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.
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.
Required actions for articles under REACH regulation
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:
- EU member states may submit substances meeting Article 57 criteria (e.g. CMR, PBT, vPvB, or substances of equivalent concern) to ECHA under Article 59. Proposed substances are published for a 45-day public consultation.
- To control SVHC risks and promote substitution, selected substances from the Candidate List are added to the Authorization List. Use requires authorization from ECHA (Article 56).
- Updated every two years. Click to view latest Authorization List
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:
- EEA branch office
- EEA importer
- Authorized representative company in the EEA
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