TOPICS : 02- QUALITY, SAFETY & ENVIRONMENT  / 11. What is the EDQM position’s on hazardous substances? 

The EDQM and the European Pharmacopoeia Commission continues the existing policy of avoiding the use of Substances of very High Concern (SvHC).

The SvHC are defined, for example, by the UN as ozone depleting substances, persistent organic pollutants, hazardous chemicals and pesticides in international trade and by the EU through registration, evaluation, authorisation and restriction of chemicals (REACH). SvHC are replaced when an alternative is technically achievable, for example, as part of revision of a monograph. Some SvHC may be necessary for analysing the quality of raw materials for medicines. The principles of the FAQ 09 apply to these substances as used at the EDQM, but the EDQM does not always have information on the quantities downstream users are processing. If you have suggestions or information on particular SvHC or in general, please contact us.

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