Legal quality of an official decision within the framework of the notification or registration procedure

Dr. Petra Kauch

Following the introduction of the new approval procedures through notification or registration, the authorities often send notices in addition to the confirmation of receipt. These notices may be titled "Notice," "Approval," "Consent," or similar. Some include information on legal remedies, while others do not. It should be noted, however, that the law does not provide for a formal notice in these cases. Rather, the operator may commence construction and operation of the genetic engineering facility and the performance of initial genetic engineering work in the case of safety level 1, as well as the performance of further genetic engineering work in the case of safety level 2, immediately upon receipt of the notification by the competent authority (Section 12 (5) GenTG). The operator may also commence construction and operation of the genetic engineering facility and the performance of initial genetic engineering work in the case of safety level 2 45 days after receipt of the notification by the competent authority (Section 12 (5) GenTG). In each case, the prerequisite is that the documents submitted to the authority have been complete beforehand. Unlike with approval, the law does not require the authority to issue a notice in these cases. If the authority nevertheless issues such a notice, it must be reviewed by the project manager and the operator to ensure that it complies with the law. Even if this notice does not contain instructions on legal remedies, case law has recognized that legal recourse can and must be taken against such a notice, provided it has regulatory content, if the operator does not agree with its content. The project manager should therefore carefully examine the content of the notice and, if applicable, note the deadlines for appeal. This is naturally difficult if the notice does not contain instructions on legal remedies. Legal assistance may be required in this case.

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

Back to blog

More articles in the AGCT Genetic Engineering report