SVHC (REACH)

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Substance of Very High Concern (SVHC)

A Substance of  Very High Concern (SVHC) is a chemical substance for which it has been proposed that the use within EU be subject to authorization under REACH Regulation. REACH is an EU regulation that enforces to all chemicals used in consumer products and for industrial purposes. The objective of REACH is to safely manage the risk of chemicals that may be dangerous to the consumers and the environment.
 

The criteria are given in article 57 of the REACH Regulation; A substance may be proposed as an SVHC if it meets one or more the following criteria: 

 
  • It is carcinogenic

  • It is mutagenic

  • It is toxic for reproduction 

  • It is persistent, bio-accumulative and toxic according to the criteria set out in Annex XIII to the REACH Regulation

  • There is "scientific" evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern, such as substances are identified on a case-by-case basis. 


Four Procedures of REACH Regulation

  • Registration of all substances manufactured or imported in more than 1 ton/year

  • Evaluation of the dossiers and the substances

  • Authorization for substances of very high concern

  • Restriction of substances causing a non-acceptable risk
     

Summary of Obligation

Obligation Notification of Substances in Articles Communication of Information on Substances in Articles
Legal basis in REACH Regulation Article 7(2) Article 33
Role Article producers and article importers Article suppliers
Substances concerned Substances included in the candidate list of substances of Very High Concern for authorization (SVHC) Substances included in the candidate list of Substances of Very High Concern for authorization (SVHC)
Tonnage threshold 1 ton per year ----
Concentration in article threshold 0.1% (w/w) 0.1% (w/w)
Exposure can be excluded Yes No