Intertek Health, Environmental & Regulatory Services

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1 Intertek Health, Environmental & Regulatory Services Vai dove Ti porta la Chimica Go where the markets for Chemicals are! Workshop Centro REACH - 3 rd December 2014 South Korea on track for its Reach Regulation Jeremy J Ramsden, Intertek Life Sciences, United Kingdom 1

2 South Korea on track for its Reach Regulation??? Themes for this presentation: 1. Background to K-REACH Why the need for change? 2. Framework of the Act Interpretation, ownership, obligations, etc. 3. Anticipated approach to implementation Final details are missing! 4. Contrasts & points of note TCCA v K-REACH v EU REACH. 2

3 Vai dove Ti porta la Chimica Go where the markets for Chemicals are! South Korea, officially the Republic of Korea and commonly referred to as Korea. Korea has survived Japanese colonization, Soviet meddling and North Korean threats to become the world s 9 th largest trading nation. Korea produces - LG TVs, Hyundai cars & Samsung phones. Chemicals are flooding into Korea, many of them new and requiring notification. Until now the Toxic Chemicals Control Act TCCA has governed new substance / polymer notification. A relatively simple regime. All is set to change with the implementation of: K-REACH 3

4 Background to K-REACH Fatal Use of Humidifier Disinfectants in Korea Disinfectants used in the water tanks of humidifiers for the prevention of germs, mould, algae, etc. Breathing in the vapour resulted in injury to the respiratory system and death. Approximately 120 pregnant women and infants are presumed to have died due to lung damage. Chemicals Incident at Korean Factory Valve was accidentally opened by workers while attempting to transfer 99% concentrated hydrofluoric acid to another tank at a factory in Eight tons of hydrofluoric acid was released. 5 deaths and 23 injuries resulted, ongoing medical treatment for residents, compensation for damages to farmland and livestock animal. Act on the Registration and Evaluation of Chemicals (Korea REACH or K-REACH) K-REACH has emerged in response to awareness of the importance of risk assessment and recognition of the need for greater management of chemicals especially for consumer products. 4

5 Background to K-REACH Act on the Registration and Evaluation of Chemicals (K-REACH) K-REACH takes its lead from the EU REACH Regulation, to protect human health and the environment from the risks associated with the use of chemicals. To be achieved through: Registration of chemicals at the substance level; Screening of hazardous chemicals; Hazard & risk assessment of products containing chemicals; Sharing of information about chemicals. The current Toxic Chemical Control Act (TCCA), which came into force on 2 nd February 1991 will be recast and divided between K-REACH and a new Chemicals Control Act (CCA). 5

6 Framework of the Act Legislation K-REACH Act on the Registration and Evaluation of Chemical Substances, published May 22, Full Implementation January 1, 2015 with transitional provisions. Chemicals Control Act (CCA) A recasting of the Toxic Chemicals Control Act (TCCA). supported by Downstream Decrees The drafts of K-REACH subordinate statutes, the Presidential Decree (also known as the Enforcement Decree) and the Ministerial Decree (also known as the Enforcement Rules) were issued for public consultation by Korea s Ministry of Environment (MoE) on February 18, These texts will detail the management of chemicals and downstream products, and specify / elucidate on the registration requirements, for example. Transitional arrangements for applications submitted under TCCA. Guidelines for preparing risk assessments and the registration process. Guidelines on data sharing and costs within Consortia. First list of designated substances to be published. As of 3 rd December 2014 the final drafts of these Decrees had not been published. 6

7 Relationship between K-REACH and the CCA Act on the Registration and Evaluation of Chemical Substances (K-REACH) Article 1 (Purpose): Chemicals management prior to placing on the market. Focus is registration and evaluation of substances. Designation of hazardous substances through registration & hazard / risk assessment and assignment, e.g. Toxic, Restricted, Prohibited, etc. Chemicals Control Act (CCA) Objective: Post placing on the market, follow-up actions, emergency management of hazardous chemicals, management of business entities. Focus is the control of hazardous substances and response to chemical accidents. 7

