You are here

Final decisions and reasons for NCEs, medicines and chemicals, November 2018

Scheduling medicines and poisons

26 April 2019

Book pagination

3.1. 2-chloro-p-phenylenediamine/2-chloro-p-phenylenediamine sulfate

Part A - Final decisions on matters referred to an expert advisory committee (November 2018)

3. Advisory Committee on Chemicals Scheduling (ACCS #23)

3.1. 2-chloro-p-phenylenediamine/2-chloro-p-phenylenediamine sulfate

Note

New text is shown as green, larger font, with a horizontal line above it.

Deleted text is shown as red, smaller font, with a strikethrough.

Delegate's final decision
Final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the current Poisons Standard in relation to 2-chloro-p-phenylenediamine/2-chloro-p-phenylenediamine sulfate as follows:

Schedule 6 - Amend Entry

PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives not elsewhere specified in these Schedules:

  1. in preparations packed and labelled for photographic purposes;
  2. in preparations packed and labelled for testing water except tablets containing 10 mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging provided the directions for use include the statement, "Do not discard testing solutions into the pool";
  3. in hair dye preparations except 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 irritation 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

  4. in eyelash and eyebrow tinting products when the immediate container and primary pack are labelled with the following statement:

    WARNING - This product contains ingredients which may cause skin irritation to certain individuals, and when used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.

    written in letters not less than 1.5 mm in height.

Schedule 10 - Amend Entry

PHENYLENEDIAMINES, including alkylated, arylated, halogenated and nitro derivatives, in preparations for skin colouration, tattooing and dyeing of eyelashes or eyebrows except when included in Schedule 6.

Appendix E Part 2 - Amend Entry

PHENYLENEDIAMINES, including alkylated, arylated, halogenated and nitro derivatives

  • Standard statements when used in hair dyes: A, E1.
  • Standard statements when used in preparations other than hair dyes: A, G1, G3, E1, S1.

Appendix F Part 3 - Amend Entry

PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives

  • Warning statements when used in hair dyes: 21.
  • Warning statements when used in in preparations other than hair dyes: 28.
  • Safety directions when used in preparations other than hair dyes: 1, 4, 8.

Index - Amend entry

PHENYLENEDIAMINES cross reference: ALKYLATED PHENYLENEDIAMINES, ALKYLATED, ARYLATED, HALOGENATED and NITRO- PHENYLENEDIAMINES, DIETHYL-PARA-PHENYLENEDIAMINE, DIMETHYL-PARA-PHENYLENEDIAMINE

INDEX

Schedule 10

Schedule 6

Appendix E, Part 2

Appendix F, Part 3

Implementation date

1 June 2019

Reasons

The reasons for the final decision remain the same as for the interim decision. It is noted that the public submission received in response to the interim decision, did not present any new evidence.

Public submissions on the interim decision

One public submission was received before the second closing date in response to an invitation published on 7 February 2019 under regulation 42ZCZP of the Regulations. The submission supported the interim decision.

The main points provided in support of the amendment were:

  • The proposed amendment will clarify that halogenated derivatives are captured by the existing scheduling entries for phenylenediamines; and
  • The clarification is not expected to result in any regulatory impact.
Interim decision

The interim decision was published on the TGA website on 7 February 2019 at Scheduling delegates' interim decisions and invitation for further comment: ACCS #23, November 2018 – 3.1 2-chloro-p-phenylenediamine.

Scheduling proposal

The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, November 2018.

Book pagination