Services

In NutraLegal we offer regulatory advice focused on food companies through the supply chain, with the intention of introducing legally compatible products and ingredients in the European market. Our client base range from artisans to multinational food companies, including producers, manufacturers, wholesalers and distributors.

Nutrition Claims
Products / ingredients not tested by any specific clinical study:

Assessment of available generic claims and recommendations for the use of authorized ingredients with the scientific base in target countries to back the promises in the communication tools.

 

Products / ingredients justified by specific clinical studies:
  • Assessment of the admissibility of the file.
    • Scientific analysis of data in accordance with the criteria of regulatory admissibility:
      • Opinions and guidelines of EFSA on the same applications / ingredients.
      • Clinical studies on the applications / ingredients.
      • Characterization data of the applications / ingredients.
    • Strategy to follow:
      • Strengths and weaknesses of the essence.
      • Suggestion of alternative claims to apply, in accordance with your expectations, the general requirements of EFSA and the available scientific data.
      • Complementary elements to provide including additional clinical studies.
  • Preparation and presentation of the file.
    • Preparation of the health claim file.
    • Presentation and monitoring of the national authority.
    • Monitoring of EFSA and the European Commission.
Labeling validation
Audit and adjustment of formulas:
  • Regulatory status of the ingredients and additives used and their dosages.
  • Verification of the acceptability of the new material according to the specifications.
Audit and adjustment of the labeling rules according to the FIC Regulation.
Audit and adjustment of communication.
Notification / Product registration in different countries and markets
Regulatory Audit.
  • Audit and adjustment of formulas:
    • Regulatory status of the active ingredients and additives, including their dosage limits.
    • Verification of the acceptability of raw materials as food ingredients according to specifications.
  • Audit and adjustment of labels according to the FIC Regulation.
  • Audit and adjustment of communication.

 

Validation of label compliance.

 

Preparation and submission of a notification / registration dossier.

In the target countries in accordance with the current national regulations, with previous registration in other countries, if necessary, to allow the process of mutual recognition.

Transmission of authorization test.

 

Obtaining Certificates of Free Sale according to country practices.
Authorization of ingredients
Regulatory status audit.
  • Review of the regulatory status of the native ingredient before processing (plant, animal product, other source …) in EU Member States that specifically mark it (positive / negative lists, potential doctrines …)
  • Analysis of the regulatory status of the processed ingredient depending on the process: extraction ratio, selectivity of solvents, technological auxiliaries and additives.
  • Analysis of the state of the ingredient in terms of quality control: compliance with quality standards for allergens, GMOs, microbiology, heavy metals, solvents, pesticides, irradiation…

 

Viability study for the authorization of Novel Foods.
  • Assessment of ingredient safety through research and analysis of data related to source safety, the manufacturing process and specific ingredient data.
  • Strategic recommendation for the best procedure to obtain authorization to market the ingredient.

 

Preparation and presentation of novel foods.
Novel Foods
Assessment of the admissibility of the file.
  • Scientific analysis of data in accordance with the criteria of regulatory admissibility:
    • Food safety data / ingredients.
    • Characterization data of the food / ingredients.
  • Strategy to follow:
    • Strengths and weaknesses of the essence.
    • Novel food route from a third country.
    • Complementary elements to be provided (including additional safety and quality studies).

 

Preparation and presentation of the file.
  • Preparation of the novel food file.
  • Presentation and monitoring of EFSA.
  • Monitoring of EFSA and the European Commission.

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