EU Food Supplement Classification of Shilajit

How Shilajit Is Classified in the EU

In the European Union, shilajit falls under the food supplement category. It’s regulated as a food product intended to supplement the normal diet, containing concentrated sources of nutrients or other substances with a nutritional or physiological effect.

Shilajit is not classified as:

  • A medicinal product (no therapeutic claims allowed)
  • A novel food (it has history of use in the EU)
  • A cosmetic ingredient (when sold for ingestion)

This classification determines what you can sell, how you label it, and what compliance steps are required.

What This Means for Brands & Distributors

You can sell it — Shilajit is legal to sell as a food supplement in EU member states.

You cannot make health claims — Unless a claim is specifically authorized under EU health claims regulation (Regulation 1924/2006), you can’t say shilajit “treats,” “cures,” or “prevents” anything.

You must follow food law — Food safety, labeling, traceability, and notification requirements apply.

Each country may have specific rules — Some member states require product notification before selling. Others have specific labeling requirements.

Food Supplement Notification

Many EU countries require food supplement notification before you can legally sell. This is an administrative process where you inform the competent authority that you’re placing a product on the market.

Countries with notification requirements include Belgium, France, Italy, Spain, Poland, and others.

Countries with simpler regimes include Germany (no mandatory notification for most supplements) and Netherlands.

The notification process varies by country — some are online forms, others require documentation. It’s not approval; it’s registration.

Labeling Requirements

Food supplements sold in the EU must have labels that include:

  • Product name (including “food supplement”)
  • List of ingredients with quantities
  • Recommended daily portion
  • Warning not to exceed stated dose
  • Statement that supplements are not a substitute for a varied diet
  • “Keep out of reach of children” (where relevant)
  • Batch number
  • Best before date
  • Storage conditions
  • Net quantity
  • Name and address of the food business operator
  • Country of origin (where required)

Labels must be in the official language(s) of the country where the product is sold.

Health Claims Restrictions

Under EU Regulation 1924/2006, you cannot make health claims on food products unless the claim is specifically authorized in the EU Register and worded exactly as authorized.

For shilajit specifically, there are currently no authorized health claims in the EU register. This means you cannot make specific claims about what shilajit does — even if those claims are made in other markets.

What you can say: Describe the product factually (origin, composition, traditional use as context).

What you cannot say: “Boosts energy,” “supports immunity,” “anti-aging,” or any specific health benefit.

Enforcement varies by country, but non-compliant claims can result in product recalls, fines, and legal action.

Novel Food Status

Shilajit is not currently classified as a novel food in the EU, meaning it doesn’t require novel food authorization before sale. This is because shilajit has a documented history of consumption in the EU prior to the 1997 cutoff date.

However, if you’re selling a significantly processed or altered form of shilajit, novel food questions may arise. Standard purified resin or powder typically doesn’t trigger novel food concerns.

Importing Shilajit into the EU

Importing food supplements into the EU requires:

  • A responsible food business operator (FBO) established in the EU
  • Product compliance with EU food law
  • Proper customs documentation
  • Traceability records from source to sale

If you’re importing directly from India or another origin country, you’re responsible for ensuring the product meets EU requirements before it enters the market.

Working with an EU-based supplier like Longevium® means the product is already imported, compliant, and warehouse-ready — reducing your regulatory burden.

→ See shilajit quality testing requirements for EU compliance.

Country-Specific Considerations

While EU regulations provide the framework, individual member states can have additional requirements:

Germany: No mandatory notification, but strict enforcement of health claims. Conservative market.

France: DGCCRF notification required. French language labeling mandatory.

Italy: Ministry of Health notification. Some ingredients require specific approval.

Spain: AECOSAN notification. Spanish labeling required.

Poland: GIS notification system.

If you’re selling across multiple EU markets, you need to understand each country’s specific requirements or work with a supplier who’s already navigated them.

Compliance Responsibility

When you sell a food supplement, you’re the responsible party. This means:

  • You ensure the product is safe
  • You ensure labels are compliant
  • You ensure claims are authorized
  • You maintain traceability records
  • You can recall products if needed

Buying from a compliant supplier doesn’t transfer all responsibility to them — but it significantly reduces your risk and workload.

→ Understand the difference between raw shilajit and finished product from a compliance standpoint.

Summary

Shilajit is legal to sell in the EU as a food supplement. The main compliance requirements are:

  1. Product meets food safety standards
  2. Labels comply with EU requirements
  3. No unauthorized health claims
  4. Notification filed in countries that require it
  5. Traceability maintained

Working with an EU-based supplier with proper documentation makes compliance significantly easier.

→ Request wholesale information | Back to shilajit supplier in Europe