EFSA - Novel and Traditional Food Applications and Notifications: Regulations and Guidance as of 1st February 2025-What Will Change?
Introduction
The landscape of food regulation in the European Union (EU) is constantly evolving to accommodate new scientific developments, changing consumer demands, and emerging food sources. As we approach February 1, 2025, substantial shifts are expected in the way the EU regulates novel foods and traditional foods from third countries, particularly in terms of application procedures, safety assessments, and labelling. These changes will reflect the increasing diversity of food products entering the market, such as lab grown meats, plant based proteins, and new biotechnology based foods. At the same time, the EU will continue to ensure that public health, safety, and sustainability remain at the heart of food regulation.
In this article, we will scrabble about the regulatory frameworks governing novel and traditional foods within the EU and explore the anticipated changes that will come into effect as of February 1, 2025. This will include an examination of the Novel Food Regulation (EU) 2015/2283, the rules for traditional foods from third countries, the evolving notification systems, and the impact of new technologies like gene editing and synthetic biology on food applications.
1. Overview of the Current Regulatory Framework
The regulation of novel and traditional foods in the EU is largely governed by the Novel Food Regulation (EU) 2015/2283, which was designed to ensure that novel food products entering the market are safe for consumption. The regulation establishes a framework for foods that were not consumed to a significant degree within the EU prior to May 15, 1997. This includes new food sources, innovative production methods, and foods with new or altered molecular structures, including:
- Foods from non traditional sources: Algae, insects, and lab grown meats.
- Foods produced using new technologies: Gene editing (e.g., CRISPR) and synthetic biology.
- Foods with new or altered ingredients: Plant based and alternative protein products, such as plant based milks or lab grown meats.
For traditional foods from third countries, the Regulation (EU) 2015/2283 also sets out a process for reviewing applications for foods that have been consumed historically in non EU countries but are not yet authorized for use within the EU. This ensures that such foods do not pose any health risks.
2. Key Challenges in Food Regulation
The complexity of food regulation stems from the need to balance several competing interests:
- Consumer health and safety: Ensuring that all new and traditional foods are safe for consumption and do not pose a risk to public health.
- Innovation and market access: Encouraging innovation and facilitating market access for new and alternative food products, including those from novel sources.
- Sustainability: Integrating environmental considerations, including the carbon footprint and environmental impact of food production, into the approval process.
- Ethical concerns: Addressing the societal and ethical implications of new food technologies, such as lab grown meats and genetically modified foods.
These challenges are further complicated by the pace of innovation and the need for food regulations to remain flexible while ensuring food safety and transparency.
3. Changes Expected by 1st February 2025
3.1 Updated Novel Food Regulation (EU) 2015/2283
One of the most anticipated changes is the revision of the Novel Food Regulation (EU) 2015/2283, which governs the approval process for novel foods. The current regulation has been in effect since 2018, and while it has provided a solid framework, there is a growing recognition of the need for reform to address the challenges posed by new food technologies and the increasing demand for sustainable food sources.
Key changes expected by February 1, 2025:
- Streamlined Application Processes: The application process for novel foods is expected to be streamlined, with more emphasis on digital tools and automated systems. This includes the introduction of digital platforms for submitting applications, making it easier for applicants to track the progress of their submissions and communicate with regulatory bodies. This move is aimed at reducing the long approval timelines, which have been a point of frustration for innovators, especially in the rapidly growing plant-based and alternative protein sectors.
- Risk Based Approach to Approval: The updated regulation is likely to emphasize a risk based approach to novel food approval, particularly in relation to foods derived from new technologies like gene editing or synthetic biology. This approach would focus on assessing the potential risks of novel foods based on their specific characteristics and the underlying science, rather than applying the same blanket approval process to all products.
- Greater Focus on Sustainability: As part of the EU’s Green Deal and Farm to Fork Strategy, the updated Novel Food Regulation will likely place a greater emphasis on sustainability assessments. This includes evaluating the environmental impact of food production, such as the carbon footprint, land use changes, and water consumption. Sustainability criteria will become a key part of the approval process, particularly for alternative proteins, plant-based foods, and lab grown meats.
