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

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.

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 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.

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

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.

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.

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 is captured by the Schedule 7 entry for azo dyes:

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.

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.

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 is in Appendix B of the Poisons Standard as follows:

Date of entry: Feb 1970

Reason for listing: a (low toxicity)

Area of use: 7.1 (Any use)

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

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

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 is in Schedule 6 as follows:

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.

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.

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.

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)

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

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.

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).