Food Additives
Evaluation of the regulatory status of the food additive, within the European Union (regulations 1333/2008).
Service details
Evaluation of the regulatory status of the food additive, within the European Union (regulations 1333/2008).
Scientific pre-diagnosis of the data, in accordance with regulatory requirements of admissibility
- Analysis of additive characterization data and analytical methods
- Exposure Calculation
- Analysis of the pharmacokinetic and stability data of the additive
- Analysis of safety/toxicity and allergenicity studies on the additive
Recommendations from our experts
- Strengths and weaknesses of the rationale
- Additional information to be provided, including any toxicological and/or quality studies to be carried out.
Constitution & submission of the dossier
- Constitution of the request for authorization
- Submission to the European Commission
Follow-up & exchanges with the authorities (EFSA, European Commission).
The best expertise on the market
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Novel foods

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.

Regulatory Compliance

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
- 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

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.

Food Additives

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.
Quality

Elaboration of specifications for manufacturing subcontracting: Standards, Rules, Responsibilities, Documentation.
Formulation

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
Training

Thanks 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 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

Strategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries)