Survey of Histamine in Fish Products. MAF Technical Paper No: 2011/ 81. ISBN No: (print) ISBN No: (online)

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1 Survey of Histamine in Fish Products MAF Technical Paper No: 2011/ 81 ISBN No: (print) ISBN No: (online) ISSN No: (print) ISSN No: (online) September 2011

2 Disclaimer Every effort has been made to ensure the information in this report is accurate. MAF does not accept any responsibility or liability whatsoever for any error of fact, omission, interpretation or opinion that may be present, however it may have occurred. Requests for further copies should be directed to: Publication Adviser MAF Information Bureau P O Box 2526 WELLINGTON Telephone: Facsimile: This publication is also available on the MAF website at Crown Copyright - Ministry of Agriculture and Forestry

3 Contents Page 1 Executive Summary 1 2 Background 2 3 Survey 2 4 Material and Methods Survey Scope Sample Collection 3 5 Methodology Analytical Testing Data Analysis 4 6 Results and Discussion Samples and Country of Origin Analytical Results 5 7 Conclusion 6 8 Reference 7 9 Appendix 8 i

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5 1 Executive Summary The objective of this survey was to verify whether samples of imported fermented fish products were compliant with the histamine limit set in the Food Standards Code. The Food Standards Code - Standard sets the maximum permitted level for histamine in fish products at 200 mg/kg. This survey was in response to a specific brand of fish cooking sauce that was recalled in Australia in September 2010 because it was found to contain high levels of histamine (600 mg/kg). Seventy-seven fish product samples were collected from a range of supermarkets, ethnic and specialty stores throughout the Auckland region during October Where possible a range of brands and date or batch numbers were sampled to increase the range of products included in the survey. All samples were analysed for histamine by Enzyme-linked immunosorbent assay (ELISA). Samples exceeding the quantitative limits of the ELISA assay were reanalysed by High Performance Liquid Chromatography (HPLC). All samples were analysed by Cawthron Institute, Nelson, New Zealand. Sixty seven of the seventy seven product samples tested (87%) complied with the Food Standards Code (FSC) maximum permissible level of 200 mg/kg for histamine. The ten product samples that exceeded the FSC level were all fish sauces. The highest histamine concentration detected in the survey was 680 mg/kg. It is noted that Codex Alimentarius has recently adopted a limit of 400 mg/kg for histamine in fish sauce. The higher limit was based on the small quantities of fish sauce that is consumed at one time. It may be appropriate for FSANZ to consider whether a limit should be set for histamine in fish sauce instead of applying the limit for fish generally. Six out of the ten samples that exceeded the Food Standards Code limit, complied with the Codex Standard limit. MAF contacted all importers of products included in this survey to notify them of the findings and remind them of their obligations under the Food Act 1981 and associated legislation. Three products (4% of the total sampled) were considered a potential risk to human health and were removed from the market through trade recalls. Ministry of Agriculture and Forestry Survey of Histamine in Fish Products 1

6 The results from this survey indicate the potential for imported fermented fish based products to pose a food safety risk. MAF is currently reviewing all prescribed foods and this survey will be considered as part of the histamine in fish review. MAF have also shared these findings with FSANZ. 2 Background In September 2010, a specific brand of fish cooking sauce was recalled in Australia because it was found to contain high levels of histamine (600 mg/kg). The purpose of this survey was to determine if fermented fish products imported into New Zealand were compliant with the histamine limit set in the Food Standards Code. The Food Standards Code - Standard sets the maximum permitted level for histamine in fish products at 200 mg/kg. Histamine is a naturally occurring biogenic amine. It can be found in foods such as fish and fish products, meat, cheese and fermented foods. The presence of histamine in these foods can indicate spoilage or poor manufacturing processes. Ingesting food with high levels of histamine can cause vomiting, diarrhoea, abdominal cramps, perspiration, flushing, headaches and burning sensations in the mouth. Certain types of fish known as the scombroid fish can contain the amino acid histidine. After being caught, bacteria within the fish begin to convert histidine into histamine. This can occur rapidly if fish are not chilled properly after being caught. The production of fish sauces varies between countries, but generally they are derived from the preservation of fish with salt for a period from six to 18 months. During the fermentation process, the free amino acids content increases and has the potential (with suitable ph and temperature conditions) to produce biogenic amines, including histamine. 3 Survey The objective of this survey was to verify whether samples of imported fermented fish products were compliant with the standard for histamine set in the Food Standards Code (Standard 2.2.3). 2 Survey of Histamine in Fish Products Ministry of Agriculture and Forestry

