REGULATORY NEWS
Update on K-BPR from the Korean government: 5-year vision
Date: 15 December 2020
On November 20th, the Korean Environment of Ministry (MoE) held a public hearing on their plans to develop the Consumer Chemical Products and Biocides Safety Act, better known as K-BPR, in the next five years. SCC attended this event and listed the positive upcoming changes and current limitations of K-BPR.
The products in scope of K-BPR are different as compared to EU BPR. Any chemical product used in the office, home or multi-use facilities is subject to K-BPR. The products in scope can be divided into two groups:
- Chemical products requiring notification, such as detergents, stain removers, bleaching agents, softeners, polishing agents etc.,
- Biocidal products which require approval
Before importing into or manufacturing these products in Korea, importers or manufactures should notify or get approval for their products. In total 80,000 chemical products were notified and approved by August 2020. 74% of these products were air fresheners, candles, detergents and deodorants. Meanwhile, 743 active biocidal substances were notified and are in the approval process.
At the time of the adoption of K-BPR, the Korean government was under significant pressure from the general public to adopt a regulation to prevent further accidents from using chemical products incorrectly. To meet the demand from the general public for swift action, the Korean government used the EU BPR as a template to create its own K-BPR. The swift adoption of K-BPR has led to some inconsistencies and gaps, which the Korean government envisages to address in the coming 5 years.
1. Hazard assessment tool for mixtures
The Korean government is planning to develop a hazard assessment tool for mixtures. Without a K-BPR risk assessment tool today, it is recommended to apply the same tools as used for EU BPR, such as EUSES (European Union System for the Evaluation of Substances). Whether the new, still to be developed, K-BPR assessment tool will be good enough to replace the existing international recognized tools remains to be seen.
2. Acceptance of prediction data
At the moment it is not known how the Korean government will evaluate non-testing data. What is known, so far, is that the government is planning to accept predicting toxicity data, such a SAR and read-across. This will be helpful when using existing EU data for K-BPR dossier preparation.
3. Extension of the chemical products in scope
The range of chemical products subject to K-BPR will be extended from 39 to 50 product types. This means that more chemical products, currently not subject to K-BPR, will be placed in the scope of - the regulation in the coming few years. It is recommended to closely monitor regulatory developments to prevent future surprises.
4. Regulation of microplastics
In line with the developments in the EU, control of microplastics in chemical products will be initiated in the coming five years. The scope and details of the regulation will be decided on the basis of the final EU regulation on microplastics, being currently developed by ECHA. It is expected that the Korean government will apply a similar restriction on microplastics.
5. Using evaluation data from EU and US
In September 2020, the Korean government announced they were accepting applications for a simplified approval for only a few weeks. The simplified approval solely applied to active substances already approved in the EU or US. The Korean government is going to use the information from the simplified approval to screen the remaining active substances on safety. This can mean that the Korean government is going to rely on information from the EU and US for the evaluation of active substances. It is also expected the Korean government is going to focus on active substances which have not been evaluated before in any other jurisdiction.
6. No extensions of existing grace periods for approvals
It has been almost two years since K-BPR was adopted and enforced, yet, there is still no proper technical guidance for preparing or evaluating the dossiers. Korean companies are complaining on the difficulties to prepare the approval dossier without available guidance. However, the Korean government drew a clear line and stated that there will be no extensions of the grace periods.
7. Public database on the evaluation progress
The Korean government is preparing to establish a public accessible database which would allow downstream users to verify the evaluation progress of active substance approvals. In the EU, this information is only shared with the applicants.
8. Active enforcement of K-BPR to verify the safety of chemical products
Due to COVID-19, there is an increasing variety of new biocidal products and treated articles on the Korean market. Therefore, the Korean government is aiming to actively enforce K-BPR and verify the safety and compliance of around 300 chemical products every year. There will be three different ways the Korean government will monitor and enforce K-BPR for the 300 chemical products targeted:
- Purchasing chemical products and verifying compliance with K-BPR through a safety assessment.
- Active enforcement in the market via labelling verifications.
- Reward system encouraging the public to notify chemical products with incorrect or insufficient labelling information.
With the general public taking an active part in the K-BPR enforcement, it is crucial for the companies to keep up-to-date with and implement latest regulation changes applicable to their products on the Korean market.
9. Establishment of a “chemical product evaluation centre”
At the moment there is no independent governmental agency regulating chemicals in Korea, such as ECHA in the EU. The Ministry of the Environment is responsible for the coordination of all activities related to the chemical regulations in place. However, the Korean government is planning to establish an independent governmental agency for evaluating chemical products. This will improve the capacity of the Korean government for processing active substance and biocidal product dossiers.
