Transparency of chemical risk assessment data under REACH

Abstract

The REACH regulation requires EU manufacturers and importers of substances to register information on the hazard and risk of their substances with the European Chemicals Agency (ECHA). Risk management of the substances is based on the provided information. It is known that conclusions on hazard and risk are influenced by expert judgements as well as potential conflict of interests. Thus, it is important that hazard and risk assessments are transparent and can be evaluated by a third party. The aim of this study is to scrutinize the transparency, i.e. the accessibility and comprehensibility, of information on substances registered under REACH. Data on repeated dose toxicity and hazard assessment conclusions were extracted for 60 substances from the REACH registration database available on the ECHA website. The data were compiled in a database for systematically evaluating the transparency of information related to the conclusions on hazard or risk. In addition, chemical safety reports (CSR) were requested from ECHA for five substances. The transparency of information on the hazard and risk of substances was found to be limited for several reasons. First, certain information was removed due to confidentiality and certain fields were not published because they could contain confidential information although the information had not been claimed confidential. Also, the extent to which registrants reported information varied, and the presentation of some data and certain terminology required further clarification. In addition, the data source for the majority of the key and supporting studies could not be identified due to confidentiality. Since registrants are only required to summarise studies, it cannot be verified whether all relevant information from non-public industry reports have been reported. Lastly, certain information related to the hazard and risk assessment were only reported in the CSR which is only available upon request; a time-consuming and work-intensive process. As information on registered chemicals is currently provided to the public, it is difficult to follow steps that are undertaken in the hazard and risk assessment. This limits the possibility for a third party to evaluate the assessment.

Toxicity studies used in registration, evaluation, authorisation and restriction of chemicals (REACH): How accurately are they reported?

“…The studies that were used in the present investigation were selected because they could be identified and accessed and thereby used for comparing the information in the published study with the study summary. However, as shown in a previous investigation, the data source could not be identified for 69% of the study summaries submitted for 59 substances on the endpoint RDT (Ingre-Khans et al 2016). Of all the cited references, 60% referred to industry data that are neither publicly available nor possible to identify under REACH.…”

Will worker DNELs derived under the European REACH regulation extend the landscape of occupational exposure guidance values?

“…There is no public consultation of wDNELs, nor does ECHA systematically control all the submitted wDNELs, as the REACH regulation only requires ECHA to control at least 5% of all submitted registration dossiers [REACH Regulation 2006, Article 41 (5)]. Lack of transparency is an issue for third party scrutiny of DNELs (Westerholm and Schenk 2014;Ingre-Khans et al 2016). The wDNELs and summaries of the data (exceptions for confidentiality are possible) they are based on are only partially publicly available through the registered substances database.…”

Improving structure and transparency in reliability evaluations of data under REACH: suggestions for a systematic method

“…The 60 substances comprised 51 substances selected from a list of substances provided by the German Federal Institute of Risk Assessment (BfR) investigating data availability in REACH dossiers (BfR 2015), as well as another nine substances undergoing the REACH authorization and/or restriction processes. The selection of substances in the original data set has been described in detail elsewhere (Ingre-Khans et al 2016). Data from 60 substances were considered as a feasible and sufficient basis for carrying out case-studies and the endpoint RDT was selected since this was a standard information requirement for all the included substances.…”