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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
The contents are the same as those for the Full Notification.
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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19
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)
The contents are the same as those for the Full Notification.
(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
The contents are the same as those for the Full Notification.
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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
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(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 ( )
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(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)
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* 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.
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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
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Result of In Vitro Chromosome Aberration Test
(1) Test title
(2) Test 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 Judgement
Result of Biodegradation Test
(1) Test method (2) Test laboratory
(3) Test year (4) Purity
(5) Negative control
Materials
(6) Concentration of
negative control
materials
(7) Concentration of
test substance
(8) Used micro-
Organism
(9) Degradability of
negative control
materials
(10) Degradability of
test materials
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Acute Fish Toxicity Test
(1) Test method (2) Test laboratory
(3) Test year (4) Purity
(5)Reference material (6)Concentration of
Reference substance
(7)Concentration of
test substance (8) Test fish species
(9) LC50 ( hr)
Daphnia Acute Toxicity Test
(1) Test method (2) Test laboratory
(3) Test year (4) Purity
(5)Reference material (6)Concentration of
Reference substance
(7)Concentration of
test substance (8) Test species
(9) EC50 ( hr)
Algae Acute Toxicity Test
(1) Test method (2) Test laboratory
(3) Test year (4) Purity
(5)Reference material (6)Concentration of
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”)
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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.
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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.
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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
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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.
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[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)
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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
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(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
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(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
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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.
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[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)
(name of confidential information
: )
⑧ Data for survey of
released or
circulated amount
(name of confidential information
: )Sum
mary
For
Pro
tection
Of
Info
rmation
⑨ Data for risk
assessment
(name of confidential information
: )
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
Applicant (Signature or Seal)
※ 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)
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[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
9th Fl., EXCON Venture-Tower, 15-24, Yeouido-dong, Yeongdeungpo-gu, Seoul, 150-872, Korea Tel:+82-2-780-0251 Fax:+82-2-780-0252
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
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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
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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.
9th Fl., EXCON Venture-Tower, 15-24, Yeouido-dong, Yeongdeungpo-gu, Seoul, 150-872, Korea Tel:+82-2-780-0251 Fax:+82-2-780-0252
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
Applicant (Signature or Seal)
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
9th Fl., EXCON Venture-Tower, 15-24, Yeouido-dong, Yeongdeungpo-gu, Seoul, 150-872, Korea Tel:+82-2-780-0251 Fax:+82-2-780-0252
43
[Exhibit Form No. 2]
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)
9th Fl., EXCON Venture-Tower, 15-24, Yeouido-dong, Yeongdeungpo-gu, Seoul, 150-872, Korea Tel:+82-2-780-0251 Fax:+82-2-780-0252
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.
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45
[Exhibit Form No. 7]
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)
9th Fl., EXCON Venture-Tower, 15-24, Yeouido-dong, Yeongdeungpo-gu, Seoul, 150-872, Korea Tel:+82-2-780-0251 Fax:+82-2-780-0252
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)
9th Fl., EXCON Venture-Tower, 15-24, Yeouido-dong, Yeongdeungpo-gu, Seoul, 150-872, Korea Tel:+82-2-780-0251 Fax:+82-2-780-0252
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.
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