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Nicnas cosmetic guidelines august 2006

NICNAS COSMETICS GUIDELINES
17 SEPTEMBER 2007
Modified 28 July 2011
Table of contents

NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 2 of 22 Terms and acronyms used in these Guidelines

AICS
Inventory of Chemical Substances Cosmetics Guidelines This document is the ‘Cosmetics Guidelines'. This is intended to be a plain-English guide for stakeholders about the requirements in relation to cosmetics. It is an administrative document only and is not a legally binding document. Cosmetics Standard This is the Standard for Cosmetics made by the Minister under section 81 of the ICNA Act. The Cosmetics Standard sets out the "rules" or "conditions" that apply to certain cosmetics. The Cosmetics Standard is a legislative instrument made under the ICNA Act and must be complied with. Failure to comply with the Cosmetics Standard is an offence under the ICNA Act. Industrial Chemicals (Notification and Assessment) Act 1989 National Industrial Chemicals Notification and Assessment Scheme The definition of ‘cosmetic' enables certain types of products to be included, and excluded, from the definition of cosmetic. This is done by the making of ‘Regulations' under the ICNA Act. There are currently no Regulations made under the ICNA Act in relation to the definition of a cosmetic. Standard for the Uniform Scheduling of Medicines NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 3 of 22 About these Guidelines
These Guidelines are issued by the Director of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to explain the recent changes to the Industrial Chemicals (Notification and Assessment) Act 1989 (the ICNA Act) in relation to cosmetics and to provide general guidance on the new legislative requirements. To this end, the Guidelines describe:  the requirements applying to cosmetics regulated by NICNAS (refer Part B);  further information about the definition of cosmetic (refer Part C);  products that are regulated as cosmetics (including specific conditions applying to certain cosmetics) (Part D);  examples of products that are not regulated as cosmetics and continue to be regulated as therapeutic goods (Part E);  the chemicals that are prohibited from use in cosmetics, or restricted in their use in cosmetics (refer Part F);  list of recommended sunscreening agents for use in cosmetic products (Part  the consequences of non-compliance with the requirements in relation to cosmetics (refer Part H); and  opportunities to seek further information (refer Part I). These Guidelines replace the NICNAS Cosmetics Guidelines dated February 2007. The requirements relating to cosmetics remain largely the same; however the structure of these new Guidelines differs from the old Guidelines (which relied, for example, on concepts of cosmetic criteria and cosmetic product categories). This is because these new Guidelines have been drafted in accordance with the amendments to the ICNA Act which distinguish between:  products that are regulated as cosmetics and products regulated as therapeutic goods; and  cosmetics that are subject to Cosmetics Standards and cosmetics that are This is explained in more detail in these Guidelines. It is important to note that the guidelines do not constitute legal advice and users are encouraged to seek professional advice about the application of the legislation to their particular circumstances. In these guidelines, some aspects of the legislation and policy have been simplified. In cases of discrepancy between the guidelines and the legislation, the legislation should be relied on. Any updates to these Guidelines will be published on the NICNAS website and stakeholders will have the opportunity to seek amendments to these guidelines NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 4 of 22 from time to time, by formal application to NICNAS. Amendment to the Guidelines will be at the discretion of the Director. NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 5 of 22 Summary of Requirements for Cosmetics

In general, cosmetics must meet the following criteria or requirements:
 The product must meet the definition of cosmetic in Australia under the
Industrial Chemicals (Notification and Assessment) Act 1989, namely: cosmetic means:
(a) a substance or preparation intended for placement in contact with any external part of the human body, including: (i) the mucous membranes of the oral cavity; and with a view to: (iii) altering the odours of the body; or (iv) changing its appearance; or (v) cleansing it; or (vi) maintaining it in good condition (also see Part C of these Guidelines) ; or (vii) perfuming it; or (viii) protecting it; or (b) a substance or preparation prescribed by regulations made for the purposes of this paragraph; but does not include: (c) a therapeutic good within the meaning of the Therapeutic Goods Act 1989; or (d) a substance or preparation prescribed by regulations made for the purposes of this paragraph. Note: Part C of these guidelines provides more explanatory information about this definition. 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 the words prevent/preventing/prevention for general cosmetic purposes. AND

