Substances subject to permission under K-REACH
Ellen Daliday of CIRS explains a key recent development in South Korea ’ s chemical regulations
On 15 October , two enforcement dates passed under South Korea ’ s Act on the Registration & Evaluation of Chemicals , which is also known as K-REACH . The first is for new rules on ‘ substances subject to permission ’, which will require companies to seek prior permission from the Ministry of Environment ( MoE ) if they want to import , manufacture or use any of the substances . The second is the enactment of Article 24 of the enforcement rules for K-REACH . This will mean that registrants have the opportunity to talk to the National Institute of Environmental Research ( NIER ) about the results of its hazard evaluations .
Substances subject to permission
Under the Chemical Substances Control Act ( CCA ) ‘ substances subject to permission ’ are defined as ‘ chemicals likely to be harmful ’. The term is not new and has been in place since the enactment of the CCA in 2015 . However , it was not until 29 July 2022 that the MoE defined its selection criteria for these substances . According to the newly added Article ( 34 ( 2 )) of K-REACH , the MoE will consider multiple criteria when selecting substances to designate as ‘ subject to permission ’ ( Figure 1 ). The ministry has yet to designate any substances , but it will need to collect a wide range of public opinions when it does . This will include information on the hazardousness of the substances , as well as understanding the alternative substances and technologies available , before it officially notifies the substances .
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Figure 1 – Criteria for substances subject to permission
Companies would be required to submit risk analysis and information on the proposed use and analysis of alternative substances in order to gain permission to manufacture , import , or use a permitted substance . If no alternatives are available , the MoE will permit companies to continue using these substances for a specific period under strict management controls .
Pilot project
Between 30 December 2021 and 20 January 2022 the MoE conducted a pilot project , which focused on the following ten substances :
• Benzo [ def ] chrysene ( benzo [ a ] pyrene ) ( Cas 50-32-8 )
• Benz [ a ] anthracene ( Cas 56-55-3 )
• Formamide ( Cas 75-12-7 )
• p- ( 1,1-dimethylpropyl ) phenol ( Cas 80-46-6 )
• Tris ( 2-chloroethyl ) phosphate ( Cas 115-96-8 )
• Sodium peroxoborate ( Cas 7632-04-4 )
Carcinogenic , mutagenic , or toxic for reproduction ( CMR ) substances
Endocrine disrupting chemicals ( EDCs ) .
Persistent bioaccumulative ( PB ) and very Persistent very Bioaccumulative ( vPvB ) substances .
Respiratory sensitizers .
Specific target organ toxicity ( slot ) substances .
Risk posed due to the volume of the substance used .
Rubstances covered by domestic and international regulations .
• Perboric acid , sodium salt ( Cas 7632-04-4 )
• Sodium tetraborate , pentahydrate ( Cas 11138-47-9 )
• 2-ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate ( Cas 15571-58-1 )
• Trixylyl phosphate ( Cas 25155-23-1 ). The MoE selected companies to participate in the pilot project . They were provided with a review summary for each substance , which provided the rationale for the ministry ’ s selection of the substance , including hazard information , a review of existing regulations overseas and current distribution domestically . The companies were asked to provide feedback on the designation process including various questions and information on : grace periods ( Figure 2 ); exemption use ; distribution volumes ; alternative substances ; and suitability of questionnaire questions . In South Korea , the government often trials projects prior to making them
44 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981