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

Scheduling medicines and poisons

17 May 2017

This consultation closes on 15 June 2017.

Invitation to comment

The TGA is seeking 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.

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS)
Substance Proposal
Isofetamid CAS Number 875915-78-9
Alternative names IKF-5411, N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA)
Current scheduling New substance not previously considered by the scheduling committee
Proposed scheduling To create a new Schedule 5 entry for isofetamid with no concentration cut-offs
Key uses / expected use Broad-spectrum fungicide
Reasons for proposal

Identified use in agricultural pesticides:

  • Scheduling application is for active ingredient only.
  • Advice from the APVMA is that there are no objections on human health grounds to approval of the active constituent.
  • No product has been proposed for registration at this time, however it is anticipated that isofetamid could be used to control diseases caused by Botrytis, Monilia and Sclerotinia (and Rhizoctonia) fungi in a range of crops.

International regulations:

  • Currently registered for use as an agricultural fungicide in some overseas markets.
Pydiflumetofen CAS Number 1228284-64-7
Alternative names N/A
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA)
Current scheduling New substance not previously considered by the scheduling committee
Proposed scheduling To create a new Schedule 5 entry for pydiflumetofen with no concentration cut-offs.
Key uses / expected use Agricultural pesticide
Reasons for proposal

Identified use in agricultural pesticides:

  • Scheduling application is for the active ingredient and two products.
  • Advice from the APVMA is that there are no objections on human health grounds to approval of the active constituent.
Lambda-Cyhalothrin CAS Number 91465-08-06
Alternative names α-cyano-3-phenoxybenzyl 3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethyl cyclopropanecarboxylate
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA)
Current scheduling

Lambda-Cyhalothrin is currently listed in Schedules 5, 6 and 7.

Schedule 5

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 1 per cent or less of lambda- cyhalothrin; or
  2. in aqueous preparations containing 2.5 per cent or less of microencapsulated lambda-cyhalothrin.

Schedule 6

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 25 per cent or less of microencapsulated lambda-cyhalothrin; or
  2. in other preparations containing 1.6 per cent or less of lambda-cyhalothrin

except when included in Schedule 5.

Schedule 7

LAMBDA-CYHALOTHRIN except when included in Schedule 5 or 6.

Proposed scheduling To amend the existing entry in Schedule 6 for lambda-cyhalothrin to emulsifiable granule formulations containing 25% or less of lambda-cyhalothrin.
Key uses / expected use Agricultural pesticide
Reasons for proposal

Identified use in agricultural pesticides:

  • Scheduling application is for a product.
  • Advice from the APVMA is that there are no objections on human health grounds for registration of the product
Duddingtonia Flagrans CAS Number N/A
Alternative names Arthrobotrys flagrans (Dudd.) Sidorova, Gorlenko & Nalepina; Trichothecium flagrans Dudd.
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA)
Current scheduling New substance not previously considered by the scheduling committee
Proposed scheduling To create a new Schedule 5 entry for Duddingtonia flagrans, with no concentration cut-offs.
Key uses / expected use Veterinary medicine
Reasons for proposal

Identified use in veterinary medicine:

  • Scheduling application is for the active ingredient and two products.
  • Advice from the APVMA is that there are no objections on human health grounds to approval of the active constituent.
Bacillus Amyloliquefaciens CAS Number N/A
Alternative names N/A
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA)
Current scheduling New substance not previously considered by the scheduling committee
Proposed scheduling To create a new Schedule 5 entry for Bacillus amyloliquefaciens with no concentration cut-offs.
Key uses / expected use Agricultural pesticide
Reasons for proposal

Identified use in agricultural pesticides:

