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.