Principles for the safety evaluation of cosmetic powders.

Consumer exposure to cosmetic (personal care) products is mostly by dermal contact, however additional considerations with regards to potential inhalation exposure from some cosmetics, such as sprays and powders, may be needed for a robust and reliable safety assessment. To get a deeper understanding of the exposure to airborne particles and droplets during product application, a team of international experts was founded under the umbrella of the European Association of the Cosmetic Industry "Cosmetics Europe" (CE) in Brussels. This expert team has worked out a pragmatic strategy how small and medium sized enterprises (SMEs), but also relevant authorities, could handle the safety evaluation of cosmetic powder products. Sufficient information on the aerodynamic diameter of sprayed droplets and here specifically of airborne particles is essential in addition to knowing the exposure after typical product application. The current article is focused on the determination of inhalation exposure to solids, and the derivation of safe exposure levels for cosmetic powder products found in the market. The principles described herein are very similar to spray products as published earlier and should be applied in a similar way (Steiling et al., 2014). Prediction models for the best estimate of inhalation exposure, developed with data from computer simulation programs, individual real-time measurements or finally by experience from the market were introduced and applied. Safety assessment approaches for exposure from powder spray products were developed and have been already considered in regulatory guidelines like the EC Cosmetics Regulation.

Review of data on the dermal penetration of mineral oils and waxes used in cosmetic applications.

Mineral oils and waxes used in cosmetic products, also referred to as "personal care products" outside the European Union, are mixtures of predominantly saturated hydrocarbons consisting of straight-chain, branched and ring structures with carbon chain lengths greater than C16. They are used in skin and lip care cosmetic products due to their excellent skin tolerance as well as their high protecting and cleansing performance and broad viscosity options. Recently, concerns have been raised regarding potential adverse health effects of mineral oils and waxes from dermal application of cosmetics. In order to be able to assess the risk for the consumer the dermal penetration potential of these ingredients has to be evaluated. The scope and objective of this review are to identify and summarize publicly available literature on the dermal penetration of mineral oils and waxes as used in cosmetic products. For this purpose, a comprehensive literature search was conducted. A total of 13 in vivo (human, animal) and in vitro studies investigating the dermal penetration of mineral oils and waxes has been identified and analysed. The majority of the substances were dermally adsorbed to the stratum corneum and only a minor fraction reached deeper skin layers. Overall, there is no evidence from the various studies that mineral oils and waxes are percutaneously absorbed and become systemically available. Thus, given the absence of dermal uptake, mineral oils and waxes as used in cosmetic products do not present a risk to the health of the consumer.

Preliminary assessment of the SensiumVitals®: A low-cost wireless solution for patient surveillance in the general wards.

This paper presents SensiumVitals(®) - an FDA cleared and CE marked wireless wearable vital signs monitoring system, developed for frequent surveillance of in-hospital patients. A number of in-house evaluations with artificial data and healthy volunteers were carried out in different stages to assess the reliability of two crucial vital signs measured by the system - respiration and heart rate. In order to illustrate the potential of the system in hospital, a subset of data collected from acutely-ill patients during a separate clinical trial was also analyzed. In all cases the results revealed satisfactory agreement between the values reported by SensiumVitals(®) and those recorded simultaneously by a clinically-approved bedside monitor. However, further work will be required to improve the reliability of the system under certain clinical conditions; which, although not crucial for our intended population (i.e. patients in general ward), pose interesting challenges for upgrading our technology for future use in these types of patients.

Special aspects of cosmetic spray safety evaluations: principles on inhalation risk assessment.

The consumer exposure to the vast majority of cosmetic products is limited to dermal contact. Even spray applications tend to be topically exposed to skin or hair. Besides this skin contact, spray products require additional considerations in regard to potential inhalation for building a robust and reliable safety assessment. Over the years, cosmetic industry developed prediction models for the best estimate of inhalation exposure combining data from computer simulation programs available in the market, individual real measured data and last but not least the experience from the market. Such attempt is driven by the toxicological profile of individual used ingredients. The focus of this review is on the determination of inhalation exposure, and the derivation of safe exposure levels for cosmetic spray products. Many of the methods employed to ensure product safety of cosmetic sprays in accordance with the general requirements of the EC Cosmetics Directive are based on industry experience which are not necessarily consistent across companies. This paper presents an approach to compile common principles for risk assessment and thus contribute to standardisation of safety assessment methodologies utilized for spray product evaluation without interfering with the flexibility of the individual safety assessor. It is based on the experience within the author's companies and may be useful as a support document as well for SME (Small and Medium Enterprises) companies safety assessors. In this respect it can be seen as one fundamental step in a tiered approach of cosmetic spray safety evaluation.