Regulatory requirements for Australia. Last Update Dec 2009
CURRENTLY, ALL SUNSCREENS SUPPLIED IN AUSTRALIA MUST BE TESTED TO THE AUSTRALIAN STANDARD.
This testing involves 10 human test volunteers and may additionally involve water resistance testing (up to 4 hours) and Broad Spectrum testing (if this is to be claimed.The standard – AS/NZS 2604 - for this testing is currently under review and may involve changes to the requirements in the future.
A copy of the Standard can be obtained from…
http://www.saiglobal.com/shop/script/Result.asp?DegnKeyword=2604&Db=AS&SearchType=publisheronly&Status=all&Max=15&Search=Proceed………………….
Primary Sunscreens
These are products with the primary purpose of sun protection. If the SPF is above 4, these must be 'Listed' with TGA before supply to the market.
TGA Listing of Primary Sunscreens
A list of regulatory consultants who can assist with this Listing can be found at http://www.atgc.com.au
Secondary Sunscreens - Last update Dec 2009
Apart from Primary sunscreens, almost all cosmetic products are not regulated as Therapeutics. Detailed guidance on this can be found at ... http://www.nicnas.gov.au/Current_Issues/Cosmetics.asp
Some products containing sunscreen actives are defined as Secondary Sunscreens and are considered to be cosmetics. These are products for which the primary usage purpose is not as a sunscreen. - Therapeutic Goods (Excluded Goods) Orders [Nos. 1 and 2] http://www.tga.gov.au/cosmetics/index.htm
Secondary sunscreens can only be labelled up to SPF 15. For a product labelled SPF15, the tested protection factor must be in the range 15-29 (inclusive). See... http://www.nicnas.gov.au/About%5FNICNAS/FAQs/Cosmetics/Moisturisers_SPF_Test_Limits.asp
These products are regulated by NICNAS and are defined under the following criteria...
Moisturisers that contain a sunscreen as and for a SECONDARY PURPOSE where the SPF ³4 and does not exceed 15 provided:
they meet the definition of "secondary sunscreen product" as defined in AS/NZS 2604:1998; and
Any SPF or equivalent category description is disclosed on the label; and
the SPF or equivalent category description disclosed on the label is determined by the method prescribed by AS/NZS 2604:1998 for the precise formulation; and
the formulation is not water-resistant; and
there is an expiry date or use by date on the label if the product is not stable for at least 36 months; and
no therapeutic claims, including any representation about skin cancer, are made; and
any representation about anti-ageing can be made only if the product is defined as a "broad-spectrum product" within the meaning of AS/NZS 2604:1998; and
the pack size does not exceed 300 mL or 300 g; and
all performance statements and markings (both "mandatory" and "optional") are expressed on the product label in the manner prescribed by AS/NZS 2604:1998 and no other; and
labeling, marketing and packaging clearly indicates the product is for use as a cosmetic.
For further information, go to http://www.nicnas.gov.au/Publications/Chemical_Gazette/Chemical_Gazette_January_2006.asp AND
http://www.nicnas.gov.au/Current_Issues/Cosmetics/Cosmetic_Guidelines_PDF.pdf
Tinted facial make-up or lipstick
These are generally secondary sunscreens. See above.
Listing of sunscreens (Primary Sunscreens)
The majority of sunscreen products require listing in the ARTG. Products are eligible for listing where...
The claimed SPF has been tested according to AS2604:1998 and is greater than 15; and
The product does not make a 'prohibited' or 'restricted' representation as defined in Appendix 6 to the Therapeutic Goods Advertising Code and
The labeling complies with AS2604:1998, the Labeling Order and the Therapeutic Goods Advertising Code.
Listed sunscreen products can only contain active ingredients that are included in the list of Sunscreening agents permitted as active ingredients in listed products (ARGOM) within the maximum concentrations stated in the list.
Registerable products containing a Sunscreen.
Sunscreen products that make therapeutic claims other than sunscreening or contain active ingredients that are not included in the list of Sunscreening agents permitted as active ingredients in listed products are not "sunscreen preparations" and must be fully Registered with TGA, rather than Listed.
