Occupational Exposure Limits in China - GBZ 2.1-2007 - Occupational exposure limits for hazardous agents in the workplace

An occupational exposure limit is an upper limit on the acceptable concentration of a hazardous substance in workplace air for a particular material or class of materials.
In China, Occupational Exposure Limits(OELs) for hazardous chemicals is set by GBZ 2.1-2007 - Occupational exposure limits for hazardous agents in the workplace. The standard was revised by the Ministry of Health in 2007 and implemented from 1 Nov 2007.
There are three types of OELs for hazardous chemicals in China:

• Maximum allowable concentration (MAC); other countries might call it the ceiling value.
• Permissble concentration-time weighed average(PC-TWA): the maximum average concentration of a chemical in air for a normal 8-hour working day and 40-hour week;
• Permissble concentration-short term exposure limit(PC-STEL): the maximum average concentration to which workers can be exposed for a short period (usually 15 minutes);

The standard has set occupational exposure limits for 339 hazardous chemicals, 47 kinds of dust and 2 types of bacteria. The standard methods of monitoring the concentration of hazardous chemicals in workplace are defined in national standards GBZ 159-2004 and GBZ/T 160-2004.

Related Occupational Exposure Limits(OELs)

Types of Occupational Exposure Limits

OSHA Permissible Exposure Limits (PELs)

California OSHA Permissible Exposure Limits (PELs)

ACGIH Threshold Limit Values (TLVs)

NIOSH Recommended Exposure Limits (RELs)

AIHA Workplace Environmental Exposure Levels (WEELs)

Occupational Exposure Limits in Europe

GESTIS: International Occupational Exposure Limit Database

Pesticides Regulations - Revised Pesticide Management Ordinance in China

In 2010, the Ministry of Agriculture of China took the lead to amend the currently most effective pesticide management laws, the administrative regulations – "Pesticide Management Ordinance", and handed in the "Pesticide Management Ordinance (Revised)" in July 2010 for the comments of the relevant pesticide management ministries, and in October 2010 submitted the "Pesticide Management Ordinance (Revised Draft to the State Council Legislative Affairs Office, who will solicit the opinions of relevant ministries.
Compared to the previous one issued in 1997, the amended pesticide regulation includes the following changes:

• Pesticide Registration System
  • Temporary registration is cancelled;
  • In case of registration of pesticide of the same active substance or change of applicable scope, method of use and dose level, one company can share other companies' data with authorization;
  • Update of registration certificate is required in case of the change of active substance, applicable scope, method of use ,dose level, and country of origin;
  • Registration information will be made public by the government.
• Production of Pesticides
  • Manufacturer shall apply for a production license. A registration certificate must be obtained first.
  • Both manufacturers and contracted manufacturers need to register and obtain production license;
  • Labels for pesticides shall be consistent with the registration and shall not include misleading information;
• Operation and Sales of Pesticides
  • An operating license must be obtained first.
  • Sellers need to comply with the requirements of ;
  • Sellers' record-keeping obligations are strengthened;
  • Management of import/export of restricted pesticides is strengthened. Clearance notification is required.

Pesticide GHS labels

Regulations for The Administration of Precursors and Chemicals Used in Production of Narcotic Drugs and Psychotropic Substances in China– 2005

In China, the main legislation regulating precursor chemicals is the Regulations for The Administration of Precursors and Chemicals Used in Production of Narcotic Drugs and Psychotropic Substances, which came into force in Nov 2005.

The purpose of the legislation is to strengthen the administration of drug precursor chemicals, regulating the production, distribution, purchase, transportation and import and export of precursor chemicals, preventing precursor chemicals from being used in manufacturing drugs and psychotropic substances.

