Welcome to GPC South Korea

Sustainability Support Services (SSS) Korea Ltd. (Name Change to GPC Korea Ltd. in Process) - is the South Korean branch of the GPC group providing chemical regulatory compliance services. SSS Korea provides Only Representative (OR) service for non-Korean chemical manufacturers and exporters who need to fulfill the obligations under K-REACH. Besides, as an OR, SSS Korea offers chemical registration and its necessary dossier preparation services. GPC Korea also provides Korean companies (Manufacturers and Exporters) a complete Regulatory Compliance Service and Advisory for all non-Korean destinations through GPC’s other global offices and global regional partner network.


Compliance advisor

Check the Regulatory requirements of your Substance in South Korea
Latest News

South Korea restrictions on heavy metals and phthalates in children’s products

South Korea restricts the contents of Heavy metals, Phthalates, and Nitrosamines in children’s products since 4 June 2020. As a result, manufacturer and importer of children’s products should test products to ensure not to exceed the maximum thresholds.

Children’s Products Safety Special Act is to limit the contents of hazardous substances in children’s products such as toys and textiles intended to be used by children aged under 13. The Ministry of Trade, Industry, and Energy set out subordinate regulations along with the Act since 2017.

Heavy metals contents in paints, coatings, and paper should not exceed the maximum limits as follows.

  • antimony – 60mg/kg;
  • arsenic – 25mg/kg;
  • barium – 1,000mg/kg;
  • cadmium – 75mg/kg;
  • chromium – 60mg/kg;
  • lead – 90mg/kg;
  • mercury – 60mg/kg; and
  • selenium – 500mg/kg. 

The total contents of lead and cadmium shall not be more than 100mg/kg and 75mg/kg, respectively.

The phthalates including DEHP (Di-(2-ethylhexyl) phthalate), DBP (Dibutyl phthalate), BBP (Benzyl butyl phthalate), DINP (Diisononyl phthalate), DIDP (Diisodecyl phthalate), DnOP (Di-n-octyl phthalate) should not exceed 0.1%.

For oral products used by infants aged under 36 months, such as dummies and toothbrushes, Nitrosamines, and potential substances that can produce Nitrosamines – which can increase the risk of cancer- should not be more than 0.01mg/kg.

Formaldehyde in textiles contacting with skin should not exceed 75mg/kg. Aromatic amines are limited to 30mg/kg, which is applied to dyed textiles. The pH of all products should be in the range of 4.0-7.5. 

Affected stakeholders and implications

Children’s products manufacturer and importer should comply with a new standard by testing their products. The contents of Heavy metals, Phthalates, and Nitrosamines in children’s products are restricted.

 

Last update: 10/22/2020

115 K-BPR chemical substances for a simplified approval

South Korean government published a list of 115 chemical substances where a simplified approval process is applicable. These 115 substances are active biocidal substances that were already approved under the EU BPR (Biocidal Product Regulation) and the US Fifra (Federal Insecticide, Fungicide, and Rodenticide Act). They are used as disinfectants, algicides, repellents, rodenticides, and insecticides (Product group 1).

Although a substance is on the list, if a substance is considered to be high risk and toxic, or there are risks the approval is not renewed under the EU BPR then the South Korean government will not approve the substance. Of these 115 substances, ten substances have the possibility of non-approval:

  • formaldehyde; formalin for use as a disinfectant;
  • coumatetralyl for use as a rodenticide;
  • boric acid for use as a disinfectant or insecticide;
  • polyhexamethylene biguanide hydrochloride; PHMB for use as a disinfectant;
  • brodifacoum; 4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin for use as a rodenticide; and
  • flocoumafen for use as rodenticides or insecticide.

By 16 October 2020, applicants are required to submit a substance identity report (SID), product, and exposure information. Even after submitting this information to the government, applicants must submit full dossiers by December 2022. The dossiers include SID reports that are issued by an ISO/IEC 17025 accredited body, less than three-years-old, and produced with three batches in triplicate. It is emphasized that most EU data are more than three-years-old since they are produced, so applicants shall review and generate new SID reports accordingly. 

To get K-BPR approvals, applicants should analyze specific data requirements under K-BPR, which might be different from the EU or US dossiers. For instance, in the case of bioaccumulation study on fish, the bioconcentration factor (BCF) value in the EU is above 2,000 whereas in South Korea, 500. 

Affected stakeholders and implications

Those who manufacture or import biocidal active substances should submit approval dossiers on time. The grace period of the first product group (Disinfectants, algicide, repellents, rodenticides, and insecticides) ends by December 2022. It is recommended to submit all dossiers by August 2021, considering the time taken for the dossier evaluation. The South Korean government will publish a list of additional test data that has to be submitted in June 2021.

 

Last update: 10/22/2020