K-REACH Subordinate Statutes Outlined at MoE’s Public Hearing

R&D substance

R&D substances are exempt from registration under K-REACH, i.e. chemicals for process and product-oriented R&D, sample production before mass production, or pilot test, etc.;

Transfer to other sites is permitted which requires a transport & safety management plan to be submitted.

Low-volume new chemical registration

New chemical substance manufactured or imported below 1 tonne per year will be subject to simplified registration, expected to achieve tonnage threshold as 0.1 tonne in 2020;

Data requirements: applicant information, chemical identification, uses and exposure information, etc.;

Processing period: generally 3 days, 7 days if necessary for further discussion;

Concerning use-oriented exposure to consumers, data should be supplemented if the accumulated amount exceeds the low-volume cutoff.

Information exchange in supply chain

Information of chemical name, hazards, and safe use information etc. should be provided, while the ingredients and its content information are not subject to communication due to CBI concern;

Amount of manufacture, import, use or sales are optional to be communicated.

Priority evaluation chemicals (PECs)  subject to existing chemical registration

PECs are selected from the Korean Existing Chemicals Inventory (KECL) based on uses and exposure, etc.;

PECs list, categorized in to priority 1, 2 and 3 chemical substances will be issued every three years with three-year grace period respectively;

List of priority 1 substances contains less than 500 substances and is expected to be published before Oct 2014.

Clarification of substances subject to registration

Impurities and byproducts, which are accidentally or unintentionally produced, are exempt from registration under K-REACH. However, the information should be documented in the registration dossier for target substance, which is in line with EU REACH;

No-isolated intermediates are exempt from registration, while isolated intermediates are not.

Data submission

Test data form previous registrant can be used after obtaining an approval from data owner;

Test plan which includes the contents of tests and schedules, etc. can be submitted in lieu of parts of test report, concerning Korea’s testing capacity;

Estimation methods such as QSAR and read-across, etc. are acceptable.

Designation of hazardous substances

Criteria for designation of toxic chemical substances are in line with Global GHS;

Criteria for designation of substances subject to authorization (e.g. carcinogenicity and reproductive toxicity, etc.) will be specified;

Socio-economic analysis will be required prior to the designation of hazardous chemical substances and a pre-implementation notice will be issued in advance.

Products containing hazardous chemicals

0.1% weight ratio threshold of hazardous substance will be reconsidered in subordinate statutes in order to be consistent with EU REACH.

SMEs protection

Fair testing cost sharing will be a priority, MoE will provide clear and reasonable expense sheet;

Reduced administration fee will be levied on SMEs (example can be referred to EC No 340/2008 under EU REACH).

Interim measures

Only the original registrant of new chemical substance having received the result of hazard evaluation under TCCA will be considered as already registered under K-REACH. If not published on the Official Gazette by 1 Jan 2015, the chemical is still considered as new and any other registrant shall comply with new chemical registration under K-REACH; (Chemlinked news on 16 Aug 2013)

The manufacturers or importers sharing the result of hazard evaluation of the same new chemical with the original registrant’s consent under TCCA are still subject to new chemical registration, however a 1~2 year grace period will be granted;

Polymers exempt from registration under TCCA while subject to registration under K-REACH will be granted with 3~5 year grace period.