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The paper aims at analysing and comparing the European and Romanian legislation in the field of manufacturing food supplements, in order to identify the correspondence between Romanian norms and the European legal framework. The research has been performed on the texts of applicable European directives and the norms in force in Romania in the field of food supplements, covered by food legislation. The methods of interpretation and the comparative method are being used. The elements of legislation under research are the provisions on the authorisation of the producer, manufacturing process, packaging and labeling of supplements. In regard to the setting up of production units and the manufacturing process it has been ascertained that the directives applicable in the European Union do not have any such provisions. In the Romanian legislation, these rules have been inferred from the legislation on food products. They set the need to authorize / register producers with the Sanitary Veterinary and Food Safety Authority at county level, as well as the obligation to observe the good manufacturing practice rules set by the producers' associations. The provisions regarding packaging and labelling of food supplements, in European and Romanian legislation, are very similar. However, they are set apart mainly by the fact that Directive 2002/46/EC establishes that labelling and presentation must not attribute to food supplements the properties of preventing, treating or curing a human disease, or refer to such properties. In Romanian legislation such provisions exist only with regard to food supplements containing just vitamins and/or minerals. The proposals refer to the harmonising Romanian standards with the European ones, by adopting these provisions also in what regards the food supplements of animal and/or vegetal origin, so as to avoid any confusion between these and medicines. [ABSTRACT FROM AUTHOR]

The paper aims at analysing and comparing the European legislation and the Romanian legislation in the field of defining food supplements, in order to identify the components of a legal definition and the correspondence between Romanian norms and the European legal framework. The research has been performed on the texts of applicable European directives and the norms in force in Romania. The method of interpretation and the comparative method are being used. Several definitions of food supplements have been identified, in various categories of normative acts, that include as elements the definition itself and the limits of nutrient concentration. The definition itself includes the composition, form of presentation and purpose of using food supplements. There are similarities between the European and the Romanian definitions in what regards the elements of the definition, and differences in what regards their contents. Qualifying a product as a food supplement has as an impact the obligation of observing the applicable legislation. Although the analysed definitions include the possibility of presenting food supplements in pharmaceutical forms, no definition provides for the possibility of associating it to a therapeutic purpose, something that clearly distinguishes these products from medicines, both at the European level and in Romania. The definitions of food supplements in the Romanian legislation are in line with the European legal framework, and are even more detailed in what regards the composition and form of presentation. The drawbacks of Romanian regulations include the lack of provisions regarding minimum and maximum limits of nutrient concentrations. [ABSTRACT FROM AUTHOR]