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| Agenda Item 6.1 | Conference Room Document 95 English only |
second fao/who global forum of food safety regulators
Bangkok, Thailand, 12-14 October 2004
(Prepared by Japan)
The situation surrounding eating habits in Japan has changed dramatically over the past 20 years. Japanese now enjoy diverse types of foods that come from all over the world. In addition, new technologies have been developed to generate novel types of foods, including genetically modified organisms and cloned animals.
Recently, several unfortunate events affecting food safety have occurred. These include the outbreak of BSE, O157 E.coli infection, the problem of pesticide residues on imported vegetables, and false labeling by large corporations. As a result of increased public awareness of such threats, food safety issues have become a growing concern to many people. Under such circumstances Japan has enacted the Food Safety Basic Law, a comprehensive law to ensure food safety for the purpose of protecting the health of the public, as well as has developed related laws. In the wake of the development of these laws, Japan has introduced a risk analysis approach to food safety work.
In July 2003, the Food Safety Basic Law became effective, which is a comprehensive law to ensure food safety by establishing basic principles, clarifying the responsibilities of national and local governments and food related businesses as well as consumers' roles, and establishing a basic direction for policy formulation in regards to the assurance of food safety. In principle, policies to ensure food safety must be formulated, revised, and repealed, based on the risk analysis approach. The risk assessment is under the responsibility of the Food Safety Commission, an administrative agency independent of the agencies that are responsible for risk management. The risk assessment must be based on the latest scientific knowledge.
The risk management organizations, such as the Ministry of Agriculture, Forestry and Fisheries (MAFF), and the Ministry Health, Labour and Welfare (MHLW) must establish food safety standards, based on risk assessment results, taking into account the opinions of interested parties, such as consumers. These agencies implement provisional risk management measures in a prompt and appropriate manner, when necessary from a preventive viewpoint.
Risk communication is conducted by the risk assessment and the risk management organizations. Responsible agencies should provide interested parties such as consumers with information on food safety and those agencies and parties should communicate each other on food safety issues.
In the wake of the Food Safety Basic Law, the Food Safety Commission was established in the Cabinet Office in July 2003. The Food Safety Commission is an organization that undertakes risk assessments, and is independent from risk management organizations. The Commission's primary goals are summarized into three main tasks:
The Food Safety Commission is headed by seven commission members who are experts in toxicology, microbiology, chemicals, organic chemistry, hygiene and public health, food production and distribution systems, consumer awareness and information exchanges. Under the commission, the 16-Expert Committees have established.
The Ministry of Health, Labour and Welfare (MHLW) takes charge of duties to implement measures for food safety. The Ministry of Agriculture, Forestry and Fisheries (MAFF) takes charge of risk management for agricultural, livestock, and fishery products. In addition to the enforcement of the Food Safety Basic Law, the Food Sanitation Law (under the jurisdiction of MHLW), and the laws regarding fertilizers, pesticides, feeds (under the jurisdiction MAFF) were drastically amended.
With regard to the Food Sanitation Law, which covers various responsibilities (including the establishment of standards/specifications for food, additives, apparatus, and food containers, inspection, and the hygiene management of the manufacture and sale of food), the amendment was aimed at stepping up measures required to ensure food safety. The major points of the amendment are outlined below:
(1) Purpose of the law and responsibilities of the national and local governments
An expression to the effect “to protect the health of the public by ensuring food safety” has been newly added in its purpose. The national and local governments must provide information on food hygiene, promote related studies, hear public opinion and reflect them in measures, and cooperate with each other. Business operators are obliged to acquire knowledge and techniques, voluntarily conduct testing, and assure the safety of raw ingredients. They are also obliged to investigate the cause if a food poisoning occurs and to retain records about sources of raw ingredients and other related information, in order to prevent the spread of food poisoning.
(2) Specifications and standards
A positive list system will be introduced for pesticides, veterinary drugs, and related chemicals. The MHLW may prohibit the use of existing food additives that have a safety problem. To ensure safety for newly developed foods, the MHLW may temporarily prohibit the distribution of foods that are consumed in a particular manner, and may prohibit false or exaggerated labeling or advertising (based on the amended Health Promotion Law).
(3) Inspection and testing system
A registration system for testing laboratories that conduct testing based on examination orders will be introduced. The national and local governments may delegate monitoring tests to registered laboratories.
The MHLW must prepare and publish guidelines for inspection/guidance and an implementation plan for inspection/testing of imported foods, and local governments must prepare and publish an implementation plan for inspection/guidance for food hygiene. To promote food safety work by business operators, HACCP approval must be renewed regularly. Food sanitation supervisors must give necessary comments to business operators, and business operators must respect these comments.
(4) Strengthening of measures for accidents arising from eating or drinking, such as food poisoning
The MHLW may ask the local government to investigate the cause when mass food poisoning occurs over a wide area. Even without notification by a medical doctor, the director of the health center must notify the local government of any food poisoning cases and conduct necessary investigations.
(5) Strengthening of penalties
The maximum penalties have been raised for labeling violations and for judicial persons.
One year has passed since the Japanese Government applied risk analysis approach in its activities to ensure food safety. It may be too early to conclude the outcome of the introduction of this new approach. As we completely separated the risk assessment organization from the risk management organizations, the relevant agencies have become acquainted with the concept of risk analysis and their roles within the framework.
On the other hand, the idea of risk analysis is not fully understood by general public. Among general public, risk is likely to be regarded as hazard, and the public tends to demand 100% free of risk.
Therefore, it is crucial that relevant agencies to make continuous efforts for better management of this new policy approach and that parties concerned promote risk communication in order to foster public understanding of risk analysis and thus strengthen the working relationships among all interested parties.