Regulations relating to the application of the Hazard Analysis and Critical Control Point System (HACCP system)(No. R. 908 of 2003)

GNR 908 GG 25123 27 June 2003 DEPARTMENT OF HEALTH FOODSTUFFS, COSMETICS AND DISINFECTANTS ACT, 1972 (ACT NO.54 OF 1972) REGULATIONS RELATING TO THE APPLICATION OF THE HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEM (HACCP SYSTEM) The Minister of Health has, in terms of section 15(1) of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), made the regulations in the Schedule. SCHEDULE Definitions 1. In these regulations, “the Act” means the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) and any word or expression defined in the Act and not defined herein bears the same meaning as in the Act and unless the context otherwise indicates “Department” means the national Department of Health; “external HACCP” auditing” means a process aimed at verifying whether or not a HACCP system implemented by a food handling enterprise is in accordance with the requirements laid down by regulations 12 and 16 in relation to the handling of the foodstuffs under consideration and which must be carried out in accordance with the requirements of SANAS; “food chain” means all the stages through which food is handled from primary production to processing, manufacturing, distribution and retail, to the point of consumption; “food handler” means a person who in the course of his or her normal duties comes into contact with food not intended for his or her own use; “food handling enterprise” means a business, as set out in column 2 of Annex A to these regulations, which during its operations produces, processes, manufactures, stores, transports, distributes or sells foodstuffs or is engaged in any activity which may impact on the safety of such foodstuffs; “food safety” means the assurance that food will not cause harm chemically, biologically or physically, to the consumer when prepared, used or eaten according to its intended use; “Good Manufacturing Practice (GMP)” means methods or manufacture procedures applied taking into account the most basic principle of hygiene, that food must not be contaminated or spoilt during the manufacturing process; “HACCP system” means the hazard analysis and critical control point system that identifies, evaluates and controls hazards which are significant for food safety; “HACCP plan” means a plan, in a document form, which outlines the control of hazards which are significant for food safety in a segment of the food chain under consideration; “HACCP certification” means the issuing of documentary evidence by a certifying body accredited to do so by the South African National Accreditation System (“SANAS”), a non profit organisation registered in terms of section 21 of the Companies Act, 1973 (Act No. 61 of 1973), registration No. 199600354108 based on the results of an external HACCP auditing, or in the case of imported foodstuffs, a certifying body accredited for the purpose by an internationally recognised accreditation authority; “representative body” means a group of persons or an organisation mandated to represent persons in a specific sector or specific food handling enterprise responsible for handling 60% or more of the foodstuff(s) under consideration; and “sector” means a classification of the food industry in South Africa in categories, as set out in column I of Annex A in these regulations, based on the foodstuffs handled and the food handling enterprises normally associated with that within the food chain. HACCP System Requirements 2. No owner of a food handling enterprise as specified in column 2 of Annex A is allowed to handle food without (a) a HACCP system fully implemented to the satisfaction of the relevant authorised health authority in relation to the foodstuffs under consideration, on or after the date specified in column 3 of Annex B as applicable to such a food handling enterprise; and (b) a valid certificate referred to in regulation 14. 3. The Minister may by notice in the Gazette list the name of a sector as specified in column 1 of Annex A regarding a specific category of food handling enterprise as specified in column 2 of the same Annex; in column 2 of Annex B; in which case the requirements in terms of regulation 2 shall come into effect on the date as specified in column 3 of the same Annex. 4. The listing referred to in regulation 3 shall be made only after (a) considering a request made by a representative body of a specific sector, including that of a specific category of food handling enterprise, to be listed in column 2 of Annex B on a specified date to be listed in column 3 of the same Annex; or (b) consultation with the representative body considering a recommendation made by the Director-General to list such a sector regarding a specific category food handling enterprise in column 2 of Annex B on a date specified in column 3 of the same Annex. 