Novel Food: strict burden of proof on the food business operator

The Higher Regional Court of Baden-Württemberg (VGH BW) is not only adhering to its case law regarding the burden of proof on the food business operator in classifying foodstuffs as novel food with respect to cannabinoid-containing products.

Bydecision of 26.01.2026 (Az. 9 S 740/24), theHigher Regional Court of Baden-Württemberg (VGH BW) rejected the admissibility of an appeal against a judgment of the VG Sigmaringen and has substantially reaffirmed its previous approach tothe burden of proof in novel food law.

Although the decision specifically concerns cannabinoid-containing products, it has significance extending far beyond that for numerous products, in particularplant extracts, isolates, concentrates, functional ingredients and technologically modified food constituents.

The central guiding principle is:
The burden of proof and evidence that a foodstuff or ingredient is not novel rests with the person who intends to place it on the market.

Legal background: structure of the Novel Food Regulation

The legal basis isRegulation (EU) 2015/2283 (Novel Food Regulation).

According toArt. 6 (2) Regulation (EU) 2015/2283, only approved and listed novel foodstuffs may be placed on the market.

A foodstuff is deemedArt. 3 (2) lit. a as 'novel' if it was not used to a significant extent in the European Union for human consumption before15.05.1997 and falls within one of the categories listed there – in particular:

• foodstuffs from plants or plant parts,
• isolated or produced substances of plant origin,
• ingredients produced by means of new processes,
• substances with deliberately modified composition.

Also central isArt. 4 Regulation (EU) 2015/2283. Under this provision, the food business operator must independently verify whether its product falls within the scope of the Regulation. According toArt. 4 (2) sentence 2, it must make the necessary information available to the competent authority.

The Higher Regional Court derives from this asubstantive burden of proof on the operator:
If the history of use prior to 1997 cannot be demonstrated, this works to its detriment.

This was the exact issue: distribution prohibition due to lack of novel food approval

In the case in question, the District Administration (Landratsamt) Ravensburg prohibited a food business operator from distributing various cannabinoid-containing products, with an order for immediate enforcement.

Reason: these wereunauthorised novel foodstuffs within the meaning of Regulation (EU) 2015/2283.

The claimant argued, among other things, that:

• extracts are not per se novel.
• The burden of proof for novelty rests with the authority.
• Historical uses demonstrated traditional use.
• The novel food catalogue is not legally binding.

The Regional Court (VG) Sigmaringen dismissed the action. The Higher Regional Court of Baden-Württemberg (VGH BW) upheld this decision in the admissibility proceedings.

The central legal considerations of the Higher Regional Court (VGH)

Burden of proof lies with the person placing on the market

The Senate makes it clear:
The allocation of the burden of proof in novel food law differs from other areas of law, such as pharmaceutical law. The EU law concept transfers to the operator the duty to demonstrate non-novelty.

The authority's duty of official investigation (§ 24 LVwVfG) is not abolished thereby, but recedes behind the obligation to cooperate and provide information as provided for in EU law and incumbent on the operator.

Indicative effect of the Novel Food Catalogue

TheEU Novel Food Catalogue maintained by the European Commission does not produce formal binding effect, but does possess considerableIndicative effect.

He lists certain traditional plant parts as not novel, however he classifies numerous extracts, isolates and cannabinoid-containing products as novel because no significant consumption prior to 1997 is documented.

This reasoning is not limited to cannabis products. Rather, what is decisive is:

• the concrete composition of the product,
• the manufacturing process,
• the targeted enrichment of certain substances,
• the alteration of nutritional value, metabolism or content of unwanted substances.

The Higher Regional Court emphasizes, with reference to the case law of the Court of Justice of the European Union (EuGH), that even minor changes can have serious health consequences. Therefore, a case-by-case examination is required.

These principles apply equally to:

• highly concentrated plant extracts,
• standardised active ingredient isolates,
• novel protein fractions,
• fermentatively obtained ingredients,
• functional ingredients with enhanced bioavailability.

High requirements for expert reports and historical evidence

According to the court's assessment, the expert reports submitted by the plaintiff were insufficient. General references to traditional use or isolated trade fair reports were not sufficient to concretely and product-specifically establish significant consumption prior to 1997.

What is therefore required:

• reliable, documented market information,
• comprehensible quantitative data,
• clear reference to the concrete product or extraction type,
• substantiated facts rather than mere valuations.

The decision clearly demonstrates:
Offers of proof must not be directed at legal assessments, but must concern concrete facts.

Transferability to other substances and product categories

The significance of the decision extends far beyond cannabinoid-containing products.

The argumentation structure of the Higher Regional Court (VGH) concerns in particular:

• botanical extracts with standardised active ingredient content,
• adaptogenic plant substances,
• isolated secondary plant substances,
• enriched mineral or vitamin forms,
• novel lipid or protein fractions,
• ingredients obtained through new extraction or purification processes.

What is always decisive is the question:

Is it still the traditional foodstuff – or a technologically modified product with a new composition?

As soon as targeted enrichment or structural modification takes place, the risk of a novel food classification increases significantly.

Practical consequences for enterprises

The decision significantly tightens regulatory requirements:

• The burden of proof lies with the enterprise.
• Missing evidence leads directly to prohibition.
• The cut-off date of 15.05.1997 remains a high hurdle.
• The novel food catalogue has a de facto guiding effect.
• Courts impose high requirements on substantiation and documentation.

Particularly high-risk are products that are marketed as "natural" or "traditional" but are in fact manufactured through modern extraction or enrichment processes.

Our recommendation: Early legal status review

Enterprises must conduct a structured novel food status analysis before market entry.

This includes:

• legal classification under Art. 3 VO (EU) 2015/2283,
• assessment of the manufacturing process,
• analysis of potential enrichment effects,
• Documentation of a robust usage history,
• if necessary, strategic preparation of an approval procedure.

Miscalculations regularly lead to immediately enforceable distribution bans with significant economic consequences.

As a law firm specializing in, among other things,food lawandadministrative law, the experts atAVANTCORE Rechtsanwältein Stuttgart provide comprehensive advice to manufacturers, importers and traders onnovel food assessment, administrative proceedings and litigation.If you want to market extracts, isolates or innovative functional ingredients or are already facing an administrative measure, you should seek legal advice at an early stage. We develop a legally sound market access strategy for you and consistently represent your interests vis-à-vis the authorities and courts.