 The product must not be scheduled in S2, S3 or S4 or S8 of the Standard for
the Uniform Scheduling of Medicines and Poisons (SUSMP). NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 6 of 22 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 of 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 conditions detailed in the new
Cosmetics 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. AND

 The product must NOT contain chemicals prohibited for use in cosmetics or
meets restrictions specified for chemicals used in cosmetics (see the Part F: Prohibited or Restricted Cosmetic Chemicals in Australia). NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 7 of 22 Further information about the definition of Cosmetic
The purpose of this section of the Guidelines is to describe the new definition of ‘cosmetic' in the ICNA Act and also to provide some guidance regarding the rationale for the definition and the interpretations of some of the terms used in the definition. The definition draws on the wording currently contained in the definition of chemical product within the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991. Previously the definition of cosmetic in the ICNA Act simply cross-referenced this definition. For the purpose of clarity, the definition has now been included, in full, in the ICNA Act. The inclusion of the definition does not represent any change in policy. For the purposes of clarification:  in general, "maintaining in good condition " includes controlling through, for example, cleansing, moisturising, exfoliating and/or drying;  the definition of a cosmetic does not preclude the use of the words prevent, preventing or prevention for general cosmetic purposes specifically qualified by the purposes detailed in (a)(iii) - (viii) of the definition of cosmetic;  the definition states that a cosmetic does not include a therapeutic good within the meaning of the Therapeutic Goods Act 1989. Again, this has been included for clarity, and to address interface issues between NICNAS and the Therapeutic Goods Administration. A change will also be made to the therapeutic excluded goods order, to provide that any product meeting the definition of a cosmetic, as defined in the ICNA Act, and the requirements in the Cosmetics Standard will not be a therapeutic good. Further information about those products that are cosmetics and those that are therapeutic goods is included in the following parts of these Guidelines; and  the definition includes, and excludes, any substance or preparation set out in Regulations made under the ICNA Act. The power to make Regulations has been included to ensure flexibility, enabling the legislation to respond, where appropriate, to: any significant changes in the nature of the cosmetics industry (which is recognised as an evolving and innovative industry); and any changes in national or international definitions that may occur over time. Rather than needing to amend the Act (which can take a considerable period of time) Regulations can be made more quickly to ensure that products do not "fall through the gaps". As at August 2007, there are no Regulations in relation to the definition of cosmetics. 1 The definition of ‘therapeutic goods' can be found in section 3 of the Therapeutic Goods Act 1989 which is available via the following weblink: http://www.tga.gov.au/legis/index.htm NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 8 of 22 Products that are regulated as cosmetics

Table A

The specific types of products contained in the right-hand column of Table A
must comply with the general requirements relating to cosmetics (detailed in Part
B of this document). However, the NICNAS Cosmetics Standard (made under
section 81 of the ICNA Act) does not apply to the following products. In other
words, there are no product-specific conditions (standards) for these products.
It is important to note that Table A is not exhaustive. Omission from the Table
does not necessarily stop a product from being classified as a cosmetic.
Product type
category
Face and Nail

Products for nail care (including preparations that are applied topically to the nails to harden or to deter biting of the nails) Products for make up Products for colouring nails/varnish Tinted bases/foundation (liquids, pastes, powders) without SPF Products for making-up and removing make-up from the face and eyes. Products intended for application to the lips without SPF Face masks and scrubs Hair care and
Hair tints and dyes and bleaches Products for waving, straightening, and fixing products
Setting products Cleansing products such as lotions, powders, shampoos Conditioning products (e.g. lotions, creams, oils) Hairdressing products (e.g. lotions, lacquers, brilliantines) Oral Hygiene
Products for care of the teeth and the mouth (other than desensitising toothpastes/gels) including dental bleaches/whiteners and denture cleansers and adhesives Perfumes
Perfumes Toilet waters Eau de colognes Personal
Feminine hygiene products Deodorants Antiperspirants Cleansers such as toilet soap, deodorant soap, astringent and 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
Moisturising products for dermal application eg creams, lotions, gels, foams (without SPF) Sunbathing products (without SPF or SPF <4). NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 9 of 22 Emollients eg creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc) Products for tanning without sun (without SPF) Skin-whitening products (without SPF) Anti-wrinkle products (without SPF) Anti-ageing products (without SPF)
Table B

