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A Necessary Evolution

Since its conception, at the end of the 1950s, until today, the hazard analysis and critical control point (HACCP) system has gone through a series of phases and circumstances that have modified it until becoming a fundamental and irreplaceable tool to ensure food safety, as recognized by numerous international bodies and institutions.

The origin of HACCP is related to the failure mode and effects analysis (FMEA) system, which we can consider its predecessor and from which it borrows part of its methodology and the systematic approach to assessing risks in a given production, for example, using flow diagrams and probability risk matrices × gravity.

Based on the FMEA, the Pillsbury Company, NASA, and US Army Laboratories in Natick developed the original formulation of HACCP for its use in flights crewed from NASA’s aerospace program. In 1971, the concept was presented publicly at the National Conference for Food Protection, co-sponsored by the Food and Drug Administration (FDA) and the American Public Health Association. At that time, the HACCP system included only three principles:

• hazard identification;
• determination of critical control points (CCPs); and
• monitoring of CCPs.

Its application in the food industry began to take shape in 1974 with the enactment by the FDA of the regulations that applied to canned food with low acidity. And already in the 1980s, its use gradually spread to other food industry sectors.

The major milestone in the application of the HACCP system occurred in the 1990s, specifically when the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) defined the seven HACCP principles in 1992. One year later, the Codex Alimentarius Commission adopted these principles and published the Recommended International Code of Practice – General Principles of Food Hygiene, which included the annex Hazard Analysis and Critical Control Point – Guidelines for Their Application, describing the HACCP system. After several revisions, the HACCP has reached the current version: CXC 1-1969 (FAO and WHO 2022).

The importance of the publication of this General Principles of Food Hygiene is unquestionable, establishing the bases and principles of the system in a definitive way. Since then, we all have started speaking the same language and knowing what elements form the system, its methodology, and the concepts and terms that define it. This document is an essential reference for food safety auditors since it contains the requirements and criteria against which they can compare the HACCP systems designed by food operators.

With the Codex document was set up what we can call the “backbone” of HACCP: a basic structure that, since then, and with the experience acquired in the implementation of the system in the food industries, has required some modifications and the intervention of other elements that are becoming necessary to overcome the difficulties involved in its practical implementation. Some of the most significant milestones in the evolution of the HACCP system since its origin could be the following:

• Publication of the Codex document.
• Universal acceptance.
• Need for prerequisite programs (PRPs).
• The emergence of the first HACCP standards with the elements of quality management systems included.
• Need for flexibility in its application to different types of operators.
• Use of the audit tool to verify its operation.
• Acceptance of HACCP as a food safety management system.
• Application of operational prerequisites.
• Need for validation of the system before its implementation.

What is not very evident in the annex Hazard Analysis and Critical Control Points – Guidelines for their Application, just mentioned in a sentence that occupies only one line, is the crucial role of the PRPs in the system’s operation, as it was recognized years later. HACCP cannot work in a vacuum; it needs to be supported on the solid basis of properly implemented prerequisites (Sperber 1998).

Over time, the practical experience gained implementing HACCP has given rise to the strong international consensus on the primary role that codes of hygiene practice should play in controlling an essential part of the hazards identified in each case. Good hygiene practices or prerequisites are the foundations of the food safety system, must be implemented first, and are valid for all food operators, including primary production; HACCP is in the second place and may not be fully applicable in some cases (Figure 1.1).

Figure 1.1 HACCP evolution.

Source: Adapted from Griffith.

Another change in HACCP is the introduction of flexibility criteria. Since in the 1990s, the HACCP system became a mandatory requirement for operators in the different sectors of the food chain – except primary production – as is the case in the European Union with Directive 93/43, the difficulties that arose in some small and medium-sized companies to be able to implement the system as a whole effectively became evident.

At that time, it became necessary to set up provisions on the flexibility necessary to adapt the application of HACCP-based procedures in some establishments. Both documents CXC 1-1969, Regulation (EC) 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, and the guidance documents prepared by Directorate – General Health and Consumer Protection (DG SANCO) provide for the application of flexibility criteria for certain food operators. These provisions must be taken into account by food safety auditors when assessing self-control systems in these kinds of operators.

These changes and adaptations in the HACCP system have led some authors to lament the loss of its essence and original identity (Cliver 2010). There have indeed been changes, but we must also consider that HACCP was born for a very particular use and for conditions that we may describe as “in vitro” to achieve an objective of “zero defects” in the feeding of astronauts, necessary to ensure the success of the aerospace program. These conditions have little to do with the reality of the agri-food industries and with the application of the HACCP system in the different stages of the food chain, in a real food production environment, where it is not feasible to assume the zero-risk approach and in which food business operators must adjust their costs to be economically viable in a highly competitive market.

One issue that for years has been, and continues to be, the subject of debate is the possibility of extending the implementation of HACCP to all stages in the food chain, particularly primary production. Given the origin of the HACCP system, we know that its application was always more oriented to the central stages of the food chain, where there are companies that can process raw materials and carry out specific operations for the control or elimination of hazards; however, at the beginning and the end of the food chain, primary production and consumption, respectively, it is more challenging to implement.

Several HACCP experts (Sperber 2005; Cerf and Donnat 2011) recognize the difficulties in implementing the system in primary production due to the need for adequate infrastructure, technology, or even proper human resources. However, there is now a broad consensus on the need to promote good hygiene practices and good agricultural or veterinary practices as the best way to avoid or minimize the risk of hazards present at the primary production stage, which otherwise can reach the following steps in the supply chain.

In the history of HACCP, the appearance of the first standards or HACCP certification schemes was relatively early; Australia, the Netherlands, and Denmark were the most innovative and those who first saw the need for or usefulness of these standards in implementing HACCP. In 1994, the first food safety standard, the Safe Quality Food (SQF), appeared in Australia, and shortly after HACCP became mandatory in Europe, the second standard, the Dutch HACCP code “Requirements for a HACCP-Based Food Safety System” appeared in 1996, followed somewhat later by the Danish standard DS 3027:1997.

The change introduced by these standards is fundamental to understanding the subsequent HACCP evolution. Although what they do is add some aspects of quality systems, such as ISO 9000, to facilitate the management of the HACCP system, the important aspect is the qualitative leap that occurs when moving from the idea of the plan or HACCP study done on paper to a food safety management system, understood as a set of procedures to be applied by the staff of a specific organization in their daily activity – something that has ended up being entirely accepted and assumed by the bodies and institutions involved in HACCP management.

The assignment of roles and responsibilities both at management levels and between operators and supervisors, document control, implementation of documented procedures, notification and withdrawal of nonconforming products, and calibration of equipment, among others, are elements of quality systems that, over time, have demonstrated their compatibility with the HACCP system and synergy with its functioning and efficiency within the framework...