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New Chemical Notification

1. Introduction

The Notification System of New Chemicals in Korea has been governed by the

Toxic Chemicals Control Law (“TCCL”) of the Ministry of Environment (“MOE”) and

the Industrial Safety and Health Law (“ISHL”) of the Ministry of Labor (“MOL”).

In order to import new chemicals to Korea, Hazard Review by NIER and MOL

has to be completed in advance of the procedure for customs clearance. Importer

must notify new chemical in the name of representative of importing company or

Korean branch office of foreign companies under the two laws, and receives the

Review Result from the National Institute of Environmental Research (“NIER”) and

MOL, respectively within 60 days (processing period). NIER and MOL publish its

Review Result, respectively, on the Official Gazette 3 years later from the day they

inform the notifier of the Review Result. After such publication, anyone may import

or manufacture the corresponding new chemical.

From Jan. 1, 2006, the notification dossiers under the said two laws can be

submitted only to MOE (actually to NIER). After receiving the notification dossiers

under two laws, NIER forwards the notification dossier under the ISHL to MOL.

The outline of the notification system under each law is as follows.

(1) TCCL of MOE

A person who intends to manufacture or import a new chemical must submit

the “Application Form for Hazard Review of Manufacture/Import of Chemical

Substance (for NIER)” and the “Review Report on Hazard and Danger of New

Substance (for MOL)” to the General Affairs Section of the NIER. NIER

forwards the notification dossier under ISHL to MOL.

The NIER mails the “Notice for Review Result” to the notifier after the

completion of Hazard Review within 60 days processing period. After 3

years, the result of Hazard Review is announced in the Official Gazette. In

case a restriction for manufacture, import or use is needed due to the high

toxicity, it is possible to restrict its manufacture, import or use in


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consultation with the Ministers of the relevant Ministries.

(2) ISHL of MOL

Before Jan. 1, 2006, a person who intends to manufacture or import new

chemicals had to submit the “Review Report on Hazard and Danger of New

Substance” to MOL. However, from that day, the application form for the new

chemical notification can be submitted to NIER as mentioned above.

Upon receipt of the “Review Report on Hazard and Danger of New Substance” from MOE, MOL requests the Research Center for Industrial Chemicals under

the Korea Occupational Safety and Health Agency, which is managed by MOL,

the Hazard Review. After the Review within the 60 days processing period,

a “Notice on Action to be Taken regarding Hazard and Danger” is mailed to

the notifier.

After that day, the result of Hazard Review is announced in the Official

Gazette after 3 years. In case a restriction for manufacture, import or use is

needed due to the high toxicity, it is possible to restrict its manufacture,

import or use in consultation with the Ministers of the relevant Ministries.

2. Where to notify New Chemical Notification

Notification dossiers are submitted to NIER having the following address.

- Address : National Institute of Environmental Research

#2-1 Site, Metropolitan Landfill Area, Kyungseo-Dong, Seo-Gu

Inchon Metropolitan City, Korea (Zip code 404-170)

- Submission of documents: General Affairs Section of NIER

- Q&A : Chemicals Examination Committee

Tel. No.: 81(Country code)-32(Area number)-560-7222∼7227

Fax No.: 81(Country code)-32 (Area number)-560-7059

3. How to confirm whether chemicals are subject to the

New Chemical Notification


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The following process can be used to check whether or not a chemical in

question is subject to the new chemical notification.

Fig.1. Procedure of confirmation on whether a chemical is subject of the New

Chemical Notification.

C o n firm th e typ e o f e xem p tio n fro map p lic a tio n o f th e T o x ic C hem ic a ls

C o n tro l L aw (A )

E xem p tio n acco rd ing to th ed e fin it io n o f c h em ica ls (B )

C o n firm w h e th e r it is lis ted o n th eE x is tin g C hem ic a ls L is t (C )

C o n firm w he the r it is new c hem ic a lno tic ed

(co n firm th e o ffic ia l g a za tte ) (D )

C o n firm o th e r c o nd itio n s o fexem p tio n

fro m th e no tif ic a tio n (E )

N ew C hem ic a l N o tif ic a tio n(to N IE R , M O L )

N o

N o

N o

N o

N o

Y es

Y es

Y es

Y es

Y es

E xem p tio n fromN o tif ica t io n

E xem p tio n fromN o tif ica tio n

(C o n firm a tio n o fre le van t la w )

E xem p tio n fromN o tif ica t io n

E xem p tio n fro mN o tif ica tio n

E xem p tio n fro mN o tif ica tio n


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(A) Which chemicals are exempt from the application of TCCL?

(1) Exemption from TCCL

(in relation to other laws)

Any chemical substances which are managed under other laws as follows are

exempt from TCCL. Therefore, for such chemicals, the procedure under

each relevant law must be followed.

① Radioactive substances defined under the Atomic Energy Law

② Pharmaceutical products, quasi-pharmaceutical products defined under the

Pharmaceutical Affairs Law

③ Narcotics defined under the Narcotics Law

④ Cosmetics defined under the Cosmetics Law

(Including raw materials of which safety review is necessary under Article 4,

Paragraph of this Law)

⑤ Pesticides defined under the Pesticide Chemicals Control Law

⑥ Chemical fertilizers defined under the Fertilizers Control Law

⑦ Foods and food additives defined under the Food Sanitation Law

⑧ Animal feeds defined under the Feeds Control Law

⑨ Gunpowder defined under the Gun, Sword and Gunpowder Control Law

⑩ Toxic gases defined under the High-Pressured Gas Safety Control

Law

(2) Exemption from ISHL

(in relation to other laws)

The relation to other laws is not clearly described in the ISHL. For that

reason, the exemption cases of the substances managed under other laws are

not stated definitely.

(B) Which chemicals are exempt according to the “Definition of Chemicals”?

(1) TCCL

The following is the definition of chemical substance under TCCL (Article 2,

Item 1 of TCCL):


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“A chemical substance” means an element, a compound and a substance

produced by creating chemical reaction artificially to an element or a

compound, or a substance extracted or purified from substances occurred in

nature.

(2) ISHL

As described above, there is no specific definition in the law, but elements,

naturally produced chemicals, and radioactive substances are exempt from

new chemical notification requirement. It is necessary to refer to the

section concerning exemption from New Chemical Notification.

(C) How to confirm whether it is an Existing Chemical Substance

A person who intends to import chemical products must confirm whether all

components of the products are listed on the “Existing Chemicals List.”

MOE published the Existing Chemicals List in Feb. 1991 under TCCL, and also

MOL published the Existing Chemicals List in Dec. 1993 under ISHL,

respectively.

However, it was confirmed that a number of chemical substances imported from

foreign countries were omitted from the Existing Chemicals List. MOE collected

the information on the chemical substances which had been manufactured or

imported before Feb. 2, 1991, but which were not on the Existing Chemicals List,

through the documents submitted by manufacturers and importers during the

fixed reporting period, and then, published Annex I (published in 1993) and

Annex II (published in 1994) of the Existing Chemicals List in sequence, based

on the above information.

