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Änderung bezüglich des Betriebs gentechnischer Anlagen mitteilen

Sachsen-Anhalt 99045004261000, 99045004261000 Typ 3

Inhalt

Leistungsschlüssel

99045004261000, 99045004261000

Leistungsbezeichnung

Notify change regarding the operation of genetic engineering facilities

Leistungsbezeichnung II

Notify change regarding the operation of genetic engineering facilities

Leistungstypisierung

Typ 3

Begriffe im Kontext

nicht vorhanden

Leistungstyp

Leistungsobjekt mit Verrichtung

Leistungsgruppierung

Gentechnik (045)

Verrichtungskennung

Entgegennahme (261)

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Einheitlicher Ansprechpartner

Nein

Fachlich freigegeben am

05.07.2024

Fachlich freigegeben durch

Federal Ministry of Food and Agriculture (BMEL)

Teaser

Do you wish to carry out genetic engineering work that has already been notified, registered or approved in another genetic engineering facility? Then you must inform the competent authority before starting the work.

Volltext

Genetic engineering work is subject to high safety standards. The aim of these standards is to limit the contact of the organisms used with humans and the environment and thus ensure a high level of safety.


Genetic engineering work is divided into different safety levels. The safety levels are differentiated according to the degree of risk to human health and the environment:

  • Safety level 1: no risk
  • Safety level 2: low risk
  • Safety level 3: moderate risk
  • Safety level 4: high risk

You must notify the competent authority if you wish to carry out genetic engineering work of safety levels 2 or 3 in another facility of the same operator. The prerequisite is that both the genetic engineering work and the facility have already been notified, registered or approved for the first time.

You do not have to notify changes to genetic engineering work at safety level 1. Changes to safety level 4 work must always be notified or approved again.

You must notify the competent authority of the change before you start the activity.

Erforderliche Unterlagen

nicht vorhanden

Voraussetzungen

  • The change concerns genetic engineering work of safety levels 1, 2 and 3.
  • Both the genetic engineering work and the genetic engineering facility have already been notified, registered or approved.
  • The change only concerns the change of location. The operator must remain the same.

Kosten

Abgabe: Es fallen keine Kosten an
There are no costs.

Verfahrensablauf

  • You make the informal notification and send it to the competent authority.
  • You then start the genetic engineering work.

Bearbeitungsdauer

nicht vorhanden

Frist

You must submit the notification before the start of the genetic engineering work.

You are in breach of the regulations if you intentionally or negligently fail to submit a notification or fail to do so correctly or on time. This can be punished with a fine of up to EUR 50,000.

Hinweise

nicht vorhanden

Rechtsbehelf

No legal remedy is provided for.

Kurztext

  • Notification on the operation of genetic engineering facilities Acceptance
  • The competent authority must be notified of any changes in the operation of genetic engineering facilities
  • Change means: genetic engineering work is to be carried out in another registered or approved facility
  • The operator may not change
  • Modification only possible for genetic engineering work that has already been notified, registered or approved
  • applies to genetic engineering work of safety levels 2 and 3
  • Changes to safety level 1 work do not have to be notified
  • Changes to safety level 4 work must be newly notified or newly approved
  • The competent authority must be notified before work commences
  • Responsible: competent authority

Ansprechpunkt

nicht vorhanden

Zuständige Stelle

nicht vorhanden

Formulare

nicht vorhanden