South Korea Regulatory News

In April 2023, the National Institute of Environmental Research (NIER) in South Korea was consulted on a draft amendment of the regulation on test methods for chemical substances under the Act on Reg...

In April 2023, the National Institute of Environmental Research (NIER) in South Korea was consulted on a draft amendment of the regulation on test methods for chemical substances under the Act on Registration and Evaluation of Chemicals (K-REACH). This was to update the regulation based on updated international chemical regulations, including OECD’s animal alternative test methods. 

On the 2nd of June 2023, according to Article 14 (1) of the Chemical Substances Registration Evaluation Act and Article 5 (1) 1 of the Enforcement Rules of the same Act, 11 items were revised to reflect the latest chemical test methods (122 items). Test methods for chemical substances were partially revised, 9 test items in the field of health effect test and added 2 new items.  

clause 4 - Eye irritation and serious eye damage test 

clause 5 - Skin Sensitization Test 

clause 14 - Toxicokinetic test 

clause 27 - In vitro skin irritation test (human skin model test) 

clause 33 - Skin hypersensitivity test (regional lymph node test, LLNA) 

clause 34 - Skin sensitization test (regional lymph node test, LLNA: DA) 

clause 36 - Chemical skin sensitization test (peptide binding test, amino acid derivative binding test, dynamic peptide binding test) 

clause 54 - Estrogen receptor transcriptional activity test 

clause 66 - Eye irritation test using Vitrigel. 

clause 71 - Skin sensitivity test (Defined Approached: 2 out of 3 methods) 

clause 72 - In vitro human skin model (RhE) phototoxicity test  

On 8 June 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised the result of the hazard assessment of chemical substances and enforced it on the same date.  ...

On 8 June 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised the result of the hazard assessment of chemical substances and enforced it on the same date. 

• Notification of the results of hazard assessment of registered chemical substances: 37 new substances 

• Revision of notified substances: 30 new substances

- Dioctylbis(2,4-pentanedionato-.kappa.O2,.kappa.O4)tin (54068-28-9)

- Carbomonocycle carboxylic anhydride polymer with alkyl(C=2~6)-(substituted alkyl(C=1~5))-alkane(C=3~6)ol and alkyl(C=1~5)alkan(C=4~8)oic acid

- 'Dichlorodimethylstannane(753-73-1) mixt. with trichloromethylstannane(993-16-8) (78643-41-1)

- 'Matte, lead (84195-51-7)

- 1,5-Diisocyanatopentane homopolymer, 2-ethyl-1-hexanol-blocked (1976005-08-9)        

- Trialkyl(C=12~14) phosphite (93686-48-7)

- Reaction product of 1,1'-biphenyl, formaldehyde, aniline and maleic anhydride 

- 'B-Benzo[b]naphtho[2,3-d]furan-1-ylboronic acid (2261008-21-1)

- Biphenyl[(diheteropolycyclic)phenyl]phenyl heteromonocycle

- Tetrahydro-1-[4-(2-methoxyethoxy)-1-naphthalenyl]thiophenium, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1) (1359824-38-6)

- [(Phenyl)-carbopolycyclic]-heteropolycycle

- N,N-Bis(2-ethylhexyl)isooctadecanamide (1616494-50-8)

- Phenol polymer with hydro-alkano(C=1~5)-carbopolycycle, glycidyl ether polymer with alkyl(C=1~5)-alkenoic(C=3~7) acid and hydroisoheteropolycyclic-dione

- Carbomonocycle carboxylic acid anhydride reaction product with substituted carbomonocycle, oxybis[alkanol(C=2~6)] and alkane(C=3~7)triol

- Fatty acids, (C=14~18) and (C=16~18)-unsatd., esters with neopentyl glycol (85116-81-0)

- Fatty acids, (C=12~16), esters with neopentyl glycol (85186-95-4)

- Mixture of fatty acids(C=15~21) and (C=16~21)-unsatd. polymers with alkyl(C=1~8) peroxide alkyl(C=1~7) alkyl(C=1~4) alkenoate(C=2~6)-linseed-oil fatty acids-alkyl(C=1~4) alkenoic(C=2~6) acid-alkenyl alkyl(C=1~4) carbomonocycle polymer, conjugated sunflower-oil fatty acids, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, linseed-oil fatty acids and hydroxyalkyl(C=1~4) alkane(C=2~6)ol, ammonium salts and linseed-oil polymer with aldo heteromonocycle, polyethylene glycol, alkyl(C=1~4) ether and polymd. linseed-oil

- 'Iron sinter (65996-66-9)

- 4,4'-Oxybis[3-(trifluoromethyl)benzenamine] (344-48-9)

