REACH – the Registration, Evaluation, Authorization and Restriction of Chemicals – is the European Union’s chemical safety and control regulation. It allows the European Chemicals Agency, ECHA, broad authority to control what chemicals are allowed to be manufactured or imported into Europe, how they may be used, how they are to be packaged and labeled, and what information manufacturers / importers must provide to users and to ECHA to help ensure health, safety and environmental protection.
REACH places significant obligations on manufacturers and importers who want to introduce their products into Europe. Like the American and Canadian systems, REACH establishes a chemical inventory and empowers a regulatory agency to monitor and control the manufacture, importation, packaging, labeling and use of chemicals. Like the American system, REACH exempts certain substances such as polymers from registration. However, registration of chemical substances in Europe is done by individual manufacturers and importers, who must provide ECHA with information about what chemical substances are bring manufactured or imported as well as expected annual volumes (divided into broad tonnage bands). Further, the manufacturer / importer must provide dossiers with information about the substances: physical-chemical properties, uses, labeling, and hazards posed to human health and the environment. Depending on the chemical, the required information can be very extensive.
Yes, but they must have a legal presence in Europe that can provide the necessary information to ECHA. This can be an “Only Representative” (OR), which is a person or organization in Europe that serves as the legal point of contact between ECHA and the importer. The OR is responsible for collecting required information about the substance and making the necessary reports (e.g., import volumes) to ECHA.
No. As a practical matter, ECHA considers polymers to be mixtures, and the components – monomers, additives, preservatives, etc. – are subject to registration requirements.
Yes. There are many chemicals / classes of chemicals that, because of their known or suspected hazards to health and / or the environment, are subject to special regulations. For example, ECHA maintains a list of Substances of Very High Concern (SVHC) that have special reporting and authorization requirements. The ECHA inventory provides a great deal of information about thousands of chemicals and should be checked prior to attempting to import chemicals into Europe. Indeed, the regulatory requirements for chemicals should often be reviewed as ECHA adds new restrictions on a frequent basis.
There is a broad exemption for chemicals manufactured or imported at less than 1 MT/ yr. This is very useful when dealing with mixtures. However, one must be aware of special regulations, e.g., SVHC.
Like almost every country or group of countries with a large and active chemical industry, Europe has its own regulations about how a Safety Data Sheet (and chemical label) must be written. There are special requirements for noting certain hazard types. Europe is also implementing a Unique Formula Identified (UFI) system for chemical and mixtures in commercial use to assist poison control centers with emergency response. Finally, individual countries in Europe may have their own national requirements such as the German WGK (Water Hazard Class).
UK REACH came into effect on January 1, 2021, replicating the EU REACH Regulation, but both operate independently. The key principles of the EU REACH Regulation have been retained, requiring the registration of substances manufactured or imported at quantities above 1 MT/year. Companies based outside of the UK will need to use a UK-based “Only Representative” (OR) to access the UK REACH scheme and market.
Yes. For many of our products, we have existing Only Representatives and can facilitate the process. Please contact your Gantrade sales representative for more information.