You are here

Scheduling delegate's final decisions: ACCS, March 2015

Scheduling medicines and poisons

27 March 2015

Book pagination

Part A - Final decisions on matters referred to an expert advisory committee (2.1-2.3)

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

2.1 Summary of final decisions

Substance Final decision
1-Butanol

New Schedule 6 entry

n-BUTYL ALCOHOL except

  1. when included in Schedule 5;
  2. in preparations containing 5 per cent or less of n-butyl alcohol; or
  3. in preparations for cosmetic or therapeutic use other than in spray form.

New Schedule 5 entry

n-BUTYL ALCOHOL in preparations containing 10 per cent of less of n-butyl alcohol except

  1. for preparations containing 5 per cent or less of n-butyl alcohol; or
  2. in preparations for cosmetic or therapeutic use other than in spray form.

New Appendix E, Part 2 entry

n-BUTYL ALCOHOL - Standard statements A, E1, S1

New Appendix F, Part 3 entry

n-BUTYL ALCOHOL - Warning statement 5, Safety directions 2, 4, 8

Implementation date - 1 October 2015

1-Propanol

New Schedule 6 entry

n-PROPYL ALCOHOL except

  1. when included in Schedule 5;
  2. in preparations containing 5 per cent or less of n-propyl alcohol; or
  3. in preparations for cosmetic or therapeutic use other than in spray form.

New Schedule 5 entry

n-PROPYL ALCOHOL in preparations containing 10 per cent or less of n-propyl alcohol except

  1. for preparations containing 5 per cent or less of n-propyl alcohol; or
  2. in preparations for cosmetic or therapeutic use other than in spray form.

New Appendix E, Part 2 entry

n-PROPYL ALCOHOL - Standard statements A, E1

New Appendix F, Part 3 entry

n-BUTYL ALCOHOL - Warning statement 5, Safety directions 1, 9

Implementation date - 1 October 2015

2-Cyclohexylphenol

Amendment to Schedule 9 entry

CYCLOHEXYLPHENOLS except:

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

Implementation date - 1 June 2015

Gamma butyrolactone

New Appendix C/Schedule 10 entry

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

Implementation date - 1 June 2015

Lemongrass oil Pending
Oxalic acid (soluble oxalates)

Amendment to Schedule 6 entry

OXALIC ACID except:

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

Implementation date - 1 June 2015

Polihexanide Pending

2.2 1-Butanol

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 create new schedules 5 and/or 6 entries with appropriate concentration cut-offs and associated warning statements.

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

In August 2013, NICNAS, under the IMAP programme, requested that the chemicals delegate consider a proposal to include spray preparations containing 5% or more of 1-butanol in Schedule 5. This proposal was first notified to the delegate in September 2013 at which time it was determined that expert advisory committee advice may not be required for this proposal.

Delegates' reasons for referring this to the committee

The delegates considered the proposal in the NICNAS IMAP report which focuses on the potential for eye damage and inhalation toxicity associated with the use of 1-butanol in cosmetics and various spray-on products used in a domestic setting. The issues raised have much in common with those in the 1-propanol IMAP report, and they could be considered together.

1-butanol was first considered by the ACCS at the March 2014 meeting. The chemicals delegate felt, in view of the potential impact on existing products, that advice was needed from the ACCS, with an appropriate public notice alerting the industry to the proposed scheduling action. At this time, advice from the Therapeutic Goods Administration (TGA) suggested that 1-butanol was used as an excipient, which is why it was not originally referred to the joint ACCS-ACMS meeting in March. The inclusion of 1-butanol (as an excipient) in one AgVet product was considered by the ACCS.

The ACCS advised the delegate that preparations containing 1-butanol at concentrations greater than 10 per cent be placed in Schedule 6. Preparations containing between 5 and 10 cent 1-butanol should be placed in Schedule 5 and preparations containing 5 per cent or less of 1-butanol be exempt from scheduling. Cosmetics and therapeutics were also to be exempted. The ACCS also recommended Appendix E Standard Statements of A, E1 and S1 and Appendix F Warning Statement 5 and Standard Statement 1, 4 and 8 (see Scheduling Status for these warnings/statements in full). The committee felt that the potential for moderate to severe eye damage or respiratory irritation consistent with the Scheduling Policy Framework (SPF) factors for Schedule 5 or Schedule 6 depending on concentration and use. The chemicals delegate supported the ACCS recommendation and published an interim decision based on the ACCS’s recommendation. Based on advice received during consultation on the interim decision to include 1-butanol in Schedules 5 and 6, the chemicals delegate determined that the interim decision be set aside, and that further advice be sought on the specific range of products containing 1-butanol that would warrant scheduling to protect against eye damage. This information should form the basis as to whether these should include such products as aerosol or spray products and/or arts & craft materials, where there may be a greater risk of being taken into the eye. This may include further consideration by the joint ACCS-ACMS of the previous ACCS advice that 1-butanol in cosmetics and therapeutic goods be exempted from any proposed schedule entry.

The delegates asked the ACCS-ACMS the following questions:

  • The principal issue raised by the NICNAS IMAP report is the potential for eye irritancy associated with concentrations of 1-butanol above 5%, with more serious eye damage expected at 10% and above. The Report also notes the potential for skin damage at higher concentrations and effects on the CNS associated with inhalation of vapours. The NICNAS report notes relevant exposure scenarios associated with the use of 1-butanol in cosmetics, domestic cleaners and in particular, spray-on products.
  • The skin-eye toxicity can be attributed to the solvent and de-fatting effects of 1-butanol, and this would be expected of any short-chain alkyl alcohol, including ethanol. It is noted that ethanol is currently included in Appendix B for all uses.
  • Does the ACCS-ACMS confirm the advice previously given by the ACCS that the toxicity potential for 1-butanol and its potential use in the listed products warrants inclusion in Schedule 6, with exemptions to Schedule 5 at 10%, and exempt below 5%?
  • If scheduling is recommended, should this be limited to certain specific product types in the retail market e.g. only spray on products? If so, what wording is recommended to achieve such limitations?
  • If scheduling is recommended, is the preferred nomenclature 1-butanol, n-butanol or butyl alcohol (consistent with the naming style for ethyl alcohol used in the Appendix B entry)? Should any of these names be cross-referenced in the SUSMP index (as per ethyl alcohol)?
  • Does the ACCS-ACMS confirm the Appendix E & F statements recommended by the ACCS for scheduled products captured by the proposed scheduling entries?
  • What regulatory impacts on existing [products] would be expected for any of the above scheduling options, and to what extent should this be considered in setting an implementation date?
Substance summary

Please refer to the NICNAS IMAP human health tier II assessment report for 1-butanol. This report is available on the NICNAS website: Inventory Multi-tiered Assessment and Prioritisation (IMAP) for1-BUTANOL.

Scheduling status

1-Butanol is not specifically scheduled; however, the scheduling proposal that was published in the initial interim decision on 27 June 2014 has been attached below.

Schedule 6 - New entry

1-BUTANOL except

  1. when included in Schedule 5;
  2. in preparations containing 5 per cent or less of 1-butanol; or
  3. in preparations for cosmetic or therapeutic use.
Schedule 5 - New entry

1-BUTANOL in preparations containing 10 per cent of less of 1-butanol except:

  1. for preparations containing 5 per cent or less of 1-butanol; or
  2. in preparations for cosmetic or therapeutic use.
Appendix E, part 2 - New entry
Poison Standard Statement
1-butanol

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 eye, wash out immediately with water.

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

Appendix F, part 3 - New entry
Poison Warning statement Standard direction
1-butanol

5. Irritant.

1. Avoid contact with eyes.

4. Avoid contact with skin.

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

Scheduling history

1-Butanol has not been previously considered for scheduling; therefore, scheduling history is not available.

Pre-meeting public submissions

Four submissions were received.

One submission believes scheduling of 1-butanol is unnecessary. However, if controls were deemed necessary, products containing up to 10% should be exempt from scheduling and any scheduling controls should be restricted to products in aerosol or spray formats.

