Extension of reporting obligations under the Zoonoses Regulation
New requirements of the Zoonoses Regulation for food business operators
Aug 2020. On 29.06.2020, the 4th amendment of the Zoonoses Regulation (in German) was announced, which, among other things, involves a considerable expansion of existing reporting obligations. In the following, we have summarised the most important facts for you.
Purpose of the Regulation
Zoonoses are diseases that are directly or indirectly transmitted between humans and animals in natural environments. They are defined in § 2 No. 1 of the Zoonoses Regulation of the German Federal Office of Justice. The Regulation governs the food law measures to be taken by food businesses. It is intended to provide a basis for the early detection of zoonoses and zoonotic agents in order to assess their origin and the developmental trends of their occurrence.
Which pathogens have to be reported?
Only zoonoses that can be transmitted between humans and animals and which can lead to disease or infection need to be reported. The following zoonoses fulfil the criteria for a notification requirement under the Zoonoses Regulation: Salmonella, Listeria monocytogenes, Campylobacter and others.
What are the amendments?
Up to now, the reporting obligation has only been effective for zoonotic agents in food. The new regulation has now been supplemented by the following studies:
- Product residues from food or smear water in cheese production for Listeria monocytogenes or other controls during the production and processing of edible food
- Testing of cleaning and disinfection success, in particular of work surfaces, piping systems or transport containers which may come into contact with ready-to-eat food, for Listeria monocytogenes
This applies exclusively to surfaces in contact with the product. As an example, we can mention piping systems that, e.g., run under the ceiling above the production lines, because the germs could drip from the ceiling or the piping system onto the product. Transport boxes and belts also belong to this category.
A positive finding e.g. in a manhole does not have to be reported as it has no contact with the food.
When do I have to report?
In case of detection of a zoonotic agent, food business operators must
- inform the competent authority without delay after becoming aware of the results of the examination
- have isolates of the zoonotic agents detected produced
- retain the samples and isolates in an appropriate manner for a period of three months, but no longer, and hand them over to the competent authority on request
On request and after consultation, we can provide you with the necessary reserve samples and the preparation of appropriate isolates, for the specified period of time and store them for you. Retention samples of the sample material such as swabs or scratch sponges cannot be formed. These are required during the examination and are subsequently used up.
Failure to notify in accordance with the German Zoonoses Regulation, or failure to notify in time or correctly, constitutes an administrative offence. This can be punished with a fine of up to 50,000 euros.
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Written by:
Eurofins NDSC Food Testing Germany GmbH