Takehome: South Korea’s Cabinet passed a new biocides law named K-BPR in Aug of 2017, which is still awaiting final approval from the National Assembly. If approved it will come into force on January 1, 2019. Manufacturers or importers should submit relevant documents to the Authority in order to avail of the grace period before practical implementation of the regulation.
Six years ago in Korea, more than one hundred people, mainly pregnant women and children died of lung diseases caused by inhalation of fungicides used in and dispersed by humidifiers. As of 2016, the government official statistics showed the total number of deaths caused by humidifier fungicides was 228, and total injuries 1528. According to the official survey, polyhexamethylene guanidine (PHMG), a chemical contained in humidifier disinfectants, was responsible for severe lung illnesses.
After the incident, household fungicide products received widespread attention from both the public and policymakers. After much deliberation on August 8, 2017, South Korea's Cabinet passed a new biocides law, the Act on Chemical Consumer Products and Biocides (also called K-BPR), which is modelled on the EU Biocidal Products Regulation (BPR). If approved by the National Assembly, the law will come into force on January 1, 2019.
According to K-BPR Article 17(2), any biocides or biocidal products must undergo safety screening by the Ministry before they go on sale. Manufacturers or importers are required to notify biocidal substances used in the product to the Authority. A grace period (no more than 10 years) can be granted to notifiers for dossier preparation provided that they have notified the authority that their active ingredients have circulated in the market before K-BPR implementation. Active ingredients currently in use will be published in a list of ‘existing biocides’. Risk assessment of biocidal substances in the market will be completed in stages.
Main contents of the legislation of K-BPR (draft):
- Application for grace period is required for any active ingredients which circulated in the market (existing biocides) before enforcement date, January 1, 2019.
- Step-wise approval will be granted to notifiers of active ingredients that have applied for the grace period.
- For a product containing active ingredients, authorization is required based on its safety, effect & efficacy information.
- After changing the name of "Risk concerned product" under K-REACH to "Household chemical product subject to suitability check" in K-BPR, corresponding product not only includes products used in the household, but also products used in the office and in multi-use facilities. It requires suitability check based on relevant safety standards every 3 years.
- Advertisements which use terminology such as "Safe", "Eco-friendly", etc. are banned.
If importers or anufacturers have already submitted biocidal substance data for registration in accordance with the Article 10 of K-REACH before December 31, 2018, they do not need to submit the corresponding data on active ingredients.