The European Chemicals Agency plays a vital role in everything from REACH to PFAS regulations. But what is the ECHA and what exactly is it responsible for?
The European Chemicals Agency (ECHA) is the European Union’s regulatory agency for the conception, implementation, and management of chemicals legislation. In addition to its role in the administration of various key pieces of EU legislation related to chemicals and the chemicals industry, the ECHA also collaborates with companies and organizations on legal compliance, maintains comprehensive databases on chemical substances, and publishes lists of substances that pose significant risks to human health and the environment. Finally, the agency promotes innovation and progress within the chemicals industry. It does this by leading gradual phaseouts of hazardous substances and encouraging corporations to find new, safer, and cleaner ways to manufacture everyday products.
The European Chemicals Agency, which is based in Helsinki, Finland, traces its origins to the establishment of the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation in 2006. The EU effectively created the agency, which began work in June 2007, to oversee the implementation and administration of REACH. Since it came into existence over 15 years ago, the ECHA has expanded its purview beyond REACH. It now oversees various other key pieces of chemicals regulation, including Classification, Labeling, and Packaging (CLP), Biocidal Products Regulation (BPR), and Prior Informed Consent Regulation (PIC). The ECHA is also tasked with administrating and advancing the EU’s Waste Framework Directive.
Though its responsibilities have expanded significantly since its inception in 2007, the ECHA’s primary role continues to be the management of REACH. As the European Commission succinctly explains on its website, the ECHA is “the central point in the REACH system: it manages the databases necessary to operate the system, coordinates the in-depth evaluation of the information provided on chemicals and runs a public database where consumers and professionals can find hazard information.”
Of all the work the ECHA executes with respect to REACH, probably the most substantial is the role it plays in processing all the information companies must register with the agency when introducing a chemical substance into the marketplace. In accordance with REACH regulation, companies are required to compile datasets, scientific properties, and other details on their substances and submit them to the European Chemicals Agency in the form of what’s called a registration dossier.
After companies submit these registration dossiers to the ECHA, the agency then carries out a multi-step evaluation process. This entails, among other tasks, reviewing whether the substance is in full compliance with REACH regulations and examining the testing proposals established by the company.
The ECHA is also responsible for maintaining the sprawling database where all these registration dossiers are housed. To date, this includes roughly 23,000 substances and all their requisite information.
As part of the REACH directive, the European Chemicals Agency also oversees the official process to identify, restrict, and, in certain cases, phase out substances of very high concern (SVHC). This begins with the ECHA recognizing that a particular substance has the potential for significant adverse effects on human health or the environment. These are, according to the ECHA, “primarily substances which are carcinogenic, mutagenic or toxic to reproduction as well as substances with persistent and bio-accumulative characteristics.” The class of substances known as per- and polyfluoroalkyl substances, or PFAS, for example, have a number of SVHC.
Once something is officially listed as an SVHC, it is entered into the “Candidate List,” where individuals and industry professionals can readily find it. On a regular basis, the ECHA assesses whether substances on the Candidate List should be moved to the “Authorisation List,” a somewhat confusingly titled roster of substances that have been scheduled to be phased out of the market. After a substance on the Authorisation List is sunsetted, it can only be used with explicit authorisation (hence the name). (For a more detailed dive into REACH and SVHC, take a look at our post on RoHS vs. REACH.)
In addition to the work the European Chemicals Agency does as the fulcrum of REACH, ECHA also plays a prominent role in several other EU regulations and directives. Chief among these is Classification, Labeling, and Packaging (CLP). CLP is a regulation established by the EU in 2008, and meant to work in congress with REACH.
Under the CLP regulation, substances or mixtures that are deemed to be hazardous or that possess explosive properties must adhere to specific requirements for the classification and labeling of those materials. The CLP has established several classes for physical hazards, health hazards, and environmental hazards, and under most circumstances it is up to the manufacturers, distributors, and other key stakeholders to determine the hazard classification and adhere to the relevant requirements. In general, labels should include the following information:
As with REACH and its databases, the ECHA is the primary administrator of the CLP, its hazard classifications, and the specific labeling and packaging requirements. As of 2022, the ECHA had received classification and labeling information for more than 200,000 substances.
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