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.

K-REACH and TCCA on Subject of Registration

Nam and Nam International Co., Ltd. is a chemical regulatory management consultancy firm in Korea with years of experience in Toxic Chemical Control Act (TCCA) of South Korea, K-REACH and Korea GHS/MSDS. With our devoted and competent consultants, we will post knowledge and insights into acts/regulations related to chemical management.

If you have any questions concerning the K-REACH, TCCA, or Korea GHS/MSDS, please feel free to leave your inquiry or send an e-mail to evelyn@namandnam.com.

For today, we will begin begin with a brief introduction to K-REACH.

With its enforcement date on 1 January 2015, Act on Registration and Evaluation of Chemicals (K-REACH)  regulates the registration section of the Toxic Chemical Control Act. Before the enforcement date, chemicals manufactured or imported into South Korea are regulated under Toxic Chemical Control Act.

K-REACH	Toxic Chemical Control Act
New Chemical Substance All chemicals that are not existing chemicals	New Chemical Substance All chemicals that are not existing chemicals
Existing Chemicals Subject to Registration Chemicals announced by Ministry of Environment that require registration for the purpose of conducting risk assessment and hazard examination

List of Existing Chemicals Subject to Registration has not been announced. We will update you promptly upon its announcement.

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