Nutraveris Experts can support you on the following skills area
Intended for children under three years old who have specific nutrition requirements, infant formulas, follow-on formulas and other foods intended for infants and young children (meals, desserts, processed cereal-based foods,…) are specifically regulated at European level concerning composition, labelling and communication by Regulation (EU) N° 609/2013 and specific delegated acts by category.
For infant formula and follow-on formula, Regulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding applies instead of Directive 2006/141/EC since 22 February 2020 (excepted infant formula and follow-on formula manufactured from protein hydrolysates, to which it shall apply from 22 February 2021).
Infant formula and some follow-on formula (depending on the composition) must be notified at the national level.
For processed cereal-based foods and baby foods, Directive 2006/125/EC continue to apply, pending the publication of a new delegated act.
General food law (food safety, information to consumers, novel foods, nutrition and health claims,…) also applies to foods for infants and young children without prejudice to their specific provisions.
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)