  • Scheduling application is for the active ingredient and product
  • Advice from the APVMA is that there are no objections on human health grounds to approval of the active constituent.
  • The scheduling secretariat is seeking independent expert advice to provide additional support for this application.
Butyl benzyl phthalate CAS Number 85-68-7
Alternative names Butyl benzyl phthalate (INCI, AAN); 1,2-Benzenedicarboxylic acid, butyl phenylmethyl ester (CAS); Benzyl butyl phthalate.
Applicant National Industrial Chemicals Notification and Assessment Scheme (NICNAS) under their IMAP program
Current scheduling Unscheduled
Proposed scheduling A new Schedule 10 entry for butyl benzyl phthalate for cosmetic use, with no exemption cut-off, in alignment with other hazardous phthalates of the same chemical category.
Key uses / expected use Cosmetic, domestic.
Reasons for proposal

Identified potential uses in Australia as a substitute for other phthalates currently listed in Schedule 10.

International regulations:

  • Cosmetic use (including nail polishes) is prohibited in the European Union.
Basic red 76 CAS Number 68391-30-0
Alternative names [7-Hydroxy-8-[(2- methoxyphenyl)azo]-2-naphthyl]-trimethylammonium chloride
Current scheduling

Basic Red 76 is captured by the Schedule 7 entry for azo dyes:

Schedule 7

AZO DYES that are derivatives by diazotisation of any of the following substances:

p-aminoazobenzene (CAS No. 60-09-3)

o-aminoazotoluene (CAS No. 97-56-3)

o-anisidine (CAS No. 90-04-0)

p-chloroaniline (CAS No. 106-47-8)

4-chloro-o-toluidine (CAS No. 95-69-2)

6-methoxy-m-toluidine (p-cresidine) (CAS No. 120-71-8)

2-naphthylamine (CAS No. 91-59-8)

5-nitro-o-toluidine (CAS No. 99-55-8)

2,4-toluenediamine (CAS No. 95-80-7)

o-toluidine (CAS No. 95-53-4)

2,4,5-trimethylaniline (CAS No. 137-17-7)

Proposed scheduling To amend the Schedule 7 entry for azo dyes to exclude Basic Red 76 from being captured and to include a new Schedule 6 entry for Basic Red 76 for use in non-oxidative hair, eyelash and eyebrow dye products with a cut-off concentration of 0.001% free o-anisidine.
Key uses / expected use Cosmetics, hair dyes.
Reasons for proposal

To allow the use of Basic Red 76 in non-oxidative hair, eyelash and eyebrow dye products.

Currently on the 'List of chemicals used as dyes in permanent and semi-permanent hair dyes in Australia'

International regulations:

  • Use in the EU, ASEAN and NZ is allowed in non-oxidative hair dyes up to 2%;
  • Use is approved in the USA, Canada and Japan.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS)
Substance Proposal
Esomeprazole A request has been made to down-schedule esomeprazole from Schedule 3 to Schedule 2 in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.
Ibuprofen combined with Paracetamol A request has been made to amend the current Schedule 2 entry for ibuprofen when combined with paracetamol to increase the pack size of preparations for oral use when labelled with a recommended daily dose of 1200 mg or less from 12 to 24 dosage units.
Sildenafil

An applicant has proposed that 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 be created.

The proposal is also to include sildenafil in Appendix H and to include additional warning statements in Appendix F for Schedule 3 sildenafil.

Stiripentol The New Chemical Entity (NCE) delegate from the Therapeutic Goods Administration proposes a new Appendix K entry for stiripentol be created.
Vardenafil A request has been made to create a new Schedule 3 entry for vardenafil in oral preparations containing up to 10 mg per dosage unit in packs containing not more than 8 dosage units.
3. Proposed amendments referred by the delegates to the Joint Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS) for scheduling advice
Substance Proposal
Chloroacetamide CAS Number 79-07-2
Alternative names Actamide, 2-chloro-, 2-Chloroacetamide (IUPAC); Chloroacetamide (INCI)
Applicant National Industrial Chemicals Notification and Assessment Scheme (NICNAS) under their IMAP program
Current scheduling Unscheduled
Proposed scheduling A new Schedule 6 entry for chloroacetamide with no exemption cut-off, and consideration of appropriate label warning statements.
Key uses / expected use Cosmetic, domestic (also therapeutic uses)
Reasons for proposal

Identified uses in cosmetic and domestic products in the Australian marketplace:

  • The chemical has been identified as being used in cosmetic products in Australia.

