China Chemical Regulatory Guidance

Helpyouknowit China REACH | Hazardous & Toxic Chemicals | GHS | Disinfectant + ‌.

HelpyouKnowit

It is complex, but no need to worry Chemical-regulation related departments

Mai Fung

| Chemical Regulatory Affair Specialist

Special thanks to the contribution of

Cora Knutson | Craig Deegan | Chris Maes | Li Hou

HelpyouKnowit

>> Content Recent update

> Order 7 by MEP (not applied in Hong Kong neither Macao)

Updated on 29 Feb 2012

> State Council Decree 591(not applied in Hong Kong neither Macao)

Updated on 16 Dec 2011

Notification of New Chemicals

Existing Hazardous Chemicals

> China GHS, SDS and labeling (GHS label and Transport label) A unified path but on its half way

Updated on 19 Apr 2012 (GHS | SDS | Label)

> Hazardous Chemical of Import & Export

Updated on 07 Mar 2012

> 158 Toxic Chemicals restricted from Import & Export

Updated on 06 Mar 2012

> SFDA: cosmetic products notification in China

In Progress since 2 May 2012

> Order 27 by MOH

Updated on 18 May 2012

AQSIQ implements inspection and enforcement

MEP released the 2012 version of the catalog of restricted toxic chemicals

Cosmetics regulations in China (Part I: Finished Imported Cosmetics)

Disinfectants regulations in China

“Linkedin” me Maij1217@gmail.com

What will come soon?  New information of tests for New chemical notification (Order 7) is being prepared  Narration is considered to be added in this presentation material

HelpyouKnowit

>> Key updates

May 18 12 China Disinfectant Products

China Disinfectant Product regulation

A briefing introduction of the Disinfectant laws in China New slides added on 23/05 Extension of Disinfectant Product Hygienic License Reissue or modification of Disinfectant Product Hygienic License

Apr 19 12 China GHS & SDS

Mar 30 12 China GHS label

Overview of China GHS & SDS

More added to complete these parts (Transport symbol)

Newly-added slides

How to practically handle the GHS label on different types of packages in China

The top rank

People’s Congress 2nd Rank

State Council The Ministry

       

MEP MoH MoR MoA MIIP MoT MPS MOH

Ministry of Environmental Protection

All the departments would be involved in some parts of the regulations either New Chemical Notification(Order 7 by MEP) or Decree 591 by SC

Ministry of Health Ministry of Railways Ministry of Agriculture Ministry of Industry and Information Technology Ministry of Transport Ministry of Public Security Ministry of Health

The State Administration

 SAWS

State Administration of Work Safety of State Council

 Customs

General Administration of Customs of China

 AQSIQ

General Administration of Quality Supervision, Inspection and Quarantine （In charge of local CIQ）

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Regulation Releasing and Management Leading Major Inspection and Enforcement

State Council Regulation releasing

MEP SEPA(State of Environmental Protection Agency) became MEP in 2008, and the latter one is short for Ministry of Environmental Protection

Pollution prevention Division(-MEP)

MIIP

MoH

MEP

MoR

Local MEP

SAWS The status of Administration is lower than Ministry, although they are in charge of critical specific areas.

‌

MoT

MoA

MPS

SAWS Customs

Chemical Registration Center (-MEP)

National Registration Center for Chemical (-SAWS)

AQSIQ

Local CIQ of AQSIQ

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Updated on 25 May 2012

The layers of Chinese Laws and regulations Which regulation is superior and which may be less important

Top level

Law: On this level, the laws was legislated through the People’s Congress

2nd level

Administrative Law: For example

Constitution

On this level, the laws was legislated through the state Council For example

Decree 591

3rd level

Measure: On this level, the laws was legislated by each functional Ministry For example

Order 7 by MEP

4th level

GB & GB/T Known as National Standard; usually be divided into GB and GB/T GB: National Standard (Compulsory) GB/T: Recommended GB (Optional) For example

GB 15258-2009

CHINAREACH Order 7 by MEP >

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China REACH is not a proper name China REACH is just a name that helps you to quickly understand

Order 7 by MEP or Environmental Administration of New Chemical Substances in China should replace the current name as China REACH

Unlike EU REACH: ‌ the EU REACH program (where there is pre-registration requirements and then submission of dossiers by a certain date, followed by government assessment of a small fraction of those submitted dossiers, and authorization/substitution of substances deemed to be of concern) >> By Karen Levins from Intertek Cantox

Non-Phase-in substance

China REACH: Order 7 by MEP for new chemicals Make an enquiry to the authority for the confirmation whether the chemical substance is new or not; the complaint implementation would be different dependent on tonnage band or according to some detailed requirements. Limited data is required as well New Chemical (similar to Non phase-in substance)

Phase-in substance

Existing chemical (especially hazardous chemicals) The management may be involved in data requirements, testing data r, risk assessment report required, national standard of risk assessment is being drafted and discussion >> By Xiao (X) Zhang from Dow Corning Existing chemical (similar to phase-in substance)

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Order 7 by MEP is New

SEPA changed to MEP Order 17 changed to Order 7 .

