DEFINITION AND REGULATIONS
The term nutraceutical, later associated with nutraceutical products, was introduced in 1989 by Dr. Stephen De Felice, who coined this definition by combining the words "nutrition" and "pharmaceutical", to indicate how the natural constituents present in foods or plants can be synthesized , in a dosed, concentrated and purified form, to create drugs useful for preventing and treating certain diseases.
Classification based on the purpose of use.
Nutraceuticals must be included in the more general definition of food supplements that the law defines as "food products intended to supplement the common diet" and which constitute a concentrated source of nutrients, such as vitamins and minerals, or other substances having a nutritional effect. o physiological, in particular, but not exclusively, amino acids, essential fatty acids, fibers and extracts of vegetable origin, both single and multi-compound, in pre-dosed forms, where by "pre-dosed forms" we mean capsules, tablets, tablets, gums chewing and the like, powders in sachets, liquids contained in vials, dropper bottles and other similar forms of liquids and powders intended to be taken in small unit quantities.
Regulation
The rules governing the safety and correct labeling of supplements are issued by EFSA (European Food Safety Authority) and governed by Regulation (EC) 1170/2009 of 30 November 2009, which amends Directive 2002/46 / EC and Regulation (EC) 1925/2006 "as regards the lists of vitamins and minerals and their forms that can be added to foods, including food supplements"
In addition to substances added for nutritional purposes, food supplements may also contain food additives, i.e. substances added to products for technological reasons (e.g. tablet coating agents, sweeteners). The list of food additives authorized for use in food supplements is available in Regulation (EC) No. 1333/2008.
The rules governing the safety and correct labeling of supplements are issued by the who defined, on the basis of specific nutritional efficacy and safety assessments, any claims (nutritional and health properties) that food supplements can boast.
The Ministry of Health has in turn provided guidelines (LGM) which contain provisions applicable to the categories of food supplements listed below, for aspects not harmonized at European level:
In addition to substances added for nutritional purposes, food supplements may also contain food additives, i.e. substances added to products for technological reasons (e.g. tablet coating agents, sweeteners). The list of food additives authorized for use in food supplements is available in Regulation (EC) No. 1333/2008.
The rules governing the safety and correct labeling of supplements are issued by the who defined, on the basis of specific nutritional efficacy and safety assessments, any claims (nutritional and health properties) that food supplements can boast.
The Ministry of Health has in turn provided guidelines (LGM) which contain provisions applicable to the categories of food supplements listed below, for aspects not harmonized at European level:
- supplements of vitamins and / or mineral salts, for which the maximum permitted levels of intake are indicated;
- supplements with probiotics, prebiotics and symbiotics, for which specific provisions are reported regarding their use to balance the intestinal flora;
- adjuvants of low-calorie diets for the reduction of body weight, for which the criteria relating to correct labeling and advertising are indicated;
- Plant-based supplements (botanicals);
- supplements with other substances having a nutritional or physiological effect, include nutrients, other than vitamins and minerals, which are permitted for use in food supplements (for example, amino acids, flavonoids, isoflavones, fibers, fatty acids). Where established, the permitted intake limits are also indicated with the daily dose and additional warnings;
- supplements based on plant substances and preparations ("botanicals"), their use is currently governed by the ministerial decree of 10 August 2018.
The term "botanicals" refers to:
• a vegetable ingredient, or the "vegetable drug" or the whole plant or its parts (whole, in pieces or cut) in untreated form, generally dried;
• a vegetable preparation obtained by subjecting the vegetable ingredient to various treatments (for example: extraction, distillation, pressing, fractionation, purification, concentration, fermentation, grinding and pulverization).
The ministerial decree lists in Annex 1 the list of substances and plant preparations allowed for use in food supplements and provides specific indications on the requirements to be carried out to support their safety and in order to raise the level of consumer protection.
The intake of food or nutraceutical supplements helps improve the health of the body and helps prevent the onset of particular diseases. The use of these products, to be safe and useful, requires knowledge of their operation and their properties and must be done in a conscious and informed manner.
It is important to remember that supplements should never be considered as a substitute for a varied and balanced diet or a healthy lifestyle.
• a vegetable ingredient, or the "vegetable drug" or the whole plant or its parts (whole, in pieces or cut) in untreated form, generally dried;
• a vegetable preparation obtained by subjecting the vegetable ingredient to various treatments (for example: extraction, distillation, pressing, fractionation, purification, concentration, fermentation, grinding and pulverization).
The ministerial decree lists in Annex 1 the list of substances and plant preparations allowed for use in food supplements and provides specific indications on the requirements to be carried out to support their safety and in order to raise the level of consumer protection.
The intake of food or nutraceutical supplements helps improve the health of the body and helps prevent the onset of particular diseases. The use of these products, to be safe and useful, requires knowledge of their operation and their properties and must be done in a conscious and informed manner.
It is important to remember that supplements should never be considered as a substitute for a varied and balanced diet or a healthy lifestyle.
