For ingredient manufacturers expanding internationally, achieving Generally Recognized as Safe (GRAS) status in the United States is often viewed as a significant regulatory milestone. However, GRAS does not authorize an ingredient for sale in the European Union. Instead, the EU regulates innovative ingredients under Regulation (EU) 2015/2283 on Novel Foods, which establishes a centralized pre-market authorization framework for foods that meet the definition of a novel food, including many foods that were not consumed to a significant degree in the EU before 15 May 1997. While a well-prepared GRAS dossier can provide valuable scientific evidence—including manufacturing information, compositional data, toxicology, and exposure assessments—it must be adapted to satisfy the European Food Safety Authority’s (EFSA) scientific requirements and the European Commission’s authorization process. Understanding the similarities and differences between these regulatory frameworks can help manufacturers accelerate market entry while avoiding costly delays.
For many food and ingredient manufacturers, obtaining U.S. GRAS (Generally Recognized as Safe) status represents a major step toward commercialization. Whether achieved through a self-determined GRAS conclusion or supported by an FDA “no questions” letter in response to a GRAS Notice, GRAS demonstrates that qualified experts generally recognize an ingredient as safe under its intended conditions of use.
As companies expand into international markets, however, a common question arises:
Can the same ingredient be sold in European Union simply because it is GRAS in the United States?
The answer is no.
Unlike the United States, the European Union does not recognize GRAS as a regulatory pathway for market access. Instead, food ingredients that meet the definition of a novel food are regulated under the EU’s Novel Food Regulation (EU) 2015/2283, which establishes a harmonized authorization process across all Member States. Novel foods must generally receive authorization before they can be placed on the European Union’s market and are added to the Union List of authorized novel foods only after a scientific safety assessment and regulatory review. Importantly, authorization does not necessarily mean unrestricted use. The Union List entry may include specific conditions of use, product specifications, labeling requirements, and other authorization conditions that must be met before the novel food can be legally placed on the EU market. Market access depends not only on obtaining authorization, but also on complying with these conditions.
That does not mean the scientific work completed for a GRAS determination is wasted. In fact, much of the information compiled in a robust GRAS dossier—including manufacturing details, analytical data, dietary exposure estimates, and toxicological evidence—can provide an excellent starting point for an EU submission. The challenge lies in adapting that information to meet the European Union’s regulatory framework and EFSA’s scientific expectations.
This article explains how GRAS compares with the EU Novel Food process, when authorization is required, what information EFSA expects to see, and how companies can leverage existing safety data to support successful entry into the European Union’s market.
Under the U.S. Federal Food, Drug, and Cosmetic Act, substances intentionally added to food are generally considered food additives unless they qualify for an exemption. One of the most important exemptions is Generally Recognized as Safe, or GRAS.
A substance may be considered GRAS when there is sufficient scientific evidence to demonstrate that qualified experts generally recognize it as safe under its intended conditions of use. Depending on the circumstances, companies may independently conclude that an ingredient is GRAS or voluntarily submit a GRAS Notice to the U.S. Food and Drug Administration (FDA) for review.
Importantly, GRAS status is not a blanket approval for an ingredient. A GRAS conclusion is specific to the ingredient being evaluated and is based on factors such as:
Changes to the manufacturing process, raw material, formulation, intended application, or exposure may require a new safety assessment.
Because of this, GRAS is best understood as an ingredient-specific scientific conclusion rather than a universal authorization applicable across all jurisdictions.
Although GRAS is not recognized as a regulatory authorization pathway under European Union food law, it is far from irrelevant.
The European Union operates under a different regulatory philosophy. Rather than relying on the concept of “general recognition” among qualified experts, innovative food ingredients are evaluated through a centralized pre-market authorization process established under Regulation (EU) 2015/2283.
For many manufacturers, the first regulatory question is not:
“Is this ingredient GRAS?”
Instead, it is:
“Does this ingredient qualify as a Novel Food under EU legislation?”
If the answer is yes, the ingredient will generally require authorization or, where applicable, follow the specific notification/authorization pathway available under the Novel Food Regulation before it can be legally marketed within the European Union. While GRAS itself is not recognized, the underlying science often is. A comprehensive GRAS dossier frequently contains information that is directly relevant to an EU Novel Food application, including:
Rather than beginning from scratch, companies can often build upon this existing body of evidence. However, additional analyses, different exposure calculations, and a submission organized according to EFSA’s guidance are typically required before the data can support an EU authorization.
