25 June 2019: The European Commission and the European Chemicals Agency (ECHA) are taking action to ensure that registration dossiers under the REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation are compliant with EU legal requirements, with the aim of improved industry data on chemicals and safer chemicals use in the EU.
While more than 22,000 substances manufactured and used in the EU are registered as part of the REACH registration procedure, registration dossiers must contain the necessary information to establish measures to manage risks from chemicals to protect human health and the environment.
The REACH Evaluation Joint Action Plan, launched on 24 June 2019, is proposing an increase in the number of compliance checks undertaken on registration dossiers, in order to address lack of compliance and to encourage industry to improve their safety data on chemicals. The Commission is proposing an amendment to REACH to increase the current 5% minimum target for compliance checks to 20%. ECHA will screen all registration dossiers submitted before 2018, and launch compliance check for at least 30% of registered substances, including those with hazardous properties, or where more information is needed to clarify a concern or determine a potential risk. The Agency aims to screen registration dossiers for substances registered in very high volumes (over 100 tonnes per year) by 2023, and for substances in the lower tonnage bands (1-100 tonnes per year) by 2027. For high tonnage substances, ECHA will determine, by the end of 2020, whether they are a priority for risk management and for data generation or a low priority for further action.
To meet its targets, ECHA will reallocate staff to evaluation tasks, simplify compliance check decisions, increase enforcement, interact with industry associations to ensure that registrants ramp up their compliance efforts, and establish a transparent monitoring system to show progress made.
Over the past 12 years, the EU has significantly reduced citizens’ exposure to harmful chemicals by requiring industry to provide data and risk management measures to demonstrate the safe use of chemicals in a registration dossier. However, a third of REACH registration dossiers still do not fully comply with EU standard information requirements. To remedy this, the Commission asked ECHA to identify the reasons for non-compliance and to develop solutions.
REACH is an EU regulation that was adopted in 2006 and entered into force in 2007. It aims to improve the protection of human health and the environment from risks posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies must register their substances and do so by working together with other companies who are registering the same substance. REACH also promotes alternative methods for substance hazard assessment to reduce testing on animals.
ECHA receives and evaluates individual registrations for companies’ compliance, while EU member States evaluate selected substances to clarify initial concerns. Authorities and ECHA’s scientific committees assess whether the risks can be managed. If risks are deemed unmanageable, the hazardous substances can be banned. REACH impacts on companies across many sectors, including those that are manufacturers, importers and downstream users. [EC Press Release] [ECHA Press Release] [REACH Evaluation Joint Action Plan] [REACH Background]