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As Germany is a federal country with 16 states, the application and approval process for a genetic engineering facility varies from region to region – and so does the calculation of the administrative fees.

Genetic engineering covers biotechnological processes that deliberately change the genetic material of a cell. As in other countries, genetic engineering is strictly regulated in Germany – for good reason. A genetic engineering facility should always be planned in advance in line with the applicable laws. Such facilities are restricted areas with safety measures in place to protect people and the environment.

All the regulatory authorities provide excellent support to make the entire application and approval process easier for everyone involved. Even so, there may well be regional differences. In this post, we take a closer look at how the administrative fees are calculated – and whether they differ at all.

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

A novel food start-up from outside Germany is planning to build a genetic engineering facility to produce a cheese protein in Komagataella phaffii (aka Pichia pastoris) by precision fermentation. Let’s assume that the estimated budget for two 1,000-litre fermenters and auxiliary equipment totals 1,200,000 euros.

Although the core legislation on genetic engineering applies throughout Germany, the 16 federal states differ slightly in how their competent authorities are organised, in their application and approval processes, and in the fees they charge for these administrative services. Each state has issued its own fee ordinance, valid only within that state.

The German Act on Genetic Engineering (Gentechnikgesetz, GenTG) describes how applicants should approach the process. Section 8 GenTG distinguishes between notification and registration of a genetic engineering facility, depending on the safety level. In either case, the authority must be involved before the work can begin. In our case study, the novel food start-up needs to submit documents to register the safety level 2 production facility (§ 8, section 2, sentence 1 GenTG).

Table 1 below compares the fees charged by the competent authorities for administrative services under the German Act on Genetic Engineering (Gentechnikgesetz, GenTG) and the Genetic Engineering Safety Ordinance (Gentechnik-Sicherheitsverordnung, GenTSV).

Table 1. Administrative fees charged by the 16 German federal states for a safety level 2 production facility.

1) in alphabetical order.
2) Link to the web page and a separate link to download the PDF file. As there may be regular updates, please check the website for current information.

Concluding remarks

• As you may already have noticed, the widely used host organism Komagataella phaffii is assigned to genetic engineering safety level 1 (BSL-1). The yeast is on EFSA’s list of QPS (qualified presumption of safety) recommended biological agents 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 fees actually charged for a BSL-1 facility may differ from those shown in Table 1.
• Unfortunately, all the web links in the table above are available in German only – as is the parent Genetic Engineering Act (Gentechnikgesetz, GenTG) as well as the Genetic Engineering Safety Ordinance (Gentechnik-Sicherheitsverordnung, GenTSV).
• At first glance, there are no major differences. With an investment of 1.2 million euros, the fees set out in the relevant regulations are modest, especially considering the enormous administrative effort involved.
• The fee ordinances appear to be very consistent across all 16 federal states. In most cases, the differences are minor and reflect Germany’s federal structure – each state likes to set itself apart a little ... However, the actual fee calculation is always at the discretion of the competent authority.
• Depending on the federal state in which you plan to set up, the fee may be calculated differently: some states provide separate forms to help calculate investment costs, while others do not consider investment costs at all. It is always at the authority’s discretion whether the fees listed in the fee ordinance are actually charged.

All authorities regulating genetic engineering in Germany have one thing in common: they are keen to support your project as early as possible. Please contact your competent authority to agree on the next steps and keep the administrative effort to a minimum 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 look forward to hearing from you.
Are you planning your own genetic engineering facility and need support?
Please send an e-mail to service [at] biosafety4u.berlin.

Last update of this Plauderblog entry: Wednesday 28 June 2023 by Christian Lange.
All rights reserved by biosafety4u.berlin GmbH.