Consultation outcome

Summary of responses and government response

Updated 17 January 2024

Executive Summary

The Bread and Flour Regulations 1998 and The Bread and Flour (Northern Ireland) Regulations 1998 primarily mandate the compulsory fortification of milled white and brown non-wholemeal wheat flour manufactured and sold in the UK.

Minimum levels are set for calcium carbonate, iron, thiamin and niacin to help protect against nutrient deficiencies within the UK population. The regulations also set labelling requirements for wholemeal bread, which must contain 100% wholemeal flour and wheat germ which must have at least 10% added processed wheat germ.

The UK government committed to review the regulations to ensure they were still fit for purpose following the UK’s departure from the EU. This was to:

• ensure alignment between the Bread and Flour Regulations and overlapping pieces of food legislation
• explore exemptions to mitigate regulatory burdens
• update enforcement provisions
• improve clarity

Following a separate UK-wide public consultation in 2019, the UK government and devolved administrations announced in September 2021 their intention to proceed with arrangements to require the mandatory fortification of non-wholemeal wheat flour with folic acid, to help prevent neural tube defects (NTDs) in foetuses.

To minimise the impact of this requirement on industry this policy was co-ordinated as part of this wider review of the regulations.

The consultation covering the wider review of the regulations in 2022 sought views and further information on proposals to:

• increase the minimum level of added nutrients to non-wholemeal flour and update criteria requirements for calcium carbonate added to flour
• introduce the mandatory addition of folic acid to flour at 250 micrograms per 100 grams of non-wholemeal wheat flour
• clarify that mandatory fortification applies to flour derived from common wheat only
• exempt small-scale mills from the fortification requirements (those producing less than 500 metric tonnes per annum)
• exempt flour used as a minor ingredient in a final product (less than 10% of the final product)
• introduce the use of improvement notices to the enforcement regime

The key aim of any changes is to ensure that the regulations:

• lead to improved public health
• support UK industry
• assist enforcement authorities
• protect consumers.

Within this the policy objectives are to:

• reduce the incidence of NTD-affected pregnancies, by increasing dietary intake of folate, and blood folate concentration, in women who could become pregnant while minimising the number of people who may exceed the guidance level for dietary folic acid intake
• take account of technological developments and developments in overlapping legislation, ensuring consistency with other food standards regulations enabling understanding, compliance, and a consistent approach to enforcement
• minimise regulatory burden for business where positive public health outcomes of the policy aren’t compromised
• ensure the enforcement regime is effective and proportionate

After undertaking a joint UK-wide public consultation on the proposals above, the UK government and devolved administrations have carefully considered the responses received and intend to proceed with the proposals as set out in the consultation, with the exception of the proposal to exempt flour used as a minor ingredient (less than 10% of the final product).

It was decided not to proceed with the exemption of flour used as a minor ingredient primarily due to the added complexity this would create which could have the potential to compromise the effectiveness and enforceability of the regulations. The UK government and devolved administrations continue to view the mandatory fortification of non-wholemeal wheat flour as playing an important function in improving public health by increasing the intakes of key micronutrients. The addition of folic acid to non-wholemeal wheat flour has a significant role to play in reducing the number of NTD-affected pregnancies across the UK and will have a wider positive health impact on families and the NHS.

The proposals brought forward will ensure that the regulations are fit for purpose in fulfilling the objectives listed above and implement changes in a way to minimise regulatory burdens were possible.

Further detail on the background, responses received, and the joint UK government and devolved administrations response is detailed below.

Introduction

The UK government and devolved administrations launched a UK-wide public consultation on proposed amendments to The Bread and Flour Regulations 1998 and The Bread and Flour (Northern Ireland) Regulations 1998 between 1 September and 23 November 2022.

The regulations primarily mandate the compulsory fortification of milled white and brown non-wholemeal wheat flour that is manufactured and sold in the UK, for public health reasons, with added calcium carbonate, iron, thiamin and niacin to protect against nutrient deficiencies within the UK population.

The consultation included proposals for the implementation of government policy to introduce the mandatory addition of folic acid to non-wholemeal wheat flour to help reduce the number of NTD-affected pregnancies. UK government and devolved administrations announced this policy in 2021 following public consultation in 2019.  

The consultation launched in September 2022 focused on the technical aspects of implementing this policy, including the level at which it will be added to non-wholemeal wheat flour and transitional arrangements to minimise impacts of implementation on industry.

This proposal was considered alongside other proposed amendments resulting from a wider review of The Bread and Flour Regulations 1998 and The Bread and Flour (Northern Ireland) Regulations 1998 which included:

• raising the minimum level of calcium carbonate, iron and niacin and replacing the criteria for the calcium carbonate specification taking into account developments in overlapping food legislation
• providing clarification on the scope of mandatory fortification requirements
• introducing exemptions where public health objectives would not be compromised
• a move to an improvement notice approach to enforcement

The proposals included in this consultation look at ways to ensure that the regulations lead to improved public health outcomes, support UK industry, assist enforcement authorities and protect consumer interests.

The consultation sought views on the policy proposals and also asked for additional information to further inform our assessment of the impacts of the proposed policy options, to ensure they meet stated policy objectives and to check against potential unintended consequences. Responses to the consultation have been used to help refine the proposals and inform the UK government and devolved administrations’ decision-making on legislative changes to be brought forward.

The consultation received responses from 369 participants. Of these responses 361 participants responded via the online English-language version of the consultation on Citizen Space, with 8 participants responding via email to Defra. The responses received came from a wide range of stakeholders.

This document provides a summary of responses as well as the UK government and devolved administrations response to the feedback received. It informs stakeholders of next steps that will be undertaken including implementation of legislative changes. The UK government and devolved administrations are grateful to all of the organisations and individuals that took the time to respond to the consultation.

Overview of relevant food regulations and national differences

The following list of regulations gives an overview of legislation referred to throughout this document. There are some differences in how food legislation is applied across the UK. To avoid repeating the distinctions throughout the document, the following abbreviations of the regulations encompass how the rules are applied across the UK. Where necessary, distinctions between how the rules apply across the UK will be explained.

The Bread and Flour Regulations

The Bread and Flour Regulations 1998 and The Bread and Flour Regulations (Northern Ireland) 1998 lay down specific rules on the labelling and compositional standards of bread and flour in Great Britain and Northern Ireland respectively.

Regulation 1925/2006

This lays down rules for the addition of vitamins and minerals and of certain other substances to food. In Great Britain, this regulation has been retained in domestic law under the European Union (Withdrawal) Act 2018 (the Withdrawal Act) and amended by the relevant legislation. In Northern Ireland, the EU regulation applies under the current terms of the Windsor Framework.

Regulation 1333/2008

This lays down the rules on food additives: definitions, conditions of use, labelling and procedures. In Great Britain, this regulation has been retained in domestic law under the European Union (Withdrawal) Act 2018 (the Withdrawal Act) and amended by the relevant legislation. In Northern Ireland, the EU Regulation applies under the current terms of the Windsor Framework.

Regulation 231/2012

This lays down specifications for food additives listed in Annexes II and III of Regulation 1333/2008. In Great Britain, this regulation has been retained in domestic law under the European Union (Withdrawal) Act 2018 (the Withdrawal Act) and amended by the relevant legislation. In Northern Ireland, the EU Regulation applies under the current terms of the Windsor Framework.

Regulation 1169/2011

This lays down rules on the provision of food information to consumers. In Great Britain, this regulation has been retained in domestic law under the European Union (Withdrawal) Act 2018 (the Withdrawal Act) and amended by the relevant legislation. In Northern Ireland, the EU Regulation applies under the current terms of the Windsor Framework.

Methodology 

The consultation asked a mixture of closed (multiple choice) and open (free text) questions. All responses were reviewed in full. The closed questions were analysed statistically, and results have been rounded to the nearest 1% (meaning the totals may exceed 100% in some cases).

We undertook a thematic analysis of the responses to the open questions in which we identified and assigned key themes of each response. Some responses received by email did not answer the consultation questions directly. These contributions have been included in the summaries of the most relevant sections. Many of the responses to questions repeated themes and issues throughout. Hence, rather than report on views on each question, this document instead provides a summary of the main themes and key points raised.

The consultation was split into 6 chapters which focused on different areas:

• The Bread and Flour Regulations’ interaction with overlapping legislation
• the addition of folic acid to flour
• scope of mandatory fortification
• exemptions
• enforcement
• general questions on implementation.

The analysis of responses follows this same structure with the government response at the end of each chapter. Respondents were asked whether they were replying as an individual or in an official capacity on behalf of an organisation or institution. They were also asked for their field or role. This has been drawn upon where relevant to characterise the views of different types of respondents.

Limitations  

Respondents were self-selecting and as such their views may not be representative of wider public or stakeholder opinions. Individual quotes have been used, where appropriate, to illustrate the narrative around specific themes. Quotes were only selected from respondents who provided permission for their views to be published.

Some responses were received from organisations, institutions or groups that represent the views of a wider membership. When overall summary statistics are provided referencing the number or proportion of respondents expressing a particular view, a response representing the views of a wide membership is treated in the same way as a response from an individual. However, where views of certain categories of respondents strongly diverge from the overall response, this has been drawn out in the analysis presented in this document.

It should also be noted that not all respondents answered each consultation question, so analysis takes into account how frequently themes were raised and views were expressed, relative to the number of responses received to each question. Additionally, some provided their response solely in the form of a written response (for example, by email). These have been considered in the qualitative analysis.

Who responded

The 369 responses came from a wide variety of stakeholders. Table 1 shows the number of responses by type of participant. The different options that were given are as follows:

• individual – responding with personal views, rather than as an official representative of a business or business association or other organisation
• public sector body – responding in an official capacity as a representative of a local government organisation or public service provider or other public sector body in the UK or elsewhere
• industry – responding in an official capacity representing the views of a business
• campaign group/NGO – responding in an official capacity as the representative of a non-governmental organisation or trade union or other organisation
• academia – responding in an official capacity as a representative of an academic institution
• other – responding in a different capacity to the options provided

Table 1

Respondent type	Number of respondents
Individual	282
Industry	33
Other	23
Campaign group/NGO	15
Academia	8
Public sector body	8

We also asked respondents which role or field was most applicable to them. Table 2 shows how respondents identified themselves.

Table 2

Respondent field/role	Number of respondents
Consumer	208
Health care professional	41
Other	41
Flour miller	34
Food manufacturer	25
Enforcement authority	6
Retailer	5
Wholesaler	1
Premix supplier	1
Not answered	7

The results in tables 1 and 2 show that individual participants belonged to a range of different fields. Where the analysis, for example, comments on general views from millers, this includes both responses from individuals belonging to this field as well as those responding on behalf of an organisation from this sector.

