Prepare and submit a detailed dossier to EFSA, including comprehensive information about the traditional food, such as its production process and safety history.
Traditional foods are those that have been a regular part of the diet for many people in at least one non-EU country for at least 25 years. These foods can include plants, microorganisms, mushrooms, seaweed, animals including insects and other species like water chestnuts.
The EFSA Traditional Food Application is the process by which these foods are assessed and authorized by the European Food Safety Authority (EFSA) for sale in the European Union (EU). Securing this approval is essential for introducing and selling traditional foods in the EU market.
If you want to introduce traditional foods from non-EU countries into the EU market, you must submit a Traditional Food Application to EFSA. This requirement applies to:
Submitting a Traditional Food Application is mandatory for anyone seeking to legally market traditional foods in the EU.
The EFSA Traditional Food Application process is designed to ensure that traditional foods meet EU safety standards before they are sold in the market. Here’s how the process works:
Prepare and submit a detailed dossier to EFSA, including comprehensive information about the traditional food, such as its production process and safety history.
EFSA conducts a thorough review of the application to ensure that the traditional food complies with EU safety standards.
During the review process, EFSA may open the application for public input to gather a wide range of perspectives on the food’s safety and use.
EFSA assesses the potential health risks associated with the traditional food, examining factors like toxicity, allergenicity, and overall safety.
Based on the safety and risk assessment results, EFSA makes a scientific decision regarding the food’s safety.
The European Commission uses EFSA’s scientific opinion to draft a legal proposal for the approval of the traditional food.
If approved, the traditional food can be legally sold in the EU market, ensuring it meets all safety and regulatory requirements.
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EFSA requires comprehensive data, including toxicology studies, allergen testing, and exposure analyses, to evaluate the safety and efficacy of food additives. This ensures compliance with food safety and quality assurance certification standards, helping the additive meet regulatory requirements for the European market.
Yes, data from FDA GRAS certification can support an EFSA application, especially for safety evidence. However, EFSA requires additional documentation tailored to European food additive compliance, including specific data on labeling, safety, and intended use in the EU market.
Traditional food applications rely on evidence of long-term, safe use in non-EU countries, focusing on historical and cultural consumption patterns. Novel food applications, by contrast, evaluate ingredients without such a history, requiring extensive scientific and toxicological testing. GRAS compliance services can support both applications by adapting safety data for EFSA requirements.
Food testing confirms that traditional foods meet EFSA’s safety standards by identifying contaminants, verifying nutritional content, and ensuring the absence of harmful residues. This data is critical for passing food safety audits and demonstrating the food’s suitability for the EU market.
Yes, EFSA allows a single application to cover variations of a traditional food, provided the variations share similar production methods, safety profiles, and usage contexts. However, each variation must be clearly documented to ensure compliance with EFSA’s ingredient and additive standards.
The EFSA Traditional Food Application process typically takes 6 to 18 months, depending on the complexity of the food and the completeness of the submission. Conducting a thorough food safety audit and providing comprehensive safety data can help streamline the process and reduce the likelihood of delays.
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