The specific product types contained in the centre column of Table B must
comply with the general requirements that apply to all cosmetics as well as the
products-specific requirements detailed in the NICNAS Cosmetics Standard (and
summarised in the right hand column).
Product category
Product type
Additional requirements as described in
the Cosmetics Standard

Face and Nail
Tinted bases or foundations The Cosmetics Standard requires that these (liquids, pastes, powders) with products must: sunscreen  contain a sunscreen for a secondary Products intended for application to the lips with  meet the definition of secondary sunscreen product as defined in AS/NZS 2604:1998  if the product states an SPF or equivalent category description on the label, the SPF or equivalent category description on the label must meet the requirements of clauses 6.2 and 6.3 of AS/NZS 2604:1998 NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 10 of 22 Skin care
Moisturising products with The Cosmetics Standard requires that these sunscreen for dermal application, including but not  contain a sunscreen for a secondary limited to anti-wrinkle, anti- ageing and skin whitening  meet the definition of "secondary sunscreen product" as defined in AS/NZS Sunbathing products (e.g. oils,  not be presented as having SPF >15 creams or gels, including  not be presented as being water-resistant products for tanning without  include an expiry date or use-by date on sun and after sun care the label if the product is not stable for at products) with SPF ≥4 and  have a pack size that does not exceed  not have therapeutic claims made in relation to the product, including any representation about skin cancer  only make representations about premature skin ageing linked to sun exposure if the product meets the performance requirements for a broad-spectrum product in clause 7.2 of AS/NZS 2604:1998  if the products states an SPF or equivalent category description on the label, the SPF or equivalent category description on the label must meet the requirements of clauses 6.2 and 6.3 of AS/NZS 2604:1998 NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 11 of 22 Skin care
Antibacterial skin products The Cosmetics Standard requires that these products:  must only be presented as being active against bacteria;  must not be presented as being: active against viruses, fungi or other microbial organisms (other than bacteria), or for use in connection with disease, disorders or medical conditions, or active against a named bacterium that is known to be associated with a disease, disorder or medical condition, or for use in connection with piercing of the skin or mucous membrane, whether for cosmetic or any other purpose, or for use in connection with any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids, or for use before any physical contact with any person who is accessing medical or health services, or who is undergoing any medical or health care procedure, or for use in connection with any procedure involving venipuncture or delivery of an injection Anti acne products (including The Cosmetics Standard requires that these spot treatments, face scrubs, cleansers and masks)  must be presented as controlling or preventing acne only through cleansing, moisturising, exfoliating or drying the skin NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 12 of 22 Oral hygiene
Products for care of the teeth The Cosmetics Standard requires that: and the mouth (such as  where benefits are claimed to result from dentifrices, mouth washes the use of the goods, such benefits must and breath fresheners) be restricted to those consequential on improvements to oral hygiene, including for the prevention of tooth decay, and/or the use of fluoride for the prevention of tooth decay  the product must not claim benefits in relation to other diseases or ailments such as gum, oral disease or periodontal condition Hair care
Anti-dandruff products The Cosmetics Standard requires that these products:  must be presented as controlling or preventing dandruff only through cleansing, moisturising, exfoliating or drying the scalp 2 The term "prevention of tooth decay" may be used for dentifrices that are marketed as cosmetics. This exclusion from the therapeutic goods legislation is strictly limited to tooth decay and is not to be extended to other diseases or ailments such as gum or other oral disease or condition. NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 13 of 22 Examples of products that continue to be regulated as
therapeutic goods

