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DESIGNATION OF, AND SAFETY AND LABELING STANDARDS FOR, CONSUMER CHEMICAL PRODUCTS SUBJECT TO SAFETY VERIFICATION

Notice No. 201904, Feb. 12, 2019

Amended by Notice No. 2020117, jun. 5, 2020

 Article 1 (Purpose)
The purpose of this Public Notice is to prescribe matters regarding designation of consumer chemical products subject to safety verification, and establishment and verification of safety standards, matters on labeling, and labeling methods, etc. by item pursuant to subparagraphs 3 and 4 of Article 3 and Articles 8, 9, and 10 of the Consumer Chemical Products and Biocides Safety Control Act (hereinafter referred to as the "Act"), Articles 5 and 7 of the Enforcement Decree of the same Act (hereinafter referred to as the "Decree"), and Articles 5 and 7 of the Enforcement Rule of the same Act (hereinafter referred to as the "Enforcement Rule").
 Article 2 (Definitions)
The terms used in this Public Notice are defined as follows:
1. The term "item" means a type of consumer chemical products subject to safety verification as designated in attached Table 1;
2. The term "product name" means the unique name given to each product to distinguish it from other products;
3. The term "public-use facility" means a facility used by many unspecified persons;
4. The term "daily living space" means a place at home, an office, or a public-use facility, etc. where a person does everyday activities or works: Provided, That the foregoing shall not apply to workspaces that are not generally used by many unspecified persons other than workers, such as production spaces in factories or maintenance spaces in automobile repair shops;
5. The term “person seeking to obtain verification" means a manufacturer or importer who can file an application with a testing and inspection institution to obtain verification as to whether a consumer chemical product subject to safety verification complies with the safety standards under Article 5, and a manufacturer shall be limited to the following persons:
(a) A person who manufactures a product under his or her name or produces a product under his or her trademark through contract manufacturing, taking responsibility for the entire process from product design to manufacturing, sales, and compensation, etc., including planning and design of the product, management of raw and subsidiary materials, and liability to consumers: Provided, That no contract acceptor shall be considered a manufacturer;
(b) A person who is in charge of the entire process from design to development and manufacturing of a product and supplies the product under the trademark of another person placing the order;
6. The term "child-resistant packaging" means any packages and containers that are designed and devised to make it difficult for children under the age of 5 to take out the contents within a certain period of time, although it is not difficult for adults to open them;
7. The term “series product” means a product which has the same purpose and formulation type as another product verified to comply with the safety standards and has no change in substances subject to the safety standards under Article 5, in which case the product verified to comply with the safety standards is called “basic product” and the series product shall not have the same name as the basic product;
8. The term "surface suitable for display" means the product’s outer surface or the surface of a product’s package on which letters, figures, etc. can be displayed: Provided, That it shall not include the bottom or any joints including handles of product containers or the concave or convex surface of the upper or lower parts of the container that is usually difficult for consumers to see;
9. The term "point" means the unit indicating the size of printing types as prescribed by the Korean Industrial Standard KS A 0201 (dimensions of printing types).
 Article 3 (Designation of Consumer Chemical Products Subject to Safety Verification)
The types of consumer chemical products subject to safety verification designated pursuant to Article 8 (3) of the Act shall be as listed in attached Table 1.
 Article 4 (Establishment of Safety Standards)
(1) The safety standards for chemical substances under Article 9 of the Act shall reflect the results of the risk assessment under Article 8 of the Act: Provided, That in cases where the risk assessment has been already conducted by a domestic or overseas research and inspection institution on the relevant substance or where scientific testing and analysis data on risks are available or in other similar cases, the safety standards may be established based on such data.
(2) Where a chemical substance in a product is deemed to have less risk to the public health or the environment in the course of using the product, such as in cases where it is used as an acid (pH) regulator in the product and is neutralized, such substance may be excluded from the safety standards for chemical substances.
(3) Where it is objectively verified that a chemical substance that cannot be contained in a product has not been artificially added but unintentionally exists and it is technically impossible to completely remove such substance, a detection limit may be established to the extent the risk assessment under Article 8 of the Act shows that the tolerable risk level is not exceeded.
