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Scheduling delegate's final decisions: ACCS, July 2015

23 July 2015

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Part A - Final decisions on matters referred to an expert advisory committee 1.4 - 1.5

1.4 AMMONIUM COCOYL ISETHIONATE

Scheduling proposal

In December 2014, the NICNAS, under its New Chemicals assessment programme, referred the following proposal to be considered by the delegate: 

  • A proposal to create a new entry for Ammonium Cocoyl Isethionate in Schedule 6 when used in cosmetic products, except when used in rinse-off cosmetic products at ≤ 10% concentration.

The reasons for the request were:

  • The notified chemical is a severe eye irritant, consistent with Schedule 6
  • The notified chemical has only been assessed for use in rinse-off cosmetic products

The proposed concentration cut-off of 10% is the concentration proposed by the notifier as their intended maximum use concentration. The NICNAS assessment determined that there was no unreasonable risk to the public when used at up to 10% in rinse-off cosmetic products.

Delegate's reasons for referring this to the committee

The delegate asked the ACCS the following questions:

  • The NICNAS assessment report notes that, while the acute toxicity of ammonium cocoyl isoethionate is quite low, there is some potential for skin irritancy and potentially severe eye irritancy. This toxicity profile is typical of an anionic detergent substance and it appears to be more consistent with SPF criteria for listing in Schedule 5, rather than the proposed Schedule 6.
  • Should a listing be made under the specific salt name AMMONIUM COCOYL ISOETHIONATE (the INCI name) or a more generic name, such as Fatty acids, coco, 2-sulfoethyl esters, ammonium salts?
  • The NICNAS report concludes that 'the risk to the public associated with the use of the notified chemical at ≤ 10% in rinse off cosmetic products is not considered to be unreasonable'. Is this a suitable cut-off concentration for exemption from any schedule listing?
  • The ASCCS considered a similar NICNAS referral at the November 2013 meeting (cocoyl glycinate). At that time, the recommended scheduling action was create a Schedule 6 entry for cocoyl glycinate, with an exemption at less than 5% and a label requirement  If in eyes wash out immediately with water when in leave-on preparations between 5 and 30%. In addition, the delegate proposed a First Aid entry in Appendix E mandating a label direction If in eyes wash out immediately with water. Is this a suitable template for listing ammonium cocoyl isoethionate? 
Substance summary

Please refer to the NICNAS New Chemical assessment report for Ammonium Cocoyl Isethionate. This report is publicly available on the NICNAS website: NICNAS final report

A CIR report for isethionate salts (a group containing the notified chemical) is available (CIR, 2013). This review does not contain test data on ammonium cocoyl isethionate. The available data in the review on sodium cocoyl isethionate indicates that in studies in rabbits using concentrations of 2.5% -49% it was a mild to primary ocular irritant, and that is was defined as an ocular irritant at concentrations ≥ 15%. The review concludes that this group of isethionate salts (including the notified chemical) are safe in the present practices of use and concentrations in cosmetics, when formulated to be non-irritating.

The outcome of the CIR supports the conclusions reached in the NICNAS assessment regarding the eye irritation hazard, as the analogue chemical in the CIR was also found to be an eye irritant and the conclusion of safety for this group was on the condition that the cosmetics containing these chemicals were formulated to be non-irritating.

Acute toxicity

The acute toxicity end-points for this chemical are listed in the below table.

Toxicity Species Ammonium Cocoyl Isethionate SPF Classification
Acute oral toxicity LD50 (mg/kg bw) Rat >2000 None
Acute dermal toxicity LD50 (mg/kg bw) Rat >2000 None
Acute inhalational toxicity LC50 (mg/m3/4h) Not provided Not provided -
Skin irritation Rabbit Slight irritant
Eye irritation Rabbit Severe Irritant
Skin sensitisation (GPMT) Guinea pig Non-sensitiser
Repeat-dose toxicity

A 28 day repeat dose study by oral gavage was conducted in rats with the notified chemical at dose levels of 15, 150 and 1000 mg/kg/day. Animals treated with a dose of 1,000 mg/kg bw/day had a range of clinical signs, a significantly elevated monocyte count, and a number of treatment related effects in the stomach including gastritis, acanthosis of the forestomach and hyperkeratosis of the forestomach.  These effects were considered to be adverse and hence the lower concentration of 150 mg/kg bw/day was established as the NOAEL for systemic toxicity, based on the absence of effects at this dose.