Table 3

Table 3 shows the results of those responding on behalf of a business, who were asked to indicate the size of the business.^{[footnote 1]}

Business size	Number of respondents
Small and medium-sized enterprises (SMEs) (businesses with 0 to 249 employees)	26
Ordinary partnership (a business run by two or more self-employed people)	11
Large business (250 or more employees)	5
Represent medium and large businesses	1

Table 4

We asked respondents where they were located in the UK (if responding on behalf of an organisation based across the UK, multiple choices could be selected). Table 4 shows the results:

Location base	Number of respondents
England	315
Scotland	41
Wales	39
Northern Ireland	23

Chapter 1: Interaction with wider food legislation

Background

The Bread and Flour Regulations set minimum levels at which the nutrients added to flour must be present for every 100 grams of flour (calcium carbonate: 235 to 390 milligrams, iron: 1.65 milligrams, nicotinic acid or nicotinamide: 1.60 milligrams, thiamin: 0.24 milligrams).

These were set at levels that represented restoration to the natural levels present in wheat prior to the milling process, except for calcium carbonate which was originally added as a way to provide more calcium in the diet to improve public health, at a time when dairy products were scarce.  

Since the introduction of the Bread and Flour Regulations, general rules on the addition of vitamins and minerals to foods have been introduced and these requirements are laid out in Regulation 1925/2006. These rules stipulate that when foods are fortified, the nutrients must be present in a ‘significant amount’. This is defined for each added nutrient in Regulation 1169/2011 as 15% of the nutrient reference value (nutrient reference values (NRVs) are established guidelines for the recommended daily energy and nutrient consumption).

This is higher than minimum levels laid out in the Bread and Flour Regulations for 3 of the 4 added nutrients (calcium 11.75% of the NRV, iron 12% of the NRV and niacin 10% of the NRV).

This has brought into question the interaction between the Bread and Flour Regulations and overlapping legislation. General rules on the addition of vitamins and minerals to foods in Regulation 1925/2006 set the minimum level of nutrients added to food at 15% NRV to ensure there is a nutritional benefit to consumers. Setting minimum levels in the Bread and Flour Regulations that are consistent with general rules would ensure this principle applies equally to flour fortification. It is our understanding that the vast majority (over 90%)^{[footnote 2]} of non-wholemeal wheat flour produced in the UK already contains nutrients at the proposed new levels. This has been done voluntarily by industry in order to maintain a single production line for domestic and export produce, since these requirements must be met when exporting to the EU.

The Bread and Flour Regulations specify certain compositional criteria that the added nutrients must meet. The criteria set out for calcium carbonate in the Bread and Flour Regulations differ from the specification laid out for calcium carbonate (E170) in Regulation 231/2012 on food additives with the latter having tighter restrictions for acid insoluble matter and fluoride content.

While it remains possible to be compliant with the calcium carbonate criteria in both the Bread and Flour Regulations and Regulation 231/2012, we recognise that consistency across overlapping food standards regulations would help improve the legislation and regulatory framework. In practice we understand that industry has now all moved to using calcium compliant with Regulation 231/2012 for both exports and the domestic market.

Proposals

In this section of the consultation, we asked respondents for views and information on the following proposals:

Proposed changes:

1. Raise the minimum level of nutrients present in flour

This option would involve moving the minimum required level present:

• of iron from 1.65 milligrams to 2.1 milligrams per 100 grams of flour
• of niacin from 1.6 milligrams to 2.4milligrams per 100 grams of flour
• of calcium carbonate from between 235 and 390 milligrams per 100 grams of flour, to between 300 and 390 milligrams per 100 grams of flour

The minimum amount of thiamin required to be present in flour would remain the same as this currently sits at above 15% of the nutrient reference value. This would align the minimum levels for these nutrients with wider rules for fortified foods. Making this amendment would reflect changes which have already been made on a voluntary basis by most of the industry ensuring a level playing field in the market.

Greater clarity on regulatory requirements would facilitate compliance and assist enforcement. Millers currently fortifying at lower levels (accounting for an estimated 9% of non-wholemeal wheat flour) would need to change to a premix ^{[footnote 3]} with higher levels of nutrients.

2. Remove calcium carbonate criteria from the regulations and replace with criteria in overlapping food legislation

This proposal would update the requirements for calcium carbonate in The Bread and Flour Regulations with that adopted for the use of calcium carbonate in foodstuffs more generally. Industry has informed us that calcium carbonate meeting this specification is already being used to fortify flour, therefore we wouldn’t expect any additional significant costs for industry resulting from this change.

Baseline option (for comparison): do nothing

The Bread and Flour Regulations would retain existing minimum levels for calcium, iron, and niacin, remaining at odds with overlapping legislation regarding the minimum level at which nutrients should be added to foods. Further action would need to be taken to provide clarification on the interaction of the rules for operability purposes.

Millers would continue to be able to use calcium carbonate which meets the criteria laid out either in The Bread and Flour Regulations or Regulation 231/2012 to ensure they are compliant with the law. However, The Bread and Flour Regulations would retain a calcium specification which is at odds with overlapping regulations. This complicates industry compliance and makes consistent enforcement of food standards rules more difficult.

Responses

Raising minimum levels of added nutrients

Respondent preferences

We asked respondents to indicate their support for the policy options presented as ‘do nothing’, ‘raise the minimum level of added nutrients’, ‘remove calcium specification’.

Table 5

Table 5 shows the overall response of 319 respondents who gave their view on raising the minimum levels for calcium carbonate, iron and niacin.

Response	Raising the minimum level of added nutrients
Yes, I support this.	29%
No, I don’t support this	50%
I don’t know or no comment	22%

The table shows that half of respondents to this question did not support the proposal, while 29% supported the increase in the minimum nutrient levels. Where responses have been broken down by stakeholder type, it shows the majority of those responding from academia (4 out of 7 responses), campaign group/NGO (7 out of 12 responses), and public sector bodies (6 out of 7 responses) supported the change whereas the majority of responses from individuals (133 out of 264 responses) and industry representatives (16 out of 29 responses) were against the proposal.

Half of those who were responding in ‘other’ capacity supported the increase in minimum nutrient levels (9 out of 18 responses) compared to 39% who were against (7 out of 18 responses). Of those responding as industry representatives all ‘large businesses’ (3 responses) who responded were in support of the proposal whereas the majority of those responding from SME’s (9 out of 14 responses), ordinary partnerships (4 out of 5 responses) and sole proprietorship (3 out of 4 responses) were against the proposal.

Overall, only 36% of respondents supported the ‘do nothing’ option with 41% of respondents opposing the ‘do nothing’ option.

Freedom of choice

We asked respondents to explain opposition to any aspect of the proposal and provide any accompanying evidence. While the removal of mandatory fortification requirements was not in scope of the consultation a significant proportion of respondents voiced opposition to fortification more generally.

Most of these responses raised concerns that mandatory fortification restricts freedom of choice for consumers. Part of these responses was a group of campaign responses expressing the view that mandatory fortification was not the best approach towards ensuring a healthy diet for consumers. Some respondents questioned the health benefit of raising the levels and raised concerns that it could be problematic for consumers with certain conditions such as haemochromatosis.^{[footnote 4]}

Health aspects

Several further responses (mainly from individual consumer respondents) raised concerns around adverse health risks related to the proposals. Among the central points related to this were lack of consideration of consumers with intolerances or allergies to synthetic forms of nutrients, and lack of research done on the potential adverse impacts of raising the levels.

Several respondents felt focus should be on consumption of naturally present nutrients with several suggesting there should be more done to promote the benefits of wholemeal and less processed methods of production to maximise nutritional value.

Several others suggested better education and promotion of a balanced healthy diet as a preferable alternative to fortification to enhance public health. A couple of respondents felt there was a lack of scientific evidence to justify changes on health grounds. Conversely a few respondents showed support for the proposals on the grounds of public health benefit.

Notably, of health professionals who responded to the closed question on whether they supported the proposal to increase the existing minimum levels for calcium carbonate, iron, and niacin the majority supported the change (25 out of 38) with around a quarter (9 out of 38) opposing the change. The remaining 4 answered ‘don’t know or no comment’).

Supportive

Many responses to the open questions in this section of the consultation contained support for proposals in some form. Of these responses, several were supportive of the proposals provided that small-scale mills were exempt. A few respondents who included lines from a campaign group/NGO were supportive of the proposed measures but felt the scope of fortification should be broadened to include gluten free flour.

One trade association representing large-scale millers showed support  for aligning The Bread and Flour Regulations with wider rules on fortification because:

“The benefit of having one set of fortification levels, compliant for both the European and the British markets, is that it helps the millers, and especially their customers, keep a streamlined production without having to duplicate SKUs (Stock Keeping Units)^{[footnote 5]} having one only premix limits the production costs and simplifies logistics.”

Calcium carbonate maximum level

The Bread and Flour Regulations set a maximum level for calcium carbonate in flour as well as a minimum level (unlike iron, thiamin and niacin which don’t have maximum levels set). The existing compliance range is 235 to 390 milligrams per 100 grams of flour. We had proposed to retain the existing maximum level which would mean narrowing the compliant range to 300 to 390 milligrams of calcium carbonate per 100 grams of flour factoring in the proposed increase to the minimum level. We asked respondents to what extent they agreed or disagreed that consistent compliance within this new range would be realistic.

Table 6

Table 6 shows the breakdown of 142 responses received to this multiple-choice question. 

Response	Results
Strongly agree	2%
Agree	11%
Neither agree nor disagree	18%
Disagree	9%
Strongly disagree	11%
Don’t know	49%

As shown by the table there were mixed views on this issue. Almost half of the respondents answered ‘don’t know or no comment’, and given the specific technical nature of this question it is unsurprising that a lot of respondents would not have practical experience in this area. A higher proportion of respondents (20%) either disagreed or strongly disagreed, than agreed or strongly agreed (13%), that consistent compliance within the proposed range would be realistic.

A few respondents took the opportunity to comment on this issue in the open text questions in this section of the consultation. A couple of industry trade associations, and the premix supplier argued that the proposed new range would pose a challenge to consistent compliance.

Based on these considerations it was argued in a couple of responses that the maximum level for calcium carbonate should be removed or increased in line with the increase to the minimum level to allow for a reasonable range for compliance. The risk that this could lead to calcium carbonate being used as a filler in flour was disputed since this would no longer be economically viable given the increase in costs of calcium fortification. One trade association also argued for the regulations to set a minimum level for calcium rather than calcium carbonate to better align with the other added nutrients and Regulation 1925/2006 on the addition of vitamins and minerals to food.

Calcium carbonate criteria

Table 7 shows the overall response of 323 respondents that gave their view on the proposal to remove the calcium carbonate specification from The Bread and Flour Regulations and replacing it with the specification criteria (E170) established in food additives legislation.

Table 7

Response	Remove and replace the calcium carbonate criteria
Yes, I support this	42%
No, I don’t support this	18%
I don’t know or no opinion	40%

As shown a significant proportion (42%) of respondents supported the proposed amendment compared to 18% who opposed this amendment. This finding was consistent across all respondent types (respondent type referring to whether the response was received from an individual or a business representative for example).

In response to the open question in this section, a couple of respondents, including a premix supplier, felt that while Brexit had driven industry to using E170 calcium carbonate, formalising this change in law would restrict supply to one viable source of calcium carbonate from the EU. Thus they argued that the existing specification in The Bread and Flour Regulations should be kept as a contingency option in the event of supply chain disruption.

