Selection of different flour types in brown sacks

Bread and flour regulations amended to help protect health of babies in England

25 November 2024 | Sharon Morey, Regulatory Affairs Manager

The long awaited amendments to the 1998 Bread and Flour Regulations in England were finally introduced on 14 November 2024 ¹. As well as including some minor technical amendments the new amending legislation will require millers and flour producers in the UK to fortify non-wholemeal wheat flour with folic acid from the end of 2026.

The Bread and Flour (Amendment) Regulations 2024 also contain some minor technical changes and updated enforcement provisions that will take effect from 13 December 2024.

The rationale behind the change

Folic acid deficiency is one of the leading causes of neural tube defects (NTDs), which can cause serious and debilitating conditions to babies in the womb, including spina bifida. The Department of Health and Social Care predict that around 200 cases of brain and spine defects in babies will be prevented every year as well as significant cost savings to healthcare needs by fortifying non-wholemeal wheat flour with folic acid ².

The history of flour fortification

This new requirement is the latest development in the saga of flour fortification in the UK, which began by adding nutrients to wheat flour back in 1941 during the Second World War, to address nutritional deficiencies caused by food rationing and shortages.

The original nutrient added to non-wholemeal flour was calcium with the aim of helping to prevent rickets. Over the years, iron, niacin, and thiamine were also added to the list of mandatory nutrients in flour to further improve public health outcomes. The existing 1998 regulations are only the latest version of the UK’s flour fortification legislation since their introduction in the 1940s, which dictate that non-wholemeal wheat flour milled in the UK must be fortified with calcium, niacin, thiamine and iron. The expansion of this list to include folic acid has been actively debated for more than 30 years.

The Scientific Advisory Committee on Nutrition (SACN) published an opinion back in 2006, which recommended folic acid fortification. In addition, the NHS echoes the advice of the UK’s Chief Medical Officer that women who are trying for a baby take a 400mcg folic acid supplement for around 3 months before getting pregnant and for at least 12 weeks after becoming pregnant ³.

This recommendation will continue after the new amendment to the Bread and Flour Regulations are in force to help provide women with a higher baseline intake of folic acid, primarily in unplanned pregnancies, to help offer better protection to babies in all scenarios.

An international story

Whilst the UK has a long history of flour fortification it is somewhat late to the party in terms of the addition of folic acid. A significant number of countries already require fortification of this and or other nutrients, mainly iron, calcium and some B vitamins such as thiamine, riboflavin and niacin. This includes Australia, New Zealand and Canada, but according to the Food Fortification Initiative there may be more than 80 countries globally who mandate the addition of folic acid to reduce the incidence of NTDs ⁴.

Practical implementation and labelling changes

The new regulations are only applicable to England, but the other UK devolved nations are considering their own measures in this area which are at various stages of development. The technical changes and updated enforcement provisions that have been made take effect from 13 December 2024. The folic acid provision will come fully into force on 13 December 2026.

The new regulations come with a two year transition period until the 13 December 2026, to allow time for the adjustment in flour production processes to incorporate folic acid fortification. UK millers have been working with Regulators on the practical implications of making this change for many years already. There is an exemption granted for small-scale millers producing less than 500 metric tonnes of flour per year, so they do not need to comply with the new requirements.

Once a miller has made the change to add folic acid into the flour, this will then have to be translated throughout the supply chain to ensure that accurate information on the compositional make up of the flour is communicated right through to the end consumer.

It will be necessary to amend the labelling and packaging of all non-wholemeal flour sold, as well as finished products where the flour is used as an ingredient to reflect the addition of folic acid. The flour is declared as a compound ingredient in an ingredient list with the added nutrients listed out after the wheat flour, for example “Wheat flour (Wheat Flour, Calcium Carbonate, Niacin, Iron, Thiamin, Folic Acid).

Changing labels is time-consuming and costly and there may be uncertainty as to when the new updated flour raw material will be ready to be incorporated into the supply chain.

To minimise the risk of either under or over declaring the presence of folic acid on a finished product label, it will be necessary for Food Business Operators to plan this latest change into a label update schedule well in advance. This will help to ensure their compliance by the end of the two-year transition period.

Incorporating the change into other labelling updates where possible is recommended. Guidance from Regulators for both industry and Enforcement officers is expected to be published in due course.

If you have any questions or require further information on the requirements of the Bread and Flour (Amendment) Regulations 2024 contact the Regulatory Affairs team at regulatoryadvice@campdenbri.co.uk

Bread and Flour Regulations changes at a glance

The new amended Bread and Flour Regulations apply in England only.
Mandatory addition of folic acid in non-wholemeal flour produced in the UK from December 2026. Note: labelling changes are required.
Technical amendments to ensure consistency with other food standards legislation including increasing minimum levels of nutrients needed by Assimilated EU Regulation No 1925/2006 and updating the specification criteria for calcium carbonate to match Assimilated EU Regulation 231/2012. (13 December 2024).
An update to the compositional rules of wholemeal flour, to ensure improved compliance while maintaining consumer protection. (13 December 2024).
An exemption from the fortification requirements for small-scale millers (producing less than 500 metric tonnes of flour per year) to remove any disproportionate burden on smaller-scale producers without compromising the public health outcomes of the policy. (13 December 2024).
Introducing the ability for Enforcement Officers to use Improvement Notices as a more proportionate and efficient way to address non-compliance thereby reducing costs associated if criminal proceedings are brought. (13 December 2024).

About Sharon Morey

Sharon has worked here at Campden BRI since 2016, and also has a wealth of knowledge and experience from previous regulatory, technical and other roles.

Sharon studied Nutrition, and has previously worked at Quest NutraPharma (Regulatory Affairs Manager/ Nutritionist and Training Manager), BioCare Ltd (Technical and Customer Development Manager) and Holland & Barrett Ltd (Regulatory Affairs Officer/Retail Training Officer/ Customer Service Manager/Public Relations Officer).

Alongside supporting clients and projects within Regulatory Affairs, Sharon presents on scheduled and tailored training courses in all aspects of Food Law. She has also contributed to and written articles for nutritional and pharmaceutical trade and consumer publications.