China Permits and Licenses

China GHS – Classification, Labelling and Packaging of Chemicals and SDS in China

“Globally Harmonized System of Classification and Labeling of Chemicals (GHS)” is a system created by UN to address the classification of chemicals by types of hazard and harmonized hazard communication elements, including labels and safety data sheets. It aims at providing a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level, an important factor also for trade facilitation.

As an international agreement GHS is non-legally binding in the member countries of United Nations.  Thus many countries and regions have published their own regulations or standards to implement GHS. For example, the GHS criteria were introduced into Europe via the Regulation (EC) No 1272/2008 on the Classification, Labeling and Packaging of substances and mixtures (CLP).

China is one of many countries that have agreed to implement GHS. Chinese government has published several compulsory national standards (starting with GB) and recommended national standards (starting with GB/T).

Companies selling chemicals to China and chemical companies in China are required to adopt these standards to classify, label and package chemicals as well as prepare safety data sheets in accordance with the requirements of GHS as from 1 May 2011.

Regulations – Who is requiring SDS and Label in China

In China, the overarching regulation governing GHS and SDS is State Council Decree No. 591- Regulations on Safe Management of Hazardous Chemicals (2011).

Under Articles 15 and 37 of Decree 591, companies involved in the production, import, storage, use, sales, marketing and transportation of hazardous chemicals are required to obtain and maintain SDS and safety labels for their chemical products. Penalties for non-compliance, are covered under Article 78, and are composed by the competent authority.

Regulations that govern hazardous chemicals registration (SAWS Order 53) and new substance notification (MEP Order 7/Article 10) also require that Chinese SDS and Labels should be submitted along with registration/licensing applications.

Under the Ministry of Transportation Decree No.2 (2013) Article 32, SDS and Labels are required for all dangerous good in China. According to the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) Announcement No. 30 (2012), Chinese Label and sample SDS are required for imported chemicals, whilst for export, SDS, Label and equivalent Chinese translations are required.

National standards – How to compose Chinese SDS and Label

There are several national standards concerning both GHS and the preparation of SDS and Labels in China. GB 13690-2009 – General rule for classification and hazard communication of chemicals, is in line with the GHS. It is due to be replaced by GB 30000.1 – 2013 soon, although it is not known when the standard will come into force.

For classifcation, the most recently released standard series are GB 30000.2-2013 to GB 30000.29 – 2013. They comprise 28 separate standards each referring to a particular GHS hazard. The standards were authored based on the 4 rev. edition of the UN purple book and became effective from 1 November 2014. All hazard classes and categories in the purple book were adopted in the Chinese classification standards.

The mandatory basic element of a Chiense safety label and printing requirements are given in the GB 15258-2009 – General rules for preparation of precautionary label for chemicals, which came into force on 1 May 2010.

Classification

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.

Harmonized Classification-China Hazardous Chemical Inventory 2015

On 9 March 2015, The Catalog of Hazardous Chemicals (2015) has been officially published, which was prepared by The State Administration of Work Safety (SAWS), The Ministry of Industry and Information (MIIT), The Ministry of Public Safety (MPS), The Ministry of Environmental Protection (MEP), The Ministry of Transport (MOT), The Ministry of Agriculture (MOA), The National Health and Family Planning Commission (NHFPC), The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), The Railway Administration of China (RAC) and The Civil Aviation Administration of China (CAAC).

There are 2828 entries have been included in this inventory. Catalog 2015 has entered into force on 1 May 2015 and replaced hazardous chemical catalog 2002 accordingly.

The obligated classification of substances in China are also given in the inventory. That means the classification in the inventory is the minimized requirement for one substance. In addition, you may add more classification of this substance in your own SDS or Label. For the classification category marked with asterisk, you may use more severe classification category instead of original one.

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 comes into force on 31st 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 SDSs and labels of hazardous chemicals. It must be a domestic landline number in China which coud provide directly Chinese launguage supporting and techinical suggestions during emergency issues. CIRS works with National Registration Centre of Chemicals (NRCC) to provide this service.

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 also between 1 May 2010 and 1 May 2011. There are some differences between this standard and CLP regulation.

  • Black frame of a pictogram is also acceptable(for domestic use);
  • Simplified label is available for volume < 0.1L;
  • No requirement on the minimum size of a pictogram;
  • There is no limit of 6 p-statements;
  • Emergency number on the label must be a domestic 24h emergency telephone number.

The second mandatory national standard (GB 190-2009) -“Packaging Labels for Dangerous goods” is based 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 also came into force on 1 May 2010.

