Before a dietary supplement is marketed, it should be registered with the GIS and the plant should be approved (art.61, 62 and 63 of the Act – food and nutrition safety). SpecChem submits an application for approval and entry into the register of establishments to the sanitary and epidemiological station competent in the area. When we obtain the approval/registration and entry into the register we inform our clients about the possibility of starting the activity. SpecChem takes care of complex activities connected with registration of the supplement.
We have described the definition of dietary supplements in more detail on our blog. Check it out in the link below.
What are dietary supplements?
We thoroughly review product documentation (specification, analysis of test results, confirmation of safe use). We carry out, or complete, laboratory tests. Before a supplement is placed on the market, GIS informs entrepreneurs of the need to carry out laboratory tests. The consistency of the test results with the actual content of the supplement can be verified by Sanepid. This body also looks at the composition of supplements for levels of contaminants, the presence of heavy metals. We take a close look at the compositions of the supplements when conducting the tests. We draw attention to the list of plant substances and raw materials that may not be used in dietary supplements based on the Resolution of the Team for Dietary Supplements operating at the National Sanitary and Epidemiological Council (Resolution No. 6/2021).
Our specialists check the maximum levels of vitamins and minerals that can be found in supplements. We also look at the levels of botanicals and other ingredients that show a nutritional or physiological effect in supplements. We produce a toxicological analysis of the product.
A product that is a supplement should be correctly labelled. The name must appear on the packaging: food supplement. The label should include information on the daily recommended intake. In addition, the label must include the name of the ingredient category and warnings relating to safe storage (out of the reach of children). It is also important to include a statement that supplements are not a substitute for a varied diet. Care should be taken to avoid wording that could attribute a medicinal or disease-preventing effect to supplements. The supplement should be labelled with nutrition and health claims.
During official inspections, the composition is assessed, as well as the amount of substances causing nutritional/physiological effects. Dosage and intended use (relevant consumer groups) are checked. On the label, the content of vitamins and other minerals should be noted in numerical labelling, as well as per the manufacturer’s recommended daily portion of the product. The content of vitamins and minerals shall also be given as a percentage, in relation to the intake values set out in Point 1 of Part A of Annex 13 attached to Regulation No 1169/201 of the European Parliament and of the Council on the provision of food information to consumers.
Our Specchem team of specialists registers supplements with the GIS (based on the register of so-called health-promoting foods). We assist in solving difficulties that may be encountered during registration to the GIS (e.g. ordering complementary laboratory tests).
