Interpretation of China Inventory of Hazardous Chemicals (2015)

The Inventory of Hazardous Chemicals (hereinafter referred as the “Inventory”) serves as an essential support document to facilitate implementation of the Regulations on the Control over Safety of Hazardous Chemicals (hereinafter referred as the “Regulations”). The Inventory of Hazardous chemicals is also an important reference for the industry to define their respective chemical management compliance requirements, in addition to aiding governmental departments in carrying out law enforcement inspections and administrative measures. In accordance with Decree 591 (the latest revision of the Regulations), the formulation of the 2015 Inventory was finalized under the joint effort of SAWS, MIIT, MPS, MEP, NHFPC, AQSIQ, MOT, NRA, CAAC and MOA. The Inventory will enter into force from May 1^st, 2015 and replace the Catalog of Hazardous Chemicals (2002) and Inventory of Highly Toxic Chemicals (2002).

Background

In Mar 2003, according to the Regulations (State Council Decree 344), the former State Safety Administration (predecessor of SAWS) issued Catalog of Hazardous Chemicals (2002) which included 3823 entries. In Jun 2003, the Inventory of Highly Toxic Chemicals (2002) containing 335 entries was jointly issued by 8 departments governing safety, public security, environmental protection, health, quality supervision, inspection and quarantine, railway, transport and civil aviation.

In light of the global progress of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), China has developed a series of national standards on chemical classification and labelling and established a chemical classification system based on 28 hazard classes. In contrast, the Catalog of Hazardous Chemicals (2002) adopted a classification system consisting of just 8 hazard classes such as explosives and flammable liquids. The Regulations was last revised as State Council Decree 591 and defined hazardous chemicals as highly toxic chemicals and other chemicals which are toxic, corrosive, explosive, inflammable, combustible, etc. and pose harms to human health, facilities and the environment. The Inventory of Highly Toxic Chemicals (2002) was considered by industry and finally regulators to contain too many chemicals and ultimately required amendment.

History

On July 21^st, 2011, the first work meeting on the revision of the Inventory was held by SAWS bringing together officials and experts from 10 relevant governmental authorities. The major achievements of this meeting included passing the Rules of Revising the Inventory, setting up the leadership and expert panel and most importantly designating the NRCC working committee to carry out the most significant revision work.

Since then, the Inventory has gone through several revisions and internal discussions. The expert panel and the working committee conducted extensive research on the management of hazardous chemicals both domestically and internationally. The “Purple Book” and the “Orange Book” were both heavily referenced in addition to the chemical classification and administrative frameworks implemented in the EU, Japan and New Zealand. The draft inventory was officially released for public consultation on Sep 26th after a significant amount of work and careful deliberation on the columns, the hazard classes and hazard categories of chemicals to be listed in the Inventory, the data sources, the determination of highly toxic chemicals, the supplementation and deletion of existing entries, etc. Many feedbacks have been collected since the issuance of the draft Inventory prompting more special sessions to be convened. The final Inventory (2015) was published on Feb 27^th, 2015.

Principle

The Inventory was formulated following the principle of stably transforming the old chemical management system and gradually keeping up with the international best practice.

In line with the national standards on chemical classification and labeling (China’s adaption of UN GHS standards), there are 95 hazard categories from 28 hazard classes, and 81 categories are adopted by the Inventory. (See Table 1) This means chemicals classified to these 81 categories are regarded as hazardous chemicals in China.

Table 1 GHS hazard categories adopeted by China's Invnetory of Hazardous Chemicals

