What is K-REACH?
The Act on Registration and Evaluation, etc. of Chemical Substances was promulgated by the Ministry of Environment of Korea (MoE) and came into force on 1 Jan 2015. The Act is well-known as K-REACH due to its similarity to the EU REACH regulation. The?revised K-REACH?legislation is a significant deviation from the regulatory mechanisms outlined in the previous version. The amendments came into effect on 1 Jan 2019,?which sets out a plan?of registering existing substances over 1 ton per year in the next 12 years.?Pre-registration of existing chemical substances (≥1 t/a) before 30 Jun 2019 is necessary to be eligible for the corresponding grace period. All new chemical substances are required to be registered. However, for new chemical substances<100kg/a, they?only require notification rather than registration.
How to Comply ?
K-REACH uses the Only Representative (OR) concept and allows non-Korean companies to register through an OR on their?behalf. The Ministry of Environment (MoE) is responsible for the registration and evaluation of chemical substances under?K-REACH.
Ways to Comply with K-REACH
1. Appoint an OR or set up branch offices in South Korea
2. Entrust local importers to comply with K-REACH
?Note: Non-Korean companies can prevent their valuable?substance information from being disclosed to the public?and their importers in Korea by appointing an OR.
Substances Subject to Registration
1.? New chemical substances (>=0.1 t/a)
2. Existing chemical substances (>=1 t/a)
3. New chemical substances and existing chemical substances designated by MOE due to their total domestic volume exceeding the standard set by the Presidential Decree ((1 t/a for new chemicals and 10 t/a for existing chemicals on a national basis))
-Existing Chemicals: Pre-registration, Joint Registration
Companies manufacturing or importing existing chemical substances over 1 t/a shall do pre-registration between 1 Jan 2019 to?30 Jun 2019 to be eligible for the corresponding grace period.
2. Late Pre-registration
From July 1 2019,Substances could do the late pre-registration before the export volume exceeds 1 ton.
3. Joint Registration
After pre-registration, companies will be granted a set grace period for their chemicals according to the hazard and tonnage
-New Chemicals: Simplified Registration, Standard Registration
1. Simplified Registration: 0.1-1t/a new substances before 31 Dec 2019.
2. Standard Registration: >= 1 t/a new substances & 0.1-1t/a new substances after 31 Dec 2019
1. New substances are not eligible for grace period. All new chemical substances should be registered/notified before manufacture/import.
2.The grace period for 510 PECs expired on 1 July 2018. The PECs (≥ 1 t/a) should be registered immediately before manufacture/import.
3. Grace period for existing substances (excluding the 510 PECs) is as below.
|>=1000t/y existing substances
>=1t/y CMR substances (364 substances)
|31 Dec 2021|
|100-1000t/y existing substances||31 Dec 2024|
|10-100t/y existing substances||31 Dec 2027|
|1-10t/y existing substances||31 Dec 2030|
1.? New substances < 0.1 t/a
2. New substances that have received exemption approval under the previous “Toxic Chemical Control Act” (TCCA)
– New substances under 0.1 t/a;
– New polymers composed of existing monomers meeting one of below criteria:
- Polymer with Mn over 10,000 D which contains oligomers with molecular weight of less than 1,000 over 5%, or oligomer with molecular weight of less than 500 over 2%.
- ?Polymer with Mn between 1000-10,000 D which contains oligomers with molecular weight of less than 1,000 over 25%, or oligomers with molecular weight of less than 500 over 10%.
- Cationic polymer
- ?Polymer with Mn under 10,000, which contains residual monomer of hazardous chemical, or priority management chemical exceeding 0.1%.
Registration Exemption Application
?? Chemical substances imported/manufactured for export-only use, including substances imported/manufactured to make export-only products
?? Chemical reagents
?? Surface treated substances
?? Non-isolated intermediates or on-site isolated intermediates which can be technically blocked from leakage or exposure
?? Polymers of low concern (PLC)
?? Substances for R&D use
1. Risk assessment is required for substances manufactured or imported for 10 tons or more per year
2. Depending on annual tonnage, the deadlines for the submission of risk assessment are listed as follows:
|Enforcement Date||1 Jan 2015||1 Jan 2017||1 Jan 2018||1 Jan 2019||1 Jan 2020|
|Criteria||100 t/y||70 t/y||50 t/y||20 t/y||10 t/y|
Chemicals Subject to Product Notification Duties
Priority Management Chemicals (PMC) present in a product exceeding a specific threshold (above 1 ton/year & 0.1% w/w).
What are PMC?
Priority Management Chemicals (PMC) are risk-posing chemical substances which fall under any of the criteria?indicated below. In total 672 substances have been designated by the MoE as PMC in Dec 2018, of which the first list of 204 substances has been effective from 1 Jul 2019 and the second list of 468 substances will be effective from 1 Jul 2021.
The following chemicals will be classified as PMC:
?? CMR substances and substances with endocrine disrupting properties (EDC)
?? Bio-accumulative and persistent substances (vPvB or PBT)
?? Substances which may damage organs such as lungs, kidneys after repeated exposure (STOT)
?? Other substances which may give the same level of concern
What to Submit?
?? Details of the Notifier
?? Chemical information of PMC
?? Content and hazard information of PMC
?? Exposure information
?? Classification and label
Supply Chain Communication
Note: The Ministry of Employment and Labor (MOEL)?requires companies exporting chemicals and products?into Korea to provide Korea SDS and labeling.
Penalty? under K-REACH
Imprisonment for not more than 5 years or a fine of up to?100 million Won will be imposed on persons who fail to?comply with the relevant obligations under K-REACH. The?fine for violation may also be imposed on the basis of the?company’s total sales (not to exceed 5%) according to the?amended K-REACH.
?? Only Representative Service
?? New Chemical Substance Search
?? Registration Dossiers Preparation and Submission
?? Lead Registrant
?? Data Sharing
?? Risk Assessment Report Preparation andSubmission
?? Product Notification
?? Exemption Application
?? Training and Consultancy on K-REACH
?? Korea Safety Data Sheet (SDS) and LabelPreparation