SVHC and Restricted Substances under REACH
REACH Substances of Very High Concern, SVHC, and the substances subject to authorisation (Annex XIV), are substances that have been listed because they fulfil any of the below criteria:
- Substances classified as CMR in categories 1A or 1B.
CMR: Carcinogenic, mutagenic or reproduction toxic chemicals.
- PBT substances and vPvB substances as specified in REACH annex XIII.
PBT = Persistent, bioaccumulative or toxic chemical.
vPvB = very persistent or very bioaccumulative or toxic chemical.
- Other substances for which there is scientific evidence of probable serious impact on human health or on environment, with similar degree of concern of the above mentioned substances. An example for this type of substances are endocrine disruptors with effects on the hormone system.
First the identified substances are listed by ECHA in the so-called candidate list. If the substance is then identified to fulfil the criteria of PBT/vPvB or of ‘wide, dispersive use’ or as having high volumes, then the substance will be proposed for inclusion in Annex XIV. Even if the substance is included in Annex XIV, the substance is not deleted from the candidate list. The use of substances subject to authorisation require prior authorisation. The application for authorisation is submitted to ECHA, but the authorisation decision is taken by the European Commission.
The purpose is to achieve:
- Full control of all risks arising from production or use of that SVHC, and
- Substitution of this SVHC where ever economically and technically feasible.
The list of SVHC is maintained by ECHA in the form of the so-called SVHC candidate list.
The authorisation process does not concern articles that are imported into the EU. However, the obligations related to the Candidate list do apply to importers of articles. Therefore, importers need to know whether the articles they import contain SVHC.
In addition, importers must be aware of the list of restricted substances (Annex XVII to REACH). The restrictions are a separate regulatory process, applied when there is unacceptable risk arising from the manufacture, use or placing on the market of any substance. If a substance is listed in Annex XVII, the substance is fully restricted under the conditions of the specific entry.
You are not sure whether any of your products contain SVHC or Restricted Substances above allowed concentrations and quantities? Then please follow the link to SVHC evaluation.
For consulting on above issues and design of any test program, please contact
Ditte Fast Bonde, Phone +45 70 22 42 76 in Denmark
or Jody Yam, Phone +852 263 632 33 or +86 131 439 879 87 in China