How to comply with K-REACH (K-REACH : Act on the Registration and Evaluation of Chemical Substances) October 21 st, 2014 Moonsun RYU Risk Assessment Center Korea Testing & Research Institute ASTM International Industry Workshop 1
Contents 1. Act on the Registration and Evaluation of Chemical Substances (K-REACH) 2. How to comply with K-REACH 2
Overview 2012.9.28 : Submission of draft K-REACH to National Assembly by the MoE. 2013.4.8 : Lawmaker Shim s proposal of another draft K-REACH 2013.4.24 : Consolidated bill of above two bills was approved by the Environment and Labor Committee 2013.4.30 : Approval by the Legislation and Judiciary Committee (with partial correction) 2013.4.30 : Approval at the plenary session of National Assembly 2013.5.22 : Promulgation of the Act 2014.2.18 : Pre-announcement of subordinate statutes 2015.1.1 : Entry Into Force 3
Relationship with TCCA Toxic Chemicals Control Act (TCCA) K- REACH Registration of chemicals hazard assessment & risk assessment Designation of hazardous chemicals Supply of information on chemicals Management of risk concerned products Confirmation of chemicals Application for Authorization chemicals Statistical survey on chemicals Safety control of hazardous chemicals Business permit for hazardous chemicals Readiness & countermeasures against chemical accidents CCA 4
Chemical Control System Reporting of Manufacturing, etc. Existing chemicals [exceeding 1 T/Yr] Announcement of existing chemicals subject to registration New chemicals [All] Registration Applicable to chemicals less than 1 T/Yr, if pose risk to human and the environment (thru. consultation with relevant Ministries and evaluation committee) Designation as a Toxic chemical Hazard assessment Risk assessment If >10 T/Yr (gradually strengthened from 100 T/Yr) Or required as a result of hazard assessment K-REACH Designation as a Authorization chemical Designation as a Restricted/Prohibited chemical Consider international treaty, etc. New chemicals [>0.1T] Hazard assessment Toxic chemical, Observational chemical TCCA Existing chemicals Consider international treaty Restricted/Prohibited chemicals 5
Reporting of manufacturing, etc Any person who manufactures/imports/sells a new chemical or existing chemical exceeding 1 ton/year shall report the data on manufacture/importation/sales for the previous year (from 1 January to 31 December) to the head of regional environmental office by 30 April of the following year. (first implementation: report 2015 s performance in 2016) Data to be reported Information on manufacturer, importer, and seller of the chemical (enterprise name, location, contact information, etc.) Information on the OR designated by overseas manufacturer (enterprise name, location, contact information, etc.) Information on the chemical (name, identification code, etc.) Quantity of the chemical manufactured, imported, or sold Use of the chemical Seller Chemical seller is a person who sells a chemical to other person who uses the chemical as a raw material or for consumption at the workplace. Chemical seller who does not acquire a chemical from up-stream supply chain may not provide information on the chemical, quantity manufactured/imported/sold, use of the chemical, as long as name of the product containing the chemical, purchaser name, confirmed chemical composition and use are submitted. 6
Exemption from chemical registration 1. Chemicals imported as incorporated in machinery 2. Chemicals imported together with machinery or equipment for their test operation 3. Chemicals contained in a product in solid form to perform a certain function without leaking during use Chemicals requiring confirmation of registration exemption A chemical substance manufactured or imported in not greater than 10 tons per year for the purpose of exporting the whole quantity The chemical reagent in the case that a chemical reagents is manufactured/imported in annual basis for scientific experiment, analysis or research purposes The chemical manufactured/imported once for R&D purpose falls under any of following cases: In case of development of a chemical or a product/goods; In case of renovation/development of a process; In case of testing of new application of a chemical; or In case of trial manufacturing of a chemical or trial production of a product/goods. The polymer of low concern is manufactured/ imported for the first time The chemical substance in the case that a chemically surface-treated chemical substance, for which base substance for surface treatment and substance to treat the surface of base substance are not new chemicals or existing chemicals subject to registration, is manufactured/imported for the first time 7
