BT-Drs. amending the GenTG has been available since 11 November 2015 – Laboratories

Even before the drafting of a Bundestag document, it had become clear that the amendment to the Genetic Engineering Act should also cover areas of closed systems. We had already discussed this in AGCT-Genetic Engineering.report 10/2015 reported. In fact, the changes to the Genetic Engineering Act for closed systems are more extensive than initially expected. These are briefly outlined here:

– the placing on the market is extended to the handling of GMOs (Section 6 (1) (2) GenTG-E)

– synthetic biology is both conceptually recorded and assigned to the area of ​​responsibility of the ZKBS (§ 3 Nos. 3, 5
Paragraph 1 GenTG-E)

– certain sampling by the authorities is exempt from the plant approval (Section 9 (6) and (7) GenTG-E)

– the possibility of issuing conditions, ancillary provisions and time limits is extended to the approval of installations
extends

– the project manager should be formally appointed in the future and be a company employee (Section 10 (2) No. 1 GenTG-E)

– Notifications must be in writing

– the costs for the ZKBS’s opinions should be refinanced as expenses

– a total of 4 additional fine regulations

– the numerous changes related to editorial changes, so that the amendment directive can be more accurately
will only be mentioned in passing here.

A critical statement from the federal government was already attached to the draft law. It therefore remains to be seen which regulations will actually pass the Bundestag.

This publication can also be found on the website of the law firm Dr. Kauch .