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Since Germany is subject to a federal system with 16 federal states, there are regional differences in the application and approval process for a genetic engineering facility. Certainly this also includes the calculation of administration fees for such services.

Genetic engineering includes biotechnological processes intentionally changing the genetic material in a cell. As for all other countries, genetic engineering is strinctly regulated in Germany - for good reasons. A genetic engineering facility should always be planned beforehand in accordance with the applicable laws. Such facilities are restricted areas with safety measures for humans and the environment in place.

All regulatory authorities share an excellent service to facilitate the complete application and approval process for all parties involved. However, there may well be regional differences. In this post, we would like to take a closer look at the differences in how management fees are calculated - if there are any.

CASE STUDY: Construction of a genetic engineering safety level 2 production facility for precision fermentation.

A novel food startup from outside Germany is projecting the construction of a genetic engineering facility for the production of a cheese protein in Komagataella phaffii (aka Pichia pastoris) through precision fermentation. Let´s assume the estimated budget for two 1,000 liter fermenters and auxiliary equipment is 1,200,000 euros in total.

Even though the basic acts regulating genetic engineering in Germany are valid for all federal states, there are slight differences in the organization of competent authorities, in the processes for application and approval, and also in the fees charged for such administrative activities between all 16 federal states of Germany. Each of them has released a separate administration fee ordinance only valid for the respective federal state.

The German Act on Genetic Engineering (Gentechnikgesetz, GenTG) describes on how the applicant should approach the process. Article 8 GenTG differenciates between an indication or a registration of a genetic engineering facility for the different safety levels available. In either case, the facility must be approved by the authority before the experimental work can be initiated. In our case study, the novel food startup needs to submit documents for the registration of the safety level 2 production facility (§ 8, section 2, sentence 1 GenTG).

Table 1 below reviews the competent authority fees charged for administrative services according to the German Act on Genetic Engineering (Gentechnikgesetz, GenTG) and the Genetic Engineering Safety Ordinance (Gentechnik-Sicherheitsverordnung, GenTSV).

Table 1. Administration Fee Charged by the 16 Federal States of Germany for a Safety Level 2 Production Facility.

1) in alphabetical order.
2) Link to the webpage and a separate link to download the PDF file. There may be regular updates; Please check the website for up-to-date information.

Concluding remarks

• As you have probably already noticed, the widely accepted host organism Komagataella phaffii is assigned to the genetic engineering safety level 1 (BSL-1). The yeast is a qualified presumption of safety (QPS) recommended biological agent intentionally added to food or feed (see the European Food Safety Authority list 16 as published). The German Central Committee for Biological Safety (Zentrale Kommission für biologische Sicherheit, ZKBS) lists Komagataella phaffii as a safety level 1 organism. The actually charged fees for a BSL-1 facility may differ from the costs reviewed in Table 1 above.
• Unfortunately all weblinks provided in the table above are only available in German, and so is the parent Act on Genetic Engineering (Gentechnikgesetz, GenTG) as well as the Genetic Engineering Safety Ordinance (Gentechnik-Sicherheitsverordnung, GenTSV).
• At first glance, there aren't any major differences to be seen. With an investment sum of 1.2 million euros, the fees specified in the relevant regulations are not significant, especially when you consider the enormous administrative effort.
• The fee ordinances seem to be very strict among all 16 federal states of Germany. In most cases the differences are not significant and are due to the federal character of Germany. The individual federal states would always like to distinguish themselves somewhat from one another ... However, the actual calculation of the fees is always at the discretion of the competent authority.
• Depending on the federal state you are planning to settle, the process for calculating the administration fee may be different: Some states provide separate forms facilitating investment costs calculation, others do not consider investment costs at all. It is always at the authority´s discretion whether scheduled fees are actually charged as regulated in the fee ordinance.

All competent authorities regulating genetic engineering in Germany have something in common: They are looking forward to providing excellent support for your project as early as possible. Please get in contact with your competent authority to coordinate the further procedure and to reduce the administrative effort for everyone involved.

Disclaimer:
The information in this article has been researched to the best of our knowledge and belief and was current at the time of publication (see final row on this page). This article is for information purposes only, and does not constitute any scientific, regulatory, or financial advice. To ensure that the information and links provided here are up-to-date, please consult the relevant websites. Thank you for your understanding.

Do you have questions or comments? We are looking forward to receiving your note.
Do you plan your own genetic engineering facility, and need support for the planning?
Please send an e-mail to service [at] biosafety4u.berlin.

Last update of this Plauderblog entry: Wednesday 28 June 2023 by Christian Lange.
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