Regulation of Sun Protection Products in the EU.

Unlike more "traditional" cosmetic products, sunscreens do not sit inertly on the skin, providing a simple decorative effect. Their recognized and important contribution to public health has led many regions in the world to treat them as drugs or special cosmetics. Against the trend at that time, in 1976, the EU legislator already took a conscious decision to treat and regulate sunscreens as fast-moving consumer products. Since then, the EU Cosmetics Directive/Regulation balances the need for strict safety and efficacy requirements, with need for rapid innovation and easy consumer availability. Whilst the EU Regulation considers that "all cosmetic products are equal," sunscreens are clearly "more equal." In several areas of the legislation, specific requirements or guidance for sunscreen products have been introduced over the years. Whilst staying in the overall spirit of the legislation, these requirements take into account the specificity of sunscreens with regard to ingredient safety (positive list for UV filters), product safety assessment (photostability, deliberate exposure to UV light), minimum efficacy (UVA/UVB), efficacy testing (standardized test methods) and labelling (clear use instructions, non-misleading information to consumers). The article presents the history of the EU Cosmetics Regulation, its main requirements, where applicable, and specific considerations relating to sunscreens are highlighted and explained.

Consumer inhalation exposure to formaldehyde from the use of personal care products/cosmetics.

We measured consumer exposure to formaldehyde (FA) from personal care products (PCP) containing FA-releasing preservatives. Six study subjects applied facial moisturiser, foundation, shower gel, shampoo, deodorant, hair conditioner, hair styling gel or body lotion at the 90th percentile amount of EU PCP consumer use. FA air concentrations were measured in the empty room, in the presence of study subjects prior to PCP use, and for one hour (breathing zone, area monitoring) after PCP use. The mean FA air concentration in the empty bathroom was 1.32 ± 0.67 µg/m³, in the presence of subjects it was 2.33 ± 0.86 µg/m³). Except for body lotion and hair conditioner (6.2 ± 0.1.9 or 4.5 ± 0.1.5 µg/m³, respectively), mean 1-h FA air concentrations after PCP use were similar to background. Peak FA air concentrations, ranging from baseline values (2.2 µg/m³; shower gel) to 11.5 µg/m³ (body lotion), occurred during 0-5 to 5-10 min after PCP use. Despite of exaggerated exposure conditions, FA air levels were a fraction of those considered to be safe (120 µg/m³), occurring in indoor air (22-124 µg/m³) or expired human breath (1.4-87 µg/m³). Overall, our data yielded evidence that inhalation of FA from the use of PCP containing FA-releasers poses no risk to human health.