In the European Union (EU), a novel food is defined as a food, food ingredient or manufacturing process that has not been consumed or used in the EU before 15th May 1997. All novel foods, must be approved before being placed on the market. To obtain approval, the applicant is required to submit a novel food dossier built in compliance with the latest guidance documents to the European Commission. The dossier will be scientifically assessed by the European Food Safety Authority (EFSA). Since the implementation of the Novel Food Regulations in 2018, EFSA has issued several guidance documents to facilitate applicants in their application activities. In September 2024, EFSA updated its guidance concerning the scientific and administrative requirements for novel food application.

On September 30, 2024, the European Food Safety Authority (EFSA) issued new regulations regarding novel foods, including: Administrative guidance for novel food applications – Guidelines on the procedural requirements for submitting applications. Scientific guidance for novel food applications – Guidelines on safety data requirements for submitted substances. Both documents have already taken effect on February 1, 2025.

According to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, in the last quarter of 2024, EFSA published assessment results for 5 Novel Foods (NF), including the application for 2 new NF and the modification for 3 novel food already authorized. Additionally, EFSA requested scientific and technical assistance as regards the evaluation of 1 Novel Food.

According to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, in the third quarter of 2024, EFSA published assessment results for two Novel Foods (NF), including two new NF applications. In addition, the EU approved ten NF in the third quarter of 2024, including amendments to the specifications and conditions of use of five already authorized NF.

Hydroxytyrosol is a naturally occurring polyphenol primarily found in olives and their products, such as olive oil and olive leaves. It is widely studied for its outstanding antioxidant properties and has numerous applications in the food and cosmetic industries. As a powerful antioxidant, hydroxytyrosol helps reduce oxidation in foods, extending shelf life and preserving flavor. Due to its health benefits, hydroxytyrosol is often added to health foods to support cardiovascular health, boost immunity, and reduce inflammation.

According to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, in the second quarter of 2024, the EFSA published assessment results for three Novel Foods (NF), including one new NF application, modification of one already authorized NF, and notification on one new traditional food from a third country. In addition, the EU approved nine NF in the second quarter of 2024, including amendments to the specifications and conditions of use of three already authorized NF.

In order to help enterprises better understand the application of GM food raw materials in Europe, China, and the United States, CIRS is launching this webinar to introduce the application process and materials required, and share our experiences.

On April 10, 2024, the European Commission issued Implementing Regulation (EU) 2024/1037, (EU) 2024/1047, (EU) 2024/1046, and (EU) 2024/1048, having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, authorizing the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acid, 3'-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637), beta-glucan from Euglena gracilis microalgae, and protein concentrate from Lemna gibba and Lemna minor as a novel food. These Regulations enter into force from April 30, 2024. On April 11, 2024, the European Commission issued Implementing Regulation (EU) 2024/1052, authorizing the placing on the market of calcidiol monohydrate as a novel food. This Regulation enters into force from May 1, 2024. Moreover, the the European Commission amended the specifications and conditions of use of 3 already authorised novel foods, namely astaxanthin-rich oleoresin from Haematococcus pluvialis algae, lactitol, and galacto-oligosaccharide.

In the first quarter of 2024, according to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, EFSA published assessment results for 6 Novel Foods, including applications for 4 new Novel Foods, notification on 1 new traditional food from a third country and the modification of 1 novel food already authorized. Additionally, EFSA requested scientific and technical assistance as regards the evaluation of 1 Novel Food, and there were no new authorizations (approvals) for Novel Food in the EU in the first quarter of 2024.

We have made a list of free webinars scheduled for 2024 for your reference.