A sample of Chinese GHS label can be found below:

Transportation of Dangerous Goods (TDG)

China’s national standards have linked TDG with UN GHS. In Oct 2011, China has released two revised national standards for dangerous goods. Those two standards are consistent with the 16th revised edition of the <UN Recommendations on the Transport of Dangerous Goods.

Those two standards are available from:
GB 6944-2012, Classification and code of dangerous goods
Gb 12268-2012, List of dangerous goods

Classification Standards & Building Blocks in China

In 2013, the Standardization Administration of the People’s Republic of China (SAC) issued 28 compulsory chemical classification standards (GB 30000.2-2013 to GB 30000.29-2013 Safety rules for classification and labelling of chemicals) and each standard corresponds to one hazard class under GHS. Those standards 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.

For those who are interested in knowing chemical classification criteria in China, they may directly refer to the English version of UN GHS Rev. 4 since GB 30000.2~29 are directly translated from UN GHS Rev. 4.

The Compulsory National Standards (GB 30000-2013) for chemical classification in present.

Standard GB 30000.2-29-2013Name: Safety rules for classification and labeling of chemicals forTo Replace
GB 30000.2-2013ExplosivesGB 20576-2006
GB 30000.3-2013Flammable gasesGB 20577-2006
GB 30000.4-2013AerosolsGB 20578-2006
GB 30000.5-2013Oxidizing gasesGB 20579-2006
GB 30000.6-2013Gas under pressureGB 20580-2006
GB 30000.7-2013Flammable liquidsGB 20581-2006
GB 30000.8-2013Flammable solidsGB 20582-2006
GB 30000.9-2013Self-reactive substances and mixtures.GB 20583-2006
GB 30000.10-2013Pyrophoric liquidsGB 20585-2006
GB 30000.11-2013Pyrophoric solidsGB 20586-2006
GB 30000.12-2013Self-heating substances and mixturesGB 20584-2006
GB 30000.13-2013Substances and mixtures which are in contact with water emit flammable gasesGB 20587-2006
GB 30000.14-2013Oxidising liquidsGB 20589-2006
GB 30000.15-2013Oxidising solidsGB 20590-2006
GB 30000.16-2013Organic peroxidesGB 20591-2006
GB 30000.17-2013Corrosive to metalsGB 20588-2006
GB 30000.18-2013Acute toxicityGB 20592-2006
GB 30000.19-2013Skin corrosion/irritationGB 20593-2006
GB 30000.20-2013Serious eye damage/irritationGB 20594-2006
GB 30000.21-2013Respiratory or skin sensitizationGB 20595-2006
GB 30000.22-2013Germ cell mutagenicityGB 20596-2006
GB 30000.23-2013CarcinogenicityGB 20597-2006
GB 30000.24-2013Reproductive toxicityGB 20598-2006
GB 30000.25-2013Specific target organ toxicity- single exposureGB 20599-2006
GB 30000.26-2013Specific target organ toxicity-repeated exposureGB 20601-2006
GB 30000.27-2013Aspiration Hazard
GB 30000.28-2013Hazardous to the aquatic environmentGB 20602-2006
GB 30000.29-2013Hazardous to the ozone layer

 

Compulsory GHS Classification in China

For chemicals listed in the Catalogue of Hazardous Chemicals, the State Administration of Work Safety (SAWS) has published harmonized chemical classifications of those chemicals.Industry must use the classifications given in the guidance or more severe ones to classify their chemicals and prepare SDSs and labels.

