NICNAS & TGA Information
NICNAS & TGA Information
What is NICNAS
In Australia the Department of Health administer the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The scheme regulates the manufacture of chemicals including those uses for cosmetics.
Their site states;
Last update 2 November 2016
Soaps and other cosmetics and toiletries are made up of industrial chemicals; they are subject to certain requirements under the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), including NICNAS Registration requirements.
In Australia, ingredients in soaps are regulated as industrial chemicals by NICNAS.
Soap makers and/or importers must comply with NICNAS requirements, as set out in the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act).
These requirements apply if you:
- Manufacture chemicals (including soap) which are used in cosmetic products.
- Import packaged cosmetic products for retail sale.
- Import chemicals which will be used in the formulation of cosmetic products.
Who needs to register with NICNAS?
You need to register with NICNAS if you do any of the following activities for commercial purposes:
- make soaps in Australia by a process involving a chemical reaction (i.e. saponification);
- import soaps into Australia from overseas manufacturers or suppliers; and/or
- import chemical ingredients into Australia for soap making.
*If you are purchasing from an Australian Company - it is prudent to check they are registered and doing things correctly to safeguard you.
Who does not need to register with NICNAS?
You do not need to register with NICNAS if you only make soaps in Australia without a chemical reaction by mixing or blending ingredients purchased from an Australian supplier.
What is mixing and blending?
Using products such as soap bases, glycerin blocks and melt and pour bases may not involve a chemical reaction because the saponification reaction has already occurred.
Soap-free cleansers, such as syndet bars, are generally made by mixing the ingredients, without a chemical reaction.
Read more about the difference between blending and manufacturing chemicals.
You should do your own research to understand whether a chemical reaction has occurred in your soap-making process.
What is considered "Soap Making"Soap making is based upon a chemical reaction between a fat and an alkali to produce glycerol and soap. The animal fat or vegetable oil is reacted with an alkali, generally (lye) sodium or potassium hydroxide or carbonate, and when the hydrolysis reaction is complete the soap is processed by one of several different methods depending on whether it is being made traditionally or industrially.
You don't usually have to register your business or your cosmetic products with the Therapeutic Goods Administration (TGA).
However, if you plan to sell specific cosmetics that contain APIs (active pharmaceutical ingredients) defined by the TGA or produce products that make pharmaceutical claims such as sunscreens, disinfectant, acne preparation, and certain skin lightening preparations; head lice prevention actives, sunscreens and others, then you do need to register your business and your products with the TGA.
You also cannot make healing claims of any types against your products without TGA approval.
See the TGA website for specific information to get more details.
What about Melt and Pour / MP
When using pre made soap bases / blocks the saponification reaction has already occurred during the manufacture of the product before it arrives in your hands. It therefore does not require a chemical reasction by yourself.
These bases are also known as “soap bases”, “glycerin blocks” and “melt and pour bases”.
Does MP need NICNAS?
If you use the pre made Melt and Pour method, you do not need to register with NICNAS, provided it fulfills 2 criteria.
I'd like to make my own from scratch
If you prefer to make your own bases and soaps, you can register with the NICNAS scheme, which in 2015 cost (for the lower turnover businesses) $138 per annum. The fee has drastically reduced since 2010.
*Please note - this may all change as per expected discussions in 2017 to formulate different teirs assessing the risks involved.
RBB will do their best to provide you with updated information
Currently to receive NICNAS approval, you need to go online, fill out your business details including your Australian Business Number (ABN), and pay the fee.
Further NICNAS Information from their direct website & Contact details
*Please note this information was correct at the time of publication to the best of our knowledge, although it may have since changed, this guide is offered for your reference only and individuals must ascertain whether this information is correct and up to date for them.
We offer it purely for sharing with you and cannot take any responsibility for anythign to do with NICNAS and their approval policy.
Download full NICNAS handbook HERE
Freecall telephone 1800 638 528
General office telephone 02 8577 8800 or +61 2 8577 8800
Fax 02 8577 8888 or +61 2 8577 8888
Street address Level 7, 260 Elizabeth Street, Surry Hills, New South Wales 2010
Postal address GPO Box 58, SYDNEY NSW 2001 AUSTRALIA
Fees and charges
You can now take a free training with NICNAS
TRAINING AND OUTREACH SESSIONS—NATIONWIDE
NICNAS's preferred approach to ensuring compliance with our legislation is to work with industry—providing advice to help them understand their regulatory obligations and assistance in finding the most practical way to meet those obligations.
As part of our commitment to raising industry awareness, NICNAS will be conducting stakeholder training and awareness sessions in major capital cities and selected regional areas in coming months, and is seeking expressions of interest from those wishing to attend.
Please note, limited places are available; and these sessions are designed for new registrants and those unfamiliar with the NICNAS scheme. For stakeholders interested in updates to the scheme please consult: NICNAS current issues of our website; The NICNAS Bulletin; Chemical Gazette and NICNAS Matters.
NICNAS training sessions are approximately 1.5 to 2 hours in duration, and there is no cost to attend. The topics discussed include:
- Who is NICNAS?
- What does NICNAS do?
- Industrial chemical introducers' regulatory obligations
- NICNAS registration
- Australian Inventory of Chemical Substances (AICS)
- New industrial chemicals
- Existing chemicals
- Prior Informed Consent (PIC) chemicals
- NICNAS compliance and enforcement functions
- Cosmetic introducers' regulatory obligations
If you wish to attend NICNAS training sessions, please provide your name, industry/company, training session, number of attendees, and preferred city, and e-mail to: email@example.com
Upon receiving your expression of interest, NICNAS officers will contact you two weeks before the training date with a confirmation of venue and sessions details.
If you have any further queries about industry training, please phone (02) 8577 8800, or Freecall 1800 638 528 or e-mail: firstname.lastname@example.org
Cosmetics and soaps
Last update 28 October 2016 (From NICNAS Website)
A 'cosmetic' is a substance or preparation that is for use on any external part of the human body—or inside the mouth—to change its appearance, cleanse it, keep it in good condition, perfume it or protect it. Cosmetics include soap, shampoo, moisturiser, hair dye, perfume, lipstick, mascara, nail polish, deodorant and many other products.
Nearly all cosmetic ingredients are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act). This includes ingredients described as 'natural', such as oils, extracts and essences of plants.
If you want to import and/or manufacture cosmetic ingredients for commercial purposes you may need to register your business with NICNAS.
Before importing and/or manufacturing a cosmetic you must check the Australian Inventory of Chemical Substances (AICS) to see if all your chemical ingredients are listed and if there are conditions for using those chemicals.
If an ingredient is not listed on AICS—or has a condition of use different to your intended use—it is a new industrial chemical to Australia. Unless an exemption applies, the new industrial chemical will need to be assessed by NICNAS for risks to the environment and human health before it can be imported and/or manufactured. Read more about notifying a new chemical.
Disclaimer notice - The information given here is provided as general information only as a guide and to offer some suggestions. It is provided to be accurate to the best of our knowledge, but it may not be currently accurate and we encourage you to seek professional advice.