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Scheduling delegate's final decisions: ACCS/ACMS, April 2014

Scheduling medicines and poisons

14 April 2014

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Part A - Final decisions on matters referred to an expert advisory committee (ACCS) - 1.13-1.17

1.13 Methanol

Scheduling proposal

On 17 September 2013, NICNAS under the Inventory Multi-tiered Assessment Prioritisation (IMAP) process recommended that the delegate consider amending the maximum authorised concentration in the finished cosmetic product to 5 per cent of methanol calculated as a percentage of ethanol and isopropyl, thereby bringing Australian regulations into line with EU Cosmetic Directive 76/768/EEC Annex III Part 1.

NICNAS recommendation

Further risk management is required. Sufficient information is available to recommend that risks to public health and safety from the potential use of methanol in domestic products be managed through changes to poisons scheduling.

Management of the chemical is considered to be sufficient provided that risk management recommendations are implemented and all requirements are met under workplace health and safety and poisons legislation as adopted by the relevant state or territory.

Regulatory control

The use of this chemical in domestic or cosmetic products is currently controlled by scheduling. The chemical is listed in the SUSMP under Schedule 5 or Schedule 6 based on its concentration in products/mixtures:

  1. The chemical in preparations for domestic use is in Schedule 5 of the SUSMP if the concentration of methanol is over 2 per cent and equal to or less than 5 per cent (packaging with signal heading 'Warning'); and
  2. Preparations containing over 5 per cent methanol are in Schedule 6 (packaging with signal heading 'Poison').

Preparations containing 2 per cent or less of methanol for domestic or cosmetic use are not scheduled.

For the purpose of revising concentration limits for scheduling, the delegate may wish to consider the form of restriction which exists in the EU Cosmetic Directive-'Maximum authorised concentration in the finished cosmetic product is 5 per cent calculated as a percentage of ethanol and isopropyl alcohol'.

The delegate's reason for referring this scheduling proposal to the ACCS was that, in accordance with section 4.2 of the Scheduling Policy Framework for Medicines and Chemicals (SPF, 2010)13, advice was required to be obtained from an expert advisory committee for all rescheduling proposals. This scheduling submission for methanol is one of several NICNAS-referred chemicals from the IMAP program. Methanol is already included in Schedules 6 and Schedule 5 with appropriate cut-offs at 10 per cent and 2 per cent, respectively. The NICNAS IMAP report addresses the need to amend the current scheduling cut-offs to provide a new-cut-off for cosmetic preparations, consistent with EU Cosmetic Directive 76/768/EEC Annex III Part 1.

The delegate sought ACCS advice and asked the committee to consider the following:

  • Does the ACCS support the need for new scheduling restrictions on cosmetics containing methanol, to bring Australian regulations into line with EU Cosmetic Directive 76/768/EEC Annex III Part 1?
  • Is the best way to implement this to draft a new entry in Appendix C covering methanol in cosmetics, or should the existing Schedule 5 and Schedule 6 entries be amended to address this, with a consequent outcome that cosmetics containing more than the prescribed amounts would be captured by Schedule 5 or Schedule 6 controls?
  • Should the current Appendix E & F statements be applied to cosmetic products; in particular, is a new set of Appendix F Statements needed for cosmetic products, deleting reference to Safety Direction No. 4 'avoid contact with skin'.
Substance details

Please refer to the NICNAS Inventory Multi-tiered Assessment Prioritisation (IMAP) Tier II Human Health Assessment Report for methanol. This report is available on from the NICNAS website.

Scheduling status

Methanol is currently listed in Schedule 5 and Schedule 6 and included in Appendices E and F.

Scheduling history

In February 1985, the Poisons Schedule Committee (PSC) decided to amend the Schedule 6 methyl alcohol entry to include preparations containing 5 per cent or less of methyl alcohol in Schedule 5.

In August 1985, the PSC decided to amend the Schedule 5 entry to raise the maximum concentration to 10 per cent and to exclude preparations containing 2 per cent or less of methanol from schedule listing. The PSC also decided to change the name from methyl alcohol to methanol.

Public pre-meeting submissions

Three submissions were received.

