FAMIC
Incorporated Administrative Agency

Food and Agricultural Materials
Inspection Center2020 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 “Act onthe Quality Control of Fertilizer” in order to provide safe
agricultural products stably.
FAMIC implements various operations related to the Act
under the directions of Ministry of Agriculture, Forestry
and Fisheries (MAFF).

3

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 from 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 2020

Number of Fertilizer Registration Application Reviews Reported to MAFF

709

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

1,626

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 2020

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

160
2493

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 2020
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 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 2020

Number of On-Site Inspections

26
out of which Technical Advice was Provided

Number of Collected and Analyzed Samples

5125

Agricultural Chemicals
Supervision
Although 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.

6

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 2020
Number of Agricultural Chemicals
Registration Application Review

For Reference Value Setting

502

For Non-Reference Value Setting

1,437

Number of Published Reports of Agricultural Chemicals Registration
Application Review

6

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

Table 6.

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

Achievement of Agricultural Chemicals Manufacturer On-Site Inspection
FY 2020

Number of On-Site Inspections of Agricultural Chemicals Manufacturers

40

Number of Collected and Analyzed Samples

8Reception 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 2020

Number of Laboratories Subject to GLP Inspection

22Surveys 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 2020
Number of Samples Tested for
Residue Levels of AgriculturalChemicals

393

Fruit and Vegetables

342

Rice51

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 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 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
Table 9.

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.

Number of On-Site Inspections of Feed/Feed Additives Manufacturers/Importers
FY 2020

Number of On-Site Inspections

244

Number of Collected and Analyzed Samples299

out of which Technical Advice was Provided0Work 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 2020
Based on MAFF Ordinance79

Based on MAFF Notification

43

On-site inspections of pet food manufacturers and importers
Under the Pet Food Safety Act, FAMIC
conducts on-site inspections of pet foodmanufacturers 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 2020
Number of On-Site Inspections

60

Number of Collected and Analyzed Samples

105

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.

Achievement of Official Assays Conducted for Feed Additives
FY 2020

Number of Official Assays Conducted for Feed Additives

133

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

Table 13. Achievement of GMP
Conformity Assessment
FY 2020
Number of GMP
Conformity Assessment

92

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 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 DNAanalysis, 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 be
conducted 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 Surveillance
FY 2020

Number of On-Site Inspections instructed by MAFF

23

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

3

Number of Scientific Inspections of Food Labeling

5,625

out of which highly dubious cases

86

out of which place-of-origin cases

2,489

out of which GM labeling cases

257

Identifying species 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 researches and studies
related to review of the standards.

Table 15. Contribution to JAS
FY 2020
Cases where FAMIC Drafted New or Revised Version of JAS Standards

16

Participation in Organic Equivalency Discussions

4 Countries

Assessments of accredited certification bodies
FAMIC conducts assessments ofapplications submitted from domestic andoverseas organizations seeking foraccreditation as certification bodies, andreassessments of accredited certification
bodies.
Table 16.

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.

Achievement of Inspections of JAS Accredited Certification Bodies
FY 2020

Number of Surveys for Accreditationof Certification Bodies

Accreditation & Renewal Survey

6Survey for Changes

318

Number of Inspections Based on JAS
Law

Number of On-Site Surveys for
Accredited Certification Bodies

68

Number of Surveys for Accredited
Certification Bodies in Foreign Countries

8

Number of Competence Surveys for
Accredited Certification Bodies

460

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 JASCD(D) Testing Method JAS15

FAMICʼs 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 2020
Number of Accreditation of Certification Bodies or Testing Organizations

4Promotion of Export of Agricultural, Forestry and Fishery Products and Food
The Act on Facilitating the Export ofAgricultural, Forestry, and Fishery Productsand Food plays a key role in the export ofthose products from Japan.
Based on the Act, FAMIC assesses(evaluates) applications submitted fromorganizations that seek for accreditationand their renewal.

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

Table 18. Achievement of Inspection of Registered Certifying Bodies under Act on Facilitating
the Export of Agricultural, Forestry, and Fishery Products and Food
FY 2020
Number of Surveys for Accreditation ofCertifying Bodies

Accreditation & Renewal Survey

5Survey for Changes

316Analysis of Chemical Hazards to Facilitate
Food Safety Risk Management
Risk management here is an approach taken by MAFF toprevent issues and accidents arising from harmful
chemical substances and/or microorganisms in food.
As an accredited testing laboratory under ISO/IEC 17025
for chemical hazard analysis, FAMIC conducts
internationally reliable analytical tests and report theresults to MAFF.

