Using the substitution of fluorinated gases employed as foam blowing agents in insulation materials as a case study, we aim to apply and adapt a well-established multi-criteria decision analysis (MCDA) method for chemical alternatives assessment, the multi-attribute utility theory (MAUT) approach, to evaluate and compare non-chemical alternatives based on technical performance and environmental impact attributes. The functional substitution approach was followed to define the functions delivered by fluorinated gases in insulation materials, and the ZeroPM alternatives database was used to identify functional alternatives. Data on environmental impacts along the life cycle, and the technical performance of the identified alternatives were collected based on previous literature reviews on insulation materials. The MAUT approach was used to compare the different alternatives. Four decision-making scenarios were defined in order to illustrate the flexibility of the MAUT method for the assessment of functional alternatives. Overall, 32 alternative materials to polyethene foams (also known as polyethylene foams) and extruded polystyrene foams containing fluorinated gases were identified. 9 insulation materials were shortlisted for further evaluation based on the amount of data available. Overall, alternatives ranked better than polyethene foams and extruded polystyrene foams in every decision-making scenario tested in this study, suggesting that suitable and safer alternatives to fluorinated gases used in insulation foams can be identified. This work highlights how the choices made by the decision-maker to develop a MAUT model influence the final ranking of the alternatives being evaluated. This might be highly relevant in a regulatory context as the availability of suitable alternatives is a critical part in the decision-making on bans of harmful substances. Although promising in the field of alternatives assessment in a regulatory context, further work is needed to develop appropriate guidance for using MAUT methods to identify suitable alternatives to substances of concern.

An ambitious EU-ban on PFAS will be an important step toward a cleaner and safer EU, and is likely to have an impact on the use of PFAS worldwide. To be truly effective, it’s important that derogations from the ban are limited in time and scope and provided only to uses where there are no viable alternatives. As PFAS will contaminate the environment for decades, it’s important to provide funding and support for research and development of safer alternatives and technologies to remediate PFAS from contaminated water and soil.

Ett heltäckande EU-förbud mot PFAS skulle vara ett viktigt steg mot ett renare och säkrare Europa och sannolikt påverka användningen av PFAS över hela världen. För att förbudet ska bli verkligt effektivt är det därför viktigt att undantag är begränsade i tid och omfattning och endast beviljas för användningsområden där det inte finns några säkra alternativ. 

Per- and polyfluoroalkyl substances (PFAS) are used in a wide range of different industrial and consumer applications. However, due to their extreme environmental persistence and their impacts on human and ecosystem health, PFAS have been subject to many regulatory activities, including initiatives to incentivize industry to transition toward PFAS-free alternatives. Although efforts have been made to map all uses of PFAS, work is still needed to provide an overview of their potential alternatives. Based on the functional substitution approach, this study develops an online database that documents all known uses of PFAS, describes the functions provided by PFAS in these uses, lists potential alternatives that can deliver equivalent or similar functions to PFAS, and evaluates the suitability of the identified alternatives to replace PFAS. Overall, the database lists 325 different applications of PFAS across 18 use categories. In total, 530 PFAS-free alternatives are identified. Based on a screening of potential concerns of the identified alternatives, their performance compared to PFAS, and their availability on the market, it is concluded that potentially suitable alternatives to PFAS are available for 40 different applications. For 83 applications, no alternatives could be identified at the time of the study and should be the focus of further research activities.

The Stockholm Convention and the EU REACH Regulation are two key pieces of legislation on chemicals at the global and European levels, respectively. Discussions have taken place on revising them. For instance, the European Commission is considering implementing the “essential-use” concept in the REACH Regulation to guide decision-making for phasing-out the use of the most harmful chemicals. By assessing 34 existing cases under the Stockholm Convention and 45 restrictions and 544 applications for authorization under the REACH regulation (as of November 2023), this study aims to capture how the essential-use concept may inform decision-making on exemptions and provide insights on its implementation. By conducting a detailed case study of the REACH restriction on intentionally added microplastics, this study also aims to explore how the existing data requirements in regulatory processes could be used in an essentiality assessment. Overall, this study suggests that the Stockholm Convention and the REACH Regulation already consider elements of the concept in their decision-making and that no drastic changes in the data requirements are necessary to apply the concept in decision-making processes.

