LEGISLATION ON HERBAL AND HEALTH PRODUCTS

The student will gain a general knowledge of the rules governing the handling, processing and production of herbal products in their various uses (pharmaceutical, healthy, cosmetics, food), as well as their presentation and marketing in herbalist's shop and pharmacy.

It will also acquired information on national and European regulations on the additional areas of interest of the herbalist (cosmetics, food and special foods, dietary supplements, fortified foods, Novel Foods).

Regulations about products obtained from plants and derivatives; Natural herbal medicine and herbal medicine. Phytochemicals: definition according to the law 219/2006; Manufacturing authorization and authorization for marketing; Authorization for marketing: the procedures; The Committee for Herbal Medicinal Products (HMPC); The National Pharmacovigilance System; Supervision and sanctions; Preparation of galenic products based on natural products; Definition and classification of cosmetic products according to the Law 1223/2009; Presentation of a cosmetic: authorized claims, labeling; minimum duration and PAO;INCI and CTFA classification; Rules relating to the production and marketing of a cosmetic product; valuation parameters on cosmetic products; Informative documentation on cosmetics: the safety assessment; Report on the safety of the cosmetic product; Specific prohibitions on production; Foods: definition and regulatory aspects; The law 258/97: the novel foods; Regulation n ° 608/2004; Regulation (EC) 1924/2006 on nutrition and health on foods; EFSA: definitions; The Regulation 432/2012 and the approved claims on foods; Value of claims on foods; procedure for insertion of new claims; Foods intended for particular nutritional uses (Law 111/1992); Classification and regulations on specific subclasses; The changes introduced by Law 609/2013; Food supplements and the Law 169/2004; Classification, Production, authorization for marketing, packaging and labeling; Supplements made from ingredients made from plants or derivatives; The BELFRIT project.

1. F. Bettiol, F.F. Vincieri, Manuale delle preparazioni Erboristiche, Tecniche nuove, 2012
2. V. Silano, M. Silano, Prodotti di origine vegetale, Tecniche Nuove, 2006
3. F.U.I. XII Ed. ed aggiornamenti
4. P. Minghetti: Legislazione Farmaceutica, ottava edizione, CEA, Milano (consultazione su Cosmetici, Codice dei Medicinali, DL.vo sugli Integratori)
5. Materiale didattico del docente