Obelis service development department, is honoured to introduce a new regulatory area within Obelis consultancy and regulatory services!
Food supplements are regulated under EU legislative framework as foodstuff. The Directive 2002/46/EC defines food supplements as ‘’ foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities’’.
This means that, as foodstuff, several pieces of horizontal legislation on food safety apply to food supplements:
· Regulation EC 852/2004 on preparation and hygiene of foodstuffs based on the principles of Hazard Analysis and Critical Control Points (HACCP);
· Regulation EU 1169/2011 on food labelling with the aim of adequately informing the consumer about the composition, properties and use of foodstuffs;
· Regulation EC 1924/2006 on the use of nutrition and health claims, which must be authorized before they can be used;
· Regulation EC 1333/2008 on Conditions for the use of additives;
· Regulation EC 369/2005 and Regulation EC 1881/2006 on maximum levels for residues and contaminants;
· Regulation EC 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety;
· Regulation EU 2015/2283 approval of novel foods and food ingredients not on the European market before 15 May 1997.
Finally, also National Legislations have to be taken into account. For all of them Obelis provides full consultancy support, and for some of them, can also register the products in the dedicated National Databases (when existing).
If you are also an Operator or Manufacturer in this fast-expanding industry, and you want to join the EU market – biggest market in the World – please do not hesitate to contact us and make acquaintance with our Food Supplement experts!