K-REACH: a specialregulatory review

Webinar, 14 May 2013, 8.30am BST

Today’s webinar – aims An introduction to K-REACH, before considering the impact of its recent adoption, including the obligations it now places upon suppliers and users of chemicals in Korea;

Our regulatory expert will be reviewing the regulation text and outlining key changes.

Speakers

Jun Ho Lee, Senior Researcher, Chemical Substance Registration Support Centre, Korea Testing & Research Institute (KTR);

Chair: Geraint Roberts, Briefing & Global Content Editor, Chemical Watch

Questions

Please submit questions during the webinar using your chat box or;

Submit by email following the webinar to lorna@chemicalwatch.com by 15 May;

Questions will then be forwarded to Jun Ho Lee who will respond to as many as possible by 21 May.

1

Act on the Registration and Evaluation of Chemical Substances

“K-REACH”

Jun Ho Lee, Senior Researcher

Chemical Substance Registration Support Centre

Korea Testing and Research Institute

2013. 5. 14

2

Korea Testing and Research Institute

■ Established by Korean Government in 1969, and is under Ministry of Trade,

Industry and Energy

■ KTR provides • Testing : GLP, Healthcare, Safety, automobiles and shipbuilding, construction, metals, chemicals,

polymers, LED, EMC…

• Certifications : CE, GOST-R, FCC, NSF, UL, C-Tick, JIS, SASO, GCC, CDM…

• Consultations : EU REACH, China REACH, Japan, Taiwan, Turkey, US and South Korea

■ Structure of KTR• 11 Head quarters,

• 6 Testing Labs,

• 4 overseas offices,

• 12 branches in industrial parks around Korea

3

Contents

1. Introductions of K-REACH

2. Obligations of K-REACH

3. Impacts of K-REACH

4

Contents

1. Introductions of K-REACH• History of K-REACH

• Overall view of K-REACH

• Definitions

• Scopes

5

History of K-REACH

■ Ministry of Environment(MoE) Proposal• Introduced initial version of K-REACH in 2011

• Intense discussions with Industry and stakeholders

• 28th of September, 2012

■ National Assembly Member’s proposal• A serious of chemical accidents

• 10 National assembly members submitted the K-REACH proposal on 8th April, 2013

■ Sub-committee of Environment and Labor Committee(ELC)• ELC came up with consolidated version of K-REACH on 24th April 2013

■ National Assembly (30th April, 2013)• Final Version of K-REACH has been approved

• Small alterations were made to the consolidated version of ELC

6

Overall view of K-REACH

■ K-REACH consists of 8 chapters, 54 articles and an addendum1. General Rules (article 1 ~ 7)

2. Registration of chemical Substances (article 8 ~ 17)

3. Hazardous Evaluation and Risk Assessment of chemical substances (article 18 ~ 24)

4. Listing and changing permissible substances (article 25 ~ 28)

5. Communication of chemical substance information (article 29 ~ 31)

6. Management of High Risk Concerned products (article 32~37)

7. Supplementary Provisions (article 38 ~ 48)

8. Penalties (article 49 ~ 54)

9. Addendum (article 1 ~ 7)

7

Overall view of K-REACH

■ Objective• To protect human health and environment by implementing procedures on

§ Registration of chemical substances,

§ Hazardous evaluation and risk assessment on products containing chemical substances and

Toxic substances,

§ Appointing toxic substances

§ Produce and use information of chemical substances

■ K-REACH will come into force on 1st January, 2015

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Overall view of K-REACH

■ Toxic Chemical Control Act(TCCA)• Chemical substances on the list of TCCA below will be transferred to K-REACH

§ Toxic substances (article 20 of K-REACH)

§ Restricted substances (article of 27)

§ Banned substances (article of 27)

• Chemical substances which has performed hazardous evaluation on TCCA are considered as

registered(article 10) and performed hazardous evaluation(artciel18) under K-REACH

§ Notification to MoE will be required

• Chemical substances which has received hazardous evaluation exemption on TCCA are considered

as chemical substances with “Confirmation of Exemption” (article 11).