- '4'-[2-(4-Aminophenoxy)ethoxy][1,1'-biphenyl]-4-amine (2014385-51-2)

- Fatty acids, tall-oil reaction products with ethanolamine, ethoxylated (61791-19-3)

- (Heteropolycycle-yl)bis[hydroxypoly[substituted(alkyl(C=1~5)-alkane(C=2~5)yl)]]

- Vinylbenzene polymer with alkyl(C=2~6) acrylate, alkyl(C=1~5) alkyl(C=1~5)-alkenoate, hydroxyethyl acrylate, alkyl(C=1~5) aminoalkyl(C=2~6) alkyl(C=1~5)-alkenoate, alkyl(C=3~7) phosphate, oxiranylalkyl(C=1~5) alkyl(C=1~5) alkenoate, hexamethylene diisocyanate, phenylalkyl(C=1~5)amine and substituted alkanoic(C=6~10) acid lactone, homopolymer [(alkyl(C=1~5)-oxo-alkenyl)oxy]alkyl(C=2~6) ester

- 'N-1-Dibenzofuranylspiro[9H-fluorene-9,9'-[9H]xanthen]-2'-amine (2641673-05-2)

- 'Chromium nitride (24094-93-7)

- '9-Ethenyl-9H-carbazole (1484-13-5)

- N,N’-{Dialkyl(C=2~6)-bis(alkyl(C=1~5)carbomonocyclic)-[alkyl(C=1~5)bis(alkyl(C=1~5)carbomonocyclic)iminocarbopolycyclic-alkyl(C=2~6)-dialkyl(C=1~5)anilinocarbomonocyclic-alkyl(C=1~5)carbomonocyclic]diammonium}tungstophosphate

- Reaction mixture of 2-(1,1-dimethylpropyl)anthraquinone and 2-(1,2-dimethylpropyl)anthraquinone

- 'Mill scale (ferrous metal) (65996-74-9)

- 2-(4'-Bromo[1,1'-biphenyl]-4-yl)benzo[b]thiophene (2641700-97-0)

- 'Bis(acetato-O)phenyliodine (3240-34-4)

- '2-(2-Naphthalenyl)-4-[7-(2-naphthalenyl)-1-dibenzofuranyl]-6-phenyl-1,3,5-triazine (2706591-68-4)

- Bicarbomonocyclic-(carbopolycyclicbenzofuranyl)-diphenylheteropolycyclic-diamine

- Di(carbomonocyclic)-(carbopolycyclic-benzofuranyl)-heteromonocycle

- '2-Bromobenzo[b]naphtho[2,3-d]furan (1627917-16-1)

- 'Iron ores, agglomerates (65996-65-8)

- N,N’-{Dialkyl(C=2~5)-bis(alkyl(C=1~4)carbomonocyclic)-[alkyl(C=1~4)bis(alkyl(C=1~4)carbomonocyclic)iminocarbopolycyclic-alkyl(C=2~5)-dialkyl(C=1~4)anilinocarbomonocyclic-alkyl(C=1~4)carbomonocyclic]diammonium}tungstophosphate

On June 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea revised the regulation on chemical classification and labeling, including pictograms, hazard statements and pr...

On June 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea revised the regulation on chemical classification and labeling, including pictograms, hazard statements and precautionary statements, and classification mark lists, and enforced it on the same date. 

Earlier this year, NIER consulted on a draft amendment of this matter, and this was to notify the classification and labeling of newly designated toxic substances, as well as existing hazardous chemicals for which hazard reviews have been completed. 

• New classification and labeling for newly designated toxic substances 

- 6 substances including 3,5-difluorophenol. 

- CAS 2713-34-01 and mixtures containing more than 5%, CAS 872-93-5 and mixtures containing more than 25%, CAS 91742-16-4 and mixtures containing more than 25%, CAS 79-00-5 and mixtures containing more than 25%, CAS 1976005-08-9 and mixtures containing it more than 1%, and CAS 84988-61-4 and mixtures containing it more than 5%. 

• Revise classification and labeling for existing hazardous chemicals 

1) 28 toxic substances 

2) 2 substances requiring preparation for accidents. 

On 1 June 2023, the National Institute of Environmental Research (NIER) in South Korea publicly notified the Designation of Toxic Substances under the Act on Registration and Evaluation of Chemicals (...

On 1 June 2023, the National Institute of Environmental Research (NIER) in South Korea publicly notified the Designation of Toxic Substances under the Act on Registration and Evaluation of Chemicals (K-REACH). 

Earlier this year, NIER consulted on a draft amendment for this matter, and the main proposed revisions included the following:  

• The new designation of toxic substances for which hazard assessment has been completed: CAS 2713-34-0, CAS 872-93-5, CAS 91742-16-4, CAS 79-00-5, CAS 1976005-08-9, and CAS 84988-61-4.

