Current biocides management policy in Korea Chemtopia Co., Ltd. Sanghee Park, Ph.D.
2 Outline - Background - Issues and current situation - Competent authority for biocide regulation - Quasi-phamaceuticals and household chemical product - The National roadmap of biocide management(proposed) - K-REACH - Conclusion
Background The definition of biocide in K-REACH (Article 2) A biocide is a substance which can kill, inhibit, and exert a controlling effect on any harmful organism except for human or animal such as insecticide, disinfectant or preservative. The estimated biocide market in Korea (Year 2010) - Chemical volume survey every 4 years by the MOE - Use category linked with the biocide use among 71 uses - 460,000 MT (0.1% of total circulated volume of chemical) based on EU identified & notified A.I. cf. 400,000 MT in EU (EU biocide final report, year 2009) Use category Manufacture (1,000 MT) Import (1,000 MT) Export (1,000 MT) Circulated Volume (1,000 MT) # of Active substance # of company Disinfectants 522 125 233 414 245 1579 Preservatives 20 17 0. 682 36.318 0.139 256 (1000 MT, 2010) Medicine/Medicine 0.217 7.4 0.212 7.405 75 79 intermediate Non-agriculture - 0.15-38 10 0.15 pesticide Biocide use 542 150 233 459 358 <1,924 3
4 Issues and current situation The current biocide management - No separate biocide regulation in Korea- Several competent ministries involved. - No active ingredient inventory for national biocide management - No clear product type category (use application) - The limitation of current TCCA focusing on industrial toxic chemicals to manage biocide and biocidal products (especially for finished biocidal product imported) New regulatory frame for biocide management is required
5 Issues and current situation The safety of a chemical product; lung damage caused by exposure to humidifier disinfectants. This tragic accident was the driving force for Congressman to pass K-REACH without any delay covering consumer product (and biocidal product) management. In the vice-minister s meeting at the end of 2012, the Ministry of Environment decided to take responsibility for some household chemical products. => Cleaning agent, air fresheners, deodorizers, Adhesives, Polish, Synthetic detergents, Bleaching agent, Fabric softenening agent
Competent authority for biocide management Competent authority and relevant regulation on product type of biocide Main Group 1: Disinfectants Main Group 2: Preservatives 1. Human hygiene 2. Disinfectants not intended for direct application to humans or animals 3. Veterinary hygiene 4. Food and feed area 5. Drinking water 6. In-can preservative 7. Film preservative 8. Wood preservatives 9. Fibre, leather, rubber and polymerised materials preservatives 10. Construction material preservatives 11. Preservatives for liquid-cooling and processing systems 12. Slimicides 13. Working or cutting fluid preservatives PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety) PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety) THE QUALITY CONTROL AND SAFETY MANAGEMENT OF INDUSTRIAL PRODUCTS ACT (Ministry of Trade, Industry and Energy) VETERINARY MEDICINE ACT (Ministry of Agriculture, Food and Rural Affair) FOOD SANITATION ACT (Ministry of Food and Drug Safety) VETERINARY MEDICINE ACT (Ministry of agriculture, food and rural affair) DRINKING WATER ACT (Ministry of Environment) TOXIC CHEMICAL CONTROL ACT (Ministry of Environment) The STANDARD OF WOOD PRESERVATIVE TREATMENT (Korea Forest Service) 6
7 Competent authority for biocide management Main Group 3: Pest control Main Group 4: Other biocidal products 14. Rodenticides 15. Avicides / 16. Molluscicides,/ 17. Piscicides 18. Insecticides, acaricides and products to control other arthropods 19. Repellents or attractants 20. Control of other vertebrates 21. Antifouling products 22. Embalming or taxidermist fluids PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety) PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety) PHARMACEUTICAL AFFAIRS ACT (Ministry of Food and Drug Safety) FOOD SANITATION ACT (Ministry of Food and Drug Safety) FEED MANAGEMENT ACT (Ministry of agriculture, food and rural affair) TOXIC CHEMICAL CONTROL ACT (Ministry of Environment) MARINE ENVIRONMENT MANAGEMENT ACT (Ministry of Oceans and Fisheries) Partially regulated in Korea Not regulated in Korea Fully regulated in Korea K-REACH by the MOE will take a key role for biocide which is not properly controlled in other Ministries.
