Biofortification standards, regulation and acceptability

Biofortification to enrich the nutrient levels of crops and foods holds great promise to improve health. But for biofortification to be effective as a way of improving public health, the products of biofortification must meet consumer preferences and demand, the commercial demands of buyers and food producers, as well as regulatory demands of governments and regulators.

Key to delivering this are the consensus-based standards and regulations that give consumers confidence in the products that also align with the requirements of food producers and regulators. To protect the value of biofortification, standards are essential to distinguish biofortified products from their regular or common market alternative.

Within the Biofortification Hub, we are keen to play a role in helping the community to come together to develop and refine standards and regulations around biofortification that are suitable for all stakeholders.

Definition of biofortification

A possible definition for biofortification would be “the process of increasing the nutrient density of crops and food.”  This is distinct from fortification with exogenous nutritious compounds that are added to foods and crops to improve their nutrient content during processing. The definition of biofortification encompasses the many different ways in which nutrient levels are improved.

It is important to note that it is products of biofortification that are subject to regulations and standards, rather than the process itself. Whatever biofortification process is used, the product will be subject to a framework of existing regulations concerning the development of novel foods, health claims and standards to ensure safety, quality and consistency. Regulations can also help with the development of standards. Currently, The Food Standards Agency (FSA) is responsible for all food and feed regulatory approval in England, Wales and Northern Ireland, working alongside Food Standards Scotland.

Nutrient-enriched crops and food products developed through biofortification can be brought to market through the current frameworks. Jenny Walton, previously Head of Commercialisation and Scaling at HarvestPlus commented, “the lack of global or unified definition of biofortification shouldn’t hold anything back.” It is equally important that current or future regulation, whilst ensuring food safety, does not hinder innovation.

Nutrient-enriched biofortified crops and food standards, regulation and acceptability

This topic was reviewed by Tora Mitra-Ganguli, Wolfgang Pfeiffer and Jenny Walton in “The global regulatory framework for the commercialization of nutrient enriched biofortified foods” (2022) Annals of the New York Academy of Sciences.

Their review of standards, regulations, and laws across the value chain in 20 countries shows that existing provisions for food labelling are sufficient to carry out sales and marketing of foods made from conventionally bred nutrient-enriched crops.

They argue that the simplest and most effective way to signpost healthier products to consumers is through promoting the natural source of the nutrients and the relevant nutrition and health claims.

They also highlight the importance of standards, through the development of a globally relevant Publicly Available Specification (PAS) that allows traders to demand nutrient-enriched staple grains such as those with increased zinc, iron, or vitamin A content.

Ultimately, the acceptability of nutritionally enhanced food via biofortification will require the involvement of all stakeholders from policy makers, to farmers and consumers.

Standards for biofortification

Standards are consensus- based, documents that provide an alternative to regulation by providing common languages, terminologies guidelines and good practice developed by and for stakeholders. For nutritionally enhanced biofortified products, standards can provide assurance and transparency for crop traders, food manufacturers, retailers, government agencies and ultimately populations that conditions that make food or its ingredients nutritionally superior have been met.

In the UK the British Standards Institution (BSI) is the national standards body and founding member of the International Standardization Organization (ISO). Standards are part of a global system, supporting businesses and organisations across the world by setting best practice to facilitate international trade.

The principle when developing standards is that they are developed by stakeholders for a market need, and HarvestPlus have worked with BSI to develop standards relating to nutrient-enriched crops that provide assurance for buyers and increase market confidence. BSI have launched 3 Publicly Available Specifications developed through this collaboration which are linked to below.

Examples of international, independent standards

Also called Publicly Available Specifications (PAS), these determine the amount of micronutrient required within a crop for it to be designated biofortified or nutrient enriched are available from the British Standards Institution (BSI).

More information on these was included in a presentation by Emily Field from the BSI at the Biofortification Hub Workshop on “Rules and regulations for biofortified commodities in the UK” held at London Metropolitan University, UK in September 2024. You can find out more about these standards at BSI’s website.