K-REACH Public Hearing

On 27 December 2013, a public hearing will be held on K-REACH. Drafts of lower statutes are expected to be introduced on the same day as the hearing. We will provide more detailed information on K-REACH following the public hearing. If you have any questions, please feel free to contact me at any time. Thank you.

Expected Effectiveness for Introduction of K-REACH

  K-REACH is a law to fulfill the global principle of “No Data, No Market” and public demand for safe use of chemicals. It can be thought of as a Korean version of EU REACH Regulation.
  Currently, the lower statutes are being legislated through gathering opinions of various interested parties, for example from communication and discussion within a conference group comprised of industries including foreign companies, and experts, etc.

  More than 85% among 44,000 species of chemicals in Korea are distributed without hazard information. Since only limited information is available for the other 15%, it would be no exaggeration to say that the impact these chemicals have on human health and the environment is not definite. It is no exaggeration to say that the impacts these chemicals have on human health and the environment are not definitive investigations because the other 15% chemicals were also figured out only restricted hazard information.
  In the future, if existing chemical substances already in circulation meet certain requirements, these substances should be registered under the K-REACH, and should only be used after evaluation of risk assessment concerning use and exposure. Safety standards and indication standards must be prepared and managed by risk assessment of chemical products, especially of the following: household items such as detergents and air fresheners, insect repellents, and biocides including disinfectants.
  With this, all chemical manufacturers, importers, and goods producers will contribute to public health and the protection of the environment by identifying and communicating information on risks and safe use of chemicals.

 For more information on regulations in Korea, please feel free to post your question or send an e-mail to ehcho@namandnam.com. Thank you.

SIMILARITIES AND DIFFERENCES BETWEEN K-REACH AND EU REACH

 K-REACH which will be implemented from January 1, 2015 in Korea has much in common with EU REACH. Let’s find out similarities and differences between K-REACH and EU REACH.

Similarities

1. Obligor and tonnage levels for registration (Existing substances)

 Obligor and tonnage levels for registration (Existing substances) are very similar in EU REACH and K-REACH. The actors with registration obligations under K-REACH are very similar to EU REACH, especially with the introduction of the concept of local representatives. The registration obligation will apply to local manufacturers and importers, and local representatives. The tonnage level for registration is 1-10 ton per annum, 10-100 ton per annum, 100-1,000 ton per annum, and over 1,000 ton per annum, the same as EU REACH.

2. Authorization system of chemical substances

 K-REACH will implement Authorization System of chemical substances which is not present in the current law - Toxic Chemical Control Act (TCCA). The Authorization system of chemical substances specifies substances subject to authorization, restricted or prohibited substances through the assessment of their uses and exposure. The authorization list is expected to be similar to the authorization list of EU REACH.

Differences

1. Substances subject to registration: registration of new chemical substances in quantities of less than one ton per year.

 The registration scope is generally similar: registration is required for new chemical substances, existing chemical substances and substances intended to be released from articles. However K-REACH requires new chemical substances manufactured∙imported in quantities of less than one ton per year to be registered as well.

 Although normally the existing chemical substances subject to registration as prescribed by the Ministerial Decree will require registration at above one ton per year, these substances may need to be registered at less than one ton per year if the substances are recognized to cause severe damage to human health and the environment. The Minister of Environment will designate and publish such substances through deliberation of the Evaluation Committee. Such existing chemical substances manufactured or imported in quantities of less than one ton per year will then need to be registered.

2. Evaluation criteria

 The testing requirements are differentiated depending on tonnage threshold for substances subject to registration. While there are a maximum of 61 testing requirements in EU, there are a minimum of 11 and maximum of 46 testing requirements in Korea. Therefore it is necessary to check the testing requirements for each tonnage level.

3. Reporting

 Unlike EU REACH, manufacturers•importers•salespersons of all new chemical substances or existing chemical substances in quantities of more than one ton per year have the obligation to report the uses of chemicals and the volume for the uses to the Minister of Environment every year as prescribed by the Ministerial Decree under K-REACH.

