You are here

Scheduling delegate's final decisions: ACCS, March 2015

Scheduling medicines and poisons

27 March 2015

Book pagination

Part A - Final decisions on matters referred to an expert advisory committee (2.4-2.6)

2. Scheduling proposals referred to the November 2014 meeting of the Advisory Committee on Chemicals Scheduling and Advisory Committee on Medicines Scheduling (ACCS-ACMS #10)

2-Cyclohexylphenol

Scheduling proposal

The delegates referred the following scheduling proposal for consideration by the joint committee of the ACCS-ACMS:

  • to create a new Schedule 6 entry for 2-cyclohexylphenol with appropriate exemption cut-offs for some specific uses, and to amend, as necessary, the current entry in Schedule 9 for CYCLOHEXYLPHENOLS.

The delegates asked that the joint committee of ACCS-ACMS consider the following:

  • revise the preamble to Appendix A to confirm that the listed exemptions do not apply to Schedule 9, and/or
  • revise the current schedule 9 generic entry for cyclohexylphenols or develop a separate and specific Schedule 6 entry for 2-cyclohexylphenol, so that the current Schedule 9 entry can remain, and/or
  • review the current listing of industrial algicides, bacteriocides and slimicides in Appendix A to see whether this exemption should be maintained.

The committee was asked to discuss and consider the resolutions with an implementation date of 1 June 2015/1 October 2015/1 February 2016.

The delegates' proposal was based on an inquiry from a company regarding paint preparations containing 2-cyclohexylphenol as a bacteriocide. The substance is not specifically scheduled. An Appendix A listing for bacteriocides for industrial use that do not fit the definition of an agriculture or veterinary chemical product may be applicable for this substance.

The chemicals delegate considered the inquiry, and noted that in February and June 2006, the National Drugs and Poisons Schedule Committee (NDPSC) considered industrial biocides. At that time, there was a complex discussion on the need to schedule 'industrial biocides'. There had been some earlier (and later) actions that included four biocides in Schedule 6, based on their acute toxicity and skin corrosivity. The delegate indicated that it was recognised that these scheduling actions contradicted an earlier policy (1993 Drugs and Poisons Scheduling Committee) that biocides for 'industrial use' did not require scheduling unless there was a clear indication that they could be used in domestic products. The four biocides, which are listed in Schedule 6 (N-coco-1,3-diaminopropane; N-oleyl-1,3-diaminopropane; alkoxylated fatty alkylamine polymer; and N-tallow alkyl-1,3-propanediamine diacetate/tallow alkylamine acetates), are assumed to be listed because they are possibly used in domestic products.

At the February 2006 meeting, the NDPSC originated the Appendix A blanket exemption of industrial algicides, bacteriocides and slimicides from scheduling. There were discussions at both the February and June 2006 meetings regarding whether an industrial biocide is too broad a term, and whether it includes, or not, all such compounds that require registration by the APVMA. The NDPSC decided if they are registered by the APVMA, scheduling actions could apply, but if they are not, the Appendix A exemption should apply. The Appendix A clause was modified at the June 2006 NDPSC meeting to ensure that the Appendix A exemption only applied to biocides not requiring registration by the APVMA.

If the biocide 2-cyclohexylphenol is assessed by NICNAS, and not the APVMA, it would seem to fit within the Appendix A exemption.

The information from the company was that 2-cyclohexylphenol will be used as an 'industrial biocide' in paints; therefore, the Appendix A exemption would probably apply.

The chemicals scheduling delegate indicated that cyclohexylphenols are currently listed in Schedule 9 except when separately specified in these schedules. The reason for this listing is not explicit. The reason for this listing could be that these chemicals may be used as an analogue or precursor in the synthesis of psychoactive compounds.

Delegates' reasons for referring this to the committee

The delegates' reason for referring this scheduling proposal to the joint meeting of the ACMS-ACCS is that, there is some confusion about whether the proposed use of this chemical in an industrial biocide satisfies the current Appendix A exemption for such products and whether any Appendix A exemption applies to chemicals listed in Schedule 9. Accordingly, the delegates seek advice from the joint committee of the ACCS-ACMS.

