FAMIC

Incorporated Administrative Agency

Food and Agricultural Materials
Inspection Center

2021 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 at
agricultural 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 OIE

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 or
notification.

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.

Table 1. Achievement of Fertilizer Registration Application Review
FY 2021
Number of Fertilizer Registration Application Reviews Reported to MAFF

569

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

1,396

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

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

Table 2. Achievement of Fertilizer Manufacturer On-Site Inspection
FY 2021
Number of Fertilizer Manufacturer On-Site Inspections
out of which Technical Advice was Provided
Number of Collected and Analyzed Samples

198
29
122

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 Conducted
for Establishing Official Fertilizer Standards
FY 2021
Number of Surveys
Conducted for Official
Fertilizer Standards

No Request Received
from MAFF

Cultivation test

On-site inspections of soil improvement materials
Under the Soil Fertility Enhancement Act,FAMIC conducts on-site inspections of
manufacturing sites of soil improvement
materials, as well as their products, rawmaterials, and account books.
FAMIC also confirms if the labeling of soil
improvement materials is appropriate.

Table 4. Achievement of On-Site Inspections of Soil Improvement Materials
FY 2021
Number of On-Site Inspections

21
out of which Technical Advice was Provided

Number of Collected and Analyzed Samples

795

Agricultural Chemicals
Supervision
Although agricultural chemicals are indispensable forstable agricultural production, chances of their negative
impact on human health and the environment cannot be
ruled out.
In Japan, agricultural chemicals are regulated by the
Agricultural 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 2021
Number of Agricultural Chemicals
Registration Application Review

For Reference Value Setting

427

For Non-Reference Value Setting

1,327

For Re-evaluation

186

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

We confirm their production records andother related documents. In addition, we
also inspect the quality and labels of the
products collected from the sites.

Table 6. Achievement of Agricultural Chemicals Manufacturer On-Site Inspection
FY 2021
Number of On-Site Inspections of Agricultural Chemicals Manufacturers

48

Number of Collected and Analyzed Samples

8

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).

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

Table 7. Achievement of GLP Inspections
FY 2021
Number of Laboratories Subject to GLP Inspection

17

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

Table 8. Details of Surveys on the Use andResidue Levels of Agricultural Chemicals
FY 2021
Number of Samples Tested for
Residue Levels of Agricultural
Chemicals

478

Fruit and Vegetables

388

Rice and Wheat

90

Scene of Residual Agricultural Chemical Analysis

8Feed and Feed Additives
Supervision
The safety and quality of feed and feed additives are
ensured by the Feed Safety Act in order to prevent the
production 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 offeed and 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 theamount of 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 2021
Number of On-Site Inspections

280

Number of Collected and Analyzed Samples289

out of which Technical Advice was Provided

1

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

Table 10. Number of BSE-Prevention-Related
On-Site Inspections
FY 2021
Based on MAFF Ordinance

63

Based on MAFF Notification

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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 by
MAFF 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. Achievement of on-Site Inspections of Pet Food Manufacturers/Importers
FY 2021
Number of On-Site Inspections

61

Number of Collected and Analyzed Samples

110

out of which Technical Advice was Provided

0

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Official assay of feed additives
Manufacturers and importers of specified
feed additives such as antibiotics are
obliged 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.

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

Table 12. Achievement of Official Assays Conducted for Feed Additives
FY 2021
Number of Official Assays Conducted for Feed Additives

68

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. Achievement of GMP
Conformity Assessment
FY 2021
Number of GMP
Conformity Assessment

97

On site survey for conformity check11

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

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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.

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

Table 14. Achievement of Food Labeling Surveillance
FY 2021
Number of On-Site Inspections instructed by MAFF

26

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

2

Number of Scientific Inspections of Food Labeling

6,153※

out of which place-of-origin cases

2,502

out of which GM food cases259※Of the total number of scientific inspections of food labeling, 127 were dubious.

Identifying place of origin of food ingredients using DNA analysis

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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 to
the 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.

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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 researches and studies
related to review of the standards.

Table 15. Contribution to JAS
FY 2021
Cases where FAMIC Drafted New or Revised Version of JAS Standards

18

Participation in Organic Equivalency Discussions

1 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-site
assessments) are conducted based on therequirements of ISO/IEC 17011.

Table 16. Achievement of Inspections of JAS Accredited Certification Bodies and Testing
Business Operators
FY 2021
Number of Surveys for Accreditationof Certification Bodies and Testing
Business Operators

Survey for Accreditation & Renewal

54

Survey for Changes

148

Number of Inspections Based on JAS
Act

Number of On-Site Surveys for
Accredited Certification Bodies

78

Number of Surveys for Accredited
Certification Bodies in Foreign Countries

11

Number of Competence Surveys for
Accredited Certification Bodies

431

Test Report

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

A
Types of JAS Marks:(A) General JAS (B) Organic JAS

B(C) Specific JAS

CD(D) Testing Method JAS

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FAMIC’s Accreditation Service
Japan 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 2021
Number of Assessment of Certification Bodies or Testing Organizations

6

Promotion 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 2021
Number of Surveys for Accreditation of
Certifying Bodies

Survey for Accreditation & Renewal

2

Survey for Changes

816Analysis of Chemical Hazards to Facilitate
Food Safety Risk Management
Risk management is an approach taken by MAFF to
improve 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/Monitoring
Program” of MAFF, we conduct analyticaltests of traces of chemical hazards such as
heavy metals and mycotoxins in agricultural

foods and feeds for their risk management,
and report the results to MAFF.

Table 19. Analytical Tests Conducted for Surveillance and Monitoring
FY 2021
Number of Tested Items

968
Mycotoxins in Wheat and Barley968

Buckwheat

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）

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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 to
ISO 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
SafetyISO/TC89/SC3

Plywood

ISO/TC218

TimberTable 20. Achievement in International- Standard-Related Activities
FY 2021
Number of ISO Japanese Mirror Committee Meetings Convened

3

Number of ISO Projects FAMIC is Participating in Their Development
and/or Revision26

out of which Already Published as ISO Documents

10

Number of Participated ISO Meetings (incl. Web Meetings)

26 Times

Participation in Codex Japanese Meeting

11 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 on
Pesticide Residue (CCPR) to work on theestablishment of maximum residue limits(MRLs) of pesticides in foods and animal feed.

FY 2021・FAMIC reviewed the draft of OECD
Guidance Document on Agricultural
Chemicals from the technical viewpoint, andforwarded the result to MAFF in FY 2021.
・FAMIC fielded two staff members to theOECD GLP working group meeting.
・Other two FAMIC staff members
participated in a meeting to consider theinternational harmonization of biologicalpesticide testing requirements in OECD
Expert Group of Bio-Pesticide (EGBP).

Meeting of OECD Working Group on GLP

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 chemicals residue analysis in Ethiopia
FY 2021
Requests from MAFF or other organizations to assign FAMIC staff orreceive trainees from foreign countries

Received two trainees
from foreign countries

Note : FAMIC, received two requests from international organizations for lending digital video materials to
introduce FAMIC activities in online lectures to overseas participants, to which FAMIC consented.

Collaborating Centre for OIE
FAMIC has been designated as theworld’s first Collaborating Centreof the World Organization for
Animal Health (OIE) in the fieldof feed safety and analysis, andhas been contributing to theiractivities through the provision ofexpertise, and supporting thedevelopment of standards in thefield of animal feed safety andanalysis.

FY 2021
・Two English articles, Summary of “Research
Report of Animal Feed” and “General Tests for Feed
Additives”, have been posted on FAMIC website
since Sep. 2021 and March 2022 each. In addition,
provisional English translation of MAFF Ordinance on
Specifications and Standards of Ingredients for Feedand Feed Additives has also been posted.
・FAMIC prepared and submitted the Annual Report
2021 to OIE headquarters.
・FAMIC convened the 3rd OIE Regional Workshop
on Animal Feed Safety / FAMIC Virtual Training on
Heavy metals (November 26) online with the OIE
Asia-Pacific Office.
・In addition, FAMIC provided lectures on antibiotic
analysis in feedstuffs and other topics in an online
training program based on the Japan-Thailand
Economic Partnership Agreement.

The 3rd OIE Regional Workshop on Animal Feed Safety/
FAMIC Virtual Training on Heavy Metals

21

Others

赤かび病の発生した小麦（農林水産省ウェブサイトから）

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Communicating the information of food and agricultural materials
FAMIC 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 FAMIC’s work outlines to them.
public relations magazine and mailmagazine.
Table 21.

Information Service
FY 2021

Information Provision through Website, etc.

478,161 Accesses

Assignment of Lecturers in Response to Requests from
Businesses, etc.

49 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 the
purpose 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 2021

Participation in External Proficiency Tests

10 Times

FAMIC maintained the following laboratory accreditation in FY 2021:· 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 Feed
Analysis Standard

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FAMIC Poster Children
Close trio from Saitama City

FAM

AMI MIC

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

FAM

MIC
AMI

Height: 7 cm
Weight: As light as feathers/FAMIC Official Facebook

FAMIC Official YouTube channel

Image Source: Pixta