Biocides Updates from South Korea
The National Institute of Environmental Research (NIER) has published, on the official submissions portal for biocides (CHEMP), a new guidance concerning the special authorisation of biocidal products containing ‘low risk’ active substances.
Many of our readers will be familiar with the concept of ‘simplified authorisation’ from Regulation (EU) No 528/2012 (the BPR) in Europe, allowing for an easier route to getting biocidal products on the market when these contain active substances known to be safe compared to other alternatives – the so-called ‘Annex I active substances’.
In Korea, biocides are regulated by the Consumer Chemical Products and Biocides Safety Control Act (the K-BPR) and a similar concept also exists there: a ‘special authorisation’ procedure is possible for products containing active substances on the low-risk active substance list. This list is very similar to the earlier-mentioned EU BPR Annex I list (with some differences), and therefore you will find substances such as lactic acid, sodium acetate and lavender oil on the list.
This is the first time the authority has published guidance on this specific topic – the publication of the guidance could encourage more companies to apply for these ‘special authorisations’, of which there are none yet granted to-date. The guidance itself lists the requirements for the special authorisations, which again will be familiar to companies already active in Europe. Special authorisations can only be granted for products which contain low-risk active substances, contain no substances such as hazardous chemicals (as defined under chemicals legislation in Korea such as K-REACH) and materials, and do not require personal protective equipment (PPE) for safe use.
Test data to be submitted include efficacy, an analysis report, stability data and data on physical-chemical properties, which means that even though the authorisation is considered to be different from the regular biocidal product authorisations, there is still a significant amount of work involved in preparing an application dossier.
If your product contains a low-risk active substance and you would like assistance in bringing your product to the Korean market, please feel free to reach out to our team of experts and we will be happy to help.