The delegates asked the ACCS-ACMS the following questions:

  • Does the proposed use of 2-cyclohexylphenol in paints as a bacteriocide qualify for the general scheduling exemption for such use in Appendix A?
  • Is it clear that 2-cyclohexylphenol's function in paints is for its bacteriocidal properties, or is it simply an impurity?
  • The preamble to Appendix A states that "this Standard does not apply to a poison in any of the following products". Does this statement need amending to indicate that the exemption does not apply to poisons listed in Schedule 9? Some States have indicated that they do not adopt Appendix A, or would not apply it in the case of Schedule 9 poisons.
  • Irrespective of whether Appendix A applies to this use, is it necessary to develop a new specific entry in Schedule 6 for 2-cyclohexylphenol? Would this then totally exempt this specific isomer from Schedule 9, because of the current entry wording (CYCLOHEXYLPHENOLS except when separately specified in these schedules) or should any new S6 entry specify the use covered by the entry?
  • Would a low-level cut-off for an S6 entry cause an exempted product to revert to S9, or would the current wording of the S9 entry allow for exempt products associated with a specified use?
  • Are there any implications for loss of control over illicit drug manufacture if the above changes are made?
Substance summary

image of a chemical structure of 2-cyclohexylphenol
Figure 4. Structure of 2-cyclohexylphenol

Acute toxicity
Toxicity Species 2-cyclohexylphenol SPF Classification
Acute oral toxicity LD50 (mg/kg bw) Rats 4100 Low toxicity
Acute dermal toxicity LD50 (mg/kg bw) Rabbits 5010 Low toxicity
Acute inhalational toxicity LC50 (mg/m3/4h) Not available Not available Unable to assess
Skin irritation Rabbit Corrosive
Eye irritation Rabbits Severe eye irritant
Skin sensitisation (add here the type of test if it is stated in the report) Not available Not available
International regulations

2-cyclohexyphenol is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).

Scheduling status

2-Cyclohexylphenol is not specifically listed in a schedule.

Cyclohexylphenol is listed in Schedule 9.

Schedule 9

Cyclohexylphenol except when separately specified in these Schedules.

Algicides, bacteriocides and slimicides for industrial use are listed in Appendix A.

Appendix A

ALGICIDES, BACTERIOCIDES OR SLIMICIDES for industrial use that do not fit the definition of an agvet chemical product.

Scheduling history

2-Cyclohexylphenol has not been considered previously.

In August 1973, the Drugs and Poisons Schedule Committee (DPSC) considered a request for advice as to whether industrial biocides would require poisons scheduling and, if so, what toxicological data would be required. The DPSC indicated that such industrial products did not require scheduling and should be assessed by the Chemicals Safety Unit/Worksafe as part of the registration process and to be labelled in the context of their end use. However, where the product was to be available for use in the home, it would need to be referred to DPSC for scheduling (and labelling).

In February 2006, the National Drugs and Poisons Schedule Committee (NDPSC) originated the Appendix A blanket exemption of industrial algicides, bacteriocides and slimicides from scheduling. There was discussion at both the February and June 2006 meetings regarding whether ‘industrial biocide’ is too broad a term, and whether or not it includes all such compounds that require registration by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The NDPSC decided that if they are registered by the APVMA, scheduling actions could apply, but if they are not, the Appendix A exemption should apply. The Appendix A clause was modified at the June 2006 NDPSC meeting to ensure that the Appendix A exemption only applied to biocides not requiring registration by the APVMA.

Pre-meeting public submissions

One submission was received that supports exemption of certain product categories from Schedule 9 and requested certain uses of 1-cyclohexylphenol should instead be included in Schedule 6, with exemption from scheduling if contained in a formulated product.

Summary of ACCS-ACMS advice to the delegates

The committee recommended that the current scheduling of 2-cyclohexylphenol remains appropriate. The committee recommended Appendix A exemption should not apply to substances in Schedule 9.

Delegates' considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS-ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • SPF Scheduling factors;
  • Other relevant information.
Delegates' interim decision

The Delegates accept the advice of the Joint ACCS-ACMS meeting, that the current Schedule 9 entry for cyclohexylphenol remains appropriate and that this entry would cover the proposed use of 2-cyclohexylphenol in paints. The Delegates note that, while the use of 2 -cyclohexylphenol as a biocide in paints could qualify for exemption under the Appendix A general exemption for ALGICIDES, BACTERIOCIDES OR SLIMICIDES for industrial use that do not fit the definition of an agvet product, there remains some potential confusion about whether an entry in Schedule 9 overrides such an exemption. The Delegates therefore propose to consult with State/Territory jurisdictions on whether the preamble to Appendix A or a specific amendment to Part 1 of the SUSMP is needed to clarify that an entry in Schedule 9 overrides an Appendix A exemption.

