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

Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.

Advisory Committee on Chemicals Scheduling (ACCS #21)

Summary of delegate’s interim decisions
Substance	Interim Decision
Fluralaner	Schedule 4 - New Entry FLURALANER except when included in Schedule 5. Index – Amend Entry FLURALANER cross-reference: CARBAMOYL BENZAMIDE PHENYL ISOXAZOLINE Schedule 4 Schedule 5 The proposed implementation date is 1 June 2018.
Metofluthrin	Schedule 5 – Amend Entry METOFLUTHRIN: in impregnated fabric mosquito repellent preparations for use in a vaporiser containing 15 mg or less of metofluthrin per disk; or when impregnated into a polyethylene slow release matrix containing 250 mg or less of metofluthrin. The proposed implementation date is 1 June 2018.
Alpha-cypermethrin	Schedule 6 – Amend Entry ALPHA-CYPERMETHRIN: in aqueous preparations containing 30 per cent or less of alpha-cypermethrin; or in other preparations containing 10 per cent or less of alpha-cypermethrin, except when included in Schedule 5. The proposed implementation date is 1 June 2018.
Silver oxide	Appendix B – New Entry SILVER OXIDE Reasons for Entry: b (Use pattern restricts hazard) Areas of Use: 7.14 (Spa/pool sanitiser) The proposed implementation date is 1 June 2018.
1-Deoxy-1-(methylamino)-D-glucitol N-C10-16 acyl derivatives	Schedule 6 – Amend Entry 1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N- ACYL DERIVATIVES IF IN EYES WASH OUT IMMEDIATELY WITH WATER, or IF IN EYES WASH OUT IMMEDIATELY WITH WATER. in cosmetic rinse-off preparations containing 8 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N- acyl derivatives when labelled with a warning statement to the following effect: in household cleaning preparations, other than those intended to be sprayed, containing 12 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N- acyl derivatives when labelled with a warning statement to the following effect: Index – Amend Entry 1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N- ACYL DERIVATIVES cross-reference: COCOYL METHYL GLUCAMIDE, LAUROYL METHYL GLUCAMIDE, MYRISTOYL METHYL GLUCAMIDE The proposed implementation date is 1 June 2018.
Phenyl methyl pyrazolone	Schedule 6 – New Entry PHENYL METHYL PYRAZOLONE except when used in hair dye and eyebrow/eyelash preparations at a concentration of 0.25 per cent or less 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. Appendix E, Part 2 – New Entry 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 Warning Statement: 28 ((Over) (repeated) exposure may cause sensitisation). Safety Direction: 4 (Avoid contact with skin). The proposed implementation date is 1 June 2018.
Dinotefuran	Schedule 5 – Amend Entry DINOTEFURAN except in preparations containing 1 per cent or less of dinotefuran. The proposed implementation date is 1 June 2018.
Afidopyropen	Appendix B – New Entry AFIDOPYROPEN. Reasons for Entry: b (Use pattern restricts hazard) Areas of Use: 1.2 (Insecticide) The proposed implementation date is 1 June 2018.