In 1996, MOE and MOL agreed to combine four Existing Chemicals Lists (three

from the MOE and one from the MOL) into one since it was inconvenient to

identify existing chemicals through four Existing Chemicals Lists. Finally, the

Combined Existing Chemicals List was published in Dec. 1996 (MOE's Public

Notice No. 96-170; MOL's Public Notice No. 96-44).

However, in addition to the said Combined Existing Chemicals List, in November


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12, 2005, MOE added 1360 existing chemicals (Public Notice No. 2005-11).

These are the chemicals which were additionally approved as existing chemicals

by NIER before the publication day of November 12, 2005.

As a consequence, companies must check the "Combined Existing Chemicals

List" and 1360 chemicals additionally published in November 12, 2005 to confirm

whether or not any chemical substance is a new chemical substance in Korea.

(D) How to confirm whether a New Chemical has been published in the Official

Gazettes

New chemicals for which a Hazard Review has been completed are announced

publicly in Official Gazette. NIER and MOL publish the result of Hazard Review

in the Official Gazettes of the Korean Government, respectively.

After completing the Hazard Review, NIER sends the “Notice for Result of

Hazard Review” to the notifier by mail, and then publishes it in the Official

Gazette of the Korean Government after 3 years. After such publication, the

manufacture or import of the corresponding new chemicals is open to everyone.

NIER classifies chemical substances into 4 categories according to the result of

the Hazard Review for new chemicals and publicly announces it separately. The

first category is “Chemicals not Relevant to Toxic Chemicals etc.,” the second is

“Toxic Chemicals,” the third is “Observational Chemicals,” and the last one is

“Prohibited or Restricted Chemicals.”

In the case of “Chemicals not Relevant to Toxic Chemicals, etc.,” number

assigned by the NIER, chemical name and CAS No. are publicly announced.

“Toxic Chemicals” are the chemicals falling under criteria for the designation of

Toxic Chemicals in accordance with Article 2 and Annex 1 of the Presidential

Decree of TCCL. In this case, number assigned by NIER, chemical name and

labeling requirement of Toxic Chemicals (hazard, precaution in handling) are

announced. “Prohibited or Restricted Chemicals” are the chemicals which are

judged to be regulated strictly in consultation with Ministers of other relevant

Ministries. For this category, the number assigned by NIER, chemical name and

the contents of restriction are announced. No new chemical falls under this

category to date.

After completing the Hazard Review, MOL sends the “Notice on Action to be


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Taken regarding Hazard and Danger” to the notifier by mail and then publishes it

in the Official Gazette of the Korean Government after 3 years. After the public

notice, the manufacture and import of the corresponding new chemicals are open

to everyone. Fig. 2-1 is an example of public notice in the Official Gazette by

NIER and Fig. 2-2 is an example by MOL.

It is very difficult to confirm the notified chemicals in the Official Gazette of

Korean government from foreign countries since Official Gazettes which can be

searched on the homepages of the authorities are limited to the recently

published. However, in our website and KCMA’s website (www.kcms.or.kr) all

chemical substances which were published in Official Gazette can be searched.


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Official Gazette

Nov. 29, 2000 (Wednesday)

National Institute of Environmental Research

Public Notice No. 2000-23

We hereby announce the following chemicals not relevant to Toxic

Chemicals, etc. in accordance with Article 10 of TCCL and Article 6,

Paragraph 1 of the Ministerial Decree of the Law.

Nov. 29. 2000

Head of National Institute of Environmental Research

Addition to the Chemicals not relevant to Toxic Chemicals, etc.

We hereby announce the following chemicals not relevant to Toxic

Chemicals, Observational Chemicals, Restricted Toxic Chemicals,

Prohibited Chemicals from manufacture, import, and use in accordance

with Article 10 of TCCL and Article 6, Paragraph 1 of the Ministerial

Decree of the law.

No. Name of chemicals [CAS No.]

2000-3-1606

2-Propenoic acid telomere with 2-methyl-2-[(1-oxo

-2-propenyl)amino]-1-propanesulfonic acid

monosodium phenylphosphinate, sodium salt [CAS

No. not designated]

2000-3-1607 Formaldehyde polymer with methanol and 6-phenyl-

1,3,5-triazine-2,4-diamine [CAS No. 72849-23-1]

.

Fig.2-1. Translation of Example for “Public Notice” of New Chemicals by NIER


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Official Gazette

Nov. 29, 2000 (Wednesday)

Ministry of Labor

Public Notice No. 1999-37

We hereby announce the names of new chemicals, possible hazards, and safety

measures to be taken in accordance with Article 40 of the ISHL and Article 91

of the Ministerial Decree of the Law, as follow:

Dec. 31, 2000

Minister of Labor

Name of new chemical, hazards and measures

` No. Name of new chemical Hazard·riskMeasures to prevent workers’

health damage

99-61

1-Dodecene, polymer

with 1-decene and 1-

octene, hydrogenated

[CAS No.: 163149-28-

8]

Colorless,

transparent

liquid

○ After contact with skin, wash

eyes and face immediately at

washing equipment near

workplace. Keep personal

hygiene by washing or

replacing contaminated

personal protective

equipment.

○ Possible risk of exposure,

workers must wear protective

clothing, glasses, gloves, and

suitable respiratory

equipment.

Fig. 2-2. Translation of Example for “Public Notice” of New Chemicals by MOL


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(E) Is a New Chemical exempt from notification requirement on account of its amount

or use?

In case a chemical is confirmed to be a new chemical from the result of

confirmation under the procedures as described from A to D, the notification

requirement is exempt if the chemical falls under the following Items.

(1) TCCL

Any chemical substance falls within any of the following categories is exempt

from the new chemicals notification requirement (Article 9 of Presidential

Decree of TCCL). However, each importer must obtain the Certificate on

Exemption from KCMA.

(i) Any chemicals of which the annual import amount is low volume of 100 kg

or less (unless the importer provides data indicating the presence of a

new chemical, the volume shall be determined based on the total weight

of the product);

(Note) The important matter in this case is that customs clearance is

possible without New Chemical Notification up to 100 kg of annual import

amount per importing company when the weight of exclusively pure new

substances is calculated. In this case of Low Volume Exemption, the

New Chemical Notification requirement is exempt. However, each

importer must obtain the Certificate on Exemption from KCMA (KCMA

confirms the total annual import amount).

(ii) Any new chemical substance used in the limited site by the persons

engaged in the test or research for the purpose of development of

chemical substance or products containing chemical substance or of

improvement of manufacturing process;

(iii) Any new chemical substance imported as contained in a machine or

equipment or any chemical substance imported together with the relevant

machinery or equipment for a test run; or

(Note) In the case of importing the chemicals that are already contained in

a machine or equipment, the New Chemical Notification requirement is

exempt. However, the notification is not exempt for any supplementary


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imports that occur afterward.

