The European Food Safety Authority (EFSA) is inviting small and medium-sized enterprises (SMEs) working on novel food products to receive advice on the requirements for applications to obtain authorization to market their innovations in the EU market.
As stated by EFSA, the initiative aims to support SMEs with no or limited experience by providing general pre-submission advice (GPSA) at two stages of their novel food development and application process:
At the very early stage of developing the novel food, even before starting the studies that will be included in the application.
At the latest stages of the application’s preparation, when most of the information that will be included in the application is already available to the SME.
Selected SMEs will receive valuable advice from EFSA, from tailored advice on requirements to specific regulatory clarifications, to improve the quality of applications
The initiative aims to help SMEs, which constitute most of the applicants in the area of novel foods, streamline the process and improve the chances of obtaining authorization to market their novel food in the EU.
Applicants can submit their Expression of Interest by the 31st October, 2024.
© Gourmey
From plants to cell-based
Any food that was not consumed “significantly” prior to May 1997 is considered to be novel food in the EU. Some plant-based ingredients, proteins from precision fermentation, certain mycoproteins, and cultivated meat fall into this category. The French startup Gourmey recently became the first company to apply for regulatory approval to sell cultivated meat in the European Union.
As explained by Mathilde Do Chi, the managing director at Forward Food Law, besides ingredients that require processing or food tech, novel food pre-market approval also concerns traditional foods from third countries (not a member of the European Union) that have been consumed abroad but not in the EU, such as chia seeds.
It is worth noting that foods produced using food tech and a previously consumed microorganism do not necessarily have to undergo the novel food process. Recently, the German startup Formo launched a range of cheese featuring a Koji protein from the fungi Aspergillus oryzae, which has been widely used in soy sauce and miso production. By using this non-GMO fungus strain the company bypassed the novel food process, allowing it to launch sooner.
© Mohith Gowda-sorck.adobe.com
Scientific advice on the safety of foods
Novel foods represent a significant opportunity in the EU, mainly because most innovations aim to replace animal products to address the impact of their production on the environment, resource use, and ethical concerns regarding animal welfare.
Nonetheless, these foods must navigate challenges like perceptions of threat to traditional foods, regulatory biases, and the need for consumer acceptance. For example, some EU member states, including Italy, France, and Hungary, view novel foods as threats to their culinary heritage, leading to initiatives to ban or restrict them.
EFSA clarifies, “An applicant who intends to place a novel food on the EU market should submit an application to the European Commission (EC). After verifying its validity, the EC makes it available to the Member States and mandates EFSA for a scientific assessment.
“EFSA does not authorize the marketing of novel foods. Its role is to provide, upon request of the EC, independent scientific advice on the safety of the novel food before it can be placed on the EU market.”
More information on EFSA’s call can be found here.
