EDITOR'S SPOTLIGHT: SCIENCE & REGULATION

Germany aligns with EC in confirming novel food classification of CBD

By Will Chu

- Last updated on GMT

©iStock/Marian Vejcik
©iStock/Marian Vejcik

Related tags: Cbd, Bucchini, Novel food

Germany’s federal government now confirms that cannabidiol (CBD) is to be classified as novel food citing an absence of evidence of its consumption before 15 May 1997.

The country’s stance mirrors that of the European Commission (EC), which added CBD to its Novel Food Catalogue in January meaning no CBD-containing product can be marketed in the EU and now Germany without authorisation.

Confirmation​ by the German courts follows guidance by the Federal Office of Consumer Protection and Food Safety, which states it was not aware of any case where CBD could be legally marketed in foodstuffs.

The government adds in its official reply​ that previous EC guidance, in which it states products containing certain hemp plant parts may not be considered as novel food, as incorrect.

But, they state that this does not mean that all food derived from the hemp plant is legally marketable. Indeed, they add that all application must be assessed, on a case-by-case basis.

Authority action   

“The significance of the ruling, beyond the technical legal arguments made under German law, is that it reaffirms that CBD hemp flowering bud extracts (as well as CBD "crystals"), when marketed as food or food supplements as in this case, are unauthorised novel foods,”​ explains Luca Bucchini, managing director of food regulation specialists Hylobates Consulting.

“Therefore, the authorities were right in blocking the commercialisation of the products.”

Bucchini explains that Dusseldorf’s Administrative Court rejected the argument that hemp in itself may not be novel, as the novel food regulation applied to the manufactured food product, even if the source is not novel in itself.

“It is also not relevant that solvent extraction or CO2 extraction, used to produce the extracts, are not novel processing method,”​ he says.

“What matters is that the end products are novel. This is standard interpretation of EU law.”

‘Much upset’ over ruling

Bucchini, an expert in food and supplement law, adds that the addition of hemp extracts​ to the novel food category caused “much upset and discussion in the industry, as it appeared to contradict a previous EC position.”

“However, the judges said that the changes do not weaken the value of the catalogue, which reflects the findings of the European Commission and the Member States' competent authorities, and were a clarification, not a change. This is in line with the position of German authorities.”

Judges from Dusseldorf’s Administrative Court also rejected documents from Bulgaria, as well as data on the processing of hemp flowering buds citing flavouring as not relevant to their final decision.

The judges also rejected the argument that hemp is listed in the Italian list of permitted plants, noting that the issue was with the CBD extract, not the plant.

Additionally, the Italian list only mentions the oil (from seeds), the seeds but not the flowers. The defendant also argued that the previous regulation did not address extracts, as it concerned only isolates (if the source was not novel).

“This was a good point,”​ Bucchini says, “but the Court - perhaps in the weakest passage - said that ‘isolated’ and ‘produced,’ - the words used in the new Regulation, have the same meaning - which is questionable at best.”

EU following US example?

“The ruling is not surprising in itself,” ​Bucchini adds.  “It is a rather plain and largely consensual reading of current EU law. What is important is that this reading is affirmed.

“Many are convinced that the EU is - or is heading - in the same direction as the US, where CBD products are not compliant with some provisions of US law (while compliant with others), but where enforcement is not exercised.

“Perhaps the same situation is occurring only in the UK - creating the wrong impression. It will take regulatory action to legitimise CBD products in the EU.”

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