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Consultation: Further proposed amendments to the Poisons Standard - Joint ACCS and ACMS meeting, and ACCS meeting, March 2017

Scheduling medicines and poisons

3 February 2017

This consultation closed on 3 March 2017.

Invitation to comment

The TGA sought comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Joint Advisory Committee on Chemicals and Medicines Scheduling (Joint ACCS-ACMS) and Advisory Committee on Chemicals Scheduling (ACCS).

Following stakeholder feedback, the TGA has expanded the scheduling proposals for selected substances to be considered by the Advisory Committees on Chemicals and Medicines Scheduling (ACCS, ACMS) to promote relevant public submissions. The TGA would appreciate feedback on the effectiveness of the expanded proposals on submissions via chemical.scheduling@health.gov.au and medicines.scheduling@health.gov.au.

1. Proposed amendments referred by the delegates to the Joint Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS) for scheduling advice.
Substance Proposal
Resorcinol CAS Number 108-46-3
Alternative names Resorcinol (INCI); ,3-benzenediol (IUPAC); benzene-1,3-diol; 1,3-dihydroxybenzene; and 3-hydroxyphenol
Applicant NICNAS under their IMAP program.
Current scheduling Unscheduled.
Proposed scheduling To create a new Schedule 6 entry for resorcinol to restrict use in cosmetic and domestic products.
Key uses / expected use Hair dyes, hair care products and human therapeutics for topical use.
Reasons for proposal
  • Identified uses in cosmetic, domestic and therapeutic products in the Australian market place
    • Included as an active ingredient in 4 products on the ARTG (2 registered OTC products and 2 Export Only products)
  • International restrictions
    • EU concentration restrictions are 2.5% in hair preparations after mixing for use under non-oxidative conditions and 1.25% under oxidative conditions; and at 0.5% in hair lotions and shampoos.
2. Proposed amendments referred by the delegate to the Advisory Committee on Chemicals Scheduling (ACCS) for scheduling advice.
Substance Proposal
m-Aminophenol CAS Number 591-27-5
Alternative names 3-hydroxyaniline, m-aminophenol (INCI)
Applicant NICNAS under their IMAP program
Current scheduling Unscheduled
Proposed scheduling To create a new Schedule 6 entry for m-aminophenol restricting its use in cosmetic and domestic products with consideration of an exemption cut-off.
Key uses / expected use Hair dyes and hair care products
Reasons for proposal
  • Identified uses in cosmetic and domestic products (specifically hair dyes) in the Australian market place
  • International restrictions
    • EU, ASEAN and NZ concentration restrictions are 1.2% after mixing for use under oxidative conditions and 2.4% after mixing for use under non-oxidative conditions
2-Chloro-6-(ethylamino)-4-nitrophenol CAS Number 131657-78-8
Alternative names 2-Chloro-6-(ethylamino)-4-nitrophenol (INCI); Phenol, 2-chloro-6-(ethylamino)-4-nitro- (CAS)
Applicant NICNAS under their IMAP program
Current scheduling Unscheduled.
Proposed scheduling To create a new Schedule 6 entry for 2-chloro-6-(ethylamino)-4-nitrophenol restricting its use in cosmetic and domestic products with exemption cut-offs in hair dye preparations.
Key uses / expected use Hair dyes and hair care products.
Reasons for proposal
  • Identified uses in cosmetic and domestic products (specifically hair dyes) in the Australian market place
  • International restrictions
    • EU and NZ concentration restrictions are 3% in non-oxidative and 1.5% in oxidative hair preparations after mixing for use.
2,4-Diaminophenoxy-ethanol CAS Number 66422-95-5
Alternative names 2,4-diaminophenoxyethanol HCl (INCI)
Applicant NICNAS under their IMAP program
Current scheduling

Schedule 6

2,4-DIAMINO-PHENOXYETHANOL in hair dye preparations except in preparations containing 4 per cent or less of 2,4-diaminophenoxyethanol when the immediate container and primary pack are labelled with the following:

KEEP OUT OF REACH OF CHILDREN

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 dying eyelashes and eyebrow; to do so may be injurious to the eye.

Written in letters not less than 1.5 mm in height.

Appendix E, Part 2
Standard statements: A, E1.

Appendix F, Part 3
Warning statement: 21.

Proposed scheduling To amend the current Schedule 6 entry for 2,4-diaminophenoxyethanol to consider concentration cut-offs in oxidative and non-oxidative hair dye preparations.
Key uses / expected use Hair dyes and hair care products.
Reasons for proposal
  • Identified uses in cosmetic and domestic products (specifically hair dyes) in the Australian market place
  • International restrictions
    • EU concentration restrictions are 4% in non-oxidative and 2% in oxidative hair preparations after mixing for use.
Isoeugenol CAS Number 97-54-1
Alternative names 2-methoxy-4-(prop-1-en-1-yl)phenol; phenol, 2-methoxy-4-(1-propenyl)
Applicant NICNAS under their IMAP program
Current scheduling

Schedule 6

ISOEUGENOL except:

  1. when included in Schedule 5; or
  2. in preparations containing 10 per cent or less of isoeugenol.

Schedule 5

ISOEUGENOL in preparations containing 25 per cent or less of isoeugenol except in preparations containing 10 per cent or less of isoeugenol.

Proposed scheduling

The final decision for isoeugenol published on 27 October 2016 and to be implemented on 1 June 2017 is:

Schedule 6

ISOEUGENOL except:

  1. when included in Schedule 5; or
  2. in preparations intended for contact with skin containing 0.5 per cent or less of isoeugenol.

Schedule 5

ISOEUGENOL in preparations not intended for skin contact containing 25 per cent or less of isoeugenol except in preparations intended for contact with skin containing 0.5 per cent or less of isoeugenol.

Reasons for proposal To reconsider the Schedule 5 and 6 entries for isoeugenol proposed for implementation on 1 June 2017 to provide greater clarity in the schedule entries.
Key uses / expected use Cosmetic/chemical fragrance and household domestic products.

Timetable

Document released for consultation on Friday 3 February 2017.

Interested parties responded by close of business Friday 3 March 2017.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

This consultation is inviting public submissions under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations).

The delegate of the Secretary of the Department of Health hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees.

Accordingly, the above scheduling proposals are open for public submissions. Submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the Poisons Standard or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the amendment/s. If you do not support the amendment/s, you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the TGA Internet website: feedback on submissions will be provided through the TGA website at Public submissions on scheduling matters.

Scheduling decisions made by the medicines and chemicals delegates following consideration of submissions from interested parties, along with advice from the ACCS and Joint ACCS-ACMS will be published on the TGA website as interim decisions.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to chemicals.scheduling@health.gov.au or medicines.scheduling@health.gov.au.