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Consultation: Invitation for public comment - ACCS meeting, March 2015

Public consultation on the proposed amendments to the Poisons Standard

28 January 2015

The closing date for submissions is 27 February 2015.

Notice inviting public submissions under subsections 42ZCZK and 42ZCZL 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 following 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.

Persons wishing to make a submission are strongly encouraged to submit them in electronic format (word or unsecured PDF) to the email address provided below by 27 February 2015.

Email: chemicals.scheduling@health.gov.au

The Secretary
Chemicals Scheduling Secretariat (MDP 88)
Office of Chemical Safety
Department of Health
GPO Box 9848
CANBERRA ACT 2601
Facsimile: 02 6289 2650

Public submissions received after the closing date may or may not be considered by the advisory committee(s).

Public submissions must include the name of the person making the submission and preferably an email or postal address.

Please note that the submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework for Medicines and Poisons (SPF). The SPF is accessible on the NCCTG scheduling policy framework page.

The relevant expert advisory committee(s) will then consider all valid submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will make an interim scheduling decision. This interim decision is expected to be published in June 2015. The applicant and persons who made a submission in response to the original invitation received on or before the closing date will be invited to comment on the delegate's interim decision.

The current Poisons Standard is available at The Poisons Standard. Queries regarding medicine scheduling can be directed to the Medicines Scheduling Secretariat at Medicine.Scheduling@tga.gov.au. Chemical scheduling related queries can be directed to the Chemicals Scheduling Secretariat at chemicals.scheduling@health.gov.au.

Proposed amendments to the poisons standard referred by the delegate for scheduling advice

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS).

Substance Proposal
2-Ethylhexanoic acid In response to issues raised in a NICNAS IMAP report for 2-ethylhexanoic acid and its derivatives, the scheduling proposal is to create a new Schedule entry in Schedule 6 for 2-ethylhexanoic acid, with appropriate low concentration exemption cut-off in cosmetic and/or domestic preparations containing esters that hydrolyse and/or metabolise to 2-ethylhexanoic acid.
2-Hydroxyethyl methacrylate In response to issues raised in a NICNAS IMAP report for 2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, the scheduling proposal is to create a new schedule 5 entry for 2-hydroxyethyl methacrylate with an appropriate cut-off to exempt. The scheduling proposal will primarily address use in cosmetic products, but may include other product types as well.
4-Aminopropiophenone Proposal to include 4-aminopropiophenone in Schedule 7.
4,5-Dichloro-2-N-octyl-3(2H)-isothiazolone To amend the current 4,5-dichloro-2-N-octyl-3(2H)-isothiazolone Schedule 6 entry to exclude from the scheduling for paints, jointing compounds and sealant preparations containing 0.12% or less of 4,5-dichloro-2-N-octyl-3(2H)-isothiazolone.
4,7-Methano-1H-indene-5-acetaldehyde, octahydro- To create a new Schedule 6 entry for 4,7-methano-1H-indene-5-acetaldehyde, octahydro- with an appropriate cut-off to exempt from scheduling for preparations with low concentrations.
Ammonium cocoyl isethionate To create a new Schedule 5 or 6 entry for ammonium cocoyl isethionate with appropriate cut-off to exempt from scheduling for rinse-off preparations with low concentrations.
Babassuamidopropyl betaine This substance was referred to the July 2014 meeting of the ACCS, under the name 1-Propanaminium, 3-amino-n-(carboxymethyl)-n,n-dimethyl-, n-(c8-18 and c18-unsatd. Acyl) derivs., inner salts. The ACCS was asked whether the substance would be captured under the generic Schedule 6 entry for QUATERNARY AMMONIUM COMPOUNDS. During the consultation phase on the delegate’s interim decision, an industry submission suggested that this compound did not share many of the toxicological characteristics of quaternary ammonium compounds and like other amidopropyl betaines, is a neutral zwitterionic surfactant, whereas the quaternary ammonium compounds are cationic surfactants. Accordingly, the scheduling proposal to be considered at the March ACCS meeting is to develop a generic Schedule 6 entry for AMIDOPROPYL BETAINES, or a specific entry for babassuamidopropyl betaine, with exemption cut-offs for different types of cosmetic and other products, along with appropriate label first aid statements if the products make eye or skin contact.
Flupyradifurone To create a new schedule 5 or 6 entry for flupyradifurone with or without a scheduling cut-off for preparations with low concentrations.
Metofluthrin The scheduling proposal is to include a schedule 5 entry for metofluthrin impregnated into a polyethylene slow release matrix containing 212 mg or less of metofluthrin.