Bringing a novel ingredient to market creates opportunities for differentiation, nutrition, functionality and sustainability, but innovation also creates regulatory uncertainty. Managing that uncertainty takes more than scientific rigor. Companies need a regulatory strategy built into the project from the very beginning, not after the development work is finished.
That means answering some early questions: whether an ingredient is already permitted, which regulatory pathway applies, what studies are needed, and what that means for cost and time to market. These decisions are most valuable before pivotal studies begin. After this, changes to the ingredient or manufacturing process can lead to costly and time-consuming launch delays, rejections, and rework.
In a recent webinar hosted with Actif’s, FoodChain ID experts Dr Jérôme Le Bloch, Head of Scientific Department, and Dr Cédric Langhi, Scientific Missions Officer, walked through how companies can structure their regulatory thinking to reduce delays and build efficient evidence programs that support their actual target markets.
Here are five practical takeaways:
1. Make regulatory strategy a part of product development from the start
Regulatory assessment belongs at the start of a project, before expensive studies are commissioned, not after them.
In the recommended sequence, two steps come straight after the initial idea: a regulatory assessment of the ingredient’s status in each target market, and an evidence strategy that maps existing data and identifies the gaps. Only then do development work and safety studies begin, followed by the application and market access.
Each step informs the next. Companies should establish the ingredient, manufacturing process, intended uses, and target markets in order to determine which studies are actually required. Starting studies before making these decisions risks doing unnecessary studies while missing the data that regulators do need.
Timing matters in both directions. The recommendation is to bring in regulatory and scientific expertise once the ingredient concept is settled, but before the manufacturing process is finalized and before any studies or analyses are commissioned. At that stage, the process can still be adjusted if a red flag appears, such as an extraction solvent that cannot be used.
2. EU and US market access require different regulatory pathways
Have a clear understanding of the applicable pathway before the evidence program begins. In the EU, the standard route for innovative ingredients is Novel Food authorization, which is required for any ingredients that had not been consumed to a significant degree in the EU before May 1997. A simpler route exists for traditional foods from third countries, though in practice it suits food products more than supplements.
In the US, the pathways differ by intended use. Ingredients used in conventional food follow the GRAS route, short for Generally Recognized as Safe. A company can reach its own GRAS conclusion, often called self-affirmed GRAS, or submit a GRAS notice to FDA; notification is currently voluntary. Ingredients used in dietary supplements need a New Dietary Ingredient notification, known as an NDI notification, which is mandatory.
The major structural distinction is the role of the authorities. EU Novel Foods require pre-market authorization: EFSA conducts the scientific assessment, and a positive opinion must be followed by European Commission authorization before the ingredient can be sold. The US has no general pre-market approval for GRAS or NDI ingredients. Companies remain responsible for establishing safety, with FDA oversight differing by pathway. A development to monitor: in August 2026, FDA proposed making GRAS notification mandatory for certain uses, which would effectively end self-affirmed GRAS for those uses. This is a proposal, not a final rule, and the text may change after the public comment period.
It’s important to confirm the regulatory pathway you intend to pursue before starting development and building the dossier to avoid costly rework. In the US, that includes confirming that an NDI candidate meets the legal definition of a dietary ingredient, a frequent reason NDI notifications run into problems.
3. Build the evidence package around the final ingredient, not a generic checklist
These are the core questions regulators ask across both markets: What is it? How is it made? What is in it? How will it be used? Is it safe?
The evidence required should answer these questions, and this will differ by ingredient. Data can include identity and characterization, manufacturing process, composition and specifications, intended use and exposure, and safety assessment through toxicological studies conducted in accordance with OECD guidelines and GLP principles. Depending on the ingredient, additional data may be needed, such as on stability, allergenicity, ADME/metabolism and specific hazards.
Because each of these elements depends on how the ingredient is made, the manufacturing process should be finalized before compositional analyses and toxicological studies begin. Even a minor process change can alter the ingredient’s characteristics and make existing data irrelevant. The material tested in the toxicological studies should be identical to the ingredient that will be placed on the market.
Disclosure also differs by pathway. Process details stay confidential in an EU Novel Food dossier and can be kept confidential in an NDI notification, but much of a GRAS notice becomes public, so decide carefully how much detail to include.
4. Decide your EU/US sequencing strategy before investing in studies
For companies targeting both markets, the order of authorization shapes what data to generate first, so it needs to be settled at the planning stage.
Because EFSA’s requirements are generally more stringent than FDA’s, there are two broad approaches:
A. EU-first. Build the evidence package to Novel Food requirements, then reuse it for the US. On top of that package, the US typically needs only one additional genotoxicity test and a US-specific exposure assessment, so the extra time and cost should be limited.
B. US-first. Generate the evidence FDA requires and reach the US market sooner. The trade-off is significant later investment for the EU, which US sales may help fund.
Neither is right for every project: the choice is a trade-off between speed to market and upfront investment. Two EU-specific rules also need to be built into the plan. Studies supporting a Novel Food application, notably stability and toxicity studies, must be notified to EFSA before they start, so notification needs to be factored into the strategy from the outset. And a Novel Food authorization can qualify for five years of data protection only if it relies on newly generated, proprietary studies; a literature-only application cannot, whereas GRAS and NDI are restricted to the applicant.
Either way, the aim is a global evidence strategy, not two separate projects.
5. Plan for the true cost and timeline, not just dossier submission
FoodChain ID scientists analyzed nearly 300 EU Novel Food applications in a paper published in npj Science of Food in 2025. They found that the overall period between submission and EFSA opinion is 2.5 years. Applicants’ responses to requests for additional data took up 47% of EFSA’s scientific evaluation time. This means stronger upfront preparation can help you shorten your timeline and achieve market access more efficiently.
On costs, there are no submission fees in either region; the expense lies in generating the evidence. Companies can expect an indicative minimum investment of €150k–€200k for a US GRAS notice and more than €300k for an EU Novel Food application, depending on the ingredient and evidence required. A single 90-day oral toxicity study, run to GLP and OECD guideline 408, can cost €80k–€350k. These figures are indicative, not fixed, and depend on your company’s internal capacity, the ingredient and study design. Toxicity studies are the largest single cost, which is why a process change that makes existing studies irrelevant is so expensive.
Conclusion
Successfully bringing your novel ingredient to market requires treating regulatory strategy as a product development input, not an output. This means that before studies begin, every ingredient development project should answer these critical questions:
- Define the project: What is the ingredient, its intended use, and its target markets?
- Build the evidence: What evidence is required and when?
- Plan the authorization strategy: Which authorization pathway fits the project’s commercial and scientific reality: EU Novel Food, US GRAS, US NDI, or a coordinated multi-market strategy?
Answering these questions early, with the right regulatory and scientific expertise, is what separates projects that reach the market efficiently from those that lose time and budget to avoidable rework.
Planning market access for an innovative ingredient? Speak with FoodChain ID’s regulatory and scientific experts about the right pathway and evidence strategy for your target markets. Contact us here.
For a deeper dive into regulatory differences across regions, watch FoodChain ID’s on-demand webinar: Building the Right Regulatory Strategy for Innovative Ingredients in Europe and the US