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Engel Hellyer & Partners

Trusted Leaders With over 25 years experience.

Track record for submitting successful applications to the Therapeutic Goods Administration (TGA) and to the Australian Industrial Chemicals Introduction Scheme (AICIS).


We are the experts in regulation and understanding your products and industry.
Cosmetic Products Regulation and Compliance
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.
Household & Industrial Chemicals
There is no one single piece of legislation or government agency which outlines the ingredient and label requirements for industrial chemical products. Rather, at least a dozen government agencies influence some aspect of the product.
TGA Medical Device Consultants
Australia has a well-established Medical Device and In Vitro Diagnostic Medical Device (IVD) compliance framework regulated by the Therapeutic Goods Administration. As trusted TGA Medical Device Consultants and will work with you to ensure a successful application.

We engage with industry associations and government to promote better regulation and continually strive to offer our clients relevant, current and strategic advice.

Our Directors will work one-on-one with you to provide clear comprehensive advice.

Common Questions

What do you mean by 'Cosmetic Products Regulation and Compliance' ?
Cosmetic Products Regulation and Compliance checks include:

1) 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).

2) 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.

3) 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).

4) 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.

5) 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.

For more information, please get in touch with Engel Hellyer today.
What is AICIS Regulation of Industrial Chemical Products?
There is no one single piece of legislation or government agency which outlines the ingredient and label requirements for industrial chemical products. Rather, at least a dozen government agencies influence some aspect of the product. Each agency administers regulations covering that agencies activities and each one does so in its own unique way.

This result of all this regulation it is easy for a non-expert to accidentally break the law by placing products on the marketplace with non-compliant ingredients or non-compliant labels. Many offences are strict-liability offences so the regulators may not be very concerned with pleas of ignorance!

For more information, please get in touch with Engel Hellyer today.
Do you provide advice on the Food Standards Australia New Zealand (FSANZ) Food Standards Code?
Yes. We provide advice and expertise on the following food consulting areas:

1) Review of formulations for conformity to the Food Standards Australia New Zealand (FSANZ) Food Standards Code.

2) Review of artwork including ingredient lists, allergens, claims, importer details and trade measures.

3) Generation of FSANZ compliant Nutrition Information Panel, Health Star and Country of Origin information.

4) Advice on food laws and fair trading laws.

5) Advice on Food Safety Standards and hygiene regulations.
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6) Advice on claims for new or competitor products.

7) Ingredients.

8) Packaging and labels.

9) Potential safety or health risks.

10) Generating supportive data for claims.

11) Importing, exporting, manufacturing and marketing.

12) Personal representation to government authorities.

13) Technical assessment and assistance with respect to Good Manufacturing Practice (and internal auditing).

For more information, please get in touch with Engel Hellyer today.
I'm looking at making Disinfectants, what do I need to know?
Disinfectants are a specialised group of products which are ‘recommended by its manufacturer for application to an inanimate object to kill micro-organisms’. These products come in different forms including products for household use such as disinfectant sprays, and disinfectant wipes. There are also industrial and hospital grade disinfectants available in bulk quantities.

Disinfectants can be marketed for a variety of uses including offices, laboratories, clean-rooms, as well as premises such as medical suites, doctors offices, dentist labs, hospitals,  barbers and hair dressers and other premises wanting to practice infection control.

For more information, please get in touch with Engel Hellyer today.
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