Ingredients, food Additives and Novel Food
The variety of ingredients that can be incorporated into food supplements is very wide. Gone are the days when the supply was limited to vitamins and minerals, nowadays it is possible to offer consumers, in addition to vitamins and minerals, foodstuffs, including food supplements, with fiber, fatty acids, amino acids, plant enzymes/extracts of plants, among other new foods that have been approved as safe to incorporate into their formulations.
The forms of vitamins and minerals that can be used in foods and drinks, and also in food supplements, are listed in Regulation (EC) N. º 1170/2009, in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002, and the reference doses of these ingredients can be found in Regulation (EU) N. º 1169/2011.
All other ingredients with nutritional or physiological effect, other than vitamins and minerals, such as fiber, fatty acids, amino acids, plant enzymes/plant extracts, must comply with the requirements of Regulation (EU) 2015/2283 on novel foods, they must have a proven history of significant food consumption in the European Union before May 15, 1997. Whenever an ingredient does not have this history of consumption, it is considered Novel food and cannot be placed on the market until its safety is proven, and its safe use is published to the European Commission.
The economic operator has the responsibility to ensure that the ingredients, additives and flavourings present in their foodstuffs are not new foods (yet to be approved), and that they are within the limits established in the European Union (EU). You must also ensure that you do not use prohibited ingredients to formulate these products, as defined in Regulation (EC) N. º 1925/2006. To do this, operators must consult all available regulations, official Lists and Catalogs of the European Community, or seek specialized help for the formulation and/or validation of the conformity of the composition of their foods and/or food supplements. If you need help from experts to evaluate and validate the ingredients of your products, Pharmilab is the partner you need.