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Food Business Operator: roles and responsibilities

The use of food supplements containing vitamins and probiotics, herbal preparations and infusions is becoming more and more frequent to maintain a general state of wellbeing or to manage mild disorders such as anxiety or insomnia.

Consumers tend to consume these products believing that the natural substances they are made of are an assurance of their safety, and that therefore there are neither contraindications nor any side effects. Among other things, these products can be taken without consulting a doctor, with few exceptions. However, these preparations can as well have contraindications or result in adverse events, even severe in some cases.

The FBO (Food Business Operator) is responsible of the food supplements they place on the market and shall therefore ensure their safety and quality. However, the intake of food supplements can cause adverse reactions; it is particularly necessary to pay attention in case they are taken by children or pregnant women, elderly subjects or people with chronic diseases or already receiving medicines for other diseases.

In response to the need of monitoring this kind of products and any adverse reactions associated with their use, a phytovigilance and surveillance system was set up for natural substances. Through this system, it is possible to send a report of a suspected adverse reaction occurred after taking and/or giving these products. The reports are then evaluated by a team of experts at the Authority.

The FBO must therefore implement a post-marketing surveillance system in order to manage and assess any adverse reaction associated with the use of particular ingredients and/or products. Through this system, the FBOs will be able, if required, to review the formulation of their products and specify other warnings and/or indications in the label.

The foodvigilance system can be placed inside or outside the FBO company organisation: it can in fact be also outsourced to consulting companies specialising in this field.
Post-marketing surveillance is only one of the activities that FBOs must undertake in compliance with the food supplements regulations.
FBOs shall in fact have a HACCP manual regulating not only the sale, but also the manufacturing of food supplements that shall take place in compliance with the good manufacturing practice of food supplements.

The food supplement manufacturing process shall be controlled and shall take place in sites duly authorised for the purpose by the relevant competent health unit (ASL). The authorisation procedure also includes an inspection by the competent authorities to verify that all the conditions established by the regulations are met.

Food supplement storage shall also take place in rooms suitable for this purpose.

The composition shall comply with all requirements provided for by the regulations on food in general, and by the specific regulation on food supplements. Official lists of admitted ingredients with the relevant acceptable maximum concentrations are also available, although not always exhaustive; the additives used must be food and not pharmaceutical additives, the microbiologic limits of the food supplement components shall comply with those admitted.

Moreover, for food supplements containing herbal substances and preparations, it is necessary to evaluate the botanical species and the admitted plant parts and prepare a technical dossier.
Therefore, the FBO shall ensure a correct and appropriate management of any activities linked to food supplements: from formulation to manufacturing and storage up to sale. But even after the marketing of the supplements, the FBO activity is not over as they shall implement the foodvigilance system.

Written by: Federica Montozzi