Cosmetic UV filters in the environment-state of the art in EU regulations, science and possible knowledge gaps.

OBJECTIVE: The aim of this work was to review the principals of environmental hazard and risk assessment (ERA) of cosmetic UV filters registered under EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Furthermore, effects as obtained from non-standardized testing methods and organisms from scientific literature were compared against the predicted no effect concentrations (PNECs) as derived based on standardized test methods for the various environmental compartments under REACH. METHODS: The REACH dossiers at the ECHA webpage were screened for available information related to basic physico-chemical data (i.e. water solubility, octanol-water partitioning coefficient), PNECs and associated data (data basis, assessment factors (AFs)). Scientific literature was screened for available ecotoxicity data and the adverse effect levels were compared against the derived PNECs under REACH. Current approaches for environmental risk assessments of UV filters were evaluated for its applicability for a direct release scenario. RESULTS: Under REACH, PNECs were derived for all hazardous UV filters. Although, PNECs were often derived for various environmental compartments (i.e. freshwater, marine water, sediment, soil), results from literature focused on aquatic data. Effects as observed within scientific literature matches in principle with the hazardous profile of the UV filters. Effects levels both on the acute and the chronic toxicity as retrieved from the non-standardized test organisms (literature) were above the derived PNECs under REACH. Currently, ERAs performed for cosmetic UV filters under REACH are solely tonnage driven and thus do not fully capture the use in sunscreens and associated leisure activities. CONCLUSION: Existing EU REACH regulation is considered as sufficient to evaluate the environmental safety of UV filters used in sunscreens. To cover the direct release of UV filters due to various leisure activities into the aquatic freshwater and marine environment, an additional application-based ERA is considered necessary.

OBJECTIF: L'objectif de ce travail était d'examiner les principes de l'évaluation des dangers et des risques environnementaux des filtres UV cosmétiques enregistrés dans le cadre du règlement REACH de l'Union européenne. En outre, les effets obtenus à partir de méthodes de test non normalisées et d'organismes issus de la littérature scientifique ont été comparés aux concentrations prédites sans effet (PNECs) dérivées des méthodes de test normalisées pour les différents compartiments environnementaux du règlement REACH. MÉTHODES: Les dossiers REACH de la page web de l'ECHA ont été examinés pour rechercher des informations disponibles concernant les données physico-chimiques de base (c'est-à-dire la solubilité dans l'eau, le coefficient de partage octanol-eau), les PNECs et les données associées (base de données, facteurs d'évaluation). Un filtrage de la littérature scientifique a permis d'obtenir les données d'écotoxicité disponibles, et les niveaux d'effets indésirables ont été comparés aux PNECs dérivées en vertu du règlement REACH. Les approches actuelles des évaluations des risques environnementaux des filtres UV consistaient en l'évaluation de leur applicabilité à un scénario de libération directe. RÉSULTATS: En vertu du règlement REACH, les PNECs ont été dérivées pour tous les filtres UV dangereux. Cependant, les PNECs ont souvent été dérivées pour différents compartiments environnementaux (c'est-à-dire eau douce, eau marine, sédiment, sol), les résultats de la littérature se concentrant sur les données aquatiques. Les effets observés dans la littérature scientifique correspondent en principe au profil dangereux des filtres UV. Les niveaux d'effets à la fois sur la toxicité aiguë et sur la toxicité chronique, extraits des organismes de test non normalisés (littérature), étaient supérieurs aux PNECs dérivées en vertu du règlement REACH. Actuellement, les évaluations des dangers et des risques environnementaux des filtres UV cosmétiques en vertu du règlement REACH sont uniquement axées sur le tonnage et ne reflètent donc pas entièrement l'utilisation des protections solaires et des activités de loisirs associées. CONCLUSION: Le règlement REACH de l'UE existant est considéré comme suffisant pour évaluer la sécurité environnementale des filtres UV utilisés dans les protections solaires. Pour couvrir la libération directe de filtres UV en raison de différentes activités de loisirs dans un environnement aquatique d'eau douce et d'eau de mer, une évaluation des dangers et des risques environnementaux supplémentaire basée sur l'application est considérée comme nécessaire.

A new visible light absorbing organic filter offers superior protection against pigmentation by wavelengths at the UVR-visible boundary region.

Skin pigmentation by solar ultraviolet radiation (UVR; ~295-400 nm) is well established. More recently, visible light (VL; 400-740 nm) has been shown to induce rapid pigmentation. Such pigmentation is thought to be caused by oxidative stress, which has associations with skin cancer and photoageing. However, the UVR-VL boundary region has been less well studied. The lower back of healthy Fitzpatrick skin type II-IV individuals was irradiated with increasing doses of narrow-band 385 nm and 405 nm radiation. Pigmentation change was measured immediately, 6 h and 24 h post-irradiation using two reflectance spectroscopy devices and visual grading. Pigmentation was dose-dependently increased in all skin types and time points for both spectra. Two sunscreens, both labelled SPF 15 and UVA protective in the EU and USA (but with different Boots star rating in the UK, 2* vs 5*) were compared. Their formulations were the same apart from the addition of a new organic filter bis-(diethylaminohydroxybenzoyl benzoyl) piperazine (BDBP) that absorbs between 350 and 425 nm. The product that lacked BDBP provided minimal protection against pigmentation, but its addition provided almost complete protection. This demonstrates the needs to improve photoprotection at the UVR-visible border and for sunscreens to act as neutral density filters.

The UV/Visible Radiation Boundary Region (385-405 nm) Damages Skin Cells and Induces "dark" Cyclobutane Pyrimidine Dimers in Human Skin in vivo.

The adverse effects of terrestrial solar ultraviolet radiation (UVR) (~295-400 nm) on the skin are well documented, especially in the UVB region (~295-320 nm). The effects of very long-wave UVA (>380 nm) and visible radiation (≥400 nm) are much less known. Sunscreens have been beneficial in inhibiting a wide range of photodamage, however most formulations provide very little protection in the long wave UVA region (380-400 nm) and almost none from shortwave visible wavelengths (400-420 nm). We demonstrate photodamage in this region for a number of different endpoints including cell viability, DNA damage (delayed cyclobutane pyrimidine dimers), differential gene expression (for genes associated with inflammation, oxidative stress and photoageing) and induction of oxidizing species in vitro in HaCaT keratinocytes and in vivo in human volunteers. This work has implications for phototherapy and photoprotection.