Engel Hellyer & Partners is one of the most trusted and experienced Pharmaceutical TGA and AICIS Regulatory Affairs consultants.

Since 1982, we have been providing quality regulatory advice to large multinationals and SMEs.

Engel Hellyer & Partners have for nearly 40 years used their knowledge and experience to conduct detailed regulatory compliance reviews. We review literately thousands of cosmetic products and their formulations, packaging and claims each year.

We can help you and your company to make your cosmetic products compliant for the Australian market. Australia does not operate a product registration system as many other countries do. In Australia companies are expected to know and comply with all the separate pieces of legislation that may apply to a cosmetic product and its ingredients.

Cosmetic Products Regulation and Compliance checks:

  • Registration with AICIS (formerly NICNAS) of Companies importing or manufacturing in Australia. NICNAS was rebranded 1 July 2020 as the Australian Industrial Chemicals Introduction Scheme (AICIS).
  • All ingredients in cosmetic products have to be on an Inventory currently known as the Australian Inventory of Industrial Chemicals (AIICs) (formerly known as the Australian Inventory of Chemical Substances (AICS). If they are not then there are six streams of introduction that  apply from 1 July 2020. The three key streams are exempted introductions, reported introductions and assessed introductions. Compliance and reporting to AICIS will be required before import from overseas or before manufacture in Australia.
  • Confidential review of advertising claims and their substantiation. The primary requirements are that cosmetic product claims must not be deceptive or misleading under the Australian Consumer Law or be therapeutic claims under definitions as issued by the Therapeutic Goods Administration (TGA).
  • Also under TGA is an additional compliance item for some products and for some ingredients. Some cosmetic ingredients or cosmetics products may be restricted or may not be allowed in cosmetics according to the Poisons Standard (also called the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). The Poisons Standard is up dated four times a year.
  • Other legislation governs the labelling of cosmetic products for consumer information such as trade measurement, country of origin, name and address, transportation and storage. Special labelling is required for aerosols