SENATE OF THE REPUBLIC
_____________XIII LEGISLATURE_____________


                                                                                                                N.4380


LAW PROPOSAL


Approved by the Chamber of Deputies on 2 December 1999 in a text version that is the result of the unification of the following law proposals:


initiatives of deputies CALDEROLI, RODEGHIERO and
BALOCCHI (number 94); POZZA TASCA, CACCAVARI,
VALPIANA, SAONARA, PROCACCI, NARDINI,
APREA, GIANNOTTI, LUCCHESE, MANCA
and CUSCUNA' (number 558); BERSELLI (number 639)

(ref: Chamber prints number 94, 558 and 639)


Transmitted by the President of the Chamber of Deputies to the presidency on 3 December 1999.

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Regulation of the herbal sector

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LAW PROPOSAL

  1. The present law disciplines the activities of processing, transformation, packaging and commercialisation both wholesale and retail, of plants, their parts and relative derivatives for herbal use, as well as the production of herbal products.

  1. For the purpose of the present law, the following definitions are established:
     a) Herbal products are products without nutritive properties or which are utilised for a non nutritive purpose and which are made of plants, their parts and their derivatives, as well as similar products, also if mixed with products of free sale, without addition of synthetic or semi synthetic products, thus that they can be defined natural.
     b) Parts of plants are the sections defined in accordance with conventional botanical nomenclature.
     c) A drug is that portion of a plant which is recognised as furnishing the primary content of the specific active principle.
     d) Herbal use is understood to be the use of the products described in letters a), b) and c) for purposes other than therapeutic, cosmetic or nutritional, directed towards stimulating the natural defenses of the human, animal or plant organism and towards assisting their physiological functions.
  2. Herbal products may not be derived from genetically modified plants.

  1. The plants, their parts, their derivatives, the drugs and the other natural products from which to obtain herbal products are classified, in accordance with the criteria established by paragraphs 2 and 3, in tables A and B which are attached to the current law. The tables may be modified by decree of the Minister of Health, after obtaining the opinion of the Commission described in Article 16.
  2. Table A lists the plants, their parts, their derivatives, the drugs and other natural products of exclusive pharmacological and therapeutic utilisation, the sale of which is reserved to pharmacists in pharmacies.
  3. Table B lists the plants, their parts, their derivatives, the drugs and the other natural products utilisable as such or as raw materials for herbal products. Sale to the public of the products indicated in table B is reserved to pharmacists and herbalists.

(Not translated. The article deals with the government promoting and supporting the cultivation of herbs by means of organic agriculture, and the harvesting and conservation of non cultivated spontaneous herbs - translator).

  1. The plants, their parts, their derivatives, the drugs and the other natural products included in table A as per article 3, paragraph 2, are subject to the discipline etsablished by legislative decree of 29 May 1991, number 178, and later amendments, concerning medicinal products.
  2. The transformation and processing of plants, their parts, their derivatives, of drugs and of the other natural products listed in table B, as per article 3, paragraph 3 for the purpose of the production of pre-packaged herbal products, are subject to authorisation by the Ministry of health.
  3. The Minister of health shall, by ministerial decree, determine the modalities for the presentation of the request for authorisation and for the granting of said authorisation.
  4. The authorisation as per paragraph 2 shall be given within 60 days of the presentation of the request, after verification of the presence of hygienic/sanitary requirements, of technical prerequisites as described in the regulation implementing the law of 30 April 1962, number 283, and later amendments, concerning the hygienic rules of production and sales of foods and drinks, approved with decree of the President of the Republic of 26 March 1980, number 327, and of the presence of a person responsible for quality control, who may serve this function also in the quality of a professional adviser. The person responsible for quality control must certify the correctness of each phase of the productive process, in accordance with current laws. The person responsible for quality control must be in possession of a degree in pharmacy or chemistry and pharmaceutical technologies or in biology or the diploma of specialisation in science and technology of officinal plants or of the university diploma in herbal technologies as per the decree of the Minister of university and scientific and technological research of 6 June 1995, published in the Official Gazette number 41 of 19 February 1996.
  5. Modifications of the data as per paragraph 4 shall be communicated to the Ministry of health.

  1. For the purpose of the present article, artisanal production is defined as the transformation and the processing of plants, their parts, their derivatives, of drugs and of other natural products listed in table B, as per article 3, paragraph 3, for the purpose of production of herbal products that are pre-packaged and labelled or accompanied by other documentation in the sense of article 9, paragraph 3, in laboratories connected to the shops where these products are sold to the public.
  2. The exercise of the activity of artisanal production as per paragraph 1 is subject to an authorisation by the competent regional authority, after verification of the hygienic/sanitary conditions and the technical prerequisites as per article 5, paragraph 4.

