Reference: "Monitoring of Imported Foods – For the Safety of Imported Food"
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/index.html

• Confirmation of legality with respect to the Act at time of import notification
  • Monitoring^*1 (FY 2015 Plan: 95,090 cases)
• Ordered inspection^*2 (As of April 1st, 2015: 17 items from all exporting countries, and 78 items from 32 countries and 1 region)
• Regulations for comprehensive import bans^*3
• Emergency measures based on overseas information

• Systematic collection of information on safety measures for foods exported to Japan and promotion of food safety measures through on-site visits
• Request for the establishment of sanitation control measures such as stronger control for agricultural chemicals, enhancement of the monitoring systems and implementation of pre-export inspections, through bilateral talks and on-site visits
• Informing the responsible governmental agencies and food business operators of food safety regulations of Japan through seminars held in exporting countries

• Pre-import guidance (known as import consulting)
• Guidance on voluntary inspections at import consulting, initial import and continued import
• Guidance on preparation and storage of records on the sanitation management of imported foods
• Raising awareness of food safety amongst importers

 To ensure the safety of imported foods, measures have been taken as described below by the Ministry of Health, Labour and Welfare and at quarantine stations based on the fundamental approach of Article 4 of the Food Safety Basic Act that necessary measures shall be taken appropriately at each stage from production, manufacturing and processing in the exporting country to post-import domestic distribution.

Examination of notifications using
computer system

 Examination on compliance with the Act was made primarily with the standards and criteria for foods under the provisions of Article 11 (1) and Article 18 (1) of the Act (hereinafter, "standards and criteria"), and inspections were carried out as required based on import notifications made under the provisions of Article 27 of the Act.
 The number of import notifications made in FY 2015 was 2,255,019, and the weight of notified items was 31,900,000 tons. Among these import notifications, inspections were carried out on 195,667 cases, of which 858 cases (running total of 897 cases) were confirmed to be in violation of the Act, and steps were taken for their reshipment, disposal, etc. These accounted for 0.04% of the number of notifications (Table 1).

Sampling at warehouse

 Monitoring inspection is conducted for the purpose of broadly monitoring the safety status of various imported foods. In order to conduct intensive, effective and efficient monitoring, inspection numbers and inspection items are specified taking into account previous importation data and violation rates for each food type, ensuring the inspection numbers required to enable detection of violations to a certain degree of statistical reliability.
 In FY 2015, monitoring inspection was conducted for 52,211 cases (97,187 cases compared to the planned cumulative total of 95,090 (implementation rate: approx. 102%)), and of which, 172 cases (running total of 173 cases) were confirmed to be in violation of the Act (Table 2), and steps were taken for recall, disposal, etc.
 For foods found to be violating the Act during monitoring inspections, etc., the inspection rate for the same exporting country and the same food type was set to 30% as necessary (Table 3). Additionally, when a certain food of a certain country was found to be violating the Act multiple times pertaining to agricultural chemical residues or veterinary drug residues, the food was then subject to ordered inspection upon each and every importation for having a high probability of violation of the Act (Table 4). Inspection of foods in which aflatoxin, etc. were detected was immediately enhanced as subjects of ordered inspections (Table 5).
 Regarding the inspection for agricultural chemical residues in processed food started in response to the cases of agricultural chemical poisoning due to frozen dumplings produced in China that occurred in January 2008, inspections were carried out on 11,005 cases in FY 2015, which found 1 case of pirimiphos-methyl being detected above the standard value in blended cereals produced in the USA.

 In order to prevent harm to public health, subject countries and regions, foods and items of inspection have been specified, and ordered inspections have been carried out under provisions of Article 26 of the Act for imported foods which are considered to have a high probability of violating the Act.
 As of March 31, 2016, 17 items from all exporting countries, and 69 items from 31 countries and 1 region were made subject to ordered inspection, and inspection was carried out for 58,874 cases (running total of 93,859 cases) in FY 2015. Of which, 239 cases (running total of 239 cases) were found to be in violation of the Act (Table 6), and steps were taken for re-shipment or disposal, etc.

