Information about substances of very high concern (the Candidate List)

Review the documentation on substances present in the equipment and related supplies.

It is also important to review the supplier's routines for traceability according to the qualification requirement " Routines for control of information regarding hazardous substances in the equipment”.

The European Chemicals Agency (Echa) publishes a list on substances of very high concern (SVHC). This list is called the Candidate List. The substances can be carcinogenic, mutagenic, and reprotoxic (CMR), as well as Persistent, Bioaccumulative, and Toxic (PBT/vPvB).). The current list can be found at the European Chemicals Agency's web site.

When a professional client is the purchaser, the supplier or reseller is legally obliged to supply information concerning the presence of substances in the Candidate List in products in concentrations exceeding 0.1% by weight. Thus, this requirement can be used to secure compliance to the REACH declaration.

According to Regulation (EU) 2017/745 on Medical Devices, Appendix 1, Section 10.4.5, the product or its packaging must be labeled if CMR substances (categories 1A and 1B) and hormone disrupting substances occur in levels above 0.1% by weight in products in contact with the body. The substances that occur must be stated and information on precautions should be provided in the instruction manual.

The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.