Scheduling delegate's final decisions: ACCS, April 2015

Scheduling medicines and poisons

21 April 2015

Notice under subsections 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations)

A delegate of the Secretary to the Department of Health hereby gives notice of the delegates' final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsections 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). This notice also provides the reasons for each decision and the date of effect (implementation date) of the decision.

The delegates' final decisions and reasons relate to:

  • scheduling proposals initially referred to the November 2014 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#12);
  • scheduling proposals initially referred to the November 2014 joint meeting of the ACCS and the Advisory Committee on Medicines Scheduling (ACMS) (joint ACCS-ACMS#10).

Scheduling proposals referred to the expert advisory committees

Pre-meeting public notice

A 'pre-meeting' public notice inviting submissions on the scheduling proposals referred to the expert advisory committees was published on 25 September 2014 at Consultation: Invitation for public comment - ACCS, ACMS and joint ACCS/ACMS meetings, November 2014.

Redacted versions of the public submissions received in response to this invitation were published on 5 February 2015 at Public submissions on scheduling matters.

Interim decisions

The delegates' interim decisions on recommendations by the ACCS#12 and the ACCS-ACMS#10 were published on 5 February 2015 at Reasons for scheduling delegate's interim decisions & invitations for further comment. These public notices also invited further comment from the applicant and from those parties who made a valid submission in response to the original invitation for submissions.

Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, may not be considered by the delegate.

Final decisions

In accordance with subsection 42ZCZR of the Regulations, if a delegate makes an interim decision on an application, the delegate may make a final decision either confirming, varying or setting aside the interim decision, but only after considering any valid submissions received in response to the interim decisions.

Matters not referred to an advisory committee

A delegate may decide not to refer a scheduling proposal to an expert advisory committee for advice and instead make a delegate-only decision. When deciding not to refer a matter to a committee, the delegate considers the scheduling guidelines as set out in the Scheduling Policy Framework for Chemicals and Medicines (SPF).

Publishing of the amendments to the Poisons Standard

The amendments to the Schedules, Appendices or other parts of the Poisons Standard are published electronically on ComLaw as amendments to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on ComLaw is available at: The Poisons Standard (the SUSMP).

Contents

Glossary

Scheduling medicines and poisons

Abbreviation Name
ACCC Australian Competition and Consumer Commission
ACCS Advisory Committee on Chemicals Scheduling
ACMS Advisory Committee on Medicines Scheduling
APVMA Australian Pesticides and Veterinary Medicines Authority
CAS Chemical Abstract Service
CIR Cosmetic Ingredient Review
CPS Committee on Poisons Schedules
DPSSC Drugs and Poisons Scheduling Sub-Committee
EPA Environmental Protection Authority
FDA Food and Drug Administration (United States)
IMAP Inventory Multi-tiered Assessment Prioritisation
LC50 The concentration of a substance that produces death in 50 per cent of a population of experimental organisms. Usually expressed as mg per litre (mg/L) as a concentration in air.
LD50 The concentration of a substance that produces death in 50 per cent of a population of experimental organisms. Usually expressed as milligrams per kilogram (mg/kg) of body weight.
LOAEL Lowest observed adverse effect level
LOEL Lowest observed effect level
MOE Margins Of Exposure
NCCTG National Coordinating Committee on Therapeutic Goods
NHMRC National Health and Medical Research Council
NDPSC National Drugs and Poisons Schedule Committee
NICNAS National Industrial Chemicals Notification & Assessment Scheme
NOAEL No observed adverse effect level
NOEL No observable effect level
NOHSC National Occupational Health & Safety Commission
OCS Office of Chemical Safety
PEC Priority existing chemical
PSC Poisons Schedule (Standing) Committee
SUSMP Standard for the Uniform Scheduling of Medicines and Poisons
SPF Scheduling Policy Framework for Medicines and Chemicals
TGA Therapeutic Goods Administration

Part A - Final decisions on matters referred to an expert advisory committee (ACCS #12)

Scheduling medicines and poisons

1. Scheduling proposals referred to the November 2014 meeting of the Advisory Committee on Chemicals Scheduling (ACCS #12)

Summary of delegate's final decisions

Substance Final decision
1,4-benzenediamine, 2-nitro-

Schedule 6 - Amendment

† PHENYLENEDIAMINES including alkylated, arylated and nitro derivatives not elsewhere specified in these Schedules:

  1. in preparations packed and labelled for photographic purposes;
  2. in preparations packed and labelled for testing water except tablets containing 10 mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging provided the directions for use include the statement, "Do not discard testing solutions into the pool";
  3. in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:
    • KEEP OUT OF REACH OF CHILDREN, and
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.
    • written in letters not less than 1.5 mm in height; or
  4. in eyelash and eyebrow tinting products when the immediate container and primary pack are labelled with the following statement:
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals, and when used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.
    • written in letters not less than 1.5 mm in height.

Appendix C - Amendment

PHENYLENEDIAMINES, including alkylated, arylated and nitro derivatives, in preparations for skin colouration, tattooing and dyeing of eyelashes or eyebrows except when included in Schedule 6.

Appendix E, Part 2 - Amendment

Phenylenediamines including alkylated, arylated and nitro derivatives

  • in hair dyes.

Warning statements A, E1

Phenylenediamines including alkylated, arylated and nitro derivatives

  • in preparations other than hair dyes.

Warning statements A, G1, G3, E1, S1

Implementation date - 1 June 2015

Formaldehyde donor

Part 1, Interpretation

"Free formaldehyde" includes all hydrated and non-hydrated formaldehyde present in aqueous solution, including methylene glycol and formaldehyde released from formaldehyde donors.

