Novel Food Status Readiness for Supplement Ingredients (EU)
Check each new ingredient against the 1997 test, keep the evidence and use authorised novel foods only under their listed conditions.
In Short
- Cut-off date: 15 May 1997.
- Unsure? Consult the Member State.
- Use only on Union list terms.
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
- The rules and who decides
- Specification to finished batch
- Test, review, investigate
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
Under Regulation (EU) 2015/2283, a food not used for human consumption to a significant degree in the Union before 15 May 1997 that falls in a listed category is a novel food. It may be sold only if authorised and on the Union list, under the listed conditions of use and labelling. Supplement ingredients such as new botanical extracts, algae and microbial ingredients often need this check. Orientation, not legal advice. Sources checked 4 Oct 2026.
What makes a food novel
Article 3(2)(a) defines a novel food as one not used for human consumption to a significant degree within the Union before 15 May 1997 that also falls in at least one listed category. Categories include new or intentionally modified molecular structures; food from microorganisms, fungi or algae; food from material of mineral origin; food from plants or animals, with exceptions for a history of safe food use; cell or tissue cultures; food from new production processes that significantly change composition; engineered nanomaterials; and vitamins or minerals from new processes.
Status check (Article 3(2)(a))
| Question | If yes |
|---|---|
| Significant EU human consumption before 15 May 1997? | Not novel; keep the evidence |
| Falls in a listed category (algae, new process, culture...)? | Likely novel; check Union list |
| Excluded (GM, enzyme, additive, flavouring)? | Other rules apply |
| Still unsure? | Consult Member State of first placing (Art. 4(2)) |
- Significant EU human consumption before 15 May 1997?
- If yes
- Not novel; keep the evidence
- Falls in a listed category (algae, new process, culture...)?
- If yes
- Likely novel; check Union list
- Excluded (GM, enzyme, additive, flavouring)?
- If yes
- Other rules apply
- Still unsure?
- If yes
- Consult Member State of first placing (Art. 4(2))
More on what makes a food novel
Article 2(2) excludes, among others, GM foods, enzymes, additives and flavourings under their own rules.
Your duty to check status
Article 4(1) puts the first responsibility on the food business operator: verify whether the food you intend to place on the market falls within the regulation. Where you are unsure, Article 4(2) requires you to consult the Member State where you first intend to place it, providing the information needed for a determination.
More on your duty to check status
Article 4(4) leaves procedural detail to implementing acts, which were not reviewed here. Evidence of use before 1997 typically includes dated product lists, invoices, recipes and catalogues showing consumption to a significant degree in the Union, not use only in supplements unless that is what the record shows.
The Union list and its conditions
Article 6(2) says only novel foods authorised and included in the Union list may be placed on the market, as such or in or on foods, in line with the conditions of use and labelling requirements in the list. For a supplement brand, that means checking the entry's specification, permitted food categories, maximum levels and any labelling statement before formulation, then holding supplier specifications that match.
More on the Union list and its conditions
The Union list itself sits in a separate implementing regulation that was not opened for this guide; read the current consolidated entry for each ingredient.
Keeping a status file per ingredient
For each ingredient, keep a file showing who checked status, the date, the evidence relied on and the conclusion. Include the supplier's specification and manufacturing process, since a new process can change status.
Worked example: status file NF-221 (algal extract)
More on keeping a status file per ingredient
Record the Union list entry and conditions where authorised, or the Member State consultation where status was unclear. Review the file when a supplier, source material or process changes. Qualified people reach and sign the conclusion; software can keep the evidence together and show revision history, but it does not decide whether a food is novel.
Questions
What is the cut-off date?
15 May 1997. A food used for human consumption to a significant degree in the Union before that date is not novel under Article 3(2)(a).
Who decides whether an ingredient is novel?
The food business operator verifies status first (Article 4(1)). If unsure, it consults the Member State of first placing (Article 4(2)). The Commission may also decide by implementing act (Article 5).
Can we use an authorised novel food freely?
Only under the conditions of use and labelling set in its Union list entry (Article 6(2)). Check the specification and permitted uses for each entry.
Is there a simpler route for foods eaten safely outside the EU?
Article 14 allows notification of a traditional food from a third country, with documented history of safe food use, instead of a full application.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
EU 10/2011 Plastics Food Contact: Union List, Migration Limits and the Declaration of Compliance
EU Food Supplements Directive 2002/46/EC: Composition and Labelling
EU PPWR & EPR Readiness for Supplement Packaging Design
Pet Food and Animal Food cGMP Readiness: 21 CFR 507
Medical Food or Supplement? The US Definition and Label Exemption
21 CFR 111 Readiness: Identity, Master and Batch Records