(iv) Any new chemical substance contained in a product having certain

function in a specific solid shape, which are not released during its use.

(v) Any new chemical substance of which 10 ton or less per year is

manufactured or imported for the export as a whole or any new chemical

substance of which 10 ton or less per year is manufactured or imported

for the production of the chemical substance to be exported as a whole;

(vi) Other new chemical substances recognized and announced by the Head of

NIER as chemical substances for which it deems not necessary to have

Hazard Review pursuant to Items 1 through 5.

(Article 26 of “Regulation concerning Hazard Review of Chemical

Substances,” NIER's Public Notice No. 2005-19)

- Polymers which are listed on the Existing Chemicals List. In

this case, reactants or monomer of 2% or less are not

considered;

- Any block polymers of which all blocks are listed on the Existing

Chemicals List;

- Graft polymers of which main stems and branches are listed on

the Existing Chemicals List;

- Non-ionic polymer of which number average polymer is 10,000

or more (will be enforced from Jan. 1, 2007);

- Non-ionic polymer of which number average polymer is 1,000 or

more and which meet the followings:

(will be enforced from Jan. 1, 2007)

Monomers should not be Toxic Chemical, Observational

Chemical, any new chemical(s), or epoxy compound(s)

Water solubility should be 5 mg/g or less

- Any chemicals which are not listed on the Existing Chemicals

List, but are proved to have been manufactured or to have been


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imported to Korea before Feb. 2, 1991 (including the chemicals

proved to have been exported from foreign countries to Korea

before Feb. 2, 1991).

(2) ISHL

The chemicals falling under any of the following Items are exempt from the

New Chemical Notification (Article 40, Paragraph 1 of ISHL; Article 32 of the

Presidential Decree of the ISHL; Articles 86 of the Ministerial Decree of

ISHL). In the case of Low Volume Exemption (⑦), a finished product for

consumers (⑥) and new chemicals for testing and research (⑧), confirmation

from MOL is required. However, to avoid overlapping with TCCL, it is

deemed to obtain confirmation by MOL if the Certificate on Exemption is

issued by KCMA under TCCL.

① Elements

② Naturally occurring substances in nature

(Note) Chemicals distributed commercially in a natural state are excluded

from the requirement of notification. However, chemicals produced for

commercial purposes through processing such as extraction or purification

from natural raw materials and not listed on the Existing Chemicals List

are subject to New Chemical Notification.

③ Radioactive substances

④ Substances already announced publicly after Hazard Review

⑤ Chemical substances listed on the Existing Chemicals List

⑥ New chemicals that are imported for consumer use and confirmed by MOL

as any of the followings (Article 88, Paragraph 1 of Ministerial Decree of

ISHL):

- The case where the relevant chemicals are finished products for

consumer use and not processed in Korea;

- The case where the packages or containers are not changed in

Korea, or the chemicals are not packaged or put into the

containers in Korea; or

- The case where the relevant chemicals are provided to

consumers directly and not used at workplace in Korea


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⑦ The case that the annual import amount of new chemicals is low

(less than 100 kg) and MOL confirms the exemption (Article 89,

Paragraph 1 of the Ministerial Decree of ISHL).

⑧ The case that the new chemicals to be imported and

manufactured are used for testing and research and the MOL confirms it

(Article 89-2, Paragraph 1 of the Ministerial Decree of ISHL)

4. What data is submitted to NIER at the time of New Chemical

Notification?

In the case of New Chemical Notification to NIER, the required data must be

submitted in accordance with TCCL and its sub-regulations, the “Regulation

concerning Hazard Review of Chemical Substances (NIER's Public Notice No. 2005-

19).”

The notification types are divided into the following three types under the

Regulation concerning Hazard Review of Chemical Substances (NIER's Public Notice

No. 2005-19): Full Notification, Reduced Notification (Simplified notification), and

Polymer Notification.

The data requirement varies according to each type. In Full Notification, the

test reports for acute toxicity, genetic toxicity, degradation, and ecotoxicity test

reports should be submitted based on the “Regulation concerning Hazard Review of

Chemical Substances (NIER's Public Notice No. 2005-19).” Test data which are

conducted in the Test Report Issuing Institution (Good Laboratory Practice (“GLP”) Laboratories) regulated under Article 14, Paragraph 2 of TCCL are acceptable

basically. The data of GLP Laboratories in OECD member countries are mostly

admitted after review by NIER. Contrary to the Full Notification, non-GLP data may

be acceptable for Reduced Notification and Polymer Notification. GLP Laboratories

are managed by the Korea Food & Drug Administration (“KFDA”) under the

Pharmaceutical Affairs Law and NIER under TCCL, representatively. Since the

Ministry of Agriculture & Forestry under the Pesticide Chemicals Control Law have

been considering the establishment of GLP system, it is deemed that the GLP

Laboratories in Korea will be managed by the above three authorities.

The required basic data set for each type of notification is as follows.


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A. Full Notification

The chemicals subject to Full Notification are all chemicals excluding the new

chemical substances subject to Reduced Notification (B) and Polymer

Notification (C).

The following data are required:

(1) Application Form for the Hazard Review of Manufacture/Import of Chemical

Substance (Exhibit Form No. 5 of the Ministerial Decree of TCCL, Fig. 3)

(2) Test reports for acute toxicity, genetic toxicity, degradation and

ecotoxicity

The copies and summaries of test reports for acute toxicity, genetic

toxicity, degradation, and ecotoxicity must be submitted (there is a fixed

form for the summary: see Fig.4, “Annex Exhibit Form of “Regulation

concerning Hazard Review for Chemical Substances”).

The summary must be written in Korean. However, the original texts of

the test data, written in English may be submitted.

‘ ① Test report for acute toxicity

The test report for acute toxicity means basically acute oral toxicity

test data for rodents. However, acute dermal or inhalation toxicity

data may be required if it is deemed from the physical-chemical

properties or use of the chemical substance that any exposure

thereto would be mainly through skin or inhalation.

② Test report for genetic toxicity

(a) Bacterial reverse mutation test (Ames test); and

(b) Chromosome aberration test using cultured mammalian cells

In case either of the above two test results is positive, the following

additional data must be submitted.

(i) In case the result of the Ames test is positive, a gene mutation


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test report using cultured mammalian cells (e.g., L5178Y mouse

lymphoma cell gene mutation) is additionally required. In case

the result of a gene mutation test using cultured mammalian cells

is positive, the genetic toxicity test report using test animals (in

vivo test)(e.g., mouse micro nucleus test) is required additionally.

(ii) In case the result of the chromosome aberration test using

cultured mammalian cells is positive, the test report for the

genetic toxicity test using test animals (in vivo test) (e.g., mouse

micro nucleus test) is required additionally.