Implementation date - 1 February 2016

Methylated spirit(s)

Schedule 5 - New entry

METHYLATED SPIRIT(S) when packed and labelled as a 'biofuel' suitable for use in 'spirit burners'.

Appendix F, Part 1 - New statement

METHYLATED SPIRIT(S) - warning statement 107

Appendix F, Part 3 - New entry

Methylated spirit(s) when packed and labelled as a 'biofuel' suitable for use in 'spirit burners' - warning statement 107

Implementation date - 1 February 2016

1.1 1,4-Benzenediamine, 2-nitro

Scheduling proposal

The chemicals scheduling delegate (the delegate) referred the following scheduling proposal for consideration by the Advisory Committee on Chemicals Scheduling (ACCS):

  • To create a new Schedule entry for 1,4-benzenediamine, 2-nitro- in Schedule 6 and Appendix C of the SUSMP or to modify the existing Schedule 6 and Appendix C entries for PHENYLENEDIAMINES to ensure that it captures this 2-nitro derivative.

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

In August 2014, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), under the Inventory Multi-tiered Assessment Prioritisation (IMAP) programme, requested that the delegate consider a proposal to create a new entry for 1,4-benzenediamine, 2-nitro- in Schedule 6 and Appendix C that copies the entries for 'Phenylenediamines'.

The NICNAS assessment report noted that although there is a group entry for 'Phenylenediamines and alkylated phenylenediamines' in Schedule 6 and Appendix C, this group entry does not include nitro substituted derivatives of phenylenediamines.

NICNAS recommended that the entries in Schedule 6 and Appendix C of the SUSMP for 'Phenylenediamines' be applied to this nitro-substituted derivative of a phenylenediamine.

Delegate's reasons for referring this to the committee

The delegate's reason for referring this scheduling proposal to the ACCS was that, the NICNAS IMAP programme had referred another phenylenediamine for scheduling consideration. This one is a 2-nitro derivative, referred with the chemical name 1,4-benzenediamine, 2-nitro-. There are existing generic SUSMP entries for phenylenediamines and their alkyl derivatives not elsewhere specified in the schedules in Schedule 6 and Appendices C, E and F. The Schedule 6 entry exempts preparations for dyeing hair and eyelash/eyebrow when labelled with warning statements for skin irritation and eye damage, while the Appendix C entry precludes use in preparations for skin colouration and dyeing eyelash/eyebrow (except when in Schedule 6). The delegate considered that the advice of the ACCS is needed on whether to develop separate entries for this compound in Schedule 6 and Appendices C, E and F, or to amend the existing generic entry.

The delegate asked the ACCS the following questions:

  • Does the ACCS consider that the NICNAS IMAP report has raised issues that require amendment to the existing entries for PHENYLENEDIAMINES in Schedule 6, or Appendices C, E and F? Specifically, does the ACCS support the proposed broadening of the generic entries to include the 2-nitro derivative, or is a separate listing the preferred option?
  • Is the in vitro (but not in vivo) mutagenicity potential for the 2-nitro derivative sufficient reason to prevent use in all hair dye and eyelash/eyebrow dyeing preparations, by creating a separate entry in Appendix C banning these uses?
  • Given that the 2-nitro derivative appears to share the sensitising potential of other phenylenediamines, are additional warning statements needed to specifically address this toxicological endpoint if the chemical is separately listed in the Schedules?
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report for 1,4-benzenediamine, 2-nitro-.

Scheduling status

1,4-Benzenediamine, 2-nitro- is not specifically scheduled.

As the substance belongs to phenylenediamine chemical group, the schedule listing for phenylenediamine is provided below.

Schedule 6

† PHENYLENEDIAMINES [including and] alkylated [and arylated] phenylenediamines not elsewhere specified in these Schedules: [changes in parentheses come into effect on 1 July 2015]

  1. in preparations packed and labelled for photographic purposes;
  2. in preparations packed and labelled for testing water except tablets containing 10 mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging provided the directions for use include the statement, "Do not discard testing solutions into the pool";
  3. in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:
    • KEEP OUT OF REACH OF CHILDREN, and
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.
    • written in letters not less than 1.5 mm in height; or
  4. in eyelash and eyebrow tinting products when the immediate container and primary pack are labelled with the following statement:
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals, and when used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.
    • written in letters not less than 1.5 mm in height.
Appendix C

PHENYLENEDIAMINES, including alkylated and arylated derivatives, in preparations for skin colouration, tattooing and dyeing of eyelashes or eyebrows except when included in Schedule 6.

Appendix E
Poison Standard statements
Phenylenediamines including both alkylated and arylated phenylenediamines
  • in hair dyes.

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 wash out immediately with water.

  • in other preparations.

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).

G1 - Urgent hospital treatment is likely to be needed.
(Note - the words 'at once' to be added to instruction A).

G3 - If swallowed, do NOT induce vomiting.

E1 - If in eyes wash out immediately with water.

S1 - If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.

Appendix F
Poison Warning statements Safety direction
Phenylenediamines including both alkylated and arylated phenylenediamines
  • in hair dyes.
21. WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to accompanying directions should be made before use. This product must not be used for dying eyelashes or eye brows; to do so may be injurious to the eye.
  • in preparations other than hair dyes.

1. Avoid contact with eyes.

4. Avoid contact with skin.

8. Avoid breathing dust (or) vapour (or) spray mist.

Scheduling history

1,4-Benzenediamine, 2-nitro- is not specifically scheduled.

