Disinfectants actually fall under three different statutory regulations, namely the CLP Regulation, the Medical Products Regulation and the Medical Drugs Act. Whichever is applicable depends on the intended purpose of the disinfectant in question. Between 4 March and 26 March 2020, as many as three general decrees of BAUA (Federal Institute for Occupational Safety and Health) were added, which now grants special approvals for certain hand disinfection formulations. These can now be produced industrially also for normal consumers, without any supply restrictions.
Affected manufacturers and distributors of hand disinfectants must comply with the requirements of the general decree by the BAUA, file reference number 5.0- 710 30/01.00002.
Recommendation: In order to avoid supply bottlenecks for the manufacturers listed under the Biocides Ordinance, the current BAUA general decree should be used. TMK Retail Service & Consulting GmbH supports you with the compliant documentation and labelling of hand disinfectants. If you have any questions, please do not hesitate to contact Boris Berndt by calling +49/40/54090410-8 or sending an e-mail message to firstname.lastname@example.org.