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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-ACMS)

2. Scheduling proposals referred to the November 2013 meeting of the joint Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS) - ACCS & ACMS # 7

2.1 Interpretation

Scheduling proposal

The Chemicals and Medicines Scheduling Delegates (the delegates) considered a proposal to include definitions, such as cosmetic use and/or personal care use, in Part 1 of the SUSMP to better define these terms and their intent and purpose.

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

  • Does the joint meeting of the ACCS and ACMS advise that definitions for the terms cosmetic use and personal care preparations be included in Part 1 of the SUSMP?
  • If so, does the joint meeting of the ACCS and ACMS concur that the definition of cosmetic adequately covers products that could be included under the definition personal care preparations (e.g. soaps, baby wipes), thus obviating the need for a separate definition for personal care products?
  • If so, does the joint meeting of the ACCS and ACMS agree that references to personal care preparations in current schedule entries be deleted as delegate-initiated editorial amendments?
  • Does the joint meeting of the ACCS and ACMS agree that a definition based on the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA) may have stronger legislative backing in Australia, and should form the basis for the SUSMP Part 1 entry? Please advise whether the full wording or a simple cross-reference to the NICNAS ICNA is suitable for the Part 1 entry.
  • Alternatively, is a form of words based on the European Union (EU), Unites States (US) Food and Drugs Administration (FDA), US National Sanitation Foundation (NSF) or Canadian FDA products descriptions a better approach?
Substance details

The following definitions were considered by the committees and the delegates:

Definition of a cosmetics/cosmetic product
  • EU - European Cosmetic Regulations - 'cosmetic product' means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
  • USA - Federal Food, Drug and Cosmetic Act (FFDCA) - defines cosmetics by their intended use, as 'articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance'.
  • Canada - Food and Drugs Act - 'cosmetic' includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.
  • Australia - Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA) - (modified on 1 August 2013) cosmetic means:
  1. a substance or preparation intended for placement in contact with any external part of the human body, including:
    1. the mucous membranes of the oral cavity; and
    2. the teeth;
    3. with a view to:
    4. altering the odours of the body; or
    5. changing its appearance; or
    6. cleansing it; or
    7. maintaining it in good condition (also see Part C of the ICNA) ; or
    8. perfuming it; or
    9. protecting it; or
  2. a substance or preparation prescribed by regulations made for the purposes of this paragraph;
  3. but does not include:
  4. a therapeutic good within the meaning of the Therapeutic Goods Act 1989; or
  5. a substance or preparation prescribed by regulations made for the purposes of this paragraph.
Personal care products

A search of various overseas government websites, including the US, EU and Canada, was unable to locate a specific definition for 'personal care use' or 'personal care product'.

The NSF, an independent, non-profit, standards development testing/certification organisation located in the United States, defines that:

'Personal care product: A non-medicinal consumable product that is intended to be used in the topical care and grooming of the body and hair and that is rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to a body, human or animal, for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Personal care products are specifically for use in such activities as cleansing, toning, moisturizing, hydrating, exfoliating, conditioning, anointing, massaging, colouring/decorating, soothing, deodorizing, perfuming, and styling.'

Cosmetic: (1) an article intended to rubbed, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) an article, other than soap, intended for use as a component of any such articles.

The document is available at: Comments on Definition section.

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Scheduling status

There is no definition for cosmetic use in the SUSMP.

Scheduling history

There is no history to be considered as the proposal is for a new entry to be included in Part 1, Interpretation of the SUSMP.

Public pre-meeting submissions

Six submissions were received.

One submission indicated that the term 'cosmetic' is used more than 50 times in the SUSMP. It therefore supports a move to better define common terms in an unambiguous way and offered the following suggestion for cosmetic use: 'A treatment or therapeutic substance whose primary effect is to enhance the appearance of a patient without any functional benefit'.

Another submission indicated that it favours setting the definition for 'cosmetic' and not for 'personal care'.

A separate submission requested that other definitions such as human or therapeutic use and extern use should also be included in the SUSMP. The submission noted that in vitro diagnostic materials are now regulated as 'medical devices' and as such are 'for therapeutic use'. As a result chemical reagents typically used in basic laboratory techniques that previously did not require scheduling controls now do require (sometimes very stringent) scheduling and in recent cases new facility licensing considerations. This is causing significant difficulty particularly at state government poisons licensing level, whereas industrial chemicals these substances do not require facility specific poisons licensing but as constituents of Class I in vitro diagnostic materials they now do. There are likely to be numerous other examples of substances that are routinely used in diagnostic materials that are now subject to (potentially excessive) scheduling.

The fourth submission supported defining the term 'cosmetic' in the SUSMP. The submission indicated that the terms 'personal care' and 'personal care use' are not currently used in the SUSMP therefore indicated that these terms need not to be included in the SUSMP.

The fifth submission indicated that it agreed that a clear definition for 'cosmetic' should be included in the Poisons Standard, since this is a term currently used within the standard.

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

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ACCS-ACMS advice to the delegates

The joint committee of the ACCS-ACMS recommended that a definition of 'cosmetic' be included in Part 1 of the SUSMP.

The ACCS-ACMS recommended an implementation date of 1 June 2014.

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

The reasons for the recommendation comprised the following:

  • The committee agreed to include the definition in the SUSMP to avoid confusion and interpretation of the standard. The proposed definition is consistent with those in the Industrial Chemicals (Notification and Assessment) Act 1989 and the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991.
Delegates' interim decision

The delegates note that there is a large number of current entries in the SUSMP that refer to 'cosmetic use', but that there is currently no definition in Part 1 that clarifies the types of products to which these entries refer. The delegates agree with the recommendation of the joint ACMS-ACCS, that a definition consistent with that currently used in the Industrial Chemicals (Notification and Assessment) Act 1989 and the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991 be included in the relevant list of definitions in Part 1, Interpretation to provide clarity to existing and future SUSMP entries that use this term.

The delegates agree with the implementation date being 1 June 2014.

The delegates made their decision in accordance with subsection 52E (1) of the Therapeutic Goods Act 1989, clause f) - any other matters that the Secretary considers necessary to protect public health.

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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 factors32;
  • Other relevant information.
Submissions on interim decision

Three submissions were received. Two submissions supported the delegates' interim decision. The third submission supported the decision to include a cosmetic definition, but suggested that the full ICNA definition be included, as clause (c) (that a cosmetic is not a therapeutic good) should be included. Should the delegates decide not to include the full definition in Part 1 - Interpretation, then the submitter suggests to at least include clause that states cosmetics do not include therapeutic goods as provision (b) on the grounds that it is important for clarity.

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

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Delegates' final decision

The delegates note the submissions received in response to publication of the interim decision and confirm the interim decision, as the comments received do not provide sufficient evidence to alter the interim decision. The delegates note there is support for using a definition of 'cosmetic' that is consistent with definitions already in use in the Industrial Chemicals (Notification and Assessment) Act 1989 and the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991. However, the delegates do not accept the proposal to add the sub-clause in these definitions that exclude therapeutic goods, because there are several existing entries in Schedules 2 and 4 where the intention is to include cosmetic use.

The delegates have confirmed that the reasons for the final decision are in keeping with those for the interim decision.

Scheduling entry
Part 1 Interpretation - New entry

"Cosmetic" means:

  1. a substance or preparation intended for placement in contact with any external part of the human body, including:
    1. the mucous membranes of the oral cavity; and
    2. the teeth;
    3. with a view to:
    4. altering the odours of the body; or
    5. changing its appearance; or
    6. cleansing it; or
    7. maintaining it in good condition; or
    8. perfuming it; or
    9. protecting it.

