Generic Plan of Implementation of ISO 22000:2005 in Canned Tuna and Assessment of FSMS Implementation on Control of Histamine
Received Date: Mar 12, 2018 / Accepted Date: Apr 03, 2018 / Published Date: Apr 10, 2018
Canned tuna can be produced from different types of the Scombroid fish family. It is a product from fish meat that goes under heat processes after several preparation and production stages in order to be appropriate for commercial purposes. One of the main problems with this product is histamine poisoning. Products with high level of histamine cause different kinds of disease like urticaria, diarrhea, anaphylactic shock and, finally, death. In this study, International Organization for Standardization 22000:2005 requirements was implemented in a canned tuna-processing unit. Histamine content was measured by gas chromatography (GC) method throughout workstations which were mentioned above. Histamine levels were measured before and after all the workstations such as frozen fish reception, temporary storage in -18°C defrosting, deheading-descaling-draining viscera, precooking, cleaning and segmenting, and sterilization by GC method. We found out that frozen fish reception, deheading-descaling-draining viscera, and cleaning-segmenting reduced histamines, 27.46%, 27.88%, and 60.87%, respectably. Also, the maximum histamine content reduction was in the cleaning-segmenting workstation. The results in this study can be applied to decrease the histamine level in canned tuna products and protect people from the above-mentioned diseases
Keywords: Canned tuna; Histamine; Gas chromatography; ISO 22000; CCP; OPRP
Fish and fish products could be a healthy diet for humans. There is some evidence for increasing demand for those products everywhere. Although they are good source of essential vitamins, minerals, highquality proteins, and polyunsaturated fatty acids, there is a toxicological effect of biogenic amines such as histamine on human health which could be a public health problem. Eating low or moderate amounts of histamine in fish can cause food intolerance [1,2]. Histamine (or scombroid) fish poisoning could be a major problem in fish and fish products safety. Insufficient cooling systems can cause bacterial histamine production and can cause scombroid poisoning at some point. Depending on the level of free histidine, the production of histamine by bacterial histidine decarboxylase would vary .
Scombroid poisoning was first described in Britain in 1799, and then it was described again many years later in Japan in the 1950s. The symptoms of histamine poisoning mostly are the same as other allergies. Thus, it is not a very well-recognized disease yet (National Marine Fisheries Service). Common symptoms of scombroid poisoning are vomiting, rash, nausea, diarrhea, anaphylactic shock, blotchy skin, urticaria, and itching of the skin. Histamine is an endogenous substance in the human body that is derived from the decarboxylation of the amino acid histidine . Histamine fish poisoning occurs when the amount of histamine in fish increases to more than 500 PPM . Three hundred forty-seven food-borne poisoned people were reported due to digestion of fried fish (by using of low quality of row fish for cooking) in southern Taiwan, in 2007. One of the contaminated samples had 52.3 mg/kg histamine content, above the 50 mg/kg hazard action level of histamine . Also, in September 2014, in southern Taiwan, thirtyseven people became ill with histamine poisoning cause by fried fish sticks. All the victims had the same allergic symptoms of nausea, rash, blotchy skin, and diarrhea, which symptoms typically develop rapidly (from ten minutes to two hours) after ingestion of food containing toxic histamine levels. The symptoms usually resolve themselves within twenty-four hours, so all the victims recovered within one day . Scombroid poisoning appeared ninety minutes after a sixty-five-yearold woman consumed fully cooked tuna fish. She reported symptoms such as itchy skin and a restless feeling, as well as a blanching rash on the skin of her back, arms, chest, legs, and feet . Also, doctors made a diagnosis of scombroid poisoning when a sixteen-year-old girl suffered from acute coronary syndrome, causing pulmonary edema, after ingesting a high level of histamine .
The level of histamine is related to fish quality, safety, and trade. Also, it can be related to the texture of tuna meat and the ingredients of canned tuna. This amount can be higher in grated canned tuna than in solid canned tuna. Also, the histamine level can be higher in canned tuna in oil than in water, and the highest level of histamine can be found in grated tuna with tomato sauce . In foodstuff, the existence of histamine is an indicator of quality of fish. This is very important for food quality control in seafood product, particularly in fish and fish products. Therefore, it is beneficial to avoid to consumption of low quality fish (dark-muscle fish), and to only consume high quality of fish (white-muscle fish) instead. The main dangerous situation that contributes to formation and increase in the amount of histamine is inappropriate storing conditions. In this circumstance, histaminedecarboxylase enzyme is produced by bacteria that converts histidine into histamine, even at low temperatures such as 5°C/40°F [2,11].
Some opportunistic pathogens such as Raoultella ornithinolytica can play a negative role to increase the production of Histamine. The histamine level can increase to higher than hazard action level (50 mg/kg) very quickly when samples are contaminated by even low concentration of Raoultella ornithinolytica at 37°C. This level can reach to thousands of milligrams per kilogram after 30 hours at usual atmosphere, gradually. However, it is possible to decrease the rate of producing histamine by decreasing the storage temperature to less than 4°C. Therefore, canned tuna fish could be a very vulnerable meat that can be histamine contaminated by bacterial histidine decarboxylation [12,13]. The seafood Hazard Analysis and Critical Control Point (HACCP) program was implemented by the United States Food and Drug Administration (FDA) to prevent seafood hazards that lead to foodborne illness (scombroid poisoning). The FDA limit on histamine of fish at the port is 50 mg/kg, and the Codex Alimentarius limit on fish and fish products is 200 mg/kg [14,15]. Therefore, measuring the level of histamine in seafood is very important. Several efficient methods such as high-performance liquid chromatography (HPLC) and gas chromatography (GC) are recommended [16,17].
The study makes recommendations for canned tuna safety; the Generic Plan of Implementation of ISO 22000:2005 in Canned Tuna and Assessment of Food Safety Management system (FSMS) Implementation Controlling of Histamine is recommended. This standard contains 8 sections with its applicable sections starting at clause number four (4). In 2011, ISO 22000 was applied in cereal food industry to determine the number of insects in wheat. They found which stations are CCPs . At the same time, researchers surveyed environmental and food safety management systems, according to ISO 14001 and ISO 22000 in fish processing plants, and determined related PRPs, OPRPs and CCPs . In 2013, ISO 22000 was applied in pistachio and measured the amount of aflatoxin B1 by HPLC before and after each stage of processing .
Materials and Methods
In this study, ISO 22000:2005 necessities were applied in the canned tuna processing unit which is described as below:
Food safety management system necessities
Food safety management system (FSMS): It is essential in this section to separate this section into 2 sub sections about the hazard identification and the documentation requirements; for this purpose, document and records control technique are inscribed .
Management responsibility: The rudimentary requirement of this standard is a management commitment. The highest management must support the food safety policy. FSMS planning will certify that the truthfulness of the FSMS is sustained when fluctuations occur in the organization. The organization must certify that adequate data on issues concerning canned tuna safety is accessible through the canned tuna chain by internal and external communication. Also, the highest level of management must launch, implement and sustain procedures to manage potential emergency situations and accidents that can affect canned tuna safety. Finally, upper management must revise the organization's food safety management system at planned intervals to confirm its enduring suitability, capability and efficiency .
Resource management: The organization must be able to provide sufficient resources for the maintenance, application, establishment, and continual improvement of the food safety management system. Also, all personnel have an important impact on canned tuna safety. Training, experience, and education have influence on human resources and on all personnel as well. Thus, some courses and training by the Ministry of Agriculture and other organizations would be important for the fisherman and for all personnel who have influence in GMP (Good Agriculture Practices). Likewise, all personnel should be informed about histamine poisoning, and all of the aspects of histamine that are related to food safety of canned tuna .
