5.000 Anyone who works with supplements (or functional foods) knows the feeling: An ingredient has been "perfectly normal" on the market for years – and then suddenly it's labeled a novel food. What happened? And who in the EU actually has the final say?
What does "novel food" even mean?
A food or ingredient is considered novel in the EU if it was not consumed to a significant extent in the EU before the cut-off date of May 15, 1997. The key point is therefore not "new in the lab," but rather: a lack of documented consumption history in the EU.
Novel foods may only be placed on the market if they are authorized and listed in the Union list – including specifications, conditions of use, and, where applicable, labeling requirements. Examples are Algae Oil and Wheat Germ Extract with Spermidine.
Who decides what?
- European Commission (EC): Gatekeeper & decision-maker: Accepts applications, manages the process, prepares the authorization, and amends the Union list by means of implementing regulations.
- EFSA (European Food Safety Authority): Scientific Risk Assessment: Reviews safety data (toxicology, ADME, exposure, specifications, stability, etc.) and publishes opinions/guidance.
- Member States & PAFF Committee: In practice, Member States contribute to the EC's decision via the committee/comitology processes (political-administrative level). (EFSA assesses, the EC decides/regulates.)
- “Novel Food Status” / Consultation Process (Article 4 Consultation): If it is unclear whether something is a novel food, companies (or authorities) can initiate a status consultation. Result: “Novel” or “Not Novel” (sometimes with restrictions, e.g., only in supplements). These results are publicly listed.
An overview of the decisions can be found here.
How does an authorization come about?
- Clarify the question: Novel or not? (If applicable, Article 4 consultation)
- Submit dossier (for novel foods, usually via the EC)
- Validation (formal check)
- EFSA safety assessment (scientific review)
- EC decision + voting/process
- Entry in the Union list (2017/2470) with precise conditions/specifications
Why are substances “suddenly” considered novel foods?
The “sudden” is almost always a communication and documentation problem – or a change in the manufacturing process:
- New extraction/manufacturing methods (e.g., CO₂ extraction, fermentation, new purification levels) → new product profile
- Different plant parts (e.g., leaf instead of root) or new specification (standardized markers)
- New use: e.g., B. “Not Novel in Supplements” does not automatically mean “Not Novel in all foods.”
- Enforcement wave: Market grows → more controls → novelty status question raised
- Missing/insufficient 1997 evidence: Retailer myths do not replace reliable evidence (import data, old catalogs, recipes, trade records)
- New scientific safety questions (gaps in toxicological data) – even if something seems “common.”
- Status lists/catalogs are clarified: Clarifications eliminate a gray area
What has changed since 2025?
Updated EFSA guidelines from February 1, 2025
The European Food Safety Authority has revised its administrative guidelines for novel food applications. More precise requirements apply to dossiers submitted from February 1, 2025 – particularly regarding data quality, study design, specifications, and exposure assessment.
Practical consequence: No new law, but effectively a higher bar. Those submitting or required to submit applications in 2025 or later should expect more intensive review and a greater need for data.
Ongoing updates to the Union list
The Union list (Regulation (EU) 2017/2470) is regularly updated – in 2025 also through specific amending regulations. For example, Implementing Regulation (EU) 2025/97 includes adjustments to the conditions of use and specifications for isomalto-oligosaccharides.
Important for supplements:
"Authorized" does not automatically mean "freely available for use." The specifications, matrix, target group, and dosage are always crucial.
Status decisions in 2025 relevant to supplements
The European Commission's public consultation list demonstrates the differentiated assessment process – even for similar substances:
- Micronized creatine monohydrate – Not Novel (Aug 2025)
- Micronization alone does not automatically result in Novel status.
- Boron glycinate/bisglycinate – Novel Food (Apr 2025)
- A new chemical form or specification can trigger novel food status.
- Mushroom extracts (e.g., Chaga, Lion's Mane, Maitake, Reishi) – Not novel in food supplements (Feb 2025)
- Key phrase: in food supplements. Other uses may be assessed differently.
- Hemp (Cannabis sativa L.) herb – Novel Food (March 2025)
- Hemp remains highly differentiated according to plant part and application.
CBD remains a regulatory hotspot
The European Food Safety Authority has derived a provisional safe intake level for CBD (0.0275 mg/kg body weight/day; approx. 2 mg/day for a 70 kg adult).
Practical implications: The novel food discussion surrounding CBD remains dynamic. For brands, a clear regulatory narrative (specification, dosage, target group, warnings) is becoming increasingly important.
Note on the Novel Food classification of high-purity plant isolates
The following substances, in their present form – especially as highly purified, standardized isolates (≥ 98% or highly enriched extracts) – in combination as a mixture, are clearly considered Novel Food (as of January 2026).
Furthermore, individual use is also potentially novel food-relevant, as these are not traditional whole plant preparations, but isolated, highly concentrated individual substances for which, in this specification, there is often no documented significant consumption history before 1997:
- Apigenin (≥ 98%) – isolated from the aerial parts of Matricaria chamomilla L. (German chamomile)
- Quercetin (≥ 98%) – isolated from the leaves/flowers of Sophora japonica L. (Japanese pagoda tree)
- Pterostilbene (≥ 99%) – isolated from the wood of Pterocarpus santalinus L. (Red sandalwood)
- Gynostemma pentaphyllum extract (80% gypenosides) – from the aerial parts of Gynostemma pentaphyllum (Thunb.) Makino (Jiaogulan)
- Centella asiatica extract (40% triterpenes) – from the aerial parts of Centella asiatica (L.) Urb. (Gotu Kola)
- Cycloastragenol (≥ 98%) – isolated from the root of Astragalus membranaceus (Fish.) Bge.
- Fisetin (≥ 98%) – isolated from the bark of Cotinus coggygria Scop. (Smokebush)
Important:
For novel foods, it is not the plant itself that counts, but rather the plant part, the extraction method, the degree of purity, standardization, and the intended use. A mixture of several high-purity isolates further increases the likelihood of novel food classification.
You can find more information about this topic and our approach here.
Haftungsausschluss
Aus rechtlichen Gründen weisen wir darauf hin, dass bei den oben genannten Aussagen teilweise weitere Forschungen sowie Studien notwendig sind, um diese wissenschaftlich zu belegen. Daher können aktuell nicht alle Aussagen von der Schulmedizin anerkannt werden.
Die in diesem Beitrag enthaltenen Informationen zu gesetzlichen Regelungen, Zulassungen und Einsatzmöglichkeiten von Rohstoffen basieren auf sorgfältiger Recherche und unserem aktuellen Kenntnisstand (Stand: Juli 2025). Wir übernehmen jedoch keine Gewähr für die Vollständigkeit, Richtigkeit oder Aktualität der Angaben.
Die rechtlichen Rahmenbedingungen für Lebensmittel und Nahrungsergänzungsmittel unterliegen laufenden Änderungen. Für die Verwendung von Rohstoffen und gesundheitsbezogenen Angaben ist daher stets eine eigenverantwortliche Prüfung der jeweils geltenden Vorschriften, EU-Verordnungen und Zulassungslisten durch den Hersteller oder Inverkehrbringer erforderlich.
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