8 PHARMACEUTICAL AFFAIRS ACT - Ministry of Food and Drug Safety Coverage of Quasi-pharmaceutical as biocide <Article 2> Non-appliance, nonmachinery or similar articles which act slightly or do not directly act upon human bodies; Preparations used for sterilization, insecticide and uses similar thereto for the purpose of preventing communicable diseases; - Toothpaste - Teeth whitening - Mouthwash - Mask, sanitary pad, etc. - Deodorant - Anti-hair loss agent - Contact lens cleaner - Repellent agent, fly or mosquito attracting agent for human or animal hygiene - Humidifier disinfectant - Disinfectant for dentures - Insecticide - Rodenticide - Sterilizer or disinfectant not directly applied to the human body : alcohols, aldehydes, cresol, soap type disinfectants - Preparation for preventing communicable diseases
9 PHARMACEUTICAL AFFAIRS ACT - Ministry of Food and Drug Safety Import of quasi-drug: Safety and efficacy test (www.kfda.go.kr) Yes - Origin - Toxicological data - Efficacy test data - Product efficacy test data - Use information in foreign country Identical product(physical state, specification, composition, etc) has been approved before? No New substance? Yes Subject to safety and efficacy test Assessment by KFDA(55 d) Standard product category Yes Submit product notification (10d) No Product approval (25 d)
The management of those product will be transferred to the MOE through K-REACH. 10 THE QUALITY CONTROL AND SAFETY MANAGEMENT OF INDUSTRIAL PRODUCTS ACT - Ministry of Trade, Industry and Energy Coverage of (household) chemical products Subject to Self safety confirmation (Article 2.9) - Battery - Anti-freezing agent - (household) chemical product - Automobile brake fluid - Automobile window washer fluid - Automobile tire - Children s product made by synthetic polymer - Adhesive(glue) - Cleaning agent(floor, bathroom, car, etc) - Room Odorizer(air freshener) - Adhesives - Polish - Deodorizing agent - Synthetic detergents - Bleaching agent - Fabric Softening agent Import of (household) chemical product: Safety standard (http://www.safetykorea.kr) - Self-confirmation by performing test in certified laboratory to determine if the chemical product meets safety standard - Report to the Safety Certificate Institute with the test results and product description
11 THE QUALITY CONTROL AND SAFETY MANAGEMENT OF INDUSTRIAL PRODUCTS ACT - Ministry of Trade, Industry and Energy Safety standard (ex. Cleaning agent (floor, bathroom, car, etc.)) - Application coverage - Safety standard : appearance, content of hazardous substance*(negative approach), container shape Hazardous substance HCl NaOH Tetrachloroethylene Trichloroethylene Cut off Less than 10% Less than 5% Less than 0.1% Less than 0.1% - Test method - Examination method for certification (sampling, # of test, etc.) - Labelling : 1) Product name / Product type / Date of manufacture / Importer information / Address and phone No. / Country of manufacture / Composition (surfactant and its content / phosphoric acid salt and its content/ Others) 2) Toxicity ( Toxic for Toxic chemicals under TCCA) 3) Weight and acidity/basicity 4) Precautionary statement
12 Biocide management roadmap (proposed) - Ministry of Environment Step-wise management plan (MOE s national project in 2013)
Biocide management roadmap (proposal) 1 st step: Building fundamental factors (2013-2015) Technical aspects (risk assessment) Regulatory aspects Support for industry - Inventory establishment of biocide active substance - The survey & monitoring of biocide active substance and biocidal product - Negative list to be controlled for biocidal product (CMR, PBT, vpvb) - Priority Biocidal product type for management - Exposure scenario analysis and establishment of exposure assessment of biocidal product type - Preparation of technical guidance for exposure scenario and evaluation - Development of Analytical method for active substance - Data requirements for biocide active substance and biocidal product. - Building fundamental factors for Efficacy test - Communication in supply chain to confirm hazardous substance in biocidal product - The Sub-ordinance preparation for biocide management(k-reach) - Organization for biocide management - Public notice of highly concerned product for risk assessment - Pubic notice of product type category for biocidal product - Public notice of guidance for exposure scenario and exposure assessment - Data requirements of biocide substance and biocidal product - Public notice of efficacy test in biocidal product assessment - Public notice of analytical method of biocide active substance - Registration training program - Support for establishing an inventory 13
