Fortification: A cornerstone of public health, food product innovation and regulatory challenges

5 February 2026 | Sharon Morey, Regulatory Affairs Manager

Food fortification is enjoying a renaissance – no longer just focussed on initiatives for improving public health, consumer interest in health optimisation and food industry innovation to capture market share and the increasing use of GLP 1 medications are shifting attention towards nutrient density rather than calorie intake alone.

In this context, food fortification is not only a public health tool but also a key driver of food innovation, with the market experiencing major growth of products aimed at specific functional areas of health and wellbeing.

Mandatory food fortification

Large scale food fortification programmes are at the core of global nutrition policy, and staple foods such as wheat flour, rice, edible oils and salt are commonly used as effective delivery vehicles for essential nutrients.

The intentional addition of vitamins, minerals or other nutrients to foods remains one of the most effective and evidence based public health interventions. Over decades, it has played a critical role in reducing micronutrient deficiencies worldwide, contributing to lower rates of anaemia, neural tube defects, and other nutrition related conditions.

Around the world the mandatory requirement to fortify certain food products varies. Examples include:

• Milk: Commonly fortified with vitamin D.
• Salt: Iodized salt helps prevent iodine deficiency.
• Flour: Fortified with calcium, iron and B vitamins including folic acid to reduce the risk of neural tube defects during pregnancy.

However, the demand for functional and “better for you” foods aimed at supporting wellbeing or health outcomes is fuelling the growth in products aimed towards more individual proactive health management and personalised nutrition rather than just the bigger public health picture.

Emerging trends in food fortification

Protein may have been the macronutrient superstar over recent years, and it remains a key driver in shaping product innovation, particularly around sustainability and plant based product development that aligns with environmental and ethical consumer values. However, fibre is gaining momentum as the new poster child for the fortification landscape with links to digestive and heart health as well as exciting new sources being used to increase the fibre content of foods.

The increase in the use of GLP 1 receptor agonists for weight management is also influencing dietary behaviour with reduced appetite and lower food intake for users of the medications. The aim of this is to help them achieve nutritional adequacy through an increase in nutrient density from the smaller portions they are able to consume. In this context, fortified foods can play an important role in supporting adequate intake of essential vitamins, minerals, protein and fibre.

For manufacturers, this creates opportunities to develop responsibly fortified products that meet the needs of health conscious consumers and those managing their nutrition medically.

The fortification regulatory landscape in the EU and UK

In the European Union (EU), Regulation (EC) No 1925/2006 governs the addition of vitamins and minerals to foods, specifying which substances and sources are permitted, as well as conditions for use and prohibitions. The UK has retained these provisions in assimilated law, but regulatory oversight is now managed domestically by authorities including the Department of Health and Social Care (DHSC) and the Food Standards Agency (FSA).

The addition of a nutrient is often for a specific reason, either to enhance the nutritional content or to serve a function which would allow the product to be marketed for a particular health aim or marketing purpose. Common foods with voluntary additions include breakfast cereals, often fortified with iron, B vitamins and vitamin D and plant-based drinks which can be fortified with calcium and vitamin B12 to match the nutritional profile of dairy milk.

Some markets require any foods that have had nutrients added to them to be notified to the relevant Competent Authority before being placed on the market. The legislation includes rules on the prohibition of vitamins and minerals being added to unprocessed foodstuffs, including fruit, vegetables, meat, poultry, fish, as well as beverages containing more than 1.2% by volume of alcohol. The definition of food includes drinks and beverages, so the same rules apply to these as well.

Minimum levels

To ensure that fortification is beneficial to health, the EU and UK legislation requires that the final food product contains a significant amount of a vitamin or mineral, meaning vitamins and minerals added to foods must meet this level. A ‘significant amount’ is defined for vitamins and minerals in Annex XIII of the Food Information to Consumers Regulation (Reg No. 1169/2011). In general, this is a minimum of 15% of the reference intake (RI) per 100 g or 100 ml for foods other than beverages, which must have 7.5% supplied by 100 ml (but this reverts to 15% per pack if the beverage pack contains only a single portion).

Interestingly, whilst providing the conditions that have to be met when adding nutrients to a food product, Regulation 1925/2006 does not provide a definition either for a ‘fortified food’ nor for any other terms such as ‘enriched’, ‘functional’ or ‘nutraceutical’ which are often used by industry to describe food products with added nutrients or those that have a perceived benefit due to their nutritional make up.

