Australia Cosmetic Notification Exemptions

Takehome:

In some circumstances, cosmetic products in Australia can be exempted from notification even if the product contains new chemicals not listed on the AICS. NICNAS found there was a high non-compliance rate when businesses used cosmetic exemptions.

In Australia, there are two notification exemption categories for cosmetics: 1). Cosmetic activities not exceeding 100kg in total volume 2). Cosmetic used at a concentration of 1% or less. NICNAS found that many NICNAS-registered businesses using the 'cosmetic used at a concentration of 1% or less' exemption category failed to meet their legal requirements, including not being able to provide information to prove that their introduction meets human health hazards, aquatic toxicity and other environmental criteria.

Introducers using the exemption pathway must meet all eligibility criteria, otherwise it is an offence under the industrial chemicals laws and subject to significant penalties. Here we provide all legal requirements for the 2 exemption categories:

1. Cosmetic use not exceeding 100kg

This exemption category includes options for introducing the chemical in volumes up to 10kg or between 10kg and 100kg in any 12 month period.

      ► To qualify for this exemption, the chemical must not:

• Pose unreasonable risks to work health and safety, public health and the environment
• Be an industrial nanomaterial
• Be used in the cosmetic as a preservative, coloring agent or ultraviolet filter
• Be prohibited or restricted for use in cosmetics in the European Union under Council Directive 76/768/EEC or in the United Stated under the Food and Drugs Cosmetics Act 1938

Where the chemical is present in the cosmetic at a concentration ≥1%, the user must have information that indicates that the chemical will be safe for use by potentially high-risk groups, including infants, elderly persons and atopic persons, consistent with the anticipated pattern of consumer exposure.

Checklist:

You will need to:

• Maintain:

→ evidence that the chemical poses no unreasonable risk to work health and safety, public health and the environment, and

→ records relating to the occupational health and safety, public health and environmental effects for 5 years after the chemical is introduced

• Monitor import and manufacture volume
• Submit an annual report to NICNAS at the end of the registration year
• If your chemical is for a volume between 10kg and 100kg in any 12-month period you must also advise NICNAS before importing and/or manufacturing the chemical by using Cosmetic exemption application Form CE-1.

2. Cosmetic use at a concentration of 1% or less

Your new chemical must meet all the following requirements to qualify for this exemption.

The chemical must:

• Be introduced in a cosmetic product at a concentration of 1% or less
• Have a very low aquatic toxicity to fish, aquatic invertebrates and algae—that is, LC50 or EC50 100 mg/L or greater
• Have one of the following characteristics:

♦ dissolves in water without dissociation or association, is not surface-active and the partition coefficient (n‑octanol/water) at 20oC as log Pow does not exceed 3

♦ solubility in water is greater than 1 mg/litre

♦ molecular weight (MW) (or number-average molecular weight (NAMW) in the case of a polymer) is greater than 1000, or

♦readily biodegradable.

The chemical must not:

• Pose unreasonable risks to work health and safety, public health and the environment
• Be a hazardous chemical
• Be a dangerous good
• Be an industrial nanomaterial
• Be used in the cosmetic as a preservative, colouring agent or ultraviolet filter, or
• Be prohibited or restricted for use in cosmetics in the European Union under Council Directive 76/768/EEC or in the United States under the Food and Drugs Cosmetics Act 1938