Botanicals

NEW ITALIAN “BELFRIT” DECREE PUBLISHED by Joris Geelen

The Italian authorities have published the highly anticipated decree on botanicals which integrates the so-called “BELFRIT” list, authorizing the use of more than 1000 plants and mushrooms in food supplements.

The decree includes a positive list of plants and mushrooms authorized for use in food supplements, together with mandatory warnings and maximum levels. Compared to Belgium, who published their version of the list last year, Italy has less restrictions, as shown in the following examples:

  • Contrary to Belgium and France, there are no maximum levels for anthranoid containing plants like Aloe or Rheum spp. (which are being disputed on EU level), Black cohosh, Hawthorn, Chamomile, Crocus, Devil's claw, Echinacea, Ginger, Hedera, Hops, Saw palmetto, Nettle, Valerian. Note that for most of them there is an EMA monograph;

  • Some plants do not have mandatory warnings as it is the case in Belgium e.g. Curcuma, Chaste tree, Verbena;

  • The decree authorizes stevia leaves, cannabis seeds and oil.

Besides this, and similar to France, the decree includes a list of information necessary for the correct and safe use of botanicals :

  • a clear definition of botanical preparation;

  • information and websites for the identification of plants; and

  • information on the preparation, the traditional use and the production process of the final product.

A separate decree on other substances establishes maximum levels for certain naturally occurring botanical substances with a physiological effect or of possible concern (for example EGCG and isoflavones).

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are compliant with the provisions of the former decree of 9 July 2012, can still be placed on the market until exhaustion of stocks.

Analysis

From the examples one could conclude that Italy takes a more liberal approach to risk management than Belgium. Where Belgium has a maximum limit for certain plants or substances of concern, Italy often resorts to less restrictive measures, mandatory warnings. On the other hand, in Italy there are no provisions exempting botanicals when these compounds have been removed or reduced to safe levels. Moreover, there are no official procedures for consulting the Italian Commission for Dietetics and Nutrition (CUDN), as is the case for the respective advisory commission in Belgium.

In our practice we help our clients to prepare the information necessary for the correct and safe use of botanicals, as part of a due diligence process. However, the authorities would most probably only ask for this information after a problem has arisen.

Overall, we remain positive about this decree. This harmonization together with the digital notification system has made the access to the European market more streamlined. 

Decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012

New recommended analysis methods for botanicals in Belgium by Joris Geelen

The Belgian authorities have published a new list of recommended analytical methods for the use of certain botanicals in food supplements. The list was drafted for 119 plants and is based on the scientific advice of the Advisory Commission on Botanicals. These methods can be used to verify if the food supplements comply with the maximum levels or if substances of concern are below the threshold mentioned in the Belgian Royal decree on Botanicals

New Italian “BELFRIT” decree on botanicals expected by Joris Geelen

The Italian authorities recently notified to the European commission a new draft decree (2017/276/I) which will update the list of botanicals authorized in food supplements.

The Italian Commission for Dietetics and Nutrition (CUDN) executed a thorough evaluation of the plants and mushrooms which were not yet on the former Italian list of plants, but mentioned in the list of plants drafted in the so-called “BELFRIT” project, a close cooperation between Belgium, France and Italy to harmonize the legislation on botanicals in food supplements. With this decree one single list of plants and one for mushrooms will apply.

Besides this, and similar to France, the decree also integrates in annex a summary of information necessary for the correct and safe use of botanicals :

§  a clear definition of botanical preparation;

§  information and websites for the identification of plants; and

§  information on the preparation, the traditional use and the production process of the final product.

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are conform with the provisions of the former decree, can still be placed on the market until exhaustion of stock.

The end of the standstill period is September 29, once the European commission and the member states approve this new decree Italy will join Belgium and officially publish the so-called “BELFRIT-list”. After this all eyes will be on the proverbial ‘lanterne rouge’, France to follow suit.

We will conduct a thorough analysis and inform you about the exact changes in anticipation of the publication.

New Belgian “BELFRIT” decree on botanicals applicable by Joris Geelen

Belgium has published a new decree, updating the three lists of botanicals. These new lists are based those drafted in the so-called “BELFRIT” project, a close cooperation between Belgium, France and Italy to harmonize the legislation on botanicals in food supplements.

The number of plants authorized in food supplements in Belgium has increased significantly, from about 645 to more than 1000 plants. Consequently a considerable number of new conditions of use are now applicable. New maximum levels and mandatory warnings for about 250 plants will have to be taken into account when notifying food supplements.

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are conform with the provisions of the former decree, can still be placed on the market until February 20th of 2019. Therefore non-compliant products can not be sold until the end of the expiry date, after the transition period. They will have to be withdrawn from the market.

Royal Decree of 29 August 1997 concerning botanicals - Consolidated version (Dutch and French)