All foods, including drinks, which have had nutrients added to them fall into the scope of Regulation 1925/2006. The only exceptions to this are foods that have their own compositional standards and requirements, for example infant formula and baby foods or food supplements.

Maximum levels

At the time of writing, no harmonised maximum levels for the addition of nutrients have been laid down in the UK or EU, but some EU Member States have introduced their own rules applicable to their domestic markets on the basis of public health concerns. This means it is advisable to check for any national provisions that may impact or restrict the placing of goods onto a specific market.

Product claims

Any claim regarding the nutritional content or benefit of a food must comply with Regulation (EC) No 1924/2006 on Nutrition and Health claims, which was laid down in EU law the same day as Regulation (EC) No 1925/2006 and which has also been assimilated into the UK statute book.

Regulation 1924/2006 provides the definition of a ‘claim’ as meaning:

“any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics”

Therefore, it could be argued that descriptions such as ‘fortified’ or ‘functional’ foods are themselves claims that imply something about the products composition, and perhaps it is no coincidence that the conditions for making a nutrition and/or health claim are essentially the same as those for adding nutrients to a food.

For example, the ‘significant amount’ needed to be added to a food product for fortification is also the amount needed to be able to claim that the product is a ‘source of’ a particular nutrient. The use of a nutrition or health claim allows the nutritional story of the product to be communicated to the consumer.

With the current focus on nutrient density, food manufacturers need to be mindful of the requirement of both pieces of legislation during product development and in all commercial communications aimed at the consumer target audience.

Nutrient density claims

The permitted list of authorised nutrition claims does not include a claim for ‘nutrient density’ or one that covers a range of nutrients as in ‘packed full of nutrients’, however it does allow for messaging around a specific nutritional content of a product, such as ‘source of’ or ‘high in’ fibre or protein.

Another useful claim to consider, if a product has been reformulated or developed to enhance the content of these macronutrients, is the option for an ‘increased X’ claim. For this the product must first meet the conditions for a ‘source of’ and then have an increased nutrient content of at least 30% compared to a similar product.

Unfortunately, this claim is not permitted to be used when increasing the nutrient density levels of vitamins and minerals by added them to the product, however the options for a ‘source of’ or ‘high in’ claim are still allowed for these if the product meets the conditions laid down in the Annex to the Regulation for these.

For smaller sized portions, it should be noted that the general conditions laid down in Article 6 of Regulation (EC) No 1924/2006 must also be taken into consideration, which means the product has to meet the conditions to make the claim for the quantity of the product that can reasonably be expected to be consumed, which may be less than 100g or 100ml.

Conclusion: Fortification opportunities vs compliance challenges

Food fortification offers clear benefits not only to consumers; it can be a key part of a food business operator’s product innovation strategy. However, it is not simply about adding nutrients – the product has to be viable and also meet any regulatory requirements.

Key challenges include:

• Ensuring nutrient safety, stability and bioavailability throughout the product’s shelf-life to be able to meet a claim;
• Managing minimum and maximum permitted levels to avoid excessive intake or restrictions in specific market arenas;
• Maintaining accurate labelling, and clear, compliant, not misleading claims on pack and in marketing communications.

Success in the fortification space requires a balance between pushing the boundaries of creativity in product innovation and maintaining a vigilance for the requirements of the regulatory landscape for safe compliant food products.

How we can help

If fortification is part of your product innovation strategy, we can help you navigate the regulatory considerations for developing responsibly fortified products that meet the needs of health-conscious consumers.

Our experienced team of Regulatory Advisers can:

• Review market entry requirements for individual markets regarding maximum nutrient limits, prohibitions or notification requirements;
• Assess compliance with the requirements of any relevant legislation and monitor evolving regulatory requirements across markets;
• Advise on the suitability of product claims in relation to the addition of nutrients and for compliance with relevant legislation.

This support is part of our valuable, extensive and authoritative information and advisory service to help clients stay compliant with food regulations in more than 80 countries. Whatever the legislative requirements of your target market, our experienced team of regulatory experts will ensure your products are compliant.

How can we help?

If fortification is part of your product innovation strategy, we can help you navigate the regulatory considerations.

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