Meal Replacements

Foods for weight control are regulated by specific provisions on composition and labeling according to Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. Regulation (EU) N° 609/2013 provides that the current directive will be replaced by a new delegated act: Regulation (EU) 2017/1798 will apply instead of Directive 96/8/EC from 27 October 2022.

From July 2016, according to Regulation (EU) N° 609/2013 concerning the revision of PARNUTS legislation, meal replacements for weight control are ordinary foods or fortified foods: the two authorized health claims on meal replacements may continue to be used, the conditions of use of those claims are amended by Regulation (EU) 2016/1413.

General food law (food safety, information to consumers, novel foods, nutrition and health claims…) also applies to foods for weight control.

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Novel foods

Regulatory evaluation
Procedure selection: consultation, 3rd countries, complete
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EFSA file development & submission
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Regulatory Compliance & Notification

Compliance analysis & adjustments of composition, rules of labelling, communications
Label validation
File development & submission to national authorities
Follow up & exchange through authorization
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Scientific review/medical writing

Efficacy literature review
Safety literature review
Botanicals & substances appendix (France requirement)
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Health claims

Scientific gap analysis
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EFSA file development & submission
Follow-up & exchange (EFSA/EC)
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Due diligences

Regulatory compliance (Formulation, claims..)
Scientific support compliance (efficacy, interactions, safety...)
Quality insurance evaluation (process, controls, analysis...)
Export feasibility in other countries
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Strategic survey

Strategic Regulatory, Quality & Scientific Watch

Ingredients
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Formulation

Formulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety

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Scientific and Regulatory Training in Nutrition and Health

Thanks to its certification as a professional training organization, scientific and regulatory experts from Nutraveris offer you personalized custom made training sessions

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Clinical study protocol

NUTRAVERIS is recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate Health Claim or Novel Food authorizations

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