The first indicated that methanol is used in Australia in both cosmetics and consumer products, but in most cases (particularly in cosmetics) is present as a denaturant in ethanol. It asserted there has been no significant new information put forward to suggest that the current scheduling controls are inappropriate. The submission did not support the proposed amendment to methanol scheduling.

The second submission indicated that although the delegate's proposal regarding methanol referred to cosmetic use, methanol is also used during manufacture of some therapeutic goods. The submission requested that the committee to confine any changes to cosmetics only so that therapeutic goods are not affected.

The last submission did not provide comments regarding the delegate's proposal and indicated that it will provide comments, if required, based on delegate's interim decision.

ACCS advice to the delegate

The ACCS recommended that the current scheduling for methanol remains appropriate.

Delegate's interim decision

The delegate accepts the advice of the ACCS that the current listings of methanol in Schedules 5 and 6 of the SUSMP remain appropriate. Noting that the presence of methanol in cosmetics is often as a component of denatured ethanol, the delegate agrees that there is no need to develop separate schedule entries for methanol purely to align with international regulatory controls over its use in cosmetics. There is no evidence that the controls requested by NICNAS would impact on the potential for products containing methanol to be abused.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 to be a) the risks and benefits of the use of the substance, b) the purposes for which a substance is to be used and the extend of use of a substance, c) the toxicity of the substance, e) the potential for abuse of a substance.

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 factors14;
  • Other relevant information.
Submissions on interim decision

Two public submissions were received. Both submissions support the delegate's interim decision on methanol.

Delegate's final decision

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

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1.14 Pentanoic acid, 3-methyl-2-oxo-, ethyl ester

Scheduling proposal

On 17 September, the delegate received an application proposing the inclusions of pentanoic acid, 3-methyl-2-oxo-, ethyl ester in Schedule 5. The basis for this proposal was:

  • Skin irritation data indicate the chemical is a slight skin irritant which meets the factors for Schedule 5.
  • Eye irritation data indicate the chemical is a slight eye irritant which meets the factors for Schedule 5.
  • Skin sensitisation data indicate the chemical is a slight skin sensitiser which meets the factors for Schedule 5.

A quantitative risk assessment for dermal sensitisation determined that the risk to the public is acceptable at concentrations of no more than 0.02 per cent in deodorants, 0.04 per cent in fine fragrances, 0.06 per cent in other leave on cosmetic products, 0.7 per cent in rinse-off cosmetic products and 0.9 per cent in household cleaning products. At these concentrations it is stated that the risk to the public from repeated exposure is expected to be acceptable.

The proposal provided to the delegate noted that 'accordingly, the strong warnings listed in Appendix F of the SUSMP and the use of distinctive packaging should apply'.

The delegate referred a proposal to schedule pentanoic acid, 3-methyl-2-oxo-, ethyl ester. The delegate's reason for referring this scheduling proposal to the ACCS was that the chemical is likely to be a component of fragrances, deodorants, cosmetics and household cleaning products (at concentrations up to 0.9 per cent in finished products). The toxicological profile of the chemical warrants scheduling (based mainly on limited acute toxicity data, including irritancy and sensitisation potential) and that the toxicological profile appears to be consistent with the SPF15 factors for listing in Schedule 5. The advice of the ACCS is requested to confirm this scheduling proposal.

The delegate sought the following specific advice from the ACCS:

  • Does the ACCS support listing of pentanoic acid, 3-methyl-2-oxo-, ethyl ester in Schedule 5?
  • Is pentanoic acid, 3-methyl-2-oxo-, ethyl ester the most appropriate name for any listing, or is another name appropriate (e.g. 3-methyl-2-oxopentanoic acid ethyl ester)?
  • Is there a need to schedule the chemical at all, given that public exposure is only likely to occur with products in which this chemical is a fragrance component, at such low concentrations that are unlikely to represent a health hazard?
  • Is there a need to develop specific Appendix E & F statements? If so, what does the ACCS suggest?
Substance details

Pentanoic acid, 3-methyl-2-oxo-, ethyl ester is intended to be used as a component of fragrances for a variety of cosmetic and domestic products (proposed usage concentration: ≤1.15 per cent in fine fragrances, ≤2.5 per cent in other cosmetic products and ≤25 per cent in household cleaning products).

