Compliance challenges with EU and UK nitrites/nitrates rules

Rear view of a woman shopping for groceries in a supermarket, standing in front of a refrigerated section filled with chilled packaged meat. The concept of choice.
Legal expert Sarah Jane-Dobson examines the product liability risks for food manufacturers and retailers selling products containing ham in the UK and EU, following WHO’s classification of processed meat as a Group 1 carcinogen. (Getty Images)

More than a decade after the World Health Organization classified processed meats such as ham as Group 1 carcinogens, concerns over nitrites/nitrates in food continue to spark debate. Sarah-Jane Dobson, partner at law firm, Ashurst, discusses.

UK scientists have recently called for the introduction of health warnings similar to cigarettes, for ham, arguing that nitrite‑preserved processed meats pose a carcinogenic risk.

Nitrites/nitrates are added to cured meats to preserve colour, enhance flavour, and prevent harmful bacterial growth such as clostridium botulinum.

In the EU and the UK, food additives are regulated under the EU Regulation (EC) No 1333/2008 and the consolidated version in Great Britain. Additives must undergo risk assessment and obtain market authorisation before use. Nitrites/nitrates are approved additives but are subject to strict maximum levels and labelling requirements.

In October 2023, the EU introduced legislative reform lowering permitted levels of nitrite/nitrate, which have applied since October 2025. In contrast, the UK’s Food Standards Agency (FSA) maintains that current nitrite/nitrate levels adequately protect consumers, finding in its October 2025 review that evidence linking these additives to serious health conditions, including cancer, remains inconclusive.

Liability assessment

Product liability claims in the UK and EU, including for food, fall under strict‑liability regimes: the EU Product Liability Directive 1985 (PLD) and the UK Consumer Protection Act (CPA), which implements the current PLD. An updated version of the PLD will apply to products placed on the market from 9 December 2026.

These regimes are complemented by contractual and negligence claims, as well as consumer‑protection and regulatory breaches, which in some European jurisdictions allow consumers to seek damages directly for product and supply‑chain issues.

These above regimes all apply to food products, including those alleged to be defective due to carcinogenic risk. Such claims are likely to present as cases arguing defect, failure to warn or inadequate instructions. Indeed, the majority of the product liability cases to date, including those that are non-food related, do tend to focus on a long-term chemical exposure which is alleged to have caused adverse health impacts, and tend to involve the invocation of all these arguments in parallel in many instances.

Excessive levels of nitrates/nitrites could therefore give rise to claims where a consumer is able to demonstrate that the damage suffered – such as cancer – resulted from levels exceeding what would generally be expected or permitted by law. Inadequate warnings or lack of appropriate information will also be taken into account when determining whether the food in question is defective.

Notably however, the case law to date is distinguishable from the current issue, as historic cases have tended to start from the basis of a contamination, or a direct breach of regulatory prohibition or threshold imposition.

Cases involving nitrates/nitrites are therefore likely to be more legally complex, and potentially more akin to more modern-day products law issues such as those involving PFAS for example. In particular, the complexity here is the prescriptive regulatory framework which implicitly allows for some content of nitrites/nitrates within certain thresholds. The existence - and adherence - to these thresholds would make arguing defect more complex. Under these regimes, a product is generally defective if it is not as safe as persons are generally entitled to expect, considering all circumstances, including warnings, marketing, and expected use.

Conversely, the scientific knowledge around the topic, which evolves continually, may provide a basis for the argument that warnings or instructions for use should be adopted more proactively by the manufacturer.

This creates a more nuanced legal context than in circumstances where an express breach of regulation occurs. Where such a breach does occur, however, this would result in a stronger foundation for any litigation that follows.

Evidential burden and scientific evidence

The Courts across Europe continue to struggle with causation and evidential issues in respect of long-term exposure in product liability causes alleging harm to consumers.

The task appears to be inherently challenging given the presence of multiple possible contributing factors, and the difficulty in establishing the effect of just one of some such causes. Many of the reforms of the new PLD were designed to address this evidential burden, and do fundamentally make it easier to do so.

The new EU PLD

The revised EU PLD is designed to make product liability claims easier to bring in Europe, and has several fundamental impacts, as follows:

It shifts the burden of proof from the individual claimant to the defendant organisation in respect of causation, which as above, is historically thought to be difficult to establish, specifically in cancer-causing causes.

In certain circumstances, courts will be entitled to presume both defect and causation, thereby increasing the potential exposure to liability.

While disclosure is already a well-established feature of UK litigation, the revised PLD introduces it as new procedural mechanism within the EU framework. This represents a significant shift for many European jurisdictions that do not currently provide for disclosure. Businesses should therefore ensure that robust document-retention policies are in place to prepare for potential litigation.

The new PLD also introduces extended limitation periods, with latency periods allowed for presentation of disease, which may be relevant for long-term exposure cases such as this.

There are other legislative changes and legal developments that also impact the relevant legal framework: The new EU Representative Actions Directive increases the risk of group and collective actions against food manufacturers, brand owners, and retailers operating across multiple jurisdictions. Moreover, revisions to the general product safety framework and various sector‑specific regimes further contribute to the evolving legal landscape.

Legal risk mitigation

To mitigate potential liability risks, food manufacturers and retailers should ensure full compliance with legal requirements governing nitrate/nitrite levels as well as labelling obligations.

In addition, supply chains should be thoroughly mapped and assessed, and contractual arrangements should be reviewed to clarify the allocation of liability across all stages of the supply chain.

Organisations should also implement effective systems for handling enquiries and complaints, review and update their product liability insurance coverage, and maintain a comprehensive Product Safety Incident Plan.

Businesses should prepare for the complex legal exposure this issue presents, by doing the following:

  • Considering nitrates/nitrites content, including whether this is within the current regulatory thresholds allowable and/or if there are breaches or historic breaches of said thresholds.
  • Consider utility of additional labelling or instructions to consumers which may result in mitigation of any risk that eventuates, including by reference to updated scientific views on the topic.
  • Track ongoing regulatory developments and scientific knowledge, implementing the same as soon as possible.
  • Consider enhancing traceability of any nitrate/nitrite containing products, to prepare for any regulatory issues and/or corrective actions required.

On a more holistic level, companies should seriously consider the phase out or reduction of use of the substances generally in long-term in line with any reforms proposed in regulation.

The evolving regulatory framework for nitrates/nitrites is increasing compliance pressures for UK and EU food manufacturers and retailers.

Stricter EU limits and the revised PLD heighten litigation risks, while the UK’s more cautious stance adds cross‑border complexity. Whether the UK will ultimately align with EU reforms remains unclear, making close monitoring of upcoming regulatory developments essential for businesses.

The litigation risk that follows will have a long tail, and therefore legal exposure should be addressed as best as possible now to minimise future-looking liability.