Consultation: Proposed Amendments to the Poisons Standard – ACCS, ACMS and Joint ACCS/ACMS meetings, March 2017

Scheduling medicines and poisons

22 December 2016

This consultation closed on 10 February 2017.

Invitation to comment

The TGA is sought comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Advisory Committee on Chemicals Scheduling (ACCS), the Advisory Committee on Medicines Scheduling (ACMS) and the Joint ACCS-ACMS.

Following stakeholder feedback, the TGA has expanded the scheduling proposals for selected substances to be considered by the Advisory Committees on Chemicals and Medicines Scheduling (ACCS, ACMS) to promote relevant public submissions. The TGA would appreciate feedback on the effectiveness of the expanded proposals on submissions via and .

1. Proposed amendments referred by the delegates to the Joint Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS) for scheduling advice.
Substance Proposal
In vitro diagnostic and analytical preparations An applicant has proposed to amend the entry in Appendix A (General Exemptions) for in vitro diagnostic and analytical preparations to include Schedule 9 substances at concentrations of up to 0.001 per cent.
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 NICNAS under their IMAP program.
Current scheduling Unscheduled.
Proposed scheduling A new Schedule 6 entry for anise alcohol 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.
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 ingredients in the TGA database.
  • 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.

IFRA has restricted the use of Anise alcohol in finished products at concentrations of 0.04–2.5% depending on the product category

Anethole CAS Number 4180-23-8
Alternative names anethole (AAN); trans-anethole (INCI); benzene, 1-methoxy-4-(1-propenyl)-, (E)- (CAS); p-propenylanisole; anise camphor; (E)-1-p-methoxyphenylpropene; 1-methoxy-4-[(1E)-prop-1-en-1-yl]benzene (IUPAC)
Applicant NICNAS under their IMAP program.
Current scheduling Unscheduled.
Proposed scheduling To include anethole in Schedule 6 with an exemption concentration cut-off for cosmetic and domestic uses.
Key uses/expected use Cosmetic, domestic and medicines.
Reasons for proposal
  • Identified uses in cosmetic and domestic products in the Australian marketplace.
    • Listed in the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 (26BB) for use as an active ingredient and an excipient. Use as an active ingredient is only for medicated space sprays and medicated throat lozenges.
    • Included as an excipient in 150 proprietary ingredients in the TGA database.
  • International alignment.
    • No international restrictions identified but use is reported in cosmetic and domestic products overseas (particularly as a fragrance ingredient) at concentrations up to 10%.
Sodium α-olefin sulfonates and sodium alkyl sulfates CAS Number/s 68439-57-6 68955-19-1
Alternative names sodium α-olefin sulfonate; sodium C14 16-olefin sulfonate (AAN); sodium AOS (INCI); sulfonic acids, C14-16-alkane hydroxyl and C14-16-alkene, sodium salts (CAS); sodium tetradecenesulfonate sodium alkyl sulfate; sulfuric acid, mono-C12-18-alkyl (even numbered) esters, sodium salts; sodium AS (INCI); sulfuric acid, mono-C12-18-alkyl esters, sodium salts (CAS); SDA 16 062-04; tallow alkyl sulfate (TAS)
Applicant NICNAS under their IMAP program.
Current scheduling Unscheduled.
Proposed scheduling To create new Schedule 6 entries for sodium α-olefin sulfonate and sodium alkyl sulfate with exemption concentration cut-offs and warning labels, restricting their use in cosmetic and domestic products.
Key uses/expected use Cosmetic, domestic and medicines.
Reasons for proposal
  • Identified uses in cosmetic and domestic products in the Australian marketplace.
    • Sodium α-olefin sulfonate is listed as an excipient in the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 only for use in topical medicines for dermal application.
  • International alignment.
    • Use is reported overseas in cosmetic and domestic products at concentrations up to 16.5%.
    • In Canada sodium α-olefin sulfonates are considered to be safe when used in rinse-off products and safe up to 2% in leave-on products.
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 NICNAS under their IMAP program
Current scheduling Unscheduled.
Proposed scheduling To include benzyl salicylate in Schedule 6 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.
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.
  • 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 NICNAS under their IMAP program
Current scheduling Unscheduled.
Proposed scheduling To create a new Schedule 6 entry for cinnamaldehyde with exemption concentration cut-offs for dermal preparations in line with international standards.
Key uses/expected use 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. 2 of 2016 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.
2. Delegate-initiated proposed amendments referred to the Joint Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS) for scheduling advice.
Substance Proposal
N-(alkylamino)cyclohexylbenzamides A proposal to include a new entry for N-(alkylamino)cyclohexylbenzamides in Schedule 9, except when separately specified in these Schedules.
3. Proposed amendments referred by the delegate to the Advisory Committee on Medicines Scheduling (ACMS) for scheduling advice.
Substance Proposal
Flurbiprofen A request has been made to down-schedule flurbiprofen from Schedule 2 to unscheduled when containing 0.25 per cent or less of flurbiprofen or, containing 10 mg or less per dose of flurbiprofen in undivided dosage forms.
Ibuprofen