 Here we have discussed about the main considerations. But the lower statutes for K-REACH are still being legislated and regular monitoring is necessary. It is important for companies to make comparisons between K-REACH and EU REACH in advance and come up with response plans.

For more information on regulations in Korea, please feel free to post your question or send an e-mail to ehcho@namandnam.com.

Tips for overseas suppliers preparing for Korea's new chemical regualtion, K-REACH

 With K-REACH coming in effect from January 1, 2015, we have organized some checklists to help non-Community suppliers to be prepared for the new regime.

1. Make early-registration of new chemical substance using Korea’s existing law – the TCCA.
 It is a good opportunity for foreign entities to make registrations for new chemical substances early under the existing law – toxic chemical control act (TCCA) while they still can. The new chemical substances registered under the TCCA will be accepted under the K-REACH.

2. Identify and join consortiums of priority existing chemicals.
 Any person who intends to manufacture ∙ import any designated ∙ published existing chemical substances as prescribed by the Ministerial Decree (Ministry of Environment) at 1 ton or more per year will need to register the substance under K-REACH. Although the list of designated existing chemicals is still under revision, when the list is published, it will be vital for companies to check if their substances are included in the list and make preparations accordingly.

3. Start looking for a local representative to submit registrations under K-REACH.
 It is required for foreign companies to appoint a local representative established in Korea who fulfils the requirement specified by the Ministerial Decree, and may have him perform the following tasks to fulfil the registration obligations of the importers. Tasks include: reporting of import volume and use, registration application, notification, other tasks specified by the Presidential Decree.

4. Prepare cost sharing plans within the supply chain.
 Korean manufacturers and importers, local representatives appointed by a manufacturer, producer established outside Korea have the obligation to register a substance. Since one registration is required per substance in a supply chain, these actors can decide who will submit the registration dossier and prepare cost sharing plans

5. Secure supply chains and make early identifications of registration status within the chains.
 Since only one registration number is required for a substance within a supply chain, companies should check beforehand if the substance has been registered somewhere along the chain.

6. Research alternative substances for authorized∙restricted∙prohibited chemical substances.
 The Minister of Environment can revoke the designation of authorization listed substance that may no longer be used as an alternative substance or new technology is developed to substitute the authorization listed substance following deliberation of the Evaluation Committee.

For more information on regulations in Korea, please feel free to post your question or send an e-mail to ehcho@namandnam.com. 

Thank you.

Different types of substances in Korea

 MOE and MOEL have different types of substances. Today we have arranged the types of substances of both institutions.

  In Korea, the two institutions, MOE and MOEL, each divide registered substances into several types through hazard and risk assessment. MOE divides the substances into four types: Toxic chemicals, Observational chemicals, Restricted or Prohibited chemicals, and Chemicals requiring preparation for accidents. MOEL divides them into three types: Administration subject listed substances, Authorization subject listed substances, and Prohibition listed substances. If your substance belongs to the aforementioned types, they will be regulated, and required to go through procedures for reporting (or permission).

 An important issue when proceeding with polymer exemption notification is to check the types of monomers. If your new polymer chemical belongs to Toxic chemicals, you have to proceed with polymer notification under TCCA. If your new polymer chemical belongs to Administration subject listed substances, Authorization subject listed substances, and Prohibition listed substances, you have to proceed with polymer notification under OSHA.

 If you have any question, please feel free to post your question or send an e-mail to ehcho@namandanam.com. Thank you.

Arrangement of some terminologies for new chemical substance registration in Korea § Nam and Nam International

 Today we have arranged some terminologies you should know for new chemical substance registration in Korea.

 

New chemical substance registration is managed by two governmental organizations: Ministry of Environment (MOE), and Ministry of Employment and Labor(MOEL).