End-points of acute toxicity Species Pentanoic acid, 3-methyl-2-oxo, ethyl ester SPF*
Acute oral toxicity LD50 (mg/kg bw) Rat >2000 Low toxicity
Acute dermal toxicity LD50 (mg/kg bw) - No data
Acute inhalation toxicity LC50 (mg/kg bw/4h) - No data
Skin irritation Rabbit Slight irritant
Eye irritation Rabbit Slight irritant
Skin sensitisation** Guinea pig Evidence of sensitisation
Mutagenicity Bacterial reverse mutation Non mutagenic

*Scheduling Policy Framework for Medicines and Chemicals (2010)

**Human skin repeated insult patch test (1and 5 per cent) studies show no evidence of skin sensitisation.

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Repeated dose toxicity

No repeated dose toxicity data were provided for the notified chemical.

Mutagenicity

The notified chemical was not mutagenic in a bacterial reverse mutation study.

Public exposure

There will be widespread and repeated exposure of the public to the notified chemical (at ≤25 per cent concentration) through the use of the household cleaning products and the rinse-off and leave-on cosmetic and personal care products. The principal route of exposure will be dermal, while ocular and inhalation exposure is also possible, particularly if products are applied by spray.

Scheduling status

Pentanoic acid, 3-methyl-2-oxo-, ethyl ester is not specifically scheduled.

Scheduling history

Not applicable.

Public pre-meeting submissions

Two submissions were received.

One submitter indicated that although this substance was assessed by NICNAS and added to the Australian Inventory of Chemical Substances (AICS) in April 2013, they had no further is information regarding this substance. The submission also indicated that it can be difficult for industry to identify chemicals used in their products, particularly for cosmetics, when the common name for the substance is not made available. While this substance may be an industrial chemical, if consideration of the substance includes its use in cosmetics and consumer products, the INCI name and common name of the substance would need to be made available for so that further comments could be made.

The other submitter did not provide comments regarding the delegate's proposal and indicated that it will provide comments, if required, based on delegate's interim decision.

ACCS advice to the delegate

The ACCS recommended that pentanoic acid, 3-methyl-2-oxo-, ethyl ester does not require a schedule listing.

Delegate's interim decision

The delegate accepts ACCS advice that this chemical does not require listing in the schedules of the SUSMP. The chemical has a low toxicity profile, with potential skin/eye irritancy and sensitisation potential the main features that would warrant control via scheduling. However, the ACCS noted that the use of the chemical as a fragrance ingredient would be at very low concentrations in consumer products, and advised that is was unconvinced that the risk assessments provided a suitable basis for setting possible (very low) cut-off concentrations for sensitisation.

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 (c) the toxicity of the substance.

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.
Submissions on interim decision

Two public submissions were received.

One submission supports the delegate interim decision of not to include the substance in a schedule.

The second submission indicated that as the delegate's interim decision had no impact on therapeutic goods, it had no further comments on the delegate's interim decision.

Delegate's final decision

The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

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1.15 Mercaptoacetic acid

Scheduling proposal

On 13 September 2013, NICNAS under the Inventory Multi-tiered Assessment Prioritisation (IMAP) process, requested that the delegate consider a proposal to include the substance in Schedule 6. This recommendation was based on the main critical effects to human health namely, severe eye irritation, skin sensitisation and harmful effects through contact with skin during short term or acute exposure. Long-term exposure may cause carcinogenicity.

The delegate's reason for referring this scheduling proposal to the ACCS is that this was one of several NICNAS-referred chemicals where the primary public exposure is likely to be via use of cosmetic products. The delegate needed ACCS advice on how best to manage the scheduling aspects of such submissions.

The delegate sought the following specific advice from the ACCS:

  • Does the ACCS support a Schedule 5 or 6 listing for this chemical with an appropriate cut-off (at 11 per cent or less with an exception to unscheduled or to Schedule 5?)?
  • Does the ACCS recommend any additional scheduling controls, or specific references to, various cosmetic products (e.g. hair care and/or depilatory products)?
  • Is there a need to specify different scheduling cut-off levels for different cosmetic products, as in the EU Directive?
  • Does the ACCS consider that the schedule entry for this compound be made under the name mercaptoacetic acid, or thioglycolic acid, and that such an entry would capture all the salts considered in the NICNAS IMAP report?
  • Can the ACCS recommend suitable entries in Appendices E & F for this class of chemicals?
Substance details

Please refer to the NICNAS Inventory Multi-tiered Assessment Prioritisation (IMAP) Human Health Tier II Assessment Report, which is available on from the NICNAS website.

