Over the past few years and with increasing frequency, we have witnessed often unexpected changes in legislation of the nutraceutical sector. In certain cases this has led to withdrawals of products from the market, often accompanied by alarmism among consumers.

What is happening “behind the scenes” of the legislation regulating dietary supplements?

Food supplement: A market in expansion

The food supplement market is continuously growing: increasing numbers of people are searching for “something natural” as a solution to their problems. Care of our health and well-being has become increasing important in daily life, as has a growing awareness of prevention.

As often happens, when a sector is expanding rapidly it attracts the attention of the authorities and large companies and is placed “under a magnifying glass”.

An approach that has not yet been unified

Italy has always been one of the main markets for the nutraceutical world and has always been one step ahead even in the use of botanicals in dietary supplements.

To understand this, we just have to mention “health claims”, statements describing the relationship between each substance and health: Europe has not yet recognised many of these health claims (currently “pending”), while Italy has for some time recognised a series of functions attributable to plant extracts.

In addition, many countries, mostly in north Europe, have a more limited view of the use of plants in supplements and would like to classify these products as herbal medicines.

Dietary supplement: Why are some substances under review?

The aspects seen so far have led to increasing recourse to article 8 of Regulation 1925/2006.

This article envisages that the European Commission, on its own initiative or at the request of Member States, may place under examination substances added to foods (the category to which dietary supplements belong) that may have a harmful effect on health.

Once the article 8 procedure has been initiated, normally the EFSA (European Food Safety Authority) is asked to deliver an opinion on the safety of the substance, which provides the basis for the decision of the European Commission.

Article 8 is a protection?

Definitely yes, Article 8 is fundamentally important for protecting the health of the consumer. What is happening is that the EFSA is faced with a world (that of botanicals) in which the mechanisms, structures and data available may not be as complete as those for other substances.

This lack of data means that the EFSA is unable to establish the maximum limit deemed safe for consumption. On the basis of such an opinion, the European Commission may decide to impose a ban on the use of these substances in supplements.

However, these data do not usually take into account the historical consumption of the plant and the benefits delivered. In addition, studies are often based on individual substances, administered as they are and mostly in vitro, while their action as part of a phytocomplex and above all their effective bioavailability and action in the body are not evaluated.

What can we do?

Trade associations are working to demonstrate the safety of the substances under examination by gathering data and carrying out special research.

Acting in this way not only has the aim of trying to bring back commercially plants that are destined to disappear but hopes to send out a strong signal to Europe. The historical and traditional use of botanicals is now also supported by organisations able to supply data regarding their use and mechanisms within the body.

Demonstrating the safety and benefits of these substances will help us promote the well-being of our consumers, while also respecting their desire for natural alternatives.

Keeping you updated on all the information necessary will be our priority, so that you can protect consumers and provide them with the correct information.


Written by Dr. Silvia Oberti