(1) Reasons for Proposal

With the amendment of the Safety Management of Household Chemical Products and Biocides Act (Act No. 17103; promulgated on March 24, 2020; to be enforced on January 1, 2021), this Partial Amendment aims to define matters delegated by the Act such as specifying information disclosure and requirements for the person designated by the foreign manufacturer and other matters necessary for the enforcement thereof, and supplement some regulations to operate the system more effectively.

(2) Major Provisions

A. Check those exempted from safety standard conformance assessment, reporting, and approval (Article 1-2)

Define a procedure where any person who manufactures or imports household chemical products or biocides can have the substance or product checked to see if Article 10 or Chapter 3 of the Act applies to the substance or product pursuant to Article 5 (2) thereof. 

B. Define change reporting and approval items for household chemical products subject to safety assurance (Articles 5 and 6)

Define change reporting items and application forms for household chemical products subject to safety assurance reporting and change approval items and application forms for household chemical products subject to safety assurance approval.

C. Disclose information about household chemical products subject to safety assurance (Article 7-2)

Require information indicated pursuant to Article 10 (8) to be disclosed under Article 10-2 thereof, and disclose such information on the information network under Article 47 (2) thereof. 

D. Specify reporting items for existing biocidal substances and the intention to not get approval (Article 14)

Delete “documentation about domestic and foreign use and regulatory information” in reporting items for existing biocidal substances, and allow the submission of a document stating the intention to not get approval after reporting.

E. Supplement approval data joint submission procedures and a list of data (Articles 15 and 16)

Allow the Minister of Environment to recommend a candidate if some problem is expected in selecting the representative to jointly submit substance approval filing data, permit any existing biocidal substance reported after June 30, 2019 to participate in ongoing approval data joint submission procedures, and update a list of data for joint submission.

F. Define temporary approval exemption in case of emergency (Articles 24 (6) through (11))

Allow the head of the relevant central administrative agency to request temporary approval exemption with the reason why it is urgent, the biocide’s ingredients, and requirements for alternative products, require the President of the National Institute of Environmental Research to review the foregoing and cancel such temporary approval exemption if any hazard is confirmed or suspected, and make it mandatory to indicate such exemption in any approval-exempted product.

G. Limit the use of any statement informing any effect/efficacy differently from what has been reported or approved in packaging or advertising (Article 34)

Allow household chemical products subject to safety assurance reporting to inform the effect/efficacy from using a biocidal substance if supporting data is submitted during reporting (Article 5), and add that any statement informing any effect/efficacy differently from the reporting certificate or approval notice cannot be used in packaging or advertising.

H. Specify criteria for the quality control of approved products (Article 36-2)

Prepare standards for manufacture and storage facilities and safety management to maintain and manage household chemical products or biocides subject to safety assurance as approved under Article 36-2 of the Act, and order a corrective action for any non-compliance with such standards by specifying that such corrections be done within a period of 6 months. 

I. Supplement test/inspection agency evaluation criteria (Article 40)

Allow for evaluating proficiency in standard sample analysis to ensure the quality control of a test/inspection agency.

J. Supplement support work by Household Chemical Product Safety Center (Article 43)

Reflect matters amended in the Act, including change reporting, in work by Household Chemical Product Safety Center and add investigation on distributed products for post-market management in its support for safety management.

K. Change the reason for document submission exemption during reporting (Article 46)

Change the reason for regular reporting exemption as “documentation required for reporting under other laws is already submitted to the Minister of Environment.”  

L. Define the requirements and reporting procedures for the person designated by the foreign manufacturer (Article 50)

Specify the requirement that only the person with Korean nationality and address can be designated by the foreign manufacturer, and define the forms and procedures to report the designation or dismissal of such person.