One submission supports the exclusion of therapeutic goods from any proposed schedule entry.

One submission noted that 1-butanol is used in very low concentrations in a number of therapeutic and cosmetic products with no issues they were aware of. The submission recommends any scheduling decision should ensure that current cosmetic and therapeutic products for which no safety issues have been identified are not affected.

One submission highlighted the concern is in aerosol product applications where ocular exposure can lead to irreversible eye damage, which could be controlled through appropriate scheduling of aerosol use of the chemical.

Summary of ACCS-ACMS advice to the delegates

The committee recommended that preparations containing 1-butanol at concentrations greater than 10 per cent in Schedule 6 except when in Schedule 5 except for preparations containing 5 per cent or less of 1-butanol. 1-Butanol used in cosmetic and therapeutic preparations except for those in spray form is to be exempted from scheduling. The committee also recommended appropriate Appendix E and F statements (provided below) for 1-butanol.

The committee discussed an extended implementation to allow industry to manage stock in hand, due to the impact on domestic cleaning products containing between 5-10%.

The committee supported an implementation date of 1 October 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:

  • Acute and ocular toxicity of the 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;
  • SPF Scheduling factors;
  • Other relevant information.
Delegates' interim decision

The delegates accept the advice of the ACCS-ACMS to include 1-butanol in Schedules 5 and 6, under the listing name n-butyl alcohol, with an index cross-reference to the name 1-butanol. The critical toxicological endpoints driving this categorisation (potential for inhalation toxicity, skin irritancy and severe eye irritancy) are consistent with SPF criteria for listing in Schedule 6, with the public health risk sufficiently ameliorated for products between 5 and 10 per cent to be included in Schedule 5, and to be exempt from scheduling when less than 5 per cent. The delegates also accept the ACCS-ACMS recommendation that cosmetics and therapeutic products, other than spray products, be specifically exempted. The recommendation to include spray products in the proposed Schedule 6 and 5 listings is because they represent a greater risk of accidental eye damage. The delegates noted an industry submission that suggested eye damage with spray products would be of minimal risk because they are designed to be sprayed away from the body. The delegates rejected this as a basis for extending the cosmetic/therapeutic use exemption to all such products.

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

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: 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

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

Delegates' final decision

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

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

Schedule entry
Schedule 6 - New entry

n-BUTYL ALCOHOL except:

  1. when included in Schedule 5;
  2. in preparations containing 5 per cent or less of n-butyl alcohol; or
  3. in preparations for cosmetic or therapeutic use other than in spray form.
Schedule 5 - New entry

n-BUTYL ALCOHOL in preparations containing 10 per cent of less of n-butyl alcohol except

  1. for preparations containing 5 per cent or less of n-butyl alcohol; or
  2. in preparations for cosmetic or therapeutic use other than in spray form.
Appendix E, Part 2 - New entry
Poison Standard statements
n-butyl alcohol

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 eye, wash out immediately with water.

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

Appendix F, Part 3 - New entry
Poison Warning statements Safety direction
n-butyl alcohol 5. Irritant.

1. Avoid contact with eyes.

4. Avoid contact with skin.

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

2.3 1-Propanol

Scheduling proposal

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

  • To create new schedules 5 and/or 6 entries with appropriate concentration cut-offs and associated warning statements.

The committee was asked to discuss and consider the proposal with an implementation date of 1 June 205/1 October 2015 or 1 February 2016.

In August 2013, NICNAS, under the IMAP programme, requested that the chemicals delegate consider a proposal to include cosmetics and domestic preparations, such as arts, craft and hobby material, containing 1-propanol in an appropriate schedule. This proposal was first notified to the delegate in September 2013 at which time it was determined that expert advisory committee advice may not be required for this proposal. However, due to the complexity of the proposal, expert advice on these substances may be required.

Delegates' reasons for referring this to the committee

The delegates considered the proposal that the NICNAS IMAP report focuses on the potential for eye damage associated with the use of 1-propanol in cosmetics and other products used in a domestic setting. It proposes inclusion in Schedule 6, with concentration cut-offs to Schedule 5 and to exempt from scheduling.