Updated in 2015: http://www.chemsafetypro.com/Topics/China/Drug_Precursor_Chemicals_List.html

Catalog and Classification of Precursor Chemicals

The precursor chemicals are classified into three categories. Category I includes the major materials that can be used for producing drugs. Categories II and III include the chemical agents that can be used for producing drugs. The detailed classification and types of precursor chemicals are shown as below:
Category I
1. 1-phenyl-2-propanone
2. 3,4-Methylenedioxyphenyl-2-propanone
3. piperonal
4. safrole
5. sassafras oil
6. iso-safrole
7. n-acetyl o-amino benzoic acid
8. o-amino benzoic acid
9. ergotic acid*
10. ergotamine*
11. ergobasine*
12. ephedrine, pseudo ephedrine, mesoephedrine, phenylpropanolamine, methylephedrine, ephedrine extractum, ephedrine extractum powder and other ephedrine substances
Category II
1. phenyl acetic acid
2. acetic oxide
3. chloroform
4. aether
5. piperidine
Category III
1. toluene
2. acetic oxide acetone
3. methyl ether ketone
4. polsassium permanganate
5. sulphuric acid
6. hydrochloric acid
Notes:
1. The saline chemicals that may exist in the substances as listed in Category I or II shall be brought into control.
2. The types marked with "*" are precursor chemicals under the item of pharmaceuticals in Category I, which include the pharmaceutical raw materials and the single preparation thereof

16 Sept 2011, China MEP to restrict the construction of chemical plants and launch a nationwide inspection - CIRS News

16 Sept 2011, “China will limit the construction and expansion of chemical plants and launch a nationwide safety campaign to target all enterprises involved in the production and use of hazardous chemicals”, Deputy Minister of Environmental Protection (MEP) Mr Zhang Lijun announced on 15 Sept 2011 at a meeting held in Beijing.

“The MEP will no longer accept applications for any new projects related to the production and storage of hazardous chemicals outside industrial parks from 15 Sept”, said Mr Zhang. Under Chinese laws, without an environmental impact assessment and official approval from MEP, a factory cannot be built.

Mr Zhang did not say when the ministry will accept applications again but admitted that the country faced worsening chemical pollution. "Environmental accidents involving toxic chemicals are on the rise, posing a grave threat to public safety and social stability. Since January last year, the ministry has dealt with 239 environmental emergencies caused by chemical spills, some of which threatened water safety”, he said.

“The country would raise the environmental standards of chemical plants and tighten penalties and fines on chemical factory owners who break the law”, said Mr Zhang. The ministry would give stricter punishments to those who build the plants without environmental approval and the factories which are put into operation without an examination of their pollution control measures.

In wake of several serious chemical pollution incidents, the ministry will start a nationwide inspection campaign of the producers of hazardous chemicals who have obtained operating license for production. The inspection campaign is to be concluded by the end of this year.

More info can be found here.
16 Sept 2011, China MEP to restrict the construction of chemical plants and launch a nationwide inspection - CIRS News

EU REACH Safety Data Sheet (SDS) and eSDS Format

Safety data sheets (SDS) have been a well-accepted and effective method for the provision to downstream users of information on chemical substances and mixtures in the EU. Most buyers(either importers or distributors or downstream users) in EU will request a copy of SDS when they buy chemicals. Other countries such as USA have used Material Safety Data Sheets (MSDS), which is very similar to SDS in terms of format and contents.

The Annex II of EU Regulation (EC) No 1907/2006 (REACH) has mandated what information should and could be included in each section of the SDS. This annex II is ammended by the COMMISSION REGULATION (EU) No 453/2010 in May 2010. All SDS shall meet the latest requirements of REACH regulation.

For substances that are sold in quantities of more than 10 tonnes per year and are classified as dangerous, Exposure Scenarios describing how a substance can be safely handled to control exposures to both human health and the environment shall be appendixed to SDS, forming extended safety data sheets(eSDS). This new SDS/eSDS is known as"REACH SDS".

Do I need to supply REACH SDS and when?

You need to supply REACH SDS to your customers before or at time of the first delivery of chemical in paper or electronic format if your product is:
- substance or a mixture that is classified as hazardous, or PBT/vPvB or SVHC;
- a mixture that is not classified as dangerous, but contains a substance posing human health or environmental hazards with a concentration of >1%w/w for non-gaseous mixtures or 0.2%v/v for gas;
- a mixture that is not classified as dangerous, but contains a substance that is PBT, or vPvB, or SVHC in an individual concentration of ≥ 0.1 % by weight for mixtures that are solid or liquids (i.e., non-gaseous mixtures);

*persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB), substance of very high conern(SVHC).

Note 1: REACH SDS is not required for substances/mixtures which are not classified as hazardous;

Note 2: REACH SDS is not required for end-user products such as cosmetics, detergents;

Note 3: Where a customer re-orders substances or mixtures, then the supplier does not need to re-supply the SDS, unless the sheet’s contents have been updated.

