To gain access to the EU market, companies must record a chemical’s safety information in a registration dossier and submit it to the European Chemicals Agency (ECHA) for evaluation under the REACH and CLP regulations. On June 17, 2021, ECHA released a report reviewing the implementation of the two pieces of legislation over the last five years, the impact they have had on the European occupational health and safety system, and highlighting shortcomings in regulatory procedures and enforcement.
Through the information provided by chemical companies and manufacturers over the last five years, ECHA has added 71 chemicals to the harmonized classification and labeling list because of their potential carcinogenic, mutagenic, or reproductive effects. ECHA found that in 90% of cases, the safety assessments companies performed on the chemicals they produce are communicated down the supply chain to allow others to implement safety procedures. However, the report also found that half the time those same chemical safety assessments are incomplete.
A shortcoming highlighted in the report is the loss of information through the steps to get from the original registration of a chemical’s production to the safety advice needed for using the chemical. This is particularly true for chemical mixtures as, according to the report, “the substance related REACH information needs to be ‘translated’ into safety data sheets for mixtures, for which – except for the classification and labeling rules – no acknowledged method currently exists” (FPF reported). In 2018, inspectors conducted checks on 3300 safety data sheets for mixtures and found 33% were not compliant due to “deficiencies in particular relating to information on hazard identification and exposure controls” (FPF reported) and 17% of mixtures were incorrectly classified “leading to unidentified risks.”
Of the approximately 180 000 substances companies self-classified, around 23 000 are manufactured or imported in volumes above one metric ton per year and thus must be registered. By changing regulations to consider substance groups and broad uses, the impact of safety regulation has increased, but the resources necessary to make a dossier and official opinion is more resource intensive (FPF reported). ECHA notes that co-registrants of the same substance are only required to share vertebrate animal data from safety testing, but extending these data-sharing rules could lead to further avoidance of unnecessary tests. If the information collected is incomplete or incompliant, ECHA and EU Member State authorities will request more information, or if the concern can be clarified without additional information, update regulations. According to ECHA, “expert group consultation has proven to be efficient and enable consistency. This is particularly the case when identifying persistent, bioaccumulative, and toxic, or endocrine disrupting substances… The great majority of expert group conclusions (over 80 % in general, up to 100 % in cases related to identification of substances of very high concern) were followed by the committees.”
ECHA’s report cites a 2019 finding that “55% of companies did not have systems in place to ensure dossier updates and 18 % of companies were found to be in breach of the obligation to update their registration” (FPF reported here and here). They note an issue in the dossier update process in that co-registrants for a chemical’s original authorization do not always continue contributing to dossier updates as there is little incentive to do so.
ECHA (June 2021). “Report on the operation of REACH and CLP 2021.”
ChemSec (June 17, 2021). “ECHA’s 5-year review paints dark picture – but there is hope.”