IMPORT FOOD INSPECTION SYSTEM In Japan Hajime Toyofuku, D.V.M. Ph.D National Institute of Public Health, Japan 1 Table of Contents Overview of the imported food, inspection system for imported food Overview of the food exported from Thailand and food safety issues Overview of current food safety criteria New system: Positive List System for Agricultural Chemical Residues, Cadmium and Aflatoxin 2 Self-supply rate for Food <60%(calorie base > year Item Rice Wheat Bean Vegetable Fruits Meat Egg Milk product Fish Sugar self-sufficiency rates ’65 ’75 ’85 ’90 ’95 ’00 ’05 ’07 ’08 95 110 107 100 104 95 95 94 95 28 4 14 15 7 11 14 14 14 25 9 8 8 5 7 7 7 9 100 99 95 91 85 82 79 81 82 90 84 77 63 49 44 41 40 41 90 77 81 70 57 52 54 56 56 100 97 98 98 96 95 94 96 96 86 81 85 78 72 68 68 66 70 100 99 93 79 57 53 51 53 53 31 15 33 32 31 29 34 33 38 73 54 53 48 43 40 40 40 41 3 Cases & Weights of Imported Foods (Nationwide) x10000 Cases Million Tones 1.86 milli 34 milli tones 4 Inspection of imported food the quarantine station Arrival of the cargo Submission of import notifications Meat Inspect. Certificate Document inspection examination NO Onsite inspection Examination order ship back Monitoring No-compliance compliance Acceptance of the notification discard Custom 5 Overview of the System of Inspections Conducted at the Time of Importation Comprehensive import ban Number of total(gross) of monitoring inspections is 83,951 cases ※ Probability of violation High Inspection rate Inspection order 95,490 193,917 Enhanced monitoring 1,759,123 49,133 Monitoring inspection Administrative Inspection etc. Low 70,143 =11.0% FY2008 Total number of inspections/Num ber of import notifications Annual Monitoring Plan (2010 Fiscal Year) Foods, etc. Analyses Samples Animal food (Meat, Milk, Egg) Animal drugs, Pesticides, Food standards, etc. 4,880 Animal processed food Animal drugs, Food Additives, Food standards, etc. 7,510 Sea food (Fish and Shellfish) Animal drugs, Food Additives, Food standards, etc 6,570 Processed sea food Animal drugs, Food Additives, Food standards, etc Agricultural products (Grain, Vegetable, Fruit) Pesticides, Aflatoxin, GMO Processed agricultural products Pesticides, Food Additives, Food standards, Aflatoxin, GMO, etc Miscellaneous Food Additives, Food standards, etc. 4,800 Drinks Food Additives, Food standards, etc. 2,200 12,360 22,280 17,150 Food Additives, utensils, etc. Food standards, etc. 2,250 50% monitoring foods 5,000 7 Total 85,000 Number of notifications, analyses and rejections Analysis sites Notifications Year ratio Weight 件 % 1000 tones 1965 94,986 - 1975 246,507 1985 No. of total analyses *1 Gov. lab Private lab 件 件 12,765 - - 20,775 384,728 105.6 1995 1,052,030 2000 *2 No. rejected cases Official Foreign lab 件 件 件 5,574 - - 679 - 21,461 - - 1,634 22,665 39,817 14,892 26,054 1,904 308 109.2 28,268 141,128 60,787 74,634 19,760 948 1,550925 110.5 30,034 112,281 52,244 63,789 (37,484) 3,796 1,037 2005 1,864,412 104.1 33,782 189,362 66,147 125,083 (73,589) 7,919 935 2007 1,797,086 96.7 32,261 198,542 58,299 144,846 (94,598) 5,818 1,150 2008 1,759,123 97.9 31,551 193,917 58,706 140,878 (95,490) 6,208 1,150 *1 行政検査、指定検査機関検査、外国公的検査機関検査の合計から重複を除いた数値 *2 ( )内の数値は、指定検査機関検査のうちの命令検査の件数 8 Inspection System for Imported Foods, etc. Food Inspectors ・・・・・・・・383 persons Notification Sites for Imported Foods ・・・・・・31 sites Laboratory facilities Two Major Laboratories: • Yokohama (Eastern Lab. for Imported Foods & Infectious Diseases) • Kobe (Western Lab. for Imported Foods & Infectious Diseases) Six Minor Laboratories: • Tokyo, Narita A.P., Nagoya, Osaka, Kansai A.P., Fukuoka 9 Notification Site Map for Imported Foods, etc. Otaru QS Nagoya QS Nagoya AP Yokkaiti Simizu Kobe QS Western Lab. Fukuoka QS Moji Simonoseki Fukuoka AP Nagasaki Kagosima Niigata QS Titose AP Sendai QS Sendai AP Tokyo QS Hunabasi(Baraki) Tiba Haneda AP Kawasaki Narita AP QS Yokohama QS Osaka QS Eastern Lab. Kansai AP QS Hirosima QS Naha QS Hirosima AP Naha AP Sakai 10 Table of Contents Overview of the imported food, inspection system for imported food Overview of the food exported from Thailand and food safety issues Overview of current food safety criteria New system: Positive List System for Agricultural Chemical Residues 11 Statistics on Food Import in Japan