The following products will continue to be regulated as therapeutic goods and will not be regulated as cosmetics:  Products that meet the definition of a therapeutic good in the Therapeutic Goods Act 1989 including products that are for preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons.  Primary sunscreens with SPF ≥ 4 as defined in AS/NZS 2604:1998.  Antibacterial skin products where information is presented on the label, or by other promotional means (e.g. advertising, internet site, point of sale material) to indicate the products: - are active against viruses, fungi or other microbial organisms other than bacteria; or are to be used in connection with a specific disease, disorder or medical condition; or are active against a named bacterium that is known to be associated with a specific disease, disorder or medical condition. are to be used in connection with piercing of the skin or mucous membrane whether for cosmetic or any other purpose; or are to be used in connection with any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids; or are to be used before any physical contact with any person who is accessing medical or health services, or who is undergoing any medical or health care procedure; or are to be used in connection with any procedure involving venipuncture or delivery of an injection. 3 This guidance is consistent with the Infection control guidelines for the prevention of transmission of infectious diseases in the health care setting, Australian Government, Department of Health and Ageing. "Medical or health services" include hospitals, general practice, day surgery centres, domiciliary nursing services, residential aged care, community services or office practices such as dentistry or podiatry. NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 14 of 22 Prohibited or Restricted Cosmetic Chemicals in Australia

The following sources of information contain names or references to chemicals
that must not be used in cosmetics or must only be used in the limited way
specified. The list of sources below is for information only and may not be
exhaustive.
As these sources are frequently updated, it is recommended that all importers
and manufacturers of cosmetics regularly check these websites to ensure they
have a complete list of prohibitions and restrictions.
In Australia, cosmetic products must not be scheduled in S2, S3, S4 or S8 of the
Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP),
Poisons Standard 2010.

1) Sources of Information On Restrictions/Prohibitions of Cosmetic

Chemicals in Australia:
Standard for the Uniform Scheduling of Medicines and Poisons No. 1 (the SUSMP 1), Poisons Standard 2010 Australian Inventory of Chemical Substances (AICS) Hazardous Substances Information System (chemicals used in the workplace) Australian Competition & Consum Commission (ACCC) Product Safety Recalls – Haircare, Oral & Dental Care, Skin Care & Cosmetics Customs (Prohibited Imports) Regul 1956, prepared 03/03/2010 National Transport Commission – Australian Dangerous Goods Code 7th edition (16 October 2009) – Part 3 Dangerous Goods Lists, Special Provisions and Limited Quantities Exceptions Code of Practice for Supply Diversion into Illicit Drug Manufacture
2) Other Useful Information Sources:

Health Canada – List of Prohibited and Restricted Cosmetic Ingredients (The
Cosmetic Ingredient Hotlist)

NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 15 of 22 U.S. Food and Drug Administration (FDA) – Ingredients Prohibited & Restricted by
FDA Regulations

EU Cosmetics Directive (European Commission)-
ANNEX II: List of substances which must not form part of the composition of
cosmetic products
ANNEX III: List of substances which cosmetic products must not contain except
subject to the restrictions and conditions laid down.
Click on "Consolidated version of Cosmetics Directive 76/768/EEC" to download pdf

RAPEX – EU rapid alert system for dangerous consumer products

European Commission – Opinions of the Science Committee on Consumer Safety
(SCCS)

NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 16 of 22 List of sunscreening agents for use in cosmetic products
The following list of sunscreening agents and concentration cut-off levels is recommended for use in cosmetic sunscreen products belonging to the following categories:  Moisturising products for dermal application (e.g. skin care creams/lotions) with SPF up to 15.  Sunbathing products with sun protection for a secondary purpose SPF up  Untinted lip products (e.g. lip balms) with SPF.
For other cosmetic products containing sunscreens such as tinted lip products
(e.g. lipsticks) with SPF and tinted bases/foundations with SPF, use of
sunscreening agents from this list is also recommended, as is compliance with
the appropriate cut-off concentrations.
Note that these product categories are also subject to certain rules under the
Cosmetic Standard 2007.


