What We Do
Mission
The FSCJ implements science-based risk assessment of food in an objective, neutral, and impartial manner to protect the health of the people. In addition, the FSCJ implements risk communication about the results of its risk assessments and scientific findings on food safety. To implement risk assessment separately from risk management*, the FSCJ was established as a part of Japan’s Cabinet Office in July 2003, independently from risk management organizations*.
*Ministry of Agriculture, Forestry and Fisheries (MAFF), Ministry of Health, Labour and Welfare (MHLW), Ministry of Environment (MOE), Consumer Affairs Agency (CAA)
Risk Assessment
FSCJ assesses risks to human health posed by microorganisms, chemicals, and others contained in food, on the basis of the scientific evidence. Its assessment is mainly conducted in response to requests from risk managers. FSCJ also carries out risk assessment on its own initiative when it finds it necessary to do so. It is called “self-tasking” risk assessment.
Standard Processing Period for Risk Assessment of the Effect of Food on Health Regarding Applications Submitted from Industries [October 4, 2022] [PDF]
Guidance on the Use of the BMD Approach in Risk Assessment by FSCJ [For toxicological data from experimental animal studies] [June 2022] [PDF]
Standards for Risk Assessment
<Food Additives>
- Guidelines for the Risk Assessment of Food Additives (Revised Guideline for Assessment of the Effect of Food on Human Health Regarding Food Additives) [April, 2024] [PDF]
- Guidelines for the Assessment of Flavoring Substances in Foods on Health [September 2021] [PDF]/ Food Safety
- Guidelines for the Risk Assessment of Additives (Enzymes) in Foods [September 2021] [PDF]
- Guidelines for the Risk Assessment of Food Additives for Fortification [September 2021] [PDF]
<Genetically modified foods>
- Standards for the Safety Assessment of Genetically Modified Foods (Seed Plants) [January 29, 2004] [PDF: 45KB]
- Stance on the Safety Assessment of GM Plants for Food Use [April 23, 2018] [PDF: 185KB]
- Stance on the Safety Assessment of GM Plants Generated through Cross-Breeding [January 29, 2004] [PDF: 59KB]
- Stance on the Safety Assessment of GM Plants Generated Through Cross-Breeding (Partial Revision) (Interpretation of the stacked GM plants that require safety assessments for “the time being” as defined in (1) a)) [Novermber 13, 2019] [PDF: 100KB]
- Standards for Safety Assessments of Food Additives Produced Using Genetically Modified Microorganisms [March 25, 2004] [PDF: 114KB]
- Stance on Safety Assessments of Additives Produced Using Genetically Modified Microorganisms, whose End Product is a Highly Purified Nonprotein Additive, such as Amino Acids (Supplementary Provisions of Standards for Safety Assessments of Food Additives produced Using Genetically Modified Microorganisms, Food Safety Commission Decision of March 25, 2004) [PDF: 35KB]
- Stance on Safety Assessments of Genetically Modified Feed and Feed Additives [May 6, 2004] [PDF: 88KB]
- Standards for the Safety Assessment of Genetically Modified Foods (Microorganisms) [June 26, 2008] [PDF: 148KB]
- Approach on the Safety Assessment of stacked events produced by cross-breeding of genetically modified plants in which the host metabolic systems are altered by the transgenes [December 22, 2017] [PDF: 100KB]
<Antimicrobial-resistant bacteria>
- Assessment guideline for the Effect of Food on Human Health Regarding Antimicrobial-Resistant Bacteria Selected by Antimicrobial Use in Food-producing Animals [September 30, 2004] [PDF]
- Ranking of the Importance of Antimicrobials against Bacteria which affect Human Health through Food Commodities [March 31, 2014] [PDF]
<Pesticide>
- Guideline for the assessment of the effect of pesticide residue in food on health [April 2024] [PDF]
- Assessment guide for “the assessment using reports by international/national risk assessment organization(s)” [October 2012] [PDF]
- Consideration on health effects of “Specified Agricultural Chemicals” in foods [June 27, 2013] [PDF]
- Guide for considering necessity of data on one-year dog study at toxicological evaluation of pesticide [December 21, 2017] [PDF]
- Interpretation of the liver hypertrophy in the toxicological evaluation of pesticides (agricultural chemicals) [October 31, 2016] [PDF]
- Guide for considerations on residue definitions for dietary risk assessments of pesticide residues [March 29, 2017] [PDF]
- Consideration on data required for re-evaluation (Article 8 of Agricultural Chemical Regulation Act) of pesticide residues [March 19, 2018] [PDF]
- Procedure for Risk Assessment of Agricultural Chemicals for which provisional standards are established [June 29, 2006] [PDF]
<Veterinary medicinal products>
- Guidelines for the Risk Assessment of veterinary medicinal products [April 2024] [PDF]
- Guidance on Risk Assessments of Veterinary Medicinal Products and Feed Additives for which the Provisional Standards are Established [January 23, 2023] [PDF]
- Guidance for assessment of additives to vaccines as veterinary medicinal products [November 7, 2017] [PDF]
- Interpretation of the liver hypertrophy in the toxicological evaluation of veterinary medicinal products [September 7, 2017] [PDF]
- Assessment guide for veterinary medicinal products with endocrinological activities [June 1, 2018] [PDF]
<Feeds, fertilizers, etc.>
- Guidance on Risk Assessments of Veterinary Medicinal Products and Feed Additives for which the Provisional Standards are Established [December 22, 2022] [PDF]
- Interpretation of the liver hypertrophy in the toxicological evaluation of veterinary medicinal products and feed additives [October 25, 2017] [PDF]
<Novel foods>
<Apparatus and containers / packages>
Research Program for Risk Assessment Study and Survey Program on Food Safety
FSCJ has implemented research and survey program to generate scientific evidence for improving risk assessment.
FSCJ has developed a road map, "Strategic direction for promoting research and survey to ensure food safety".
The roadmap defines overall research and survey directions for the next five years to seek effective and strategic approaches to ongoing research and investigation. Every fiscal year, the research and survey program is selected on a priority basis.
<Research Program for Risk Assessment on Food Safety>
Seven to eight programs are selected annually. Research period is approximately two years.
The research program is implemented to collect scientific evidence necessary for conducting risk assessment and developing assessment guidelines.
<Survey Program on Food Safety>
Four to six programs are selected annually.
The survey program is implemented to collect, organize and analyze the data and information necessary for the risk assessment.
Risk Communication
FSCJ implements various activities to communicate its risk assessment results as well as basic knowledge on food safety to the public. Details