from Thailand Notification 1600000 140000 Weight(ton) 1400000 Notification 120000 1200000 100000 1000000 80000 800000 60000 600000 40000 400000 20000 200000 0 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 12 Top 5 items from Thailand 2008 Notification Number Non-glutinous rice Analysis Weight(t) Number Violation Weight(t) Number Weight(t) 261 203592 121 106335 14 3293 15580 184043 1046 9099 1 2 289 108003 54 26337 0 0 Chemically modified starch 1510 89106 243 11740 0 0 Saccharides 1239 72978 20 500 0 0 Cooked meat product(packed after cooking) Tapioca flour 13 Abstract: Subject Foods by Country, for which Inspection Orders were Issued Target countrie s/area All exporting countries (16 items) Subject foods Inspection items Pufferfish Identification of fish species Salted salmon roe Nitrite Conditions Limited to lots from which different species of pufferfish have been found in on-site inspections Manioc and its processed Cyanide products (other than starch) Thailand Cultured shrimp and its (26 processed products items) (simple processing only) Oxolinic acid Okra and its processed products (simple processing only) EPN Basil seeds Aflatoxin Excluding products with attached certificates issued by the Thailand government concerning oxolinic acid, as separately indicated Excluding products exported by the exporters separately indicated Inspection orders were issued to all exporting countries for 16 items and to 36 countries for 190 items. (As of April 1, 2009) Inspection Order at Thailand 2010 products Subject Shrimp and Processed product Oxolinic acid Neptunia oleracea and Processed product Triazophos Feverweed and Processed product Chlorpyrifos, Cypermethrin, buprofezin Okra and Processed product EPN Mango and Processed product Chlorpyrifos Mango and Processed product Propiconazole Pandanus Odorus and Processed product Chlorpyrifos Green Asparagus EPN Banana Cypermethrin Mangosuteen Imazalil Lemon grass EPN Citrus hystrix Profenofos Pandanus Odorus 15 No of notifications and violations(2008) No of Notifications Violations agaisnt the Food Sanitation Law China 473,343 26.9% China 259 22.5% US 209,145 11.9% US 140 12.2% France 179,868 10.2% Thailand 110 9.6% Thailand 128,792 7.3% Vietnam 72 6.3% Korea 110,098 6.3% Taiwan 57 5.0% 16 Violation in 2009(Thailand) Violations categories no of Violations Aflatoxin Undesignated use of Food Additives Undesignated Food additives Rottenness, spoilage and molded Exceeding level of Pesticide residue E.coli positive ( Frozen food consumed after cooking) Exceeding levels of bacterial count (Frozen food) Coliform positive (frozen food, Surimi etc) others 5 4 4 19 18 7 31 29 5 total 122 17 Violations by products 2009(Thailand) Products Events Frozen food(Squid) Frozen food (Shrimp) Frozen fish Viable count (5), coliform (1) Fish meat kneated products Frozen food (Meat) Others No of cases 6 Viable count (16), E.coli (1), coliform(3) Coliform(14), E.coli (2), viable count (2) Coliform (2) , E.coli (4), 20 E.Coli (4), coliform (2) 6 17 6 16 18 Table of Contents Overview of the imported food, inspection system for imported food Overview of the food exported from Thailand and food safety issues Overview of current food safety criteria New system: Positive List System for Agricultural Chemical Residues 19 Microbiological criteria (1) Frozen fish or shellfish intended to be consumed raw microbial count: <100 000 /g product Coliform: negative Vibrio parahaemolyticus: < 100 MPN count /g 20 Microbiological criteria (2) Oyster intended to be consumed raw - Vibrio parahaemolyticus: < 100 MPN/g - E. coli: <230/100 g product - microbial count: < 50 000/g product 21 Microbiological criteria for Frozen food served after cooking and cooked immediately before freezing served without cooking served after cooking (other than those cooked immediately before freezing) Aerobic microorganisms @ 30°C Coliforms Aerobic microorganisms @ 30°C <100,000 Not detectable <100,000 Coliforms Not detectable Aerobic microorganisms @ 30°C <3,000,000 Escherichia coli Not 22 detectable Microbiological criteria for boiled crab Not frozen Vibrio parahaemolyticus: negative Frozen boiled crab microbial count: <100 000 /g product Coliform: negative Vibrio parahaemolyticus: negative 23 Food Additives Usage Sulfur dioxide, Benzoic