Difference between a notification, a registration and an approval?

Dr. Petra Kauch

All three approvals occur in a genetic engineering facility; what is the difference with regard to the start of the activity? – Series: Part 2: Registration

At a Registration (Construction and operation of an S2 plant) can 45 days after receipt of the (complete) Registration with the competent authority or with its consent even earlier (Section 12 (5) Sentence 1 GenTG). Here, too, a valid application must have been submitted (correct form and complete signatures). The application must actually have been received by the authority (registered mail with return receipt). If this is the case, the expiry of the deadline shall be deemed consent to the construction and operation of the genetic engineering facility and to the performance of the genetic engineering work (Section 12 (5) Sentence 2 GenTG = legal fiction). Legalization takes effect upon expiry of the deadline.

But be careful: The deadline is suspended as long as the authority that Waiting for the documents to be completed or until the required statement of the Central Commission for Biological Safety (ZKBS) on the safety classification of the proposed genetic engineering work and the necessary safety measures is present (Section 12 (5) sentence 3 GenTG). This means that the deadline is suspended by law as long as additional documents are requested and until the ZKBS's statement is available. According to the wording itself, a corresponding order from the competent authority (administrative act) is not required. However, the operator must be informed that their documents are incomplete or, exceptionally, that a statement from the ZKBS is requested, so that a corresponding notification is usually sent by the authority. This usually sets a deadline for completion, at least if the documents are missing, so that the operator has an indication of when the deadline begins again. This is more difficult in the case of a statement from the ZKBS, since the operator usually does not know when the ZKBS will decide on their case.

The question here is whether the 45-day period had already begun to run before the competent authority requested additional documents and whether only the remainder of the period expires after the documents were submitted. This could be supported by the wording, which states that the period is already suspended. A similar phenomenon exists in law – namely in criminal law – when the statute of limitations for prosecution is suspended. There, the period can also be suspended under certain conditions. This means that the period does not continue to run for a certain period and, after the suspension, the remaining period continues to run. It is questionable whether this is also applicable to genetic engineering law. The term "suspension" suggests that the period simply continues and expires when the documents are completed. For example, 10 days had already passed before the additional request for documents, and then 35 days remained after the documents were completed. This follows from the wording of the term "suspension". The meaning and purpose of a suspension period also supports such an interpretation. The authority has already pre-examined the application documents at the time of the additional request and determined exactly which documents must be submitted, so that a shorter deadline must also be sufficient for the subsequently submitted documents. Another argument for this could be that the legislature intended the legal fiction to take effect after the expiration of a certain period of time, and this should not depend on an act of the authority. However, this is only reliable for the operator if the period is set at 45 days in total and not if the operator has to constantly recalculate the deadline independently. Consequently, the 45 days refer to the entire period interrupted by the suspension phase.

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