0.35% or less carbendazim.

Key uses/expected use Fungicide in paints, jointing compounds and sealants.
Reasons for proposal
  • New toxicology data is available to support a scheduling amendment for carbendazim when it is used for industrial purposed as a film biocide to provide fungal protection to stop the growth of mould.

Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #19

Substance Proposal
2-Butoxyethanol CAS number 111-76-2
Alternative names Ethylene glycol monobutyl ether; Butyl Cellosolve; 2-butoxy-1-ethanol; 2-n-butoxyethanol; butyl glycol; butyl monoether glycol.
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA).
Current scheduling

2-Butoxyethanol is in Schedule 6 of the Poisons Standard as follows:

Schedule 6

2-BUTOXYETHANOL and its ACETATES except in preparations containing 10 per cent or less of such substances.

Proposed scheduling

To amend the exemption concentration for 2-butoxyethanol and its acetates in Schedule 6 from 10 per cent to 20 per cent or less of such substances as follows:

Schedule 6 - Amend Entry

2-BUTOXYETHANOL and its ACETATES except in preparations containing 1020 per cent or less of such substances.

Key uses/expected use Diverse uses as a solvent and excipient in pesticide formulations.
Reasons for proposal
  • Acute toxicity studies indicate the same degree of eye irritation at either 10 or 20 per cent.
Dimethyl sulfoxide (DMSO) CAS number 67-68-5
Alternative names DMSO; methyl sulfoxide; (methylsulfinyl)methane; sulfinylbismethane.
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA).
Current scheduling

DMSO is in Schedules 4 and 6 of the Poisons Standard as follows:

Schedule 4

DIMETHYL SULFOXIDE (excluding dimethyl sulfone) for therapeutic use except:

  1. when included in Schedule 6; or
  2. in in vitro test kits.

Schedule 6

DIMETHYL SULFOXIDE (excluding dimethyl sulfone):

  1. when not for therapeutic use; or
  2. for the treatment of animals:
    1. when combined with no other therapeutic substance(s);
    2. in liquid preparations containing copper salicylate and 1 per cent or less of methyl salicylate as the only other therapeutic substances; or
    3. in clay poultices containing 2 per cent or less of dimethyl sulfoxide.
Proposed scheduling

To establish a concentration cut-off for dimethyl sulfoxide in Schedule 6, at 10 per cent or less as follows:

Schedule 6 - Amend Entry

DIMETHYL SULFOXIDE (excluding dimethyl sulfone):

  1. when in preparations not for therapeutic use containing 10 per cent or less of dimethyl sulfoxide; or
  2. for the treatment of animals:
    1. when combined with no other therapeutic substance(s);
    2. in liquid preparations containing copper salicylate and 1 per cent or less of methyl salicylate as the only other therapeutic substances; or
    3. in clay poultices containing 2 per cent or less of dimethyl sulfoxide.
Key uses/expected use DMSO has diverse uses as an industrial solvent, excipient in human therapeutics (especially in topical dermal formulations) and AgVet formulations.
Reasons for proposal
  • Acute toxicity of DMSO supports a concentration cut-off.
Aliphatic allyl esters CAS numbers and names

1797-74-6
allyl phenylacetate; benzeneacetic acid, 2-propenyl ester (CAS); 2-propenyl benzeneacetate.

2835-39-4
allyl isovalerate; butanoic acid, 3-methyl-, 2-propenyl ester (CAS); 2-propenyl isovalerate.

4728-82-9
allyl cyclohexaneacetate; cyclohexaneacetic acid, 2-propenyl ester (CAS); acetic acid, cyclohexyl-, allyl ester.

2705-87-5
allyl cyclohexanepropionate; cyclohexanepropanoic acid, 2-propenyl ester (CAS).

123-68-2
allyl hexanoate; hexanoic acid, 2-propenyl ester (CAS); allyl caproate.

142-19-8
allyl heptanoate; heptanoic acid, 2-propenyl ester (CAS).

4230-97-1
allyl octanoate; octanoic acid, 2-propenyl ester (CAS).

68132-80-9
allyl trimethylhexanoate; hexanoic acid, trimethyl-, 2-propenyl ester (CAS).

7493-72-3
allyl nonanoate; nonanoic acid, 2-propenyl ester (CAS).

Applicant The National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Office of Chemical Safety.
Current scheduling

Aliphatic allyl esters are captured by the Schedule 7 and Appendix J entries for allyl alcohol in the Poisons Standard as follows:

Schedule 7

ALLYL ALCOHOL.

Appendix J

ALLYL ALCOHOL - Not to be available except to authorised or licensed persons.