A request has been made to amend the Schedule 3 entry for ibuprofen to include a modified release oral dose form of 600 mg of ibuprofen per dosage unit in packs of 32 or less dosage units when labelled:

  1. with a recommended daily dose of 1200 mg or less of ibuprofen and
  2. not for the treatment of children under 12 years of age

and include ibuprofen 600 mg in modified release dosage form in Appendix H.

Penciclovir A request has been made to down-schedule penciclovir from Schedule 2 to unscheduled in preparations containing 1 per cent or less of penciclovir for the treatment of Herpes labialis in packs containing 10 g or less.
Loratadine A request has been made to exempt from scheduling loratadine 10 mg or less in divided preparations for oral use in packs containing not more than 5 dosage units when used in children 6 -12 years of age for the treatment of seasonal allergic rhinitis.
Ulipristal A request has been made to allow advertising of ulipristal by inclusion in Appendix H for emergency post-coital contraception.
1,3-Dimethylbutylamine (DMBA) and other aliphatic alkylamines with similar stimulant properties including 1,5-dimethylhexylamine (DMHA) A request has been made to include an entry for 1,3 dimethylbutylamine (DMBA) and other aliphatic alkylamines with stimulant properties including 1,5 dimethylhexylamine (DMHA) in Schedule 10, except when separately specified in these schedules.
4. Delegate-initiated proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS) for scheduling advice.
Substance Proposal
Dihydrocodeine

To reconsider whether the Schedule 2 and Schedule 3 entries for dihydrocodeine should be amended or deleted, in view of the recent reconsideration of codeine scheduling.

Consideration may be given as to whether all current Schedule 2 and Schedule 3 entries for dihydrocodeine should be rescheduled to Schedule 4, or other scheduling options. Other scheduling options include amending or deleting the Schedule 2 entry and amending or deleting the Schedule 3 entry, reducing the pack size, and the inclusion of a label warning that dihydrocodeine can cause addiction.

5. Proposed amendments referred by the delegate to the Advisory Committee on Chemicals Scheduling (ACCS) for scheduling advice.
Substance Proposal
Ethyl hexanediol CAS Number 94-96-2
Alternative names Ethyl hexanediol (INCI); 1,3-hexanediol, 2-ethyl- (CAS); hexanediol; octylene glycol; ethohexadiol (AAN)
Applicant NICNAS under their IMAP program.
Current scheduling

Ethyl hexanediol is currently listed in Schedules 4 and 10 as follows:

