What exactly are notifications according to Section 9 Paragraph 4a GenTG and if so, to whom?
Dr. Petra Kauch
Notifications are rather rare within the framework of the approval procedures according to the GenTG: Nevertheless, there is one!
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The GenTG primarily provides for notification, registration, and approval as possible types of authorization. Accordingly, mere notifications are generally insufficient. Nevertheless, Section 9 (4a) GenTG also provides for such notification within the framework of the authorization. According to this, a notification from the operator to the competent authority before the start of work is sufficient if previously notified, registered, or approved genetic engineering work at safety level 2 or 3 is to be carried out in another registered or approved genetic engineering facility owned by the same operator in which corresponding genetic engineering work may be carried out. This somewhat cumbersome and complex situation applies to notified (as part of the authorization of the facility) S2 work and notified (post-notified) S2 work, as well as approved S3 work. However, the prerequisite is that the facility operator has an equivalent S2 or S3 facility in which the corresponding work may actually be carried out. This covers so-called "uni-hopping cases," which naturally also applies to private facilities. In these cases, an operator has several equally equipped S2/S3 facilities (the latter being rather unlikely), and the work actually carried out there does not differ in terms of the facility's characteristics. At this point, the law does not require a new registration/approval of the facility or notification/approval of the activity. A mere notification from the operator, not the BBS or the PL, is therefore sufficient. The notification must be addressed to the licensing authority, not the supervisory authority. The licensing authority should only know exactly in which specific facility of the same operator the work is being carried out at a specific time. It is clear that the requirements for risk assessment and record-keeping remain unchanged, and that, with this in mind, the change of facility must also be documented.