List of sunscreening agents for use in cosmetic products containing sunscreen

INCI Name
Synonyms / Trade Names /
CAS Number
Australian Approved Name (AAN)
Benzophenone 3
Oxybenzone (AAN) Benzophenone 4
methoxybenzene sulphonic acid Sulisobenzone (AAN) Benzophenone 5
methoxybenzene sulphonic acid, sodium salt Sulisobenzone sodium (AAN) Benzophenone 8
Dioxybenzone (AAN) Benzylidene camphor
sulfonic acid**
Bemotrizinolum (AAN) methoxyphenol triazine Bemotrizinol
Butyl methoxy
4-tert-butyl-4'-methoxy dibenzoylmethane NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 17 of 22 INCI Name
Synonyms / Trade Names /
CAS Number
Australian Approved Name (AAN)
1-(4 tert butylphenyl)-3(4-methoxyphenyl)-propane-1,3-dione ylidenemethyl)anilinium methyl sulfate Cinoxate
Benzoic acid, 2-[4-(diethylamino)-2- hydroxybenzoyl hexyl
hydroxybenzoyl]- hexyl ester Disodium phenyl
1H-Benzimidazole-4,6-disulfonic acid, 180898-37-7 2,2'-(1,4-phenylene)bis-, disodium salt trisiloxane
Ethylhexyl dimethyl
dimethylaminobenzoate Octyl dimethyl PABA Padimate O (AAN) Ethylhexyl
Octyl methoxycinnamate (AAN) Ethylhexyl salicylate
2-Ethylhexyl salicylate Octyl salicylate (AAN) Ethylhexyl triazone
Octyl triazone (AAN) Homosalate
Homomenthyl salicylate 3,3,5-Trimethylcyclohexyl 2-hydroxybenzoate NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 18 of 22 INCI Name
Synonyms / Trade Names /
CAS Number
Australian Approved Name (AAN)
Isoamyl p-
Isoamyl-4-methoxycinnamate (AAN) Isoamyl methoxycinnamate Menthyl anthranilate
Menthyl 2-aminobenzoate 2,2'-Methylene-bis-6-(2H-benzotriazol- 103597-45-1 10% butylphenol
Octocrylene
2-cyano-3,3-diphenyl acrylic acid, 2-ethyl hexyl ester 2-Ethylhexyl-2-cyano-3,3 diphenylacrylate PEG-25 PABA
Ethoxylated ethyl 4-aminobenzoate sulfonic acid
Diethylbezylidene malonate dimethicone Diethylmalonylbenzylidene oxypropene dimethicone Trolamine salicylate Triethanolamine salicylate (AAN) dicamphor sulfonic
Titanium dioxide
Zinc oxide
NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 19 of 22
** These sunscreening agents are not currently listed on the Australian Inventory
of Chemical Substances (AICS) and usage is restricted. These chemicals are
permitted for use as a sunscreening agent in cosmetic products applied to the
skin within the specified maximum concentration levels, without an assessment
as a new chemical. Anyone wishing to use these chemicals for other purposes
must submit a new chemicals notification to NICNAS.


NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 20 of 22 The consequences of non-compliance with the
requirements in relation to cosmetics

As noted previously, it is the responsibility of each manufacturer or importer of cosmetics to ensure that they comply with the legislation including the new Cosmetics Standard (where applicable). Non-compliance may have significant consequences. For example, under the ICNA Act it is an offence to:  import into, or manufacture in, Australia a cosmetic that is subject to a standard set under section 81 (i.e. the Cosmetics Standard) and that does not meet the standard; and  import into, or manufacture in, Australia an industrial chemical that is subject to a condition under section 13 (i.e. a condition of use listed on the Australian Inventory of Chemical Substances) and that breaches the condition. The maximum penalty for failure to comply with each of these offences is 120 penalty units which is equivalent to $13,200 for an individual or $66,000 for a corporation. NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 21 of 22 Opportunities to seek further information
For further information relating to the regulation of cosmetics, please contact NICNAS. Level 7, 260 Elizabeth Street SURRY HILLS NSW 2010 GPO Box 58 SYDNEY NSW 2001 Phone Free Call 1800 638 528 Web NICNAS Cosmetics Guidelines 2007 (Modified 28 July 2011) Page 22 of 22

Source: https://www.aussiecandlesupplies.com.au/media/msds/Cosmetic_Guidelines.pdf

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