Global GHS SDSs and Labelling Compliance
What is GHS
GHS (Globally Harmonized System of Classification and Labeling of Chemicals) is a technical guidance published in 2003 by the United Nations (UN), also referred to as the UN GHS/purple book, which is used to address the classification of chemicals by types of hazard and harmonized hazard communication elements, including labels and safety data sheets. Now the lastest version is the 9th rev. UN GHS. It aims at providing a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level.
Global GHS Implementation
GHS provides the flexibility to allow countries to adopt the building blocks that they require to meet domestic requirements. There may be differences in categories adopted by different countries. However, the overall information such as label elements (pictograms, signal words, hazard and precautionary statements) are harmonized.
The main areas and countries like Europe Union, US, Japan, Korea, China, Brazil, etc. have continuously implemented GHS. In the other words, almost all the industrial countries in the world have implemented GHS or will implement GHS very soon. Even though it is called a "harmonized system", every country or area still has its own specific requirement, such as language or some differences in regulation details.
EU CLP
The United Nations developed a Globally Harmonized System for the classification and labeling of chemicals, known as GHS. As an international agreement GHS is non-legally binding in Europe, therefore the GHS criteria was introduced into Europe via CLP.
EU CLP stands for the Regulation (EC) No 1272/2008 on the Classification, Labeling and Packaging of substances and mixtures. CLP introduces the United Nations globally harmonized system (UN GHS) for classification and labeling of chemicals into Europe. CLP entered into force on 20th January 2009.
How to Comply with CLP Regulation
The CLP Regulation, Article 46, on Enforcement and Reporting, states that “Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled, notified and packaged in accordance with this Regulation”.
Generally speaking, companies shall classify substances or mixtures, submit C&L notifications to ECHA, and label and package their products in accordance with the CLP regulation. CLP compliant Safety Data Sheet containing the CLP classification and labelling shall also be prepared and communicated to downstream users.
China GHS
In China, the overarching regulation governing GHS and SDS is?State Council Decree No. 591- Regulations on Safe Management of Hazardous Chemicals (2011). Under Article 15 and 37 of Decree 591, companies involved in the manufacture, import, storage, use, distribution and transportation of hazardous chemicals are required to obtain and maintain SDS(s) and GHS labels for their chemical products. Penalties for non-compliance, are specified under Article 78, and are composed by the competent authority.
China is a country adopted?UN GHS?by building block approaches. Chinese government has published several compulsory national standards (starting with?GB) and recommended national standards (starting with?GB/T) regarding classifications, safety data sheet (SDS), labeling and packaging for chemical products as following.?
1. Classifications
16 Oct 2013, the Standardization Administration of the People's Republic of China (SAC) published 28 new GHS classification standards for chemicals and the implementation date is 1 November 2014. The new compulsory national standards (GB 30000-2013) for chemical classifications are fully aligned with UN GHS Rev. 4 and have adopted all building blocks under UN GHS Rev. 4 including aspiration hazards and hazards to the ozone layer.
The Detail of Compulsory?National Standards (GB 30000.2-29-2013) for chemical classification can be found in Further information.
2. Safety Data Sheet Standards
The most important national standard related to Safety Data Sheet (SDS) in China is?"Safety data sheet for chemical products: content and order of sections" (GB/T 16483 -2008). This recommended standard was published in June 2008 and entered into force in February 2009. It specifies the structure, content and format of Safety Data Sheet in line with China GHS.
The other important standard is?GB/T 17519-2013?"Guidance on the compilation of safety data sheet for chemical products", which was issued in September 2013 and came into force on 31 Jan 2014. This recommended standard provides detailed guidelines for SDS authoring in China.
Please note that 24h emergency telephone number is mandatory required for the SDS(s) and labels of hazardous chemicals in China. It must be a domestic landline number in China which can provide directly Chinese launguage supporting and techinical suggestions for emergency issues.?CIRS?works with the National Registration Centre of Chemicals (NRCC) to provide this service.
3. Labeling and Packaging Standards
China released 2 main national standards related to the labeling and packaging of chemical products in line with GHS in 2008 and 2009.
The first mandatory national labeling standard?(GB 15258-2009) “General rules for preparation of precautionary label for chemicals” came into force on 1 May 2010. Examples of precautionary labels, transport symbols, and precautionary statements for different categories of chemicals are given in this standard. The transition period is between 1 May 2010 and 1 May 2011. There are some differences between this standard and CLP regulation.
The second mandatory national standard?(GB 190-2009)?-“Packaging Labels for Dangerous goods" is based on the 15th revised edition of the UN recommendations on the Transport of Dangerous Goods. This standard specifies the requirements of pictogram, label size, color and packaging of hazardous goods.?This standard came into force on 1 May 2010.
A sample of Chinese GHS label can be found below:
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Korean OSHA
The Ministry of Employment and Labor (MoEL) of South Korea revised and issued the Occupational Safety and Health Act (OSHA) in 2019. The revised South Korean OSHA regulations has come into force since January 16th 2021. The revised regulation applies to manufacturers and importers of hazardous chemicals based in Korea. Related enterprises should submit the (M)SDS to MoEL before manufacturing or importing.
1. Scope of Exemption:
2. Korea Label Standards (MoEL Notice No.2020-130)
3. KOSHA SDS submission
From January 16th 2021, for manufacturers and importers of hazardous chemicals based in Korea, they should submit the (M)SDS to MoEL before manufacturing or importing in accordance with current amended regulation. However, there is a transitional period for enterprises that previously prepared an SDS in accordance with Article 41(1) or (6) of the former K-OSHA Act. Those meeting the exception may submit the SDS to MoEL within specified deadlines based on manufacture or importation volumes as noted below:
Manufacturers of hazardous chemicals based outside of South Korea may entrust an Only Representative (OR) based in Korea to submit the (M)SDS.
There are three options to submit (M)SDS with required materials:
For overseas manufactures, confirmation of chemical substance with LoC?should also be submitted with (M)SDS together through online IT system.
After submitting the (M)SDS, related enterprises will be granted a serial number (AA00000-0000000000)
issued by MoEL. The number shall be written on the upper side of front page on the (M)SDS. If information in the (M)SDS is altered, then related enterprises must submit the updated (M)SDS to MoEL as soon as possible.
In principle, manufacturers of non-hazardous ingredients based outside of South Korea do not need to provide (M)SDS. They can appoint an OR based in South Korea to submit full ingredients list instead of the (M)SDS.
4. CBI Application
For hazardous chemicals exceeding the concentration limit, they must be reflected in the MSDS.?However, manufacturers or importers are allowed for applying for CBI protection and to use an alternative name and/or alternative content for claiming trade secrets, but they need to get approval from MoE first. It is worth mentioning that enterprises cannot apply for CBI Protection for substances that are prohibited in South Korea, restricted substances, hazardous substances under control, CMR substances, etc.?
Information required for CBI Protection Application includes:
After the application for CBI Protection is approved, MoEL will issue an authorization number to the applicant. Applicant shall fill it in Part 3 of the (M)SDS. The validity period for CBI Protection is 5 years and enterprises may apply for extension of the validity period. Substances that have registered under K-REACH and passed the CBI assessment do not need to apply for CBI Protection under OSHA.
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