Subject

- New chemicals under 100 kg

- Substance that has received Low volume exemption(less than 100kg/year) and Low concern polymer exemption under the previous " Toxic Chemical Control Act " 

Submission period

Prior to manufacture or import the substance

Submission method

Through online IT system(Chemical Information Processing System)

Authority

The NIER(National Institute of Environment Research) under MOE

Required information

- Company information (manufacturer, importer or Only representative)

- Chemical name

- Classification and labelling

- Use classification and category (Industrial/professional use, consumer use)

- Toxicological data only if the applicant owned

Simplification of

registration dossier for 

non-hazardous chemicals

There are lots of data to be submitted in terms of tonnage, but for non-hazardous existing chemicals (not having GHS classification or labelling for health and environmental hazards), data corresponding to lower tonnage band (1-10 ton) regardless of its tonnage band are required.

But, this simplification will not be applied in case for consumer use

Transported isolated intermediate(TII)[1]: Exempt from data requirements for less than 1,000t of TII.  Only data corresponding to lower tonnage band (1-10 ton) should be submitted for over 1,000t of TII.  However, it is necessary to submit documents to verify transport or use(s) are under strictly controlled conditions and record the management log.

Change of 

Polymer exemption rule

condition

In the case of polymer with less than 10,000 average molecular weight, they shall not be exempted if they are; hazardous chemicals, priority control chemical substance, new chemical remains at 0.1 % or more as non-reactive monomers and it affects on the hazards of polymers

Improvement to

organize Substance Information Exchange Forum (K-SIEF or CICO)

Separate SIEF may be organized if

- the use and characteristics of substance is different within CICO member and difficulties in discussing issues in CICO

- those who manufacture or import the substance for consumer use

If the characteristics such as molecular weight, solubility etc. are clearly different for a polymer with the same chemical name, they can form separate SIEFs, considered as different substances.

Improved application for exemption of chemical reagent registration

In the case of reagents, it is allowed to submit the application for registration exemption within 30 days after its manufacture and import

If multiple substances are imported on a product basis, it is allowed to apply for an exemption (including the remaining components) as representative substance of the product.

Sharing new chemical evaluation results with the Ministry of Employment and Labor(MOEL)

The MOEL is prosecuting the revision of relevant regulations in consultation with the MOE to replace current hazards·risk assessment of new chemicals under the occupational safety and health administration (OSHA) by registration of new chemical substances under K-REACH in order to avoid duplicate tasks (OSHA pre-announcement of legislation, March 30 2018)

The MOE also revised regulations for the MOEL to access new chemical registration dossier submitted by companies to the Information Processing System (IT).