As 1,4-benzenediamine, 2-nitro- belongs to the phenylenediamines chemical group, the scheduling history for phenylenediamines is provided below.

In January 1955, the Committee on Poisons Schedule decided to list phenylene toluene and other alkylated benzene diamines in Schedule 2. At that time Schedule 2 substances were considered to be poisons, the sale of which was restricted to certain specified categories of vendors and which were subject to identical packing and labelling requirements to those of Schedule 1 but which were not required to be entered in a Poisons Register.

In March 1980, the Poisons Schedule Committee (PSC) decided to delete the Schedule 6 aromatic amines entry and amend the Schedule 6 phenylenediamines entry to include alkylated phenylenediamines.

In May 1985, the PSC noted that a number of phenylenediamines in Schedule 6 were individually listed as well as being included in the general entry for phenylenediamines. The PSC agreed that the individual entries were not required in addition to the general entry for phenylenediamines and decided to delete the individual entries. The PSC agreed that no change was required to the Schedule 2 phenylenediamines entry.

In August 2000, the National Drugs and Poisons Schedule Committee (NDPSC) agreed to exempt hair dye products containing phenylenediamines or toluenediamines from scheduling, conditional upon specified labelling.

In February and June 2004, the NDPSC considered the outcomes of investigations into incorrectly packed and labelled eyelash/brow tints containing phenylenediamines/toluenediamine and in October 2004, the NDPSC agreed to foreshadow amendments to prohibit use for eyelash/brow tinting. This proposal was varied by the February 2005 NDPSC meeting which instead agreed to foreshadow two options: to allow either salon use only, or all domestic use, of these eyelash/brow tints as Schedule 6 products (when compliant with the specified labelling).

In June 2005, the NDPSC concluded that the potential risk of causing a strong allergic response in a small number of individuals could be minimised through appropriate labelling. The NDPSC therefore agreed to that eyelash/brow tints were Schedule 6 poisons when appropriately labelled.

In June 2006, the NDPSC considered a request for flexibility in applying the mandatory labelling for eyelash/brow tints containing phenylenediamine and toluenediamine. The NDPSC indicated that, as the main risk was sensitisation, which in this case did not demonstrate a clear dose response, strong label warnings were required before such products could be available as Schedule 6. As there was a risk of separation of an outer pack from the immediate container, it was appropriate that all mandatory labelling continued to be applied to the immediate container, regardless of pack size. That the Schedule 6 warning statement would need to be applied, whether the use was domestic or industrial, or the product would default to Appendix C. The NDPSC further confirmed that the introduction to both Appendix E and F provided sufficient flexibility to allow for variation of product use and formulation.

In February 2007, the NDPSC considered the labelling requirements for single use composite pack hair preparations, including those containing phenylenediamines or toluenediamine, in view of amending various references to 'hair dyes' to 'hair preparations'. The NDPSC decided not to amend these references as there was potential for inadvertent capture of products for non-dying use patterns.

In February 2008, the NDPSC considered the scheduling of phenylenediamine and toluenediamine in eyelash/brow tints including restrict non-professional supply to ≤5 mL and limit non-professional supply to 'complete kit' forms (i.e. all reagents). The NDPSC agreed that it was not appropriate to address separate supply of a developer for eyelash/brow tinting through the scheduling process as there was little evidence of an actual public health risk from products not being sold in 'complete kit' form. The NDPSC also agreed that there was little evidence to support a pack size restriction on the availability of eyelash/brow tints containing phenylenediamine/toluenediamine.

In April 2014, the delegate considered three phenylenediamine dyes and referred them to the ACCS for advice. In July 2014, the ACCS considered the delegate's proposal to amend the phenylenediamine group entry and recommended that the Schedule 6 phenylenediamine group entry be amended to include arylated derivatives. The ACCS also recommended that a new Appendix C entry be created for skin colouration (including tattooing), hair dye, eyelash and eyebrow tinting preparations containing 1,2-benzenediamine and 1,3- benzenediamine.

Pre-meeting public submissions

One submission was received that tentatively supports the inclusion of 1,4-benzenediamine, 2-nitro- in hair dyes in Appendix C.

Summary of ACCS advice to the delegate

The committee recommended that the current Schedule 6 and Appendix C entries for phenylenediamines be amended to explicitly include nitro derivatives.

The committee recommended appropriate Appendix E and F statements for phenylenediamines.

The committee supported the implementation date of 1 June 2015.

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

The reasons for the recommendation comprised the following:

  • Similar toxicity profile to other scheduled phenylenediamines.
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;
  • SPF scheduling factors;
  • Other relevant information.
Delegate's interim decision

The scheduling of the phenylenediamines is complex and it has been considered over a number of years. It uses a combination of listing in Appendix C, to restrict their use in certain types of dye products where the risks of mutagenicity and skin/eye irritancy are unacceptable (skin colouration and dyeing of eyebrows and eyelashes), and listing in Schedule 6 for hair dyes and other permitted products where label warning statements can provide appropriate protection to product users. In July 2014, the ACCS recommended some changes to the scheduling of phenylenediamines to further restrict the use of those considered to have the highest mutagenic potential and to ensure that the generic Schedule 6 entry included both alkyl and aryl derivatives. The current proposal seeks to expand the generic Schedule 6 phenylenediamine entry to include nitro derivatives, on the basis that they share a common toxicological profile and there uses, particularly in hair dyes, require similar restrictive scheduling.

