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Scheduling delegate's final decisions: ACCS, October 2014

Scheduling medicines and poisons

28 October 2014

Book pagination

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

1. Scheduling proposals referred to the July 2014 meeting of the Advisory Committee on Medicines Scheduling (ACMS#12)

1.1 Lauryl sulfates

Scheduling proposal

On December 2013, the National Industrial Chemicals and Notification Assessment Scheme (NICNAS), under its Inventory Multi-tiered Assessment and Prioritisation (IMAP) programme, requested the delegate consider amending the current Schedule 6 and Appendix E sodium lauryl sulfate entries to include ammonium lauryl sulphate and potassium lauryl sulfate.

The delegates' reasons for referring this proposal to the joint meeting of the Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS) include:

  • The scheduling of sodium lauryl sulfate was last considered at the February 2010 and June 2010 meetings of the National Drugs and Poisons Scheduling Committee (NDPSC), and finalised at a joint meeting of the ACCS and ACMS in December 2010. The current proposal, referred via a NICNAS IMAP report, is to broaden the current entry so that it captures the potassium and ammonium salts.
  • If the joint committee of ACCS-ACMS (ACCS-ACMS) considers that the current scheduling of sodium lauryl sulfate remains appropriate, the simplest amendment might be to delete the words (excluding its salts or derivatives) from the current Schedule 6 entry. If so, should current citations of the specific sodium salt also be deleted from the wording and should the entry be generalised to LAURYL SULFURIC ACID and its salts?
  • Alternatively, the ACCS-ACMS might recommend that separate, parallel entries be developed for the two specified salts. If this is the proposed solution, are all the current sub-clauses and cut-offs appropriate?
  • At the June 2010 NDPSC meeting, it was noted that preparations containing other salts of lauryl sulfate could be scheduled inadvertently, unless the words (excluding its salts or derivatives) were included in the Schedule 6 entry. The ACCS-ACMS may want to consider this in relation to the proposed broadening on the current entry to include the potassium and ammonium salts, as specified in the NICNAS IMAP report. Are the use patterns and toxicological profiles of the potassium and ammonium salts sufficiently similar to the sodium salt to warrant comparable sub-clauses? Are there likely to be different types of products on the market containing the ammonium and potassium salts that would now be scheduled?
  • Are the current Appendix E statements for sodium lauryl sulfate (there is no Appendix F entry) appropriate for the potassium and ammonium salts, or should new entries be developed?
  • Is the ACCS-ACMS able to offer any advice on whether the packaging issue (potential for children to ingest bright coloured liquid laundry detergent capsules) is an issue that requires scheduling consideration?
Substance details

Please refer to the NICNAS IMAP human health tier II assessment report for sodium, ammonium and potassium lauryl sulfate. This report is available on from the NICNAS website: Human Health Tier II Assessment for Sodium, ammonium and potassium lauryl sulfate.

Scheduling status

Sodium lauryl sulfate (SLS) is listed in Schedule 6 and Appendix E.

SODIUM LAURYL SULFATE (excluding its salts and derivatives) except:

  1. in wash-off preparations containing 30 per cent or less of sodium lauryl sulfate and, if containing more than 5 per cent sodium lauryl sulfate, when labelled with a warning to the following effect:
    • IF IN EYES WASH OUT IMMEDIATELY WITH WATER;
  2. in leave-on preparations containing 1.5 per cent or less of sodium lauryl sulfate;
  3. in toothpaste and oral hygiene preparations containing 5 per cent or less of sodium lauryl sulfate;
  4. in other preparations for animal use containing 2 per cent or less; or
  5. in other preparations containing 30 per cent or less of sodium lauryl sulfate and, if containing more than 5 per cent sodium lauryl sulfate, when labelled with warnings to the following effect:
    • IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and
    • IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.
Appendix E, Part 2
Poison Standard statement

Sodium lauryl sulfate

  • leave-on or wash-off preparations above 5 per cent
  • E1 - If in the eyes wash out immediately with water.

Sodium lauryl sulfate

  • other preparations above 5 per cent
  • E1 - If in the eyes wash out immediately with water.
  • S1 - If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.
Scheduling history

SLS was first considered by the NDPSC in February 2010. This consideration was based on an Office of Chemical Safety (OCS, then OCSEH) evaluation report on SLS. The NDPSC generally agreed that a parent entry in Schedule 6 was appropriate for SLS given its potential for serious eye and skin irritation. The NDPSC also decided that the schedule entry should remain specific to SLS at that time. Given the widespread use of SLS in many sectors, the NDPSC indicated there would be significant potential for unintended regulatory impact from this decision. NDPSC therefore agreed that it was appropriate to foreshadow the proposed SLS scheduling for consideration at the June 2010 meeting to allow time for additional public consultation.

