Australia Launched Public Consultation on Proposed Amendments to the Poisons Standard

On January 17, 2025, Australia’s Therapeutic Goods Administration (TGA) initiated a public consultation regarding proposed amendments to the Poisons Standard for six substances. Among them, three substances are relevant to cosmetic use, with the proposed amendments outlined below. Proposed additions are highlighted in green.

1. Proposed Amendments for Cyanoacrylate esters

Cyanoacrylates are used in fast-setting adhesives for cosmetic, domestic, commercial, and site-limited applications. Cyanoacrylate esters are currently included in Schedule 5 Caution, with some exceptions. The proposed amendments to the current Poisons Standard are as follows.

Schedule 5 Caution – Amend Entry

CYANOACRYLATE ESTERS in contact adhesives except:

(a) when included in Schedule 7; or

(b) when labeled with the warning:

KEEP OUT OF REACH OF CHILDREN. Avoid contact with skin and eyes and avoid breathing vapour. Bonds on contact. Should fingers stick together apply a solvent such as acetone to contact areas then wash off with water. Do not use solvents near eyes or open wounds. In case of eye contact immediately flush with water; and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use;

or

(c) when packed in sealed measure packs each containing 0.5 g or less of cyanoacrylate esters:

i. labeled with the approved name or trade name of the poison, the quantity and the warning:

Can cause eye injury. Instantly bonds skin; and

ii. enclosed in a primary pack labeled with the warning:

KEEP OUT OF REACH OF CHILDREN. Avoid contact with skin and eyes and avoid breathing vapour. Bonds on contact. Should fingers stick together apply a solvent such as acetone to contact areas then wash off with water. Do not use solvents near eyes or open wounds. In case of eye contact immediately flush with water; and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use.

Schedule 7 Dangerous Poisons – Create Entry

CYANOACRYLATE ESTERS when used in eyelash adhesives.

Index – Amend Entry

CYANOACRYLATE ESTERS

Schedule 5

Schedule 7

2. Proposed Amendments for Acrylates and methacrylates based on bisphenol A (BPA)

Acrylates and methacrylates based on bisphenol A (BPA) are primarily used commercially in a wide range of products such as adhesives, coatings, and printing inks. Additionally, five of these chemicals are used in cosmetic nail products.

• BPA glycidyl dimethacrylate (CAS No.1565-94-2)

• BPA glycidyl diacrylate (CAS No. 4687-94-9)

• ethoxylated BPA dimethacrylate (CAS No. 41637-38-1)

• ethoxylated BPA diacrylate (CAS No. 64401-02-1)

• BPA bis (methacryloyloxyethoxyethyl ether) (CAS No. 56744-60-6)

BPA glycidyl dimethacrylate and BPA glycidyl diacrylate are not specifically scheduled in the current Poisons Standard. The proposed amendments to the Poisons Standard are as follows.

Schedule 6 Poison – New Entries

BPA GLYCIDYL DIMETHACRYLATE

BPA GLYCIDYL DIACRYLATE

Index

BPA GLYCIDYL DIMETHACRYLATE

Schedule 6

Appendix F, Clause 4

BPA GLYCIDYL DIACRYLATE

Schedule 6

Appendix F, Clause 4

Appendix F, clause 4 – Warning statements and safety directions

Item	Poison	Safety Direction Item Number and Statement
50	BPA GLYCIDYL DIMETHACRYLATE	4 – Avoid contact with skin
51	BPA GLYCIDYL DIACRYLATE	4 – Avoid contact with skin

3. Proposed Amendments for Medium and Long Chain Alkyl Sulfates

Medium and long-chain alkyl sulfates and alkyl sulfuric acids are widely used as anionic surfactants in various consumer products including personal care products and household cleaning and laundry products.

Currently, only two long-chain alkyl sulfates, sodium tetradecyl (C14) sulfate in preparations for injection and lauryl (C12) sulfate salts, are listed in Schedule 4 Prescription only medicines and prescription animal remedies and Schedule 6 Poison, respectively. The proposed new entry for medium to long chain (C6-C15) alkyl sulfates are as follows.

Schedule 6 Poison – New entry

MEDIUM AND LONG CHAIN (C6-15) ALKYL SULFATES except when separately specified in these Schedules and

(a) in wash-off preparations containing, in total, 30% or less of medium and long chain alkyl sulfates and, if containing, in total, more than 5% of total medium and long chain alkyl sulfates, when labeled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; or

(b) in leave-on preparations containing, in total, 1.5% or less of medium and long-chain alkyl sulfates; or

(c) in toothpaste and oral hygiene preparations containing, in total, 5% or less of medium and long-chain alkyl sulfates; or

(d) in other preparations for animal use containing, in total, 2% or less of medium and long-chain alkyl sulfates; or

(e) in other preparations containing, in total, 30% or less of medium and long chain alkyl sulfates and, if containing, in total, more than 5% of medium and long chain alkyl sulfates, when labelled with warnings to the following effect:

i. IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

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

Index

MEDIUM AND LONG CHAIN (C6-15) ALKYL SULFATES

Cross reference: 

• Sulfuric acid, monododecyl ester, compound with 2,2',2''-nitrilotris[ethanol] (1:1) (CAS No. 139-96-8)

• Sulfuric acid, monooctyl ester, sodium salt (CAS No. 142-31-4)

• Sulfuric acid, monodecyl ester, sodium salt (CAS No. 142-87-0)

• Sulfuric acid, monododecyl ester, compound with 2,2'-iminobis[ethanol] (1:1) (CAS No. 143-00-0) and others.

  (See the full list)

Schedule 6

Appendix E, clause 3