Each of them has supporting organizations to support policies: National institute of Environmental Research (NIER), and Korea Occupational Safety and Health Agency (KOSHA). For reference, there is one more supporting organization under the MOE: Korean Chemical Management Association (KCMA).

 New chemical substances are regulated under the Toxic Chemicals Control Act (TCCA) by the ‘MOE’, and the Occupational Safety and Health Act (OSHA) by the ‘KOSHA’.

You can search for existing chemical substances in the Korean Existing Chemicals Inventory (KECI), available at National Chemicals Information System (NCIS).

 The following are websites of above-mentioned organizations.

⊙ MOE: http://eng.me.go.kr/main.do

⊙ MOEL: http://www.moel.go.kr/english/main.jsp

⊙ NIER: http://www.nier.go.kr/eric/portal/eng

⊙ KOSHA: http://english.kosha.or.kr/english/main.do

⊙ NCIS: http://ncis.nier.go.kr/main/Main.jsp

⊙ KCMA: http://www.kcma.or.kr/eng/index.asp

For more information on regulations in Korea, please feel free to post your question or send an e-mail to ehcho@namandnam.com. 

Thank you.

Korea Label

Today we post useful information on Korea Label:

1.) If there are more than seven (7) precautionary statements, only up to six (6) statements can be stated on the label (one or more Precautionary, Respond, Storage and Disposal statements each)

2.) Format

3.) Size

A. Label size per capacity of container or package

Capacity of container or package	Size of printing or label
Capacity≥500 l	Equal to or more than 450㎠
200l≤ Capacity <500 l	Equal to or more than 300㎠
50l≤Capacity <200 l	Equal to or more than 180㎠
5l≤Capacity <50 l	Equal to or more than 90㎠
Capacity <5 l	5% or more of surface excluding top and bottom area of package

B. Size of pictogram

a. Size of each pictogram should be at least one-fortieth of the label.
b. The minimum size of pictogram shall not be less than 0.5㎠.

4.) Subjects excepted from use of Korean Label
A. Samples that already has labels in language other than Korean and that are used only in the laboratory for the purpose of R&D and test
B. Final products that are in transit or in storage for exportation

5.) Labels for transport of hazardous chemical or risky chemicals can comply with UN Recommendations on the Transport of Dangerous Goods, Model Regulations

6.) If the unpackaged containers such as drum is indexed according to the UN Recommendations on the Transport of Dangerous Goods, Model Regulations, the label does not need to contain pictograms.

7.) Labels for mixture must explicitly state the poisonous component’s name and the content ratio (It is acceptable to indicate the CAS No. instead of the chemical name of the poisonous component)

K-REACH and TCCA on Record Keeping Responsibility and Penalties

Today we compare Toxic Chemical Control Act and K-REACH on record keeping responsibility and penalties:

1.) Record Keeping Responsibility

According to the Toxic Chemical Control Act (TCCA), one whose application for manufacture/import notification or new chemical registration/exemption notification has been approved is required to keep related documents for five(5) years. K-REACH, one that would be in force in year 2015, requires the notifier/register to keep related records but the duration is not implicitly mentioned. However, we  prospect that the K-REACH may require the same number of years (five years) as TCCA and that more information would be available once enforcement regulations are announced.

2.) Penalties

TCCA levies less than five years of imprisonment or less than fifty million Won (approximately US$46,472.72 according to the September 23 currency) of fine to those who manufactures or imports a chemical without registration or notification. On the other hand, K-REACH levies more than five years or one hundred million Won (approximately US$ 92,945.44 according to the September 23 currency) of fine to those who manufactures or imports a chemical without registration.

