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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2017

Scheduling medicines and poisons

17 May 2017

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3. Summary of delegate's interim decisions

3. Advisory Committee on Chemicals Scheduling (ACCS #19)

Summary of delegate's interim decisions
Substance Interim decision
Ethyl hexanediol

Schedule 10 - Delete Entry

Schedule 6 - New Entry

ETHYL HEXANEDIOL except in preparations containing 5 per cent or less of ethyl hexanediol.

Schedule 4 - Delete Entry

Appendix E, Part 2 - New Entry

ETHYL HEXANEDIOL

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.)

Appendix F, Part 3 - New Entry

ETHYL HEXANEDIOL

Warning Statements: 79 (will irritate eyes).
Safety directions: 1 (avoid contact with eyes).

The proposed implementation date is 1 October 2017.

Climbazole

Schedule 6 - Amend Entry

CLIMBAZOLE except:

  1. when included in Schedule 5; or
  2. in leave-on hair, face and foot cosmetic preparations containing 0.5 per cent or less of climbazole; or
  3. in other preparations (that are not leave-on cosmetic preparations) containing 2 per cent or less of climbazole.

Schedule 5 - Amend Entry

CLIMBAZOLE in preparations containing 40 per cent or less of climbazole except:

  1. in leave-on hair, face and foot cosmetic preparations containing 0.5 per cent or less of climbazole; or
  2. in other preparations (that are not leave-on cosmetic preparations) containing 2 per cent or less of climbazole.

The proposed implementation date is 1 June 2018.

m-Aminophenol

Schedule 6 - New Entry

m-AMINOPHENOL except when used in hair dye and eyebrow/eyelash preparations at a concentration of 1.2 per cent or less of m-aminophenol 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

m-AMINOPHENOL

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

m-AMINOPHENOL

Warning Statements: 28 ((over) (repeated) exposure may cause sensitisation).

Safety directions: 4 (Avoid contact with skin), 8 (Avoid breathing dust (or) vapour (or) spray mist).

The proposed implementation date is 1 June 2018.

2-Chloro-6-(ethylamino)-4-nitrophenol

Schedule 6 - New Entry

2-CHLORO-6-(ETHYLAMINO)-4-NITROPHENOL except:

  1. in non-oxidative hair dye preparations containing 3 per cent or less of 2-chloro-6-(ethylamino)-4-nitrophenol 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, and

    written in letters not less than 1.5 mm in height; or

  2. in oxidative hair dye preparations containing 1.5 per cent or less of 2-chloro-6-(ethylamino)-4-nitrophenol 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, and

    written in letters not less than 1.5 mm in height.

Appendix E, Part 2 - New Entry

2-CHLORO-6-(ETHYLAMINO)-4-NITROPHENOL

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

2-CHLORO-6-(ETHYLAMINO)-4-NITROPHENOL

Warning Statements: 28 ((over) (repeated) exposure may cause sensitisation).

Safety directions: 4 (Avoid contact with skin).

The proposed implementation date is 1 June 2018.

2,4-Diamino-phenoxy-ethanol

Schedule 6 - Amend Entry

2,4-DIAMINOPHENOXYETHANOL except when used in hair dye and eyebrow/eyelash preparations at a concentration of 2 per cent or less of 2,4-diaminophenoxyethanol 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 - Amend Entry

2,4-DIAMINO-PHENOXYETHANOL

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 - Amend Entry

2,4-DIAMINO-PHENOXYETHANOL

Warning statement: 28 ((over) (repeated) exposure may cause sensitisation), 79 (Will irritate eyes).

Safety directions: 1 (Avoid contact with eyes), 4 (Avoid contact with skin).

The proposed implementation date is 1 June 2018.

Isoeugenol

Schedule 6 - Amend Entry

ISOEUGENOL except:

  1. when included in Schedule 5; or
  2. in preparations not intended for skin contact containing 10 per cent or less of isoeugenol; or
  3. in preparations intended for skin contact containing 0.02 per cent or less of isoeugenol.

Schedule 5 - Amend Entry

ISOEUGENOL in preparations not intended for skin contact containing 25 per cent or less of isoeugenol except in preparations containing 10 per cent or less of isoeugenol.

Appendix E, Part 2 - New Entry

ISOEUGENOL

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)], E1 (if in eyes wash out immediately with water), S1 (If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water).

Appendix F, Part 3 - New Entry

ISOEUGENOL

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), 4 (Avoid contact with skin).

The proposed implementation date is 1 October 2018.

Aureobasidium pullulans (strains DSM 14940 and DSM 14941)

Appendix B - New Entry

AUREOBASIDIUM PULLULANS (Strains DSM14940 and DSM14941).

The proposed implementation date is 1 October 2017.

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