Australia Cosmetics Regulation

 Cosmetic is defined in Australia as a substance or preparation (product) intended to be placed in contact with any external part of the human body (skin, hair, nails), including the teeth or inside the mouth. Functions are to protect the body, alter the body’s odors, perfume the body, changing the body’s appearance (such as coloring, tinting, or bleaching), cleans the body, maintain the body in good condition (such as by moisturizing, exfoliating, or drying).

Cosmetics in Australia are classified under the scope of industrial chemicals. Therefore cosmetics are controlled by “Industrial Chemicals (Notification and Assessment) Regulations 1990”, the overarching regulation for industrial chemicals.Australian Government Department of Health empower “National Industrial Chemicals Notification and Assessment Scheme (NICNAS)” to fully in charge of industrial chemicals (cosmetics).

Importers/manufacturers have to register their business with NICNAS before importing/manufacturing cosmetics. New ingredients that are not listed on the Australian Inventory of Chemical Substances (AICS) must be notified and assessed by NICNAS, unless exemptions apply. There are two broad categories exist for assessing a new ingredients: permits and assessment certificates. Permits need shorter assessment time, but cannot list new ingredients to AICS, while assessment certificates need more requirements and time, but can list ingredients on AICS, which means the listed ingredients are permitted to use forever and by every company.

There is a specific regulation “Cosmetic Standard 2007” for 6 special scopes of cosmetics to compile with. That means these 6 scopes should compile with both the overarching regulation and “Cosmetic Standard 2007”. The 6 scopes are:

1. Face and nail

Tinted bases/foundation with SPF

Lip products with SPF

2. Skin care

Moisturising products with SPF ≤15

Sunbathing products with sun protection for a secondary purpose SPF ≥4 and ≤15

3. Skin care

Anti-bacterial skin products

4. Skin care

Anti-acne skin products

5. Oral hygiene

Products for the care of teeth and mouth

6. Hair care

Anti-dandruff products

NICNAS is currently undergoing significant regulatory reform, and will be replaced by the new scheme “Australian Industrial Chemical Introduction Scheme (AICIS)” from 1 July 2018. The AICIS will initiate an evaluation of new chemicals by risk assessment and have broader monitoring and compliance power to reduce pre-market assessment of lower risk chemicals introductions and strengthen post-market surveillance.

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