- Increased Transparency and Public Access: One of the key criticisms of the current system is the lack of transparency in the approval process. By 2025, it is expected that the EU will introduce greater public transparency by making safety evaluations, risk assessments, and the reasoning behind approvals publicly available. This would help address public concerns about new food technologies and improve consumer confidence.
3.2 Regulation of Traditional Foods from Third Countries
Under the current regulation, foods that are traditionally consumed outside of the EU, but not yet authorized in the EU, must go through a traditional food notification procedure. By February 2025, the EU will likely simplify and expand this procedure to address the growing demand for foods from around the world, including those from Asia, Africa, and South America.
Expected changes include:
- Faster Approval Processes: One of the major changes will likely be a move toward a more expedited approval system for traditional foods from third countries. Currently, the process can take years due to the need for comprehensive safety assessments and the lack of clear guidance on what constitutes “traditional” usage. By 2025, the EU is expected to introduce clearer guidelines and faster timelines for approving such foods, particularly for those with extensive safety histories in their countries of origin.
- Digital Submissions and Notifications: The EU will likely introduce digital notification systems that will allow applicants to submit their data electronically and track the progress of their applications in real time. This system will be easier to navigate, more transparent, and less time consuming for both the applicants and the regulatory authorities.
- Public Consultation on Traditional Foods: Another expected change is the introduction of public consultationsfor traditional foods. The EU may encourage stakeholder engagement through online platforms, where the public can provide feedback on new food applications. This will ensure that traditional foods are evaluated with public input, and that any concerns about safety or cultural significance are addressed.
3.3 Gene Editing and Novel Biotechnologies
Advances in gene editing technologies such as CRISPR and synthetic biology are expected to play a critical role in the food industry by 2025. The EU has yet to fully adapt its food regulations to account for these innovations, and there is likely to be a significant overhaul in how such foods are regulated.
Expected changes include:
- Clearer Definitions and Guidelines for Gene Edited Foods: One of the main regulatory challenges has been differentiating between genetically modified (GM) foods and gene-edited foods. Gene edited foods do not involve the insertion of foreign genes but rather modify existing genes. By February 2025, the EU is expected to establish clear guidelines to distinguish between the two, which will impact how these foods are approved and labelled.
- Updated Safety Assessments: For foods produced using gene-editing or synthetic biology, the EU is likely to introduce specific safety assessment protocols that focus on the unique risks posed by these technologies. These assessments will look at the potential long-term health impacts of consuming foods that have been modified using gene-editing tools, as well as their environmental impact.
- Regulation of Lab Grown Meats: Lab grown meats (also referred to as cultured or cell-based meats) are likely to be subject to stricter safety protocols and regulatory scrutiny. The EU will likely develop specific guidelines for these products, particularly in terms of labelling, production methods, and ethical considerations related to animal welfare.
3.4 Food Labelling and Claims
Food labelling regulations will also evolve to reflect the changing nature of food products. The EU has recognized that existing labelling rules may not be sufficient to address the growing demand for plant based, lab grown, and other alternative protein products.
Expected changes include:
- Labelling for Plant Based and Alternative Protein Products: There is expected to be a clearer distinction between traditional animal-based products and plant-based or alternative protein products. For instance, the use of terms like “milk,” “cheese,” and “meat” may be restricted or redefined for plant based alternatives. This is to avoid misleading consumers and to ensure that plant-based products are clearly identified as such.
- Health Claims and Functional Ingredients: With the rise of functional foods, which offer health benefits beyond basic nutrition, the EU will likely introduce stricter regulations on health claims made by food products. Foods derived from novel sources or containing new ingredients will be required to undergo rigorous scientific evaluation before any health claims are approved.
4. Conclusion
As of February 1, 2025, significant changes are expected in the EU’s regulations surrounding novel and traditional food applications. These changes will address the increasing demand for innovative food sources, like alternative proteins, plant-based foods, and lab grown meats, while maintaining high standards of safety, transparency, and sustainability. The EU is likely to streamline approval processes, introduce more digital and automated systems, and place greater emphasis on environmental and ethical considerations. The impact of gene editing and biotechnology will also be a key factor in the evolving regulatory landscape.