Registration and Risk Assessment under Korea REACh (K-REACH)

1.) Public announcements to watch for after the registration under Korea REACH
- A registered chemical’s name and CAS No. is publicly announced; however, only the generic name is announced for chemicals protected as confidential during the term of its protection.
- If a registered chemical is hazardous, such chemical is designated as a toxic chemical.
- Following chemicals and chemicals that are considered risky as a result of the hazard examination and risk assessment are publicly announced as authorization substance and are required to be authorized by the Ministry of Environment before the manufacture or importation. (The public announcement of authorization substance contains information such as chemical name, the use that needs to the authorized prior to the manufacture/importation, and authorization grace period)
① chemical that causes or is concerned to cause cancer, mutation, adverse fertility, or disruption in endocrine system;
② chemical that highly accumulates in human body, animal and in plant and that remains for a long period of time in the environment;
③ chemical that may cause significant risk equal to or greater than that of chemicals that fall under the preceding categories.
- Following chemicals are publicly announced as restricted or prohibited substance
① chemical that is considered to be hazardous as a result of hazard examination and risk assessment;
② chemical recognized as risky by an international organization; 
③ chemical that is prohibited or is restricted from use by the international treaty; and
④ chemical that is revoked from the designation of authorization substance

2.) Risk Assessment
- Ministry of Environment decides whether to conduct risk assessment of a chemical that falls under one of the categories below based on the result of the hazard examination. MoE can also order the registrant of the chemical to submit needed information for risk assessment.
① chemical manufactured or imported in quantity equal to or more than 10 ton per year; 
② chemical deemed necessary for Risk Assessment as a result of the hazard examination.
- Implementation date for risk assessment based on the tonnage band
① January 01 2015 - A chemical manufactured or imported in quantity equal to or more than 100 ton per year
② January 01 2017 - A chemical manufactured or imported in quantity equal to or more than 70 ton per year
③ January 01 2018 - A chemical manufactured or imported in quantity equal to or more than 50 ton per year
④ January 01 2019 - A chemical manufactured or imported in quantity equal to or more than 20 ton per year
⑤ January 01 2020 - A chemical manufactured or imported in quantity equal to or more than 10 ton per year

Cautionary notes to Korea MSDS Authoring II

5.) If the subject of the MSDS is concerned to cause serious health damage to the workers, then such MSDS must disclose all the information and not apply confidentiality in the third section. Chemicals that cannot apply confidentiality in its MSDS is as 
     A. Prohibition listed in Occupational Safety Health Act (OSHA)
     B. Authorization subject listed in the OSHA
     C. Administration subject listed under OSHA Regulation
     D. Toxic chemicals under Toxic Chemical Control Act

6.) It is acceptable to indicate the content ratio of a chemical’s component in a range format such as “lower limit ~ upper limit”, but has to be within ± 5% range. If the content ratio of a component is below 5%, then it is acceptable to state the lower limit as equal to or higher than 1% (equal to or higher than 0.1% for carcinogenicity and mutagenicity; 0.2% for respiratory sensitization; lastly 0.3% for reproduction toxicity).

7.) Conditions in which one MSDS can cover several products:
     A. Components of different products(in mixture) is the same;
     B. The variation of content ratio of the composition is below 10%
     C. All products have similar hazard

8.) Poisonous substance or chemicals with poisonous substance as its component : Principle of priority in public notices that designates poisonous substances
     A. Public announcement that designates the classification of poisonous substances in accordance with the Toxic Chemical Control Act
     B. A mixture is considered poisonous if its component is poisonous substance and the content ratio of such component exceeds the existing standard. Under this case, the classification of the mixture is to conform to the public notifice that designates poisonous substance.
     C. A poisonous substance or a product that contains poisonous substance must be in compliance with Toxic Chemical Control Act first than Occupational Safety Health Act.

Cautionary Notes to Korea MSDS Authoring I

1.) MSDS of imported chemicals has to contain emergency contact details of the importer in South Korea. But for MSDS of chemicals directly imported into South Korea without an importer can indicate the contact details of the exporter.
2.) All the sections of MSDS must not contain symbols such as hyphen (-) to express inapplicability or non existence of the relevant data but a word or phrase such as “Inapplicable” or “No data available” must be expressly stated. 
3.) Authoring of MSDS and Label in Korean language is the general principal. But if a chemical is to be used only in the laboratory for R&D and test purpose, then such chemical may be accompanied with an MSDS of English version.
4.) The third section of the MSDS - Composition/information on ingredients – is the only section where confidentiality of information is applicable. if the information in third section of the MSDS is concealed as CBI, then such fact has to be explicitly stated.

Applicable and inapplicable Korea MSDS subjects

- All chemicals and products that contain chemicals except the following inapplicable subjects regulated by other laws are applicable subjects of MSDS

1.) Radioactive substances under the Atomic Energy Act 
2.) Medicines and non-pharmaceutical drugs under the Pharmaceutical Affairs Act
3.) Cosmetics under the Cosmetics Act
4.) Narcotics and psychotropic drugs under the Act on the control of Narcotics
5.) Agrochemicals under the Agrochemicals Control Act
6.) Livestock feeds under the Control of Livestock and Fish Feed Act
7.) Fertilizers under the Fertilizer Control Act
8.) Foods and food additives under the Food Sanitation Act
9.) Explosives under the Control of Firearms, Swords, Explosives, etc. Act
10.) Waste under Wastes Control Act
11.) Consumer goods such as detergents
12.) Others as publicly announced by Ministry of Employment and Labor 

(But, if the raw material of above inapplicable MSDS subjects are not regulated by the relevant laws/acts as mentioned, then such raw material is subject to Occupational Safety Health Act.)

Ministry of Employment and Labor public notice no's 2013-37 and 2013-38 amendments

Ministry of Employment and Labor public notice no. 2013-37 (Standards on Classification, Labelling and Material Safety Data Sheet) and Ministry of Employment and Labor public notice no. 2013-38 (Standards on Chemical and Physical Factor Exposure) have been amended as of August 14, 2013.

The changes in the amendments are as follows:

	Public notice before the amendment (Announced on January 26, 2012)	Public notice after the amendment (Announced on August 14, 2013)
Chronic Aquatic Toxicity (Mixture)	1.) Acute aquatic toxicity L(E)C50 value / M factor (Multiplication coefficient)	1.) Acute aquatic toxicity value / M factor (Multiplication coefficient) 2.) Chronic aquatic toxicity NOEC value / Multiplication coefficient M 3. Inclusion of chronic aquatic toxicity classification and chronic aquatic toxicity formula for classification
Aspiration Hazard (Substance)	Chemical that is not classified as category 1 and its kinematic viscosity is lower than 14mm2/s in 40℃.	Chemical that is not classified as category 1 and its kinematic viscosity is lower than 14mm2/s in 40℃ and that is considered to be aspiration Hazard based on previously animal test results, surface tension, solubility, boiling point and volatility.
Standards on Chemical and Physical Factor Exposure	Cadmium and Arsenic Trioxide are included in Occupational exposure limits list	Cadmium and Arsenic Trioxide are excluded from Occupational exposure limits list

Polymer exemption notification in Korea before enactment of K-REACH

1.) Two laws to comply with when it comes to polymer exemption notification before January 1, 2015 (enactment of K-REACH)

Regulation Name	Responsible Gov’t Body
Toxic Chemical Control Act (TCCA)	Ministry of Environment (MoE)
Occupational Safety and Health Act	Ministry of Employment and Labor (MOEL)

2) Polymer exemption criteria under each law: If a polymer satisfies conditions from both laws, then in compliance with TCCA, submission of polymer exemption notification only to Korea Chemicals Management Association (KCMA) is required since submission to KCMA equally exempts the polymer from the requirements under OHSA.

