FAMIC
Incorporated Administrative Agency

Food and Agricultural Materials
Inspection Center

2022 ANNUAL REPORTCONTENTS
03 Fertilizer and Soil Improvement Materials Supervision
・Review of applications for fertilizer registration
・On-site inspections of fertilizer manufacturers
・Setting official fertilizer standards
・On-site inspections of soil improvement materials

06 Agricultural Chemicals Supervision

・Evaluation of agricultural chemicals for registration
・On-site inspections of agricultural chemicals manufacturers
・GLP inspection of test facilities
・Surveys on the current status of use and residue levels of agricultural chemicals atagricultural production sites

09 Feed and Feed Additives Supervision・On-site inspections of feed and feed additives manufacturers and importers
・Work related to prevention of BSE
・On-site inspections of pet food manufacturers and importers
・Official assay of feed additives
・Confirmation of GMP conformity of feed and feed additives

12 Food Labeling Surveillance・Food labeling surveillance

14 Contribution to Japanese Agricultural Standards

・Development of JAS (enactment, amendment, confirmation, abolishment)
・Assessment of accredited certification bodies
・FAMIC’s Accreditation Service
・Promotion of Export of Agricultural, Forestry and Fishery Products and Food

17 Analysis of Chemical Hazards to Facilitate Food Safety Risk Management
・Analysis for risk management

19 International Relations Work・National mirror committee for ISO
・International effort on the proper management of agricultural chemicals
・International cooperation
・Collaborating Centre for WOAH

22 Others

・Communicating the information of food and agricultural materials
・Ensuring Reliability

Fertilizer and Soil Improvement
Materials Supervision
The safety and quality of fertilizers are ensured by “theAct on the Quality Control of Fertilizer” in order toprovide safe agricultural products stably.
FAMIC implements various operations related to the Act
under the directions of Ministry of Agriculture, Forestry
and Fisheries (MAFF).

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Review of applications for fertilizer registration
The production, imports, and sales offertilizers are allowed only after theapproval of the relevant registration ornotification.

Table 1.

FAMIC reviews applications for theregistration submitted by manufacturers,and conducts laboratory analyses and fieldtests on sample fertilizers in order todetermine whether they meet the standards
required by the Act.

Achievement of Fertilizer Registration Application Review
FY 2022

Number of Fertilizer Registration Application Reviews Reported to MAFF

693

Number of Inquiries Received regarding Change of Raw Materials or Production
Processes

1,317

On-site inspections of fertilizer manufacturers
FAMIC conducts on-site inspections offertilizer manufacturerʼs facilities such as
plants and storehouses to examine theirproduction records and other documents.
Table 2.

We also collect fertilizer samples frommanufacturers in order to analyze anddetermine whether they meet the standards
required by the Act.

Achievement of Fertilizer Manufacturer On-Site Inspection
FY 2022

Number of Fertilizer Manufacturer On-Site Inspections
out of which Technical Advice was Provided
Number of Collected and Analyzed Samples

223
29144

Sampling of fertilizer at on-site inspection

4Setting official fertilizer standards

FAMIC confirms the safety and efficacy
of fertilizers for providing scientificfindings, necessary for establishing new
official standards or revising existing ones.

Table 3. Achievement of Surveys Conductedfor Establishing Official Fertilizer Standards
FY 2022
Number of Surveys
Conducted for OfficialFertilizer Standards

No Request Receivedfrom MAFF

Cultivation test

On-site inspections of soil improvement materials
Under the Soil Fertility Enhancement Act,FAMIC conducts on-site inspections ofmanufacturing sites of soil improvement
materials, as well as their products, raw

Table 4.

materials, and account books.
FAMIC also confirms if the labeling of soil
improvement materials is appropriate.

Achievement of On-Site Inspections of Soil Improvement Materials
FY 2022

Number of On-Site Inspections

26
out of which Technical Advice was Provided

Number of Collected and Analyzed Samples

5165

Agricultural Chemicals
SupervisionAlthough agricultural chemicals are indispensable forstable agricultural production, chances of their negative
impact on human health and the environment cannot beruled out.
In Japan, agricultural chemicals are regulated by theAgricultural Chemicals Regulation Act so that only thoseeffective on plant pests and diseases and safe for humans
and the environment, if applied in accordance with thelabel instructions, are manufactured, sold and used.
FAMIC provides various services related to the Act under
the directions of MAFF.