The NDPSC decided to foreshadow including SLS in Schedule 6 with exemptions for:

  • wash-off preparations, containing 30 per cent or less of sodium lauryl sulphate;
  • in leave-on preparations containing 1 per cent or less of sodium lauryl sulphate; or
  • in other preparations containing 2 per cent or less of sodium lauryl sulfate.

At the meeting, the NDPSC also agreed to consider at the June 2010 meeting whether additional labelling requirements were warranted for SLS products.

In June 2010, the NDPSC generally agreed that, based on the toxicological information provided, a Schedule 6 parent entry was appropriate for SLS given its potential for serious eye irritation.

The NDPSC decided to include SLS (excluding salts and derivatives) in Schedule 6 with exemptions for:

  • wash-off preparations, 30 per cent of or less;
  • leave-on preparations, 1.5 per cent of or less;
  • toothpaste and oral hygiene preparations, 5 per cent or less;
  • in other preparations for animal use, 2 per cent or less; or
  • in all remaining preparations, 30 per cent or less of sodium lauryl sulfate.

This matter was referred to the delegate for consideration under the new scheduling arrangements which commenced on 1 July 2010. The delegate agreed with the NDPSC''s recommendations and decided to include these in the SUSMP.

In March 2011, the delegate considered SLS label warning statements and indicated that additional labelling may be required for SLS. The delegate decided to refer this matter to the joint meeting of ACCS-ACMS for advice. The delegate noted, as SLS is a severe eye and skin irritant, the label warning (for products containing greater than 5 per cent SLS) was appropriate. Based on the ACCS-ACMS advice, the delegate decided to include preparations containing more than 5 per cent of SLS in Appendix E with standard statements:

  • E1 "If in eyes wash out immediately with water"; and
  • S1 "If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water" for preparations which are not leave-on or wash-off preparations.

The delegate also decided to amend the Schedule 6 entry for SLS to add the following labelling criteria for products to qualify for the current exemptions from the entry:

  • wash-off preparations, greater than 5 up to 30 per cent or less, are to be exempt only when labelled with a warning to the effect of "If in eyes wash out immediately with water";
  • leave-on (1.5 per cent or less), toothpaste and oral hygiene preparations (5 per cent or less) and other animal use (2 per cent or less) - no additional labelling required; and
  • all other preparations, greater than 5 up to 30 per cent or less, are to be exempt only when labelled with warnings to the following effect "If in eyes wash out immediately with water" and "If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water".
Public pre-meeting submissions

Two pre-meeting public submissions were received.

The first submission supported the principle of broadening the sodium lauryl sulfate (SLS) entry to include ammonium lauryl sulfate (ALS) and potassium lauryl sulfate (PLS), noting that all 3 substances have similar properties. However, the submission stated for the extension of the entry to include ALS and PLS, all 3 salts must have the same hazard or risk characterisation. The submission noted that the IMAP report stated the substances had similar but not identical properties. The submission also provided information regarding ALS and SLS being on the TGA Australian Register of Therapeutic Goods (ARTG) ingredients list, with them being used in therapeutic washes, shampoos and other topical products. The submission raised concerns regarding the potential impact on products currently marketed and whether it was appropriate to apply the same cut-off levels in view of a lack of product formulation information. The submission asked the delegates to consider an appropriate transition period should the decision be made to widen the scope of the Schedule 6 entry to allow manufacturers and suppliers time to make the required changes.

The second submission noted that ALS and PLS have similar irritancy profile as that of SLS and that this was the basis to align the scheduling of the 3 salts. As most surfactants, like the lauryl sulfate salts, are likely to be eye irritants, the submission requested that the committee and the delegates consider removing SLS and other surfactants from the SUSMP as they are unconvinced that the scheduling of a surfactant based on its irritancy is warranted. Removing SLS and not scheduling ALS and PLS aligns with current practice in the European Union and the United States of America. If scheduling were to remain and include other surfactants, then the submissions asked to increase the exemption to 35 per cent for rinse-off products as currently available cosmetic products contain ALS concentrations between 30 and 35 per cent.

Summary of the ACCS-ACMS advice to the delegates

The committee recommended that ammonium lauryl sulfate and potassium lauryl sulfate do not require schedule listing with sodium lauryl sulfate as the information provided to the committee was not sufficient to warrant scheduling.

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.

