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Scheduling delegate's final decisions, June 2016

Scheduling of medicines and poisons

23 June 2016

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1.16 Methyldibromo glutaronitrile

Part A - Final decisions on matters referred to an expert advisory committee

1. Scheduling proposals referred to the March 2016 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#16)

1.16 Methyldibromo glutaronitrile

Referred Delegate's scheduling proposal
  • To resolve an apparent ambiguity between the Schedule 6 and Schedule 10 entries relating to duplication of the exception clause "except in preparations intended to be in contact with the skin, including cosmetic use".
Applicant's application and scheduling proposal

On 30 November 2015 the chemicals scheduling Delegate identified possible ambiguity in the current SUSMP entries for the chemical. The proposal is to amend the Schedule 6 entry to remove the exception clause "except in preparations intended to be in contact with the skin, including cosmetic use".

Substance summary

How to access a pdf document

Please refer to the NICNAS Chemical assessment report for methyldibromo glutaronitrile (pdf,196kb) which is available from the NICNAS website.

Figure 13. Structure of methyldibromo glutaronitrile
Figure 13. Structure of methyldibromo glutaronitrile

Public exposure

No information provided.

International regulations

No information provided.

Current scheduling status

Methyldibromo glutaronitrile is currently listed in Schedules 6 and 10 and Appendix F.

Schedule 6

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

Schedule 10

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use except when in Schedule 6.

Appendix F, Part 3

Warning statement 28

Safety directions 1, 4, 7

Scheduling history

Methyldibromo glutaronitrile (MDBG) was first considered for scheduling in June 2008. Due to an administrative error the substance was reconsidered at the October 2008 meeting.

The Committee decided: to include MDBG in Appendix C when in preparations intended to be in contact with the skin, including cosmetic use; and in Schedule 6 except when in preparations intended to be in contact with the skin, including cosmetic use. Appendix F warning statement 28 and Safety directions 1, 4 and 7 were also agreed.

The current wording of the Schedule 10/Appendix C entry was published in the first version of the Standard in 2015.

Pre-meeting public submissions

Two public submissions were received. The first submission did not support the proposed amendments. They noted that MDBG is entered in the ARTG ingredient list and is allowed in therapeutic goods as an excipient in OTC medicines. They requested that the ACCS considers exemptions (from either Schedule 6 or Schedule 10, as appropriate) for the use of the substance as an excipient in therapeutic goods, with a suitable cut-off concentration if appropriate. The second submission supports clarification of the current Schedule entries and included proposed wording for an amended Schedule 6 entry.

The public submissions are available at Public submissions on scheduling matters.

Summary of ACCS advice to the delegate

In response to the Delegate's request, the Committee advised that the current schedule entries for MDBG were ambiguous. They recommended that the entries could be improved by simplifying the cross reference between the entries as follows; for the schedule 6 entry, replacing the exception clause with "except when in Schedule 10", and for the Schedule 10 entry, referring to the use that is subject to prohibition and deletion of reference to the Schedule 6 entry.

The Committee recommended the following amendments to the Poisons Standard:

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.

The Committee recommended an early implementation date of 1 October 2016.

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: f) amendments clarify which uses are subject to prohibition in Schedule 10.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors16;
  • Other relevant information.
Delegate's interim decision

The delegate notes, and accepts, ACCS advice to amend the Schedule 6 and 10 entries for methyldibromo glutaronitrile, since they appeared to contain mutually exclusive exemption clauses. The purpose of the Schedule 10 entries was to prevent the availability of products that would be directly applied to human skin. Retaining the existing Schedule 6 entry would be consistent with SPF criteria for such a listing and would ensure that labelling and supply restrictions for other types of products are retained.

The delegate notes the industry submission that seeks an exemption from the entries where the substance may be used in therapeutic goods. The chemicals scheduling delegate has therefore referred the matter to the medicines scheduling delegate for further consideration.

The proposed implementation date is 1 October 2016. This is a clarification of existing schedule entries, so it should be implemented in the earliest revision of the Poisons Standard.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (b) the purposes for which a substance is to be used and the extent of use of a substance; and (c) the toxicity of a substance.

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.

Public submissions on the interim decision

No submissions were received.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the final decision and reasons are in keeping with those for the interim decision.

The implementation date is 1 October 2016.


Footnote

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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