Global Overview of Novel Foods Mayowa Afolayan, July 24, 2024July 24, 2024 Generally, novel foods have been defined as foods that have not been significantly consumed to be considered safe for human consumption or foods with no history of human consumption. However, the use or adoption of this definition and foods that can be considered novel depends on the regional or national regulations in place to regulate such foods. In Europe, the European Commission is the singular authorized body responsible for defining, authorising, assessing, evaluating, implementing, and managing information about the status of novel foods. According to European Union Regulation (EC) No 258/1997, a novel food is defined as any food that was not used for human consumption to a significant degree within the continent before 15 May 1997. Before the introduction of this Regulation, no restriction was placed on what food can be placed or cannot be placed in the market as the consumption of traditional and new food products is generally regarded as safe for human consumption. This regulation was established to ensure that the novel foods would not pose safety risks to the consumers, would not misinform, or mislead the consumers, and would not cause nutritional disorder. However, a gap was noticed in this Regulation which left out a grey area that was not addressed adequately, this grey area is divided into two categories: the food products that can be subjected to different interpretations, and those food products that were erroneously not considered as novel due to gap and inadequacies in the Regulation. This gap has now been closed with the introduction of the new Novel Foods Regulation (EU) 2015/2283. This Regulation apart from defining what novel food is, which is not different from how it is defined in Regulation (EC) No 258/1997, Article 3, paragraph 2 of Regulation (EU) 2015/2283 went further to clearly state which foods can be qualified to be regarded as novel foods. Food products or ingredients are thus considered to be novel if: The food has a new molecular structure, or the structure has been intentionally modified and provided such structure was not in existence before 15 May 1997 The food consists of or has been isolated or produced from microbes, such as fungi or algae The food consists of or has been isolated or produced from material of mineral origin The food consists of or has been isolated or produced from plants or plant parts, except the food has been historically considered as safe and was produced through traditional propagating methods used before or non-traditional practices which have not been used before 15 May 1997 and have not altered the composition or structure of the food. The food consists of or has been isolated or produced from animal or animal parts, except for animals that were bred with practices that have been in use before 15 May 1997 and are known to have a history of safe use. The food consists of or has been isolated or produced from cell culture or tissue culture obtained from animals, plants, microbes, fungi, or algae. Food produced using a production process that has not been used before 15 May 1997, gives rise to significant alteration of the food composition or structure which can affect its nutritional value, metabolism, or toxicity level. The food consists of engineered nanomaterials or vitamins, minerals, and other substances that contain or consist of nanomaterials or a production process that has not been used before 15 May 1997. Countries such as China, Canada, Australia, and New Zealand have also come up with Standards and Regulations to define and regulate novel foods. In Australia and New Zealand, novel foods are regulated by Food Standard 1.5.1, the Standard forbids the sale of novel foods unless they are authorised and listed in the Standard with full compliance to any special conditions that have been spelt out. The Standard defines novel food as food with no history of human consumption in Australia or New Zealand or derived from food or substances with no history of human consumption. In Canada, novel foods are defined and regulated by the Food and Drug Regulations, which were set out in B.28.001 of the Regulations. It defines novel food as food or substances with no history of safe use, or food that has been produced by a new process or genetically modified food derived from animal, plant, or microbes. In China, novel foods are regulated by the Administrative Measures of Novel Foods (2007), which is a subset of China Food Hygiene Law. Novel foods are regarded as animals, plants, and microbes that are not traditionally consumed in China, or derived from animals, plants, and microbes with no history of consumption in China. New class of microorganisms used during food processing, and food materials that have been structurally or compositionally modified by a new processing technology. In the US, no special definition or recognition is given to any food that might be considered novel, for example in the EU. The food regulatory agency in the US, the Food and Drug Administration (FDA) has no formal definition for novel food and as such not recognised. Therefore, the food considered as a novel food in other clime is treated like any other food in the US, and if any new substance is to be added to food, such food is subject to pre-market approval by the FDA through the Food Additive Petition (FAP) process unless it has been generally recognized (GRAS) as safe by a qualified expert. And once approval is given through FAP the food can access the US market without any restriction. Agri-Tech Food security Innovation Novel foods