South Korea conducts public hearing on proposed amendment of Decree and Rules of K-REACH

The Ministry of Environment (MOE) of South Korea issued a preliminary notice of legislation of partial amendments to the presidential decree and enforcement rules of the Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH), conducting public hearing on the draft amendments from June 3 to July 13, 2021.

On April 13, 2021, an amendment to the K-REACH was published (effective date: October 14, 2021). Under the amended Act, MOE can confirm the performance of mandated registration and report on manufacture and import of chemicals by requesting heads of relevant administrative agencies to submit dossiers on import and export of regulated chemicals, as needed, as prescribed by the President. Accordingly, MOE has preliminary noticed the legislation of amendment of the Decree of the K-REACH (Presidential Decree No. 30849), in order to define the scope of information that can be requested, to supplement defects of the current chemical evaluation and registration system and to achieve more effective registration of chemicals by business entities.

The major provisions of the draft amended Presidential Decree are as follows.

Chemicals for which some of data submission requirements are exempted for registration (Article 13 of the draft)

• When applying for registration of polymeric compounds, submission of data on their physical/chemical properties and hazards are waived under a special exemption rule as set forth in Appendix 1, Item 6 of an MOE Ordinance. However, currently such an exemption is not applied to submission of risk information. To supplement this rule, this draft adds polymeric compounds that are manufactured or imported in quantities less than 1,000 ton per year to the list of chemicals for which some data submission requirements are exempted.
• When applying for registration of chemicals that are subject to both of (i) the mandatory registration under the K-REACH and (ii) the mandatory approval as a biocidal substance under the Consumer Chemical Products and Biocides Safety Act (K-BPR), to reduce applicants’ burden, data that has been submitted to obtain approval under K-BPR are not required to submit under the K-REACH (i.e., chemicals that have satisfied data submission requirements under the K-BPR are added to the list of chemicals for which some data submission requirements are exempted).

Improved procedure for designation of substances subject to authorization (Article 19 of the draft)

• When designating substances subject to authorization, the MOE should select and announce the candidate substance(s) in advance, and then invite opinions from stakeholders and perform risk review on the candidate substances. In addition, when necessary, MOE also conducts a survey on the current status of distribution of the candidate substances across the market.
• To deliberate designation of substance subject to authorization and the necessity of transition periods, MOE may establish and operate a consultative group consisting of manufacturers, importers and users of the concerned chemical substances.

Request of dossiers on export and import of chemicals (Article 29-3 of the draft)

• To confirm the performance of mandated registration and/or notification on manufacture and import of chemicals, the Minister of Environment may request the Director General of the Customs Administration to submit data on declaration documents on export, import and return, as needed, pursuant to Article 245, Paragraph 2 of the Presidential Decree of the Customs Act.

Supplements to provisions on delegation of tasks (Article 31 of the draft)

• Regarding the approval of use of information on hazard tests under Article 19, Paragraph 2 of the K-REACH, the task of collecting usage fees will be delegated to the Korea Environment Corporation.
• Operations related to support for the provision of data on chemicals as set forth in Article 29, Paragraphs 1 and 5 of the K-REACH, and operations related to administrative, technical, and financial support for securing and utilizing existing information on test results conducted for vertebrate animals as set forth in Article 42-2 of the same Act shall be delegated to the Association established in accordance with Article 53 of the Act.

Criteria for imposed administrative penalties and fines (Schedule 5 and 6)

• The criteria for the number of violations and aggravated punishments imposed will be clarified in accordance with the recommendations on the improvement of the aggravated administrative punishment scheme issued by the National Rights and Interests Commission.

For polymeric compounds, at the time of registration, depending on the quantities to be manufactured or imported, a special exemption has been made for the data on physical and chemical properties and toxicity test results. However, no special exemptions have been made for risk data. Therefore, the draft amendment of the Enforcement Rules for the Chemicals Evaluation Act stipulates that if data required under the K-BPR have already been submitted at the time of registration, they can be exempted from the submission requirements under the K-REACH. The draft amendment also stipulates the scope of safety data required to be prepared and submitted, and defines the grounds for omitting the submission of the application form for protection of information submitted, and stipulates documents required to be submitted in applying for registration of nanomaterials.

The major provisions of the draft amendment of the Enforcement Rules are as follows.

Documents that can be omitted when submitting an application for registration of chemical substances (Article 5, Paragraph 2 of the draft)

• For polymeric compounds that are intended to be manufactured or imported less than 1,000 tons per year, the submission of data on their hazards can be omitted at the time of application for registration pursuant to Article 5, paragraph 1, item 2 of the draft amendment.
• When a person intends to register a chemical substance for non-biocidal purposes under the K-REACH, the requirements on submission of data on the substance can be omitted if the applicant has submitted data on the substance required for obtaining approval as a biocidal substance under the K-BPR.

Submission of opinions on notification of the results of hazard assessment (Article 24 of the draft)

• The draft allows applicants to submit their opinion to Director-General of the National Institute for Environmental Research regarding the results of hazard assessment.

Method for preparing and providing chemical safety information (Article 36, Paragraph 4 of the draft)

• Notwithstanding the provision of Article 36, paragraph 1, if a chemical substance, for which transition period is given, is registered as an existing chemical substance without any data on its hazards, because there is no hazard data prepared or because the quantity to be manufactured or imported is less than 10 tons, etc., the registration/declaration number of the concerned chemical substance can be provided in the chemical safety information.

Omission of application process for protection of chemical information submitted (Article 55, Paragraph 3 of the draft)

• Even if any information for which protection of the information has been requested and accepted is changed through a registration or notification of changes, making another request for information protection is not required if the nature of the information to be protected has not been changed.

Dossiers to be submitted at the time of registration of nanomaterials (Schedule 1, Appendices 2, 4, 5-2, 12 and 13, and Form 25)

• At the time of registration of nanomaterials, data on particle size, particle size distribution, particle shape, and aspect ratio are required to be submitted in order to confirm whether or not they fall under the definition of nanomaterials. In addition, the classification “nanomaterials” is added to relevant Forms.

Criteria for administrative penalties (Schedule 10)

• The criteria for the number of violations and aggravated punishments imposed will be clarified in accordance with the recommendations on the improvement of the aggravated administrative punishment scheme issued by the National Rights and Interests Commission.

The draft amendment can be viewed at:
https://www.epeople.go.kr/cmmn/idea/redirect.do?ideaRegNo=1AE-2106-0000065
https://www.epeople.go.kr/cmmn/idea/redirect.do?ideaRegNo=1AE-2106-0000066