Since the new EU regulation on novel food came into effect in January 2018, the process for scientific risk assessment of a novel food application has been centralised. EFSA performs risk assessments on the safety of a novel food upon request by the European Commission. Novel food. EFSA carries out its safety assessment based on dossiers provided by applicants. Dossiers need to contain data on the compositional, nutritional, toxicological and allergenic properties of the novel food as well. Novel food applications: regulations and guidance. EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for the evaluation. EFSA's guidance is updated regularly so applicants should check they are using the latest version before applying In accordance with the requirements laid down in the Novel Food regulation, the European Commission will make the summary of the application publicly available based on the information concerning the name and address of the applicant, the name and description of the novel food and scientific evidence demonstrating that the novel food does not pose a safety risk to human health To best support novel food applicants, EFSA is organising a dedicated webinar to explain the procedure for handling applications in the area of regulated products. The webinar will be structured around the questions that are most commonly received from applicants. Applicants, including business operators, small and medium-sized enterprises, as well as laboratories/testing facilities will be able..
All the resources you need to assist you with the submission and the monitoring of an application for regulated products, substances and processes, and the substantiation of claims submitted for authorisation in the European Union. Second webinar on: Application procedure for feed additives (08/07/2021) 'Novel Food' can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU. Examples of Novel Food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic Krill oil rich in phospholipids from Euphausia superba), agricultural products from third countries (chia seeds, noni fruit juice), or food derived from new production processes. The Novel Food Catalogue lists products of animal and plant origin and other substances subject to the Novel Food Regulation, based on information provided by the EU Member States. It is a non-exhaustive list and serves as orientation on whether a product will need an authorisation under the Novel Food Regulation. EU countries may restrict the marketing of a product through specific legislation. For information, businesses should address their national authorities .g. novel foods, food contact materials, food/feed additives and pesticides. The Guidance takes account of the new developments that have taken place since publication of the previous Guidance in 2011. Potential future developments are suggested in the scientiﬁc literature for nanoencapsulated delivery systems and nanocomposites in.
The Regulation requires that all applications for the authorisation of novel foods shall be submitted to the Commission who may then request a risk assessment from the European Food Safety Authority (EFSA). In assessing the safety of novel foods, EFSA shall, where appropriate, consider the following The single public interface for all information related to EFSA's scientific work. Follow the risk assessment process from receipt of the dossier to adoption of the opinion: status of assessments, dossier and studies (non-confidential versions), meetings agenda and minutes, info on experts, etc... Open EFSA
Among these insects, the yellow mealworm (Tenebrio molitor larva) is the first which has been evaluated by EFSA following a novel food application. EFSA has recognized that this insect larva was safe under the proposed uses and use levels. The dried Tenebrio molitor larva contains between 56 and 61% protein and 25-30% fat. It is proposed to be used in various foodstuffs, including snacks. EFSA said the most popular novel food applications in the last two years have been for plants, micro-organisms, fungi, algae and modified molecular structures. Other eye-catching products include mushroom powder enhanced with vitamin D2 and the dried miracle berry , a West African fruit that can make sour foods consumed afterward taste sweet, such as lemons and limes, according to its manufacturers As of 1 July 2022, a new composition of the Management Board of the European Food Safety Authority (EFSA) will be put in place. Applications are therefore invited for the positions of members of the Management Board of the European Food Safety Authority demonstrating active involvement in organisations representing civil society and food chain interests. The duration of the term of office of the new members, will be four years, starting 1 July 2022 The Commission has prepared a user guide to give assistance to food businesses on the use of the e-submission system for novel foods applications. EFSA has developed two guidance documents that outline the scientific information and data needed for the safety assessment of novel foods
Novel foods authorisation requirements and what you need to submit as part of a novel food application. This page is part of the Regulated products application guidance Novel foods are foods which have not been widely consumed by people in the UK or European Union (EU) before May 1997. This means that the foods don't have a 'history of consumption'. Examples of novel foods include: new. The application has been written in the EFSA register of questions meaning that EFSA will assess the safety of the use of the compound under the proposed uses. The application follows an initial novel food application on hemp-derived cannabidiol launched in 2016. With the subsequent application, the company hopes to bypass the distrust around the hemp origin of the substance The safety assessment of novel foods (NF) (defined by EU legislation as foods or ingredients that have not been used for human consumption to a significant degree in the EU before 15 May 1997) and nutrient sources (NS) (e.g. sources of vitamins and minerals) is carried out by EFSA, particularly the Panel on Nutrition, Novel Foods and Food Allergens (NDA Panel) and its Working Group on. EFSA are currently considering a novel food application for CBD for use in food supplements in adults with a daily intake of up to 130 milligrams (mg). A final opinion is expected from March 2019. If EFSA's opinion is positive, the EC will draft an implementing act permitting the use of the product within seven months. The European Industrial Hemp Association (EIHA), which only last October.
2 an application for authorisation of a Novel Food 3 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) 4 5 Abstract 6 Following the adoption of a new Regulation ((EU) 2015/2283) of the European Parliament and of the 7 Council on Novel Foods, the European Commission requested the European Food Safety Authority to 8 update and develop scientific and technical guidance for the.