Definition of a Cosmetic

Date: August 2019


Prepared by Ric Williams  - ASCC Technical Committee

Executive Summary and Position:

Due to the recent changes to the regulations of cosmetics in Australia, the Australian Society of Cosmetic Chemists (ASCC) feels that it is necessary to revise the ASCC definition of a cosmetic and associated items.

The previous change, after reviewing a wide range of international definitions, (references attached) and to minimise confusion we have agreed to base it on the Australian definition with the added inclusion that; "a cosmetic should not be intended to be systemically absorbedand this is maintained in the ASCC definition.

Acronyms Used

ASCC - the Australian Society of Cosmetic Chemists, a professional scientific organisation, founded in 1961, that promotes the advancement of the theory and practice of the science and technology of cosmetics, toiletries and perfumery.

NICNAS - National Industrial Chemicals Notification and Assessment Scheme, a division of the Federal Department of Health, that 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 cosmetics, toiletries, soaps and many other products.

IC(NA) Act 1989 - Industrial Chemicals (Notification and Assessment) Act 1989, an Act to establish a national system of notification and assessment of industrial chemicals, to provide for registration of certain persons proposing to introduce industrial chemicals, to provide for national standards for cosmetics imported into, or manufactured in, Australia, and for related purposes

TGATherapeutic Goods Administration, a division of the Federal Department of Health, that is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia and for export from Australia, are of an acceptable standard.

ACLAustralian Consumer Law, sets out consumer rights that are called consumer guarantees. These include your rights to a repair, replacement or refund as well as compensation for damages and loss and being able to cancel a faulty service.

ACCC - Australian Competition and Consumer Commission, is an independent Commonwealth statutory authority whose role is to enforce the Competition and Consumer Act 2010 and a range of additional legislation, promoting competition, fair trading and regulating national infrastructure for the benefit of all Australians. It is responsible for regulating cosmetic safety, cosmetic claims and cosmetic ingredient labelling legislation.

AMAG Australian Made, Australian Grown, is a registered certification trademark. The AMAG logo can only be used on products that are registered with the not-for-profit Australian Made Campaign Ltd (AMCL), and which meet the criteria set out in the Australian Consumer Law and the AMAG Logo Code of Practice.

Current Regulations:

The recent changes, detailed here, are based on the NICNAS Stakeholder update for October 2018, that was circulated on 22/10/18.
Issues that are considered worthy of further mention are;

2a. the cessation of the Cosmetics Standard 2007, as of October 1, 2018.

2b. the transfer of products, mentioned in the Cosmetics Standard 2007 to the control of the TGA (Therapeutic Goods (Excluded Goods) Determination 2018 as of October 1, 2018).

2c. the formal adoption of the new definitions of “Naturally Occurring Chemicals” and “Skin Whitening Products”, under the TGA and NICNAS.

 See below for details


1. Current Definition

 The current definition of a “Cosmetic” remains unchanged under both NICNAS and TGA and the product must meet the definition of cosmetics in Australia under the Industrial Chemicals (Notification and Assessment) Act 1989, namely:

A Cosmetic means:

(a) a substance or preparation intended for placement in contact with any
external part of the human body, including:


(1) the mucous membranes of the oral cavity; and

(2) the teeth

with a view to

(3) altering the odours of the body; or

(4) changing its appearance; or

(5) cleansing it; or

(6) maintaining it in good condition: includes controlling through, for example,
cleansing, moisturizing, exfoliating, and or drying: or

(7) perfuming it; or

(8) protecting it; or


(b) a substance or preparation prescribed by regulations made for the purposes
of this paragraph;

(c) a substance or preparation that should not be intended to be systemically
absorbed

But does not include:

(d) a therapeutic good within the meaning of the Therapeutic Goods Act 1989

AND
The product must NOT be for preventing diagnosing, curing or alleviating a disease, ailment, defect or injury in persons. However, this does not preclude use of words prevent/preventing/prevention for general cosmetic purposes.

AND
The product must not be scheduled by S2,S3,S4 or S8 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSMP)

AND
The product must be marketed as a cosmetic taking into account the labelling, packaging, advertising and/or the label statements:
The product must have full ingredient disclosure in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991;
The product may be presented as being explicitly for cosmetic purposes only; and
The product name would NOT by itself make the product a therapeutic good, unless that name makes a reference to a disease, ailment, defect or injury in persons.

AND
The product must meet any applicable condition detailed in the new Cosmetics Standard (made under section 81 of the IC(NA) Act). The Cosmetics Standard sets out the standards (or conditions) that apply to certain product categories.

AND
The product must NOT contain chemicals prohibited for use in cosmetics or meets restrictions specified for chemicals used in cosmetics

The recent changes based on the NICNAS Stakeholder update for October 2018 are;

2a.  the cessation of the Cosmetics Standard 2007, as of October 1, 2018.

2b. the transfer of products, mentioned in the Cosmetics Standard 2007 to the control of the TGA (Therapeutic Goods (Excluded Goods) Determination 2018 as of October 1, 2018).

Details can be found below;

New TGA Excluded Goods Determination replaces the Cosmetics Standard

The Cosmetics Standard 2007 ceased to exist on 1 October 2018.

Products that were covered by the Cosmetics Standard are now covered by the new TGA determination with the same requirements applying.