Mutagenicity

Ammonium cocoyl isethionate was not mutagenic in a bacterial reverse mutation test (in the presence or absence of metabolic activation).

Genotoxicity

Ammonium cocoyl isethionate was not clastgenic in an in vitro mammalian chromosome aberration test.

Carcinogenicity

No information was provided.

Reproduction and developmental toxicity

No information was provided.

Observation in humans

No information was provided.

Public exposure

There will be widespread and repeated exposure of the public to the notified chemical (at ≤10% concentration) through the use of body and hair cleansing products. The principal route of exposure will be dermal, while oral and ocular exposure is also possible.

The notified chemical was found to cause serious eye damage when administered to rabbits at a concentration of approximately 30% and is slightly irritating to the skin.  However, as the notified chemical will be present in cosmetic products at concentrations ≤ 10%, skin and eye irritation effects are expected to be reduced.  The notified chemical is also proposed to be used only in rinse off cosmetic products, further reducing the potential for exposure.

The potential systemic exposure to the public from the use of the notified chemical in cosmetic products was estimated to be 0.90 mg/kg bw/day. Using a NO(A)EL of 150 mg/kg bw/day, which was derived from a 28 day repeated dose toxicity study on the notified chemical, the MOE was estimated to be 167. A MOE value greater than or equal to 100 is considered acceptable to account for intra- and inter-species differences; therefore, the MOE is considered to be acceptable.

As the notified chemical may also increase the dermal absorption of other components of cosmetic products, due to its surfactant nature, care should be taken when reformulating the notified chemical into the end-use products.

Therefore, based on the information available, the risk to the public associated with the use of the notified chemical at ≤ 10% in rinse off cosmetic products is not considered to be unreasonable.

International regulations

No information was provided.

Scheduling status

Ammonium cocoyl isethionate is not specifically scheduled.

Scheduling history

Ammonium cocoyl isethionate has not been previously considered for scheduling; therefore, scheduling history is not available.

Pre-meeting public submissions

One submission was received, which did not support scheduling. The submission noted their long held view that surfactants do not require scheduling, and that cocoyl isethionates are used as milder alternatives to lauryl sulfates.

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

Summary of ACCS advice to the delegate

The committee recommended a new Schedule 6 entry be created for ammonium cocoyl isethionate except in preparations containing 5 per cent or less.

Schedule 6 – new entry

Ammonium cocoyl isethionate, except in cosmetic rinse-off preparations containing 30 per cent or less and if containing more than 5 per cent of ammonium cocoyl isethionate when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER

The committee also recommended an Appendix E entry as follows:

Appendix E, Part 2 – New Entry
Poison Standard Statement
Ammonium cocoyl isethionate E1 - If in eyes wash out immediately with water

The committee recommended an implementation date of 1 February 2016.

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

The reasons for the recommendation comprised the following:

  • Severe eye irritation potential.
  • Only rinse-off cosmetic products have been specified to date.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors4;
  • Other relevant information.
Delegate's interim decision

The delegate accepts ACCS advice that a new entry be created in Schedule 6 for ammonium cocoyl isethionate, with appropriate exemption cut-offs for products with low concentrations.

The delegate notes that, while the toxicity of the substances in this category meet SPF criteria for listing in Schedule 6, based on severe eye irritancy potential, their widespread use in cosmetic products, particularly shampoos, suggests they can be used safely at low concentrations in products with appropriate safety directions to wash product from the eyes. The ACCS has now considered a number of similar surfactant substances and the scheduling recommendations are consistent with the need to provide appropriate label warnings to protect against eye damage, while exempting from scheduling many products currently on the Australian market containing low substance concentrations, provided they carry the appropriate label warning statements. One submission noted that surfactant substances used in cosmetics generally do not require controls imposed via scheduling. The delegate rejects that proposal and instead accepts ACCS advice that inclusion in Schedule 6 in a manner consistent with other surfactants is more appropriate. The recently promulgated scheduling of a related compound (cocoyl glycinate) was used as a template. The proposed wording allows for low-concentration exemptions for rinse-off products, and exemption from most scheduling controls for other products subject to 'reverse labelling' with appropriate warning statements and safety directions.  The ACCS noted that there was insufficient information to determine an appropriate exemption cut-off for leave-on cosmetic products, so these would be captured by the Schedule 6 listing.

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.

The delegate agrees with the proposed implementation date of 1 February 2016. An extended implementation date should allow sufficient time for existing affected products to be re-labelled or withdrawn.

