Advancing the Environmental Risk Assessment and Management of Cosmetics, Sunscreens and Personal Care Products

Carys L. Mitchelmore, University of Maryland Center for Environmental Science; Alistair Boxall, University of York; Elaine K. Jennings, WSP; Harald Streicher, Beiersdorf AG

At the SETAC Europe 36th Annual Meeting in Maastricht, the Netherlands, the session “Advancing the Environmental Risk Assessment and Management of Cosmetics, Sunscreens and Personal Care Products” explored recent advances in assessing and managing the environmental risks of these widely used products. Given the ubiquitous presence of many chemical ingredients in environmental matrices and growing public interest, the session brought together perspectives from environmental chemistry, toxicology, regulation and science communication to examine the state of the science and novel approaches for managing risks. Participants represented academia, industry, regulatory agencies and the nonprofit sector.

The session attracted many submissions for oral and poster presentations, as well as strong attendance and lively discussions during and after the talks. The session was organized into distinct themes, with the first focusing on environmental exposure and fate, including talks on laboratory, field and modeling approaches. Four presentations provided new information on both measured and modeled exposure concentrations of UV filters and preservatives in the aquatic environment, highlighting the ubiquitous presence of a diverse array of contaminants in both freshwater and marine waters. The presentations also showed how field monitoring and analytical approaches can influence the provision of reliable and accurate environmental concentrations for use in environmental risk assessments (ERAs). For example, Carys Mitchelmore, University of Maryland Center for Environmental Science, presented findings showing how temporal and spatial variability and sample fractionation — such as dissolved, particulate or total measures — can affect reported concentrations of UV filters at a beach site. The importance of temporal resolution was also demonstrated in the presentation by Jun Li, University of York, following an extensive year-long monitoring program of 13 personal care chemical ingredients across 19 river sites, which showed no simple seasonal pattern but highlighted flow, precipitation and temperature as drivers of concentrations and mass loads. As an alternative approach to field monitoring for determining environmental exposure concentrations, Margret Fleming, Personal Care Products Council, discussed a new model, verified using field monitoring data, to estimate UV filter concentrations in coastal areas. Zakaria Naddi, Beiersdorf AG, presented a use-based exposure framework for PCP ingredients that combines the European Commission’s Scientific Committee on Consumer Safety (SCCS) cosmetic-use information with the BPR Product Type 1 wastewater-emission logic to translate consumer product use into local emissions, surface-water predicted environmental concentrations (PECs) and risk characterization. Rounding off the first session on exposure and fate, Michael Gonsior, Catalan Institute for Water Research (ICRA), demonstrated the ability of many UV filters to form novel disinfection by-products during treatment, which should be included in ERAs.

The second part of the session consisted of five talks focusing on the bioavailability, bioaccumulation, toxicity and risk of Personal Care Products (PCPs) in aquatic ecosystems, with the final talk addressing cosmetic claims, highlighting the need for better risk communication of products to the public. Maura Hall, Procter & Gamble, outlined a weight of evidence framework integrating bioaccumulation mechanistic principles, toxicokinetic and emerging analytical approaches to assess the bioavailability and bioaccumulation potential of water-soluble polymers. The next presentations focused on the risks of PCPs to aquatic organisms. Lalita Chomphen, University of York, highlighted species and contaminant differences in growth impacts in 12 phytoplankton and periphyton species exposed to individual and mixtures of UV filters. Using the effects data, monitoring data (see Li’s presentation) and mixture models, she determined that these UVFs pose a low risk to primary production in freshwater environments. Aurelia Lapczynski, Research Institute for Fragrance Materials (RIFM), described RIFM’s environmental framework to address the environmental safety of fragrances, particularly with respect to widening its scope of use outside Europe and the USA. Continuing the risk assessment theme, Harald Streicher, Beiersdorf AG, used triclosan not as a substance-defense case but as a data-rich case study demonstrating how the established 10-step human next-generation risk assessments (NGRA) framework can be transferred to animal-free environmental safety assessment of cosmetic ingredients. Concluding the session was a presentation by Cristiana Gheorghe, University of Birmingham, highlighting the need for much clearer communication of risks associated with cosmetic ingredients, giving examples of common drivers of public perception of their safety.

