Cosmetic Labelling Australia
Date: March 2019
Prepared by Ranelle Anderson and Malie Zauber - ASCC Technical Committee
Disclaimer
This Position Paper seeks to summarise a number of complex regulatory documents. While care has been taken, users should seek independent expert advice prior to any final decisions on matters mentioned in this document.
Introduction
This position paper provides information compiled from various sources around cosmetic labelling claims and requirements regarding cosmetics manufactured and retailed within Australia (including imported cosmetics).
Included in this paper is the definition of a cosmetic, guidelines regarding cosmetic claims, appropriate product labelling and packaging, and country of origin.
For definitions and abbreviations used throughout this paper please see below.
Definitions
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
Cosmetics standards and sunscreens
NICNAS define a cosmetic as a substance that is designed to be used on any external part of the human body—or inside the mouth—to change its odours, change its appearance, cleanse it, keep it in good condition, perfume it or protect it.[2]
TGA
The Therapeutic Goods Act give guidance to chemists in order to determine should a product fall under the cosmetic or a medicine (or a medical device) regulation. Here they focus on the claims made about the product. For example, moisturisers that contain a sunscreening agent as a secondary component and have a stated therapeutic purpose (e.g. 'helps protect skin from the damaging effects of UV radiation') are medicines.
Should the product be promoted a cosmetic, it may be classified as a medicine. This depends on:
NCCTG
National Co-ordinating Committee on Therapeutic Goods
NMI
National Measurement Institute
UTML
Uniform Trade Measurement Legislation
Trade measurement legislative framework that all the states and territories adopted and that forms the basis of the National Trade Measurement Regulations 2009.
AQS
Average Quantity System
An internationally recognised system for sampling and testing groups of packages to determine whether, on average, they contain the quantities with which they are marked.
ACL
Australian Consumer Law
AMCL
Australian Made Campaign Limited
AICS
Australian Inventory of Chemical Substances. [4]
Regulatory Bodies
NICNAS link - https://www.nicnas.gov.au/
TGA link - https://www.tga.gov.au/
ACCC link - https://www.accc.gov.au/
Background
Cosmetic products need to be classified and labelled according to requirements for the mandatory standard by the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991.
The standard defined cosmetic products as substances or preparations intended for placement in contact with any external part of the body, including the mouth and teeth, for the purpose of:
- altering the odours of the body
- changing the appearance of the body
- cleansing the body
- maintaining the body in good condition
- perfuming the body
- protecting the body.[1]
Changes to the regulation of cosmetics - 2018
- a. the cessation of the Cosmetics Standard 2007, as of October 1, 2018.
- b. 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.
- c. the remaining products (listed below) are continuing to be regulated as “Industrial Chemicals” under the IC(NA) Act ie the Industrial Chemicals (Notification and Assessment) Act 1989, and under the control of National Industrial Chemicals Notification and Assessment Scheme (NICNAS).
The definition of Cosmetics in the IC(NA) Act
However some limitations exist, ie.
The product must NOT be for preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons. However, this does not preclude the use of the words prevent/preventing/prevention for general cosmetic purposes. This is the definition of a therapeutic good and is controlled by the Therapeutic Goods Association (TGA),
The product must not be scheduled by S2, S3 or S4 0r S8 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSMP). If it is a poison then it is immediately a therapeutic good.
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 must be presented as being explicitly for cosmetic purposes only; and
- The product name would NOT of itself make the product a therapeutic good, unless the name makes a reference to a disease, ailment, defect or injury in persons.
The product must meet any applicable conditions detailed in the new Cosmetic Standard (made under section 81 of the ICNA Act). The Cosmetics Standard sets out the standards (or conditions) that apply to certain product categories. These requirements are described in Table B of Part D of these Guidelines
The product must NOT contain chemicals prohibited for use in cosmetics or meets restrictions specified for chemicals used in cosmetics (see the List of Prohibited or Restricted Cosmetic Chemicals in Part F).
