Gentechnik: Gentechnische Anlagen errichten und betreiben

• §§ 8, 9, 12 and 21 Genetic Engineering Law (GenTG)
• Genetic Engineering Safety Ordinance (GenTSV)
• Genetic Engineering Procedures Ordinance (GenTVfV)
• Genetic Engineering Recording Ordinance (GenTAufzV)
• Genetic Engineering Hearing Ordinance (GenTAnhV)
• Genetic Engineering Emergency Ordinance (GenTNotfV)
• Administrative Costs Law of the Free State of Saxony (SächsVwKG)
• Saxon Directory of Costs (SächsKVZ), No. 45 - Genetic Engineering

Submitting notifications AND applications ONLINE

Genetic engineering facilities are, for example, laboratories, functional rooms (storage, microscopy, autoclave, cell culture rooms, et cetera), production facilities, animal husbandry and animal testing rooms or greenhouses.

According to the Genetic Engineering Law (GenTG), the construction and operation of a genetic engineering facility is subject to notification, registration or even approval. For this reason, a notification, registration or approval procedure is carried out with the responsible authority of the respective federal state prior to construction, commissioning or carrying out the first genetic engineering work. The type of procedure depends on the safety level of the (planned) genetic engineering facility or work.

Safety level 1

Genetic engineering work that is not expected to pose a risk to human health or the environment

• Notification is required for a new genetic engineering facility and initial safety level 1 work, as well as for significant changes to the facility.
• No notification is required for further genetic engineering work at safety level 1.

Safety level 2

Genetic engineering work involving a low risk for human health or the environment

• For a new genetic engineering facility and first-time work at safety level 2, as well as for significant changes to the facility, either a notification or approval procedure is required.

• For further genetic engineering work at safety level 2, either a notification or a licensing procedure is required.

Safety level 3 or 4

Genetic engineering operations involving a moderate or high risk for human health or the environment

• A licensing procedure is required for a new genetic engineering facility and first-time work at safety level 3 or 4, as well as for significant changes to the facility and also for further genetic engineering work at safety level 3 or 4.

Note: It is not possible to apply for a permit online. Please contact the Saxon State Ministry for Energy, Climate Protection, Environment and Agriculture in advance (contact details under "Responsible department") for information on how to proceed.

Submitting applications and notifications online

The following notifications and registrations can be submitted electronically with the online application:

• Notification of the construction and operation of a genetic engineering facility of safety level 1, including initial work
• Notification of further genetic engineering work of safety level 2
• Notification of significant changes to the location, condition or operation of a genetic engineering facility of safety level 1
• Notification of the construction and operation of a genetic engineering facility of safety level 2, including initial work
• Notification of significant changes to the location, condition or operation of a genetic engineering facility of safety level 2
• Notification in the event of a change or addition of project managers or biological safety officers (BBS)
• Notification in the event of a change in safety-relevant facilities and precautions
• Notification in the event of cessation of operation of a genetic engineering facility
• Notification in the event of incidents or accidents with a suspected risk to human health or the environment
• Notification of new information on risks to human health or the environment

Other applications

As part of the individual procedures, you can make further applications if necessary, for example for the authority to allow the appointment of external project managers or SMOs or to permit the use of chemical inactivation procedures.

procedure-dependent (listed in the forms)

Examples:

• Plans showing the location of the facility, the rooms and their equipment
• Operating instructions, hygiene plan, skin protection plan, in-house emergency plan
• Certificates, diplomas, confirmation of participation in further training courses
• Excerpt from the commercial register, etc.
• Agreements or contracts to ensure the fulfilment of tasks by project leaders or SMOs not employed by the company
• Publications, vector maps, etc.
• Proofs, protocols on safety-relevant facilities

• The operator of the genetic engineering facility itself or a person authorised to represent it submits the application.
• Further requirements according to genetic engineering law are fulfilled:
  • in terms of personnel (such as project leader and BBS)
  • structurally (for example, suitable laboratories)
  • technically (e.g. autoclave)
  • organisationally

for the online application:

The applicant has an ID card, an eID card or an electronic residence permit (eAT) with activated online ID function and PIN and a mobile device with ID app or a card reader.