The reasons for the recommendation comprised the following:

  • Information provided is not sufficient to warrant scheduling.
Delegates' interim decision

The delegates have considered the advice provided by the joint meeting of the ACCS-ACMS and the two public submissions considered at that meeting. The delegates have not accepted the advice of the ACCS-ACMS and instead have made an interim decision to amend the current Schedule 6 and Appendix E entries for sodium lauryl sulfate (SLS) to include other lauryl sulfate salts, as recommended in the NICNAS IMAP report. The NICNAS supplementary advice also emphasised the need to capture all salts of lauryl sulfate in the current entry. The delegates note that skin irritancy and the potential for severe eye damage have driven the current scheduling of SLS, and that current SLS scheduling is consistent with SPF criteria for Schedule 6 listing for the pure substances. The NICNAS IMAP report makes the case that other salts of dodecyl (lauryl) sulphate would have similar skin/eye irritancy potential, and it therefore makes sense to broaden the current SLS entries (that currently exclude salts and derivatives) to bring consistency to the scheduling of products that use any of the lauryl sulphate salts for their surfactant properties. The delegates note the points raised in industry submissions that the toxicity profile of most surfactants are comparable to the lauryl sulphate salts and that current cut-offs from Schedule 6 to exempt may capture some products not currently scheduled. Accordingly, the delegates propose an implementation date (1 June 2015) that should enable product re-labelling to occur in an orderly manner.

The intent of the proposed actions in this interim decision is to capture the ammonium and potassium salts in the current Schedule 6 entry for the sodium salt (SLS), with the same exemption cut-offs. This could be achieved by either deleting references to the sodium salt in the current Schedule 6 and Appendix E entries, or creating parallel entries for the ammonium and potassium salts (believed to be the only other salts currently used in products available in Australia). The delegates have opted for the first approach, but including cross-references in the SUSMP index to SLS to alert product manufacturers to the schedule changes.

The delegates note an issue raised in an industry submission, that the irritancy potential of the ammonium and potassium salts may be less marked than that of SLS, and that some products have been marketed with up to 35 per cent of these salts without apparent public health harm. However, the delegates had insufficient information at this time to justify modification of the exemption concentrations in the current SLS entry.

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 delegates 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

Two submissions were received. The first submission indicated that it supports the delegates' interim decision to amend the current sodium lauryl sulfate entry to include all lauryl sulfate salts. By making the entry specific to lauryl sulfate salts, lauryl sulfate derivatives are still exempt from scheduling, considering ingredients such as sodium laureth sulfate are commonly used as a safer alternative to SLS in cosmetic products.

The second submission noted that as there are no regulatory restrictions placed on any of these surfactants anywhere else in the world, including sodium lauryl sulfate, and noting that mild to moderate skin and eye irritancy of surfactants is well known by the general public, these surfactants should be unscheduled. This would remove the current need for some imported rinse-off cosmetic products to be over-labelled with the Appendix E statement.

Edited versions of these submissions are available at Public submissions on scheduling matters.

Delegates' consideration

The delegates considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS-ACMS advice;
  • Supplementary advice from NICNAS;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors1; and
  • Other relevant information.
Delegates' final decision

The delegates note the points made in public submissions relating to the pre-meeting consideration and the interim decision. Noting that the joint meeting of the ACCS and ACMS did not support overturning previous scheduling recommendations and decisions to remove the current schedule 6 entry for sodium lauryl sulphate, the delegates confirm their intent to simply broaden the entry to include other salts of lauryl sulphate. The delegates note that this action is supported in the public submission. However, the submissions note that removing reference to 'derivatives' in the entry potentially broadens the scope of the intended change. This was not the intent, nor the advice of the joint ACCS-ACMS meeting. Accordingly, the delegates have decided to vary the interim decision, and to restore the exclusion of 'derivatives' to the schedule entry. While there is a separate and closely parallel entry in Schedule 6 for LAURETH CARBOXYLIC ACIDS, restoration of the words 'excluding its derivatives' in the modified LAURYL SULFATE SALTS entry would allow for the continued exemption from scheduling for sodium laureth sulfate at the present time.

The delegates confirm the implementation date of 1 October 2015 to allow for product re-labelling to occur in an orderly manner.

