In the EU, a supplement is a food
What the US calls a dietary supplement, EU law calls a food supplement: a concentrated source of nutrients or other substances, sold in measured doses such as capsules, tablets, powders or drops (Directive 2002/46/EC). It is regulated as a food, not a medicine. There is no EU-wide pre-market approval, but the rules on what may go in, what must be on the label and what may be claimed are strict, and they are enforced at the border and on the shelf.
The legal responsibility sits inside the EU. The business that places the product on the market, usually the brand owner or its importer, must be able to show that every batch complies. A manufacturer outside the EU supplies the evidence; it cannot carry the responsibility for you.
This checklist follows the order in which problems usually surface: ingredients first, then the responsible business, contaminants, the label, claims, notification and the border. Each step ends with what to ask your manufacturer for.
Step 1: Confirm every ingredient is allowed
Composition problems are the most expensive to find late, because they mean a new formula, new samples and a new label. Check each ingredient against four sets of rules before you commit to a formula.
Novel foods. An ingredient not consumed to a significant degree in the EU before 15 May 1997 is a novel food and needs authorisation under Regulation (EU) 2015/2283. Check the Union list of authorised novel foods and the Commission's Novel Food Status Catalogue. Many traditional Ayurvedic and Himalayan botanicals sit close to this line, so screen them first.
Vitamin and mineral forms. Only the chemical forms listed in Annex II of Directive 2002/46/EC may be used, for example magnesium citrate or zinc gluconate. Maximum amounts are still set nationally, so the same dose can be legal in one Member State and too high in another.
Restricted substances. Some ingredients are banned or capped EU-wide under Regulation (EC) No 1925/2006. Yohimbe bark is prohibited; hydroxyanthracene derivatives (found in some aloe and senna preparations) are banned or restricted; daily intake caps apply to green tea catechins and to monacolins from red yeast rice.
National botanical lists. Several countries, including Belgium, France and Italy, publish lists of plants allowed in supplements, sometimes with required warnings. A botanical acceptable in Germany may need extra work in France.
Ask your manufacturer for: the full quantitative formula per daily dose, the botanical name, plant part and extract ratio of every herbal ingredient, and the chemical form of each vitamin and mineral.
Step 2: Name the EU business that is responsible
Every supplement sold in the EU needs a food business operator established in the EU. That business is named on the label, keeps the records and answers to the authorities.
Who it is. The business under whose name the product is marketed. If that business is outside the EU, the importer takes on the responsibility for the food information (Regulation (EU) No 1169/2011, Article 8).
Registration. The importer or brand owner registers as a food business with its national authority, and needs an EORI number for customs.
Traceability. It must be able to name the supplier and the business customers of every batch (Regulation (EC) No 178/2002, Article 18).
Warehousing. A third-party warehouse or fulfilment centre in another Member State must also be registered there, but the responsibility for the product stays with the operator.
One EU address is enough for the whole EU market. Brands without their own EU entity usually appoint an importer or distributor that takes this role.
Ask your manufacturer for: batch traceability from raw material to finished lot, and a named contact who answers authority questions within an agreed time.
Step 3: Meet the contaminant and residue limits
Regulation (EU) 2023/915 sets maximum levels that apply to the finished food supplement as sold (summary).
Lead: 3.0 mg/kg — all food supplements
Cadmium: 1.0 mg/kg — most food supplements (3.0 mg/kg if mainly dried seaweed or bivalve molluscs)
Mercury: 0.10 mg/kg — all food supplements
Benzo(a)pyrene: 10 µg/kg — supplements containing botanicals, propolis, royal jelly or spirulina
Sum of 4 PAHs: 50 µg/kg — the same group
Pyrrolizidine alkaloids: 400 µg/kg — supplements of botanical preparations and extracts (500 µg/kg if pollen-based)
Citrinin: 100 µg/kg — supplements based on red yeast rice
Three more checks matter for botanical products made in India:
Pesticide residues. Maximum residue levels under Regulation (EC) No 396/2005 apply to the ingredients. Ethylene oxide is not approved in the EU, and its residues (measured as ethylene oxide plus 2-chloroethanol) keep appearing in EU alerts. India has been the largest single origin of those alerts since 2023, with spices and botanical extracts the most frequent products (RASFF analysis).
Mycotoxins. Aflatoxin and ochratoxin limits apply to ingredients such as spices, nuts and dried fruit, so test spice-based and seed-based formulas.
Microbiology. The EU sets few specific microbiological criteria for supplements, but buyers and authorities expect total plate count, yeasts and moulds, E. coli and Salmonella results against a stated specification.
Ask your manufacturer for: a Certificate of Analysis for every batch, from an ISO/IEC 17025-accredited laboratory, covering heavy metals, PAHs where botanical, pesticides including ethylene oxide, mycotoxins where relevant and microbiology. Our guide How to read a Certificate of Analysis explains what to look for.
Step 4: Get the label right
A food supplement label must meet the general food labelling rules of Regulation (EU) No 1169/2011 and the supplement-specific rules of Directive 2002/46/EC, in a language consumers in each country understand.
Supplement-specific particulars (Directive 2002/46/EC)
The words "food supplement" in the local language as the name of the food
The categories of nutrients or substances that characterise the product, or their nature
The recommended daily portion
A warning not to exceed the recommended daily dose
A statement that food supplements should not be used as a substitute for a varied diet
A statement that the product should be kept out of the reach of young children
The amount of each vitamin, mineral or other substance per daily portion, with vitamins and minerals also as a percentage of the reference intake
General particulars (Regulation (EU) No 1169/2011)
Ingredients list in descending order, with allergens emphasised
Quantity of characterising ingredients (QUID) where required
Net quantity, such as the number of capsules and their weight
Best-before date and lot number
Storage conditions and directions for use
Name and address of the EU food business operator
Country of origin where its absence could mislead
Minimum text size of 1.2 mm x-height (0.9 mm on packs whose largest surface is under 80 cm²)
Food supplements are exempt from the standard nutrition declaration table. Some countries, including Germany and France, require extra warnings in set wording for certain ingredients, so localise the label rather than only translating it.
Ask your manufacturer for: draft label copy for your destination market, checked against both regulations before the first sample is made.
Step 5: Use only claims the EU allows
Any statement that a supplement benefits health is a health claim, whether it is on the pack, on your website or in an advert. Under Regulation (EC) No 1924/2006 only claims in the EU Register of nutrition and health claims may be used, with the exact meaning of the authorised wording and only when the product contains enough of the nutrient to justify it.
Vitamins and minerals have many authorised claims, for example "Magnesium contributes to a reduction of tiredness and fatigue", provided the product supplies a significant amount.
Botanicals are different. Around two thousand plant claims have been "on hold" for years. Some Member States tolerate on-hold wording, others do not, so brands often pair a botanical with a vitamin or mineral that carries an authorised claim.
Disease claims are banned. Food may not claim to prevent, treat or cure a disease. "Vitamin C contributes to normal collagen formation for the normal function of cartilage" is authorised; "relieves arthritis" never is.
Your website counts. Product pages, blog posts and social media are commercial communications under the same rules.
Ask your manufacturer for: a claim map for each formula, showing which ingredient and dose carry which authorised wording.
Step 6: Notify each country before the first sale
The EU has no central registration for food supplements, but most Member States require a notification to their national authority before the product is first placed on their market. A notification is not an approval: the authority can still object or ask questions, and responsibility stays with the operator. Each country you sell into needs its own notification, usually with a label in its language (overview).
Germany: notify the BVL (Federal Office of Consumer Protection and Food Safety) through its online form. This is a registration only; the product is not assessed.
France: notify through the TeleIcare portal. Substances outside the French positive lists need an extra procedure before sale.