The matter was first considered by the ACCS at the March 2014 meeting. The chemicals delegate felt, in view of the potential impact on existing products, that advice was needed from the ACCS, with an appropriate public notice alerting the industry to the proposed scheduling action. At the time, advice from the APVMA and TGA suggested that 1-propanol is not used in products they regulate; which is why the matter was not referred to the joint ACCS-ACMS meeting in March.

The ACCS advised the delegate that preparations containing 1-propanol at concentrations greater than 10 per cent be included in Schedule 6. Preparations containing between 5 and 10 per cent 1-propanol be included in Schedule 5 with preparations containing 5 per cent or less of the substance be exempt from scheduling. Cosmetics and therapeutics were also to be exempted. The ACCS also recommended Appendix E Standard Statements of A and E1 and Appendix F Warning Statement 5 and Standard Statement 1 and 9 (see Scheduling Status for these warnings/statements in full). The committee felt that the potential for moderate to severe eye damage was consistent with the SPF factors for Schedule 5 or Schedule 6 depending on concentration and use.

Based on advice received during consultation on the interim decision from the March 2014 ACCS meeting to include 1-propanol in Schedules 5 and 6, the chemicals delegate determined that the interim decision be set aside and further advice be sought on the specific range of products containing 1-propanol that would warrant scheduling to protect against eye damage. This information would be useful in determining whether the schedule entries should include such products as alcohol-based handrubs, and/or arts & craft materials, where the 1-propanol concentrations are likely to be substantively higher than the proposed scheduling cut-offs or spray products where there may be a greater risk of being taken into the eye. This may include further consideration by the joint ACCS/ACMS meeting of the pervious ACCS advice that 1-propanol in cosmetics and therapeutic goods be exempted from any proposed schedule entry.

The delegates asked the ACCS-ACMS the following questions:

  • The principal issue raised by the NICNAS IMAP report is the potential for eye irritancy associated with concentrations of 1-propanol above 5%, with more serious eye damage expected at 10% and above. The Report also notes the potential for skin damage at higher concentrations and effects on the CNS associated with inhalation of vapours. The NICNAS report notes relevant exposure scenarios associated with the use of 1-propanol in cosmetics, domestic cleaners and, in particular, art, craft and hobby materials.
  • The skin-eye toxicity can be attributed to the solvent and de-fatting effects of 1-propanol, and this would be expected of any short-chain alkyl alcohol, including ethanol. It is noted that ethanol is currently included in Appendix B for all uses.
  • Does the ACCS-ACMS confirm the advice previously given by the ACCS that the toxicity potential for 1-propanol and its potential use in the listed products warrants inclusion in Schedule 6, with exemptions to Schedule 5 at 10%, and exempt below 5%?
  • If scheduling is recommended, should this be limited to certain specific product types in the retail market e.g. on spray-on products? If so, what wording is recommended to achieve such limitations?
  • If scheduling is recommended, is the preferred nomenclature 1-propanol, n-propanol or propyl alcohol (consistent with the naming style for ethyl alcohol used in the Appendix B entry)? Should any of these names be cross-referenced in the SUSMP index (as per ethyl alcohol)?
  • Does the ACCS/ACMS confirm the Appendix E & F statements recommended by the ACCS for scheduled products captured by the proposed schedule entries?
  • What regulatory impacts on existing would be expected for any of the above scheduling options, and to what extent should this be considered in setting an implementation date?
Substance summary

Please refer to the NICNAS Inventory Multi-tiered Assessment Prioritisation (IMAP) human health tier II assessment report for 1-propanol. This report is publicly available on the NICNAS website: Inventory Multi-tiered Assessment and Prioritisation (IMAP) Human Health Tier II Assessment for 1-PROPANOL.

Scheduling status

1-propanol is not specifically scheduled; however, the scheduling proposal that was published in the initial interim decision on 27 June 2014 has been included below.