Schedule entry
Schedule 6 - amend entry as follows:

SODIUM LAURYL SULFATE SALTS (excluding its salts and derivatives) except:

  1. in wash-off preparations containing 30 per cent or less of sodium lauryl sulfates and, if containing more than 5 per cent sodium lauryl sulfates, when labelled with a warning to the following effect:
    • IF IN EYES WASH OUT IMMEDIATELY WITH WATER;
  2. in leave-on preparations containing 1.5 per cent or less of sodium lauryl sulfates;
  3. in toothpaste and oral hygiene preparations containing 5 per cent or less of sodium lauryl sulfates;
  4. in other preparations for animal use containing 2 per cent or less; or
  5. in other preparations containing 30 per cent or less of sodium lauryl sulfates and, if containing more than 5 per cent sodium lauryl sulfates, when labelled with warnings to the following effect:
    • IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and
    • IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.
Appendix E, Part 2 - Amend entry to
Poison Standard statement

Sodium Lauryl sulfates

  • leave-on or wash-off preparations above 5 per cent
  • E1 - If in the eyes wash out immediately with water.

Sodium Lauryl sulfates

  • other preparations above 5 per cent
  • E1 - If in the eyes wash out immediately with water.
  • S1 - If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.
Index - New entry

SODIUM LAURYL SULPHATE

  • See LAURYL SULFATE SALTS

DODECYL SULFATES

  • See LAURYL SULFATE SALTS

2. Scheduling proposals referred to the July 2014 joint meeting of the Advisory Committee on Chemicals Scheduling and Advisory Committee on Medicines Scheduling (ACCS-ACMS 9)

2.1 3,7-dimethyl-2,6-octadienal isomers (citral, geranial and neral)

Scheduling proposal

The joint committee of the ACCS-ACMS considered the following proposal referred by the chemicals scheduling delegate and the medicines scheduling delegate (the delegates) for advice:

  • Proposal for a new Schedule 5 entry with a yet to be determined low concentration cut-off level.

The committee also considered and discussed the resolutions with an implementation date of 1 February/1 July/1 October 2015.

The application relating to three isomers of 3,7-dimethyl-2,6-Octadienal (citral, geranial and neral) is one of several chemicals referred by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) following assessment under the Inventory Multi-tiered Assessment and Prioritisation (IMAP) programme.

The delegates' reasons for referring this scheduling proposal to the joint meeting of the ACCS-ACMS are that the primary public exposure to citral compounds is likely to be via use of cosmetics, fragrances and other domestic products (polishes, paints, washing and cleaning products, finger paints and modelling clay), with other possible uses as a component of pest control products, flavourings and disinfectants, and possibly as fragrance ingredients of therapeutic goods.

The matter was first considered by the ACCS at the November 2013 meeting. The ACCS advised the delegate that the three substances should be included in Schedule 5, but that a cut-off to exempt from scheduling could not be determined. The ACCS advised that further information be sought on the extent of use and/or presence of these substances in fragrances in Australian products in order to assess the potential regulatory impact of setting an exemption cut-off level. The ACCS also pointed to the potential for these substances to be components of essential oils, some of which would have different existing schedule entries (e.g. geranium oil is currently exempt from scheduling via listing in Appendix B).

The delegates sought further information from industry in relation to these matters and sought further advice from the joint committee of the ACCS-ACMS on how best to manage the scheduling aspects of this submission. The advice from the joint meeting of the ACCS-ACMS was sought on the basis that, while the industry-provided information relates mainly to uses in cosmetics, fragrances and household cleaners, some therapeutic goods may include these substances as excipients.

The delegates asked the following specific questions to the ACCS-ACMS:

  • The relatively low toxicity profile of these chemicals suggests consistency with the Scheduling Policy Framework for Medicines and Chemicals (SPF, 2010) criteria for Schedule 5. However, public exposure is only likely to occur through the use of products with concentrations ranging up to 5%, at which concentration adverse health effects are unlikely. Does the joint committee of the ACCS-ACMS 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%?)?
  • If scheduled, what name should be used in the listing (e.g. 3,7-dimethy-2,6-Octadienal, with indexing cross-references to the three isomers of citral, geranial and neral)?
  • Some of these isomers are known to be components of various essential oils. If the three isomers are listed in Schedule 5, is there a potential ambiguity with the current listing of geranium oil and lemongrass oil in Appendix B or any other schedule entries for essential oils, including those not specifically scheduled?
  • There are quite low concentration limits (0.001% and 0.01%) 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?
  • Does the information provided by industry assist the ACCS-ACMS to recommend a suitable cut-off level for a Schedule 5 entry? Should any Schedule 5 entry be specific for cosmetic/cleaning products to limit any regulatory impacts on other types of products?
  • How does the ACCS-ACMS advise on a schedule entry that could potentially exclude the presence of any of the three isomers in essential oils - note that the highest concentrations in some Schedule 5 or unscheduled essential oils can be in the 20-40% range, or even 80% citral in the case of lemongrass oil (currently listed in Appendix B)? Is there a case for a proposed Schedule 5 listing to specifically exempt the three isomers when added or present as a component of an essential oil?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report for citral and related compounds. This report is available on the NICNAS website: Human Health Tier II assessment for citral and related compounds.

