On 28 Feb 2018, the amendments of the Act on Registration, Evaluation and etc. of Chemicals (“K-REACH”) were passed by the plenary session of the National Assembly. The proposal was promulgated by the president on 20 Mar as Law No. 15512 and will take into force on 1 Jan 2019.
Major changes compared to the current K-REACH include:
(1) Annual reporting system abolished
The current annual reporting system is abolished. Instead, a pre-registration system will be adopted.
(2) Significant deviation from the current registration mechanisms
Pre-registration before 30 Jun 2019 is necessary to be eligible for the phase-in registration grace period. An IT system will be established by the authority to facilitate pre-registration. Phased-in registration of around 7,000 existing chemicals should be complied with based on tonnage band by 2030. However, designated CMR substances with a volume over 1 ton per year should be registered as a priority by 2021. The phase-in deadlines will be set based on tonnage band, as below
- >1000 t/y; or designated CMRs above 1 t/y: by 2021
- 100-1000 t/y: by 2024
- 10-100 t/y: by 2027
- 1-10 t/y: by 2030
For new chemical substances<100kg/y, they only require notification rather than registration.
(3) Strengthened management on high hazard substances
Carcinogenic, very persistent and very bio-accumulative, or substances that can cause damage to the lungs, liver and other organs, etc. will be designated as “substances subject to priority management” and require product notification of the substance name, use, content, hazards, simple exposure information, etc. Some substances will be restricted or prohibited to use in products when necessary.
(4) Strengthened management on certain chemicals which are of low hazards and circulated in high volume
For such kind of substances, if manufactured/imported exceeding a standard volume (to be specified in subordinate regulations) can be designated and published as “substances subject to registration” after deliberation of the chemical evaluation committee. Relevant enterprises should then prepare hazard information for registration.
Penalty will be charged based on downstream retail and final sale (5% of the sale, 2.5% for enterprises of single site for business).
(6) Broadened hazard information communication
Hazardous chemical regardless of whether it has been registered or not should provide relevant hazard information to the purchasers.
(7) Registration exemption
As long as a chemical substance is manufactured or imported for the purpose of export only, regardless of volume (currently limit is set as less than 10 ton per year), it can be exempt from registration.
(8) Substances subject to authorization
Currently, only published uses need authorization application in advance. There is no prohibition on other uses. After revision, the uses other than published uses are completely prohibited.
(9) OR responsibility
The only representative (OR) shall bear legal liability if a violation of K-REACH is found.
(10) New provisions about punishment
Testing institutes deliberately/unpremeditatedly tampering experiment results are subject to imprisonment up to 5 years /fine up to 100 million won. Manufacturers or importers provide false data for hazard examination are subject to imprisonment up to 3 years /fine up to 50 million won.
Currently, amending work for subordinate regulations and rules of K-REACH is under preparation.
It should be noted that for the 510 priority existing chemicals already issued in 2015 for joint registration, the original deadline of 30 Jun 2018 will still apply. In addition, the annual report of 2017 should be submitted before 30 Jun 2018 as well.