7 4 Material and Methods 4.1 SURVEY SCOPE This survey focused on fermented fish products including fish sauces, fish based marinades, mixes, condiments, soups and broths. Fish and fish pastes were excluded as these foods are tested at the border as part of MAF s imported food requirements. Data available from Customs New Zealand was unable to assist with developing a statically valid sampling plan representative of fermented fish products and country of origin. Therefore a targeted survey was carried out instead where products identified as within scope of this survey were taken from retail stores. 4.2 SAMPLE COLLECTION Samples of imported fermented fish based products were collected from a range of supermarkets, ethnic and specialty stores throughout the Auckland region during October Where possible a range of brands and date or batch numbers were sampled to increase the range of products included in the survey. Agri-Chain Centre Limited staff collected the samples. 5 Methodology 5.1 ANALYTICAL TESTING All samples were analysed for histamine by Enzyme-linked immunosorbent assay (ELISA). The manufacturer reports the coefficient of variance of the analysis kits is on average 10.6%. Samples exceeding the quantitative limit of the ELISA assay were re-analysed by High Performance Liquid Chromatography (HPLC). The laboratory reports the coefficient of variance (determined during validation) for the HPLC analysis as % at concentrations between mg/kg. All samples were analysed by Cawthron Institute, Nelson, New Zealand. Ministry of Agriculture and Forestry Survey of Histamine in Fish Products 3

8 5.2 DATA ANALYSIS Results for histamine were assessed against the maximum permitted level in Standard of the Food Standards Code. For histamine in fish and fish products this is 200 mg/kg. MAF s toxicologists reviewed the non-compliant results to determine if exposure to high levels of histamine in fish sauces poses a public food safety risk. 6 Results and Discussion 6.1 SAMPLES AND COUNTRY OF ORIGIN Seventy seven fish product samples were collected for the survey. Sixty six samples were described as fish sauce, four samples described as fish stock and soup, and three samples described as fish condiments. Four samples were described as miscellaneous fish products and included products such as cooked seafood. Product descriptions were based on product labels or sampler opinion where labelling was unclear. Customs New Zealand data indicated that imported fermented fish products are mostly of Asian origin. The Middle East, Italy and United Kingdom are also sources of some of these products. The country of origin distribution seen in the samples collected in the survey was similar to the Customs New Zealand data. Samples collected in this survey were mostly from Asia (68 samples or 89%) with the remaining samples originating from Europe (9 samples or 11%). No samples from the Middle East appeared in this survey. 4 Survey of Histamine in Fish Products Ministry of Agriculture and Forestry

9 Country of origin based on International Region For samples collected in survey Asia 68 Europe 9 Asia Europe 6.2 ANALYTICAL RESULTS The survey results are included in Appendix 1. A summary is provided below. Sixty seven of the seventy seven product samples (87%) tested complied with the Food Standards Code maximum permitted level of 200 mg/kg for histamine in fish and fish products. Number of samples below the Food Standards Code (FSC) Limit For histamine concentration in fish based products Above FSC limit (Histamine > 200mg/kg) Below FSC limit (Histamine < 200mg/kg) Ministry of Agriculture and Forestry Survey of Histamine in Fish Products 5

