Sunscreen is a crucial element in protecting our skin from the harmful effects of ultraviolet (UV) radiation. To ensure the effectiveness and safety of these products, various countries around the world have established regulations governing Sun Protection Factor (SPF) and Ultraviolet A Protection Factor (UVA-PF) testing. These regulations are designed to guarantee that sunscreens provide the necessary protection against both UVA and UVB rays. Let’s explore the regulatory landscape surrounding SPF and UVAPF testing across some of the regions.
European Union:
In the European Union, sunscreen products are categorized as cosmetics and regulated by “Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products”. European law imposes very stringent requirements on the safety of cosmetics.
The sunscreen efficacy and labelling are described in the “Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto (2006/647/EC)”.
For sunscreen testing, the EU has adopted a standardized in vivo method for SPF determination known as the “ISO 24444 – Cosmetics – Sun protection test methods – In vivo determination of the sun protection factor (SPF)”. Regarding UVA-PF testing, two methods are adopted:
- in vivo “ISO 24442 – Cosmetics – Sun protection test methods – In vivo determination of sunscreen UVA protection”;
- and in vitro “ISO 24443 – Cosmetics – Determination of sunscreen UVA photoprotection in vitro”.
An additional claim of water resistance can be confirmed using a combination of ISO 24444 and two other in vivo methods:
- «ISO 18861 – Cosmetics – Sun protection test methods – Water immersion procedure for determining water resistance”;
- “ISO 16217 – Cosmetics – Sun protection test methods – Percentage of water resistance”.
Sunscreen labelling is described in different sources, depending on the claim. SPF in vivo labels are described in 2006/647/EC, where the UVA logo can be found in Cosmetics Europe document “N° 23 Important Usage and Labelling Instructions for Sun Protection Products”. The water resistance claim follows the recommendations of Cosmetics Europe in their Notice “N°16 Water Resistance Labelling”.
United States:
In the United States, sunscreen products are regulated by the Food and Drug Administration (FDA). FDA is the legal agency body for sunscreen products regulated as therapeutic substances and considered as OTC (over-the-counter) sunscreen drug products.
FDA has released its document for sunscreen testing and labelling, and no other documents can be used (like ISO methods). The Final Monograph was published in 2011 for “Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use” and shall be used for any sunscreen product submission in the USA. The document describes methods:
- SPF in vivo;
- water resistance in vivo;
- broad spectrum in vitro.
The in vitro broad spectrum method is similar to the UVAPF in vitro method. However, only the measurement of critical wavelength (CW) is necessary, which has to be min. 370 nm. In the EU, except for CW, also UVAPF is measured and needs to be at least 1/3 of labelled SPF for the tested product.
US sunscreen restrictions also concern active ingredients, some of the UV filters that are allowed in the EU are prohibited in the US.
Australia:
Australia, with its high levels of UV radiation, has stringent regulations for sunscreen products. The Australian Government Department of Health – Therapeutic Goods Administration (TGA) oversees the testing and approval of sunscreens. Sunscreens are divided into:
- primary (considered as therapeutic products; are used primarily for photoprotection, e.g products for the beach);
- secondary (considered as cosmetic products; are used primarily not as sunscreen products, e.g. skin care, makeup).
Sunscreens regulated as therapeutic goods (primary sunscreen) by TGA, have to be included in the Australian Register of Therapeutic Goods and have compliance in testing (AS/NZS 2604 standard) and labeling (Therapeutic Goods Order No. 69).
In sunscreen testing, there is the adoption of ISO standards for SPF in vivo (ISO 24444), and UVAPF in vitro (ISO 24443) determination. There is also a correlation with water resistance methods (ISO 18861 and ISO 16217), however, the main difference is in water immersion which lasts 40 min/ 2 h/ 4 h depending on the tested SPF value.
Japan:
Japanese regulations require testing for SPF and UVAPF protection. Sunscreen product testing shall be conducted in terms of ISO methods. However, no in vitro methods are allowed. Thus, for UVAPF determination only in vivo method ISO 24442 can be adopted.
Sunscreen labeling in Japan is described in the Japan Chemical Industry Association (JCIA) document. The SPF labeling is determined in numbers (actual values from SPF 2 to SPF 50, SPF 50+ for higher values), where the UVAPF labeling is expressed in PA scale with pluses (from one plus to four pluses with increasing values of measured UVAPF).
As we can see, regulations regarding SPF and UVAPF testing vary across different regions, but the common goal is to ensure the efficacy and safety of sunscreen products. These regulations play a crucial role in protecting consumers from the harmful effects of UV radiation and contribute to the overall well-being of individuals who rely on sunscreen for sun protection. As the understanding of sun protection evolves, regulatory standards will likely continue to be refined to keep pace with advancements in the field.
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