(1) Reasons for Proposal

This proposal aims to, in accordance with the amendment to the Cosmetics Act (Act No. 15488, promulgated on Mar. 13, 2018, effective on Mar. 14, 2020) which newly inserted customized cosmetics sales businesses, enable smooth enforcement of the system by prescribing detailed matters delegated to it under the Act such as the reporting requirements for customized cosmetics sales businesses, matters to be observed by customized cosmetics sellers, method of operation of the qualification test for customized cosmetics manufacturer-managers, etc.;

In accordance with the amendment to the Cosmetics Act (Act No. 15947, promulgated on Dec. 11, 2018, effective on Dec. 11, 2019) which provided a legal basis for setting hazard levels for hazardous cosmetics, provide hazard levels and sorting standards for hazardous cosmetics; and,

In accordance with the amendment to the Cosmetics Act (Act No. 16298, promulgated on Jan. 15, 2019, effective on Jan. 16, 2020) which imposed a requirement on responsible cosmetics sellers to prepare and keep evidentiary records regarding the safety of cosmetics for use by infants or children to strengthen safety control regarding such cosmetics, provide detailed operational regulations necessary for implementation of the system such as the scope of records to be prepared, etc.;

While, improving and supplementing certain shortcomings that have surfaced during the operation of the current system by: extending the period for suspension of required registration of change in place of business as a result of administrative district reform from the current 30 days to 90 days; extending the scope of cosmetics subject to report submission (exemption from examination) to include functional cosmetics with sunblock ingredients that have undergone examination for functional cosmetics in combination with wrinkle-improvement or whitening ingredients notified by the Minister of Food and Drug Safety; and deleting provisions on checking of report requirements.

(2) Major Provisions

A. Prescription of Scope of Contents of Customized Cosmetics (Article 2-2)

1) In accordance with the amendment to the Cosmetics Act (Act No. 15488, promulgated on Mar. 13, 2018, effective on Mar. 14, 2020), customized cosmetics sales businesses were newly inserted and the definition of customized cosmetics was provided.

2) Therefore, this proposal aims to clearly prescribe the definition of customized cosmetics and the scope of related contents to enhance the understanding of businesses and consumers and to provide a basis for smooth operation of the system.

B. Provision of Detailed Operational Standards Following Introduction of Customized Cosmetics Sales Business (Articles 4-2, 5-2, and 12-2 and attached Table 7)

1) In accordance with the amendment to the Cosmetics Act (Act No. 15488, promulgated on Mar. 13, 2018, effective on Mar. 14, 2020), customized cosmetics sales businesses were newly inserted and the definition of customized cosmetics was provided.

2) Therefore, this proposal aims to prescribe detailed matters necessary to the smooth operation of the system such as reporting requirements and procedures as well as change reporting requirements and procedures for customized cosmetics sales business, matters to be observed by customized cosmetics sellers, administrative measure standards in the case of violation of matters to be observed, etc.

C. Relaxation of Period for Suspension of Registration in Change of Place of Business Due to Administrative District Reform (Article 5)

1) Under the current Act, even in case of registration of a change in place of business due to administrative district reform, a business had to register the change within the same period as that required for registration of a change in place of business due to business concerns.

2) Therefore, this proposal aims to relax the requirement regarding period for suspension of registration in change of place of business due to administrative district reform that is not the fault of the business from the current 30 days to 90 days, thereby lessening the inconvenience to businesses.

D. Provision of Detailed Matters Necessary to Operation of the Test for Qualification as Customized Cosmetics Manufacturer-Manager (Article 8-2 and attached Table 2-2)

1) In accordance with the amendment to the Cosmetics Act (Act No. 15488, promulgated on Mar. 13, 2018, effective on Mar. 14, 2020), a person in charge of mixing or subdividing customized cosmetics was newly established as a customized cosmetics manufacturer-manager, a person who desires to become a customized cosmetics manufacturer-manager must pass a qualification test implemented by the Minister of Food and Drug Safety, and detailed matters necessary to the operation of the qualification test were delegated to an Ordinance of the Prime Minister.