Order 7 by MEP Entered into force

15 Oct 2010

Order 7 by MEP Issued

19 Jan 2010

Order 7: Revision of Provisions on the Environmental Administration of New Chemical Substances in China

Order 17 by SEPA Entered into force

X 15 Oct 2003

Order 17: Provisions on the Environmental Management of New Chemical Substances in China

7 years

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Updates on 05 Dec 2011

Notification under Order 7 matters to you & your Business

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No Notification, No Market

Your new substances shall be prohibited in China without notification

Severe punishment

If a new substance notification failed to be submitted ď Ž ď Ž

The company will be warned, fined and even forced to close And not be allowed to submit notifications within next 3 years;

It also matters to the environment

Whether a new substance has been notified is a crucial aspect of environmental impact assessment, so please do obey the rules

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Updated on 29 Feb 2012

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Step by step

To evaluate if you have been affected by the regulation before you start your compliance

Who are affected Whether your products have be affected because of some chemicals

What substances are new Whether those chemicals are new in China

Comply If you do have been affected, then learn how to comply with it

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Updated on 29 Feb 2012

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A chemical regulation on New Chemical Substances The new rule clearly specify what should be regulated and taken under control

What would be regulated in the scope of Order 7 by MEP

New Chemicals (Not in IECSC)  A New Substance itself  New substances in Preparation  New substances in articles intended to be released ----------------------------------------------------New substances as raw material ( Ingredients ) or intermediates for producing  Pharmaceuticals  Pesticides Please be informed, we are now confirm TGAI(Technical Grade Active Ingredient) and  Veterinary drugs technical are not in the scope of Order 7 by MEP, because the use of those products have  Cosmetics been identified as pesticide products.  Food additives  Feed additives IECSC: Inventory of Existing Chemicals Substances

- 45,602 existing chemical substances (till Dec 7 2010)

Where to find IECSC （in English） http://www.crc-mep.org.cn/iecscweb/IECSC.aspx?La=1

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Updated on 29 Feb 2012

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A chemical regulation on New Chemical Substances Some categories of chemicals may benefit from exemption from this law

Chemical substances or related products Category 1: Products subject to other existing regulations

Category 2: Substances exist in nature

Category 3: Substances of noncommercial purpose or unintentionally produced

Category 4: Substances of special categories

Exempt from the Order 7 by MEP

Radioactive substances, military industry products, pyrotechnics, biotic substances, pesticides, veterinary drugs, pharmaceuticals, cosmetics, foods, food additives, feed, feed additives, tobacco and tobacco products.

1. Chemical substances unprocessed or only processed in the ways below 1) Manual; 2) Mechanical; 3) Gravitational; 4) Soluble in water; 5) Floatation in water; 6) Heat dehydration.

2. By any means, substances extracted from the air 3. Natural polymer with no chemical modification 4. Biomacromolecule like RNA, DNA or protein

Chemicals for Non-commercial purpose or chemicals unintentionally produced 1. Impurity, produced from raw materials or secondary reactions. One single of those impurities in final products should not be over 10% w/w, all impurities in final products should not occupy over 20% w/w 2. Chemical produced from reactions 1) new chemicals from random reactions 2) new chemicals produced from random reactions between chemicals, mixtures or articles in storage 3) new chemicals produced from random reactions between chemicals, mixtures or articles in final use (unintentionally) 3. Waste water, gas or solid waste or other by-products

1 Material: Glass; .Frit; Pottery raw materials and ceramic ware; Steel and steel products; High-alumina cement; Portland cement; 2. Homogeneous and heterogeneous alloys, except for metal compounds and precisely defined intermetallic compounds 3. Non-isolated intermediates 4. New chemicals in Articles expect 1) new chemicals intentionally released from the final articles 2) new chemicals intentionally released from the final articles in use (quite the same as the definition under EU REACH)

Updates on 03 Dec 2011

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Notification body – like EU REACH, only within China Who shall and who is not obligated

Out of China Mainland

China Mainland

Hong Kong & Macao are not affected by this law

Chinese NA* Subsidiary of Foreign Companies

1 Foreign Companies Selling new substances to China

Manufacturers of New Chemicals Importer of New Chemicals or Companies hope to change the registered uses of New Chemicals

Notification not required

Notification required

* Notification Agent= NA Notify on behalf of Foreign companies The uses under “Priority hazards for environmental management” on IECSC

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What the notification Process looks like?

Different Roles Process

MEP

MEP issued Order 7 MEP decides the results MEP takes charge of management

Ministry of State Council

Technical evaluation provide Feedbacks

Taskforce for Evaluation

Catalog of Hazardous Chemicals (SAWS) New hazardous chemicals classified Hazardous and Priority Environmental Management of MEP Would likely be included Catalog of Hazardous Chemicals of SAWS

Receive Registration Application Formal Check of submitted documents（CRC）

CRC-MEP

Notification Result –Every 6-month reported New chemical classified: - General (5 years before included in IECSC) - Hazardous (Pending and Evaluation) - Priority Environmental Management

Local MEP Inspection

+86 10 8491 765 6 Call for technical supports from CRC Submit related dossier and data

9 qualified labs in China for eco-toxic

Notification Body

 Search through IECSC portal to find your substance in the list or not  Make enquiry for 3166 confidential Substances (22Euro or 30USD)  Confidential substance: another database to help define substance

Updates on 29 Nov 2011

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Foreign companies – choosing notification bodies strategically Please be advised: choose the notifier carefully be careful if you choose your Chinese customer(importer) as the notifier instead of you, you may lose your upper hand because you have to rely on them because of their notification certificates in China.