Further comments made on the proposal included a few responses querying whether alternative forms to calcium carbonate could be used for the purposes of flour fortification.

Composition of wholemeal flour

Currently, The Bread and Flour Regulations state that wholemeal flour shall naturally contain iron, thiamin and niacin in accordance with the minimum levels (iron: 1.65mg, niacin: 1.60mg, thiamin: 0.24mg) per 100 grams. This is linked to the composition of wholemeal flour, which is made using the whole grain of wheat, so wholemeal flour should retain the nutritional value of the original wheat used. The levels set out for wholemeal flour are based on an 80% extraction rate for flour.^{[footnote 6]} Prior to the consultation some stakeholders raised concerns around the existing wording, as nutritional characteristics of wheat are subject to natural variability and can be affected by external factors such as climatic conditions. The way the regulations are worded prohibits the addition of nutrients to meet the minimum levels required, potentially causing non-compliance beyond the control of flour millers. Given these concerns we asked respondents for their views on whether this requirement should be revised.

There were mixed views on this issue and many responses to this open question were deemed to be out of scope on the basis that the respondents had misunderstood the requirements relating to the composition of wholemeal flour. Unlike non-wholemeal flour, the minimum nutrient levels set for wholemeal flour are those which are to be naturally present in flour. Many respondents thought that the requirements involved the mandatory addition of nutrients to wholemeal flour (as with non-wholemeal flour as discussed above). In most cases these responses indicated a preference for wholemeal flour to not contain added nutrients.

Consumers

From the consumer perspective a slightly greater proportion of respondents favoured retaining existing compositional requirements on wholemeal flour compared to those who felt requirements should be revised or removed. This suggests there is an expectation held by most of these respondents that wholemeal should contain the specified minimum levels of micronutrients naturally.

Of responses from consumers that supported revision, several suggested removing these requirements for wholemeal flour. A few supported replacing current requirements with a legally enforceable definition of the term ‘wholemeal’ which must include 100% of the original kernel. Other individual responses suggested: removing requirements relating to thiamin and niacin only or widening the scope of mandatory fortification to include wholemeal flour.

In response to the open question asking for any additional comments on proposals in this section of the consultation a range of respondents used the opportunity to discuss concerns around certain labelling and marketing terms. A group of campaign responses argued for the introduction of legal definitions including the term ‘wholemeal’ among others (which were out of scope of this consultation) to avoid the misuse of the term in marketing.

Industry

There were mixed responses from industry stakeholders. Several responding as individuals who belonged to one of the industry professions (millers, food manufacturers, premix supplier and retailers) and those responding as business representatives supported retaining existing requirements. However, trade associations representing their wider members in the food sector, as well as some other business representatives, were in favour of revising requirements related to wholemeal flour on the basis that wholemeal is a natural product with factors affecting the compositional characteristics outside the control of the millers.

Where the opportunity was provided to add any further comments in this section responses from a few trade associations supported improved wording regarding the legal description of wholemeal to clarify it as a reserved description. These respondents and one large business argued the need for the legislation to allow the use of wholemeal flour with other types of wheat flour to make 50/50 bread products with these products helping to increase fibre in UK diets.

One trade association noted they had conducted sampling of nutrient levels both from wheat and the flour derived from it. It was noted that the wheat naturally contained the required minimum levels for iron, and thiamin in most cases, but the levels of niacin were lower, and this presented a barrier to compliance for wholemeal flour.

Several responses from a range of stakeholders raised concerns around the impacts on small-scale mills if the scope of mandatory fortification was broadened to include wholemeal flour. Read more under the heading ‘Impacts of proposals’.

Health professionals

There were mixed views from health care professionals and associated bodies. These responses included suggestions to increase the level of nutrients required in wholemeal flour and broaden the scope of fortification to include all flour including wholemeal and rice. One response supported relaxing the wording of the requirement to allow for the addition of nutrients in wholemeal flour to meet the minimum levels where necessary. Conversely, some felt the minimum nutrient level requirements for wholemeal flour could be removed.

Many responses from a range of different stakeholders (including some health care professionals and NGO groups) argued that any revision of the compositional requirements for wholemeal flour should not include a requirement to fortify this type of flour. One response from an NGO said:

“These nutrients are already present in wholemeal. A nutritional factor in wholemeal flour is the presence of phytates which provide mineral binding capacity in the gut and may reduce iron absorption. It seems appropriate to leave this form of flour unfortified as it provides an available consumer option. It is reasonable to say that consumers selecting wholemeal flour and prepared to pay the higher price for this and for wholemeal bakery products at retail, may also be selecting a reasonably diverse range of foods.”

Impacts of proposals

We asked respondents whether the cost-benefit analysis of the preferred options were accurately presented in the impact assessment (pages 34 to 37) that accompanied the consultation for industry, consumers and government/enforcement authorities.

Industry impacts

We asked respondents to select whether they agreed or disagreed that the cost-benefit analysis of the proposals was accurately presented for industry. Of 335 responses received:

• 13% agreed
• 15% neither agreed nor disagreed
• 15% disagreed
• 57% selected ‘don’t know or no comment’

Small-scale mills

In response to the open text questions in this section of the consultation, the most common theme raised was concerns around the impacts on small-scale mills. These concerns were raised by a mixture of individual respondents and business representatives from the milling sector, as well as an association for traditional mills.

Of those who expressed concerns around the impacts for small-scale mills, most felt that mandatory fortification of flour imposes greater costs on small-scale millers compared with industrial size mills. Some responses raised concerns about costs being passed on to customers who buy from local bakeries while others felt proposals could lead to the closure of small-scale mills which play an important role in local communities and are often housed in valued heritage sites. Some responses also raised concerns around the ability of small-scale millers to comply with requirements with space and resource constraints preventing the installation of machinery necessary to allow for accurate dispersion of nutrients within flour.

Current practice and logistical benefits

A few respondents from trade associations whose membership represent larger retailers, millers, and manufacturers noted that the proposals set out are already in line with industry practice. The vast majority of flour produced in the UK is already being fortified with the proposed higher levels outlined in the consultation, and all flour producers have moved to using the calcium carbonate which meets the criteria set out in Regulation 231/2012. This has been done voluntarily by industry to avoid needing different production lines for products containing flour which are to be sold domestically and abroad (since these are requirements which already need to be followed for fortified food sold on the EU market).

This has involved some increased production costs predominantly due to the switch in calcium carbonate sourced abroad which needs to be imported into the UK. However, the formalisation of this in law as proposed would not represent further increases in these costs. A trade association representing large-scale mills in the UK said:

“Consistency throughout the UK (including Northern Ireland) means that foods made with flour in the UK will be freely marketable throughout the UK and the European Union, which is the major export market for flour and goods made using flour, without the need for separate packaging. Over 95% of our members already comply with the proposal. It would add an unnecessary level of complexity to have to comply with different rules.”

Familiarisation costs

Some respondents noted that industry costs were presented as costs to millers in the impact assessment and said even small increases to production costs would be passed on to wholesale and retail. A few respondents also noted that the familiarisation costs were only factored in millers and felt manufacturers and retailers of products containing non-wholemeal flour would also need to spend time to familiarise themselves with changes.

Consumer impacts

We asked respondents to select whether they agreed or disagreed that the cost-benefit analysis of the proposals was accurately presented for consumers. Of 333 participants who responded, 15% said they agreed, 14% said they neither agreed nor disagreed, 21% said they disagreed, and 50% answered ‘don’t know or no comment’.

The open text question regarding impacts involving consumers largely focused on themes which have been discussed: removal of consumer choice and concerns around adverse health impacts. Conversely, a few commented on the scope being too narrow, excluding certain groups from the public health benefit (this is discussed in further detail in chapter 3 on the scope of mandatory fortification).

Several respondents felt that any increased costs to producers would be passed on to consumers. 

Impacts on government/enforcement authorities

We asked respondents to select whether they agreed or disagreed that the cost-benefits of the proposals had been accurately presented for government and enforcement authorities. Of the 333 responses received:

• 13% agreed
• 16% neither agreed nor disagreed
• 12% disagreed
• 59% answered ‘don’t know or no comment’

Of the 6 responses received from enforcement authorities, 4 agreed with the costs presented for government/enforcement authorities, compared to one who disagreed, and one who answered ‘don’t know or no comment’.

Most open text responses did not provide feedback on cost to government/enforcement authorities but one response from an enforcement authority indicated that the familiarisation costs given were too low and had undervalued the hourly rate of staff.

Government response

After considering the feedback from the consultation, the UK government and devolved administrations have agreed to take forward the proposals to increase the minimum level of calcium carbonate, iron and niacin in non-wholemeal flour to 15% of the nutrient reference value per 100g of flour.

This change takes account of developments in overlapping legislation on the addition of vitamins and minerals to food. This ensures that the principle that fortified foods should contain a significant amount of nutrients to provide sufficient nutritional benefit to consumers applies equally to mandatory flour fortification as to voluntarily fortified foods. Providing consistency across overlapping legislation brings greater clarity over how the rules interact facilitating understanding, compliance, and a consistent approach to enforcement.

We acknowledge that several respondents felt mandatory fortification of non-wholemeal wheat flour should be removed from the regulations. Removing mandatory fortification of flour was not in scope of this consultation as this policy continues to be viewed as an important vehicle for improving the population’s nutrient intake. The Department for Environment, Food and Rural Affairs, previously consulted on the removal of mandatory fortification requirements in 2013, and responses to that consultation highlighted that there continued to be a considerable public health benefit in keeping the mandatory fortification of flour.  The most recent data from the National Diet and Nutrition Survey indicated that calcium intake was below the reference nutrient intake for those aged between 11 and 18 years of age.

The National Diet and Nutrition Survey also shows that cereals and cereal products provide 38% of calcium intake, the majority of which is coming from flour containing products. There also remain significant concerns around a lack of iron consumption leading to iron deficiency anaemia. This is of particular concern for large groups of the population. According to the most recent National Diet and Nutrition Survey, just under half of girls aged 11 to 18 have iron intakes below the lower reference nutrient intake. For adult women, this was 25%.

While clinical deficiency of thiamin and niacin is rare, the response to the previous consultation indicated that a single averted case of deficiency could save more than the additional cost of fortification.^{[footnote 7]} The Scientific Advisory Committee on Nutrition (SACN)^{[footnote 8]} report on the impacts of repealing The Bread and Flour Regulations found the proportion of the people whose intakes would fall below the Lower Reference Nutrient Intake would be greater for lower socio-economic groups. This is because low-income groups tend to have lower intakes of these and other nutrients compared with the rest of the population, and bread makes a larger contribution to their nutrient intake.^{[footnote 9]}

The maximum level for calcium carbonate will be increased by the same amount as the minimum level to 455 milligrams per 100 grams of non-wholemeal flour. This decision follows feedback from the consultation that a reduced compliant range for the presence of calcium carbonate in flour would present an obstacle to consistent compliance. We have received sampling data that supports this argument, hence the increase in level is necessary to ensure the regulations are fit for purpose.

