Reasons for Proposal
Recently concerns about the safety of harmful substances, such as the fipronil-contaminated egg crisis, humidifier disinfectant, and VOCs (volatile organic compounds) in sanitary pads, to which the public may frequently be exposed to in daily life through food, livestock and fishery, and quasi-drugs have been raised, and there is increasing interest and concern about harmful substances to the extent that the new term “chemophobia” has appeared.
Currently, since products for the human body such as food, cosmetics, pharmaceuticals, quasi-drugs, and hygiene products are individually assessed and managed for risk based on the product in accordance with the relevant laws for each product, it is difficult for consumers to comprehensively recognize the risks of a specific hazardous substance to the human body through various exposure routes.
In addition, even if the results of the risk assessment of individual products are safe for the human body, the total amount of harmful substances consumed and exposed through all products for the human body may be hazardous. It is necessary to establish a management system such as assessing the risk of products for the human body by integrating various exposure routes and setting safety standards accordingly.
Therefore, this Act aims to contribute to the improvement of public health by transforming the current one into an overall control system in which the matters on comprehensive risk assessment and management for products for the human body closely related to people's daily life and health are enacted as a separate Act.
Details
A. Purpose, definition of terms, relationship with other Acts, etc. (Article 1 through Article 4)
1) Define related terms such as products for the human body, toxicity, hazards, risk, risk assessment, risk management, and business entities which are subject to the purpose and application of this Act.
2) Individual risk assessment and risk management of products for the human body under other Acts shall be excluded from the application of this Act.
B. Establish basic risk assessment plans and organize the Risk Assessment Policy Committee (Article 5 through Article 7)
1) Prescribe matters concerning the establishment of basic plans and action plans reflecting the mid- to long-term policy goals and directions for risk assessment of products for the human body.
2) Establish a Risk Assessment Policy Committee under the Ministry of Food and Drug Safety to deliberate matters on risk assessment, etc., and prescribe necessary matters for the composition and operation of the committee.
C. Implementation of risk assessment, risk management, etc. (Article 8 through Article 16)
1) Prescribe the subjects to risk assessment, etc., such as products for human use, etc., for which the standards and specifications for safety have not been established, using or applying new technologies to products for the human body, new raw materials, or ingredients that have been recognized as harmful to human health and banned from production or sales by foreign governments, etc.
2) Prescribe the considerations for risk assessment, assessment methods and procedures, and matters necessary to conduct the risk assessment, and allow joint risk assessment in consultation with the heads of relevant central administrative agencies.
3) Prescribe that toxicity tests may be conducted to secure data necessary for risk assessment.
4) Prescribe that relevant public officials can engage in entry, inspection, and collection for risk assessment.
5) Prescribe that temporary measures such as a ban on the production and sales of the product in question may be taken even before the end of the risk assessment when precautionary measures are necessary for the safety and health of the public.
6) Require the Minister of Food and Drug Safety to take risk management measures according to the result of the risk assessment, and if necessary, allow him/her to conduct risk management jointly in consultation with the heads of the relevant central administrative agencies.
7) Prescribe that the information on risk assessment results, temporary bans, and risk management shall be disclosed to the public.
8) Make it possible to conduct a risk assessment at the request of a consumer and to investigate cases of consumer health damage caused by products for the human body.
D. Provide a base for activating risk assessment (Article 17 through Article 20)
1) Prescribe matters necessary for the establishment and operation of a computerized system that manages the collection and analysis of information related to risk assessment.
2) Prescribe matters related to education and publicity for business operators and consumers, training of risk assessment experts, and promotion of international cooperation for the safe manufacture, production, processing, and use of products for the human body.
E. Supplementary provisions (Article 21 through Article 24)
1) Prescribe provisions such as the delegation of authority, entrustment of affairs, and legal fiction of public officials in the application of penalty provisions.
2) Require penalties to be applied to those who produce or sell products for the human body that are temporarily prohibited.