The delegate notes the industry submission that tentatively supports inclusion in Appendix C of the use of 1,4-benzenediamine, 2-nitro- in cosmetics, on the basis that such uses are banned in the European Union. However, the delegate notes advice from the ACCS that evidence for the mutagenic potential of 1,4-benzenediamine, 2-nitro- is not as strong as with the 1,2- and 1,3-benzenediamines added to Appendix C to prevent use in cosmetics. Therefore, the restrictions in the current Schedule 6and Appendix C generic entries for phenylenediamines are considered as appropriate for the nitro derivative, as they are for the alkyl and aryl derivatives.

The delegate agrees with the implementation date 1 June 2015.

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

Public submissions on the interim decision

No public submissions were received.

Delegate's final decision

The delegate 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.

The delegate has confirmed the proposed implementation date of 1 June 2015.

Schedule entry
Schedule 6 - Amendment

† PHENYLENEDIAMINES including alkylated, arylated and nitro derivatives not elsewhere specified in these Schedules:

  1. in preparations packed and labelled for photographic purposes;
  2. in preparations packed and labelled for testing water except tablets containing 10 mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging provided the directions for use include the statement, "Do not discard testing solutions into the pool";
  3. in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:
    • KEEP OUT OF REACH OF CHILDREN, and
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.
    • written in letters not less than 1.5 mm in height; or
  4. in eyelash and eyebrow tinting products when the immediate container and primary pack are labelled with the following statement:
    • WARNING - This product contains ingredients which may cause skin irritation to certain individuals, and when used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.
    • written in letters not less than 1.5 mm in height.
Appendix C - Amendment

PHENYLENEDIAMINES, including alkylated, arylated and nitro derivatives, in preparations for skin colouration, tattooing and dyeing of eyelashes or eyebrows except when included in Schedule 6.

Appendix E, Part 2 - Amendment
Poison Standard statement
Phenylenediamines including alkylated, arylated and nitro derivatives
  • in hair dyes.

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 wash out immediately with water.

  • in preparations other than hair dyes.

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).

G1 - Urgent hospital treatment is likely to be needed.
(Note - the words 'at once' to be added to instruction A).

G3 - If swallowed, do NOT induce vomiting.

E1 - If in eyes wash out immediately with water.

S1 - If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.

Appendix F, Part 3 - Amendment
Poison Warning statement Standard statement
Phenylenediamines including alkylated, arylated and nitro derivatives
  • in hair dyes.
21. WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to accompanying directions should be made before use. This product must not be used for dying eyelashes or eye brows; to do so may be injurious to the eye.
  • in preparations other than hair dyes.

28. (Over) (Repeated) exposure may cause sensitisation.

1. Avoid contact with eyes.

4. Avoid contact with skin.

8. Avoid breathing dust (or) vapour (or) spray mist.

1.2 Formaldehyde donors

Scheduling proposal

The delegate referred the following scheduling proposal for consideration by the ACCS:

  • To include the specified seven formaldehyde donor chemicals in the index of the SUSMP with a cross-reference to the formaldehyde schedule entries or to develop separate entries in Schedules 2 and 6, and Appendix C, that mirror the formaldehyde entries in those Schedules.

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

In August 2014, NICNAS, under its IMAP programme, referred the following proposal to be considered by the delegate:

  • An amendment to the current listing of formaldehyde in the SUSMP be considered to include the specified formaldehyde donor chemicals in the index to the SUSMP with a cross reference to formaldehyde.
  • Formaldehyde in cosmetic products is controlled under the SUSMP, and these controls apply to formaldehyde present in cosmetics for any reason. Therefore, the chemicals proposed are already subject to controls; however, the clarity of this link should be improved.

The reasons for the request were:

  • Skin sensitisation is a concern for cosmetic products containing these chemicals as preservatives,
  • Quaternium 15 (CAS No. 4080-31-3 and CAS No. 51229-78-8) is also a teratogen.
Delegate's reasons for referring this to the committee

The delegate's reason for referring this scheduling proposal to the ACCS was that, this is a complex scheduling matter where the delegate required advice from the ACCS. The key issue was whether the seven chemicals listed in the NICNAS IMAP report should be separately listed in the same Schedules as formaldehyde, with the same exemptions, or whether cross-referencing to formaldehyde via the SUSMP index is sufficient.

The Delegate asked the ACCS the following questions:

  • The scheduling history of formaldehyde is quite complex. The latest considerations were in May 2012, when the delegate, acting on advice from the February 2012 ACCS meeting, agreed to proposals to clarify the meaning of the definition 'free formaldehyde' in Part 1 of the SUSMP. This clarification included cross-referencing methylene glycol in the SUSMP index as the hydrated form of formaldehyde in aqueous solution.
  • Would cross-referencing the seven IMAP- listed compounds to formaldehyde in the SUSMP index achieve a similar outcome to the cross-referencing of methylene glycol?
  • Would cross-referencing in the SUSMP index imply that all the scheduling restriction relevant to the formaldehyde entries in Schedules 2, 6 and Appendix C (including the exemptions) would apply to products containing any of the seven compounds at the relevant concentrations? Put another way, would jurisdictional poisons regulations adopt relevant restrictions if the chemicals are only listed in the SUSMP index?
  • Given that the listed compounds all have different molecular weights, would the concentration cut-offs currently in the formaldehyde entries be appropriate for each 'formaldehyde donor'?
  • Would it be clearer if the seven compounds were separately listed in Schedules 2 and 6, with the same (or different) concentration cut-offs and exemptions as formaldehyde?
  • Would it be necessary to create parallel entries for all seven formaldehyde donors in Appendix C?
  • The NICNAS IMAP report contains only limited information on the toxicological properties for most of the chemicals outside the sensitisation and systemic toxicity of the released formaldehyde, although there is a suggestion that one of them (Quaternium 15) is suspected to have teratogenic potential. Is the limited available toxicological data sufficient to inform individual scheduling decisions?
  • Is there an alternative approach, where the formaldehyde donors could be identified in Part 1 of the SUSMP as a corollary to the definition of 'free formaldehyde'? If so, what specific wording would achieve that outcome?
  • None of the seven named 'formaldehyde donors' appear to be listed in the Schedules under a synonym or different name, but can this be guaranteed?
  • No specific uses in Australian products have been identified in the NICNAS IMAP report, but there are a number of potential uses in consumer products (cosmetics, adhesives, cleaners, paints) in products overseas. Is there sufficient information on potential uses to apply all the scheduling restrictions of formaldehyde to the seven listed formaldehyde donors?
  • The ACCS might note that the restrictions placed on these seven formaldehyde donors by international cosmetics and other regulations range from concentration limits to unlimited approvals.
Substance summary

Please refer to the NICNAS IMAP human health Tier II assessment report for formaldehyde donors.

Scheduling status

Formaldehyde donors are not specifically scheduled.

Similar chemical groups, namely formaldehyde and paraformaldehyde, are listed in Schedules 2 and 6 and Appendices C and E. The formaldehyde's scheduling status mirrors the paraformaldehyde's schedule status; therefore, paraformaldehyde's scheduling status is not provided.

Free formaldehyde is listed in Part 1, Interpretation.

Furthermore, formaldehyde is cross-referenced to metacresolsulphonic acid and formaldehyde condensation product. Metacresolsulphonic acid and formaldehyde condensation product are listed in Schedule 6 (all concentrations for the treatment of animals) and Appendix F (Safety Directions 1 'Avoid contact with eyes' and 4 'Avoid contact with skin'.)

Methylene glycol is cross-referenced to free formaldehyde and formaldehyde.

Formaldehyde's scheduling status is provided below.

Schedule 2

FORMALDEHYDE (excluding its derivatives) for human therapeutic use except:

  1. in oral hygiene preparations containing 0.1 per cent or less of free formaldehyde; or
  2. in other preparations containing 0.2 per cent or less of free formaldehyde.'
Schedule 6

FORMALDEHYDE (excluding its derivatives) in preparations containing 0.05 per cent or more of free formaldehyde except:

  1. for human therapeutic use;
  2. in oral hygiene preparations;
  3. in nail hardener cosmetic preparations containing 5 per cent or more of free formaldehyde;
  4. in nail hardener cosmetic preparations containing 0.2 per cent or less of free formaldehyde when labelled with the statement: protect cuticles with grease or oil;
  5. in all other cosmetic preparations; or
  6. in other preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement: contains formaldehyde.
Appendix C

FORMALDEHYDE (excluding its derivatives):

  1. in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;
  2. in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;
  3. in nail hardener cosmetic preparations containing 5 per cent or more of free formaldehyde; or
  4. in all other cosmetic preparations containing 0.05 per cent or more of free formaldehyde except in preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement: contains formaldehyde.
Appendix E
Poison Standard statement
Formaldehyde (see also paraformaldehyde)

A - For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800764 766) or a doctor (at once).

G3 - If swallowed, do NOT induce vomiting.

E2 If in eyes, hold eyelids apart and flush the eye continuously with running water. Continue flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor, or for at least 15 minutes.

R1 - If inhaled, remove from contaminated area. Apply artificial respiration if not breathing.

S1 - If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.

Part 1, Interpretation

"Free formaldehyde" includes all hydrated and non-hydrated formaldehyde present in aqueous solution, including methylene glycol

Scheduling history

The formaldehyde donors have not been previously considered for scheduling.

Pre-meeting public submissions

Three submissions were received. One submission supported the proposal to cross-reference formaldehyde donors to formaldehyde in the in the index. Two submissions did not support cross-referencing formaldehyde donors to formaldehyde.

Summary of ACCS advice to the delegate

The committee recommended that Part 1, Interpretation of the SUSMP be amended to include formaldehyde donors.

The committee supported the implementation date of 1 June 2015.

As this amendment is for clarity, not a scheduling decision, no reason under 52E(1) was required.

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;
  • SPF scheduling factors;
  • Other relevant information.
Delegate's interim decision

The scheduling of formaldehyde is quite complex, with existing entries in Schedules 2 and 6, and in Appendices C and E, regulating the types of products where it may be used. There are also separate mirror entries for paraformaldehyde on the basis that it is converted in solution to formaldehyde. These entries include specific exemption concentrations where the potential for sensitising and skin/eye irritancy effects are appropriately controlled. The exemption cut-offs for these entries rely on defining the amount of free formaldehyde that is released in aqueous solutions. The February 2012 ACCS meeting recommended proposals to clarify the meaning of the definition 'free formaldehyde' in Part 1 of the SUSMP and this clarification included cross-referencing methylene glycol in the SUSMP index as the hydrated form of formaldehyde in aqueous solution.