Public submissions on the interim decision

One submission was received. The submission had no objection to the delegate's interim decision.

An edited version of the submission is available at Public submissions on scheduling matters.

Delegate's final decision

The delegate notes the submission received in response to publication of the interim decision and, in particular, the points made repeatedly in public submissions that scheduling controls over surfactant substances in cosmetics and consumer products are not appropriate. The delegate rejects that view and confirms the interim decision as no evidence has been received to alter the interim decision, noting that it is consistent with scheduling controls applied to other surfactant chemicals and provides for exemptions from other scheduling controls when appropriate label warnings are used on products. 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 6 – New Entry

AMMONIUM COCOYL ISETHIONATE, except in cosmetic rinse-off preparations containing 30 per cent or less and if containing more than 5 per cent of ammonium cocoyl isethionate when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER

Appendix E, Part 2 – New Entry
Poison Standard statements
Ammonium cocoyl isethionate E1 - If in eyes wash out immediately with water

1.5 BABASSUAMIDOPROPYL BETAINE

Scheduling proposal

In September 2013, the NICNAS proposed 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts, which is also known as babassuamidopropyl betaine for scheduling. The substance was considered by the ACCS in its July 2014 meeting together with another 1-propaniminium compound. The ACCS recommended that 1-propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride (1:1) and 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsaturated acyl derivatives, inner salts), meet the factors of the Scheduling Policy Framework  for including them in the generic Schedule 5, Schedule 6 and Appendix E entries for quaternary ammonium compounds. A separate listing in the Schedules is, therefore, not required for these substances.

A public submission received for the delegate's interim decision in October 2014 requested consideration of a separate schedule entry for amidopropyl betaines. The submission noted that:

  • the delegate's interim decision on 1-propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride (1:1) (OR stearoxypropyltrimonium chloride) may fit the typical description of a quaternary ammonium compound. However, this is not the case for 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsaturated acyl) derivatives, inner salts (OR babassuamidopropyl betaine) and other amidopropyl betaines.
  • chemically, these two substances fit into different categories: stearoxypropyltrimonium chloride is a cationic surfactant (like most quaternary ammonium compounds); babassuamidopropyl betaine, like other amidopropyl betaines, is a zwitterionic surfactant (ie a neutral molecule). While amidopropyl betaines contain a quaternary ammonium segment within the molecule and may be described by some as a quaternary ammonium compound, it also contains an organic acid segment and may be described as an organic acid. Amidopropyl betaines are used in cosmetics as a milder substitute for lauryl sulfates and sodium lauryl ether sulfates, and provide similar foaming properties as these substances.
  • it would be more appropriate to schedule amidopropyl betaine in a separate schedule entry, with controls that are aligned with lauryl sulfates; this approach would address the concerns regarding some existing products that may become scheduled (S5), noting that due to the differences in chemistry of amidopropyl betaines from typical quaternary ammonium compounds, these may not have been considered quaternary ammonium compounds by some in industry. Separate scheduling would align with the Human and Environmental Risk Assessment on Ingredients of Household Cleaning Products which concluded that household laundry and cleaning products containing cocamidopropyl betaines raise no safety concerns for the consumers. The Cosmetics Ingredient Review has noted that amidopropyl betaines are safe for use in cosmetics if they are formulated to be non-sensitising (noting that sensitisation potential was likely due to an impurity rather than the substance itself).

The submission requested consideration of the following separate schedule entry for amidopropyl betaines to align with lauryl sulfate. This schedule entry allows higher concentrations of the surfactant in wash-off preparations (than quaternary ammonium compounds), while decreasing the amount allowed in leave-on preparations.

Schedule 6

AMIDOPROPYL BETAINES except:

  • in cosmetic wash-off preparations containing 30 per cent or less of amidopropyl betaine and, if containing more than 5 per cent of amidopropyl betaine, when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

  • in cosmetic leave-on preparations containing 1.5 per cent or less of amidopropyl betaine.
  • in other preparations containing 30 per cent or less of amidopropyl betaine and, if containing more than 5 per cent of amidopropyl betaine, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

The delegate noted the submission received, determined in his final decisions to set aside the interim decision for 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salt and to seek further advice from the ACCS on whether the proposed Schedule 5 entry for amidopropyl betaines is a better way to manage the scheduling of this group of zwitterionic detergents.

