EU Food Supplement Registration: Directive 2002/46/EC & Why Notification Still Happens Per Member State

This is the single most important structural fact about EU food supplements, and it is easy to get wrong: there is no single EU-wide food supplement registration or notification system.

Unlike pharmaceuticals, which may follow the centralised EMA procedure, or cosmetics, which use the single Cosmetic Products Notification Portal (CPNP) covering all 27 EU Member States, food supplement rules are harmonised at EU level but, in many cases, notified nationally.

A product that complies with the EU legal framework may still require a separate notification in each Member State whose national legislation requires notification before it is placed on the market.

The Harmonising Framework

Directive 2002/46/EC establishes the EU-wide legal definition and core rules for food supplements as concentrated sources of vitamins, minerals, or other substances with a nutritional or physiological effect that are marketed in dose form.

Annex I lists the vitamins and minerals permitted for use in food supplements, while Annex II specifies the approved vitamin and mineral sources (chemical forms). These provisions harmonise the rules for these substances across the European Union.

However, the Directive does not establish a harmonised EU notification procedure. Instead, Member States implement the Directive through their own national legislation and may require manufacturers or distributors to notify the competent authority before placing a product on the market.

What the Registration Dossier Actually Needs to Demonstrate

In many EU Member States that operate food supplement notification systems, the notification typically includes:

• The product label or artwork.
• Basic formulation details.
• A list of ingredients.
• Information about the food business operator.

Some Member States also charge an administrative notification fee. For example, Italy currently charges €160.20 per notified product.

Certain countries, including France and Belgium, may require a more detailed qualitative and quantitative breakdown of the formulation, particularly for products containing botanicals or other regulated substances.

These procedures are administrative notifications intended to support market surveillance rather than scientific pre-market authorisations.

They do not normally require:

• Toxicological studies.
• Stability testing.
• Clinical trial data.
• A formal GMP dossier as part of the notification itself.

Food business operators must nevertheless comply with all applicable food hygiene and manufacturing requirements. More extensive scientific evidence is generally required only where products fall within other regulatory frameworks, such as the EU Novel Foods Regulation or medicinal products legislation.

Notification procedures and timelines vary considerably between Member States. Some countries operate purely administrative notification systems that allow products to be placed on the market immediately or shortly after notification, while others require a review period or apply additional procedures in certain situations, such as notifications relying on the mutual-recognition principle.

Manufacturers should therefore verify the applicable national requirements before marketing a product in each Member State.

Why "EU Compliant" Doesn't Mean "Ready for Every Member State"

Each Member State that operates a notification system maintains its own national procedure, administrative requirements, and, in some cases, additional national rules governing specific substances.

A supplement that fully complies with Directive 2002/46/EC and has been notified in Belgium, Finland, or Italy may still require a separate notification before it can legally be marketed in another Member State that requires notification.

There is no "notify once, sell everywhere" mechanism comparable to the EMA's centralised medicines procedure or the Cosmetic Products Notification Portal (CPNP).

Ongoing Monitoring Is a Genuine, Active Obligation

Once a food supplement has been notified, manufacturers must continue to ensure ongoing compliance.

Manufacturing facilities may be subject to regular inspections, while products can undergo periodic testing to verify continued compliance with applicable requirements.

Failure to comply may result in enforcement actions, including:

• Regulatory fines.
• Mandatory product recalls.

Novel Foods: The One Area With Genuine EU-Wide Centralisation

A notable exception to the country-by-country notification model is novel food authorisation.

Ingredients without a documented history of consumption within the EU before 15 May 1997 require authorisation through the centralised EU Novel Foods procedure.

Once authorised, the ingredient is added to the EU Union List of Novel Foods and may be used across all EU Member States without requiring separate national authorisations for that ingredient.

If a supplement's distinguishing feature is a genuinely novel ingredient, this authorisation step is EU-wide, even though the broader food supplement notification process remains national.

Health Claims: Centralised List, Locally Enforced

Only nutrition and health claims included in the EU Register of Nutrition and Health Claims, established under Regulation (EC) No. 1924/2006, may be used on food supplements.

The register is centrally maintained at EU level, providing manufacturers with a single reference source for authorised claims.

However, enforcement of claim usage on product labels remains the responsibility of each Member State's market surveillance authority.

How OMC Medical Can Help

OMC Medical manages food supplement compliance across individual EU Member States by coordinating national notification procedures where required, rather than assuming one country's notification applies across the entire EU.

We also assess novel food status, verify health claims against the EU Register of Nutrition and Health Claims, and develop country-specific regulatory strategies that support compliant market access throughout Europe.