The delegates 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; (c) the toxicity of the substance; and (e) the potential for abuse of the substance.

Public submissions on the interim decision

One public submission was received. The submission noted that a biocide (ortho-phenylphenol) with cyclohexylphenol impurity is currently used in industrial setting, and that they have concerns that clarifying an entry in Schedule 9 overrides an Appendix A exemption could potentially have a significant impact. The submission requests the Delegates reconsider the interim decision and propose an alternate Schedule 9 entry be considered:

CYCLOHEXYLPHENOLS except:

  1. when separately specified in these Schedules; or
  2. in preparations containing 0.5 per cent or less.
Delegates' final decision

The delegates note the submissions received in response to publication of the interim decision and have determined to vary the interim decision by amending the current Schedule 9 entry for CYCLOHEXYPHENOLS, to allow a scheduling exemption for products containing a low concentration. The delegates were persuaded that the presence of 2-cyclohexylphenol as an inadvertent manufacturing byproduct in the biocide o-phenylphenol would not enable extraction of cyclohexylphenol for illicit purposes. However, advice from the jurisdictions that the current listing of cyclohexylphenol in Schedule 9 at any concentration would negate the product exemption for industrial biocides available under Appendix A would result in a significant regulatory impact on products containing 2-cyclohexylphenol as an impurity.

The delegates have therefore determined to amend the Schedule 9 entry in accordance with the proposal in the public submission.

Schedule 9 - vary the entry to:

CYCLOHEXYLPHENOLS except:

  1. when separately specified in these Schedules; or
  2. in preparations containing 0.5 per cent or less.

The delegates 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; (c) the toxicity of the substance; and (e) the potential for abuse of the substance.

The delegates agree to a proposed implementation date of 1 June 2015.

Schedule entry
Schedule 9 - Amendment

CYCLOHEXYLPHENOLS except:

  1. when separately specified in these Schedules; or
  2. in preparations containing 0.5 per cent or less.

2.5. Gamma butyrolactone

Scheduling proposal

The delegates referred the following scheduling proposal for consideration by the joint committee of ACCS-ACMS:

  • To consider whether a separate entry for gamma butyrolactone is required in either Appendix C/Schedule 10 or Schedule 9 to restrict its use in cosmetics or other types of products.

The committee was asked to discuss and consider the resolutions with an implementation date of 1 June 2015/1 October 2015/1 February 2016.

In June 2014, the Drug Control Section (DCS), now with the TGA, asked the delegates to consider the scheduling of gamma butyrolactone, suggesting a potential entry in Appendix C for cosmetic use.

DCS regulates the import, export, and manufacture of controlled drugs and chemicals to fulfil Australia’s obligations under international drug conventions and national legislation received a number of enquiries regarding the importation. The section received a number of inquiries regarding the importation of acetone free nail wipes which contain gamma butyrolactone as it is a known chemical precursor for the manufacture of the Schedule 9 substance gamma-hydroxybutyric acid (GHB). A summary of the reasons why the scheduling request was lodged by DCS has been provided below:

  • Gamma-butyrolactone (GBL) is a substance which is known to metabolised, when ingested, into gamma-hydroxybutyric acid (GHB and a Schedule 9 substance) and can be also used as a chemical precursor to manufacture GHB.
  • GBL is currently available for retail sale in Australia and is being imported as a component of acetone free nail wipes (15-17mL in a container of 30 nail wipes).
  • A search of the internet identified incidences where persons were using similar acetone-free nail wipes at night clubs and at least one report of an infant going into a coma.
  • Of concern is the metabolism of GBL to GHB. This is similar to the incidence with bindeez beads some years ago where children were exposed to 1,4 butanediol when the beads were ingested. Bindeez beads were recalled by the ACCC and an Appendix C entry was made in the Poisons Standard.
  • Noting that GBL is also legitimately used by industry for various industrial purposes, we are seeking options under the scheduling framework to help determine whether the use of GBL in a cosmetic does/does not pose a risk to public health. If a risk is identified options could include an Appendix C entry restricting its use in consumer (cosmetic) products.
Delegates' reasons for referring this to the committee

The delegates' reason for referring this scheduling proposal to the ACMS-ACCS was that this matter requires advice from committees because the possible scheduling actions include consideration of a current Schedule 9 listing for gamma hydoxybutyrate (GHB) and a possible Appendix C listing for gamma butyrolactone (GBL), with a potentially large overlap in the types of products affected by any scheduling decision.