Labelling of sunscreens
The labeling of Primary sunscreen products must comply with:
- The Labeling Order (Therapeutic Goods Order No. 69)
- The Therapeutic Goods Advertising Code
- Australia/New Zealand Standard AS2604:1998.
Mandatory (as relevant for your product) requirements for the labeling of sunscreens under AS2604:1998 are...
- Category description
- Specifications for the declaration of the SPF
- Broad spectrum claims
- Water resistant claims.
For broad spectrum products with SPF of 30 +, other statements related to premature ageing and and reduction of risk of skin cancer are also permitted, provided that the product label highlights the need for avoidance of prolonged exposure to the sun and the importance of wearing protective clothing, hats and eyewear.
http://www.tga.gov.au/docs/pdf/argom_10.pdf
The labels of all sunscreen products should...
- (as appropriate) Advise consumers to apply generous an appropriate amounts of sunscreen over all exposed areas 15 to 20 minutes before sun exposure, and again after swimming or toweling.
- Highlight the need for avoidance of prolonged exposure to the sun and the importance of wearing protective clothing, hats and eyewear.
- Advise consumers to keep the product out of the eyes.
Other Useful Documents
General information on TGA Listing and Registration - http://www.nicnas.gov.au/Current_Issues/Cosmetics.asp
GMP Licenced Manufacture information http://www.tga.gov.au/docs/html/gmpsunsc.htm
Therapeutic Goods Advertising Code - http://www.tga.gov.au/advert/
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FDA Requirements for the USA - Last Update Dec 09
The FDA published a new Draft Sunscreen Monograph in October 2007. Comments were sought by end Dec 2007. The Final monograph is due for publication. Sunscreens are regulated as therapeutic substances in the USA. They must be tested according to the method set out in the Monograph. http://www.fda.gov/cder/drug/infopage/sunscreen/default.htm
European Requirements - Last Update Feb 2010
The "International Sun Protection Factor (SPF) Test Method has been adopted in the EU, as well as by Japan and South Africa.(see below) and by the CTFA in USA. This method covers static SPF testing. Additions to this include documents covering water resistance, UVA methods and instrumental calibration.
According to E.U. requirements, member countries must adopt the European Community Cosmetics Directive, which includes, by inference, the requirement to test sunscreens for their efficacy. The larger European manufactures have adopted the COLIPA method and test to this.
For instance, in the U.K., the Consumer Products (Safety) Regulations pick up this requirement and are also regulated under other consumer legislation, such as The General Product Safety Regulation (1994), the Trade Descriptions Act (1968) and the Sale of Goods Act (1979).
In the UK, sunscreens are covered under The Cosmetic Products (Safety) Regulations 2004. These regulations interpret the E.U. requirements and cover safety and performance requirements for these goods considered as cosmetics. It also lists the approved actives.
ISO Test Methods - Last Update Dec 2009
Working Group 7 of ISO TC 217 has held a number of meetings to progress development of 4 documents related to sunscreen products. It is expected that the first two of these, covering in-vivo SPF testing and in-vivo UVA testing, will appear in June 2010. Current document titles are...
ISO 24442 - Cosmetics – Sun protection test methods — In Vivo Determination of Sunscreen UVA Protection (UVA-PF).
ISO 24443 - - Cosmetics – Sun protection test methods — In Vitro Determination of Sunscreen UVA Protection (UVA-PF).
ISO 24444 – Cosmetics — Sun protection test methods — In-vivo determination of SPF (Sun Protection factor)
WD 24445 Cosmetics – Sun protection test methods — In-vitro determination of SPF (Sun Protection factor) based on transmittance
ASEAN Requirements - last updated Feb 2010
Asean regulations and other requirements are essentially alligned with the E.U. and include general requirments for cosmetics, GMP, permitted actives and labelling.
ASEAN Permitted Actives
ASEAN GMP
: DISCLAIMER We will attempt to keep this site updated with current requirements for various markets as a service to customers. However, as regulation is always dynamic, you should consult further in your local market for amendments and updates. No certification is made as to the completeness or currency of this information. It should be considered only as general guidance.
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