Registration of chemicals Any person who intends to manufacture/import a new chemical or an existing chemical subject to registration in quantity of 1 ton or more per year shall register the substance prior to manufacture/importation. However, the chemical substance designated and announced by the MoE through deliberation by the Evaluation Committee as the one having high potential to cause significant damage to public health or the environment shall be registered even if the quantity to be manufactured/imported is less than 1 ton per year. Existing chemicals subject to reg. The Minister of Environment shall designate and announce existing chemical substances subject to registration from existing chemical substances through the deliberation by the Evaluation Committee with consideration of domestic trade volume and information on hazards/risks. Designation cycle : 3 years Registration grace period : 3 years after announcement Designation of existing chemicals subject to registration In case that the Minister of Environment intends to designate existing chemical substances subject to registration, the Minister shall announce in advance the name of chemical substances, etc. through an official gazette or internet. Items to be announced Chemical name and identification code Granted registration grace period Test data to be submitted (if manufactured/imported quantity is less than 1 ton/year.) 8
Registration data Required Data for Registration Physicochemical properties Toxicity to human body Environmental toxicity Total 1-10T 8 4 3 15 10-100T 11 10 5 26 100-1000T 13 11 13 37 >1000T 13 15 19 47 9
Joint Registration Any person who intends to file a registration for an existing chemical substance subject to registration within the grace period shall file a registration individually, but the registration data set by the Environment Ministerial Decree may be jointly submitted through a lead registrant designated. Joint submission data Physico-chemical properties of chemical Hazards of chemical Testing Proposal Risks of chemical (if all registrant have agreed upon) Guidance data for safe use (if all registrant have agreed upon) Individual submission In the case that there is a possibility of disclosure of the enterprise s confidential business information that may cause significant commercial loss. In the case that the joint submission costs more than individual submission. In the case that test data for the identical test item is showing differences in chemical classification and label. In the case that the owner of test data does not provide a fair and clear basis for the expenses of the test. Obtain a Confirmation of Individual Submission from the MoE. 10
Risk Assessment The MoE shall conduct Risk Assessment, based on the result of Hazard Examination, for the chemical falling under any of followings among the chemicals registered and shall notify the result to a registrant. Target chemicals Chemicals being manufactured/imported in 10 tons or more per year Chemicals deemed as one requiring a risk assessment from the hazard assessment results Grace period Manufacture(Import) 100 or more ton/year: 1 Jan. 2015 ~ Manufacture(Import) 70 or more ton/year: 1 Jan. 2017 ~ Manufacture(Import) 50 or more ton/year: 1 Jan. 2018 ~ Manufacture(Import) 20 or more ton/year: 1 Jan. 2019 ~ Manufacture(Import) 10 or more ton/year: 1 Jan. 2020 ~ The MoE may request the registrant to submit additional data deemed necessary for the risk assessment. The MoE may take necessary measures to minimize the risks based on the result of Risk Assessment. 11
Notification of products containing hazardous chemical Any person who produces/imports a product, containing a hazardous chemical more than 0.1 weight %, in aggregate quantity of 1 ton or more per year shall notify. Definition of Products Any of the following items for end users or its components or accessories with a potential to cause consumers to be exposed to a chemical substance: 1 An item consisting of preparation 2 An item in which the chemical substance contained in solid form performs a certain function without leaking during use (no notification required) Information to be notified Info. on notifier(or) (shop name, address, contact info., etc.) Product info. (product, trade name, capacity, user manual, etc.) Name of hazardous chemical contained, content (including confirmed impurities & by-products) Known classification/hazard info. on the contained hazardous chemical Use(function) of the hazardous chemical in the product Use of product Confirmation of Notification Exemption If exposure of the chemical to human or the environment can be avoided as long as it is used in an usual manner. If the chemical has already been registered for that use of the product. 12
