Additional provisions for S1 and S2 systems

Dr. Petra Kauch

In the system of legalizing genetic engineering facilities/activities through legal fiction, the authorities retain the option of imposing ancillary provisions.

S1 and S2 facilities/activities become legal by virtue of legal fiction solely through the passage of time (immediately/after 45 days) following notification/registration. A decision by the authority is not required for legalization. Accordingly, the licensing authority can make adjustments to genetic engineering work pursuant to Section 12 Paragraph 6 of the Genetic Engineering Act (GenTG) through ancillary provisions. Accordingly, the competent authority can make the performance of the notified or registered genetic engineering work subject to conditions, set a time limit, or impose requirements, insofar as this is necessary to ensure the purposes specified in Section 1 No. 1 of the Genetic Engineering Act (GenTG); Section 19 Sentence 3 of the Genetic Engineering Act applies accordingly. The wording itself ("performance of the notified or registered genetic engineering work") already indicates that ancillary provisions can only be issued in relation to the activity, namely with regard to genetic engineering work. The wording does not justify ancillary provisions relating to the genetic engineering facility. The competent authority in this case is the authority that is also responsible for receiving the notification/application, i.e. the licensing authority. Conditions, time limits or requirements relating to the genetic engineering work are conceivable. An additional restriction is that the time limit, condition or requirement must be necessary to ensure the protection of humans and the environment. The reference to Section 19, Sentence 3 of the Genetic Engineering Act ensures that corresponding ancillary provisions can also be issued retrospectively. Even if this will be rather rare in practice, ancillary provisions can also be issued verbally. This follows from a comparison with Section 12, Paragraph 7, Sentence 2 of the Genetic Engineering Act, which expressly requires the written form for an injunction. Conversely, this means that the ancillary provisions according to Section 12, Paragraph 6 of the Genetic Engineering Act can also be issued verbally.

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