Sun Care Regulations Round-up!

TAGS:  Sun Care   

The sun’s harmful rays not only cause photo-aging, they can also cause serious skin conditions and cancer. Because cosmetics are defined as substances to maintain the skin in good condition and protect it, the line can be blurred around the world as to:

• When a product is a cosmetic, or
• When it is more a drug (or therapeutic agent)

Here is a round-up of the latest regulations on sunscreens in major regions as their rules and regulations can vary greatly depending on where the product is being marketed!

We would like to acknowledge Belinda Carli and Julian Hewitt for providing technical information needed to develop this article.

When is a Sunscreen a Cosmetic & When is it a Drug?

First, how do the major players categorize sunscreens? Here is a summary table, and explanatory notes below.

	AUS	EU, UK, ASEAN,  Africa, NZ	USA	JAPAN
Sunscreen products/products with SPF claims	Cosmetic: when SPF is a secondary function, OR Therapeutic: when SPF is primary function	Cosmetic	Drug	Cosmetic

To explain this summary table in words, products such as tinted bases, foundations and lip preparations with sunscreen added as well as any skin care product containing SPF, are considered differently in different parts of the world. They include:

• Self-tanning agents
• Skin-whitening products, and
• Anti-aging products

In Australia

• Considered cosmetic when moisturizers and an SPF of 15 or less, where the SPF claims are not the major focus of the promotional campaign or ‘protect the skin from the damaging effects of the sun’s rays’.
• Considered cosmetic when they are balms or colored cosmetics (any SPF rating)
• Considered therapeutic when a moisturizer and the SPF rating is higher than 15 and/or claims are predominantly about the sun protection activity of the product rather than its moisturizing or other action and/or representations are made about protection from skin cancer or other physiological damage induced by the sun.
• Cosmetic sunscreen formulas can contain any sunscreen active within the limits stated in Regulation 9.1 of the Australian Regulatory Guidelines for Sunscreens (ARGS) and may contain any excipient ingredients suitable for use in cosmetic products.
• Therapeutic sunscreen formulas can contain any sunscreen active within the limits stated in Regulation 9.1 of the Australian Regulatory Guidelines for Sunscreens (ARGS) but must only contain excipients as stated in Regulation 9.2.

In Europe, the UK, ASEAN, Africa, and NZ

• Sunscreens are regulated as cosmetics, and can only contain UV filters as listed within Annex VI of the EU Cosmetic regulations, and only within the limits as specified.
• All other cosmetic ingredient and claim compliance requirements as specified in the Cosmetic regulations must be met. Where nanomaterials are used in the product, this must also be indicated on the label in the ingredient list, directly after the ingredient name; for example, Titanium Dioxide (nano).

In the US

• Sunscreens are regulated as drugs and require ‘drug fact’ labeling amongst other requirements.
• UV filters can only be used up to the quantities specified in the Code of Federal Regulations document 21 CFR 352.10 and 352.20
• Testing must be to the following standards: SPF: 21 CFR 201.327(i); broadspectrum (UVA): 21 CFR 201.327(j)

In Japan

• Sunscreens are regulated as cosmetics and must comply with the Japanese Ministry of Health and Welfare Standards for Cosmetics - only UV filters listed in this standard may be used, within the limits specified.
• All other cosmetic ingredient and claim compliance requirements as specified in the Cosmetic regulations must be met.

Is SPF Evidence Required?

The short answer is YES. Products claiming SPF also need to comply with additional requirements (except the USA, where they are considered drugs and subject to different regulations – but SPF testing is still required for these as they are drug products):

• Whether cosmetic or therapeutic, any product making a claim about sun protection must meet specific requirements regarding the evidence required to make such claims.
• SPF and UVA test protocols accepted by different countries/regions are listed below.
  
