Expertise
Nutraveris Experts can support you on the following skills area
Meal Replacements
Foods for weight control are regulated by specific provisions on composition and labeling according to Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. Regulation (EU) N° 609/2013 provides that the current directive will be replaced by a new delegated act: Regulation (EU) 2017/1798 will apply instead of Directive 96/8/EC from 27 October 2022.
From July 2016, according to Regulation (EU) N° 609/2013 concerning the revision of PARNUTS legislation, meal replacements for weight control are ordinary foods or fortified foods: the two authorized health claims on meal replacements may continue to be used, the conditions of use of those claims are amended by Regulation (EU) 2016/1413.
General food law (food safety, information to consumers, novel foods, nutrition and health claims…) also applies to foods for weight control.
Novel foods
Scientific serviceTo 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.
Regulatory texts we are working with
Regulatory Compliance
Regulatory serviceTo 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
- Austria
- Belgium
- Bulgaria
- Croatia
- cyprus
- Czech Republic
- Denmark
- Estonia
- Europe
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Monaco
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
Health Claims
Scientific serviceDetermine 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.
Regulatory texts we are working with
Food Additives
Scientific serviceEvaluation of the regulatory status of the food additive, within the European Union.
Regulatory texts we are working with
Scientific review / medical writing
Scientific serviceResearch, 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.
Quality
Regulatory serviceElaboration of specifications for manufacturing subcontracting: Standards, Rules, Responsibilities, Documentation.
Formulation
Scientific serviceFormulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety
Clinical study protocol
Scientific serviceWe are recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate Health Claim or Novel Food authorizations
Training
Regulatory & Scientific servicesThanks to its certification as a professional training organization, scientific and regulatory experts from Nutraveris offer you personalized training sessions in Nutrition and Health
Due Diligence
Regulatory & Scientific servicesRegulatory compliance review (Formulation, claims..), Scientific support compliance (efficacy, interactions, safety…), Quality insurance evaluation (process, controls, analysis…), Export feasibility in other countries, Strategic recommendations
Strategic survey
Scientific serviceStrategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries)