PLT Health Solutions has announced its Earthlight Whole Food Vitamin D has received approval from the Brazilian Health Regulatory Agency (ANVISA), enabling the dietary ingredient to be used in food, beverages and supplements produced and sold in Brazil. In Brazil, ANVISA is responsible for coordinating, supervising, and controlling the activities of registration, inspection, and risk control of all raw materials. ANVISA is the third international regulatory agency to approve the product. In 2020, it received Novel Foods Approval in Europe and allowance in various food and beverage categories in the United States via Food Additive Petition (FAP).
To secure this approval, the company consulted with Brazilian regulatory specialist Visanco Assistencia Tecnica e Administrativa Eireli (Brasilia), which assembled the dossier to address ANVISA's requirements. It worked with the ingredient's manufacturer, Oakshire Naturals, and its exclusive Brazilian distributor for retail products, Tovani Benzaquen Ingredientes, to compile the information for the dossier and respond to comments and questions from ANVISA. The approval process reportedly took nearly two years.
The ingredient is produced from mushrooms via a patented process which involves exposing them to UV light, causing them to produce Vitamin D. The product is minimally processed, without using any extract solvents, enabling consumer-friendly labelling. The non-GMO ingredient delivers 1,000 micrograms (40,000 IU) of Vitamin D per gram of ingredient. This high concentration enables low use levels, mitigating its impact on organoleptic qualities. The ingredient is available in both conventional and organic grades.
Jay Martin, MD, Global Sales at PLT Health Solutions, said: "Earthlight is the right ingredient at the right time for food and beverage producers and over-the-counter supplement formulators in Brazil, as well as multinationals seeking to create global formulations. Interest in Vitamin D and its role in supporting immunity, bone health, healthy aging and overall good health has increased dramatically in the last three years. As a whole-food, plant-based, non-GMO and organic ingredient, Earthlight supports virtually every major food, beverage and supplement market trend and will give product formulators the cleanest label option on the market."
Moses Benzaquen, Director Presidente of Tovani Benzaquen, said: “Vitamin D has been a subject of intense interest in Brazil over the last two years. Earthlight is a perfect way to introduce a high quality Vitamin D into products for health conscious people. Made from high quality mushrooms, it is organic, non-GMO, minimally processed and sustainable. We look forward to working with PLT in bringing these benefits to the Brazilian market."
