Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, November 2016

Scheduling medicines and poisons

Book pagination

2 February 2017

1. Summary of delegate's interim decisions

Part A - Interim decisions on matters referred to an expert advisory committee (November 2016)

Advisory Committee on Chemicals Scheduling (ACCS #18)

Summary of delegate's interim decisions
Substance Final Decision
Pegbovigrastim

Appendix B - New Entry

PEGBOVIGRASTIM

Part 1 - Reasons for entry

a (low toxicity)

Part 2 – Area of use

2.1 (For animal use)

The proposed implementation date is 1 June 2017.

3-Nitro-p-hydroxyethylaminophenol

(4-[(2-hydroxyethyl)amino]-3-nitrophenol)

Schedule 6 - New Entry

3-NITRO-p-HYDROXYETHYLAMINOPHENOL except:

  1. in non-oxidative hair dye preparations containing 1.85 per cent or less of 3-nitro-p-hydroxyethylaminophenol 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, and

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

  2. in oxidative hair dye preparations containing 3 per cent or less of 3-nitro-p-hydroxyethylaminophenol after mixing under oxidative conditions 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, and

    Written in letters not less than 1.5 mm in height.

Appendix F, Part 3 - New Entry

3-NITRO-p-HYDROXYETHYLAMINOPHENOL

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

Index - New Entry

3-NITRO-p-HYDROXYETHYLAMINOPHENOL
cross reference: 4-[(2-hydroxyethyl)amino]-3-nitrophenol

Schedule 6
Appendix F, Part 3

The proposed implementation date is 1 June 2017.

Hydroxyethyl-3,4-methylenedioxyaniline

Schedule 6 - New Entry

HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE (including its salts) except in oxidative hair dye preparations containing 1.5 per cent or less of hydroxyethyl-3,4-methylenedioxyaniline after mixing under oxidative conditions 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, and

Written in letters not less than 1.5 mm in height.

Appendix E, Part 2 - New Entry

HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE

Standard statements: 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

HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE

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

The proposed implementation date is 1 June 2017.

HC Blue 16

(1,3-bis(2,4-diaminophenoxy)propane tetrahydrochloride)

Schedule 6 - New entry

HC BLUE 16 (including its salts) except when in hair dye preparations containing 1.2 per cent or less of HC Blue 16 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, and

Written in letters not less than 1.5 mm in height.

Appendix E, Part 2 - New Entry

HC BLUE 16

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

HC BLUE 16

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

Safety directions: 1 (Avoid contact with eyes).

Index - New entry

HC BLUE 16
cross reference: 1,3-bis(2,4-diaminophenoxy)propane tetrahydrochloride

Schedule 6
Appendix E, Part 2
Appendix F, Part 3

The proposed implementation date is 1 June 2017.

HC Red 13

(2,2'-[(4-amino-3-nitrophenyl)imino]bisethanol and its monohydrochloride)

Schedule 6 - New Entry

HC RED 13 (including its salts) except:

  1. in non-oxidative hair dye preparations containing 2.5 per cent or less of HC Red 13 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 1.25 per cent or less of HC Red 13 after mixing under oxidative conditions 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, and

    Written in letters not less than 1.5 mm in height.

Appendix E, Part 2 - New Entry

HC RED 13

Standard statements: E1 (if in eyes wash out immediately with water).

Appendix F, Part 3 - New Entry

HC RED 13

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

Index - New Entry

HC RED 13
cross reference: 2,2'-[(4-AMINO-3-NITROPHENYL)IMINO]BISETHANOL

Schedule 6
Appendix E, Part 2
Appendix F, Part 3

The proposed implementation date is 1 June 2017.

HC Violet 1

(2-[(4-amino-2-methyl-5-nitrophenyl)amino]-ethanol)

Schedule 6 - New Entry

HC VIOLET 1 except:

  1. in non-oxidative hair dye preparations containing 0.28 per cent or less of HC Violet 1 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 0.25 per cent or less of HC Violet 1 after mixing under oxidative conditions 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, and

    Written in letters not less than 1.5 mm in height.

Appendix E, Part 2 - New Entry

HC VIOLET 1

Standard statements: E1 (if in eyes wash out immediately with water).

Appendix F, Part 3 - New Entry

HC VIOLET 1

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

Index - New Entry

HC VIOLET 1
cross reference: 2-[(4-AMINO-2-METHYL-5-NITROPHENYL)AMINO]-ETHANOL

Schedule 6
Appendix E, Part 2
Appendix F, Part 3

The proposed implementation date is 1 June 2017.

Abamectim

Schedule 5 - Amend Entry

ABAMECTIN:

  1. in preparations, for internal use for the treatment of animals, containing 1 per cent or less of abamectin; or
  2. in gel formulations containing 0.05 per cent or less of abamectin in applicators containing 50 mg or less of abamectin.

The proposed implementation date is 1 June 2017.

1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives

Schedule 6 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES except:

  1. in cosmetic rinse-off preparations containing 8 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives when labelled the following statement:

    IF IN EYES WASH OUT IMMEDIATELY WITH WATER, or

  2. in household cleaning preparations, other than those intended to be sprayed, containing 10 per cent or less of 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives when labelled with the following statement:

    IF IN EYES WASH OUT IMMEDIATELY WITH WATER.

Appendix E, Part 2 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES

Standard statement: E1 (if in eyes wash out immediately with water).

Appendix F, Part 3 - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES

Warning statement: 79 (Will irritate eyes).

Safety direction: 1 (Avoid contact with eyes)

Index - New Entry

1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES
cross reference: cocoyl methyl glucamaide

Schedule 6
Appendix E, Part 2
Appendix F, Part 3

The proposed implementation date is 1 June 2017.

o-Toluidine and o-anisidine

Schedule 10 - New Entries

o-TOLUIDINE in preparations for skin colouration (including tattooing) and dyeing of hair, eyelashes or eyebrows.

o-ANISIDINE in preparations for skin colouration (including tattooing) and dyeing of hair, eyelashes or eyebrows.

The proposed implementation date is 1 June 2017.

Book pagination