The delegates asked the ACCS-ACMS the following questions:

  • Is the potential for extensive conversion of GBL to GHB by metabolism sufficient reason to consider restrictive scheduling for all/any products formulated with GBL?
  • Do the provisions of SUSMP Part 1 (2) imply that GBL should be considered a 'derivative', 'active principle' or stereoisomer of GBH, and thus be already captured by the Schedule 9 entry for GBH or the Appendix C entry for 1,4-butanediol?
  • If scheduling action is required to restrict the use of GBL in commercial products, should this be via Schedule 9 or Appendix C, and should the scheduling be limited to specific products types (e.g. cosmetics, nail wipes)?
  • What weight should be given to media and published reports outlining abuse patterns or inadvertent toxicity of acetone-free nail wipes overseas? Should information be sought on whether this type of abuse or toxicity has been reported in Australia?
  • What could be the unintended consequences of any proposed scheduling action on products already on the market where GBL has been used as a solvent or minor ingredient?
Evaluation

The delegates determined that an external evaluation was not required for this scheduling proposal.

Substance summary

Drug monographs to not appear to be available for gamma butyrolactone; however, the following links have been provided for general background:

As listed in the WHO paper, GBL has wide spread industrial use. It is an intermediate in the synthesis of polyvinylpyrrolidone, DL-methionine, piperidine, phenylbutyric acid and thiobutyric acid. It is used as a solvent for polyacrylonitrile, cellulose acetate, methylacrylate polymers, and polystyrene. It is a constituent of paint removers, textile aids and drilling oils.

International regulations

European Union: GBL is a non-scheduled drug precursor and in accordance with the EU legislation on control and monitoring of trade in drug precursors (Regulation (EC) No 273/2004(4) and Regulation (EC) No. 111/2005(5)), GBL is covered by the EU voluntary monitoring scheme for drug precursors.

Australia: GBL is a border controlled substance and is illegal to import into Australia without a permit. The importation of a commercial quantity of a border controlled drug (over 1 kg of GBL) is punishable by up to life imprisonment and/or an $825,000 fine.

Austria: GHB was included in the list of substances controlled by the Austrian Narcotic Substances Act in 2003. In November 2008 amendments to the Decree on Narcotic Drugs were sent out for examination. They include the synthetic substances BZP and GBL as well as the opiate Oripavin.

Bulgaria: From April 2010 both GHB precursors (GBL and 1,4-BD) are enlisted in Schedule III - "Dangerous substances".

Canada: GBL is a Controlled Substance under Schedule VI of the "Controlled Drugs and Substances Act" in Canada. Schedule VI of the "Controlled Drugs and Substances Act" requires vendors to collect information regarding purchases of GBL. The Act also prohibits the import and export of GBL into or out of Canada classifying it as either an indictable offense punishable with up to 10 years in prison or an offense punishable on summary conviction liable to imprisonment for up to eighteen months. It is not illegal for an individual to possess GBL in Canada.

Germany: GBL is not listed in the narcotics law, but its distribution is controlled. Possession is not illegal, but may be punished according to the Medicines Act, when intended to be sold for human consumption or synthesis of GHB. In recent years, an increase of GBL consumption has been observed due to the prohibition of GHB.

Hong Kong SAR: GBL is a dangerous drug controlled under Schedule 1 of the Dangerous Drugs Ordinance, Cap.134 (with exemption clause at Paragraph 16D). Any person who is found to have in his possession of it not in accordance with this Ordinance can be liable, on conviction upon indictment, a fine of HK$1,000,000 and to imprisonment for 7 years.

Israel: GBL has been classified as a proscribed substance since 2007.

The Netherlands: September 2011, based on the CAM advice, the Minister of Health has recently decided to promote GHB from class 2 to class 2 of the Opium law. It is now in the class of hard drugs. It is advocated to place GBL and 1,4 BD in the highest class of the Wvmc (European trade treaty; 273/2004).