  1. The holders of authorisation for production of medicinal specialities as per legislative decree of 29 May 1991, number 178, or of authorisation for the production of foods for particular nutritional purposes as per legislative decree of 27 January 1992, number 111, or of galenic products and raw materials for pharmaceutical products who intend to produce, transform or package herbal products as per article 5, paragraph 2 of the present law, are obliged to communicate this to the ministry of health no less than sixty days prior to starting this activity.
  2. In the communication as per paragraph 1, the following shall be indicated:
     a) name and official address of the possessor of the authorisation;
     b) indication of the factory;
     c) description of premises and equipment;
     d) qualification of the person responsible for quality control and letter of acceptance of nomination.
  3. Any modifications of the data as per paragraph 2 must be communicated to the Ministry of health.

  1. Herbal products, also if mixed with products that are freely sold, may be sold both as pre-packaged products or in loose forms. They may be freely mixed and prepared on the spot by a pharmacist or herbalist, but limited to those plants, parts of plants, derivatives, drugs and other natural products included in table B as per article 3, paragraph 3.
  2. The plants, their parts, their derivatives and the drugs, when sold in a loose state, shall be handed to the public in packages that bear the name of the plant or plants contained, the name and address of the commercial establishment and any warning statements. The products as per this paragraph shall be visible in the place of sale to the public in containers which bear, in Italian language, written with indelible and readable characters, the following indications:
     a) the common and botanical name of the plant according to international botanical usage, followed by the identification of the part of the plant;
     b) whether the plant is of spontaneous nature or has been cultivated, as well as the place and method of cultivation;
     c) the date of harvest and of packaging;
     d) the lot number;
     e) the method of preparation, and any treatment with chemical substances to aid conservation;
     f) the mode of storage, if the product requires particular treatment;
     g) the date of expiry;
     h) the indication of possible risk, as per existing regulations for the labelling of dangerous products;
     i) the name and address of the processor or the person responsible for the the commercialization of the product;
     l) the price per sales unit, which may also be written in a price list to be consulted by the public;
     m) the percentage, if known, of the active principle which characterises the plant.

  1. Pre-packaged herbal products must bear on their boxes or on their labels, written in Italian language, with indelible and readable characters, the indications required by article 3, paragraph 1, letters a), b), c), d), e), f), g), h), i), specifying the mode of use for children, l), and m) of legislative decree 27 January 1992, number 109, (provisions for food labelling - translator), the name "herbal product" as well as the indication of the common and the botanical name of the plant according to international botanical usage, followed by the indication of the part of the plant used, the specific properties and any necessary precautions of use of the product. The common name and the designation "herbal product" on the packaging of pre-packaged herbal products shall be written also in Braille characters.
  2. The indications of the ingredients required by article 3, paragraph 1, letter b) of the cited legislative decree of 27 January 1992, number 109 has to be given in sequence of decreasing quantity with reference to weight and volume, specifying, where known, any important active principles recognised by one of the official pharmacopeas of the European union, or in the case of extracts, the type of extract and its percentage as contained in the product.
  3. The indications regarding the specific properties of the herbal product and regarding any necessary precautions of use, may be additionally written on other explanatory documentation to accompany the products.
  4. Pre-packaged herbal products may be identified also with names of fantasy.

Whoever intends to introduce into commerce pre-packaged herbal products shall communicate to the Ministry of health, before introduction into commerce, the labels and any other explanatory documentation to accompany the products, as per article 9. Within thirty days from receipt of the documentation, the ministry of health may request further specific information regarding the indications contained on the label and on any additional explanatory documentation accompanying the product. When sixty days have passed from receipt of the documentation, the product may be introduced into commerce.

  1. The exercise of the activity of retail commerce of herbal products is subject to the dispositions of legislative decree of 31 March 1998, number 114, and is reserved to those persons who are in possession of a university degree in pharmacy or in chemistry and pharmaceutical technologies, of a diploma of specialisation in science and technology of officinal plants or in pharmacognosy, or of a university diploma in herbalist technologies as per the decree of the Ministry of University and scientific and technological research of 6 June 1995, published in the Official Gazette number 14 of 19 February 1996.
  2. The persons described in paragraph 1 shall supply consumers with information on the use of the products sold.

The hygienic/sanitary supervision of the wholesellers and the retailers of herbal products, is a task of the regional authorities, who shall exercise such controls through the local health units, in accordance with legislative decree of 30 November 1992, number 502, and later amendments.

  1. The import of pre-packaged herbal products from countries outside of the European Union is subject to authorisation by the Ministry of health, which verifies the compliance of these products with the requisites of the present law.
  2. The Minister of health defines, within sixty days of the entering into force of the present law, through a ministerial decree, the modalities for giving the authorisation as per paragraph 1.

  1. The publicity of herbal products may not induce a false perception in the buyer about the characteristics of the product, and may not attribute to it different properties and functions from those indicated in article 2, paragraph 1, letter d). To the publicity of herbal products are also applicable the dispositions of legislative decree of 25 January 1992, number 74.