 Article 5 (Safety Standards)
(1) The safety standards applicable to consumer chemical products subject to safety verification designated pursuant to Article 9 of the Act shall be as follows:
1. Safety standards for chemical substances by item as specified in attached Table 2;
2. Safety standards for containers or packages, and their weight as specified in attached Table 3;
3. Safety standards for child-resistant packaging as specified in attached Table 4.
(2) Where it is objectively verified that there unintentionally exists any prohibited substance for which the detection limit is not prescribed in the safety standards under paragraph (1) 1, such as being transferred from the packaging material during the production or storage process, and it is technically impossible to completely remove such substance; the detection limit can be permitted to the extent the risk assessment conducted by the president of the Korea Environmental Industry and Technology Institute pursuant to Article 8 of the Act shows that the tolerable risk level is not exceeded: Provided, That materials regarding hazard, etc. necessary for the risk assessment shall be submitted to the president by the person who requests establishing the detection limit.
(3) With regard to a consumer chemical product subject to safety verification whose formulation type or purpose is not prescribed in the safety standards under paragraph (1) 1, or which is made of any hazardous chemical substance, etc. with no applicable testing methods, where it is impossible for a testing and inspection institution under Article 10 (1) of the Act to verify whether such product complies with the safety standards, such product may be permitted only when the risk assessment conducted by the president of the Korea Environmental Industry and Technology Institute pursuant to Article 8 of the Act shows that the tolerable risk level is not exceeded. In such cases, the permitted product shall be deemed to comply with the safety standards under paragraph (1) 1: Provided, That materials regarding hazard, etc. necessary for the risk assessment shall be submitted, along with an application for risk assessment in attached Form 6, to the president by the person who requests the risk assessment.
(4) Where a person intends to obtain verification as to whether the safety standards under any of the subparagraphs of paragraph (1) are complied with due to changes in the shape and material of a product container or for any other reason after having obtained verification of compliance with the safety standards under paragraph (1) for the product, he or she may obtain verification of the safety standards under the relevant subparagraph only: Provided, That in cases of the first verification or verification for renewal of the valid term, the verification shall be obtained for all of the safety standards under the subparagraphs of paragraph (1).
(5) Where a person intends to obtain verification of compliance with the standards for children-resistant packaging under paragraph (1) 3, he or she shall file with a testing and inspection institution an application for verification of children-resistant packaging in attached Form 7, either when filing an application for verification of consumer chemical products subject to safety verification pursuant to Article 10 (1) of the Act and Article 5 (1) of the Enforcement Rule or before filing such application, and shall be issued with a written confirmation of filing; and in cases of a change in any relevant details after the issuance of such confirmation, he or she shall file an application for change of children-resistant packaging in attached Form 8 and shall be issued with a written confirmation of filing for change.
(6) With respect to any product derived (hereinafter referred to as “series product”) from another product that is verified to comply with the safety standards under paragraph (1) (hereinafter referred to as "basic product"), it is deemed that the basic product has complied with the safety standards under paragraph (1) on behalf of the series product.
(7) Where a person defined in subparagraph 5 (b) of Article 2 obtains verification of compliance with the safety standards for a product in order to supply the same kind of products to several persons placing an order, the safety standards under paragraph (1) shall be deemed to have been complied with for an individual product supplied to each person placing an order.
(8) In cases of a product whose compliance with the safety standards under paragraph (1) has been verified by a testing and inspection institution within three months from the expiration of the valid term of verification pursuant to Article 10 (3) of the Act, the verification of the safety standards for the product shall be deemed obtained on the following day of the expiration of the valid term.
 Article 6 (Labeling Standards)
(1) Matters required to be labeled on the surface or package of a consumer chemical product subject to safety verification pursuant to Article 10 (6) of the Act and Article 7 of the Enforcement Rule of the same Act shall be as specified in attached Table 5.
(2) Detailed methods of labeling matters specified in paragraph (1) on the surface or package of a consumer chemical product subject to safety verification shall be as prescribed in attached Table 6.
(3) Statements subject to restrictions on labeling for a consumer chemical product subject to safety verification shall be as prescribed in Article 34 (1) of the Act and Article 34 (1) of the Enforcement Rule of the same Act.
