28 Dec. 2018, South Korea Ministry of Environment (MOE) released the final list of CMR substances, priority control substances and substances exempted from registration. The draft lists were released on 12 Oct. 2018.
Compared with the draft version, the final lists are significantly amended. The number of substances in the CMR substance list is reduced from 544 to 364; the number of exempted substances is decreased to 44; and the number of priority control substances is reduced from 1195 to 672.
In accordance with the requirements of the amended K-REACH, enterprises who manufacture or import existing substances exceeding 1t/y (excluding substances listed in the first batch of registration list) shall submit pre-registration between 1 Jan. 2019 and 30 Jun. 2019 to obtain a registration grace period. CMR substances more than 1 ton per year and existing substances exceeding 1000 ton per year, if they submit pre-registration by June 2019, they can be granted a grace period until 2021 for registration.
The above substances must complete registration before 31 Dec. 2021, or they cannot be imported or manufactured from then on.
Substances exempted from registration
Substances exempted from registration refer to the substances exemption from registration without any separate procedures. These substances are mainly substances themselves existing in the nature or substances composing DNA or RNA.
Priority control substances
According to the K-REACH Amendment, priority control substances have been issued for reporting prior to the production and import of products containing chemicals that are concerned to be risk by regulations.
The priority control substances are designated and publicly notified by the Ministry of Environment as they are hazardous to humans and the environment, which also fall under the following:
- Substances which may be or concerned to be carcinogenic, mutagenic, toxic for reproduction or disruptive to endocrine system to human beings or animals;
- Substances which is easily accumulated in the bodies of human beings, animals or plants, and remains in the environment for a long period of time;
- Substances which may damage organs of human beings if human beings are exposed for a long period of time or repeatedly to such substances;
- Substances which may give the same or higher level of serious risks to human beings, animals or plants compared with the above substances;
List of priority control substances cover 2 inventories. Inventory 1: 204 substances in total, which includes substances currently circulated in Korea or controlled substances at home and abroad. This inventory will come into effect from 1 Jul. 2019; Inventory 2: 468 substances in total, which includes substances that are uncertain whether they are circulated in Korea. This inventory takes effect from 1 Jul. 2021.
Enterprises that produces or imports any product containing any substance of priority control shall report to the authority before they produces or imports the product if it corresponds to both of the following requirements.
- The content of the individual substance of priority control per one product exceeds 0.1 weight percent;
- The gross weight by substance of the substances of priority control contained in the total products exceeds one ton per year
Enterprises that transfers a product containing a substance of priority control shall provide the safety information on the substances contained in the product to the person who acquires the product prior to the transfer or at the same time as the transfer.
If any consumer requests provision of information, such information shall be provided free of charge within 45days from the date of such request.
- Name of the relevant product
- Name and content of the substance of priority control contained in the relevant product
- The uses available for use or restricted uses of the relevant product
- Method of proper use and service condition of the relevant product
- Precautions in handling the relevant product such as measures at the time it is exposed.
It is worth mentioning that in polymer registration， if a polymer whose number average molecular weight is less than 10,000, in which not less than 0.1% in weight of the non-reacting monomers falling under new chemical substances, hazardous chemicals or remain of priority control substances, cannot apply for PLC exemption.
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