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 the time of import notification
• Monitoring*1 (FY 2017 Plan: 97,509 cases)
• Ordered inspection*2 (As of April 1st, 2017: 17 items from all exporting countries, and 68 items from 31 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
• Providing technical support at exporting countries pertaining to food sanitation measures through dispatching specialists to the exporting countries, accepting trainees from governmental agencies of the exporting countries, etc.

• 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 stipulated by Article 4 of the Food Safety Basic Act that necessary measures for ensuring the safety of food shall be taken appropriately at each stage of the food supply process from production, manufacturing and processing in the exporting country, to post-import domestic distribution.

Examination of notifications using a computer system

 An 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 2017 was 2,430,070, and the weight of notified items was 33.75 million tons. Among these imported notifications, inspections were carried out on 200,233 cases, of which 821 cases (running total of 852) were confirmed to be in violation of the Act, and steps were taken for their reshipment, disposal, etc. These accounted for 0.03% of the number of notifications (Table 1).

 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 of each food type, ensuring the inspection number required to enable detection of violations to a certain degree of statistical reliability.
 In FY 2017, monitoring inspections were conducted for 54,088 cases (99,455 cases compared to the planned cumulative total of 97,509 cases (implementation rate: approximately 102%)), and of which, 140 cases (running total of 153 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, in order to grasp the management state of the exporting country, inspections were carried out by raising the inspection rate for the same exporting country and the same food type to 30% as necessary, and the monitoring system was changed to normal for cases where the possibility of foods in violation of the Act being imported is low (no cases of similar violation have been found after 1 year has elapsed since the date of starting the enhanced monitoring inspections or after carrying out inspections for at least 60 cases) (Table 3). Additionally, when a certain food of a certain country was found to be violating the Act multiple times pertaining to agricultural chemical residue or veterinary drug residue, 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). For foods in which chemicals feared to have adverse health effects (e.g., aflatoxin) were detected, inspection was immediately enhanced as subjects of ordered inspection (Table 5).
 Regarding the inspection of agricultural chemical residue 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 11,713 cases in FY 2017 and no violations were found.

 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 the provisions of Article 26, paragraph 3 of the Act for imported foods that are considered to have a high probability of violating the Act.
 As of March 31, 2018, 17 items from all exporting countries, and 72 items from 30 countries and 1 region were made subject to ordered inspection, and inspections were carried out for 59,477 cases (running total of 91,685 cases) in FY 2017. Of which, 228 cases (running total of 228 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, 461 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), 256 cases violated Article 6 (e.g., adhesion of hazardous or toxic substances such as aflatoxin), 66 cases violated Article 10 (use of undesignated additives), 25 cases violated Article 18 (standards for apparatus or containers and packaging), 14 cases violated Article 9 (absence of health certificates of meat), which relates to health certificates for meat, and 3 cases 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 were found in 220 cases (26.7%) (Table 8-1), violations relating to existence of hazardous or toxic substances and contamination with pathogenic microbes in 202 cases (24.5%) (Table 8-2), violations relating to the use of undesignated additives and criteria on the use of additives in 137 cases (16.6%) (Table 8-3), violations of standards on agricultural chemical residue in 91 cases (11.0%) (Table 8-4), violations relating to decay and deterioration (e.g., generation of unpleasant smell or mold) in 60 cases (7.3%) (Table 8-5), violations of standards on veterinary drug residues in 36 cases (4.4%) (Table 8-6), violations on standards of apparatus, containers and packaging in 25 cases (3.0%) (Table 8-7), and other violations in 54 cases (6.5%) (Table 8-8).

1. Violations of standards on microbes (Table 8-1)
 By country, the rankings were China with a running total of 81 cases (35.1%), followed by Vietnam with 38 cases (16.5%), and Thailand with 26 cases (11.3%). The principle item in violation in these cases were microbes (bacterial count, coliform bacteria, E. coli) as an index of contamination for frozen food with 177 cases (76.6%).

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 77 cases (37.9%), followed by China with 37 cases (18.2%) and Italy with 14 cases (6.9%). The principle violation in these cases was adhesion of aflatoxin to almonds, peanuts, pistachio nuts, etc. in the USA, adhesion of aflatoxin to peanuts in China, and detection of methanol in brandy and detection of cyanide in prepared seed and fruit products in Italy.
 The most common material responsible for these violations was aflatoxin in 160 cases (78.8%), followed by cyanide in 23 cases (11.3%), and radioactive materials in 8 cases (3.9%). By product, the rankings were peanuts (including processed peanut products) with 63 cases (31.0%), followed by almonds with 24 cases (11.8%), and pistachio nuts with 15 cases (7.4%).

3. Violations relating to the use of undesignated additives and criteria on the use of additives (Table 8-3)
 By country, the rankings were China with 21 cases (14.5%), followed by France with 18 cases (12.4%) and Spain with 15 cases (10.3). The principle violation was the use of cyclamic acid and excessive sulfur dioxide residues in China, the use of azorubine etc. in France, and excessive sulfur dioxide residue in Spain.
 The principle materials responsible for violations relating to the use of undesignated additives were coloring agents (azorubine, quinoline yellow, iron oxide (red), iron oxide (black), iron oxide (yellow), patent blue V, brilliant black BN) in 32 cases (43.8%), followed by TBHQ in 24 cases (32.9%), and cyclamic acid in 8 cases (11.0%). The principle materials responsible for violations of criteria on the use of additives were sulfur dioxide in 35 cases (48.6%), followed by sorbic acid in 11 cases (15.3%), and polysorbate in 6 cases (8.3%).

