Regulations and Guidelines on Human Health Products in Japan
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Yoshitada Yoshioka Faculty of Education and Welfare Science, Oita University, Oita, Japan
Key Words Chemical Substances Control Law; Pesticide Control Act; Drugs, Cosmetics, and Medical Instruments Act; Ecotoxicological assessment Correspondence Address Yoshitada Yoshioka, Faculty of Education and Welfare Science, Oita University, 700 Dannoharu, Oita 870–1192, Japan (e-mail: [email protected]).
Regulations and Guidelines on Human Health Products in Japan
INTRODUCTION Japan has learned much from the experiences of Minamata disease, itai-itai disease, Yusho, asthmatic caused by SO2, and so on. These incidents showed that chemical pollution could lead to serious health and environmental damage if not controlled. Itai-itai disease was caused by cadmium, with softening of the bones and kidney failure. Cadmium was released into the Zintu River from mining companies. The river water was used for irrigation of rice fields, drinking, washing, fishing, and so on. Cadmium accumulated in people through contaminated food, and 184 victims have been legally recognized since 1967. In 1992, the average annual health expense compensation was US $6.8 million, and agricultural damage was compensated with US $16 million per year. Another US $5.6 million was invested annually to reduce further pollution of the river. The first patient with Minamata disease was reported as an individual suffering from neurological symptoms of unknown cause in 1956. Patients were also reported in the Agano River basin in northern Japan in 1965. The disease is caused by methyl mercury compound, which poisons the central nervous system. Methyl mercury compound accumulated in fish and shellfish through the food chain. Consequently, the disease occurred when inhabitants ate a large
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Following a short history of chemical disasters in Japan, the chemical management system is reviewed. Three kinds of products (general chemicals, agricultural chemicals, and veterinary medical products [VMPs]) are and will be regulated for the environmental safety in Japan. The regulation of pharmaceutical products is discussed, and the procedure can be similar to that for general chemicals.
amount of these foods. About 3,000 persons were certified by the end of 2005, and more than 3,000 persons have requested certification. The direct total payment to the certified patients amounted to approximately US $13 billion by March 2001. A mass poisoning, the so-called Yusho incident, occurred in western Japan in 1968 because of cooking oil accidentally contaminated by heat-degraded polychlorinated biphenyls (PCBs), which also contained polychlorinated dibexo-p-dioxin (PCDDs) and polychlorinated dibenzofuran (PCDFs). About 14,000 persons were estimated to be affected, but only 1,860 persons were certificated as affected. PCBs are persistent organic pollutants, and the environmental transport of PCBs is complex and global. These historical incidents affected the Japanese policy of chemical regulation. Japan enacted the Law Concerning the Examination and Regulation of Manufa
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