Ministry of Health, Labour and Welfare

Japanese

Procedure for Safety Assessment:
The safety assessment of foods and food additives produced by recombinant DNA techniques (hereafter GM foods) is mandatory under the Food Sanitation Law.  The Ministry of Health, Labour, and Welfare (MHLW) receives application, and the Food Safety Commission (FSC) evaluates the safety in terms of human health.

Procedure for Safety Assessment


<Transition of Safety Assessment of Foods Produced by Recombinant DNA Techniques>

(1)Enforcement under the Guideline (December 1991)
The World Health Organization (WHO), Organization for Economic Cooperation and Development (OECD), and other organizations have developed scientific guidelines for the development of safety assessments of foods and food additives produced by recombinant DNA techniques.  In 1991, the Ministry of Health and Welfare established "Guideline for Safety Assessment of Foods and Food Additives Produced by Recombinant DNA Techniques" based on these international guidelines.  On a voluntarily basis, the assessment of foods produced by recombinant DNA techniques began. The Food Sanitation Investigation Council assessed GM foods individually based on the Guideline.

[The assessment of the effects of genetically modified crops on the environment and safety assessments of such crops as feedstuff are carried out by the Ministry of Agriculture, Forestry and Fisheries.]

(2)Mandatory Requirement of the Safety Assessment (April 2001)
As the development of genetically modified foods and their commercial use have rapidly spread internationally and are expected to spread even further, the MHLW, the successor to the Ministry of Health and Welfare, decided to legally impose the safety assessment of genetically modified foods so that those that have not undergone safety assessments would not be distributed in the country.

Since April 1, 2001, the safety assessment of GM foods has been mandatory under the Food Sanitation Law.  It is forbidden to import or sell genetically modified foods or food products made from such foods that have not undergone safety assessment.

For related ordinances and announcements: http://www.mhlw.go.jp/english/topics/food/sec03.html

(3) Establishment of the Food Safety Commission (July 2003)
In July 1, 2003, the FSC was established in the Cabinet Office.  The safety evaluation of GM foods, which had been conducted by the Food Sanitation Investigation Council, has since been conducted by the FSC.

MHLW requests FSC to evaluate the safety of GM foods.  Within FSC, the Expert Committee of Genetically Modified Foods conducts safety assessments based on following standards and policies.

  (1)   Standards for the Safety Assessment of Genetically Modified Foods (Seed Plants)
  (2)   Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants
  (3)   Standards for the Safety Assessment of Food Additives Produced Using Genetically Modified Microorganisms
  (4)   Policies Regarding the Safety Assessment of Highly Purified Non-Protein Food Additives including Amino Acids Produced Using Genetically Modified Microorganisms

FSC website: http://www.fsc.go.jp/english/index.html

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