Sunscreens in Europe (and most markets) are considered cosmetic products. However, in the case of United States, they are considered over-the-counter (OTC) medicines and are therefore more strictly regulated.
Therefore, in the European Union (EU), sunscreens are regulated under Regulation (EU) No. 1223/2009 on cosmetic products. It sets out the rules that all cosmetics marketed in the EU must comply with in order not only to install the free market among all EU members, but also to achieve a high level of protection of human health, as stated in its first article.
The Regulation considers the filters approved for use in the EU, with their respective individual considerations that are mandatory for including any of these filters in your sunscreen.
However, it is not only important to consider the regulated filters when formulating a sunscreen. It is also important to take into account the degree of protection we want for our product, with the following categories:
| Labelled Category | SPF | Mean SPF |
|---|---|---|
| Low Protection | 6 | 6 – 9,9 |
| 10 | 10 – 14,9 | |
| Medium protection | 15 | 15 – 19,9 |
| 20 | 20 – 24,9 | |
| 25 | 25 – 29,9 | |
| High protection | 30 | 30 – 49,9 |
| 50 | 50 – 59,9 | |
| Very High protection | 50+ | ≥ 60 |
But how do we find out the actual degree of protection of our product?
We have the following European standards for the determination of both SPF (UVB) and UVA:
- ISO 24442:2011. In vivo determination of sunscreen UVA protection
- ISO 24443:2012. Determination of sunscreen UVA photoprotection in vitro
- ISO 24444:2019. In vitro & In vivo determination of Sun Protection Factor (SPF)Furthermore, within these standards, specifically in ISO 24444:2019, we can also find the way to carry out Water Resistance studies of the product, for example.
In short, a sunscreen in the EU is considered a cosmetic product. Therefore, the whole process of review and registration of a cosmetic product is intrinsic to it. But it also requires additional safety studies to determine the degree of protection.
Do not hesitate to ask us all your questions about the process, now is the time to register all your sunscreens in Europe for next summer.