Scheduling status

3,7-Dimethyl-2,6-octadienal isomers are not specifically scheduled.

Scheduling history

3,7-Dimethyl-2,6-octadienal isomers are not currently listed in the schedules, although there was some initial consideration of possible listing in Schedule 5 at the November 2013 ACCS meeting.

Pre-meeting public submissions

Two submissions were received. The first submission indicated that if scheduling is required for these substances, a low concentration exemption cut-off in line with the International Fragrance (IFRA) Standards may be appropriate.

The second submission indicated that the substance should remain unscheduled. If, however, a schedule listing is required, cosmetic preparations containing the substance should be exempted from scheduling.

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

Summary of ACCS-ACMS advice to the delegate

The joint committee of the ACCS-ACMS recommended that cosmetic and household cleaning preparations containing more than 5% of citral be listed in Schedule 5.

The ACCS-ACMS recommended an implementation date of 1 February 2015.

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; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Due to extensive use of these substances in products available in Australia, there is a risk for excessive repeated exposure.
  • Risk of skin irritation and sensitisation at concentrations greater than 5%.
  • Toxicity profile is consistent with the scheduling factors for Schedule 5.
  • Use in cosmetics coming into contact with skin.
Delegates' interim decision

The delegates accept the advice of the ACCS-ACMS that a new Schedule 5 entry be created for citral, based on a toxicological profile that is consistent with SPF criteria for listing in Schedule 5, specifically the potential to cause skin irritation and sensitisation. However, the delegates note that this would only capture one of the three isomers under consideration. While there are INCI names for two of the three isomers under consideration (citral and neral), the third isomer would need to be separately scheduled under its chemical name. The delegates consider that listing in schedule 5 under the name 3,7-Dimethyl-2,6-octadienal would capture all three isomers, and that cross-referencing the names citral, neral and geranial in the SUSMP index would facilitate industry understanding of the schedule listing. The delegates also accept ACCS-ACMS advice that the Schedule 5 listing be specific for cosmetic and household cleaning products, where the potential for skin sensitisation is most relevant. This avoids capturing therapeutic goods containing these substances, where the regulatory risk assessment can be applied on an individual product basis.

The delegates note the difficulties in determining an appropriate exemption cut-off for the proposed Schedule 5 entry, and accept the ACCS-ACMS advice that a 5% cut-off to exempt provides appropriate public health protection, while minimising regulatory impacts on industry associated with the widespread use of the three isomers as fragrance ingredients.

The delegates also note that some essential oils can contain varying amounts of 3,7-Dimethyl-2,6-octadienal isomers, and this could result in the inadvertent capture of essential oils containing more than the 5% cut-off. The advice from the ACCS-ACMS indicated that the proposed Schedule 5 listing could impact on two currently exempted essential oils listed in Appendix B, geranium oil and lemongrass oil. The proposed Schedule 5 listing may not be a problem for geranium oil, where the geranial component would only exceed 5% when a substantial amount of the geraniol content (up to 25%) is converted to geranial by autoxidation. Unlike geranial, geraniol is not considered to be a potential sensitiser. On the other hand, lemongrass oil, containing up to 90% citral, would be captured by the proposed Schedule 5 listing. The delegates therefore propose to foreshadow the removal of lemongrass oil from Appendix B, to list it in Schedule 5 with a 5% cut-off, and to seek industry comment on any regulatory implications.

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 the 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 the substance.

The preferred listing (see notes above) is:

3,7-DIMETHYL-2-6,-OCTADIENAL and its isomers, in cosmetic and household cleaning preparations except in preparations containing 5 per cent or less of 3,7-Dimethyl-2,6-octadienal isomers.

Delegates' considerations

The delegates considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS-ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors2;
  • Other relevant information.
Public submissions on the interim decision

One submission was received, which was in support of the delegates' interim decision.

Delegates' final decision

The delegates note the submission 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 considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (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.

A longer implementation period may be needed to allow for orderly re-labelling of any products affected by the scheduling decision. The delegates propose an implementation date of 1 June 2015.

Schedule entry
Schedule 5 - New entry

3,7-DIMETHYL-2-6,-OCTADIENAL and its isomers in cosmetic and household cleaning preparations except in preparations containing 5 per cent or less of 3,7-DIMETHYL-2-6,-OCTADIENAL isomers.