  1. Those who, at the date of entry into force of the present law, exercise the activities of transformation and of processing of plants, their parts, their derivatives, of drugs and other natural products for the purpose of the production of pre-packaged herbal products may continue to exercise these activities for a period no longer than thirty-six months, on the condition that, within six months of that date, they present to the Ministry of Health a request for authorisation as per article 5.
  2. Those who, at the date of entry into force of the present law, exercise, also in a condition of employment, the activities as per articles 6 and 11 or the activities of processing of plants, their parts, their derivatives and of drugs, in preparation of the final processing of same or in preparation of furnishing them to authorised retailers, and who are in possession of the herbalist diploma as per article 6 of the law of 6 January 1931, number 99, or of a university degree in biological sciences or in medicine and surgery or in agrarian science or of a diploma obtained in a special school for herbalists at a pharmacy faculty, may continue to exercise those same activities, subject to the dispositions of paragraph 4 of the present article.
  3. Those who, at the date of entry into force of the current law, exercise, also in a condition of employment, the activities as per articles 6 and 11 of the present law or the activities of processing of plants, their parts, their derivatives and of drugs, in preparation of the final processing of same or of furnishing them to authorised retailers, without possessing the herbalist diploma as per article 6 of the law of 6 January 1931, number 99, may continue to exercise those same activities on the condition that within three years of the date of entry into force of the present law they pass a specific examination, which may be given at the end of a brush-up course to be regulated by a decree of the Minister of university and of scientific and technological research, in cooperation with the Minister of Health, to be published within six months of the date of entry into force of the present law. Any costs deriving from the organisation of the brush-up courses are to be covered by payments of the enrollees, according to procedures to be established by a decree of the Minister of the university and of scientific and technological research, without creating expenses for the national budget.
  4. The person in possession of the herbalist diploma as per article 6 of the law of 6 January 1931, number 99, who have not exercised the activity of herbalist for more than 5 years, are eligible for the specific examination as per paragraph 3 of this article.
  5. The pre-packaged herbal products that are on the market at the date of entry into force of the present law may continue to be sold for a period of time not exceeding thirty-six months from that date.

  1. Within thirty days of the coming into force of the present law, the Minister of Health, by means of a decree issued in cooperation with the Minister of university and of scientific and technological research, the Minister of agricultural politics and forestry and the Minister of industry, commerce and arts, shall establish a technical/scientific Commission to be presided by the director of the Superior Health Institute and composed of nine members experts in herbs, pharmacology, toxicology and pharmaceutical botanics, of which five are to be designated by the Ministers of Health, of Agricultural politics and forestry, of Industry, commerce and arts, and of University and scientific and technological research, and four are to be designated by the associations of herbalists and the producers, by the national federation of the orders of medical doctors, surgeons and dentists, and by the national federation of the orders of pharmacists. The members of the commission shall serve for two years and may have their mandate renewed for no more than two consecutive terms. The establishment and the functioning of the commission shall not add costs to the national budget.
  2. The Commission as per paragraph 1 shall have proponent and consultive functions towards the Minister of Health with regard to the dispositions of article 3, paragraph 1.

  1. The National Research Council, the Superior Institute of Health and the Ministry of agricultural politics and forestry shall, within the programs of specific research and within the limits of allocated resources, finance specific projects with the aim of study and exploitation of officinal plants and connected technologies of cultivation and transformation.
  2. The regions and autonomous provinces of Trento and Bolzano shall inform the Minister of University and of scientific and technological research of any projects financed by them that have the same aims as described in paragraph 1.

  1. Within a year of entry into force of present law, the regions shall regulate the protection of plant life, establishing the limits within which harvesting of spontaneously grown officinal plants on the part of trained herbalists for commercial purposes and on the part of individuals for personal purposes shall be allowed, and they shall determine which are the officinal plants to be protected, the harvesting of which shall be regulated.

  1. The regions, within their respective health education programs, through the communes, the local health units and schools, may promote knowledge of officinal plants that may be utilised for herbalist purposes, ensuring correct information and health education about the use of these plants, also with reference to popular traditions, as well as for the scope of protection and development of the natural plant patrimony as a useful biological resource for human health.

  1. The present law applies to the regions with a special status and to the autonomous provinces of Trento and Bolzano within the limits and with consideration of their special status and of relative regulations.

(Not translated - determines the penalties for not following the disposition of the present law - translator)

(Not translated - lists other previous laws that are cancelled by the present law - translator)

  1. The present law enters into force the day following it's publication in the Official Gazette. The dispositions of articles 5, 6, 7, 8, 9, 10, 11, 12, 13 paragraph 1, 14, 21 and 22 are applicable from the ninetieth day after that of the publication of the law in the Official Gazette.