What Are Food Supplements?
Food supplements are food products intended to supplement the normal diet. They are concentrated sources of vitamins, minerals, plant extracts, amino acids or other substances with nutritional or physiological effects. They come in forms such as tablets, capsules, powders, liquids, or sachets.
They are not medicines, medical devices, or pharmaceutical products. Their legal status is strictly regulated under food law at both EU and national level.
Types of Food Supplements
Supplements may contain various categories of active substances:
- vitamins and minerals,
- plant and herbal extracts,
- amino acids and proteins,
- probiotics and prebiotics,
- fiber and other bioactive ingredients.
Their intended use may include supporting the immune system, digestion, nervous system, cognitive functions, weight loss, skin and hair health, or sports performance.
Legal Status of Food Supplements
Food supplements fall under food law, and their definition is laid out in Directive 2002/46/EC. They must be safe for consumers, properly labelled, and must not have medicinal properties.
In Poland, oversight is managed by the Main Sanitary Inspectorate (GIS) and local SANEPID offices.
Requirements Before Placing a Supplement on the Market
Before launching a food supplement, the manufacturer or responsible entity must:
- register the manufacturing facility with local authorities (Sanepid) at least 14 days in advance,
- implement HACCP (Hazard Analysis and Critical Control Points),
- notify GIS about the product (product registration in the EU),
- maintain quality documentation for ingredients and batches.
Labelling Requirements for Food Supplements
All food supplements must comply with Regulation (EU) 1169/2011 and national rules. Labels must include:
- product category name: “food supplement”,
- full list of ingredients with declared quantities and forms,
- recommended daily dosage, usage instructions, warnings,
- name and address of the manufacturer/importer,
- expiration date and storage conditions.
Medical claims are prohibited. Only approved health claims in accordance with EFSA can be used.
Manufacturer Responsibility and Regulatory Inspections
The manufacturer (or importer) is fully responsible for ensuring legal compliance. GIS and Sanepid may carry out inspections covering:
- quality and origin of ingredients, label compliance,
- declared vs. actual composition,
- consumer complaints and adverse event reporting,
- banned substances or excessive doses.
Misclassification or incorrect labelling may result in market withdrawal or suspension.
Supplements and Borderline Products
Many products fall into the borderline category, exhibiting features of:
- pharmaceuticals,
- medical devices,
- cosmetics,
- biocidal products.
Proper product classification is critical from the development stage. Incorrect qualification may result in regulatory penalties, confiscation, or legal liability.
How to Register a Food Supplement in Poland
The registration process includes the following steps:
- Develop product composition, label, and documentation,
- Check ingredient legality and maximum allowed doses,
- Submit online notification to GIS,
- Launch the product (notification is sufficient – no pre-approval needed),
- Track regulatory changes and adverse event reports.
How PureClinical Supports Food Supplement Manufacturers
PureClinical supports manufacturers and importers in launching compliant and safe food supplements on the EU market. Our services include:
- correct product classification (supplement, medical device, medicine),
- ingredient and dose verification, including chemical form and origin,
- labelling and marketing material audits,
- GIS registration and regulatory consultation,
- implementation of HACCP, GHP, ISO 22000,
- export consulting and adaptation to EU country-specific rules.
FAQ
Is registration required for food supplements?
How long does registration take?
What are the risks of incorrect labelling?
How to distinguish a supplement from a medical device?