Scheduling status

Mercaptoacetate salts are not specifically scheduled.

Scheduling history

Not applicable.

Public pre-meeting submissions

Two public submissions were received.

One submission indicated that although mercaptoacetic acid (or thioglycolic acid) is not currently scheduled it is in Annex III (restricted use) of the EU Cosmetics Directive. The safety of mercaptoacetic acid has also been reviewed by the Cosmetic Ingredients Review (CIR) panel. The CIR conclusion was that mercaptoacetic acid is "safe for use in hair straighteners permanent waves, tonics, dressings, and so forth, wave sets, other non-colouring hair products, and hair dyes and colours, at concentrations up to 15.2 per cent; hairdressers should avoid skin contact and minimize consumer skin exposure; safe for use in depilatories when formulated to be non-irritating under conditions of recommended use". The submission tentatively supported scheduling of mercaptoacetic acid (with cross reference to thioglycolic acid in the index) as Schedule 6 with exemptions for cosmetic products containing 15.2 per cent or less of mercaptoacetic acid.

The other submission did not provide comments regarding the delegate's proposal and indicated that it will provide comments, if required, based on delegate's interim decision.

ACCS advice to the delegate

The ACCS recommended that mercaptoacetic acid in cosmetic products be included in Schedule 6 except when in Schedule 5 or in preparations containing 5 per cent or less of mercaptoacetic acid.

The committee, in addition to recommending when included in Schedule 6, also recommended that Appendix E and F statements were required.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the committee included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used; and (d) the dosage, formulation, labelling, packaging and presentation of a substance

The reasons for the recommendation comprised the following:

  • Chemicals properties used in cosmetics but has a low to moderate toxicity at higher concentration levels. Is a skin irritant.
  • Use in cosmetics can be unscheduled but higher concentrations needs to be regulated.
  • Cut-off levels based on international regulatory approaches.
Delegate's interim decision

The delegate accepts ACCS advice that new entries be created for the strongly acidic substance mercaptoacetic acid (thioglycolic acid) in Schedules 6 (cosmetic preparations with concentrations above 20%) and Schedule 5 (cosmetic preparations between 5 and 20%), with an overall exemption from scheduling at 5%. The entries are specific for cosmetic products, based on the main expected sources of public exposure through use in hair care and depilatory products, with potential for skin/eye irritancy and sensitisation driving the scheduling and cut-offs for the chemical and its salts. The delegate also accepts ACCS advice relating to new entries in Appendices E & F, providing for appropriate First Aid Instruction, Safety Directions and Warning Statements.

The delegate agrees to the implementation date of 1 June 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the committee 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; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance.

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 factors17;
  • Other relevant information.
Submissions on interim decision

Two public submissions were received.

One submission indicated that while it supports the delegate's decision to list cosmetic preparations containing mercaptoacetic acid in Schedules 5 and 6, the delegate should consider excluding mercaptoacetic acid's derivative from the proposed schedule listing. The submission asserted that mercaptoacetic acid is a simple molecule and inclusion of derivatives in the schedule entry can have unintended consequences of capturing a large number of substances that do not reflect the hazard and risk profile of the substance. The submission also indicated that the implementation time should be extended, i.e. 1 June 2016, to allow industry with sufficient time to either reformulate or even relabel products currently marketed in Australia.

The other submission indicated that as the delegate's interim decision on mercaptoacetic acid had no impact on therapeutic goods, it had no further comments on delegate's interim decision on this substance.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and agrees to minor clarifications to the proposed Schedule 5 and 6 entries, so that they cover the acid and its salts, but not derivatives. The delegate also notes the need to clarify the method of calculation of the proposed cut-offs. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

Industry submissions indicate that a longer implementation period is needed to allow for the orderly re-labelling of affected products. Therefore a later implementation date (1 June 2015) is proposed. The delegate has not accepted industry proposals for an even longer implementation period, until 1 June 2016, in the interests of balancing industry compliance needs with the need to adequately inform the general public of the potential risks.

