In this edition of the Weekly Compliance Digest, we cover amendments to K-REACH, which is South Korea’s regulation on the registration and evaluation of hazardous substances.
Act on the Registration and Evaluation of Chemicals
What is it?
The Act on the Registration and Evaluation of Chemicals (known as “Korea REACH” or “K-REACH”) was passed in 2013 and entered into force on January 1, 2015. It is de facto South Korea’s version of the EU REACH regulation, although there are differences between the two. The main provisions on K-REACH include:
- Registration of substances
- Screening of hazardous substances
- Hazard and risk assessment of products containing chemical substances and hazardous substances
- Information sharing on chemical substances
On December 28, 2016, the South Korean Ministry of the Environment proposed important amendments to K-REACH, which would make the regulation more stringent.
Who is affected?
K-REACH applies to companies in South Korea that manufacture or import chemicals, but also to foreign companies that export chemicals into the country. Foreign companies that do not export to South Korea but are part of supply chains with downstream actors that either export to South Korea or are located in the country may also be impacted.
It is important to note that K-REACH does not apply to the following:
- Radioactive substances
- Pharmaceutical drugs
- Food, food additives, food containers, and food packaging
- Livestock feed
- Explosives, ammunitions
- Military supplies
- Functional health foods
- Medical devices
See article 3 of the text of the regulation (in English) for the scope of application and more details around exemptions.
What are the requirements?
Here are the main amendments to K-REACH that are being proposed:
- Registration of all existing chemicals used in volumes of one ton per year or above. A pre-registration system will allow companies to benefit from a grace period. Pre-registration should start at the end of 2018. Whereas previously only 510 “designated existing substances” were subject to registration, the amendment would expand registration requirements to all existing chemicals manufactured or imported in volumes of one ton per year or above.
- Abolition of the annual reporting requirement, because it is considered as a duplicate of a similar requirement under the Chemicals Control Act.
- Expansion of requirements to provide information in the supply chain to users of hazardous substances and the mixtures containing them.
- Substances subject to authorization would not be manufactured, imported, used or sold unless an authorization or specific exemption is granted.
- Substances that fall under the following classifications will require notifications if they are included in products:
- Carcinogenic, mutagenic or toxic for reproduction (CMRs)
- Persistent, bioaccumulative and toxic (PBTs)
What is next?
The proposals were announced on December 28, 2016, and a comment period will end next week on February 6, 2017. Here are additional resources on the amendments to K-REACH:
- South Korea Proposes Major Amendments to K-REACH (ChemicalWatch article)
- Korea Proposes Changes to K-REACH (Blog post from 3E Company)
- Korea Proposes Significant Changes to K-REACH (Blog post from ChemADVISOR)
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