Este servicio forma parte de nuestra experiencia científica y reglamentaria en materia de nutrición saludable para ayudarle a diseñar y lanzar sus productos en Europa, Estados Unidos y Asia, a través de un panel de servicios : Evaluación de consultoría sobre nuevos alimentos, cumplimiento de la normativa y notificación, declaraciones de propiedades saludables, …
Evaluación de la situación reglamentaria del ingrediente nativo,
antes de su transformación, en los Estados miembros que lo califiquen en la Unión Europea (lista positiva o negativa, posible doctrina).
Determinación del procedimiento a seguir:
- Procedimiento de consulta según el Reglamento de aplicación (UE) 2018/456
- Procedimiento para terceros países según el Reglamento (UE) 2015/2283
- El procedimiento completo de Novel Foods según el Reglamento (UE) 2015/2283
Prediagnóstico científico de los datos, de conformidad con los requisitos reglamentarios de admisibilidad
- Análisis de los datos de caracterización del producto/ingrediente
- Análisis de los datos sobre el histórico de consumo en el producto/ingrediente
- Análisis de los datos farmacocinéticos del producto/ingrediente
- Análisis de los datos de alergenicidad sobre el producto/ingrediente
- Análisis de estudios de seguridad/toxicidad en el productos/ingrediente
Recomendaciones de nuestros expertos
- Fortalezas y debilidades de la justificación
- Elementos adicionales que deberá presentar, incluidos los posibles estudios toxicológicos y/o Calidad que se realicen.
Constitución y presentación del expediente
- Constitución de la solicitud de alegación
- Presentación a la autoridad nacional y después a la EFSA
Seguimiento e intercambios
con las autoridades (Estados miembros, EFSA y Comisión Europea).
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Expertos doctorales dedicados a la fisiología y la toxicología
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La mejor experiencia del mercado
This first EFSA opinion obtain by Nutraveris on curcuminoids demonstrates that some of the turmeric preparations currently on the market are clearly novel and should be authorized in accordance with the novel food regulation.
Nutraveris* obtain a new EFSA positive opinion for the authorisation as a NOVEL FOOD of AstraGin, a proprietary extract from Panax notoginseng and Astragalus membranaceus.
Nutraveris* has obtained 2 new approvals for specific chia seeds extracts (Salvia hispanica L.). Submitted as soon as the new novel food regulation was in place, these two applications were related to the use of Chia seed fibers and Chia seed Proteins in food supplements and in a range of foodstuffs. In its opinion, EFSA considered that both ingredients were safe for human consumption.
Thanks to its substantial experience in the novel food process and management in Europe, Nutraveris* has just obtained a new success for the Belgian company Eytelia sprl. And their innovative source of silicon (orthosilicic acid-vanillin complex). Following a complete evaluation of the application, with deep and important discussions on all the aspects of a novel food application (i.e. characterization of the ingredient, bioavailability and safety), the European Food Safety Authority (EFSA) has recognized that this silicon source is safe for human consumption.
Nutraveris* experts have obtained several European Novel Food authorizations for DHA-rich oils for various international companies, such as Fermentalg (France), Bioplus Life Sciences (India), Polaris (France) or Changsha SunnyCare Inc. (China), etc. Nutraveris* has become a leader on the regulatory aspects of all microalgea products, either through the substantial equivalence procedure, but also by submitting full novel food applications.
Following a substantial equivalence application, Nutraveris* has obtained an approval for the coriander seed oil manufactured by Ovalie Innovation (France). The application, constituted and submitted in accordance with Regulation (EC) No 258/97 has been evaluated by the Food Safety Authority of Ireland. After evaluation, the coriander seed oil has been authorized for use in food supplement with a maximum dose of 600 mg/day
Nutraveris has worked with the Korean company Naturalendo Tech Co., Ltd in order to obtain the authorization to put EstroG-100® on the European market. Estro-G100® is a hot-water extract of a mixture of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz and Angelica gigas Nakai), already used in Korea, USA and Canada for the management of menopausal symptoms. EFSA has now recognized that EstroG-100® is safe for the use of food supplements intended for post-menopausal women.
After successes in health claim approval, Nutraveris* experts have obtained a new European Novel Food authorization for Vitamin K2 oil from Vesta Ingredients Inc. of Indianapolis in the USA. Nutraveris* has constituted and submitted for evaluation an application for an opinion under Article 3.4. of the novel food Regulation (EC No. 258/97) on the substantial equivalence of Vesta vitamin K2 oil (MK-7) 1,500 ppm to the same ingredient previously authorised to NattoPharma by Commission Decision 2009/345/EC.
A novel food remains defined in Regulation (EU) 2015/2283 as a food for which human consumption was negligible in the European Union before 15 May 1997, when the first novel food regulation came into force with Regulation (EC) 258/97.
The sources from which novel foods are derived are plants, animals, microorganisms, cell cultures, minerals, etc. Novel foods may come from specific categories of foods (insects, vitamins, minerals, food supplements, etc.), foods resulting from production processes and advanced practices and technologies (e.g. new or intentionally modified molecular structure, nanomaterials), which were not produced or used before 1997 and can therefore be considered as novel foods.
*Nutraveris se unió a las empresas de FoodChain ID en 2020. Todos los servicios, conocimientos y herramientas que proporciona Nutraveris están ahora disponibles bajo la marca única FoodChain ID.