What does a legal fiction actually mean and when exactly does it come into effect?

For S1 and S2 facilities as well as other S2 work, such a legal fiction is provided for in Section 12 Paragraph 5a Sentence 1 and Paragraph 5 GenTG. The regulations for legalization are different in the case of notification and in the case of registration, so they should be considered separately. Today, legalization is in the case of notification. In the next AGCT-Gentechnik.report, legalization is in the case of registration. The following applies to projects subject to notification: The operator can begin the construction and operation of the genetic engineering facility and the implementation of the initial genetic engineering work in the case of safety level 1, as well as the implementation of further genetic engineering work in the case of safety level 2, immediately after receipt of the notification by the competent authority (Section 12 Paragraph 5a Sentence 1 GenTG). A regulation such as that for registration under Section 12 Paragraph 5 GenTG, "according to which the expiry of the deadline shall be deemed consent to the construction and operation of the genetic engineering facility and to the implementation of the genetic engineering work," is missing here. This is justified by the fact that there is no "time limit" that can expire, as in Section 12 (5) of the GenTG in this case. According to the wording of the law, three conditions must be met for legality to begin the establishment/activity:

• the Advertisement must be at the
• competent authority
• received be.

In the case of an S 1 system, notification means that form AZ-S1, and in the case of another S 2 work, form A, together with the required additional forms (S, AL, AP, AG, AT and GA, GS, GE, GV and GO as well as form M) must be completed and signed in triplicate (operator, PL and BBS).

The competent authority is the licensing authority, not the supervisory authority.

The notification must have been received there, which can be proven by a registered letter with return receipt.

The legal consequence is that carrying out the work is then legal by operation of law. A written decision by the licensing authority is not required in these cases. If the requirements are met, this effect is not cancelled out by the fact that individual documents are missing. According to Section 12 Paragraph 5a Sentence 2 GenTG, the competent authority can provisionally prohibit the carrying out or continuation of the genetic engineering work until 21 days after receipt of the additional documents requested under Paragraph 3 or the opinion of the Commission to be obtained under Paragraph 4, insofar as this is necessary to ensure the purposes set out in Section 1 No. 1 are achieved. This constitutes an empowerment basis for the authority in the form of a discretionary decision. This means that the authority can simply request missing documents informally, i.e. without a formal administrative act, or with a formal administrative act (prohibition order), which must then be accompanied by information on legal remedies. Since S1 work generally does not pose a risk to humans or the environment, a prohibition order for the request for further documents should generally not be considered. If documents are simply requested informally, the legalization pursuant to Section 12 Paragraph 5a Sentence 1 GenTG remains in effect, even if additional documents are requested. The construction and operation of the S1 facility and the performance of the S1 work as well as the further S2 work remain legal. The question of whether the documents are complete from the authority's perspective is irrelevant based on the wording.