April 2024 Blog

Comprehensive reporting obligation for laboratory representatives

The Federal Administrative Court has ruled that laboratories are also obliged to notify the authorities if an analysis was carried out as part of a release test and the placing on the market of the product should be made dependent on the result of the analysis.

The facts of the case

The plaintiff operates private laboratories throughout Germany and carries out analyses of foodstuffs on behalf of food companies, among other things. It was commissioned by a client to carry out a microbiological analysis of almond kernels. The sample of the product tested positive for salmonella. The laboratory informed the client of this and asked for further information, including whether the product had been placed on the market as a foodstuff in Germany. The client denied this. An employee of the applicant then decided not to report the case in accordance with Section 44 (4a) of the German Food and Feed Code (LFGB). The supervisory authority became aware of the test report during an inspection at the client's premises. The authority imposed a fine on the laboratory for failing to inform the competent authority. An appeal was lodged against the decision. At second instance, the Higher Administrative Court allowed an appeal on points of law due to its fundamental importance.

Fundamental decision

In its judgement of 14 December 2023, the competent senate found that the laboratory was obliged to inform the competent authority of the microbiological examination of the sampled almond kernels in accordance with Section 44 (4a) sentence 1 LFGB.

According to Section 44 (4a) sentence 1 LFGB, the person in charge of a laboratory that carries out analyses of foodstuffs must inform the competent authority immediately of the result of an analysis if he has reason to believe that the foodstuff would be subject to a marketing ban in accordance with Article 14 (1) of Regulation (EC) No 178/2002. The latter is the case if it can be assumed that the analysed product is harmful to health or unfit for human consumption.

According to the decision of the Federal Administrative Court, this must also be assumed if the laboratory has carried out the analysis as part of a so-called release test, i.e. if the food business operator placing the order has made the placing of the food on the market dependent on an analysis without objections or has declared to the laboratory that the food will not be placed on the market in the unsafe condition.

In the opinion of the Senate, the existence of the obligation to notify - in contrast to the possible existence of an administrative offence - does not depend on the subjective perception of the person responsible for the laboratory and the justifiability of his legal assessment of the actual circumstances.

There are no indications that laboratory representatives should not be obliged to report a release test, neither from the wording of Section 44 para. 4a sentence 1 LFGB nor from the legislative history of the provision, nor are they supported by the legal system.

There is also no contradiction of values in the fact that food business operators do not have to report the analysis result of the laboratory and also do not have to inform the authority if they have reason to believe that a foodstuff that has been produced but not yet placed on the market would be subject to a marketing ban without being analysed in a laboratory. There would be a legitimate interest in obliging the person responsible for the laboratory to report a positive analysis result. In this way, the authority would be made aware of the complaint at the earliest possible point in time and the possibilities of effectively monitoring whether the business operator in question is fulfilling its obligations under food law would be improved.

Although Regulation (EC) No. 178/2002 only obliges food business operators to inform the competent authority and does not provide for a corresponding obligation on laboratories or persons responsible for laboratories to inform the competent authority of positive analysis results, the Third Senate is of the opinion that the provision is also manifestly compatible with Union law in view of the protective purpose of the Regulation.  The fact that a feed business operator who has commissioned a laboratory to carry out an analysis of its product for dioxins must instruct the laboratory in accordance with Annex II of Regulation (EC) No 183/2005 to notify the competent authority if the specified maximum dioxin levels are exceeded does not mean that Union law has conclusively regulated the group of persons obliged to notify. On the contrary, there is no evidence to support the assumption that the European Union wanted to prevent the Member States from obtaining information on unsafe food from laboratories on the basis of national legislation.

Although the decision emphasises that the reporting obligation interferes with laboratory operators' freedom to exercise their profession, the interference is justified and the regulation is proportionate. This provides the competent authority with information at the earliest possible stage that a food is probably not safe, thereby enabling it to effectively monitor whether the food business operators concerned fulfil their obligations under food law. A milder means is not apparent.

Practical implications

Although the Federal Administrative Court dealt with questions of food law in its decision, it can be assumed that the judgement will have the same effect on feed law. Although the special rules on dioxin monitoring mentioned by the Senate exist here, it can be assumed that the argument of the admissibility of stricter national legislation will also apply despite the clearer European legal framework. Food and feed business operators should always block goods immediately in the event of suspicion and take all necessary steps as quickly as possible after thoroughly examining their goods.

(Federal Administrative Court, judgement of 14 December 2023 - BVerwG 3 C 7.22)

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