Are you operating a genetic engineering facility in Germany – or planning to set one up? Appoint biosafety4u.berlin GmbH as your external Biosafety Officer (in German: Beauftragter für Biologische Sicherheit, BBS) in accordance with § 29 GenTSV.
What you get
- Complete set of formsThe application forms of the LAG Gentechnik with extended functionality – plus forms that individual state authorities require in addition (e.g. form E). English versions are available.
- Appointment templateA ready-to-use template “Appointment of a Biosafety Officer” that you simply copy onto your letterhead.
- Clear responsibilitiesA Service Level Agreement defines the duties of all parties in detail and includes a non-disclosure agreement.
- Support with the authorityWe help you prepare the notification or application and are happy to get in touch with your competent supervisory authority.
Frequently asked questions
What is a Biosafety Officer (BBS) and whom does he or she advise?
According to § 3 No. 9 GenTG, the Biosafety Officer is “a person or a group of persons (committee for biological safety) who monitors the fulfilment of the project leader's duties and advises the operator”. This sentence already names all relevant roles of a genetic engineering facility: operator, project leader and Biosafety Officer.
The operator is the legal entity that sets up or runs a genetic engineering facility – represented, for example, by the managing director of a GmbH or the head of a university institute. Our clients include:
- a contract research organisation (CRO) with a GLP quality assurance programme,
- a testing laboratory involved in medicinal product manufacturing with a GMP certificate,
- a logistics company that stores and transports products containing genetically modified organisms,
- start-up incubators with shared laboratory space and core facilities,
- a producer of novel foods using new food production technologies under the Novel Food Regulation (EU) 2015/2283.
What are the tasks of a Biosafety Officer?
The tasks are laid down in § 31 GenTSV. In short, the Biosafety Officer
- monitors how the project leader fulfils the safety-related duties – in particular through regular inspections of the facility, reporting deficiencies to the operator and the project leader, and checking that they have been remedied;
- advises the operator, the responsible persons and – on request – the works or staff council on the risk assessment under § 6 (1) GenTG, the planning and performance of genetic engineering work, the procurement of equipment and the introduction of new procedures, the selection and testing of personal protective equipment, and before equipment and procedures are put into operation;
- submits an annual written report to the operator on the measures taken and planned.
Genetic engineering experiments at schools
Teachers at upper secondary schools who want to make genetic engineering tangible in their advanced biology course can do so: the competent authorities support small genetic engineering experiments at schools.
Usually, however, no teacher holds the university degree and the three years of experience in genetic engineering required by § 28 (2) GenTSV. For safety level 1 work for teaching purposes – exclusively with certain organisms, donor and recipient in risk group 1 and with biological safety measures – teachers with a suitable science teaching qualification can be appointed as project leader and as Biosafety Officer. In addition, they need a certificate of attendance from a recognised training course covering the knowledge required by § 28 (5) GenTSV.
Do you need support or have a question? Simply write to us.
