On the South Korea of CMR substances and priority control substances regulations and industry countermeasures

Release time:

2019-09-06 14:49

Prior to the K-REACH implementation of the 2019 revision, the Ministry of the Environment of South Korea announced an administrative notice on "CMR substances", which are "priority controlled substances" registered before 2021 as the subject of product notifications and included in manufactured or imported products. The final list of substances will be published within this year after the industry reflects its views on the list.

CMR Substance

Ministry of Environment Notice No. 2018-761

Any existing chemical substance that is carcinogenic, mutagenic and toxic to reproduction or any substance associated with humans or animals should be designated as a CMR substance and should be registered by 2021. By 2021, 544 CMR substances and their hydrates have been pre-declared for registration. This list of CMR substances is compiled from the list of foreign carcinogens (IARC, NTP, EPA, etc.).

Anyone producing or importing 1 tonne or more of CMR substance or its hydrates per year should pre-register by the end of June 2019. Moreover, the registration of these substances must be completed by 2021, which is equivalent to the registration deadline for regular substances exceeding 1,000 tons/year.

Priority Control Substances

02
Ministry of Environment Notice No. 2018-748

According to the revised K-REACH regulations, a chemical substance with a high risk of concern should be designated as a priority control substance, so that the product can declare these substances before production or import.

"Priority controlled substances" include:

-Substances that cause or may cause cancer, mutation and reproductive toxicity to humans or animals or have endocrine disrupting properties (CMR and EDC);

-Persistent, bioaccumulative and toxic substances (PBT);

-Prolonged or repeated exposure to substances that may adversely affect human organs such as the lungs, liver and kidneys (STOT);

-Substances that are likely to have serious effects on human health or the environment that raise the same level of concern as other substances.

Any person producing or importing a priority controlled substance contained in a product shall notify the Ministry of the Environment prior to production or import if it meets the following two criteria:

1) The content of individual preferential control substances per product exceeds 0.1% by weight (w/w).

2) The total amount of priority control substances for each product exceeds 1 ton/year.

The 785 priority controlled substances (see Annex) have been announced to be implemented from April 1, 2019, and the other 410 substances (see Annex) will be implemented two years later, that is, April 1, 2021.

industry countermeasures

In response to the CMR and priority controlled substances on the list, the Ministry of the Environment of the South Korea is conducting a public opinion gathering campaign until November 1, 2018. As the final list will be published by the end of this year, please note the following deadlines:

1) Implementation date of pre-registration CMR substance registration: January 1, 2019,

2) The implementation date of product declaration for priority controlled substances: April 1, 2019 for 785 priority controlled substances and April 1, 2021 for the other 410 substances.

in order to fulfill the obligations within the deadline and follow up actions,

1) Check whether your product or substance list includes CMR substances, if so, pre-register

Pre-registration of 1 tonne or more of existing chemical substances per year must be completed by the end of June 2019. Once the pre-registration is complete, it needs to check the previous content and be ready to register soon, because their registration deadline is 2021.

2) If your product contains priority controlled substances that exceed the threshold, you should be prepared and proceed with the product declaration.

Any Party that produces or imports a product containing a priority controlled substance that exceeds the threshold shall submit a "declaration of a product containing a priority controlled substance" before the production or import of the product, with relevant instructions, pictures, etc. of the product. Within a period of time starting from the next day, verify that the cumulative total amount of each priority controlled substance contained in the product is 1 ton or more per year.

3) Communicate with consumers using products containing priority controlled substances

Suppliers of products containing priority controlled substances shall provide consumers with sufficient information on the product free of charge within 45 days, including the product name, the name and content of the priority controlled substance contained in the product, available uses, restricted uses, safe use instructions and conditions of use, exposure measures, preventive measures, etc.

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