Planning and realization of safe products: This section describes how to control and manage possible hazards of the canned tuna chain. The initial stage is applying PRPs (Prerequisite Programs). Maintaining a hygienic environment during the tuna canning chain is important during some rudimentary activities and conditions like PRPs  such as:
i. Good placement for fishing (spring coldness, hot and long summer, low relative humidity, raining time, etc.)
ii. Suitable distance between deck and processing unit
iii. Harvesting factors
iv. Post harvesting handling
v. Processing conditions
vi. End processing
Second stage risk assessment which should be completed as below:
Food safety group appointment: The organization should establish a multidisciplinary group. That is important to fully understand FSMS, CCPs (Critical Control Points), OPRPs (Operational Prerequisite Programs), and the ability to recognize of risks and hazards . Raw materials, product description and intended use. The canned tuna must conform to the Codex Standards, and Iran’s national standards about acceptable level of histamine and its planned use, as shown in Table 1.
|Characteristics||Product name: Canned tuna|
|Biological, chemical and physical characteristics||Texture of tuna fish must be natural. It must have no smells and no abnormal textures such as rough, smooth, creamy, or spoiled texture .|
|It must be fit for human consumption and without any chemical or physical contamination. PH must be between 4.6 and 6.5 [21-23].|
|The maximum level of extracted peroxide must be 2 meq.gr/Kg .|
|Histamine content must be less than 10 ppm .|
|The maximum level of Pb must be 0.3 ppm .|
|The maximum level of Hg must be 1 ppm .|
|The maximum level of Sn must be 250 ppm .|
|It must not have any mesophilic aerobic, mesophilic anaerobic, aerobic thermophilic bacteria, or anaerobic thermophilic bacteria [21-24].|
|For other specifications should see the Codex Standard .|
|Shelf life and storage conditions||If stored it in a cool, dark, dry space away from furnaces, pipes, and places where temperatures change, shelf life can be 2 years.|
|Packaging||Tuna fish is commercially canned in metal cans which are suitable for food storage .|
|Labeling||Manufacturer must print nutrition labelling, grade, size class, count and moisture content, code markings, net weight, production and expiration date, production license number, country of origin, and storage condition .|
|Distribution methods||There is no specific condition for distribution|
|Intended usage||Toddlers and people who are suffering from high blood pressure should avoid because of the high level of sodium|
Table 1: Product description work sheet.
Flow diagrams preparation: Below is a flow diagram which demonstrates process stages that are confirmed by food safety group, as shown in Figure 1.
Hazard analysis and control plans: Food safety group identifies all hazards which are expected to occur and related to histamine production and identifies the possibility of the increase of histamine. It is shown in Table 2. Risk assessment is performed using appropriate methods based on the possible severity of adverse health effects and the likelihood of their occurrence after identification of hazard. The food safety group then uses the scaling method from 1 to 4, 1 as the least and 4 as the highest possible severity of adverse health effects or the likelihood of hazard. In the next step, a suitable control plan is selected from OPRP or HACCP. This selection is done in regard to the type of the main control measure. It is considered an OPRP plan if a prerequisite program is used as the control measure. However, an HACCP plan is used in other situations. One should note that the OPRP and HACCP are different only in terms of critical limits of the CCPs in the HACCP plan. Table 3 shows the mixed OPRP and HACCP plan [22-24]. The association defines confirmation planning, after designing the HACCP and OPRP plan. Multiplying the severity number by the likelihood of occurrence number calculates the risk number. The risk numbers which are more than 6 are considered as actual hazards. Consequently, the food safety group must control actual hazards by the OPRP or HACCP plan, as shown in Table 4.
|Frozen fish reception||Composition and increase of histamine because of long distance between deck and processing unit||GAqP|
|Closing the gap between deck and processing unit|
|High temperature||Good timing, FIFO|
|Receipt of decomposed and spoiled fish||Refrigerated trucking|
|Temporary storage in -18°C||Composition and increase of histamine because of inappropriate temperature||Strict control of the temperature and atmosphere of fish|
|Defrosting||Composition and increase of histamine because of water temperature, fish’s size, and atmosphere temperature||Strict control of the temperature and atmosphere of water|
|Deheading-descaling-draining viscera||Composition and increase of histamine because of inappropriate cleaning||Personnel training|
|Use of unhygienic equipment||Continual movement in Deheading-descaling-draining viscera, section|
|Removal of all inside materials of fish|
|Washing||No hazard detected||-|
|Precooking||Composition and increase of histamine because of inadequate cooking||Adequate cooking|
|Cleaning-segmenting||Composition and increase of histamine because of extended times during the cleaning-segmenting work station
Inappropriate separation of honey-combed flesh
|Continual movement during the cleaning-segmenting work station|
|Filling||No hazard detected||-|
|Flavoring (salt and oil)||No hazard detected||-|
|Exhausting||No hazard detected||-|
|Putting lid||No hazard detected||-|
|Washing||No hazard detected||-|
|Sterilization||Composition and increase of histamine because of inadequate final cooking during sterilization||Adequately sterilize|
|Labeling||No hazard detected||-|
|Packing||No hazard detected||-|
Table 2: Potential hazards affecting contamination by histamines.
|No.||Stages||Hazard||OPRP/ CCP||Critical limit||Monitoring||Correctio /Corrective action|
|1||Frozen fish reception||Composition and increase of histamine because of long distance between deck and processing unit
Receipt of decomposed and spoiled fish
|OPRP||Max temp.: 4°C,
Rejecting decomposed and spoiled fish
|Recording harvest starting time and processing starting time.||Rejecting input of damaged fish to the processing according to nonconformity batch|
|Inspecting temperature and relative humidity (equipment and atmosphere) constantly.||Appropriate cooling system|
|Sampling and testing|
|2||Temporary storage in -18°C||Composition and increase of histamine because of inappropriate temperature||OPRP||Max stopping time 3 h,
Min temp. between -15°C and -18°C
|Recording and inspecting RH and T storage||Strictly controlling RH and T|
|Appropriate arranging in fish stocking|
|3||Defrosting||Composition and increase of histamine because of water temperature, fish’s size, and atmosphere temperature||OPRP||Atmosphere temp. between 20°C and 15°C||Recording and inspecting RH and T||Suitable conditioning up to desired relative humidity and temperature|
|Appropriate arranging in fish stocking|
|4||Deheading-descaling-draining viscera||Composition and increase of histamine because of inappropriate cleaning
Use of unhygienic equipment
|CP||TPC: according to the Codex or the EC or No.2326||Controlling removing all of inside materials of fish.||Personnel training
|Avoiding touching clean and unclean meat|
|5||Precooking||Composition and increase of histamine because of inadequate cook||CP||-||Recording calibrating steam cooking machine||Machine operation correction
|6||Cleaning-segmenting||Composition and increase of histamine because of extended times during the cleaning-segmenting work station separation of honey-combed flesh||CCP||TPC: According to the Codex or the EC or No. 2326 appropriate separation of honey-combed flesh and uncooked meat||Recording hygienic controlling personnel||Personnel training|
|Quick personnel performance|
|7||Sterilization||Composition and increase of histamine because of inadequate final cook as a sterilization||CCP||T: 121°C
t: 100 min
|Recording calibrating Autoclave||Machine operation correction|
|Eliminating all form of life and biological agents|
CCP: Critical Control Point; HACCP: Hazard Analysis and CCP; CP: Control Point; OPRP: Operational Prerequisite Program.
Table 3: HACCP plan/OPRP plan.
|Likelihood of hazard
|Frozen fish reception||Composition and increase of histamine because of long distance between deck and processing unit High Temperature Receipt of decomposed and spoiled fish||3||4||12||√|
|Temporary storage in -18°C||Composition and increase of histamine because of inappropriate temperature||3||3||9||√|
|Defrosting||Composition and increase of histamine because of water temperature, fish’s size, and atmosphere temperature||3||2||6||√|
|Deheading-descaling-draining viscera||Composition and increase of histamine because of inappropriate cleaning
Use of unhygienic equipment
|Pre-cooking||Composition and increase of histamine because of inadequate cooking||3||2||6||√|
|Cleaning-segmenting||Composition and increase of histamine because of extended times during the cleaning-segmenting work station Inappropriate separation of honey-combed flesh||3||3||9||√|
|Sterilization||Composition and increase of histamine because of inadequate final cooking during sterilization||3||2||6||√|
Table 4: Risk assessment.
