Clinmark offers comprehensive services in the field of placing dietary supplements on the European Union market. We have extensive experience in the field of notification of dietary supplement products. We have been advising our clients and developing full notification documentation for their products for years.
Dietary supplements, due to their composition and purpose of use, are classified as foodstuffs.
Their introduction to the market and all issues related to production, distribution or labeling, presentation and advertising are governed by food law (not pharmaceutical law). The regulations for placing dietary supplements on the market are set out in Art. 29, 30, 31 of the Act on food safety and nutrition of August 25, 2006 [Journal of 2018, item 1951].
In order to monitor products placed on the market in Poland, a food business operator that introduces or intends to place on the market for the first time is obliged to notify the Chief Sanitary Inspector.
It includes:
- infant formulas and foods for particular nutritional uses that do not belong to the groups specified in art.24 section 2 points 1–3
- dietary supplements
- foodstuffs to which vitamins, minerals or substances are added, referred to in Annex III, part B and C to Regulation No. 1925/2006
The notification shall be made in the form of an electronic document created by entering data into the electronic notification form, the specimen of which is specified in the provisions issued under Article 31 paragraph 6 point 1: https://www.wsse.gda.pl/nadzor-sanitarny/oddzial-bezpieczenstwa-YWnosci-zywanie-i-produktow-kosmetycznych/suplementy-diety/56-zasady-woszenia-do-obrotu-suplementow-diety.
In the notification, following data shall be provided:
- name of the product and its manufacturer
- the form of the product in which it is placed on the market
- labeling template in Polish
- qualification / type of foodstuff accepted by the food business operator
- qualitative composition including data on ingredients contained in the product, including active substances
- composition quantitative amount of ingredients
- name and surname or name, address and tax identification number (NIP) of the entity notifying about the first placing on the market
If the supplement is on the market in a wine Member State of the European Union, the notification should also indicate the competent authority of that country that was notified of the placing on the market of the food or authorized the placing on the market of the food in that country. state with a copy of the prior notification or authorization.
The composition of dietary supplements may be inspected by both the local sanitary inspection and the Chief Sanitary Inspector, who may initiate an explanatory procedure in case of doubt.
Each dietary supplement must have appropriate labeling – in accordance with Polish and EU regulations.
Labeling, presentation and advertising of dietary supplements must not contain information stating or suggesting that a balanced and varied diet cannot provide sufficient amounts of nutrients for the body.
Acc. to Art. 7 sec. 1 and 3 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (…) [Dz. Of UE L 304, 22.11.2011, pp. 18-63, as amended.] Food information shall not mislead the consumer and shall not attribute to any food the property of preventing, treating or treating disease, or refer to such properties. Moreover, acc. to Art. 52a of the Act of August 25, 2006 on food safety and nutrition, foodstuffs may be labeled with nutritional and health claims provided that the requirements set out in Regulation 1924/2006 are met.
Vitamins, minerals or other substances with a nutritional or other physiological effect may be added to food, taking into account the requirements set out in Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006. on adding vitamins and minerals and certain other substances to food (Journal of Laws UE L 404z 30.12.2006, p. 26, as amended – Regulation No. 1925/2006).
Notification (registration) of dietary supplements:
- can be made before the product is placed on the market or at the time of its introduction
- is made on a special electronic form available on the GIS website – it must be completed online and sent electronically (or send the form by post)
- does not require waiting for a GIS response – however, all requirements specified by Polish and European law must be met, because in case of doubt, the GIS may initiate an explanatory procedure, and in the event of product deficiencies, local sanitary inspection authorities may with draw the dietary supplement, e.g. withdraw from the market
- submission of notification, i.e. de facto registration of the supplement, allows it to be legally placed on the market
The dietary supplement product market is a broad category including everything from herbal products, vitamins, and minerals to omega-3s and probiotics. These products are regulated as dietary supplements in the U.S., natural health products (NHPs) in Canada, and food supplements in the EU.
Each jurisdiction has different compliance requirements and for example in Canada, NHPs require pre-market approval from Health Canada before they can be legally sold. This requires a Site Licence and Product Licence. In the U.S., products must meet the criteria set by the Food and Drug Administration (FDA) but do not require approval before going to market.
Clinmark provides full regulatory, clinical trials, and analytical and bioanalytical testing solutions to help our clients launch dietary supplements globally. Through our expert regulatory leadership and full suite of clinical services, we will help you launch your supplement quickly, successfully, and with regulatory confidence. Our team can also help you navigate the regulatory framework so you can gain access to one or more regions simultaneously – without additional work or excess costs.
