ABSTRACT
The particular food products addressed in Chapter 8 include food supplements and genetically modified, fortified and novel foods. Control of environmental risk assessment and of risks for human beings are the main objectives of the legislation to ensure the safety of GMOs in the European Union, where the limited number of approvals for cultivations is clearly distinct in procedural terms from the more frequent authorizations for importing and processing. According to Directive 2002/46/EC, food supplements are concentrated sources of nutrients (vitamins and minerals) and other substances with a nutritional or physiological activity, on its own or in combination. They are marketed in dosed forms intended to be ingested in small and measured amounts with the objective of integrating the normal diet. Vitamins and minerals and their chemical forms in food supplements and their significant levels in foods and beverages have been harmonized at the European level. For other substances such as amino acids and fatty acids, the authorization takes place at national levels and the mutual recognition procedure applies. The consumer information on food supplements must be in compliance also with Regulation (EU) 1169/2011 and Regulation (EC) 1924/2006. The EU Regulations applicable to fortified foods aim at the harmonization of Member States Regulations concerning the addition of vitamins, minerals and some other substances to foods. The food restoration and fortification are finalized at avoiding or reducing the states of deficiency concerning vitamins and minerals caused by a lack in the diet of foods providing these nutrients. A Community Register is foreseen by the Regulation for fortified food. The main features and improvements of Regulation (EU) 2015/2283 on novel foods are:
expanded categories;
generic authorizations;
establishment of a Union list of authorized novel foods;
a simplified, centralized authorization procedure managed by the European Commission using an online application submission system based on the safety evaluation to be carried out by the EFSA;
a faster and structured notification system for traditional foods from third countries on the basis of a history of safe food use. which are considered novel foods in the EU; and
data protection provisions.