Scheduling entry
Schedule 6 - new entry

MERCAPTOACETIC ACID and its salts, but excluding its derivatives, in cosmetic preparations except:

  1. when included in Schedule 5; or
  2. in preparations containing 5 per cent or less of mercaptoacetic acid or its salts (as mercapturic acid).

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Schedule 5 - new entry

MERCAPTOACETIC ACID and its salts, but excluding its derivatives, in cosmetic preparations containing 20 per cent or less of mercaptoacetic acid or its salts (as mercapturic acid), except in preparations containing 5 per cent or less of mercaptoacetic acid or its salts (as mercapturic acid).

When in Schedule 6 the following Appendix E and F statements.

Appendix E, part 2
Poison Standard Statements
Mercaptoacetic acid A - For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once). E1 - If in eyes washout immediately with water.
Appendix F, part 3
Poison Warning Statements Safety Direction
Mercaptoacetic acid 5. Irritant 28. (Over) (Repeated) exposure may cause sensitisation. 1. Avoid contact with eyes. 31. Do not use on broken skin.

Appendix E and F statements when in Schedule 5.

Appendix E, part 2
Poison Standard Statements
Mercaptoacetic acid A - For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once). E1 - If in eyes washout immediately with water.
Appendix F, part 3
Poison Warning Statements Safety Direction
Mercaptoacetic acid 5. Irritant 1. Avoid contact with eyes.

In addition to the above entries, the delegate proposes cross-referencing in the SUSMP index as follows:

  • MERCAPTOACETIC ACID
    • See also THIOGLYCOLIC ACID
  • THIOGLYCOLIC ACID
  • See MERCAPTOACETIC ACID

In response to submissions requesting that the new Schedule 5 and 6 entries not only specify that the scheduling relates only to use in cosmetics, that there is an additional need to exclude derivatives of thioglycolic acid. Accordingly, the delegate agrees to wording changes as set out above.

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1.16 1,3-cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester

Scheduling proposal

On 17 September 2013, the delegate received an application proposing the inclusion of 1,3-cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester in a schedule with exemption for scheduling for cosmetic products and fragrances containing less than 1 per cent of the substance. The basis for this recommendation is the results of the skin irritation and skin sensitisation tests.

Data also suggested that products containing the chemical at concentrations of 1 per cent or above available to the public must carry safety directions and warning statements on the label consistent with the following statement: 'May cause allergy.'

The delegate considered the proposal for including 1,3-cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester in a schedule with exemption for cosmetic products and fragrances containing less than 1 per cent and referred the proposal to the Advisory Committee on Chemicals Scheduling (ACCS). This proposal is one of several chemicals where the primary public exposure is likely to be via use of cosmetic products. This issue therefore required ACCS advice on how best to manage the scheduling aspects of such submissions.

The delegate sought the following specific advice from the ACCS:

  • Given the relatively low toxicity profile of this chemical, and the fact that public exposure is only likely to occur through the use of cosmetic products containing up to 0.025 per cent of this fragrance chemical (or in perfumes at up to 1 per cent) , does the ACCS consider that listing in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is appropriate? If so, in which schedule should it be listed?
  • If scheduled, what name should be used in the listing (1,3-Cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester or a trade name
  • Is the potential for skin sensitization associated with its use in fragrances sufficient to warrant scheduling of such substances? If so, which schedule is suggested and what Appendix E & F statements should be applied?
Substance summary

The chemical will be used as a fragrance ingredient in a variety of cosmetic, toiletry and household products. It will be present at a maximum concentration of 1 per cent in fine perfumes, and a maximum of 0.025 per cent in other products.

End-point of acute toxicityM Species 1,3-cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester SPF*
Acute oral toxicity LD50 (mg/kg bw) Rat >2000 Low toxicity
Acute dermal toxicity LD50 (mg/kg bw) Rat >2000 Low toxicity
Acute inhalational toxicity LC50 No data No data Not determined
Skin irritation Rabbit Irritating
Eye irritation Rabbit Slightly irritating with reversible effects.
Skin sensitisation Mouse Evidence of sensitisation.

