Options for an environmental risk assessment of intentional and unintentional chemical mixtures under REACH: the status and ways forward

It is acknowledged that a variety of chemicals enter the environment and may cause joint effects. Chemicals regulated under the European Chemicals Regulation REACH are often part of formulated mixtures and during their processing and use in various products they can be jointly released via sewage treatment plants or diffuse sources, and may combine in the environment. One can differentiate between intentional mixtures, and unintentional mixtures. In contrast to other substance-oriented legislations, REACH contains no explicit requirements for an assessment of combined effects, exposures and risks of several components. Still, it requires ensuring the safe use of substances on their own, in mixtures, and in articles. The available options to address intentional as well as unintentional mixtures are presented and discussed with respect to their feasibility under REACH, considering the responsibilities, communication tasks and information availability of the different actors (registrants, downstream-user and authorities). Specific mixture assessments via component-based approaches require a comprehensive knowledge on substances properties, uses, fate and behaviour, and the composition of the mixture under consideration. This information is often not available to the responsible actor. In principle, intentional mixtures of known composition can be assessed by the downstream-user. But approaches have to be improved to ensure a transparent communication and sound mixture assessment. In contrast, unintentional mixtures appear to be better addressable via generic approaches such as a mixture allocation factor during the chemical safety assessment, although questions on the magnitude, implementation and legal mandates remain. Authorities can conduct specific mixture risk assessments in well-defined and prioritized cases, followed by subsequent regulatory measures. In order to address intentional and unintentional mixtures within the current REACH framework, legal mandates together with guidance for the different actors are needed. Furthermore, further data on mixture compositions, uses and co-exposures need to be made accessible via shared databases.

Persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances pose an equivalent level of concern to persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances under REACH

Background Under the EU chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals EC 1907/2006), registrants are not obliged to provide information related to intrinsic substance properties for substances that pose a threat to the drinking water resources. In 2019, perfluorobutane sulfonic acid (PFBS) and 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)-propanoic acid (HFPO-DA trade name GenX) were demonstrated to have an equivalent level of concern (ELoC) to persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBT/vPvB) substances owing to their persistent, mobile and toxic (PMT) substance properties and very persistent and very mobile (vPvM) substance properties, respectively. They were both subsequently identified as substances of very high concern (SVHC) applying Article 57(f) in REACH. This work follows up on this regulatory decision by presenting a science based, conceptual level comparison that all PMT/vPvM substances pose an ELoC to PBT/vPvB substances. Using the two cases named above, as well as 1,4-dioxane, 16 categories were developed to evaluate a) serious effects on human health, b) serious effects on the environment and c) additional effects. 1,4-dioxane has recently been proposed to be classified as Carcinogenic 1B by the Committee for Risk Assessment (RAC). The aim was to enable an objective and scientifically justified conclusion that these classes of substances have an equivalent level of concern for the environment and human health. Results In all of the categories related to human health, the environment and other effects, the PMT/vPvM case study substances exhibited comparable effects to PBT/vPvB substances. A difference in the human and environmental exposure pathways of PMT/vPvM and PBT/vPvB substances exists as they vary temporally and spatially. However, effects and impacts are similar, with PMT/vPvM substances potentially accumulating in (semi-)closed drinking water cycles and pristine aquatic environments, and PBT/vPvB substances accumulating in humans and the food chain. Both PMT/vPvM and PBT/vPvB substances share the common difficulty that long term and long-range transport and risk of exposure is very difficult to determine in advance and with sufficient accuracy. Conclusion The registration process of substances under REACH should reflect that PMT/vPvM substances pose an equivalent level of concern to PBT/vPvB substances.

How to Reach a Safe Circular Economy?—Perspectives on Reconciling the Waste, Product and Chemicals Regulation

This article discusses the regulation of ‘substances of concern’ in the circular economy (CE) in the European Union (EU). It analyses the tensions and obstacles that the present sectoral separation of waste, product and chemicals legislation sets for the development of the CE. We argue that in a longer term perspective the aim should be to erase the border between waste and chemicals regulation and create a single regime for the regulation of materials and their flow. However, the eventual aim of such non-toxic material circulation can be achieved only via precautious transitional measures that outweigh the costs and benefits of each material flow and set restrictions for the particular substances of concern. Regulatory actions addressing the risks posed by the substances of concern in the waste-based material flows are urgently needed. New measures are necessary to protect human health and the environment and to support the development of the markets for the secondary materials.

The High Persistence of PFAS is Sufficient for their Management as a Chemical Class

Per- and polyfluoroalkyl substances (PFAS) are a class of synthetic organic substances with diverse structures, properties, uses, bioaccumulation potentials and toxicities. Despite this high diversity, all PFAS are alike in that they contain perfluoroalkyl moieties that are extremely resistant to environmental and metabolic degradation. PFAS are therefore either non-degradable or transform ultimately into stable terminal transformation products (which are still PFAS). Under the European chemicals regulation this classifies all PFAS as very persistent substances (vP). We argue that this high persistence is sufficient concern for their management as a chemical class, and for all “non-essential” uses of PFAS to be phased out. The continual release of highly persistent PFAS will result in increasing concentrations and increasing probabilities of the occurrence of known and unknown effects. Once adverse effects are identified the exposure and associated effects will not be easily reversible. Reversing PFAS contamination will be technically challenging, energy intensive, and costly for society, as is evident in the efforts to remove PFAS from contaminated land and drinking water.

Benefits of Ryegrass on Multicontaminated Soils Part 1: Effects of Fertilizers on Bioavailability and Accumulation of Metals

Effects of three phosphorus fertilizers on the shoot biomass and on the accumulation of alkali, alkaline earth, and transition metals in the shoots and roots of ryegrass were studied with two contaminated garden soils. Phosphates were added in sustainable quantities in order to reduce the environmental availability of carcinogenic metals (e.g., Cd and Pb) and to enhance the bioavailability of alkali and alkaline earth metals as well as micronutrients needed by plants. Addition of Ca(H2PO4)2 was the most convenient way to (i) limit the concentration of Cd and Pb, (ii) keep constant the transfer of macro- and micronutrient from the soil to the ryegrass shoots, (iii) decrease the availability of metals, and (iv) increase the ratio values between potential Lewis acids and Cd or Pb in order to produce biosourced catalysis. For instance, the real phytoavailability was reduced by 27%–57% and 64.2%–94.8% for Cd and Pb, respectively. Interestingly, the real phytoavailability of Zn was the highest in the least contaminated soils. Even if soils were highly contaminated, no visual toxicity symptoms were recorded in the growing ryegrasses. This indicates that ryegrass is suitable for the revegetation of contaminated gardens. To promote the sustainable ryegrass production on contaminated soils for production of new organic fragrance and drugs in green processes according to REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulation, two processes should be recommended: assisted phytostabilization of the elements, and then assisted phytoextraction by using chelators.

Regulation of Chemicals

This chapter examines the regulation of chemicals, with emphasis on commonalities and differences in regulatory approaches. It begins with a brief overview of key concepts that underlie chemicals regulation, explaining what chemicals regulation is, the hazards and risks associated with chemicals, policy principles, informational inputs, and how chemicals are identified. The chapter then considers the general components of chemicals regulation, namely: screening and prioritization, risk assessment and decision analysis, and risk management. It also discusses regulatory fragmentation, risk management through the supply chain, and the complementary roles of regulation and liability systems. Finally, it shows how common aspects of chemical risk laws fit into the EU’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation and the US Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA).