2019 Compliance Review: K-REACH Updates
The Act on Registration and Evaluation of Chemicals , hereinafter referred to as K-REACH, has been implemented for five years. It is another international influential chemical regulation act after EU REACH. The implementation of K-REACH has a huge influence on global chemical industry. The management method of K-REACH is quite similar with EU-REACH, such as the registration, evaluation, authorization and restriction of chemicals and downstream products. For chemical suppliers outside Korea, they need to complete the registration through the only representative (OR) in Korea.
On January 1, 2019, the new version of K-REACH was officially implemented, which comprehensively revised the implementation of the regulations, expanded the number of registered substances, introduced pre-registration, and increased penalties. A series of new measures have strengthened the management of high-tonnage and hazardous chemicals, and have reduce requirements for low-risk, low-tonnage materials.
Compliance Review
Notification of CMR List and Priority Substance Chemicals、Exemption Substance List Published South Korea’s Ministry of Environment (MOE) issued a list 2018-232 of 364 CMR substances. The revised K-REACH will be effective on 1 Jan 2019 which requires all existing chemicals manufactured/imported in quantities of one tone per year or more need to be officially registered by December 31, 2021.
On 28 of December, 2018, South Korea’s Ministry of Environment issued the notification 2018-233 to revise the list of key management substances. The revised Schedule 1 contains a total of 204 substances, which will be implemented from July 1, 2019; the Schedule 2 contains total 468 substances, each substance will be implemented from July 1, 2021.
On that same day, South Korea’s Ministry of Environment issued notice No. 2019-234 regarding regulations and lists of registered exempt substances.
The Revised Version of K-REACH Officially Implemented on 1 Jan 2019
The pre-registration of existing chemical substances was also opened on the same day. Companies need to complete pre-registration before June 30, 2019. Meanwhile, a grace period for registration will be granted if enterprises pre-register their substances before the before mentioned date.
The new regulation specifies the registration of substances in terms of harmfulness / circulation, with more than 7,000 existing chemical substances expected to be registered in batches by 2030. The deadline for registration of existing chemical substances of more than 1,000 tons per year and CMR substances of more than 1 ton per year is December 31, 2021, which means that companies need to carry out joint registration as soon as possible to ensure that registration can be successfully completed before the deadline.
Companies that manufacture / import new chemical substances with an annual tonnage above 100KG should be registered. For cases below 100KG, companies will be required to notify the substance name and annual manufacturing / import volume range to the Ministry of Environment, . This measure is aimed at reducing the burden on enterprises.
The Ministry of Environment Releases English Version of K-REACH OR Selection Guide for Overseas Manufacturers
In order to help companies better understand the concept of the Only Representative in Korea, the Ministry of Environment released the English version of the OR selection guide to help companies better prepare for K-REACH.
Ministry of Environment Releases 61 Pre-registered Lists of Toxic Substances
As there are 61 toxic substances that do not have KE numbers, many companies may not need to be pre-registered. Officials say that even without KE numbers, these substances require pre-registration.
Deadline Set for Pre-registration: 30 of June, 2019
From January 1, 2019 to June 30, 2019, existing substances with an annual manufacturing and import volume of more than 1 ton will need to complete pre-registration to have access to the grace period.
Application of Products Containing Priority Management Substances is Officially Implemented
Notification of products containing the priority management substance is required if the quantity is above 1t/y and the content exceeds 0.1% w/w.
July 2019: Ministry of Environment Issues Notice for Pre- registration to Fast Supplement Period
On 8 July, 2019, the Ministry of Environment issued a notice which grants registrants a chance to directly supplement or update submitted information by 19 July, 2019. Otherwise, a modification application should be applied for afterwards if any changes occur. For intermediates, UVCB substances, and some substances that cannot be pre-registered due to trade secrets, companies can directly mail the Korean Environmental Corporation (KECO) for pre-registration.
September 2019: Ministry of Environment Issues a Joint Registration Support Policy Announcement for SMEs
Due to the known difficulties that surround joint registration in Korea –long processing time, difficulty and high expenses– the Ministry of Environment has issued a policy for SMEs to support the successful completion of joint registrations by these enterprises. For specific substances, a collective agreement by SMEs could apply to the Korea Chemicals Management Association (KCMA) to be the object of this support policy. The Ministry of Environment will provide support in the areas of agreement operation, material identity confirmation and data gap analysis.
October 1st 2019: Ministry of Environment Releases Summary of Pre-Registration Results
The document involved 16,744 substances, with an average of 10 substances per company. Through this document, it is possible to roughly understand how many members the collective agreement of each substance has, which substances have higher tonnages which will require the first batch of formal registration.
Chemical Substance Information Communicative Organization (CICO) for Joint Registration Officially Launched
Companies can join CICO by completing the pre-registration or late pre-registration process. When applying to join CICO, companies should indicate whether want to become an LR.
If more than one member expresses interest in becoming the LR, (generally the LR is the first company to join CICO), a “coordinator” will be responsible to operate CICO before LR is determined (The coordinator cannot quit after joining CICO, but ordinary membership can withdrawal from the organization). An election will be required to confirm the final LR candidate. CICO members will vote for the final LR, the election can be conducted as early as 30 days after the coordinator’s identity is confirmed.