Australia Solicits Public Feedback on the Restrictions of Isothiazolinones

All medicines and poisons available in Australia are listed in the Poisons Standard and are stratified based on their inherent risks. In April 2020, Australia’s Department of Health kicked off a consultation on ten proposed amendments to the existing Poisons Standard, two of which are relevant to the cosmetic sector.

1. Increased Restrictions Proposed for Isothiazolinones

Isothiazolinones are antimicrobial agents widely applied in cosmetics and personal care products, as well as certain industrial formulations like paint. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) noted that their use should be tightly controlled as many of these substances are identified as known skin sensitizers.

At NICNAS’s suggestions, the Health Department planned to create a new entry for isothiazolinones group in Schedule 6 (a list of restricted substances), with a 0.05% exemption cut-off for preparations not intended for direct skin application. But in cases where the isothiazolinones content exceeds this threshold, a warning statement “CONTAINS ISOTHIAZOLINONES. REPEATED EXPOSURE MAY CAUSE SENSITISATION” shall be written in letters not less than 1.5 mm in height on the product label.

Besides, the following six isothiazolinones would be added in this new category:

• Methylisothiazolinone;

• Methylchloroisothiazolinone;

• Benzisothiazolinone;

• 2-Methyl-1,2-Benzisothiazol-3-One;

• 4,5-Dichloro-2-N-Octyl-3(2H)-Isothiazolone;

• Octhilinone.

2. Modified Ingredient Specification and Labeling Requirements for Methylisothiazolinone and Methylchloroisothiazolinone

Currently, the chemicals methylisothiazolinone and methylchloroisothiazolinone have separate entries under Schedule 6 of the Poisons Standard. The proposed revisions would reduce their exemption cut-offs from 0.1% to 0.05% for applications in preparations that are not intended for direct skin contact, along with an additional labeling requirement. Specifies are as follows:

Both the above proposals will be addressed during the June 2020 meetings of the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #25). Any suggestions or comments on the proposals shall be sent back by email at [email protected] before May 18, 2020.