How Expert Support Moves Your Project Forward
5 Steps to Achieve Regulatory Readiness
Assess ingredients early
Identify regulatory status, risks and market options before development.
Select regulatory pathway
Determine if you need novel food registration, GRAS/NDI or other routes.
Build scientific foundation
Strengthen formulation, claims and dietary supplement testing evidence before submission.
Build dossiers and documentation
Prepare novel food dossiers, submissions, technical files and supporting evidence.
Review labels and launch
Finalize labeling, notifications and go-to-market compliance.
How We Help
Benefits of Supplements Consulting with FoodChain ID
Complex ingredient and novel food expertise
Assess novel food status, applications and ingredient restrictions early
Avoid uncertainty on novel food registration, ingredient registration and use
Multi-market regulatory alignment
Align products across Europe, North America and global markets
Avoid duplicating regulatory for each target market
Scientific and regulatory integration
Align formulation, dosage and claims with regulations
Avoid claims or formulas that fail regulatory review
Authority-ready documentation
Prepare novel food dossiers and other authority-ready files aligned with authority expectations
Eliminate delays from incomplete or non-compliant files
End-to-end project support
Support decisions from concept through market entry
Avoid gaps between R&D, regulatory and launch teams
Specialist-led advisory
Get input from our supplement experts on GRAS, NDI, novel food and claims
Stop guessing on complex regulatory and scientific topics
Regulatory and scientific supplement consulting
FoodChain ID offers consulting expertise across health and nutrition products, building on the heritage of Nutraveris, the European food supplements regulatory consultancy that joined FoodChain ID in 2020.
Assess whether your ingredients can be used across supplements, fortified foods, FSMPs and infant formula. We support novel food applications and registration in the EU, GRAS and NDI ingredient registration in North America, and food additive compliance — including checks against our food additives database — to define status, conditions of use and approval requirements before development.
Novel Foods (Europe)
Comprehensive support for novel food applications in the EU – regulatory assessment, gap analysis, dossier preparation and submission, and authority interactions aligned with EFSA expectations to reduce approval risk.
Novel food is one of the most complex, and most searched, regulatory categories our clients face. Under EU Regulation 2015/2283, any ingredient not consumed to a significant degree before May 1997 requires a formal novel food application, supported by a full novel food dossier before EFSA grants market authorization.
In North America, the equivalent path often falls under novel food ingredient registration through GRAS or NDI notification. Getting novel food registration right the first time, in either market, is what our regulatory scientists help you achieve, from initial classification through final authorization.
GRAS & NDI (North America)
Ingredient status evaluation (ODI vs NDI), GRAS strategy definition, and full novel food ingredient registration support, from dossier preparation to notification, helping you select the right pathway and avoid unnecessary submissions.
Food Additives
Assessment of additive authorization, conditions of use and compliance, cross-checked against our EU food additives database, to confirm correct classification and use across markets.
Develop products aligned with regulatory constraints and scientific expectations, guided by our dietary supplement formulation consultants. Support includes formulation aligned with dosage limits and target markets, and health claim definition to ensure positioning is compliant and substantiated.
Formulation
Development aligned with regulatory status, dosage limits and target markets to ensure formulations are viable and compliant from the start.
Health Claims
Evaluation of ingredient–benefit relationships and identification of permitted claims to ensure claims can be supported and used without risk.
Build the scientific foundation required to support product safety, efficacy and claims. Support includes clinical study design, literature review and scientific documentation aligned with regulatory expectations.
Clinical Study Protocol
Design of clinical studies supporting claims or regulatory applications with endpoints and methodology aligned with authority expectations.
Scientific Review & Medical Writing
Literature review on efficacy and safety and preparation of scientific dossiers to ensure evidence is structured, relevant and defensible.
Ensure products meet regulatory requirements before commercialization. Support includes compliance validation, dietary supplement testing review, labeling and notification processes to enable market entry across regions.
Regulatory Compliance & Notification
Formula analysis, labeling validation and product notification to confirm compliance with country-specific rules before launch.
Quality
Review of product and ingredient quality against regulatory standards – supported by dietary supplement testing across US and EU requirements – to ensure consistency, compliance and brand protection.
Build internal capability and maintain compliance over time. Support includes training and advisory services aligned with evolving health and nutrition regulations.
Scientific & Regulatory Training
Customized training across Europe, North America and Asia regulations to improve internal decision-making and reduce dependency on external support.
FAQ
Supplement regulatory consulting involves expert support to ensure products meet regional and global regulatory requirements. It is important because it helps companies avoid delays, reduce compliance risks and accelerate market access. Companies entering multiple markets often rely on regulatory and scientific affairs consulting to navigate evolving requirements efficiently. FoodChain ID’s consultants have extensive expertise from their experience at the renowned company Nutraveris.
A food supplement consultant provides expert guidance on regulatory requirements, ingredient approval, labeling and market entry. At FoodChain ID, expert supplement consultants help companies develop compliant products, reduce risk and navigate complex global regulations efficiently. This support can be especially valuable when managing product claims and requirements related to food certifications and claims.
A dietary supplement consultant supports product development by advising on formulation, regulatory pathways, claims, and compliance requirements. This ensures products are safe, compliant, and ready for successful market launch. Companies may also pursue product and label certification to help demonstrate compliance and support commercialization efforts.
Food supplement regulatory consulting involves expert support to ensure products meet local and global regulatory requirements. It is important because it helps companies avoid delays, reduce compliance risks, and accelerate market access. This is particularly important for products intended for export to markets such as the United States.
Food regulatory consulting services help ensure compliance by providing up-to-date regulatory guidance, reviewing formulations and labels, and supporting documentation. This enables companies to meet legal requirements across multiple markets, including regions such as Europe where regulatory frameworks can vary significantly.
Supplement compliance consulting services reduce regulatory risk by identifying potential issues early, validating ingredients and claims, and ensuring alignment with current regulations. This helps prevent product rejections, recalls, and delays.
A novel food application requires demonstrating that an ingredient is safe for its intended use under Regulation (EU) 2015/2283, typically supported by compositional, toxicological and exposure data submitted to EFSA. Our Novel Food team manages the process end-to-end, from initial classification to authorization.
In the EU, novel food registration follows Regulation (EU) 2015/2283 and requires EFSA authorization before market entry. In the US, the equivalent path is novel food ingredient registration through GRAS self-affirmation or NDI notification to the FDA. Our Novel Food and GRAS/NDI consulting services cover both pathways.
Our supplement experts focus exclusively on food supplements, fortified foods, FSMPs and infant formula, combining regulatory, scientific and formulation expertise in one team, so you get specialist-level guidance instead of general food-industry advice.
Yes! Nutraveris, previously Europe’s leading food supplements regulatory consultancy, joined FoodChain ID in 2020. Its regulatory scientists and expertise are now part of FoodChain ID’s Health & Nutrition consulting team.
FoodChain ID’s Regulatory Limits product includes a food additives database covering authorized uses, limits and conditions across markets, so you can confirm additive compliance before finalizing a formulation.
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