Out of China Mainland Role A : * Parent Companies

*

1 Service Providers playing as NA will serve Foreign companies better. They are not involved in real business, but offer technical supports and keep confidentiality.

Predominant

2 The Factories or Subsidiary Companies

applying for certificate as importer will benefit more themselves when they sell or make purchase .

China Mainland

Role B : Assigned by A NA Company

1

Belongs to A: Importer Factory Plant & Subsidiary

2

Belongs to A: Notification Agent Factory Plant & Subsidiary

3

Role C: Notification Body Importer and Manufacturer (business partner)

4

Role D: Unqualified Distributor

5

3 The

Factories or Subsidiary Companies assigned as NA will be allowed to notify on behalf of their Parent companies(Role A) But they have to meet NA requirements* as Role B.

Predominant

4 Your business partners, Importers or Manufacturers , as

notification body would hold predominant positions and more say throughout supply chains.

5

If Distributors are not the direct importers of the substance, they are unobligated to complete notification .

*Predominant: - This is more about what Role A may benefit *NA requirements: - approx. 330,000euro registered capital (for more, please make requests)

X

Who is the Certificate Holder?

1

3

NA’s name is Certificate Holder Role A’s name is Applicant

2

4

Importer(Manufacturer)’s name is both Certificate Holder & Applicant

Updates on 14 Dec 2011

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Implementation- before notification

Preparation

Preliminary Stage What information needed during inquiry  Company information  Substance profile (CAS# | molecular formula etc.)

Notification

Post-notification

Necessary Steps

Certificate Management

IECSC Inquiry

For confidential substances

Some more information helps to decide  3 types of Notification (next page)

No need for other information here The inquiry is submitted online, after payment. The result would be sent back as paper copy.

200RMB + (service charge by 3rd party consultant)

Typical Notification Simplified Notification Scientific Research Record

No obligation under the law

Updates on 05 Dec 2011

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3 Notification types based on different cases Typical Notification

>

Simplified Notification

>

Scientific Research Record

Tonnage band Criteria

At or Above the Annual Volume of 1 ton of New Chemicals

Annual Volume of New Chemicals Between 0.1 Ton to 1 Ton

Annual Volume of New Chemicals Less than 0.1 Ton

Other Criteria

(4 tonnage level) 1-10 ; 10-100; 100-1000; over 1000tpa

Divided into 2 parts Basic condition and Specific condition

Used for scientific research or the sample is to be lab tested in China

Time for Notification Remark

4-18 Months (largely dependent on testing arranged and conducted)

3-10 Months(basic condition) 4-5 Months (specific condition)

For polymers containing less than 2% new

 Basic :

chemical substance (w/w), if the polymer is planned to be included in the IECSC, then typical notification is required (not recommended)

a) b)

Low concern Polymer: Only chem-physic data for typical notification

For specific case

 

 Specific: *

c) d)

Not Low-concern polymer: Full tests for typical notification

e)

Low concern condition: No Heavy metal Not Soluble in water Not Soluble in organic solvent Unstable in different PH solutions

a)

New chemicals for export lower than 1tpa For scientific research with tonnage between 0.1 to 1 ton per year For technological research with tonnage less than 10 ton per year For polymer consisting of monomers already listed in IECSC for polymers containing less than 2% new chemical substance weight by weight （no quantity limit of such polymer imported） for low concern polymers (if the polymer itself is not listed in IECSC);.

Chemicals used for PPORD * to be notified, and notification maintained valid within 2 years afterward

14 workdays

Please be informed that: Scientific Research Record is the necessary work before Typical Notification and basic condition of Simplified Notification because samples need to be tested in China

Scientific Research Record could be started once the notification form submitted (other 2 not)

Where you may find the required data for Notification: http://www.cirs.ie/China_Chemical_Regulation/Data_Requirements_New_Chemical_Notification_in_China_REACH.html

• •

Specific condition: A specific report for new chemicals (now developed by notification bodies on their own) PPORD: Product and Process Oriented Research and Development

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Updates on 14 Dec 2011

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Implementation- Compliant guidance

Typical Notification

Preparation

Post-notification

Notification

Preliminary Stage IECSC Inquiry

Necessary Steps

Data & Dossier

The body of notification

4 Special formats of typical notification

Certificate Management

Tonnage level unrelated

  -

Serial Notification Similar substances notification at same time Joint Notification Co-notification(data or cost-share policy needed to be talked between co-notification bodies)  Repeated Notification - Notification by referring to the data owned by previous notification bodies.  Re-notification - Notification for amount increased or uses changed; additional data required; old notification certificate replaced by the new one Find more by contacting maij1217@gmail.com