TCCA	Every monomer of the polymer is Korean existing chemical and number-average molecular weight(Mn) of the polymer is higher than 1000; and
	Monomer is not Toxic Substance
OSHA	Every monomer of the polymer is Korean existing chemical and number-average molecular weight(Mn) of the polymer is higher than 1000; and
	Polymer does not produce cation; it is not carcinogenic, mutagenic, reprotoxic or other characteristics harmful to the human health; it is not one of the Administration subject listed; and it satisfies one of the below: 1. Does not dissolve in water or in organic solvent, and does not contain Sodium, Magnesium, Calcium or other metals. 2. If dissolved in water or in organic solvent, then a component with less than 1,000 molecular weight should be more than one percent. And if Mn is less than 1,000, then the polymer should not contain carbon to carbon double bond, carbon to carbon triple bond, carbon to nitrogen double bond, carbon to nitrogen triple bond, aziridine group, epoxy group, sulfonate group, hydrazine group, phenol hydroxyl group or fluorine group

If a polymer does not satisfy both the TCCA and OSHA criteria for exemption, then following TCCA exemption criteria (as mentioned in my post three days ago) has to be considered.

- A polymer that is not enlisted in Korea Existing Chemical List (aka a new chemical) is considered to be an existing chemical thus liable for exemption if its monomers (whether these monomers are new or existing chemical), excluding those with content ratio lower than 2%, result to a existing chemical.

- Block polymers whose blocks are not new chemicals;

- Graft polymers whose stem and branch sections are not new chemicals;

- Non-ionic polymers whose number average molecular weight is greater than 10,000

However, OSHA only states two criteria for polymer exemption, as mentioned above, a polymer that does not satisfy these two criteria is considered as a new chemical under OSHA and has to be registered to Ministry of Employment and Labor.

Therefore, a careful analysis and identification of exemptions are necessary in the polymer exemption notification.

Basic Information on Korea GHS/MSDS

Together with insights into K-REACH and TCCA, we will also post information concerning Korea GHS/MSDS. Starting with some basic information on Korea GHS/MSDS.

- Implemented UN GHS edition in South Korea: 3rd Edition

- Compared to the fourth edition, below are the building blocks not implemented in Korea:

• Flammable Liquid Category4
• Acute Toxicity Category 5
• Skin Corrosion/Irritation Category 3 and its sub-categories (1A, 1B, 1C)
• Respiratory or Skin Sensitization sub-categories (1A, 1B)
• Hazardous to the aquatic environment –Acute Aquatic Hazard categories 2, 3
• Ozone Depleting Substance Category 1

- Applicable Regulations:

1. Ministry of Environment and Labor – Occupational Safety and Health Department – Occupational Safety and Health Act – Ministry of Environment and Labor public notice no. 2012-14
2. Ministry of Environment – National Institute of Environmental Research – Toxic Chemical Control Act – National Institute of Environmental Research public notice no. 2013-20
3. National Emergency Management Agency - Safety Control of Dangerous Substances Act

Data required for registration under K-REACH

Documents/data (Basic)	1.) Name, location and company representative who intends to manufacture or import the chemical 2.) Chemical name, molecular formula, structural formula and other chemical identity information 3.) Information on use of the chemical 4.) Classification and labeling of the chemical 5.) Physical/Chemical characteristics 6.) Hazard information 7.) (In case of manufacture/importation in volume equal to or greater than 10 ton) information on risk including exposure scenario 8.) Guidance on safe use of the chemical such as protection equipment, emergency measures in case of explosion or fire. 9.) Test reports according to the volume manufactured/imported
Enforcement date depending on the annual importation or manufacture volume (grace period)	January 01, 2015	The volume of the chemical to be manufactured or imported is equal to or greater than 100 ton per year
	January 01, 2017	The volume of the chemical to be manufactured or imported is equal to or greater than 70 ton per year
	January 01, 2018	The volume of the chemical to be manufactured or imported is equal to or greater than 50 ton per year
	January 01, 2019	The volume of the chemical to be manufactured or imported is equal to or greater than 20 ton per year
	January 01, 2020	The volume of the chemical to be manufactured or imported is equal to or greater than 20 ton per year
Joint submission	Any person who intends to register an “existing chemicals subject to registration” within the grace period may apply for registration individually but the registration document/data has to be submitted by a lead registrant, elected among the registrants.

