Animal pathogens; application for a permit and notification of activities

You need a permit if you want to work with animal pathogens. In cases where no permit is required, the activity must be notified.

If you want to work with animal pathogens, you need a permit. Pathogens capable of reproduction or parts of pathogens capable of reproduction are affected

• notifiable animal diseases and
• other diseases transmissible to domestic animals or freshwater fish.

The ordinance applies in particular to experiments, microbiological or serological tests to determine transmissible animal diseases or the further breeding of pathogens, as well as to the acquisition or supply of pathogens.

Working with animal pathogens capable of reproduction can pose a significant risk to the livestock in a region. It is therefore essential to know and regularly monitor the institutions that handle this material. Before a permit is issued by the responsible government, it is checked whether the requirements for a permit are met. Appropriate appendices and ancillary provisions in the permit notice ensure that the legal requirements are implemented and that the safety under epidemiological law is guaranteed.

In cases where no permit is required due to Section 3 of the German Ordinance on Animal Pathogens, the activity must be notified.

An exception to the licensing requirement and therefore only a notification requirement generally exists for the following activities:

• Sterility testing and determination of the colony count
  • in connection with the manufacture and testing of medicinal products,
  • in the manufacture and testing of foodstuffs including drinking water, tobacco products, cosmetics and consumer goods and
  • in the testing of water used for swimming or bathing, or

• bacteriological meat inspection in official veterinary inspection bodies after at least three months of prescribed training.

Insofar as work is not carried out with pathogens of notifiable animal diseases, the following further exemptions from the licensing requirement exist and thus only a notification requirement:

• Veterinarians and doctors for diagnostic examinations or therapeutic measures as part of their practice
• Veterinary clinics and hospitals for diagnostic tests or therapeutic measures in their field of work under veterinary or medical supervision
• Public institutions

The requirements listed below must be proven by appropriate documentation. The competent authority must be notified immediately of any change in the person responsible for managing the activity and any significant change to the premises or facilities. The government is the competent authority for both the permit and the notification.

• Proof of expertise is required to carry out/manage the activity. According to Section 4 (2) of the Ordinance on Animal Pathogens, proof of expertise is as follows
  • Licensed veterinarian, doctor or pharmacist or university degree in biology or food chemistry and
  • at least three years' experience with animal pathogens within the meaning of Section 2 para. 1 no. 1
• Proof of the personal reliability of the applicant and the head of the activity if the applicant does not take over the management of the activity.
• Proof of suitable premises or facilities
• Animal disease control concerns must not conflict with this

The regulations on activities involving pathogens in the Infection Protection Act and the requirements of the Biological Agents Ordinance must also be taken into account.

For the diagnosis of animal disease pathogens within the meaning of Article 9(1)(a) or (b) (animal diseases of category A or B in accordance with the Annex to Implementing Regulation (EU) 2018/1882) and investigations of poultry flocks in accordance with Annex II of Delegated Regulation (EU) 2019/2035, an additional designation by the Bavarian State Office for Health and Food Safety as an official laboratory is required.