• Revise the name of toxic substances: DMAB; Dimethylamine borane; CAS 74-94-2, CAS 68-11-1 and mixtures containing more than 1%, CAS 126-98-7 and mixtures containing more than 1%, Selenium [CAS 7782-49-2] or its compounds and 1% a mixture containing the above. However, selenium, cadmium sulfoselenide orange (CAS 12656-57-4), cadmium sulfoselenide red (CAS 58339-34-7), except that it contains less than 25 % of CAS 10026-13-8 and mixtures containing it more than 1%, CAS 102-82-9 and mixtures containing it more than 1%, and CAS 1702310-11-9.

• Regulate newly designated toxic substances on import declaration & business license under Chemical Control Act (CCA), labeling hazardous chemicals, and transitional measures for handling. 

On May 24, 2023, the Chemical Materials Research Division of the National Institute of Environmental Research published an article regarding guidelines for changing the format of the application for p...

On May 24, 2023, the Chemical Materials Research Division of the National Institute of Environmental Research published an article regarding guidelines for changing the format of the application for pesticide approval. 

According to Article 12 and Article 20 of the "Act on the Safety Management of Household Chemical Products and Biocides," a law in Korea aimed at ensuring the safe use and management of household chemical products and biocides, anyone intending to manufacture or import biocidal products must obtain approval for the respective biocidal products. 

In relation to the above, the South Korean authority has informed that there has been a change in the format for submitting documentation for the approval of biocidal products. The change involves the addition of additional composition information per product. For the previously submitted format (ver 1.0), no changes are required for the review process. However, for new submissions or revised documents, the updated format must be used. 

On 17 May 2023, the Chemical Materials Research Division of the National Institute of Environmental Research uploaded its plans to conduct evaluations of biocidal substances submitted for approval un...

On 17 May 2023, the Chemical Materials Research Division of the National Institute of Environmental Research uploaded its plans to conduct evaluations of biocidal substances submitted for approval under the "Act on the Safety Management of Household Chemical Products and Biocides." 

In relation to this, the authority has provided guidance regarding the exemption of efficacy test data for biocidal substances (wood preservatives). 

The Exemption Guidelines for Test Data on Efficacy and Effectiveness of Biocidal Substances (Wood Preservatives) are as follows: 

 
For wood preservatives listed under the Korean standard on wood preservatives and similar substances, the submission of test data on efficacy and effectiveness may be exempted according to the Industrial Standardization Act. KSM 1701 is a standard number issued by the government agency, the Korea Agency for Technology and Standards (KATS), to designate wood preservatives. 

 
Seven out of the 40 existing wood preservatives are subject to deferred approval in 2024. When applying for approval of these confirmed biocidal substances and their representative example products, the submission of test data on efficacy and effectiveness is exempted. 
However, general data on the efficacy and effectiveness of the biocidal substances (such as their functions, control methods, mechanisms of action, limitations, etc.) should still be submitted. 
The exemption for test data on efficacy and effectiveness only applies to wood preservatives and does not extend to other types of biocidal products. The exemption for test data on efficacy and effectiveness of wood preservatives is independent of the designation of existing biocidal substances and internationally approved evaluated substances. Changes in the inclusion or removal of substances under KSM 1701 may result in modifications to the eligibility for exemption from test data on efficacy and effectiveness. 

 
For wood preservatives that are not included under KSM 1701, test data on efficacy and effectiveness should be submitted when applying for their approval. If the efficacy and effectiveness of the biocidal substance are not sufficiently proven or if individual testing is not feasible, evaluation of the representative example product can be used to demonstrate the efficacy and effectiveness of the biocidal substance. As wood preservatives fall under the category of preservatives used in biocidal treatment products, test data demonstrating the desired efficacy and effectiveness in treated biocidal products using the representative example product should be submitted. Both domestic and internationally recognized test methods can be used for evaluating the efficacy and effectiveness of wood preservatives. Refer to the information provided in the Chemical Products Management System.  

Please note that the information provided is based on the referenced guidelines and regulations. It is advisable to consult the official regulatory authorities or seek legal guidance for precise and up-to-date information regarding the exemption of test data on efficacy and effectiveness for wood preservatives. 

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Eval...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on May 9th, 2023. This is to notify substance name, hazard information, classification and etc as the hazard reviews are completed for registered substances.

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances: 37 new substances
• Revision of notified substances: 30 new substances

If you have any opinion on this amendment, please write your opinion and submit it to the NIER.

The deadline for this consultation is May 29th, 2023.