Below we highlight some of the key take-home points from the ten oral presentations and eleven posters in this session:

• Highly variable spatial and temporal concentrations of  PCPs in aquatic ecosystems. 
  A number of monitoring studies showed variable concentrations of PCP ingredients over time (seasonally, daily) and spatially (distance from shoreline) in fresh and saltwater locations, as demonstrated in presentations by Mitchelmore and Li, as well as Harshada Sakpal, Julius Kühn-Institut, with obvious ramifications for exposure estimates in ERAs. Todd Gouin, TG Environmental Research, discussed this and other concerns in a critical review of octocrylene occurrence in aquatic systems, highlighting the need for well-defined and representative monitoring studies to provide accurate measured environmental concentrations (MECs) for ERAs. Li’s sampling method used a pooled sampling approach to minimize the variability obtained with discrete sampling, while Mitchelmore highlighted the need to measure both dissolved and particulate fractions showing significant underestimations of environmental concentrations for low solubility UV filters (e.g., octocrylene) if just dissolved concentrations are used. These studies highlight the importance of standard protocols for monitoring programs.
• Utility of various modeling approaches for estimating exposure and fate.
  As highlighted above, to provide accurate exposure data carefully designed monitoring studies must be used, although these are expensive to conduct. Various modeling approaches have been proposed, including the model presented by Fleming, which was verified using monitoring data and may be used to provide predicted environmental concentrations (PECs) for risk assessment. Other presentations described new frameworks for bioavailability and bioaccumulation estimates, including Hall's framework, and exposure-based risk assessment frameworks presented by Samantha Crotty, RIFM, and Lapczynski.
• New methods and approaches to investigate toxicity and environmental risk.
  New Approach Methodologies (NAMs), mechanistic evidence and structured environmental NGRAs are becoming important tools for animal-free, weight-of-evidence-based environmental assessment of PCP ingredients. Presentations highlighted in silico models (e.g., Paul Thomas, KREATiS SAS, and Hristiana Ivanova Stoyanova, Laboratory of Mathematical Chemistry (LMC) Burgas State University "Prof. Dr. Asen Zlatarov"), exposure-route considerations (e.g., Dorothy-Ellen Abigail Renegar, Nova Southeastern University), prioritization frameworks for chemicals of emerging concern (e.g., Renske Hoondert, KWR Water Research Institute), and structured approaches for toxicity and ERA, including those presented by Streicher and Hoondert.
• Toxicity and multiple mixture effects.
  Regulations and ERAs require toxicity data of individual compounds; however, single compounds (and stressors) do not occur in the environment and the impact of multiple mixtures of chemicals and co-stressors has been a topic at SETAC for many years. The poster of Isabel Lopes, University of Aveiro, highlighted this, showing elevated toxicity in combined polymer mixtures and suggesting that single-compound tests can underestimate environmental risk of personal care products. Studies of PCP ingredients that currently have limited toxicity data, such as cinchonidine (Patrícia Veríssimo Silva, University of Aveiro) and PVAs (Alessandra Maganza, The Veterinary Medical Research Institute for Piedmont, Liguria and the Aosta Valley), showed responses in the organisms of choice, although data on environmental concentrations are required to put these results in context.
• Enhancing education and communication on the risk of cosmetic products.
  Consumers, policy makers and regulators are being presented with news and social media claims regarding the safety of PCPs and their risk to the environment. These are often not based on scientific data or may misrepresent the current state of the science and available data. As highlighted in Gheorghe’s talk, clearer scientific communication is needed so consumers can make educated decisions. A new online training course for cosmetic safety assessors was highlighted in the poster of Marlies Bergheim, Henkel AG & Co. KGaA, that may also help bridge the gap between scientists and the public.

Overall Conclusions From the Session

The environmental safety of PCPs is an issue receiving increasing attention in the news, online and on social media. For many product ingredients, little data is available on their exposure and hazard/toxicity to feed into regulatory and ERAs. Given the sheer number and diversity of chemical ingredients, a collaborative approach between academia, industry and government agencies is needed to prioritize chemicals and conduct research to fill critical data gaps. Numerous approaches, including new techniques, were presented in this session, ranging from field and laboratory studies to modeling and predictive efforts. The studies demonstrated how data collection methods can affect the utility of data in developing accurate and reliable ERAs. Collectively, NAMs, predictive exposure models and structured risk frameworks demonstrate the growing potential for integrated, evidence-based environmental assessment of diverse PCP ingredients, including UV filters, polymers and fragrances. It is essential that academia, industry, government agencies and other stakeholders continue to work together, not only to increase the data available on the environmental risks of PCPs but also to translate and communicate results and risks to the general public.

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