Hazards and hazard classes		Hazard categories
Physical hazards	Explosives	Unstable explosives	1.1	1.2	1.3	1.4	1.5	1.6
	Flammable gases	1	2	A (Chemically unstable gases)	B (Chemically unstable gases)
	Aerosols	1	2	3
	Oxidizing gases	1
	Gases under pressure	Compressed gases	Liquefied gases	Refrigerated liquefied gases	Dissolved gases
	Flammable Liquids	1	2	3	4
	Flammable Solids	1	2
	Self-reactive substances and mixtures	A	B	C	D	E	F	G
	Self-heating substances and mixtures	1	2
	Pyrophoric liquids	1
	Pyrophoric solids	1
	Substances and mixtures, which in contact with water, emit flammable gases	1	2	3
	Corrosive to metal	1
	Oxidizing liquids	1	2	3
	Oxidizing solids	1	2	3
	Organic peroxides	A	B	C	D	E	F	G
Health hazards	Acute toxicity	1	2	3	4	5
	Skin corrosion/irritation	1A	1B	1C	2	3
	Serious eye damage/ eye irritation	1	2A	2B
	Respiratory or skin sensitization	Respiratory sensitizer 1A	Respiratory sensitizer 1B	Skin sensitizer 1A	Skin sensitizer 1B
	Germ cell mutagenicity	1A	1B	2
	Carcinogenicity	1A	1B	2
	Reproductive toxicity	1A	1B	2	Additional category (Effects on or via lactation)
	Target organ systemic toxicity (TOST) - single exposure	1	2	3
	Target organ systemic toxicity (TOST) - repeated exposure	1	2
	Aspiration hazard	1	2
Environmental hazards	Hazardous to the aquatic environment	Acute 1	Acute 2	Acute 3	Chronic 1	Chronic 2	Chronic 3	Chronic 4
Environmental hazards	Hazardous to the ozone layer	1
* Shaded hazard categories are adopted by the Inventory

According to the formulation principle, all the chemicals in the Catalog of Hazardous Chemicals (2002) and the Inventory of Highly Toxic Chemicals (2002) have been included in the Inventory unless there were sufficient reasons for the deletion after going through expert reviews and gaining ministerial agreement. The inventory was formulated referencing relevant international conventions such as the Recommendations on the Transport of Dangerous Goods, Rotterdam Conventions and the EU C&L Inventory, and by carefully considering China’s unique chemical regulatory requirements. Addition of new chemicals to the inventory was decided on after first going through expert review and gaining ministerial agreement.

Comparison of the Inventory and the Catalog (2002)

I. Newly added entries of hazardous chemicals

40 chemicals under the Rotterdam Conventions and Stockholm Conventions, such as short-chain chlorinated paraffin (C_10~C13), polychlorinated terphenyl, etc.
29 chemicals in the List of Toxic Chemicals Severely Restricted for Import and Export in China and Use Quantities Standard for Hazardous Chemicals (2013), such as mercury sulfide, triphosgene, etc.
Referring to the UN Recommendations on the Transport of Dangerous Goods and the EU C&L Inventory and taking the hazard information and production information into consideration, 123 chemicals were added to the Inventory, such as titanium disulphide, nitrogen dioxide, etc.
Learning from relevant criminal cases (major work safety accidents due to chemical hazards) in the recent years, to meet the requirement of public safety management, the addition of succinylcholine chloride and methyl fluoroacetate was proposed by related departments and approved by the 10 authorities.

II. Combined, adjusted or deleted chemical entries

1. 10 generic entries in the Catalog of Hazardous Chemicals (2002) were combined, namely:

Flammable solvent based synthetic resin, class I [-18℃≤ flash point ＜23℃]
Flammable solvent based synthetic resin, class II
Flammable solvent based　paints, auxiliary agents and coatings, class I
Flammable solvent based　paints, auxiliary agents and coatings, class II
Benzol or toluol based preparations
Acetone based preparations
Alcohol preparation or ethyl ether preparation
Flammable solvent based adhesive, class I [-18℃≤ flash point ＜23℃]
Flammable solvent preparations, class I, N.O.S.
Flammable solvent preparations, class II, N.O.S.

The 288 specific chemicals under the 10 generic entries were all listed in the Inventory under generic entry No. 2828 “other products including synthetic resins containing flammable solvents, paints, auxiliary materials, coatings, etc. [closed cup flash point ≤ 60℃]”. Other chemicals matching the specification of entry No. 2828 all belong to hazardous chemicals.

2. Some entries with the same CAS number were consolidated to a single entry.

3. 10 toxicants and articles for military uses in the 2002 Catalog were removed, including di(2-chloroethyl)thioether (a.k.a. mustard gas), aluminum wire solder, etc..

4. More than 400 other chemicals, e.g. hot curing rubber patch and Bomyl, were deleted for reasons of unconformity with the Inventory formulation principle, unclear composition, pesticides not registered in China, etc..

