South Korea passes new biocides law (K-BPR)

Nov. 28th, 2017
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Six years ago, more than one hundred person, mainly pregnant women and children died of unexplained lung disease caused by inhalation of fungicides in the humidifier. As of 2016, the government official statistics showed the total number of deaths caused by humidifier fungicides were 228, the total number of victims has reached 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 have received widespread attention. After a long gestation period, on August 8, 2017, South Korea 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). After being submitted to the National Assembly for adoption, the law is expected to come into force on  January 1, 2019.

According to K-BPR Article 17(2),  all biocides or biocidal products for safety must be screened in advance by the ministry before they go on sale. Manufacturers or importers are required to notify biocidal substances used in the product to the Authority spontaneously and also can apply for grace period by submitting the relevant documents, this grace period shall not be longer than ten years in principle. A penalty will be given to whom do not notify the active ingredients. Active ingredients currently in use will be published in a list of ‘existing biocides’, then risk assessment of the biocidal substances in market will be completed by stages.

Main contents of the legislation of K-BPR (draft):

·Application for grace period is required for approval of active ingredients being circulated before enforcement date, January 1, 2019.

·Step-wise approval for active ingredient that is already applied for grace period. For a product containing active ingredient, authorization is required based on its safety, effect & efficacy information.

·After changing name of “Risk concerned product” under K-REACH to “Household chemical product subject to suitability check” in K-BPR, corresponding product includes not only products used in household, but also products used in office and in multi-use facilities. It requires suitability check on safety standard every 3 years.

·It is banded for advertisement using a phrase such as “Safe”, “Eco-friendly”, etc. which may lead misunderstanding to consumer.

If importers or manufacturers have already submitted the data with respect to biocidal substances for registration in accordance with the Article 10 of the K-REACH before December 31, 2018, they do not need to submit the corresponding data regarding the active ingredients in case that the substances were registered for use of biocidal substances or products at that time.

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