The differences among UN GHS, CLP, China GHS and US HCS

Classification Differences among UN GHS, China GHS, US HCS and EU CLP

ClassificationCategoriesUN GHS rev. 5China GHS(rev.4)HCS(rev.3)CLP(rev.5, shall be rev.6 shortly)
1.ExplosivesUnstable Explosive
Division 1.1
Division 1.2
Division 1.3
Division 1.4
Division 1.5
Division 1.6
2.Flammable GasesFlammable Gases Category 1
Flammable Gases Category 2
Chemically Unstable Gases Category ANA
Chemically Unstable Gases Category BNA
3.AerosolsCategory 1
Category 2
Category 3NA
4.Oxidizing GasesCategory 1
5. Gas Under PressureCompressed Gas
Liquefied Gas
Refrigerated Liquefied Gas
Dissolved Gas
6.Flammable LiquidsCategory 1
Category 2
Category 3
Category 4NA
7.Flammable SolidsCategory 1
Category 2
8.Self-reactive Substances and mixturesType A
Type B
Type C
Type D
Type E
Type F
Type G
9.Pyrophoric LiquidsCategory 1
10.Pyrophoric SolidsCategory 1
11.Self-heating Substances and mixturesCategory 1
Category 2
12.Substances and mixtures which in contact with water emit flammable gasesCategory 1
Category 2
Category 3
13.Oxidising LiquidsCategory 1
Category 2
Category 3
14.Oxidising solidsCategory 1
Category 2
Category 3
15.Organic peroxidesType A
Type B
Type C
Type D
Type E
Type F
Type G
16.Corrosive to metalsCategory 1
17.Acute toxicityCategory 1
Category 2
Category 3
Category 4
Category 5NANA
18.Skin corrosion/irritationCategory 1: Corrosive 1A
Category 1: Corrosive 1B
Category 1: Corrosive 1C
Category 2: Irritant
Category 3: Mild IrritantNANA
19.Serious eye damage/eye irritationCategory 1: Irreversible effects on the eye
Category 2A: Irritating to eyes
Category 2B: Irritating to eyesNA
20.Respiratory or skin sensitisationRespiratory Category 1A
Respiratory Category 1B
Skin Category 1A
Skin Category 1B
21.Germ cell mutagenicityCategory 1A
Category 1B
Category 2
22.CarcinogenicityCategory 1A
Category 1B
Category 2
23.Reproductive toxicityCategory 1A
Category 1B
Category 2
Additional category for effects on or via lactation
24.Specific target organ toxicity — single exposureCategory 1
Category 2
Category 3
25.Specific target organ toxicity — repeated exposureCategory 1
Category 2
26.Aspiration hazardCategory 1
Category 2NANA
27.Hazardous to the aquatic environmentCategory Acute 1NA
Category Acute 2NANA
Category Acute 3NANA
Long-term aquatic hazardNA
28.Hazardous to the ozone layerCategory 1NA
Other HazardsNANANAPyrophoric Gas
Simple Asphyxiant
Combustible Dust
NA

China GHS Standard: GB/T 16483-2008 Safety data sheet for chemical products: Content and order of sections

In China, the most important standards specifying the content and format of SDSs in China are GB/T 16483-2008 safety data sheet for chemical products: content and order of sections issued in 2008 and GB/T 17519-2013 Guidance on the compilation of safety data sheet for chemical products issued in 2013. GB/T 16483-2008 specifies the basic content and order of 16 sections in Chinese SDSs while GB/T 17519-2013 provides detailed guidelines on how each section should be compiled in China.

  • Product identification: Consistent with names on label;
  • Composition information: Hazardous ingredients displayed in a descending order based on concentration or concentration ranges;
  • 24h emergency telephone number: Required;
  • Language: Must be prepared in simplified Chinese.

Content and Generic Forms of SDS

SDS shall provide the information on chemical products as in the following 16 sections, and the title, numbering and the order of each section should not be changed without solid excuse.

1) Chemical product and company identification

2) Hazard overview

3) Composition/information on ingredients

4) First-aid measures

5) Fire-fighting measures

6) Accidental release measures

7) Handling and storage

8) Exposure controls/personal protection

9) Physical and chemical properties

10) Stability and reactivity

11) Toxicological information

12) Ecological information

13) Disposal

14) Transport information

15) Regulatory information

16) Other information

Requirements on Chinese GHS Labels

GB 15258-2009 General rules for preparation of precautionary label for chemicals has set detailed requirements on the content and format of chemical labels. China has adopted standard GHS label elements (see example given below) and set additional requirements on language, 24h emergency telephone number, and sizes, etc.

  • Language: simplified Chinese; ;
  • Chemical identification: in both Chinese and English;
  • Display of hazard statements: physical hazards must be displayed first followed by health hazards and environmental hazards;
  • Domestic 24h emergency telephone number: required for imported hazardous chemicals;
  • Small packages (<=100ml): precautionary statementscan be omitted;
  • Border color of a pictogram: black only allowed for chemicals for domestic use;
  • Pictogram size: not specified; must be visible from a distance;
  • Label size: depending on package capacity( please refer to the table below);

For workplace labelling, companies shall refer to GB 30000.30-201x (draft version available). For labelling of consumer products, companies shall refer to a separate standard called “risk-based GHS labelling of consumer product” which is also being drafted by SAC.

Trade Secret/ Information Disclosure in SDSs

Both GB 15258-2009 and GB/T 17519-2013 have given clear guidance on information disclosure on labels and in SDSs. Hazardous ingredients contributing to the classification of a substance or mixture and their concentration or concentration ranges shall be disclosed. Generic names are acceptable.

For trade secret ingredients, real substance names and CAS numbers can be hidden. However, hazards shall be fully disclosed.