SUSMP Index - New entries

Citral - see 3,7-Dimethyl-2,6-octadienal

Neral - see 3,7-Dimethyl-2,6-octadienal

Geranial - see 3,7-Dimethyl-2,6-octadienal

2.2 Triethanolamine

Scheduling proposal

The joint committee of the ACCS-ACMS considered the following proposal referred by the chemicals scheduling delegate and the medicines scheduling delegate (the delegates) for advice:

  • Proposal to include an entry for triethanolamine in Schedule 4 (or Appendix C) to address the potential use of this chemical in preparations for tattoo removal.

The committee considered and discussed the resolutions with an implementation date of either 1 February/1 June/1 October 2015.

The delegates' reasons for referring this scheduling proposal to the joint meeting of the ACCS-ACMS was that, in accordance with section 4.2 of the Scheduling Policy Framework for Medicines and Chemicals3 (SPF, 2010), advice is required to be obtained from an expert advisory committee for all rescheduling proposals.

The risk assessment report for triethanolamine was prepared by the National Industrial Chemical Notification and Assessment Scheme (NICNAS) under its Inventory Multi-tiered Assessment and Prioritisation (IMAP) programme and is a publicly available document containing sufficient information for the ACCS-ACMS to provide advice. Furthermore, its recommendations would be known to industry.

The NICNAS IMAP report draws specific attention to the risks of using triethanolamine in preparations injected intra-dermally to assist with the removal of tattoos. Advice of the joint committee of the ACCS-ACMS is needed as to whether this specific use requires control via listing triethanolamine preparations for such use in Schedule 4 (or Appendix C).

The delegates sought the following specific advice from the ACCS-ACMS:

  • What scheduling actions could best give effect to the NICNAS recommendation to restrict the use of triethanolamine applied intra-dermally for tattoo removal? Would this be a specific listing in Appendix C, or a new entry in Schedule 4 (similar to that for ethanolamine)?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report for ethanol, 2,2',2''-nitrilotris-. This report is available on the NICNAS website: Human Health Tier II assessment report for ethanol, 2,2',2''-nitrilotris-.

Scheduling status

This chemical (excluding its salts and derivatives, except in preparations containing 5% or less of triethanolamine) is listed in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) in Schedule 5.

Schedule 5 chemicals are labelled with 'Caution'. These are substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.

This chemical is included in Appendix E with the standard statements of G3 'If swallowed, do NOT induce vomiting', E1 'If in eyes wash out immediately with water' and S1 'If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water'; and in Appendix E with a warning statement 'Irritant' and safety directions of 'Avoid contact with eyes' and 'Avoid contact with skin'.

Scheduling history

The toxicological information relating to triethanolamine (TEA), diethanolamine (DEA) and monethanoloamine (MEA) were considered by the NDPSC over several meetings in 1995, 1996 and 2000. Issues raised in the NICNAS IMAP report relating to the use of TEA in cosmetics and domestic products were considered at the November 2014 meeting of the ACCS. At that time, the delegate, acting on the advice of the ACCS, determined that the current listing of TEA in Schedule 5 remains appropriate. However, the delegate noted the advice of the ACCS that the issue of appropriate scheduling to limit the use of TEA in preparations for removal of tattoos should be referred to a joint meeting of the ACCS and ACMS for advice.

Pre-meeting public submissions

One submission was received and the submission suggested that any consideration of triethanolamine should be restricted to the intradermal use in tattoo removal preparations, noting that other uses of triethanolamine had been considered previously.

The public submission is available at Public submissions on scheduling matters.
Summary of ACCS-ACMS advice to the delegate

The joint committee of the ACCS-ACMS recommended that triethanolamine be included in Schedule 4 when in preparations for tattoo removal.

The ACCS-ACMS recommended an implementation date of 1 February 2015.

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.

The reasons for the recommendation comprised the following:

  • Evidence of significant adverse health effects when used in tattoo removal. This use potentially requires medical supervision.
Delegates' interim decision

The delegates accept the advice of the ACCS-ACMS that triethanolamine be listed in Schedule 4 in preparations used to aid tattoo removal in humans. The delegates noted concerns raised about the potential for adverse effects associated with the use of chemical products containing triethanolamine in tattoo removal due to the irritant nature of such products, especially when injected intradermally. Tissue reddening, inflammation and possibly subsequent infection are likely consequences of using the substance as a tattoo removal agent, where the removal of the pigments is dependent upon the inflammatory response. The delegates noted that laser removal is a medically-regulated procedure for tattoo removal and medical supervision via listing in Schedule 4 could ensure safer use of tattoo-removal preparations containing triethanolamine. Furthermore, the delegates agreed with the ACCS-ACMS that listing in Schedule 4 is a better option than attempting to restrict such products through listing in Appendix C.

