By Natalie Popova, Legal Consultant | Express Law Solutions
Recent legislative reforms in England have introduced significant changes to the regulation of flour and certain food products through the mandatory fortification of non-wholemeal wheat flour with folic acid. These reforms were enacted through the Bread and Flour (Amendment) (England) Regulations 2024, amending the long-standing Bread and Flour Regulations 1998, and represent one of the most substantial interventions in UK food composition law in recent decades.
The new regulatory framework must be understood within the broader context of public health policy, food safety legislation, and consumer protection law, as governed by the Food Safety Act 1990, the assimilated EU General Food Law Regulation (EC) No 178/2002, the Food Information Regulations 2014(implementing Regulation (EU) No 1169/2011), and the oversight of the Food Standards Agency (FSA).
The Legal Reform: Mandatory Fortification of Flour
Under the Bread and Flour (Amendment) (England) Regulations 2024, manufacturers of non-wholemeal wheat flour are required to add folic acid at a prescribed level of 250 micrograms per 100 grams of flour. This amendment supplements the existing mandatory enrichment regime under the Bread and Flour Regulations 1998, which already requires the addition of calcium, iron, thiamine (vitamin B1) and niacin (vitamin B3) to white flour.
The reform follows the recommendations of the Scientific Advisory Committee on Nutrition (SACN), which advised the UK Government that mandatory fortification would significantly reduce the incidence of neural tube defects such as spina bifida and anencephaly. The policy decision was confirmed by the Department of Health and Social Care following public consultation conducted between 2019 and 2021.
The implementation period extends to 2026, allowing manufacturers to adapt production processes and update labelling in accordance with the Food Information Regulations 2014 and the retained provisions of Regulation (EU) No 1169/2011 on the provision of food information to consumers.
Regulatory Structure and Enforcement
The enforcement of the amended regime is carried out by local authority Trading Standards and Environmental Health departments under the powers conferred by the Food Safety Act 1990. The Food Standards Agency remains the central competent authority responsible for monitoring compliance, issuing guidance and coordinating enforcement policy.
In addition, food business operators remain subject to the general food safety obligations under Article 14 of Regulation (EC) No 178/2002, which prohibits the placing on the market of unsafe food. This includes food that is injurious to health or unfit for human consumption due to composition, contamination or mislabelling.
Manufacturers must also comply with the compositional and labelling requirements imposed by the Food Information Regulations 2014, ensuring that added nutrients are accurately declared and that consumers are not misled as to the nature or nutritional characteristics of the product.
Public Health Justification
The legal rationale for mandatory fortification is grounded in public health policy and preventative medicine. The Scientific Advisory Committee on Nutrition (SACN) concluded that voluntary supplementation alone was insufficient to ensure adequate folate intake among women of childbearing age, particularly in socio-economically disadvantaged groups.
The Department of Health and Social Care relied upon epidemiological evidence demonstrating that countries with mandatory folic acid fortification regimes, including the United States, Canada and Australia, have experienced significant reductions in neural tube defects.
Under section 4 of the Food Safety Act 1990, Ministers are empowered to make regulations in the interests of public health, including the control of food composition and the prevention of nutritional deficiency.
Consumer Protection and Transparency
From a consumer law perspective, the introduction of mandatory additives engages the principles of transparency and informed choice. Food labelling must comply with the Consumer Protection from Unfair Trading Regulations 2008, which prohibit misleading omissions and false nutritional claims, and the Consumer Rights Act 2015, which requires that goods sold to consumers correspond with their description.
The Food Standards Agency has issued updated guidance on flour and bread labelling to ensure that consumers are informed of the presence of added folic acid and other mandatory nutrients.
Arguments in Favour of the Reform
Proponents of the reform argue that mandatory fortification constitutes a proportionate and evidence-based public health intervention. The policy aligns with the UK’s obligations under the World Health Organization Global Nutrition Targets and supports the preventative health objectives of the NHS.
From a regulatory perspective, the regime provides legal certainty for manufacturers by establishing a uniform national standard and reducing reliance on voluntary fortification schemes, which previously created inconsistencies across the market.
Criticisms and Regulatory Concerns
Critics of the reform have raised concerns regarding the principle of mass medication and the risk of over-consumption in certain demographic groups, particularly older adults who may already receive adequate folate intake through diet or supplementation.
Small-scale millers and artisan producers have argued that the regime imposes disproportionate compliance costs, raising issues under the principles of regulatory proportionality reflected in the Regulators’ Code and the Better Regulation Framework.
There is also ongoing debate regarding the scope of permitted processing aids and dough conditioners under retained EU food additive law, including substances such as azodicarbonamide, which remains lawful in the UK but is prohibited in the European Union.
Broader Legal Context: Regulation of Food Additives
The regulation of food additives in England is governed by retained EU law, including Regulation (EC) No 1333/2008 on food additives and Regulation (EC) No 1331/2008 establishing a common authorisation procedure. These regimes continue to apply post-Brexit as assimilated law under the European Union (Withdrawal) Act 2018.
The Food Standards Agency is responsible for risk assessment and authorisation decisions in relation to new additives, processing aids and fortification substances.
Other Regulatory Frameworks Governing Food Additives in UK Law
In addition to the specific regime governing flour fortification, food additives in England are regulated within a comprehensive and multi-layered legal framework derived from retained EU law, domestic food safety legislation and technical standards.
General Food Law
The cornerstone of UK food regulation is the assimilated EU General Food Law Regulation (EC) No 178/2002, which continues to apply as retained law under the European Union (Withdrawal) Act 2018. This Regulation establishes the fundamental principles of food safety, including:
- the prohibition on placing unsafe food on the market (Article 14);
- the principle of traceability throughout the food supply chain (Article 18);
- the precautionary principle in cases of scientific uncertainty (Article 7);
- the obligation on food business operators to ensure food safety at all stages of production and distribution.
Under this framework, any food additive or fortified product must be demonstrably safe for human consumption and supported by scientific risk assessment.
Regulation of Food Additives and Authorisation Procedures
Food additives are regulated under retained versions of:
- Regulation (EC) No 1333/2008 on food additives, which establishes a harmonised list of authorised substances, permitted uses and maximum levels;
- Regulation (EC) No 1331/2008, which creates a common authorisation procedure for food additives, enzymes and flavourings.
These regimes require that any new additive or fortification substance undergo a scientific risk assessment before being authorised for use in food products. In the UK, responsibility for this process now lies with the Food Standards Agency (FSA) and the Food Standards Scotland (FSS).
The Food Standards Agency Regulatory Framework
The Food Standards Agency is the central competent authority responsible for food safety and standards in England. Its statutory mandate derives from the Food Standards Act 1999 and the Food Safety Act 1990.
The FSA oversees:
- risk assessment and risk management of food additives;
- enforcement policy and compliance guidance;
- food composition and labelling standards;
- surveillance of emerging food safety risks.
The FSA operates within a science-led regulatory model and relies on expert committees such as the Scientific Advisory Committee on Nutrition (SACN) and the Committee on Toxicity (COT) when evaluating the safety of additives and fortification schemes.
EN and Technical Standards
In parallel with statutory regulation, food production is governed by a body of technical and quality standards, including British and European Norms (EN standards), which specify:
- compositional requirements;
- manufacturing processes;
- hygiene and safety controls;
- testing and verification methods.
While EN standards do not carry the force of statute, they are frequently incorporated into contractual obligations and regulatory compliance frameworks and are relied upon by enforcement authorities when assessing industry best practice.
Labelling and Consumer Information
Food additives must be declared in accordance with the Food Information Regulations 2014, which implement retained Regulation (EU) No 1169/2011 on the provision of food information to consumers. This regime requires:
- clear identification of additives by category and name or E-number;
- accurate nutritional declarations;
- prohibition of misleading health or nutrition claims.
Failure to comply may constitute both a regulatory offence and a breach of consumer protection law.
Conclusion
The reform of flour fortification law in England represents a significant development in food regulation and public health policy. By embedding mandatory folic acid enrichment into the statutory framework, the government has exercised its powers under the Food Safety Act 1990 to address a demonstrable nutritional deficiency affecting population health.
While the reform has been broadly welcomed by the medical and public health communities, it continues to attract debate in relation to consumer autonomy, regulatory proportionality and the scope of permissible food additives. As with all food law interventions, its long-term legitimacy will depend upon transparent enforcement, scientific oversight and continued evaluation of its public health impact.
Frequently Asked Questions (FAQs)
1. What has changed in the law on flour and food additives in England?
From 2024, the Bread and Flour (Amendment) (England) Regulations 2024 introduce a mandatory requirement for non-wholemeal wheat flour to be fortified with folic acid. This supplements the existing enrichment requirements under the Bread and Flour Regulations 1998, which already mandate the addition of calcium, iron, thiamine and niacin.
2. Why has folic acid been made mandatory in flour?
The reform follows recommendations of the Scientific Advisory Committee on Nutrition (SACN) and aims to reduce the incidence of neural tube defects, such as spina bifida. Evidence from jurisdictions with mandatory fortification regimes demonstrates measurable public health benefits.
3. Does the regulation apply to all types of flour?
No. The mandatory folic acid fortification applies to non-wholemeal wheat flour. Wholemeal flour and certain small-scale millers may be exempt, subject to production thresholds and regulatory guidance issued by the Food Standards Agency (FSA).
4. Who enforces the new rules?
Enforcement is carried out by local authority Trading Standards and Environmental Health departments under powers granted by the Food Safety Act 1990, with oversight and guidance provided by the Food Standards Agency.
5. Are other food additives regulated in the UK?
Yes. Food additives are regulated under retained EU law, including Regulation (EC) No 1333/2008 on food additives and Regulation (EC) No 1331/2008 on authorisation procedures, as well as the General Food Law Regulation (EC) No 178/2002. Only authorised additives may be used, and they must meet strict safety and labelling requirements.
6. Can manufacturers add any vitamin or additive they choose?
No. Any additive or fortification substance must be authorised following scientific risk assessment. In the UK, this process is overseen by the Food Standards Agency and expert advisory committees such as SACN and the Committee on Toxicity (COT).
7. How are consumers informed about added ingredients?
Labelling must comply with the Food Information Regulations 2014, which require clear declaration of added nutrients and additives. Misleading or incomplete labelling may breach both food law and consumer protection legislation.
8. What happens if a manufacturer fails to comply?
Non-compliance may result in enforcement action under the Food Safety Act 1990, including improvement notices, product withdrawal, prosecution and financial penalties.
9. Are there concerns about mandatory fortification?
Yes. Some critics argue that mass fortification limits consumer choice and may lead to over-consumption in certain groups. Others express concern about regulatory burden on small producers. These issues remain part of the ongoing policy debate.
10. Is the UK aligned with international standards on food fortification?
Yes. The UK policy aligns with recommendations of the World Health Organization and mirrors fortification regimes in countries such as the United States, Canada and Australia.
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References
Bread and Flour Regulations 1998 (SI 1998/141).
Bread and Flour (Amendment) (England) Regulations 2024.
Food Safety Act 1990.
Food Standards Act 1999.
European Union (Withdrawal) Act 2018.
Regulation (EC) No 178/2002 (General Food Law Regulation) (as assimilated into UK law).
Regulation (EC) No 1333/2008 on food additives (retained EU law).
Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, enzymes and flavourings (retained EU law).
Food Information Regulations 2014.
Consumer Protection from Unfair Trading Regulations 2008.
Consumer Rights Act 2015.
Scientific Advisory Committee on Nutrition (SACN), Folate and Disease Prevention.
Department of Health and Social Care, Consultation on the Mandatory Fortification of Flour with Folic Acid(2021).
Department of Health and Social Care, Government Response on Folic Acid Fortification (2022).
Food Standards Agency, Guidance on Bread and Flour Regulations.
Food Standards Agency, Food Additives and Ingredients Guidance.
World Health Organization, Guideline: Daily Iron and Folic Acid Supplementation in Pregnant Women.
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