Poland: GBL is not classified as a drug and can be purchased in chemistry shops as a solvent.

Romania: GBL is controlled by Governmental decision that entered in force on 15 February 2010.

Sweden: February 1st, 2000 GHB was scheduled in Sweden. Since 1 September 2005 GBL and 1,4-butandiole are also under control.

United Kingdom: GBL has been classified as a Class C drug since 23 December 2009, with a prison term of up to two years for possession and 14 years for dealing.

Norway: 1,4-butandiol and GBL were added to the Norwegian National Drug List with effect from 24 March 2010.

Scheduling status

Gamma butyrolactone is not currently scheduled. It is, however, a precursor for the Schedule 9 substance 4 hydroxybutanoic acid (gamma hydroxybutrate or GHB).

Scheduling history

In November 1996, the NDPSC decided to include gamma butyrolactone in Schedule 9. This decision was rescinded in June 2002.

Pre-meeting public submissions

One submission was received that states any scheduling consideration should be restricted to gamma butyrolactone and not include its derivatives. The submission also notes that scheduling controls should be limited to the types of products that could be misused, i.e. where gamma butyrolactone is a major ingredient in the product with no other toxic or unpleasant tasting ingredients, or where gamma butyrolactone can be easily extracted from the product.

Summary of ACCS-ACMS advice to the delegates

The committee recommended gamma butyrolactone be included in Appendix C (soon to be Schedule 10), exempting the polymerised form, in preparations for domestic and cosmetic use.

The committee supported the implementation date of 1 June 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: (b) the purposes for which a substance is to be used and the extent of use of a substance; and (e) the potential for abuse of a substance.

The reasons for the recommendation comprised the following:

  • It has industrial uses, for which controls are in place through other mechanisms.
  • GBL is a is a well-known drug precursor that can be used for illicit manufacture of GHB, is also metabolised to GHB in vivo and, therefore, has no place in domestic or cosmetic products.
Delegates' considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS-ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • SPF Scheduling factors;
  • Other relevant information.
Delegates' interim decision

The Delegates accept the advice of the Joint ACCS-ACMS meeting, to create a new entry in Appendix C/Schedule 10 to restrict the use of gamma butyrolactone (GBL) in cosmetic and domestic preparations. These restrictions are necessary to prevent potential diversion of this well-known drug precursor to illicit use or in manufacture of GHB, a substance controlled in Schedule 9. An industry submission suggested that the EU permits use of GBL as a solvent in some cosmetics and, while GBL use in Australian products may be quite low, it should not represent an abuse problem because it is difficult to extract from products like nail polishes and hardeners. However, the delegates were also informed of some instances where such products had been abused. Accordingly, the interim decision is to restrict its use via listing in Appendix C/Schedule 10.

The delegates agree with the implementation date being 1 June 2015.

The delegates considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (c) the toxicity of the substance; (e) the potential for abuse of the substance.

Public submissions on the interim decision

One public submission was received, which supported the Delegates' interim decision.

Delegates' final decision

The delegates note the submissions received in response to publication of the interim decision and confirm the interim decision as no evidence has been received to alter the interim decision. The delegates have confirmed that the reasons for the final decision are in keeping with those for the interim decision.

The delegates have confirmed the proposed implementation date of 1 June 2015.

Schedule entry
Appendix C/Schedule 10 - New entry

GAMMA BUTYROLACTONE (excluding its derivatives) in non-polymerised form in preparations for domestic and cosmetic use.

2.6. Oxalic acid (soluble oxalates)

Scheduling proposal

The delegates referred the following scheduling proposal for consideration by the joint committee of the ACCS-ACMS:

  • At the March 2014 meeting of the ACCS, an issue was raised regarding whether soluble oxalate salts used in therapeutic goods such as mouthwashes would be captured by the current Schedule 6 entry OXALIC ACID except its derivatives and insoluble salts. This issue needs to be clarified along with the need for a specific clause exempting soluble oxalates in mouthwashes.

The committee was asked to discuss and consider the resolutions with an implementation date of 1 June 2015/ 1 October 2015/1 February 2016.

