Occasionally, components may be used in IVD products that are classified as “Substance of Very High Concern” (SHVC). SHVCs include substances that meet the criteria for classification as
- carcinogenic, mutagenic or reprotoxic (CMR) category 1 or 2,
- persistent, bio-accumulative and toxic (PBT) substances.
- very persistent and very bio-accumulative (vPvB) substances;
- substances for which there is evidence for similar concern, such as endocrine disruptors.
Examples are for instance borate, perfluorinated substances and Triton X100.
When a substance is identified as a Substance of Very High Concern (SVHC) and included in the Candidate list under the REACH (Council on the Registration, Evaluation, Authorization and Restriction of Chemicals) regulation of the European union, users, suppliers, producers and importers have to adhere to legal obligations. Among others, the use of these substances must be avoided or safe substitutes must be used. This means that these chemicals cannot be used in IVDs once identified as SHVC.
Future Diagnostics has broad knowledge about the characteristics of chemicals and their effect in buffers and assay components.
From that knowledge we efficiently source substitutes for SVHCs. We can follow-up any design change that may be associated with the substitution of SVHCs from basically demonstrating equivalence, to a full design change including verification under our QCMS.
We are happy to help you find the right SHCV replacements for your IVD immunoassay
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