Photo from MAFF

17

Analysis for risk management
Based on the “Surveillance and Monitoring
Plan” of MAFF, we conduct analytical testsof traces of harmful substances 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 2020

Number of Tested Items

896
Mycotoxin in Wheat, Barley and Rye

Analysis by using LC-MS-MS

896

Created the Standard Procedure
for Aflatoxin Analysis in Job's tear

Created the Standard Procedure for Pyrrolizidine Alkaloids Analysis

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 FoodSafetyISO/TC89/SC3Plywood

ISO/TC218

TimberTable 20. Achievement in International- Standard-Related Activities
FY 2020
Number of ISO Japanese Mirror Committee Meetings Convened

1

Number of ISO Projects FAMIC is Participating in Their Development
and/or Revision41

out of which Already Published as ISO Documents

19

Number of Participated ISO Meetings (incl. Web Meetings)

20 Times

Participation in CODEX Japanese Meeting

3 TimesInternational 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.

FY 2020
・FAMIC reviewed the draft of OECD
Guidance Document on Agricultural
Chemicals from the technical viewpoint, andforwarded the result to MAFF in FY 2020.
・FAMIC fielded a staff to discuss thealteration of OECD GLP on-site inspection
schedule that had been necessitated by theCOVID-19 pandemic.
・Another FAMIC staff participated in ameeting to consider the international
harmonization of biological pesticide testing
requirements in OECD Expert Group of BioPesticide (EGBP).

Meeting of OECD Working Group on GLP20

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 2020
Requests from MAFF or other organizations to assign FAMIC staff orreceive trainees from foreign countries

No Requests Received

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

Collaborating Centre for OIE

FAMIC has been designated as theworldʼs first Collaborating Centreof the World Organization forAnimal 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 2020
・Two English articles, Summary of “Research Reportof Animal Feed” and “General Tests for Feed Additives”,
have been posted on FAMIC website since Nov. 2020
and March 2021 each. In addition, provisional English
translation of MAFF Ordinance on Specifications andStandards of Ingredients for Feed and Feed Additives
has been posted on FAMIC website.
・FAMIC prepared and submitted the Annual Report2020 to OIE headquarters. FAMIC also replied toinquiries from OIE regarding the FAMIC’s Five Year
Activity Plan 2020-2024 as OIE-Collaborating Centre,
which had been previously submitted.
・FAMIC carried out a questionnaire survey to collectthe feedback on the FAMIC-hosted technical workshop
from the participated Lab Network countries, aiming at
improved feed quality and safety in Asian region.
・FAMIC participated in the 3rd Regional Meeting for
OIE Reference Centres in Asia and the Pacific (Feb 2425, 2021), and made presentations on Lab Networkdevelopment.

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）

22

Communicating the information of food and agricultural materials
FAMIC provides the information of food,We also accept facility tours throughout thefertilizers, agricultural chemicals and feed
year and introduce FAMICʼs work outlines
via seminar, website, telephone consultation, and inspection facilities.
public relations magazine and mailmagazine.
Table 21.

Information ServiceFY 2020

Information Provision through Website, etc.

462,524 Accesses

Assignment of Lecturers in Response to Requests fromBusinesses, etc.

42 Assignments

Organization of Seminars, etc.

24 Times

Ensuring Reliability
Based on the concept of ISO/IEC 17025,
FAMIC adheres to the inspection andtechnical management conformed to thestandard documents.
FAMIC establishes the quality assurance
system appropriate for the purpose of eachanalysis 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 byFAMIC itself.

Ensuring FAMIC’s Inspection and Analysis Reliability
FY 2020

Participation in External Proficiency Tests

12 Times

FAMIC maintained the following laboratory accreditation in FY 2020:· 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

23FAMIC Poster Children
Close trio from Saitama CityFAM

AMIMIC

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

FAM

MIC
AMI

Height: 7 cm
Weight: As light as feathers

Image Source: Pixta