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

Scheduling medicines and poisons

12 May 2016

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1 Summary

Part A - Interim decisions on scheduling proposals referred to an advisory committee (March 2016)

1. Advisory Committee on Chemicals Scheduling (ACCS#16)

Summary of delegate's interim decisions
Substance Interim decision
Crystal violet and related dyes

Schedule 10 - new entry

METHYLROSANILINIUM CHLORIDE (formerly known as crystal violet CAS No. 548-62-9) AND THE FOLLOWING TRIARYLMETHANE DYES - for use in hair dyes

  • Acid Violet 49 (CAS No. 1694-09-3)
  • Ethyl Violet (CAS No. 2390-59-2)
  • Basic Blue 7 (CAS No. 2390-60-5)
  • Basic Blue 26 (CI 44045) (CAS No. 2580-56-5)

Schedule 6 - New entries

METHYLROSANILINIUM CHLORIDE (formerly known as crystal violet CAS No. 548-62-9) AND THE FOLLOWING TRIARYLMETHANE DYES

  • Acid Violet 49 (CAS No. 1694-09-3)
  • Ethyl Violet (CAS No. 2390-59-2)
  • Basic Blue 7 (CAS No. 2390-60-5)
  • Methylium, 4-(dimethylamino)phenylbis4-(ethylamino)-3-methylphenyl-, acetate (CAS No. 72102-55-7)
    • except when included in Schedules 4 or 10

BASIC BLUE 26 (CAS No. 2580-56-5) except when used as a colourant in cosmetics not intended to be in contact with mucous membranes.

Schedule 4 - Amend entry

CRYSTAL VIOLET for human use except when used as a dermal marker. - replace "CRYSTAL VIOLET" with "METHYLROSANILINIUM CHLORIDE"

Index entries:

Crystal violet - see methylrosanilinium chloride

Gentian violet - see methylrosanilinium chloride

Proposed implementation date: 1 October 2016.

Disperse yellow 3

Schedule 10 - New entry

DISPERSE YELLOW 3 - for use in hair dyes

Schedule 6 - New entry

DISPERSE YELLOW 3 - except when in Schedule 10

Appendix E, Part 2 - New entry

DISPERSE YELLOW 3

Standard statements: A, S1

Appendix F, Part 3 - New entry

DISPERSE YELLOW 3

Warning Statement: 28

Safety direction: 4

Proposed implementation date: 1 October 2016.

Chrysoidine base

Schedule 6 - New entry

CHRYSOIDINE except when in Schedule 10

Schedule 10 - New entry

CHRYSOIDINE in preparations for use in hair dyes.

Appendix E, Part 3 - New entry

CHRYSOIDINE

Standard statements: A, S1, E1

Proposed implementation date: 1 October 2016.

p-Aminophenol

Schedule 6 - New entry

p-AMINOPHENOL except when used in hair dye and eyebrow/eyelash colouring products at a concentration of 1 per cent or less of p-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

p-AMINOPHENOL

Standard statements: A, S1

Appendix F, Part 3 - New entry

p-AMINOPHENOL

Warning Statement: 28

Proposed implementation date: 1 June 2017.

2-Methylresorcinol

Schedule 6 - New entry

2-METHYLRESORCINOL except:

  1. in non-oxidative hair dye preparations containing 1.8 per cent or less of 2-methylresorcinol when the immediate container and primary pack are labelled with the following statements:

    KEEP OUT OF REACH OF CHILDREN, and

    WARNING -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

  2. in oxidative hair dye preparations containing 1.8 per cent or less of 2-methylresorcinol 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 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.

Appendix E, Part 2 - new entry

2-METHYLRESORCINOL

Standard statements: A, E1

Appendix F, Part 3 - new entry

2-METHYLRESORCINOL

Safety direction: 1

Proposed implementation date: 1 June 2017.

2,4-Diamino-5-methylphenetole

The current scheduling remains appropriate.

Index - new entry

2,4-DIAMINO-5-METHYLPHENETOLE
cross reference: PHENYLENEDIAMINES

Proposed implementation date: 1 October 2016.

2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine

The current scheduling remains appropriate.

Index - new entry

2-CHLORO-5-NITRO-N-HYDROXYETHYL-p-PHENYLENEDIAMINE
cross reference: PHENYLENEDIAMINES

Proposed implementation date: 1 October 2016.

BIS-Isobutyl PEG/PPG

Schedule 6 - New entry

BIS-ISOBUTYL PEG/PPG-20/35/AMODIMETHICONE COPOLYMER except in rinse-off cosmetic products containing 1 per cent or less of bis-isobutyl PEG/PPG-20/35/amodimethicone copolymer.

Appendix E, Part 2 - New entry

BIS-ISOBUTYL PEG/PPG-20/35/AMODIMETHICONE COPOLYMER

Standard statements: A, E1

Appendix F, Part 3 - New entry

BIS-ISOBUTYL PEG/PPG-20/35/AMODIMETHICONE COPOLYMER

Safety direction: 1

Proposed implementation date: 1 June 2017.

Propamocarb The current scheduling remains appropriate.
Fluopicolide

Appendix B, Part 3 - New entry

FLUOPICOLIDE

Part 1 - Reasons for Entry - a) low toxicity

Part 2 - Area of Use - 1.3 Fungicide

Proposed implementation date: 1 October 2016.

Nonanoic acid

Schedule5 - New entry

NONANOIC ACID except in preparations containing 10 per cent or less of nonanoic acid

Proposed implementation date: 1 February 2017.

Di-bak Parkinsonia

Schedule 5 - New entries

LASIODIPLODIA PSEUDOTHEOBROMAE except when used as a herbicide in capsule preparations at a concentration of 16 CFU or less per capsule.

NEOSCYTALIDIUM NOVAEHOLLANDIAE except when used as a herbicide in capsule preparations at a concentration of 16 CFU or less per capsule.

MACROPHOMINA PHASEOLINA except when used as a herbicide in capsule preparations at a concentration of 16 CFU or less per capsule.

Proposed implementation date: 1 October 2016.

Streptomyces lidicus

Appendix B, Part 3 - New entry

STREPTOMYCES LYDICUS WYEC 108

Part 1 - Reasons for Entry - a) low toxicity

Part 2 - Area of Use - 1.3 Fungicide

Proposed implementation date: 1 October 2016.

Isopyrazam

Schedule 6 - New entry

ISOPYRAZAM

Proposed implementation date: 1 October 2016.

4,5-Dichloro-2-N-octyl-3(2H)-Isothiazolone The current scheduling remains appropriate.
Methyldibromo glutaronitrile

Schedule 6 - Amend entry

METHYLDIBROMO GLUTARONITRILE except when in Schedule 10

Schedule 10 - Amend entry

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use

Proposed implementation date: 1 October 2016.

Potassium hydroxide and Sodium hydroxide

Schedule 6 - Amend entry

POTASSIUM HYDROXIDE (excluding its salts and derivatives) except:

  1. when included in Schedule 5 or 10; or
  2. in preparations containing 5 per cent or less of potassium hydroxide being:
    1. solid preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or
    2. liquid or semi-solid preparations, the pH of which is 11.5 or less

SODIUM HYDROXIDE (excluding its salts and derivatives) except:

  1. when included in Schedule 5 or 10; or
  2. in preparations containing 5 per cent or less of sodium hydroxide being:
    1. solid preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or
    2. liquid or semi-solid preparations, the pH of which is 11.5 or less

Proposed implementation date: 1 October 2016.

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