site image

    • Eu novel food application. Faster approvals will support overall food innovation.

  • Eu novel food application Based on information from EU Member States, it provides guidance on foods and food ingredients requiring special authorisation for market entry in the EU. g. This update is particularly important as it will apply to all novel food applications submitted starting in February 2025. For example, Japan's red yeast rice incident prompted stricter oversight of functional food labeling regulations. Making an application. Food business operators can place a novel food on the European Union market only after the Commission has processed an application for the authorisation of a novel food, and has adopted an implementing act authorising the placing on the market of a novel food and updating the Union list. Food businesses can apply through the GB Regulated Products Application Novel food is defined as food that has not been consumed to any significant degree in the EU before 15 May 1997 (when the first novel food legislation entered into force). Novel foods in Europe will be subject to new safety assessments early next year as the European Food Safety Authority updates processes to better reflect the changing landscape and potentially speed up approvals. It describes the administrative This ensures that all Novel Foods are rigorously assessed for safety before reaching consumers. The application dossier is developed in accordance with Commission Implementing Regulation (EU) 2017/2469 . FDA's shift in collaboration with AAFCO is redefining the An applicant who intends to place a novel food on the EU market should apply to the European Commission. To obtain approval, the applicant is required to submit a novel food dossier built in compliance with the latest guidance documents to the European EU Novel Food application Feasibility analysis; EU Novel Food application service; Other customized compliance services; Our strengths . Although algae are considered a safe food, their consumption in the human diet raises concerns about the contaminants that may be present in • The Novel Foods (England) Regulations 2018 (SI 2018/154) (Separate, equivalent legislation in other UK countries) • Aim –to put in place a proportionate and risk based approach to Novel ingredients, such as those produced using precision fermentation, cell culturing, or plant molecular farming, must submit a novel food dossier to the European Food Safety Authority. That is, until now. EIHA estimates that an individual company registering a single product under Novel Food guidelines need to invest between €350,000 and €500,000. Nov 10, 2016 · Summary. Centralised, safety evaluation of the Novel Foods will be Oct 3, 2024 · It also takes into account the updated Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283, which provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. How to apply for authorisation. Faster approvals will support overall food innovation. A food business that wishes to market a novel food or food ingredient for the first time in the Community must submit directly to the European Commission an application using the e-submission system. 1 Novel foods were approved after assessment of the safety data by a suitability of the application The application procedure for novel food authorisation is set down in Article 10 of Regulation EU 2015/2283. Feb 1, 2025 · EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for Novel food applications. Here’s what EIHA’s Board proposed to its members during the General Assembly of June 2019 to create a Novel Food Consortium, with the aim of submitting a joint Novel Food application and share the costs. Application procedure. l. French company Gourmey has applied for approval to the EU for its cultivated foie gras, at the same time as submitting approval Dec 23, 2024 · Currently, there are 1550 different species of algae growing in EU waters, but only 23 have been included as foods or food supplements in the EU Novel Food Catalog (De Araújo and Peteiro Citation 2021). With extensive experience, we have a proven track record of successful cases in Nov 1, 2020 · The main scientific requirements for a novel food application are outlined in the EFSA’s “Guidance on the preparation and presentation of an application for authorization of a novel food in the context of Regulation (EU) 2015/2283” (EFSA NDA Panel, 2016a). In January 2025, EFSA published its scientific opinion on the safety of oil from Schizochytrium limacinum (strain ATCC-20889) for use in infant and follow-on formula as a novel food. 10 and 16 of Regulation (EU) 2015/2283 on novel foods). The guidance applies to all novel food applications, including those for cell-based foods and food ingredients. Aug 15, 2024 · 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. This means that the foods don’t have a ‘history of consumption’. The simplified application route is only applicable where the EU member national competent authority, e. Both documents have already 2. EFSA has launched a call for expressions of interest open to all SMEs working in the area of novel foods who are interested in receiving EFSA’s advice on the application requirements for novel food authorisation in the EU. It is to be read in conjunction with the above-mentioned Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested the European Food Safety Authority (EFSA) to update and develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. Sep 30, 2024 · Administrative guidance for the preparation of novel food applications; This document provides guidance to applicants submitting applications for a new authorisation or for the modification of an existing authorisation of a novel food in the EU, which are to be evaluated by EFSA (art. r. The scope of this administrative guidance document relates to Regulation (EU) 2015/22835 regarding applications on novel foods6, for inclusion in the Union list of novel foods established by Commission Implementing Regulation (EU) No 2017/24707. Additionally, EFSA requested scientific and technical assistance as regards the evaluation of 1 Novel Food. Nov 17, 2022 · To help ensure applicants don't make unnecessary applications, the public has access to the novel foods catalogue - an informal record of discussions at EU level about the novel food status of numerous foods and ingredients. Image/Getty. the scope and included in a specific legislation, which only left the other categories as part of the Novel Food definition. It lays down rules for the placing of novel foods on the market in the European Union (EU), ensuring a high level of protection for human health and consumers’ interests. This is the EU’s first cultivated meat application. Sep 30, 2024 · The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. Novel foods which were authorised in the EU prior to EU exit remain authorised in GB and are listed in The Novel Foods and Smoke Flavourings (Modification of Authorisations) (Scotland) Regulations 2022. The updates include both scientific and administrative guidance that will apply to all new novel food applications from February 2025. Oct 15, 2024 · EFSA releases new novel foods guidance for EU applications. The European Commission and EU Member State authorities decide on whether to approve novel foods for sale on the Request for a novel food authorisation. Sep 30, 2024 · The EFSA guidance identified the essential elements that need to be part of novel food applications pursuant to Article 10 of Regulation (EU) 2015/2283 to support their safety, and served as the basis for the implementation of Commission Implementing Regulation (EU) 2017/2469. This summary will include the name and address of the applicant, the name and description of the traditional food and a brief description demonstrating the history of safe food use in the non-EU country. This can be newly developed, innovative food or food produced using new technologies and production processes, as well as food traditionally eaten outside of the EU. It describes the administrative Under the old Regulation (EC) No 258/97 on novel foods, 228 applications have been submitted to the EU countries pursuant to Article 4 and more than 400 notifications pursuant to Article 5 of that Regulation. Why Apply for EU Novel Food Authorization? The EU Novel Food authorization process is mandatory for products containing Novel Food ingredients. Oct 10, 2024 · This article provides a summary of the EU EFSA Novel Food application and approval status for the third quarter of 2024, for the reference of businesses. The authorisation and use of novel foods and food ingredients have been harmonised in the European Union since 1997 when Regulation EC 258/1997 on novel foods and novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997 ingredients was adopted. It describes the administrative requirements for the preparation and online submission of the dossier to support an application pursuant to Article 10 of Regulation (EU) 2015/2283 for a new authorisation or for the modification of an existing Feb 7, 2025 · In 2024, major regulatory changes were driven by high-profile incidents and evolving policy landscapes. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food Mar 11, 2025 · Uthever® is pioneering the EU novel food application process, the first NMN brand to enter the risk assessment stage, and is now pending approval. , the National Agency for Food, Environmental, and Occupational Health & Safety (ANSES) in France, believes that the novel food in question is substantially equivalent to an existing food or food ingredient. All novel foods, must be approved before being placed on the market. It describes the administrative requirements for the preparation and online submission of the dossier to support an application pursuant to Article 10 of Regulation (EU) 2015/2283 for a new authorisation or for the modification of an existing novel food applications in the context of Article 10 of Regulation (EU) 2015/2283 European Food Safety Authority (EFSA) Abstract This document provides guidance to applicants submitting applications on novel foods in the European Union, which are to be evaluated by EFSA. 6 %¿÷¢þ 317 0 obj /Linearized 1 /L 821769 /H [ 3176 697 ] /O 324 /E 330334 /N 27 /T 815309 >> endobj xref 317 47 0000000015 00000 n 0000001341 00000 n 0000001512 00000 n 0000001659 00000 n 0000001761 00000 n 0000001848 00000 n 0000003176 00000 n 0000003873 00000 n 0000004359 00000 n 0000011570 00000 n 0000025782 00000 n 0000025952 00000 n 0000031601 00000 n 0000031659 00000 n Apr 9, 2025 · Case A: Novel Food Application. The EFSA will issue an opinion within six months of a valid application receipt. The pre-announced changes to the framework are General Pre-Submission Advice : call for expressions of interest in EFSA’s advice for Novel Food SMEs – 2025 edition. 6 As this Regulation came into effect after the EFSA guidance was Mar 24, 2025 · 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. Sep 30, 2024 · The European Food Safety Authority (EFSA) has published new guidance on the submission of novel food applications, which will come into effect in February 2025. Nov 10, 2016 · Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of novel foods. In 2013 Mar 27, 2025 · EFSA’s scientists are responsible for assessing the safety of each novel food application. Aug 1, 2024 · French start-up Gourmey has submitted a novel food application to the EU for cultivated foie gras. If approved, Uthever® NMN will be the first NMN ingredient to receive EU Novel Food certification, granted with the green PASS in the EU market. Oct 3, 2024 · This document provides guidance to applicants submitting applications on novel foods in the European Union, which are to be evaluated by EFSA. Oct 9, 2024 · The updated Guidance on the Scientific Requirements for an Application for Authorisation of a Novel Food in the Context of Regulation (EU) 2015/2283 provides detailed information on the scientific data that applicants must submit. Novel food can be innovative, Oct 23, 2024 · The European Food Safety Authority (EFSA) has updated the guidelines for applications for novel foods in the EU. novel food applications in the context of Article 10 of Regulation (EU) 2015/2283 European Food Safety Authority (EFSA) Abstract This document provides guidance to applicants submitting applications on novel foods in the European Union, which are to be evaluated by EFSA. It involves: Oct 9, 2024 · 1️⃣ 新型食品申请的行政指南（Administrative guidance for the preparation of novel food applications in the context of Article 10 of Regulation (EU) 2015/2283） 2️⃣ 针对第一类新型食品（新食品原料）授权的科学要求指南 （Guidance on the scientific requirements for an application for authorisation of a Why do I need to submit a novel foods application? Foods that were not consumed ‘to a significant degree’ in the EU before 15 May 1997 require an application for use. Novel foods are any food that was not used for human consumption to a significant degree within the United Kingdom (UK) or the European Union (EU) before 15 May 1997. It covers: the description of the novel food; the production process; compositional data; specifications; proposed uses Mar 27, 2025 · Novel Foods are regulated in the European Union by Regulation (EU) 2015/2283. Jan 31, 2025 · 2025’s update means food and drink companies applying for EU approval will spend more time preparing their novel food application. Novel Food is defined as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force. Applicants who intend to place on the EU market a novel food should submit an application to the European Commission (EC), following the requirements established in the May 16, 2025 · Uthever® is pioneering the EU novel food application process, the first NMN brand to enter the risk assessment stage, and is now pending approval. Acheta domesticus powder. Oct 31, 2024 · The EU Novel Food Status Catalogue, established by the European Commission, is a helpful tool to navigate the regulatory landscape around foods that may be considered “novel”. The key goal of a novel foods application is to establish that the food/ingredient is safe under Mar 12, 2021 · This document provides guidance to applicants submitting applications on novel foods in the European Union, which are to be evaluated by EFSA. Meanwhile, new regulations in Brazil and the EU on novel food are shaping future application pathways, and the U. As a result of this legal commitment, the initial Union list contains 125 entries. Mar 26, 2021 · Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. After having verified its validity, the European Commission makes it available to the Member States and mandates the EFSA for a scientific assessment. According to the opinion, no toxicological studies were performed with this novel food substance (NF). The Food Business Division at CIRS Group boasts a professional technical team specializing in the field of “Three New Foods”. It