On February 28, 2018, the Korean National Assembly passed the Act on the Safe Control of Common Household Chemical Products and Biocides (“Biocides Act” or the “Act”), which was proposed by the Ministry of Environment (“ME”) on August 16, 2017. The new Biocides Act was promulgated on March 20, 2018, and is scheduled to become effective on January 1, 2019. 


Major provisions of the new Act are as follows:


1. Safe control regime for household chemical products

  • If after a hazard assessment, a household chemical product* is determined to be hazardous, the Minister of Environment shall designate the product as a “household chemical product subject to safety confirmation.” An importer or manufacturer of such a product is then required to obtain a safety confirmation from a certified laboratory that the product is in compliance with the safety standards (Articles 3 and 10).\
  • “Potentially hazardous products” regulated under K-REACH will be newly designated as “household chemical products subject to safety confirmation” under the Biocides Act. In so doing, the scope of chemical products subject to safety confirmation is expanded to now include products used in offices and multi-use facilities, as well as those for home use (Article 3).


2. Biocidal active substance approval system

  • A manufacturer or importer of a biocidal active substance** is required to obtain an approval from the Minister of Environment. If the chemical structure, hazard level, efficacy and effectiveness of the biocidal active substance are equivalent to those of an authorized substance, the approval can be deemed to have been obtained (Article 16).
  • Among the active substances that have already been distributed in the market before December 31, 2018, only those substances that are declared to the ME by June 30, 2019 will be designated as “existing substances,” depending on the harmfulness, hazard level and type of product using the substance. Once designated, the product is exempt from needing approval for up to ten years (Article 18).



3. Biocidal product approval and labeling system

  • A manufacturer or importer of a biocidal product is required to obtain an approval from the Minister of Environment. Products that have been recognized as “similar” to an already-authorized biocidal product shall be deemed to have been approved. Here, “similar” means, among others, products that contain the same biocidal active substance(s), have substances with similar composition/content, have similar use/application, have similar levels of hazardousness, and have similar levels of effect/efficacy of eliminating harmful organisms.
  • Manufacturers or importers of approved biocidal products shall affix a label to the products indicating the composition and content of biocidal active substance(s) used, information on dangers associated with the use of the products, and first aid methods (Article 27).


4. Safe management and labeling standards for biocidal treated articles

  • Only approved biocidal products may be used in biocidal treated articles (Article 28).
  • Manufacturers and importers are required to warn of the risk of the biocidal-treated article, and give precautions for handling (i.e., provide information regarding the efficacy and biocidal effect of eliminating harmful organisms of the relevant biocidal article) (Article 28).


5. Standards for distribution management of household chemical products & biocides

  • Advertisements for household chemical products subject to safety confirmation and biocidal products cannot use expressions such as “non-toxic” and “environmentally-friendly” (Article 34).
  • Safety containers/packaging must be used to prevent accidents during handling/use of biocidal products (Article 20).
  • For biocidal products or biocidal treated articles which have not been approved by the ME, advertisements or claims that may mislead consumers to believe the product has a biocidal function is prohibited (Article 34).
  • When a manufacturer or importer becomes aware of any side effects of its product, such manufacturer or importer shall report this finding to the Minister of Environment. Here, manufacturer or importer refers to those who: (i) obtained an approval for the biocidal active substance/product; and/or (ii) manufactures/imports a household chemical product subject to safety confirmation/biocidal-treated article (Article 36).
  • An administrative fine, corresponding to the sales revenue, may be imposed for failing to conduct conformity testing for a household chemical product subject to safety confirmation, or for manufacturing or importing unapproved or unauthorized products (Article 38).



Significance:

Once the Biocides Act takes effect, in principle, marketing of all biocidal active substances and biocidal products is possible in Korea only if they are proved to be safe, except for those which were granted a grace period. 

As the Biocides Act will take effect on January 1, 2019, companies that handle any biocidal active substances, biocidal products or biocidal-treated articles should carefully review the main provisions of the Act to identify any potential issues that need to be addressed.


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* A household chemical product refers to a product used in living spaces, such as a home, office or multi-purpose facility, and has the potential to cause exposure of chemicals to humans or the environment.

** A biocidal active substance is a chemical substance, natural substance or microorganism that has the effect of eliminating, controlling, rendering harmless or deterring harmful organisms.

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