5. A request referred to in regulation 4(a) shall be in writing and only if such sector or specific category of food handling enterprise is of the opinion that it is in a position to comply with the restrictions specified in regulation 2. 6. A recommendation referred to in regulation 4(b) may only be made if the Director-General is of the opinion that it is in the interest of the safety of food handled by a specific sector or category of food handling enterprise, and also the health of the consumer, that such a sector or food handling enterprise must comply with the requirements specified in Regulation 2. 7. The owner of a food handling enterprise listed in Annex B is responsible for ensuring that (a) prior to the implementation of a HACCP system as required in terms of regulation 2, the enterprise already operates in accordance with good manufacturing practices and that it complies with all the relevant health and safety legislation applicable to the foodstuff and food handling operation under consideration; and (b) foodstuffs received from a producer or supplier for further handling by the food handling enterprise in question comply with all the requirements for safety applicable to the foodstuffs under consideration. 8. The owner of a food handling enterprise, when implementing a HACCP system must ensure that the system is in accordance with the principles as provided for by the Joint Food and Agricultural Organization / World Health Organization (“FAO / WHO”) Food Standards Programme Codex Alimentarius Commission’s general requirements (food hygiene), entitled: “Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application”, published in the Supplement to Volume 113-1997 document of the Commission; as updated from time to time (see Annex C). 9. The owner of a food handling enterprise may apply a system equivalent to the one referred to in regulation 8 if such equivalent system includes at least the principles and process of the HACCP system in question. Application of the HACCP system to a specific sector or category of food handling enterprise 10. A HACCP plan for a specific sector or category of food handling enterprise must be compiled by a representative body or the Director-General and the plan shall contain the requirements for a HACCP system applicable to its members. 11. The HACCP plan referred to in regulation 10 must accompany a request referred to in regulation 4(a). Verification of the HACCP system 12. The external HACCP auditing must be carried out by a person suitably qualified and experienced in the application of the HACCP system and who is employed by a certifying body that is accredited by SANAS. 13. Information related to the external HACCP auditing activities conducted by certifying bodies referred to in regulation 12 must be submitted to the relevant health authority and to the Director-General in a format as determined by the Director-General. 14. A HACCP certification must be conducted by a certifying body referred to in regulation 12 based on the results of an external HACCP audit and in a format as determined by the Director-General and such certificate is valid for a period not exceeding one year. Requirements for a HACCP system applicable to imported foodstuffs 15. The requirements for the application of the HACCP system as specified in these regulations become applicable to imported foodstuffs on the same date per sector or a specific category of food handling enterprise as specified in column 3, Annex B. 16. The Director-General may request documentary evidence of the country of origin for the external HACCP auditing and certification with regard to imported foodstuffs. General requirements 17. The owner of a food handling enterprise must take steps to ensure that all the food handlers involved in its operation are sufficiently trained on an ongoing basis regarding the application and requirements of the HACCP system and the level of training shall be determined by the HACCP system in question. ME TSHABALALA-MSIMANG MINISTER OF HEALTH ANNEX A CATEGORIES OF FOOD HANDLING ENTERPRISES AS PER SECTOR BASED ON FOODSTUFFS HANDLED SECTOR FOOD HANDLING ENTERPRISE 1) MEAT AND EDIBLE MEAT OFFAL, PREPARATIONS AND PRODUCTS WHOLESALERS (FRESH MEAT) PROCESSORS (AS PER TYPE OF FOODSTUFF TRANSPORTERS (FRESH MEAT) RETAILERS (BUTCHERIES) (INCLUDING THOSE ON SUPERMARKET PREMISES) 2) FISH, CRUSTACEANS, MOLLUSCS AND OTHER AQUATIC INVERTEBRATES, PREPARATIONS AND PRODUCTS WHOLESALERS (FRESH PRODUCTS) PROCESSORS (AS PER TYPE OF FOODSTUFF) TRANSPORTERS (FRESH PRODUCTS) RETAILERS (FISH SHOPS) (INCLUDING THOSE ON SUPERMARKET PREMISES) 3) SUGARS, HONEY AND SUGAR CONFECTIONARIES PROCESSORS (AS PER TYPE OF FOODSTUFF) RETAILERS 4) EDIBLE OILS AND FATS EXPRESSERS (AS PER TYPE OF FOODSTUFF) PROCESSORS (AS PER TYPE OF FOODSTUFF) 5) VEGETABLES, FRUIT NUTS OR OTHER PARTS OF PLANTS, PREPARATIONS AND PRODUCTS PACKING SHEDS (FRESH PRODUCTS) WHOLESALERS (FRESH PRODUCTS) PROCESSORS (AS PER TYPE OF FOODSTUFFS) TRANSPORTERS (FRESH PRODUCTS) RETAILERS (FRESH PRODUCTS) (INCLUDING THOSE ON SUPERMARKET PREMISES) 6) GRAINS, CEREALS, COCOA, STARCH AND PASTRY-COOK, PREPARATIONS AND PRODUCTS MILLERS (AS PER TYPE OF FOODSTUFFS) WHOLESALERS PROCESSORS (AS PER TYPE OF FOODSTUFFS) 7) BEVERAGES, BEER, WINE AND SPIRITS, PREPARATIONS AND PRODUCTS PROCESSORS (AS PER TYPE OF FOODSTUFFS) 8) MILK AND DAIRY, PREPARATIONS AND PRODUCTS MILKING SHEDS (PARLOURS) SUPPLIERS (FRESH MILK) PROCESSORS (AS PER TYPE OF FOODSTUFFS) TRANSPORTERS (FRESH MILK) RETAILERS (MILK SHOPS) (INCLUDING THOSE ON SUPERMARKET PREMISES) SECTOR FOOD HANDLING ENTERPRISE 9) FOOD PREPARATION AND CATERING (EXCLUDING STREET VENDORS) RESTAURANTS DELICATESSENS (INCLUDING THOSE ON SUPERMARKET PREMISES) HOTELS CAFES CATERERS (INDUSTRIAL) CATERERS (RETAIL) 10) STREET VENDED FOODS CATERERS OTHER PERISHABLE PRODUCTS 11) COFFEE, TEA, SALT, HERBS AND SPICES PROCESSORS (AS PER TYPE OF FOODSTUFFS) PACKERS (AS PER TYPE OF FOODSTUFFS) 12) POULTRY, PREPARATIONS AND PRODUCTS WHOLESALERS (FRESH MEATH) WHOLESALERS (FRESH EGGS) PROCESSORS (AS PER TYPE OF FOODSTUFFS) TRANSPORTERS (FRESH PRODUCTS) RETAILERS (INCLUDING THOSE ON SUPERMARKET PREMISES) ANNEX B NAME AND DATE OF A SECTOR OF THE FOOD INDUSTRY OR A FOOD HANDLING ENTERPRISE ASSOCIATED WITH SUCH A SECTOR LISTED BY THE MINISTER OF HEALTH IN TERMS OF REGULATION 3 SECTOR FOOD HANDLING ENTERPRISE DATE LISTED Vegetables, Fruit, Nuts or other parts of Plants Preparations and Products Processors: Groundnuts: a. Peanut sorting / grading Facilities b. Peanut Butter Manufacturers Within One Year of the Publication of the Final Notice [Annexure B Amended by GNR 1060, GG 32695, 13/11/2009] ANNEX C HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES FOR ITS APPLICATION Annex to CAC/RCP 1-1969, Rev. 3(1997) Preamble The first section of this document sets out the principles of the Hazard Analysis and Critical Control Point (HACCP) system adopted by the Codex Alimentarius Commission. The second section provides general guidance for the application of the system while recognizing that the details of application may vary depending on the circumstances of the food operation1. 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. In addition to enhancing food safety, implementation of HACCP can provide other significant benefits like aiding inspections by regulatory authorities and promoting 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, where appropriate, expertise in agronomy, veterinary health, production, microbiology, medicine, public health, food technology, environmental health, chemistry and engineering, according to a 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. While the application of HACCP to food safety was considered here, the concept can be applied to other aspects of food quality. Definitions Control (verb): To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan. Control (noun): The state wherein correct procedures are being followed and criteria are being met. Control measure: Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss% of control. 1 The Principles of the HACCP System set the basis for the requirements for the application of HACCP, while the Guidelines for the application provide general guidance for practical application. Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Critical limit: A criterion which separates acceptability from unacceptability. Deviation: Failure to meet a critical limit. Flow diagram: A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item. HACCP: A system which identifies, evaluates, and controls hazards which are significant for food safety. HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration. Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence and to decide which of them are significant for food safety and therefore should be addressed in the HACCP plan. Monitor: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control. Step: A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption. Validation: Obtaining evidence that the elements of the HACCP plan are effective. Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan. Principles of the HACCP System The HACCP system consists of the following seven principles: PRINCIPLE 1 Conduct a hazard analysis. PRINCIPLE 2 Determine the Critical Control Points (CCPs). PRINCIPLE 3 Establish critical limit(s). PRINCIPLE 4 Establish a system to monitor control of the CCP. PRINCIPLE 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. PRINCIPLE 6 Establish procedures for verification to confirm that the HACCP system is working effectively. PRINCIPLE 7 Establish documentation concerning all procedures and records appropriate to these principles and their application. Guidelines for the Application of the HACCP System Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP CAC/RCP 1 Annex Page 21 of 27 system. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, 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, categories of consumers of concern, and epidemiological evidence relative to food safety. The intent of the HACCP system is to focus control at CCPs. Redesigning the operation should be considered if a hazard which must be controlled is identified but no CCPs are found. HACCP should be applied to each specific operation separately. CCPs 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 s made in the product, process, or any step. It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation. Application The application of HACCP principles consists of the following tasks as identified in the Logic Sequence for Application of HACCP (Diagram 1). 1. ASSEMBLE HACCP TEAM The food operation should assure that the appropriate product’s specific knowledge and expertise is available for the development of an effective HACCP plan. Optimally, this may be accomplished by assembling a multi-disciplinary team. Where such expertise is not available on site, expert advice should be obtained from other sources. The scope of the HACCP plan should be identified. The scope should describe which segment of the food chain is involved and the general classes of hazards to be addressed (e.g. does it cover all classes of hazards or only selected classes). 2. DESCRIBE PRODUCT A Bill description of the product should be drawn up, including relevant safety information such as: composition, physical/chemical structure (including Aw, pH, etc.), microcidal/static treatments (heat treatment, freezing, brining, smoking, etc.), packaging, durability and storage conditions 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, e.g. institutional feeding, may have to be considered. 4. CONSTRUCT FLOW DIAGRAM The flow diagram should be constructed by the HACCP team. The flow diagram should cover all steps m the operation. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation. 5. ONSITE CONFIRMATION 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 POTENTIAL HAZARDS ASSOCIATED WITH EACH STEP, CONDUCT A HAZARD ANALYSIS, AND CONSIDER ANY MEASURES TO CONTROL IDENTIFIED HAZARDS (SEE PRINCIPLE 1) The HACCP team should list all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption. The HACCP team should next conduct a hazard analysis to identify for the HACCP plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food. In conducting the hazard analysis, wherever possible the following should be included:  the likely occurrence of hazards and severity of their adverse health effects;  the qualitative or quantitative evaluation of the presence of hazards;  survival or multiplication of micro-organisms of concern;  production or persistence in foods of toxins, chemicals or physical agents; and  conditions leading to the above. The HACCP team must then consider what control measures, if any, exist which can be applied for each hazard. More than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified control measure. 7. DETERMINE CRITICAL CONTROL POINTS (SEE PRINCIPLE 2)2 There may be more than one CCP at which control is applied to address the same hazard. The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree (e.g. Diagram 2), which indicates a logic reasoning approach. Application of a decision tree should be flexible, depending on whether the operation is for production, slaughter, processing, storage, distribution or other. It should be used for guidance when determining CCPs. This example of a decision tree may not be applicable to all situations. Other approaches may be used. Training in the application of the decision tree is recommended. If a hazard has been identified at a step where control is necessary for safety, and no control measure exists at that step, or any other, then the product or process should be modified at that step, or at any earlier or later stage, to include a control measure. 8. ESTABLISH CRITICAL LIMITS FOR EACH CCP (SEE PRINCIPLE 3) Critical limits must be specified and validated if possible for each Critical Control Point. In some cases more than one critical limit will be elaborated at a particular step. Criteria often used include measurements of temperature, time, moisture level, pH, Aw, available chlorine, and sensory parameters such as visual appearance and texture. 