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BiopSafe^® follows the EU regulation on classification, labelling and packaging of substances and mixtures, effective from January 1, 2016. BiopSafe^® is CE marked and compliant with the Medical Device EU IVD 2017/746 Regulation.

AS PER REGULATION (EC) No 1272/2008 (LAST VERSION 14th NOV 2020) OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL: FORMALDEHYDE IS DECLARED CARCINOGENIC CLASS 1B AND MUTAGENIC CLASS 2.

AS PER DIRECTIVE 2004/37/EC (LAST VERSION 26th JUL 2019) OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL: the employer shall ensure that the carcinogen or mutagen is, in so far as is technically possible, manufactured and used in a closed system.