Additional provisions in notices

Dr. Petra Kauch

In addition to the so-called tenor of decisions on genetic engineering law, these usually also contain ancillary provisions.

The ancillary provisions in decisions regarding genetic engineering facilities or work are diverse. Some are addressed to the facility operator, but others also to the project manager. From a legal perspective, the term "ancillary provision" is extremely broad. It is mentioned in Section 19 of the Genetic Engineering Act (GenTG). Accordingly, the competent authority may add ancillary provisions to its decision if this is necessary to ensure compliance with the approval requirements (Section 19, Sentence 1 of the Genetic Engineering Act). This already clarifies that such ancillary provisions must be necessary to ensure compliance with the approval requirements (Section 11 of the Genetic Engineering Act). Similarly, conditions can be imposed to stipulate procedural procedures or safety precautions, or to specify the characteristics or equipment of a facility (Section 19, Sentence 2 of the Genetic Engineering Act). Both conditions and orders can be issued retroactively (Section 19, Sentence 3 of the Genetic Engineering Act). Ultimately, the provision of Section 19 of the Genetic Engineering Act does not go beyond the wording of Section 36 (1) of the Administrative Procedure Act (VwVfG), which, as a general provision for binding decisions, limits the addition of ancillary provisions. According to this, an administrative act to which a claim exists may only be provided with a secondary provision if it is permitted by law or if it is intended to ensure that the legal requirements of the administrative act are met. What does this mean in concrete terms? Firstly, it must be made clear that a binding decision, as provided for in Sections 11 (1) and 16 (1) of the GenTG, does not become a discretionary decision by the authority through the addition of secondary provisions. Secondary provisions are only permissible to the extent that they are necessary to ensure the approval requirements are met. This must be examined in each specific individual case. If a secondary provision, for example, for installations and work in closed systems, goes beyond the legal requirements of Section 11 GenTG, it must be objected to. For example, if the secondary provisions for an S1 area require windows that cannot be opened. In each individual case, it must then be clarified whether the inadmissible secondary provision can only be challenged together with the entire decision or whether it can possibly be challenged in isolation. In the latter case, the addressee of the notice can challenge the ancillary provision in isolation without jeopardizing the benefits of the remaining content of the notice. Whether a ancillary provision can be challenged in isolation must be examined on a case-by-case basis and depends largely on whether the remaining content of the notice can remain valid without this ancillary provision or whether the ancillary provision shapes the remaining content of the notice in such a way that the ancillary provision only makes sense in conjunction with the notice. In case of doubt, legal advice should be sought.

Back to blog

More articles in the AGCT Genetic Engineering report