Germany is an important market for nutraceutical and food supplement companies, but market entry is not simply a matter of submitting a product notification and moving forward.
Under the EU Novel Food framework, a food which was not consumed to a particular degree in the European Union before 15 May 1997 may require authorisation if it falls within one of the categories defined by Regulation (EU) 2015/2283. The assessment can depend not only on the source ingredient, but also on its composition, plant part, extraction or production process, intended use, and historical food use.
For companies assessing nutraceutical registration Germany, this distinction is particularly important. A familiar botanical does not automatically mean that every extract, preparation, processing method, or plant part has the same regulatory status. This article explains how companies can assess that distinction before placing a food supplement on the German market.
A German Food Supplement Notification is Not a Product Approval
One of the first points companies need to understand about food supplement registration Germany is that notification and approval are not the same thing.
Under Section 5 of the German Food Supplements Regulation (NemV), manufacturers or importers intending to place a food supplement on the German market must notify the product to the Federal Office of Consumer Protection and Food Safety (BVL) no later than the time of first placing on the market and submit a specimen of the product label.
However, the BVL notification does not constitute a marketing authorisation or a confirmation that the product is legally marketable. The BVL itself states that the receipt confirmation only confirms submission of the notification and does not certify the product’s marketability.
This creates an important compliance distinction:
For nutraceutical regulations Germany, the broader assessment can involve EU food law, German requirements, ingredient-specific restrictions, claims legislation, contaminants, maximum levels where applicable, and Novel Food requirements.
When Does a Nutraceutical Ingredient Become a Novel Food Issue?
The starting point is Regulation (EU) 2015/2283. A Novel Food is generally a food which was not consumed to a particular degree by humans in the EU before 15 May 1997 and falls within at least one of the categories specified in the Regulation. These include foods with a new or intentionally modified molecular structure, foods derived from microorganisms, fungi, algae, plants or animals in specified circumstances, foods resulting from certain new production processes, engineered nanomaterials, and certain substances used in food supplements.
For nutraceutical companies, the practical issue is that ingredient familiarity is not enough. A botanical may have a long history of food use, while a particular extract or preparation derived from it may need a separate assessment. Likewise, an ingredient may have been used in food supplements before 1997 but not necessarily in other food categories.
The assessment should therefore consider:
- Ingredient identity and form: Species, plant part, preparation, and final ingredient form.
- Processing and composition: Extraction, concentration, processing method, and resulting composition.
- Intended use: Proposed food category and conditions of use.
- Consumption history: Evidence of significant EU food use before 15 May 1997.
- Regulatory status: Union List, Novel Food Catalogue, and relevant consultation outcomes.
This is why botanical extract novel food assessments should be conducted at the level of the actual ingredient being placed on the market rather than simply relying on the common name of the source plant.
Why Ingredient Form and Processing Can Change Regulatory Status
The regulatory status of a botanical is not necessarily transferable across every preparation derived from that botanical. The source may remain the same, but the resulting food may not be equivalent for Novel Food purposes.
Regulation (EU) 2015/2283 specifically covers foods resulting from production processes that were not used for food production in the EU before 15 May 1997 where the process causes significant changes in composition or structure affecting nutritional value, metabolism or levels of undesirable substances.
The Union framework also specifically addresses new molecular structures and engineered nanomaterials. This particularly same principle applies to food supplement botanical ingredients where processing, concentration, purification or technological treatment changes the nature of the resulting food.
The 15 May 1997 Consumption History: Why It Matters
The date 15 May 1997 is a central reference point in EU Novel Food assessment. The question is not simply whether an ingredient existed before that date. The relevant issue is whether it was consumed by humans within a significant degree in the European Union before 15 May 1997.
