What is a Seller of Record in Europe?

A Seller of Record is responsible for VAT, compliance, invoicing, and consumer obligations for sales within the European Union. EuroSOR acts as the official seller for non-EU brands so they can enter Europe without forming a local company.

Do I need a European company to start selling in the EU?

No. A non-EU brand can operate in the EU without opening a BV or GmbH by using a compliant Seller of Record model. EuroSOR provides the regulatory layer while the brand continues to own the customer and pricing.

How does EuroSOR handle VAT across Europe?

EuroSOR manages VAT registrations, filings, invoice compliance, and audit support. The objective is to give one consistent VAT framework for selling across multiple EU markets.

How does EuroSOR handle VAT deferment for imports into Europe?

EuroSOR uses the Dutch Article 23 VAT deferment scheme. This allows VAT to be postponed at import and settled later through VAT returns instead of paying it at the border.

Can EuroSOR support Importer of Record requirements?

Yes. EuroSOR works with an Importer of Record partner to manage customs clearance, duty calculation, and compliant entry of goods into the EU.

What delivery timelines can brands expect?

From our Netherlands hub, EU deliveries follow standard European timelines through integrated carrier networks, providing fast access to major markets across the EU.

Who controls pricing, brand, and customer experience?

The brand controls pricing, marketing, customer relationships, and product strategy. EuroSOR manages compliance, VAT, import coordination, and fulfilment.

Does EuroSOR support both B2C and B2B shipments?

Yes. EuroSOR supports both direct-to-consumer deliveries and wholesale shipments to retailers or distributors.

EU Food Supplement Regulations: Critical Steps Non EU Brands Must Master Before Their First Shipment

EuroSOR · Health & Wellness Series

EU Food Supplement Regulations:
What Non-EU Brands Must Know
Before Their First Shipment

Most non-EU supplement brands entering Europe research the EU-level directive and feel comfortable. Then they hit the per-country, per-SKU notification requirements that sit above it. That is the layer that delays launches and leaves stock in a warehouse that cannot legally go on sale.

EU member states, each with its own notification rules

Compliance obligations most non-EU brands miss before first sale

18mo

Minimum novel food authorisation timeline for a flagged ingredient

€0

EU entity capital required with a Seller of Record structure

Health & Wellness EU Food Supplement Regulations Seller of Record Novel Food FBO EPR

The compliance requirement that catches non-EU supplement brands is not the EU-level directive. It is the per-country, per-SKU notification system above it. Germany, France, Italy, and Spain each run separate systems with separate timelines, and every SKU needs its own filing in each target country before it can legally go on sale.

The EU Framework and What It Leaves to Member States

Directive 2002/46/EC sets the EU-level baseline: which vitamin and mineral forms are permitted, what nutrient levels apply, and what qualifies as a food supplement. It does not create a single pre-market approval that unlocks all 27 markets. Member states layer their own notification requirements on top, and there is no EU-wide path around them. A non-EU brand that has read the directive but has not mapped the country-level rules has half the picture.

EU Level - Harmonised

What the directive covers

Permitted vitamin and mineral forms. Nutrient levels where set at EU level. Definition of what qualifies as a food supplement. Requirement that products placed on the EU market are safe and accurately labelled.

Member State Level - Not Harmonised

What each country adds

Pre-market notification per SKU. Permitted botanical and adaptogen lists. Country-specific maximum dosage limits. Mandatory review periods before first sale. National food authority registration timelines.

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The directive covers vitamins and minerals, not botanicalsBotanicals, adaptogens, nootropics, and amino acid derivatives - standard in many non-EU functional formulations - are not harmonised. Each member state applies its own rules. Something unremarkable on a non-EU label may require novel food authorisation or sit on a member state's restricted list.

Per-Country, Per-SKU Notifications

Several EU member states require the FBO to file a pre-market notification per product SKU before that product can go on sale. These are not approvals - they are mandatory filings, and a missing one is an infringement regardless of whether anyone has flagged it. A non-EU brand with five SKUs entering Germany, France, and Italy needs up to 15 separate filings before the first unit can ship to a customer.

Country	Status	Authority	Timeline	Key Note
🇩🇪 Germany	Required	BVL	2-4 weeks	Must be filed before first sale; HMSM dosage limits apply
🇫🇷 France	Required	DGCCRF (TeleIcare)	8-12 weeks	Botanical restricted list; sale not permitted during review period
🇮🇹 Italy	Required	Ministry of Health	4-8 weeks	One of the EU's most restrictive botanical positive lists
🇪🇸 Spain	Required	AESAN	4-8 weeks	Botanical ingredients subject to separate AESAN assessment
🇳🇱 Netherlands	Recommended	NVWA	2-4 weeks	Commodity Act; specific upper limits for certain vitamins
🇵🇱 Poland	Required	GIS	2-4 weeks	Mandatory pre-market filing; largest supplement market in CEE

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All notifications must be filed by the EU-established FBONon-EU brands cannot submit directly. Every filing must come from an EU-established food business operator. Appointing a functioning FBO - not just a label address - is the first operational decision before entering any EU supplement market.

Novel Food: The Ingredient Check That Gates Everything

Under Regulation (EU) 2015/2283, any ingredient not consumed to a significant degree in the EU before 15 May 1997 requires pre-market authorisation before it can appear in any EU product. A meaningful share of standard non-EU functional supplement ingredients have no documented pre-1997 EU history - and authorisation takes a minimum of 18 months, with no shortcut available once the application is in progress.

Common triggers include ashwagandha extracts (KSM-66, Sensoril), NMN, lion's mane and other mushroom extract forms, CBD isolates, berberine, and certain marine collagen sources. Ingredient clearance must happen before label work begins. A novel food finding at label stage restarts the timeline entirely.

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Traditional food notification: a faster route for some ingredientsIf an ingredient has 25 years of documented safe consumption outside the EU and EFSA raises no objections within four months of notification, it can enter the EU market. A qualified EU regulatory adviser can assess eligibility in two to four weeks.

Dosage Limits and Health Claims

The EU has not fully harmonised maximum permitted levels for vitamins and minerals in supplements. Germany, France, the Netherlands, and Italy each set their own upper limits for nutrients including vitamin D, B6, zinc, and magnesium. A product formulated to non-EU market serving sizes can exceed the permitted daily dose in one or more EU markets without any visible flag on a standard label review. A 5,000 IU vitamin D capsule standard in the US market is non-compliant in Germany, where the recommended supplemental maximum sits at 800 IU.

Health claims operate under a closed list (Regulation (EC) 1924/2006). Non-EU market structure/function claims - "supports immune health," "promotes cognitive function," "aids recovery" - are not EU-authorised in those forms. All copy across packaging, Amazon listings, and DTC product pages must be rewritten against the EU register using exact approved wording before anything goes live.

Compliance Checklist Before Stock Ships

Requirement	What It Involves	Timing
Novel food clearance	Ingredient-by-ingredient check against EU catalogue, EFSA opinions, and member state restricted lists. Gates all other steps.	First
Dosage review	Cross-reference each nutrient against maximum permitted levels per target market. Resolve any reformulation before label artwork is committed.	Before label
FBO appointment	EU-established entity under Directive 2002/46/EC. Name and address on all labels. Holds HACCP documentation. Submits country notifications.	Before first sale
Country notifications (per SKU)	Pre-market filing per SKU per country by the FBO. Timeline: 2-4 weeks (DE, PL) to 8-12 weeks (FR).	8-12 weeks ahead
Importer of Record	EU entity with EORI and VAT registration to file customs declarations and pay duties.	Before first inbound
EU VAT registration	Storing inventory in the EU creates a VAT obligation. Fiscal representative required for non-EU companies.	Before stock ships
EPR - packaging	Registration with national packaging EPR scheme per country of sale. No minimum volume exemption.	Before first sale
GPSR Responsible Person	EU-established RP mandatory since December 2024. Name and contact on product or packaging. Amazon EU enforces at listing level.	Before first sale

Steps 3 and 4 can run concurrently once ingredient clearance is confirmed. Step 1 cannot be skipped or started late.

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Operational commitments before compliance checks cause the longest delaysBrands that sign a warehouse contract and order EU-language packaging before completing novel food checks and notification filings are the ones with stock in a Dutch facility that cannot go on sale. Compliance structure first. Warehouse and channel agreements second.

How EuroSOR Handles This

Without a single structure, a non-EU brand entering three EU markets with five SKUs manages an FBO service, a notification filing agent for three national systems, a customs broker, a VAT representative, and EPR registration agents - five providers, five contracts, no single point of accountability.

EuroSOR acts as the EU-established FBO on your labels, files country notifications per SKU, acts as Importer of Record at the border, and handles VAT, EPR, and GPSR registrations. One contract. Your brand keeps full pricing control and all customer relationships.

One EuroSOR contract covers FBO, per-SKU notifications, IoR, VAT, EPR, and GPSR. No fragmented providers.

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In practice: six SKUs, three marketsGermany, France, and the Netherlands means up to 18 notification filings, FBO label registration on all SKUs, EPR in two countries, an IoR for inbound stock, and VAT in two jurisdictions. EuroSOR coordinates the full stack under one contract.

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Frequently Asked Questions

What are EU food supplement regulations and do they apply to non-EU brands?

Yes. Directive 2002/46/EC governs vitamins and minerals. Regulation (EU) 2015/2283 covers novel food ingredients. Regulation (EC) 1924/2006 controls health claims. Individual member states add their own notification requirements. Any non-EU brand - whether from the US, UK, India, Australia, or elsewhere - selling into Germany, France, or Italy is subject to all of these simultaneously.

Do I need a separate notification for each supplement SKU in each EU country?

Yes. Germany, France, Italy, Spain, Poland, and others each require a pre-market notification per SKU filed by the EU-established FBO. A brand with five SKUs entering three markets needs up to 15 separate filings.

Which supplement ingredients commonly trigger novel food checks in the EU?

Common triggers include ashwagandha (KSM-66), NMN, lion's mane and mushroom extracts, CBD isolates, berberine, and certain marine collagen sources. Authorisation takes a minimum of 18 months, making ingredient clearance the first step before anything else.

Can I carry non-EU market health claims over to EU packaging?

No. The EU operates a closed list under Regulation (EC) 1924/2006. Non-EU market structure/function claims are not EU-authorised. All copy must use exact approved wording referenced to specific authorised nutrients.

Can I sell supplements on Amazon EU without a European company?

Yes. You need an EU FBO, per-SKU notifications, an Importer of Record, EPR registrations, and a GPSR Responsible Person, but not your own EU legal entity. EuroSOR's Seller of Record structure covers all of these under one arrangement.

How does EuroSOR handle per-country notifications?

EuroSOR acts as the EU-established FBO, filing per-SKU notifications to BVL, DGCCRF, Ministry of Health Italy, AESAN, and other authorities on the brand's behalf alongside IoR, VAT, EPR, and GPSR under one contract.

This page is updated periodically. Nothing here constitutes legal, regulatory, or tax advice. Verify all requirements with a qualified EU adviser before acting.

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EU Food Supplement Regulations:What Non-EU Brands Must KnowBefore Their First Shipment