5-HTP REGULATION IN FOOD SUPPLEMENTS

Griffonia (Griffonia simplicifolia (DC.) Baill.) is a shrub of African origin that belongs to the family of legumes, a genus of flowering plants. Its use in food supplements is very common as it is a plant allowed in mostly all European Union countries. Additionally, it is traditionally used for its support and contribution to the nervous system and brain activity.

The most nutritionally interesting active substance contained in Griffonia seeds is 5-hydroxytryptophan (known as 5-HTP), which is a natural amino acid and chemical compound that serves as a precursor and intermediate in the biosynthesis of the neurotransmitters serotonin and melatonin out from tryptophan.

Although Griffonia seeds are not considered a novel in food supplements, and therefore it can be used in these products, the selective extraction of 5-HTP is considered as novel, regardless of whether it is chemically synthesized or selectively extracted from Griffonia simplicifolia seeds. According to the information available to the competent authorities of the Member States, selective 5-HTP extract was not consumed to a significant degree as food in the EU before May 15, 1997. Therefore, in order to be used, a prior authorization as a novel food in the EU market is required, in accordance with Regulation (EU) 2015/2283 (Regulation on Novel foods).

So, the issue we previously had was determining what happened in the case that a food supplement contained Griffonia seed extract with a very high percentage of naturally occurring 5-HTP. In that case, there were more than reasonable doubts as to whether that ingredient could or could not be considered a non-authorised novel food allowed in food supplements.

However, that doubt has finally been dicussed and solved with the update of the EU Novel Food status Catalogue, which the European Commission regulates by expressly determining that seeds and aqueous extracts of Griffonia simplicifolia seeds containing up to a maximum of 30% 5-HTP are not considered novel in food supplements, so their use is allowed in the manufacture and commercialization of these products.

According to the information available to the competent authorities of the Member States, Griffonia Simplicifolia seed extract has been used in food supplements in the European Union since before May 15, 1997 in a significant degree. Therefore, its use in food supplements is not considered new and is not subject to prior authorization for marketing in accordance with Regulation (EU) 2015/2283.

However, it should be noted that any other food use of this product, other than as a food supplement could be considered new and, consequently, may require authorization in accordance with the requirements of the Regulation on novel foods (EU) 2015/2283 before it can be marketed as food in the EU market.

 

WE CAN HELP YOU

At LexSupplements Food Legal Consulting, we specialize in the importation, manufacturing, and distribution of food supplements internationally, as we are up to date to the latests news affecting these products. Contact us for more information.

If you are interested in composition and labeling revision for the marketing of food supplements in Spain and the European Union, we can help you. At LexSupplements Legal Food Consulting, we review that both the composition and labeling of your product comply with the novel foods regulations, as well as the rest of the applicable regulations for food supplements.