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Our specialized regulatory & scientific compliance software on dietary supplements and knowledgeable, experienced scientific and regulatory departments enable us to offer innovative, personalized and strategic solutions. Our wide range of nutraceutical expertise enables our team to solve the greatest challenges and address even the most complex issues.
A novel food is defined in Regulation (EU) 2015/2283 as a food for which human consumption was negligible in the European Union before 15 May 1997, when the first novel food regulation came into force with Regulation (EC) 258/97.
Novel foods may not be placed on the market or used in food for human consumption until they are included in the European Union list.
FoodChain ID provides the services you need to evaluate the regulatory status of the native ingredient before processing.
We provide audits of the regulatory status of ingredients for use in foods and/or dietary supplements in the US, to determine whether the ingredient is an old dietary ingredient (ODI) or has to be notified to the Food and Drug Administration (NDI or GRAS notification depending on the case).
FoodChain ID helps you determine what needs to be done and provides professional support during every step of the FDA application process.
Product notification is mandatory in most EU countries before a product is placed on the market. A notification must be made for each product and each country it will be marketed in. Each country has its own regulations and procedures and its own deadlines for evaluation and validation.
Our specialists help you with the formula analysis, labelling compliance and the mandatory notification(s) for your product in the countries you want to market it in.
A health claim is any statement about a relationship between food and health.
We help you understand what you have the right to say about your product and the relationship between its ingredients and health benefits. We determine if you can use an already known and authorized claim, or if you need to do an health claim dossier; if it is the latter, we work with you to obtain a new one.
Food additives may also be added to dietary supplements for a variety of reasons ( coating agents for tablets, sweeteners for flavour, etc.). Food additives authorized for use in dietary supplements can be found in Regulation (EC) 1333/2008. We support businesses by evaluating the regulatory status of food additives within this regulation, conducting the scientific pre-diagnosis of the data in accordance with regulatory requirements of admissibility, and help to build application dossiers and communicate with the appropriate authority (EFSA, European Commission) if further follow-up is required.
Our Efficacy & Safety Literature Review Service supports businesses by researching, analysing and synthesizing all data related to the efficacy/physiological effect/safety of ingredients when taken orally, according to existing scientific literature published in peer reviewed journals and applicable regulatory requirements.
The quality of your products depends on the quality of the development and manufacturing processes in place. Our experts can help ensure the quality of your products and protect your brand by developing manufacturing subcontractor specifications (standards, rules, etc)); integrating European and other national quality standards (microbiological criteria, heavy metals, pesticides, solvent residues, GMOs, allergens and more) and evaluating procedures already in place (ingredient quality standards, controls, batch records, etc.)
Our team develops theoretical formulations, taking into account appropriate efficacy and safety dosages of selected ingredients, potential additional ingredients more likely to be identified and recognized by consumers, and other ingredients that may allow the use of Health claims.
Our experts are recognized as one of the leaders in designing EFSA-compliant clinical study protocols aiming to substantiate health claims or novel food authorizations. Following the evaluation of the strengths and weaknesses of the previously performed studies and EFSA opinions we will design the relevant protocol in line with EFSA-requested criteria for the evaluation of applications for authorization of health claims made on foods.
We provide training to help your team to understand the regulatory framework, regulatory status of ingredient, health claims, labeling and formulation, so they have the skillset to launch compliant products in the US, Europe, and Asia.
Manage risk by having our experts evaluate your product portfolio. We can review regulatory compliance (formulation, claims, etc), scientific support compliance (efficacy, interactions, safety), quality assurance (process, controls, analys), and export feasibility for new markets. Our broad-ranging expertise in the industry Strategic recommendations.
Strategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries).
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Dozens of Novel Food Successes
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6407 Product Analyses/Notifications Completed
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Experts with 12 Years of Experience
I would highly recommend (this team). They have delivered regulatory service beyond what was expected. I trust the (them) to deliver the most up-to-date and relevant information. During a very challenging EU Novel Food application – my consultant was able to navigate a strategy with positive results. In fact, our project was completed within budget and ahead of schedule. I would not hesitate to engage FoodChain ID on any of our future EU projects.
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Supplements R&D Insight assist you in the daily creation of compliant products for the European, American and Asian markets: finding regulatory statuses, gathering scientific evidence, choosing the right regulatory status or monitoring the market and its evolutions is still as easy as ever.
Supplements Compliance: automate the audit of your formulas and the generation of your labels with the same ease!
Substantial Equivalence of BioDHA Algal Oil from Schizochytrium sp. : Nutraveris succeeded
Nutraveris constituted and submitted for evaluation an application on behalf of Bioplus Life Sciences Pvt. Ltd. for an opinion under Article 3.4. of the novel food Regulation (EC No. 258/97) on the substantial equivalence of BioDHA algal oil to DHA-rich algal oil which was authorised for the EU market to Martek Biosciences Corporation through Commission …Nutraveris won a positive opinion for Sylvan Bio’s Health Claim on red yeast rice
Nutraveris succeeded in getting a positive opinion from EFSA for the French company Sylvan Bio, on a claim promoting the cholesterol-managing effects of their red yeast rice, under article 13.5 of the EU Health Claim regulation. EFSA’s opinion recognizes that monacolin K in Sylvan Bio red yeast rice is sufficiently characterized. The maintenance of normal …The benefits of orange juice on cholesterol
A recent controlled clinical trial conducted in Brazil evaluated the effect of the consumption of 750mL/day concentrated orange juice for 60 days on the lipid profile and metabolism of 14 hypercholesterolemic subjects and 31 normolipidemic subjects. In parallel, 8 control subjects did not consume orange juice. The results showed a decrease in plasma levels of LDL …
*Nutraveris joined FoodChain ID companies in 2020. All the services, expertises and tools provided by Nutraveris are now available under the unique brand FoodChain ID.