European Market
This regulation was established by the EU to reduce risks posed by chemicals to human health and the environment, provide alternative methods for hazardous substance assessment, and enhance the competitiveness of the EU chemical industry. It mandates the registration, evaluation, authorization, and restriction of chemicals entering the EU market, significantly raising the requirements for chemical-related products. As a result, it has a broad impact across supply chains. The regulation entered into force on June 1, 2007, and is primarily enforced by the European Chemicals Agency (ECHA).
REACH classifies products into substances, mixtures, and articles (as illustrated below). Its scope covers a wide range of products. Except for certain exemptions (such as radioactive substances and defense-related exempt products), most products are subject to REACH requirements. Consumer products are fully within its regulatory scope.
Requirements differ for substances, mixtures, and articles. For example, substances and substances in mixtures mainly require registration and authorization before entering the EU market. For articles (including finished products), the focus is on whether SVHC (Substances of Very High Concern) and Annex XVII restricted substances comply with concentration limits. When SVHC concentration exceeds 0.1%, communication along the supply chain is required. If SVHC exceeds 0.1% and total annual export exceeds 1 ton, notification to ECHA (SVHC notification) is also required.
Refers to chemical elements and their compounds as naturally occurring or obtained through manufacturing processes.
Examples: gold, silver, copper, toluene, acetone, ethanol, etc.
Refers to a mixture or solution containing two or more substances.
Examples: paint, plastic pellets
Refers to an object which, during manufacturing, is given a specific shape, surface or design that determines its function more than its chemical composition.
Examples: screws, IC lead frames, gold wires, etc.
Taking articles as an example, REACH regulation mainly covers two aspects. First, when SVHC concentration in an article exceeds 0.1% (1000 ppm), safety information must be provided to buyers and consumers according to Article 33. Second, hazardous substances in articles are restricted with specific concentration limits and usage restrictions depending on the substance type.
Under REACH regulation, to manage risks posed by SVHCs in the EU, there are three lists: “Recommendation List”, “Candidate List”, and “Authorization List” as described below:
Under Article 8, non-EEA manufacturers cannot perform (pre-)registration or notification. They must appoint an Only Representative within the EEA to fulfill importer obligations, which may be:
Since SVHC Candidate List and REACH Article 33 are also referenced by the Waste Framework Directive (WFD), SCIP notification is required when SVHC concentration in articles exceeds 0.1% (w/w).
Please refer to REACH FAQ
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