Latest Developments of Chemical Regulations in Korea 14 May 2019, Madrid, Gayoung Lee

Knoell Business Areas

Agrochemicals Biocides Industrial Chemicals

Medical Devices Food contact material Cosmetics

Veterinary Medicine Training Regulatory Software Solutions

knoell Companies/ Locations

3

UK NETHLERLANDS GERMANY

SPAIN SWITZERLAND

PORTUGAL

FRANCE KOREA

JAPAN CHINA

CANADA

USA TAIWAN

Knoell Korea Ltd. Service Scope

4

K-REACH Registration Preparation and support for all stages of relevant registration dossiers incl. chemical risk assessment

Consortium Management Support for all stages of SIEF/consortium for joint registration and data/cost sharing

Representative Service Only Representative service for foreign manufacturer

GHS/Product Safety Classification /re-classification and labelling according to local laws and legislations

Compliance check of existing SDS

Preparation and translations into national languages (>46 languages)

Biocidal Regulation

Regulatory and technical supports for K-BPR compliance

Coordinate the global project Efficient interface between Korean clients and knoell subsidiaries worldwide

Liaising with Korean authorities Translation

Latest Development of Chemical Regulations in Korea

Background

6

From humidifier disinfectant incident

To chemiphobia

Korea Regulations on Chemicals

7

Chemical Control Act (CCA)

Verification of chemicals (LoC requirement)

Management of hazardous chemicals

Statistical survey on chemicals

Expected to be amended

K-REACH

Registration: ≥1 t/a existing substances and ≥0.1 t/a new substance

Notification: < 0.1 t/a new substance

Pre-registration: ≥1 t/a existing substances (except 510 PECs)

Product notification containing Priority Control Substances

Amendment effective from 1st January 2019

Chemical Product Safety Act (a.k.a. K-BPR)

Occupational Safety and Health Act (OSHA)

Classification and GHS labelling

MSDS requirements

Hazard data submission for new substance ≥ 0.1 t/a

Amended in Jan 2019, to be effective from Jan 2020 (new rules for MSDS from 2021)

Approval of biocidal substances

Authorisation of biocidal products

Labelling of treated articles

Safety and labelling standard of consumer products

Effective from 1st January 2019

Overview of K-REACH

8

510 PECs by 30 June 2018

CMR Substances ≥ 1 t/a, Existing substances ≥ 1,000 t/a

2015 2015 2016 2019 2021

• Enforcement of the Act (1st Jan) • Announcement of 510 PECs subject

to registration (Jul)

2024 2030

Existing substances ≥ 100 t/a

Existing substances ≥ 10 t/a

Existing substances ≥ 1 t/a

Enforcement of the Amendment (1 January 2019)

Legi

slat

ion

Subs

tanc

e

Registration of new chemicals regardless tonnage

Registration of new chemicals ≥ 0.1 t/y Notification of new chemicals < 0.1 t/y

Annual reporting (by 30 June)

Pre-registration of existing substances (30 June 2019, late pre-registration available) (No more annual report)

Prod

uct Product Notification of

consumer products containing hazardous chemicals*

Safety and Labelling standard on products of concern over risk

Product Notification of ‘Priority Control Substances’ contained products**

Consumer chemical products safety and labelling standard

K-BPR

* Consumer products containing hazardous substance(s) over 0.1 % weight ratio per product and the total amount of the substance is more than 1 t/a.

** Consumer products containing Priority Control Substances (CMR, vPvB, etc. set by MoE; similar concept with SVHCs) over 0.1 % weight ratio per product and the total amount of the substance is more than 1 t/a.

2027

K-REACH PEC Registration

PEC Registration status (as of 10 September 2018) ● Among 510 PECs, 445 lead dossiers were registered.

Our experience shows that… ● Many Korean consortia contact EU consortia to request for LoA

● Understanding of both EU-REACH and K-REACH regulatory framework is essential to go forth with discussions

● Liaising directly with the Korean authorities is the key to clarify any questions ● Close communication with importers is necessary to acquire relevant information for dossier

preparation ● Foreign manufacturers often face language-barriers ● In-country support (e.g. OR / local consultant) is inevitable

[N.B.] No more grace period to PECs. Any PECs imported/manufactured ≥ 1 t/a shall be registered before import/manufacture.

9

K-REACH Pre-registration

OR Appointment ● Under K-REACH, OR appointment shall be certified by the authority via K-REACH Portal system. ● Substances already appointed OR for annual reporting shall appoint OR again for pre-registration

purpose. ● Bulk upload for OR appointment application is available from May. ● For now, OR certificate is issued in 7 working days.

Pre-registration ● Required information: substance identification number, use and importer ● Use information needs to be precisely described. ● At least one importer needs to be listed. ● Bulk upload is available up to 100 substances at a time (up to 20 uses, 20 importers) ● K-REACH Portal system has been changing to compatible to new rules and unstable from time to

time.

10

K-BPR Legislation (from 1 January 2019)

Consumer chemical products safety and labelling standard ● Manufacturer/importer of consumer products subject to safety test shall have test result from designated test institute

(result valid 3 years), report to MoE and comply with labelling standard.

● Transferred from safety and labelling standard of product over risk concern under current K-REACH.

● Biocidal products shall meet the standard during the grace period for the approval of biocidal product!

Approval of biocidal active substance and biocidal product ● Approval of biocidal active substance

● Manufacturer/importer of active substance(s) shall get an approval from MoE before manufacture/import.

● Existing active substance(s) (placed on Korean market before 31 December 2018) can be manufactured/imported within given grace period.

● Approval of biocidal product ● Manufacturer/importer of biocidal product(s) shall get an approval from MoE before manufacture/import.

● Approved biocidal product shall meet labelling standard.

● Treated article safety and labelling standard ● Manufacturer/importer of treated article(s) shall use approved biocidal product(s) only.

● If manufacturer/importer intends to promote efficacy of biocidal function of the product, risk and handling precaution shall be provided on product label.

11

K-BPR: Approval of Active Substance

12

● Approval valid for max. 10 years (max. 7 years to mitigated criteria applied substances and high risk substances to respiratory system)

Submission of Application

Assessment/ Draft Assessment

Report

Review of Draft Assessment

Report

Applicant MoE Applicant

Comments on Draft Assessment

Report

Applicant

Review of Assessment Report

K-BPR Committee

Final Decision on Approval/non-

Approval

MoE

Before manufacture or import (except for existing substances grace period granted by MoE) One year before expiration date

At least 30 days

Up to 30 days + additional 30 days if requested by the applicant

Up to 30 days + additional 30 days if the authority needs more

With conditions of • Purity and impurity • Product type • Users • Valid period

Up to 1 year from receipt of the application (6 moths for renewal)

Max. 18 months until final decision on approval

K-BPR: Approval of Biocidal Product

13

● Approval valid for max. 10 years (max. 5 years to mitigated criteria applied products and products used with biocidal substances with 7 years validity)

● Grace period to biocidal products:

● Containing all existing substances with grace period: 2 years after the expiration of grace period

● Containing existing substances without grace period: 1 year after the designation of existing substance

Submission of Application

Assessment/ Draft Assessment

Report

Review of Draft Assessment

Report

Applicant MoE Applicant

Comments on Draft Assessment

Report

Applicant

Review of Assessment Report

K-BPR Committee

Final Decision on Approval/non-

Approval

MoE

Before manufacture or import One year before expiration date (Only approved ASs shall be used)

At least 30 days

With conditions of • Product name and type • Valid period • User and uses • All ingredients and contents • Treated articles and uses

Up to 6 months from receipt of the application (4 months for renewal)

Max. 12 months until final decision on approval

Up to 30 days + additional 30 days if requested by the applicant

Up to 30 days + additional 30 days if the authority needs more

K-BPR: Labelling of Biocidal Product and Treated Article

Labelling of authorised biocidal product ● All biocidal substances and contents in the product ● Manufacturer or importer information: name of company, address, contact information ● Risk over use of the product and first-aid method ● Expiration date of the product and disposal method ● If Nano material intentionally contained, name of the Nano material and its use, etc.

Safety and Labelling standard on treated article ● Treated article shall use approved biocidal product for the approved use ● Treated article to promote its efficacy on destroy of harmful organism shall include following

information on the label: ● A phrase indicating the article is treated with biocidal product ● All biocidal substances (name and function) contained in the used biocidal product ● The fact that Nano material used in the used biocidal product, if applicable ● Risk and safety information of the used biocidal product

● Grace period on certain biocidal product plus 1 year will be given to treated articles.

14

K-BPR: Notification of Existing Active Substances

15

Application for grace period

By 30 June 2019

Manufacturer/Importer

Designation of Existing Substances with grace period*

By end of 2019

MoE

Submission of application plan (Joint submission)

By end of 2020

Manufacturer/Importer

Existing Active Substance Active substances contained in biocidal products which were placed in Korea until 31 December 2018.

Existing active substances can be granted grace period for approval up to 10 years.

If grace period is not granted,

no more manufacture or import of biocidal substances will be allowed.

Biocidal products containing those substances can be placed in the market for 1 year. !NO TRANSITION PERIOD for biocidal substances!

K-BPR: Grace Period to Existing Active Substances

16

From the date of MoE Notice (~2019.12.31)

3 years (~2022.12.31)

5 years (~2024.12.31)

8 years (~2027.12.31)

10 years (~2029.12.31)

Biocidal product type

• Disinfectants

• Algaecides

• Rodenticides

• Insecticides

• Repellents

• Preservatives for wood

• Control of other vertebrates

• Control of other invertebrates

• Preservatives for products during storage

• Preservatives for surface treatment

• Preservatives for fibre, leather, rubber, etc.

• Preservatives for construction materials

• Preservatives for materials and equipment

• Embalming and taxidermist fluids

• Antifouling products

● Grace period to be applied depending upon product types based on exposure risk in daily life

K-BPR: Transition Period for Biocidal Products and Treated Articles

Approval of biocidal products ● If all active substances are granted as existing active substances,

● 2 years later from the end date of the grace period on existing active substance ● If active substance is not subject to grace period,

● Within 1 year after MoE notice the list of existing active substances subject to grace period

Treated articles safety and labelling standard ● Grace period on active substance +3 years

17

K-BPR: Timeline

18

2019 (Jun)

2019 (Dec)

2020 (Dec)

2022 (Dec)

2024 (Dec)

2027 (Dec)

2029 (Dec)

2031 (Dec)

K-BPR (2019.1.1)

Notification of existing ASs

MoE Notice Existing ASs

Approval of ASs within grace period (Deadline applies depending on product types, Max. 18 months for review and approval from the authority)

Approval of BPs within grace period (Deadline applies depending on product types, Max. 12 months for review and approval from the authority) N

otifica

tion o

f ex

isting A

Ss

Without

notifica

tion Manufacture/import/sa

le of ASs possible

Manufacture/import/sale of BPs possible

Manufacture/import/sale of TAs possible

2023 (Jun)

2026 (Jun)

2028 (Jun)

2021 (Jun)

Submission of plan for approval application

2023 (Dec)

2026 (Dec)

2028 (Dec)

2030 (Dec)

Chemical Control Act (CCA) Obligations

Verification of Chemicals ● Domestic importers and manufacturers are obliged to declare whether the products

contain any PEC, new substances and hazardous substances prior to import or manufacture.

Chemicals Authorization/Declaration ● Prohibited substance / Substance subject to authorization / Restricted substance /

Toxic substance Statistical Survey on Chemicals ● Obligation to carry out a statistical survey for all chemical use, including manufacture,

import, sales, storage, and transport in every 2 years.

19

Expected Changes of CCA Ministry of Environment (MOE) announced the CCA Amendment passed cabinet meeting on 2 April 2019.

Notification and Tracking of Chemical Ingredients ● Stricter enforcement: report ▶ notification ● Periodic notification: one-off at the time of first import ▶ every 5 years ● Chemical identification number will be assigned by the authority.

Introduction of OR Concept ● To avoid false notification or failure of data collection from foreign suppliers ● Appointed OR by foreign suppliers can fulfil importer’s obligations

Provision of chemical information ● Chemical identification number, hazardous substances, hazard/risk information, etc. ● Can be included and provided in safety data sheet

Implementation of the change ● Not promulgated yet ● Chemical ingredients notification and tracking clauses will be effective 2 years after the

enforcement announcement

20

OSHA Amendment (Changes of MSDS rules) Amendment will be effective from 16 Jan 2020. MSDS related clauses will be effective from 16 Jan 2021.

Preparation/submission/provision of MSDS ● Chemical substances or mixture containing chemical substances with hazard/risk properties

according to the OSHA shall be disclosed in the MSDS. ● Chemical substances or mixture not disclosed in the MSDS shall be submitted to the MOEL

(Ministry of Employment and Labour). ● Letter of Confirmation (LoC) from foreign manufacturer is acceptable to prove that there is no

chemical substances with hazard/risk properties.

Confidential Information of MSDS ● If manufacturer/importer does not want to disclose chemical name and contents in the MSDS due to

confidentiality matters, it shall have approval from MOEL (5 year validity, renewal available). ● Upon the approval from MOEL, alternative name and contents shall be provided in the MSDS.

Data submission via Only Representative (OR) of foreign manufacturer ● Foreign manufacturer can appoint OR for following tasks to cover importer’s obligation:

● Submission of chemical name and contents to MOEL ● Application for CBI approval on chemical name and contents from MOEL

● The fact of OR appointment/dismissal shall be notified to MOEL.

21

Take Home Message

22

Keep in mind to be compliant: ● Deadline for registration application submission of PECs is over. Any PECs to be manufactured or

imported ≥ 1 t/a from now on shall be registered before the manufacture or import. ● Pre-registration requires to get grace period for existing substances ≥ 1 t/a by end of June 2019.

Late pre-registration is available. ● New substances shall be registered (≥ 0.1 t/a) or notified (< 0.1 t/a) before manufacture/import. ● Specific K-BPR rules are still under development. ● The more chemical information shall be disclosed to Korean authorities.

Get ready for impact: ● Evaluate your products sold to Korea and identify the inventory status of chemicals ● Communicate with importers/downstream users ● Improve quality of SDS ● Track the volume per chemical ● Keep yourself informed of the official announcement ● Check your needs for external help

Thank you for your attention

knoell Korea Ltd. Seoul, South Korea Gayoung Lee Managing Director E-mail: gayoung.lee@knoell.com Tel: +82 2 6671 0211

www.knoell.com