June 18, 2024. Sunscreens protect us from UV radiation and, therefore, are of the highest importance for consumers. Sunscreen products are regulated differently in the European Union (EU) and United States (US). Here is our guide to help companies understand the requirements they must comply with.
European Union
In the EU, sunscreens are classified as cosmetic products. Thus, they are regulated by Regulation (EC) 1223/2009. That said, due to their specific protective action, some additional requirements apply as well.
Firstly, sunscreens must undergo an SPF test to determine their Sun Protection Factor (SPF). The SPF is calculated through in-vivo testing by dividing the time it takes for sunscreen-covered skin to burn by the time it takes to bare skin to burn.
Secondly, the European Commission issued a recommendation with specific labelling and claims requirements to ensure consumers can properly use such products. Hence, they should display clear warnings and instructions for use. Furthermore, they shall not display claims such as ‘sun blocker’, ‘total protection’, ‘all day prevention’. Although recommendations are not legally binding, this document represents the best practices to follow to market sunscreens in the EU.
Lastly, it is worth noting that for products providing sun protection as an additional benefit to their primary cosmetic function (e.g., make-up products with SPF), their presentation shall not imply that they can be used in place of a primary sunscreen.
United States
In the US, sunscreen products are not classified as cosmetics, but over-the-counter (OTC) drugs, namely drugs that do not require a prescription by a health professional. Therefore, sunscreens must comply with the requirements set in the category-specific monograph to be generally recognized as safe and effective (GRASE) to be marketed in the United States. If a product complies with the monograph, it can be sold on the US market without prior approval from the FDA.
The current monograph for sunscreen establishes requirements on the following topics:
- Allowed UV filters and their maximum concentration
- Labelling and claims – claims such as ‘sunblock’, ‘sweatproof’, ‘waterproof’ and similar are considered as false and misleading.
- Forms and SPF value
- Testing methods, including SPF water resistance, and broad spectrum tests
On September 24, 2021, the FDA posted a proposed order for sunscreens to amend and revise the existing monograph. This proposed order, if finalized, will replace the current monography establishing new requirements for sunscreens to comply with.
Products with dual function (drug and cosmetic, as for example, a sunscreen lipstick) must comply with the requirements for both cosmetics and drugs.
UV filters allowed for use
The protection from UV radiation is achieved through UV filters, either physical or chemical. In the US, these substances are known as sunscreen active ingredients, namely substances that absorb, reflect, or scatter radiation in the ultraviolet (UV) range at wavelengths from 290 to 400 nanometers.
Both jurisdictions strictly regulate what are the UV filters allowed for use in sunscreens to ensure the safety of consumers. The lists of allowed UV filters are the following:
- For the EU: annex VI to the EU Cosmetics Regulation
- For the US: part B of the monograph
For manufacturers who want to market the same formula in both territories, it is important to keep in mind that the US allows fewer UV filters than the EU.
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