The foundation of the European Union regulatory framework is Regulation (EU) 2015/2283 on Novel Foods, which came into full application on 1 January 2018 and replaced the previous Novel Food Regulation.
Under this Regulation, a novel food is generally defined as a food that was not consumed to a significant degree within the European Union before 15 May 1997 and that falls into one or more specified categories.
The legislation recognizes that food innovation continues to evolve and therefore includes a broad range of products, including those consisting of, isolated from, or produced from:
Foods with a new or intentionally modified molecular structure may fall within the definition of a novel food. Ingredients produced using manufacturing technologies that were not used for food production in the EU before the 1997 cut-off may also be considered novel foods if those technologies significantly affect nutritional value, metabolism, or the levels of undesirable substances.
The Regulation also specifically addresses traditional foods from third countries, creating a simplified authorization pathway where applicants can demonstrate a documented history of safe food use outside the European Union. This provision was introduced to facilitate market access for foods that may be new to European Union countries but have been safely consumed elsewhere for many years.
Importantly, not every innovative ingredient is automatically considered a novel food. Determining whether an ingredient falls within the Regulation requires careful evaluation of its history of consumption, production method, composition, and intended use. This regulatory assessment is often one of the first and most critical steps in planning an EU market entry strategy.
If an ingredient meets the definition of a novel food, it generally cannot be placed on the EU market until it has been authorized in accordance with Regulation (EU) 2015/2283 and included in the Union List of authorized novel foods.
Unlike the voluntary nature of FDA GRAS notifications, the Novel Food process is a mandatory pre-market authorization system for qualifying products.
Applications are submitted to the European Commission, which coordinates the authorization process. Where a scientific assessment is required, the application is subject to a scientific safety assessment by the European Food Safety Authority (EFSA), whose experts evaluate the safety of the ingredient under its proposed conditions of use.
EFSA’s role is not simply to determine whether an ingredient appears safe in general. Rather, it evaluates whether the available scientific evidence demonstrates that the novel food is safe for the intended population, at the proposed use levels, and under the proposed conditions of use. Factors such as nutritional impact, anticipated intake, toxicological profile, allergenicity, and manufacturing consistency all contribute to the overall assessment.
Once EFSA completes its scientific opinion, the European Commission, together with the Member States, determines whether the ingredient should be authorized and added to the Union List. Any authorization may include conditions of use, labeling requirements, specifications, or other restrictions designed to ensure consumer safety.
A successful Novel Food application is far more than a collection of scientific studies. EFSA expects applicants to present a comprehensive body of evidence demonstrating that the novel food is safe under its proposed conditions of use. To help applicants prepare consistent, scientifically robust submissions, EFSA published updated guidance in 2024 outlining the information required for a Novel Food application.
Although every application is unique, most submissions are built around several core components.
The application begins by clearly defining exactly what is being assessed.
Depending on the type of ingredient, this may include:
A precise description is essential because EFSA’s opinion applies only to the ingredient as characterized in the application. Changes to the source material, manufacturing process, or composition may require additional regulatory consideration.
How an ingredient is produced can be just as important as the ingredient itself.
Applicants are expected to describe the manufacturing process in sufficient detail to demonstrate consistency and identify any potential safety concerns. This may include information on:
Manufacturing information helps EFSA understand whether the production process could introduce hazards or significantly alter the ingredient’s composition.
Novel Food applications must demonstrate that the product being evaluated can be manufactured consistently.
Applicants typically provide:
EFSA’s guidance places significant emphasis on analytical methods, representative batch analyses, and addressing compositional variability across production lots.
Safety cannot be evaluated without understanding how consumers are expected to use the ingredient.
Applicants must describe:
Unlike a GRAS determination, which generally focuses on U.S. consumption patterns, EU applications require exposure estimates relevant to European consumers.
The extent of toxicological data required depends on the nature of the ingredient and the available scientific evidence.
Depending on the nature of the novel food, its composition, intended use, exposure, and existing evidence, applicants may need to provide information relating to:
EFSA applies a tiered, science-based approach to determine the type and extent of toxicological evidence needed based on the characteristics of the novel food and the available evidence.
Novel foods should not create nutritional disadvantages for consumers or introduce unacceptable allergenic risks.