In considering the referral of seven substances that can function as 'formaldehyde donors' the ACCS advice was that separate individual listings in the Schedules or Appendices was not the optimum way of regulating these substances via scheduling. One reason for this is that concentration cut-offs suitable for formaldehyde would not be appropriate for compounds of different molecular weights and that release different amounts of formaldehyde. The approach favoured by the ACCS was to amend the definition of 'free formaldehyde' in Part 1 of the SUSMP, so that the amount of formaldehyde released by these 'donors' would define the way in which they are regulated by the SUSMP. The delegate accepts this advice as a pragmatic way of extending controls over the use of substances that release formaldehyde and thereby present sensitisation and/or irritancy risks. The delegate also notes that this approach was endorsed by the European Union Scientific Committee on Cosmetic Products and Certain Non-Food Products intended for Consumers (SCCNFP) in a report (SCCNFP/586/02) referred in an industry pre-meeting consultation submission. The EU report addressed four of the seven substances assessed in the NICNAS IMAP report.

The ACCS considered, but did not support, the approach adopted for methylene glycol, whereby listing of the seven specified 'formaldehyde donors' in the SUSMP index would cross- reference their scheduling status with that of formaldehyde. The delegate notes that one pre-meeting industry submission did not support cross-referencing the seven 'formaldehyde donors' in the SUSMP index, but seeks further advice on whether such SUSMP index cross-referencing would assist with understanding the extension of scheduling controls where these substances are used as formaldehyde donors or precursors.

The delegate has decided the implementation date 1 February 2016. The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (f) any other matters that the Secretary considers necessary to protect public health i.e. clarity of controls.

Public submissions on the interim decision

One public submission was received, which supported the delegate's interim decision. The submission notes that they do not support cross-referencing of formaldehyde donors to the formaldehyde schedule entry; however, there is merit in considering some referencing to provide users of The Poisons Standard, that for formaldehyde donors, the formaldehyde schedule entry should be checked against the level of formaldehyde in the product.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and confirms the interim decision. The delegate notes the suggestion that there should be some advice to product manufacturers to check the concentration of free formaldehyde that could be released from 'formaldehyde donors' but that no pragmatic advice was given on how to achieve this via an amendment to the either formaldehyde entries in the SUSMP or to the Part 1 definition of 'free formaldehyde'. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

The delegate has confirmed the proposed implementation date of 1 February 2016.

Schedule entry
Part 1, Interpretation

"Free formaldehyde" includes all hydrated and non-hydrated formaldehyde present in aqueous solution, including methylene glycol and formaldehyde released from formaldehyde donors.

1.3 Methylated spirit(s)

Scheduling proposal

The delegate referred the following scheduling proposal for consideration by the ACCS:

  • Based on advice received during consultation on the interim decision from the March 2014 ACCS meeting to develop suitable label statements to warn consumers of the fire risks associated with using methylated spirits to refill burners while alight or hot, the delegate determined that the interim decision be set aside. The delegate now proposes to seek further advice on the practicality of attaching the suggested warning statements to either/both the burners and/or the fuels. The delegate also notes that, under the current Schedule 5 entry for METHYLATED SPIRIT(S), some fuels would not be captured even if a warning statement were to be included in the schedule entry (e.g. those in containers containing 5 litres of more and those biofuels not meeting the current specification for methylated spirits). The delegate proposes to seek advice on which ingredients may be used to denature alcohol, in order to better align the SUSMP methylated spirits definition with current industry practice and to ensure that biofuels to which any warning statement would be applied are consistent with the wording of the Schedule 5 entry.

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

This was a delegate initiated scheduling matter.

In March 2014, the ACCS considered the delegate's referral for advice regarding a proposed label warning statement (stated below) alerting consumers regarding the serious burn hazard methylated spirit poses when refuelling ethanol burners.

'WARNING: DO NOT attempt to refill methylated spirit burner while it is in use or still warm; it could lead to serious burn injury or death.'

In June 2014, the delegate made an interim decision not to include the requested warning statements by amending the current Schedule 5 entry for methylated spirit, nor by amending Part 2 Clause 7(h), nor by creating a specific Appendix F entry, and invited further submissions. A further submission was made in response to the delegate's interim decision, indicating that the efficacy of warning statement is a key factor in the development of effective and efficient responses to product hazards. The current warning statements do not address a specific hazard and individuals are being injured though lack of understanding of the nature of the risk. The submission requested that the delegate consider amending the current methylated spirit(s) entry to provide a prominent new warning statement as follows:

'WARNING: DO NOT ATTEMPT TO REFILL A METHYLATED SPIRIT BURNER WHILE IT IS IN USE OR STILL WARM; IT COULD LEAD TO SERIOUS BURN INJURY OR DEATH', (or similar)

Delegate's reasons for referring this to the committee

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 (SPF), advice is expected to be obtained from a relevant advisory committee for all rescheduling proposals.

The delegate asked the ACCS the following question:

  • Please refer to the information under the heading 'Scheduling Proposal'.
Substance summary

Methylated sprit, which is also known as denatured ethanol, or denatured alcohol, is a clear, colourless, mobile liquid. It is miscible with water in all proportions1. Methylated spirit is mainly used as a fuel for spirit burners and camping stoves and also as a solvent for cleaning preparations.

Ethanol is a volatile, flammable, colourless liquid. An ethanol-water solution that contains 40% alcohol by volume will catch fire if heated to about 26°C and if an ignition source is applied to it. The flash point of pure ethanol is 16.60°C, less than average room temperature. Ethanol is a versatile solvent, miscible with water and with many organic solvents, including acetic acid, acetone, benzene, carbon tetrachloride, chloroform, diethyl ether, ethylene glycol, glycerol, nitromethane, pyridine, and toluene. It is also miscible with light aliphatic hydrocarbons, such as pentane and hexane, and with aliphatic chlorides such as trichloroethane and tetrachloroethylene.

