ACT ON RISK ASSESSMENTS OF PRODUCTS FOR HUMAN USE

CHAPTER I GENERAL PROVISIONS

Article 1(Purpose) #

The purpose of this Act is to comprehensively evaluate the risks that may arise when risk factors existing in products directly applicable to the human body are exposed to the human body and to prescribe matters for safety management, thereby protecting and improving the public health.

Article 2(Definitions) #

The terms used in this Act are defined as follows:

1. The term "product for human use" means any of the following products that can directly affect the human body through its consumption, administration, contact, inhalation, etc. by a human:

(a) Foods, food additives, apparatus, containers, and packages defined in subparagraphs 1, 2, 4 and 5 of Article 2 of the Food Sanitation Act;

(b) Agricultural and fishery products and processed agricultural and fishery products defined in Article 2 (1) 1 and 13 of the Agricultural and Fishery Products Quality Control Act;

(d) Alcoholic beverages defined in subparagraph 1 of Article 2 of the Liquor Tax Act;

(e) Health functional foods defined in subparagraph 1 of Article 3 of the Health Functional Foods Act;

(f) Drugs, herbal drugs, herbal medications, and quasi-drugs defined in subparagraphs 4 through 7 of Article 2 of the Pharmaceutical Affairs Act (excluding animal drugs and quasi-drugs under Article 85 (1) of the Pharmaceutical Affairs Act);

(g) Narcotics defined in subparagraph 1 of Article 2 of the Narcotics Control Act;

(h) Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act;

(i) Medical devices under Article 2 (1) of the Medical Devices Act;

(j) Hygiene products defined in subparagraph 1 of Article 2 of the Hygiene Products Control Act;

(k) Other products managed by the Minister of Food and Drug Safety pursuant to statutes prescribed by Presidential Decree;

ACT ON RISK ASSESSMENTS OF PRODUCTS FOR HUMAN USE

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Relationship to other statutes) #

Article 4(Responsibilities of the State) #

Article 5(Comprehensive risk assessment and control) #

Article 6(Master plan for risk assessments) #

Article 7(Risk assessment Policy Committee) #

Article 8(Composition of Committee) #

Article 9(Subjects of risk assessments) #

Article 10(Performance of risk assessments) #

Article 11(Performance of toxicity test) #

Article 12(Access, investigation, and collection) #

Article 13(Temporary prohibition measures) #

Article 14(Establishment of comprehensive health-based guidance values) #

Article 15(Disclosure of results of risk assessments) #

Article 16(Consumer's request for risk assessment) #

Article 17(Investigation of adverse events caused by products for human use) #

Article 18(Collection, analysis, and utilization of information related to risk assessments) #

Article 19(Education and public relations) #

Article 20(Training experts in risk assessments) #

Article 21(Facilitation of international cooperation in risk assessments) #

Article 22(Delegation of authority) #

Article 23(Entrustment of business affairs) #

Article 24(Legal fiction as public officials for purposes of applying penalty provisions) #

Article 25(Penalty provisions) #