IT SEEMS THAT K-REACH, THE SOUTH KOREAN version of the Registration, Evaluation, Authorization and Restriction of Chemicals, has been a topic of conversation for quite some time, and it is likely to continue that way for the foreseeable future. K-REACH covers existing chemicals, new chemicals and products. It was originally published in April 2013 but went through a significant revision in 2018. The revision seems to address some of the chemical industry’s concerns.
For existing substances, the amendment offered an opportunity to pre-notify regulators to receive a grace period for registration. Pre-notification ended on June 1, 2019, and the registration deadlines currently in place are based on the tonnage bands (see below).
For new substances, these must be registered prior to their import or manufacture. The amendment did change the requirements for substances that are manufactured or imported at <0.1 ton/year. These substances are only required to go through notification. This process is much less burdensome and will be helpful to those smaller companies that might not have the resources to complete the full registration process.
Product notification covers the exposure of chemicals to consumers through the use of articles or mixtures. There are two criteria to evaluate in order to determine whether your product will require registration. The first is that the product contains a priority control substance (substances that are carcinogenic, mutagenic or toxic for reproduction, or CMRs; very persistent and very bioaccumulative, or vPvBs; persistent, bioaccumulative and toxic, or PBTs; some specific-target organ toxicity substances, or STOTs; and substances of similar concern) and that the total amount of the substance is in the composition at more than 0.1%.
The second criteria is that the total amount of the priority control substance in each product is more than 1 ton/year. The first list of priority substances came into force in July 2019; the second list comes into force July 1, 2021. As with substances, products can also be exempt under certain circumstances. These include when there is no expected exposure to the consumer under normal use, registration has been completed for the priority control substance, or if the priority control substance is not subject to registration because of reasons such as being below the tonnage required for registration.
This is a complex regulation that will likely continue to generate a lot of discussion as both industry and regulators continue to work through the requirements.
Sphera’s Take
K-REACH was originally published in April 2013, but it was then amended in 2018. The 2018 amendment came into force on Jan. 1, 2019.
Existing Substances: Pre-notification was required for existing chemical substances being manufactured or imported at ≥1 ton/year. The pre-registration period began on Jan. 1, 2019, and concluded on June 1, 2019.
The following deadlines apply based on tonnage:
▸ Dec. 31, 2021: Substances exceeding 1,000 ton/year and exceeding 1 ton/year for CMR substances
▸ Dec. 31, 2024 for substance with tonnages between 100-1,000 ton/year
▸ Dec. 31, 2027 for substance with tonnages between 10-100 ton/year
▸ Dec. 31, 2030 for substances with tonnages between 1-10 ton/year