In an article published on September 5, 2022, in the journal Environmental Sciences Europe, Flora Borchert and co-authors from Stockholm University and the Karolinska Institutet, Stockholm, Sweden, investigated the use of scientific evidence to restrict chemicals under REACH. The authors wanted to (i) find out which types of key studies the Committee for Risk Assessment (RAC) hosted by the European Chemicals Agency (ECHA) uses to restrict hazardous substances, (ii) “analyse if the REACH registration database provided the key studies used in these restrictions, and (iii) investigate potential disagreements between experts related to the use of non-standard studies in the restrictions.” Standardized studies use test methods approved for regulatory use by the ECHA or following internationally validated standardized test guidelines (e.g. from the OECD, ISO), while non-standard studies follow other protocols. In contrast to standard studies which are considered suitable for regulatory assessment by default, the suitability of non-standard studies is less clear leading to debate within the scientific community over their suitability in risk assessments.
In the first six month of 1021, Borchert and co-authors identified the REACH restrictions in which RAC supported the proposed restriction and provided at least one key study (i.e., assessing (eco)toxicological hazard(s)) leading to the restriction. This process led to the selection of 18 RAC opinions supported by 53 key studies in total. The authors found that 58% of the 53 key studies were non-standard studies showing that these contribute to or are even “indispensable” in the identification and management of hazardous chemicals under REACH. The non-standard studies were used in 11 of the 18 analyzed RAC opinions with seven opinions only using non-standard studies. Moreover, 30% of the key studies were not included in the REACH registration database with the majority of them being non-standard studies. Therefore, “the REACH registration database does not contain all data relevant to the restriction of hazardous chemicals.” The scientists further reported that 9% of the key studies (all standard studies) were not publicly available indicating a lack of transparency in REACH restrictions. This makes it impossible for third parties to examine REACH registration data and retrace RAC decision-making.
Based on these findings, Borchert et al. emphasized the need for more transparency: they recommend registrants make their data publicly available and RAC and ECHA justify selecting certain key studies in decision making. Furthermore, the authors “recommend the European Commission to promote the use of all available evidence in the assessment and management of chemicals.”
The objective of the EU’s REACH regulation is to protect humans and the environment from hazardous chemicals. For instance, it outlines which hazard information companies need to submit when aiming to register a substance. The REACH registration process is currently subject to revision and potential updates may include assessing chemical mixtures, simplifying safety data sheets, and incorporating the essential-use concept (FPF reported and here). REACH requires all restriction proposals to be assessed by RAC prior to a final decision by the European Commission.
Reference
Borchert, F. et al. (2022). “Characterisation and analysis of key studies used to restrict substances under REACH.” Environmental Sciences Europe. DOI: 10.1186/s12302-022-00662-8
Read more
Turley, A. (September 15, 2022). “Analysis shows non-standard studies are ‘indispensable’ to REACH restrictions.” ChemicalWatch
