Chemical Registration Challenges in Korea

  •   24 Sep 2013
  •    Nam & Nam International

    Nam &Nam International

    In Korea, new chemical substance registration is managed by the Toxic Chemicals Control Act (TCCA) of the Ministry of Environment (MoE) and the Occupational Safety and Health Act (OSHA) of the Ministry of Employment and Labor (MoEL). However major changes in the chemical registration system can be expected as the existing TCCA has been overhauled and the brand new Act on Registration and Evaluation of Chemical Substances (K-REACH) will come into effect on Jan 1, 2015. We will analyze and compare the chemical registration system under the existing TCCA and OSHA with that under the forthcoming K-REACH.

    1) TCCA and OSHA

    New chemical substances should be notified under TCCA and OSHA prior to the manufacture or import activities. Different exemption conditions and different data requirements apply to the two Acts, a major source of regulatory compliance problems for the chemical industry.

    The following are the exemption provisions the two Acts share in common.

    1. Substances in quantities of less than 100 kg a year
    2. New chemicals manufactured or imported are intended for use in research and development only
    3. New chemicals manufactured or imported for export only in quantities less than 10 MT a year
    4. Chemicals listed as polymers which are constituted of chemical substances other than new chemicals

    For Point 4, more specific preconditions should be considered before you proceed with the exemption.

    Table 1. Additional Explanation for Point 4 Exemption Conditions in Common

    Regulation

    Applicable conditions for exemption

    TCCA

    a) Mn(Number-average molecular weight) of a polymer is more than 1,000 and monomers of the polymer are not new chemical substance and toxic chemical substance The exemption is not applied for monomers which are inorganic toxic chemicals.

    OSHA

    a) Polymers exempted from hazard∙risk assessment and have Mn≥1,000 without making cations, monomers constituting the polymers do not apply as new chemicals or prohibited substances from manufacture, substances subject to authorization and administration listed hazardous substances but apply to any of the following.

    • Insoluble in water or organic solvents, do not include metals other than sodium, magnesium, potassium or calcium in the polymer
    • If soluble in water or organic solvents, the Mw(molecular weight) <1,000 should be less than 1% content. In this case if Mn<10,000, monomers constituting the polymer should not contain C-C double bonds, triple bonds, C-N double bonds, triple bonds, aziridine group, epoxy groups, sulfonic acid group, hydrazine groups, the phenolic hydroxyl group or fluorine groups.

     

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