Under the regulations of
REACH certification, chemicals are divided into three categories: substances, mixtures, and articles.
substance : refers to chemical elements and their compounds in their natural state (existing) or obtained through the production process, including additives necessary to maintain their stability and impurities generated during processing, but excluding separable solvents that will 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 manufacturer according to a certain proportion, such as color masterbatch, additive masterbatch, etc.
items: refers to objects that obtain a specific shape, appearance or design during the manufacturing process. The chemical composition of these shapes, appearances and designs determines their functionality.
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1 for a substance or a substance in a mixture
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Under the REACH regulations, all companies that produce or import chemical substances greater than 1 ton/year into the EU need to register the chemical substances they produce or import with the European Chemicals Agency.
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5 Substance in article
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Since items may contain substances of very high concern (SVHC) specified in the REACH regulations, they are subject to compliance assessment obligations. That is, items in the EU or imported into the EU market need to undergo SVHC testing to determine whether the items contain SVHC substances, and subsequent response steps will be determined based on the test results.
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If an article contains an SVHC substance and the content exceeds 0.1% of the entire product, and the annual export volume of the substance exceeds 1 ton (both conditions must be met at the same time), the product meets the notification requirements, and the company must notify ECHA.
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If an article contains intentionally released substances (such as air fresheners, erasers), and the amount in the article is greater than 1 ton/year, these substances will also be subject to (pre-)registration obligations. 0