Publication date: January 03, 2025
Dietary supplements with vitamins are subject to regulations contained in the Act of 25 August 2006 on food and nutrition safety. The definition of a dietary supplement is found in Article 3 of the aforementioned Act. A dietary supplement is a food product that is a source of vitamins or minerals or other nutrients, the purpose of which is to supplement the diet. A dietary supplement does not belong to the group of pharmaceutical products but to the group of food products.
In order for a dietary supplement to be placed on the market, it is not required to obtain a certificate. According to Article 29 of the Food and Nutrition Safety Act, the product must be reported to the Chief Sanitary Inspectorate (Polish GIS) at least 14 days before being placed on the market.
The certificates that a plant producing dietary supplements can obtain are the GMP and HACCP certificates.
GMP (Good Manufacturing Practice) Certificate – this is a certificate confirming that the plant producing specific products meets standards guaranteeing high quality, safety and compliance with legal requirements. When issuing a GMP certificate, such criteria as, among others, production conditions are taken into account. This certificate is issued by authorized certification organizations, and in the case of plants producing drugs or medical products, the GMP Certificate is issued by the Chief Pharmaceutical Inspectorate. For dietary supplements in Poland, obtaining a GMP certificate is not a mandatory requirement.
HACCP Certificate (Hazard Analysis and Critical Control Points) – This is a legally required standard for food producers and related industries confirming that the production plant applies a food safety management system based on hazard analysis and designation of critical control points. The HACCP system is recognized worldwide as the basic standard for ensuring safety in the production of food and dietary supplements. The HACCP certificate is also awarded by independent, accredited certification bodies. In the food industry, the implementation of the HACCP standard is mandatory under Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs and the Act on food and nutrition safety.
A notified body is an institution designated by the relevant state authority to assess the conformity of products with the requirements specified in national and European law. In accordance with Article 65 of the Act on Conformity Assessment and Market Surveillance Systems of 13 April 2016, notified bodies cooperate with market surveillance authorities to determine whether the product meets the requirements or poses a risk. Notified bodies are reported to the European Commission and EU Member States and are entered into the NANDO database (New Approach Notified and Designated Organisations). Notified bodies are not involved in certifying products classified as food products. In accordance with Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002, it is not obligatory for a food product to obtain a certificate issued by a notified body. Notified institutions are involved in the assessment of medical devices, which do not include dietary supplements.
Dietary supplements are not the same as products for special medical purposes (FSMP). FSMP is a type of food intended for the nutrition of patients with impaired ability to receive, digest, absorb, metabolize or excrete regular food or some nutrients contained in that food. In addition to the general requirements for food products, FSMP must also meet additional requirements. FSMP products must also be reported to the Chief Sanitary Inspector and before being introduced to the market, the manufacturer must ensure that the product meets all the requirements regarding the safety and quality of nutrition.
Novel Food – this category refers to food products that were not used in the European Union before 15 May 1997, regardless of the date of accession of the country to the EU. This includes not only newly developed or innovative food, but also food from third countries outside the EU that has not been introduced to the EU market. The exact criteria for products recognized as ” Novel Food” are regulated by Article 3 of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015. In order for a product from the “novel food” category to be introduced to the market, it must undergo the procedure specified in Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017. This procedure consists of the manufacturer or importer submitting an application containing, among others, detailed data on the product, the production process and evidence of food safety to the European Commission via the electronic system. Once an application has been submitted, the European Food Safety Authority (EFSA) examines the application and assesses the risks associated with placing the product on the market. Based on the EFSA opinion, the Commission decides to include the product in the EU Novel Food List.
– Act of 25 August 2006 on food and nutrition safety (Journal of Laws 2006 No. 171 item 1225)
– Act of 13 April 2016 on conformity assessment and market surveillance systems (Journal of Laws 2016, item 542)
– Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs and the Food and Nutrition Safety Act.
– Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002
– Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015
– Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017