DRAFT 1 APPLICATION OF THE HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP)SYSTEM IN THE FOOD PROCESSING AND MANUFACTURING INDUSTRIES L INTRODUCTION 1. 1 Promotion of exports from developing countries to the European Union(EUand other industrialized countries-al n overview Supplying safe and high quality foods is more important than ever, as importers of food products demand safe food in compliance with strict hvgiene rules Quality improvement, however, is a continuous process The present concems in quality with respect to insects, extraneous matter, moisture, ash, micro-organisms insects, mites, mycotoxin, pesticide residues, heavy metals, non permitted colors, animal excreta, etc. will be addressed if appropriate pre and post-harvest operations, storage and packaging are adopted Though this is not an easy task, a fair degree of acceptability of produce will be attained, if normal care and attention are given at various stages of handling the produce, from growing to packaging. Anyone who owns, manages or works in a food business in the EU - apart from those working in primary food production- is affected directly (and indirectly if supplying to the eu) by the common food hygiene rules across the European Union, as set the Food Hygiene Drective(93/43/EEC). Application of the Food Hygiene Directive(93/43/EEC) will force exporters to a higher and safer quality of produce supplied and to improve production circumstances and methods in the country of origin. Every process which deals with preparing or selling food can be classed as a food business activity including. preparation, processing, manufacturing, transportation, distribution, ling and supplying. 1.2 Hazard Analysis Critical Control Points(HACCP)system The Food Hygiene Directive(93/43/EEC) obliges food businesses in the European Union to implement systems that are based on the principles of Hazard Analysis and Critical Control Point(HACCP). Though non-EU suppliers of food products do not legally have to comply directly with the eu directive on Food Hygiene, they are affected by the eu Hygienic rules. It was clearly confirmed that food businesses in Europe, implementing systems to ensure that hazards are identified and controls are in place, have became increasingly selective in dealing with their(foreign)suppliers and requested a strict application of HACCP in the countries of origin of imported products. In some cases, they have even set out additional hygienic requirements for their suppliers regarding specific product(s) Food businesses in Europe and in other industrialized countries applying systems to food safety, will not buy any raw material if they think that, even after sorting and processing, it could make food unfit for human consumption. Any raw material or processed food product which is only suspected or known to be infected or contaminated with parasites or foreign substances will not be accepted Therefore there is a growing need to promote appreciation for and understanding of HACCP by govemments and food industry, particularly in developing countries So. from rket point of view manufacturers and non-EU exporters of food products to the EU should It the introduction of systems based on haccp in food businesses in the eu. consider food fely pro s and apply HACCP Even more, manufacturers and exporters of food stuff should also
DRAFT 1 APPLICATION OF THE HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) SYSTEM IN THE FOOD PROCESSING AND MANUFACTURING INDUSTRIES I. INTRODUCTION 1.1 Promotion of exports from developing countries to the European Union (EU)and other industrialized countries - an overview Supplying safe and high quality foods is more important than ever, as importers of food products demand safe food in compliance with strict hygiene rules. Quality improvement, however, is a continuous process. The present concerns in quality with respect to insects, extraneous matter, moisture, ash, micro-organisms, insects, mites, mycotoxin, pesticide residues, heavy metals, non permitted colors, animal excreta, etc. will be addressed if appropriate pre- and post-harvest operations, storage and packaging are adopted. Though this is not an easy task, a fair degree of acceptability of produce will be attained, if normal care and attention are given at various stages of handling the produce, from growing to packaging. Anyone who owns, manages or works in a food business in the EU - apart from those working in primary food production - is affected directly (and indirectly if supplying to the EU) by the common food hygiene rules across the European Union, as set out in the Food Hygiene Directive (93/43/EEC). Application of the Food Hygiene Directive (93/43/EEC) will force exporters to a higher and safer quality of produce supplied and to improve production circumstances and methods in the country of origin. Every process which deals with preparing or selling food can be classed as a food business activity, including: preparation, processing, manufacturing, transportation, distribution, handling, packaging, storage, selling and supplying. 1.2 Hazard Analysis Critical Control Points (-HACCP) system The Food Hygiene Directive (93/43/EEC) obliges food businesses in the European Union to implement systems that are based on the principles of Hazard Analysis and Critical Control Point (HACCP). Though non-EU suppliers of food products do not legally have to comply directly with the EU directive on Food Hygiene, they are affected by the EU Hygienic rules. It was clearly confirmed that food businesses in Europe, implementing systems to ensure that hazards are identified and controls are in place, have became increasingly selective in dealing with their (foreign) suppliers and requested a strict application of HACCP in the countries of origin of imported products. In some cases, they have even set out additional hygienic requirements for their suppliers regarding specific product(s). Food businesses in Europe and in other industrialized countries applying systems to assure food safety, will not buy any raw material if they think that, even after sorting and processing, it could make food unfit for human consumption. Any raw material or processed food product which is only suspected or known to be infected or contaminated with parasites or foreign substances will not be accepted. Therefore there is a growing need to promote appreciation for and understanding of HACCP by governments and food industry, particularly in developing countries. So. from a market point of view. manufacturers and non-EU exporters of food products to the EU should take into account the introduction of systems based on HACCP in food businesses in the EU. consider food safely procedures and apply HACCP . Even more, manufacturers and exporters of food stuff should also
any hygiene codes which contain specific recommendations of(foreign) supply for a specitIc produc our contact their importers or brand organizations, in the countries to which they export, to find out if there are The HACCP system is a relatively new approach to the prevention and control of food borne diseases. The Hazard Analysis Critical Control Point (HACCP) system identifies specific hazards and preventative measures for their control to ensure the safety of food haccp is a tool to assess hazards and establish control systems that focus on preventative measures rather than relying mainly on end-products testing. Any HACCP system is capable of accommodating change, such as advances in equipment, design, processing procedures or technological developments related to the product. II PREREQUISITE PROGRAMMES Prerequisite programmes are defined as the universal procedures used to control the conditions in the food plant environment which contribute to the overall safety of the products; documented prerequisi programmes as the foundation of food safety management. HACCP is not a stand alone programme but part of a larger control programme; implementation of HACCP relies on adherence to prerequisite programmes. Prerequisite programmes MUSt be developed, implemented and documented. Prerequisite programmes include good Manufacturing Practices(GMP)and other programmes IIL. HACCP APPLICATION TO FOOD MANUFACTURING AND PROCESSING HACCP can be applied throughout the food chain from the primary producer to final consumer. As well as enhanced food safety, benefits include better use of resources and more timely response to problems. In addition, the application of HACCP system 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 workforce. It also requires a team approach this team should include appropriate experts; examples might be agronomists, veterinarians, production personnel, microbiologists, food technologists, chemists and engineers, according to the particular stud The application of HACCP is compatible with the implementation of quality management systems, such as ISO 9004 series, and is the system of choice in the management of food safety within such systems. Many food manufacturers and processors have already applied the HACCP system to their operations. The level of safety assurance offered by the HaCCp system is fast becoming the standard for the food industry in industrialized countries Food safety authorities in the United States, Canada and European Union(EU) promote the use of HACCP HACCP is also being incorporated into the Codex Codes of Practice for a number of food commodities Consequently, there is a growing need to promote appreciation for and understanding of HACCP by govemments and the food industry particularly in developing countries The application of HACCP is not limited to food manufactured and processed by mediumto large-scale operations but may also be applicable to smaller operations where safety of foods is of critical importance There are numerous benefits for the food industry while applying HACCP system as a management tool for food safety control. Some key benefits are as follows The HACCP approach is a systematic approach which can be applied to all aspects of food safety including biological, chemical and physical hazards, to all stages of the food chain, including raw materials, growth, harvesting, purchase, production, distribution, and storage to final product use
contact their importers or brand organizations, in the countries to which they export, to find out if there are any hygiene codes which contain specific recommendations of (foreign) supply for a specific product. The HACCP system is a relatively new approach to the prevention and control of food borne diseases. The Hazard Analysis Critical Control Point (HACCP) system identifies specific hazards and preventative measures for their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control systems that focus on preventative measures rather than relying mainly on end-products testing. Any HACCP system is capable of accommodating change, such as advances in equipment, design, processing procedures or technological developments related to the product. II PREREQUISITE PROGRAMMES Prerequisite programmes are defined as the universal procedures used to control the conditions in the food plant environment which contribute to the overall safety of the products; documented prerequisite programmes as the foundation of food safety management. HACCP is not a stand alone programme but is part of a larger control programme; implementation of HACCP relies on adherence to prerequisite programmes. Prerequisite programmes MUST be developed, implemented and documented. Prerequisite programmes include Good Manufacturing Practices (GMP) and other programmes. III. HACCP APPLICATION TO FOOD MANUFACTURING AND PROCESSING HACCP can be applied throughout the food chain from the primary producer to final consumer. As well as enhanced food safety, benefits include better use of resources and more timely response to problems. In addition, the application of HACCP system 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 workforce. It also requires a team approach; this team should include appropriate experts; examples might be agronomists, veterinarians, production personnel, microbiologists, food technologists, chemists and engineers, according to the particular study. The application of HACCP is compatible with the implementation of quality management systems, such as ISO 9004 series, and is the system of choice in the management of food safety within such systems. Many food manufacturers and processors have already applied the HACCP system to their operations. The level of safety assurance offered by the HACCP system is fast becoming the standard for the food industry in industrialized countries. Food safety authorities in the United States, Canada and European Union (EU) promote the use of HACCP. HACCP is also being incorporated into the Codex Codes of Practice for a number of food commodities. Consequently, there is a growing need to promote appreciation for and understanding of HACCP by governments and the food industry, particularly in developing countries. The application of HACCP is not limited to food manufactured and processed by mediumto large-scale operations but may also be applicable to smaller operations where safety of foods is of critical importance. Benefits There are numerous benefits for the food industry while applying HACCP system as a management tool for food safety control. Some key benefits are as follows: * The HACCP approach is a systematic approach which can be applied to all aspects of food safety, including biological, chemical and physical hazards, to all stages of the food chain, including raw materials, growth, harvesting, purchase, production, distribution, and storage to final product use
HACCP system provides scientifically sound bases for demonstrating that all reasonable protections have been taken to prevent a hazard from reaching the consumer he HACCP approach shifts emphasis from statistically unreliable end-product testing which is often retrospective to a prevention-oriented approach for the production of safe food products Application of the HACCP concept is a cost-effective method of assuring food safety and preventing food bone disease and injuries HACCP system focus resources on those parts of the process critical for assuring safe products HACCP system can reduce product losses due to spoilage HACCP system encourage confidence in the safety of food products and thu promotes confidence in food trade and stability of food businesses HACCP system can facilitate the design and construction of new food processing facilities and equipment by predicting potential hazards and suggesting control measures HACCP is a system which identifies specific hazard(s) and preventative measures for their control. The system consists of following seven principles Identify the potential hazard(s) associated with food production at all stages. from growth. processin manufacture and distribution. until the point of consumption Assess the likelihood of occurrence of the hazard(s) and identify preventative measures for their control. A hazard is an unacceptable contamination of a biological, chemi /sical nature and/or survival or multiplication of microorganisms of concern for food safety, and/or ur ble production or persistence in foods of toxins or other undesirable products of microbiological metabolism Biological hazards include pathogenic microbes (parasites, bacteria and viruses) and toxigenic plants and anim Chemical hazards include, among others, pesticides, cleaning compounds, antibiotics, heavy metals, and additives such as sulfites Physical hazards include objects- such as metal fragments, glass and stones, that may cut the mouth, break teeth, cause choking or perforate the alimentary tract. Control measures are those actions and activities that can be used to eliminate hazards or reduce their impact or occurrence to acceptable levels. More than one measure may be required to control a specific hazard and more than one hazard may be controlled by a specified measure. No attempt is made at this step to establish CCP Principle 2 azard(s)or minimize its likelihood of occurrence- Critical Control Point(CCP. A step means any stage of food
* HACCP system provides scientifically sound bases for demonstrating that all reasonable protections have been taken to prevent a hazard from reaching the consumer. * The HACCP approach shifts emphasis from statistically unreliable end-product testing which is often retrospective to a prevention-oriented approach for the production of safe food products. * Application of the HACCP concept is a cost-effective method of assuring food safety and preventing food borne disease and injuries. * HACCP system focus resources on those parts of the process critical for assuring safe products. * HACCP system can reduce product losses due to spoilage. HACCP system encourage confidence in the safety of food products and thus promotes confidence in food trade and stability of food businesses. * HACCP system can facilitate the design and construction of new food processing facilities and equipment by predicting potential hazards and suggesting control measures. Principles HACCP is a system which identifies specific hazard(s) and preventative measures for their control. The system consists of following seven principles: Principle 1 Identify the potential hazard(s) associated with food production at all stages. from growth, processing manufacture and distribution, until the point of consumption Assess the likelihood of occurrence of the hazard(s) and identify preventative measures for their control. A hazard is an unacceptable contamination of a biological, chemical or physical nature and/or survival or multiplication of microorganisms of concern for food safety, and/or unacceptable production or persistence in foods of toxins or other undesirable products of microbiological metabolism. Biological hazards include pathogenic microbes (parasites, bacteria and viruses) and toxigenic plants and animals. Chemical hazards include, among others, pesticides, cleaning compounds, antibiotics, heavy metals, and additives such as sulfites. Physical hazards include objects - such as metal fragments, glass and stones, that may cut the mouth, break teeth, cause choking or perforate the alimentary tract. Control measures are those actions and activities that can be used to eliminate hazards or reduce their impact or occurrence to acceptable levels. More than one measure may be required to control a specific hazard and more than one hazard may be controlled by a specified measure. No attempt is made at this step to establish CCP. Principle 2 Determine the points/ procedures/operational steps that can be controlled to eliminate the hazard(s) or minimize its likelihood of occurrence - Critical Control Point (CCP). A step means any stage of food
production and or manufacture IncLu raw materials their receipt and/or production. harvesting transport formulation processing storage. etc. After hazards have been identified, a CCp decision tree may be used to determine whether a step is a CCP for the identified hazard. A model HACCP decision tree for establishing CCP is given in Annex Ill. Application of the model decision tree may differ slightly, depending on whether the operation is for production, slaughter, processing and manufacturing, storage, distribution or other sectors. All hazards which may be reasonably expected to occur, or to 6e introduced at each step, should be considered. If a hazard has been identified for which no control measure exists, the product or process should be modified so that the hazard is eliminated or reduced to acceptable or minimal levels Principle 3 Establish critical limit(s) which must be met to ensure the ccp is under control Critical limits must be specified for each control measure at each CCP. In some cases, more than one critical limit will be specified at a particular CCP. Criteria often used include temperature, time moisture level, pH, water activity, available chlorine, and sensory parameters such as visual appearance and texture. Critical limits may be derived from a variety of sources such as regulatory standards or guidelines, literature surveys experimental studies and/or expert advice Princple 4 Establish a system to monitor control of the ccp by scheduled testing or observations target level has been met. The monitoring procedure must be able to detect loss of control at the cC ritical limit or Monitoring is the periodic measurement or observation at a CCp to determine whether Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control Corrective actions are those actions to be taken either when monitoring results show that a ccp has deviated from its specified critical limit or target level, or, preferably, when monitoring results indicate a trend towards loss of control. In the latter case, action may be taken to adjust the process and maintain control before the deviation leads to a loss of control and hence to a safety hazard Disposition action need to be taken with food that has been produced during the time period that the CCP was out of control. Both corrective actions and disposition actions should be documented in the HACCP record-keeping. Responsibility for documenting these actions must be clearly assigned. Principle 6 Establish procedures for verification which include supple and procedur HACCP system is working effecti Procedures for verification must be established to ensure that the HACCP system is working correctly Monitoring and auditing methods, procedures and tests including random sampling and analysis can be used
production and / or manufacture including raw materials their receipt and/or production. harvesting transport. formulation processing. storage. etc. After hazards have been identified, a CCP decision tree may be used to determine whether a step is a CCP for the identified hazard. A model HACCP decision tree for establishing CCP is given in Annex III. Application of the model decision tree may differ slightly, depending on whether the operation is for production, slaughter, processing and manufacturing, storage, distribution or other sectors. All hazards which may be reasonably expected to occur, or to 6e introduced at each step, should be considered. If a hazard has been identified for which no control measure exists, the product or process should be modified so that the hazard is eliminated or reduced to acceptable or minimal levels. Principle 3 Establish critical limit(s) which must be met to ensure the CCP is under control. Critical limits must be specified for each control measure at each CCP. In some cases, more than one critical limit will be specified at a particular CCP. Criteria often used include temperature, time moisture level, pH, water activity, available chlorine, and sensory parameters such as visual appearance and texture. Critical limits may be derived from a variety of sources such as regulatory standards or guidelines, literature surveys, experimental studies and/or expert advice. Principle 4 Establish a system to monitor control of the CCP by scheduled testing or observations. Monitoring is the periodic measurement or observation at a CCP to determine whether a critical limit or target level has been met. The monitoring procedure must be able to detect loss of control at the CCP. Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. Corrective actions are those actions to 6e taken either when monitoring results show that a CCP has deviated from its specified critical limit or target level, or, preferably, when monitoring results indicate a trend towards loss of control. In the latter case, action may be taken to adjust the process and maintain control before the deviation leads to a loss of control and hence to a safety hazard. Disposition action need to be taken with food that has been produced during the time period that the CCP was out of control. Both corrective actions and disposition actions should be documented in the HACCP record-keeping. Responsibility for documenting these actions must be clearly assigned. Principle 6 Establish procedures for verification which include supplementary tests and procedures to confirm that the HACCP system is working effectively. Procedures for verification must be established to ensure that the HACCP system is working correctly. Monitoring and auditing methods, procedures and tests including random sampling and analysis can be used for this purpose
Principle I Establish documentation conceming all procedures and records appropriate to these principles APPLICATION OF THE PRINCIPLES OF HACCP During the hazard analysis and subsequent operations in designing and applying HACCP system, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, consumer populations at risk and epidemiological evidence relative to food safety. The intent of the HACCP system is to focus control at CCP Redesign of the operation should be considered if a hazard is identified but no CCP are found. HACCP should be applied to each specific operation separately. CCP identified in any given example in any Codex code of hy gienic practice might not be the only ones identified for a specific application or might be of a different nature The HACCP application should be reviewed and necessary changes made when any modification is made in the product process or any step. It s important when applying haCCp to be flexible given the contest of the application. of HACCP pr quires the following tasks as identified in the LOGIC SEQUENCE for the Application of HACCP- Annex Ill Assemble haccp team Assemble a multi disciplinary team that has specific knowledge and expertise appropriate to the product. Where such expertise is not available on site, expert advice should be obtained from other sources 2 Describe product A full description of the product should be drawn up, including information on composition and method of distribution Identifv intended use The intended use should be based on the expected uses of the product, by the end user or consumer. In specific cases, vulnerable groups of the population, eg, institutional feeding, may have to be considere 4 Construct flow diagram The flow diagram should be constructed by the HACCP team. Each step within the specified area of operation should be analyzed for the particular part of the operation under consideration to produce the flow diagram. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation On-site verification of flow -diagram The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate List all hazards associated with each step and consider any preventative measures to control hazards (Principle D
Principle 7 Establish documentation concerning all procedures and records appropriate to these principles. APPLICATION OF THE PRINCIPLES OF HACCP During the hazard analysis and subsequent operations in designing and applying HACCP system, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, consumer populations at risk and epidemiological evidence relative to food safety. The intent of the HACCP system is to focus control at CCP. Redesign of the operation should be considered if a hazard is identified but no CCP are found. HACCP should be applied to each specific operation separately. CCP identified in any given example in any Codex code of hygienic practice might not be the only ones identified for a specific application or might be of a different nature. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process or any step. It is important when applying HACCP to be flexible given the contest of the application. The application of HACCP principles requires the following tasks as identified in the LOGIC SEQUENCE for the Application of HACCP- Annex III: 1. Assemble HACCP team Assemble a multi disciplinary team that has specific knowledge and expertise appropriate to the product. Where such expertise is not available on site, expert advice should be obtained from other sources. 2. Describe product A full description of the product should be drawn up, including information on composition and method of distribution. 3. Identify intended use The intended use should be based on the expected uses of the product, by the end user or consumer. In specific cases, vulnerable groups of the population , eg., institutional feeding, may have to be considered. 4. Construct flow diagram The flow diagram should be constructed by the HACCP team. Each step within the specified area of operation should be analyzed for the particular part of the operation under consideration to produce the flow diagram. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation. 5. On-site verification of flow -diagram The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate. 6. List all hazards associated with each step and consider any preventative measures to control hazards (Principle 1)