 Article 7 (Verification of Safety Standards and Documents to Be Submitted for Reporting)
(1) Products and documents to be submitted to a testing and inspection institution and the scope and methods of preparing the documents to be submitted for reporting to the president of the Korea Environmental Industry and Technology Institute pursuant to Article 5 (7) of the Enforcement Rule by a person seeking to obtain verification as to whether a consumer chemical product subject to safety verification meets the safety standards under Article 5, shall be as specified in attached Table 7.
(2) When the president of the Korea Environmental Industry and Technology Institute issues to an applicant a certificate of reporting verification of compliance with the safety standards to an applicant, the guidelines for assigning a report number for a consumer chemical product subject to safety verification shall be as specified in attached Table 8.
 Article 8 (Exception to Application of Safety Standards)
Among consumer chemical products subject to safety verification designated pursuant to Article 3, those whose safety standards have not been publicly notified and therefore shall be approved by the president of the National Institute of Environmental Research pursuant to Article 10 (5) of the Act (hereinafter referred to as “products subject to approval”), shall be as follows; and the necessary matters regarding the standards for approving products subject to approval shall be governed by the Regulations on Approval of Consumer Chemical Products Subject to Safety Verification publicly notified by the president of the National Institute of Environmental Research:
1. Antibacterial and disinfectant agents for humidifiers;
2. Sterilizing and disinfectant agents to prevent infectious diseases;
3. Other disinfectant agents to prevent epidemics;
4. Insecticides to destroy, repel, prevent, and attract insects for public health;
5. Repellents for public health;
6. Insecticides to prevent infectious diseases;
7. Rodenticides to prevent infectious diseases;
8. Consumer chemical products for humidifiers.
 Article 9 (Re-Examination of Regulation)
In accordance with Article 8 of the Framework Act on Administrative Regulations and the Rules on the Issuance and Management of Directives and Established Rules (Presidential Directive No. 248), the appropriateness of regulation shall be examined every three years, counting from the enforcement date of this Public Notice (referring to the period that ends on the day before every third anniversary of the enforcement date of this Public Notice), and measures shall be taken such as making improvements.
ADDENDA <Public Notice of the Ministry of Environment No. 2019-45, Feb. 12, 2019>
Article 1 (Enforcement Date)
This Public Notice shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures regarding Labeling Standards for Products Subject to Approval)
With respect to consumer chemical products subject to safety verification referred to in any subparagraph of Article 8 for which permission by item has been obtained or a notification by item has been accepted pursuant to Articles 31 (4) and 42 (1) of the previous Pharmaceutical Affairs Act before this Public Notice enters into force, labeling under the previous provisions is allowed in lieu of the labeling standards under Article 6 for products manufactured or imported by December 31, 2019.
Article 3 (Special Cases regarding Safety Standards and Labeling Standards for Products Used in Public-Use Facilities)
With respect to consumer chemical products subject to safety verification including cleaners and disinfectants that are used by a professional worker employed directly or by means of an entrustment contract for hygiene, etc. of public-use facilities, the safety standards under Article 5 and the labeling standards under Article 6 shall begin to apply to products manufactured or imported on or after July 1, 2020.
Article 4 (Transitional Measures regarding Safety Standards and Labeling Standards for Previous Products of Risk Concern)
(1) A product of risk concern for which a certification number has been assigned pursuant to Article 6 (3) of the previous Designation of, and Safety and Labeling Standards for, Products of Risk Concern before this Public Notice enters into force, shall be governed by the previous Public Notice in lieu of the safety standards under Article 5 and the labeling standards under Article 6 during the period of transitional measures prescribed in Article 2 (2) of the Addenda of the Act. In such cases, where any change occurs as prescribed in Article 13 of the previous Public Notice during the period of transitional measures, a report on changes shall be filed in accordance with the previous Public Notice.
(2) A product of risk concern for which an inspection report under Article 6 (3) of the previous Designation of, and Safety and Labeling Standards for, Products of Risk Concern has not been issued after making a request to a testing and inspection agency pursuant to Article 6 (1) of the previous Designation of, and Safety and Labeling Standards for, Products of Risk Concern as at the time this Public Notice enters into force, shall be deemed a consumer chemical product subject to safety verification for which an application for verification of safety standards under Article 10 (1) of the Act is filed. In such cases, the safety standards under Article 5 and the labeling standards under Article 6 shall begin to apply to the relevant product from March 1, 2019. Before the effective date of such standards, the previous Public Notice shall be followed.
