Novel foods are ingredients or substances that were not used as food on a significant scale in the EU prior to 15 May 1997. If an ingredient in your supplement falls under this definition, you will need official authorisation from the European Commission before you can place the product on the European market. This applies to both new botanical extracts and innovative substances such as certain algae, insect proteins or modified food components. In this article, we answer the most frequently asked questions about the Novel Foods Regulation and what it means for your range of supplements.
Which ingredients in supplements fall under the Novel Foods Regulation?
An ingredient falls within the scope of the Novel Foods Regulation (EU) 2015/2283 if it was not consumed to a significant degree as food within the EU prior to 15 May 1997. This covers a wide range of categories, from new botanical extracts and synthetic substances to foods that are common outside the EU but are new here.
In practice, supplements often contain the following types of ingredients:
- New plant extracts which have not previously been sold as food supplements in the EU, such as certain adaptogens or exotic herbs
- Algae and microbial sources which have recently emerged as sources of protein, such as certain types of spirulina or chlorella that are processed into specific concentrated forms
- Insect protein, some of which have now been approved, whilst others are still undergoing the approval process
- Synthetic variants of existing substances, such as certain synthetically produced cannabinoids or modified amino acids
- Foodstuffs from third countries which are traditionally eaten elsewhere but have no history of consumption in the EU
Important: this does not only apply to completely new substances. An existing ingredient in a new form, at a new concentration or produced using a new manufacturing process may also be classified as a novel food. An extract from a plant that is normally drunk as tea may, for example, suddenly fall within the scope of the regulation when contained in a highly concentrated capsule.
How do you determine whether an ingredient was already in use in the EU before 1997?
To determine whether an ingredient was used as a foodstuff on a significant scale in the EU prior to 15 May 1997, you must gather historical evidence. The burden of proof lies with the market operator, not with the regulatory authority. This involves demonstrable, documented use as a food supplement or foodstuff in one or more EU Member States.
Useful sources for historical research include:
- Historical sales figures or product catalogues dating from before 1997
- Scientific literature or dietary reports from that period
- Member States’ national databases on authorised food supplements
- Designation of national competent authorities, such as the NVWA in the Netherlands
The European Commission also manages a public Novel Food Catalogue, a searchable database in which it has already been established for many ingredients whether they are considered to be novel foods. This is the first place to check. If an ingredient is not listed, or if the assessment is listed as ‘uncertain’, further investigation is required.
Are you still unsure after consulting the catalogue? If so, you can request a formal consultation with the national authority of an EU Member State. In the Netherlands, this is the NVWA, which can issue an opinion on the novel food status of a specific ingredient.
What are the steps involved in applying for novel food authorisation?
Applications for novel food authorisation are processed through a centralised EU procedure. The application is submitted to the European Commission via the EFSA portal, after which the European Food Safety Authority (EFSA) carries out a scientific risk assessment. The entire procedure takes an average of one and a half to two years.
The steps, in order, are:
- Preparation of the file: Gather all the necessary data, including the characterisation of the ingredient, the production process, food safety data, proposed conditions of use and data on the nutritional composition.
- Submission via the EU portal: The dossier is submitted to the European Commission, which assesses its completeness before forwarding it to EFSA.
- EFSA assessment: EFSA carries out a scientific assessment, during which the Panel on Nutrition, Novel Foods and Food Allergens (NDA) analyses the dossier. EFSA may request further information.
- EFSA’s advice: EFSA publishes a scientific opinion. This is made public and forms the basis for the European Commission’s decision.
- Decision of the European Commission: On the basis of the EFSA’s opinion, the Commission decides whether the ingredient is to be added to the Union list of authorised novel foods, subject to specific conditions of use where appropriate.
The costs involved in compiling a dossier are considerable, particularly if new toxicological studies are required. For small and medium-sized enterprises, it is advisable to engage a specialist regulatory consultant to assist with putting the dossier together.
Are you allowed to sell a novel food ingredient whilst the application is still being processed?
No, in principle, you are not permitted to place a novel food ingredient on the market until authorisation has been granted. The Novel Foods Regulation prohibits the placing on the market of unauthorised novel foods in the EU. This also applies if the application has already been submitted and the procedure is ongoing.
There is one exception: the traditional food procedure. If an ingredient has a safe history of use spanning at least 25 years in a third country (outside the EU), a simplified notification procedure may be used to notify that the ingredient is being placed on the market. Member States or EFSA may raise objections to this, but if there are no substantiated objections, the product may be placed on the market.
Apart from this exception, the rule is: await approval. Placing an unauthorised novel food on the market may result in enforcement action by the NVWA, product recalls and reputational damage. The risks do not outweigh the speed you gain from doing so.
What is the difference between a novel food and a ban on health claims?
Novel foods and health claims are two separate legal frameworks, both of which are relevant to supplements but address fundamentally different issues. A novel food assessment concerns whether an ingredient may be sold in the EU at all. A health claim concerns what you are permitted to state on the label about that ingredient.
Specific difference:
- Novel Food Regulation determines the authorisation status of the ingredient itself. Is it safe enough to be placed on the European market? Without authorisation, the product may not be sold, regardless of what is stated on the label.
- Regulation (EC) No 1924/2006 on health claims regulates what claims may be made on the label or in marketing regarding the effects of an ingredient. Only claims that have been approved by EFSA and included in the EU list of permitted claims may be used.