Amendment to definition of highly toxic chemicals

I. Definition

Highly toxic chemicals are chemicals with severe acute toxicity, including artificially synthesized chemicals and their mixtures or natural toxins, as well as chemicals with acute toxicity and which can easily pose threats to the public safety.

The major change is the addition of “chemicals with acute toxicity and which can easily pose threats to the public safety”. This indicates that even some chemicals that are not assigned to the severe acute toxicity category (i.e. acute toxicity Cat. 1), may be regarded as highly toxic chemical by the 10 authorities if their toxicity is relatively high (acute toxicity Cat.2) and pose threats to the public safety.

II. Determination of severe acute toxicity

Acute toxicity category 1, meet any of the following requirements: Rat experiment, oral LD5 0≤ 5mg/kg, dermal LD50 ≤ 50mg/kg, inhalation (4h) LC50 ≤ 100ml/m3 (gas) or 0.5mg/L (vapor) or 0.05mg/L (dust/mist). Data of dermal LD50 from rabbit experiment is acceptable.

The threshold data changed a lot as compared with the 2002 Catalog. (See Table 2)

Table 2 – Comparison of the threshold data for determining severe acute toxicity

	The Inventory (2015)	The Inventory of Highly Toxic Chemicals (2002)
Oral	LD₅₀ ≤ 5 mg/kg	LD₅₀ ≤ 50 mg/kg
Dermal	LD₅₀ ≤ 50 mg/kg	LD₅₀ ≤ 200 mg/kg
Inhalation	(4h) LC₅₀ ≤ 100 ml/m³ (gas) or 0.5 mg/L (vapor) or 0.05 mg/L (dust/mist)	(4h) LC₅₀ ≤ 500 ml/m³ (gas) or 2 mg/L (vapor) or 0.5 mg/L (dust/mist)
Hazard categories	Acute toxicity, Cat.1	Acute toxicity, Cat.1 & 2

III. Changes

The Inventory (2015) contains 148 entries of highly toxic chemicals, 187 fewer than those in the Inventory of Highly Toxic Chemicals (2002).

140 chemicals in the Inventory of Highly Toxic Chemicals will continue to be regulated as highly toxic chemicals, 160 were adopted by the 2015 Inventory as hazardous chemicals and the rest 35 were deleted (including 28 pesticides and 7 toxicants for military uses).
4 highly toxic chemicals were newly added, namely N-(4-bromophenyl)-2-fluoro-acetamide, 2,3,4,7,8-pentachlorodibenzofuran, 2-nitro-4-methoxyaniline and methyl fluoroacetate.
4 chemicals listed in the Catalog of Hazardous Chemicals (2002) will be regulated as highly toxic chemicals, namely cyanogen chloride, tri-n-butyl amine, calcium arsenite and 1-(p-chlorophenyl)-2,8,9-trioxa-5-aza-1-silabicyclo(3.3.3)undecane (a.k.a. silatrane, p-chlorophenyl-).

Additional specifications

As new chemicals are continually being developed and marketed and people’s awareness of chemical hazards is rising, in the light of Article 3 of the Regulations, 10 competent authorities will make adjustment and continuous improvement of the Inventory accordingly. Not being listed in the 2015 Inventory does not necessarily mean a chemical is not hazardous. Unlisted chemicals identified to be hazardous (according to SAWS Order 60) still need to comply with relevant regulations.
To facilitate and integrate hazardous chemical management, the 10 authorities all agreed to merge the Inventory of Highly Toxic Chemicals into the Inventory of Hazardous Chemicals.

China’s hazardous chemical management system is founded on chemical inventories and corresponding regulatory compliance requirements for chemicals listed in specific inventories. Chemicals in the Inventory are subject to enhanced regulatory control schemes such as administrative approvals. For mixtures and unlisted chemicals, hazchem registration and hazard identification and classification are necessary in order to ascertain hazardous properties all chemicals within the territory of China. Therefore, industry stakeholders should carry out hazard identification of such chemicals in accordance with SAWS Order 60 and register the identified hazardous chemicals in accordance with SAWS Order 53. This enables source control of hazardous chemicals and ensures use safety. The combination of list-based management and criteria-based management add to the full-scale and comprehensive management of hazardous chemicals in China.