acid, Sorbic acid Undesignated food additives TBHQ, Azorubine, Polysorbate 24 Table of Contents Overview of the imported food, inspection system for imported food Overview of the food exported from Thailand and food safety issues Overview of current food safety criteria New system: Positive List System for Agricultural Chemical Residues 25 Positive List System for Agricultural Chemical Residues 【 Previous Regulation 】 Pesticides, Feed Additives, and Veterinary Drugs 【 Enforcement of Positive List System】 May 29 2006~ Pesticides, Feed Additives and Veterinary Drugs Chemicals for which MRLs are established Chemicals for which MRLs are established 283 substances 799 substances MRLs for 250 Pesticides and 33 Veterinary Drugs Foods containing chemicals above the MRLs are enjoined from domestic distribution Chemicals for which MRLs are not established Basically, even foods found to contain chemicals are not enjoined from distribution. Establishment of provisional MRLs for agricultural chemicals, considering Codex standards, Japanese registration withholding limits, and other standards established based upon scientific evaluation 758 substances Acceleration of the establishment of MRLs Foods containing chemicals above the MRLs are enjoined from domestic distribution. Chemicals for which MRLs are not established Chemicals designated by MHLW Establishment of a certain level that is determined to pose no adverse health effects Chemicals that do not pose adverse health effects 0.01 ppm Foods found to contain chemicals above the level are enjoined from domestic distribution. 65 substances Not subject to the positive list system 26 Status of Violations under the Positive List System (FY 2008) Categories Residual agricultural chemicals Criteria Number of violations New criteria 104 Uniform limits 202 Non-detection criteria 1 Conventional criteria 52 359 Total Residual veterinary drugs New criteria 1 Uniform limits 0 111 Non-detection criteria 3 Conventional criteria 115 Total (For reference) Average number of violations per month before and after the Positive List System became effective Categories FY2005 FY2006 FY2007 FY2007 (April 2005March 2006) (June 2006March 2007) (April 2007-March 2008) (April 2007March 2008) Residual agricultural chemicals 4.8(-) 44.7(9.4 times) 23.2(0.52 times) 29.8(1.3 times) Residual veterinary drugs 4.5(-) 23.2(5.2 times) 15.4(0.66 times) 9.6(0.6 times) 67.9(7.3 times) 38.6(0.56 times) 39.4(1.1 times) Total 9.3(-) ( ):the ratio compared to the previous fiscal year Guidelines on Hygiene Control of Import Processed Foods 1. The purpose : not only to prevent contamination by poisonous or harmful substances, etc., but also to emphasize basic matters for guidance on processed foods required of importers under the Imported Foods Monitoring and Guidance Plan, to promote hygiene control of import processed foods, and to take steps to improve safety 2 Scope: for importers who manufacture and import products to be exported to Japan under direct contract with overseas manufacturers, as well as importers of processed food in general. Moreover, even importers who are not in a direct contractual relationship with an overseas manufacturer should also, through the agency of an exporter or other such concern in the exporting country, strive to confirm the matters stated in these Guidelines with said manufacturer Sec 2 Raw Material Acceptance Stages Sec 3 Product Manufacturing and Processing Stages Sec 4 Product Storage, Transportation and Distribution Stages Sect 5 Recall and Disposal, Sec 6 Education and training , record keeping http://www.mhlw.go.jp/english/topics/importedfoods/guideline/01.html Cadmium 29 Epi study of adverse health effects and an indicator Cadmium Long term exposure absorption・ metabolize a low molecular weight protein as an indicator β2-microglobulin (β2-MG) Adverse effects on Kidney proximal tubular 30 Conclusion of the risk assessment by Food Safety Commission in Japan Tolerable weekly intake Cd 14.4 ⇒7 µg/kg b.w/week 31 Current control measures for CADMIUM in food in Japan CADMIUM Limits in Rice ( brown rice ) ,Soft drinks and powdered soft drinks are established in Japan , based on Food Sanitation Law, For rice, the limit is less than 1.0mg/kg in rice, however, rice containing more than 0.4mg/kg and less than 1.0mg/kg is bought by MAFF in order to prevent distribution in the food chain Food Limits Less than 1.0 mg/kg Rice(brown rice) Soft drink (including mineral water Powdered soft drink mix Source water Less than 0.01 mg/L 以下 Finish product Not detected Not detected 32 Codex CADMIUM standards <Standard for contaminants in food> Codex STAN 193-1995, Rev.3-2007) Food categories Cereal grains buckwheat ) Wheat ( excluding Potato Pulses Root and tuber, stalk and stern vegetable Leafy vegetables 。 