ContentsϨ

Backgroundϩ

Achievements for New Regulation

Ϫ

Korea REACH Outline

ϫMain Provisions

Ϭ

Data Requirement (draft)ϭFuture Plan

Ϩ. Background
Registration and evaluation system of chemicals is being globally
standardized
ü Since introduction of REACH by the EU (introduced in Dec 2006),
major trading partners have strengthened management of chemicals

Concerns about risk and competitiveness with change inmanufacture · import volume
ü Chemicals import increased 20.4%, but Manufacture decreased 11.3%
Subject
ImportvolumeProduction
volume2006 (million ton)2010 (million ton)

Total tonnage (including other sector)

189.3

222.1(17.3%)

Coke / refined petroleum product136.2

128.6(5.9%)

Chemicals & chemical product maker

20.1

24.2(20.4%)

Total tonnage (including other sector)

286.3

284.3(∆0.6%)

Coke / refined petroleum product127.5

134.6(5.6%)

Chemicals & chemical product maker

103.6

91.9(∆11.3%)

Ϩ. BackgroundTo establish legal basis for precautionary management
ü Under the current ଴Toxic Chemicals Control Act (TCCA)ଵ, data on
chemicals circulated are insufficient and not properly managed
э Establishing data generation and evaluation system of chemicals

To prepare preventive measure against exposure of substances ofvery high concern (SVHC) on the basis of risk dataü Scientific chemicals management based on risk data and measureagainst exposure of SVHC such as carcinogens is neededэ Shift to a risk assessment concerning exposure to health and theenvironment

To strengthen industrial competitivenessü Legislation to encourage industries to respond to green chemistry isneededซUGAchievements for New Regulation : 2011G

Year

Achievements
Ø Consultation among 8 ministries, preliminary announcement on
legislation on ૶Act on Registration and Evaluation of Chemicals ( Korea
REACH)૷ (Feb ~ April, 2011)2011

Ø Stakeholders’ opinions on ‘Korea REACH’ collected (total 11 times)• Forum organization and host (Jan ~ Nov 2011, 6 times),• Public hearings (March ~ June 2011, 4 times)• Government and Industry Meeting (Sep 2011)

ซUGAchievements for New Regulation : 2012G

Year

Achievements
Ø 5 time working level meeting with Ministry of Knowledge Economy(MKE) (Feb ~ March, 2012)Ø Policy Council between MOE and MKE (March 19, 2012)• The final agreement reached2012• Legislation and pilot project will be pushed forward simultaneously

Ø Review by Regulatory Reform Committee [RRC] (Aug, 2012)
Ø Review by Ministry of Government Legislation (Sept, 2012)Ø Submission of Act to National Assembly (Sept 28, 2012)

ซUGAchievements for New Regulation : Pilot ProjectG
Pilot project jointly conducted by MOE and MKE and extended
from 1 to 3

Scope of existing
project

Implementation TeamLed by MOE ∙ Contract
Research Organization(CRO)

General Management Team(co-heads:
directors from MKE & MOE)

Stakeholders’ ForumTeam
Led by MOE ∙ MKE

Operation of CRO work

Advised by MKE
pilot project
implementation
Guidance development

Stakeholders’ opinion
collection
Legislation revision

Industry Support TeamLed by MKE ∙ CRO
Advised by MOE
Prepare measures toreduce corporate’s burden
Develop measures tosupport corporate

Ϫ. Outline : TCCA vs Korea REACH
Basic Concept of Korea REACH

Korea
REACH

• Registration and evaluationof chemicals• New + Existing chemicals• Hazard + risk

VS

TCCA

• Management of Toxic Chemicals• Hazard• New chemical notification• 袼蹓輀踕芓议 縸膱茽Ϫ. Outline : Flow Scheme
1.

