REACH SVHC Compliance Analysis
REACH SVHC Compliance Analysis
Under the framework of the European Union's REACH regulation, Substances of Very High Concern (SVHC) are chemical substances that pose significant risks to human health or the environment. Once a substance is added to the Candidate List, relevant enterprises are legally mandated to fulfill compliance obligations, including information disclosure and notification.
SVHC Identification Criteria
SVHC identification criteria are established by the European Chemicals Agency (ECHA) through scientific assessment and review under the REACH Regulation. The list primarily covers the following types of substances:
• CMR Substances: Carcinogenic, Mutagenic, or toxic to Reproduction.
• PBT Substances: Persistent, Bioaccumulative, and Toxic.
• vPvB Substances: Very Persistent and Very Bioaccumulative.
• Other Substances: Substances with evidence of an equivalent level of concern.
If an assessment determines that the risks require further control, the substance may be added to the Authorisation List (Annex XIV). In such cases, companies must obtain official authorization before they can continue using the substance in the EU market.
As of March 2026, the SVHC Candidate List has been updated to the 34th batch, containing a total of 253 substances.
Phthalates (16P) in the SVHC List
Currently, the Candidate List includes 16 phthalates. Most have been categorized as SVHCs due to their reproductive toxicity or potential health risks. These substances are a primary focus for enterprises managing product compliance.
Related Link: ECHA Candidate List of SVHCs
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Author: Dr. TC Wu | RD Supervisor | Group Research and Development Center
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