Ultimately, these changes will not only facilitate the introduction of new food products but also help ensure that food safety and public trust remain central to the EU’s food regulatory system. As the food industry continues to evolve, the EU’s regulatory framework will need to remain adaptable and forward-thinking to keep pace with emerging technologies and market demands.
How TOXLAB May Help Your Business
TOXLAB offers significant support in the context of food safety, novel food applications, and regulatory compliance. As food regulations continue to evolve, particularly with the growing importance of novel and traditional food products, having reliable tools to manage risk assessments, toxicity testing, and regulatory filings is crucial. Below are several ways in which TOXLAB can assist stakeholders in the food industry, ranging from producers to regulatory authorities to navigate these challenges effectively.
1. Comprehensive Toxicological Assessments
The primary role of TOXLAB lies in conducting toxicological assessments to ensure that food products meet safety standards. Whether dealing with novel foods, gene edited crops, plant based proteins, or traditional foods from third countries, we can:
- Evaluate Toxicity: For novel foods or ingredients, we can conduct in vitro, in vivo, and in silico toxicity assessments to ensure that these foods do not pose health risks to consumers. This is essential for regulatory approval in the EU, where comprehensive safety data is required for any food entering the market.
- Screen for Potential Hazards: Using state of the art techniques such as high throughput screening, we can identify any potential chemical hazards in raw ingredients and processed foods, assessing whether any substances pose carcinogenic, mutagenic, or reproductive toxicity risks.
- Safety for Novel Ingredients: Novel food ingredients (such as those derived from fungi, algae, or lab grown meat) need to undergo toxicity testing to ensure they are safe for human consumption. we can provide the necessary reports for regulatory submission to ensure these foods meet EU standards under Regulation (EU) 2015/2283.
2. Regulatory Compliance Assistance
TOXLAB can also help businesses understand and navigate the complex regulatory landscape, particularly in the context of EU food regulations and the approval of novel foods and ingredients.
- Navigating Novel Food Regulations: The EU Novel Food Regulation (EU) 2015/2283 stipulates that any food or food ingredient not consumed significantly within the EU before 1997 must undergo a safety assessment and approval process. We can guide businesses through the necessary steps to prepare toxicological dossiers, which are required for submitting novel food applications to the European Food Safety Authority (EFSA).
- Support for Traditional Food Applications: Foods from third countries that have a long history of consumption but are not yet authorized in the EU require a traditional food notification. We can help with the scientific safety assessments needed for this notification, including toxicology studies, nutritional analysis, and allergen testing.
- Gene Editing and Biotechnology Regulation: With the rise of genetically modified organisms (GMOs) and gene-edited foods, the regulatory framework for such products is constantly evolving. We can assist companies in conducting the necessary testing to comply with both EU and global regulations. They help distinguish between GMOs and gene edited foods (such as those made using CRISPR technology), ensuring that these products meet the appropriate safety standards.
- Ensuring Compliance with Labelling Regulations: Food labels must be accurate and reflect the product’s ingredients, production processes, and any health or environmental claims. We can provide the data needed for labelling compliance, including allergen information, nutritional analysis, and evidence supporting any health claims (e.g., claims related to functional foods or probiotics).
3. Risk Assessment and Safety Evaluation
As the market for new foods, including alternative proteins and functional foods, continues to grow, so does the need for robust risk assessment processes. TOXLAB can provide services to evaluate potential risks associated with new food ingredients or production processes, helping businesses stay ahead of the curve.
- Predictive Toxicology: Through in silico (computer based) models, at TOXLAB, we can predict the potential toxicity of new food ingredients or novel food products without the need for animal testing. These predictive models can provide a cost effective, ethical, and scientifically rigorous means of assessing risks.
- Comprehensive Risk Assessments for Novel Foods: As novel foods often involve new sourcing methods, ingredients, or biotechnologies, TOXLAB conducts in depth risk assessments that include the evaluation of chemical contaminants, allergens, and microbiological risks associated with new foods. These assessments are key in ensuring the safety of foods entering the market.
- Human and Environmental Impact: For gene edited foods, lab-grown meats, or novel crops, assessing the environmental and health impact is essential. TOXLAB evaluates not only the safety of consumption but also the potential long term effects on human health and the environment, such as ecological changes due to new agricultural practices.