other vegetables(Brassica veg, Bulb veg, fruiting vege, cucurbits, Rice polished Marine bivalve molluscs Cephalopods(squids and octopus) Limits (mg/kg) Note/remarks 0.1 Excluding what and rice and bran and germ 0.2 0.1 0.1 Peeled Excluding soya bean (dry) 0.1 Excluding potato and celeriac 0.2 0.05 Excluding tomatoes and edible fungi 0.4 2 2 Excluding oyster and scallop 33 Without viscera Conclusions at food standard committee in MHLW Revised Cadmium standard in Rice ( 1.0ppm → 0.4ppm : from the end of February, 2011) Cadmium Standards for other food categories will not established. Request stakeholders to make efforts to reduce the levels of cadmium in foods 34 Aflatoxins 35 Risk management of Aflatoxin in food ① Current control in Japan In 1971, Food contained aflatoxin was regarded as adulterated food, and sales, use and distribution of such food is prohibited as a violation of the Food Sanitation Law, Article 6. In the official test methods, Aflatoxin B1 is designated as the target, and the detection limit was established at 10ppb. This value is considered as “standard”. Codex Total aflatoxin (sum of B1, B2, G1 and G2) ・ peanuts for further processing ( almond, hazelnuts, pistachios for further processing):15ppb ・ almond, hazelnuts, pistachios for ready to eat:10ppb Contamination statues ・Some foods were contaminated with both B &G group Aflatoxins. ・In some peanut samples, levels of Aflatoxin G is higher than those of 36 Aflatoinx B group Risk management of Aflatoxin in food 2 Risk assessment based on epidemiological investigations, liver cancer risk of life time oral exposure of Aflatoxin B1 at 1ng/kg b.w./day • • Results of exposure assessment, differences of risks of liver cancer under deferent scenarios are negligible: • • HBsAg positive; 0.3 cases /100,000 population /year HBsAg negative: 0.01 cases /100,000 population /year current control at Aflatoxin B1 at 10ppb total afratoxin at 8, 15, 20ppb Afratoxin intake from food should be reduced as low as reasonablely achievable The Conclusion of the MHLW Food Stanadrd Committee The regulatory target Aflatoxin should be amended as the total aflatoxin with 37 the detection limit at 10ppb. Diagram 2 RISK ASSESSMENT Food Safety Commission ・ To conduct a risk assessment. ・ To recommend that agencies in charge of risk management implement necessary measures for food safety, based on the risk assessment results. ・ To monitor the risk management by related agencies. ・ To collect and analyze domestic and international information on food safety hazards. ・ To comprehensively manage total risk communication including activities of the risk management agencies. Food Safety Basic Law RISK MANAGEMENT MHLW MAFF ・ Regional Agricultural ・Quarantine Stations ・Regional Bureaus of Health and Welfare ・Health Centers, etc. Risk management for food safety Administration Offices ・ Centers for Food Quality, Labeling and Consumer Services, etc. Risk management for agricultural, livestock, and fishery production. Food Sanitation Law, etc. Agricultural Chemicals Regulation Law, etc. RISK COMMUNICATION ・Disclosure of information on food safety ・Securing consumers’ opportunities to express their opinions 38 Conclusions Application of Risk Analysis framework Risk assessment conducted by Food Safety Commission Risk communication Taking Codex standards into account Contribution to the Codex standard setting activities Toward harmonization with ISO microbiological test methods Farm to table approach Identify and implement appropriate control measures 39 along entire food chain MHLW Import food website at http://www.mhlw.go.jp/english/topics/importedfoods/index.html Positive List System for Agricultural Chemical Residues in Foods http://www.mhlw.go.jp/english/topics/foodsafety/positivelist0602 28/index.html 40