Cosmetic products include but are not limited to:
- Oral care – mouthwash and toothpaste
- Skin washes – soaps, bath gels, body washes, hand washes and acne washes
- Hair care – shampoos, conditioners, hair dye, hair styling products
- Body odour care – deodorants, antiperspirants, hygiene powders
- Skin care – facial and body moisturisers, cleansers, acne creams and washes, lip balms, anti-ageing creams, hand/foot skin creams, hand and feet emollients, anti-ageing cream, anti-wrinkle cream, face masks and scrubs
- Make up and beauty – foundation, facial powder, beauty balms, concealers, blush and eye shadow, mascara, lip and eye liners, nail polish
- Hair removal – shaving creams/foams, depilatory creams and waxes
- Scents – perfumes and perfumed sprays
- Some baby care – including creams, lotions, powders, wipes
Added to this definition is the products, mentioned in the Cosmetics Standard 2007 but transferred to the control of the TGA (Therapeutic Goods (Excluded Goods) Determination 2018 as of October 1, 2018. These are;
For a product imported into, or manufactured in, Australia on or after 1 August 2018, all of the following:
2. Skin care
3. Skin care
Antibacterial skin products
The product must:
4. Skin care
Anti‑acne products (including spot treatments, cleansers, face scrubs and masks)
The product must be presented as controlling or preventing acne only through cleansing, moisturising, exfoliating or drying the skin
5. Oral hygiene
Products for care of the teeth and the mouth (eg dentifrices, mouth washes and breath fresheners)
Both:
6. Hair care
Anti‑dandruff products
The product must be presented as controlling or preventing dandruff only through cleansing, moisturising, exfoliating or drying the scalp.
Cosmetic labelling: Ingredient Listing
A mandatory standard for ingredient labelling applies to products manufactured and sold within Australia and products which are imported into Australia.
The ACCC has a mandatory standard for cosmetic labelling which came into effect on 29 October 1991 and was last amended 23 May 2008[5]. Key requirements includes listing of ingredients in descending order by volume or mass (except colour) in concentrations of 1% or higher. Ingredients that are under 1% will be listed next in any order (except colour). Lastly colour additives must be listed in any order under the ‘may contain’ or +/- heading. Important to note a colour additive that is not in the product may be listed if it could be potentially added for colour matching when batching or it is used in one or more of a range of cosmetic products. This list must be clearly legible and prominently shown on the packaging.
This standard does not require the % of ingredients to be written or disclosed. It is also important to note that this information must be available to consumers at the point of sale. The listing of ingredients must be on the product itself. Where the container space/size is limited the label information is required to be displayed to allow consumers to be informed.
The names of the ingredients may be either written as their English names or their International Nomenclature Cosmetic Ingredient (INCI) names. The INCI format is preferred especially for exporting.
If the Products include any flavours (i.e. a material or combination of materials to produce or to mask a particular flavour), the list of ingredients must include one of the following words: flavour, flavours, aroma, aromas.
If the Products include any fragrances (defined in the Regulations as a substance used to impart an odour to a cosmetic product), the list of ingredients must include one of the following words: fragrance, fragrances, parfum, parfums.
Cosmetic products which are exempt include free samples or testers and therapeutic goods.
All ingredients in a cosmetic product must be listed on the Australian Inventory of Chemical Substances (AICS)[6] or notified to NICNAS for pre-market assessment unless an exemption applies. All ingredients not on the AICS and notified to NICNAS will be subject to public health, work health and safety and environmental risk assessment.
Cosmetic labelling: Claims – legislation and deceptive claims
The purpose of cosmetic labelling is to describe what a particular product contains particularly for public awareness. In particular, this is becoming more necessary for people with allergies or intolerance to specific ingredients. Labelling in Australia is governed by the Australian Competition and Consumer Commission (ACCC)[7] and requires ingredients to be listed in descending order of concentration.
Ingredients should be listed using the International Nomenclature of Cosmetic Ingredients (INCI). This ensures that globally the same names are used allowing a commonality between products across the world.
The Australian Consumer Law (ACL) offers protection for consumers against misleading or deceptive conduct, false or misleading representations and other related offences. Under the ACL, it is illegal to engage in conduct that is misleading or deceptive, or would be likely to mislead or deceive consumers. Further, any false or misleading representations about the existence, exclusion or effect of a condition, warranty, guarantee, right or remedy are prohibited. Significant penalties apply to any person who fails to substantiate a claim or for misleading consumers.
Claims on cosmetic labels are usually determined by the ingredients used, in particular the concentration. Claims must ensure that they relate to a cosmetic only and no offering any therapeutic remedies (refer to section on cosmetic versus therapeutic). All claims must be appropriately substantiated. Claims can be substantiated via;
- Clinical testing
- Sensory testing
- Market research
- Technical Literature
Clinical Testing
Usually involves testing the finished product on humans and having a particular measurement via an instrument or a subjective result determined via an assessment. For example, a clinical test involving a measurement may be testing hydration via transepidermal water loss using a TEWA meter. A subjective assessment may be a dermatologist assessing a decrease in redness or irritation of the skin of volunteers on a scale of 1 to 10.
Sensory Testing
This involves either a trained or untrained panel to use the product and complete an assessment on how effective they think the product was. This usually has some room for error if it’s a long term test (i.e. using over a month) as the panel may not be monitored over the entire use of the product. For example, the correct application procedure for dosage and time may not be followed, cleansing and other products may be used when they shouldn’t and different environmental conditions may alter the results. The more specific the questions the more accurate average result will be produced when collating all assessments.
Market Research
Usually involves a market research company to specifically test the product via the correct target audience with a set aim in mind e.g. 10 out of 10 women felt their skin more hydrated when using this product. It can also be performed to gain further insight to consumers’ needs and preferences and is used by large companies to steer their product development in the right direction before releasing it onto the market.
Technical Literature
It is becoming more common to source ingredients from suppliers who have a particular claim in mind for example ‘contains apple seed oil from the Swiss Alps’. Having this claim on the packaging means that you should be able to prove via a paperwork trail that the apple seed oil used in your product is from the Swiss alps. Ingredients from suppliers which for example reduce wrinkle depth by 17% in 28 days need to be carefully researched into how often the product was used and at what concentration. In order to make that claim the cosmetic product must be using the specific concentration that the original study used and when required be able to readily pass on this study. It would be seen as deceptive to use this claim in marketing when the study used the ingredient and 3% and only use it at 0.1% and also be unfair to the consumer of the product.
Deceptive Labelling
Deceptive labelling can include both the packaging and the product inside the packaging.
Deceptive labeling is governed by the Competition and Consumer Act 2010 which says ‘you can't give false, deceptive or misleading information to customers’[8]. For deceptive packaging an example is a 15mL product sold in a box that is large enough for 1000mL would be seen as misleading as a consumer would think they are purchasing a large sized product. A deceptive label may include a claim that cannot be substantiated as discussed above for example ‘contains apple seed oil from the Swiss alps’ when the apple seed oil is not from the Swiss alps and cannot be backed up via any technical documentation and is in fact from another source would be seen as deceptive.
Where a claim about a cosmetic is misleading or deceptive the ACCC can provide fines or take the company to court to stop the offending action.
Guideline to assist with wording [9]
The National Co-ordinating Committee on Therapeutic Goods (NCCTG) provided guidance in relation to the cosmetic/therapeutic interface in respect of product claims, prior to the change in 2007.
Cosmetic labelling - packaging
National Measurement Institute controls the trade measurement regulations which includes sale of pre-packaged goods.[1] The Trade measurement system regulates the buying or selling of goods and services – where the value is determined by measurement.[10]
Pre-Packaged Goods
- Weight
The measurement of weight can be determined by two methods of pre-packed goods with common measurements or ‘constant nominal content’.
- Uniform Trade Measurement Legislation (UTML)
- The average content of a sample size cannot be less than the stated quantity on the package. The pre-packed product cannot have a shortfall of more than 5% of the stated weight.
- Allowances are made for articles such as soap or products that lose weight after packing
- Average Quantity System (AQS) which cover 3 rules
- Looks at the average net content in a sample from the production run of pre-packed articles. The quantity measured cannot be less than the stated quantity listed on the package.
- A small number of articles can exceed a ‘tolerable deficiency’
- None of the articles in the sample can have more than twice the prescribed tolerable deficit
Labelling
- Position
The weight or volume measure must be displayed on the main part of the packaging. The display must be on one of the parts to the buyer.
Cylindrical, spherical, oval or conical packaging should have a measurement marking which is wholly contained within a 60-degree arc either side of the line drawn vertically through the center of the main display panel.
Character size
The measurement marking on the packaging is determined by packaging. The maximum height determines the minimum character size marking. Reference are made to the type of packaging and the measurement markings.
