(1) Reasons for Proposal

This amendment aims to solve the problem that in the case of a polymer, special cases are applied, depending on its manufactured or imported quantities, to test data on its physical and chemical properties and hazards that must be submitted at the time of registration but are not for its risk data; allow the submission of risk data to be omitted at the time of registering chemical substances in the case where the data to be submitted at the time of registering chemical substances have already been submitted for the approval of biocidal substances in accordance with the Safety Control of Household Chemicals and Biocides Act; define the subject of the simplification of preparation and provision of chemical substance safety information, reasons for omitting the submission of written application for data protection, and application documents for the registration of nanomaterials.

(2) Major Provisions

A. Documents that may be omitted when submitting a chemical registration application (Article 5 (2)) 

1) When applying for the registration of a polymer that will be manufactured or imported at a rate of less than 1,000 tons per year, allow the submission of the risk data under Article 5 (1) 2 to be omitted.

2) Allow the data submitted by a person who intends to manufacture or import chemical substances for the approval of a biocidal substance under the Safety Control of Household Chemicals and Biocides Act to be omitted when applying for its registration if he/she registers the chemical substance for use other than as a biocidal product.

B. Submission of an opinion on the notice of findings of hazard review (Article 24) 

In the case where an applicant has an opinion on the notified findings of hazard review, allow him/her to submit his/her opinion to the President of the National Institute of Environmental Research.

C. Methods for preparing and providing chemical substance safety information (Article 36 (4)) 

Notwithstanding the proviso to Article 36 (1), allow writing and providing the registration/report number of the relevant chemical substance in the Materials Safety Data Sheets in the case where the relevant chemical substance is an existing chemical within the registration grace period with no risk information because risk data have not yet been prepared, or where a chemical substance is registered without submitting risk data because the quantity of the chemical substance to be manufactured or imported is less than 10 tons, etc.

D. Omission of a written application for data protection (Article 55 (3)) 

Allow the submission of a data protection application to be omitted in the case where the nature of the information to be protected has not changed despite a change in the information for which data protection has been applied and accepted due to a change in registration and reporting.

E. Submission data for nanomaterial registration (attached Table 1, Forms 2, 4, 5-2, 12, 13, and 25) 

Request submitting data on its particle size, particle size distribution, particle shape, and aspect ratio when registering a nanomaterial to check whether it falls under the definition of nanomaterials, etc., and add nanomaterials to the category of registration in various forms.

F. Criteria for administrative disposition (attached Table 10) 

Clarify the criteria for the number of violations and the cumulative number of aggravated dispositions in accordance with the recommendation of the Anti-Corruption and Civil Rights Commission to systematically improve the plan for clarifying criteria for aggravated dispositions of administrative sanctions.