Sunscreen regulations

Whilst testing has become harmonised, regulations for Sunscreen products vary significantly from country to country. We can support your application requirements for most countries. Dermatest can provide SPF, Water Resistance, Broad Spectrum data as well as Topical Safety Testing. Our associated facility at Technical Consultancy Services (located in an adjoining building), can provide analytical, stability, validation and microbiological testing where this is required.

Regulatory Consultants – for assistance with your regulatory application contact ATGC.

For information on regulatory requirements for a specific country, select from below.

Australia

Last Update 8th Aug 2017

ALL SUNSCREENS SUPPLIED IN AUSTRALIA MUST BE TESTED TO THE AUSTRALIAN STANDARD.

This testing involves 10 human test volunteers as well as Broad Spectrum testing(see chart below) and may additionally involve water resistance testing (up to 4 hours) if this is to be claimed. The standard – AS/NZS 2604 (2012) involves changes to the requirements. The adoption of these changes was completed by TGA on 13th Nov 2012. The test methods for SPF and UVA (Broad Spectrum) are ISO 24444 and ISO 24443.

http://www.tga.gov.au/industry/sunscreens-args.htm

Classification of Sunscreens for Australia (Final June 2012)

Water Resistance Claims
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

Stability Testing of Sunscreens
Requirements for this can be found on http://www.tga.gov.au/industry/sunscreens-args-07-stability.htm

If you require stability testing, see…   http://www.techconsult.com.au/stability.html

Secondary Sunscreens – Last update July 2017
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 https://www.nicnas.gov.au/cosmetics-and-soaps/cosmetics-standard-and-sunscreens

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 Moisturisers 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: https://www.nicnas.gov.au/cosmetics-and-soaps/cosmetics-standard-and-sunscreens

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 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 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; 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: and no other; and
  • labeling, marketing and packaging clearly indicates the product is for use as a cosmetic.

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 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

Permitted Actives and Concentrations
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 ARGS 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 AS/NZS 2604 (2012)

Mandatory (as relevant for your product) requirements for the labeling of sunscreens under AS2604:2012 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

Cosmetics Regulations (general labelling information) Cosmetics Regulations 1991

General information on NICNAS Secondary Sunscreens http://www.nicnas.gov.au/chemical-information/cosmetics

GMP Licenced Manufacture information http://www.tga.gov.au/industry/manuf.htm#.U88Krcar3Hg

TGA Fact Sheet: Sunscreens – http://www.tga.gov.au/industry/sunscreens.htm#.U88K3sar3Hg

New Zealand

Last update Jan 2017

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

USA

FDA Requirements for the USA –

Last Update Jan 2016

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 Rulemaking History FDA Sunscreens

Canada

Last update July 2017

Sunscreens containing organic actives are regulated as drugs and pre-marketing approval is required. The Canadian Sunburn Protectants Monograph was updated in 2012.. Both ISO and FDA testing are recognised. The final calculation of SPF must be arrived at by applying the FDA method of calculating. Critical Wavelength may be determined using COLIPA. ISO or FDA. Water Resistance of 40 min or 80 min is permittred, with testing to FDA or COLIPA.

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/natural-health-products/draft-guidance-document-sunscreen-monograph-consultation-document.html

Mercosur

Last update July2017

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)http://www.cvs.saude.sp.gov.br/zip/U_RDC-ANVISA-30_010612.pdf

ANMAT (Argentina)

South Africa

Last update Jan 2016

Sunscreens are self regulated by CTFA South Africa, which is a signatory to the COLIPA sunscreen “International” SPF test method. SANS 1557:2012 refeneces ISO 24444 and Applies from March 2012 . This will be updated to include reference to ISO 24443 in 2013.

CTFA South African Self Regulation

SANS 1557

European Union

Last Update Jan 2017

ISO test methods have been adopted in the E.U. and recognised by Cosmetics Europe. These methods replace the older “International” and “COLIPA” protocols and covercover 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 ISOmethod and test to these.

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).

Guidelines on Product Information File (PIF) Requirement, 2015

Cosmetics Europe Publications (previously COLIPA)

European Union Commission Recommendation – Sunscreens 2006

United Kingdom

Last update Jan 2016

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.

ISO test methods

Last Update July 2015

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

ISO Adoption – Updated July 2015

Israel

Updated July 2014

In general, Israel now follows ISO and E.U. Requirements for both SPF and UVAPF . This includes the option for UVA test to either ISO24443:2012 (In vitro) or ISO24442:2011 (In vivo). For water resistance product should retain at least 75% of the experimental SPF post immersion. This is above the 50% required in E.U.

ASEAN

Last updated Jan 2016

ASEAN regulations and other requirements are essentially alligned with the E.U. and include general requirements for cosmetics, GMP, permitted actives and labelling. nformation on member country requirements can be found at http://aseancosmetics.org/default/asean-cosmetics-directive/technical-documents

ASEAN Harmonised Agreement

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
Cosmetic unit is responsible for handling the cosmetic notification procedure in-line with the Medicines (Cosmetic Products) Regulations, 2007 and ASEAN Cosmetic Directive (ACD).

Ministry of Health Brunei

India

Last update Sept 2012

Indian regulations date from the Indian Drug and Cosmetic Act (1940) as ammended from time to time. Bureau of Indian Standards sets the relevant product standards. For sunscreens, the requirements generally follow the broad principles of E.U., and BIS is a Participating Member of the ISO Working Group 217. Sunscreens ar considered as cosmetics. Stability data is required (similar to Australia). There is no maximum SPF rating.

PR China

Last updateApril 2017

Sunscreens are regulated under the Technical Safety Standard for Cosmetics 2015. 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. Currently sunscreens can only be labelled up to SPF 30+. The product must be labelled in Chinese language and have a Chinese name.

CDFA Special Use Cosmetics

Technical Safety Standard for Cosmetics (TSSC) (No. 268 of 2016)

Japan

Last update Jan 2016

Japan Cosmetic Industry Association (JCIA) provides self regulated standards. JCIA is a signatory to the COLIPA International SPF test method and JCIA has adopted ISO standards as they are published. For SPF, ISO 24444 is accepted. For UVA, in-vivo testing is required and labelling is according to ratings of PA + , PA++ and PA +++. Additionally, PA++++ will apply from 1st January 2013.

Japan Cosmetic Industry Association

Korea

Last update Jan 2016

Sunscreens are regulated by Korean Ministry of Food and Drug Safety. as Functional Cosmetics.Data for testing to recognised protocols is accepted, but should be in a standardised format which meets the MOH requirements. Up to SPF 50+ is permitted.

Korea – Cosmetics Act

Sri Lanka

Last update Jan 2016

The Cosmetic Devices and Drugs Regulatory Authority (CDDA) is the institution in which the Ministry of Health has vested the authority to ensure that the Pharmaceuticals and Medical Devices available to the public meet the required standards of quality and are within the existing legislative framework with respect to the production, marketing and dispensing of these items.

CDDA

Sri Lankan Standards Institute

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.