Some respondents raised concerns about potential adverse health impacts of raising the nutrient levels in non-wholemeal flour. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT)^{[footnote 10]} has carried out an assessment of the dietary exposure of calcium carbonate, iron, niacin, and thiamin at current and proposed fortification levels. This found that chronic exposures of calcium (as calcium carbonate), iron, niacin and thiamin (for which no change was proposed) from non-wholemeal wheat flour at the current and proposed fortification levels did not exceed their respective guidance levels. The change to the proposed levels of fortification would not result in any material increase in risk of adverse health effects particularly when considering the entire diet and consumption of supplements.

Many of the responses that opposed mandatory fortification did so on the basis that it removed consumer choice. We consider that this concern is addressed by limiting the scope of mandatory fortification to non-wholemeal flour derived from common wheat so that an element of choice remains for those consumers who wish to avoid fortified flour. Additionally, we have decided to exempt small-scale mills from fortification requirements mitigating concerns raised around the impacts on these businesses. This is expanded upon in greater detail in the government response to chapters 3 and 4 respectively.

The UK government and devolved administrations have agreed to take forward proposals to remove the existing calcium carbonate criteria from The Bread and Flour Regulations and replace them with the criteria established in Regulation 231/2012 which sets out specifications for food additives. This will correct misalignment between the Bread and Flour Regulations and overlapping legislation ensuring the calcium carbonate specification requirements for flour fortification are consistent with the requirements which apply to the use of calcium carbonate in foods for other purposes.

We acknowledge that some responses raised concerns about supply chain vulnerability and queried whether alternative forms of calcium could be permitted for the purposes of flour fortification. However, there have been no reported issues with the supply chain and the quarry which served as the previous domestic source of calcium carbonate is no longer producing calcium carbonate for human consumption.

It is necessary that the standards for calcium carbonate used for the purposes of flour fortification be updated to align with the same high standards which have been adopted for the use of calcium carbonate as a food additive. The specifications laid out in Regulation 231/2012 take account of the latest specifications and analytical techniques as set out in the Codex Alimentarius drafted by the Joint FAO/WHO Expert Committee on Food Additives.

Currently, we have insufficient evidence on the suitability of other forms of calcium for the purposes of flour fortification to add alternative permitted forms of calcium to The Bread and Flour Regulations. Should we receive a proposal for a suitable alternative form to calcium carbonate to be added in the future we would be open to considering this. This would require an assessment from SACN and COT as well as further consultation.

The UK government and devolved administrations have agreed to amend the compositional requirements for wholemeal flour. It is recognised that due to natural variation in the nutritional characteristics of wheat, which is outside the control of millers, these requirements on the natural levels of iron, thiamin and niacin in wholemeal flour represent a technical barrier to compliance.

We have received sampling evidence that shows differential results on levels of niacin in wheat of which wholemeal flour is made. This discrepancy with niacin levels in wheat with national databases has been observed in other countries as well as the UK. This has been linked to more modern testing methods being adopted that can test for bioavailable niacin accurately.^{[footnote 11]}

To maintain consumer protection so that consumers can be assured wholemeal flour is authentic, we will be introducing a legal description that means wholemeal flour must consist of the whole product from the milling and grinding of cleaned cereal. Millers should be able to demonstrate that wholemeal flour production meets this requirement upon an inspection from an enforcement officer.

Chapter 2: Folic acid

Background and previous consultation

Following a UK-wide public consultation in 2019, the UK government and devolved governments announced in September 2021 that they would require the mandatory fortification of non-wholemeal wheat flour with folic acid and would legislate on this basis.

The consultation covered public health protection benefits as well as consideration of any negative consequences on population groups and the impact for businesses and trade. The proposal aimed to ensure the policy is proportionate, effective, and ultimately enforceable.

Consumption of folic acid in the pre-conception period and up to the 12th week of pregnancy, has been shown to reduce the population risk of Neural Tube Defect (NTD) affected pregnancies.^{[footnote 12]} NTDs arise in the first few weeks of pregnancy, often before a woman knows that she is pregnant. NTDs can have a significant impact on pregnancy outcome, life expectancy and quality of life of the baby, with approximately 1000 NTD-affected pregnancies each year in the UK. Therefore, all women who could become pregnant are advised to take a daily 400 microgram folic acid supplement before conception and up to the 12th week of pregnancy.

However, as pregnancies may be unplanned or women in the first few weeks of pregnancy may not know they are pregnant, many women do not or cannot follow this recommendation. Further details on NTD-affected pregnancies were provided in the previous proposal to add folic acid to flour.

In 2017, the Scientific Advisory Committee on Nutrition (SACN) re-iterated their previous recommendation for mandatory folic acid fortification to improve the folate status of women most at risk of NTD-affected pregnancies, confirming that its previous recommendations on folic acid (2006 and 2009) remained unchanged.

SACN also recommended ensuring mandatory fortification does not lead to an increase in the proportion of the population with folic acid intakes above the Guidance Level^{[footnote 13]} of 1 milligram per day.

Since discussion on whether to proceed with the fortification of non-wholemeal flour has already been subject to public consultation, the consultation launched in September 2022 specifically focused on the technical aspects of implementing this policy.

Proposal

In this section of the consultation, we asked respondents for views on implementing the proposal to add 250 micrograms of folic acid per 100 grams of non-wholemeal flour.

This proposed level was informed by Food Standards Scotland (FSS) modelling, estimating the potential impact of fortification of flour with folic acid in the UK (2017).

The modelling exercise explored the potential impact of fortification of non-wholemeal wheat flour with folic acid and estimated the effectiveness and safety of different levels of folic acid for the purpose of maximising dietary intakes to reduce the number of NTD-affected pregnancies in the UK, whilst not increasing the numbers of people exceeding the Guidance Level for folic acid.

It should be noted that the calculations used in the modelling applied an average 25% production loss of folic acid before reaching the final consumer. This is equivalent to 187.5 micrograms per 100 grams of flour present in the final product for consumption.

The FSS modelling indicated that mandatory fortification of non-wholemeal flour with folic acid would be expected to reduce prevalence of low folate intakes, resulting in a reduction in the number of NTD-affected pregnancies. According to the modelling, 250 micrograms of folic acid added for every 100 grams of non-wholemeal flour would bring about a reduction in the rate of NTDs by 15 to 22% a year. This would result in a minimal increase in the number of people exceeding the Guidance Level for folic acid from 0.4% to 0.6% of the whole population above their age-specific Guidance Level.

Responses

Views on the addition of folic acid to flour

Freedom of choice

While this consultation focused on the technical aspects of implementing the mandatory fortification of flour with folic acid,^{[footnote 14]} in response to the open questions on the proposal many respondents used the opportunity to give their view on the policy more broadly.  

Of 170 responses, just over half were broadly characterised as being against the government policy to require fortification of flour with folic acid. The most common reason for this was the perceived removal of consumer choice. Many of these responses suggested alternative approaches with more targeted action for pregnant women and government spending on public health campaigns. These responses predominantly came from individual consumer respondents, as well as a few industry representatives from the milling sector.

Health aspects

Many responses welcomed the introduction of a requirement to add folic acid to flour with several responses encouraging this to be implemented as soon as possible. These responses came from a range of respondent types including health care professionals, academia, NGOs/campaign groups and individuals but also several industry representatives, trade associations representing larger businesses from the food sector, and consumers. Among these responses, several raised points around the proposed level and monitoring aspects.

Several responses opposed to the policy raised concerns around perceived health risks. These concerns were predominantly raised by consumers, as well as a few industry representatives, but also included the thoughts of a couple of health professionals. Often, evidence was not provided for the various concerns raised. Where concerns raised did contain additional information, this was reviewed by the SACN secretariat who confirmed nothing raised changed SACN’s existing considerations with respect to folic acid fortification.

While understanding the desire to reduce incidences of NTDs through the addition of folic acid, a response from a group of academics also raised concerns around associated risks and suggested mitigations. These suggestions included:

• using a natural form of folate
• if folic acid is used, to accompany this with B12 fortification
• capping the amount of folic acid permitted in supplements

These respondents felt the 2019 consultation response overlooked evidence of associated health risks, specifically unmetabolised folic acid present in the blood from lowered vitamin B12 levels.

Communication

Some respondents said they would welcome a comprehensive wide-reaching government communications campaign to highlight the benefits of the policy on fortification of flour with folic acid. It was suggested by one respondent that this would help reduce costs associated with answering customer queries around the inclusion of folic acid in products and noted that some had been critical of the policy since it was announced.

Level of folic acid

Of those who responded to the open questions in this section, many called for an increase to the proposed level of folic acid added to flour from 250mcg to 1mg per 100g of flour. These responses predominantly came from health care professionals responding in an official capacity for academic institutions, public health organisations and charities.

The arguments for raising the level centred around academic literature, which projects that a higher level of fortification could eradicate up to 80% of NTD cases. Some of these respondents suggested that the Guidance Level should be reassessed as they consider it to be too low.  They suggested that if the Guidance Level could be safely removed or raised, a higher level of folic acid can be added to non-wholemeal flour.

The respondents suggested that this could result in higher blood folate levels in the population, which would prevent a greater number of new NTD cases (than at the proposed level).

Drafting preference

We asked respondents to indicate their preference on how the requirements for fortification of flour with folic acid should be drafted in legislation. The options presented were that the regulations should require that folic acid is either:

• added at 250 micrograms per 100g of flour; or
• present at 187.5 micrograms per 100g of flour

Table 8

Table 8 shows the overall results for the 335 participants who responded to this question.

Response	Result
I agree, the regulation should require that folic acid must be added at 250mcg per 100g wheat flour.	33%
I disagree, the regulations should require that ‘folic acid must be present at 187.5mcg per 100g wheat flour’ (accounting for the anticipated 25% production loss in the fortification process).	18%
Don’t know or no comment	50%

Most responses to the open questions did not expand upon the different drafting options. Of the responses that did comment on this, trade associations representing members from across the food sector supported mirroring existing drafting language used in The Bread and Flour Regulations for the other added nutrients.

One manufacturing business noted that specifying the level present in flour would support manufacturers’ quality assurance checks and that product specifications would normally contain this information.

One NGO noted it would be sensible to set a recommended factory addition rate as well as a regulatory minimum level. They argued this approach would standardise fortification practice while allowing for acceptable variance for the presence of folic acid in the flour.

One respondent was concerned that if the regulations only specified an amount that is to be added to flour, the level in the end product could vary widely. A few respondents felt the level set should factor in the natural presence of folate already in the flour prior to the addition of folic acid. 

Responses from trade associations representing retailers and the largest millers queried assumptions made in the consultation document around production loss. It was highlighted in one response that the production loss of folic acid does not occur at the fortification stage but rather in further processing in a final product where flour is used as an ingredient.

Impacts

We asked respondents whether the main costs of implementing folic acid fortification at a level of 250 micrograms per 100 grams of flour were accurately represented for industry, consumers, and government/enforcement authorities in the accompanying impact assessment, pages 30 to 33.

