- Regulation (EU) No 609/2013 — food for specific groups
- Directive 2002/46/EC — food supplements
- Regulation (EC) No 1924/2006 — nutrition and health claims
- Regulation (EU) No 1169/2011 — food information
Who has to appoint one
Anyone placing sports nutrition on the EU market. Total diet replacement for weight control has its own compositional rules under Regulation 609/2013; ordinary protein powders and bars are foods or food supplements depending on presentation.
Thresholds and exemptions
None. National notification applies where the product is presented as a food supplement, with procedures differing per member state.
What must appear on the label
Name, ingredients with allergens emphasised, nutrition declaration, net quantity, durability, storage, the EU operator's details, portion guidance and warnings where relevant. Health and nutrition claims may only be those on the authorised list, in the approved wording.
Marketplace fields
Marketplaces remove listings with muscle-building, fat-burning or testosterone claims, which are not on the authorised list. Amino acid and stimulant content is scrutinised, and several member states restrict specific ingredients nationally.
Documentation you must hold
Food business registration, notification where required, specifications and certificates of analysis, HACCP documentation, traceability, and evidence supporting any authorised claim used.
Standards and testing
Protein content verification, heavy metals, microbiology, and screening for prohibited or doping-relevant substances, since contamination cases have led to product bans and to athlete sanctions.
Language requirements
The complete label in the official language of each member state of sale.
When it applies
Notification before first sale where the member state requires it.
How long records are kept
Batch and traceability records per national food law.
What happens if you do not comply
Withdrawal, seizure and fines. Unauthorised claims are the most common infringement, and contamination with prohibited substances brings both regulatory and civil consequences.
Who enforces it
National food safety authorities and consumer protection authorities.
Where the boundary lies
A protein product marketed to build muscle is making a claim that is not authorised, whatever the science says: the closed list governs. Products containing stimulants at high doses have been treated as medicinal in several member states.
Questions we are asked
- Can we say our protein builds muscle?
- Only using an authorised claim in its approved wording. 'Protein contributes to the growth and maintenance of muscle mass' is authorised; stronger formulations are not.
- Is a meal replacement a normal food?
- Total diet replacement for weight control has specific compositional and labelling rules under Regulation 609/2013 and its delegated act.
Who signs for you
EU representative Europe Services, SE — Na Čečeličce 425/4, Smíchov, 150 00 Praha 5, Czech Republic
UK representative REP27 LTD — Unit 82a James Carter Road, Mildenhall, Suffolk IP28 7DE, United Kingdom