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2.2 Ethanol, 2-(dimethylamino) - or deanol

Scheduling proposal

On 13 September 2013, NICNAS under the Inventory Multi-tiered Assessment Prioritisation (IMAP) process, requested the chemicals and medicines scheduling delegates (the delegates) consider a proposal to include ethanol, 2-(dimethylamino)- in Schedules 5 or 6 and to make relevant amendments to the current Schedule 4 entry for deanol.

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

  • Does the ACCS-ACMS support the separate listing of 2-diethylaminoethanol in either Schedule 5 or Schedule 6, based on its acute toxicity potential (including irritancy)?
  • If so, please recommend consequential edits for the current Schedule 4 listing.
  • Is 2-diethylaminoethanol the preferred listing name rather than any of the other names included in the NICNAS IMAP report?
  • Is there sufficient information on the comparative toxicity profiles of 2-diethylaminoethanol and othe ethanolamines currently listed in Schedule 5 and Schedule 6 to inform the scheduling of 2‑diethylaminoethanol, including possible cut-offs and entries in Appendices E & F?
  • Given that consumer products (including cosmetics) are unlikely to have sufficiently high concentrations of 2-diethylaminoethanol to warrant risk-based scheduling, is there sufficient information to recommend a scheduling cut-off to exempt?
  • Is it necessary to apply scheduling to enable alignment of Australian cosmetic product regulation with that of the EU, which places a limit of 2.5 per cent in leave-on cosmetics?
  • If the ACCS/ACMS advice is to include 2-diethylaminoethanol in either Schedule 5 or Schedule 6, is there sufficient information to determine any scheduling impacts on AGVET or other commercial products containing this chemical as an ingredient?
Substance summary

Please refer to the NICNAS IMAP Tier II Human Health Assessment Report for ethanol, 2-(dimethylamino)- available on the NICNAS website.

Two-dimethylaminoethanol (DMAE), a precursor of choline, may enhance central acetylcholine formation. It has been employed as a central stimulant in the treatment of hyperactive children but its efficacy has not been substantiated33.

DMAE has been used as an ingredient in skin care, and in cognitive function and mood enhancing products. It is marketed as a free base or salt, and in theory, the two forms should be equally effective and able to substitute for each other in pharmaceutical formulations34.

The NICNAS notes that the substance will be used for various purposes, including:

  • cosmetic (as a buffering agent in cosmetic products);
  • domestic (in paints, lacquers and varnishes and in cleaning/washing agents); and
  • site-limit use (as a catalyst in the production of flexible and rigid polyurethane foams and polyurethane lacquers, reactant in the manufacture of ion exchange resins and pharmaceuticals and component of corrosion inhibitor formulations).

Image of figure 8. The structural formula of deanol

Figure 8. Structural formula of deanol.

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End-point of acute toxicity DMAE SPF*
Acute oral toxicity LD50 (mg/kg bw) 1183 (1203 mg/kg bw in males and 1220 mg/kg bw in females) Moderate to high toxicity
Acute dermal toxicity LD50 (mg/kg bw) 1220 - 3135 Low to moderate toxicity*
Acute inhalational toxicity LC50 (mg/L) 6.5
Skin irritation Irritant
Eye irritation Irritant
Skin sensitisation Sensitiser

*Scheduling Policy Framework for Medicines and Chemicals (2010)

[Secretariat's Note: if the acute dermal toxicity LD50 value is between 200 mg/kg and 2000 mg/kg, it is considered to be a Schedule 6 substance (moderate to high toxicity) and if the value is above 2000 mg/kg, it meets the Schedule 5 factors (low toxicity).]

Repeat-dose toxicity

Oral

No data is available.

Dermal

No data is available.

Inhalation

Apart from decreased body weight gain and lesions in exposed areas due to the corrosive nature of the chemical, no other adverse systemic effects were reported in the single study available. Groups of 20 rats/sex were exposed to the chemical vapour at 0, 8, 24 or 76 ppm for six hours/day, five days/week for 13 weeks. Decreased body weight gain and histopathological lesions of the eye, respiratory and olfactory epithelium was observed at 76 ppm. Transient corneal opacity occurred at the end of each of the exposure periods at 24 and 76 ppm. This reversible effect is likely to be due to the corrosive properties of the undiluted substance. The study included histopathological examination of the testes-no adverse effects were reported for this organ. The no observed adverse effect concentration (NOAEC) for systemic effects was 24 ppm, but the NOAEC was 8 ppm for local effects on the eye (OECD, 2001).