Italy: notify the Ministry of Health on the NSIS platform. An Italian label is required, and a fee applies per product.
Czech Republic: notify the Ministry of Agriculture. The product is entered in the national register and supervised by the SZPI.
Poland: notify the Chief Sanitary Inspectorate (GIS), with the Polish label, before first sale.
Procedures, fees and timescales change, so confirm the current process with the authority or your importer before launch.
Ask your manufacturer for: the composition, specification and label data each notification asks for, in a format your importer can file directly.
Step 7: Clear the border
Most plant-based supplements clear customs on standard documents. Some ingredients from India, however, are on the EU's list of foods under increased official controls, Implementing Regulation (EU) 2019/1793. After the February 2026 update, the India entries for ethylene oxide included pepper (Piper), dried or ground capsicum and pimenta, and calcium carbonate (AGRINFO summary). Listed goods must be pre-notified to the border control post and can be sampled before release. The lists are reviewed every six months, so check the current annexes before each new product.
Documents to ship with every consignment
Commercial invoice and packing list
Certificate of Origin
Batch Certificate of Analysis matching the lot numbers on the cartons
Product specification
Free Sale or health certificate, if your importer or authority asks for one
Organic certificate of inspection issued in TRACES, for organic products only
Pre-notification at the border control post (CHED-D), only for goods on the increased-controls list
Ask your manufacturer for: documents prepared to your importer's checklist before dispatch, and lot numbers that match across the COA, cartons and invoice.
What your manufacturer must give you, and what stays with you
Your manufacturer supplies
Full quantitative formula and ingredient specifications
Botanical names, plant parts, extract ratios and vitamin and mineral forms
Batch Certificates of Analysis from an accredited laboratory
Stability data supporting the best-before date
Draft label copy and a claim map for the market
Allergen, GMO, vegan and BSE/TSE statements
GMP and HACCP certificates and the batch manufacturing record summary
Certificate of Origin and export documents
Traceability from raw material to finished lot
You, or your EU importer, remain responsible for
Confirming every ingredient and dose is legal in each country you sell into
Novel food status checks and any national botanical list procedures
Accepting or rejecting each batch against the agreed specification
The best-before date printed on the pack
Final label approval, translations and every claim you publish, online included
Keeping the technical file and producing it for an inspector
Registration as a food business and an EORI number
Notification in each Member State before first sale
Traceability from your warehouse to your customers, and any recall
At Giva Agro we screen the composition and the claim wording against the destination market before the first sample is made, and every batch ships with its Certificate of Analysis and the full export document pack.
Frequently asked questions
Do I need EU approval before I can sell a supplement?
Not an EU-wide approval. Most Member States require a notification before first sale, and any novel food ingredient needs authorisation first.
Can I sell the same product in every EU country?
Usually, yes, but national maximum levels for vitamins and minerals, national botanical lists and local warning wording differ. Check each target market before you print packaging.
Can I use Shilajit and other Himalayan botanicals in EU supplements?
Check each ingredient's status in the Novel Food Status Catalogue and confirm with the national authority before launch. We screen novel food status for every Shilajit format and botanical blend before quoting.
How long does notification take?
From an instant online confirmation to several weeks, depending on the country. In Italy, for example, the authority has 90 days to object.
Does the UK follow the same rules?
No. Great Britain has had its own food supplement and claims rules since leaving the EU, while Northern Ireland follows EU food law.
Planning an EU launch?
Send us the product, the target countries and the volume. You will get a formula screened against EU composition, contaminant and claim rules, draft label copy, and a clear list of what your importer will need to file.
Request a quote · Herbal supplements and nutraceuticals · Himalayan Shilajit
Related guides: Private label, white label, contract manufacturing or OEM — which do you need? · How to read a Certificate of Analysis: the eight tests that matter
This guide is general information for brand owners, current as of October 2026, and is not legal advice. Confirm requirements with your importer or national authority before launch.