Biocide management roadmap (proposal) 2nd step: The registration of biocide and assessment of biocidal product (2015-2019) Technical aspects Regulatory aspects Support for industry - Adoption of product notification of biocidal product - Establishment of hazard and risk database of biocide active substance - Step-wise risk assessment of biocidal product by Government - Guidance of safety and labelling standard for biocidal product type - Guidance of efficacy test for biocidal product assessment - Gathering exposure factors and enhanced risk assessment for biocidal product type - Development of risk assessment modelling and assessment system - The adoption of an Eco-mark for biocidal products that do not contain hazardous substances - Public notice of safety and labelling standard through risk assessement for biocidal product - Regulatory adoption of biocidal product notification - Registration and assessment of biocide substance under K- REACH - Authorization process for hazardous substance in biocidal product - Urgent suspension of use of highly concerned product - Regulatory adoption of an Ecomark for biocidal products that do not contain hazardous substances - Information sharing of biocidal product - Training for product risk assessment - Test laboratory incubator for biocide assessment - Voluntary participation of ecofriendly biocidal product use - Support for sound chemical management in industry - Database of substitutes for highly concerned biocide active substances - Training program for safety and labeling of biocidal product 14
15 Biocide management roadmap(proposal) 3rd step: The registration of biocidal product led by industry (2020-) Technical aspects Regulatory aspects Support for industry - Registration guidance of biocidal product - Positive list preparation and maintenance for biocide management - Technical development for re-registration of biocidal product - Regulatory adoption of the industry led registration of a biocidal product - Maintenance of Regulatory positive list - Adoption of re-evaluation of biocidal product - Registration training program for biocidal product
16 K-REACH - Ministry of Environment K-REACH overview <Substance> Existing Chemicals ( 1ton/year) All New Chemicals Existing Priority Substance 1ton/year and All New Chemical Toxic Chemical Substance for Authorization Reporting of Manufacture, etc. Registration Completeness Check Hazard Evaluation Risk Assessment <Product- consumer product> Communication in supply chain Restricted/ Prohibited Chemical Chemical Product Notification of hazardous chemicals contained in a product exceeding 1 ton/year Risk assessment of products with high risk concerned product Safety standard and labeling criteria & recall
17 K-REACH Main obligation K-REACH Biocide* Reporting Registration Communication in supply chain Product notification Risk assessment of highly concerned product - Chemical business (manufacturer, importer and seller) shall report the volume and use information of all new chemicals and existing chemicals over 1 ton/year every year. - Manufacturer and importer - All new chemicals and existing chemicals subject to registration over 1 ton/year are required to be registered (3 year batch system). - Supplier is required to provide information related to registered substance to downstream users and sellers. Downstream users and sellers shall provide chemical information to supplier upon request. - Manufacturer and importer of consumer product - When hazardous chemicals are present in a product at quantities greater than the specific tonnage ( 1 ton/year), name of chemical, content, hazard information, use, etc. shall be reported. - Government (MOE) - The manufacturer and importer should follow Safety standard and labelling criteria Biocide substance & Ingredient of industrial/ consumer biocidal product Biocidal product only for consumer use
18 K-REACH - Ministry of Environment Exclusion from K-REACH application Exclusion (Article 3) - Radioactive substances - Medicines and quasi-pharmaceuticals - Narcotics - Cosmetics and active ingredient used for cosmetics - Agrochemicals and active ingredient - Fertilizer - Food and food additives, food instrument, food container, package - Livestock feeds - Explosives - Military supplies - Health functional food - Medical devices
