Reasons for Proposal
A safety issue was raised for hazardous materials contained in food, livestock and marine products, and quasi-drugs, to which people are often exposed through various pathways, such as fipronil in eggs contaminated with insecticide, disinfectants used as humidifier sterilizers, and volatile organic compounds in sanitary pads. Even a new term, “chemophobia,” or a fear of chemicals in daily necessities has emerged, showing that people are increasingly concerned about hazardous materials.
Currently health hazards of food, drugs, quasi-drugs and hygiene products are assessed and managed individually for each product according to respective relevant laws. Therefore, it is difficult to make a comprehensive assessment of health hazards of a certain hazardous material that penetrates the human body through various pathways. Hence, by compiling various exposure pathways, the risks of food, drugs, etc., need to be assessed, and based on these results, a risk management system including safety standards need to be established. It is because, despite the results of assessment of risks of individual products showing they are safe, an aggregate risk from exposure to or absorption of a hazardous material contained in various food, drugs, etc. can still be harmful.
Hence this legislation aims to govern matters regarding a comprehensive risk assessment and management of food, drugs, etc. that are closely related to people’s daily lives and health, and to institute an implementation framework, thereby contributing to improvement of public health.
Details
A. Definition of terms and relation with other laws (Article 2 through Article 4)
1) Ensure that the terms to be defined include food, drugs, etc. subject to this Act, toxicity, toxicity tests, risk elements, risks, risk assessment, risk management, and related businesses.
2) Exclude the individual risk assessment and management for food, drugs, etc. subject to other laws in this Act.
B. Establishment of a basic plan for risk assessment and the composition of a risk assessment policy committee (Article 5 through Article 7)
1) Establish the basic plan that reflects mid- and long-term policy goals and directions regarding risk assessment of food, drugs, etc.
2) Install the risk assessment policy committee that deliberates on the government’s policies concerning risk assessment of food, drugs, etc., under the Ministry of Food and Drug Safety, and specify the provisions regarding the composition and operation thereof.
C. Performance of risk assessment, risk management, etc. (Article 8 through Article 14)
1) Determine the scope of subjects for risk assessment, including food, drugs, etc., the use of which is restricted in foreign countries and materials and products that use new technology, or new raw materials and ingredients.
2) Determine the matters concerning the risk assessment, and the methods and procedures therefor.
3) Ensure that a toxicity test is conducted to obtain data necessary for risk assessment
4) Allow the authority of government officials to access, inspect and collect materials and information to perform risk assessment for food, drugs, etc.
5) Take safety measures such as a temporary order to suspend the use of a certain product when deemed necessary for the sake of people’s safety even when risk assessment thereof has not been completed.
6) Allow the Minister of Food and Drug Safety to take measures to manage risks based on risk assessment results, and if deemed necessary, to request the cooperation of the heads of relevant central administrative organizations.
7) Disclose to the public the information concerning the results of risk assessment, temporary suspension measures, and risk management.
D. Laying the ground work for promotion of risk assessment (Article 15 through Article 20)
1) Prescribe the matters concerning the collection and analysis of toxicity and risk assessment information and the establishment of an electronic data processing system to facilitate such tasks.
2) Prescribe the matters concerning the education and promotional activities for businesses and consumers with regard to safe handling and use of food, drugs, etc., cultivation of professional personnel for risk management, international cooperation, etc.
3) Empower the Minister of Food and Drug Safety to designate and entrust an institution to conduct projects with the aim to promote risk assessment, and if necessary, to provide guidance and supervision.
E. Supplementary provisions (Article 21 through Article 23)
1) Specify the provisions concerning the delegation of authority, legal fiction as public officials in application of penalty provisions, etc.
2) Enforce the penalty provisions for individuals who handled food, drugs, etc. whose use is temporarily banned.