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Updates on 14 Dec 2011

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Implementation- Compliant guidance

Typical Notification

Preparation

Notification

Preliminary Stage

Necessary Steps

Post-notification

Data & Dossier The body of notification

IECSC Inquiry

Submission

Certificate Management

Data gap analysis

You need more attention to this work; it affects cost and time

Testing Proposal

Largely dependent on the capacity of the contracted lab

Testing arrangement

Largely dependent on the capacity of the contracted lab

Dossier generation

Dossier template decided by CRC, some information needed from company (like uses of new chemical)

1

 Spectrum  Chem-physic data

2

 Toxic data

3

 Eco-toxic data

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Updates on 14 Dec 2011

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Data & Lab- Must all data be generated in China?

Typical Notification

Mostly Not

The data of 1st and 2nd category is preferred being generated from GLP labs, following OECD methods if outside China

1

 Spectrum  Chem-physic data

 Please be informed again: Scientific Record is needed here since the sample of the substance is imported for test in China

 Toxic data

3

 Eco-toxic data

Part of data in the 3rd category is strictly required to be generated by 9 MEP-approved eco-toxic labs in China.

We suggested more tests be carried out in China.

 Many companies would be worried about whether data generated outside China accepted.

It turns out that the data acceptance is not so exclusive as its political system of this country showed in front of the western nations. Most studies may be referenced if they were performed to accepted standards by a lab meeting MEP requirements.

2

Tests must be carried out in China

Minimum tests conducted in China

Recommend: 1-10tpa tests + inherent bio-degradation + one of 3 optional tests In some case, ready biodegradation would not be necessary, if qualified tests generated outside China as solid proof. So only inherent degradation needed

1-10tpa +10-100tpa tests + chronic toxicity test for fishes

1-10tpa Around 3 Months (At least )One Toxicity test for aquatic organism & (Ready biodegradation)

10-100tpa Around 3-5 Months 14 days extended toxicity study in fish (about 3Months) Or Daphnia magna Reproduction study (about 4-5Months) Or Bioaccumulation (about 4-5Months) Please be advised, at least one test must be picked between all above 3 tests

100+tpa- Around 6 Months Chronic toxicity test for fishes

9 Eco-toxic labs approved by the MEP http://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htm

Updates on 14 Dec 2011

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Implementation- Compliant guidance

Typical Notification

Preparation

Notification

Preliminary Stage

Necessary Steps

IECSC Inquiry

Post-notification

Certificate Management

Notify

 MSDS and hazardous information communicated to downstream users  Risk Control Measures conducted

 First-activity report submission Approved

by MEP

 Registered information to be updated (tonnage level, uses, activity, the holder of the notification certificate)  Keep documents on file for over 10 years  New hazard to be updated if needed be  Only downstream users who are capable of the implementation of risk measures allowed to buy products from the certificate holders.

General New Chemicals

Hazardous New Chemicals Authorized Priority hazardous new chemical substances for environmental management Restricted

For those 2, more obligations added

Updates on 14 Dec 2011

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Implementation- Compliant guidance

Typical Notification

5-year Notification completed New chemicals Added in IECSC First activity Using (sale) or Manufacturing of the new chemical for the first time after its notification in China 1st

5-year

The activity should be reported to the MEP as the first date of 5-year period. (Report template given by MEP)

This period decided by the MEP is more like a transitional time after the first activity date before new chemicals allowed to be added in IECSC ď Ž For general new chemicals, after 5 years, they would triggered the action of being added in the IECSC automatically. ď Ž For other 2 categories, Hazardous new chemicals, Priority hazardous new chemical substances for environmental management would be evaluated from multi-aspect during the 5 years. So the process could be much more complex.

+

Hazardous New Chemicals(Authorization) - 1st activity report + annual activity report Priority hazardous new chemical substances for environmental management (Restricted ) - 1st activity report + each activity report + annual activity report for the last year + annual activity plan for this year

Updates on 31 Dec 2011

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Implementation- Compliant guidance

Simplified Notification > Basic Condition

Notification duration: 5-10 Months

Studies required

Notification

Preparation

Preliminary Stage

Post-notification

Data & Dossier & Doc Development

   

IECSC Inquiry 1

Submission

Scientific Record Form Simplified Notification Form Test report Other information: ES, production process

 Chem-physic data

 melting point  water-solubility  Partition coefficient n-octanol/water

2

Test duration: 4-6 Months

9 Eco-toxic labs approved by the MEP http://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htm

 Eco-toxic data within China

 Ready biodegradation  Acute toxicity test for fishes  Acute toxicity test for earthworm

Annual Report to the authority: Before 01 Feb  The figures of the production of notified new chemical substance (annual tonnage, production days ); or tonnage imported etc.  The transfer information of the notified new chemicals, including the overall tonnage of transfer and major recipients etc. in last year  The updated or renewed information of the notified new chemical substances during last year.

Updates on 31 Dec 2011

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Implementation- Compliant guidance

Simplified Notification > Special Condition

No Studies required

Notification duration: 3-4 Months

Notification

Preparation

Preliminary Stage IECSC Inquiry

Acquiring certificate consumes much time

Post-notification

Annual Report to the authority: Dossier and Document Development

   

Submission

Scientific Record Form Simplified Notification Form Documents as proof of specific condition Other information: ES, production process

Polymer: GPC – Gel Permeation Chromatography

Before 01 Feb  The figures of the production of notified new chemical substance (annual tonnage, production days ); or tonnage imported etc.  The transfer information of the notified new chemicals, including the overall tonnage of transfer and major recipients etc. in last year  The updated or renewed information of the notified new chemical substances during last year.

Updates on 31 Dec 2011

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Implementation- Compliant guidance Bring your doubts after reading the following pages

Simplified Notification > Special Condition

No Studies required

A Special case

Case Study

to know new substances in polymer

Please remember, polymers containing less than 2% each new chemical substance weight by weight.

Simplified Notification(Specific Condition) is enough

Polymer product exempted from notification under Order 17 ( later replaced by Order 7 by MEP )

Order 7 by MEP entered into force

Oct 2010

1 year

<

2%

Sep 2010

A new substance in Polymer Monomer is less than 2% (w/w) Simplified Notification

Aug 2011

Please be advised: No tonnage limit on the import of such polymer product is required, so please consider about higher tonnage band during notification

â&#x20AC;&#x153;Please be noticed: One year of exemption transitional time has passed.â&#x20AC;?

Updates on 31 Dec 2011

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Implementation- Compliant guidance

Scientific Research Record

Scientific Research Record

Preparation

Preliminary Stage IECSC Inquiry

For scientific research use only

Notification Material Development

Typical notification Simplified notification basic condition The above 2 types of notification demand scientific record because a sample is asked for testis

Post-notification

Submission

Documents to be prepared:  The Record Form (template offered)  Attachments including license of notification companies and scientific research institutions (apply substances directly; test proposal  More than one substance notified together allow to be covered in one scientific research record

2 weeks

 Scientific project starts to be conducted  Laboratories conduct related tests for new substances

Updates on 17 Feb 2012

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About notification cost- you need to know To help you understand the structure of notification cost, and make it cost-effective

Cost breakdown Administrative fee

 MEP not charge for notification |  IECSC search will be charged for a small amount of fee

Local agent fee

 Companies who want to register new chemicals but located outside China need to appoint local service provider as notifier

Test fee

 Test fee would take the largest part of your cost especially when the cases fall into typical notification

3% 17%

Smart-cost tips Try saving test cost

Be sure your notification type is correct: More information please refer to previous pages

80%

Reasonable data source is a key point:  Avoiding unnecessary testing by taking advantage of referring to literature, some database or data resulted from QSAR, reading-across reference etc.  Consider the lowest-required tests according to different notification types.  Foreign companies may use GLP-generating data for notification using More information please refer to previous pages

Test cost 80%

3 Notification types based on different cases

(Dependent on specific cases)

Data & Lab- Must all data be generated in China?

Strategic arrangements of studies: basic studies first, then come the advanced  Finish basic or compulsory studies, and then higher-level studies to be carried out; In some cases, based on the results from previous studies, higher-level studies would benefit from waiving.

 Case- the applicant could firstly conduct skin corrosive study and if the result is positive, then 28-

Administrative

Local agent service fee

Test fee

Source: Eric Xiong from CIRS

day repeated oral toxicity study could be waived, by which hundreds of thousands RMB for testing can be saved (from Eric Xiong from CIRS)

Special formats of typical notification may save you much money:  Serial Notification -Similar substances notification for avoiding unnecessary tests on group substances.  Joint Notification - Data or cost-sharing between co-notification bodies of the same substances. (like

Joint-submission of registration dossier under REACH)

 Repeated Notification - Notification by referring to the data owned by previous notification bodies (Like the game rule of LOA purchase under REACH)

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Updates on 31 Dec 2011

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How we offer our help Not just providing compliance work, we are also well known to your suppliers in China

1

Preparation Preliminary Stage

IECSC Search & Decide

2

Notification  Information collection  document preparation

1.

2.

3.

Typical Notification Simplified Notification Scientific Record

Scientific Record The easiest notification

Basic or Special Condition?