International regulations:

  • Use is reported overseas in cosmetic and domestic products at concentrations up to 1 %;
  • EU concentration restrictions include up to 0.3 % when used as a preservative in cosmetics; however the European Commission is currently considering prohibiting the chemical.
  • In Canada the chemical is prohibited for use in cosmetic products;
  • According to the SCCS opinion (2011), chloroacetamide is not safe for consumers when used under the current use conditions of 0.3% in cosmetic products; and
  • According to the US Cosmetic Ingredient Review (CIR), (1991), chloroacetamide is unsafe for use as a cosmetic ingredient.
Docusate sodium CAS Number 577-11-7
Alternative names butanedioic acid, sulfo-, 1,4-bis(2-ethylhexyl) ester, sodium salt (CAS); sodium;1,4-bis(2-ethylhexoxy)-1,4-dioxobutane-2-sulfonate (IUPAC); diethylhexyl sodium sulfosuccinate (INCI); dioctyl sodium sulfosuccinate; succinic acid, sulfo-1,4-bis(2-ethylhexyl)ester, sodium salt
Applicant National Industrial Chemicals Notification and Assessment Scheme (NICNAS) under their IMAP program
Current scheduling

Docusate sodium is in Appendix B of the Poisons Standard as follows:

Appendix B, Part 3 - Substances considered not to require control by scheduling

DOCUSATE SODIUM (DIOCTYL SODIUM SULFOSUCCINATE

Date of entry: Feb 1970

Reason for listing: a (low toxicity)

Area of use: 7.1 (Any use)

Proposed scheduling A new Schedule 6 entry for docusate sodium to restrict the use in cosmetic and domestic products (similar to lauryl sulfate salts); and to remove the existing chemical listing from Appendix B Part 3.
Key uses / expected use Cosmetic, domestic (also therapeutic uses)
Reasons for proposal

Identified uses in domestic products in the Australian marketplace; however the maximum concentration of the chemical in domestic products in Australia is not known.

The chemical is reported to be used in cosmetic and domestic products overseas that are potentially available for use in Australia.

International regulations:

  • For products containing dialkyl sulfosuccinate salts (including docusate sodium), the United States (US) Cosmetic Ingredients Review (CIR) Expert Panel recommended that 'care should be taken to avoid irritancy, especially in those products intended for prolonged contact with the skin' (CIR, 2013).
  • The chemical is reported to be used in cosmetic and domestic products overseas at concentrations up to 4.4 % and 5.0 %, respectively (CIR, 2013).
Epidermal growth factor CAS Number 1807528-51-3
Current scheduling

Epidermal growth factor is currently listed in Schedule 7 of the SUSMP as follows:

Schedule 7

EPIDERMAL GROWTH FACTOR except in preparations for human therapeutic use.

It is also included under the entry EPIDERMAL GROWTH FACTOR in Appendix J, Part 2 with the following statements:

Appendix J - Part 2

EPIDERMAL GROWTH FACTOR

Standard statement: 1 (Not to be available except to authorised or licensed persons).

Proposed scheduling To amend the existing Schedule 7 entry for epidermal growth factor (EGF) to include topical preparation containing 0.0002 % or less of transgenic, plant-made EGF.
Key uses / expected use Topical cosmetic preparations.
Reasons for proposal

Identified potential use in cosmetic products in the Australia.