19 K-REACH Definition (Article 2)- Registration of existing substance - Existing chemicals subject to registration for its hazard assessment or risk assessment - Existing chemicals subject to registration will be designated and announced based on its amount and hazard/exposure information through the deliberation of the assessment committee Priority (June 27. 2011. Public hearing, MOE) Criteria for registration of an Existing chemical HAZARD EXPOSURE # of substances 1 st CMR or PBT HPV 2 nd CMR or PBT H410(R50/53) or Toxic chemical HPV 20-20,000 ton 20,000 ton 1-20 ton 10-20,000 ton 1,000-20,000 ton 372 791 3 rd H410(R50/53) or Toxic chemical HPV 1-10 ton 100-1000 ton 923
20 K-REACH Data requirements for biocide substance 1 Company information 2 Chemical identity 3 Use information -Company name, address, name of representative, telephone no., -Only representative information (Company name, address, contact point, etc.) - Information of lead registrant (in case of joint submission) -Chemical name, molecular formula, chemical structure, CAS No. -Product name -Purity (%) -Identified impurity, by-product information (Chemical name, content) -Use category -Brief description of chemical s specific use -Uses advised against 4 Classification Biocide and -GHS classification Physico-chemical and labelling property & Toxicological data labelling 0.1-1 ton General Data requirements for 1-10 ton/year (Starting 5 Physicochemical from Jan. 1, 2020) properties 6 Toxicological information 1-10 7 Risk ton assessment report for substance General Data 10 requirements ton/year for 10-100 ton/year 810-100 Method ton of Safe Handling (Protective General Data equipment, requirements emergency for 100-1000 measures ton/year for explosion, fire or release) - Data generated by Domestic & Foreign GLP laboratories can be acceptable (logkow : GLP) - >100 Test ton plan report for tests for high General level Data submitted requirements instead for >1000 ton/year
K-REACH Data requirements for Biocide substance registration (Starting Jan. 1, 2020 for new biocide) K-REACH Data requirements 0.1-1 1-10 10-100 >100 Physico-chemical properties 1) Physical status O O O O 2) Water solubility O O O O 3) Melting/freezing point O O O O 4) Boiling point O O O O 5) Vapor pressure O O O O 6) Octanol/water partition coeff. O O O O 7) Relative density O O O O 8) Granulometry O O O O 9) Flammability O O O 10) Explosive property O O O 11) Oxidizing property O O O 12) Viscosity O O 13) Dissociation constant O O 21
K-REACH (Starting Jan. 1, 2020 for new biocide) Data requirements 0.1-1 1-10 10-100 >100 Human health effect 1) Acute oral toxicity O O O O 2) Acute dermal toxicity O(or inh) O(or inh) O(or inh) 3) Acute inhalation toxicity O(or dermal) O(or dermal) O(or dermal) 4) Ames test O O O O 5) In vitro Mammalian Chromosomal Aberration Test O O O 6) In vitro gene mutation test in mammalian cells O(In case positive only in 4) 7) In vivo mammalian gene mutation test (micronucleous test) O(In case positive in 4 and/or5) O(In case positive only in 4) O(In case positive in 4 and/or5) O(In case positive only in 4) O(In case positive in 4 and/or5) 8) Additional mutation test( germ cell mutagenicity etc.) O O 9) Eye corrosion/irritation O O O 10) Skin corrosion/irritation O O O O 11) Skin sensitization O O O O 12) Screening for Reproductive/ developmental toxicity O O O 13) Repeated dose toxicity (28 days) O O O 14) Sub chronic toxicity study (90 day) O 15) Pre natal developmental toxicity study O 16) Two generation reproductive toxicity O 17) Carcinogenicity study O 22
K-REACH (Starting Jan. 1, 2020 for new biocide) Data requirements 0.1-1 1-10 10-100 >100 Ecotoxicity 1) Acute fish toxicity O O O O 2) Acute daphnid toxicity O O O O 3) Acute algae toxicity O O O 4) Ready biodegradability O O O O 5) Inherent biodegradability O O 6) Hydrolysis as a function of ph O O O 7) Identification of degradation products O O 8) Chronic fish toxicity O O 9) Chronic daphnid toxicity O O 10) Activated sludge respiration inhibition test O O 11) Adsorption/desorption screening test O O 12) Addtional Adsorption/desorption screening O 13) Short term toxicity to plants O O 14) Short term toxicity to invertebrates(earthworm) O O 15) Fate and behaviour in the environment O 16) Bioconcentration O 17) Long term toxicity to sediment organisms O 18) Long-term toxicity testing on plants O 19) Long term toxicity testing on invertebrates (earthworm) O 23