Basic Condition + Scientific Record  Forms and documents  Studies analysis and tests proposal  Eco-toxicology properties tests arrangement & follow up  Dossier develop and submission; progress report

Specific Condition  Information collection and document preparation  Notification dossier submission and follow up

Typical Notification

+ Scientific Record  Forms and documents preparation  Data valuation, literature review, tests proposal  Tests arrangements and follow up  Dossier develop and submission; progress report

Post-Notification & follow up

Simplified Notification

3 1. Preparation and Updating of information 2. Keep contacting the local authorities, reporting necessary issues to fulfill obligation

Updates on 22 Nov 2011

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Please be advised-Way of Simplified Notification changed soon

Transitional Time Till 31 Dec 2011

Online Simplified Notification Started 2012

Alternative 1: Paper Notification Material （SEAL）

Alternative 2: Email Notification Material （SEAL）

Notification Body

Alternative 1: Paper Notification Material （SEAL）

Ok

On test: Web-based Notification System

CRC-MEP

X Alternative 2: Web-based Notification System

CRC-MEP

Client-side Download: http://www.crcmep.org.cn/news/NEWS_DP.aspx?TitID=379&T0=01000&Lan guageType=CH&Sub=125

Contact： Ma Xin - Max@crc-mep.org,cn IT Support： Deng Qing- Dengq@crc-mep.org,cn

Simplified Notification Material Basic condition:

Limited Information & 3 Studies needed

Specific condition:

Very Limited information needed

Updates on 27th Apr 2012

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Please be advised-Way of Scientific Research Record has changed

Transitional Time Till 01 May 2012

Online Record Started afterward

Alternative 1: Paper Notification Material （SEAL）

Alternative 2: Email Notification Material （SEAL）

Notification Body

On test: Web-based Notification System

Alternative 1: Paper Notification Material （SEAL）

Ok

CRC-MEP

X Alternative 2: Web-based Notification System

CRC-MEP

Client-side Download: http://www.crcmep.org.cn/news/NEWS_DP.aspx?TitID=392&T0=01000&Lan guageType=CH&Sub=125

Contact：+ 86 010-849 176 56 Zhao Yuan- Zhaoyuan@crc-mep.org.cn IT Support：+86 010-849 152 89 Deng Qing- Dengq@crc-mep.org,cn

Contact： Ma Xin - Max@crc-mep.org,cn IT Support： Deng Qing- Dengq@crc-mep.org,cn

Updates on 24 May 2012

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FAQ â&#x20AC;&#x201C; selecting questions you may be interested in

Ingredients in mixture

During each shipment of mixture products exported to China, will a confirmation statement with all ingredients disclosed is a must?

Cosmetics

New chemicals used in cosmetics would benefit from exemption ? Test report should be carried out by approved Chinese labs?

Supplementary questions: Food additives exempted from Order 7 (New chemical)

Answer:

Rules violation

Answer: There is no specified measure on how to prove the due diligence has been carried out; however to reduce risks, confirmation letters for each shipment may be a way saving a lot of trouble

Answer: New chemicals used as raw material to produce cosmetics should be considered not being exempted from the scope of Order 7; cosmetics would be managed under specific rules

New chemicals used to produce food additive or cosmetics, Veterinary drugs will fall into the scope of Order 7; while the finished product of food additive, cosmetics etc. would be administrated under specific regulations in China.

Should follow the same requirements for testing of other new chemicals. â&#x20AC;&#x153;For chemphysic data, it could be generated outside China, but recommended GLP following OECD standards

In chemicals of any violation of rules, what may

Answer:

happen to notifier and related parties

The authority will forbid the substance notifer to submit new notification of any new chemical substances within a period of 3 years; while the related parties will be exempted from the punishment.

Updates on 24 May 2012

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FAQ – selecting questions you may be interested in

After substance listed in IECSC after 5 years

What will happen to a new chemical through typical notification after 5 years; any volume limit applicable

IECSC supplementation procedure on “New chemicals in trade between the year of 01-01-1992 and 15-10-2003” has been called off since the end of last year.

In a typical case, a new chemical through typical notification will be listed in IECSC regarded as existing substance in 5 years; then no obligation will be imposed over importers.

Follower will not notify the substance after existing chemicals approved.

Would non-test methods be accepted by the

Answer:

What happens to chemicals in trade before 2004

Answer:

Waving and Read-across

Answer:

technical committee of MEP?

Only if practical testing is impossible to be carried out, non-test methods would be the second best choice.

However, data waiving should be seriously considered as your weapon cutting your cost for regulation compliance. So please do contact and talk about more.

Substance without CAS

Would other classification number offered as alternative for substance with no CAS in IECSC?

Answer: 1. Substances protected by confidential terms would not be provided with CAS# 2. Other substances in IECSC followed with no CAS# will be arranged with a serial number by the authority for the purpose of identification

Next sector is about â&#x20AC;&#x153;Decree 591â&#x20AC;?

This is the major hazardous chemical control law in China, which is highly related with China GHS implementation and other inspection issues mentioned in later sectors

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State Council DECREE591 >

HelpyouKnowit Driving Green Chemical

NEXTPAGE >

Decree 591 is revised

State Council SC Decree 591 Will Enter into force

State Council[2002] Decree 344 replaced by Decree 591 by SC

The 1st Regulation replaced by State Council[2002] Decree 344

SC Decree 591 Issued SC Decree 344 Entered into force SC 1st Regulation Issued & Entered into force

Substance + Mixture regulated at same time

01 Dec 2011 02 Mar 2011

X 15 Mar 2002

China GHS started on 1 May 2011 (both Substance + Mixture regulated at same time)

X 17 Feb 1987

1987: Regulation On the safe Management of Hazardous Goods

Decree 344: Regulation on the Control over Safety of Hazardous Chemicals

Decree 591: Regulation on Safe Management of Hazardous Chemicals

HelpyouKnowit Driving Green Chemical

Updates on 28 Nov 2011

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What the registration looks like?