• Registrations: depending on expenses, at least EUR 360.00
• depending on expenses, at least EUR 180.00
• Permission of external project management / Biosafety Officer (BBS): EUR 45.00 per person
• Expenses (e.g. example of a statement by the ZKBS)

Exemption from fees

for legal entities according to § 12 Saxon Administrative Costs Law (SächsVwKG), in particular public corporations such as universities (expenses excluded)

Note: Research institutions recognised as non-profit organisations have been obliged to pay fees and expenses since 01.10.2021.

With the application, you initiate the above-mentioned procedures under genetic engineering law (notification, application). You can also use the forms to submit a notification required under the Genetic Engineering Act and thereby apply for certain permits / approvals. You will receive a written confirmation of receipt from the authority.

In many cases, the authorities have queries or additional requirements. In the case of a notification, registration or other applications, you will receive a (chargeable) decision or a final letter at the end of the procedure.

Application

The application must be sent by a person authorised to represent the operator. If this person has a new identity card with activated ID function, he or she can submit the completed forms electronically via Amt24. Otherwise, the application can be prepared in Amt24 and subsequently

• be submitted by post in paper form with the signature of the person authorised to represent the applicant, or
• the signature of the person authorised to represent the applicant can be sent by post and the rest of the application submitted electronically.

Online application

Have electronic copies of the required documents ready for the online application. Set up a service account in Amt24 (if not available) and log in to the service portal via this account. An Amt24 service account is required for each person processing the application.

• Follow the link under -> "Online application and forms", an application wizard will guide you step by step through the online procedure. Fill in the data fields according to the instructions. You can save the information at any time and complete it later.
• Once you have filled in all the data fields, you can complete the application and the data will be transmitted to the responsible office.
• You will receive a confirmation of transmission via the mailbox of your Amt24 service account (but this does not replace the written confirmation of receipt).

Written application

Either complete the online forms and print them out or use the forms provided by the Working Group on Genetic Engineering of the Federal States and the Government. Submit the documents signed by the operator's representative to the responsible department by post.

Examination and issue

• The responsible department examines the application or notification received.
• In the case of a notification, the procedure ends with an acknowledgement of receipt from the authority, provided there are no queries or additional requirements.
• In the case of a notification, application or in the case of applications within the scope of notifications, you will receive a (chargeable) decision or a final letter by post at the end of the procedure.

Amendments

• You can also apply for changes via this procedure.

• Notification, registration or communication: before implementation of the measure or commencement of the genetic engineering work
• Start/implementation of the measure:
  • in the case of notifications and communications: after acknowledgement of receipt
  • in the case of notification or application: after receipt of the decision

Note: If you have not received a notification for a genetic engineering facility of safety level 2 within 45 days of receipt of your notification, you may commence construction and operation (or implement significant changes to an S2 facility). This does not apply as long as enquiries / additional requirements are still open or a possibly required statement by the ZKBS is still outstanding.

Authorisation to represent

Operators are often universities, university hospitals, research institutions or companies, represented by, for example, the rector, chancellor, board of directors, director or managing director. These authorised representatives may also delegate the submission of applications to a third person. A corresponding power of attorney must be submitted for this purpose.

The forms can be prepared and processed by any person (for example, project manager or BBS). The application must be sent by a person authorised to do so by the operator.

Depending on the procedure, you will receive a decision with regulations (approval of something with conditions, requirements, time limits and the like as well as a decision on costs) or a final letter based on your application, registration, notification or communication.

You can file a complaint against a decision or individual regulations with the competent administrative court within one month after notification. For more details, please refer to the instructions on appealing the decision.