Regulatory requirements for Australia. Last Update Oct 2011
 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 will involve changes to the requirements in the future.
Proposed Classification of Sunscreens for Australia (Oct 2011)
A copy of the Standard can be obtained from… SAI Global InfoStore Search : AS/NZS 2604
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 Association of Therapeutic Goods Consultants
Secondary Sunscreens - Last update Oct 2011
Apart from Primary sunscreens, almost all cosmetic products are not regulated as Therapeutics. Generally, they fall into two sub-groups - Skin Care (e.g Moisturisers) and Colour and Lip (mostly colour cosmetics but including clear lip products). Detailed guidance on this can be found at ... NICNAS : Current Issues : Cosmetics
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] Therapeutic Goods Excluded Orders
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... NICNAS Cosmetics FAQs
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 NICNAS Chemicals Gazette 2006 AND
Cosmetics Standard 2007
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 in ARGOM Chapter 10 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 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.
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 NICNAS Secondary Sunscreens- http://www.nicnas.gov.au/Current_Issues/Cosmetics.asp
GMP Licenced Manufacture information http://www.tga.gov.au/industry/manuf-basics.htm
TGA Fact Sheet: Sunscreens - http://www.tga.gov.au/safety/alerts-medicine-sunscreens-051202.htm
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 New Zealand - Last update Oct 2011
Sunscreens are currently not regulated as therapeutics and do not require approval or consent before marketing but compliance with the joint Australia/New Zealand Standard AS/NZS 2604 is encouraged. However, testing is not mandatory and sale of products imported from other markets is permitted. Future legislation may control sunscreens as therapeutic products.
For classification ....Importing and Manufacturing Cosmetics
For industry information .... CTFA New Zealand/
The Commerce Commission has power under the Fair Trading Act to ensure that SPF claims on the product at point of sale are correct irrespective of testing at point of manufacture. Commerce Commission Fair Trading Act
 FDA Requirements for the USA - Last Update Oct 2011
The FDA published its Final Sunscreen Monograph in June 2011. Sunscreens are regulated as therapeutic substances in the USA. They must be tested according to the method set out in the Rules and Regulations. Final Rules June 2011
FDA Sunscreen Information FDA Sunscreens
 Canada - Last update Oct 2011
Sunscreens containing organic actives are regulated as drugs and pre-marketing approval is required. The Canadian Sunburn Protectants Monograph applies from 2006 and is currently under revision - due late 2011 or early 2012. ISO will most likely be adopted in some form. "UVA Protection" is the permitted claim. "Any reference to highlight UVA protection, beyond combined UVA and UVB protection against sunburn, is considered inappropriate. A consensus as to the accepted methodology to separately measure the UVA portion of the spectrum and its clinical significance has not yet been determined. A claim for the combined UVA and UVB protection against sunburn is acceptable only for products containing a UVB absorber and a UVA absorber identified in this monograph or for titanium dioxide and zinc oxide. The terms “water resistant,” “very water resistant” (the term “waterproof” may be used in place of “very water resistant”) are acceptable provided data is available to show that the product meets the testing requirements for these terms outlined in the latest United States Federal Register monograph for sunscreens (FDA 2005)."
Health Canada Sunburn Protectants 2006.pdf
 Mercosur - Last update Oct 2011
Mercosur Common Market Members are Argentina, Brazil, Uraguay and Paraguay has implemented technical regulations in 2011. These have to be implemented by the member countries by 1st Jan 2012. Essentially, they follow along the lines of the requirements of the E.U. Sunscreen products are generally classified as cosmetics. The driving force is international harmonisation.
Anvisa Cosmetics (Brazil)
ANMAT (Argentina)
 South Africa - Last update July 2011
Sunscreens are self regulated by CTFA South Africa, which is a signatory to the COLIPA sunscreen "International" SPF test method. SANS 1557:2009 - Sunscreen Products specifies protection categories which are mostly aligned with EU
CTFA South African Self Regulation
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 European Requirements - Last Update Aug 2011
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).
COLIPA Publications
European Union Commission Recommendation - Sunscreens 2006
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 United Kingdom - Last update Nov 2011
In the UK, sunscreens are covered under The Cosmetic Products (Safety) Regulations 2008. 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. Boots Star Rating is used to express a ratio of UVA protection which differs from that required by the E.U. Use of the logo on labelling is licenced.
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 ISO Test Methods - Last Update July 2011
Working Group 7 of ISO TC 217 has held a number of meetings to progress development of 4 documents related to sunscreen products. The first of these has been published and two are in their final stages.
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) Published 2010
WD 24445 Cosmetics – Sun protection test methods — In-vitro determination of SPF (Sun Protection factor) based on transmittance -ON HOLD
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 ASEAN Requirements - last updated July 2011
ASEAN regulations and other requirements are essentially alligned with the E.U. and include general requirments for cosmetics, GMP, permitted actives and labelling. General information can be found at..
http://aseancosmetics.org/default/asean-cosmetics-directive/technical-documents
ASEAN Permitted Actives
ASEAN GMP
MALAYSIA
Guide for the Control of Cosmetic Products in Malaysia
THAILAND
Food and Drug Administration Thailand
PHILIPPINES
Department of Health Phillipines
VIETNAM
Ministry of Health Portal
CAMBODIA
Ministry of Health Cambodia
BRUNEI
Ministry of Health Brunei
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 India - Last update July 2011
Indian regulations date from the Indian Drug and Cosmetic Act (1940) as ammednded from time to time. Bureau of Indian Standards sets the relevant product standards. For sunscreens, the requirements generally follow the braod principles of E.U., and BIS is a Participating Member of the ISO Working Group 217.
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 PR China - Last update July 2011
Sunscreens are regulated under the Hygienic Standard for Cosmetics 2007. For Static testing and a Notice on the Relevant Issues was issued in Feb 2003. For Water Resistance, Chinese Standard for Water Resistance 2007 applies. Special formatting for reports is applicable.
Hygienic Standard for Cosmetic 2007 (Chinese version)
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 Japan - Last update July 2011
Japan Cosmetic Industry Association (JCIA) provides self regulated standards. JCIA is a signatory to the COLIPA International SPF test method and JCIA will adopt ISO standrds as they are published. For UVA, in-vivo testing is currently required and labelling is accoridng to ratings of PA + , PA++ and PA +++.
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 Korea - Last update Oct 2011
Sunscreens are regulated by Korean Ministry of Health and Welfare. Data for testing to recognised protocols is accepted, but should be in a standardised format which meets the MOH requirements.
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: 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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