To manage a rising number of chemicals marketed in the EU and to better protect human health and the environment against the most harmful substances, the European Commission suggests to improve the current REACH authorisation by implementing the essential-use concept as a potential tool to guide decision-making in order to make it faster, less-resource intense, and aligned with societal needs. Figure 1 illustrates how the information required as part of an application for authorisation could be used for an essentiality assessment of the use applied for.
4.1. The information required for an authorisation should already provide sufficient and relevant information to assess the essentiality of a use by ECHA
As shown in the results section, applicants for authorisation are expected to explain the precise technical function provided by the SVHC in the use applied for, how the use of the substance influences the functionality and performance of consumer goods and/or services, if and how a decrease in functionality and/or performance would affect consumers, and whether safer and suitable alternatives are available to the applicant. These data could be useful to the authorities to properly understand the importance of the technical function and level of performance provided by an SVHC for society, to distinguish essential end-uses from the “nice-to-have” ones, and from the “substitutable” ones. Therefore, it appears that applicants are already supposed to provide relevant information to ECHA to assess the essentiality of the use applied for, especially if they attempt to demonstrate that the socio-economic benefits of their use(s) outweigh the risks posed to human health and the environment.
Under REACH, applicants are expected to explain why there are no suitable alternative for their use(s) applied for by taking into account the technical and economic feasibility of the implementation of a potential alternative, as well as its availability. However, in the CSS, the European Commission only included the term “…alternative that are acceptable from the standpoint of environment and health” and didn’t provide its definition with respect to an essential use 13. Considerations on the suitability of an alternative should be kept in an assessment for essentiality, as it is done under the Montreal Protocol 14. Such discussion is important in order to avoid the difficult situation in which a use would be considered as non-essential because a safer alternative exists, even though substitution is not possible in practice due to unbearable costs and/or technical issues for the implementation of the alternative.
At last, it is important to emphasize that neither the guidance documents nor the REACH legal text specify the definition and the scope of the “socio-economic benefits” and that “the level of detail and scope of the socio-economic analysis […] shall be the responsibility of the applicant for authorisation”, as specified in Annex XVI of REACH. Hence, the feasibility of an essentiality assessment of the use applied for will mainly depend on the scope and level of details of the socio-economic analysis submitted by the applicants. Further work is needed to analyze the quantity and quality of information that is contained in an application for authorization submitted to ECHA to determine if the applicants are providing sufficient information to conclude the essentiality of a use.
4.2. The “safe use” paradigm could hamper implementing the essential-use concept
Based on the analysis of the legal text, it appears that there are no clear legal barriers to implementing the essential-use concept to guide the decision on an application for authorisation. However, if an applicant successfully demonstrates that the risk(s) linked to the use(s) of an SVHC is (are) adequately controlled, i.e. its use is considered safe, it could not be legally justified for the European Commission to refuse an authorisation by arguing that the use applied for is non-essential (supplementary Table S1), which supports previous findings recently published 21,22. Therefore, the relevance of an essentiality assessment for uses of SVHC for which the risks are expected to be adequately controlled could be questioned. In general, the pertinence of a “safe use” approach for the most harmful substances could be challenged. Indeed, as illustrated by the decrease of several orders of magnitude of the guideline values for some PFAS based on biological effects 23, the (eco-)toxicological safety level of other SVHCs could decrease over time if additional scientific evidence emerges and the risk would then not be adequately controlled. Furthermore, even a small continuous release of a highly-persistent substance will lead to its accumulation somewhere in the environment and the eventual exceedance of a known or unknown effects threshold level, even if the risk appears controlled today24.
4.3. Potential benefits and challenges of an essentiality assessment in the Authorisation process
Previous studies on the authorisation process have demonstrated that the socio-economic analysis attributes a relatively high weight to impacts that can be quantified and monetized (e.g. loss of profit) compared to impacts that are difficult to quantify in monetary values (e.g. social impacts, emissions of pollutants in the environment) 25,26. For this reason, Gabbert et al. (2014) demonstrated that the current authorisation approach is not appropriate for SVHCs for which no (eco-)toxicological safety level can be determined (e.g. PBT/vPvB substances) as it does not properly consider the impacts of such chemicals on human health and the ecosystems. As it is defined so far, the essential-use approach does not contain any explicit economic elements but is rather centered on social-welfare components. Therefore, it could help tackle this challenge by increasing the weight of non-monetizable impacts in the socio-economic analysis performed in an application. How, and to what extent economy-related information should be integrated into an essential-use assessment still needs to be determined. According to article 55 of REACH, “the aim of [the authorisation process] is to ensure the good functioning of the internal market while assuring that the risks from Substances of Very High Concern are properly controlled” (supplementary Table S1). Therefore, any potential decision from the authorities made according to the essential-use concept should still consider the potential impact of a refused (or granted) authorisation on the internal market due to potential impacts on society. The main objective of the European Commission in implementing the essential-use concept in the authorisation process is to render decision-making on applications “more efficient and aligned with societal needs” 12. However, the efficiency of a decision-making on the essentiality of a use applied for will also depend on the quality of the information and the amount of details provided by the applicant.
4.4. The multicriteria analysis could be the central tool for weighing qualitative and quantitative impacts in an essential-use assessment
ECHA admits that it can be difficult for the applicants to make a quantitative assessment for a certain type of impact (e.g. loss of welfare of customers), but still “the analysis should involve quantifying and monetising impacts as far as is practicable (and appropriate) and combining the monetised results with qualitative and/or quantitative descriptions of all non-monetised impacts”. ECHA encourages applicants to present at least qualitative conclusions on the expected severity and extent of each impact in the form of a multicriteria analysis-like approach to clarify the uncertainties in their assessment and to clearly explain to authorities the assumptions they made to reach their conclusions on the evaluated impacts 18. As described in Appendix F of the guidance on socio-economic analysis, multicriteria analysis is a structured approach used to compare the impacts and/or the objectives of several alternative options. Through the measurement of indicators like scoring, ranking, and weighting systems, these options are often based on quantitative analysis of a wide range of qualitative and quantitative impact categories and criteria. According to ECHA, “the key features of multicriteria analyses are the identification of criteria to provide a means of measuring the degree to which the various objectives are met, and the relative weighting of the objectives which directly incorporates their value judgments in the assessment of options. This contrasts with economic analysis (particularly the efficiency-based approaches of cost-benefit analysis and cost-effectiveness analysis) which is aimed at providing an objective measure of the net value (or social worth) of a proposed option” 18.
Such approaches could be useful when performing a structured evaluation of the criticality for human health, safety, and/or functioning of the society of a use applied for, which could facilitate the decision-making. As already highlighted by Gabbert et al. (2014), an efficient, social-welfare-oriented management of risks relies mostly on transparent and coherent decision-making. To that end, regulators could develop a precise framework based on the multicriteria analysis approach with a clear definition of the minimum amount and type of information that applicants should provide. By clearly explaining to the applicants how it can be demonstrated that a use is essential and by encouraging them to be as transparent as possible on how they reach their conclusion on the essentiality of the use applied for, it can be expected that regulatory authorities will be able to reach a reliable decision faster and less resource-intense. The potential novel framework should be illustrated with concrete examples to explain how authorities would decide on an application for authorisation based on the quantity and quality of the information provided, so the outcome of the process could be more predictable for the applicants. A more detailed description of information requirements for an essential-use assessment within an application for authorisation would be needed to ensure the workability and predictability of this novel risk management approach.