DEFINITION
Last update: 08/04/2024
The definition of a Novel Food may vary by geographies
In China, Novel food materials refer to items that have less than 30 years of eating history in a province area of China and can be of the following types:
- Animals, plants and microorganisms;
- Components isolated from animals, plants and microorganisms;
- Food ingredients whose original structure has changed;
- Other newly developed food raw materials.
According to Regulation (EU) 2015/2283 [1], ‘novel food’ is “any food that was not used for human consumption to a significant degree within the Union before 15 May 1997” and that falls under at least one of the following categories of foods consisting of, isolated from or produced from:
- Food with a new or intentionally modified molecular structure;
- Microorganisms, fungi, algae;
- Material from mineral origin;
- Plants or their parts without history of use;
- Animals or their parts without history of use;
- Cell cultures or tissue cultures derived from animals, plants, micro-organisms, fungi or algae;
- Food resulting from a production process significantly changing the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
- Food consisting on engineered nanomaterials;
- Vitamins, minerals and other substances manufactured with a process without history of use or containing or consisting of engineered nanomaterials;
- Food used exclusively in food supplements intended to be used in foods other than food supplements.
This Regulation does not apply to the following foods:
- Genetically modified foods (ref.: Regulation (EC) No 1829/2003)
- Food enzymes (ref.:Regulation (EC) No 1332/2008)
- Food additives (ref.: Regulation (EC) No 1333/2008)
- Food flavorings (ref.:Regulation (EC) No 1334/2008)
- Extraction solvents for foodstuffs or food ingredients (ref.:Directive 2009/32/EC).
The traditional process to get a product approved as a Novel Food is to submit a dossier to the EC that can request an opinion from the European Food Safety Authority (EFSA), to act as an impartial source of scientific advice to evaluate the risks and benefits of the product.
Novel food has not been formally defined by federal regulations. The current regulatory approach to “novel” or new foods, food substances and food technologies can be a collaborative effort involving the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA). The FDA approach to new or “novel” food relies on the existing protocols applied to conventional food. A novel food or food ingredient may be authorized through a Generally Recognized as Safe (GRAS) notification in which a company can submit a GRAS notice to the FDA, or self-affirm the GRAS status based on an independent scientific review by qualified experts of the ingredient and its intended use. If a new substance is regulated as a food additive, then the additive should obtain pre-market approval through the FDA Food Additive Petition process. The USDA and FDA collaborate in the development of regulations and split regulatory oversight of some new foods such as human food made from cultured animal cells [3].
Dietary supplement products can legally contain any ingredients accepted in the U.S. food supply prior to October 1994. If a dietary supplement manufacturer introduces a New Dietary Ingredient (NDI), then a NDI notification affirming the safety of the ingredient must be submitted to the FDA prior to marketing the product.
In 2017 [5] the Food Standards Australia New Zealand,defined novel foods as:
- Non-traditional foods requiring public health and safety assessment considerations with regard to potential for adverse effects in humans, or composition or structure, or the preparation process, or the source of derivation, or the patterns and levels of consumption, or any other relevant matters. Those may include, but not limited to, the following: plants or animals and their components and extracts; herbs and their extracts; dietary macro-components; single chemical entities; microorganisms, including probiotics; foods produced from new sources, or by a process not previously applied to food.
- Non-traditional food:
- a) food without history of consumption;
- b) food-derived substance without history of consumption;
- c) any other substance and its source without history of consumption.
ANVISA (Agência Nacional de Vigilância Sanitária) published in 1999 a guidance document on “new foods” where they were defined as “FOOD AND/OR NEW INGREDIENTS: foods or substances with no history of consumption in the country, or foods containing substances already consumed which in the meantime have been added or used at levels much higher than those observed in foods used in a regular diet”. The guidance is now under review to include all novel foods and new ingredients [11].
The National Department of Health (DOH) is the primary regulatory authority for food safety. There is currently no regulations defining new or novel foods in South Africa.