Product Risk Assessment In order to prevent any risk to public health or the environment by hazardous chemicals in a product, the MoE shall conduct a risk assessment for each item of a risk concerned product. Manufacturer/importer/seller/distributor of a product may be requested to submit necessary data. Risk Concerned Products Following chemical products announced by the MoE after having consultation with the head of relevant central administrative organ as one deemed potentially risky to public health or the environment: 1 Products used by consumers on their daily lives such as cleaner, air fresheners, adhesives, polishers, deodorants, synthetic detergents, bleaches or fabric softeners. 2 Products used to kill, interrupt or immobilize harmful organisms except for human beings and animals such as insect repellents, sanitizers or preservatives. Safety Standard Labeling Standard No one shall sell products not meeting the safety and labelling standards. Any person who manufactures/imports a risk concerned product for which no safety and labelling standards are announced yet shall obtain an approval by submitting registration application data on the chemical. 13
Only Representative Any manufacture/producer of a chemical or a product being imported from overseas to Kore a may appoint an OR to perform the obligatory tasks of the importer under K-REACH. Qualification of OR Knowledge in chemical information Minimum 3 years of work experience in chemical control Tasks of OR Reporting of use and quantity of chemical pursuant to Art.8 Application for registration pursuant Art.10(3) Notification under Art.32 Reporting of changes pursuant to Art.8(3) Application for confirmation of registration exemption under Art.10(2) Amendment of registration/notification under Art.12 Confirmation of individual submission under Art.15 Inquiry on existence of previous registration of the same chemical under Art.16(2) Confirmation of owner s refusal to use vertebrate animal test data under Art.17(2) Supply of information on chemicals pursuant to Art.29 Information supply pursuant to Art.30(2) Application for a Confirmation of Notification Exemption under Art.32(3) Supply of information on chemical substances contained in products pursuant to Art.35. Approval for manufacture/importation of a risk concerned product with no safety and labelling standards announced pursuant Art.36(2) Application for data protection under Art. 45 of the Act 14
Transitional Measures Hazardous chemicals Toxic, restricted, or prohibited substances designated and announced as such under the former TCCA shall be deemed to have been designated as a toxic chemical or a restricted substance or prohibited substance. Hazard assessment Any person who went through a examination of toxicity under the former TCCA shall be deemed to have completed the registration of the chemical and the hazard assessment.. A notification shall be made to the MoE in accordance with the procedures set by the Presidential Decree. Confirmation of exemption Any person who obtained a confirmation of exemption from a examination of toxicity under the former TCCA shall be deemed to have obtained a confirmation of registration exemption. 15
1. Act on the Registration and Evaluation of Chemical Substances (K-REACH) 2. How to comply with K-REACH 16
How to comply with K-REACH Review of K-REACH Act, Lower Decrees and Participation in seminar for the updates Raise awareness within the Company, Establishment of Task Force Team for internal Communication In difficulty of independent compliance consider external service provider Review if the chemical substance is exemption from chemical registration. (medicine, cosmetics etc) Consult with importer in Korea and decide who is complying (Importer, Only Representative) - Registration intention check within supply chain Identification of the handling product s component, quantity of manufacture/import/sales per substance base Chemical Inventory Check If Existing chemical(existing chemical subject to registration) or New chemical In the case of New chemical substance - Check if they can fall under exemption rule (If not, registration strategy has to be set up) In the case of Existing chemical subject to registration - Registration strategy has to be set up Review of K-REACH Compliance Cost Vs Sales profit (Sales forecast) Registration strategy setup - SIEF(Substance Information Exchange Forum) Monitoring, Lead Registrant(Potential registrant), Substance sameness, Data sharing cost, Registration schedule/type 17
Thank You! Contact Info Moonsun RYU, Risk Assessment Center Korea Testing & Research Institute (KTR) Tel : +82-31-999-3061 Email : sunny@ktr.or.kr 18