Delegates' reasons for referring this to the committee

The delegates' reason for referring this scheduling proposal to the ACMS-ACCS was that, in accordance with section 4.2 of the Scheduling Policy Framework (SPF), advice is expected to be obtained from an expert advisory committee for all rescheduling proposals.

The delegates asked the ACCS-ACMS the following question:

  • ACCS consideration of a proposal to review the current Schedule 6 entry for oxalic acid raised an issue of whether mouthwashes containing soluble oxalates would be captured by the current wording, which specifies that the entry exempts derivatives of oxalic acid and its insoluble salts. Can soluble oxalates used in mouthwashes be considered to be 'derivatives', or is there a need to create a separate exemption for this specific use?
Scheduling history

Oxalic acid was first considered in May 1956 by the PSC and the PSC decided to include oxalic acid and metallic oxalates in (the then) Schedule 5.

In November 1985, the PSC decided to amend the Schedule 6 oxalic acid entry to exempt its derivatives and insoluble salts from the Schedule 6 entry.

In August 2014, the delegate considered a scheduling application requesting that the Schedule 6 entry for oxalic acid be amended to either exempt from scheduling household and domestic cleaning preparations containing 8% or less oxalic acid, or to list such products in Schedule 5. The delegate made a final decision, based on advice received from the ACCS and the public submissions received, not to change the scheduling status of oxalic acid. The delegate indicated that the toxicity profile of oxalic acid is consistent with the SPF Schedule 6 criteria and that the current listing of oxalic acid in Schedule 6 remains appropriate. The label signal heading, First Aid statements (Appendix E), Safety Directions and Warning Statements (Appendix F) remain appropriate for the type of cleaning products in the re-scheduling submission. The delegate also noted that the available information was insufficient to develop an exemption threshold for the Schedule 6 entry at that time. The delegate noted the proposals in public submissions that scheduling therapeutic goods containing oxalates is not appropriate, but concludes that the current entry (excepting derivatives and insoluble salts) should not apply to derivatives used in medicines. The delegate concluded that the matter of providing an exemption threshold for the use of soluble oxalates in mouthwashes requires further consideration and it would be referred back to a future meeting of the ACCS-ACMS.

Public pre-meeting submissions

Five submissions were received. All supported the exclusion of oral care preparations (e.g. mouthwashes, but also other products such as swabs) containing soluble oxalates from scheduling. Most submissions agreed that the cut-off concentration for exempting these products should be <3%. However, one submission requested an exemption for therapeutic oral care products which provide <20 mg oxalic acid per day. One submission also requested exempting household and domestic cleaning products containing <8% oxalic acid. Three submissions supported appropriate labelling for consumers, but that this should align with the statements already in use in the European Union.

Summary of ACCS-ACMS advice to the delegates

The committee recommended that current Schedule 6 oxalic acid schedule entry be amended to exempt for mouthwash preparations containing potassium oxalates at less than 1.5% from scheduling, and remove the exemption of derivatives.

The committee supported the implementation date of 1 June 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: (c) the toxicity of a substance.

The reasons for the recommendation comprised the following:

  • low toxicity of potassium salts, at low concentrations, in mouth wash products.
Delegates' considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS-ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • SPF Scheduling factors;
  • Other relevant information.
Delegates' interim decision

The delegates accept the advice of the ACCS-ACMS to exempt mouthwashes containing soluble salts of oxalic acid from the current Schedule 6 entry for OXALIC ACID. However, the Delegates also note advice included in pre-meeting submissions that soluble oxalates in mouthwashes and therapeutic dental preparations may contain up to 3% soluble oxalates. Accordingly, the delegates vary the proposed Schedule 6 amendment to incorporate the 3% exemption.

The delegates agree with the implementation date being 1 June 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: (a) - the risks and benefits of the use of a substance; (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.

Public submissions on the interim decision

Three public submissions were received. All supported the Delegates' interim decision.

Delegates' final decision

The delegates note the submissions received in response to publication of the interim decision and confirm the interim decision as no evidence has been received to alter the interim decision. The delegates have confirmed that the reasons for the final decision are in keeping with those for the interim decision.

The delegates have confirmed the proposed implementation date of 1 June 2015.

Schedule entry
Schedule 6 - Amendment

OXALIC ACID except:

  1. in dental care preparations, including mouthwashes, containing 3% or less of soluble salts of oxalic acid; or
  2. its insoluble salts.

Book pagination