Chemical legislation serves as an important regulatory tool to protect human health and the environment from the risks posed by substances of concern. Discussions at the EU level have focused on implementing the “essential-use” concept in chemical regulations to improve their efficiency. In short, a use of a substance of concern should be permitted only if it is deemed “essential” – that is, if it is necessary for health, safety, or critical for the functioning of society, and that there is no safer alternative available. Although the European Commission recently published guiding criteria to consider for implementing the “essential-use” concept as a tool to guide decision-making, more work is needed to investigate its practical implementation. 

By taking the examples of uses of per- and polyfluoroalkyl substances (PFAS) (Paper I and III), three persistent, mobile, and toxic (PMT) substances (i.e. allura red, benzophenone-4, and climabazole) (Paper II), and microplastics (Paper IV), this thesis aims to determine the type and amount of information needed to make a proper essentiality assessment. The functional substitution approach was followed to determine the chemical functions provided by the case study substances in their respective uses, and how these functions are linked with the services the substances provide in the end product. Based on this information, one use of allura red (Paper II), and two uses of microplastics (Paper IV) were deemed “non-essential” as the functions delivered by the substances are not necessary for the technical performance of the end product. Existing alternatives assessment frameworks were followed to identify, evaluate, and compare potential alternatives to the substances of interest to determine if suitable alternatives were available for the uses being considered. Suitable and safer alternatives could be identified for 28 uses of PFAS (Paper I and III), for all uses of allura red, benzophenone-4, and climbazole (Paper II), and for seven uses of microplastics (Paper IV), which were deemed “non-essential”. 

This thesis also evaluates how the “essential-use” concept differs from current chemical legislation, and the implications of implementing such a concept to guide decision-making by taking the examples of the Stockholm Convention and the REACH Regulation. The analysis suggests that no fundamental changes are needed in regulatory requirements to implement the “essential-use” concept as authorities already have the capacity to gather the relevant information needed to determine if a use is (non-)essential. However, good cooperation with industry throughout the value chain is necessary for the competent authorities to properly understand the true purpose a substance of concern serves in the end product (Paper IV). Overall, the results suggest that the “essential-use” concept can be a valuable tool which presents the potential to speed-up the decision-making by focusing on identifying the non-essential uses of substances of concern.

The essential use concept aims to better protect consumers, vulnerable groups, and the environment from the most harmful chemicals by phasing out uses considered non-essential for society. Given the lack of empirical research evaluating this novel approach for chemical management in real-world settings, the aims of the present analysis were to 1) investigate if the information provided in applications for authorisation under REACH allowed for the identification of non-essential uses of substances of very high concern (SVHCs), and 2) identify data gaps, challenges and potential needs for revising the assessment criteria to effectively implement the essential use concept in the REACH authorisation. In total, 100 uses covering 11 SVHCs were analysed. 4-(1,1,3,3-tetramethylbutyl) phenol (OPnEO) and chromium trioxide were among the most frequently used substances, covering 42% and 35% of the analysed uses. Using the current essential use criteria, 55% of all analysed uses were categorised as essential, while 10% were categorised as non-essential. Potentially, authorisations would not have been granted for the identified non-essential uses under REACH if the concept had been implemented at the time. However, for 35% of the uses it was not possible to assess their essentiality and these uses were therefore categorised as “complex.” These challenges were due to the multiple purposes of the technical function, lack of detailed information on the spectrum of end-uses, and difficulties in interpreting the essential use criteria. Consequently, for a successful implementation of the essential use concept, we recommend the European Commission to develop guidance for applicants and refine the essential use criteria to ensure a transparent and resource-efficient authorisation procedure under REACH.

