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Australia Cosmetic Regulation

  •   10 Feb 2017
  •    Jo Zhou
  •  108692
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     Australia Cosmetics Legislation

    Overarching Regulation
    Industrial Chemicals (Notification and Assessment) Act 1989
    Therapeutic Goods Act 1989
    Competent Authority
    National Industrial Chemicals Notification and Assessment Scheme  (NICNAS)
    Main Supporting Rules 
    1 Aug 2019Industrial Chemicals (Notification and Assessment) Regulations 1990
    21 Mar 2019Therapeutic Goods Regulations 1990

    Australia legally classifies beauty products into two categories: cosmetics and therapeutic goods. The regulations governing each category differ greatly. The difference between therapeutic goods and cosmetics is not always clear. The main factors in determining whether a product is a cosmetic or a therapeutic good are:

    • its ingredients
    • the route of administration
    • if therapeutic claims are made on its label, or in advertising

    Cosmetics in Australia are classified as industrial chemicals. “National Industrial Chemicals Notification and Assessment Scheme (NICNAS)” is responsible for managing industrial chemicals (cosmetics) and Australian Competition and Consumer Commission (ACCC) regulates the product safety and cosmetic labelling standards.

    Therapeutic goods are managed by Therapeutic Goods Administration. TGA is responsible for formulating and implementing the regulations concerning registration of sponsors, advertising, labelling and manufacturing of therapeutic goods.

    Contents

     

    Main Regulatory Framework

    RegulationsFunctionsLatest Revision dateStatus
    Industrial Chemicals (Notification and Assessment) Act 1989Overarching regulation for industrial chemicals including cosmetics2019-4-3In force
    Industrial Chemicals (Notification and Assessment) Regulations 1990Implementation rules in respect of notification and assessment2019-8-1In force
    Australian Inventory of Chemical Substances (AICS)Database of existing chemical ingredients, if new ingredients are not on the list, notification will be required. In force
    Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991A product information standard on how information about ingredients is displayed on the label of the cosmetic product2008-5-23In force
    Ingredients Labelling on Cosmetics (Supplier Guide)A summary of labeling requirements for cosmetic ingredients2018-12-20In force
    Therapeutic Goods Act 1989Overarching regulation for therapeutic goods2019-3-12In force
    Therapeutic Goods Regulations 1990enforcement rules of Therapeutic Goods Act 19892019-3-21In force
    Australian Register of Therapeutic Goods (ARTG)A database of therapeutic goods lawfully supplied in Australia In force
    Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019Collection of permissible ingredients2019-06-17In force
    Therapeutic Goods (Manufacturing Principles) Determination 2018principles to be observed in the manufacture of therapeutic goods for use in humans2019-3-31In force
    Therapeutic Goods Advertising Code (No.2) 2018Requirements for advertising2019-7-30In force
    Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicinesStandard for labels of non-prescription medicines2016-08-02In force

    Competent Authority of Cosmetics

    NICNAS regulates the manufacture and importation of cosmetic ingredients.

    The Therapeutic Goods Administration (TGA) is responsible for administering the Therapeutic Goods and related manufacturing, labelling and advertising requirements. Goods that meet the terms of their exclusion in the new Determination are not subject to the operation of the Therapeutic Goods Act 1989.

    Product safety and cosmetic labelling standards (under the mandatory standard for ingredient labelling of cosmetics) are the responsibility of the Australian Competition and Consumer Commission (ACCC).

    State and Territory Government authorities regulates the use and disposal of cosmetics.

    Definition

     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.

    Examples of cosmetics:

    TypesExamples
    Face and nail
    • Nail care products including nail hardeners and products to deter nail biting
    • Make up (mascara, eyeshadow, primer, bronzer etc)
    • Nail polish and varnish
    • Tinted bases and foundation (liquids, pastes, powders) without SPF sunscreen
    • Make up removers
    • Lipstick and lip balms without SPF sunscreen
    • Face masks and scrubs
    Hair care and hairdressing products
    • Hair tints, hair dyes and bleaches
    • Products for waving, straightening, and fixing hair
    • Hair setting products (e.g. gels, sprays, lotions)
    • Shampoo and hair cleansing products including lotions and powders
    • Hair conditioner (e.g. lotions, creams, oils)
    • Hairdressing products (e.g. lotions, lacquers, brilliantines)
    Oral and dental hygiene
    • Toothpaste and gel
    • Some dental bleaches/whiteners
    • Denture cleansers and adhesives
    Note: Desensitising toothpastes/gels are NOT cosmetics. These are therapeutics and regulated by the Therapeutic Goods Administration.
    Perfumes
    • Perfumes and colognes
    • Eau de toilette
    • Eau de colognes
    • Eau de parfum
    Personal hygiene
    • Feminine hygiene products — intimate cleaners, deodorants, wash, powder, moisturise and gels. We do not regulate pads, tampons and panty liners as these are articles.
    • Deodorants
    • Cleansers such as soap (e.g. toilet, deodorant, astringent, skin washes)
    • Shaving products (e.g. creams, foams, lotions)
    • Bath and shower preparations (e.g. salts, foams, oils, gels, etc.)
    • Depilatories
    • After-bath powders
    • Hygienic powders
    Skin care
    • Skin moisturisers without SPF sunscreen such as creams, lotions, gels, foams
    • Sunbathing products without SPF sunscreen or with SPF sunscreen <4
    • Emollients eg creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc)
    • Products for tanning without sun (without SPF sunscreen)
    • Some skin-whitening products (without SPF sunscreen)
    • Anti-wrinkle products (without SPF sunscreen)
    • Anti-ageing products (without SPF sunscreen)

    Note:
    1. These examples are not exhaustive. Omission from the list does not necessarily mean that a product is not classified as a cosmetic.
    2. Click the official link to determine if your product is a cosmetic.

    Approval Procedures of Cosmetics

    1. Business Registration

    Enterprises must register their business with NICNAS if they want to import and/or manufacture cosmetic products or cosmetic ingredients for commercial purposes (click the official link to determine if you need to register). This applies regardless of the amount that they import and/or manufacture. The registration obligations does not relate to the toxicity or hazardous nature of cosmetic ingredients.

    For Foreign (non-Australian) companies, they must have an Australian Registered Body Number (ARBN) for registration. If they use an Australian distributor who is registered with NINAS, the registration of business can be exempt.

    If an enterprise needs to register, it should calculate registration level (click the official link to calculate) first, then sign up the NICNAS Business Services and register the business. The registration year runs from Sep.1st to Aug.31st the next year. Enterprises must renew the registration by 31 August each year if they continue to import and/or manufacture cosmetic products or cosmetic ingredients, otherwise they may be liable to pay a late renewal penalty—an additional 15% of the total registration cost.

    2. AICS Checking

    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' or 'organic' such as oils, extracts and plant essences. The Australian Inventory of Chemical Substances (AICS) is a database of more than 40,000 industrial chemicals that can be manufactured or imported (introduced) into Australia. The Inventory holds chemical identity information and regulatory obligations associated with that chemical.

    After business registration and before importing and/or manufacturing a cosmetic, enterprises must check if all the cosmetic ingredients of a product are listed in the AICS and complies with the conditions of usage. If yes, the product can be imported or manufactured without notifying NICNAS provided it meets any relevant conditions. If any one of the ingredients is not listed on the Inventory or has a condition of use different to the intended use, it is a new industrial chemical to Australia. Unless an exemption applies, the new industrial chemical will need to be notified and assessed by NICNAS for risks to the environment and human health before it can be imported and/or manufactured.

    AICS Categories

    AICS contains two categories: public AICS and confidential AICS.

    There are over 40,000 chemicals listed on the public AICS which can be searched (click the official link to search the public inventory).

    If there are no results in the public AICS, enterprises can make an online request with the chemical name or a CAS number for each chemical to search the confidential AICS. NICNAS will help to search the confidential AICS if they consider an enterprise/individual to have a genuine intention to manufacture and/or import a chemical. Results can be viewable online.

    Exemptions

    For the following 6 exemption categories, the notification can be unnecessary.

    1. Research, development or analysis - Quantities cannot be more than 100kg/year
    2. Transshipment - Introduced at a port or airport
    3. Non-cosmetic use not exceeding 100kg - Must pose no unreasonable risk to human health and the environment
    4. Cosmetic use not exceeding 100kg - Must pose no unreasonable risk to human health and the environment
    5. Cosmetic use at a concentration of 1% or less - Must be non-hazardous
    6. Polymers of low concern - Must meet PLC criteria
    There is a special exemption example - naturally-occurring chemicals. If all the chemicals of a product are naturally-occurring, business registration and notification can be exempt. 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
    Many products with ingredients (chemicals) derived from natural sources such as plants and minerals that are marketed or labelled as 'natural', 'organic' or 'pure' do NOT meet the legal definition of a naturally-occurring chemical. This is usually because of the process used to extract the chemical from its source before introducers and suppliers can use them in a product.

