Transparency of chemical risk assessment data under REACH.
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.
Department of Environmental Science and Analytical Chemistry, Stockholm University, 106 91 Stockholm, Sweden. ellen.ingre-khans@aces.su.se.
Ellen
http://orcid.org/0000-0002-4371-2847
E
Ingre-Khans
Department of Environmental Science and Analytical Chemistry, Stockholm University, 106 91 Stockholm, Sweden. ellen.ingre-khans@aces.su.se.
Marlene
http://orcid.org/0000-0003-2697-2310
M
Ågerstrand
Institute of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden.
Anna
A
Beronius
Department of Environmental Science and Analytical Chemistry, Stockholm University, 106 91 Stockholm, Sweden. ellen.ingre-khans@aces.su.se.
Christina
C
Rudén
D002617:Chemical Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D016208:Databases, Factual; D005062:European Union; D015386:Hazardous Substances / Q000592:standards* / Q000633:toxicity*; D006801:Humans; D018570:Risk Assessment / Q000331:legislation & jurisprudence* / Q000592:standards*
D015386:Hazardous Substances