10 Ten product samples (13% of the total sampled) exceeded the Food Standards Code maximum permitted level. These samples were all fish sauces. Histamine concentrations above 400 mg/kg were detected in four of these product samples, with the highest concentration (680 mg/kg) detected in fish sauce. MAF contacted all importers of products included in this survey to notify them of the findings and remind them of their obligations under the Food Act 1981 and associated legislation. 7 Conclusion Not all imported fermented fish products are compliant with current New Zealand Standards. Sixty seven of the seventy seven samples tested (87%) complied with the Food Standards Code maximum permitted level of 200 mg/kg for histamine. Many of the fish sauces tested contained low or negligible levels of histamine. This indicates that histamine is not an automatic consequence of the fermentation process. The histamine levels are likely to be largely influenced by the quality of the raw fish coming in. There may also be other process parameters that need to be better managed to control histamine levels. Ten samples exceeded the Food Standards Code maximum permitted level for histamine. These ten samples were described as fish sauce products. Three samples (4% of the total sampled) were considered to pose a food safety risk, by MAF s toxicologists. MAF toxicologists concluded that for histamine levels of 550 mg/kg an adult consumer would need to consume around 40ml of fish sauce a day to reach a level of histamine that may result in a consumer experiencing poisoning symptoms. Trade recalls for these products were carried out. The remaining seven samples contained histamine at levels that MAF deemed unlikely to pose a food safety risk. Importers of these seven products were contacted and reminded of their obligations under the Food Act 1981 to ensure products comply with the Food Standards Code. 6 Survey of Histamine in Fish Products Ministry of Agriculture and Forestry

11 The Codex Alimentarius has now adopted a limit of 400 mg/kg for histamine in fish sauce recognising the small quantities of fish sauce eaten in a serving. Prior to the Codex fish sauce standard, there was no Codex standard that covered fish sauce products. This limit was still under discussion at the time of the survey but has now been adopted by Codex. The three products recalled all exceeded this limit. It may be appropriate for FSANZ to consider the need for a different limit for histamine in fish sauce in light of this development. MAF is currently reviewing all prescribed foods and this survey will be considered as part of the histamine in fish review. MAF has also shared these findings with FSANZ. 8 Reference Food Standards Code Standard Codex Standard Ministry of Agriculture and Forestry Survey of Histamine in Fish Products 7

12 9 Appendix Appendix 1: Raw Data - results from imported fermented fish products tested for histamine Histamine Analysis Sample Date Concentration* method Reference Sampled Product Type (mg/kg) SY1 11/10/2010 Fish sauce < 1 ELISA SY2 11/10/2010 Fish sauce 80 ELISA SY3 11/10/2010 Fish sauce < 1 ELISA SY4 11/10/2010 Fish sauce 78 ELISA SY5 11/10/2010 Fish sauce 38 ELISA SY6 11/10/2010 Fish sauce < 1 ELISA SY7 11/10/2010 Fish sauce 83 ELISA SY8 13/10/2010 Fish sauce < 1 ELISA SY9 13/10/2010 Fish sauce < 1 ELISA SY10 13/10/2010 Fish sauce 1 ELISA SY11 14/10/2010 Fish sauce 24 ELISA SY12 14/10/2010 Fish sauce < 1 ELISA SY13 14/10/2010 Fish sauce 112 ELISA SY14 14/10/2010 Fish sauce 7 ELISA SY15 14/10/2010 Fish sauce 10 ELISA SY16 14/10/2010 Fish sauce 350 HPLC SY17 14/10/2010 Fish condiment 68 ELISA SY18 14/10/2010 Fish sauce 1 ELISA SY19 14/10/2010 Fish sauce 370 HPLC SY20 14/10/2010 Fish stock and soup < 1 ELISA SY21 14/10/2010 Fish sauce < 1 ELISA SY22 11/10/2010 Fish sauce 4 ELISA SY23 11/10/2010 Fish sauce < 1 ELISA SY24 11/10/2010 Fish sauce 96 ELISA SY25 11/10/2010 Fish sauce < 1 ELISA SY26 11/10/2010 Fish sauce < 1 ELISA 8 Survey of Histamine in Fish Products Ministry of Agriculture and Forestry

13 SY27 11/10/2010 Fish sauce < 1 ELISA SY28 13/10/2010 Fish sauce 15 ELISA SY29 13/10/2010 Fish sauce 8 ELISA SY30 13/10/2010 Fish sauce < 1 ELISA SY31 13/10/2010 Fish sauce 340 HPLC SY32 13/10/2010 Fish sauce 4 ELISA SY33 17/10/2010 Fish sauce 77 ELISA SY34 17/10/2010 Fish sauce 43 ELISA SY35 11/10/2010 Fish sauce 57 ELISA SY36 11/10/2010 Fish sauce 38 ELISA SY37 11/10/2010 Fish sauce 35 ELISA SY38 11/10/2010 Fish sauce 1 ELISA SY39 11/10/2010 Fish sauce < 1 ELISA SY40 11/10/2010 Fish sauce 58 ELISA SY41 11/10/2010 Fish sauce < 1 ELISA SY42 11/10/2010 Fish sauce 87 ELISA SY43 11/10/2010 Fish sauce < 1 ELISA SY44 11/10/2010 Fish sauce 34 ELISA SY45 11/10/2010 Fish sauce 24 ELISA SY46 11/10/2010 Fish sauce 52 ELISA SY47 14/10/2010 Fish sauce < 1 ELISA SY48 11/10/2010 Fish sauce 1 ELISA SY49 14/10/2010 Fish sauce 350 HPLC SY50 11/10/2010 Fish sauce < 1 ELISA SY51 14/10/2010 Fish sauce 2 ELISA SY52 11/10/2010 Fish sauce 176 ELISA SY53 14/10/2010 Fish sauce 270 HPLC SY54 10/10/2010 Fish sauce 2 ELISA SY55 14/10/2010 Fish sauce 230 HPLC SY56 10/10/2010 Fish sauce < 1 ELISA SY57 11/10/2010 Fish sauce 190 ELISA SY58 13/10/2010 Fish sauce 550 HPLC SY59 12/10/2010 Fish sauce 620 HPLC SY60 13/10/2010 Fish stock and soup 166 ELISA Ministry of Agriculture and Forestry Survey of Histamine in Fish Products 9

14 SY61 13/10/2010 Fish sauce 680 HPLC SY62 16/10/2010 Fish stock and soup < 1 ELISA SY63 16/10/2010 Fish condiment 1 ELISA SY64 20/10/2010 Fish sauce 8 ELISA SY65 20/10/2010 Fish sauce 83 ELISA SY66 20/10/2010 Fish sauce 1 ELISA SY67 20/10/2010 Fish sauce 98 ELISA SY68 20/10/2010 Miscellaneous fish < 1 ELISA product SY69 20/10/2010 Miscellaneous fish < 1 ELISA product SY70 20/10/2010 Miscellaneous fish 2 ELISA product SY71 20/10/2010 Fish stock and soup 1 ELISA SY72 22/10/2010 Fish sauce 2 ELISA SY73 25/10/2010 Fish sauce 64 ELISA SY74 25/10/2010 Miscellaneous fish 9 ELISA product SY75 25/10/2010 Fish condiment 16 ELISA SY76 25/10/2010 Fish sauce 410* HPLC SY77 26/10/2010 Fish sauce < 1 ELISA Results as listed by the laboratory The Coefficient of Variation (CV) of the ELISA assay is 10.6%. The CV of the HPLC assay is 2.2% to 3.4% over the range from 25 to 250 mg/kg. Sample SY76 was reported as having 410 mg/kg. Given a CV of 3.4%, as 410 is less than the 95 th percentile (422) for the Codex limit of 400 mg/kg, no recall action was deemed necessary 10 Survey of Histamine in Fish Products Ministry of Agriculture and Forestry