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Novel food is becoming increasingly popular, but food manufacturers need to comply with regulations and laws to remain compliant. The EU Novel Food Regulations are a set of rules that govern how and when products that have not been previously consumed or used in the European Union (EU) can be marketed to consumers. You may be wondering why this is important, but if you have recently developed a novel food product it is important that you know what the rules surrounding its marketing are before you begin selling your new product. For more information on the European compliance services we offer click here:
Novel food is food or ingredients that are not traditionally consumed by humans. It could be a product of new technologies and practices, such as plant-based meat alternatives, non-dairy milks, nutraceuticals, and enzyme products. Manufacturers of these products need to meet strict safety standards issued in the European Union (EU) Novel Food Regulation.
Foods with long-established history of safe use in the EU are not considered novel foods: for example bread, milk, cheese and butter; meat products such as beefburgers; fish fingers; soft drinks etc.. In addition to these many other categories of processed foods which have been produced over many years will also not be considered new or innovative enough to require authorisation under Regulation EC/1829/2003 as amended by Regulation EC/1072/2008.
You can find out more about the regulations around Novel Foods in the European Union on the following websites:
Similarly, Ireland’s Food Safety Authority has published an extensive list of guidance documents relating to novel foods that are worth checking out if you’re interested in learning more about this topic.
Novel foods and ingredients can be used to create new and innovative products within the food industry. They have great potential in terms of both texture, flavor and nutrition, and provide an excellent platform for product developers to explore different options, offering meals that are healthier yet still enjoyable. Examples may include nutrient-dense snacks, probiotic fermented drinks, plant-based dairy alternatives or vegetable-based entrees.
The EU Novel Food Regulations are set out in the EU Novel Food Guidance Document. This document is intended to assist you with your compliance with the regulations and it should be read in conjunction with the EU Novel Food Regulation (EC) No. 258/97 and Commission Delegated Regulation (EU) 2016/1052.
The Commission has also published a Guidance Note on how national authorities should apply the principles of mutual recognition when considering applications under Articles 10(1)(a) and 10(2) of Regulation 258/97. The Guidance Notes were updated in 2016 following input from stakeholders at an industry forum held in Brussels on 26 September 2015 as well as comments received during a public consultation exercise conducted between 17 January 2016 – 2 April 2016.”
Novel food regulations are designed to protect consumers from potential risks associated with the consumption of novel food. Manufacturers must comply with the EU’s Novel Food Regulation to ensure safety and quality standards for their products. Regulations affect novel food in a variety of ways, including ensuring that the food is free from contaminants, properly labeled, and meets nutritional requirements. It also requires manufacturers to conduct testing on the ingredients used in their products and provide evidence of safety for both consumers and the environment.
Labelling is a key component of the novel food regulations in Europe and other countries. Manufacturers must ensure that the labels for their products are clear, accurate, and informative about the ingredients, nutritional content, and potential allergens present in their products. In addition, any health claims made by manufacturers must be supported by scientific evidence. In some cases, manufacturers may also need to provide information about the production processes used for their products.
Before any new food ingredient is determined to be safe for human consumption, it must undergo thorough evaluation and approval from the appropriate authorizing bodies such as the European Food Safety Authority (EFSA). As a regulatory environment, the EU requires that all novel foods and ingredients within its jurisdiction meet safety criteria in terms of potential toxicity or allergenicity. In addition to this, other areas such as nutrition, processing methods and labelling requirements are also strictly examined. After the process has been successfully completed, the novel food will then receive authorization allowing commercial use.
In the European Union, guidelines for novel food are governed by the European Commission (EC), and detailed regulations are enforced by the European Food Safety Authority (EFSA). Other countries have their own independent regulatory bodies, so it’s important to research the guidelines in each region you plan to sell your products. Additionally, many governments have specific requirements for obtaining approval before offering a novel food product on the market. Make sure you understand all relevant regulations and obtain the necessary approvals before launching your product.
Companies marketing and selling novel food products need to be aware of government regulations as well as consumer expectations. Packaging should clearly explain what the product is and how it differs from conventional foods, as consumers may not be familiar with these ingredients or products. Additionally, companies must provide clear nutrition labeling that meets all legal requirements, as this information helps consumers make an informed choice about their food purchases.
The Foodlaw-Reading database is a free online resource for companies and individuals who want to find out more about food law. It contains information on all aspects of food law, including the regulations around novel foods. For specific and dedicated support in ensure your complying with novel food regulations we’d recommend you book a consultation with one of our food experts. You can learn more about the EFSA traditional and novel food ingredient regulations by clicking here:
With a team of federal experts, we inform and guide businesses about Food Product Classification, Food Supplement Classification, Formula Review, Label and Claims Review, Claims Consultation and Substantiation, EU Country-specific Regulatory Support, Dossier Compilation and Submission, Food products / Food Supplements Import Guidance. Our end-to-end EFSA regulatory solutions:
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