Existing chemicals(1 ton/year)

For existing chemicals for registration, grace period is imposed by stages (Maximum 8 year)

2. Different testing data required depending on tonnage levels → 11~46 testing item (TCCA: 16)
3. Data for submission: usage, physicochemical property, hazard/risk data

Notification ofChemicals for registration- If above 100 ton, risk data shall be submitted
4. Same chemicals are subject to joint submission, mandatory sharing for vertebrate test data

1 ton or more by company(hazard * distribution volume)

Toxic
chemical substance
Reporting of
manufacture,etc
Registration

New chemicals(1 ton or more)

Completenesscheck

Hazardevaluation

Chemical
substance forauthorization
Risk
assessment

1) 100 ton or more
2) If risk assessment
is required following
hazard assessment(estimated 1% ofregistered chemical
substance)

Restricted ·prohibited chemical
substance
Reflection ofinternational
conventions, etcϪ. Outline : Major Provisions
Description
Ø Reporting of Manufacture of chemicals (≥1 ton)
• Manufacturer· importer required to report the volume ofOpinion Collection
Ø Reporting frequency :1 year → 2 years

Manufacture·importØ Registration of chemicals

Ø Criteria for registration :• Grace period : maximum 8 years

0.5 ton/yr →1 ton/yr• Modification of registration : in case of an increase in manufactureØ Pre-registration process :volume, etc.

deleted• Submission data : the identity of chemicals, physicochemical

properties, toxicological information, etc.

Ø Authorization and Restriction·Prohibition of chemicals• Designation and Modification of chemicals for authorization andØ Product-related articles
deletedRestriction·Prohibition

Ø Communication on chemicals• Chemicals Evaluation Result provided to the recipientØ Tool for communication :MSDSϪ. Outline : Chapter and Articles
Chapter

Provision

Ch.1

General Provision (Article 1~7)

Ch. 2

Registration of Chemicals (Article 8~17)

Ch. 3

Evaluation of Chemicals (Article 18~23)

Ch. 4

Designation of Chemicals for Authorization(Article 24~27)

Ch. 5

Communication on Chemicals (Article 28~29)

Ch. 6

Supplementary Provision (Article 30~41)

Ch. 7

Penalties (Article 42~46)

ϫ. Main Provisions : Registration of Chemicals (1)Reporting of Manufacture or Import of Chemicals
ü In the case of chemicals(≥1ton/yr), manufacturer or importer are
required to report the volume of manufacture, etc. to MOE

Designation of Priority Evaluation Chemicals
ü Amongst existing chemicals, priority chemicals shall be designatedbased on hazard, trading volume, etc

Registration
ü Manufacturer or importer of new chemicals and priority chemicals
shall submit a registration to MOE prior to manufacture or importü Grace period of maximum 8-year shall be granted to priority chemicals

Exemption of Registration
ü ‘Chemicals manufactured or imported less than 1 ton/yr’, ‘R&D’, etc.

ϫ. Main Provisions : Registration of Chemicals (2)Modification of Registration
ü In case of modification to registered dossiers due to increase in
manufacture volume, etc., modifications or additional dossiers shall be
submitted

Registration dossiersü Information on chemical identity and properties, usage, C&L, etc.

Joint Submission of Registration dossiersü Joint submission of registration dossiers on the same chemicals is ofobligation

Prohibition on Repetitive Generation of Test Data
ü If vertebrate test data already exist, repetitive generation forregistration shall be prohibitedü In case of refusal of test data sharing without justification, thesubmission of the data for registration can be prohibitedϫ. Main Provisions : Reporting & Registration List
Reporting of manufacture, etc- Frequency : once in two years- Information : manufacture · import volume and use (65 categories)- Exemption : <1t/y, imported as contained in machineries, contained inarticle (solid state of specific shape), R&D, etc.

Priority evaluation chemicals- The draft lists are planned to be released in 2013
- Criteria for prioritization : exposure + hazard• Exposure : volume (national level) and use• Hazard : CMR, PBT, H410 (GHS Chronic aquatic hazard cat 1),
Toxic Chemicals under TCCA

ϫ. Main Provisions : Reporting & Registration List
Grace period for priority chemicals- Priority 1, 2 & 3 chemicals : 2, 5 & 8 year, respectively- The number of priority 1 chemicals will be minimized- Total number of priority chemicals may be 2,000~ 2,500

Data requirement and tonnage level- Registration of chemicals (<100t/y) similar to TCCA data requirement
Level 1

Level 2

Level 3

Level 4

(1-10t/y)(10-100t/y)(100-1000t/y)(>1000t/y)

Physical and Chemical Properties

5

7

9

12

Human Health Hazards

4

8

11

15

Environmental Hazards

2

5

13

19

11

20

33

46

Data Requirement

Total

ϫ. Main Provisions : Evaluation (Hazard and Risk)
Hazard Evaluation
ü MOE (NIER) conducts hazard evaluation of registered chemicals
ü Chemicals being harmful to human health or the environment based on
hazard evaluation are designated as Toxic Chemicals

Open to public of Evaluation Results
ü MOE shall notify the results of hazard evaluation
ü Names of chemicals subject to data protection shall be notified as
generic names during a protection period

Designation and revocation of test facility (GLP)ü MOE shall designate test facilities where data necessary for hazard
evaluation can be produced and conduct a periodic inspection on adesignated facility

Risk Assessment
ü MOE seek measures on risk prevention by evaluation risk data anddesignating chemicals with high risks as chemicals for authorization or
for restriction∙prohibitionϫ. Main Provisions : Evaluation procedure

Application for registration of
new and priority chemicals(Manufacturer · importer)

Review of registration dossiers(within 1 month) and notification
results

Hazard evaluation, order tosubmit data of hazard and risk (ifnecessary)

Risk assessment

Designation of Toxic
chemicals

Designation of authorization
or restriction · prohibition
chemicals

Business registration andReport on import under
TCCA

Permission for manufacture,import or use of authorization
chemicals under TCCA

ϫ. Main Provisions : Authorization and Restriction
Designation of chemicals for authorization
ü SVHC such as CMR, PBT, etc. shall be designated as authorization
chemicals based on hazard and risk assessment data

ü In case that alternative chemicals becomes available, designation ofchemicals for authorization is subject to modification

Designation of chemicals for restriction · prohibition
ü Hazardous chemicals shall be designated as restriction· prohibition
chemicals on the basis of a risk assessment, etc.
ü Manufacturer, importer, seller and user of chemicals for restriction·prohibition shall comply with provisions on restriction · prohibitionϫ. Main Provisions : Authorization and Restriction Chemicals

v Chemicals for Authorization: chemicals of high concern which require permission by MOE prior to

manufacture, import and use

v Restricted Chemicals: chemicals having risk when they are used for a specific purpose that is designatedby MOE to prevent use for such purpose

v Prohibited Chemicals: chemicals having risk that designated by MOE to prevent use for all purposeϫ. Main Provisions : Communication of Chemicals
Provision of Chemical Evaluation Result
ü Upon the provision of Chemicals whose hazard assessment is complete,
it is of obligation to provide chemical assessment result (chemical name,registration number, hazard, risk, etc) to recipients
ü Upon the provision of Chemicals subject to authorization or restriction· prohibition, it is of obligation to provide details of authorization or

restriction · prohibition, etc to recipientsü In cases of modification to data provided, it is of obligation to provide
modifications to recipients (within 3 month)ญU Main Provisions : Supplementary
Only Representative (OR)
ü A foreign manufacture who intends to perform obligations required toa importer under this act shall appoint a legal entity in Korea as anonly representative

Designation and operation of center for green chemistryü MOE, in order for technology development, etc. concerning chemicals
hazard and risk prevention, can designate and operate the center forgreen chemistry

Disclosure of registration information
ü MOE shall make a part of data registered such as chemical hazard
available to the pubic