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Evaluation of agricultural chemicals for registration
The manufacture and import of agriculturalchemicals are permitted only after theapproval for the relevant registration.
FAMIC reviews applications for theregistration of agricultural chemicals underthe Act.
The application data include test results ofthe efficacy/phyto-toxicity of agriculturalchemicals, as well as residues in/on crops,
the toxicity to humans and animals, andeffects on the environment.

FAMIC also gathers scientific knowledge
and information on safety evaluation ofagricultural chemicals in order to improve
the review process as necessary.
All registered agricultural chemicals shall bereassessed at certain intervals in the light ofthe most up-to-date scientific knowledge
and information.

Table 5. Achievement of Registration Application Review of Agricultural Chemicals
FY 2022
Number of Agricultural Chemicals
Registration Application Review

For Reference Value Setting

415

For Non-Reference Value Setting

1,127

For Re-evaluation

784

On-site inspections of agricultural chemicals manufacturers
FAMIC conducts on-site inspections ofmanufacturing plants of agriculturalchemicals.

Table 6.

FAMIC confirms their production records
and other related documents. In addition,
FAMIC also inspects the quality and labelsof the products collected from the sites.

Achievement of Agricultural Chemicals Manufacturer On-Site Inspection
FY 2022

Number of On-Site Inspections of Agricultural Chemicals Manufacturers

48

Number of Collected and Analyzed Samples

6

Reception of application for registrationof agricultural chemicals

Complete set of application documents
and related test results

7

GLP inspection of test facilities
The Japanese government adheres to theGood Laboratory Practice (GLP) principles
established by the Organization for
Economic Cooperation and Development(OECD).
Table 7.

FAMIC is the responsible authority for
GLP compliance monitoring program ofagricultural chemicals in Japan.

Achievement of GLP Inspections
FY 2022

Number of Laboratories Subject to GLP Inspection

24Surveys on the current status of use and residue levels of agricultural chemicals atagricultural production sites
FAMIC conducts surveys on the current
status of agricultural chemical use andtheir residue level in/on agricultural
products collected at production sites.

Table 8. Details of Surveys on the Use andResidue Levels of Agricultural Chemicals
FY 2022
Number of Samples Tested forResidue Levels of AgriculturalChemicals

469

Fruit and Vegetables379

Rice60

Tea30

Scene of Agricultural Chemical Residue Analysis

8Feed and Feed Additives
Supervision
The safety and quality of feed and feed additives areensured by the Feed Safety Act in order to prevent theproduction of harmful livestock products that may cause
health problems due to the use of unsuitable feed etc.
FAMIC implements various operations related to the Act
under the directions of MAFF.

9On-site inspections of feed and feed additives manufacturers and importers
FAMIC conducts on-site inspections of feedand feed additives manufacturers andimporters, and examines their production /import records and other documents toconfirm if they are produced in accordancewith the standards and the guidelines
established by MAFF. FAMIC also collects
samples of feed and feed additives forlaboratory analyses to confirm if the amountof feed additives and harmful substances is
kept at the defined level.
Table 9.

Number of On-Site Inspections of Feed/Feed Additives Manufacturers/Importers
FY 2022

Number of On-Site Inspections

304

Number of Collected and Analyzed Samples

292

out of which Technical Advice was Provided

1

Work related to prevention of BSETable 10. Number of BSE-Prevention-Related
On-Site Inspections

FAMIC also conducts on-site inspectionsof manufacturers of animal-derived feed
ingredients for the purpose of preventing
Bovine Spongiform Encephalopathy(BSE).

FY 2022
Based on MAFF Ordinance93

Based on MAFF Notification33

On-site inspections of pet food manufacturers and importers
Under the Pet Food Safety Act, FAMIC
conducts on-site inspections of pet food
manufacturers and importers to examine
their related documents such as
production records and import records,and confirms if their products are inconformity with the standards set byMAFF and the Ministry of theEnvironment.
FAMIC collects samples of pet food toconfirm if the amount of additives andharmful substances is kept at the definedlevel.

Table 11. Number of On-Site Inspections of Pet Food Manufacturers/Importers
FY 2022
Number of On-Site Inspections

65

Number of Collected and Analyzed Samples

107

out of which Technical Advice was Provided010

Official assay of feed additives
Manufacturers and importers of specified
feed additives such as antibiotics areobliged to take an official assay conductedby FAMIC before they offer their products
to the market. They will be exempted fromthe assay only if their manufacturing
facilities have been registered by MAFF.
Table 12.

In response to the applications from feedadditives manufacturers, etc., FAMIC
conducts lot-based inspections and provides
verification stickers to conforming additives.

Number of Official Assays Conducted for Feed Additives
FY 2022

Number of Official Assays Conducted for Feed Additives

101

Titer testing of antibiotic agents

Confirmation of GMP conformity of feed and feed additives
In response to applications frombusinesses such as feed production,FAMIC confirms the compliance of feeds
with GMP guidelines by on-site
inspections, and issues confirmation
certificates if their conformity is verified.

Table 13. Number of GMP Conformity
Assessment
FY 2022
Number of GMP
Conformity Assessment

107

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Food Labeling Surveillance

The Food Labeling Act requires that all the food products
on sale carry the proper food labeling according to theFood Labeling Standards.
Making use of scientific technology, FAMIC closely
monitors food labeling in cooperation with MAFF.

12

Food labeling surveillance
FAMIC conducts scientific inspections onquestionable food items, in response to theadvice from consumers, to verify theauthenticity of descriptions of labeling.
The inspection methods include DNA
analysis, element analysis, and stable
isotope ratio analysis, etc. with reference tothe label-described place of origin of food,species and variety of ingredients.

Table 14.

In the case of high possibility of false
labeling, on-site inspections will beconducted by FAMIC under the instructionof MAFF.
FAMIC also develops the technologies fordetermining the geographical origin ofingredients in collaboration with research
institutions.

Achievement of Food Labeling SurveillanceFY 2022

Number of On-Site Inspections instructed by MAFF

27

Number of Voluntary On-Site Inspections at the Request of MAFF

14

Number of Scientific Inspections of Food Labeling

5,822※

out of which place-of-origin cases

2,643

out of which GM food cases

254※Of the total number of scientific inspections of food labeling, 115 were dubious.

Identifying place of origin of food ingredients using DNA analysis

13

Contribution to Japanese
Agricultural Standards
In the "JAS (Japanese Agricultural Standard) system"
based on the JAS Act, JAS marks can be put on
agricultural, forestry and fishery products conforming tothe JAS.
Businesses that want to display the JAS mark must obtainconfirmation from accredited certification bodies that they
comply with the standard. Producers and manufacturers
can propose standards related to their business to MAFF
in the system. In addition to the spread of JAS system,
FAMIC conducts various tasks related to the system.

14

Development of JAS (enactment, amendment, confirmation, abolishment)
FAMIC encourages producers andmanufacturers to propose ideas for JAS.
The JAS are to be reviewed within five
years after their enactment or previous

review in order to meet the changing needsof society.
FAMIC conducts and supports researches
and studies related to review of the JAS.

Table 15. Contribution to JAS
FY 2022
Cases where New or Revised Version of JAS were Drafted

47

Participation in Organic Equivalency Discussions

0 Country

Assessments of accredited certification bodies
FAMIC conducts assessments ofapplications submitted by domestic andoverseas organizations seeking foraccreditation as certification bodies, andreassessments of accredited certification
bodies.

In addition, FAMIC audits their postaccreditation performance.
The assessments and audits (e.g. document
assessments, witnessing, on-siteassessments) are conducted based on therequirements of ISO/IEC 17011.

Table 16. Achievement of Inspections of JAS Accredited Certification Bodies and Testing
Business Operators
FY 2022
Number of Surveys for Accreditationof Certification Bodies and Testing
Business Operators

Survey for Accreditation & Renewal

42

Survey for Changes

124

Number of Inspections Based on JAS
Act

Number of On-Site Surveys for
Accredited Certification Bodies

73

Number of Surveys for Accredited
Certification Bodies in Foreign Countries

12

Number of Competence Surveys for
Accredited Certification Bodies

419

Test Report・ Lutein in spinach○○○mg/kg・ Lycopene in raw tomato○○○mg/kg

A

B

Types of JAS Marks:(A) General JAS (B) Organic JASC(C) Specific JAS

D(D) Testing Method JAS15

FAMICʼs Accreditation ServiceJapan Accreditation Service for agriculture,
forestry and fisheries (JASaff) accredits
certification bodies and testing laboratories
in the field of agriculture, forestry andfisheries complying with ISO/IEC 17011.
Table 17. Achievement of JASaff Accreditation
FY 2022
Number of Assessment of Certification Bodies or Testing Organizations

6Promotion of Export of Agricultural, Forestry and Fishery Products and Food
The Act on Facilitating the Export ofAgricultural, Forestry, and Fishery Products
and Food plays a key role in the export ofthose products from Japan.
Based on the Act, FAMIC assesses(evaluates) applications submitted byorganizations that seek for accreditationand their renewal.

In addition, FAMIC audits their postaccreditation performance throughdocument assessments, witnessing and onsite inspections.

Table 18. Achievement of Inspection of Registered Certifying Bodies under the Act on
Facilitating the Export of Agricultural, Forestry, and Fishery Products and Food
FY 2022
Number of Surveys for Accreditation ofCertifying BodiesSurvey for Accreditation & Renewal

1

Survey for Changes

28

16Analysis of Chemical Hazards to Facilitate
Food Safety Risk Management
Risk management is an approach taken by MAFF toimprove food safety and ensure consumers' healthprotection from chemical and microbiological hazards infood.
As an accredited testing laboratory under ISO/IEC 17025
for chemical hazard analysis, FAMIC conducts
internationally reliable analytical tests and reports theresults to MAFF.

Photo from MAFF

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Analysis for risk management
Based on the “Surveillance/MonitoringProgram” of MAFF, we conduct analyticaltests of traces of chemical hazards such as
heavy metals and mycotoxins in agricultural
Table 19.

products and feed for their risk
management, and report the results toMAFF.

Analytical Tests Conducted for Surveillance and Monitoring
FY 2022

Number of Tested Items

907
Mycotoxins in Wheat and Barley892

Pyrrolizidine Alkaloids in Echinacea

15

Analysis by using LC-MS-MS

18

International Relations WorkFAMIC serves as a national mirror committee forInternational Organization for Standardization (ISO).
We implement operations related to international
harmonization of registration systems for agriculturalchemicals.
Furthermore, we provide international cooperation toforeign countries.

赤かび病の発生した小麦（農林水産省ウェブサイトから）

19National mirror committee for ISO
As a national mirror committee for theTechnical Committees (TC) and Sub
Committees (SC) of ISO shown in the table,
FAMIC incorporates Japanese perspective
and comments to have them reflected toISO standards. We also attend meetings as
a part of the Japanese delegation.

ISO/TC34

Food Products

ISO/TC34/SC10

Animal Feeding Stuffs

ISO/TC34/SC12

Sensory Analysis

ISO/TC34/SC16

Horizontal Methods for Molecular
Biomarker Analysis

ISO/TC34/SC17

Management Systems for Food Safety

ISO/TC89/SC3Plywood

ISO/TC218

TimberTable 20. Achievement in International- Standard-Related Activities
FY 2022
Number of ISO Japanese Mirror Committee Meetings Convened

2

Number of ISO Projects FAMIC is Participating in Their Development
and/or Revision33

out of which Already Published as ISO Documents

10

Number of Participated ISO Meetings (incl. Web Meetings)

26 Times

Participation in Codex Japanese Meeting

12 Times

International effort on the proper management of agricultural chemicals
FAMIC participates in OECD meetings andcontributes to the international harmonizationof registration systems for agriculturalchemicals.
We also take part in the Codex Committee onPesticide Residue (CCPR) to work on theestablishment of maximum residue limits(MRLs) of pesticides in foods and animal feed.

Meeting of OECD Working Group on GLP

FY 2022
・FAMIC reviewed the draft of OECD GuidanceDocument on Agricultural Chemicals from technicalviewpoints, and forwarded the result to MAFF in FY
2022.
・Two FAMIC staff members attended the 36th and37th OECD GLP Working Group meetings to exchange
views on international harmonization of the GLP.
・FAMIC fielded two staff members to the 6th meetingof OECD Expert Group on Biopesticide (EGBP), sixstaff members to the Special Meeting, and two staff
members to the 7th meeting to discuss issues related tointernational harmonization of testing requirements forbiopesticides.
・In addition, a FAMIC staff participated in FAO/WHO
Joint Meeting on Pesticide Residues (JMPR) in 2022 toprepare a pesticide evaluation report and to consider
international pesticide residue standards.
・In FY 2021, FAMIC examined the OECD-prepareddraft Guidance Document from technical perspectives,and submitted the result to MAAF.
・FAMIC fielded two staff members to the OECD GLP
Working Group meeting.
・In addition, two staff members participated in thediscussion in OECD EGBP (Expert Group onBiopesticides) on the issue of international
harmonization of testing requirements for biopesticides.

20International cooperation
In response to the requests from MAFF,etc., FAMIC sends its staff overseas astechnical experts, and receives trainees
from foreign countries.

Technical support for agricultural chemical residue analysis in Cambodia

FY 2022
Requests from MAFF or other organizations to assign FAMIC staff orreceive trainees from foreign countries

Received trainees fromforeign countries fivetimesCollaborating Centre for WOAHFY 2022

FAMIC has been designated as the worldʼsfirst Collaborating Centre of the World
Organization for Animal Health (WOAH)
in the field of feed safety and analysis, andhas been contributing to their activities
through the provision of expertise, andsupporting the development of standards
in the field of animal feed safety andanalysis.

In FY2022, FAMIC published the summary of its
feed research reports as well as test results ofspecified feed additives in Japanese and English
on its website. In addition, FAMIC sequentiallyproceeded with English translation of MAFF’s
Ordinances on Ingredient Standards for Feed andFeed Additives, etc., and posted them on FAMIC’swebsite.
FAMIC summarized its activities in 2022 in anannual report, and submitted it to WOAH.
FAMIC Virtual Training on Pesticides in Feed washeld online, on February 1, 2023, in collaboration
with the WOAH Asia-Pacific Regional Office. In
connection with the training, we conducted aquestionnaire survey on the pesticides analyzed in
the participating countries in WOAH laboratorynetwork.

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Others

22

Communicating the information of food and agricultural materialsFAMIC provides the information of food,We also accept visitors for our guided
fertilizers, agricultural chemicals and feedfacility tours throughout the year, andvia seminar, website, telephone consultation, introduce FAMICʼs work outlines to them.
public relations magazine and mailmagazine.
Table 21.

Information Service
FY 2022

Information Provision through Website, etc.

481,377 Accesses

Assignment of Lecturers in Response to Requests fromBusinesses, etc.

61 Assignments

Organization of Seminars, etc.

17 Times

Ensuring Reliability
Based on the concept of ISO/IEC 17025,
FAMIC adheres to the inspection andtechnical management conformed to thestandard documents.
FAMIC has established the quality
assurance system appropriate for thepurpose of its analysis work.
Table 22.

Furthermore, in order to ensure theviability of such system, FAMIC has beenworking on the application for the third
party accreditation of ISO/IEC 17025 andthe self-declaration of conformity by
FAMIC itself.

Ensuring FAMIC’s Inspection and Analysis Reliability
FY 2022

Participation in External Proficiency Tests

11 Times

FAMIC maintained the following laboratory accreditation in FY 2022:· LC-MS/MS-Based Quantification Test of Fusarium Toxins in Wheat and Barley· Qualitative Test of Recombinant DNA in Soybeans and Soybean-Processed Products· Quantitative Test of Mycotoxins (16 Varieties) in Corn by LC-MS/MS· Detection Test of Mammal-Derived DNA, Ruminant-Derived DNA, Bovine-Derived
DNA, Cervid-Derived DNA in Feed using Thermal Cycler based on Chapter 16 of FeedAnalysis Standard

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FAMIC Poster Children
Close trio from Saitama CityFAM

AMI

MIC

They represent the image of FAMIC that ensures foodsafety and consumers’ reliance.

FAM

MIC
AMI

Height: 7 cmWeight: As light as feathers/FAMIC Official Facebook

FAMIC Official YouTube channel

Image Source: Pixta