ZMUni Compliance Centre

ZMUni Compliance Centre

EU Novel Food Application
EU Novel Food Application

Our Services

  • Feasibility analysis for EU Novel Food application
  • Application for EU Novel Food
  • Testing services
  • Other customized compliance services

 

Definition of EU Novel Food

Novel Food refers to any food that has not been widely consumed by humans in the European Union before May 15, 1997 (Regulation (EU) 2015/2283). It can include newly developed and innovative foods, foods produced using new technologies and production processes, as well as foods with traditional consumption habits in regions outside the European Union.

 

For example, foods such as vitamins with new sources, extracts from existing foods (such as Antarctic krill oil rich in phospholipids), agricultural products from third countries outside the European Union (such as chia seeds, noni juice), and foods produced using new production processes (such as ultraviolet-treated foods like milk, bread, mushrooms, and yeast) all fall under the definition of Novel Food.

 

Classification of EU Novel Food Application

Category 1 (Authorization Application):

  1. Foods composed of animal, plant, microbial, fungal, algal, and mineral sources, or composed, isolated, and produced from cell cultures and tissue cultures;
  2. b) Foods using new processes and structures (including foods containing engineered nanomaterials and foods with molecular modifications and new molecular structures, as well as foods produced using new processes that change the original ingredients and structures, such as vitamins and minerals);
  3. c) Foods originally intended for food supplements that are now intended to be classified as regular foods.

 

Category 2 (Notification Application): Traditional foods from third countries outside the European Union (should have a consumption history of more than 25 years).

 

It is worth noting that EU Novel Food does not include genetically modified foods, food enzyme preparations, food additives, edible spices, and extraction solvents used in food and food ingredient production.

 

EU Novel Food Application Documents: Category 1 (Authorization)

  • Name and address of the applicant
  • Name and description of the novel food
  • Description of the production process of the novel food
  • Detailed composition of the novel food
  • Scientific evidence proving that the novel food does not pose a safety risk to human health
  • Relevant analysis and validation methods, if necessary
  • Recommendations on the expected scope of use and specific labeling requirements

 

EU Novel Food Application Documents: Category 2 (Notification)

  • Name and address of the applicant
  • Name and description of the traditional food from the third country
  • Detailed composition of the traditional food from the third country
  • Country of origin of the traditional food from the third country
  • Documented data proving the safe history of food use in the third country
  • Recommendations on the expected scope of use and specific labeling requirements

 

Related Regulations and Supporting Documents of EU Novel Food

  • Regulation (EU) 2015/2283 (Novel Food Framework and Related Systems)
  • Regulation (EU) 2018/456 (Requirements for Novel Food Application Materials)
  • Regulation (EU) 2017/2469 & 2017/2468 (Implementation Methods and Related Provisions for Novel Food)
  • Regulation (EU) 2017/2470 (Novel Food List Catalog)
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