The European Food supplement directive 2002/46/EC including amendments sets the rules for the category of food supplements. There is no general European legislation apart from common European pharmacological legislation approving or limiting the use of other nutrients than vitamins and minerals. The regulation of ”other nutrients” is a national matter where differences from member state to member state vary considerably.
The legal regulation of the area ”other nutrients” is thrifty, leaving ”traps and loop-holes” partially concealed. Consequently a number of these ingredients are ”randomly” at risk as the use of these ingredients are fully regulated on a national basis. The authorities in various member states are watching this area carefully and the majority of them have tightened their regulations. Labeling is controlled by the regulation 1169/2011 which are the overall regulations for all food and therefore also regulating food supplements unless the areas that are covered by specific legislation.
Having a mixture of EU and national legislation applying numerous products are quite carefully monitored by the national authorities who eventually may decide to stop the product or the ingredient. Being the producer of any such product or ingredient gives you the obligation to ensure a good safety assessment report (hyperlink til “safety study”), together with either a PMSA, or even a PSUR, in order to establish the safety documentation needed and thus justify the dosage and the strength of the ingredient as well the method of production with respect to safety.
We have extensive experience in label review for any kind of food. We ensure that you are informed about all claims and uses possible. We consider whether the product is suitable other food categories. Furthermore we contribute to commercialization if needed.
First of all – the review covers all legislative parts applying in the country of produce and sale. 1A Food Consulting keeps you safe within label demands as allergens and obliged text which is very different from one country to another even within the European countries.
We handle label text translation in Danish, Swedish and Norwegian, Germany and English. The procedure normally is that we receive a pdf or word sample of a label ( we prefer pdf as pictures on labels are claims as well as text). An alternative is labels in “Scandi” i.e. Danish, Swedish and Norwegian into one text, taking into account national legislation in these countries in one text.
Food supplements may contain a variety of nutrients as well as other ingredients: Vitamins, minerals trace-elements, amino acids, fatty acids, fibers, plant extracts or –isolates along with spices.
Especially the use of innovative and consequently ”interesting” raw materials originating from plants, spices and herbs calls for a persistent need for advice in relation to borderline-issues related to Novel-food (hyperlink til European applications “novel food”) and pharmaceuticals.