Regulatory Guidelines for Nutraceuticals in the European Union

Nutraceuticals include a wide range of substances that can be used as medicinal products, feed material, or feed additives. This makes a substantial difference in the regulatory aspect of the marketing authorization in the European Union (EU) because for obtaining the appropriate marketing authorization, different procedures have to be followed. Since specific regulations do not apply to nutraceuticals, when they are used as feed additives for animal nutrition, they shall comply with Regulation No 1831/2003 on additives for use in animal nutrition. While nutraceuticals are administered as feed ingredients, they must comply with Commission Regulation (EU) No 68/2013. If nutraceuticals are administered with medical claims or if they exert a pharmacological effect, their use must comply with Directive 2001/82/EC. The EU legislation on this topic is very detailed and complex. Nevertheless, it allows the obtaining of marketing authorization with a wide safety margin, precautionary for animal health, human health, and the environment. The Scientific Committees and panels of the European Food Safety Authority (EFSA) are responsible for producing opinions that are used by the European Commission to adopt legislation related to animal nutrition. For veterinary medicinal products, the responsibility for marketing authorization is both granted by competent national authorities of the Member States or by the European Medicine Agency (EMA). This chapter describes legislation that is relevant to the marketing authorization of nutraceuticals for animals in the EU, elucidating the different categories of use, i.e., feed materials, feed additives, and veterinary medicinal products.