Since the adoption of the General Food Law Regulation in 2002 (1) which created the European Food Safety Authority (EFSA), the pursuit of ‘zero risk’ has become the main goal for every food business operator (FBO). But at the same time, scientific progress has constantly improved analytical methods, making detection threshold always lower, and often tipping the balance one way or another. Therefore, food product withdrawals and even, recalls, are commonplace, and food crises regularly make headlines in the mainstream press.

On 7 June 2025, the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) dedicated the day on the theme: science in action for food safety. This was a timely reminder of the central role science plays in preventing food hazards and of the obligations that fall upon them before placing any product on the European market aiming at ensuring food safety. 

All of this is an opportunity to highlight and to understand, in more details, the importance of scientific knowledge in preventing food crises and helping FBOs deal with them when they arise.

But first of all, it should be remembered that while EFSA is officially and generally entrusted with the assessment of risks in the EU, the primary and concrete responsibility for managing risks, at all stages, from production until the placement on the market, and on a day-to day basis, rests with operators themselves.

Actually, considering that “a food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe (...)(2)”, several essential obligations are imposed on them, in particular the obligation to verify, at all stages of production, processing, transport and distribution, that foodstuffs meet all health and safety requirements.

This obligation is absolute. Indeed, Article 14 of Regulation 178/2002 laid out the principle that “Food shall not be placed on the market if it is unsafe. 2. Food shall be deemed to be unsafe if it is considered to be: (a) injurious to health; (b) unfit for human consumption”. In other words, the very act of placing a product on the EU market implies, in theory, a guarantee that it is totally free from any unacceptable, even potential, risk.

Beyond this principle, also lies a broader duty of prevention. Article 17 of the same Regulation requires that “Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met.”

Conversely, those fundamental principles have legitimised, ever since, the increasing role, and sometimes interference, of national authorities in food risk management, the latter considering that the safety of consumers are not admissible nor negotiable.

This situation calls for some comments. 

Science is truly at the crossroads of food law

Science has always been a key element to food law application, but while the legal principles set out in Regulation 178/2002 have not fundamentally changed since its entry into force, science itself, however, has evolved rapidly. Analytical techniques are now so sensitive that they can detect traces of contaminants which would have remained undetected decades ago. As a result, this evolution can create the impression that crises are more frequent, when in reality, it is, simply, our ability to detect that has sharpened.

Consequently, it means for FBOs reinforcing their uncompromising commitment to ensure that no food is placed on the market if it is unsafe. Unfortunately, there is only a limited number of legal texts that they can rely on. Apart from the technical requirements set out in the Regulation 852/2004 on the hygiene of foodstuffs and, more generally, in the “Food Hygiene Regulation,” (3) the responsibility to assess risk and design a robust Hazard Analysis and Critical Control Point (HACCP) plan, therefore, primarily lies on their shoulders.

FBOs must often navigate with limited guidance

Articles 4 and 5 of the Food Hygiene Regulation together with the General Food Law Regulation are the legal basis for the European Food Safety Management System (FSMS) to be complied with by FBOs.

A comprehensive FSMS is supposed to be built on two essential pillars.

The first pillar is a set of Prerequisite Programs (PRPs), which provide the foundation for safe operations. PRPs refer to the preventive practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety. These include good hygiene practice (such as appropriate cleaning, disinfection, and personal hygiene requirements) and good manufacturing practice (such as correct dosing of ingredients, adherence to appropriate processing temperatures, and equipment maintenance). Without these fundamentals, no risk management system can function effectively.

The second pillar is the regulatory framework itself, and especially the obligations arising from Regulation 178/2002. Operators must ensure traceability of all food products, so that any unsafe product can be identified quickly. In this regards, Article 18 paragraph 1 states that “the traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution. 2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.”

FBOs must also establish strong and efficient withdrawal and recall procedures and be ready to activate them when it is needed.

This structure is dynamic. Admittedly, these criteria are regularly reassessed to reflect the latest scientific findings. For instance, a recent revision concerning Listeria, which has seen unprecedented peaks in contamination over the last five years, has taken place and will apply from 1 July 2026.

FBOs must, therefore, remain aware not only of current obligations but must also pay attention to forthcoming changes that could impact their business.

A toolbox to mitigate withdrawals and recalls

When it comes to the handling of unsafe food already placed on the market, rules remain particularly strict. Indeed, Article 19, paragraph 1, of Regulation 178/2002 states that “If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.”

The imperative is clear: unsafe food must not remain on the market. In practice, however, FBOs have some tools at their disposal to ensure a swift process and prevent abusive recalls.

The way such situations are handled depends on the nature of the crisis and the severity of the outcomes already visible - for example, cases of illness among consumers. In the most serious situations, such as in the ‘Buitoni case’ several years ago, the national authorities may intervene directly and impose strict measures, including the closing of the plant, leaving the company with little room to manage this stage of the crisis itself.

But food crisis can arise from various sources - hopefully ahead of any consumer illness linked to a product – such as, internal quality controls revealing a potential hazard. Other crises are sparked by analyses carried out by regulatory authorities in the context of official controls.

Therefore, each scenario requires a tailored approach. When dealing with them, FBOs have procedural safeguards they can use to try to mitigate the crisis.

The most important one is for FBOs to conduct immediate risk assessments to determine the precise nature and extent of the issue. In practice, this means assessing the situation by themselves to identify the cause and distinguish between a potential hazard and an actual risk, while also determining the nature and, above all, the scope of the measures to take. If the outcome is positive, FBOs should share their scientific conclusions with the authorities. If it remains unfavourable for them, they must, then, implement, without delay, measures to eliminate the hazard, which may include blocking the product, withdrawing products already on the market, or, in the most serious cases, recalling products from consumers.

When the crisis is already out of the control of the FBOs, but managed by a national authority, FBOs still have the right to request a reanalysis, since laboratories sometimes make mistakes. Even in this case, it is worth asking to have the product tested again before following an administrative injunction to recall a product. Article 35 of Regulation 2017/625 on official controls (4) explicitly provides that, in the context of official controls, operators may seek a second expert opinion.

Therefore, while the obligation to withdraw unsafe food is strict, there are safeguards to prevent unnecessary or excessive action. FBOs can rely on risk assessments to decide on the scope and nature of a withdrawal and may request additional analyses if doubts remain.

Conclusion: Science is a daily ally

Managing food crises is undoubtedly an integral part of the FBO’s environment. They can rely both on the regulatory framework and, more importantly, on the systematic use of science in risk analysis.

Together, this enables them to take the most appropriate action to ensure consumer safety while limiting the intervention of national authorities once a problem occurs.