Introduction
Cosmetics and personal care products (PCP) have been regulated for decades in order to ensure consumers safety. The US-FDA Cosmetic Ingredient Review (CIR) Expert Panel or the EU Scientific Committee on Consumers Safety (SCCS) are examples of the regulatory bodies responsible for the safety assessment of these products. There are regulatory differences between the legislative acts ensuring the need for a safety assessment among jurisdictions. Some include a pre-authorization process, prior to marketing, while in other cases the approach focuses on specific lists indicating the ingredients that cannot be used or only under restricted conditions. Despite these differences, a common approach has been to focus the assessment on the safety for the user, not addressing the possible environmental risks including the risks for humans exposed via the environment. The concerns regarding the release of human pharmaceuticals to the aquatic environment, were rapidly extended to some cosmetic ingredients and PCP, asking for regulatory actions.
In the US, ad hoc assessments by the FDA under the National Environmental Policy Act were initiated already in the 1990s (Vincent, 1995); in general, the assessments focus on aquatic ecosystems, and the number has increased exponentially in the last two decades; not only in the US, also in other jurisdictions (Chatzigianni et al., 2022). In addition to regulatory assessments, academic institutions and experts from the regulated industries have developed specific models and tools, such as “in-stream exposure model” iSTREEM(®), a web-based model fostered by the American Cleaning Institute (Kapo et al., 2016). The worldwide main interest was, and still is, on biologically active substances such as the chlorinated aromatic antimicrobial triclosan (2,4,4′-trichloro-2′-hydroxydiphenyl ether) (Perez et al., 2013; Liu et al., 2022) and sunscreen products (Straub, 2002; Burns et al., 2022); extended to the use of nanomaterials (Schneider and Lim, 2019).
In Europe, the approach has been to maintain the basic regulation of consumers safety focusing on consumers health, and complement the regulatory requirements with environmental assessment as part of the REACH (Registration, Evaluation, (Restriction), and Authorization of Chemicals) Regulation. Consequently, chemical substances used in cosmetics and PCP should be registered under REACH, the human health assessment is covered by the specific regulation for cosmetics, while the environmental risks are covered under REACH.
Other consumer products in addition to cosmetics and PCP may also require environmental risk assessments. These assessments are included as part of the generic risk assessment for chemicals intended to be used by consumers or that can be released during the use of consumer articles. In fact, the REACH regulation requires environmental (and health) safety assessment for all chemicals manufactured or imported above one ton per year; and includes specific considerations for chemicals in articles. The assessment is part of the registration process conducted by manufacturers and importers, and starts with a hazard assessment. If the substance requires classification as hazardous and/or is identified as persistent, bioaccumulable, and toxic (PBT) or very persistent and very bioaccumulable (vPVB), the assessment should continue with the exposure estimation and the risk characterization. If the annual tonnage reaches or exceeds 10 tons, the conclusions are reported in a Chemical Safety Report and the Exposure Scenarios are annexed to the extended Safety Data Sheets. Although there is no obligation to provide these Safety Data Sheets to consumers, the providers are responsible for communicating the potential risks and required risk management measures to the consumers. When the product is marketed as a substance or mixture, the producer must also consider the obligations under the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008), based on the United Nations’ Globally Harmonized System (GHS). Consumer products classified as dangerous must be labelled accordingly, and the classification includes the environmental hazards. The obligation for protecting and informing consumers is not limited to chemical products, and is also applicable to consumer articles for which a potential environmental risk has been identified either during use or at the end of life of the product. In Europe as well as in many other areas, there is also specific information alerting and informing consumers on the risks associated to some categories of articles, such as batteries, electronic equipment, and paints and solvents, particularly related to recycling and waste management; for example, in the US, through the Consumer Product Safety Commission (CPSC).
This chapter presents the methodologies applied to cosmetics, PCP and chemicals released from consumer products. Pharmaceuticals, pesticides, and biocides require specific assessments, which have been described in other chapters and, therefore, are not covered here. The focus is on emissions to the aquatic compartment and those linked to waste management. Regarding the air compartment, releases may be relevant for volatile substances and in some cases for releases associated to particles. For obvious reasons most efforts in this field have concentrated on indoor exposure to humans, and the environmental emissions in urban areas associated with traffic, heating systems, and related activities, also with a focus on human health effects. The main environmental concerns for the atmosphere connected, at least partially, with consumer products are the hole in the stratospheric ozone layer, and the emission of greenhouse gases. Between 1979 and 2000 a depletion in the stratospheric ozone layer was detected, with the ozone hole, defined as the area for which ozone column values amount to 220 Dobson Units (DU) or less, reaching the maximum extend in 2000. The phasing out of ozone-depleting substances under the Montreal Protocol, including the use of these substances in consumer products, ceased this progression and currently the ozone layer is showing signs of healthy (https://www.eea.europa.eu/themes/climate/ozone-depleting-substances-and-climate-change-1, consulted on 17 February 2023). On the contrary, the emission of greenhouse gases is still growing, although the consumers contribution has been established in some countries (https://www.epa.gov/ghgemissions/sources-greenhouse-gas-emissions, consulted on 17 February 2023).