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chemtopia

K-BPR

Biocide

In April 2011, the issue of biocides was raised by the deaths of infants, pregnant women, and adults due to respiratory exposure to sterilizing substances in domestic humidifier cleaners. A biocide is a non-agricultural pesticide, used to remove harmful organisms except humans and animals, and includes non-agricultural insecticides, fungicides, disinfectants, preservatives and antimicrobial agents.



In Europe or the United States, separate legislation on biocides has been enacted to systematically manage not only the active substance of biocidal products but also the evaluation and approval of the biocidal products. Furthermore, it’s also included the treated article with the biocidal product in the range. So, when you export the active substances, products and treated article to Europe, the United States and Japan, etc., registration and evaluation should be completed according to the relevant procedure.



The Toxic Chemicals Control Act has been comprehensively regulated by the [Act on Registration and Evaluation of Chemical Substances (K-REACH)] and the [Chemical Control Act (CCA)] as the segmentalized management. In addition, on 1st January 2019, the Ministry of the Environment has enacted the [Safety of Household Chemicals and Biocidal Products Act (Chemical Product Safety Act)] which regulates biocidal products and chemical-containing products. Likewise, Korea has established a systematic management system for biocide (active substances, biocidal products, and treated article) like EU. The definitions of biocides on Act are as follows.

biocides

Biocide management includes active substance, biocidal products, treated article and follows the definition below

Biocide

Includes all active substance, biocidal product and treated article

· Active substance

      A substance or microorganism that has the effect or property of eliminating,
      controlling, rendering harmless of deterring harmful organisms.

· Biocidal product (excludes mere physical or mechanical action)

      - A substance, mixture of product (e.q., disinfectant, insecticide, preservative, etc.) consisting
      of or containing one or more active substances, and having the primary purpose of elimi-
      nating harmful organisms; or

      - A substance, mixture of product (e.q., ion/ozone-generating air sterilizer, sterilizing water
      generator, etc.) that generate active substances from a substance or mixture, and having
      the primary purpose of eliminating harmful organisms.

· Treated article

      Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products for
      the purpose of eliminating harmful oranaisms (a treated article thet has a biocidal function as its primary function shall
      be considered a biocidal product) (e.q., Article treated with preservative)

biocides

Any person who intends to manufacture and import active substance and biocidal products must obtain approval from the Minister of the Environment for the relevant substances and products. The purpose of approval is to validate its risks and hazard beforehand to be distributed on the market only if the safety, effectiveness and efficacy are proven.

Chemtopia's consulting service

  • · Domestic Active Substances Approval, Biocide Products Approval, etc, Overall consulting
  • · Review and registration consulting about the United States FIFRA
  • · Review and registration consulting about Europe BPR
  • · Review and registration consulting about Japan SIAA
  • · Review and registration consulting about biocide in other countries
  • · Required test arrangement and scheduling
  • · Response to the client’s inquiry about Regulatory compliance