MAXIMUM DIMENSION HEIGHT OF PACKAGE | MINIMUM CHARACTER HEIGHT OF PRINTED NUMBERS/LETTERS |
120 mm or less | 2.0 mm |
over 120 to 230 mm | 2.5 mm |
over 230 to 360 mm | 3.3 mm |
over 360 mm | 4.8 mm |
NMI approved printing device for the measurement marking | least 3 mm high |
The size of the measurement marking must be at least three times the minimum printed character size as stated above should it be stamped or embossed instead of printing.
- Name and address
The name and street address of the packer (or the person on whose
behalf it was packed) must be clearly evident on the products packed in Australia.
The address must be a street address within Australia and substitutes ie PO boxes, email addresses or website addresses are not permitted.
The size or location is not referenced or required but it must be legible.
- Labelling requirements [11]
Ingredients [12]
- Information of the ingredients listed on the product should be available to consumers at the point of sale.
- The ingredient list must be listed on the container or outer pack/carton.
- Should a container be of a size, shape or nature that prevents ingredient labelling by any of the listed methods above, the mandatory information standard requires the display of information to allow consumers to be informed. This can be done an additional leaflet at the point of sale.
- Refer to cosmetic labelling: ingredient listing section of this paper for further information
Deceptive packaging
Deceptive labelling can include both the packaging and the product inside the packaging.
Deceptive labeling is governed by the Competition and Consumer Act 2010 which says ‘you can't give false, deceptive or misleading information to customers’[2]. For deceptive packaging an example is a 15mL product sold in a box that is large enough for 1000mL would be viewed as misleading as a consumer would think they are purchasing a large sized product. A deceptive label may include a claim that cannot be substantiated as discussed above for example ‘contains apple seed oil from the Swiss alps’ when the apple seed oil is not from the Swiss alps and cannot be backed up via any technical documentation and is in fact from another source would be seen as deceptive.
Where a claim about a cosmetic is misleading or deceptive the ACCC can provide fines, or take the company to court to stop the offending action.
The code of practice for Australian packaging involves:
- Free space – maximum permitted is 25%
- Recesses – the aggregate volume of recesses is 10% maximum
- Cavities – aggregate volume of cavities must not exceed 15%
Additional Symbols
The European Union provide a solution since it was highlighted deterioration of the product may lead to harm to the consumer after its opening. [13]
The Period After Opening (PAO) is indicate by an open-jar symbol adopted by the
Commission on 5 September 2003, where period of time is expressed in months and/or in years, inside or alongside the symbol. [14]
Country of Origin
Australian Rules of Origin are used to determine whether a product is Australian made or not and what terminology can be used on labelling, packaging, logos and advertising.
Section 53 of the Trade Practices Act prohibits businesses from making a false or misleading representation of the origin of goods. [15]
Under the Australian Consumer Law (ACL) it is not mandatory to declare country of origin on the label, although other laws may do so. [16]
Claims are expressed as: Made in; words or images such as a flag are acceptable.
There has been major changes to the Country of Origin Guidelines (ACCC) that took effect as of July 1, 2018, with changes to the guidelines that may require the removal of the “Australian Made” (AM) logo from 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.
‘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 the 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;
Therefore, proof of substantial transformation will have to be provided by the “Substantial Transformation” test.
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.
Australian Made Campaign Limited (AMCL) oversee the use of ‘Australian grown, Australian made’ kangaroo logo.[17]
Conclusion
Cosmetic labelling and claims within Australia is governed by a number of regulatory bodies/agencies as discussed throughout this paper, care needs to be taken to ensure that cosmetics are within the definition guidelines of what defines a cosmetic followed by ensuring that the claims are genuine, can be proven with available data and not deceptive to a consumer. Labelling and packaging of a cosmetic is of upmost importance as it is the first point of contact which a consumer has and details how a product is going to be used and work. The update of the Australian made logo is of importance as we see the trend of Australian made cosmetics representing quality, safety and honesty.
Regulatory Bodies
Cosmetic Ingredients
Cosmetics are made from a range of ingredients, which are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act). [1]
Cosmetic labelling
All cosmetic products must be labelled in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991.[2]
Product liability
Product liability is governed by the Competition and Consumer Act 2010, which allows for legal action against the supplier of a defective product that results in injury or loss.[3]
Label requirements
National Measurement Institute (NMI) administers regulations that stipulate labelling requirements relating to measurement marking and packer's identification.[4]
References
Background
1.Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulation 1991 https://www.legislation.gov.au/Details/F2008C00244
Definitions
Label claims: Legislation, deceptive claims
Packaging: label requirements