Structure of ethanol
Figure 1. Structure of ethanol

Methanol is commonly used as an additive in the methylated spirit because its boiling point is close to that of ethanol.

Methylated spirit is classified as a Schedule 5 poison and the products' label includes the signal word "CAUTION". It is available from supermarkets, hardware stores and camping/outdoors stores. Safe Work Australia has classified methylated spirit as a hazardous substance. Methylated spirit is also classified as a dangerous good according to the criteria of the Australian Dangerous Goods (ADG) Code. The products' label includes the following information:

  • 'Highly Flammable' symbol and risk phrase;
  • 'Keep out of reach of children', 'Keep container tightly closed'; and
  • 'Keep away from ignition source - No smoking' safety phrases.

Since the introduction of ethanol burners into the Australian market, methylated spirit has also been used as a common fuel for these products. One product label was found to indicate (although not prominently) that the product is suitable for use as 'burner fuel' and provides instructions of use of filling the product into the burners. The labels of other brands were not found to have this information.

From May 2010 until now, the ACCC is aware of twenty-seven incidents relating to ethanol burners, in which twenty-two resulted in burn injuries ranging from minor burns and up to serious burns to 55 % of the body. Most of the injuries required hospitalisation. Five of the reported incidents resulted in injuries to child and elderly bystanders.

The majority (64%) of burn injuries reported occurred during the refilling of the burner while it was still lit or warm. The number and severity of injuries related to ethanol burners suggest that ethanol burners pose a hazard to the Australian consumers due to the following reasons:

  • Lack of safety warnings on fuel packaging; and
  • Lack of safety warnings on burners and burners' packaging.
Scheduling status

Methylated sprit is listed in Schedule 5 and Appendix E. It is also listed in Part 2, Labels and Containers under Child-resistant closures.

Schedule 5

METHYLATED SPIRIT(S) (being ethanol denatured with denatonium benzoate, methyl isobutyl ketone and fluorescein) except:

  1. when included in preparations or admixtures; or
  2. when packed in containers having a capacity of more than 5 litres.
Appendix E
Poisons Standard statements
Methylated spirit

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).

G3 - If swallowed, do NOT induce vomiting.

Part 2, Labels and Containers
Column 1
Name of the poison
Column 2
Nominal capacity
Methylated spirit excluding preparations or admixtures 5 litres or less
Scheduling history

Methylated spirit was first considered in May 1956 by the Poisons Schedules Committee (PSC). The PSC decided to include methylated spirit and all substances containing more than 20% of methylated sprit in Schedule 5.

In July 1963, the PSC decided to amend the methylated spirit entry to exempt 20% or less of methylated spirit which are labelled in accordance with the then Appendix I (prescribed letter weights).

In February 1978, the Poisons Schedule Sub-Committee (PSSC) decided to amend the Schedule 5 methylated spirit entry to exempt containers having capacity of more than 5 litres and preparations containing 75% or less of methylated spirit.

In November 1978, the PSSC decided to amend the Schedule 5 methylated spirit entry to exclude its preparations and admixtures and methylated spirits in containers having a capacity of more than 5 litres.

In August 2014, the delegate noted the serious nature of burns that have occurred through misuse of fuels that already have prominent flammability warnings and research on the proposed more explicit warning statement suggesting the potential for greater awareness of the dangers and possible preventive actions. The delegate decided to seek further information on the practicality of attaching the suggested warning statements to either/both the burners and/or the fuels. The delegate also noted that, under the current schedule 5 entry for METHYLATED SPIRIT(S), some fuels would not be captured even if a warning statement were to be included in the schedule entry (e.g. those in containers containing 5 litres of more and those biofuels not meeting the current specification for methylated spirit). The delegate had already noted the need to refer back to the ACCS the matter of which ingredients may be used to denature alcohol, and to better align the methylated spirit definition with current industry practice. Accordingly, the delegate decided to refer the matter back to the ACCS for further advice, and also to seek further input from industry and the Australian Competition and Consumer Commission (ACCC). This would include advice on the practicality of limiting the proposed warning statements to methylated spirit in products specifically packaged as biofuels for use in spirit burners and on the need to adjust the schedule entry so that warnings could be applied to the larger containers that are currently exempt from the Schedule 5 listing.

Pre-meeting public submissions

Two submissions were received.

One submission supports including nationally consistent warnings and extending the scope of the definition for methylated spirit to capture 'biofuels' and other types of methylated spirits using different combinations of denaturant and of removing the current Schedule 5 exemption for containers exceeding 5 litres.

The second submission did not support including additional warning statements on methylated spirits.

Summary of ACCS advice to the delegate

The committee recommended that a new Appendix F, Part 1 Warning Statement be created: 'WARNING: Do not attempt to refill burner while it is in use or still warm; it could lead to serious burn injury'.

The committee recommended that this new Appendix F, Part 3 Warning Statement be added for Methylated spirit(s).

The committee supported the implementation date of 1 February 2016.

The committee recommended that the current definition of methylated spirits remains appropriate.

