Standards Compliance Tick


The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) helps protect the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use. This covers a broad range of chemicals used in inks, plastics, adhesives, paints, glues, solvents, cosmetics, soaps and many other products.

The Therapeutic Goods Administration, (TGA) is part of the Department of Health and helps to safeguard and enhance the health of the Australian population through effective and timely regulation of therapeutic goods. The TGA is responsible for regulating the supply, import, export manufacturing and advertising of therapeutic goods.

RCM Compliance Tick

What you can expect from our NICNAS/Cosmetics/TGA Compliance service

  • Current regulatory awareness
  • Early warning of changes in relevant areas of regulation by regulatory authorities
  • Confidential assessment of potential safety or health risks for products
  • Confidential review of advertising claims and their substantiation
  • Assistance with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Australian Inventory of Chemical Substances (AICS)
  • Coordination between industry and agencies with respect to technical, scientific or toxicological evidence
  • Technical assessments for acquisitions
  • Provision of information to marketing personnel as required
  • The review of products for compliance to the National Trade Measurement Act and Regulations

Compliance: Cosmetics

  • Confidential review of ingredients in cosmetic products to ensure they are on the AICS and not restricted by entries in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
  • Confidential review of packaging to check country of origin, trade measurement and ingredient labelling compliance
  • Advice on cosmetic versus therapeutic claims
  • Advice on claims for new or competitor products
  • Advice on manufacturing, marketing, import or export of cosmetic products
  • Assistance with registration with NICNAS as a cosmetic or industrial chemical importer
  • Interaction with NICNAS to notify or exempt new ingredients not on AICS including writing notifications and permit applications
  • Advice on the safety or health risks of cosmetic or industrial chemical ingredients and products
  • Advice on the writing of Safety Data Sheets (SDSs) to the Australian approved format
  • Advice on compliance with NICNAS Cosmetic Guidelines and Cosmetic Standard
  • Compliance with Environmental Protection Authority (EPA) New Zealand Group Standards including the Cosmetic Group Standard

Compliance: Medicines / Medical Devices

  • Compilation and submission of applications and evidence for:
    • Registrations for Therapeutic Goods onto the Australian Register of Therapeutic Goods (ARTG)
    • Listings for Therapeutic Goods onto the ARTG via the Therapeutic Goods Administration’s (TGA’s) eBusiness Services (eBS) website
    • New excipients to be added to the ARTG via the TGS’s eBS website
    • APIs and Complementary Medicines Actives to the TGA
  • Confidential review and assistance with the following for Therapeutic Goods and Therapeutic Devices:
    • Advice on claims for new or competitor products
    • Ingredients, packaging and labels, potential safety or health risks
    • Importing, exporting, manufacturing and marketing
  • Medical Device inclusions for Therapeutic Goods onto the ARTG via the TGA’s eBS website
  • Notification of Therapeutic Devices to New Zealand Medicines and Medical Safety Authority (Medsafe) via Web Assisted Notification of Devices (WAND)
  • Related Product Notifications and Registrations to Medsafe (NZ)
  • Personal representation to government authorities (state and federal)
  • Safety and quality issues

NICNAS/Cosmetics /TGA Compliance FAQs

Exemptions are available from NICNAS. Generally, products that occur naturally and that are not extracted or processed chemically will gain an exemption from NICNAS. However, BWES Compliance and Consulting are well positioned to provide expert advice on this topic.

It is important that you notify NICNAS ASAP as to the chemical properties and planned import volumes of your products. If requested, BWES can provide guidance with these matters up to and including liaising with the appropriate contact within NICNAS on your behalf.

If your product is for use by humans, claims to have therapeutic benefits, or it claims to diagnose, prevent, monitor, alleviate, replace or modify human body function, it is very likely that it will fall under the scope of the TGA. BWES Compliance and Consulting will be able to advise and provide guidance on the process and even liaise with the TGA on your behalf.

Want to know more?

1300 792 937

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