Companies may therefore need to investigate historical evidence such as:
- Published literature and scientific references
- Historical food-use records
- Product catalogues or commercial documentation
- Historical recipes or food references
- Evidence from national or regional markets
- Documentation showing actual food use rather than medicinal or technical use
- Evidence concerning the specific form, preparation or plant part being assessed
The evidence also needs to relate to the relevant food use. For example, use of a botanical as a medicinal product does not automatically establish its history of use as a food. Similarly, evidence for one plant part or preparation may not necessarily establish the status of another.
An additional nuance applies to substances used exclusively in food supplements before 15 May 1997. The Novel Food Regulation provides specific treatment for foods used exclusively in food supplements before that date and subsequently intended for use in foods other than food supplements.
What the EU Novel Food Catalogue Can and Cannot Tell You
The European Commission’s Novel Food Catalogue is one of the first resources companies should consult when assessing an ingredient. However, it should not be treated as a definitive authorisation database.
The Commission describes the two resources differently:
- Novel Food Catalogue = Non-binding orientation on Novel Food status
- Union List = Authorised Novel Foods + conditions of use, labeling services requirements and specifications
The Catalogue contains information on products of plant and animal origin, algae, fungi, micro-organisms and other substances, based on information provided by EU Member States. It is a non-binding and non-exhaustive tool that helps businesses assess whether a product may require authorisation under the Novel Food Regulation.
This creates three important practical rules:
- Catalogue status is not authorisation. The Catalogue provides orientation on Novel Food status, while the Union List identifies Novel Foods authorised for use in the EU and their applicable conditions.
- Status can depend on the specific preparation. Plant part, extraction or processing method, composition and intended use can affect the assessment. A Catalogue entry for one preparation should not automatically be applied to another.
- No Catalogue entry does not mean non-novel. Because the Catalogue is non-exhaustive, companies remain responsible for establishing the regulatory status of their ingredient and supporting a relevant history of consumption where required.
Germany's BVL Consultation: When Should Companies Use It?
When the Novel Food status of an ingredient cannot be established confidently from available evidence, a formal status consultation can provide a more structured route to a determination.
EU rules provide for consultation with the competent authority of the Member State where the food is intended to be placed on the market first. The consultation process operates under Commission Implementing Regulation (EU) 2018/456.
In Germany, the BVL’s responsibilities include consultation procedures for determining Novel Food status under Article 4 of Regulation (EU) 2015/2283.
Companies should first build a well-supported assessment of the ingredient’s identity, composition, manufacturing process, intended use and consumption history. Where uncertainty remains material, the consultation route can help establish the Novel Food status before market entry. This is particularly valuable for products intended for the German market because a BVL notification does not itself resolve an underlying Novel Food question.
2026 Examples: Echinacea, CBD and Emerging Nutraceutical Ingredients
Recent developments illustrate why ingredient-level assessment remains important in 2026.
Echinacea: the source plant is not the whole regulatory story
Echinacea demonstrates how plant species, plant part and preparation can affect the regulatory assessment.
The EU Union List includes specific authorised Novel Foods such as Echinacea angustifolia extract from cell cultures and Echinacea purpurea extract from cell cultures, with conditions for use in food supplements. At the same time, the EU Novel Food Catalogue has continued to evolve around different Echinacea preparations and uses. A 2026 update has drawn attention to distinctions involving traditional roots, herbs, teas, flowers and whole-plant preparations.
CBD: repeated regulatory activity does not equal blanket authorisation
The European Commission’s Novel Food consultation records identify various CBD isolates and extracts as Novel Foods. At the same time, the Commission has continued to terminate individual CBD-related Novel Food authorisation procedures in 2026 without updating the Union List in those cases. This demonstrates why companies should not interpret the existence of applications, consultation outcomes or regulatory activity as equivalent to a general permission to market every CBD preparation.
For CBD-containing nutraceutical products, the precise substance, source, production method, composition and intended use must be assessed against the applicable EU framework.
Emerging ingredients: status can change as evidence develops
The 2026 EU consultation records also demonstrate the continuing evolution of Novel Food assessments.