International regulations:

  • Limited information on the clinical use of EGF in the USA and EU; however it has been used experimentally to treat diabetic foot ulcers and mucositis in patients undergoing radiotherapy.
  • No cosmetic regulatory controls of epidermal growth factor, nor other growth factors or cytokines in cosmetic products internationally
Methylisothiazolinone CAS Number 2682-20-4
Alternative names 2-methyl-3-isothiazolone; N-methylisothiazolin-3-one
Applicant Referred by the chemicals scheduling delegate
Current scheduling

Methylisothiazolinone is in Schedule 6 as follows:

Schedule 6

METHYLISOTHIAZOLINONE in leave-on cosmetic products or therapeutic goods intended for leave-on topical application, except in preparations containing 0.01 per cent or less of methylisothiazolinone.

Appendix F, Part 3

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

Proposed scheduling

Schedule 6 - Amend Entry

METHYLISOTHIAZOLINONE except:

  1. In rinse-off cosmetic preparations or therapeutic goods intended for topical rinse-off application containing 0.0015 per cent or less of methylisothiazolinone; or
  2. In other preparations that are not intended for direct application to the skin containing 0.1 per cent or less of methylisothiazolinone.
Key uses / expected use Domestic (E.g. car wash soaps, floor finishing/protection products), industrial (E.g. coatings and paint), cosmetic (E.g. baby wipes, hand and body lotions, shampoos, surfactants and conditioners).
Reasons for proposal

Methylisothiazolinone has exhibited skin sensitisation effects and may also cause systemic acute toxicity and local effects such as eczema and contact allergy reactions.

International regulations:

  • Use in the US, EU and ASEAN is currently restricted to a maximum concentration of 0.01%.
  • On the basis of the December 2015 SCCS report on methylisothiazolinone, the EU have proposed the following regulatory controls:
    • restricting the use of methylisothiazolinone to 15ppm (0.0015%) (previously 100 ppm) in rinse-off products, with the obligation of a "contains methylisothiazolinone" labelling; and
    • banning methylisothiazolinone use as a preservative in leave-on cosmetic products.
Plasmid DNA Vaccine CAS Number N/A
Alternative names plasmid DNA (rE. coli DH5α pINGhT)
Applicant Australian Pesticides and Veterinary Medicines Authority (APVMA)
Current scheduling New substance not previously considered by the scheduling committee
Proposed scheduling To create a new Schedule 4 entry for plasmid DNA (rE. coli DH5α pINGhT) with no concentration cut-offs.
Key uses / expected use Veterinary medicine
Reasons for proposal

Identified use in veterinary medicines:

  • Scheduling application is for the active ingredient and product.
  • Advice from the APVMA is that there are no objections on human health grounds to approval of the active constituent.
  • The scheduling secretariat is seeking independent expert advice to provide additional support for this application.
Quinine and its salts CAS numbers and names

130-95-0
quinine (INCI); cinchonan-9-ol, 6'-methoxy-, (8.alpha.,9R)- (CAS); quinine anhydrous

549-56-4
cinchonan-9-ol, 6'-methoxy-, (8.alpha.,9R)-, sulfate (1:1) (salt) (CAS); quinine sulfate (1:1)

804-63-7
cinchonan-9-ol, 6'-methoxy-, (8.alpha.,9R)-, sulfate (2:1) (salt) (CAS); quinine sulfate (2:1)

6119-70-6
methoxy-, (8.alpha.,9R)-, sulfate(2:1) (salt), dihydrate (CAS); quinine sulfate (2:1) dehydrate

6183-68-2
cinchonan-9-ol, 6'-methoxy-, (8.alpha.,9R)-, sulfate (1:1) (salt), heptahydrate (CAS); quinine sulfate (1:1) heptahydrate

60-93-5
cinchonan-9-ol, 6'-methoxy-, dihydrochloride, (8.alpha.,9R)- (CAS); quinine dihydrochloride

130-89-2
cinchonan-9-ol, 6'-methoxy-, monohydrochloride, (8.alpha.,9R)- (CAS); quinine monohydrochloride

6119-47-7
cinchonan-9-ol, 6'-methoxy-, monohydrochloride, dihydrate, (8.alpha.,9R)- (CAS); quinine hydrochloride dehydrate

7549-43-1
cinchonan-9-ol, 6'-methoxy-, hydrochloride, (8.alpha.,9R)- (CAS); quinine hydrochloride (unspecified)

Applicant National Industrial Chemicals Notification and Assessment Scheme (NICNAS) under their IMAP program
Current scheduling

Quinine is in Schedules 4, 5 and 7 as follows:

Schedule 7

QUININE for veterinary use except when included in Schedule 5.