Genotoxicity

Based on the data available, the chemical is not considered genotoxic.

Carcinogenicity

No data is available.

Reproductive/developmental toxicity

Based on the limited data available, the chemical is not considered to have reproductive or developmental toxicity.

Public exposure

Considering that the chemical is used in cosmetics and domestic products, the main public exposure is expected to be through the dermal route. Inhalation and accidental ingestion may also be possible.

However, as the chemical is expected to be used only as a buffering agent in cosmetics, high concentrations of the chemical as the free amine are not expected to be present in cosmetic formulations or products.

Duration of exposure to the chemical will depend on the type of product (i.e. a rinse-off or a leave-on cosmetic product). No data on the Australian use pattern are available for cosmetic use and there are no restrictions for using this chemical in Australia. The EU has restrictions on the use of this chemical in cosmetics (2.5 per cent maximum in leave-on products).

The irritant and corrosive properties of the chemical can be attributed to its strong alkaline nature. When used as a buffering agent in cosmetic products, extremes of pH are not expected and no irritation risk is likely.

The chemical is used as a dispersant aid and a neutralising agent in waterborne paint products (OECD, 2001). Although up to 5 per cent concentration is used in industrial products, only a fraction of a per cent is used in consumer products (OECD, 2001). Therefore, the chemical at very low concentrations (<1 per cent) in consumer products is not expected to cause unreasonable risk to the public.

International regulations

The NICNAS indicates that under EU regulation this chemical is restricted under 'trialkylamines, trialkanolamines, and their salts' where the maximum concentration allowed in leave-on products is 2.5 per cent.

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Scheduling status

Deanol is listed in Schedule 4.

Other amines such as ethanolamine, diethanolamine and triethanolamine are listed in Schedule 5 and Appendices E and F. Apart from Schedule 5 listing, ethanolamine is also listed in Schedules 4 and 6. Diethanolamine is also listed in Schedule 6.

Scheduling history

Deanol is listed in Schedule 4.

Other amines such as ethanolamine, diethanolamine and triethanolamine are listed in Schedule 5 and Appendices E and F. Apart from Schedule 5 listing, ethanolamine is also listed in Schedules 4 and 6. Diethanolamine is also listed in Schedule 6.

Scheduling history
Deanol

Deanol is first listed in Schedule 4 in February 1971 by the Poisons Schedule Sub-Committee (PSC). No reasons were given for this decision.

Ethanolamine

In May 1993, the Drugs and Poisons Schedule Sub-Committee decided to include ethanolamine for therapeutic use in preparations for injections in Schedule 4. In November 1999, the NDPSC decided to delete 'therapeutic use' from ethanolamine's Schedule 4 entry based on a recommendation from the Trans-Tasman Harmonisation Working Party.

In May 1995, the NDPSC decided to include preparations containing more than 5 per cent and up to 20 per cent ethanolamine (excluding its salts and derivatives) in Schedule 5 and all other preparations (except when included in Schedules 4 and 5) in Schedule 6. The NDPSC also decided to include ethanolamine in Appendices E and F. This decision was based on ethanolamine's potential for corrosive injury to eyes and skin.

Diethanolamine and triethanolamine

In May 1974, the PSC decided to include triethanolamine in Appendix B. No rationale was given for this decision. In May 1995, the NDPSC decided to remove triethanolamine from Appendix B entry.

In February 1997, the NDPSC decided to include preparations containing more than 5 per cent and up to 20 per cent diethanolamine (excluding its salts and derivatives) in Schedule 5 and all other preparations in 6. The NDPSC also decided to include preparations containing more than 5 per cent triethanolamine (excluding its salts and derivatives) in Schedule 5. Moreover, the NDPSC decided to include diethanolamine and triethanolamine in Appendices E and F.

