Section 23 of the Administrative Procedure Act: The official language is German! What does this mean for laboratories?

In view of the general reference to German as the official language, the submission of English-language applications, the conduct of records in English and the use of English-speaking project managers/BBS are often rejected.

But where does the principle come from and what does it mean that the official language is German?

The Genetic Engineering Act (GenTG) itself and the Genetic Engineering Safety Ordinance (GenTSV) do not contain any statement on this language. Accordingly, general administrative law, in particular Section 23 of the Administrative Procedure Act (VwVfG), can be used as the lex generalis.

It stipulates that the official language is German (Section 23 (1) of the Administrative Procedure Act). If applications are submitted to an authority in a foreign language, the authority must immediately request a translation or commission one itself (Section 23 (2) of the Administrative Procedure Act).

The consequences, especially for applications intended to achieve a specific effect, are also regulated:

Should a deadline at the authority If a specific deadline is set – such as the 90-day deadline for approval (Section 10, Paragraph 5 of the GenTSV) – within which the authority must act in a certain way, the corresponding application is deemed to have been submitted at the time of receipt by the authority at which the translation is available. This means that the application deadline is postponed to the time the translation is available. The 90-day deadline for the authority then begins.

If such a notification or application a deadline must be met by the authority – such as the 45-day deadline for legalizing a registration for an S2 facility (Section 12 (5) Sentence 1 of the GenTG) – the application is deemed to have been submitted upon receipt by the authority if, upon request, a translation is submitted by the authority within a reasonable period to be set by the authority. This means that the 45-day deadline only begins to run once the translation has been received by the authority.

Overall, this means that submitting German-language documents immediately triggers the deadline, whereas submitting English-language documents, for example, may not trigger the deadline until German-language documents have been submitted. Whether the authority actually requests a translation is at the discretion of the authority. This, in turn, means that the applicant cannot predict when the deadline will start when application documents are submitted in English. The only safest option is to submit the documents bilingually from the outset.

The requirement to submit German-language documents is regulated only for formal administrative procedures initiated by applications. For genetic engineering, this means that the principle may only be relevant for notifications, applications, or approvals that initiate such administrative procedures.

The exception to this principle, which applies to formal administrative procedures, regarding documents in German applies if the procedure is not formal at all. In this case, German cannot be required as the official language for such a non-formal procedure. This applies, for example, to the mere exchange of information between the party involved and the authority, for the BBS reports, which are only exchanged internally between the BBS and the operator anyway, the risk assessments for further S1 work (not for further S2 work and above), and Form Z for records. In these cases, it is a mere exchange of information without any specific reference to an administrative procedure (Section 9 of the Administrative Procedure Act). The principle that German is not the official language in this form applies to this exchange of information. This means that German cannot be required as the official language in discussions, explanations, or outside of an administrative procedure; this also applies to information sheets, which is why the operating instructions (BA) can ultimately be written in an understandable language. Overall, according to established literature and case law, the last result found regarding the areas not covered cannot be “corrected” by reference to the idea of ​​the procedural discretion vested in the authority, since otherwise the clearly regulated legal cases in which German can be required as an official language, namely in formal administrative proceedings, would be undermined, according to case law and literature.

The distinction can be difficult in individual cases, which is why advice may need to be sought.