4. Consulting and Technical Guidance for Regulatory Filings
Navigating the complex landscape of regulatory filings, particularly for novel foods, requires specialized expertise. TOXLAB can provide consulting services for businesses in the food industry to help them understand and prepare for regulatory submissions.
- Novel Food Application Preparation: TOXLAB helps in compiling the necessary toxicological and scientific data for EFSA submissions related to novel foods. The approval process can be lengthy, but with the right toxicological data, safety studies, and environmental impact assessments, TOXLAB can help ensure that applications are complete and well supported.
- Gene Editing and GMOs: For novel foods developed using biotechnology, including gene editing, TOXLAB can provide expertise in the approval process for genetically modified organisms (GMOs) and genetically modified foods, ensuring that all required documentation is provided in accordance with EU regulations.
- Health Claims and Nutritional Claims: The EU Regulation (EC) No 1924/2006 on nutrition and health claims places strict guidelines on the types of claims that can be made on food packaging. TOXLAB can guide businesses on how to substantiate health claims, functional food claims, and nutritional claims using appropriate scientific evidence.
5. Support with Consumer and Stakeholder Communication
As the food industry becomes more focused on sustainability, ethical considerations, and consumer health, communicating the safety and benefits of new foods becomes increasingly important. TOXLAB helps stakeholders effectively communicate food safety and regulatory compliance to consumers, regulatory bodies, and other stakeholders.
- Public Communication of Safety Data: With increasing public concern over new food technologies, including gene-edited crops or lab-grown meats, TOXLAB can assist in creating comprehensive and transparent safety reports for consumers. This enhances the credibility and trust of new products, ensuring that consumers feel confident in the products they consume.
- Engaging Stakeholders in Risk Communication: For novel food producers, TOXLAB can offer support in presenting complex scientific data in an accessible way. By using clear communication, companies can help demystify new food technologies and ensure that stakeholders (including consumers, regulators, and advocacy groups) are informed and engaged.
6. Sustainability and Environmental Impact Analysis
The future of food regulation is increasingly tied to sustainability, particularly as part of the EU Green Deal and Farm to Fork Strategy, which focus on making food production more sustainable and environmentally friendly. TOXLAB can assist food producers in conducting sustainability assessments to evaluate the environmental impact of new food products.
- Carbon Footprint Analysis: For alternative proteins, plant-based foods, and lab-grown meats, TOXLAB can help assess the carbon footprint and resource use (such as water and land) associated with their production. This information is increasingly important for both regulatory approvals and marketing, as sustainability becomes a key concern for both regulators and consumers.
- Lifecycle Analysis: By evaluating the entire lifecycle of a product, from raw material sourcing to processing and distribution, TOXLAB can help identify opportunities to reduce environmental impacts and improve sustainability.
7. Ethical and Consumer Acceptance Considerations
The growing market for alternative proteins, genetically modified foods, and other novel food products requires careful attention to ethical issues and consumer acceptance. TOXLAB can support businesses by offering ethics assessments and consumer acceptance studies to ensure that new foods meet both safety standards and societal expectations.
- Ethical Assessments for Biotechnology and GMOs: As novel food technologies such as gene editing and synthetic biology raise ethical concerns, TOXLAB can assist businesses in evaluating the ethical implications of their products. This includes considerations around animal welfare, environmental impact, and the societal consequences of adopting such technologies.
- Consumer Perception Studies: Understanding consumer attitudes toward novel foods is crucial for market success. TOXLAB can conduct studies to assess public perceptions, helping food businesses tailor their marketing strategies and improve consumer acceptance.
As the food industry rapidly evolves with the introduction of novel ingredients, gene-edited crops, alternative proteins, and new biotechnologies, TOXLAB is poised to become an invaluable partner in ensuring that these innovations meet safety, environmental, and ethical standards. From conducting toxicity testing to helping businesses navigate EU food regulations, TOXLAB provides the necessary expertise and tools to ensure that new food products are safe, compliant, and market-ready. Whether you are looking for toxicological assessments, regulatory compliance assistance, or guidance on sustainability and consumer communication, TOXLAB offers a complete solution to address the complex challenges in food innovation.
Contact us : www.toxlab.co
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