  • Schedule 10
    ETHYLHEXANEDIOL for human use.
  • Schedule 4
    ETHYLHEXANEDIOL for animal use.
Proposed scheduling To replace the Schedule 10 entry for ethyl hexanediol with a Schedule 6 entry to allow for human use.
Key uses/expected use Cosmetic and domestic.
Reasons for proposal
  • Identified uses in cosmetic and domestic products in the Australian marketplace.
  • International alignment.
    • International sources have determined that ethyl hexanediol is a safe cosmetic ingredient.
Climbazole CAS Number 38083-17-9
Alternative names climbazole (INCI and AAN); 2-butanone, 1-(4-chlorophenoxy)-1-(1H-imidazol-1-yl)-3,3-dimethyl- (CAS); Crinipan AD; Baypival; (RS)-1-(4-Chlorophenoxy)-1-imidazol-1-yl-3,3-dimethylbutan-2-one (IUPAC); 1-[(4-chlorophenoxy)(tert-butylcarbonyl)methyl; 1-(4-chlorophenoxy)-1-(1H-imidazolyl)-3,3-dimethyl-2-butanone
Applicant NICNAS under their IMAP program
Current scheduling

Climbazole is in Schedule 5 and Schedule 6 of the Poisons Standard.as follows:

  • Schedule 6
    CLIMBAZOLE except:
    1. when included in Schedule 5; or
    2. in preparations containing 2 per cent or less of climbazole.
  • Schedule 5
    CLIMBAZOLE in preparations containing 40 per cent or less of climbazole except in preparations containing 2 per cent or less of climbazole.
Proposed scheduling To amend the current entries for climbazole in Schedules 5 and 6, to restrict its use in cosmetic products except at concentrations below 0.5% in leave-on hair and face cosmetics, and up to 2% for rinse-off hair cosmetics.
Key uses/expected use Cosmetics (preservative or antimicrobial), domestic and medicines.
Reasons for proposal
  • Identified cosmetic and domestic uses in the Australian marketplace.
    • Permitted for use as both an excipient and active ingredient in biological and prescription medicines.
    • The use of climbazole was approved by the Medicines Evaluation Committee (MEC) in 2004 for dermal use only at up to 0.5% in leave-on, and up to 2% in rinse-off products.
  • International alignment.
    • The EU concentration restrictions include up to 0.5% when used as a preservative in cosmetics, up to 2.0% in rinse-off and 0.5% in leave-on products when used as an anti-dandruff active agent in hair cosmetic preparations, and up to 0.5% when used in leave-on face creams.
Aureobasidium pullulans (strains DSM 14940 and DSM 14941)

The APVMA submitted a scheduling proposal to consider the need for scheduling a new biological fungicide containing two fungal strains of Aureobasidium pullulans (strains DSM 14940 and DSM 14941)*.

*The delegate has not cited the entire scheduling application and is awaiting further information from the APVMA to support this application. The delegate notes that this fungicide is available overseas with minimal restrictions and the seasonality of this product. Without further information to support this application early in the new year, it will be withdrawn from the March 2017 scheduling process.

Timetable

Document released for consultation on Thursday 22 December 2016.

Interested parties responded by close of business Friday 10 February 2017.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

This consultation is inviting public submissions under subsection 42ZCZK/42ZCZL of the Therapeutic Goods Regulations 1990 (the Regulations).

The delegate of the Secretary of the Department of Health hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees.

Accordingly, the above scheduling proposals are open for public submissions. Submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the Poisons Standard (Chemicals) or other identified issues.

In addition, submissions might include:

  • Suggested improvements;
  • Whether or not you support the amendment/s. If you do not support the amendment/s, you may make suggestions for an alternative acceptable to you; 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 submissions will be placed on the TGA website unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the TGA website: feedback on submissions will be provided through the TGA website at Public submissions on scheduling matters.

Scheduling decisions made by the chemicals delegate following consideration of submissions from interested parties, along with advice from the Advisory Committee on Chemicals Scheduling (ACCS) will be published on the TGA website as interim decisions.

Privacy information

  • The TGA collects your personal information in this submission for the following reasons:
    • 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; and
    • To 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 website (i.e. make this information publicly available) if you consent to the publication of your name on the TGA website (please complete the cover sheet).
  • 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 chemicals.scheduling@tga.gov.au or .