2. Summary of delegate's interim decisions | Therapeutic Goods Administration (TGA)

Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS #16 and ACCS-ACMS #15)

Summary of delegate's interim decisions
Substance	Interim Decision
Plasmid DNA Vaccine	Schedule 4 – New Entry VACCINES - PLASMID DNA for animal use except when separately specified in these Schedules. Index – New Entry VACCINES - PLASMID DNA cross reference: PLASMID DNA (rE. coli DH5α pINGhT) Schedule 4 The proposed implementation date is 1 February 2018.
Quinine and its salts	Schedule 6 – New Entry QUININE in cosmetic preparations except: in rinse-off hair preparations containing 0.5 per cent or less of quinine; or in leave-on hair preparations containing 0.2 per cent or less of quinine. Appendix F, Part 3 – New Entry QUININE Warning Statement: 28 (Repeated exposure may cause sensitisation). Index – Amend Entry QUININE cross reference: QUININE (CAS No. 130-95-0), QUININE SULFATE (1:1) (CAS No. 549-56-4), QUININE SULFATE (2:1) (CAS No. 804-63-7), QUININE SULFATE (2:1) DIHYDRATE (CAS No. 6119-70-6), QUININE SULFATE (1:1) HEPTAHYDRATE (CAS No. 6183-68-2), QUININE DIHYDROCHLORIDE (CAS No. 60-93-5), QUININE MONOHYDROCHLORIDE (CAS No. 130-89-2), QUININE HYDROCHLORIDE DIHYDRATE (CAS No. 6119-47-7), QUININE HYDROCHLORIDE (UNSPECIFIED) (CAS No. 7549-43-1) Schedule 7 Schedule 6 Schedule 5 Schedule 4 Appendix F, Part 3 The proposed implementation date is 1 February 2018.
Phenibut	Schedule 9 – New Entry PHENIBUT. Index – New Entry PHENIBUT cross reference: BETA-PHENYL-GAMMA-AMINOBUTYRIC ACID Schedule 9 The proposed implementation date is 1 February 2018.
Docusate sodium	The delegate's interim decision is that the current Appendix B (7.1, any use) entry for docusate sodium in the Poisons Standard remains appropriate.
Vinyl acetate	Schedule 6 – New Entry VINYL ACETATE MONOMER (excluding its derivatives) except: in preparations for therapeutic use; or in preparations for domestic use containing 1 per cent or less of vinyl acetate; or in preparations containing 0.01 per cent or less of vinyl acetate as residual monomer in a polymer. Appendix E, Part 2 – New Entry VINYL ACETATE Standard Statements: A (For advice, contact a Poisons Information Centre or a doctor); R1 (If inhaled, removed from contaminated area. Apply artificial respiration if not breathing). Appendix F, Part 3 – New Entry VINYL ACETATE Warning Statement: 11 (Vapour may be harmful). Safety Directions: 8 (Avoid breathing vapour); 9 (Use only in well ventilated area). The proposed implementation date is 1 June 2018.
Methylisothiazolinone	Schedule 6 − Amend Entry METHYLISOTHIAZOLINONE except: in rinse-off cosmetic preparations or therapeutic goods intended for topical rinse-off application containing 0.0015 per cent or less of methylisothiazolinone; or in other preparations that are not intended for direct application to the skin containing 0.1 per cent or less of methylisothiazolinone. The proposed implementation date is 1 June 2018.
Epidermal growth factor	Appendix G – New Entry Column 1 – Poison: EPIDERMAL GROWTH FACTOR Column 2 – Concentration (quantity per litre or kilogram): 10 micrograms Index – Amend Entry EPIDERMAL GROWTH FACTOR cross reference: SH-OLIGOPEPTIDE-1, RH-OLIGOPEPTIDE-1 Schedule 7 Appendix G Appendix J, Part 2 The proposed implementation date is 1 February 2018.
Chloroacetamide	Schedule 6 – New Entry CHLOROACETAMIDE in preparations for cosmetic use; or in preparations for topical therapeutic use; or in other preparations containing more than 0.3 per cent of chloroacetamide. Appendix E, Part 1 – New Entry CHLOROACETAMIDE 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 1– New Entry CHLOROACETAMIDE Warning Statement: 28 (Repeated exposure may cause sensitisation). Safety Direction: 4 (Avoid contact with the skin). The proposed implementation date is 1 June 2018.
Benzyl salicylate	Schedule 6 – New Entry BENZYL SALICYLATE except: in preparations intended for therapeutic use; or in domestic preparations: intended for skin contact containing 15 per cent or less of benzyl salicylate when included in the list of ingredients; or not intended for direct skin contact when included in the list of ingredients; or in leave-on cosmetic and personal care preparations: containing 0.001 per cent or less of benzyl salicylate; or when included in the list of ingredients; or in rinse-off cosmetic and personal care preparations: containing 0.01 per cent or less of benzyl salicylate; or when included in the list of ingredients. The proposed implementation date is 1 June 2018.
Cinnamaldehyde	Schedule 6 – New Entry CINNAMALDEHYDE except: in preparations intended for therapeutic use; or 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 in leave-on cosmetic and personal care preparations containing 0.001 per cent or less of cinnamaldehyde; or in rinse-off cosmetic and personal care preparations containing 0.01 per cent or less of cinnamaldehyde. The proposed implementation date is 1 June 2018.
Anise alcohol	Schedule 6 – New Entry ANISE ALCOHOL except: in preparations intended for therapeutic use; or in domestic preparations not intended for direct skin contact containing 5 per cent or less of anise alcohol when declared on the label; or in leave-on cosmetic and personal care preparations containing more than 0.001 and up to 2.5 per cent of anise alcohol when declared on the label 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 in rinse-off cosmetic and personal care preparations containing more than 0.01 and up to 5 per cent or less of anise alcohol when declared on the label 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 in leave-on cosmetic and personal care preparations containing 0.001 per cent or less of anise alcohol; or 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). The proposed implementation date is 1 February 2019.
Resorcinol	Schedule 6 – New Entry RESORCINOL except: in preparations for human therapeutic use; or in oxidative hair dye preparations containing 1.25 per cent or less of resorcinol after mixing for use 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 sensitisation 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 in oxidative eyelash and eyebrow dye preparations containing 1.25 per cent or less of resorcinol after mixing for use 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 sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. written in letters not less than 1.5 mm in height; or in hair lotions/shampoo products containing 0.5 per cent or less of resorcinol when the immediate container and primary pack are 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. Appendix E, Part 2 – New Entry RESORCINOL 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)), E2 (If in eyes, hold eyelids apart and flush the eye continuously with running water. Continue flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor, or for at least 15 minutes), S1 (If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.) Appendix F, Part 3 – New Entry RESORCINOL Warning Statements: 19 (WARNING – Skin contact may be dangerous. Take every precaution to avoid contact – wash off after spillage and after use), 28 ((Over) (Repeated) exposure may cause sensitisation), 79 (Will irritate eyes) Safety Directions: 1 (Avoid contact with eyes), 3 (Wear eye protections when mixing or using), 4 (Avoid contact with skin) Index – New Entry RESORCINOL cross reference: 1,3-benzenediol Schedule 6 Appendix E, Part 2 Appendix F, Part 3 The proposed implementation date is 1 February 2019.
Trans-anethole	The delegate's interim decision is to defer the decision and refer the application back to the applicant.