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 the substance; 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 a substance.

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;
  • Scheduling factors4;
  • Other relevant information.
Public submissions on the interim decision

One submission was received, which was in support of the Delegates' interim decision.

Delegates' final decision

The delegates note the submission 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 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; and e) the potential for abuse of a substance.

The implementation date is 1 February 2015. An early implementation date is considered appropriate.

Schedule entry
Schedule 4 - New entry

TRIETHANOLAMINE when in preparations for tattoo removal.

2.3 Zinc lactate

Scheduling proposal

The joint committee of the ACCS-ACMS considered the following proposal referred by the chemicals and medicines scheduling delegate (the delegates) for advice:

  • Proposal for new a Schedule 6 entry for zinc lactate except in toothpastes containing 2.5 per cent or less of zinc lactate.

The committee considered and discussed the resolutions with an implementation date of either 1 February/1 June/1 October 2015.

Zinc lactate is a chemical referred by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) following assessment as a new chemical.

The delegates' reasons for referring this scheduling proposal to the joint committee of the ACCS-ACMS is that the proposed use of zinc lactate is as an ingredient of toothpastes, but other potential uses that could result in public exposure have not been identified. The NICNAS recommendation is that inclusion in Schedule 6 is warranted on the basis of its acute toxicity profile, particularly its irritancy potential, but that use in toothpastes at up to 2.5% should not produce adverse health effects in persons aged 12 years or older. The NICNAS new chemical assessment public report notes that this conclusion also applies to chronic exposure to absorbed zinc from the use of toothpastes. Advice from the joint committee of the ACCS-ACMS is needed on whether it is necessary to use scheduling to limit the use and concentration of this chemical in toothpastes and, if so, what is an appropriate schedule entry.

The delegates asked the following specific questions from the ACCS-ACMS:

  • Does the ACCS-ACMS support inclusion of zinc lactate in Schedule 6, based on its acute toxicity profile, including its irritancy potential, with a cut-off to exempt at 2.5% when an ingredient of toothpastes?
  • During consultation on the proposed scheduling action, including a submission relating to the interim decision, apparent inconsistencies were raised relating to the estimates on zinc exposure associated with the use of toothpastes containing 2.5% zinc lactate. The NICNAS assessment report indicated a potential oral intake of 0.0029 Zn++ mg/kg/d, which is approximately 0.174 mg/d for a 60 kg adult. An industry-related submission on the delegate's interim decision (for the November 2013 ACCS meeting, which was published on 27 February 2014) estimated the maximum daily zinc exposure to be 18.7 mg/d (assuming 100% bioavailability). This was reduced to approximately 1 mg Zn++/d after accounting for dilution and rinsing associated with toothpaste use. Both these intake estimates, while markedly discrepant, appear to be within the Food Standards Australia New Zealand (FSANZ) recommended dietary intake (RDI) values of 12 mg/d for adults and 4.5 mg/d for children and provide an adequate Margin of Exposure (MOE), if compared to the no observed adverse effect level (NOAEL) of 50 mg Zn++/d used in the NICNAS assessment.
  • The zinc intake estimates are also well below the 25 mg/d dose recommendation for medicines exempted from listing in Schedule 4 of the SUSMP.
  • The delegate subsequently withdrew the interim decision of February 2014 to list toothpaste preparations containing zinc lactate in Schedule 6 except when 2.5% or less, and determined to seek further advice from a joint meeting of the ACCS-ACMS to resolve the question of whether the proposed 2.5% exemption is consistent with the Zn intake and MOE estimates.
  • If there is justification for preventing the use of toothpastes containing zinc lactate in children less than 12 years of age, what specific scheduling and/or 'reverse scheduling' label statements are required?
Substance summary

Please refer to the NICNAS assessment report for zinc, bis[(2S)-2-(hydroxyl-.kappa.O)propanato-.kappa.O]-, (T-4)- (Zinc lactate). This report (STD/1388) is available on the NICNAS website: New Chemical Assessments.

Scheduling status

Zinc lactate is not currently scheduled. A Schedule 4 entry exists for Zinc compounds for human internal use; however, as the use for this substance is not for human internal use, this entry is not applicable.

Scheduling history

Zinc lactate is not currently listed in the schedules, although there was some initial consideration of possible listing in Schedule 6 at the November 2013 ACCS meeting.

Pre-meeting public submissions

One submission was received. The submission requested that toothpastes containing zinc lactate when labelled with "not recommended for children under 12 years of age" be exempted from scheduling.