Persistent, mobile, and toxic (PMT) substances have recently garnered increased attention by environmental researchers, the water sector and environmental protection agencies. In this study, acute and chronic species sensitivity distributions (SSDs) were retrieved from literature data for previously quantified contaminants of emerging concern (CECs) in Swedish surface waters (n = 92) and risk quotients (RQ) were calculated. To better understand the characteristics of the detected CECs in non-urban lake sites (n = 71), these compounds were checked against established criteria for potentially toxic PMs (PM(T)s) and occurrence in the aquatic environment, respectively. For the CECs with missing SSDs (n = 15 [acute], n = 41 [chronic]), ecotoxicity data were extracted for eight taxonomic groups, and if data were sufficient (n ≥ 3), SSDs were derived. The retrieved and newly developed SSDs were then used in an environmental hazard assessment (EHA) in the investigated Swedish rivers and lakes. In the rivers, 8 CECs had RQ> 1 in at least one location, and 20 CECs posed a moderate risk (0.01 < RQ < 1). In total, 21 of the 71 detected substances had already been identified as PM(T)/vPvM substances. Our study shows the importance of studying field data at large spatial scale to reveal potential environmental hazards far from source areas.

Measures are needed to protect water sources from substances that are mobile, persistent and toxic (PMT) or very persistent and very mobile (vPvM). PMT/vPvM substances are used in a diverse range of applications, including consumer products. The combined application of the essential-use and functional substitution concepts has been proposed to phase out substances of concern and support the transition to safer and more sustainable chemicals, a key goal of the European Commission’s Chemicals Strategy for Sustainability. Here, we first identified the market share of PMT/vPvM containing cosmetic products. We found that 6.4% of cosmetic products available on the European market contain PMT or vPvM substances. PMT/vPvM substances were most often found in hair care products. Based on their high occurrence, the substances Allura red (CAS 25956-17-6), benzophenone-4 (CAS 4065-45-6) and climbazole (CAS 38083-17-9) were selected as case-studies for assessment of their functionality, availability of safer alternatives and essentiality. Following the functional substitution framework, we found that the technical function of Allura red was not necessary for the performance of some cosmetic products, making the use non-essential. For other applications of Allura red, as well as all applications of benzophenone-4 and climbazole, the technical function of the chemical was considered necessary for the performance. Via the alternative’s assessment procedure, which used experimental and in silico data and three different multicriteria decision analysis (MCDA) strategies, safer alternatives were identified for all case-study chemicals. All assessed uses of PMT/vPvM substances were thus deemed non-essential and should consequently be phased out.

Background In 2020, the European Commission published the Chemical Strategy for Sustainability (CSS) in which it aims to increase the level of protection for human health and the environment from hazardous chemicals. Part of the implementation of the CSS will involve a reform of the REACH authorisation and restriction processes. One option for the reform of the authorisation process is to implement the essential-use concept as a tool to guide decision-making on applications for authorisation to make the process more efficient and to align it with societal needs. The purpose of this study is to investigate whether changes in the legal text that defines the authorisation process, and of the amount and type of information that applicants should provide in an application for authorisation, are needed to enable an implementation of the essential-use concept.

Results The results suggest that no fundamental changes in the regulatory requirements are needed and that applicants should already provide sufficient and relevant information to the authorities to determine if the use(s) applied for is (are) essential.

Conclusions Although the REACH authorisation already provides a legal and practical basis for an implementation of the essential-use concept, the feasibility of the essentiality assessment and its potential to make the decision-making on applications more efficient are highly dependent on the quality of the information provided and the clearness of decision criteria. However, if an applicant successfully demonstrates that the risk related to the use(s) applied for is adequately controlled, it could not be legally justified for the European Commission to refuse an authorisation by arguing that the use(s) applied for is (are) non-essential.