  

  Country/Region	SPF Methods (in-vivo)		UVA Methods (in-vivo)	UVA Methods (in-vitro)
  	ISO 24444	FDA 2011	ISO 24442	ISO 24443	FDA 2011
  EU ✗	✓	✗	✓	✓	✗
  USA	✗	✓	✗	✗	✓
  Canada	✓	✓	✓	✓	✓
  Mercosur	✓	✓	✓	✓	✗
  Mexico	✓	✓	✓	✓	✓
  South Africa	✓	✗	✓	✓	✗
  ASEAN	✓	✗	✓	✓	✗
  Japan	✓	✗	✓	✗	✗
  Korea	✓	✗	✓	✗	✗
  Australia/NZ	✓	✗	✗	✓	✗



• Current SPF ratings are limited to SPF 50+ on products, and additional safety is required for any sprayable products.
  • Water resistance claims may be made up to 80 minutes in all the above-listed countries except Australia and New Zealand where time limits may be higher. So, long as the product achieves a minimum SPF rating, and in that case, must be tested according to the standard AS/NZS 2604:2012:
    
    

    Maximum Water Resistance  Time Claim	Must Achieve at Least  SPF Rating
    Not permitted	< 8
    40 minutes	8 < 15
    2 hours	15 < 30
    4 hours	≥ 30

  
  
  • There is a big misconception out there that products with an SPF claim below 15 don’t need full SPF testing to be conducted. This is not true – any product making an SPF claim MUST hold evidence to the ISO standard (or AS/NZS standard if in Australia or NZ) to support any SPF rating stated, even if no number is stated!
  • The term ‘sunblock’ is perceived to be total protection against the sun and is not permitted for cosmetic products, because they do not provide total ‘block’ protection from the sun.
  • The terms ‘sweatproof’ and ‘waterproof’ imply that the product will still provide its stated SPF rating when the skin has been wetted by sweat and water, which is not possible, as some of the product will be removed. Therefore, the terms ‘sweatproof’ and ‘waterproof’ are not permitted claims for cosmetics containing SPF. Sweat resistant and water resistant are permitted as long as testing has been conducted to support these statements and maximum times are listed as per the section on water resistance above.

Are Sunscreens Damaging our Reef System?

There is a lot of conflicting information and various studies supporting both a yes and a no answer, as well as a ‘depends’ on concentration, depth of water and population of tourism. There are also some UV filters that have had greater evaluations conducted while many others have not been evaluated as rigorously.

• An excellent report compiled by Dr. Elizabeth Wood summarizes most of the studies to date while identifying knowledge gaps, the shortcomings of ex-situ studies (out of the normal marine environment) and further research required.¹


• The latest study by Fel et. al, suggests normal levels of 5 UV filters tested do not negatively impact the photosynthetic abilities of coral (benzophenone-3 was not included in this study). There is also the question of the impact of heat stress from increased water temperatures. This has been recorded and correlated with historical reef bleaching events and appears to be the biggest impact on reef bleaching, not UV filters – but whether this exacerbates the problem as the world’s oceans continue to warm also requires further investigation.

There are multiple articles referenced in both Dr Wood’s research and some readily accessible I’ve listed below that show the different viewpoints. My professional opinion on this, at this stage, is that we should be reading research critically and considering how it may apply in the real-world marine environment (in situ) in line with:

• Consumer use rates
• Marine exposures in high-tourism areas, and
• Ongoing global warming of our oceans

In addition, before a product claims ‘reef safe’ it should be subjected to ISO regulated Ecotoxicity Tests in the Marine Environment and OECD Biodegradability tests rather than just avoiding the use of certain UV filters. We should also be considering what other contaminants may be impacting our marine environments as sunscreens aren’t the only chemicals to reach our waters.

Upgrade your UVA/SPF Test Strategy for Regulatory Compliance

Take the course by Julian Hewitt where he will help you avoid running expensive tests and show you how to support formulation work & UVA / SPF claims for your targeted markets (EU, US, Japan). Also, learn about conducting right test at the right time (in-vitro or in-vivo) & how to interpret test results better.

Sun Care Ingredients for Cosmetics

View all the commercially available sun care ingredients used in cosmetics, analyze technical data of each product, get technical assistance or request samples.

Select UV Filter for Formulating Sunscreens

This article was originally published on March 8, 2019 and updated on March 5, 2020.