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Food for Special Medical Purposes form part of a larger framework of Food for Specific Groups (FSG). The unique regulatory requirements of Foods for Special Medical Purposes can bring about possible hurdles for Food Business Operators.
In this report, we take a closer look at the legal requirements, specific regulatory framework and we provide tips on how to prevent potential pitfalls from the start.
The appetite for alternative proteins as a substitute to animal proteins is increasing. This is evidently nourishing numerous developments with the innovative use and mixing of plant, algae, insect ingredients through innovative techniques, such as precision fermentation and cell differentiation. To make the research and development worthwhile it is essential to adequately grasp and manoeuvre the regulatory pathway for bringing innovative foods to the actual tables of consumers. This report outlines the legal framework applicable to alternative protein products in the European Union. It particularly focuses on the EU novel food Regulation, being the core Regulation for foods that have no established history consumption in the Europe Union. Explained are the process steps and timelines as well as the important elements to consider for the risk evaluation and the labelling of alternative protein products to guarantee a successful entry into the European Union Market.
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Rapid improvements in the field of cellular agriculture, especially within the area of cultured meat, has regulatory authorities awaiting companies to start submitting applications for the registration of these products. Risk management and risk assessment of foods in the European Union are the responsibility of the European Commission (EC) and the European Food Safety Authority (EFSA). It is currently believed that the first applications for cultured meat will be evaluated in the same way as novel foods for regulatory approval. The existing guidelines that are applicable to all novel foods should be followed by food business operators when submitting applications for cultured meats, as confirmed by EFSA.
In this comprehensive report, we cover the regulatory context for cultured meats in the European Union and demonstrates how they can be adequately assessed for safety in line with EFSA´s Novel Food Guidance.
An interesting addition to this report is the inclusion of the Singapore Food Agency’s updated Novel Food guidance on cultured meats, as Singapore is the first country to approve a cultured meat product.
A comprehensive introduction to the legal definition of GMOs in the EU and the modification techniques that can be applied to food and feed products.
Find out which GM techniques are permitted and how you can still use GM techniques without having to register your product as a GMO food or feed in the EU.
Save time by accessing all key legislation concerning GMOs and links to additional reading material on articles, processes and studies directly from this report.
In the regulatory world, getting the legal classification right is the first step towards regulatory success and can drastically impact your product’s compliance pathway.
Did you know that a product cannot be classified as a feed additive and feed material in the EU at the same time? Follow our guidance on selecting the correct legal status, learn the basics on the registration process of feed additives and find out how to notify a feed material on the EU feed materials register.
Getting innovative food and feed products to market is a complex process and costs a significant amount time and money.
In this report, learn how you can protect the data and studies that you have invested in to support the registration of your product. You will also learn how to navigate the new EU regulation on transparency and understand the process for requesting that data be kept as confidential and which data you can actually request as confidential.