Requirements for Articles

Restricted substances (Annex XVII)

Any substance on its own, in a mixture or in an article, subject to a restriction under Annex XVII of REACH, cannot be manufactured, placed on the market or used unless it complies with the conditions of the restriction.

Authorisation substances (Annex XIV)

Before a substance can be included in Annex XIV, it must be identified as an SVHC and placed on the Candidate List. Periodically, ECHA will look at the substances on the Candidate List and identify and recommend priority substances to add to Annex XIV.

Substances included in Annex XIV (Authorisation List) of REACH cannot be placed on the market or used after the sunset date^[1] unless authorisation has been granted for a specific use, or the use is exempt from authorisation. Any EU producer of articles that incorporates such a substance into the produced articles, either as such or in a mixture, needs to check if such a use after the sunset date will require authorisation.

Candidate list (SVHCs)

The Candidate List is a list of chemical Substances of Very High Concern (SVHC) for human health or the environment. These include substances that are carcinogenic, mutagenic, toxic for reproduction, or particularly hazardous to the environment (PBT^[2] or vPvB^[3] ). Endocrine disruptors may also be included on the list.

The Candidate List contains substances that are candidates for inclusion on the list of substances requiring authorisation under REACH. Even if the substance is finally included in Annex XIV, the substance is not removed from the candidate list.

The European Chemicals Agency (ECHA) updates the Candidate List twice a year with new substances.

Summary of obligations in articles resulting from inclusion of SVHC in the Candidate List

• Requirement to inform customers and consumers under REACH: If an article contains substances on the Candidate List in a concentration above 0.1% w/w.
• Requirement to notify ECHA under REACH: If an article contains a substance on the Candidate List in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% w/w.
• Requirement to notify ECHA under the Waste Framework Directive (SCIP Database).
  Click here to learn more about SCIP Database Notification.

Registration of substances in articles

Registration of substances in articles (although there are some exemptions) is required when:

• The substance is intended to be released under normal or reasonably foreseeable conditions of use; AND
• The total amount of the substance present in all articles with intended release (i.e. including the amounts that are not intended to be released) produced or imported by one actor exceeds 1 tonne per year.