Part 4. Licensing and notification obligations (Biological Agents Ordinance – BioStoffV) German law

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

Part 4
Licensing and notification obligations

Section 15
Licensing obligation

(1) The employer shall require a licence issued by the competent authority before first starting activities of protection levels 3 or 4 in laboratories, the husbandry of laboratory animals or biotechnology. The licence shall cover the physical, technical and organisational requirements pursuant to this Ordinance for the protection of employees and other persons against the hazards caused by such activities. Clause 1 shall also apply to healthcare facilities where activities of protection level 4 are to be performed. A licence shall not be required for activities involving biological agents of risk group 3 marked with (**).

(2) When another administrative decision, in particular a concession or licence under public law includes the licence specified in para. 1, the requirement pursuant to para. 1 shall be fulfilled by sending a copy of this administrative decision to the competent authority. Where necessary, the competent authority may request further documentation.

(3) The application for the licence pursuant to para. 1 shall either be made in writing or electronically. The following documentation shall be provided with the application:

1. name and address of the employer,

2. name and qualification of the person appointed pursuant to section 10 para. 2 or section 11 para. 7 no. 3,

3. name of the licence holder pursuant to section 44 of the Protection against Infection Act (Infektionsschutzgesetz),

4. site map, floor plan and designation of the rooms including escape and emergency routes,

5. description of the intended activities,

6. outcome of the risk assessment including information on

a) the biological agents which are used or present and the protection level of the activity,

b) the physical, technical, organisational and personal protective measures including information on the planned maintenance and repair of physical and technical measures,

7. the plan pursuant to section 13 para. 3,

8. information on waste and wastewater disposal.

Where necessary, the competent authority may request further documentation. If the application is made electronically, the competent authority may also require the applicant to send multiple copies and the accompanying documentation in writing.

(4) The licence shall be granted when the requirements of this Ordinance needed to ensure the protection of employees and other persons against the hazards involving biological agents are fulfilled.

Section 16
Notification obligation

(1) As specified in the provisions of paras. 2 and 3, the employer shall notify the competent authority of:

1. the initial start of

a) a specific activity involving biological agents of risk group 2,

b) an activity involving biological agents of risk group 3 insofar as such activities are not subject to the licensing obligations pursuant to section 15,

in laboratories, the husbandry of laboratory animals and biotechnology,

2. any modification of the licenced or notified activities when significant for the protection of the safety and health of employees, for instance activities aimed at enhancing the virulence of the biological agent or the start of activities involving additional biological agents of risk groups 3 or 4,

3. the admission of an infected patient to a patient ward assigned to protection level 4,

4. the discontinuation of an activity requiring a licence pursuant to section 15.

(2) The notification shall include the following information:

1. name and address of the employer,

2. description of the intended activities,

3. outcome of the risk assessment pursuant to section 4,

4. the type of biological agent,

5. the planned actions for the protection of the safety and health of employees.

(3) The notification pursuant to para. 1 nos. 1, 2 or no. 4 shall be made no later than 30 days prior to starting or discontinuing the activities, the notification pursuant to para. 1 no. 3 shall be made immediately.

(4) The notification obligation may also be fulfilled by transmitting to the competent authority, within the deadline set out in para. 3, a copy of a notification, concession or licence pursuant to other legislation that contains equivalent information.

Table of contents (Biological Agents Ordinance – BioStoffV)

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