A health claim is any statement about a relationship between food and health. We help you to choose between existing claim, specific claim and if so, to follow the EU authorisation procedure for individual applications.
Scientific Gap analysis of the data in accordance with Regulatory admissibility criteria
- EFSA opinions and guidance on the same applications/ingredients.
- Clinical studies on the applications/ingredients
- Characterization data on the applications/ingredients
- Strengths and weaknesses of the substantiation
- Suggestion of alternative claims to apply, in line with your expectations, general EFSA requirements and available scientific data.
- Complementary elements to provide including additional clinical studies.
File constitution & submission
- Preparation of the health claim file.
- National then EFSA authority submission
Authorities follow up & exchange (Member states, EFSA & European Commission
The best expertise on the market
New Health Claim for Nutriose ® 06 from Roquette FreresNutraveris has get a positive opinion for Nutriose® 06, a resistant dextrin made from wheat or maize starch, developed and commercialized by the French company Roquette Freres, one of the five world leaders in the starch manufacturing industry. The application, related to the reduction of post-prandial glycaemic response, provided six proprietary and unpublished clinical trials in accordance with EFSA requirements.
Positive opinion for Sylvan Bio’s Health Claim on red yeast riceNutraveris succeeded in getting a positive opinion from EFSA for the French company Sylvan Bio, on a claim promoting the cholesterol-managing effects of their red yeast rice, under article 13.5 of the EU Health Claim regulation. EFSA’s opinion recognizes that monacolin K in Sylvan Bio red yeast rice is sufficiently characterized. The maintenance of normal blood LDL-cholesterol concentrations has been also acknowledged by EFSA as a beneficial physiological effect. However, the main factor that made this achievement possible is the proven efficacy of Sylvan Bio’s red yeast rice to lower LDL-cholesterol levels in blood, as clearly highlighted by two proprietary clinical trials. These studies, conducted in a population accepted by EFSA (i.e. non-treated hypercholesterolemic subjects), have shown a significant reduction in LDL-cholesterol levels after at least 12 weeks of consumption of Sylvan Bio’s Red yeast rice.
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To evaluate the regulatory status of the native ingredient before processing.
Procedure selection, Scientific gap analysis of the data in accordance with Regulatory admissibility criteria, Recommandations, File constitution & submission.
To declare the placing on the market of your food supplements to the national authorities.
Formula analysis, labeling compliance and notification of your product for Europe and USA
- Czech Republic
Determine whether you need a specific claim and if so, prepare and submit the claim file.
Scientific Gap analysis of the data in accordance with Regulatory admissibility criteria, reccommendations of our experts, file constitution and submission.
Evaluation of the regulatory status of the food additive, within the European Union.
Scientific review / medical writing
Research, analysis and synthesis of all data related to the efficacy/ physiological effect/safety of ingredients when taken orally, according to existing scientific literature published in peer reviewed journals and according to regulatory requirement in force.
Elaboration of specifications for manufacturing subcontracting: Standards, Rules, Responsibilities, Documentation.
Formulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety
Clinical study protocol
We are recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate Health Claim or Novel Food authorizations
Thanks to its certification as a professional training organization, scientific and regulatory experts from Nutraveris offer you personalized training sessions in Nutrition and Health
Regulatory compliance review (Formulation, claims..), Scientific support compliance (efficacy, interactions, safety…), Quality insurance evaluation (process, controls, analysis…), Export feasibility in other countries, Strategic recommendations
Strategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries)