Service Finder
Notification for activities with biological agents (biosubstances) according to § 16 Biosubstances Ordinance
Service Description
The employer has to take up for the first time:
- targeted activities with biomaterials of risk group 2 , protection level 2 as well as with biomaterials of risk group 3 **, protection level 3 (§ 16 para. 1 No.1a BioStoffV) as well as
- non-targeted activities of protection level 2 with biosubstances of risk group 3, including those marked with (**), provided that the activities are directed at these biosubstances and are to be carried out on a regular basis, (§16 Para. 1 No.1 b BioStoffV)
in laboratories, in laboratory animal husbandry and in biotechnology.
Non-targeted activities according to § 16 para. 1 no. 1b with biosubstances of risk group 3 are:
- non-targeted activities with biosubstances of risk group 3, which are marked with (**)
- non-targeted activities with biosubstances of risk group 3,
which are assigned to protection level 2 according to the result of the risk assessment.
These are exclusively those activities that are targeted at these biostuffs and are to be carried out on a regular basis.
The obligation to notify also applies to changes in already permitted or notified activities that are relevant to the safety and health protection of employees.
If an activity requiring a permit under Section 15 is to be discontinued, this must also be notified.
Process flow
The written notification must be submitted by a person authorized to represent the company. The required notification form is available for download here.
Who should I contact?
Locally responsible Regional Inspectorate of Department 6 Occupational Safety of the Thuringian State Office for Consumer Protection (TLV).
Requirements
Every company that wants to carry out such activities with biosubstances requires the specialist knowledge of the personnel required according to TRBA 200 in order to be able to carry them out.
Which documents are required?
The notification must at least contain information on :
- No. 3: Assignment of tasks in accordance with § 13 Para. 2 ArbSchG No. 7: Location sketch, floor plan of the rooms
- to No. 8: List of biological agents in accordance with § 7 Para. 2 BioStoffV (list of biological agents)
- to No. 8: Activity description including the designation of the rooms in which these activities are to be carried out
- to No. 9: Deviations from protective measures
What are the fees?
There are no fees to pay.
What deadlines do I have to pay attention to?
The notifications must be made at least 30 days before:
- the start of the activities specified under § 16 Paragraph 1 No. 1 BioStoffV,
- in case of planned changes of permitted and notified activities according to § 16 Paragraph 1 No. 2 BioStoffV and
- in the case of discontinuation of activities requiring a permit in accordance with Section 15 BioStoffV, to the competent regional inspectorate of the TLV.
The notification of the commissioning of a patient care unit of protection level 4 upon admission of an infected patient and the subsequent decommissioning must be submitted without delay.
Processing duration
Processing is carried out in compliance with the seven-day deadline
Appeal
Notification for activities with biological agents (biosubstances) according to § 16 Biosubstances Ordinance (BioStoffV)
What else should I know?
Activities in HIV, HBV or HCV diagnostics classified in risk group 3 (**) must be notified if the activities are directed at these biomaterials and are to be performed regularly.
Only the contact with blood samples during processing is not notifiable, if the activities are not aimed at these biological agents in diagnostics and are not to be carried out regularly.
Supporting institutions
Notifications should be submitted to the regional inspectorate responsible within the scope of your application subject. They can assist you with any questions that arise regarding the application.
Author
The text was automatically translated based on the German content per DeepL.
Technically approved by
Thuringian Ministry of Labor, Social Affairs, Health, Women and Family Affairs
Thuringian State Office for Consumer Protection
Professionally released on
24.03.2022
Source: Zuständigkeitsfinder Thüringen (Linie6PLus)
No competent authority found
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