Food supplements

Content

Introduction

Food supplements are defined by the sector legislation (Directive 2002/46 / EC, implemented with the legislative decree 21 May 2004, n. 169), as "food products intended to supplement the common diet and which constitute a concentrated source of nutrients, such as vitamins and minerals, or of other substances having a nutritional or physiological effect, 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'.

Generally, food supplements are sold in capsules, tablets, powders in sachets, vials and the like, and can contribute, based on their composition, to improve the state of health and to favor the regular functioning of the organism.

Food supplements are food products and as such:

  • they cannot boast therapeutic properties or ability to prevent and cure diseases (labeling, presentation and advertising) (read the hoax)
  • are subject to food safety regulations

Production and marketing

In order to guarantee product safety and correct information to consumers, the placing on the market of a food supplement must be preceded by communication (notification) to the Ministry of Health, which assesses its compliance with the legislation in force. Food supplements that pass this verification procedure are included in a Register with a specific code that can be reported on the label.It is possible to consult the Register of notified supplements directly from the web portal of the Ministry of Health: the search can be performed by product or by manufacturing company.

Furthermore, the national establishments used for the production and / or packaging of food supplements must be authorized in advance. In order to ensure an adequate level of quality and safety of these products, the Ministry of Health published in November 2018 the Recommendations on the good manufacturing practices of food supplements, aimed at providing technical indications that meet the specific needs of the manufacturing industries.

On the Portal of the Ministry of Health it is possible to consult the Lists of establishments authorized for the production and / or packaging of food supplements.

Ministerial guidelines

The Ministry of Health has issued the Ministerial 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 levels of contribution allowed are reported
  • supplements with probiotics, prebiotics and symbiotics, for which specific provisions are reported relating to their use to balance the intestinal flora
  • adjuvants of low-calorie diets for weight reduction, for which the criteria relating to correct labeling and advertising are indicated
  • supplements with other substances with a nutritional or physiological effect, include nutrients, other than vitamins and minerals, admitted 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 herbal 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 "plant 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 reports in Annex 1 the list of plant substances and 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.

It is essential to clarify that any substance, in order to be used in a food supplement, as proof of its safety must have been used in adequate quantities in the European context before 17 May 1997. In the absence of this requirement, the substance is considered a new ingredient or a new food product (novel food) and its use is subject to prior authorization at European level (EU Regulation 2015/2283).

Correct use of food supplements

Food supplements are formulated to be used in some particular situations such as, for example, the lack of a nutrient or its increased need for the body, to promote health and well-being.

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 way. It is important to remember that:

  • supplements should never be considered as a substitute for a varied and balanced diet or a healthy lifestyle
  • before using a supplement should be consulted beforehand with your doctor if:
    • you are not in good health or are being treated with drugs because unwanted effects and interactions between the different substances may appear
    • it is thought of using multiple supplements together
  • the employment is intended for vulnerable groups of the population such as children and women during pregnancy and breastfeeding
  • supplements should not be taken for prolonged periods or in doses higher than those recommended on the label
  • be wary of supplements available outside the common commercial channels like, for example, the internet
  • in the event of unwanted or unexpected effects, it is necessary to stop taking it and inform the doctor or pharmacist. The suspected adverse reaction can be reported, via fax, by citizens and health professionals, to the phytosurveillance system of the Istituto Superiore di Sanità (ISS). The report form can be downloaded from the Epidemiology for Public Health portal (Epicenter) of the ISS. From 2018, the report can also be made online by connecting to the VigiErbe website following the guided procedure

In-depth link

Ministry of Health. Register of food supplements

Ministry of Health. Marketing / production, requirements

Ministry of Health. Daily Intakes of Vitamins and Minerals Allowed in Food Supplements (Revision 2019)

Ministry of Health. Guidelines on Probiotics and Prebiotics (Revised March 2018)

Ministry of Health. Recommendations on food supplements proposed as adjuvants to diets for weight control or weight reduction (Revised March 2018)

Ministry of Health. Other nutrients and other substances with a nutritional or physiological effect (Revision September 2019)

Ministry of Health. List of plants allowed in supplements

Ministry of Health. Decalogue for the correct use of food supplements; 2019

EpiCentro (ISS). Phytosurveillance

VigiErbe

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