Food supplements are foodstuffs intended to supplement a normal diet, such as a concentrated source of vitamins in the form of capsules or tablets.
What are dietary supplements?
Dietary supplements are foods that supplement the daily diet, a concentrated source of vitamins and minerals. They can be marketed in various forms: tablets, capsules, jets, powder sachets, ampoules with liquid, dropper bottles intended to be consumed in small measured unit quantities, excluding products which have the characteristics of a medicinal product in accordance with pharmaceutical legislation.
What are the types of food supplements?
|vitamins and minerals|
|plant ingredients or extracts|
|probiotics or prebiotics|
What is the purpose of food supplements
- support of the immune system,
- supporting the weight loss process,
- support of the digestive system,
- to support the process of seeing,
- to support the proper functioning of the cardiovascular system,
- impact on concentration or vitality,
- impact on the nervous system,
- impact on the locomotive organs,
- impact on ageing processes,
- the effect on the condition of skin, hair and nails,
- reducing the risk of osteoporosis,
- for athletes and active people.
What is the law governing food supplements?
A food supplement as a foodstuff, used in a specific form by virtue of its intended use, is subject to food law. The definition of a food supplement in Directive 2002/46/EC implies a distinction between food supplements and medicinal products, i.e. a product having the characteristics of a medicinal product is not a food supplement.
Many products combine the characteristics of medical devices, medicinal products, food supplements, cosmetics and biocides to form the so-called borderline product group. Inappropriate qualification of a product may result in a decision by the supervisory authorities to suspend/withdraw it from the market.
What conditions must be met to become a food supplement manufacturer?
Before the dietary supplements as well as other foodstuffs are placed on the market, an application must be submitted (at least 14 days before the start of the activity) for entry in the register of establishments or for approval of an establishment and entry in the register of establishments subject to Sanitary Inspection.
How can dietary supplements be placed on the EU market?
The manufacturer shall be obliged to notify the Competent Authority of the placing on the market of the food supplement or of his intention to place it on the market, once the requirements relating to the labelling of the food supplement have been met. The manufacturer shall also be responsible for the quality verification and distribution of the food supplement. The provisions relating to such products shall describe in great detail the product specification and labelling.
As MDR Regulator, we are ready to assist the manufacturers of food supplements in all activities related to the introduction of food supplements on the EU market.
How to register a food supplement?
Producers who wish to place a food supplement on the market should notify the Chief Sanitary Inspectorate.