Notifications and authorisations in the field of biosafety

Pursuant to the Containment Ordinance, those institutes, companies and organisations that handle genetically modified, pathogenic or alien organisms in contained systems are subject to the notification or authorisation obligation.

Notification and Authorisation Obligation

An identification of risk and risk assessment must be carried out before handling organisms in contained systems so as to assign the activity to a particular class. Notification (class 1 and 2 activities) and authorisation applications (class 3 and 4 activities) shall be submitted to the Federal Coordination Centre for Biotechnology. The Coordination Centre provides on its website information on these procedures.

Registration and examination of notifications and authorisation requests

The submitted notifications are registered by the Coordination Centre for Biotechnology, checked for completeness and, depending on the activity, forwarded for processing to the Federal Office for the Environment (FOEN) or to the FOPH.

Technical examination of notifications and authorisation requests

The FOPH is responsible for evaluating the risk identification and assessment of activities of classes 2 to 4, in which the risk is primarily for humans. The FOPH decides by taking into account the opinions of the specialised agencies (FOEN, FOAG, FSVO, SECB, SUVA, ECNH, SECO as well as the cantonal specialised agencies) on the activities of the classes 1 and 2. Authorisations are granted by the FOPH for activities of classes 3 and 4.

Legislation

Biosafety legislation

The Ordinance on Handling Organisms in Contained Systems (ContainO) as well as various acts and additional ordinances govern activities with genetically modified, pathogenic or alien organisms in contained systems.

Further information

Biosafety

Here you can find information on the concept of biosafety and the role of the FOPH in the implementation of the Containment Ordinance.

Activities with organisms in contained system

Here you can find information on the notion of contained systems, on the risk assessment and related study, as well as on the safety measures set out under ContainO.

Last modification 02.10.2019

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Contact

Federal Office of Public Health FOPH
Biomedical Department
Biosafety, Human Genetics and Reproductive Medicine Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel. +41 58 463 51 54
Fax-Nr +41 58 462 62 33
E-mail

Print contact

https://www.bag.admin.ch/content/bag/en/home/gesetze-und-bewilligungen/gesuche-bewilligungen/meldungen-bewilligungen-bereich-biologische-sicherheit.html