Industry costs

We asked respondents to select whether they agreed or disagreed the costs to industry had been accurately presented. Of 355 responses received:

• 10% agreed
• 14% ‘neither agreed nor disagreed’
• 17% disagreed
• 60% answered ‘don’t know or no comment’

Small-scale mills

In response to the open text questions in this section of the consultation, the most common theme raised was concerns around the impacts to small-scale mills. This was predominantly raised by individual consumers as well as millers (both those responding as individuals and as business representatives from this section of industry).

The arguments put forward mirror those in the first chapter of the consultation linked to disproportionate costs for smaller producers, as well as practical difficulties with achieving accurate dispersion of nutrients to comply with requirements. A few responses noted that they would support the proposals provided there was an exemption for small-scale mills.

Labelling

Many responses from industry representatives of manufacturers, retailers, and trade associations raised concerns around the consequential labelling costs for products containing non-wholemeal flour as an ingredient.

The consultation proposed an overall 24-month transition period to allow businesses to adjust their processes and adapt to changes in both the composition and labelling, and spread the cost into their natural relabelling cycles.

However, some concerns were raised around the challenges related to synchronising the timings of composition and labelling changes together, since fortification takes place at the milling stage and flour is a staple ingredient in a range of foods. It was suggested that if the labelling change had to occur as soon as folic acid has been incorporated into the flour, then the cost would be greater than estimated, since the cost of wasted packaging material has the potential to exceed that of routine artwork changes. Some argued the cost of artwork changes to the labels would be greater than anticipated and provided estimates. A few respondents suggested in some cases they hold more than 2 years’ worth of packaging and there would not be a relabelling cycle within the transition period.

Many of these responses proposed ways to mitigate these costs, which would involve some easing of labelling requirements while business adjust to new requirements or enforcement pragmatism over this period. Others suggested aligning with other expected changes such as the planned harmonisation of recycling logos in 2026 to 2027.

Familiarisation

Some industry representatives pointed out that the familiarisation costs were lower for industry than for enforcement authorities and suggested that manufacturers and retailers of products containing non-wholemeal flour would also need to familiarise themselves with the legislation.

Consumer costs

We asked respondents to select whether they agreed or disagreed that the costs to consumers had been accurately presented. Of 332 responses received:

• 13% agreed
• 14% neither agreed nor disagreed
• 24% disagreed
• 49% answered ‘don’t know or no comment’

Increased prices

The responses to the open text question regarding impacts involving consumers largely focused on themes already discussed, most commonly concerns around freedom of choice. Some responses questioned the accuracy of the costs in the context of current inflation and the cost-of-living pressures. Several responses felt that the additional implementation costs for industry would be passed on to consumers, but responses expanding upon this noted they would not be able to quantify these costs.

Missed benefits

A few responses argued that there are costs related to not fortifying all flour as there is a risk that certain groups of the population will miss out on the benefits of the proposal and noted that this was not reflected in the impact assessment which accompanied the consultation.

Most of the responses received from health professionals and their organisations were supportive of the mandatory addition of folic acid to flour although many called for an increase in the proposed level. Of these responses some commented on the costs arguing that the low costs of fortification were vastly outweighed by the public health benefits of the policy.

Government/enforcement costs

We asked respondents to select whether they agreed or disagreed that the costs to government/enforcement had been accurately presented. Of 333 responses received:

• 11% agreed
• 15% neither agreed nor disagreed
• 15% disagreed
• 59% answered ‘don’t know or no comment’

Of those responding from enforcement authorities, 4 out of 6 responses agreed with the representation of costs compared with one out of 6 responses who disagreed.

Government response

In 2021, the UK government and devolved administrations published their response to the joint 2019 consultation on the mandatory addition of folic acid to non-wholemeal wheat flour.  All 4 administrations remain fully committed to this policy. After considering the feedback from the 2022 consultation, the government and devolved administrations will legislate to ensure that non-wholemeal wheat flour will be required to contain 250 micrograms of folic acid per 100 grams of flour.

The government and devolved administrations intend to amend The Bread and Flour Regulations accordingly. The government position to fortify at 250 micrograms of folic acid per 100 grams of flour is supported by the 4 UK chief medical officers and SACN.

The health effects of folic acid have been widely researched and its safety was considered specifically in SACN’s Folate and disease prevention report in 2006 and SACN’s Update on folic acid report in 2017.

Research has demonstrated that folic acid is effective in the prevention of NTDs. SACN considered the relationship between folic acid intake and the presence of unmetabolized folic acid in the blood in their 2017 Update on folic acid report. Scientific evidence suggests that the presence of unmetabolised folic acid in the blood is not representative of intakes above the ability of the body to metabolise folic acid into a form which can be absorbed.

It was noted in some responses that the level of 250 micrograms per 100 grams of flour was too low, with those respondents advocating for fortification at up to 1 milligram of folic acid per 100 grams of flour, which would have a greater impact on reducing the number of NTDs.

In May 2023, the European Food Safety Authority consulted on its draft scientific opinion on the tolerable upper limit for folic acid. It re-evaluated the safety in use of folic acid and the draft recommendation is for a revised upper level of 1 milligram per day, which aligns with the current UK Guidance Level.

The level of fortification will be kept under review as part of the monitoring and evaluation of the policy, which will assess both positive and postulated negative impacts. Central to the view relating to the Guidance Level for folic acid is the risk of masking B12 deficiency, when folic acid is consumed above the Guidance Level. In the event that more reliable testing becomes routinely and consistently applied across the UK, the level of fortification may be reconsidered.

Following responses received on the drafting preferences, the decision has been made to mirror the language used currently in The Bread and Flour Regulations for the other added nutrients. This means that non-wholemeal wheat flour will be required to contain 250 micrograms of folic acid per 100 grams of non-wholemeal wheat flour.

Feedback from the consultation has highlighted that production loss occurs during the further processing of products which contain flour as an ingredient rather than during the fortification process. As with the addition of calcium carbonate, folic acid is being added to supplement diets rather than replenish levels of folate naturally found in flour.

The proposed mandatory fortification of flour with folic acid will not replace UK government and devolved administration advice for women who could become pregnant to take folic acid supplements before conception and up until the 12th week of pregnancy.  It has been suggested in response to the consultation that using a natural form of folate 5-methyl tetrahydrofolate rather than folic acid could help mitigate health risks.

In their 2017 Update on folic acid report, SACN noted that folic acid is widely used for food fortification and in supplements because it is more stable in foods than natural folates and is better absorbed.

Folic acid will be added to flour in the form of pteroylmonoglutamic acid, which is in line with the assumptions that informed the FSS modelling projections and is the most commercially available form.

A UK-wide monitoring group has been set up to develop an evaluation of the proposed implementation of amendments to The Bread and Flour Regulations, relating to micronutrient levels. The monitoring group is chaired by Food Standards Scotland and comprises colleagues from: the Department of Health and Social Care; the Department of Health Northern Ireland; Welsh Government; Scottish Government; the Department for Environment, Food and Rural Affairs; and the Food Standards Agency in Northern Ireland. The group is considering monitoring at a UK level as standard and at the devolved administrations level where feasible, for both positive and postulated negative impacts of the policy.

The group will also review the total population and sub-groups where relevant. Plans will be informed and reviewed by SACN. More details about the monitoring programme will be published in due course.

Chapter 3: Scope of mandatory fortification

Background

In this section of the consultation, respondents were asked their views on proposals to clarify the scope of fortification so that it is clear that the requirements apply to non-wholemeal flour derived from common wheat only.

Currently, The Bread and Flour Regulations specify that ‘flour derived from wheat’ is subject to the fortification requirements aside from certain exemptions around wholemeal, wheat malt flour and self-raising flour. Industry stakeholders have taken the view that the requirements apply to flour which is derived from the wheat species Triticum aestivum usually referred to as ‘common wheat’ or ‘bread wheat’.

However, there are other grains of wheat that are species of the Triticum genus, including Triticum Spelta (used for spelt flour) as well as other ancient grains which could be considered to be included. Hence, the proposed change set out in the consultation looked to provide greater clarity on requirements across industry and enforcement, to help ensure compliance and consistent enforcement.

Responses

Many responses to the open question in this section of the consultation used the opportunity to give their thoughts on mandatory fortification more generally rather than comment specifically on the proposals related to the scope of fortification.

Many of these respondents outlined their opposition to fortification of foods. The following analysis has focused on comments received specifically in relation to the proposal outlined in this section with comments related to other proposals discussed in more detail in the relevant chapters.

Respondent preferences

We asked respondents to indicate their support for the following policy options:

Proposed change

Add clarification on the scope of the regulations limiting fortification requirements to flour derived from ‘common wheat’.

Baseline: do nothing

Taking no action would likely see the continuation of current industry practice whereby only flour derived from ‘common wheat’ is fortified. We may miss the chance to bring greater clarity to the regulations.

Table 9

Table 9 shows the overall results of the 266 responses that related to the baseline ‘do nothing’ option.

Response	Do nothing
Yes, I support this	31%
No, I don’t support this	37%
I don’t know or no opinion	32%

Table 10

Table 10 shows the overall results of the 292 responses that related to the proposal to add clarification on the scope of the regulations limiting fortification requirements to flour derived from ‘common wheat’.

Response	Add clarification on the scope of the regulations limiting fortification requirements to flour derived from ‘common wheat’
Yes, I support this	46%
No, I don’t support this	22%
I don’t know or no opinion	33%

As shown by the results in the tables, respondents who gave a view on policy options predominantly supported the proposed change to add clarification on the scope of the regulations limiting fortification requirements to flour derived from ‘common wheat’.

Public health

Of the responses to the open question in this section of the consultation a common theme was concern that limiting the scope of fortification to flour derived from common wheat could dilute the public health benefits of the policy.

Many responses from health professionals and associated bodies, and NGOs felt that the proposals were too narrow in scope and argued that all flour should be fortified as well as other staple products such as rice. Many argued that the consultation did not acknowledge the potential benefits which could be realised via fortification of all flour and rice in reducing potential incidences of NTDs by 80%, at 1 milligram of folic acid per 100 grams. Respondents criticised the consultation for not presenting options for a ‘fully effective’ fortification regime which would prevent a greater proportion of NTDs and save related expenditure for taxpayers in NHS and social care costs. Several of these responses were campaign responses with mirroring language used.

We received a few responses from a campaign group and supporters responding as consumers which raised concerns around the exclusion of gluten free flour from the scope of fortification requirements. It was argued that this excludes a subsection of the population who are at an increased risk of micronutrient deficiency. It was suggested that fortification of these types of flour could play a particularly important role for individuals with coeliac disease because:

“After diagnosis of coeliac disease and the uptake of a gluten free diet it can take up to five years for the gut to heal so therefore people with coeliac disease may continue to have ongoing malabsorption of nutrients and micro-nutrients.”

The NGO/campaign also said it has been reported that 12% of UK adults avoid gluten, and ‘gluten free’ is the most commonly bought type of free-from food in the UK. This suggests that the current scope of the fortification requirements has the potential to exclude a large section of the population beyond those with coeliac disease.

Some further responses raised concerns that the exclusion of certain types of flour could lead to further health inequalities.

Consumer choice

Conversely, another common theme throughout this section was concern raised around the principle of mandatory fortification and the limitations to freedom of choice. We asked respondents whether they felt limiting the scope of mandatory fortification to flour derived from common wheat provided greater choice for consumers.

Table 11

Table 11 shows the results from the 287 responses we received to this question.

Response	Result
Strongly agree	15%
Agree	31%
Neither agree nor disagree	14%
Disagree	11%
Strongly disagree	8%
Don’t know	22%

As shown in this table, 46% of respondents either strongly agreed or agreed that the proposal maintains greater choice for consumers. Several respondents to the open questions welcomed the improved clarity on the scope of requirements, including a group of campaign respondents who also agreed that the option would provide greater consumer choice.

It was noted that this is unlikely to significantly affect the market for flour made from common wheat as flour from other grain performs differently and therefore cannot always be used as direct replacements. One milling business responding said that the cost of flour made from alternative grains can be considerably higher, which may mean consumers have to spend more if they wish to consume unfortified flour.

However, it was also questioned by some of those who opposed the proposal whether there is a need for greater consumer choice given that those not wanting to consume fortified products already have the option of buying wholemeal flour.

Use of common wheat

We asked respondents what the chances are that there will be a decrease in the use of common wheat used for the production of flour.

Table 12

Table 12 shows the results from 271 responses received on this question.

Response	Result
Highly likely	5%
Likely	7%
Neither likely nor unlikely	15%
Unlikely	17%
Highly unlikely	8%
Don’t know	49%

As shown by this table there were mixed views on the risk associated with the likelihood of decreased use of common wheat in the production of flour. It was noted in the consultation that the increased use of alternative grains in the production of flour could place at risk the effectiveness of the fortification policy in increasing nutrient intake.

While several responses from industry representatives welcomed the added clarity to the regulations, it was noted by one trade association representing retailers that the public health outcomes should be the main driving factor rather than providing additional choice. They highlighted that:

“Over recent years there has been an increase in use of other flours to produce more traditional, artisan products. This trend is likely to remain.”

A trade association representing millers said that the proposals aligned with their understanding of the intended scope of fortification requirements. They also suggested that it is reasonable to think there will be a decrease in consumption of flour made from common wheat.

They argue this is likely driven by alternatives available (particularly flour made from pulses or other grains) and the negative perception around refined carbohydrates. However, they suggested that it was unlikely that other flours would become mainstream soon.

It was proposed that this should be kept under review by government so that, if this changes, the legislation can be reviewed accordingly. One response from an NGO questioned the accuracy of the figures stated in the consultation of flour made from alternative grains accounting for 1.8% of flour produced in the UK. This respondent felt that more robust data was needed to quantify the impacts of restricting mandatory fortification to non-wholemeal flour made from common wheat.

Guidance

Responses from a couple of industry trade associations called for updated interpretational guidance. They asked that this include labelling best practice, clarification on whether functional wheat flour is within scope, and clarification that the legislation does not regulate imported finished products or compound ingredients that contain wheat flour.

Government response

After considering the feedback from the consultation, the UK government and devolved administrations have agreed to proceed with the amendment to clarify that fortification requirements apply to non-wholemeal flour derived from common wheat only.

UK-wide agreement to add folic acid to flour was conditional on the scope not going beyond flour which is currently fortified in order to mitigate excessive burdens to industry. The response to the consultation confirmed that this amendment would be in line with current industry practice. When mandatory fortification of non-wholemeal wheat flour was originally introduced, alternative grains were not commonly used in the production of flour.

The intention of introducing mandatory fortification measures was to prevent nutrient deficiencies by increasing the population’s dietary intake of the required nutrients through targeting a food which was part of the staple diet: flour derived from common wheat. Therefore, wheat flour produced with other grains that are less commonly available and consumed, and not part of the population’s staple diet could be considered to fall outside the intent of the regulations.

Additionally, the minimum nutrient levels set out in the regulations are based on what was said to be present in flour with an extraction rate of 80% (extraction rate is a measure of the percentage of the grain that is made into flour during the milling process).^{[footnote 15]}

The naturally present levels of nutrients in flour made from other species of wheat differ to those of common wheat, and therefore the amount of nutrients which would need to be added to restore these nutrient levels to the amount lost during the milling process would be different.

The fact only one set of values is provided in the regulations supports the argument that fortification of flour was primarily introduced to restore the nutritional value of common wheat specifically. Hence, industry have operated on the basis that flour derived from alternative grains were not intended to be in scope of requirements.

Alternative grains to common wheat account for around 1.8% of the wheat milled in the UK.^{[footnote 16]} Insisting on the addition of nutrients to these flours which are not currently fortified may place a disproportionate burden on industry while it is unlikely to have a significant impact on nutrient intakes.

A recurring theme throughout the consultation, particularly from a consumer perspective, was freedom of choice, with many suggesting consumers should have the ability to choose whether to consume fortified products. Taking this into account this amendment preserves the choice of unfortified flour derived from alternative grains, as well as wholemeal and non-wheat-based flours (such as gluten free).

We acknowledge that concerns were raised around limiting the scope of fortification to flour derived from common wheat could leave certain sections of the population such as those with coeliac disease to miss out on the health benefits of the policy. Those with coeliac disease make up approximately 1% of the population. While limiting mandatory fortification to non-wholemeal wheat flour will not benefit those who avoid gluten, individuals with coeliac disease are likely to receive appropriate advice in relation to nutrient intake from specialists such as health care professionals.

Chapter 4: Exemptions

Background

This section of the consultation explored potential exemptions from fortification requirements where health objectives would not be compromised. This looked in particular at exempting small-scale mills (producing less than 500 metric tonnes of flour per year).

This part of the industry is made up mainly of mills using traditional milling methods, producing flour using horizontal millstones in historic mill buildings powered by wind and water energy. The methods adopted by these mills make it difficult to ensure accurate distribution of vitamins and minerals added to flour.

Installing the machinery needed to ensure consistent dispersion of nutrients is not feasible for many of these small mills due to space constraints of the buildings that the mills are housed in, which are often listed. Equally, many smaller mills are restricted by funds available to finance installation of such machinery. Thus, compliance with the regulations places a disproportionate burden on these mills compared to standard industrial scale mills.

The consultation also looked at exempting flour used as a minor ingredient in a product (less than 10% of the final product). Changes to labelling rules in 2014 (under Regulation 1169/2011) required that the vitamins and minerals which are added to flour be declared in the ingredients list of the label. It has been suggested that this has led to a competitive disadvantage when exporting products to certain EU member states who do not currently legislate for mandatory fortification of flour. EU member states thereby can opt for an alternative unfortified flour product which is readily available from GB competitors from other countries.

Steps have already been taken to address this with legislative changes made in 2021 allowing unfortified flour to be sold (or imported) if destined for export or for use in a product destined for export. However, manufacturers have argued the costs that come from having 2 separate production lines for the export and domestic markets often outweigh the benefit of using unfortified flour in products containing a minimal amount of flour for export.

Proposals

In this section of the consultation, we asked respondents their views on the following proposals.

Small-scale mills

Proposed change

Exempt small scale-mills producing less than 500 metric tonnes of flour per year from fortification requirements: This regulatory change would allow mills producing less than 500 metric tonnes of non-wholemeal wheat flour per year to opt not to add the required nutrients to flour, taking into account the disproportionate burden that compliance with fortification requirements places on these small-scale mills.

Flour used as a minor ingredient

Proposed change

This proposal would allow unfortified flour to be sold for use as an ingredient in a product where it makes up less than 10% of the final product, enabling businesses to use one production line for both domestic and international markets and providing a level playing field for UK businesses in international markets.

This suggested level has been proposed as products under this threshold are not deemed to be the key vehicles which contribute to the dietary intakes of these added nutrients. It is therefore expected that exempting these products would have negligible impact on the effectiveness of the policy as a public health measure.

Baseline - do nothing: no additional exemptions to be brought forward

Small-scale mills would continue to be required to fortify non-wholemeal wheat flour. There is a risk that this would lead to closures of some mills due to the higher relative burden of fortification for smaller mills compared to large industrial scale mills. If the mills were able to continue production, there may be technical barriers to consistent compliance due to the difficulties in distributing nutrients. Consequently, there is a greater chance consumers would be misled as to nutrients present in the flour.

The introduction of folic acid to the list of nutrients that must be added to flour may put UK manufacturers of products containing minimal amounts of flour at a disadvantage when exporting to EU member states compared to manufacturers from other countries which do not mandate that flour must be fortified.

However, businesses already have an option to use unfortified flour in products for export, albeit with extra costs attached to having separate lines of production for domestic and export production.

Responses

Respondent preferences

Baseline option: do nothing

We asked respondents to indicate their support for the policy options outlined in this consultation.

Table 13

Table 13 shows the overall results from 254 respondents who answered on the baseline option ‘do nothing’.

Response	Do nothing – no new exemptions.
Yes, I support this	24%
No, I don’t support this	59%
I don’t know or no opinion	17%

As shown by the table, over half (59%) of respondents were against the ‘do nothing’ option, suggesting that most respondents saw a benefit to introducing new exemptions to requirements.

Around a quarter of respondents (24%) supported the ‘do nothing’ option, suggesting these respondents were against or considered there to be no need to introduce new exemptions to the regulations. The remaining respondents (17%) answered don’t know or no opinion.

Small-scale mills exemption

We asked respondents to indicate their support for the policy proposal to exempt small-scale mills producing less than 500 metric tonnes per year.

Table 14

Table 14 shows the overall results from 327 responses received.

Response	Exempt mills producing less than 500 metric tonnes of flour
Yes, I support this	84%
No, I don’t support this	7%
I don’t know or no opinion	9%

As shown by the results in the table the majority of responses (84%) were in favour of this proposal. Of those responding from academia, 3 out of 5 were opposed to the proposal compared with 2 out of 5 who supported the proposal.

Supportive

Most responses to the open questions in this section of the consultation expressed support for the exemption for small-scale millers. This was predominantly from consumers and millers (from this section of the industry) but also included support from a range of different stakeholders. These respondents commonly argued changes to the legislation would place disproportionate burden of both costs and practicality on this section of the industry. Many consumers were supportive of the proposal on the basis that it creates further choice or saw the exemption as vital for the continued operation of local mills.

Against

A trade association representing large millers suggested that the exemption proposals diverged from the central aim of the policy, which is to provide the population with key nutrients. They also noted imported mixes and doughs are not fortified and these represent, on average, another 75,000 tonnes per year of flour used to make unfortified bread and baked products. A few respondents from health care professionals responding from academic institutions felt that the costs of suboptimal folic acid fortification hadn’t been considered.

They believe that the benefits of wider folic acid fortification would significantly outweigh the costs of fortifying flour and were concerned the public health message would be diluted by too many exemptions. It should be noted though that most health professionals who responded to the multiple-choice question on the proposal indicated their support for the exemption (16 out of 29 responses, compared to 7 out of 29 responses that did not support the exemption).

Threshold

We asked respondents for their views on the production threshold being set at less than 500 metric tonnes of flour per year for this exemption to apply.

