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Enactment of New Biocides Regulation in Korea
Category Policy/Management


Social interest in biocides has been increasing with the use of biocides for humidifiers, resulting in casualties in 2011. Biocides refer to any nonagricultural pesticides to control and remove unwanted organisms. They are very widely used in everyday life and cause damage accordingly. While the management of biocides is being strengthened worldwide to avoid such damage, Korea still lacks systematic management in this area. In this study, the need for effective domestic management of biocides is emphasized by analyzing domestic and foreign regulations of biocides. Regulatory actions that should be urgently implemented are also proposed. 

The status and level of biocide management in Korea is examined based on analysis of the biocide regulations of the EU, the U.S., Japan, and Korea, including the Act on Registration and Evaluation of Chemical Substances. The analysis revealed that the increased use of biocides around the world has led to the establishment of regulations specific to biocides. It, however, also indicated that biocide regulations are scattered under various laws in the U.S., Japan, and Korea. These countries have not clearly assigned a governing body for biocide regulations. Additionally, the Act has been found insufficient in managing biocidal-active ingredients and products because it covers only a portion of such products.
A comprehensive investigation was conducted on the EU BPR, the main set of biocide regulations, in order to derive regulatory contents necessary for the establishment of biocide-related management laws. The EU BPR was also analyzed and compared with the EU REACH and the Act. Unlike the REACH and the Act, the BPR regulates all biocides regardless of tonnage. The BPR requires the industry to submit efficacy data and draft risk assessment reports for the approval of active ingredients. As for biocidal products, a management system is being developed with consideration of the characteristics of biocides, including additional information on cumulative effects, because of combined uses. Risk assessment for biocides was compared with risk assessment for industrial chemicals by analyzing foreign risk assessment technology and policies that support the biocide industry. In Korea, it is necessary to institutionalize proper approval and authorization procedures for the risk assessment of active ingredients and biocidal products. Additional evaluation technologies for efficacy and cumulative effects should be developed to secure the safety of biocides. In addition, the development of procedures and appropriate guidelines for evaluation techniques is essential to encourage the industry to obtain approval and permission for biocides on their own.

Based on the information above, the need for domestic biocide management as well as legal measures, technology, and industry-supporting policies were derived as follows:


①	Given the increasing use of biocides in modern society, it is vital to assess the cumulative effects of combined uses. Separate registration and evaluation procedures are demanded to fit the unique characteristics of biocides, which are clearly distinct from that of industrial chemicals. Regulatory measures to test the risks of all biocides are necessary because the Act is inadequate in verifying the safety of biocides due to lack of assessment for the uses of biocides in small quantities. In Korea, biocides are managed by different criteria in a variety of laws under various departments. Thus, unified laws should be established to allow identical criteria to be applied to biocides. 

②	For efficient management of biocides safety, development of domestic technologies to evaluate the efficacy and cumulative effects, which are currently unsatisfactory in Korea, is proposed. The EU test method/guideline by product type and the standard operating procedures of the U.S. should be used as a reference in developing test methods that are applicable the domestic situation. In light of cumulative effects, it is also necessary to develop domestic evaluation techniques with reference to assessment of cumulative effects on human and environment of the EU, the U.S. EPA, and OECD, as well as cumulative risk assessment of the U.S. EPA. Two legal measures for biocides were proposed.

③	As part of supporting the industry, training should be provided using a new manual that covers the latest contents related to biocides. New guidelines should be created to help the industry in understanding detailed legal information about biocide management, such as human and environmental risk assessment, including evaluation of efficacy and cumulative effects and other information requirements by product type. Furthermore, it is indispensable to directly assist biocide-related field staff by providing customized support in the form of hosting workshops, seminars, and presentations to promote mutual communication, and by offering online consultation services.


(eng) 14Biz-44_Enactment of New Biocides Regulation in Korea.pdf 
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