*Scheduling Policy Framework for Medicines and Chemicals (2010)

Repeat-dose toxicity

Repeated exposure to the notified chemical for 28 days was investigated in the rat at dose levels of 30, 300 and 1000 mg/kg bw/day. The effects in the liver and thyroid were observed at 1000 and 300 mg/kg bw/day. Centrilobular hepatocyte enlargement of the liver was evident in animals of both sex treated with 1000 and 300 mg/kg/day. Thyroid changes identified as follicular cell hypertrophy were evident in animals of either sex treated with 1000 mg/kg bw/day or males only treated with 300 mg/kg bw/day. These effects were considered as adaptive changes to the treatment. The no observed adverse effect level (NOAEL) was established as 1000 mg/kg bw/day, based on no adverse effects at this dose level.

Mutagenicity

The chemical was not mutagenic in a bacterial reverse mutation test and in a mammalian chromosome aberration test.

Genotoxicity

The chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test.

Carcinogenicity

No data provided.

Public exposure

Public exposure to the notified chemical is expected to be widespread and frequent particularly through daily use of personal care products and household products containing the notified chemical. Exposure to the notified chemical will vary depending on individual use patterns. The principal route of exposure will be dermal and accidental ocular exposure may also occur. Inhalation exposure is also possible if products are applied by spray. Accidental ingestion from the use of these types of products is also possible from facial use. Considering the low concentrations used in personal care and household products (up to 0.025 per cent), significant exposure is not expected from using these product types.

Public exposure to the notified chemical in fine fragrances at 1 per cent was estimated using the Scientific Committee on Consumer Products' (SCCP's) Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation using a default 100 per cent dermal absorption factor for a 60 kg female (SCCP, 2006).

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Scheduling status

1,3-Cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester is not specifically scheduled.

Scheduling history

Not applicable.

Public pre-meeting submissions

Three submissions were received.

The first submitter noted that the identity of many fragrance components are considered commercial-in-confidence by the suppliers, it is possible that the substance is being used in consumer products and cosmetics and disclosed on the label simply as "fragrance". The submission asserted that control of fragrances and flavour components through the scheduling system is unwieldy and inefficient. This is particularly true when an international scientific assessment and risk management body like International Fragrance Association (IFRA) publishes Codes of Practice and Standards that are specifically relevant for fragrance and flavours. The submission indicated that it would support a separate discussion on the controls of fragrance and flavours rather than through individual scheduling consideration of each fragrance and flavour.

The second submission indicated that it was unclear on what concentration cut-off had been proposed and requested that the committee to consider that while not all these ingredients appear on the Australian Register for Therapeutic Goods (ARTG) ingredient list, some of these substances may be included in proprietary ingredients that are used in therapeutic goods. The submission further requested that the committee consider existing usage within proprietary ingredients and to propose cut-off concentrations that will not impact existing use in proprietary ingredients and in therapeutic goods.

The third submission did not provide comments regarding the delegate's proposal and indicated that it will provide comments, if required, based on delegate's interim decision.

ACCS advice to the delegate

The committee recommends that 1,3-cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester does not require a schedule listing.

Delegate's interim decision

The delegate accepts ACCS advice that it is not necessary to use the scheduling process to regulate fragrance chemicals when there is no evidence of a significant public health hazard associated with the very low concentrations likely to be found in consumer products in Australia. Industrial uses are adequately regulated under other legislation, and there is an international scientific assessment and risk management body that publishes Codes of Practice and Standards that are specifically relevant for fragrance and flavours. Accordingly, the interim decision of the delegate is to NOT include this chemical in the SUSMP.

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; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance.

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 factors18;
  • Other relevant information.
Submissions on interim decision

Two submissions were received.

One submission indicated that as the delegate's interim decision on the substance had no impact on therapeutic goods, it had no further comments in relation to the delegate's interim decision.

The other submission supported the delegate's interim decision.

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 reasons for the final decision are in keeping with those for the interim decision.

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1.17 3,7-dimethyl-2,6-octadienal isomers (citral, geranial and neral)

Scheduling proposal

On 29 August 2013, NICNAS under the Inventory Multi-tiered Assessment Prioritisation (IMAP) process, recommended that the delegate consider creating a new Schedule 6 entry for citral and its related compounds.