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Public pre-meeting submissions

Three public pre-meeting submissions have been received. One submission states that for deanol for therapeutic use, the current Schedule 4 entry remains appropriate. However, to accommodate non-therapeutic uses of the substance, the Schedule 4 entry could be amended to state deanol for therapeutic use. The submission did not provide comment on the suggestion of Schedule 5 or Schedule 6 entries.

The second submission noted no reports of deanol being used in Australia for industrial purposes, but did provide a list of industrial uses internationally. The submission also noted that salts and derivatives of deanol being used in cosmetics and topical therapeutics like sunscreens. Based on this, the submitter suggested amending the Schedule 4 entry to read 'deanol for therapeutic use excluding topical therapeutic use'.

The third submission did not provide comment at this time, but wished to be advised of the committees' recommendations and the delegates' interim decision so to provide a further submission if appropriate.

ACCS/ACMS advice to the delegates

The committees recommend that the current entry in Schedule 4 for deanol be amended to include 'for therapeutic use'. In addition, the committee recommends that a cross-reference with IUPAC and INCI names is appropriate.

The implementation date will be 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, b) the purpose for which a substance is to be used and the extend of use, c) the toxicity, d) the dosage, formulation, labelling, packaging and presentation, e) the potential for abuse of a substance.

The reasons for the recommendation comprised the following:

  • When used therapeutically it needs to remain in Schedule 4. There are other legitimate uses that are regulated by other means.
  • Potential for misuse.

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Delegates' interim decision

The delegates accept the advice of the joint ACMS/ACCS that there is insufficient evidence of a public health risk to consider regulating the use of this chemical in cosmetics and household products by inclusion in Schedule 5. However, it is necessary to edit the current Schedule 4 to ensure that it regulates only products for therapeutic use. The delegates also agree that cross-referencing the DEANOL entry in the index under other commonly used names (DMEA, dimethyl MEA and 2-(dimethalamino)ethanol will assist interpretation of the entry.

The delegates agree with the implementation date being 1 June 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegates included: b) the purpose for which a substance is to be used and the extent of use and f) - any other matters that the Secretary considers necessary to protect public health.

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 factors35;
  • Other relevant information.

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Submissions on interim decision

Two submissions were received. Both submissions supported the delegate's interim decision.

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

Delegates' final decision

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

Scheduling entry
Schedule 4 - Amendment

DEANOL for therapeutic use.

Index - cross-reference
  • DEANOL
    • See 2-(dimethylamino)ethanol, DMEA, DIMETHYL MEA
  • 2-(dimethylamino)ethanol
    • See DMEA, DIMETHYL MEA, DEANOL
  • DMEA
    • See DIMETHYL MEA, DEANOL, 2-(dimethylamino)ethanol
  • DIMETHYL MEA
    • See DEANOL, 2-(dimethylamino)ethanol, DMEA

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2.3 Salicylic acid

Scheduling proposal

On 13 September 2013, NICNAS under the Inventory Multi-tiered Assessment Prioritisation (IMAP) process, requested the chemicals and medicines scheduling delegates (the delegates) consider a proposal to amend the current Schedule 3 and Schedule 4 entries for salicylic acid and possibly create a new Schedule 5 entry to align with the restrictions of European Union (EU) on the use of salicylic acid in cosmetics to a maximum concentration of 3 per cent.

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

  • Does the joint meeting of the ACCS and ACMS support the creation of a separate schedule entry for salicylic acid to conform with European Union (EU) restrictions on its use in cosmetics?
  • Can the joint meeting of the ACCS and ACMS suggest any justification for a schedule entry that is so restrictive of dermal use in cosmetics, when use for therapeutic purposes is unrestricted for dermal preparations containing up to 40 per cent salicylic acid?
  • Which schedule is the more appropriate for a cosmetic entry for salicylic acid (if needed), with what cut-offs, and with what Appendix E and F entries?
  • Please suggest any necessary consequential amendments to the current Schedule 3 and Schedule 4 entries.
Substance details

Please refer to the NICNAS IMAP Human Health Tier II Assessment Report available on the NICNAS website.

