The Belgian authorities submitted, a list of 41 plants, which has been reduced in number over time, as data supporting their use in food was found for some of them prior to May 15, 1997, in which authorities in other European countries were asked for support in evaluating them as “novel foods.”
At the center of the issue is Pelargonium sidoides DC, a variety of Geranium in the Geraniaceae family that grows in the southeastern region of South Africa, also known as ‘African Geranium.’
As is well known, Pelargonium sidoides DC is included in the Ministry of Health’s list of plants for use in food supplements introduced by Annex 1 to the August 2018 DM, as amended by editorial decree August 1, 2022.
The inclusion of Pelargonium sidoides DC occurred in 2014 against the adoption in Italy of the Belfrit list, in which Pelargonium sidoides DC had been included by Belgian authorities.
The Belfrit list is so-called for having been developed by Belgium, France and Italy as the first step in an agreed project to arrive at a common framework on the use of plants and derivatives in the food supplement sector, with a view to also promoting harmonization of the subject at the European level.
Subsequently, Belgium requested the European Commission to conduct a consultation among member states to ascertain traditional use in foods prior to 1997.
Simultaneously with the consultation among member states under Article 4 (2) of European Regulation 2015/2283 with collection of information under Article 7 of European Implementing Regulation 2018/456, a consultation of the novel food status of Pelargonium sidoides DC was submitted by the German Authorities.
After these evaluations, it emerged that there are only indications for medicinal use of Pelargonium sidoides DC, so these data cannot be considered for a food consumption history.
As a result, Pelargonium sidoides DC received the status of a novel food falling under the category “Foodstuffs derived from plants or parts of plants.”
It should also be noted that the FBO (Food Business Operator) when placing a supplement on the market and consequently notifying the Ministry of Health, assumes responsibility for ensuring that the product complies with all applicable provisions of food legislation.
It is, therefore, the obligation of the FBO (Food Business Operator) to verify that the ingredients used are not novel foods ex Regulation 2015/2283.
The Ministry of Health requests that significant consumption data prior to May 15, 1997, accompanied by copies of labels or food supplement packaging and evidence of the claims, be collected by Dec. 31, 2022.
In the absence of evidence, Pelargonium sidoides DC remains confirmed in the list of novel foods.
Finally, please note that food products containing unauthorized novel foods cannot be placed or remain on the market.
We offer strategic-regulatory consulting services in domestic and international markets
