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How to perform a formulation evaluation of food supplements

valutazione formulativa degli integratori alimentari

The sector of food supplements is regulated, among others, by Directive 2002/46/EC of 10 June 2002 adopted in Italy by Legislative Decree 21 May 2004, no. 169.

One of the goals of this directive is to ensure a high level of public health protection ensuring the best protection of consumers, also via suitable and appropriate labelling.

According to the definition reported in this directive, food supplements are “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination”.

This definition seems to identify a simple and well-defined set of products. Actually, it is not possible to identify a limited group of products, as in reality there is a very wide variety of food supplements with specific peculiarities.

Differences between products depends on the different form of presentation: there are, in fact, food supplements in the form of tablets, capsules, pills, sachets of powder, ampoules of liquids, drop dispensing bottles and vials and other similar forms of liquids and powders.

But, of course, main differences are to be found in the composition, and from this arises the need to perform a careful formulation evaluation of food supplements.

The function of food supplements

Therefore, the function of a food supplement is always to provide a defined supply of nutrients and/or substances with physiological effect, but compositions may vary based on the goal and therefore on the properties attributed to a product.

There are specific indications regarding the ingredients that can be used in a food supplement. Food supplements can be formulated with vitamins and minerals, but not all vitamin sources are admitted and the acceptable quantities should be checked, as well as if there are limits and restrictions for both the type of ingredient and the target population for which the product is intended.

Another type of food supplements are those containing lactic ferments such as probiotics and prebiotics. It is worth to underline, in this case as well, that in order to be able to state in the label the indication of rebalancing of intestinal microflora a specific amount of live cells for microorganism should be reached.

There are, then, also food supplements containing plants, and in this case the evaluation of the admitted ingredients can be even more difficult. In this case, a list of the Italian Ministry of Health can be referred to, including a list of herbal substances and preparations that can be used in food supplements.

This document also specifies many details, including the part of the plant that can be used and the physiological effects that can be attributed to the ingredient based on the part used.

Formulation evaluation and label requirements

For some ingredients, the warnings to be mandatorily reported in the label or the limits to the quantity of an ingredient that can be present in the food supplements are also indicated.

There are, then, food supplements with no significant history of consumption that should be first authorised as novel foods to be used safely in food supplements.

This is a rather time-consuming procedure that the company can follow applying for an authorisation to the European Commission and submitting a technical dossier including all information on the new ingredient (such as identity, safety, stability, proposed uses) to be assessed by EFSA.

It is therefore clear that formulating a supplement is not easy, and that a formulation evaluation of food supplements should be performed to check and ensure that the composition is compliant, and also that the indications reported in the labels are correct and complying with the regulations of this sector.

Even after all controls on the composition and labelling of the food supplements have been carried out, it is not possible to sell the product directly. In Italy, in fact, the marketing of food supplements can only take place after a regular online notification of the products to the Ministry of Health.

However, even after the food supplement has been placed on the market, the activity of the FBO (Food Business Operator) is not concluded as vigilance activities should be carried out anyway to control the occurrence of any adverse reaction associated to the supplement use.

Moreover, regulations are continuously progressing and updating, so changes in terms of composition (to eliminate or reduce the dosage of certain ingredients) or labelling to update the text to the latest regulations (such as changing a claim or including a new warning) can be required in time. Therefore, the formulation evaluation of food supplements is not an activity to be performed at the beginning of the life of a product, but rather an operation to be repeated in the following years in light of the progress of regulations and scientific knowledge.

Written by: Federica Montozzi

Foto di renateko da Pixabay