This includes products such as:

  • tinted bases or foundation with sunscreen
  • products for application to the lips with sunscreen
  • skin moisturisers with sunscreen
  • sunbathing products with SPF at least 4 and no more than 15
  • anti-bacterial skin products
  • anti-acne skin products
  • oral hygiene products
  • anti-dandruff products

Please refer to this new TGA determination to understand the requirements and standards for cosmetic products in these categories. Your obligations around cosmetic ingredients and cosmetic products are essentially the same as before.

NICNAS will continue to regulate the manufacture and importation of cosmetic ingredients —noting that cosmetic ingredients are regulated as industrial chemicals. You can read more about this in the cosmetics and therapeutic goods section on the TGA website.

2c. the formal adoption of the new definitions of “Naturally Occurring Chemicals” and “Skin Whitening Products”, under the TGA and NICNAS.
Naturally-occurring chemicals

A naturally-occurring chemical is one of the following:
  • an unprocessed chemical occurring in a natural environment — chemicals obtained from plants, microorganisms, the earth, sea or animals without any processing at all, for example blood and milk from animals, minerals, ores, crude oil, coal and natural gas obtained without any processing.
  • a chemical occurring in a natural environment that is extracted using a process that does not cause a chemical change in the substance — this refers to chemicals that occur in nature but which have been extracted using certain processes without changing their chemical composition. If introducers and suppliers extract a chemical by some other means, such as steam distillation or solvent extraction, it will not be a naturally-occurring chemical.

Skin-whitening products

  • Products that produce a skin-whitening effect by colouring the skin are regulated as cosmetics. If the product influences, inhibits or modifies a physiological process to produce the skin-whitening effect then it does not meet the definition of a cosmetic product under the Industrial Chemicals (Notification and Assessment) Act 1989.
    An example of a skin-whitening product that does not meet the definition of a cosmetic is one, which inhibits the physiological process of melanin production (eg. contains hydroquinone or arbutin).

3. Country of Origin Labelling. 

There has been major changes to the Country of Origin Guidelines (ACCC Guidelines) that took effect as of July 1, 2018, with changes to the definitions and guidelines that may affect the use of the “Australian Made” logo (AMAG) on some cosmetics and most nutritional capsules.

Making a country of origin claim

In general, businesses are free to make any representation they wish to about their goods. However, any claims a business does make must not be false, misleading or deceptive.

When it comes to country of origin claims, it is up to individual businesses to determine what type of claim to make. This self-assessment should include a careful consideration of the origin of each ingredient or component in the good as well as the country or countries in which any manufacturing or processing has occurred.

DEFINITIONS

‘Grown in’ claims

A claim that a good was ‘grown in’ a particular country is often used for food products but may also be used for other naturally derived products.

A good may safely represent to have been ‘grown in’ a country if:

  • each significant ingredient/component of the goods was grown in that country, and
  • all, or virtually all, processes involved in the production or manufacture of the goods happened in that country.
‘Product of’ claims
If you want to safely represent that a good is the ‘product of’ a certain country, you must be able to demonstrate that:
  • each significant ingredient/component of the good originated in that country, and
  • all, or virtually all, processes involved in the production or manufacture of the goods happened in that country.
 ‘Made in’ claims
A claim that a good was made, manufactured, or otherwise originated in a particular country is simply a representation about where the good itself was created. Unlike the ‘grown in’ or ‘product of’ claims, the source of a product’s individual ingredients or components is not relevant to a ‘made in’ claim. This means that a good doesn’t need to contain any ingredients or components from a country to be able to claim that it ​was ‘made’ in that country.


Under Australian Consumer Law (ACL), a good may safely represent that it was made in a particular country if the business can demonstrate that it underwent its last substantial transformation in the country claimed.
This will enable the sponsor to put the “Australian Made” logo on their pack as a claim. ie

This is the claim (“Made in Australia”) that is most applicable to cosmetics however, the issue is, the requirement to prove substantial transformation. No longer is the test that Australia is where the greatest cost, of producing the product, was incurred.


From the guidelines (and the “Australian Made Campaign” interpretation, it appears that;

a.  Cosmetic creams, lotions, pastes, etc are substantially transformed.

b.  Solutions and Serums, etc may not be substantially transformed.


Therefore, proof of substantial transformation will have to be provided by the
“Substantial Transformation” test.
ie Goods are substantially transformed in a country if:
• they were ‘grown in’ or ‘produced in’ that country, or
 • as a result of processing in that country, the goods are fundamentally different in identity, nature or essential character from all of their imported ingredients or components. Note; proof of this may be difficult.


References:

1. Personal Care Asia –May 2008 37-38 “Cosmeceuticals: Advertising Rules and Claims”
2. http://www.cfsan.fda.gov/ “Is it a Cosmetic, a Drug or Both?”
3. NICNAS Cosmetic Guidelines 2007
4.  NICNAS Stakeholder Update October 2018
5. The following link is for the transfer of products, mentioned in the Cosmetics Standard 2007 to the control of the TGA (Therapeutic Goods (Excluded Goods) Determination 2018 as of October 1, 2018).
https://www.tga.gov.au/therapeutic-goods-excluded-goods-determination-2018-explanatory-notes
6.  The following is a link to “Naturally Occurring Chemicals” and “Skin Whitening Regulations”.
https://www.nicnas.gov.au/cosmetics-and-soaps/cosmetics-and-therapeutic-goods
7.  The following is a link to Country of Origin claims and Australian Consumer Law https://www.accc.gov.au/system/files/1168_Country%20of%20Origin%20and%20the%20ACL_FA.pdf
8.  Australian Made Campaign Ltd (AMCL) website
https://www.australianmade.com.au/why-buy-australian-made/about-the-logo/