Validation, verification and improvement of FSMS: This section contains five sub sections that show planning and performance confirmation, equipment standardization determinations and the requirements associated with auditing, enhancement and updating [21,25]. After application of ISO 22000:2005 necessities, histamine content was measured by GC method throughout workstations which were mentioned above. Thus, the amount of histamine was measured in frozen fish reception, temporary storage in -18°C, defrosting, deheading-descaling-draining viscera, precooking, cleaning and segmenting, and sterilization.
Materials and standard solution: The solvents used in this study were liquid chromatographic grade purchased from Merck., Germany, the chemicals should be extra pure, and water should be 18 МΩ/cm reagent water. Extract solution was made up with 0.2 ml 3-ethylamine in 1000 ml methanol, the standard solution of histamine was made up 0.0125 g histamine 99% in 25 ml extract solution, and inter standard was made up 0.0125 g 2-naphtholin 25 ml extract solution. In this study, the pH of methanol extract from samples obtained was between 4 and 5.
Sampling: Samples were selected before and after 7 workstations which were mentioned, according to Iran national standard no. 13534, and they were carried in coolers to the laboratory for measuring the amount of histamine content. Three samples before and three samples after were selected. First, the sample was mixed by blender until all the rough texture turned to soft texture and weighted 1 g into a test tube. Then 150 μL internal standard solution and 3 ml extract solution was added. After that, there was an ultra-sonication extraction in an ice bathing sonicator and ultrasonic for 5 minutes; then the tuna was put it into 4000 RPM centrifuge machine for 3 minutes. Next, the supernatant of extract solution was picked for GC analysis.
GC quantification: The GC system YL6100 (Young Lin Instrument Co., Ltd., south Korea, 132 Model) consists of FID detector and cyan propyl (30 m× 0.25 mm-0.25 μm) as an analytical column. Carrier gas is hydrogen, column temperature is 160°C, injector Temperature is 250°C, detector Temperature is 270°C, flow rate is 0.8 ml/min, and Inj. Volume is 3 μL. Oven temperature is controlled with a temperature elevation program during analysis, which was initially set at 160°C for 3 min, elevated to 250°C after 9 min and stay 7 min in 250°C. The detection limit of histamine by GC analysis is also determined using diluted authentic histamine when the settings of FID range is at 1, attenuation at 1, and signal/noise ratio>2. With above condition, the detection limit was found to be about 5 mg/g.
The quantification of histamine was achieved by measurement of peak area at histamine retention time and comparison with the related calibration curve (Histamine 96% (2-(4-imidazolyl)-ethylamine and 4.5, 9, 15, 22.5 ppm, r=0.8530) which was purchased from Sigma Aldrich, USA.
Statistical analysis: 42 samples were selected and their histamine content was measured by Gas chromatography (GC). Minitab software was used to perform t-test for sample means under 5% significance level.
Method validation: In order to confirm the method, the recovery test was necessary. Thus, the blank without histamine was contaminated with 5 ppm histamine and after preparation as defined, a quantification sample was injected in to GC system. The recovery factor was calculated as 91.6%. Also, the limit of recognition of this method was 4.5 ppm.
Results and Discussion
The level of histamine was analyzed before and after seven workstations of processing, including frozen fish reception, temporary storage in -18, defrosting, deheading-descaling-draining viscera, precooking, cleaning and segmenting, and sterilization, as shown in Table 5.
|Stages||Histamine content (PPM)|
|Before treatment||After treatment|
|Frozen fish reception||25.087 ± 0.583||18.197 ± 1.075|
|Temporary storage in -18°C||18.545 ± 0.475||19.188 ± 0.866|
|Defrosting||18.854 ± 0.895||19.336 ± 0.929|
|Deheading-descaling-draining viscera||19.507 ± 0.989||12.651 ± 1.018|
|Precooking||12.435 ± 0.523||15.903 ± 0.130|
|Cleaning and segmenting||15.966 ± 0.119||6.246 ± 0.484|
|Sterilization||6.313 ± 0.512||5.536 ± 0.480|
The values are shown mean value ± standard deviation.