Delegate's reasons for referring this to the committee

This substance was referred to the July 2014 meeting of the ACCS, under the name 1-Propanaminium, 3-amino-n-(carboxymethyl)-n,n-dimethyl-, n-(c8-18 and c18-unsatd. Acyl) derivs., inner salts. The ACCS was asked whether the substance would be captured under the generic Schedule 6 entry for QUATERNARY AMMONIUM COMPOUNDS. During the consultation phase on the delegate's interim decision, an industry submission suggested that this compound did not share many of the toxicological characteristics of quaternary ammonium compounds and like other amidopropyl betaines, is a neutral zwitterionic surfactant, whereas the quaternary ammonium compounds are cationic surfactants.

Accordingly, the scheduling proposal to be considered by the committee at the March ACCS meeting is to develop a generic Schedule 6 entry for AMIDOPROPYL BETAINES, or a specific entry for babassuamidopropyl betaine.

The committee should also consider exemption cut-offs for different types of cosmetic and other products, along with appropriate label first aid statements if the products make eye or skin contact. 

Substance summary

Please refer to the NICNAS New Chemical Assessment Report for 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts. This report is publicly available on the NICNAS website: NICNAS Final Report.

The reasons for the original scheduling request were:

  • Skin and eye irritation data indicate 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts is a slight to moderate irritant and meets the Scheduling Policy Framework's Schedule 5 criteria.
  • The assessment indicated that the risk of adverse effects from repeated exposure to the chemical at no more than 6% in rinse-off products and 2% in leave-on products is considered to be acceptable. 
  • The risk of skin sensitisation from impurities was considered acceptable based on the probability of very low concentrations of impurities. 
  • As toxicity data were not provided, 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts cannot be classified according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). However, based on the information available, the 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts should be considered as though it is classified with at least the following risk phrase: R36 Irritating to eyes.
Acute toxicity  

The acute toxicity end-points for this chemical are listed in the below table.

Toxicity Species Babassumamido propyl betaine SPF classification
Acute oral toxicity LD50 (mg/kg bw) Rats 1800 - 5000 From low to moderate toxicity
Acute dermal toxicity LD50 (mg/kg bw) Rats 2000 Low toxicity
Acute inhalational toxicity LC50 (mg/m3/4h) Not determined Not determined
Skin irritation Irritant
Eye irritation Severe irritant
Skin sensitisation (LLNA, maximisation test) Guinea pig Sensitiser
Repeat-dose toxicity

There are no repeat dose toxicity data on the notified chemical. In a 28-day repeated dose oral toxicity study, rats were administered a 30.6% solution of the analogue chemical at 0, 100, 500 or 1000 mg/kg bw/day. Inflammation of the non-glandular stomach was noted in animals of the high-dose group, although this effect was attributed to the irritant properties of the test material. Mortality was also observed in this study at all treatment levels but there was no dose-response relationship (CIR, 2010).

In another 28-day repeated dose oral toxicity study, rats were administered a solution containing the analogue chemical (concentration not stated) at 0, 250, 500 or 1000 mg/kg bw/day. The NOEL was reported as 500 mg/kg bw/day, which appears to be based on non-systemic irritant effects on the non-glandular stomach. No mortalities were observed (CIR, 2010).

In a 90-day repeated dose oral toxicity study, rats were administered a solution containing the analogue chemical (concentration not stated) at 0, 250, 500 or 1000 mg/kg bw/day. There were no mortalities and the noted effects are isolated to the stomach region and appear to be irritant in nature. The NOEL established by the study authors was 250 mg/kg bw/day, based on these effects (CIR, 2010).

Mutagenicity

Babassuamidopropyl betaine was not mutagenic in bacterial reverse mutation assays. Negative results were also obtained for the analogue chemical in a mouse lymphoma test and a micronucleus test in mice.

Carcinogenicity

Babassuamidopropyl betaine was not carcinogenic in 20-month dermal study using analogue chemical at concentration of 0.09% in mice.

Reproduction and developmental toxicity

No information provided.

Observation in humans

This substance was non-sensitising under the conditions of the human repeat insult patch test.

Public exposure

The general public will be repeatedly exposed to the notified chemical (at up to 6% concentration) through the use of rinse-off and leave-on cosmetic products.

International regulations

No information provided.

Scheduling status

Babassuamidopropyl betaine is not specifically scheduled; neither there is a class/group entry for amidopropyl betaines in the Poisons Standard.