Examples include L-theanine, identified as Novel Food in the Commission’s consultation records, and certain newly assessed botanical, microbial and other preparations. Other preparations have been determined not to be novel, including some specific extracts used in food supplements.
The broader lesson for companies is important: Novel Food assessment is not a static exercise based only on the name of an ingredient. As new evidence becomes available and Member States assess particular preparations, the regulatory picture can become more specific.
A Practical Novel Food Decision Framework for Nutraceutical Companies
A structured decision framework can help companies assess an ingredient before investing in German market entry.
Step 1: Define the ingredient
Confirm the scientific name, plant part, preparation, processing method, composition and final specification.
Step 2: Confirm the intended use
Identify the food category, proposed daily intake and target population, as Novel Food status and conditions of use can depend on the intended application.
Step 3: Check the EU regulatory status
Review the Union List and Novel Food Catalogue for the specific ingredient and preparation. Do not assume that an entry for one form applies to another.
Step 4: Assess pre-1997 food use
Where relevant, establish evidence of significant consumption in the EU before 15 May 1997, ensuring the evidence relates to the ingredient and form being marketed.
Step 5: Assess processing and composition
Determine whether extraction, concentration, purification, fermentation, cell culture or other processing has changed the ingredient in a way relevant to Novel Food status. This is particularly important for botanical extract novel food assessments.
Step 6: Review wider regulatory requirements
For nutraceutical regulatory requirements Germany, assess composition, labelling, claims, contaminants, applicable maximum levels, pesticides, additives and potential medicinal-product borderline issues.
Step 7: Resolve uncertainty and complete notification
Where Novel Food status remains unclear, consider a BVL consultation before market entry. Once compliance is established, complete the applicable BVL food supplement notification.
How DDReg Supports Nutraceutical Market Entry in Germany
Entering Germany with a nutraceutical product requires more than understanding the notification mechanism. Companies need to establish that the product, its ingredients and its presentation fit within the applicable European and German food regulatory framework.
DDReg can support companies by helping assess ingredient status, review formulations and botanical preparations, evaluate Novel Food considerations, examine available historical-use evidence, and identify regulatory gaps analysis before market entry.
Support can also extend to reviewing product labels and claims, assessing the regulatory implications of manufacturing and processing methods, preparing documentation for regulatory consultations where appropriate, and supporting the German food supplement notification process.
Conclusion
The EU Novel Food Catalogue is a valuable starting point, but it is non-binding and non-exhaustive. The Union List must be checked separately, and where uncertainty remains, the appropriate national consultation mechanism can provide a more robust route to determining Novel Food status.
For nutraceutical companies, this distinction can prevent a common market-entry mistake: treating a German food supplement notification as evidence that every ingredient in the product has already cleared the regulatory assessment. Novel Food status should be resolved at the ingredient level before formulation, labelling and German market entry not after a product has already been formulated, labelled and launched. The stronger approach is to assess the complete regulatory identity of the ingredient—its species, plant part, preparation, manufacturing process, composition, intended use and evidence of consumption before 15 May 1997.
Frequently Asked Questions
No. A food supplement must generally be notified to the BVL before first placing on the German market, but the notification is not an approval or confirmation of marketability. The operator remains responsible for compliance with applicable food-law requirements.
An ingredient may be considered a Novel Food when it was not consumed to a significant degree as food in the EU before 15 May 1997 and falls within the scope of Regulation (EU) 2015/2283. The assessment can depend on the ingredient’s identity, preparation, processing, composition and intended use.
No. The Novel Food Catalogue is a non-binding, non-exhaustive orientation tool. It should be considered alongside the Union List, which contains authorised Novel Foods and their applicable conditions of use and specifications.
A consultation should be considered when the Novel Food status of an ingredient remains uncertain after reviewing its identity, form, processing, consumption history and relevant EU information. Under the EU framework, businesses should consult the competent authority in the Member State where they first intend to place the food on the market.