Applying the Essential Use Concept Within the REACH Authorisation Process
The Role of Behavioral Ecotoxicology in Environmental Protection
Emerging investigator series: use of behavioural endpoints in the regulation of chemicals
Interest in behavioural ecotoxicology is growing, partly due to technological and computational advances in recording behaviours but also because of improvements of detection capacity facilitating reporting effects at environmentally relevant concentrations. The peer-reviewed literature now contains studies investigating the effects of chemicals, including pesticides and pharmaceuticals, on migration, dispersal, aggression, sociability, reproduction, feeding and anti-predator behaviours in vertebrates and invertebrates. To understand how behavioural studies could be used in regulatory decision-making we: (1) assessed the legal obstacles to using behavioural endpoints in EU chemicals regulation; (2) analysed the known cases of use of behavioural endpoints in EU chemicals regulation; and (3) provided examples of behavioural endpoints of relevance for population level effects. We conclude that the only legal obstacle to the use of behavioural endpoints in EU chemicals regulation is whether an endpoint is considered to be relevant at the population level or not. We also conclude that ecotoxicity studies investigating behavioural endpoints are occasionally used in the EU chemicals regulation, and underscore that behavioural endpoints can be relevant at the population level. To improve the current use of behavioural studies in regulatory decision-making contribution from all relevant stakeholders is required. We have the following recommendations: (1) researchers should conduct robust, well-designed and transparent studies that emphasize the relevance of the study for regulation of chemicals; (2) editors and scientific journals should promote detailed, reliable and clearly reported studies; (3) regulatory agencies and the chemical industry need to embrace new behavioural endpoints of relevance at the population level.
On the issue of transparency and reproducibility in nanomedicine
Reliability and relevance evaluations of REACH data
Regulatory authorities rely on hazard and risk assessments performed under REACH for identifying chemicals of concern and to take action. Therefore, these assessments must be systematic and transparent. This study investigates how registrants evaluate and report data evaluations under REACH and the procedures established by the European Chemicals Agency (ECHA) to support these data evaluations. Data on the endpoint repeated dose toxicity were retrieved from the REACH registration database for 60 substances. An analysis of these data shows that the system for registrants to evaluate data and report these evaluations is neither systematic nor transparent. First, the current framework focuses on reliability, but overlooks the equally important aspect of relevance, as well as how reliability and relevance are combined for determining the adequacy of individual studies. Reliability and relevance aspects are also confused in the ECHA guidance for read-across. Second, justifications for reliability evaluations were mainly based on studies complying with GLP and test guidelines, following the Klimisch method. This may result in GLP and guideline studies being considered reliable by default and discounting non-GLP and non-test guideline data. Third, the reported rationales for reliability were frequently vague, confusing and lacking information necessary for transparency. Fourth, insufficient documentation of a study was sometimes used as a reason for judging data unreliable. Poor reporting merely affects the possibility to evaluate reliability and should be distinguished from methodological deficiencies. Consequently, ECHA is urged to improve the procedures and guidance for registrants to evaluate data under REACH to achieve systematic and transparent risk assessments.
Improving structure and transparency in reliability evaluations of data under REACH: suggestions for a systematic method
The goal of identifying hazardous chemicals registered under the Registration, Evaluation, Authorization and restriction of CHemicals (REACH) Regulation and taking appropriate risk management measures relies on robust data registrations. However, the current procedures for European chemical manufacturers and importers to evaluate data under REACH neither support systematic evaluations of data nor transparently communicate these assessments. The aim of this study was to explore how using a data evaluation method with predefined criteria for reliability and establishing principles for assigning reliability categories could contribute to more structured and transparent evaluations under REACH. In total, 20 peer-reviewed studies for 15 substances registered under REACH were selected for an in-depth evaluation of reliability with the SciRAP tool. The results show that using a method for study evaluation, with clear criteria for assessing reliability and assigning studies to reliability categories, contributes to more structured and transparent reliability evaluations. Consequently, it is recommended to implement a method for evaluating data under REACH with predefined criteria and fields for documenting and justifying the assessments to increase consistency of data evaluations and transparency.
Toxicity studies used in REACH ‐ How accurately are they reported?
Toxicity studies on chemicals registered under REACH are provided as summaries instead of submitting a full study report. Since the registration data are used by regulatory agencies to identify chemicals of concern, the study summaries must accurately reflect the information in studies. A “study summary” should include sufficient information on the objectives, methods, results and conclusions in the full study report to determine the relevance of the study. Sometimes a “robust study summary” is required, which should contain more detailed information to enable an independent assessment of the study. The aim of this investigation is to examine how well published toxicity papers were reflected in study summaries submitted by registrants under REACH. Summaries of 20 published studies (peer‐reviewed studies including one abstract) were examined and broad categories of various types of observed differences were derived. As seen, the extent to which information in the published studies was reported in the study summaries varied. It also varied how accurately the information was reflected. Differences between the published studies and the summaries included simple typing errors, unclear and incomplete reporting as well as the omission of information on for example study design, results or interpretation of the results, which in some of the cases could be considered relevant for the risk assessment. This raises concerns regarding the accuracy of study summaries and their use for decision‐making. Moreover, the possibility for third parties to independently assess and scrutinise the summaries is limited. Considering that we rely on REACH registration data for chemical safety, all data used for risk assessment should be accessible for thorough examination and fully independent assessment.
A call for action: Improve reporting of research studies to increase the scientific basis for regulatory decision‐making
This is a call for action to scientific journals to introduce reporting requirements for toxicity and
ecotoxicity studies. Such reporting requirements will support the use of peer‐reviewed research
studies in regulatory decision‐making. Moreover, this could improve the reliability and reproducibility
of published studies in general and make better use of the resources spent in research.