(3) Any product that falls into the same model category (hereinafter referred to as “series model product”) as the product for which verification of the safety standards by product model is obtained (hereinafter referred to as “basic model product”) pursuant to Article 6 (1) of the previous Designation of, and Safety and Labeling Standards for, Products of Risk Concern before this Public Notice enters into force, shall be deemed to have obtained verification of the safety standards within the effective period for the verification of the basic model product.
Article 5 (Applicability to Safety Standards and Labeling Standards for New Items under Control)
With respect to any of the following consumer chemical products subject to safety verification, the safety standards under Article 5 and the labeling standards under Article 6 shall begin to apply to products manufactured or imported on or after July 1, 2019: Provided, That in the case of subparagraphs 1 through 3, the foregoing shall begin to apply to products manufactured or imported on or after January 1, 2020:
1. Disinfectants (limited to those for air disinfection, only for children's products, and for tooth brushes or tongue cleaners);
2. Insect repellents (limited to those for winged insects);
3. Preservative-treated filter products;
4. Artificial snow sprays;
5. Candles (limited to those made of soy wax other than conventional paraffin).
Article 6 (Applicability to Safety Standards for New Substances under Control)
In the safety standards for chemical substances by item as prescribed in attached Table 2, the provisions regarding "preservative substances and preservatives that can be used in products as specified in I. General Standards", "the standards for content of substances used in products as specified in II. Safety Standards by Item", and "preservative substances that can be used in spray-type products” shall begin to apply to products manufactured or imported on or after January 1, 2020: Provided, That the provisions regarding “the standards for content of substances used in products” and "preservative substances that can be used in spray products” which are prescribed for cleaners, remover, air fresheners, and deodorizing agents shall apply on the date this Public Notice enters into force.
Article 7 (Applicability to Safety Standards for Child-Resistant Packaging)
The safety standards for child-resistant packaging under Article 5 (1) 3 shall begin to apply to products manufactured or imported on or after January 1, 2020: Provided, That cleaners, coatings, adhesives, air fresheners, and antifreezes that are required to use child-resistant packaging as specified in attached Table 6 of the previous Designation of, and Safety and Labeling Standards for, Products of Risk Concern before this Public Notice enters into force shall comply with the previous standards for products of risk concern required to use child-resistant packaging or may, in advance, apply the safety standards for child-resistant packaging as prescribed in the Public Notice to enter into force, until December 31, 2019.
Article 8 (Applicability to Statements Subject to Restrictions on Labeling)
The statements subject to restrictions on labeling for consumer chemical products subject to safety verification under Article 6 (3) shall begin to apply to products manufactured or imported on or after January 1, 2020.
Article 9 (Transitional Measures regarding Testing and Inspection Institutions)
A testing and analysis institution defined in subparagraph 4 of Article 2 of the previous Designation of, and Safety and Labeling Standards for, Products of Risk Concern before this Public Notice enters into force may conduct a testing and inspection as to whether a product complies with the safety standards as prescribed in this Public Notice before such institution is designated as a testing and inspection institution under Article 41 of the Act: Provided, That the designation of testing and inspection institutions shall be governed by the Public Notice of the National Institute of Environmental Research titled Regulations on Designation, Evaluation, and Management of Testing and Inspection Institutions for Consumer Chemical Products and Biocides.
ADDENDA <Public Notice of the Ministry of Environment No. 2020-117, Jun. 5, 2020>
Article 1 (Enforcement Date)
This Public Notice shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures regarding New Items under Control)
With respect to consumer chemical products subject to safety verification which are included in the amendments to the types of consumer chemical products subject to safety verification in attached Table 1, the safety standards under Article 5 and the labeling standards under Article 6 shall begin to apply to products manufactured or imported on or after January 1, 2021.
Article 3 (Applicability to Safety Standards for New Substances under Control)
The safety standards for “microplastics” among prohibited substances for cleaners, removers, laundry detergents, bleaching agents, and fabric softeners as prescribed in “II. Safety Standards by Item” in the amendments to the safety standards for chemical substances by item in attached Table 2 shall begin to apply to products manufactured or imported on or after January 1, 2021.