South Korea Regulatory News

Unlike EU-REACH, K-REACH requires manufacturers and importers to register polymers. Based on definitions and scope of polymer registration specified in K-REACH, they shall either register manufactured...

Unlike EU-REACH, K-REACH requires manufacturers and importers to register polymers. Based on definitions and scope of polymer registration specified in K-REACH, they shall either register manufactured and imported polymers or apply for an exemption certificate. This article will introduce key definitions, scope, major obligations, and processes of registration/exemption.

Scope

Key definition (K-REACH Enforcement Decree Article 2)

• Monomer: a chemical substance forms a polymer in combination with at least two other molecules and a reactant that forms a part of the polymer engaging in such chemical reaction
• Monomer unit: a structure where monomers are repeated in a polymer
• Polymer is
  • Composed of molecules in which at least one kind of monomer unit is continuously repeated,
  • Representing the characteristic distribution of molecular weights in accordance with repetitive numbers of monomer units in each molecule,
  • Molecules consisted of at least three monomer units forming a covalent bond with at least one monomer unit or other reactants be >= 50%
  • Molecules of the same molecular weight are < 50% of the weight ratio
• Number average molecular weight (Mn): the value obtained by dividing the total molecular weight of all molecules consisting of a polymer by the total number of molecules

Exempted polymers

Polymers are exempted from registration and reporting (often called “polymers having less concern”, K-REACH Enforcement Decree Article 11, paragraph 1) when their:

• Mn >= 10,000 & the contents of molecules weighted < 1,000 is less than 5% & the contents of molecules weighted < 500 is less than 2%
• 1,000 =< Mn molecular weight < 10,000 & the contents of molecules weighted < 1,000 is less than 25% & the contents of molecules weighted < 500 is less than 10%

Non-exempted polymers

Although polymers meeting exemption criteria, the outlined polymers require registration and reporting (K-REACH Enforcement Decree Article 11, paragraph 2):

• A cationic polymer (except the one used in solid form, not dissolved and soluble in water)
• A polymer whose Mn < 10,000 & having an unreacted monomer >= 0.1% by weight which are,
  • A hazardous substance,
  • A substance subject to intensive control,
  • A non-phase-in substance (excluding the ones have had a hazard review)

Polymer registration process

The polymer registration process is alike with Existing and New substance registration. Polymer registration starts from identifying a substance and join a CICO, which is a substance registration committee like a SEIF under EU-REACH. After a CICO is formed, Lead Registrant (LR) and all potential registrants sign a CICO agreement. Often, a consulting company works on behalf of LR to manage a CICO, figure out data requirements and prepare required dossiers. After confirming data requirements and finalizing data purchase negotiation, Active members and LR pay for the data so that they can submit them to the authority. When all dossier is ready then LR proceeds an application then gain a registration certificate.  

Polymer exemption

When? Once before you manufacture and import to South Korea

Required information?

• Monomer information
• Polymer structure (formula)
• Mn and contents of molecule weight (%)
• A proof showing a concerned substance meets the criteria of polymer exemption
  • A cationic polymer: polymer structure formula should prove that a concerned substance is not a cationic polymer
  • A proof showing that contents do not contain unreacted monomers consisted of a hazardous, a substance subject to intensive control and a non-phase-in substance is not more than 0.1 by weight (Mn < 10,000)

Affected stakeholders and implications

Who? All companies who manufacture and import “polymer” over 1 ton per year

When?

• If you have pre-registered your substance, you need to register before your grace periods end.
• If you have not pre-registered your substance, you need to register or apply for an exemption before the substance is manufactured and imported to Korea.

What? Identify and pre-register your substance. Then either register the substance or get an exemption certificate

How? If you are foreign manufacturers, you need to appoint an only representative (OR) then your OR will proceed registration for you. Please note that OR will need your chemical information for registration and you need to give proper information such as chemical identification number and importers’ contacts etc.

Relevant Services provided by GPCKOREA

• Regulatory compliance support
• Only Representative to fulfil various obligations under K-REACH

Last update: 18 September 2020

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 sho...

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

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 un...

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