The public submission is available at Public submissions on scheduling matters.

Summary of ACCS-ACMS advice to the delegate

The joint committee of the ACCS-ACMS recommended that toothpaste preparations containing more than 2.5% zinc lactate be included in Schedule 6.

The committee, in addition to recommending a Schedule 6 entry, also recommended an Appendix F statement, namely "Not recommended for children under twelve years of age" for toothpaste containing zinc lactate.

The ACCS-ACMS recommended an implementation date of 1 February 2015.

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.

The reasons for the recommendation comprised the following:

  • Potential risk of ingestion of excessive amounts of zinc in toothpaste, especially in children under 12 years of age.
Delegates' interim decision

The delegates note that the ACCS-ACMS has essentially confirmed the advice given by the ACCS at its November 2013 meeting, that the use of zinc lactate in toothpaste preparations be limited to 2.5% by listing toothpastes containing more than 2.5% zinc lactate in Schedule 6. The delegates further note that the ACCS-ACMS has confirmed the need to restrict the use of zinc lactate in toothpastes used by children under 12, by including a requirement for a label warning statement ('not recommended for children under twelve years of age'.) for both Schedule 6 products, via a new Appendix F warning statement, and for exempt products, via a 'reverse scheduling' statement in the Schedule 6 exemption clause.

The delegates note that the primary purpose behind the recommendation in the NICNAS report on zinc lactate, and the subsequent advice from the ACCS and ACCS-ACMS, was to restrict the concentration in toothpastes to 2.5% based on risk assessment calculations of daily zinc systemic intake. The Schedule 6 proposal is also partly based on the imprecise estimate of the acute lethal dose of zinc lactate, and an uncertain characterisation of its eye irritancy potential.

The delegates accept the ACCS-ACMS advice, noting that the TGA has approved zinc lactate (anhydrous and dihydrate) for use as a dental excipient in registered and listed toothpaste products, at a maximum concentration of 2.5%, for use only by adults and children aged 12 years and older.

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

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;
  • Scheduling factors5;
  • Other relevant information.
Public submissions on the interim decision

One public submission was received. This submission indicated that the proposed concentration cut-off for toothpaste preparations containing 2.5% or less of zinc lactate was lower than the US National Institute of Health (NIH) reported Tolerable Upper Intake Level for Zinc (Table 3 in the public submission). Therefore the more appropriate cut-off level to exempt zinc lactate from scheduling is 3%. Additionally, given that young children use smaller amounts of toothpaste with special care taken with toothpaste containing fluoride, it is expected that children get exposure to half of the adult exposure to toothpaste. Further, given the consideration of the tolerable upper intake level of zinc and the extremely conservative estimate of zinc exposure from toothpaste, the submitter believes that warning statements are unnecessary for toothpaste containing 3% or less zinc lactate. Consuming the entire quantity of toothpaste provides as much zinc as a single serving of some breakfast cereal.

Edited versions of these submissions are available at Public submissions on scheduling matters.

Delegate's final decision

The delegates note the submission received in response to publication of the interim decision and confirm the interim decision.

The delegates note that the submission again raises the issue of disparities between the estimated amounts of systemic intake of zinc associated with the ingestion of toothpaste during use. The submission points out the estimated zinc intake would be below the Recommended Daily Intake (RDI), even for children under twelve years of age, and well below US NHI estimates of a tolerable upper limit for daily zinc intake, even if the proposed cut-off from Schedule 6 to exempt were to be lifted from the proposed 2.5% to 3%. The delegates agree that this appears to be a conservative assessment and to be inconsistent with the Margin of Exposure (MoE) estimates in the NICNAS report (59 for adults and lower for children).

Nevertheless, the delegates note that the proposed scheduling entries align with current restrictions on the concentration of zinc lactate in toothpaste (2.5%) and the recommendation that such toothpastes are not recommended for use by children under 12 years of age. This is the primary reason that the delegates have decided to confirm the interim decision.

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

The implementation date is 1 February 2016. This was the proposed implementation date published with the interim decision. It allows for an orderly process to re-label any products affected by the scheduling decision.

Schedule entry
Schedule 6 - New entry

ZINC LACTATE in toothpaste except in toothpaste preparations containing 2.5 per cent or less of zinc lactate and labelled with the statement 'not recommended for children under twelve years of age'.

Appendix F, Part 1 - New entry

107. Not recommended for children under twelve years of age.

Appendix F, Part 3 - New entry
Poison Warning statement Standard statement
Zinc lactate in toothpaste. 107. Not recommended for children under twelve years of age

Footnotes

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