③ Test reports for ecotoxicity

This requirement is applied from Jan. 1, 2007.

For the new chemical substance of which import amount is greater

than 1 ton/y, the following ecotoxicity test reports are required:

(i) Fish toxicity;

(ii) Algae toxicity; and

(iii) Daphnia toxicity

④ Test report for biodegradation test

If abiotic degradation occurs rapidly, the test report on degradation

proving this fact can be replaced with biodegradation test data. The

cases of fast abiotic degradation may fall under any of the following

chemicals.

- The chemicals of which the half-life of degradation at room

temperature and neutral pH range is within twelve hours in the

result of hydrolysis test in accordance with pH or aquatic

residue test.

- The chemicals of which the half-life of photodegradation is

within twelve hours as the result of aquatic photodegradation

test using natural light or artificial light similar to natural light.

- The chemicals of which the half-life of degradation in a general

environment is within three months as the result of residue test

in soil.


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(3) The document regarding the main release channel to the environment and

the estimated release amount

The following Items must be included in the data:

① The channel released to environmental media during the manufacture,

use or disposal under the consideration of use, physical-chemical

properties, and manufacturing (in the case of manufacture) or use (in

the case of use) process

(Note) In case a new chemical is used for an anticipated use (if

various uses are anticipated, explain some representative uses), and

then disposed, explanation on the exposure channel to the human

body or the environment through the air, water, waste, etc. is

required. Explain all processes from manufacture (in the case of

manufacture) or use (in the case of import) to disposal.

* The flowchart is convenient to explain all processes.

② The estimated amount released to each environmental media in

accordance with the above Item ①

(Note) The estimated release amount to each environmental media

when a new chemical substance (if various uses are anticipated,

make a statement concerning some representative uses) is exposed

during its use to the human body or the environment through the air,

water and waste, etc., is stated. Explain all processes from

manufacture (in the case of manufacture) or use (in the case of

import) to disposal.

* Flowchart is convenient to explain all processes.

B. Reduced Notification (Article 2, Item 6 of “Regulation concerning Hazard

Review for Chemical Substances”)

The chemicals subject to the “Reduced Notification" refer to the chemicals

under the provision of Article 3, Item 2 of the Regulation and the existing

chemicals distributed prior to Feb. 2, 1991 in two or more countries (the


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European Union is regarded as one nation) enforcing the system similar to

Article 8 of TCCL.

The following data for the chemicals subject to Reduced Notification are

required basically.

(1) Application Form for the Hazard Review of Manufacture/Import of Chemical

(Exhibit Form No. 5 of the Ministerial Decree of TCCL, Fig. 3)

(2) The document concerning main purpose of use and physical-chemical

properties such as melting point, boiling point, vapor pressure, solubility,

octanol/water partition coefficient, etc.

The contents are the same as those for the Full Notification.

(3) Test Report for acute toxicity, genetic toxicity and acute fish toxicity

The summary must be written in Korean. However, copies of original texts

of the test data, written in English may be submitted. In the case of

Reduced Notification, either of following two sets can be submitted. Copies

and summaries of the test reports (there is a fixed form for the summary:

see Fig. 4, Annex Exhibit of “Regulation concerning Hazard Review for

Chemical Substances”) must be submitted.

① Acute toxicity + microbial reverse mutation test (Ames test);

The test report for acute toxicity is acute oral toxicity test data for

rodents. However, acute dermal or inhalation toxicity data may be

required if it is deemed from the physical-chemical properties or use

of the chemical substance that any exposure thereto would be mainly

through skin or inhalation.

In case the result of the Ames test is positive, a gene mutation test

report using cultured mammalian cells (e.g., L5178Y mouse

lymphoma cell gene mutation) is additionally required. In case the

result of a gene mutation test using cultured mammalian cells is

positive, the genetic toxicity test report using test animals (in vivo

test)(e.g., mouse micro nucleus test) is also required.


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② Microbial reverse mutation test (Ames test) + Fish acute toxicity test

data

In case the result of Ames test is positive, a gene mutation test

report using cultured mammalian cells (e.g., L5178Y mouse

lymphoma cell gene mutation) is additionally required. In case the

result of a gene mutation test using cultured mammalian cells is

positive, the genetic toxicity test report using test animals (in vivo

test)(e.g., mouse micro nucleus test) is also required.

(4) The document regarding the main release channel to the environment and

the estimated release amount


C. Polymer Notification (Article 2, Item 3 of “Regulation concerning Hazard

Review for Chemical Substances”)

The substances falling under the following definition of polymer are subject

to the Polymer Notification.

"Polymer" means a chemical substance which contains sequences built up

from one or more types of monomer units, which shows a characteristic

distribution of molecular weights primarily according to the number of

repetitions of a monomer within each molecule. It also contains at least

three monomer units covalently linked to at least one other monomer unit or

another reactant, and 50% or more of such molecules. Furthermore, the

weight percentage of the molecules of the same molecular weight does not

exceed 50%.

However, the polymers falling under any of the followings are exempt from

the new chemical notification.

- Polymers which are listed on the Existing Chemicals List. In

this case, reactants or monomer of 2% or less are not

considered;

- Any block polymers of which all blocks are listed on the Existing


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Chemicals List;

- Graft polymers of which main stems and branches are listed on

the Existing Chemicals List;

- Non-ionic polymer of which number average polymer is 10,000

or more (will be enforced from Jan. 1, 2007);

- Non-ionic polymer of which number average polymer is 1,000 or

more and which meet the followings:

(will be enforced from Jan. 1, 2007)

Monomers should not be Toxic Chemical, Observational

Chemical, new chemical(s), or epoxy compound(s)

Water solubility should be 5 mg/g or less

The data requirement for the chemicals falling under Polymer Notification is

as follows:

(1) Application Form for the Hazard Review of Manufacture/Import of

Chemical Substance (Exhibit Form No. 5 of the Ministerial Decree of

TCCL, Fig. 3)


(2) The documents concerning the main purpose of use and physical-

chemical properties such as melting point, boiling point, vapor pressure,

solubility, octanol/water partition coefficient, etc.

The contents are the same as those for the Full Notification. However,

in the case of polymer, octanol/water partition coefficient is not required.

(3) The data on number-average molecular weight, composition of

monomers, the content of residual monomers and stabilities of polymer

The following Items must be included.

① The test data showing the number-average molecular weight and

the molecular weight distribution (e.g., GPC test data, etc.)


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② The document on chemical name, CAS No., and composition (%) of

monomers used in the manufacture of polymer. However, the

composition (%) of each monomer can be calculated on the basis of

its constituent ratio in the finally manufactured product

③ The data on the content (%) of residual monomers

④ The data on the content (%) of substances with molecular weight of

1,000 or less

⑤ The data on stability in acidic and alkaline condition

* The requirement of stability test depends on the water solubility

of polymer. Please see Fig. 5.

