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I. Key Aspect of K-REACH Amendments
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1. Main Amendments on Subordinate Ordinance
O Registration of imported and manufactured all existing chemicals
exceeding 1 ton/year
- Existing chemicalsdatashould be registered by 2030 according to its volume
and hazard of chemicals in order to obtain and manage hazardous information
of the chemicals circulated in Korea.
- The Presidential decree clearly stipulates that 10 to 100 tons must be
registered by 2027 and 1 to 10 tons by 2030.
-However, it needs “pre-registration”from January to June 2019 in
order to obtain a grace period for each tonnage band of existing chemicals.
Following information is required for pre-registration; company information,
chemical name, annual manufacturing and importing volume, classification and
labeling and use information of chemical.
O Change from registration to
notification for new chemicals under 100 kg
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Subject
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- New
chemicals under 100kg
- Substance that has received Low volume exemption(less than 100kg/year)and
Low concern polymer exemption under the previous " Toxic Chemical
Control Act "
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Submission
period
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Prior
to manufacture or import the substance
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Submission
method
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Through
online IT system(Chemical Information Processing System)
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Authority
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The
NIER(National Institute of Environment Research) under MOE
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Required
information
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-
Company information (manufacturer, importer or Only representative)
- Chemical name
- Classification and labelling
- Use classification and category(Industrial/professional use, consumer
use) - Toxicological data only if the applicant owned
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O Registration based on accumulated
total domestic manufacturing/import amount
- Even if the total domestic manufacturing and import volume is not subject
to registration by individual companies, it can be designated as substance
subject to registration consideration of 1 ton for new chemicals and 10 tons
for existing chemicals as a whole.
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Category
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Based on individual company
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Total domestic manufacturing and import amount
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New chemical
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100 kg and above per year
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Exceeding 1ton in total
(Even if below 0.1ton for individual company)
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Existing chemical
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1ton and above per year
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Exceeding 10t in total
(Even if below 1ton for individual company)
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O Penalty Provisions
-In addition to penalties, fines (less than 5 % of the total sales of
the company) are imposed when a substance is imported/manufactured without registration
or change registration. It is implemented toredeem economic profits.
- The total sales amount shall be the average annual sales of the three years
prior to the year when violated the law. Fine can beadjusted according to the
significance, period·number of violations, and profit and liability earned
for the offence.
O Amendments to reduce industry’s
burden
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Simplification
of registration dossier for non-hazardous chemicals
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There
are lots of data to be submitted in terms of tonnage, but for non-hazardous
existing chemicals (not having GHS classification or labelling for health
and environmental hazards), data corresponding to lower tonnage band (1-10
ton) regardless of its tonnage band are required.
But, this simplification will not be applied in casefor consumer use
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Transported
isolated intermediate(TII) : Exempt from data requirements for less than
1,000t of TII. Only data corresponding to lower tonnage band (1-10
ton) should be submitted for over 1,000t of TII. However,it is necessary to
submit documents to verify transport or use(s)are under strictly controlled
conditions and record the management log.
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Change
of polymer exemption rule
condition
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In
the case of polymer with less than 10,000 average molecular weight, they
shall not be exempted if they are; hazardous chemicals, prioritycontrol
chemical substance, new chemical remains at 0.1 % or more as non-reactive
monomers and it affects on the hazards of polymers
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Improvement
to organize Substance Information Exchange Forum(K-SIEF or CICO)
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Separate
SIEF may be organized if
- the use and characteristics of substance is different within CICO member
and difficulties in discussing issues in CICO
- those who manufacture or import the substance for consumer use
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If
the characteristics such as molecular weight, solubility etc. are clearly
different for a polymer with the same chemical name, they can form separate
SIEFs, considered as different substances.
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Improved
application for exemption of chemical reagent registration
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In
the case of reagents, it is allowed to submit the application for
registration exemption within 30 days after its manufacture and import
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If
multiple substances are imported on a product basis, it is allowed to apply
for an exemption (including the remaining components) as representative
substance of the product.
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Sharing
new chemical evaluation results with the Ministry of Employment and
Labor(MOEL)
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The
MOELis prosecuting the revision of relevant regulations in consultation with
the MOEto replace current hazards·risk assessment of new chemicals under
the occupational safety and health administration (OSHA) by registration of
new chemical substances under K-REACHin order to avoid duplicate tasks(OSHA
pre-announcement of legislation, March 30 2018)
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The
MOE also revised regulations for the MOEL to access new chemical
registration dossier submitted by companies to the Information Processing
System (IT).
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* Transported isolated
intermediate(TII): A substance manufactured for or
used for chemical processing in order to be transformed into another
substance, the synthesis of which is transported between or supplied to other
sites.
O The transfer of chemical
information in supply chain
-The person who supplies the chemicaland chemical
productsshouldprovidethe registered chemical substance as well as the
hazardous chemicals designated by the MOE and Chemical safety information of
hazardous chemicals(registration number, chemical name, hazard and risk
information, and safe use information) to downstream users in supply chain.
- In this occasionregistration number or notification number may be omitted
for new chemicals or unregistered chemicals, but information shouldbe
provided if any hazardous chemicals are contained higher than the cut off
limit of content.
-Chemical information of CMR substances to be published by the MOEshould be
provided if itscontent ishigher than the cut off limit in accordance with GHS
standard.
O Improving the assessment method of chemicals in NIER
-Under current K-REACH, the NIER is to evaluate all of chemicals
submitted. But after the amendment, when evaluating the hazard assessment of
existing substances, factors such as amount of domestic manufacture/import,
hazard,possible risk to health and environment, etc., are prioritized and
reviewed by NIER.
-The existing chemicals to be jointly registered clearly regulatesall lead
registrants and members of K-SIEF to complete registration or to start
evaluation when the grace period expires.
2. Amendment and Enforcement date
-The enforcement ordinance must be passed by the Cabinet meeting, and
must go through a process of regulatory review and legislative review after
the notice of legislation.
-It is expected that the revision will be completed later this year
considering that it usually takes 40 days for legislative announcement, 1 to
2 months for regulatory review, and 1 to 2 months for legislative review.
-However, the amended subordinate statutes will be implemented in Jan 1 2019
along with the Act.
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Ⅱ. Industry's Countermeasure
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1. Public opinions are accepted until July 9 2018.
2. Preparation of pre-registration of existing chemicals
-A person who manufactures/imports existing chemical substances must
pre-register basic information such as chemical name,
manufacture/import amount etc.to ensure its grace period for registration
deadline.If the substance is not pre-registered on time, the
manufacturing/import, use, and sale of the substance is immediately suspended
after July 1 2019, and the grace period to manufacture/import the following
substance cannot be granted. Therefore, it is recommended to establish the
inventory of manufacturing/import chemicals to prevent omission
3. Measures to provide information about chemicals in supply chain
-Management of relevant information in chemical products is required since
supplier should provide chemical information regarding hazardous chemicals as
well as registered chemicals as mandatory.
4. The measures to penalty
- Thorough management of manufacturing and importing chemicalswithin the
company is highly required as fines (less than 5 % of the total sales of the
company) are imposed when a substance is imported/manufactured without
registration or change registration apart from the penalties.
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