Schedule 5

QUININE in preparations for veterinary use containing 1 per cent or less of quinine.

Schedule 4

QUININE for human therapeutic use except when the maximum recommended daily dose is 50 mg or less of quinine.

Proposed scheduling A new Schedule 6 entry for QUININE with exemption concentration cut-offs for leave-on and rinse-off hair preparations in alignment with international regulations/standards and skin sensitisation warning labels.
Key uses / expected use Cosmetic (also food flavouring, therapeutic and pesticide uses)
Reasons for proposal

Although there is no specifically identified use in cosmetic and domestic products in the Australian marketplace, the chemicals are known to be used in cosmetic products internationally.

  • Quinine is present in four products on the ARTG and it permitted for use in registered and listed medicines as an excipient.
  • Quinine is present in two veterinary medicines (fish tank medication products)

International regulations:

  • EU concentration restrictions include up to 0.5 % (as quinine base) in rinse-off and 0.2 % (as quinine base) in leave-on hair preparations.
Vinyl acetate CAS Number 108-05-4
Alternative names ethenyl acetate (IUPAC); vinyl acetate (INCI); acetic acid ethenyl ester (CAS); vinyl acetate monomer (VAM)
Applicant National Industrial Chemicals Notification and Assessment Scheme (NICNAS) under their IMAP program
Current scheduling Unscheduled
Proposed scheduling A new Schedule 6 entry for Vinyl acetate with 1 % exemption concentration cut-off for use in domestic products; and a new Schedule 10 entry for cosmetic use
Key uses / expected use Domestic (also therapeutic uses)
Reasons for proposal

Identified uses in domestic products in the Australian marketplace in paints, lacquers and varnish, adhesives and automotive products.

International regulations:

  • Domestic uses identified overseas include products containing the chemical up to 67% in a home maintenance paste, however, available data suggest that most products contain 1% or less; glues/adhesives (0-1%), foam sealants (0.1-2%), or paints/varnish/primer (0.1-0.5%) (US Household Products Database); and
  • Previously allowed cosmetic use as a film forming substance (in 2006) in the European Union (EU); this use has been prohibited from 1 January, 2015 under Reg 944/2013 (CosIng).

Timetable

Document released for consultation on Wednesday 17 May 2017.

Interested parties should respond by close of business Thursday 15 June 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 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.
  • 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.

How to respond

All submissions should be accompanied by a TGA submission coversheet. Submissions must include full personal or organisational contact details (including address, telephone number and email).

How to access a Word document

Electronic submissions are preferred:

  • Submissions regarding substances referred to the ACMS or Joint ACCS-ACMS should be emailed to . Please include 'Proposed Amendments to the Poisons Standard (Medicines)' in the subject line of the email.
  • Submissions regarding substances referred to the ACCS should be emailed to . Please include 'Proposed Amendments to the Poisons Standard (Chemicals)' in the subject line of the email.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).

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

Scheduling decisions made by the medicines and/or chemicals delegates following consideration of submissions from interested parties, along with advice from the Advisory Committee on Chemicals Scheduling (ACCS), the Advisory Committee on Medicines Scheduling (ACMS) and the Joint ACCS-ACMS will be published on the TGA website as interim decisions.

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).
  • 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 (for substances referred to the ACMS or Joint ACCS-ACMS) or (for substances referred to the ACCS).