REGULATION & COMPLIANCE
Figure 1 - K-REACH Registrations ( as of September 2022 )
substances or products containing hazardous chemical substances into South Korea may appoint an Only Representative to fulfil the relevant obligations under K-REACH .
As of 22 September 2022 , 8,568 existing substances and 10,367 new substances had been registered under K-REACH . Of the latter , 4,199 were priority existing substances ( PECs ) and 4,370 non-PEC . Figure 1 shows the progress of registration and notification .
Exemptions
Chemical substances are exempted from registration if they are :
• Imported contained in machinery
• Imported along with machinery or equipment for a test run .
• In a product in solid state with specific shape for a certain function and not discharged during its use
• Designated and publicly notified by the MoE after deliberation by the Chemical Substance Evaluation Committee as being extremely low risk
• Impurities , by-products , minerals , ores , glass , vegetable fats and oils , hydrogen , oxygen , etc .
• Present in nature and obtained by using manpower , machinery or gravity or by selection after dissolving or floating in water
• A base composing DNA or RNA , or nucleoside that is a combination of base and sugar . In addition , reagents for testing , research or inspection , and chemical substance for demonstration are also exempt from registration or notification once confirmation of exemption has been made via the Chemical Substance Information Processing System before manufacturing or importation . In the latter case the application must be submitted within 30 days from manufacture or import .
TII registration
A transported isolated intermediate ( TII ) is defined under K-REACH as a substance that is made in order to be used to manufacture another substance , the entire amount of which is consumed during final substance production . These intermediates must also be used under strictly controlled conditions by specially trained staff and accurate use records must be maintained .
As part of the registration process the use of a particular substance must be indicated in the dossier , under K-REACH use number 33 . Intermediate registration is an option . The advantage of this is that the information requirements for such substances are significantly reduced across all tonnage bands ( Table 1 ).
However , TII registration still has some downsides . In the initial registration phase , justification must be submitted to the MoE to prove that the substance satisfies the TII requirements . Additionally , all users of the substance must satisfy the requirements , including all downstream users during its lifecycle .
There are also additional postregistration obligations that must be completed following the completion of a TII registration . Users are required to maintain accurate records of the use of the substance and it must be handled by trained personnel throughout the supply chain . Registrants must update the TII justification to add new users satisfying the requirements and the registration dossier with TII justification for new users .
Finally , potential registrants should consider that a TII registration applies to all users of the substance . This means that if a single-user substance is not compliant with the requirements , this may lead to issues with the authorities . Potential registrants should conduct due diligence on current and future users to ensure that they are operating within the requirements of the TII registration .
JAN / FEB 2024 SPECCHEMONLINE . COM
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