The supplier must have routines for controlling and managing information on the presence of hazardous substances in the equipment and supplies covered by the contract. The routines shall secure that information regarding presence of hazardous substances in concentrations above 0.1% by weight shall systematically be requested from sub-suppliers. The subjects referred to are substances that are listed in:
- REACH-declaration Candidate List (article 59 in Declaration (EG) no. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals)
- REACH-declaration appendix XVII (restricted substances list, declaration g (EG) nr 1907/2006)
- RoHS Directive appendix II (2011/65/EU, on the restriction of the use of certain hazardous substances in electrical and electronic equipment).
- The medical device regulation (EU 2017/745), appendix 1, section 10.4.1.
The routines must also secure that the information above is available for the procurer.
