K-REACH: Polymer Registration

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