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 interim decision comprised the following:

  • To mitigate the risk of serious burn injury accident.
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;
  • SPF scheduling factors;
  • Other relevant information.
Delegate's interim decision

This matter was initially referred to the March 2014 meeting of the ACCS, at which time the advice to the delegate was that flammability warnings on containers of methylated spirits provide sufficient warning of the risks associated with use as fuel for 'spirit burners' and that the specific additional and more specific and directive Warning Statement (WARNING: DO NOT attempt to refill methylated spirit burner while it is in use or still warm; it could lead to serious burn injury or death) should NOT be imposed via a new statement in the Appendix F entry for methylated spirits. The delegate accepted this recommendation, but arising from a further submission responding to the interim decision, decided to re-commit the matter for consideration at the November 2014 ACCS meeting. This submission suggested that the efficacy of a warning statement is a key factor in the development of effective and efficient responses to product hazards. The current warning statements do not address a specific hazard and individuals are being injured though lack of understanding of the nature of the risk. The submission requested that the delegate consider amending the current methylated spirit(s) entry to provide a prominent new warning statement, as above.

One issue, highlighted in a pre-meeting industry submission to the November 2014 ACCS, was that warning statements on burners themselves would be more effective than labelling fuel containers, and that accidents associated with re-filling hot burners imply that some people simply ignore existing flammability and other warnings on container labels. Furthermore, methylated spirits have uses other than as biofuels, and to require the labelling of all containers with the specific Appendix F Warning Statement would be excessive.

The advice from the November 2014 ACCS meeting supported the development of a new Appendix F warning Statement, although the advice was not unanimous. The delegate accepts this advice and proposes a new Warning Statement (107. WARNING: Do not attempt to refill burner while it is in use or still warm; it could lead to serious burn injury) in Part 1 of Appendix F. The issue then arises whether it is appropriate to apply WS 107 to a new entry for methylated spirit in Appendix F.

One of the options considered (but not supported) by the ACCS was that a new Schedule 5 entry be created for methylated spirit when used specifically as a biofuel, and that the Appendix F WS be applied to only that entry. The delegate is attracted to this option because it restricts the application of WS 107 to the specific use for which it was developed. Furthermore, the new Schedule 5 entry could be broadened to cover methylated spirit that does not fit the definition of methylated spirit in the current Schedule 5 entry. The Schedule 5 entry for METHYLATED SPIRIT specifies that it is ethanol denatured with three specific denaturants (one or more?). This definition was, in part, developed to counter the potential for methylated spirit to be ingested as an alcohol substitute. Information provided to the ACCS indicates that methylated spirit currently available in commerce and defined by other legislation (e.g. the Excise Act 2011) may be denatured with a larger range of substances. Some of these products are packaged and labelled as 'biofuels' suitable for use in spirit burners. Therefore, it is possible that such packaging may avoid specific packaging and labelling required under the current Schedule 5 entry for methylated spirit. Since the ACCS declined to support amending the Schedule 5 definition of methylated spirit, the delegate proposes a new Schedule 5 entry, to which WS 107 would be required.

The delegate agrees with the implementation date 1 February 2016. 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; and (e) the potential for abuse of a substance.

Public submissions on the interim decision

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

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.

The delegate has confirmed the proposed implementation date of 1 February 2016.

Schedule entry
Schedule 5 - New entry

METHYLATED SPIRIT(S) when packed and labelled as a 'biofuel' suitable for use in 'spirit burners'.

Appendix F, Part 1 - New statement

107. WARNING: Do not attempt to refill burner while it is in use or still warm; it could lead to serious burn injury.

Appendix F, Part 3 - New entry
Poison Warning statement Standard statement
Methylated spirit(s) when packed and labelled as a 'biofuel' suitable for use in 'spirit burners'. 107. WARNING: Do not attempt to refill burner while it is in use or still warm; it could lead to serious burn injury'

Footnotes

  1. Safe handling and storage of methylated spirit (pdf,574kb). Department of Transport and Main Roads, Queensland.

Part A - Final decisions on matters referred to an expert advisory committee (ACCS-ACMS #10)

Scheduling medicines and poisons

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

Summary of delegates' final decisions

Substance Final decision
Lemongrass oil
Appendix B - Delete entry

LEMONGRASS OIL

Schedule 5 - New entry

LEMONGRASS OIL in cosmetic and household cleaning preparations except in preparations containing 5 per cent or less of 3,7-dimethyl-2,6-octadienal.

Implementation date - 1 June 2015

Polihexanide
Schedule 5 - Delete entry

POLIHEXANIDE except in preparations containing 5 per cent or less of polihexanide.

Schedule 6 - New entry

POLIHEXANIDE except:

  1. in preparations containing 5 per cent or less of polihexanide; or
  2. when packed and labelled for therapeutic use.
Appendix E, Part 2 - New entry

POLIHEXANIDE - Standard Statements - E1

Implementation date - 1 June 2015

2.1 Lemongrass oil

Scheduling proposal

The chemicals and medicines scheduling delegates (the delegates) referred the following scheduling proposal for consideration by the joint committee of the Advisory Committee on Chemicals Scheduling and the Advisory Committee on Medicines Scheduling (ACCS-ACMS):

  • To delete the lemongrass oil entry from Appendix B and to develop a listing in Schedule 5 to complement the entry for 3,7-dimethyl-2-6,-octadienal and its isomers.

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

This item was initiated by the delegates as one of the outcomes foreshadowed in the delegates' interim decision on 3,7-dimethyl-2-6,-octadienal and its isomers.

In August 2014, the delegates indicated that, based on advice received from the November ACCS meeting and the July ACCS-ACMS meeting, an interim decision was made for a new listing in Schedule 5 for 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. The interim decision noted that since lemongrass oil can contain up to 90% of citral, there is a need to review the current Appendix B entry for lemongrass oil.

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