Expertise
Nutraveris Experts can support you on the following skills area
Ingredients
Vitamins/Minerals, Botanicals, Bioactives, Additives…
Numerous legislations concerning food ingredients have to be taken into account for product formulation, particularly:
- Regulation (EC) N° 1333/2008 on food additives
- Regulation (EC) N° 1334/2008 on food flavourings
- Regulation (EC) N° 1332/2008 on food enzymes
- Positive lists of vitamins and minerals from Directive 2002/46/EC, Regulation (EU) N° 609/2013 and Regulation (EC) N° 1925/2006
- Regulation (EU) 2015/2283 on novel foods which have not been used for human consumption to a significant degree within Europe prior to 15 May 1997, for which an authorization is needed to place the product on the market
Some specific domestic rules may exist for substances with a nutritional or physiological effect and botanicals, for which use is currently not harmonized at the European level. Each European Member State may have its own positive and/or negative list, with possible specific conditions of use (parts of plants, warnings, maximum doses…).
The communication on those ingredients is regulated by Regulation (EC) N° 1924/2006 on nutrition and health claims.
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)
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
Formulation
Formulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety
Read more Contact usScientific 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
Read more Contact usClinical 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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