Table 5: Histamine content before and after seven workstations of canned tuna processing.
Considering the results at 5 percent significance level, work stations including temporary storage in -18, defrosting, precooking, and sterilization have no significant impact on histamine reduction. On the other hand, frozen fish reception, deheading-descaling-draining viscera, and cleaning-segmenting reduced histamine level by 27.46%, 27.88%, and 60.87%, respectively. One should note that the maximum histamine content reduction is in the cleaning-segmenting workstation. The percentage of histamine reduction in workstations is evaluated and shown in Table 6. The amount of histamine was reduced (27.46%) after passing through the first workstation (frozen fish reception), because histidine decarboxylase is normally produced in high temperature. Also, histidine decarboxylase can maintain its activity above 5°C. Therefore, it is important to control the first workstation’s temperature. Likewise, the histamine level was diminished (by 27.88%) after passing through the deheading-descaling-draining viscera, because of the removing unpleasant parts of fish. Similarly, the amount of histamine was reduced significantly (by 60.87%) after passing through the cleaning-segmenting work station because of removing honey-combed parts and unusual texture and uncooked meat of fish. Therefore, this workstation plays a big role on level histamine reduction.
|Stages||Histamine content reduction percentage (%)||Significant/Non-significant|
|Frozen fish reception||-27.46 ± 0.056||*|
|Temporary storage in -18°C||3.46 ± 0.023||NS|
|Defrosting||2.55 ± 0.097||NS|
|Deheading-descaling-draining viscera||-27.88 ± 0.019||*|
|Precooking||2.55 ± 0.062||NS|
|Cleaning-segmenting||-60.87 ± 0.022||*|
|Sterilization||-12.3 ± 0.082||NS|
* Significant steps from the view point of histamine content reduction (p≤0.05).
NS: Nonsignificant; Negative sign means reduction.
Table 6: The percentage of histamine content reduction in canned tuna processing.
Accordingly, application of beneficial scientific methods based on preventive measures for controlling the histamine level in different work stations canning the process is important. The methods related to quality assurance and process control based on ISO 22000:2005 can be the most appropriate measures for controlling the histamine rise in products. In this study, ISO 22000:2005 requirements have been executed in a tuna fish canning factory; the histamine levels have been measured before and after each work station by GC machine, and the results have been analyzed. It is illustrated that the most significant decrease in histamine level occurred in cleaning-segmenting the work station. According to this, it can be determined that the operational prerequisite programs (OPRP) and critical control points (CCP) steps are the same in critical control; however, they have different approaches in controlling measures. Also, it can be concluded that it is necessary to have efficient infrastructures in order to implement an effective food safety management system.
In this study, we demonstrated that three workstations, including frozen fish reception, deheading-descaling-draining viscera, and cleaning-segmenting play a big role in reduction of histamine level in canned tuna by measuring histamine levels using GC machine during the whole process. Also, we observed that the maximum histamine content reduction was in the cleaning-segmenting workstation. By controlling those three mentioned workstations, especially cleaning segmenting section, it’s possible to reduce the chance of accruing Scombroid poisoning. In General, operational prerequisite programs (OPRP) and critical control points (CCP) steps are the same in critical control; however, they have different approaches in controlling measures. Also, it can be concluded that it is necessary to have efficient infrastructures in order to implement an effective food safety management system (FSMS). Therefore, it’s very important to strictly monitor CCPs, because they are the last point for hazard control.
The authors would like to express the deepest appreciation to Dr. Marcia R. Silva. Without her encouragement, this paper would not have materialized.
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Citation: Behrouzinia M, Fallah A (2018) Generic Plan of Implementation of ISO 22000:2005 in Canned Tuna and Assessment of FSMS Implementation on Control of Histamine. J Food Process Technol 9: 727. Doi: 10.4172/2157-7110.1000727
Copyright: © 2018 Behrouzinia M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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