EDQM FAQs
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Answer:
The EDQM and the European Pharmacopoeia Commission maintain the existing policy of avoiding the use of Substances of very High Concern (SvHC).
SvHC are defined by the UN as ozone-depleting substances, persistent organic pollutants, hazardous chemicals and pesticides in international trade; they are regulated in the EU through registration, evaluation, authorisation and restriction of chemicals (REACH). SvHC are replaced when an alternative is technically feasible, for example, as part of the regular revision of a monograph. However, the use of some SvHC is still necessary when analysing the quality of raw materials for medicines.