.* .Test guideline for stability of polymer in acidic and alkaline

condition was standardized by the NIER on Feb. 2001.

However, for polymer, the following data may be submitted instead of the

aforesaid data set. This set is the same with data set required for the

reduced notification.

① Acute toxicity + microbial reverse mutation test (Ames test); or

The detailed matters are same as those for the reduced notification.

② Microbial reverse mutation test (Ames test) + Fish acute toxicity test

data

The detailed matters are same as those for the reduced notification.

(4) The document regarding the main release channel to the environment

and the estimated release amount



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[Exhibit From No.5] (Page 1)

Processing

period □ Manufacture

□ Import

Application Form for Hazard Review of

Chemical Substance 60 days

① Company name ② Business entity

registration No.

③ Representative’s

Name ④ Person in charge

Applicant

⑤ Address (Tel : )

⑥ Business place (Tel : )

⑦ Chemical name

⑧ Structural formula ⑨ Purity %

⑩ Exporting country

⑪ Estimated annual

manufacture (import)

amount

Kg

⑫ Type of application □ 1 ton or less □ Polymer

□ Listed in more than 2 countries □ Others

Conte

nts

of

application

⑬ Application for

confidentiality

protection

□ Applicable □ Not Applicable

⑭ Function of chemical

Physical state and use

of product

Main

use

Content (%) in product

⑮ Type of use facility

Average daily use

Amount

Estimated annual use

days

Estimated release

Amount to each media

Info

rmation o

n r

ele

ase t

o

the e

nvir

onm

ent

Basis of estimation


22

(Page 2)

Item submissionNumber

of pages

Attachment

No.

Physical state

Melting point

Boiling point

Vapor pressure

Solubility

Octanol/water partition coefficient

Physic

o-chem

ical pro

pert

ies

Others ( )

Acute oral toxicity test report

Acute dermal toxicity test report

Acute inhalation toxicity test report

Acute

toxic

ity

Others ( )

Reverse mutation test report

Chromosome aberration test report

Genetic

toxic

ity

Others ( )

Ready biodegradation

Bio

degra

dation

Others ( )

Fish toxicity

Daphnia toxicity

Algae toxicity

Aquatic e

colo

gy

toxic

ity

Others ( )


23

(Page 3)

Item submissionNumber

of pages

Attachmen

t No.

Document on number average

molecular weight

Document on composition of

monomers

Documents on contents of residual

monomers

Docum

ents

on p

oly

mer

Test report on stability in acidic or

basic condition

In accordance with Article 10, Paragraph (3) of Toxic Chemicals Control Law, and

Article 5, Paragraph (1) of the Ministerial Decree of the law, we hereby apply for Hazard

Review of Chemical Substance.

Month day year

Applicant (Signature or Seal)

To: Head of National Institute of Environmental Research

Fee ※ Attachment

1. Documents concerning the main use and physico-chemical

properties such as melting point, boiling point, vapor pressure,

solubility and octanol/water partition coefficient, etc. 50,000 won

2. Test reports concerning acute toxicity, genetic toxicity, degradation and aquatic

ecotoxicity.

3. Documents concerning main release channels to the environment and estimated

release amount

4. Documents concerning number average molecular weight, composition of

monomers, contents of residual monomers and stability of polymer, etc.

5. Documents concerning Hazard•Danger Review under Article 40 of the Industrial

Safety and Health Law.

Fig. 3. “Application Form for Hazard Review of Manufacture/Import of Chemical

Substance” (Exhibit Form No.1 of the Ministerial Decree of TCCL)


24

* Note

①Company name: the importing company’s name in Korea

②Business License No.: the importing company’s business license number

in Korea

③Representative's name: the name of the representative of importing

company in Korea

⑤Address: the address of the importing company in Korea

⑥Business place: the address of the importing company in Korea (the

address of the factory if it has a factory)

⑦Chemical name: IUPAC (International Union of Pure and Applied

Chemistry) name or CA (Chemical Abstract) name must be submitted.

* In case CAS No. is available, CAS No. should be submitted.

⑧Structural formula:

In case the structural or rational formula is not declared, the reason must

be described.

⑪Estimated amount to be manufactured (imported) per year:

Average anticipated amount for three years.


25

Summary of Test Reports

Acute (oral, dermal, inhalation) Toxicity Test

(1) Test method OECD No. (2) Test laboratory

(3) Test year (4) Vehicle

(5) Purity (6) Test animal

species/strain

(7) Clinical sign

(8) Necropsy

(9) LD50, LC50 ( hr)

Reverse Mutation Assay

(1) Test title

(2) Test bacteria or

used cell

(3) Test method (4) Test laboratory

(5) Test year (6) Purity

(7) Negative control

materials

(8) Positive control

materials

(9)Concentration of

test substance

(10) Result -S9 +S9 Judgment


26

Result of In Vitro Chromosome Aberration Test

(1) Test title

(2) Test cell


(5) Test year (6) Purity %


Materials

(8) Positive control

Materials

(9) Concentration of

test substance

(10) Result -S9 +S9 Judgement

Result of Biodegradation Test




Materials


negative control

materials


test substance

(8) Used micro-

Organism

(9) Degradability of

negative control

materials

(10) Degradability of

test materials


27

Acute Fish Toxicity Test



(5)Reference material (6)Concentration of

Reference substance

(7)Concentration of

test substance (8) Test fish species

(9) LC50 ( hr)

Daphnia Acute Toxicity Test




Reference substance

(7)Concentration of

test substance (8) Test species

(9) EC50 ( hr)

Algae Acute Toxicity Test




Reference substance

(7)Concentration of

test substance (8) Test species

(9) LC50 ( hr)

Prepared by ___________________ Contact point (Telephone No,):

Fig. 4. Translation of Summary Form of Test Reports (Annex Exhibit of “Regulation

concerning Hazard Review of Chemical Substances”)


28

5. Can the basic data set be exempt or alternative data be submitted?

For the following chemicals, which the Head of NIER deems the submission of

the test report to be not necessary and which it announces on the basis of the

physical-chemical properties [Article 9 of “Regulation concerning Hazard Review for

Chemical Substances” (NIER's Public Notice No. 2005-11)], the submission of the

test report may be exempt or alternative data may be submitted.

(1) A chemical substance which can not be administered for test(s) at the

adequate dose level or of which concentration can not be maintained at the

adequate level due to its physical properties dangers, such as explosion,

oxidizing properties, corrosion, etc.

(2) A chemical substance for which the data on any chemical substance similar

to its structure have already been submitted

(3) An inorganic chemical substance

(4) A chemical substance of which another submitted test report is determined

to be more relevant

6. Can NIER request supplementary data in addition to basic data set?

Supplementary data can be required in the following cases.

(1) The chemical substances which have concern on ecotoxicity as chemical

substance which is directly exposed to the environment during its use, such

as water treatment agents, fungicides, or insecticides, etc. except for

agricultural use, (including polymer) or a non-biodegradable neutral organic

chemical substance of which water solubility is 100 mg/L or more.