The delegate considered the proposal for including 3,7-dimethy-2,6-Octadienal (citral, geranial and neral) in Schedule 5.

The delegate reason for referring this scheduling proposal to the Advisory Committee on Chemicals Scheduling (ACCS) was that this scheduling submission relating to three isomers of 3,7-dimethy-2,6-Octadienal (citral, geranial and neral) is one of several NICNAS-referred chemicals where the primary public exposure is likely to be via use of cosmetics, fragrances and other domestic products (polishes, paints, washing and cleaning products, finger paints and modelling clay). There are other possible uses as a component of pest control products, flavourings and disinfectants. The delegate needed the ACCS advice on how best to manage the scheduling aspects of such submissions.

The delegate sought the following specific advice from the ACCS:

  • The relatively low toxicity profile of these chemicals suggests consistency with the SPF factors for Schedule 5. However, public exposure is only likely to occur through the use of products with concentrations ranging up to 5 per cent, at which concentration adverse health effects are unlikely. Does the ACCS consider that listing in the SUSMP is appropriate? If so, should they be listed in Schedule 5, with an appropriate cut-off to exempt (5 per cent)?
  • If scheduled, what name should be used in the listing (3,7-dimethy-2,6-Octadienal, with indexing cross references to the three isomers citral, geranial and neral)?
  • Although it is not known whether any of these isomers is present in geranium oil, is there any potential ambiguity with the current listing of geranium oil in Appendix B?
  • There are quite low concentration limits (0.001 per cent and 0.01 per cent) in EU Cosmetic Directive 76/768/EEC Annex III Part 1 specifying the highest concentrations permitted in cosmetic and personal care products without labelling. Is it feasible to include these limits in any scheduling proposal?

Is it feasible to include concentration limits in other types of products in the schedules, based on the calculations in the dermal sensitisation Quantitative Risk Assessment (QRA) of the International Fragrance Association (IFRA), as reported in the NICNAS IMAP report?

Substance details

Please refer to the NICNAS Inventory Multi-tiered Assessment Prioritisation (IMAP) Human Health Tier II Assessment Report, which is available on from the NICNAS website.

Scheduling status

Citral, geranial and neral are not currently scheduled.

Scheduling history

As the isomers of 3,7-dimethy-2,6-Octadienal are not scheduled, scheduling history is not available.

Public pre-meeting submissions

Four public submissions were received.

The first indicated that there are other fragrance compounds that are closely related to citral that may also be used widely (e.g. citrol) and the submission focus on citral due to the short timeframe for comments and the large number of agenda items. The organisation requested that any scheduling decisions made should reflect the fact that industry may not have had sufficient time to consider the impact of scheduling decisions on all derivatives of citral and other substances on the agenda. They indicated that in the EU and the USA citral must be disclosed on the label of cosmetic products when used in rinse-off products at concentrations greater than 0.01 per cent and in leave on products at concentration greater than 0.001 per cent. The submitter suggests that these criteria recognise that citral can cause allergic reactions in some individuals. They also stated that there appeared to be no restrictions on neral or geranial, or citral when used in consumer products. It was highlighted that the International Fragrance Association (IFRA) Standard restricts the use of citral in some consumer products and cosmetics and therefore the use of the scheduling process for fragrances and flavours would be inefficient. The submission therefore requested a separate discussion on the controls of fragrance and flavours rather than commenting on each individual fragrance and flavour.

The second submission indicated that it was unclear on what concentration cut-off had been proposed and requested that the committee to consider that while not all these ingredients appear on the Australian Register for Therapeutic Goods (ARTG) ingredient list, some of these substances may be included in proprietary ingredients that are used in therapeutic goods. The submission further requested that the committee consider existing usage within proprietary ingredients and to propose cut-off concentrations that will not impact existing use in proprietary ingredients and in therapeutic goods.

The third submitter indicated that citral should remain unscheduled as the safety of the ingredient when used in fragrances has been established by IFRA. Citral has been used in fragrances contained in their cosmetic products for many years with no known safety issues. Additionally no other market restricts the use of citral in cosmetic products. If a Schedule 5 entry is adopted we strongly urge the committee and the delegate to exempt the use of citral in fragrances and flavours contained in cosmetic products.