Different Roles Process

State Council Regulation releasing

SAWS State Administration of Work Safety of State Council

…

Regulation issued by State Council

SAWS takes charge of management SAWS plays as leader role in Decree 591 & releases Catalog of Hazardous Chemicals Catalog of Hazardous Chemicals (2002) To be renewed

Check catalog: www.chinasafety.gov.cn/whpcx.htm

NRCC-SAWS Registrant Importer & Manufacturer in CHINA

Receive Registration Application Formal Check of materials （NRCC）

+86 532 8378 659 3 Registration Call-in

Submit information (easier than China REACH) for 3-year-valid certification & Renew 3 months before expiry

 Search through the Catalog to see if registration needed;  Obligation: safety evaluation report, production license, safe use license, operating license, registration of hazardous chemicals, SDS and chemical labels (China GHS)

Other government bodies involved in implementation of the law

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MIIP | MoH | MEP | MoR | MoT | MoA | MPS

Administration of Custom | AQSIQ

Updates on 16 Dec 2011

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2 Major catalog of chemicals under SC Decree 591

Finally Over 7,000 in new version

New China GHS and Catalog of Hazardous Chemicals(first 4000 substances) would be published first half year of 2012 Catalog of Hazardous Chemicals

3,800

Over

Version 2002 came up with Decree 344, and the new Catalog is to be published early next year Manufacturers, Importer, other roles (distributors, warehousing and storing companies ) chemicals within Chinese territory need to be sure whether any of their chemical products are listed in the Catalog, especially sensitive to the newest version upcoming.

But as we believe, the new version firstly comes up as a draft before it become the decided one.

Likely to be merged

Catalogue of Extremely Toxic Chemicals(2002rev.)

Pure Substance

335

This is a domestic rule, import and export of those toxic chemicals are not in the scope

Version 2002, substances majorly came from Catalog of Hazardous Chemicals , but some chemical substances were borrowed from â&#x20AC;&#x153;Catalog of Dangerous Goods (GB122681990)- now has been replaced by 2012 ver.â&#x20AC;? or even other lists.

If purchase or transport of chemicals in the catalog of extremely toxic chemicals happens, companies will be required to apply for some licenses before actions.

Download

NEXTPAGE >

You may feel less interested,

because

If your company is located outside of mainland China, it will not be directly affected by Decree 591.

You will also find information of

China GHS

However, your suppliers, business partners, importers, or customers likely to have obligations under the Decree which may affect your business.

Be sure those companies are fully understanding their requirements so that your business

Stays Out of Trouble

HelpyouKnowit Driving Green Chemical

Updates on 05 Dec 2011

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Under Decree 591,

registration is the responsibility of Importer & Manufacturers in China

But,

If you are the roles below, what are your obligations?

Key words found in next several pages Manufacturer in China Importer in China Distributor and warehouse, storage company

obligation, registration, license, implementation, enforcement authorities

Transportation company in China Manufacturer (chemical user) in China Companies located outside China

You should pay more attention to under 591 GHS compliant, SDSs and labels are necessary You may have your contracted suppliers or partners in China be aware of this law

Updates on 05 Dec 2011

NEXTPAGE >

Obligation: Registration & License Led by SAWs

Roles

Registration

Main License

1

Manufacturer China

Registration Certificate

License of Manufacturing Safety

2

Importer China

Registration Certificate

License of Operation Safety Classification & labels SDS

3

Distributor Warehousing

License of Operation Safety

4

Transportation Companies

5

Manufacturer Chemical User

X X X

Chemical List

License of Transportation on Road License of Transportation in Water License of Using Safety

Roles

1

Bulk Chinese producers of Hazardous Chemicals

2

Hazardous Chemicals importers within Chinese territory

3

Hazardous Chemicals Distributor s or warehousing service providers

4

Bulk Chinese producers of Hazardous Chemicals

5

Companies using Hazardous Chemicals to produce some chemicalbased goods in certain industries (follow the link by clicking here)

Chinese Manufacturers Distributors

Catalog of Hazardous Chemicals (Ver.2002 to be updated) Chinese Manufacturers Distributors

Inventory of Toxic Chemicals

Chinese Manufacturer Chemical User

The Directory of Industries Criteria for Limit Volume

Updates on 05 Dec 2011

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Your roles decide your obligations under Decree 591 Different roles mean different obligations and enforcement authorities

Manufacturers in China  In case that a company using hazardous chemicals in its production and the final product still a hazardous chemicals in the Catalog of Hazardous Chemicals, this company needs to do registration and apply for the License of Manufacturing Safety.