24 K-REACH The transition period for registration - An existing substance is subject to registration : 1) Three years from the publication of the priority list 2) During transition period, manufacturer and importer can continue their business without registration - New substance : No transition period given Public notice of existing chemical subject to registration 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Publication of K-REACH sub-ordinance First batch & registration Second batch & registration Third batch & registration
25 K-REACH Joint Submission of Registration dossiers (Article 15) - Joint submission of registration dossiers on the same chemicals is mandatory - Opt out due to CBI protection, cost, etc. is possible, but approval by MOE is required in advance Registration update (Article 12) - In case the registered tonnage band changes, the updated dossier shall be submitted within 1 month after the change takes place - In case the registered use category and specific use changes, the updated dossier shall be submitted within 1 month after the recognized changes - In case the physicochemical information, toxicological data and CSR changes, the updated dossier shall be submitted within 6 months after the recognized change
26 K-REACH Definition (Article 2) Product: Articles for consumer use, its parts or component with potential exposure of chemicals including the following items: - Product in mixture - Article having specific function in solid form which is not released during its use High risk product of concern: Product with risk to human health and environment and published by MOE through consultation with relevant Ministries. - Household product for general consumer use such as cleansing agent, air freshener, adhesive, polish, deodorizer, detergent, whitener and softener - Biocidal products such as insecticide, disinfectant, and preservative
27 K-REACH Product notification (Article 32) - Product notification is required when hazardous chemicals are present in a product at quantities greater than the specific tonnage ( 1 ton/year). The hazardous chemical name, content, hazard information and use in the product shall be declared in advance. (Article exempt) 1. Legal entity for product notification: - Manufacturer and Importer (Only representative) of Product 2. Hazardous chemicals - Toxic chemical, Chemicals requiring authorization, Restricted/Prohibited chemicals - The number of hazardous chemicals will be over 2,000-3,000 substances when compounds or salts are taken into consideration 3. Product notification condition: 1 + 2 1 Total amount of each hazardous chemical contained in a manufactured or imported product yearly, (Jan. 1 Dec. 31) that exceeds 1 ton/year 2 Content of the hazardous chemical contained in a product exceeding 0.1%(w/w)
28 K-REACH Product risk assessment (Article 33) - Product risk assessment is required for a product with a high risk concern* that will be published by the MOE. This risk assessment will be performed by a specialized institution appointed by the Ministry of Environment. - After the risk assessment, the Ministry of Environment will issue the safety standard and labeling criteria. * Consumer products such as cleaning agent, air freshener, adhesive, polish, detergent, bleaching agent, softener and biocidal product Grace period(article 4 of Presidential decree, supplement) - The grace period of Safety standard and labeling criteria for High risk concerned product will be given until the MOE s public notice for those products and current MOTIE s standard according to the Quality control and Safety management of industrial products act should be followed in between.
29 Conclusion No separate biocide regulation and no biocide product type category exists in Korea Biocide is managed by different ministries according to its use application. The MOE will take a key role in biocide management under K-REACH K-REACH requires registration only of biocide substances and the MOE assesses the risk assessment of highly concerned product including biocidal product. Pay attention to the transition of 8 household products from MOTIE to MOE s control and keep you update the MOE s publication of Safety standard and Labelling criteria. Treated article is not considered yet. Still gray zone exists in the application scope of K-REACH concerning registration of biocide substance.
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