2) Therefore, this proposal aims to prescribe detailed matters delegated to it under the Act such as the timing, procedure, method, test subjects, issuance of license, and designation of a testing institution, etc., regarding testing for qualification as a customized cosmetics manufacturer-manager, thereby providing a basis for smooth operation of the test.

E. Expansion of the Scope of Functional Cosmetics Subject to Report Submission (Exemption from Evaluation) and Exemption from Checking of Report Requirements, etc. (Article 10)

1) Under the current Act, functional cosmetics combining sunblock, whitening, and wrinkle improvement functions are subject to evaluation (lasting 60 days), which leads to difficulties in the prompt release of new products, and there is a process for checking report requirements prescribed in the Enforcement Rule that has no basis in the Act.

2) Therefore, this proposal aims to include functional cosmetics combining sunblock ingredients whose safety and effectiveness have been secured through previous evaluations and whitening and wrinkle improvement ingredients notified by the Minister of Food and Drug Safety in the scope of cosmetics subject to report submission (exemption from evaluation), and delete the provision regarding checking of report requirements, while improving and supplementing shortcomings in the operation of the current system, such as by including cream form in the scope of forms recognized as the same product, etc.

F. Provision of Detailed Matters Regarding Safety Control and Factual Survey of Cosmetics for Use by Infants and Children, etc. (Articles 10-2 and 10-3, and attached Table 7)

1) In accordance with the amendment to the Cosmetics Act (Act No. 16298, promulgated on Jan. 15, 2019, effective on Jan. 16, 2020), a responsible cosmetics seller is required to prepare and keep evidentiary records regarding the safety of cosmetics labeled or advertised as usable by infants or children to strengthen safety control regarding such cosmetics, a legal basis enabling the Minister of Food and Drug Safety to periodically conduct factual surveys regarding consumer usage of such cosmetics has been provided, and detailed matters regarding the scope of necessary safety records to be prepared and the scope of factual survey plans, etc. has been delegated to an Ordinance of the Prime Minister.

2) Therefore, this proposal aims to provide a basis for operation of the system by prescribing matters for safety control of cosmetics for use by infants or children delegated to it under the Act such as permitted age, scope of labeling and advertising, scope of factual survey plan establishment, timing, procedures, etc.

G. Provision of Hazard Levels and Sorting Standards for Hazardous Cosmetics and Improvement of Recall Procedures, etc. (Articles 14-3 and 28)

1) In accordance with the amendment to the Cosmetics Act (Act No. 15947, promulgated on Dec. 11, 2018, effective on Dec. 12, 2019), a legal basis regarding establishment of hazard levels for hazardous cosmetics has been provided and the hazard levels and sorting standards has been delegated to an Ordinance of the Prime Minister.

2) Therefore, this proposal aims to provide hazard levels and sorting standards, and improve recall procedures and public announcement channels to accurately inform consumers of cosmetic hazards while, at the same time, strengthening management of hazardous cosmetics.

H. Permission Regarding Labeling or Advertising of Research Institutes Related to Research and Development of Cosmetics (attached Table 5)

1) Under the current Act, a research institute is prohibited from labeling or advertising content that states or implies, etc., that it has conducted research and development regarding cosmetics, such that it has acted as a hindrance to research and development activities regarding cosmetics.

2) Therefore, this proposal aims to enable a research institute, in case it participated in cosmetics research and development, to label or advertise that fact, thereby contributing to encouragement of cosmetics research and development.

I. Reduction of Evaluation Period for Functional Cosmetics (attached Form 7)

1) Even in the case of functional cosmetics for which certain evaluation materials are exempted under notice of the Minister of Food and Drug Safety regarding ingredients and content or standards and testing methods, the evaluation period is uniformly prescribed as 60 days, which hinders the prompt release of new products.

2) Therefore, this proposal aims to reduce the evaluation period in the case of functional cosmetics whose evaluation materials have been partially exempted from evaluation from the current 60 days to 30 days, thereby providing a legal basis for prompt and efficient evaluation.