8 Framework of the Act Competent Authority Ministry of Environment ( MOE ) Principal body responsible for K-REACH Regional MoE offices will be responsible for annual reporting and the notification of products containing hazardous substances. Regulatory Bodies National Institute of Environmental Research ( NIER ) Responsible for registrations, reduced registrations, amendments to registrations, registration of enquiries. Korean Chemicals Management Agency ( KCMA ) Applications for confirmation of exemption from notification, exemptions from notification of products containing hazardous substances. Ministry of Labor ( MOL ) Takes care of Industrial Safety and Health Act (ISHA), regulation of chemicals in the workplace - GHS, etc. 8

9 South Korea on track for its Reach Regulation 9

10 Framework of the Act K-REACH The Act includes 8 chapters and 54 articles (24 pages in translation). Chapter 1 General Provision (Article 1 to 7) Chapter 2 Registration of Chemicals (Article 8 to 17) Chapter 3 Hazard & Risk Assessment of Chemicals (Article 18 to 24) Chapter 4 Designation & Amendment of Authorization Chemicals, etc. (Article 25 to 28) Chapter 5 Communication on Chemicals (Article 29 to 31) Chapter 6 Management of Risk Concerned Products (Article 32 to 37) Chapter 7 Supplementary Provisions (Article 38 to 48) Chapter 8 Penalties (Article 49 to 54) Addendum (Articles 1 to 7) November 10 th 2014, the Ministry of Environment (MoE) published an English version of the Act on Registration and Evaluation of Chemical Substances, which can be downloaded at: N.B. ref. to Chapters lost in translation! 10

11 Chapter 1. General Provisions Article 2 (Definitions) Existing Chemicals: The term "existing chemical substance" means any of the following chemical substances: a) Chemical substances announced by the Minister of Environment in consultation with the Minister of Employment and Labor, which were distributed in the Republic of Korea for commercial purposes before February 2, 1991 (~ 37,000 substances); b) Chemical substances announced by the Minister of Environment, the hazard reviews thereof have been conducted pursuant to the former Toxic Chemicals Control Act after February 2, 1991 (~ 7,000 substances). Existing Chemicals subject to Registration: The term "existing chemical substances subject to registration" means chemical substances announced by the Minister of Environment after deliberation by the Chemical Substance Evaluation Committee under Article 7 where the Minister deems such chemical substances required to be registered for hazard reviews under Article 18 or risk assessments under Article 24 among existing chemical substances; New Chemical Substances: The term "new chemical substances" means all chemical substances excluding existing chemical substances. Transitional Chemical Substances (not defined) Notified under the TCCA, but not published in the Official gazette, must be notified to regulator by June 30, 2015 to avoid re registration under K-REACH. 11

12 Chapter 1. General Provisions Article 2 (Definitions) Hazardous Substances: The term "hazardous chemical substances" means any of the toxic substances, substances subject to permission, restricted substances, prohibited substances, and other chemical substances [announced by the Minister of Environment after consultation] that pose or likely to pose hazards or risks. Product of risk concern: The term "product of risk concern" means any of the chemical product announced by the Minister of Environment in consultation with the heads of relevant central administrative agencies as the products are likely to risk people's health or the environment among the following: a) Products mainly used by ordinary consumers for daily uses, such as detergents, fragrances, adhesives, polishes, deodorants, synthetic detergents, bleaching agents and fabric softeners; a) Products used to kill all harmful organisms, excluding humans and animals, or to interfere with or hinder organisms' activities, such as insecticides, disinfectants and preservatives. 12

13 Chapter 1. General Provisions Article 3 (Scope of Application) The Act shall not apply to substances falling into any of the following: 1. Radioactive substances as per the Nuclear Energy Safety Act; 2. Pharmaceutical products and quasi-pharmaceutical products as per the Pharmaceutical Affairs Act; 3. Narcotics as per the Act on the Control of Narcotics; 4. Cosmetics and raw materials used for cosmetics as per the Cosmetics Act; 5. Pesticides and active ingredients as per the Pesticides Control Act; 6. Fertilizers as per the Fertilizers Control Act; 7. Food, food additives, apparatus, containers and packages as per the Food Sanitation Act; 8. Feeds as per the Control of Livestock and Fish Feed Act; 9. Materials as per the Control of Firearms, Swords, Explosives, etc. Act; 10. Military supplies as per the Management of Military Supplies and Defense Acquisition Program Act; 11. Functional health foods as per the Functional Health Food Act; 12. Medical devices as per the Medical Devices Act; 13

14 Chapter 2. Registration of Chemical Substances Article 8 (Reporting of manufacture, etc. of Chemical Substances) Subject: New chemicals (all) or Existing chemicals ( 1 ton/year). By whom: Manufacturers, importers, sellers (Except direct sellers to consumers such as supermarkets, etc.). To whom: Local MoE office. When: By 30 th April each year (first reports due April 2016 for the volume manufactured, imported or sold from Jan. 1 to Dec ). Data requirement: Company info., chemical identity, volume, use. (In case of sellers, they can omit the information on chemical identity, sales volume and use of chemical substance when reporting and should submit product name, purchaser, identified ingredients and use). Exemptions: Chemicals in machinery, Chemicals imported with machines for trials, Articles, Chemicals for R&D, Non-isolated intermediates. Change of reporting should be submitted for following cases: Company information has changed. Use has changed (There are 65 defined use categories). 14

15 Chapter 2. Registration of Chemical Substances Article 9 (Designation of Existing Chemical Substances Subject to Registration) The Minister of Environment (MoE) shall designate and announce Existing Chemical Substances Subject to Registration (ESR). Publication anticipated to be every 3 years based on volume and the hazard / risk profile candidate chemicals. Grace period for registration: 3 Years from designation / publication. MoE shall give prior notice for the designation of an Existing Chemical subject to Registration in the Government Gazette and their Website. MoE published 518 candidate substances for Existing Chemicals subject to Registration (ESR) on their website on 31 st October 2014 for public consultation until 15 th December Web link is in Korean: MoE has stated that the final list of ESRs would be published June 2015 after the Chemical Substance Evaluation Committee has reviewed the candidate substances. 15

16 Chapter 2. Registration of Chemical Substances Article 10 (Registration of Chemical Substances) Scope: New chemicals (all); or Existing chemicals subject to registration ( 1 ton/year); or Chemicals deemed likely cause significant damage to humans or the environment (even if < 1 ton/year). By whom: Manufacturers or importers. To whom: National Institute of Environmental Research ( NIER ). When: Before manufacture or import. In case of existing chemicals subject to registration, within the given grace period (3 years). Evaluation period: Technical completeness check (TCC) - within 30 days of submission, after which manufacture/import is allowed. Hazard examination after TCC: - For new chemical - within 6 months, - For existing chemicals subject to registration - within a year. New chemical at low volume - within 3 days (7 days if detailed review is required). 16

17 Chapter 2. Registration of Chemical Substances Article 11 (Registration Exemption of Chemical Substances) Exemptions: Chemicals in machinery; Chemicals imported with machinery for trials; Articles; Chemicals with Confirmation of Registration Exemption such as: Chemicals manufactured or imported for export only up to 10 t/y, Chemical reagents imported/manufactured annually for scientific experiment, analysis or research, Chemicals for R&D (PPORD, pilot production and etc.), Low-concern polymers which meet prescribed criteria (slide 43). Surface treated substances. 17

18 Chapter 2. Registration of Chemical Substances Article 12 (Change in Registration, Reporting of Changes, etc.) Amendment to a registration shall be submitted for the following cases: 1. Where the annual amount of manufacturing or importing a registered chemical substance is changed beyond the range prescribed by Ordinance of the Ministry of Environment; 2. Where matters prescribed by Ordinance of the Ministry of Environment concerning uses, hazards and risks of registered chemical substances are changed. 3. Where the name, location or representative of a registrant is changed. 18

19 Chapter 2. Registration of Chemical Substances Article 14 (Data to be Submitted When Applying for Registration of Chemical Substances) Required data for registration: Details of importers / manufacturers; Chemical identity (identified impurity and by-product shall be indicated); Use; Data on classification and labeling; Data on physico-chemical properties; Data on hazards Data on risks including exposure scenario * Guidance data on safe use, etc. Estimated manufacturing / import volume Information on exposure related to use (exposure route and exposure type) * Initially required if 100 ton/year with transitional provisions: 100 ton (2015) 70 ton (2017) 50 ton (2018) 20 ton (2019) 10 ton (2020). 19

20 Chapter. 2 Registration of Chemical Substances Article 15 (Method for Data Submission upon Registration Application for Existing Chemical Substance Subject to Registration) Joint submission is required for Existing chemicals subject to registration. (Opt-out is acceptable after getting permission from MoE in advance.) Data required to be submitted jointly : Data on physico-chemical properties; Data on hazards; Test plan. Data on risk and guidance data on safe use can be submitted jointly, if all joint registrants agree with it. A potential registrant can make an inquiry to NIER before registration [how?] if the same chemical substance has been registered and NIER has to inform him of the result within 14 days. 20

21 Chapter 3. Hazards Review & Risk Evaluation of Chemical Substances Chapter 4. Designation and Change of Authorized Substances, etc. Chemicals and Mixtures Anticipated approach to implementation Existing Chemicals ( 1 ton/year) Manufacture/ import is allowed. Designation as Existing Chemicals subject to Registration Designation as Toxic Chemicals Designation as Authorization Chemicals Reporting New Chemicals (all) Registration Technical completeness check (In 30 days) Hazard Assessment Risk Assessment If 10 ton/year (2020) Strengthening in stages from 100 ton (2015) or depending on hazard assessment results Designation as Restricted/Prohibited Chemicals Considering international treaty Products Products Notification of Hazardous Chemicals in Products Risk Concerned Products Risk Assessment by MoE Publication of Criteria of Safety/Labeling If violated : Order of withdrawal If no criteria : Submission of risk data 21 Follow-up management of toxic, authorization, restricted, prohibited chemicals to follow regulation under the Chemicals Control Act.

22 Chapter 5. Information Provision of Chemical Substances Article 29 (Information Provision on Chemical Substances) By whom: Supplier of registered chemical or the mixture containing it. To whom: Downstream users. When: Prior to transferring or supplying the chemical substance or the mixture containing it or simultaneously. What: Company details, Product name, Chemical name * (or generic name), Registration no. (can be omitted for a new chemical substance), Classification & labelling, Recommended use and restrictions on use, Data on physico-chemical properties and hazards, Data on risks, Data on content (%) of hazardous substances and etc., if contained, Data on safe use, Regulatory information. How: MoE official form describing reg. no., chemical name *, data on hazard & risk and etc., or Material Safety Data Sheet with risk data. 22 * It is not required to be provided if it is considered as CBI.

23 Chapter 5. Information Provision of Chemical Substances Article 30 (Provision of Information by Downstream Users, etc.) Information provided by manufacturer or importer to downstream user or seller, if requested: Company name Chemical name * (or generic name) and product name Manufacturing ㆍ import volume (Can be omitted) Recommended use and restrictions on use Data on safe use such as handling method, fire-fighting measures, accidental release measures, protective equipment, disposal method and etc. Data on physico-chemical properties and hazards Regulatory information Information provided by downstream user or seller to manufacturer or importer, if requested: Company name Chemical name * (or generic name) and product name Use ㆍ sales volume (Can be omitted) Detailed information on use Exposure information Information on safe use 23 * It is not required to be provided once it is considered as CBI.

24 Chapter 6. - Control of Product with Risks, etc. Article 32 (Reporting of Product Containing Hazardous Chemical Substances) Product Notification: Some sources claim 1.0% Subject: A product containing hazardous chemical substances at 0.1% or more, if > 1 ton/year of the hazardous substance in that product is placed on the market (Articles are exempted). By whom: Product manufacturer or importer. To whom: Local MoE office. When: Once > 1 ton is exceeded presumably. Data requirement: Information on applicant (Company name, address, tel. no. and etc.); Data on a product (Product name or trade name, instruction manual, etc.); Chemical name and content of hazardous chemicals (Identified impurities and byproducts shall be included.); Classification and hazards for hazardous chemicals; Use (function) of hazardous chemicals in a product; Product use. Exemption: Chemicals whose exposure to human or the environments can be prevented under normal use conditions; Chemicals already registered as per Article 10 of the Act for the product s use in question. 24

25 Chapter 7. Supplementary Provision Article 38 (Application, etc. for Registration by Persons Appointed by Overseas Manufactures or Producers) Requirement of Only Representative (OR): Qualifying legal entity in South Korea; Knowledge of chemical information; More than 3 years working experience in chemical management. Scope: Reporting on the uses & quantity of chemical substances in accordance with Article 8; An application for registration under Article 10 (3); Reporting under Article 32; Other affairs prescribed by Presidential Decree. Obligations of the OR: Report appointments or dismissals (represented party), as their OR to local MoE office. 25

26 Chapter 7. Supplementary Provision Article 39 (Establishment and Operation of Chemical Substance Data Processing System) IT Tool MoE will establish and operate IT tools to support manufacturers and importers of chemical substances or product in performing following tasks: Reporting - import volumes, etc., Registrations, Notifications. IT Tool will not be IUCLID. Detail will be in the Presidential Decree (pending). 26

27 Chapter 8 - Penalties Article (Penalties) Misdemeanour Penalty Non compliance for products of concern based on their risk to human health and the environment. Non compliance with registration, amendment registration for tonnage upgrade or hazard information change. Non compliance with notification of product containing a hazard substance(s). Non compliance with annual reporting, exemption from registration, exemption from notification of hazardous product. Violation of data request order for products of concern based on their risk to human health and the environment. Non compliance with information provision. Imprisonment not exceeding 7 years or fine not exceeding 200 M KRW (EUR 145k) Imprisonment not exceeding 5 years or fine not exceeding 100 M KRW (EUR 72k) Imprisonment not exceeding 3 years or fine not exceeding 50 M KRW (EUR 36k) Imprisonment not exceeding 1 years or fine not exceeding 30 M KRW (EUR 22k) Non compliance with amendment notification, keeping documentation. Fine not exceeding 10 M KRW (EUR 7k) Additional Provisions ADDENDA <Act No , May 22, 2013> Article 1 (Enforcement dates) Article 2-7 (Transitional measures with respect to the TCCA) + 27

28 Anticipated approach to implementation Transition from Toxic Chemical Control Act (TCCA) Chemical substances for which hazard evaluation has been performed under the TCCA are considered as registered (Article 10) and to have completed hazard evaluation (Article 8) under K-REACH. Notification to MoE as applicable will be required for products. Chemical substances which have received hazard evaluation exemption under the TCCA are considered to have "Confirmation of Exemption" (Article 11). The following substances as designated under the TCCA will be transferred to K-REACH: Toxic substances (Article 20), Restricted substances (Article 27), Banned substances (Article 27). 28

29 Anticipated approach to implementation Types of notification permitted Substances Quantity per annum Type of Notification < 1,000 kg per annum Simplified (before 2020) < 100kg per annum Simplified (after 2020) 100kg < 1,000 kg per annum General (after 2020) 1 ton 10 tons per annum General Level 1 > 10 tons 100 tons per annum General Level 2 > 100 ton 1,000 tons per annum General Level 3 > 1,000 tons per annum General Level 4 29

30 Registration Simplified (Low Volume) Before 1 st January 2020 < 1,000 kg per annum, and after 1 st January 2020 < 100 kg per annum: Data Requirements: Registrant information (name, address, contact info.); Substance identity (name, CAS no, concentration, molecular formula, impurities, etc.); Estimated manufacturing / import volume; Uses; Exposure information (exposure route & exposure type related to use). No Hazard data required. Process time 3 days, 7 days if detailed review required. 30

31 Registration - General After 1 st January kg to < 1,000 kg per annum: Data Requirements: Registrant information (name, address, contact info.); Substance identity (name, CAS no, concentration, molecular formula, impurities, etc.); Estimated manufacturing / import volume; Uses; Exposure information; Additionally, Physico-Chemical Properties; Hazard data (four endpoints); Classification & Labelling; Guidance on safe use; Process time 30 days. 31

32 Registration - General Levels 1 to 4 Four general tonnage bands (same ranges as EU REACH) Data Requirements: Registrant information (name, address, contact info.); Substance information (name, CAS no, concentration, molecular formula, impurities, etc.); Tonnage (amount from 1 st January to 31 st December of the year of submission); Uses; Classification & Labelling; Physico-Chemical Properties; Hazardous & Risk Information; Guidance on safe use; Other information requested by Ministerial Decree; Announcement: Substance name and CAS RN / KE No. (grace period). 32

33 Data Requirements for Substances Chapter 2 Registration of Chemical Substances Data Requirements for Substances: EU-REACH N/A Annex VII Annex VIII Annex IX Annex X K-REACH K-REACH K-REACH K-REACH K-REACH K-REACH Endpoint OECD * Physical state Annex VII Melting point/freezing point Annex VII Boiling point Annex VII Density Annex VII Vapour pressure Annex VII Water solubility Annex VII Physico-chemical Properties Partrition coefficient Annex VII 1) 1) 1) 1) Flammability Annex VII Explosive properties Annex VII Oxidizing properties Annex VII Granulometry Annex VII Dissociation constant Annex IX Viscosity Annex IX : Test plan can be submitted at first. * : It will be required from Jan. 1,

34 Data Requirements for Substances Chapter 2 Registration of Chemical Substances Data Requirements for Substances: EU-REACH N/A Annex VII Annex VIII Annex IX Annex X K-REACH K-REACH K-REACH K-REACH K-REACH K-REACH Endpoint OECD * Skin irritation / corrosion 404 Annex VIII Sensizitation & Irritation Eye irritation / corrosion 405 Annex VIII Skin sensitisation 406/429 Annex VII In vitro gene mutation study (Ames test) 471 Annex VII 3) 4) 4) 4) Genotoxicity In vitro cytogenicity study in mammalian cells (CA) 473 Annex VIII 4) 4) 4) Additional in vivo genotoxicity 478/483/485/486, etc. Annex IX Acute toxicity - by oral route (rats) 420/423/425 Annex VII Acute Toxicity Acute toxicity - by inhalation (rats) 403 Annex VIII 2) 2) 2) Acute toxicity - by dermal route (rats) 402 Annex VIII 2) 2) 2) Repeated Dose Toxicity Short-term repeated dose toxicity study (28 days) 407 Annex VIII Sub-chronic repeat dose tox. study (90 days) 409 Annex IX Screening for reproductive-/developmental toxicity 421 Annex VIII Reproductive toxicity Teratogenicity 414 Two-generation reproductive toxicity study, oral gavage 416 Annex IX Toxicokinetics Carcinogenicity study 451 Annex X : Test plan can be submitted at first. * : It will be required from Jan. 1,

35 Data Requirements for Substances Chapter 2 Registration of Chemical Substances Data Requirements for Substances: EU-REACH N/A Annex VII Annex VIII Annex IX Annex X K-REACH K-REACH K-REACH K-REACH K-REACH K-REACH Endpoint OECD * Acute toxicity to fish 203 Annex VIII Acute toxicity to aquatic invertebrates 202 Annex VII Aquatic Toxicity Growth inhibition study aquatic plants 201 Annex VII Long-term toxicity testing on fish 210/212/215 Annex IX Long-term toxicity testing on invertebrates 211 Annex IX Activated sludge respiration inhibition test 209 Annex VIII Degradation biotic Ready biodegradability 301 Annex VII Inherent biodegradability 302 Annex X abiotic Hydrolysis as a function of ph 111 Annex VIII Identification of degradation products Annex IX : Test plan can be submitted at first. * : It will be required from Jan. 1,

36 Data Requirements for Substances Chapter 2 Registration of Chemical Substances Data Requirements for Substances: EU-REACH N/A Annex VII Annex VIII Annex IX Annex X K-REACH K-REACH K-REACH K-REACH K-REACH K-REACH Endpoint OECD * Adsorption/desorption 106/121 Annex VIII Fate and behaviour in the environment Bioaccumulation 305 Annex IX Further information on adsorption/desorption Annex IX Further information on the environmental fate and behaviour Annex X Short-term toxicity to terrestrial plants 208/227 Annex IX Short-term toxicity to invertebrates, earthworms 207 Annex IX Effects on terrestrial organisms Long-term toxicity testing on invertebrates, earthworms 222 Annex X Long-term toxicity testing on terrestrial plants ISO22030 Annex X Long-term toxicity to sediment organisms 218/219 Annex X : Test plan can be submitted at first. * : It will be required from Jan. 1,

37 Data Requirements for Substances Notes : 1) Partition Coefficient among physico chemical properties shall be conducted at GLP-certified laboratory. 2) Either acute dermal or inhalation test is required. 3) Following 5 cases shall be considered. 1 Ames (Negative) => OK 2 Ames (Positive) + CA (Negative) + forward gene mutation (Negative) => OK 3 Ames (Positive) + CA (Negative) + forward gene mutation (Positive) + micronucleus => OK 4 Ames (Positive) + CA (Negative) + micronucleus => OK 5 Ames (Positive) + CA (Positive) + micronucleus => OK 4) Following 6 cases shall be considered. 1 Ames (Negative) + CA (Negative) => OK 2 Ames (Negative) + CA (Positive) + micronucleus => OK 3 Ames (Positive) + CA (Negative) + forward gene mutation (Negative) => OK 4 Ames (Positive) + CA (Negative) + forward gene mutation (Positive) + micronucleus => OK 5 Ames (Positive) + CA (Negative) + micronucleus => OK 6 Ames (Positive) + CA (Positive) + micronucleus => OK 37

38 Data Requirements for Polymers The definition of a polymer under K-REACH, is understood to be identical to that in the European Union, the USA and China. Tonnage Band Required Data Remarks tons per annum Required from Jan. 1, tons per annum tons per annum 100 1,000 tons per annum 1,000 tons per annum Data on polymer characteristics Data on polymer characteristics + 1. Appearance 2. Water solubility 3. Melting point/freezing point 4. Boiling point 5. Vapor pressure 1 T <10 ton polymer data + 1. Acute oral toxicity 2. Ames 3. Acute fish toxicity 4. Ready biodegradation Tests/studies for 1 T <10 ton of a chemical substance Tests/studies for 10 T <100 ton of a chemical substance Data on polymer characteristics : Mn with GPC data Monomer composition Content (%) of residual monomers Content (%) of Mw < 1,000 Polymer stability test 38

39 Data Requirements for Polymers Exemption from notification as a Polymer of Low Concern The criteria for exemption from notification as a polymer of low concern under K-REACH (different from the requirements under the TCCA) are: 1. Polymers with Number-average molecular weight 10,000 Daltons, which contain < 2% oligomer content by weight < 500 Daltons and < 5% oligomer content < 1,000 Daltons. or Note - Polymers meeting the above criteria that are non-solid cationic polymers, which are soluble or dispersed in water are not exempt. 2. Polymers with Number-average molecular weight 1,000 Daltons and < 10,000 Daltons, which contain < 10% oligomer content < 500 Daltons and less than 25% oligomer content < 1,000 Daltons. Note - Polymers meeting the above criteria that are non-solid cationic polymers, which are soluble or dispersed in water are not exempt. Note - Polymers meeting the above criteria that are composed of monomers whose weight percent contained in the polymer is over 2% that are hazardous chemicals (toxic, authorization, restricted, prohibited), new chemicals, epoxy or aziridine compounds are not exempt. Reported but not verified that if a polymer, excluding monomer contained in it at < 2% by weight, falls into the characterisation of an existing chemical pursuant to Article 2(3) of K-REACH, the polymer shall be considered as an existing chemical (2% Rule). 39

40 Data Requirements for Biocides Tonnage Band tons per annum Required from Jan. 1, 2020 Required Data Tests/studies for 1 T <10 ton chemical substance 1 10 tons per annum Tests/studies for 10 T <100 ton chemical substance tons per annum Tests/studies for 100 T <1000 ton chemical substance 100 tons per annum Tests/studies for 1,000 T ton chemical substance 40

41 Data Requirements for... Category Required Data Remarks Isolated-Intermediate Chemicals with QSAR data Chemicals with in-vitro data 1. Details on importers/manufacturers. 2. Chemical identity. 3. Use. 4. Data on classification and labeling. 5. Data on physico-chemical properties. Relevant test / studies can be omitted. Relevant test / studies can be omitted. - It is restricted only to the chemical substances manufactured/imported below 10MT/y. Chemicals (Read-across approach) Relevant test / studies can be omitted. 41

42 Contrasts & points of note Comparison of TCCA and K-REACH TCCA K-REACH Subject for Registration New Chemical Substances New + Existing Chemicals subject to Registration (ca. 2,100) Content for Evaluation Hazard Focused Hazard + Risk Focused Target Subject Industrial Raw Materials Industrial Raw Materials + Products (1) (1) Products regulated under K-REACH: Mixtures that are likely to result in the exposure of chemicals to consumers as final consumer goods or parts thereof and accessories. 42

43 Contrasts & points of note Comparison of K-REACH vs. EU REACH K-REACH Pre-registration No Yes Registration New chemicals (all) Existing chemicals subject to registration ( 1 ton/year) Chemicals that may cause significant damage to humans and the environment EU REACH New chemicals ( 1 ton/year) Existing chemicals ( 1 ton/year) Reporting of Annual Volume Yes No (but an OR must track) Notification Product containing hazardous chemicals SVHC in article Registration of Polymer Required Not applied Data provision after registration 1. MoE official form describing reg. no., chemical name, data on hazard & risk and etc.; or 2. MSDS with risk data (for chemicals subject to the preparation of MSDS) Joint Submission Yes Yes Risk Assessment 100 tpa 100 tpa down to 10 tpa to be phased in from 2015 to 2020 MSDS / Label 10 tpa IT-System Yes, but not IUCLID Yes IUCLID/REACH-IT 43

44 Contrasts & points of note Here s something's you can / should be getting on with: Preparation of inventory for imported substances (manufactured as well if so). Implementation of volume tracking system per substance for annual reporting. Gather information on use for each substance. Consider specific registration requirements, e.g. polymers, biocides, et al. Development of communication tool in supply chain (maybe your OR or Importers resp.). Checking which toxicological / eco-toxicological data are available for substances in your products, regulated by K-REACH in order to submit (consumer) product notification. Understand the sub-regulations once published. Monitor lists of designated chemical substances. 44

45 South Korea on track for its Reach Regulation Worldwide registration of chemicals The main steps of any successful registration project can be summarized as: 1. Assess requirement for registration, (at the earliest opportunity) 2. Develop a registration strategy, (from the outset include a time plan) 3. Business approves proposed strategy, (establish a budget data, dossier, government fees) 4. Define project resource, (insource/outsource) 5. Preparation of a representative sample, (vital for characterization) 6. Start registration process, 7. Develop refined testing strategy, get business approval and initiate tests, (data gaps identified, read across/waivers/qsar addressed) 8. Receive and assess test reports and their validity, 9. Business assesses any critical data that becomes available and decides on modifications, 10. Prepare first compilation of registration dossier, 11. Business approves dossier for submission, 12. Dossier submission to the Competent Authority(ies), (translations may be required) 13. Assessment of the dossier by Competent Authority(ies), (budget for this in the time plan) 14. Address any matters raised by the Competent Authority(ies), 15. Registration granted, certificate issued, (celebrate!) 16. Closure of registration project. (maintain your archives) 45

46 European & Global Services in collaboration with International colleagues... EU REACH Regulation Comprehensive REACH registration services (Lead & joint registrant dossiers, CSRs, testing strategies, ECHA inquiries, etc.) Consulting - SVHCs, esds, strategy & more Only Representative services Compliance footprint auditing Global Notification (Substances/Polymers) USA / Canada China / Japan / Taiwan The Philippines / South Korea Australia / New Zealand Turkey, Switzerland, et al.. Classification & Labelling for Supply EU CLP Regulation UN GHS - global implementation SDS Authoring... Transport of Dangerous Goods Dangerous Goods Advisor (DGSA) ADR - Road IATA - Air IMDG Sea Biocide Regulation EU Biocidal Products Directive EU Member State registrations Other jurisdictions.. Indirect Food Contact EU EFSA Dossiers US requirements.. Regulatory Affairs & Product Safety is our business! 46

47 Global Chemical Registration / Notification Services Project Management New Chemical (Substance / Polymer) Notifications Asia (China, Taiwan, Japan, South Korea, Philippines) Australia & New Zealand USA Canada EU REACH, CLP and the BPD Turkey, Switzerland Emerging requirements; Russia, Ukraine, Malaysia, South America... Develop notification strategy for one or many jurisdictions Design testing protocols, include country-specific testing Manage required toxicological & eco-toxicological studies Dossier preparation (in native language) Discussion and negotiation with Competent Authorities for waiving strategies, post submission, etc. 47

48 Global presence Intertek offices Regulatory expertise in local language, local culture Intertek regional HQ s PS&R locations: Toronto, Ottawa New York, New Jersey, Pennsylvania, Texas Sao Paolo PS&R locations: Stockholm, Copenhagen Manchester, Teeside, London Chalon, Lille Basel, Stuttgart Bologna PS&R locations: Mumbai Shanghai Manila Seoul Tokyo Melbourne 48

49 Intertek Health, Environmental & Regulatory Services Global Notification Consultancy and more.. Dank u wel Visit us at /regulatory or send an to jeremy.ramsden@intertek.com 49