K-REACH and TCCA on Exemptions from Registration/Hazard Examination

K-REACH

TCCA

Chemicals that fall under any of the following is exempted from registration without submitting any exemption notification: 1.) Chemical substance imported as already equipped in a machinery; 2.) Chemical substance imported together with relevant machineries or equipments for the purpose of trial test; 3.) Chemical substance that are contained and are not released from a solid product with specific function; Chemicals that fall under any of the following is exempted from registration after submitting the exemption notification: 1.) Existing chemical manufactured/imported below one ton per year (except those with high risk); and 2.) Chemical for sole purpose of research and development; 3.) Designated under Presidential Decree, chemicals that have received exemption confirmation from Ministry of Environment such as those that are manufactured or imported into South Korea in a volume less than 10 ton for the sole purpose of exportation. Note of Caution: Please note that no enforcement decree or enforcement regulation has been released under K-REACH to officially set the polymer exemption. Upon the release of any public notice or announcement concerning it, we update such.

Chemicals that fall under any of the following is exempted from hazard examination after submitting the exemption notification: 1.) New chemicals manufactured or imported in a quantity below 100Kg; 2.) New chemicals used only by an investigator or researcher within a restricted area for the purpose of developing a product that contains such chemicals or for an improvement of the process; 3.) New chemicals manufactured or imported in a quantity not more than 10 ton per year or chemicals manufactured or imported in a quantity not more than 10 ton per year that are imported or manufactured in order for produce a chemical for the sole purpose of exporting the whole quantity; 4.) Polymers with number average molecular weight greater than 1,000 and with constituent monomer that is neither a new chemical nor a poisonous substance; 5.) A polymer that is not enlisted in Korea Existing Chemical List (aka a new chemical) is liable for exemption if its monomers, excluding those with content ratio lower than 2%, result to a polymer that is an existing chemical. 6.) Block polymers whose blocks are not new chemicals; 7.) Graft polymers whose stem and branch sections are not new chemicals; 8.) Non-ionic polymers whose number average molecular weight is greater than 10,000 9.) Chemicals which have been manufactured or imported in South Korea prior to February 2, 1991 (If there are any available evidence of a chemical being commercialized in Korea prior to February 2, 1991, then such chemical can apply for an exemption); and 10.) Surface treated chemicals in which both the base and the treated chemicals do not contain the new chemicals.

K-REACH and TCCA on Scope of Application

K-REACH	TCCA
1. Common Area of Exemptions:
Radioactive substances under the Atomic Energy Act
Pharmaceutical and quasi-drugs under Pharmaceutical Affairs Act
Narcotics under the Narcotics Control Act
Cosmetics and raw materials used in cosmetics under Cosmetics Act
Pesticides and active ingredients for pesticides under Pesticides Control Act
Fertilizers under Fertilizers Control Act
Feed under Feeds Control Act
Gunpowder pursuant under Firearms, Swords, and Gunpowder Control Act
Military supplies pursuant to the Defense Acquisition Program Act
2. Different Area of Exemptions:
Food and Food additives under Food Sanitation Act	Food, food additives, device and container/packing under Food Sanitation Act
Functional Health foods under Functional Foods for Health Act	Toxic gases under the High-Pressure Gas Safety Control Act
Medical devices under Medical Devices Act

Except the Cosmetics raw material and pesticides active ingredients as explicitly stated by the above two Acts, raw materials/active ingredients used in other products (for example in pharmaceutical product), may also need to comply with Toxic Chemical Control Act as a chemical substance.

If you have any question, please feel free to contact us at evelyn@namandnam.com.