The European Food Safety Authority (EFSA) provides regulatory guidance and oversees the approval process for novel foods in the European Union (EU). Novel foods are foods or ingredients not consumed significantly within the EU before May 15, 1997. If you are interested in submitting a novel food application to EFSA or seeking regulatory guidance, here are the general steps and considerations:
- Determine Novel Food Status: Determine whether your product falls under the novel food category according to the EU’s Novel Food Regulation (EU) 2015/2283. You must go through the approval process if your product is considered unknown.
- Pre-Submission Consultation (Optional): Before submitting a formal application, you can request a pre-submission consultation with EFSA. This allows you to discuss the novel food application process, potential data requirements, and other aspects with EFSA experts.
- Compile Scientific Data: Prepare a comprehensive dossier containing scientific and safety data for your novel food. This data should address the safety, nutritional profile, and any other relevant aspects of your product.
- Submit a Novel Food Application: Submit a formal novel food application to the European Commission and the competent authority of an EU Member State. The application should include detailed information about your product, its composition, production process, intended use, proposed labeling, and the scientific data supporting its safety.
- Risk Assessment by EFSA: Once the application is submitted, EFSA performs a thorough scientific risk assessment of the novel food. This assessment evaluates the safety of the novel food for human consumption, considering factors such as potential allergenicity, toxicity, and nutritional value.
- Public Consultation: EFSA may conduct a public consultation to gather input from stakeholders, including industry, consumers, and other interested parties.
- Opinion by EFSA: EFSA provides a scientific view on the safety of the novel food based on the data submitted and the risk assessment conducted.
- European Commission Decision: Based on EFSA’s opinion, the European Commission and EU Member States decided to authorize the novel food. If allowed, the novel food can be placed on the EU market.
Suppose you are considering submitting a novel food application. In that case, it is advisable to seek professional advice and guidance from regulatory experts familiar with the latest requirements and procedures.
The European Food Safety Authority (EFSA) procedure for evaluating novel foods and assessing their safety
The Novel Food Regulation (EU) 2015/2283 outlines the steps and requirements for the novel food authorization process. Remember that procedures and guidelines may have evolved since then, so it’s essential to consult the most up-to-date resources EFSA provides.
Here is a general overview of the EFSA novel food procedure:
- Application Submission: A company seeking authorization for a novel food application to a designated EU Member State. The application includes detailed information about the novel food, its composition, intended use, production process, labeling, and scientific data on safety.
- Validation: The EU Member State reviews the application for completeness and accuracy. If the application is deemed valid, the process continues.
- Initial Assessment: The EU Member State conducts an initial assessment of the novel food application and prepares a draft assessment report. This report includes information on the novel food’s safety, nutritional profile, and potential risks.
- Consultation with Other Member States: The draft assessment report is shared with other EU Member States and the European Commission. They have the opportunity to provide comments and feedback.
- EFSA Involvement: If there are no objections from Member States, the European Commission sends the application to EFSA for a scientific evaluation. EFSA’s Panel on Nutrition, Novel Foods, and Food Allergens (NDA Panel) is responsible for conducting the risk assessment of the novel food.
- EFSA Evaluation: The NDA Panel reviews the application, scientific data, and any additional information the applicant provides. EFSA evaluates the safety of the novel food for human consumption, considering factors such as potential allergenicity, toxicity, and nutritional value. EFSA may also consider the potential impact of the novel food on consumers with specific dietary needs.
- Public Consultation: EFSA may initiate a public consultation to gather input from stakeholders, including industry, consumers, and other interested parties. This consultation helps ensure that all relevant perspectives are considered.
- Scientific Opinion: Based on its evaluation, EFSA provides a scientific opinion on the safety of the novel food. This opinion is published and made available to the public.
- European Commission Decision: The European Commission and EU Member States use EFSA’s scientific opinion to decide on authorizing the novel food. If allowed, the novel food can be placed on the EU market.
To obtain the most accurate information on the EFSA’s novel food procedure and Novel Food regulations, visit the official EFSA website. To learn about the role of the NDA Panel, I recommend visiting the official EFSA website and reviewing the latest guidance documents and regulations. Did you know this process could also apply to products with CBD ingredients, learn more here:
How Quality Smart Solutions can help:
Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, dietary supplement compliance, NHP compliance, and food labeling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!