4. Violations of standards on agricultural chemical residue (Table 8-4)
 By country, the rankings were China with 24 cases (25.5%), followed by Venezuela with 12 cases (12.8%), and Ecuador with 8 cases (8.5%). The principle material responsible for violations was thiamethoxam in onions in China, and 2,4-D in cacao beans in Venezuela and Ecuador.
 By product, the rankings were cacao beans with 28 cases (29.8%), followed by sesame seeds and chili with 8 cases (8.5%).

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 25 cases (41.7%), followed by Thailand with 15 cases (25.0%), and Australia with 9 cases (15.0%). The principle product in violation in these cases was rice in the USA and Australia, and rice in all cases in Thailand.
 By product, the rankings were rice with 38 cases (63.3%), followed by wheat with 13 cases (21.7%), and soybeans and rapeseed with 3 cases (5.0%).

6. Violations of standards on veterinary drug residues (Table 8-6)
 By country, the rankings were Vietnam with 23 cases (62.2%), followed by India with 6 cases (16.2%), and South Korea with 4 cases (10.8%). The principle material responsible for violations in these cases was enrofloxacin in shrimp in Vietnam, furazolidone was responsible for all violations in shrimp in India, and oxytetracycline in flounder in South Korea.
 By product, the rankings were shrimp with 26 cases (70.3%), followed by processed bee larva products with 3 cases (8.1%) and flounder with 3 cases (8.1%).

7. Violations on standards on apparatus, containers and packaging (Table 8-7)
 By country, the rankings were China with 14 cases (56.0%), followed by Mexico with 2 cases (8.0%). By material, the principle material responsible for violations in these cases was synthetic resin.

8. Other violations (Table 8-8)
 The principle violations in other violation cases were absence of health certificates for beef etc. in 14 cases, mixing in of puffer fish not permitted for import in 8 cases, and violation of compositional standards for food additives in 8 cases.

 When the violation of the Act is at a considerable degree and deemed necessary for preventing 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), a request for improvement is made to the exporting country, etc., and investigations, etc., on the status of sanitation control in the exporting country are conducted for imported foods that exceed a 5% violation rate in the last 60 ordered inspections. As a result, in FY 2017, no foods were subject to such measures.

 Investigation into domestic distribution has been carried out, and appropriate measures including recalls of distributed goods and suspension of import notification were ordered and the monitoring system at the time of importation was enhanced after confirming a record of their import (Table 9), including possible contamination of cheese with Listeria monocytogenes in France, and possible contamination of hemoglobin powder with metal wire pieces in the Netherlands. Additionally, an inspection system related to genetically modified salmon for which safety has not been demonstrated was established for salmon from Canada, Panama and the USA, and one related to fipronil was established for chicken eggs etc. from EU member countries, South Korea and Taiwan. For Pueraria mirifica and Pueraria mirifica-containing food products, importers were requested to submit reports on the production control etc., and a guidance step to suspend import was taken when no report is submitted. The investigation was based on information on 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.

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 recurrence prevention measures have been established in South Korea for retort pouch food (potential microbe growth) and in France for soft and semi-hard type natural cheese (Listeria monocytogenes and enterohemorrhagic E. coli O103).
 For Paraguayan sesame seeds, as a result of the on-site inspection that was carried out in March 2017 in response to the cause unfolding and recurrence prevention measures on the agricultural chemical residue presented by the Paraguayan government, it was confirmed that a control system has been established for the Japan export verification program and, in July 2017, exporters registered by the Paraguayan government were made exempt from ordered inspections.
 For South Korean Oriental melon, as a result of the on-site inspection that was carried out in response to the cause unfolding and recurrence prevention measures on the agricultural chemical residues presented by the South Korean government, it was confirmed that a control system has been established for the Japan export verification program and exporters registered by the South Korean government were exempted from ordered inspections.
 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 residue, specialists were dispatched to carry out on-site inspections, etc., as necessary.
 For Canadian and American beef, observance of the Japan export verification program was confirmed by on-site inspections as a regular audit at facilities authorized for export to Japan.

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 2017, inspections were carried out for Taiwan, New Zealand and Belgium in 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, 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 the two countries.
 For FY 2017, a working-level consultation was held, and the Chinese side provided an explanation 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 residue and shellfish poison in bivalves, and agricultural chemical residue 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.
http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/yunyu_kanshi/exporter/index.html
^* Currently the General Administration of Customs

4. Technical cooperation
 In order to take measures against agricultural chemical residue in sesame seeds in Paraguay, long-term service specialists were dispatched.
 In order to provide support in establishing a system to swiftly gather and analyze information and to take measures for any food safety-related problems in Indonesia, long-term service specialists were dispatched.
 Additionally, the Ministry of Health, Labour and Welfare, quarantine stations, quarantine and inspection centers for imported foods, etc., accepted trainees from governmental agencies of exporting countries and provided explanations on the import food monitoring systems, etc., in Japan, and exchanged opinions.

 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).

 Regarding risk communication on the safety of foods, in February 2018 in Tokyo and Osaka, information was provided to consumers, food business operators, etc., about the situation of guidance on monitoring of imported foods, content of the Monitoring and Guidance Plan, etc., and opinions were exchanged.