 Breaking down violations by provision, 541 cases violated Article 11 of the Act (e.g., compositional standards for food (microbial, agricultural chemical residues, and veterinary drug residues) and standards for the use of additives in food), 243 cases violated Article 6 (e.g., adhesion of hazardous or toxic substances such as aflatoxin), 42 cases violated Article 10 (use of undesignated additives), 31 cases violated Article 18 (standards for apparatus or containers and packaging), 1 case violated Article 9 (absence of health certificates of meat), which relates to health certificates of meat, and 1 case violated Article 62 (mutatis mutandis application), which relates to criteria for toys (Table 7).
 Breaking down violations by inspection type, violations of standards on microbes in frozen foods, etc. were found in 222 cases (25.9%) (Table 8-1), violations relating to existence of hazardous or toxic substances and contamination with pathogenic microbes in 153 cases (17.8%) (Table 8-2), violations of standards on agricultural chemical residues in 135 cases (15.7%) (Table 8-3), violations relating to the use of undesignated additives and violations of criteria on the use of additives in 121 cases (14.1%) (Table 8-4), violations relating to decay and deterioration (e.g., generation of unpleasant smell or mold) in 106 cases (12.4%) (Table 8-5), violations of standards on veterinary drug residues in 52 cases (6.1%) (Table 8-6), violations of standards on apparatus, containers and packaging and toys in 32 cases (3.7%) (Table 8-7), and other violations in 38 cases (4.4%) (Table 8-8).

[1] Violations of standards on microbes (Table 8-1)
 By country, the rankings were China with 62 cases (27.9%), followed by Thailand with 28 cases (12.6%), and South Korea with 21 cases (9.5%). The principle item in violation in these cases was microbial criteria (bacterial count, coliform bacteria, E.coli) as an index of contamination for frozen food with 179 cases (80.6%).

[2] Violations relating to existence of hazardous or toxic substances and contamination with pathogenic microbes(Table 8-2)
 By country, the rankings were the USA with 36 cases (23.5%), followed by China with 25 cases (16.3%), and Italy with 16 cases (10.5%). The principle violation in these cases was adhesion of aflatoxin to peanuts in the USA and in China, and adhesion of aflatoxin to pistachio nuts paste in Italy.
 The most common material responsible for these violations was mycotoxin (aflatoxin and patulin) in 115 cases (75.2%), followed by cyanides in 21 cases (13.7%), and radioactive materials in 8 cases (5.2%). By product, the rankings were peanuts with 42 cases (27.5%), followed by pistachio nuts (including pistachio nuts paste) with 15 cases (9.8%), and adlay seeds with 10 cases (6.5%).

[3] Violations of standards on agricultural chemical residues (Table 8-3)
 By country, the rankings were China with 34 cases (25.2%), followed by Venezuela with 18 cases (13.3%), and Ecuador with 16 cases (11.9%). The principle material responsible for violations in China was thiamethoxam in onion, and 2,4-D in cacao beans was responsible for all violations in Venezuela and Ecuador.
 By product, the rankings were cacao beans with 45 cases (33.3%), followed by sesame seeds with 13 cases (9.6%), and onion with 12 cases (8.9%).

[4] Violations relating to the use of undesignated additives and violations of criteria on the use of additives (Table 8-4)
 By country, the rankings were France with 13 cases (10.7%), followed by China with 11 cases (9.1%), Taiwan and Brazil with 10 cases (8.3%). The principle violation was the use of undesignated additives (azorubin, quinoline yellow) in chocolates in France, overuse of sucralose in pickles (vegetable) in China, and off-label use of sorbic acid in confectionaries in Taiwan.
 The principle materials responsible for violations relating to the use of undesignated additives (42 cases) were coloring agents (azorubin, orange II, quinoline yellow, patent blue V, fast red E, brilliant black BN) in 17 cases (14.0%), followed by TBHQ in 14 cases (11.6%) and cyclamic acid in 5 cases (4.1%). The principle materials responsible for violations of criteria on the use of additives (79 cases) were sulfur dioxide in 34 cases (28.1%), followed by sorbic acid in 17 cases (14.0%), and polysorbate in 5 cases (4.1%).

[5] Violations relating to decay and deterioration (e.g., generation of unpleasant smell or mold) (Table 8-5)
 By country, the rankings were the USA with 22 cases (20.8%), followed by Thailand with 16 cases (15.1%), and Columbia with 15 cases (14.2%). The principle product in violation in these cases was wheat in the USA, rice in Thailand for all violations, and coffee beans in Columbia for all violations.
 By product, the rankings were coffee beans with 50 cases (47.2%), followed by rice with 23 cases (21.7%), and wheat with 22 cases (20.8%).

[6] Violations of standards on veterinary drug residues (Table 8-6)
 By country, the rankings were Vietnam with 33 cases (63.5%), followed by India with 8 cases (15.4%), and France with 4 cases (7.7%). The principle material responsible for violations in these cases was enrofloxacin in shrimp in Vietnam and furazolidone in shrimp in India, and nicarbazin was responsible for all violations in chicken in France.
 By product, the rankings were shrimp with 32 cases (61.5%), followed by thread-sail filefish with 7 cases (13.5%), and chicken meat with 5 cases (9.6%).

[7] Violations of standards on apparatus, containers and packaging and toys (Table 8-7)
 By country, the rankings were China with 22 cases (68.8%), followed by Taiwan with 3 cases (9.4%), and Germany with 2 cases (6.3%).

[8] Other violations (Table 8-8)
 The principle violations in other violation cases were violation of standards for food additives in 14 cases, detection of genetically modified papaya that has not undergone safety assessment in 5 cases, contamination with puffer fish that is not permitted to be imported in 5 cases, and detection of genetically modified rice that has not undergone safety assessment in 2 cases.

 When the violation of the Act is at a considerable degree and when deemed necessary for preventing occurrence of harm, the Minister of Health, Labour and Welfare may ban the import or sale of specific foods from specific countries without requiring an inspection (comprehensive import ban).
 According to the "Guidelines for the Banning of the Sale or Import of Specific Foods under Article 8 (1) and Article 17 (1) of the Food Sanitation Act" (SHOKUHATSU No. 0906001 dated September 6, 2002), request for improvement is made and investigation etc. on the status of sanitation control at the exporting country is conducted for imported foods that exceed a 5% violation rate in the last 60 ordered inspections. As a result, in FY 2015, no foods were subject to such measures.

 The monitoring system at the time of importation has been enhanced and investigation into domestic distribution has been carried out, and appropriate measures including recalls of distributed goods and suspension of import notification were ordered after confirming a record of their import (Table 9), including salmonella contamination of natural cheese produced in France, contamination of wine with glass pieces in South Africa, contamination of beverages with glass pieces in the USA, and unauthorized use of copper sulfate in olives in Italy. The investigation was based on information on the overseas outbreaks of food poisoning or recall of food products in violation of laws that has been collected by the Ministry of Health, Labour and Welfare, the National Institute of Health Sciences, and the Food Safety Commission of Japan.

Farm of Filipino mango

[1] Bilateral consultations and on-site inspection (Table 10)
 Information on products in violation of the Act has been provided to the governments of exporting countries where the products were made subject to ordered inspection or enhanced monitoring inspections, and further, requests have been made through bilateral consultations for investigations into the causes of violations and for taking measures to prevent the recurrence of such violations. As a result of bilateral consultations, it was confirmed that the Japan export control system has been established in South Korea for green hot pepper and tomato.
 To confirm the adequacy of safety measures during the production and processing stages in the exporting country, with regards to, for example, observance of the Japan export verification program for beef (as a measure against bovine spongiform encephalopathy (BSE)) and promotion of sanitary measures in exporting countries relating to agricultural chemical residues, specialists were dispatched to carry out on-site inspections, etc., as necessary.
 For USA and Canadian beef, observance of the Japan export verification program was confirmed by on-site inspection as regular audit at facilities authorized for export to Japan.
 For Swedish, Brazilian, Norwegian, Danish, Swiss, Liechtenstein and Italian beef, the implementation preparation status of a Japan export verification program, etc., was confirmed by on-site inspection, and import from these countries was resumed (import ban was lifted in FY 2016 for Swiss, Liechtenstein and Italian beef).
 For Australian beef, observance of the export conditions was confirmed by on-site inspections at facilities registered for export to Japan.
 For Thai asparagus, okra, banana, mango and mangosteen, recurrence prevention measures for violation of the Act proposed by the Thai government and the indications made at on-site inspections of business operators registered for export to Japan were reflected on the Japan export control program, and additional safety measures were promoted in the exporting country.
 For Vietnam foods, in response to the cause unfolding and recurrence prevention measures on the contamination of foreign matter presented by the Vietnam government, in FY 2014, the recurrence prevention measures were verified by on-site inspection, and the monitoring system was changed to normal.
 For Australian bivalves, appropriate implementation of recurrence prevention measures was confirmed by on-site inspection, and the monitoring system was changed to normal.
 For Filipino mango, in response to the cause unfolding and recurrence prevention measures on the agricultural chemical residues presented by the Filipino government, on-site inspection was carried out.

[2] Inspections of exporting countries (Table 11)
 To prevent occurrence of safety issues, information gathering has been systematically conducted as part of an investigation on safety measures in exporting countries, and on-site inspections have been carried out where necessary.
 In FY 2015, inspections were carried out for Indonesia, Germany, France and Vietnam into initiatives taken by the national government, producers and manufacturers of the exporting countries.
 Along with the inspections, seminars on the import food monitoring systems and sanitation regulations in Japan were held targeting government officials and/or food suppliers.

[3] The Japan-China Food Safety Promotion Initiative
 In May 2010, both the Minister of Health, Labour and Welfare of Japan and the Minister of General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) of the People’s Republic of China signed a memorandum of understanding on the Japan-China Food Safety Promotion Initiative. As a result, the first ministerial meeting was held and working-level consultations and field studies were conducted. Both parties determined that bilateral exchange and cooperation should continue to be promoted in the field of safety for food exports and imports between two countries.
 For FY 2015, a working-level consultation was held, and the Chinese side provided explanation on why there were no issues in exported foods including those exported to Japan, in regard to the case of processed food produced using expired chicken that occurred in 2014, and on the sanitary measures for exported foods. The Japanese side requested the Chinese side to take effective and practical preventive measures in cooperation with agencies related to China’s domestic and exported food sanitation measures regarding aflatoxin in peanuts, agricultural chemical residues and shellfish poisons in bivalves and agricultural chemical residues in oolong tea and edamame, and to continue to ensure the safety of foods exported to Japan.
 More details on the results, etc., of the Japan-China Food Safety Promotion Initiative are posted at the URL below.

https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/exporter/index.html

[4] Technical cooperation
 In order to improve the experimental testing techniques for agricultural chemical residues in coffee beans in Ethiopia, specialists were dispatched from quarantine stations to the relevant local sites during the period from September 9 to November 4, 2015.
 Additionally, in order to improve the experimental testing techniques for agricultural chemical residues in sesame seeds in Paraguay, specialists have been dispatched from the Ministry of Health, Labour and Welfare to the relevant local sites since November 1, 2015.

 For cases violating the Act, details including the names of importers and imported foods in violation of the Act were published on the Ministry of Health, Labour and Welfare website, based on the provisions of Article 63 of the Act, in order to clarify the harm in terms of the food sanitation. The content of improvement measures, the cause of the violation, and the status of measures taken to rectify the matter (e.g., disposal) were published as identified.
 For imported foods that were identified to be in violation of the Act during inspection at the time of importation yet had already passed customs, the relevant importer was instructed to promptly recall such imported foods in cooperation with the relevant prefectural governments.
 When imported foods already on the domestic market were identified to be in violation of the Act during inspections by prefectural governments, the inspection system at the time of importation was enhanced as necessary (Table 15).