Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance – BioStoffV) German law

Last Updated on July 4, 2021 by LawEuro

Full citation: Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance – BioStoffV) of 15 July 2013 (Federal Law Gazette [BGBl.] Part I p. 2514), last amended by Article 146 of the Law of 29 March 2017 (Federal Law Gazette I p. 626)

Part 1
Scope, definitions and classification into risk groups

Section 1 Scope
Section 2 Definitions
Section 3 Classification of biological agents into risk groups

Part 2
Risk assessment, assignment to protection levels, documentation and record-keeping obligations

Section 4 Risk assessment
Section 5 Activities with an assigned protection level
Section 6 Activities not assigned to a protection level
Section 7 Documentation of the risk assessment and record-keeping obligations

Part 3
Basic obligations and protective measures

Section 8 Basic obligations
Section 9 General protective measures
Section 10 Additional protective measures and requirements for activities of protection levels 2, 3 or 4 in laboratories, the husbandry of laboratory animals and biotechnology
Section 11 Additional protective measures and requirements for activities of protection levels 2, 3 or 4 in healthcare facilities
Section 12 Preventive occupational health care
Section 13 Incidents, accidents
Section 14 Operating instructions and training of employees

Part 4
Licensing and notification obligations

Section 15 Licensing obligation
Section 16 Notification obligation

Part 5
Enforcement rules and Committee on Biological Agents

Section 17 Information of the authority
Section 18 Exemptions granted by the authority
Section 19 Committee on Biological Agents

Part 6
Administrative offences, criminal offences and transitional provisions

Section 20 Administrative offences
Section 21 Criminal offences
Section 22 Transitional provisions