Australia Proposes Amendments to the Poisons Standard

Between April 22 and May 22, 2024, the Therapeutic Goods Administration (TGA) of Australia organized a public consultation on proposed amendments to the country's Poisons Standard. The Standard categorizes substances utilized in medicines, cosmetics, etc. into different schedules to regulate their availability to the public based on the assessment of their benefits and risks.

The proposed amendments primarily target five substances: sildenafil, allyl esters, glyoxylic acid, intravenous potassium salts, and sulfonamides. Among these, this article focuses on the suggested newly addition of glyoxylic acid, which holds particular significance for the cosmetic industry.

The aim of this inclusion is to mitigate potential risks associated with dermal and ocular exposure to these chemicals, especially for workers and end users. Detailed proposed amendments involve the creation of new entries to restrict the exemptible concentration of glyoxylic acid in cosmetics, as well as the provision of specific warning statements and safety directions, as outlined below:

New entry in Schedule 6—Poisons

GLYOXYLIC ACID (including its salts and esters) in cosmetic products or when packed and labelled for use as an agricultural chemical except in cosmetic preparations containing up to 12% w/v of glyoxylic acid for salon use only, when labelled in accordance with requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time.

Appendix E, Clause 3 (First Aid Instructions for Poisons) – New Entry

Item	Poison	Statement Code (and Statement)
138a	GLYOXYLIC ACID	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 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.)

Appendix F, Clause 4 (Poisons That Must Be Labelled with Warning Statements and Safety Directions) – New Entry

Item

Poison

Warning Statement Item Number (and Statement)

Safety Direction Item Number (and Statement)

160a

GLYOXYLIC ACID

79 (Will irritate eyes)

1 (Avoid contact with eyes)

5 (Wear protective gloves when mixing or using)

6 (Wash hands after use)

31 (Do not use on broken skin)

Australia Proposes Amendments to the Poisons Standard

New entry in Schedule 6—Poisons

Appendix E, Clause 3 (First Aid Instructions for Poisons) – New Entry

Appendix F, Clause 4 (Poisons That Must Be Labelled with Warning Statements and Safety Directions) – New Entry