Schedule 6 - New entry

1-PROPANOL except:

  1. when included in Schedule 5;
  2. in preparations containing 5 per cent or less of 1-propanol; or
  3. in preparations for cosmetic or therapeutic use.
Schedule 5 - New entry

1-PROPANOL in preparations containing 10 per cent or less of 1-propanol except:

  1. for preparations containing 5 per cent or less of 1-propanol; or
  2. in preparations for cosmetic or therapeutic use.
Appendix E, part 2 - New entry
Poison Standard statement
1-propanol

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 eye, wash out immediately with water.

Appendix F, part 3 - New entry
Poison Warning statement Safety direction
1-propanol 5. Irritant.

1. Avoid contact with eyes.

9. Use only in well ventilated area.

Scheduling history

1-Propanol has not been considered previously; therefore, scheduling history is not available.

Pre-meeting public submissions

Four submissions were received.

One submission believes scheduling of 1-propanol is unnecessary. However, if controls were deemed necessary, these controls should be restricted to the aerosol or spray format products containing >10% 1-propanol.

One submission supports the exclusion of therapeutic goods from any proposed schedule entry.

One submission noted that 1-propanol is used in very low concentrations in a number of therapeutic and cosmetic products with no issues they were aware of. The submission recommends any scheduling decision should ensure that current cosmetic and therapeutic products for which no safety issues have been identified are not affected.

One submission highlighted the concern is in aerosol product applications where ocular exposure can lead to irreversible eye damage, which could be controlled through appropriate scheduling of aerosol use of the chemical.

Summary of ACCS-ACMS advice to the delegates

The committee recommended that preparations containing more than 10 per cent 1-propanol be included in Schedule 6 except when in Schedule 5, except for preparations containing 5 per cent or less of 1-propanol. 1-Propanol used in cosmetic and therapeutic preparations, other than for those in spray form, are to be exempted from scheduling. The committee also recommended appropriate Appendix E and F statements (provided below) for 1-propanol.

The committee discussed an extended implementation to allow industry to manage stock in hand, due to the impact on domestic cleaning products containing between 5-10%.

The committee supported the implementation date of 1 October 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:

  • Acute and ocular toxicity of the 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;
  • SPF Scheduling factors;
  • Other relevant information.
Delegates' interim decision

The delegates accept the advice of the ACCS-ACMS to include 1-propanol in Schedules 5 and 6, under the listing name n-propyl alcohol, with an index cross-reference to the name 1-propanol. The critical toxicological endpoints driving this categorisation (potential for inhalation toxicity, skin irritancy and severe eye irritancy) are consistent with SPF criteria for listing in Schedule 6, with the public health risk sufficiently ameliorated for products between 5 and 10 per cent to be included in Schedule 5, and to be exempt from scheduling when less than 5 per cent. The delegates also accept the ACCS-ACMS recommendation that cosmetics and therapeutic products, other than spray products, be specifically exempted. The recommendation to include spray products in the proposed Schedule 6 and 5 listings is because they represent a greater risk of accidental eye damage. The delegates noted an industry submission that suggested eye damage with spray products would be of minimal risk because they are designed to be sprayed away from the body. The delegates rejected this as a basis for extending the cosmetic/therapeutic use exemption to all such products.

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

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: 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

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

Delegates' final decision

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

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

Schedule entry
Schedule 6 - New entry

n-PROPYL ALCOHOL except:

  1. when included in Schedule 5;
  2. in preparations containing 5 per cent or less of n-propyl alcohol; or
  3. in preparations for cosmetic or therapeutic use other than in spray form.
Schedule 5 - New entry

n-PROPYL ALCOHOL in preparations containing 10 per cent or less of n-propyl alcohol except:

  1. for preparations containing 5 per cent or less of n-propyl alcohol; or
  2. in preparations for cosmetic or therapeutic use other than in spray form.
Appendix E, Part 2 - New entry
Poison Standard statements
n-propyl alcohol

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 eye, wash out immediately with water.

Appendix F, Part 3 - New entry
Poison Warning statements Safety direction
n-propyl alcohol 5. Irritant.

1. Avoid contact with eyes.

9. Use only in well ventilated area.

Book pagination