What the novel food regulation covers
Under the novel food regulation, Regulation (EU) 2015/2283, a food not consumed to a significant degree in the EU before 15 May 1997 needs authorisation before sale. Food supplements are foods, so supplement ingredients fall within its scope, except those excluded by Article 2(2), such as food additives and food enzymes used as such. A novel ingredient may only be used if it appears in the Union list, under the conditions of its entry.
The Union list is set out in Commission Implementing Regulation (EU) 2017/2470. It applies in every member state. Unlike maximum levels or rules on botanicals, novel food status is harmonised at EU level.
The date test is the core of the regulation. What counts is consumption as food, within the EU, to a significant degree, before 15 May 1997. Use outside the EU, or use in medicinal products, does not by itself establish that history.
Which ingredients count as novel
A food is novel only if it fails the date test and also falls into at least one category in Article 3(2)(a) of the regulation. The categories most relevant to supplement manufacturers are:
- food with a new or intentionally modified molecular structure;
- food consisting of, isolated from or produced from microorganisms, fungi or algae;
- food consisting of, isolated from or produced from material of mineral origin;
- food from plants or their parts, unless it has a history of safe food use in the EU;
- food from cell or tissue culture;
- food from a production process not used before 15 May 1997 that significantly changes its composition or structure;
- food consisting of engineered nanomaterials;
- vitamins, minerals and other substances produced by such a new process, or containing engineered nanomaterials;
- food used exclusively in food supplements before 15 May 1997, when intended for other foods.
The last category matters for this sector. An ingredient with a pre-1997 history only in supplements is not novel in supplements. It becomes novel if you put it into a conventional food.
How Directive 2002/46/EC and the novel food rules interact
The food supplements directive, Directive 2002/46/EC, and the novel food regulation answer different questions. Annex II of the directive lists the chemical forms of vitamins and minerals that may be used in supplements. Novel food status asks whether a substance, source or process has an EU consumption history.
A vitamin or mineral form must satisfy both. Some forms have been added to Annex II after a novel food authorisation. Where the source or production process is new, a listing in Annex II does not settle novel food status on its own. The guide to permitted vitamin and mineral forms covers Annex II in detail.
For other substances, such as amino acids, botanicals, carotenoids and enzymes, the directive has no positive list. National rules largely govern their use and they differ between member states, although EU law prohibits or restricts some substances in Annex III of Regulation (EC) No 1925/2006. Novel food status still applies EU-wide on top of those national rules.
The directive also fixes the units for declaring vitamins and minerals, and these are metric. Specifications from outside the EU often give vitamin D or vitamin E in international units. Convert vitamin D from IU to mcg, or vitamin E from IU to mg, with the vitamin unit converter before checking any level or drafting the label.
Reading a Union list entry
An authorisation covers the novel food as specified, under stated conditions. Each entry in Implementing Regulation (EU) 2017/2470 has these parts:
| Part of the entry | What it tells a supplement manufacturer |
|---|---|
| Authorised novel food | The exact substance or material covered |
| Conditions of use | Food categories, such as food supplements as defined in Directive 2002/46/EC, and maximum levels |
| Specific labelling requirements | The designation to use and any mandatory statement |
| Other requirements | Further conditions attached to the authorisation |
| Data protection | Whether use is restricted to the applicant for a period |
| Specification | Source, production process, composition and purity criteria |
The specification is decisive. A material from another source or process may fall outside the entry, even if chemically similar. Conditions of use for supplements may also restrict the target population or exclude certain groups.
Under Articles 26 and 27, an authorisation based on proprietary data can be restricted to the applicant for five years. During that period, other operators may not rely on the entry. The Union list is amended often, so always work from the current consolidated version on EUR-Lex.
Checking the status of an ingredient
A regulatory manager can work through these steps for each ingredient:
- Identify the exact substance, source organism and production process from the specification sheet.
- Search the consolidated Union list for an entry and compare the specification line by line.
- If there is no entry, establish whether significant EU food consumption before 15 May 1997 can be documented.
- If the status remains unclear, use the consultation procedure in Article 4 with the competent authority of the member state of first marketing.
- For a vitamin or mineral, confirm that the form is in Annex II of Directive 2002/46/EC.
- Check national rules on other substances and maximum levels in each target market.
The Commission also keeps a catalogue of status views discussed with member states. It is a non-binding guide, not law, and does not replace steps 2 to 4.
SoleChem sends the specification sheet and the certificate of analysis with its quote. You can then compare the material with the Union list specification before you place an order through the quote form.
Ingredient types that need a status check
The status of the ingredients below depends on the material you buy, so check each one individually.
| Ingredient type | Why the question arises | What to check |
|---|---|---|
| Algae-derived materials, such as astaxanthin and spirulina | Source organism and extraction process define the material | Species, process and any Union list entry or documented pre-1997 history |
| Molecules made by fermentation or synthesis, such as resveratrol, glutathione and coenzyme Q10 | The same molecule can be covered for one process and not another | Production process and specification against the entry |
| New vitamin and mineral forms | Annex II and novel food status are separate questions | Both Annex II and the Union list |
| Botanical extracts | A concentrated extract can differ from the traditionally eaten plant | Consumption history of the extract itself, plus national botanical rules |
| Materials in nanoform | Engineered nanomaterials form their own category | Particle form stated in the specification |
Traditional foods from third countries
Article 14 provides a notification route for traditional foods from third countries. It requires a documented history of safe food use in a third country. If no reasoned safety objection is raised within the set period, the food is added to the Union list. This route rarely suits isolated or purified ingredients.
The authorisation route for a new ingredient
An applicant submits a dossier to the Commission. The Commission may ask the European Food Safety Authority for a risk assessment. Authorisation is granted by an implementing act that amends the Union list, with the specification and conditions of use.
Labelling and claims
A Union list entry may set the designation and statements for the label. These apply alongside Regulation (EU) No 1169/2011 and the labelling rules of Directive 2002/46/EC. The labelling guide covers the general requirements.
A novel food authorisation does not authorise any health claim. Claims fall under Regulation (EC) No 1924/2006 and the EU Register of nutrition and health claims. See the health-claims guide for how the Register works.