South Korea Korea relaxes registration and declaration requirements for small volume chemicals and chemicals for R&D

Korea relaxes registration and declaration requirements for small volume chemicals and chemicals for R&D

On March 15, 2022, the Ministry of Environment of South Korea announced that it would promote the Scheme for Simplification of Registration and Exemption Confirmation of Chemical Substances to simplify the documents required for registration of chemical substances whose annual production or import volume is less than one ton (hereinafter referred to as small volume chemicals), and to exempt chemical substances imported for R&D purposes from declaration, considering the characteristics and uses of each chemical substance. The Scheme for Simplification follows a request for regulatory improvement by the Korea Federation of Small and Medium Business and the Federation of Middle Market Enterprises of Korea. According to the press release, small and medium-sized enterprises handle many small volume chemicals and are spending a lot of money to obtain the necessary documents for registration.

 

It is necessary to submit the name and CAS number of a chemical substance in order to obtain an exemption from registration for chemical substances for R&D. However, there have been cases where the import of such chemical substance cannot be conducted because the detailed information on the chemical substance is not smoothly provided by the foreign manufacturer. In order to obtain an exemption from registration for chemical substances for R&D, it is necessary to apply for the exemption with the required documents to the Ministry of Environment in accordance with Article 11 of the Act on Registration, Evaluation, etc. of Chemicals.

To improve these issues, the Ministry of Environment formulated a draft amendment to the Implementation Rules on the Act on Registration, Evaluation, etc. of Chemicals and solicited opinions from February 18 to March 30, 2022. However, since it will take a certain period of time before the draft amendment to the Implementation Rules are officially published, the Ministry of Environment announced that the Scheme for Simplification of Registration and Exemption Confirmation of Chemical Substances will be applied from March 16, 2022. The main contents of the Scheme are as follows.

 

  • New chemical substances manufactured/imported in quantities of less than one ton per year and with a solubility in water of less than 1 mg/L or manufactured/imported exclusively for the use as intermediates or process regulators, are exempt from submitting two documents on hazards to the environment when applying for registration. The following nine documents were previously required to be submitted, but now seven documents will be required to be submitted.
Documents to be submitted Number of documents to be submitted After amendment
Documents on physical and chemical properties 5 (No change)
Documents on hazards to the human health 2 (No change)
Documents on hazards to the environment 2 Omittable

 

  • For chemical substances for R&D (less than 0.1 tons) for which the foreign manufacturer does not provide information on ingredients due to trade secrets, it is possible to omit the preparation of the name and CAS number of the substance concerned if the MSDS is attached and submitted when applying for confirmation of exemption from declaration.

 

The original text of this article (press release from the Ministry of Environment) can be viewed at the following URL (in Korean).
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