TECNOLOGIA DEI PRODOTTI ERBORISTICI E DELLA SALUTE - LEGISLAZIONE DEI PRODOTTI ERBORISTICI E DELLA SALUTE

Module LEGISLAZIONE DEI PRODOTTI ERBORISTICI E DELLA SALUTE

Teaching activities are carried out primarily through lectures (Delivery Teaching, DE), aimed at presenting and exploring theoretical content related to regulatory frameworks, production, marketing, and control of herbal products, food supplements, and health products, with a focus on legislative aspects, labeling, safety, and regulatory compliance.

To complement the lectures, when the nature of the topics allows, interactive teaching activities (Interactive Teaching, DI) based on active learning methodologies are proposed. These include group work, guided discussions, label analysis, case studies, or simulations of regulatory compliance procedures. Such activities promote active student engagement, stimulate peer and instructor discussions, encourage the application of regulations to solve practical problems, and develop communication, collaboration, and independent judgment skills.

The integration between delivery teaching and active learning activities contributes to achieving the expected learning outcomes, fostering both the acquisition of theoretical knowledge and the ability to apply it critically within the professional context of herbal and health products.

Should the course be delivered in a blended or distance learning format, any necessary variations to the above will be introduced in order to adhere to the schedule outlined in this syllabus.

Attendance is mandatory, as required by the Degree Programme regulations. Absences are permitted for no more than 30% of the total teaching hours, regardless of the mode of delivery. Further details are available in the Degree Programme Academic Regulations: https://www.dsf.unict.it/it/corsi/l-29_sfa/regolamento-didattico

According to the Academic Regulations (RDA), Article 12 - University Educational Credits (CFU), the standard workload of 25 hours of total student commitment, corresponding to one credit, may include:

a) 7 hours devoted to lectures or equivalent teaching activities, with the remaining hours dedicated to

individual study;

b) a minimum of 12 and a maximum of 15 hours devoted to classroom exercises or equivalent supervised activities (laboratory work), with the remaining hours dedicated to individual study and personal elaboration of the acquired knowledge.

LEGISLATION OF THE HERBAL SECTOR

Notes on national and supranational legislation

The national normative sources and their hierarchical placement; The main normative sources: ordinary laws and acts having the force of law (legislative decrees and legislative decrees), regional laws, regulations, single texts and codes, circulars. Institutional health bodies: Ministry of Health, Higher Council of Health, Higher Institute of Health, Italian Medicines Agency. Supranational legislation: acts of the European Union, United Nations Organization, European Union, European Medicines Agency, Food and Drug Administration, World Health Organization. Definition and development of medicines. Definition of medicinal product, classification of medicinal products; Legislative Decree 219/06; Relationship between medicines and complementary sectors of health interest; Legislation on the production and marketing of medicines: AP (GMP); AIC (related procedures, application for registration). Pharmacovigilance.

 Regulatory framework for plant-based products and their derivatives

Herbal medicine and herbal medicine; Herbal medicines (prepackaged products and extemporaneous preparations); Regulations on phytotherapeutic products: Community Directive 2004/24; Traditional herbal medicine and herbal medicine (traditional use; well-established use); Community monographs and community list; Special provisions relating to traditional herbal medicines; Committee for Herbal Medicines (HMPC). Norms on officinal plants: law 6 January 1931, n. 99 "Discipline of the cultivation, harvesting and trade of medicinal plants"; Royal Decree 26 May 1932, n. 772 "List of plants declared officinal"; Regional law 23 May 1994, n. 9 "Rules for the exercise of herbal professional activities"; Legislative Decree 21 May 2018, n. 75 “Consolidated law on the cultivation, harvesting and first processing of medicinal plants”. Phytovigilance: epicenter, vigierbe, phytotherapeutic interactions and conventional drugs.

LEGISLATION OF COMPLEMENTARY SECTORS

Regulations concerning the food sector

Foods: definition, regulatory aspects and classification (Regulation (EC) No. 178/2002); European Food Safety Authority (EFSA); Rapid Alert System for Food and Feed (RASFF); Preservation of food products (HACCP system; self-control plan); Food labeling (Regulation (EU) 1169/2011); Claims (Regulation (EC) 1924/2006; nutrition and health claims).

Foods for specific groups (FSG): definition, regulatory aspects and classification: regulation (EU) 609/2013; baby food (infant formula and follow-on formula; cereal-based and baby food); Foods for special medical purposes (AFMS); Substitutes for the entire daily food ration for weight control; Authorization for the production and packaging of FSG foods; Labeling, marketing and advertising of FSG foods;

Novel food: definition and classification according to Regulation (EC) n. 258/97 and the new Regulation (EC) 2015/2283; marketing authorization and labeling; Union list. - Food supplements: definition, regulatory aspects; Vitamin and / or mineral supplements (Regulation (EC) No. 1170/2009 and subsequent amendments and additions); supplements containing probiotics and prebiotics; supplements containing plant substances (DM 9 July 2012; BELFRIT project; DM 10 August 2018); weight control supplements. Labeling, manufacturing and packaging.

Enriched foods

Notes on the legislation in the cosmetics sector

Definition of cosmetic, current legislation, safety of cosmetics, active ingredients in cosmetics of plant origin, production, traceability and label of cosmetics. Vigilance on cosmetic products.

1. F. Bettiol, F.F. Vincieri, Manuale delle preparazioni Erboristiche, III ed. Tecniche nuove.

2. V. Silano, M. Silano, Prodotti di origine vegetale, Tecniche Nuove, 2006
3. P. Minghetti: Legislazione Farmaceutica, ottava edizione, CEA, Milano (consultazione su
Cosmetici, Codice dei Medicinali, DL.vo sugli Integratori)
4. L. Casettari, G. Barberini, Legislazione farmaceutica nella pratica professionale Copertina rigida – 15 novembre 2021

5.Capasso – Grandolini:  FITOFARMACIA, aggiornamento Ed. Sprinter, 2a Ediz. 2006.

6. Materials provided by the professor

7. Text of the law

Learning assessment is carried out through an oral examination designed to verify the achievement of the course learning objectives. Evaluation will take into account the correctness, completeness, and relevance of the knowledge acquired and of the answers provided, the ability to apply knowledge to discipline-specific contexts, the level of understanding and mastery of the topics covered, the appropriate use of scientific terminology, the clarity of presentation, and the logical organization of content. In addition, students will be assessed on their ability to establish coherent connections among the different topics addressed during the course, their critical thinking skills, independence of judgment, and their ability to identify appropriate solutions to problems related to the subject matter of the course.

Based on the above, the assessment and grading are expressed on a 30-point scale according to the following scheme:

Fail (Non idoneo)

Knowledge and comprehension of the topic: Significant deficiencies and inaccuracies

Analysis and synthesis capability: Irrelevant, frequent generalizations

Use of references: Completely inappropriate

Grade: 18–20

Knowledge and comprehension of the topic: Very modest, evident imperfections

Analysis and synthesis capability: Barely sufficient

Use of references: Barely appropriate

Grade: 21–23

Knowledge and comprehension of the topic: Slightly more than sufficient knowledge

Analysis and synthesis capability: Fair capacity for analysis and synthesis, argues in a logical and coherent manner

Use of references: Uses standard references

Grade: 24–26

Knowledge and comprehension of the topic: Good knowledge

Analysis and synthesis capability: Possesses good analytical and synthetic skills, topics are presented coherently

Use of references: Uses standard references

Grade: 27–29

Knowledge and comprehension of the topic: More than good knowledge

Analysis and synthesis capability: Possesses remarkable analytical and synthetic skills

Use of references: Has explored topics in depth

Grade: 30–30 cum laude (30 e lode)

Knowledge and comprehension of the topic: Excellent knowledge

Analysis and synthesis capability: Possesses remarkable analytical and synthetic skills

Use of references: Significant in-depth studies

Learning assessment may also be carried out on-line, should the conditions require it.
To ensure equal opportunities and in compliance with current laws, interested students may request a personal interview in order to plan any compensatory and/or dispensatory measures based on educational objectives and specific needs.
Students can also contact the CInAP (Centro per l’integrazione Attiva e Partecipata — Servizi per le Disabilità e/o i DSA, (https://www.cinap.unict.it/content/referenti) and referring teacher (prof.ssa Santina Chiechio email: santina.chiechio@unict.it) within of department.

The exam dates are published on the Degree Course website: [https://www.dsf.unict.it/it/corsi/l-29_sfa/calendario-esami](https://www.dsf.unict.it/it/corsi/l-29_sfa/calendario-esami)

Students may use AI as a study aid, in compliance with applicable regulations including those regarding copyright and the use of intellectual works, as outlined in section 5.1 of the guidelines (https://www.unict.it/it/ateneo/cidia-centro-l%E2%80%99informatica-la-digitalizzazione-e-l%E2%80%99intelligenza-artificiale)

• Regulations on medicinal plants;
• Foods for specific groups: definition, regulatory aspects and classification