Module 1. Concepts of quality, safety and food laws

Lesson 3


3.1 Introduction

With India being a member of the Codex Alimentarius Committee since 1970, the Ministry of Health and Family Welfare (FSSAI acting as the National Codex Contact Point), has the primary responsibility for determination of government policy relating to food standards and enforcement of food control including national position on various issues relating to Codex. With the global food industry looking towards India as a food hot-spot, it is about time the national food legislation is aligned with Codex, encouraging innovation and facilitating trade without compromising consumer safety. Whilst formulating and implementing a single unified standard is a prodigious task, one of the major concerns of the industry which needs to be addressed by the government while finalizing the Food Safety and Standards Regulations, 2010 is tuning of international best practices with the domestic ground realities. Both the domestic and international industry is looking forward to FSSAI for the harmonization of Indian food standards for all food categories with the Codex Alimentarius Commission (CAC) standards. CAC is regarded as the ‘World Authority’ on food standards (Joint FAO/ WHO Food Standard Programme). Codex’s focused objectives of (1) protecting consumers and (2) facilitating trade are shared by member countries and its standards based on scientific evidence and risk analysis principles are followed and/or adopted partially or in totality by countries around the world. The WTO in its Sanitary and Phytosanitary (SPS) Agreement recognizes the Codex standards as the global reference standards for consumers, food producers, processors, national food control agencies and all others involved in international food trade. The Agreement on the Application of SPS Measures and the Agreement on Technical Barriers to Trade (TBT) also encourage the international harmonization of food standards. Codex standards have thus become the benchmarks against which national food control measures and regulations are evaluated under the relevant provisions of the WTO Agreements.

3.2 Setting Public Health Goals

3.2.1 Concept of appropriate level of protection

During the past decade, there has been increased interest and effort in developing tools to more effectively link the requirements of food safety programs with their expected public health impact. An appropriate level of protection (ALOP), expressed in terms of a desired reduction in the current level of risk, could be defined as the food safety goal. An ALOP is currently defined as ‘a statement of the degree of public health protection that is to be achieved by the food safety system’. An explicit description of an ALOP may be in terms of the probability of an adverse public health consequence or the incidence of disease (e.g. the number of cases per 1,00,000 populations per year). Translation of an ALOP into a Food Safety Objective (FSO), expressed in terms of the required level of hazard control in food, provides a measurable target for producers, manufacturers and control authorities. An FSO is defined as ‘the maximum frequency and/or concentration of a microbiological hazard in a food at the time of consumption that provides an appropriate level of protection’. An alternative definition of an FSO might be a limit to the prevalence and the average concentration of a microbial hazard in food, at an appropriate step in the food chain at or near the point of consumption that provides the appropriate level of protection. This ALOP has also been called ‘acceptable level of risk’ (ALR). This term is similar to the expression ‘tolerable level of risk’ (TLR) preferred by the ICMSF, because it recognizes that risks related to the consumption of food are seldom accepted, but at best tolerated. One of the tasks of governmental risk managers is thus to decide upon what is adequate, appropriate or tolerable in terms of food safety or health risk. How they have to do this is not described in detail by the WTO or the Codex. However, the determination of ALOP/ TLR should be science based, should include economic and social factors and should minimize negative trade effects. Integral to the agreement is that imported food should not compromise the ALOP. An exporting country can contest an importing country's judgment that a food is not meeting the ALOP by using scientific methods such as risk assessment, Codex standards, codes and guidelines. A country cannot demand that imported foods are ‘safer’ than similar domestically produced foods.

3.3 Concept of Risk Analysis

Risk analysis (RA) and its component parts (risk assessment, risk management and risk communication) should be used as a tool in evaluating and controlling microbiological hazards. A risk-management based approach (Fig. 3.1) is required to develop recommendations to ensure consumer protection and facilitate fair practices in the food trade. This structured approach may employ microbiological risk assessment and may utilize a spectrum of risk communication products including guidance documents, codes of hygiene practice, food safety objectives (FSO) and microbiological criteria. Some general guidelines used to manage pathogens in foods have been described by ICMSF (2002), indicating the respective roles of industry and government. A series of steps is described, including:
  1. analysis of epidemiological data which may give rise to concern for public health or a need for improved controls;
  2. risk evaluation by an expert panel or through quantitative risk assessment;
  3. establishment of an FSO when necessary;
  4. assessing whether the FSO is technologically achievable through preliminary process and/or product formulation criteria and
  5. if the FSO is achievable, establishment of process/ product requirements.


Fig. 3.1 Principle of risk assessment described by codex alimentarius commission

3.3.1 Risk assessment

Risk assessment is the characterization and estimation of potential adverse health effects associated with exposure of individuals or populations to hazardous materials or situations. Risk assessment of microbiological hazards in foods has been identified as a priority area of work by the CAC. Risk assessment for microbiological hazards in foods is defined by the CAC as a scientifically based process consisting of four components: hazard identification, exposure assessment, hazard characterization, and risk characterization.

I. Hazard identification is predominantly a qualitative process intended to identify microorganisms or microbial toxins of concern in food or water. It can include information on the hazard of concern as well as relevant related data, such as clinical and surveillance data.

II. Exposure assessment should provide an estimate, with associated uncertainty, of the occurrence and level of the pathogen in a specified portion of food at the time of consumption, or in a specified volume of water using a production-to-consumption approach. While a mean value may be used, more accurate estimates will include an estimate of the distribution of exposures. This will typically include identification of the annual food and water consumption frequencies and weights or volumes for a given population or sub-populations(s), and should combine the information to estimate the population exposure to pathogens through a certain food or water commodity.

III. Hazard characterization provides a description of the adverse health effects that may result from ingestion of a microorganism. When data are available, the hazard characterization should present quantitative information in terms of a dose-response relationship and the probability of adverse outcomes.

IV. Risk characterization is the integration of the three previous steps to obtain a risk estimate (i.e. an estimate of the likelihood and severity of the adverse health effects that would occur in a given population, with associated uncertainties).

The goal of a risk assessment may be to provide an estimate of the level of illness from a pathogen in a given population, but may also be limited to evaluation of one or several step(s) in a food production or processing system. When requesting a risk assessment, the risk manager should be specific with regard to the problem with which the risk manager needs to deal, the questions to be addressed by the risk assessment, and an indication of the measures the manager would consider or has available for the reduction of illness.

3.3.2 Risk management

The process, distinct from risk assessment, of weighing policy alternatives in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

3.3.3 Risk communication

The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.

3.4 Codex Alimentarius Commission

The CAC is a body of United Nations (UN) established by FAO in 1961 and is an inter-governmental organisation that coordinates food standards at the international level. Its main objectives are to protect the health of consumers and ensure fair practices in food trade. The Codex Food Code (CFC) attempts to create harmonized standards. Prior to the SPS Agreement, the CFC could be adopted, applied and/ or ignored at the discretion of a government. However, the CFC has now been adopted within the SPS Agreement as the benchmark. The CAC has proved to be most successful in achieving international harmonization in food quality and safety requirements. It has formulated international standards for a wide range of food products and specific requirements covering pesticide residues, food additives, veterinary drug residues, hygiene, food contaminants, labelling, etc. These codex recommendations are used by governments to determine and refine policies and programmes under their national food control system. More recently, Codex has embarked on a series of activities based on risk assessment to address microbiological hazards in foods, an area previously unattended. Codex work has created worldwide awareness of food safety, quality and consumer protection issues, and has achieved international consensus on how to deal with them scientifically, through a risk-based approach. As a result, there has been a continuous appraisal of the principles of food safety and quality at the international level. There is increasing pressure for the adoption of these principles at the national level. Quality assurance systems have become a focal point for inclusion in the work of Codex. As an example, the CAC has recently adopted guidelines for the application of the HACCP system. The HACCP approach, along with the use of GMPs, is strongly recognized and recommended by Codex. The principal consideration behind the development of any Codex standard, guideline or other recommendation is the protection of consumer’s health.

3.5 HACCP System

HACCP stands for Hazard Analysis Critical Control Point. HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards. It is a proactive strategy where hazards are identified and assessed, and control measures are developed to prevent, reduce, or eliminate a hazard.
The HACCP system, which is science based and systematic, identifies specific hazards and measures for their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing. Any HACCP system is capable of accommodating change, such as advances in equipment design, processing procedures or technological developments.

HACCP can be applied throughout the food chain from primary production to final consumption and its implementation should be guided by scientific evidence of risks to human health. As well as enhancing food safety, implementation of HACCP can provide other significant benefits. In addition, the application of HACCP systems can aid inspection by regulatory authorities and promote international trade by increasing confidence in food safety. The successful application of HACCP requires the full commitment and involvement of management and the work force. It also requires a multidisciplinary approach; this multidisciplinary approach should include, when appropriate, expertise in agronomy, veterinary health, production, microbiology, medicine, public health, food technology, environmental health, chemistry and engineering, according to the particular study. The application of HACCP is compatible with the implementation of quality management systems, such as the ISO 9000 series, and is the system of choice in the management of food safety within such systems.

3.6 Management Systems for Quality and Food Safety

Excellence in food quality and safety has taken a tangible form with the advent of ISO 9000 Quality Management System and HACCP standards. ISO 9000 encompasses all the activities of a company to ensure that it meets its quality objectives, while HACCP is directed towards ensuring food safety. The ISO 9000 standards were brought by the International Organization for Standardization (ISO) and the HACCP standards by the CAC. These standards have assumed importance worldwide both as an essential requirement to tap the market potential and as a marketable feature of the company. Since the global market has become more demanding in terms of quality, safety and timely delivery, installation of the ISO 9000 Quality Management System and HACCP by the food industry is essential for getting a competitive international edge. Food Safety Programs may need to be implemented to meet regulatory requirements, retailer requirements or manufacturer’s requirements.

ISO 9000 Quality Management Systems: The ISO 9000 system is looked at as a system with minimum quality requirements. It builds a baseline system for managing quality. The focus, therefore, is on designing a total quality management system, one that complies with external standards, but includes the specific requirement of industry and integrates elements of competitiveness.
Last modified: Tuesday, 6 November 2012, 7:12 AM