What is the scope of chemicals that South Korea K-REACH need to register?

Release time:

2024-05-07 15:36

South Korea K-REACH is the abbreviation of the South Korea Chemical Registration and Evaluation Act, which was formally implemented on January 1, 2015. The scope of chemical substances that need to be registered mainly includes the following aspects:

1. Chemical substances manufactured or imported in excess of certain standards:Specifically, the annual manufacture or import of more than 100kg of new chemical substances or more than 1 ton of existing chemical substances must be registered with the South Korea Environment Department before manufacture or import.

Substances that are harmful to human health or the environment:Such substances, regardless of their annual manufacture or import volume, are required to be registered. If the total annual domestic manufacturing or import volume exceeds the specified standard (1 ton of new substances and 10 tons of existing substances), and the chemical substances designated or publicized by the Ministry of Environment have been considered by the Evaluation Committee, the enterprise must also complete the registration of the relevant chemical substances within 3 years from the date of designation or publicity by the Ministry of Environment.

3. Chemical substances with low annual manufacturing or import but specified:For new chemical substances that are manufactured or imported less than 100Kg per year, or new chemical substances that are only composed of polymers consisting of existing substances and are designated and publicized by the Ministry of Environment, if they want to manufacture or import, the company must report to the Ministry of Environment in advance.

In addition, the declaration of new chemical substances under the South Korea K-REACH is divided into notification and registration: tonnage ≤ 0.1t/a, notification needs to be completed; If the tonnage is ≥ 0.1t/a, formal registration shall be submitted according to the requirements of each tonnage data. Substances that have been listed in KECL (List of South Korea Existing Chemical Substances) and belong to PEC (Priority Management Chemical Substances) need to be registered before production/import/use activities can be carried out. Substances that are listed in KECL, but do not belong to PEC, need to complete (pre) registration before production/import/use activities can be carried out.

In addition, for existing chemical substances (PEC substances), enterprises must pre-register existing substances that produce or import greater than or equal to 1 ton per year to obtain a buffer period for continued production or import. The cut-off time for pre-registration varies according to the annual production volume of the substance.

Please note that specific registration requirements and procedures may change as South Korea K-REACH regulations are updated and circumstances apply. In the actual registration, it is recommended to refer to the latest South Korea K-REACH and regulatory requirements, and consult the relevant agencies or professional lawyers for accurate guidance.

None

South Korea K-REACH which chemicals need to be registered?

None

South Korea K-REACH which chemicals need to be registered?

Latest developments

Key Illustration of Railway Transportation Regulations for Consumer Lithium Battery Cargo

Recently, the Ministry of Industry and Information Technology of the National Railway Administration China National Railway Group Co., Ltd. announced the guidance on the railway transportation of consumer lithium battery goods. For details, please refer to our public article. Official

Answers to Frequently Asked Questions about the Environmental Management Measures for New Chemical Substances (Order No.7)

I recommend: For pre-registration projects with large tonnage and short grace period, or small tonnage pre-registration projects that are clearly registered in the future, it is recommended to choose joint registration and join the joint registration IT system agreement this time. For pre-registration projects that are clearly not registered in the future, it is recommended to choose subsequent registration. May I ask you

Cancellation of GMP certification means stricter supervision of drug production?

The cumbersome process of GMP and GSP certification has made many pharmaceutical manufacturers and distribution companies feel the strict supervision of the pharmaceutical industry. On September 25, 2019, the State Food and Drug Administration issued a notice on the study, publicity and implementation of the the People's Republic of China Drug Administration Law., It is clearly proposed to strengthen dynamic supervision and cancel the drug production quality management practice (GMP) certification and the drug business quality management practice (GSP) certification.

Dry goods! Common technical questions and answers on new raw materials for cosmetics