Guides

What EU rules expect you to prove

Updated 16/09/2026

There is no EU licence for a food supplement. You place it on the market yourself, and you carry the burden of proof that it is safe and labelled correctly. Testing is how that proof gets built.

Key points

  • As the brand on the label, you are the food business operator responsible for compliance.
  • Contaminant limits come from Regulation (EU) 2023/915.
  • Every quantitative label claim needs analytical backing, including at end of shelf life.
  • Retailers routinely ask for more than the legal minimum.

Who is responsible

Under Regulation (EC) 178/2002 the operator whose name is on the label is responsible for the product, even when a contract manufacturer produced it. Directive 2002/46/EC and national notification rules govern supplements specifically. If an authority asks how you know your product is compliant, an internal assumption is not an answer.

Contaminants and safety

Regulation (EU) 2023/915 sets maximum levels for contaminants in food, including specific entries for food supplements. In practice this means a heavy metals panel, plus contaminants that follow the ingredient: mycotoxins for grains and botanicals, PAHs for smoked or dried material, pesticide residues for plant material, and 3-MCPD or glycidyl esters where refined oils are involved.

Label claims

Regulation (EU) 1169/2011 requires declared values to be accurate, and the tolerance guidance for vitamins and minerals is what an inspector will measure you against. Two consequences follow.

  • Active content must be measured in the finished product, not calculated from the recipe.
  • The declared value has to still hold at the end of the stated shelf life, which is what stability testing demonstrates.

What retailers add

Listing specifications usually go beyond the law: a full microbiology panel, allergen verification if the label carries a free-from claim, and a certificate of analysis for the batch being delivered. Because these are commercial requirements, they change from buyer to buyer, and it is cheaper to ask before you test than to test twice.

Questions

Is testing legally required for supplements in the EU?
The law requires the product to be safe and correctly labelled, and requires you to be able to demonstrate it. Testing is the practical way to meet that obligation, and it is what authorities and retailers accept as evidence.
Does my manufacturer's certification cover me?
Certification covers how the site is run. It does not prove what is in your batch, and responsibility for the product stays with the name on the label.
Which tests should I start with?
For most brands: heavy metals, a microbiology panel and active content on the finished product. Send us the product link or label and we recommend the panel.

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