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Scheduling status

Salicylic Acid is listed in Schedule 3 in preparations for dermal use except in preparations containing 40 per cent or less of salicylic acid.

Sodium Salicylate (Benzoic acid, 2-hydroxy-, monosodium salt) is listed in Schedule 4 in preparations for injection for the treatment of animals.

Scheduling history

In February 1974, the Poisons Standard Sub-committee reviewed the scheduling of analgesics after reports of bleeding from gastric ulcers and renal damage were received. The committee decided that all non-narcotic analgesics should be scheduled to limit availability to the public and to seek the opinion on limitation of pack size from the States' Poisons Advisory Committees. The recommended scheduling for salicylic acid was Schedule 3.

At the February 1974 meeting, the committee received correspondence from the Chiropody Board of South Australia which highlighting adverse effects of preparations containing caustic substances, mainly salicylic acid. The Board suggested products should carry warning labels. Again the committee sought the opinion of the State Poisons Advisory Committees. It was last mentioned in the meeting minutes of February 1975 after being deferred in previous meetings, where the committee was still waiting for the opinion of the Australasian College of Dermatologists.

In November of 1998, the NDPSC decided to include sodium salicylate in Schedule 4 in preparations for injection for the treatment of animals, as sodium salicylate would be expected to have a similar toxicity profile to that of aspirin (Schedule 4 for injection) and that veterinary supervision was needed to ensure appropriate use of the injectable form.

The Schedule 3 entry for salicylic acid appeared in the 2007 publication of the SUSMP. The entry was referred to in the June 2006 NDPSC meeting in relation to Trans-Tasman Harmonisation - asking New Zealand to consider amending its entry from 'external use' to 'dermal use' in line with Australian Scheduling. However, the decision for the Schedule 3 entry cannot be located.

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Public pre-meeting submissions

Four public pre-meeting submissions have been received. One submission believes the current scheduling of salicylic acid is appropriate, however if there is a need to set a limit for cosmetic preparations, the wording should be carefully considered so only to apply cosmetics.

The second and the third submission do not support the proposal and has provided evidence from the 2001 Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNRP), which the submitter believes the NICNAS IMAP report for salicylic acid is based on.

The fourth submission did not provide comment at this time, but wished to be advised of the committees' recommendations and the delegates' interim decision so to provide a further submission if appropriate.

ACCS-ACMS advice to the delegates

The committees recommend that the current salicylic acid listing in the Schedules remains appropriate.

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

The reasons for the recommendation comprised the following:

  • No evidence for failure in the existing control system being used therapeutically at concentrations higher than the proposed cut-off.
Delegates' interim decision

The delegates accept the advice of the joint committee of ACMS and ACCS that there is no need to amend the current schedule entries for salicylic acid, simply to align with overseas regulation of its use in cosmetics. The delegates note that the current Schedule 3 entry, regulating the dermal use of salicylic acid in therapeutic goods, exempts preparations containing less than 40%.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegates included: a) the risks and benefits, b) the purpose for which a substance is to be used and the extent of use and c) the toxicity of the substance.

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 factors36;
  • Other relevant information.
Submissions on interim decision

Three submissions were received. All 3 submissions supported the delegates' interim decision.

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

Delegates' final decision

The delegates have confirmed 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.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (2010)
  2. Martindale. Thirty-second edition.
  3. Structural characterization and stability of dimethylaminoethanol and dimethylaminoethanol bitartrate for possible use in cosmetic firming. Clares et al.
  4. Scheduling Policy Framework for Medicines and Chemicals (2010)
  5. Scheduling Policy Framework for Medicines and Chemicals (2010)

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