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.

Nutraveris Experts

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Novel foods

Regulatory evaluation
Procedure selection: consultation, 3rd countries, complete
Scientific gap analysis
Experts recommendations
EFSA file development & submission
Follow-up & exchange (EFSA/EC)
Dedicated physiology & toxicology PhD experts
The best expertise in the market

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EU & USA Regulatory Compliance & Notification

Compliance analysis & adjustments of composition, rules of labelling, communications
Label validation
File development & submission to national authorities (EU only)
Follow up & exchange through authorization
Experts & artificial intelligence solutions
The largest practice in the market (more than 4000 products authorized)

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Scientific review/medical writing

Efficacy literature review
Safety literature review
Botanicals & substances appendix (France requirement)
Dedicated Experts PhD in Pharmacy, Physiology, Biochemistry, Nutrition, Toxicology
Optimal synergistic knowledge

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Health claims

Scientific gap analysis
Expert recommendations
EFSA file development & submission
Follow-up & exchange (EFSA/EC)
Dedicated physiology & biochemistry PhD experts
The best expertise on the market

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Quality

Elaboration of specifications for manufacturing subcontracting

Reminder of European and national quality standards in force
Quality control
Experts dedicated to quality for our customers
The choice to go beyond regulatory compliance

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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
Strategic recommendations
Experts in all these areas of expertise
Regular practice for investment funds and on most recent deals

Strategic survey

Strategic Regulatory, Quality & Scientific Watch

Ingredients
Product categories
Health applications
Claims
Countries
Experts & artificial intelligence solutions
The most powerful solution on the market

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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