Food supplements are distinguished, with respect to the generality of the products, for the purposes of use and the relative indications on the label (cd claims). Focus on botanical ingredients, cd botanicals.
Food supplements, premise
Food supplements qualify as'food products intended to supplement the normal diet and which constitute a concentrated source of nutrients or other substances having a nutritional or physiological effect'.
Appropriatedosage forms, i.e. forms of marketing ' are provided, 'such as capsules, tablets, tablets, pills and the like, powders in sachets, liquids contained in ampoules, dropper bottles and other similar forms, of liquids and powders intended to be taken in small unit quantities'. (1)
The labeling is characterized for the legal denomination, 'dietary supplement'. And a series of 'mandatory elements:
a) the name of the categories of nutrients or other substances that characterize the product or an indication of the nature of those substances,
b) the dose of the product recommended for daily intake,
c) a warning not to exceed the recommended daily doses,
d) the indication that food supplements are not intended as a substitute for a varied diet,
e) a statement that the products must be kept out of the reach of small children'. (2)
The placing on the market of food supplements is also subject to a notification procedure - in Italy, to the Ministry of Health, DGISAN, Office V - in compliance with the composition and nutritional requirements.
Food supplements, botanical ingredients. The Ministerial Decree 10.8.18
To the Ministry of Health deserves the credit for having preserved the centuries-old Italian herbal tradition. Thanks to a specific discipline of the use of plant substances and preparations in food supplements. (3)
The ministerial decree 10.8.18 updates the list of herbal substances and preparations allowed in the production of food supplements. With specific indications on the formalities required for the best guarantee of their safety and appropriate information to the consumer.
This is how it consolidates BelFrIt, single list of plant substances allowed in food supplements. Defined in agreement between the health administrations of Italy, France and Belgium, pending European harmonization.
The new list therefore it extends the list of admitted botanical varieties. By 'plant substance and preparation' we mean:
- a vegetable ingredient, i.e. the plant in its entirety or its parts (whole, in pieces or cut) in untreated form, generally dried,
- a vegetable preparation, obtained by subjecting the vegetable ingredient to various second transformation treatments (eg extraction, distillation, pressing, fractionation, purification, concentration, fermentation, grinding and pulverization).
The requirements of laboratories and factories processing of these substances and preparations are finally clarified by the ministerial decree. Which offers a clear guideline on structural, hygienic and sanitary requirements necessary for products not always intended for food purposes, as well as on the criteria for analysis and titration of preparations.
It will also need to be prepared appropriate documentation on the procedures followed for use in food supplements of herbal substances and preparations ('botanicals') in the EU. With reference to their nature, the production process and the final product to be obtained.
Botanical ingredients and Officinal Consolidated Text, operating instructions
Il Unified Officinali admits a first business transformation without the mandatory presence of a pharmacist or herbalist, as required in the past. (4) As a consequence, the entrepreneurial capacity of farmers in productive segments with high added value is enlarged.
Due to the above, whoever intends to market vegetable substances or preparations that qualify as food supplements or their ingredients must carry out the notification procedure at the Production Activities Office (SUAP) of the Municipality where the company has its registered office. And ensure correct labeling, according to the appropriate procedures.
Food business operators (FBO) must in any case keep the appropriate documentation available to the control authorities to demonstrate the compliance of each notified food supplement with the required requirements. With attention not to fall within the scope of the regulation 'Novel foods', and if necessary to fulfill the obligations established by it. (5)
Dario Dongo
Footnotes
(1) See dir. 2002/46 / EC, article 2
(2) See Dir. 2002/46 / EC, article 6
(3) See http://www.gazzettaufficiale.it/eli/id/2018/09/26/18A06095/sg
(4) Unified Officinali, Legislative Decree 21.5.18, n. 75
(5) Cf. reg. EU 2015/2283. For some application examples, see the previous article https://www.greatitalianfoodtrade.it/idee/il-nuovo-che-avanza-a-scaffale
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
