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Ministry of Environment (i) Strengthens Safety/Labeling Standards for Potentially Risky Products and (ii) Introduces Biocides Act Modeled After EU’s Similar Regulation
On December 30, 2016, Korea’s Ministry of Environment (“MOE”) announced an amendment to the “Potentially Risky Product Designation & Safety/Labeling Standards” (“MOE’s Notice”), which strengthens the safety and labeling standards relating to potentially risky products, as well as the “Act on the Safe Control of Household Chemical Products & Biocides” (“Biocides Act”) modeled after the EU BPR (Biocidal Products Regulation) to regulate active substances and biocidal products.
1. Key Requirements under MOE’s Notice
Printer inks/toners, ironing aids, and algicides have been designated as potentially risky products.
– Safety and labeling standards have been established for each of the above product types, and they have been added to the potentially risky product list.
Safety standards strengthened (effective March 30, 2017)
– Use of CMIT/MIT (biocides at issue in the humidifier sterilizer incident) is prohibited in all spray-type potentially risky products and air fresheners.
– Use of PHMG, PGH and PHMB is prohibited in air fresheners, and regarding spray-type deodorizing agents and coating agents, prohibited substances have been added, and new content limitations for permitted substances have been established.
Labeling standards strengthened (effective June 30, 2018)
– If a potentially risky product contains a hazardous substance (including a biocide, toxic chemical, restricted chemical or prohibited chemical), the product must affix a label describing the substance name, function (i.e., reason for adding the substance), and content, regardless of the content.
– For products that contain a biocide, the product label cannot use potentially misleading language, such as “low risk,” “non-toxic,” “harmless,” “environmentally friendly,” or the like.
Sanctions
– In the event a non-compliant potentially risky product is sold, or provided, or is imported, displayed, preserved, or stored for the purpose of sale or provision, such conduct may result in criminal liability, namely, imprisonment of seven years or less, or a criminal fine of up to KRW 200 million, as well as administrative measures, including recall, sales ban, and destruction orders relating to the product at issue.
2. Key Requirements under the Biocides Act
Active substance approval system introduced
– An “active substance” is a substance or microorganism that has the effect or property of eliminating, controlling, rendering harmless or deterring harmful organisms. The Biocides Act prohibits the use of active substances that have not undergone MOE’s approval in biocidal products.
– Substances already in market circulation as of December 31, 2018 must be declared to the MOE by March 31, 2019, and those existing substances will be granted a grace period of up to 10 years.
– Anyone that has obtained approval under the Biocides Act (or holds a “consent to use data” from someone who has obtained approval) is deemed to have registered that same substance under K-REACH.
Biocidal product authorization system introduced
– A “biocidal product” refers to either: (i) a substance, mixture, or product consisting of, or containing one or more active substances, and having the primary purpose of eliminating harmful organisms; or (ii) a substance, mixture, or product that generates active substances from a substance or mixture, and having the primary purpose of eliminating harmful organisms. This definition excludes products that eliminate harmful organisms by mere physical or mechanical action.
– The Biocides Act requires manufacturers or importers of biocidal products to obtain prior MOE authorization, and sets forth criminal sanctions for manufacturing or selling biocidal products without having obtained such authorization.
Safety standards established for treated articles
– A “treated article” means any substance, mixture, or article, which has been treated with, or intentionally incorporates, one or more biocidal products for the purpose of eliminating harmful organisms (a treated article that has a biocidal function as its primary function is considered a biocidal product).
– The Biocides Act requires treated articles to use only authorized biocidal products, and requires compliance with the applicable safety standards. The manufacture or sale of non-compliant treated articles is subject to criminal sanctions.
– The Biocides Act also allows downstream buyers to request information on biocides used on the treated articles, and requires manufacturers or importers to provide the relevant information upon buyer’s request.
Legislative timeline established
– The Korean government plans to enforce the above Biocides Act starting January 1, 2019, and will establish further details through lower regulations prior to the effective date.
Significance / Potential Impact:
As the MOE’s Notice and the Biocides Act could apply to industries across the board, we expect these legal developments to potentially impact the entire product supply chain from product manufacture or import, all the way through sale. The draft law has not yet been finalized, and companies are well advised to continue to monitor developments in this area.