Table 15

The overall results from 338 responses received are shown in table 15.

Response	500 metric tonne threshold
About right	32%
Too low	22%
Too high	11%
Don’t know or no comment	35%

As shown by the results in the table, there were mixed views on the production threshold for this exemption proposal. While the most common response was ‘don’t know or no comment’, almost a third of respondents felt the threshold was ‘about right’ compared to 22% who felt this was ‘too low’, and 11% who deemed this to be ‘too high’ a threshold.

Some responses to the open questions included comments on the threshold level. A group of campaign responses would support a higher production threshold of 1000 metric tonnes of flour per year as they feel the current proposal could exclude some small mills which should benefit from the exemption. A few other responses from consumers and industry representatives also suggested some further flexibility to ensure all ‘small mills’ can be exempted from the requirements and provide some room for modest expansion. One response suggested adding specific exemptions for mills employing stone grinders and specialising in high-quality wheat flour.

Conversely, a few responses suggested the threshold may be too high, one noting that “500 tonnes of flour are enough for one million loaves of bread” and commenting that “it is not clear why mills that are currently fortifying should stop doing it”.

The premix supplier suggested the threshold be reduced to 50 metric tonnes to truly support wind and water mills but suggested that any inclusion of exemptions would have some impact on this public health measure.

Health impacts

We asked respondents whether they agree or disagree that the proposal to exempt small-scale mills would be unlikely to have a significant impact on the nutrient intake levels of consumers.

Table 16

Table 16 shows the overall response from 336 respondents who answered this question.

Response	Unlikely to have a significant impact on nutrient intake
I agree	80%
I disagree	6%
Don’t know or no comment	13%

As the results in the table show, the majority of respondents agreed that the proposal to exempt small-scale mills would be unlikely to have a significant impact on the nutrient intake levels of consumers. Of the 20 responses received from health professionals, 14 agreed the proposal would be unlikely to have a significant impact on nutrient intakes compared to 5 out of 29 responses who disagreed (10 answered don’t know or no comment).

Although several responses to the open questions indicated they were against exemptions generally on the grounds that providing exemptions may dilute the public health message, and a couple of responses noted some may miss out on the nutritional benefits of the policy if they buy products containing flour exclusively from exempt mills.

Enforcement

We asked whether there were any major concerns for enforcement authorities around the monitoring of mills producing less than 500 metric tonnes per year under the proposed exemption.

Table 17

Table 17 shows the overall response from 168 respondents who answered this question.

Response	Result
Yes, I have major concerns	11%
No, I do not have major concerns	54%
Don’t know or no comment	35%

As shown by the table above most respondents did not have major concerns related to enforcement of the exemption. Notably all responses received from enforcement authorities (5 out of 5) said they did not have major concerns. Of the 35 responses which expanded on the reason why they had concerns (multiple choice question) 10 answered ‘lack of resource”, 8 answered ‘lack of clear process’, 12 answered ‘other’.

Products with minimal flour content

Respondent preference

We asked respondents to indicate their support for the policy proposal to exempt flour which is to be used as a minor ingredient in a final product (making up less than 10% of the final products composition).

Table 18

Table 18 shows the overall response from the 302 respondents who answered this question.

Response	Exempt flour to be used as a minor ingredient in a final product (<10%)
Yes, I support this	63%
No, I don’t support this	11%
I don’t know or no opinion	27%

As the results in the table show, most respondents to this question supported the proposal to exempt flour which is to be used as a minor ingredient (less than 10% of the final product).

Out of the responses received from academic institutions, 3 out of 4 did not support the proposed exemption. Out of the responses received from retailers, 3 out of 4 did not support the proposed exemption.

Consumer choice

A common theme in the open text responses in this section of the consultation was concern around consumers’ ability to choose unfortified food, suggesting some of the support for the exemptions was expressed on this basis.

Benefits for business

A couple of responses from large food businesses showed support for the exemption, one noting that this may be beneficial when exporting to EU countries that view fortified products unfavourably. However, it was noted in one of these responses some manufacturers that produce products which would contain less than 10% flour, and other products containing more than 10% flour may not make use of such an exemption, since using different flour for different product lines may entail greater costs.

Complexity

This was also raised in a response from a trade association representing retailers who questioned the benefit of the proposal due to the high cost of segregating production lines.

It was also noted that there is already an existing exemption, thus trade associations representing millers and retailers questioned whether additional exemption is warranted. It was also suggested that, while the introduction of this exemption may reduce the need for some manufacturers who only produce products containing minimal amounts of flour, to maintain separate production lines for export and domestic markets, this would move the complexity to millers.

This is because if the exemption is to be used, mills would be expected to produce both unfortified and fortified flour creating the need for separate production lines. Although currently we understand certain mills do produce unfortified flour for exempt products destined for export, our understanding is most mills have a single production line of fortified flour which can be sold both domestically and abroad.

Several responses from industry stakeholders suggested that it was not clear how the exemption would operate. A number of these responses questioned how the exemption would work if a product contained 2 different types of flour, one used as a minor ingredient for specific functional purposes, the other used as base product.

A response in favour of the exemption noted the difficulty of sourcing flour with specialist functional purposes which is fortified (as this is often sourced from EU countries which is now required to be fortified, thus adding complexity and costs). It was argued by some that the secondary flour used in small amounts for functional purposes should qualify for the exemption. Others questioned how the 10% composition would be calculated and called for interpretative guidance to be provided on this if the exemption was introduced.

Health impacts

We asked respondents whether they agree or disagree that the proposal to exempt flour used as a minor ingredient would be unlikely to have a significant impact on the nutrient intake levels of consumers.

Table 19

Table 19 shows the overall response from 336 respondents who answered this question.

Response	Unlikely to have a significant impact on nutrient intake
Strongly agree	32%
Agree	29%
Neither disagree nor agree	9%
Disagree	4%
Strongly disagree	3%
Don’t know or no comment	22%

As the results in the table show, over half of responses either strongly agreed or agreed that the exemption for flour used as a minor ingredient (less than 10% of the final product) would be unlikely to have a significant impact on the nutrient intake levels of consumers, compared to 7% that disagreed or strongly disagreed.

A few responses to the open questions noted that this exemption would be unlikely to have a significant impact on nutrient levels, though some felt that any exemptions would dilute the public health message.

One public health body noted that while providing an exemption for small-scale mills would be reasonable given that the output of these mills comprises a very small proportion of the population’s diet, the proposal to exempt flour to be used as a minor ingredient (less than 10% of the final product): “does not seem proportionate and just further restricts the likely benefits of fortification. In addition, it is likely to complicate enforcement efforts.”

One response from a public health organisation raised concerns about exemptions more broadly, that they may reduce the public health benefit of the policy and widen health inequalities.

They noted that if the government proceed with exemptions, steps should be taken to inform women who may not benefit from the measure:

“A public communications campaign to highlight the benefits of folic acid in the prevention of NTDs and to launch the revised regulations could explicitly outline the scope of the policy, for example, that it will only impact non-wholemeal flour, to inform consumer decision-making.”

Enforcement

Several responses to the open questions in this section of the consultation raised concerns that the proposal to exempt flour used as a minor ingredient (less than 10% of the final product) would lead to added complexity in terms of compliance with the law as well as enforcement.

In this context it was questioned how enforcement officials would be able to verify whether products contain less than 10% flour and suggested that the proposed change may lead to unintentional non-compliance.

Concerns were also raised around apportioning liability appropriately since the regulations currently place primary obligations on millers who do not have control over the use of the flour once it has been sold.

We asked respondents whether they have any major concerns around the enforcement of the regulations if the proposal to exempt flour in products where it makes up less than 10% of the final product were to go ahead.

Table 20

Table 20 shows the overall breakdown of the 105 responses to this question.

Response	Result
Yes, I have major concerns	10%
No, I do not have major concerns	39%
Don’t know or no comment	51%

As shown in the table, over half of responses answered ‘don’t know or no comment’, 39% said they did not have major concerns, and 10% said they did have major concerns. All 5 responses from enforcement authorities said they did not have major concerns related to enforcement, were the exemption proposal to be adopted.

Of 21 respondents who gave a reason for their concerns (multiple choice question), the most common response was ‘a lack of clear process’ (8), with 7 respondents citing ‘lack of resource’, and 6 answering ‘other’.

Of those who responded ‘other’, the reasons cited (open text question) included concerns around liability and added complexity, with the burden of responsibility being extended across the supply chain rather than being limited to the milling stage.

Alternative exemptions

Several responses suggested alternative exemptions, including for organic flour and for any mill which can prove the nutrients are already present at high levels in the flour produced naturally. One wholesaler also suggested that flour should be allowed to be imported unfortified provided that it is fortified before reaching the final consumer.

Government response

After considering the feedback from the consultation, the UK government and devolved administrations have agreed to proceed with the proposal to exempt small-scale mills from fortification requirements. This proposal was supported by the majority of respondents to the consultation and should mitigate the disproportionate burden that the requirements place on smaller scale producers without compromising the public health outcomes of the policy.

Some respondents were against exemptions generally on the basis that it added complexity as well as diluting the public health message. However, since fortification of non-wholemeal flour and enforcement of the regulations primarily takes place at the milling stage, monitoring of fortification would be concentrated in fewer larger mills and therefore this should simplify monitoring the effectiveness of the policy and compliance going forward.

The majority of respondents agreed that this would be unlikely to have a significant impact on nutrient intakes since these mills are estimated to account for less than 0.05% of total UK flour production. This amendment acknowledges the ongoing difficulties of this section of the industry to comply with existing requirements due to space and technological constraints.

Since this exemption is in part to account for space constraints, we would be defining a mill in this context as being a site for the production of flour. Qualification for this exemption is to be conditional on the production capacity not exceeding 500 metric tonnes of flour per annum and upon the production of flour not exceeding 500 metric tonnes in any of the last 3 calendar years. This ensures a new site with the production capacity well exceeding this level would not qualify for the exemption intended for small-scale mills (due to production capacity) and also provides a reference point for enforcement officers by which to judge whether a flour production site qualifies for the exemption (production records).

After considering the feedback from the consultation, the UK government and devolved administrations have agreed not to proceed with the proposal to exempt flour which is used as a minor ingredient in a final product sold to consumers.

While this was supported by the majority of respondents, some of the feedback received highlighted the complexity which this exemption would add to the regulations. The complexity of complying, monitoring and enforcing this exemption may compromise the ability to meet desired objectives. While this exemption may help with managing production of certain lines it is notable that there is an existing exemption supplied for products destined for export.

The benefits would be limited since many factories produce a range of products with some applicable for the exemption and others not. The additional costs associated with segregating the different flours (unfortified and fortified) would need to be factored in.

Additionally, while many industry representatives supported the proposal it was noticeable that large representative associations from certain sectors of industry had significant reservations and viewed the exemption as an inconvenience which would carry undue complexity in the supply chain including on millers, retailers and enforcement.

Chapter 5: Enforcement

Proposal

In this section of the consultation, we asked respondents for their views on proposed changes to enforcement. The existing enforcement regime provides for criminal sanctions to address non-compliance, and we proposed to change to a more proportionate and targeted regime allowing the use of improvement notices.