Protection of information
ü Confidential business information such as chemical name, etc shall not
be made public during a protection periodϼ. Data Requirement : TCCA (1)Generalü Chemical name / CAS RN, Structure, Purity
ü Major use of product and function of new chemical substanceü Annual import volume
ü % in a productü Information on importer/user

Physico-chemical properties
ü Appearanceü Melting point / Boling pointü Vapor pressureü Solubilityü Partition coefficient

Environmental release information
ü Information on detailed use facility and environmental prevention facility, etc
ü Estimation of environmental release amount – air, water, soil
ü Information of daily use amount and average working day, etc.

ϼ. Data Requirement : TCCA (2)Full
Notification

Low volume
Notification

Polymer
Notification

Simplified
Notification

CommonCoCommo
mon dataddaatat ((physico- chemical property data, environmental release, use information etc)

· GPC data, information
monomers, polymer
stability test etc· Acute toxicity Test
· Genetoxicity Test
(Ames Test &Chromosome aberration)· Biodegradation Test
· Ecotoxicity Test
(Fish & Daphnia & Algae)· Dermal Irritation Test
· Eye Irritation Test
· Skin Sensitisation Test

· Acute toxicity Test
· Genetoxicity Test
(Ames Test &Chromosome aberration)· Acute toxicity Test
· Ames Test

· Acute toxicity Test
· Ames Test

· Biodegradation Test
· Ames Test
· Fish Acute Toxicity
Test· Ames Test
· Fish Acute Toxicity
Testϼ. Data Requirement : Health Hazards (draft)
Level 1(1~10ton)

Level 2
(10~100ton)

Acute Toxicity (oral)
Acute Toxicity (dermal(OECD TG 420/423/425) or inhalation) (402,403)

Skin Irritation (404)

Eye Irritation (405)Skin Sensitization(406/429)

Ames (471)
In vitro Chromosome
Aberration (473/485)

In vitro gene mutation(476) orin vivo Chromosome
Aberration (474/475)

4 items

8 items (level 1 + 4)

Level 3(100~1,000ton)

Level 4(>1,000ton)

Repeated Toxicity(28d) (407,410,412)

Repeated Toxicity(90d) (408/409, 411,
413)

Genotoxicity(further information)

Carcinogenicity(451/453)

Reproductive Toxicity(screening)(421/422)

Reproductive Toxicity(developmental) (414)(two-generation) (416)

11 items (level 2 + 3)

15 items (level 3 + 4)

ϼ. Data Requirement : Environmental Hazards (draft)
Level 1(1~10ton)
Acute Fish toxicity(203)

Level 2
(10~100ton)
Acute Daphnia
Toxicity (202) andAlgae Growth
Inhibition (201)

Level 3(100~1,000ton)

Level 4(>1,000ton)

Fish Toxicity (long-term)(201/212/215)
Daphnia Toxicity (longterm) (211)
Toxicity to Plant (shortterm) (208/227)
Earthworm Toxicity(short term) (207)

Toxicity to Plant (longterm) Earthworm
toxicity (long-term)(222)

Activated sludge
Toxicity to Sedimentrespiration inhibition (209) Organism (218/219)
Biodegradability(Ready) (301/310)

2 items

Hydrolysis (111)

5 items (level 1 + 3)

Biodegradability(Inherent) (302)
Identification of
Degradation Products

Bioconcentration (305)
Fate and Behavior of
Degradation Products(further information)

Adsorption/desorption(screening)

Adsorption/desorption(further information)

13 items (level 2 + 8)

19 items (level 3 + 6)

ϭ. Future Plan

Forum for stakeholders (monthly), open forum (half-yearly)

Pilot
Project

Guidance development and Implementation Project
Development of measures to support industry

Publication of Final Act (the first half, 2013)

Legislation

Development of subordinate regulations (2013)

Enforcement of Act (2015)