9. ESTABLISH A MONITORING SYSTEM FOR EACH CCP (SEE PRINCIPLE 4) Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. The monitoring procedures must be able to detect loss of control at the CCP. Further, monitoring should ideally provide this information in time to make adjustments to ensure control of the process to prevent violating the critical limits. Where possible, process adjustments should be made when monitoring results indicate a trend. Since the publication of the decision tree by Codex, its use has been implemented many times for training purposes. In many instances, while this tree has been useful to explain the logic and depth of understanding needed to determine CCPs, it is not specific to all food operations, e.g. slaughter, and therefore it should be used in conjunction with professional judgement, and modified in some cases. The modifications should be made before a deviation occurs. Data derived from monitoring must be evaluated by a designated person with knowledge and authority to carry out corrective actions when indicated. If monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee that the CCP is in control Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will not be time for lengthy analytical testing. Physical and chemical measurements are often preferred to microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product. All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing official of the company. 10. ESTABLISH CORRECTIVE ACTIONS (SEE PRINCIPLE 5) Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur. The actions must ensure that the CCP has been brought under control Actions taken must also include proper disposition of the affected product. Deviation and product disposition procedures must be documented in the HACCP record keeping. 2 Since the publication of the decision tree by Codex, its use has boon implemented many times for training purposes. In many instances, while thus free has boon useful to explain the logic and depth of understanding needed to determine CCPs, it is not specific to all food operations, e.g slaughter, and therefore it should be used in conjunction with professional judgement, and modified in some cases. 11. ESTABLISH VERIFICATION PROCEDURES (SEE PRINCIPLE 6) Establish procedures for verification. Verification and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly. The frequency of verification should be sufficient to confirm that the HACCP system is working effectively. Examples of verification activities include:  Review of the HACCP system and its records;  Review of deviations and product dispositions;  Confirmation that CCPs are kept under control. Where possible, validation activities should include actions to confirm the efficacy of all elements of the HACCP plan. 12. ESTABLISH DOCUMENTATION AND RECORD KEEPING (SEE PRINCIPLE 7) Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP procedures should be documented. Documentation and record keeping should be appropriate to the nature and size of the operation. Documentation examples are:  Hazard analysis;  CCP determination;  Critical limit determination. Record examples are:  CCP monitoring activities;  Deviations and associated corrective actions;  Modifications to the HACCP system. An example of a HACCP worksheet is attached as Diagram 3. CAC/RCP 1-Annex Page 24 of 27 Training Training of personnel in industry, government and academia in HACCP principles and applications, and increasing awareness of consumers are essential elements for the effective implementation of HACCP. As an aid in developing specific training to support a HACCP plan, working instructions and procedures should be developed which define the tasks of the operating personnel to be stationed at each Critical Control Point. Cooperation between primary producer, industry, trade groups, consumer organizations, and responsible authorities is of vital importance. Opportunities should be provided for the joint training of industry and control authorities to encourage and maintain a continuous dialogue and create a climate of understanding in the practical application of HACCP. CAC/RCP 1 - Annex Page 25 of 27 DIAGRAM 1 SEQUENCE FOR APPLICATION OF HACCP 1. 2. 3. 4. 5. 6. 7. See diagram 2 8. 9. 10. 11. 12. Assemble HACCP Team Describe Product Identify Intended Use Construct Flow Diagram On-site confirmation of Flow Diagram List all Potential Hazards Conduct a Hazard Analysis Consider Control Measures Determine CCPs Establish Critical Limits for each CCP Establish a Monitoring System for each CCP Establish Corrective Actions Establish Verification Procedures Establish Documentation and Record Keeping DIAGRAM 2 EXAMPLE OF DECISION TREE TO IDENTIFY CCPs (answer questions in sequence) Q1 Q2 Q3 Q4 * Proceed to the next identified hazard in the described process. ** Acceptable and unacceptable levels need to be defined within the overall objectives in identifying the CCPs of HACCP plan. Do control preventative measure(s) exist? Yes No Is control at this step necessary for safety? Modify step, process or product Yes No Not a CCP Stop (*) Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level? (**) Yes No Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable levels?(**) Yes No Not a CCP Stop (*) Will a subsequent step eliminate identified hazard(s) or reduce likely occurrence to an acceptable level? (**) Yes No CRITICAL CONTROL POINT Not a CCP Stop (*) DIAGRAM 3 EXAMPLE OF A HACCP WORKSHEET 1. 2. 3. LIST Step Hazard(s) Control Measure(s) CCPs Critical Limit(s) Monitoring Procedure(s) Corrective Action(s) Record(s) 4. Describe Product Diagram Process Flow Verification