Businesses would also have the opportunity to appeal against an improvement notice if they disagreed. A failure to comply with an improvement notice would be a criminal offence for which a fine may be imposed. A move towards using improvement notices as part of the enforcement regime is seen as a means to correct non-compliance efficiently while reducing cost and time for businesses in resolving issues more quickly.

This approach has also been viewed as a way of reducing excessive costs associated with court time when criminal proceedings are brought, and is now routinely used in other food laws.

In England, businesses would have the opportunity to appeal against an improvement notice to the First-tier Tribunal.

Read the Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009.

In Wales & Northern Ireland, businesses would have the opportunity to appeal against an improvement notice to the Magistrates Court.

A separate consultation was held on the introduction of compliance notices for food standards requirements in Scotland and in June 2023, the Food (Scotland) Act 2015 (Compliance Notices) Regulations 2023 came into force, which introduced a compliance notice approach for food composition and labelling law breaches.

Hence, the proposals considered in this consultation apply to potential changes to The Bread and Flour Regulations in England, Wales and Northern Ireland only.

Improvement notices

We asked respondents to what extent they agreed or disagreed that a move to improvement notices to address non-compliance is a more proportionate approach to enforcement than the existing enforcement regime, which only provides for criminal sanctions.

Table 21

Table 21 shows the overall response from the 304 respondents who answered.

Response	Result
Strongly agree	15%
Agree	22%
Neither disagree nor agree	17%
Disagree	6%
Strongly disagree	5%
Don’t know or no comment	36%

As the results in the table show, 37% of respondents either strongly agreed or agreed that the use of improvement notices to address non-compliance with The Bread and Flour Regulations would be a more proportionate approach to enforcement compared to 11% who either strongly disagreed or disagreed. Notably, of the 6 responses received from enforcement authorities, 5 either strongly agreed or agreed compared with one who disagreed.

We asked respondents to what extent they agreed or disagreed that using improvement notices would resolve issues with non-compliance more efficiently.

Table 22

Table 22 shows the overall breakdown of the 303 responses we received to this question.

Response	Result
Strongly agree	8%
Agree	22%
Neither disagree nor agree	19%
Disagree	6%
Strongly disagree	4%
Don’t know or no comment	41%

As the results in the table show, 30% of respondents either strongly agreed or agreed that improvement notices would help to resolve issues with non-compliance more efficiently, compared to 10% who either strongly disagreed or disagreed. 

The responses to the open text questions in this section of the consultation were broadly supportive of the move to improvement notices, providing that the provisions against which they are to be used are clear. One local authority felt that improvement notices can be difficult to use.

Extending enforcement

We asked respondents an open question about whether they agreed or disagreed that enforcement of the regulations should extend to manufacturers of flour-based products where unfortified flour is purchased under the condition it is to be used in an exempt product.

Of the 77 responses received, approximately half of respondents agreed that enforcement should extend to manufacturers of flour-based products, and approximately a quarter of responses disagreed.

Other responses were either unsure or deemed out of scope. Responses that agreed came from a range of stakeholders. Several responses noted that if the additional exemptions were brought forward, it would be necessary for the manufacturer to be able to demonstrate that unfortified flour is being used appropriately in accordance with the regulations.

One trade association representing millers considered this to be a very important point since millers can’t control the use of flour once it has been sold. Enforcement authorities responding agreed that this would enable consistency in enforcement and a level playing field for all.

Of the respondents that disagreed, most did not provide their reasoning. A couple of trade associations who disagreed raised concerns about a lack of resourcing of local authorities especially if they were extended to export products. However, the responses did note that due diligence for millers should be limited to specifying that unfortified flour sold can only be used for producing products that are exempt according to the regulations and that food business operators should have documentation on their use of unfortified flour.

Other responses suggested the labelling should explicitly state the use of fortified and unfortified flour and that alternative enforcement options were available in other legislation such as the Trade Descriptions Act. A few responses emphasised the need for clarity over where obligations sit.

Other comments received on enforcement.

A few respondents from campaign groups and other NGOs and a local authority felt free training should be provided for enforcement officers to ensure they understand the regulations in this complex area of law. Many responses highlighted the need for updated guidance, some emphasising the need for a clear legal framework with no room for ambiguity around requirements. Many responses also highlighted concerns over lack of resource for local authorities to enforce the regulations effectively.

Government response

After considering the feedback from the consultation, the UK government and devolved administrations in Wales and Northern Ireland have agreed to proceed with introducing improvement notices as the primary enforcement regime. This is in line with government policy to reduce the burden on court time and is proportionate with a non-food-safety breach.

Retaining criminal sanctions as a backstop enforcement mechanism is important to ensure this legislation can be effectively enforced if improvement notices are not complied with, thus protecting the significant public health benefits this policy can deliver.

Respondents who gave their view broadly welcomed the change, which is less bureaucratic, more proportionate and aligned with the approach of other food standards legislation.

Chapter 6: General question on implementation

Proposal

This section of the consultation asked respondents for their views on a proposed transition period to allow businesses time to adjust to the new requirements. The proposal to add folic acid to non-wholemeal wheat flour requires time for industry to adapt premixes and make subsequent labelling changes which will impact a wide range of products. We proposed a 24-month transition period before proposals brought forward are enforced, to accommodate this.

We asked respondents a multiple-choice question on what they thought of the proposed 24-month transition period.

Table 23

Table 23 shows the overall breakdown of the 319 responses we received to this question.

Response	Result
Reasonable	27%
Too short	16%
Too long	12%
Don’t know or no comment	46%

As the results in the table show, of those that had a view on this question around half of respondents expressing an opinion felt the proposed period was reasonable (27% of responses overall), with the views of others split between those who felt it was too long (12% of responses overall) and those who felt it was too short (16% of the responses overall) with 46% answering ‘don’t know or no comment’.

Over half of responses from industry representatives (16 out of 30 responses) said they thought the proposed transition period was reasonable as did most of those responding from public sector bodies (7 out of 8 responses). Most of those responding from academia (5 out of 8 responses) felt the proposed transition period was too long.

Half of the responses from health professionals (19 out of 38 responses) answered ‘too long’ compared with 7 out of 38 who said this was a reasonable period for adjustment. 

Too long

We asked respondents who did not agree with the proposed transition period to provide an explanation (open question). Those who felt the transition period was too long predominantly argued that it was due to health-related reasons including the number of babies born with NTDs which could be prevented by earlier implementation.

Many responses suggested that industry would have known about the planned addition of folic acid to the list of nutrients which must be added to flour since the government response to the 2019 consultation on the policy was published in 2021 and that the length of time needed to adapt should be reduced since flour is already fortified with other nutrients. Several argued that the changes required are inexpensive.

Too short

Of those who indicated that the proposed transition period was too short, several felt the timing of the changes is inappropriate in the current context of rising costs. A few responses raised points in relation to labelling, suggesting changes should be harmonised with other planned labelling changes.

A few responses explicitly raised concerns about small-scale, traditional mills getting the necessary equipment required to comply with the changes (assuming we did not proceed with the exemption for small-scale mills).

A few other responses raised other logistical issues such as updating premixes (containing the combination of micronutrients added to flour) and other additional costs to industry.

Reasonable

Several responses that said the proposed 24-months would be a reasonable length for a transition period also provided additional comment. While they agreed the length was reasonable, many from industry urged some flexibility in terms of co-ordinating the timing of labelling and compositional changes.

Several responses suggested allowing the composition of flour to change (folic acid added) with the labels allowed to catch up later to reflect this. Alternatively, some responses suggested that the labels could be allowed to be changed first in anticipation of the compositional change. Given that a significant number of food products contain non-wholemeal wheat flour respondents suggested that – if a flexible approach was not taken – manufacturers would incur greater costs and more waste would be created due to packaging write-off. It was noted that other means of informing consumers of the products’ composition could be utilised for a short period.

Government response

After considering the feedback from the consultation on implementation, the UK government and devolved administrations have agreed to provide an adjustment period that will come to an end 24-months from the laying date of the statutory instrument.

While we acknowledge the urgency and importance of the policy in reducing the cases of neural tube defects, we also appreciate logistical challenges that the changes will pose to industry due to the sheer scale and volume of the products impacted.

In light of the comments received, the UK government and devolved administrations believe the 2-year period is necessary to allow industry to co-ordinate changes across a range of products to:

• mitigate excessive re-labelling costs
• reduce waste as far as possible
• implement the changes to composition in a responsible and effective manner to the benefit of the public

Next steps

The UK government and devolved administrations will be notifying the World Trade Organisation jointly on planned legislative changes. For proposed changes in Northern Ireland there is also a legal requirement to notify the European Commission. This notification will be done concurrently. Following this the UK government and devolved administrations expect to make the proposed legislative changes in 2024 subject to parliamentary process.

1. For the purposes of this consultation, official government business size classifications were used to distinguish categories. ↩

2. This estimate is based on sales figures of the vitamin and mineral premix which is added to flour 2020-21. ↩

3. All non-wholemeal flour produced in the UK is currently fortified late in the milling process via a premix which has been proven to be the most straightforward approach to fortification. ↩

4. Haemochromatosis is an inherited condition where iron levels in the body slowly build up over many years. ↩

5. Stock keeping units are unique codes which are used to identify products and track inventory. ↩

6. Extraction refers to the amount of flour made as a percentage of total wheat ground. For example, wholemeal flour uses the whole wheat meaning the extraction rate should be close to 100%. ↩

7. Bread and Flour Regulations 1998: A summary of responses to the consultation and Government Reply 2013. ↩

8. SACN advises on nutrition and related health matters. It advises the Office for Health Improvement and Disparities (OHID) and other UK government organisations. ↩

9. Scientific Advisory Committee on Nutrition: Nutritional Implications of Repealing the UK Bread and Flour Regulations 2012 ↩

10. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) is an independent scientific committee that provides advice to the Food Standards Agency, the Department of Health and Social Care, and other Government Departments and Agencies on matters concerning the toxicity of chemicals. ↩

11. Chamlagain, B. et al. (2020) ‘Niacin contents of cereal-milling products in food-composition databases need to be updated,’ Journal of Food Composition and Analysis, 91, p. 103518 https://doi.org/10.1016/j.jfca.2020.103518. ↩

12. NTDs are major birth defects of the brain, spine or spinal cord of the foetus, the most common are spina bifida and anencephaly. ↩

13. Guidance Levels for a vitamin or mineral are provided if a Safe Upper Level may not be established from available scientific literature - Safe Upper Levels for Vitamins and Minerals - Expert Group on Vitamins and Minerals - 2003. Guidance Levels for folic acid have been established by a number of risk assessment bodies, based on the observations of nerve damage in patients with pernicious anaemia. ↩

14. The question of whether to add folic acid to flour was the subject of a consultation in 2019. ↩

15. Extraction refers to the amount of flour made as a percentage of total wheat ground. For example, wholemeal flour uses the whole wheat meaning the extraction rate should be close to 100%. ↩

16. Industry contact indicative figure. ↩