* Note: Ecoxicity such as fish toxicity may be required.

(2) The chemical substances subject to the classification under Globally

Harmonized System.


29

7. What data is submitted to MOL at the time of the New Chemical

Notification?

In the case of New Chemical Notification to MOL, the required data must be

submitted in accordance with ISHL and its subordinate regulation, the “Regulation

concerning Hazard Review of New Chemicals (on June 24, 1991, last amended on

Dec. 24, 1997, MOL's Public Notice No. 1997-46).” The type of New Chemical

Notification by MOL is the same for all new chemical substances while TCCL divides

them into three classifications.

The data for toxicity and degradation tests are not included in the data

submitted to MOL. Therefore, the submission of test data by the GLP test institute

is not required.

The following data must be submitted.

(1) Review Report on Hazard and Danger of New Substance

(Exhibit Form No. 18 of the Ministerial Decree of ISHL, Fig. 5)

① Name of business place (company name): the name of importing company

② Name : the name of representative of importing company

③ I.D. number:

Residence registration No. of representative of importing company

④ Type of business:

A classified type of business classification for importing company (e.g.,

trading business, manufacturing business, etc.)

⑤ Number of employees:

Total number of workers employed by the importing company

⑥ Number of employees handling new chemical substance:

Number of workers handling chemicals among the workers

⑦ Address: the address of importing company

⑧ Name of new chemical:

IUPAC(International Union of Pure and Applied Chemistry) name or

CA(Chemical Abstract) name must be submitted.

* In case CAS No. is available, CAS No. should be submitted.

⑨ Structural or rational formula of new chemical:

In case the structural or rational formula of new chemical substance is

determined, it should be declared.


30

⑩ Physical-chemical properties of new chemical:

Appearance, molecular weight, melting point, boiling point and other Items

must be declared. The information concerning pure new chemicals is

stated basically. However, in case there are some reasons that the

chemical could not be manufactured as a pure substance or was not

manufactured as pure chemicals from the beginning of the manufacturing

due to the physical-chemical properties and commercial reasons, the data

concerning mixture with solvents will be acceptable only if the reason is

fully explained.

⑪ Estimated quantity of new chemical to be manufactured or imported for

recent 3 years.

⑫ Use of new chemical:

If the purpose of use is diverse, the representative use is stated.

⑬ Address of manufacturing area for new chemical

* in the case of import, state the name of exporting country

⑭ References: state other facts for reference

(2) The Document concerning safety and health effects of New Chemicals (e.g.

MSDS)

For the “Document concerning safety and health effects of New Chemicals,” the Material Safety Data Sheet (MSDS) may be submitted. The MSDS

concerning pure new chemicals must be submitted principally and prepared

in the Korean language based on the “Standards for Preparing and keeping

on File the Material Safety Data Sheet, etc. (The MOL's Public Notice No.

1997-27).”

In case a pure substance cannot be manufactured due to physical-chemical

properties of new chemicals or commercial reasons (e.g., in the case of a

polymer, it may be manufactured in a state of solution or suspension from

the beginning by reason of adhesion to the reaction vessels) or polymer

itself is not manufactured exclusively due to a commercial reason, it may be

acceptable to submit MSDS for distributed chemical product (i.e., mixture

etc.) if a sufficient reason is submitted.

(3) The document regarding the manufacturing, using or handling of New

Chemicals


31

In the case of import, the method of use and handling must be stated. The

matters regarding precautions during its use and handling must be stated in

connection with a flowchart on use of new chemicals stated in the following

Item (4), and the exposure to workers in each process through the entire

use progress must be stated in detail. Especially, the form of the exposed

substance (liquid, mist, granule, etc.) and the estimated exposure level must

be mentioned.

(4) Flowchart on manufacture or use of the New Chemicals

In the case of import, a flowchart on the use of new chemical is prepared to

show all processes during its use.


32

[Exhibit Form No. 18] (front page)

Review Report on Hazard and Danger of New Substance

Sum Male Female① Name of business place (company name)

② Name (representa tive)

③ I.D. number

④ Type of business

⑤ Number of employees

⑥ Number of Employees handling new chemical substance

⑦ Address (Tel: )

⑧ Name of new Chemical

⑨ Structural or rational formula of new chemical

Appearance Molecular weight Melting point Boiling point Other Properties

⑩ Physical- chemical properties of new chemical

2001 2002 2003 ⑪ Expected quantity of new chemical to be manufactured or imported for recent 3 years after importation

Kg

Kg

Kg

⑫ Use of new Chemical

⑬ Address of manufacturing area for new chemical (name of exporting country in the case of importing)

⑭ References

As set forth on the provision of the Paragraph 1 of the Article 40 of the ISHL and the Article 86 of the Ministerial Decree of the same Law, I submit the Report of Toxicity Review Result for the □ Manufacture ■ Import of new chemical. Month day Year Applicant Representative of employer (Signature or seal) Minister of Labor

※ Attachments: 1. A copy of document concerning safety and health effect of new chemicals 2. A copy of documents regarding the manufacturing, using or handling of new chemicals 3. A copy of flowchart on the manufacturing or using of new chemicals

32321-10611 210mm×297mm (newsprint 54g/m2) Oct. 11, 1995 revised

Fig. 5. Translation of the Format for “Review Report on Hazard and Danger of New

Substance” (Exhibit Form No.18 of the Ministerial Decree of ISHL)


33

8. Request for Protection of Confidential Information

The system protecting confidential information, such as the chemical name

submitted by the notifier of new chemicals legally, is administered under TCCL and

ISHL.

(1) TCCL

Article 51 of TCCL; Article 50 of the Ministerial Decree of TCCL; Regulation

concerning Hazard Review of Chemical Substances (NIER's Public Notice No.

2005-19).

In case the person intending to manufacture or import new chemical applies

for Hazard Review and requests Protection of Confidential Information to be

submitted to NIER, NIER protects the information from being disclosed.

Additionally, in case a foreign exporter does not want to disclose relevant

information to a Korean importer, that is, a notifier in Korea, he/she can

entrust another individual to submit the application or submit the relevant

information exclusively from abroad to NIER directly. In the case of

entrusting handling and submission of the information to other persons in

Korea, the letter of attorney on which the importer, that is, a notifier has

affixed a signature or a seal must be submitted.

The details for Protection of Confidential Information are as follows:

(i) In case protection of the information is not granted

It is not possible to protect information for all new chemicals.

Information is not protected for the chemicals falling under any of the

followings:

(a) Chemicals of which chemical names are declared on the lists of

foreign countries; or

* In this case, specific use can be protected.

(b) Chemicals falling under Toxic Chemicals or Observational Chemicals

from Hazard Review


34

(ii) Protection period

The protection period for information is five years, but if the applicant

files application for extension of protection of the information, the

protection period may be extended for an additional five years.

