The cosmetics industry is one of the most dynamic and rapidly growing sectors worldwide. As such, pharmaceutical companies including those manufacturing skincare products must navigate the world of regulations designed to protect consumer health and safety. In Australia, as well as in international markets, cosmetic regulations play a critical role in ensuring that products are safe, effective, and trustworthy.

How does Ego Pharmaceuticals manage to comply with the differing regulations in Australia and abroad? We look into the challenges faced by Ego Pharmaceuticals in understanding and adhering to both Australian and global cosmetic regulations, and ensuring compliance in this regulated environment.

Key things to consider when making a skincare product: what is the primary use of the product, which ingredients will we choose, and what claims will we make. In Australia, cosmetic ingredients are regulated by the Australian Industrial Chemicals Introduction Scheme, also known as AICIS.

To be a cosmetic, the product has to be used on the external part of the body to change its odour or appearance, cleanse it, keep it in good condition or protect it. Products that claim to prevent, diagnose, cure or alleviate a disease, ailment or defect in people are considered therapeutic goods (not cosmetics) and this is a space where we have to tread carefully to ensure we are in the right category.

Will the product contain any ingredients from the Poisons Standard (also known as SUSMP), if so this may make the product a therapeutic good rather than a cosmetic.

We also need to consider labelling and need to comply with the Australian Competition and Consumer Commission’s (ACCC) mandatory standard for ingredient labelling. The requirements of this mean we need to have the ingredients listed from highest concentration to lowest, with colour additives included last.

ACCC also requires that a claim or representation must be substantiated with test results and evidence, which means we cannot mislead our consumers with unjustified claims or false advertising.

Ego Pharmaceuticals also considers European legislation, as the ASEAN Cosmetics Directive and Middle East cosmetic regulations align closely with the EU, and given we export into these markets. There is extensive information on the ingredients used, including: Preservatives,  UV filters and Colorants allowed in cosmetic products and their maximum concentrations, Symbols to be used on packaging, no Animal Testing claims (as animal testing is not allowed for cosmetics in Europe), prohibited and restricted ingredients due to CMR – Carcinogenic (C), Mutagenic (M), and Reprotoxic (R), referring to substances that can cause cancer, damage genetic material, or harm reproductive health - or if ingredients are pharmaceutical in nature (similar to what Australia has with the Poisons Standard), and the use of nanomaterials.

Like Australia, European legislation stipulates that companies cannot claim characteristics or functions of a cosmetic product which they do not have. 

Taking into account what is required in Australia and overseas, we are able to navigate the complex cosmetic and therapeutic regulations designed to protect consumers in both health and safety. Ensuring compliance with local and international regulations means we remain a trusted leader in cosmetic and therapeutic skincare.