An ingredient may therefore be entirely legal (not a novel food, or an approved novel food) and yet you are not permitted to make a health claim about it if that claim is not included on the EU list. Conversely, an ingredient may have an approved health claim, but if it is also classified as a novel food, you will still need a separate novel food authorisation.
For supplement brands, this means in practice: check both frameworks separately for each ingredient. An approved health claim is not proof that the ingredient is not a novel food, and vice versa.
How does a private-label manufacturer help with novel food compliance?
An experienced private-label manufacturer plays a crucial role in navigating novel food legislation, as they deal with ingredient lists, supplier specifications and food safety regulations on a daily basis. A good manufacturing partner identifies potential novel food issues as early as the concept phase, before you invest time and money in a product that cannot be placed on the market straight away.
In practice, a private-label manufacturer contributes to compliance in the following ways:
- Ingredient screening: When developing a recipe, ingredients are assessed for their novel food status using the EU Novel Food Catalogue and supplier documentation.
- Label check: The product information on the label is checked for permitted health claims and legally required information, so that you do not inadvertently include prohibited claims.
- Food Safety Plan: A certified manufacturer draws up an HACCP-based food safety plan that is specifically tailored to your product range, which is essential for market authorisation.
- Documentation for the authorities: Should the NVWA or other regulatory authorities make enquiries, the manufacturer can provide traceability documentation and raw material specifications.
At MixMasters, we actively support our clients throughout this process. Our quality team works alongside specialist consultants to develop a food safety plan tailored to your specific range of supplements, including label checks for health and nutrition claims. We are BRCGS-certified, which means that our production processes comply with internationally recognised standards for food safety, traceability and quality management. View our full range of services or get in touch to discuss how we can ensure your product is compliant and ready for the market.
Frequently Asked Questions
What happens if I accidentally use a novel food ingredient without authorisation?
If you discover that an ingredient in your product is an unauthorised novel food, it is advisable to cease sales immediately and seek legal or regulatory advice. Report this proactively to the NVWA, as voluntary action is generally viewed more favourably than retrospective enforcement. Depending on the situation, you can choose to reformulate the product using an approved alternative, or submit a novel food application if the ingredient is of strategic commercial importance.
Are there any alternative ingredients that offer similar effects to a novel food, but which have already been approved?
Yes, in many cases there is a functionally comparable ingredient with a proven history of use in the EU prior to 1997 that does not have novel food status. A specialist regulatory consultant or an experienced private-label manufacturer can help identify such alternatives based on your desired product positioning. It is worth investigating this early on in the product development process, so that you do not waste time and budget on a regulatory application process that you can avoid.
Does the Novel Foods Regulation also apply to supplements that I export to Europe from a non-EU country?
Yes, the Novel Foods Regulation (EU) 2015/2283 applies to all foodstuffs and food supplements placed on the European market, regardless of where they are produced. If, as a non-EU producer, you sell products to consumers or retailers within the EU, you are obliged to comply with EU regulations, including the novel food requirements. The responsibility lies with the party placing the product on the EU market, even if this is done via an importer or distributor.
How long is a novel food authorisation valid for, and do I need to renew it periodically?
In principle, a novel food authorisation has no fixed expiry date; once an ingredient has been included in the Union list of authorised novel foods, that authorisation remains valid until new safety information gives rise to a review. However, the European Commission may decide to review an authorisation if new scientific evidence regarding the safety of the ingredient becomes available. It is therefore advisable to continue actively monitoring relevant scientific developments relating to your ingredients.
As a small brand, can I submit a novel food application, or is that only open to large companies?
Formeel staat de aanvraagprocedure open voor elk bedrijf, ongeacht de grootte. In de praktijk zijn de kosten voor het samenstellen van een volledig dossier — inclusief toxicologische studies — aanzienlijk en kunnen ze oplopen tot tienduizenden euro’s. Voor kleine merken is het vaak efficiënter om samen te werken met een regulatory consultant die het dossier coördineert, of om te onderzoeken of een bestaande goedkeuring van een ander bedrijf van toepassing is op jouw gebruik van hetzelfde ingrediënt, wat de drempel aanzienlijk verlaagt.
What is the difference between a product-specific novel food authorisation and a generic authorisation?
Sommige novel food-goedkeuringen zijn gebonden aan de specifieke aanvrager en het specifieke productieproces dat in het dossier is beschreven; andere toelatingen gelden generiek voor het ingrediënt en mogen door alle marktdeelnemers worden gebruikt. In de Unielijst staat per ingrediënt vermeld of er sprake is van een zogenaamde ‘data protection’-periode, waarbij de goedkeuring tijdelijk exclusief is voor de aanvrager. Na het verstrijken van die beschermingsperiode — doorgaans vijf jaar — mag iedereen het ingrediënt onder dezelfde voorwaarden gebruiken zonder een nieuw dossier in te dienen.
How can I keep up to date with changes to the EU list of authorised novel foods?
The Union List is regularly updated through implementing regulations issued by the European Commission, which are published in the Official Journal of the EU. You can keep track of changes via the official EU legislation database EUR-Lex, the Novel Food Catalogue on the EFSA website, or via newsletters from trade associations such as NPN (Natural Products Netherlands) or NutraIngredients. For supplement brands that are actively exploring new ingredients, it is advisable to carry out systematic checks at least twice a year.
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