title: Regulations applicable to plant food supplements and related products in the European Union.
abstract: This paper deals with the current regulatory and legal settings of traditional plant food supplements and herbal medicinal products in the European Union (EU). Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, including the use of additives and maximum levels of contaminants and residues. However, due to limited harmonization at the EU level, specific national regulations adopted at a Member State level also apply and mutual recognition is the mechanism through which such products can be marketed in EU countries other than those of origin. Unlike food supplements, marketing of traditional herbal medicinal products is regulated by an ad hoc Directive (i.e. Directive 2004/24/EC) covering in detail all the relevant aspects of these products, including a facilitated registration procedure at national level. However, by distinguishing traditional herbal medicinal products from plant food supplements and establishing selective marketing modalities for these two product categories, the EU has been confronted with implementation difficulties for traditional herbal medicinal products and a lack of homogeneity in the regulatory approaches adopted in different EU Member States. In fact, currently the nature of the commercial botanical products made available to consumers as traditional medicinal products or food supplements, depends largely on the EU Member State under consideration as a consequence of how competent National Authorities and manufacturing companies interpret and apply current regulations rather than on the intrinsic properties of the botanical products and their constituents. When the EU approach is compared with approaches adopted in some non-European countries to regulate these product categories, major differences become evident.
authors: Faculty of Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome. vittorio.silano@alice.it
authors: Vittorio
authors: V
authors: Silano
authors: Patrick
authors: P
authors: Coppens
authors: Ainhoa
authors: A
authors: Larrañaga-Guetaria
authors: Paola
authors: P
authors: Minghetti
authors: René
authors: R
authors: Roth-Ehrang
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D019587:Dietary Supplements / Q000009:adverse effects / Q000032:analysis; D005062:European Union; D005515:Food Labeling / Q000331:legislation & jurisprudence; D029001:Herbal Medicine; D006801:Humans; D007881:Legislation, Food; D008517:Phytotherapy / Q000009:adverse effects; D028321:Plant Preparations / Q000009:adverse effects / Q000737:chemistry; D010945:Plants, Edible / Q000009:adverse effects / Q000737:chemistry; D014481:United States
chemical_list: D028321:Plant Preparations