Proposed scheduling

To amend the current Schedule 7 entry for allyl alcohol to exclude allyl esters as its derivatives and to allow low levels of allyl alcohol as a impurity in preparations containing allyl esters at 5 per cent or less as follows:

Schedule 7 - Amend Entry

ALLYL ALCOHOL (including its derivatives) except

  1. when included in Schedule 6; and
  2. in preparations containing 5 per cent or less of allyl esters and containing less than 0.1 per cent allyl alcohol by weight of allyl esters.

AND

To create a new entry in Schedule 6 for allyl esters for use in consumer products, with a purity criterion and a concentration cut-off at 5 per cent, below which the requirements of the standard do not apply as follows:

Schedule 6 - New Entry

ALLYL ESTERS containing less than 0.1 per cent allyl alcohol by weight of allyl ester except in preparations containing 5 per cent or less of allyl esters and containing less than 0.1 per cent allyl alcohol by weight of allyl esters.

Key uses/expected use Cosmetic, domestic and non-industrial use as food additives, medicines and other therapeutic goods.
Reasons for proposal
  • Identified uses in domestic products in the Australian marketplace:
    • Two chemicals (CAS No. 123-68-2 and 2705-87-5) have reported domestic uses in automobile products.
  • Identified therapeutic uses in medicines and other therapeutic goods:
    • Three chemicals (CAS No. 2705-87-5, 123-68-2 and 142-19-8) are used in products listed on the ARTG.
  • International alignment:
    • The chemicals in this group are known to be used as fragrance ingredients in cosmetic and domestic products up to 5 %.
    • European Union, New Zealand (NZ) and the International Fragrance Association (IFRA) Standard have restrictions for allyl esters when used in cosmetic products: the level of free allyl alcohol in the ester shall be less than 0.1 %.
Benzyl salicylate CAS number 118-58-1
Alternative names Benzyl salicylate (INCI and AAN); benzoic acid, 2-hydroxy-, phenylmethyl ester (CAS); salicylic acid, benzyl ester; benzyl 2-hydroxybenzoate (IUPAC); phenylmethyl 2-hydroxybenzoate.
Applicant Delegate initiated proposal (previously National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Office of Chemical Safety).
Current scheduling Unscheduled.
Proposed scheduling

To create a new Schedule 6 entry for benzyl salicylate in the Poisons Standard for use in cosmetics and domestic products, with exemption cut-off concentrations for leave-in and rinse-off products and appropriate skin sensitisation warning labels as follows:

Schedule 6 - New Entry

BENZYL SALICYLATE except:

  1. in preparations intended for therapeutic use; or
  2. in domestic preparations:
    1. intended for skin contact containing 15 per cent or less of benzyl salicylate when included in the list of ingredients; or
    2. not intended for direct skin contact when included in the list of ingredients; or
  3. in leave-on cosmetic and personal care preparations:
    1. containing 0.001 per cent or less of benzyl salicylate; or
    2. when included in the list of ingredients; or
  4. in rinse-off cosmetic and personal care preparations:
    1. containing 0.01 per cent or less of benzyl salicylate; or
    2. when included in the list of ingredients.

Appendix E, Part 2 - New Entry

BENZYL SALICYLATE

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)), S1 (If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water).

Appendix F, Part 3 - New Entry

BENZYL SALICYLATE

Warning Statement: 28 ((Over) (Repeated) exposure may cause sensitisation).

Safety Direction: 4 (Avoid contact with skin).

Key uses/expected use Cosmetic (including perfumes and fragrances, personal care products and as an ultraviolet radiation absorber); and domestic (including polishes and waxes, softeners, surface treatments, air care products and washing and cleaning products).
Reasons for proposal
  • Identified uses in cosmetic and domestic products in the Australian marketplace.
    • Permitted in listed medicines for use only in combination with other permitted ingredients as a flavour (up to 5%) or a fragrance (up to 1%).
    • Included as an excipient in 230 proprietary ingredients.
  • Benzyl salicylate is an excipient in 331 listed and registered products (both oral and topical) on the ARTG.
  • International alignment:
    • Use is reported overseas in cosmetic and domestic products. In particular, as a fragrance, solvent and UV light absorber at concentrations up to 7%.
    • The EU concentration restrictions for cosmetics and personal care products are 0.001% in leave-on products and 0.01% in rinse-off products.
Cinnamaldehyde CAS number 104-55-2
Alternative names 2-Propenal, 3-phenyl- (CAS); (2E)-3-phenylprop-2-enal (IUPAC); cinnamal; cinnamic aldehyde.
Applicant Delegate initiated proposal (previously National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Office of Chemical Safety).
Current scheduling Unscheduled.
Proposed scheduling

To create a new Schedule 6 entry for cinnamaldehyde in the Poisons Standard with exemption concentration cut-offs for dermal preparations in line with international standards as follows:

Schedule 6 - New Entry

CINNAMALDEHYDE except:

  1. in preparations intended for therapeutic use; or
  2. in domestic preparations not intended for direct skin contact containing 0.4 per cent or less of cinnamaldehyde when included in the list of ingredients; or
  3. in leave-on cosmetic and personal care preparations containing 0.001 per cent or less of cinnamaldehyde; or
  4. in rinse-off cosmetic and personal care preparations containing 0.01 per cent or less of cinnamaldehyde.
Key uses / expected use Medicines, cosmetic, domestic and personal care products.
Reasons for proposal
  • Identified uses as a flavour and fragrance in cosmetic and domestic products in the Australian marketplace.
  • Listed in the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018 for use as an excipient flavour (up to 5%) or fragrance (up to 1%).
  • International alignment:
    • The New Zealand concentration restrictions for cosmetics are 0.001% in leave-on products and 0.01% in rinse-off products.
    • IFRA guidelines restrict use of cinnamaldehyde to concentrations of 0.02% in lip care and deodorant/anti-perspirant products, 0.04% in intimate wipes, 0.4% in mouthwashes and 0.05% in all other personal care products including fragrances.
Anise alcohol CAS number 105-13-5
Alternative names Anise alcohol (INCI and AAN); benzenemethanol, 4-methoxy- (CAS); anisyl alcohol; 4-methoxybenzyl alcohol; anisic alcohol; p-methoxybenzyl alcohol.
Applicant Delegate initiated proposal (previously National Industrial Chemicals Notification and Assessment Scheme (NICNAS)).
Current scheduling Unscheduled.
Proposed scheduling

To create a new Schedule 6 entry for anise alcohol in the Poisons Standard for use in cosmetic and domestic products with separate exemption concentration cut-offs in leave-in and rinse-off preparations in alignment with international regulations as follows:

Schedule 6 - New Entry

ANISE ALCOHOL except:

  1. in preparations intended for therapeutic use; or
  2. in domestic preparations [not intended for direct skin contact] containing 5 per cent or less of anise alcohol when included in the list of ingredients; or
  3. in leave-on cosmetic and personal care preparations containing 2.5 per cent or less of anise alcohol when included in the list of ingredients and labelled with the following statement:
    • WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals.
    written in letters not less than 1.5 mm in height; or
  4. in rinse-off cosmetic and personal care preparations containing 5 per cent or less of anise alcohol when included in the list of ingredients and labelled with the following statement:
    • WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals.
    written in letters not less than 1.5 mm in height; or
  5. in leave-on cosmetic and personal care preparations containing 0.001 per cent or less of anise alcohol; or
  6. in rinse-off cosmetic and personal care preparations containing 0.01 per cent or less of anise alcohol.

Appendix E, Part 2 - New Entry

ANISE ALCOHOL

Standard Statement: 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

ANISE ALCOHOL

Warning Statement: 28 ((Over) (Repeated) exposure may cause sensitisation).

Safety Direction: 4 (Avoid contact with skin).

Key uses / expected use Cosmetic, domestic and medicines
Reasons for proposal
  • Identified uses in cosmetic and domestic products in the Australian marketplace.
  • Included as an excipient (flavour/fragrance only with concentration restrictions) in 70 proprietary ingredient (PI) formulations.
  • International alignment:
    • Reported widespread use of anise alcohol in cosmetic and domestic products overseas at concentrations up to 2.5%.
    • EU concentration restrictions are 0.001% in leave-on and 0.01% in rinse-off products.
Astodrimer sodium CAS number 676271-69-5
Alternative names Astodrimer sodium (INN, USAN); 2, 6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt; Tetrahexacontasodium N2,N6-bis{N2,N6-bis[N2,N6-bis(N2,N6-bis{N2,N6-bis[(3,6-disulfonatonaphthalen-1-yloxy)acetyl]-l-lysyl}-l-lysyl)-l-lysyl]-l-lysyl}-N1-(diphenylmethyl)-l-lysinamide; SPL7013.
Applicant Delegate initiated.
Current scheduling Unscheduled.
Proposed scheduling

To create a new Schedule 4 entry, as follows:

Schedule 4 - New Entry

ASTODRIMER SODIUM except when used as a condom lubricant.

Key uses / expected use Medicines and medical devices
Reasons for proposal
  • The substance is a topical microbicide that is used in a class 2A medical device for the treatment of bacterial vaginosis, and for prevention of sexually transmitted diseases as a condom lubricant.
  • Bacterial vaginosis requires medical diagnosis, management and monitoring before the substance is used in alignment with Schedule 4 scheduling factors of the Scheduling Policy Framework (2018).

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Submissions must:

Submissions might also include:

  • Suggested improvements; and/or
  • 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.

What will happen

All public submissions will be published on the TGA website Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments will be published as interim decisions on the TGA website Scheduling delegate's interim decisions & invitations for further comment on 13 September 2018.

Privacy information

  • The 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 you consent to the publication of your name on the TGA Internet site (please complete the coversheet, see How to respond above).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • 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.

Enquiries

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