The final submission did not provide comments regarding the delegate's proposal and indicated that it will provide comments, if required, based on delegate's interim decision.

ACCS advice to the delegate

The ACCS recommends that a new Schedule 5 entry for 3,7-dimethyl-2,6-octadienal isomers be created. However, there was insufficient information available to finalise the recommendation. The committee recommends that the delegate seeks further information on

  • the extent of use and concentrations of this material in commercial products in Australia
  • the possible regulatory impacts of scheduling
  • the basis for any possible cut-off concentrations to be applied to the Schedule
  • an implementation date suitable for this Schedule.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the committee 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, and c) the toxicity of a substance.

The reasons for the recommendation comprised the following:

  • The ubiquity in products in the public domain containing these isomers resulting in extensive potential exposure.
  • The potential for perceived public health concerns associated with these fragrances in domestic products.
  • The extensive use of these isomers in products in Australia.
  • The toxicological profile of these isomers being consistent with SPF factors for S5.

Recommendations for other action by delegate:

  • Committee recommends that this substance should be listed in Schedule 5 but is unable to provide advice on whether a cut-off to exempt from scheduling is warranted and if so at what level due to lack of data provided to the committee.
Delegate's interim decision

The delegate has noted that this is not a straightforward scheduling matter. Ostensibly, the toxicity profile of the three isomers of 3,7-dimethy-2,6-Octadienal (citral, geranial and neral) appear to satisfy SPF factors for inclusion in Schedule 5, based on relatively low acute systemic toxicity, and mild skin irritancy potential. Sensitisation potential appears to be a driving force behind the NICNAS recommendation to include these substances in Schedule 5, with appropriate warning statements for those likely to suffer allergic reactions. Factors complicating the interim scheduling decision are:

  • The lack of information on the extent of use of the three isomers in fragrances used in Australian products.
  • The fact that some of these isomers (especially citral) may be components of essential oils that are already included in Appendix B (e.g. lemongrass oil, geranium oil), and therefore exempt from scheduling.
  • If they were to be included in Schedule 5, what cut-off concentration(s) to exempt would be appropriate, and should this be driven by overseas (e.g. EU) regulations on permitted concentrations in cosmetics and/or fragrances.

The interim decision of the delegate is to defer this scheduling matter, pending the receipt of further information from industry on product types, concentrations used and the likely presence of these isomers in various essential oils. When available, this information will be referred back to the ACCS for further consideration.

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 factors19;
  • Other relevant information.
Submissions on interim decision

Four public submissions were received.

Two submissions supported the delegate's interim decision to defer scheduling of the substance.

The third submission indicated that as some of the 3,7-dimethyl-2,6-octadienal isomers may be components of essential oils, which may be found in therapeutic goods, future scheduling matters relating to the isomers should be considered by the joint ACCS & ACMS to ensure the cut-off limit, route of administration, function of the ingredient and possible impact on the therapeutic goods have been considered.

The fourth submission noted that there are about 20 essential oils or absolutes containing >1% citral. Many of the essential oils are used in aromatherapy and other complementary medicines and marketed or sold as pure oil products or in blends in quantities of between 0.5 to 12%w/w. The submission therefore requested the delegate consider these facts while scheduling the substance.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and confirms the decision to defer scheduling of these three chemicals, pending further consideration by the advisory committees. The delegate will refer information received on product types, concentrations used and the likely presence of these isomers in various essential oils to the advisory committees, including consideration of the potential for any scheduling actions to impact on therapeutic goods and essential oils used in aromatherapy.

The delegate has confirmed that the reasons for deferral of a scheduling decision at this time are in keeping with those for the interim decision.

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Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (2010)
  2. Scheduling Policy Framework for Medicines and Chemicals (2010)
  3. Scheduling Policy Framework for Medicines and Chemicals (2010)
  4. Scheduling Policy Framework for Medicines and Chemicals (2010)
  5. Scheduling Policy Framework for Medicines and Chemicals (2010)
  6. Scheduling Policy Framework for Medicines and Chemicals (2010)
  7. Scheduling Policy Framework for Medicines and Chemicals (2010)

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