    3. Notification

    Once enterprises have established the necessity to notify NICNAS about the new chemical to import or manufacture (excluding a chemical introduced under exemption), they will have to determine the most appropriate notification category.

    Notification Categories

    Two broad categories exist for assessing a new chemical—permits and assessment certificates. Each category include several different types, shown as below:
     
    CategoryTypeDescriptionNote
    PermitCommercial evaluation permits (CEC)CEC permits are issued for new industrial chemicals introduced solely for commercial evaluation where the maximum quantity to be introduced is 4000 kg in a maximum period of two years.Having a permit essentially means:
    • allowed to introduce fixed quantities of the chemical for the permit duration
    • a notice of the permit will be published in the Chemical Gazette
    • the chemical will not be added to the AICS
    • a shorter assessment time and lower fees than for assessment certificates
    • renew the existing permit in certain circumstances
    Low volume chemical permits (LVC)LVC permits are issued for new industrial chemicals to be introduced at a maximum volume of 100 kg/year (1000 kg/year where the low hazardous criteria are met) for a period of three years.
    Controlled use permits (CUP)CUPs are issued for the introduction of low-risk new chemicals used in highly controlled circumstances for a maximum of 3 years (note: certain prescribed criteria apply). There is no volume restriction.
    Controlled use (export only) permits (EOP)EOPs are issued for the controlled introduction of a new chemical for export. The entire quantity of the new chemical must be exported within a maximum of three years.
    Early introduction permits (EIP)An EIP is issued in conjunction with an LTD, STD or PLC notification for chemicals meeting prescribed criteria. As the holder of an EIP, you can start introducing the chemical before the NICNAS assessment is completed.
    Assessment CertificatePolymer of low concern (PLC) 

    Having an assessment certificate essentially means:
    • allowed to introduce the chemical
    • brief facts about the identity of the notifier, and chemical's identity and key hazard, volume and use information on the chemical will be published in the Chemical Gazette and a public report will be made available on this website
    • the chemical will eventually be added to the Inventory.
    Limited (LTD)LTDs are for chemicals fitting 1 of these categories:
    • small-volume chemicals, biopolymers, and low MW synthetic polymers (NAMW <1000 Da)—that is, chemicals to be imported or manufactured at a rate of up to 1 tonne/12-month period
    • site-limited chemicals, biopolymers, and low MW synthetic polymers (NAMW <1000 Da)—that is, chemicals restricted to their manufacturing site and manufactured at a rate of not more than 10 tonnes/12-month period
    • synthetic polymers with NAMW >1000 Da that do not meet the PLC criteria.
    Standard (STD)STDs are for chemicals, biopolymers and low MW synthetic polymers (NAMW<1000 Da) imported or manufactured at greater than 1 tonne/year that do not fulfill the requirements of any other category.
    Self assessmentSelf-assessment applications can be made for these categories of chemicals:
    • PLC introductions and
    • Non-hazardous chemicals or polymers
    Extension of an original assessment certificate (EX)Extension of a current assessment certificate may cover other companies intending to import or manufacture a notified chemical, where the holder of the original certificate agrees and as long as certain criteria are met.
    (Click the official link to find more)
     
    Comparison of permits and certificates
    CertificatePermit
    Assessment certificate issuedPermit issued with conditions stipulated, including duration and volume
    Data requirements as per categoryReduced data requirements
    Eventual listing on the InventoryNo eventual listing on the Inventory
    Publication of a risk assessment report (with recommendations) on our websitePublication of notice in the Chemical Gazette with summary details
    Statutory timelines: 28–90 daysShorter statutory timelines: 14–28 days
    Higher costReduced cost

    To decide which to use, the following information should be considered: type of chemical, amount you are introducing, use of the chemical, period of use and company's business needs and commitments. Enterprises may apply for an assessment certificate for chemicals that do not meet the permit criteria or where they prefer a certificate notification resulting in listing the chemical on the AICS.

    Notification Requirements

    All applications and information relating to notifications can be sent to NICNAS by post or courier.
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