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Substances of very high concern (SVHCs) are chemicals that have serious effects on human health or the environment. These chemicals may be individual substances or present in articles contained within a complex product. Some examples of the criteria for these substances, as stated in Article 57 of the EU REACH Regulation, include substances that are carcinogenic, mutagenic, bio-accumulative, or toxic for reproduction. Individual substances and articles within products may not contain an SVHC over the allotted 0.1 percent weight by weight threshold.
How Are Substances Identified as SVHCs?
Member states or ECHA identify substances as SVHCs. In the first step of this process, a dossier is prepared to explain why the substance meets the criteria established in Article 57 of REACH. A list of proposed substances is then published to the ECHA website. This publication gives interested parties — including companies importing, manufacturing, or using the substance in the EU — the opportunity to comment on the addition of the substance. Following this comment period, the substance is either automatically added to the Candidate List, or it is referred to the Member State Committee for further deliberation if comments have been made.
Company Obligations Once an SVHC Is Added to the Candidate List
Once a substance has been added to the Candidate List, companies manufacturing, importing, or using the substance in the EU have immediate legal obligations to fulfill. Companies must notify ECHA if a substance listed on the Candidate List is present in their articles above the specified threshold, or in quantities totaling more than one metric ton per year. Notification must be made no later than six months after inclusion of the substance on the Candidate List. Suppliers of articles that contain an SVHC above the threshold have a legal obligation to provide information on safe use of the article to their customers under Article 33 of REACH. Companies should also be aware of other requirements they may be in scope of, such as Authorisation and Restriction requirements, to ensure they are conducting comprehensive due diligence.
Use the Assent Materials Declaration Tool to upload, edit, validate, and generate IPC-1752A and IPC-1754 XML declaration files.