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Pays d'origine: France

Résumé

A French scientific and regulatory consultancy SME in nutrition and health offers to make diagnosis and prepare health claim files according to the European regulation 1924/2006 under article 13.5 and 14. The expertise consists in determinating the file admissibility, considering if the available data allow to prove the product health benefits and in case of a positive analysis, to prepare and submit the health claim file to the EFSA. The SME seeks Commercial agreement with technical assistance.

Description complète

Claims are used to present foodstuffs (Food, drink products, food for particular nutritional uses, supplements) as having an additional health or nutritional benefit. The European regulation 1924/2006 on nutrition and health claims was adopted to ensure a high level of consumer protection by guarding against unsubstantiated, exaggerated or untruthful claims and also to harmonize legislation across Europe (enabling fair competition and protecting innovation in the food industry).

To obtain an authorization for a new claim the manufacturer must submit an application to the Member State concerned, which will forward it to the European Food Safety Authority (EFSA). The Commission then makes a decision on the use of the claim on the basis of the EFSAs opinion.

The French SME's expertise enables to constitute and submit the health claim files through EFSA/EC under Articles 13.5 and 14 in accordance with Regulation 1924/2006.

For the claim file preparation, it was ascertained relevant to conduct successively the following steps, in accordance with 353/2008 regulation and EFSA Guidance plan:

STEP I:
- Collection and analysis of relevant scientific data coming from scientific literature related to the positioning retained, execution of the comprehensive review by carrying out a synthesis partly developed, as well as the data concerning possible own clinical studies and preparation of their synthesis partly developed on part 4 « Body of pertinent scientific data identified.
- Submission of the prepared file, choice of the claim the most relevant, related to the positioning retained and assessment of request admissibility and then what will come afterwards during a consultation meeting.
- If the analysis of scientific data highlights a lack of information: description of the weaknesses and additional clinical studies to carry out through protocol synthesis coming from relevant literature in this field and help to conceive the ideal protocol.

STEP II:
- In case the analysis is positive: completion of the health claim file with protection data via Part I and II preparation, modification and complete development of the next parts: III, IV, V in accordance with the claim defined and submission to the European Commission via the member state retained, for EFSA evaluation (European Food Safety Agency) in accordance with article 18 procedure and related to article 13.5 of the European Regulation 1924/2006 concerning health claims.
- Follow-up all along the evaluation procedure through EFSA and through European Commission and answers to possible questions, requests for further details, objections or justifications.

Aspects innovants

This assessment of proof's relevance is made through the French company expertise and can also result from the scientific experts partnerss opinions. The diagnosis can go with the publication of the customer's studies in a famous international scientific revue which is of great interest and really in favor of a positive opinion from the EFSA panel. The case file can be constituted by the French SME's scientific department. The strategy chosen is different and adapted for each case file.

In case the analysis of the data is negative, The French SME assists in setting up the protocol of an additional study. The French SME can help to carry out a study in accordance with the customer target's health claims, the target population, the form and the daily dosage of the end product using a rigorous methodology and validated criteria of assessment.

Expertise recherchée:

- Type of partner sought:
Laboratories, Manufacturers, Raw material suppliers

- Specific area of activity of the partner:
Nutrition and health, Food, Food supplements, Fortified foods

- Task to be performed by the partner sought: To provide specifications for the claim file in order to success easily and quickly in developping and formulating new products

Listé dans: Médecine et Santé \ Sciences du Vivant \ Aliments et boissons

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Dates clés Profil créé le: 08 March 2010 Valide jusque: 04 February 2011

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