However, if the contents of the patent are accepted as protected

information, such contents may be excluded from protection upon

expiration of the term of the patent. In case an applicant wishes to

extend the protection period, the applicant must file an “Application

Form for Extension of Protection of Confidential Information” 30 days

prior to the expiration date of the protection period. If the applicant

fails to file such an application within this time limit, the protection will

be considered expired on the expiration date of the current protection

period.

(iii) The document to be submitted for an application for protection of

information

In order to request the protection of information at the time of New

Chemical Notification, two sets of notification dossiers for Hazard

Review and an “Application Form for Protection of Confidential

Information (Exhibit Form No. 43 of the Ministerial Decree of TCCL, Fig.

6)” must be submitted.

One set of the notification dossiers for Hazard Review is the foregoing

data set and the other one is the sanitized form in which the part desired

to be protected is sanitized and not to be shown. In case the applicant

wishes to protect information regarding the chemical name, the applicant

must submit its generic name on the Item for chemical names in the

document. In such case, the generic name must be under the

nomenclature of “Regulation concerning Protection of Confidential

Information (MOE's Public Notice No. 2006-15).”

Another set of notification dossiers for Hazard Review is described in

the following Item (c). The document must be submitted along with the

document described above.

(a) Application Form for Protection of Confidential Information


35

(Ministerial Decree of TCCL, Exhibit No. 43, Fig. 6)

- Data to be protected on Hazard Review:

Ex. 1. Chemical name, CAS No., structure, the data on physical

properties, the data on toxicity tests, etc.

Ex. 2. Chemical name, constituent monomers and their contents on

polymer

* A chemical name is stated in parentheses.

- Protection period:

5 years from the application date.

Extended for an additional 5 years by every re-application.

(b) Outlines of the information to be protected and the reasons for its

protection

- Detailed reason of application in relation to specific matters such

as patent, agreement, etc. is described for each piece of

information to be protected. Also, explain that the confidential

information is related to the technical expertise or business

information of which the disclosure may result in economic loss

or disadvantages to the applicant.

- When preparing the statement for the reason for protection, the

loss which the disclosure of the contents to be protected will

cause to the applicant's economic interest or competitive status,

should be described in detail. In particular, if an applicant files

for protection regarding matters other than the chemical name,

the reason for the application should be reasonably presented.

(c) Data on information to be protected

An applicant indicates the contents to be protected by underlining

the relevant passage with red pen. The applicant then collects only

the pages concerned, and puts them into an envelope that is then

tightly sealed. Thereafter, he/she lists the confidential information

concerned and describes the contents by writing “confidential


36

information” with red pen on the front side of the envelope.

(iv) Nomenclature of generic name

Nomenclature of generic name is subject to the following basic

principles.

(a) In the case of protecting substituents

- The prefix indicating the position or numbers of substituents can

be named as generic name

- The word, 'substituted' is used for the protection of substituents.

However, the word can only be used one time.

Ex. 2,3,5,-Tribromo-2-fluoropentane --→

Trisubstituted-fluoropentane or

Substituted-fluoropentane

(b) The prefix indicating the name and number of simple cation and

anion of salt can be named as the generic name.

Ex. 1. Tetramethylammonium bromide --→

Methylammonium salt

Ex. 2. Sodium chloride --→ Metal chloride salt

(c) Both skeleton and substituent cannot be protected at the same time.

However, in the case where skeleton is stated as the generic name,

the indication of the position and number of substituents can be

protected.

(v) Acceptance of protection for confidential information

In case the protection of confidential information is accepted by the

NIER, the applicant receives “Confidentiality Protection Notice [Exhibit

Form No. 2 of Regulation concerning Protection of Confidential

Information (MOE's Public Notice No. 2006-15), Fig. 6].” The

information is protected for five years from the day of receipt, and

thereafter the applicant must apply for the extension of protection.


37

[Annex Exhibit Form No. 43]

Processing period Application Form For Protection of

Confidential Information 15 days (In the case of

Toxicity review, it is fixed on the

basis of the examination period)

① Company name

② Name

(representative)

③ Resident

registration No.

Applicant

④ Address (Tel : )

⑤ Business place (Tel : )

⑥ Evidentiary

information on

chemical identity

(name of confidential information

: )

⑦ Application

Documents for

Hazard Review

Chemical name (Generic name)


: )

⑧ Data for survey of

released or

circulated amount


: )Sum

mary

For

Pro

tection

Of

Info

rmation

⑨ Data for risk

assessment


: )

⑩ Protection period Until month day year

In accordance with Article 51, Paragraph 1, and Article 50, Paragraph 1 of the

Ministerial Decree of the law, we hereby apply for Protection of Confidential

Information.

Month Day Year


※ Attachments Fee

1. A copy of outlines of the information to be protected and the

reasons for its protection None

2. A copy of the document on information to be protected

Fig. 6. Translation of “Application Form for Protection of Confidential Information”

(Exhibit No. 43 of Ministerial Decree of TCCL)


38

[Annex Exhibit Form No. 2]

Fig. 7. Translation of “Confidentiality Protection Notice” (Exhibit Form No. 2 of

Regulation concerning Protection of Confidential Information)

No. Confidentiality Protection Notice

① Company name

② Name

(representative)

③ Resident

registration No. Applicant

④ Address

⑤ Business place

⑥ Chemical name

(or generic name)

⑧ Expected termination date of

protection of confidential

information

⑦ Items subject

to protection

of confidential

Information

Item

Cause

Results of

Acceptance ⑨ Denial of

protection of

confidential

information Period for

Application of

Objection

I hereby notify the result of acceptance of application for protection of confidential

information filed by you in accordance with Article 51 of TCCL, as mentioned above.

(Date)

Head of Competent Authorities


39

(2) ISHL

(Article 91 of Ministerial Decree of ISHL; Article 5, Paragraph 1 of Regulation

concerning Hazard Review of New Chemicals)

In case the person intending to manufacture or import new chemicals applies

for Toxicity Review and requests protection of confidential information to be

submitted to the MOL, the MOL prevents the information from being disclosed.

Also in case a foreign exporter does not want to disclose the relevant

information to an importer who is a notifier in Korea, he/she can entrust

another individual to submit the application or submit the relevant information

exclusively from abroad to the MOL directly. In the case of entrusting the

duty of handling and submitting the information to persons in Korea, the letter

of attorney on which the importer, that is, a notifier has affixed a signature or

a seal must be submitted.

(i) The case in which the protection of information is accepted

The protection of information is accepted only in cases where the

following conditions of screening for protection of information (Regulation

concerning Hazard Review of New Chemicals, Article 5, Paragraph 2) are

satisfied.

(a) The contents to be protected must not be published inside or outside

Korea through the print media.

(b) The argument for seeking legal protection must be reasonable.

(c) The chemical name and CAS No. must not be listed on the Existing

Chemicals Lists of foreign countries.

(d) The chemical must not be severely hazardous to workers.

(ii) Protection period

The period of protection of information (Article 5, Paragraph (3) of

Regulation concerning Hazard Review of New Chemicals) is three years.

If the applicant files the “Application Form for Extension of Protection

Period of Information on New Chemical” 30 days prior to expiration date

of the protection period, the protection period may be extended. If the

applicant fails to file such an application within this time limit, the


40

protection of information is automatically cancelled on the expiration date

of the current protection period.

(iii) The documents to be submitted

A notifier of new chemicals who intends to apply for protection of

information must submit the following documents.

(a) Application Form for Protection of Information on New Chemical

(Regulation concerning the Hazard Review of New Chemicals, Exhibit

Form No. 1, Fig. 8)

- Name of new chemical

IUPAC (International Union of Pure and Applied Chemistry)

name or CA(Chemical Abstract) name must be stated.

* In case CAS No. is allocated, the CAS No. must be stated.

- Substance name for protection of information

(trade name or common name)

(b) A document of the reason for application for protection of

information

- Detailed reason for the application in relation to specific matters

such as patents, agreements, etc. should be described for each

piece of information to be protected. Also, explain how the

confidential information is related to the technical expertise or

business information of which the disclosure may result in

economic loss or disadvantages to the applicant.

- When preparing the statement, the possible losses which

disclosure will cause to the applicant's economic interest or

competitive status, should be described in detail. In particular,

if an applicant files for protection of matters other than the

chemical name, the reason for the application should be

reasonably presented.

(c) The information confirming whether the relevant chemicals are


41

disclosed or not in Korea and abroad. The document showing the

current situation of registration to chemicals lists of foreign

countries or the searched from database (STN of Chemlist)

(iv) Acceptance of protection for confidential information

In case the protection of confidential information is accepted by MOL,

the applicant receives the “Notice for Review Result for the Protection

of Information on New Chemical (Regulation concerning Hazard Review

of New Chemicals, Exhibit Form No. 2, Fig. 9).” The information is

protected for three years from the day of receipt, and thereafter the

applicant must apply for extension of protection.


42

[Exhibit Form No. 1]

Fig. 8. Translation of “Application Form for Protection of Information on New

Chemical” (Exhibit Form No. 1 of Regulation concerning Hazard Review of New

Chemicals)

Processing

Period Application Form

for Protection of Information on New Chemical 30 days

Name of new chemical

(IUPAC name and C.A. name)

Substance name for protection

of information

(trade name or common name)

I hereby apply for protection of information (or name) on the □ manufacture

□ import of new chemical in accordance with Article 5 of Regulation concerning

Toxicity Review of New Chemicals.

Month Date Year


To the Minister of Labor

※ Attachment:

1. A document of the reason for application for protection of information

2. Data confirming whether the relevant chemical is disclosed or not in Korea and in

abroad


43


Fig. 9. Translation of “Notice for Review Result for the Protection of Information

on New Chemical” (Exhibit Form No. 2 of Regulation concerning Hazard Review of

New Chemicals)

Notice for Review Result for

the Protection of Information on New Chemical No.

①

Company name

② Name

③ Tel. No. Applicant

④ Address

⑤ Name of new chemical

⑦ Expiration date of

protection of confi-

dential information Review

Results

⑥ Name for

protection of

information

AcceptedNot

Accepted

⑧ Acceptance of

protection of

confidential

information

Reason

for

rejection

I hereby notify the review results for the protection of information on new

chemicals in accordance with the provision of Article 5 of the Regulation concerning

Hazard Review of New Chemicals as above.

Month Date Year

Minister of Labor (Seal)


44

11. Notice for Result of Hazard Review

(1) TCCL

After completing Hazard Review of new chemicals, NIER sends notice of the

review result to the notifier [Exhibit Form No. 7 of Ministerial Decree of TCCL,

Fig. 10)].

The main contents of the notice concern whether the chemical is subject to

the Regulated Chemicals case (e.g., Toxic Chemicals, Observational Chemicals,

Restricted Toxic Chemicals and Chemicals Prohibited from manufacture,

import and use). For chemicals falling under the Toxic Chemicals, labeling,

Items on safety management are indicated on the Notice Form.

In case the protection of information on the chemical name is accepted, the

generic name for the relevant chemical is noticed.

(2) ISHL

After reviewing the “Review Report on Hazard and Danger of New Substance”

submitted by the notifier for a new chemical, MOL sends “Notice on Action to

be Taken regarding Hazard and Danger” (Exhibit Form No. 18-2 of the

Ministerial Decree of the ISHL, Fig. 11)] to the notifier .

In case the business owner who submitted the “Review Report on Hazard and

Danger of New Substance” transfers (including the case of offering) the

relevant new chemical to another business place, “Notice on Action to be

Taken regarding Hazard and Danger” (Article 86, Paragraph 3 of the

Ministerial Decree of ISHL)” must be transferred with such chemical.


45


Review No.

Notice for Review Result

① Company name

②Representative's

Name

③ Resident

registration No. of

representative

Applicant

④ Address

⑤ Chemical Name (Generic name)

⑥ Classification

□ Toxic Chemicals

□ Observational Chemicals

□ Not applicable

□ Content Limit in case of Toxic Chemical or

Observational Chemical: %

Indication of Toxic Chemicals

⑦ Hazard mark ⑧ Hazard ⑨ Precaution in

Handling

⑩ Other necessary matters for safety management

(including restricted matters)

Result of

Examination

In accordance with Article 12 of TCCL and Article 9, Paragraph 2 of the

Ministerial Decree of the law, we hereby inform you of the result of the Toxicity

Review.

Date

Head of the National Institute of Environmental Research (official seal)

Fig. 10. Translation of “Notice for Result of Toxicity Review”

(Exhibit Form No. 7 of the Ministerial Decree of TCCL)


46

[Exhibit Form No.18-2]

Notice on Action to be Taken regarding Hazard and Danger

① Company

Name

② Representa

tive's name ③ I.D. number

④ Type of

business

⑤ Number of

Employees

⑥ Address (Tel: )

⑦ Name of new

chemical

substance

Actions to be taken to protect worker's health

Others

⑧ Result of

Hazard

Review

In accordance with Article 40 of the ISHL and Article 86, Paragraph 2 of the

Ministerial Decrees of the Law thereof, we hereby inform you of the Toxicity Review

Result of the new chemical substance.

(Date) (Month) (Year)

Minister of Labor (Official seal affixed)

Fig. 11. Translation of “Notice on Action to be Taken regarding Hazard and Danger” (Annex 18, Exhibit No. 2 of the Ministerial Decree of the ISHL)


47

12. Public Notice of Hazard Review Result

NIER and MOL publish its Review Result, respectively, on the Official Gazette

3 years later from the day they inform the notifier of the Review Result. After such

publication, anyone may import or manufacture the corresponding new chemical.