Applications may therefore include assessments of:
Applicants are also expected to discuss uncertainties and explain how the available evidence supports the overall safety conclusion.
Rather than evaluating each section independently, EFSA considers the totality of the evidence to determine whether the novel food is safe under its proposed conditions of use.
| Area | U.S. GRAS | EU Novel Food Regulation |
| Primary question | Is the ingredient generally recognized as safe under its intended conditions of use? | Is the novel food safe under its proposed conditions of use? |
| Legal framework | Federal Food, Drug, and Cosmetic Act | Regulation (EU) 2015/2283 |
| Regulatory submission | May be submitted voluntarily to FDA through a GRAS Notice | Required for foods subject to Novel Food authorization requirements |
| Scientific review | Qualified expert consensus (FDA notification optional) | EFSA scientific risk assessment |
| Premarket authorization | Not always required | Required before qualifying novel foods are marketed |
| Geographic scope | United States | European Union |
| Outcome | GRAS conclusion or FDA “no questions” letter | Authorization and inclusion in the Union List |
| Primary objective | Demonstrate general recognition of safety | Demonstrate safety through centralized regulatory review |
While the regulatory pathways differ, both systems rely on high-quality scientific evidence to support ingredient safety.
One of the most common misconceptions is that companies must start from scratch when pursuing EU authorization after obtaining GRAS status.
In reality, a well-developed GRAS dossier often provides much of the scientific foundation required for a Novel Food application.
Information that can frequently be adapted includes:
However, adaptation is rarely as simple as submitting the same dossier to a different authority.
The regulatory questions being answered are different.
A GRAS dossier is designed to demonstrate that qualified experts generally recognize an ingredient as safe under its intended conditions of use in the United States.
An EU Novel Food application is designed to enable EFSA to independently evaluate whether the ingredient satisfies the safety requirements established under Regulation (EU) 2015/2283.
Consequently, applicants often need to reorganize existing data, perform additional analyses, update exposure assessments using European consumption data, and address EFSA-specific scientific expectations.
For companies with an existing GRAS package, this can represent a significant advantage. Rather than recreating years of scientific work, the focus shifts toward identifying gaps, supplementing the evidence where necessary, and presenting the information in a format that aligns with EU regulatory requirements.
Successfully commercializing an innovative ingredient in Europe Union involves more than demonstrating scientific safety. Many delays occur because companies misunderstand the regulatory pathway rather than the science itself.
Some of the most common mistakes include:
Assuming GRAS status automatically applies internationally.
GRAS is a U.S. regulatory concept and does not provide legal authorization within the European Union.
Waiting too long to determine Novel Food status.
Identifying whether an ingredient qualifies as a Novel Food should be one of the earliest steps in product development. Waiting until commercialization can significantly delay market entry.
Treating a GRAS dossier as a complete EU submission.
Although much of the underlying science may be reusable, EFSA expects applications to follow its own guidance and address European Union regulatory requirements.
Overlooking European dietary exposure.
Exposure estimates prepared for U.S. populations may not reflect European consumption patterns or intended uses.
Underestimating regulatory timelines.
Novel Food authorization is a structured scientific and regulatory process. Timelines can be influenced by several factors, including the completeness of the application, requests for additional information during EFSA’s scientific assessment, the need to address data gaps, and the interaction between the scientific evaluation and the European Commission’s authorization process.
Early planning allows manufacturers to identify potential regulatory challenges, assess data requirements, and address gaps before they lead to unnecessary delays. Companies that consider regulatory strategy during product development, rather than waiting until commercialization is planned, are generally better positioned to achieve efficient market access.
Bringing an innovative ingredient to the European Union market requires more than strong science—it requires a clear understanding of the regulatory pathway and the evidence needed to support a successful authorization.
dicentra helps food manufacturers, ingredient suppliers, and product developers navigate the EU Novel Food framework by providing strategic regulatory guidance and scientific support throughout the authorization process. Whether you are evaluating a new botanical extract, fermentation-derived ingredient, cultured food, algae-based ingredient, or another innovative food product, our multidisciplinary team can help identify the most appropriate pathway to market.
Our Novel Food consulting services include:
With more than two decades of regulatory consulting experience, dicentra helps companies transform existing scientific evidence into regulatory submissions that support efficient market access across multiple jurisdictions.
Talk to our team about your Novel Food strategy for the EU →