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European Union
CIRS Group is to exhibit at the Vitafoods Europe 2025 during 20-22 May, 2025 in Barcelona. Come visit our stand where we will be happy to discuss global food regulations (EU, China, and USA), and offer our advice and share our experience in the food regulatory areas.
As defined in the Regulation (EC) No 1333/2008, food additive shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods.
As defined in the Regulation (EC) No 1332/2008 on food enzymes, “food enzyme” means a product obtained from plants, animals or micro-organisms or products thereof including a product obtained by a fermentation process using micro-organisms “food enzyme preparation” means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.
The application of synthetic biology in food production continues to deepen. In response to this trend, the European Food Safety Authority (EFSA) has updated its guidance for novel food applications, further refining requirements for products derived from synthetic biology
Regulation (EC) No 1831/2003 defines feed additives as substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the following functions: satisfy the nutritional needs of animals, favourably affect: the characteristics of feed or animal products; the colour of ornamental fish and birds; the environmental consequences of animal production; animal production; performance or welfare; or have a coccidiostatic or histomonostatic effect.
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.