9

Definitions

■ Definitions• Chemical substance :

§ Element/compound and substances resulting from artificial reactions of elements/compounds

§ Result of chemical re-engineering, extraction or refinement of a substance occurring in nature

• Toxic substance : means a hazardous chemical substance as listed by the Minister of Environment in

accordance with the criteria set out in the Presidential Decree

• Permissible substance : means a chemical substance listed by the Minister of Environment after

consultation with the head of the relevant central authority under Article 25 and deliberation by the

Chemical Substance Assessment Committee under Article 7 as one potentially hazardous and thus

requiring permission from the Minister before its manufacture, import or use.

10

Definitions

■ Definitions• Restricted substance: means a chemical substance as listed by the Minister of Environment after

consultation with the head of the relevant central authority under Article 27 and deliberation by the

Chemical Substance Assessment Committee under Article 7 as one deemed to have high risk if used

for a specific purpose and thus required to be banned from its manufacture, import, sales, stocking,

storage, transport or use for that purpose.

• Banned substance: means a chemical substance as listed by the Minister of Environment after

consultation with the head of the relevant central authority under Article 27 and the deliberation by the

Chemical Substance Assessment Committee under Article 7 as one deemed to have high risk and

thus required to be banned from its manufacture, import, sales, stocking, storage, transport or use for

any purpose.

11

Definitions

■ Definitions• Hazardous chemical substance: means a toxic substance, a permissible substance, a restricted

substance, a banned substance or any other chemical substance that carries, or is likely to carry,

hazard or risk.

• Product: means an item or its component or part used by an end user with a possibility to cause

consumers to be exposed to a chemical substance, including

§ An item of preparation

§ An item in which the chemical substance contained in it performs a certain function in the form

of a solid without leaking during use

12

Definitions

■ Definitions• High risk concerned products: means a chemical product listed by the Minister of Environment after

consultation with the head of the relevant central authority as one deemed to have potential risk to

human health or the environment, including, but not limited to:

§ A product used by consumers on their daily lives such as a detergent, an air freshener, an

adhesive, a polisher, a deodorant, a bleach or a fabric softener.

§ A product used to kill, interrupt or immobilize harmful organisms except for human beings and

animals such as an insect repellent, a sanitizer or a preservative.

13

Scopes

■ Products not applicable to K-REACH• Radioactive substances

• Pharmaceuticals and non-pharmaceutical drugs

• Narcotics

• Cosmetics and its materials

• Ingredients and agrochemicals Fertilizers

• Food, food additives, tools, containers and package

• Livestock feeds

• Ammunitions

• Military supplies

• Health functional food

• Medical devices

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Contents

2. Obligations of K-REACH• Registration

• Hazardous Chemical Substances

• Risk Assessment

• Permissible Substances

• Communication

• Notification of Product

• High Risk Concerned Products

• Sole/Only Representative

• Documentation

• Fees and penalties

15

Registration

■ Annual Reporting of chemical substances• Chemical substances subject to reporting

§ Non phase-in chemical substances

§ Phase-in substances manufactured, imported or sold more than 1 ton per annum

• Anyone who manufactures, imports or sells is required to report

• Uses and Tonnages of the chemical substances are required to be reported

• Change of uses are required to be reported

• Exemptions

§ Chemical substances imported as incorporated in machines;

§ Chemical substances imported along with machines or devices for commissioning test

§ Chemical substances in products in solid form, performing certain functions and does not

release during normal condition of use

§ Other chemical substances as listed in the Presidential Decree that are manufactured or

imported for uses in research, studies, etc

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Registration

■ Designation of chemical substances subject to Registration• The Minister of Environment shall select one or more phase-in substances based on the following

criteria

§ Total tonnage circulating in Korean market

§ Hazardous/Risk characteristics

■ Registration• Chemical substances subject to Registration

§ Non phase-in substances (regardless of tonnage)

§ Phase-in chemical substances subject to Registration (over 1 ton per annum)

§ Certain chemical substances which are likely to cause significant damage to human health and

environment, regardless of the tonnage.

• Anyone who manufactures or imports is required to Register

• Manufactures and importers of phase-it substances subject to registration will be allowed to

manufacture and import without Registration until the Registration deadline.

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Registration

■ Deadline of Registration for priority substances are to be set by MoE• 1st list of priority substances will be required to be registered in 2 years from the publication date

• 2nd list of priority substances will be required to be registered in 5 years from the publication date

• 3rd list of priority substances will be required to be registered in 8 years from the publication date

■ Exemption of Registration• Not requiring “Confirmation of Exemption”

§ Chemical substances imported as incorporated in machines;

§ Chemical substances imported along with machines or devices for commissioning test

§ Chemical substances in products in solid form, performing certain functions and does not

release during normal condition of use

• Requiring “Confirmation of Exemption”

§ Manufactured or imported less than 10 ton per annum AND

§ All of the manufactured or imported chemical substances are exported

§ Others set by Presidential Decree

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Registration

■ Re-Registration and Notification of changes• Re-Registration of changes

§ Annual tonnage of manufactures and imports exceeds range as set out in the Environment

Ministerial Decree

§ Changes of uses, hazards, risk and etc., which are set out in the Environment Ministerial

Decree

• Notification of changes

§ Name of Registrant

§ Address

§ Representative

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Registration

■ Submission of Registration• The name, address and representative of the manufacturer or the importer

• Chemical substance Identification information including its name, molecular formula and chemical

structure

• Uses

• Classification and labelling

• Physicochemical properties

• Hazard information

• Risk information including exposure scenarios describing Handling instruction, exposure control and

management (Applicable only when the substance is manufactured or imported 10 tons or more per

annum)

• Guidance on safe use (including personal protective equipment, measures to an explosion, a fire or a

leak)

• Other information as specified in the Environment Ministerial Decree

20

Registration

■ Submission of Risk Information• Risk assessment of chemical substances between 10~100 ton per annum will have different

active date of provision regarding submission of risk information.

• E.g. If you are importing 15 tons of a substance (subject to Registration). And is on 1 st list of

priority substances. Then the chemical substance needs to be registered within 2 years of

publication. But as below table says the provision becomes live at 2020 for 10 and above tpa,

the obligation to submit risk information becomes live on 2020. So Risk information are to be

submitted by 2020.Tonnage Active date of provision regarding submission

of risk information

100 or more ton per annum 1st Jan 2015

70 or more ton per annum 1st Jan 2017

50 or more ton per annum 1st Jan 2018

20 or more ton per annum 1st Jan 2019

10 or more ton per annum 1st Jan 2020

21

Registration

■ Partial exemption of data submission is available for chemical substances

designated by Presidential Decree

■ Test Proposal describing testing information and schedules may replace test data for

certain physicochemical, toxicity and eco-toxicity data

22

Registration

■ Joint Submission• Anyone who intends to submit a registration before the deadline

• Individual submissions but certain tests are required to be submitted by the lead registrant.

• Opt-out possible when

§ Exposure of CBI causes commercial damage

§ joint submission requires higher cost than individual submission

§ Other cases listed in Presidential Decree

§ Requires “Confirmation of Individual Submission” from Minister of Environment

■ Use of data already Jointly submitted• Data already submitted for registration and listed in the Environment Ministerial Decree

• Permission to use for the Registration from data owner are required

• Data submitted over 15 years ago are available to be used freely

• Enquiry of existing available data can be made to Minister of Environment

23

Hazardous Chemical Substances

■ Hazardous evaluation• Hazardous evaluation is to be performed by Minister of environment and notify the results to the

registrants

• The Minister of Environment may request additional data deemed necessary for the hazardous

evaluation.

■ Depending on the result of hazardous evaluation minister of Environment will

designate any chemical substance as Toxic substance that has been found

hazardous.

■ Disclosure of hazard evaluation• Chemical substance name, hazardous characteristics, decision on “Toxic chemicals”

• Generic name will be used for information protection requested substances

• Use of generic name for toxic substances will not be accepted

24

Risk Assessment

■ Substances subject to Risk assessment• Registered substances manufactured or imported for 10 or more ton per annum

• When the result of Hazardous evaluation implies the necessity of further assessments

■ The Minister of Environment may request additional data deemed necessary for the

risk assessment.

■ The Minister of Environment may choose to adapt required measures depending on

the results of risk assessment to minimize risks .

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Permissible Substances

■ Designation of Permissible substances• Result of hazardous evaluation and risk assessment implying risk concerns

• CMR, endocrine disruptors substances or substances with high possibilities

• PBT, vPvB

• Other chemicals substances which have similar or higher level risks

• Permission is required before manufacture, import or use

• The Minister of Environment may grant a period during which the chemical substance can be

manufactured, imported or used without permission

■ Removal of Permissible substances• Replacement chemical substances is available or the Permissible substance is no longer required as

the effect of implementing new technology

• The substances has no risk as the effect of implementing new technology

• New scientific data, which proves that Permissible substance has no risk

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RestrictedㆍBanned Substances

■ Designation of RestrictedㆍBanned substances• Result of hazardous evaluation and risk assessment showing risks

• Listed by international organization

• Banned or restricted from manufacturing, import or use under international treaties

• Permissible substances which have been removed from the Permissible substance list

■ Warning of Designation of RestrictedㆍBanned substances• Warning with chemical name and designating date will be on homepage or official gazette

• Immediate designation without warning where urgency of designation is required

■ Removal of RestrictedㆍBanned substances• The substances has no risk as the effect of implementing new technology

• New scientific data, which proves that Permissible substance has no risk

27

Communication

■ Substance or preparation provider must provide• Registration no

• Name

• Hazardous and risk information

• Safe use information

■ Communication• These information may be included in MSDS

• Providing Information only on the first time is fine when providing to identical downstream user.

• Any changes in information must be informed to upstream user and downstream user within 1 month.

• Communication of information is required only when chemical substance or preparation is used as

base material of products, or is used for consuming purposes

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Communication

ManufacturerImporter

Downstream UserSeller

• Characteristics

• Uses

• Manufactured/import tonnage

• Safe use information

• Uses

• Exposure information

• Use/sell tonnage

• Safe use enquiries

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Notification of Product

■ Anyone who manufactures or imports products which contain 1 or more tons of

hazardous chemical substances

■ Notifying information• Chemical substance name

• Containing amount of hazardous chemical substances

• Hazardous information

• Use of the hazardous chemical substance within the product

■ Exemptions• “Exemption from Notification” is not required when the release of the hazardous chemical substance

is under control

• “Exemption from Notification” is required when the chemical substance in the product is already

registered

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High Risk Concerned Products

■ Risk Assessment of products• Minister of Environment will perform Risk Assessments on product categories containing hazardous

chemical substances which may cause harmful damages to human health and environment

• Minister of Environment may request required data for risk assessment to manufacturer, importer,

seller or retailer

■ Safety and Labelling criteria of High Risk Concerned products• Minister of Environment will establish Safety and Labelling criteria for High Risk Concerned Product

categories

• Safety and Labelling criteria will include

§ Chemical substances not to be used in High Risk Concerned Product

§ Threshold level of content, migration and evaporation, etc

31

High Risk Concerned Products

■ Information to be provided for notified product• Chemical substance name, use, condition, etc. are to be provided to downstream users in writing

• Safe use information must be provided on consumer’s request

■ Ban or Recall of sales• No one shall sell or provide, or import, display stock or store for before mentioned purposes when

High Risk Concerned Product is not compliant with Safety and Labelling criteria

• Data requirement specified in article 14.1.(Information requirement for Registration) for chemical

substances within product are required to be submitted in order to manufacture or import High Risk

Concerned Products without Safe and Labelling criteria been set by MoE

• Minister of Environment may takes measures including recall, sales ban and discard for non-

compliant High Risk Concerned Products which likely to cause damages to human health and

environment.

32

Only Representative

■ Foreign manufacturers exporting chemical substances or products into South Korea

may appoint an Only Representative

■ Qualification of Only Representative is to be decided by MoE

■ Only Representative’s obligations are• Annual Reporting of use and tonnage of chemical substances

• Registration

• Notification of Products

• Other activities as set out in the Presidential Decree

■ Only Representative must report the appointment or release of the appointment by

foreign manufacturers to Minister of Environment.

33

Documentations

■ Anyone who manufacture, import, sell or use must document below information

(where applicable)• Annual Reporting of Manufacture

• Registration

• “Confirmation of Exemption”

• Product Notification containing hazardous chemical substances

• “Exemption of Notification” for products containing hazardous chemical substances

• Submission of data for High Risk Concerned Products without set Safety and Labelling criteria

34

Fees and Penalties

■ Fees are payable for • Registration

• Application of “Confirmation of Exemption”

• Re-Registration of chemical substances

• External use of MoE’s Hazardous evaluation result

• Notification of products containing hazardous chemical substances

• Application of “Exemption of Notification” for products containing hazardous chemical substances

■ Penalties – 6 categories• Up to 7 years of imprisonment or a fine up to 200 million Korean won

• Up to 5 years of imprisonment or a fine up to 100 million Korean won

• Up to 3 years of imprisonment or a fine of up to 50 million Korean won

• Up to 1 years of imprisonment or a fine of up to 30 million Korean won

• Joint penal provisions

• Up to a fine of 10 million Korean won

35

Contents

3. Impacts of K-REACH• Obligations for Korean Companies

• Obligations for Foreign Companies

36

Obligations for Korean Company■ Korean Companies

• Build up inventory of manufacturing, importing or using chemical substances

• Check if your substances are subject to Registration

• Search for “hazardous chemical substances” in inventory

• Check if your product is categorized as High Risk Concerned ProductObligations To do

Annual Reporting Manufacturer, importer or seller- Submit uses and annual tonnage

Registration Manufacturer or importer- Joint Submission- Prepare and Submit data according to article 10.- Or apply for “Confirmation of Exemption”

Communication If providing registered chemical substance- Name & Registration No- Hazardous and Risk information- Safe use information

Notification When manufacturing or importing product containing Hazardous Chemical Substances over 1 ton per annum- Name and use of the chemical substance (to both notification and transferee)- Hazardous Information and chemical content (to notification)- Use condition (to transferee) - Or apply for “Exemption of Notification”

High Risk Concerned Product

Manufacturer of High Risk Concerned Products must follow- chemicals with restricted conditions of use in such products- Threshold of content, migration and evaporation of certain chemical substances

37

Obligations for Foreign Companies

■ Foreign Companies • Build up inventory of exporting substances

• Identify applicable obligations under K-REACH

§ Check if your substances are subject to Registration

§ Search for “hazardous chemical substances” in inventory

§ Check if your product is categorized as High Risk Concerned Product

■ 2 Options1. Get your importer to do all the work for the compliance of K-REACH

2. Or appoint an Only Representative for

§ Annual Reporting

§ Registration

§ Notification

§ Or others set by presidential decree

38

Obligations for Foreign Companies

1. Foreign Companies getting Korean importer to comply with K-REACH• Depending on the applicable obligations below information are to be provided

Obligations To do

Annual Reporting - Chemical contents of products

Registration When exporting chemical substance subject Registration- Content % of chemical substances subject to Registration- Substance identification data of such chemical substance- Classification and Labelling

Communication Not applicable as the chemical substance will be registered by Korean importer

Notification As importers will not have information of the product, basically all information are required- Name and use of the chemical substance- Hazardous Information and chemical content - Use conditions

High Risk Concerned Product

Exporting High Risk Concerned Products must follow below conditions- chemicals with restricted conditions of use in such products- Threshold of content, migration and evaporation of certain chemical substances

39

Obligations for Foreign Companies

1. Foreign Companies appointing an Only Representative• Depending on the required obligations, below information are to be provided

Obligations To do

Annual Report Manufacturer, importer or seller- Submit uses and annual tonnage

Registration Manufacturer or importer- Joint Registration- Submit data according to article 10.- Or apply for “Confirmation of Exemption”

Communication When providing and receiving registered chemical substances- Name & Registration No- Hazardous and Risk information- Safe use information

Notification When manufacturing or importing products containing Hazardous Chemical Substances over 1 ton per annum- Name and use of the chemical substance (to both notification and transferee)- Hazardous Information and containing % (to notification)- Use condition (to transferee) - Or apply for “Exemption of Notification”

High Risk Concerned Product

Manufacturer of High Risk Concerned Products must follow- chemicals with restricted conditions of use in such products- Threshold of content, migration and evaporation of certain chemical substances

40

Jun Ho Lee

Tel no. : +82-2-2164-0049

Email : junho78@ktr.or.kr

KTR homepage : http://ktr.or.kr

KTR Chemical Substance Registration Support Centre homepage : http://ktr.or.kr/reach

Thank you for attending

A downloadable recording of this presentation (with slides) will be available shortly. If you have any questions, please contact Lorna (lorna@chemicalwatch.com)