Expertise
Nutraveris Experts can support you on the following skills area
Ingredients
Vitamins/Minerals, Botanicals, Bioactives, Additives…
Numerous legislations concerning food ingredients have to be taken into account for product formulation, particularly:
- Regulation (EC) N° 1333/2008 on food additives
- Regulation (EC) N° 1334/2008 on food flavourings
- Regulation (EC) N° 1332/2008 on food enzymes
- Positive lists of vitamins and minerals from Directive 2002/46/EC, Regulation (EU) N° 609/2013 and Regulation (EC) N° 1925/2006
- Regulation (EU) 2015/2283 on novel foods which have not been used for human consumption to a significant degree within Europe prior to 15 May 1997, for which an authorization is needed to place the product on the market
Some specific domestic rules may exist for substances with a nutritional or physiological effect and botanicals, for which use is currently not harmonized at the European level. Each European Member State may have its own positive and/or negative list, with possible specific conditions of use (parts of plants, warnings, maximum doses…).
The communication on those ingredients is regulated by Regulation (EC) N° 1924/2006 on nutrition and health claims.
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)