Based on the recommendations made by the ACCS in July 2014 meeting, the delegate decided that another related compound, namely 1-propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride (1:1) met the factors of the Scheduling Policy Framework  for including it to the generic Schedule 5, Schedule 6 and Appendix E entries for quaternary ammonium compounds. A separate listing in the Schedules is therefore not required for this substance. Scheduling history of quaternary ammonium compounds is available below under 'scheduling history'.

The public submission proposing a separate scheduling for amidopropyl betaines suggested the scheduling to align with that of similar group of chemicals, lauryl sulfates. In March 2014, the joint committee of ACCS-ACMS considered a scheduling proposal to broaden the current entry for sodium lauryl sulfate to include ammonium, potassium and sodium sulfates. The delegate made a final decision in October 2014 to amend the existing entry with the implementation date of 1 October 2015.

SCHEDULE 6 – amend entry as follows:

SODIUMLAURYL SULFATE SALTS (excluding its salts and derivatives) except:

  • in wash-off preparations containing 30 per cent or less of sodium lauryl sulfates and, if containing more than 5 per cent sodium lauryl sulfates, when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

  • in leave-on preparations containing 1.5 per cent or less of sodium lauryl sulfates;
  • in toothpaste and oral hygiene preparations containing 5 per cent or less of sodium lauryl sulfates;
  • in other preparations for animal use containing 2 per cent or less; or
  • in other preparations containing 30 per cent or less of sodium lauryl sulfates and, if containing more than 5 per cent sodium lauryl sulfates, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

APPENDIX E, Part 2 – Amend entry to
Poison Standard Statement

Sodium Lauryl sulfates

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

In August 1973, the Poisons Schedule Sub-Committee decided to create a new Schedule 5 entry for preparations containing more than 10% of quaternary ammonium compounds.

In November 1997, the NDPSC decided to amend the Schedule 5 entry to include preparations containing 5 to 20% of quaternary ammonium compounds in Schedule 5 and created a new Schedule 6 entry for all other preparations containing quaternary ammonium compounds.

In November 1998, the NDPSC decided to amend the Schedules 5 and 6 entries to exempt only di-tallow dimethyl ammonium chloride was broadened to 'dialkyl quaternary ammonium compounds where the alkyl groups are derived from tallow or hydrogenated tallow or similar alkyl chain length sources'.

In November 2000, the NDPSC decided to exempt from scheduling all dialkoyl quaternary ammonium compounds.

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

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

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

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

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

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

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

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

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

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

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

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

1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts, was considered by the ACCS in July 2014 meeting.

In December 2014, the delegate made a final decision that a separate listing for another 1-propanaminium compound, namely 1-propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride (1:1) was not required. The delegate noted, and accepted, the ACCS advice that the toxicological profile of the substance was sufficiently similar to other quaternary ammonium compounds covered by the generic listing in Schedules 5 and 6. The decision included a determination that the current cut-offs from Schedule 6 to Schedule 5 (20%) and to exempt (5%) remain appropriate for these three substances.

Schedule 5

QUATERNARY AMMONIUM COMPOUNDS in preparations containing 20 per cent or less of quaternary ammonium compounds except:

  • when separately specified in these schedules;
  • dialkyl or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or hydrogenated tallow or similar chain length (C16/C18) sources; or
  • in preparations containing 5 per cent or less of such quaternary ammonium compounds.
Schedule 6

QUATERNARY AMMONIUM COMPOUNDS except:

  • when separately specified in these Schedules;
  • when included in Schedule 5;
  • dialkyl or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or hydrogenated tallow or similar chain length (C16/C18) sources; or
  • in preparations containing 5 per cent or less of such quaternary ammonium compounds.
APPENDIX E
Poisons Standard statements

Quaternary ammonium compounds except when separately specified

  • above 20 per cent

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.

E2 - If in eyes, hold eyelids apart and flush the eyes 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.
  • 20 per cent and below
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).

E2 - If in eyes, hold eyelids apart and flush the eyes 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.
  • in pressurised spray paints
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).

E2 - If in eyes, hold eyelids apart and flush the eyes 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.

G6 – If sprayed in mouth, rinse mouth with water.
Pre-meeting public submissions

One submission was received, which supported the scheduling of amidopropyl betaines. The submission suggested the following entry:

Schedule 6

AMIDOPROPYL BETAINES except:

  • in cosmetic wash-off preparations containing 30 per cent or less of amidopropyl betaine and, if containing more than 5 per cent of amidopropyl betaine, when labelledwith a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

  • in cosmetic leave-on preparations containing 1.5 per cent or less of amidopropyl betaine.
  • in other preparations containing 30 per cent or less of amidopropyl betaine and, If containing more than 5 per cent of amidopropyl betaine, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

The submission did not support the scheduling of alkyl amidopropyl betaines and notes that babassuamidopropyl betaine has been used by industry to replace potentially higher risk ingredient and therefore there is a need to ensure that industry continues to have access to ingredients for innovation.

An edited version of this submission is available at Public submissions on scheduling matters.

Summary of ACCS advice to the delegate

The committee recommended a group entry for amidopropyl betaines in Schedule 6 with exemption for preparations containing low concentrations.

Schedule 6

AMIDOPROPYL BETAINES except:

  • in cosmetic wash-off preparations containing 30 per cent or less of amidopropyl betaines and, if containing more than 5 per cent of amidopropyl betaines when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

  • in cosmetic leave-on preparations containing 1.5 per cent or less of amidopropyl betaines.
  • in other preparations containing 30 per cent or less of amidopropyl betaines  and, if containing more than 5 per cent of amidopropyl betaines, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

The committee also recommended the following Appendix E, Part 2 entry:

Poison Standard Statement
Amidopropyl betaines
  • Above 5 per cent in cosmetic wash-off preparations
E1 – If in eyes wash out immediately with water
  • Above 5 per cent in other preparations
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.

The committee recommended an implementation date of 1 February 2016.

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

The reasons for the recommendation comprised the following:

  • Does not pose same level of risk as cationic quaternary ammonium surfactants.
  • Severe eye irritant.
  • Widely used in cosmetics but risks can be mitigated by appropriate labelling.
Delegate's considerations
  • The delegate considered the following in regards to this proposal:
  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors5;
  • Other relevant information.
Delegate's interim decision

The delegate accepts ACCS advice that a new generic entry be created in Schedule 6 for amidopropyl betaines, with appropriate exemption cut-offs for products with low concentrations.

The delegate notes that, while the toxicity of the substances in this category meet SPF criteria for listing in Schedule 6, based on acute toxicity and skin/eye irritancy potential, their widespread use in cosmetic products, particularly shampoos, suggests they can be used safely at low concentrations in products with appropriate safety directions to wash product from skin and/or eyes. One submission noted that this group of substances offered a milder set of irritancy properties compared with other surfactant ingredients, and that controls imposed via scheduling are not necessary. The delegate rejects that proposal and instead accepts ACCS advice that inclusion in Schedule 6 in a manner consistent with other strong surfactants is more appropriate. The proposed wording allows for low-concentration exemptions for leave-on and rinse-off products, and exemption from most scheduling controls for other products subject to 'reverse labelling' with appropriate warning statements and safety directions.

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.

The delegate agrees with the proposed implementation date of 1 February 2016. An extended implementation date should allow sufficient time for existing affected products to be re-labelled or withdrawn.

Public submissions on the interim decision

One submission was received. The submission had no objection to the delegate's interim decision.

An edited version of this submission is available at Public submissions on scheduling matters.

Delegate's final decision

The delegate notes the submission received in response to publication of the interim decision and, in particular, the points made repeatedly in public submissions that scheduling controls over surfactant substances in cosmetics and consumer products are not appropriate. The delegate rejects that view and confirms the interim decision as no evidence has been received to alter the interim decision, noting that it is consistent with scheduling controls applied to other surfactant chemicals and provides for exemptions from other scheduling controls when appropriate label warnings are used on products. 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 6 – New Entry

AMIDOPROPYL BETAINES except:

  • in cosmetic wash-off preparations containing 30 per cent or less of amidopropyl betaines and, if containing more than 5 per cent of amidopropyl betaines when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

  • in cosmetic leave-on preparations containing 1.5 per cent or less of amidopropyl betaines.
  • in other preparations containing 30 per cent or less of amidopropyl betaines  and, if containing more than 5 per cent of amidopropyl betaines, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

Appendix E, Part 2 – New Entry
Poison Standard statements
Amidopropyl betaines
  • in cosmetic wash-off preparations when included in Schedule 6
E1 – If in eyes wash out immediately with water.
  • in other preparations when included in Schedule 6
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.

Footnotes

  • 4, 5Australian Health Ministers' Advisory Council (AHMAC): Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015) [Scheduling Policy Framework]

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