Assessment of Boron Glycinate and Boron Bisglycinate as Novel Foods in the EU

In April 2025, the Czech Republic's Ministry of Agriculture received a consultation request to determine the novel food status of boron glycinate and boron bisglycinate under Article 4 of Regulation (EU) 2015/2283. These compounds are chemically synthesized chelates of boron and glycine, intended for use in food supplements. They are characterized as white to yellowish powders, slightly soluble in water, and free from engineered nanomaterials. The production process involves dissolving glycine in water, heating, adding boric acid, followed by cooling, filtration, drying, and sieving, with quality control measures ensuring purity and appropriate boron content. The compounds are classified as novel foods under Article 3(2)(a)(i) and (ix) due to their new molecular structure and the application of a production process not previously used for food production in the EU before 15 May 1997. The conclusion was based on insufficient evidence of significant consumption of these substances as foods within the EU prior to that date.