depicts the criteria for what constitutes a novel food and states the requirements for how they are approved and marketed in the industry. These foods must be safe for human consumption, and not mislead the customer in relation to nutritional value if there is the intention that this food will replace another Apr 19, 2024 · 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. (Application submitted on June 11, 2020) Specifications: Feb 24, 2025 · 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. Two legal experts guide us through the often lengthy process and identify common stumbling blocks. In addition, the EU approved nine NF in the second Jun 21, 2022 · As food regulatory consultants, Ashbury can carry out formulation checks to identify whether an ingredient would be permitted in the UK as a non-novel food, an approved novel food, or whether it would need to go through the novel food authorisation process / traditional food process under UK and EU law. Applicant: Società Agricola Italian Cricket Farm S. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well‐structured application to EPRS Updating rules on novel foods Members' Research Service Page 2 of 8 Introduction 'Novel Foods' are foods or food ingredients which were not used for human consumption to a significant degree in the European Union before 15 May 1997 (date of entry into force of the current Novel Foods Regulation). . A simplified, centralised authorisation procedure manged by the European Commission using an online application submission system. Oct 1, 2024 · The EU's food watchdog EFSA has updated its guidelines for novel food applications including cell-based and fermented foods to streamline approval times and clarify that food safety is its highest priority when recommending novel food products for market authorisation. This guidance presents a common format for the organisation of the information to be presented in Sep 30, 2024 · The European Commission tasked EFSA with updating the guidance on how to prepare and submit applications to market novel foods in the EU. Full novel food application . S. %PDF-1. To date, two companies have submitted novel food applications to the European Food Safety Authority (EFSA) for precision fermentation-derived dairy proteins. However, this should reduce the likelihood of delays and help them get products to market quicker. Dec 10, 2024 · In September and October 2024, the European Food Safety Authority (EFSA) revised its guidance concerning the scientific and administrative requirements for novel food applications,. Examples of novel foods include: new foods, for example Dec 31, 2017 · Once a novel food is added to the Union list, then it is automatically considered as being authorised and it can be placed in the European Union market. Jan 23, 2025 · This document provides guidance to applicants submitting applications on new nutrient sources in the European Union, which are to be evaluated by EFSA. From 1997 to 2017 inclusive, decisions have been taken on 103 non-GMO novel food applications and about 77 were still in the process. Additionally, EFSA requested scientific and Apr 17, 2024 · Precision fermentation-derived dairy players have started submitting novel food applications for pre-market approval in the EU. Scientific guidance for novel food applications – Guidelines on safety data requirements for submitted substances. New NF Applications. Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, the European Commission requested the European Food Safety Authority (EFSA) to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of novel foods. Feb 6, 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. When a novel food is intended to replace another food on the market, EFSA ensures that its consumption is not nutritionally disadvantageous. It describes the administrative requirements for the preparation and online submission of the dossier to support an application for a new authorisation of substances proposed as source of nutrients which may be added to food, including food New NF Authorisation Without Delay EC verifies whether the application falls within the scope of the Novel Food Regulation (EU) 2015/2283 and the requirements set out in Jun 25, 2024 · What is regulation EU 2015 2283 on novel foods? Regulation (EU) 2015/2283 is the overarching framework and outlines the list of requirements for novel foods in the EU. It should be acknowledged that the guidance document aims both to be self As of December 2024, several extracts from cell cultures of plant cells to be used in food supplements, as well as compounds produced via precision fermentation, have been authorized as novel foods in the EU; a first application for a cell-based meat product has been submitted in July 2024 (see Section 2). This update consists of two key documents: First, the scientific guidance outlines the scientific information applicants must provide. pyrcfy vfuh uqjzwp gpckyby hqil kszdrb zhhld umeak zvvuybpy rsae