The full name of the EU REACH regulation is "Registration, Evaluation, Authorization and Restriction of Chemicals", which refers to the registration, evaluation, authorization and restriction of chemicals. It is the EU's preventive management regulation for all chemicals entering its market. The EU REACH regulation officially came into effect on June 1, 2007 and came into effect on June 1, 2008.
According to the EU REACH regulation, companies are required to submit a registration to the European Chemicals Agency (ECHA) for chemical substances (substances themselves, substances in mixtures, or substances intentionally released in articles) with an annual production or import volume exceeding 1 ton within the EU. Otherwise, the company will not be allowed to continue manufacturing, importing, or selling the chemical within the EU. In addition, the regulations for some registered substances also stipulate the obligation to continue to perform evaluations, notifications/authorizations, and restrictions.
▶The core content governed by the EU REACH regulation
Five major obligations
Registration, evaluation, notification/authorization, restriction, (e) SDS transmission
Three major objects
Under the EU REACH regulation, chemicals are classified into three main categories: substances, mixtures, and articles.
Substance: refers to chemical elements and their compounds obtained in their natural state (existing) or through production processes, including necessary additives to maintain their stability and impurities generated during processing, but does not include separable solvents that do not affect the stability of the substance or change its composition.
Mixture: refers to a mixture or solution composed of two or more substances. This mixture is artificially mixed by the producer in a certain proportion, such as color masterbatch, auxiliary masterbatch, etc.
Article: refers to an object that obtains a specific shape, appearance, or design during the manufacturing process, and the chemical composition of these shapes, appearances, and designs is more likely to determine its function.
Four major responsible roles
EU manufacturers
EU Importers
Unique Representative (OR)
Downstream users
Three major management tools
REACH-IT online submission channel
IUCLID file creation software
Chesar software
▶ Scope of registration under the EU REACH regulation
1. Chemical substances exceeding 1 ton/year released on the EU market;
2. Chemicals exceeding 1 ton/year in the mixture released on the EU market;
Intentionally released chemicals in items placed on the EU market, with a total amount exceeding 1 ton per year.
Note: Intentional release of substances from an item: Substances intentionally released from an item under normal or reasonably foreseeable use, usually to achieve some auxiliary function of the item, such as air freshener.
Registration subject of EU REACH regulation
1. Producers of substances, preparations, and goods within the European Union;
2. Importers of substances, preparations, and goods within the European Union;
3. Non EU manufacturers of substances, preparations, and items must fulfill the registration obligations required by the EU REACH regulation through a sole representative (OR) within the EU.
