The Novel Food Regulation (EU) 2015/2283, which came into force in January 2018, modernized the European Union’s approach to novel foods, aiming to balance consumer safety, innovation, and market harmonization. The regulation is particularly relevant for food business operators (FBOs) seeking to introduce new foods or ingredients, including botanicals, to the EU market.
Like any regulatory process, the novel food application has its own set of advantages and disadvantages that worth to be discussed. Below is an overview of both the positive and negative aspects.
Pros
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Enhanced Consumer Safety
The regulation mandates a rigorous pre-market safety assessment by the European Food Safety Authority (EFSA), ensuring that only foods proven safe reach consumers.
Comprehensive analytical and toxicological characterization is required, minimizing risks of adverse health effects.
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Centralized and Streamlined Procedure
Applications are now submitted directly to the European Commission, with EFSA conducting scientific assessments, reducing duplication and inconsistencies among Member States.
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Support for Innovation
Data protection provisions safeguard proprietary scientific data for five years, incentivizing investment in research and development.
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Harmonization and Market Access
The regulation harmonizes requirements across the EU, reducing the risk of divergent national interpretations and facilitating the free movement of goods within the internal market.
The establishment of a Union list of authorized novel foods provides transparency and clarity for food business operators (FBOs) and regulators.
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Special Pathway for Traditional Foods
Foods with a documented history of safe use for at least 25 years outside the EU benefit from a simplified notification procedure, easing market entry for traditional products from third countries.
Cons
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Regulatory Complexity and Uncertainty
The process remains complex, particularly for botanicals, due to the lack of a harmonized EU list of traditionally used plants and inconsistent approaches among Member States.
FBOs must provide robust evidence of significant consumption before 15 May 1997 to avoid the novel food route—a task often hampered by incomplete historical records and ambiguous definitions of “significant consumption”.
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High Costs and Resource Demands
Preparing a novel food application requires extensive scientific data, including detailed characterization of the ingredient and its production process, which can be costly and time-consuming, especially for small and medium enterprises (SMEs).
The need for toxicological studies and analytical data may put novel food applications out of reach for smaller operators.
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Challenges with Botanicals
Botanical extracts often lack comprehensive historical documentation and standardized production methods, making it difficult to prove non-novel status or demonstrate safety.
Variability in botanical preparations and absence of titrated mixtures complicate the assessment and approval process.
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Time to Market
Although the process is faster than before, the 18-month timeline (which may be extended if additional data is required) can still delay innovation and market entry, especially for rapidly evolving food technologies.
Over the past year, Chemsafe has demonstrated a strong commitment to the novel food sector. We have successfully prepared and submitted several novel food, food additive, and enzyme dossiers to the European Commission.
Chemsafe is ready to support you in developing both a robust toxicological strategy and a comprehensive dossier, as well as in crafting an effective strategy to ensure the smooth introduction of your food product to the market.
If you have any questions or need assistance, don’t hesitate to contact Chemsafe.