Note 4: EU SDS is consistent with GHS Safety Data Sheets. If you are new to GHS, please read the following basic GHS topics.

Introduction to GHS

GHS Hazard Class and Hazard Category

GHS Signal Word

GHS Pictogram

GHS Hazard Statement

GHS Precautionary Statement

GHS Label Element

GHS Safety Data Sheet

UN GHS Purple Book

Related GHS Info & Resources

• GHS in EU/CLP
• GHS in USA
• GHS in Switzerland
• GHS in Turkey
• GHS in Australia
• GHS in Canada
• GHS in Brazil
• GHS in China
• GHS in Korea
• GHS in Japan
• GHS in Taiwan
• GHS in Singapore
• GHS in Indonesia
• GHS in Malaysia
• GHS in Thailand
• GHS in Vietnam
• GHS in Philippines
• GHS in New Zealand
• GHS in Other Countries

REACH Registration Deadlines 2010, 2013 and 2018

REACH requires all companies manufacturing or placing a substance on the EU market in quantities greater than 1t/year to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration; however, non-EU companies may submit registration by appointing an EU-based Only Representative to register on their behalf, in which case their importers will be regarded as downstream users and do not need to do registrations.

REACH Registration Deadlines 2010, 2013 and 2018

Substances can be categorized into two groups under REACH: phase-in substances and non phase-in substances. Each group has different REACH registration deadlines.

Phase-in substances("existing substances") enjoy benefits of extended registration deadlines if pre-registered before Dec 2008. The principle is that the higher the tonnage, the earlier the registration deadline. Substances classified as CMR1/2 or R50/53(100t/y+)need to be registered before 30 Nov 2010.

Non phase-in substances("new substances not covered by the definition of a phase in substance") need to be registered immediately before being placed in the EU market.

More info about REACH registration can be found below.
REACH Registration Deadlines

Reminder: Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply. Switzerland has its own chemical regulations adopting REACH-like registration and restriction requirements. Please refer to Swiss Chemicals Ordinance (ChemO) and Swiss Chemical Risk Reduction Ordinance (ORRChem) for more info.

What is New? Top 10 Differences between Taiwan TCSCA and EU REACH Compared

Taiwan TCSCA is another new important REACH-like chemical regulation that imitates EU REACH regulation. Despite many similarities, Taiwan TCSCA and EU REACH are different in many aspects. In this article, we have summarized the top 10 differences between Taiwan TCSCA and EU REACH to help you comply with TCSCA.

REACH Registration Beginners' Guide

REACH requires all companies manufacturing or placing a substance on the EU market in quantities greater than 1t/year to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration; however, non-EU companies may submit registration by appointing an EU-based Only Representative to register on their behalf, in which case their importers will be regarded as downstream users and do not need to do registrations.

The Scope of REACH Registration

- Substances manufactured/imported above 1t/y on its own or in preparations;(Note: some substances are exempted.)
- Substances in articles if present above 1 t/y and intended for release(for example, ink a pen);
- Monomer substances if present at a concentration above 2% in a polymer(for polymers, monomers shall be registered);
- Intermediates - reduced requirements and lower costs;
- Substances subject to Product and Process Oriented Research and Development( PPORD ) exempted from registration for 5 (+ 5) years; However, PPORD notification needs to be submitted.

The Deadline of REACH Registration

Substances can be categorized into two groups under REACH: phase-in substances and non phase-in substances. Each group has different REACH registration deadline.

Phase-in substances("existing substances") enjoy benefits of extended registration deadlines if pre-registered before Dec 2008. The principle is that the higher the tonnage, the earlier the registration deadline. Substances classified as CMR1/2 or R50/53(100t/y+)need to be registered before 30 Nov 2010 (see next diagram).

Non phase-in substances("new substances not covered by the definition of a phase in substance") need to be registered immediately before being placed in the EU market.

More info about REACH registration can be found below:
REACH Registration

Reminder: Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply. Switzerland has its own chemical regulations adopting REACH-like registration and restriction requirements. Please refer to Swiss Chemicals Ordinance (ChemO) and Swiss Chemical Risk Reduction Ordinance (ORRChem) for more info.