This company should be considered as a Manufacturer rather than a Manufacturer (Chemical User)  If new hazardous chemicals are being manufactured after acquiring registration certificate and license, the manufacturer needs to update both certificate as well as License of Manufacturing Safety

Obligation Submit Registration

NRCC registration platform: http://register.nrcc.com.cn/

License of Manufacturing Safety Information changed

Safety License of Occupational Hygiene

Responsible Authorities  NRCC of SAWS - (final check)  Local registration offices(province) - (receive registration and check)

State Administration of Work Safety of State Council (SAWS)

NA

SAWS: http://www.chinasafety.gov.cn/newpage/ NRCC: http://www.nrcc.com.cn/ TEL: +86 (0)532 83 8891 91

Local Registration office:

http://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=243&ChannelID=180

What to be prepared (different forms and documents usually)

 Registration Form  Technical Safety Instruction of chemicals (Important)  Label (Important)  Emergency call (or contracted service)  Business license issued by Industrial and Commercial Bureau  Documents and Application  Manufacturing Safety rules Routine Practice Stewardship Documents  Safety Management personnel document  Safety Assessment Report by 3rd party  Emergency Rescue Plan & Record  Emergency Rescue Checklist …

NA

HelpyouKnowit Driving Green Chemical

Updates on 05 Dec 2011

Your roles decide your obligations under Decree 591

NEXTPAGE >

Different roles mean different obligations and enforcement authorities

Obligation

Importer in China

Submit Registration

Responsible Authorities  NRCC of SAWS - (final check)  Local registration offices(province) - (receive registration and check

NRCC registration platform: http://register.nrcc.com.cn/

License of Operation Safety (Same required as Distributor Warehousing & Storing)

Local Work Safety Department – (province )

 The Record of Hazardous Chemicals Imported  The Application for quarantine inspection

 General Administration of Quality Supervision, Inspection and Quarantine  Local CIQ (for direct implementation

SAWS: http://www.chinasafety.gov.cn/newpage/ NRCC: http://www.nrcc.com.cn/ TEL: +86 (0)532 83 8891 91

Local Registration office:

http://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=24 3&ChannelID=180

AQSIQ: http://www.aqsiq.gov.cn/

What to be prepared (different forms and documents usually)

 Registration Form  Technical Safety Instruction of chemicals (Important)  Label (Important)  Emergency call (or contracted service)  License issued by Industrial and Commercial Bureau  Application form of business license of hazardous chemicals  Catalog of relevant production safety documents  Work safety standards and manual  Safety training and training materials  Budget raised for manufacturing safety of hazardous chemicals and budget report FIND MORE IN NEXT PAGE  The Record is Optional (suggested)  The Application composed with - self-declaration - SDS and label document - If the Record completed, submit it （to be confirmed）

HelpyouKnowit Driving Green Chemical

Updates on 09 Dec 2011

Your roles decide your obligations under Decree 591

NEXTPAGE >

Different roles mean different obligations and enforcement authorities

Distributor Warehousing & Storing

Obligation

Responsible Authorities Local Work Safety Department – (City-level) Responsible for the management of  Specialized in hazardous sales and warehousing business

License of Operation Safety (Same required as Importer )

Local Work Safety Department – (County-level ) Responsible for the management of  Sales of toxic chemicals *  Explosive chemicals *  Storing and sales of hazardous chemicals(gas station etc.)

What to be prepared (different forms and documents usually)

 Application form of business license of hazardous chemicals  Catalog of relevant production safety documents  Work safety standards and manual  Safety training and training materials  Budget raised for manufacturing safety of hazardous chemicals and budget report  Injury Insurance for employees or production liability insurance proof  Business license issued by Industrial and Commercial Bureau  Property or leasing documents of business venues and facilities equipped with  Emergency Rescue Plan & Record  Extra documents required when a company is equipped with storage facilities(gas station for example)

*Extremely toxic chemicals – a list of chemicals issued in 2002 (335 chemicals up till now) *Explosive chemicals - also a separated list of chemicals

SAWS: http://www.chinasafety.gov.cn/newpage/ 



Please be informed that you may find the contact information of Local Work Safety Departments, however we do not believe that is necessary, simply ask for help from your local distributors or consultants , they have ways.

All documents to be shown to city-level or county-level Work Safety Department dependent on the business your companies are running.

HelpyouKnowit Driving Green Chemical

Updates on 15 Dec 2011

NEXTPAGE >

Your roles decide your obligations under Decree 591 Different roles mean different obligations and enforcement authorities

Obligation

Transportation Companies

Responsible Authorities

Transport License of Dangerous Goods on Road (GB12268-2012 *) (GB6944-2012P *)

Ministry of Transport of P.R.C

NA

NA

Transport of Dangerous Goods on Road

Implementation (different forms and documents usually)

 “TDG business” Application Form  Daft report of dangerous goods, classification and operation plan  Special vehicles used for transport  Identification documents and copies of Investor and personnel in charge  Testimonial documents of parking area for special vehicles, capabilities of safety protection, environmental protection and fire fighting device equipped …

NA

Transport of Dangerous Goods by Water

Transport License of Toxic Chemicals on Road (Inventory of Toxic Chemicals *)

Public Security Bureau (County-level) Transport of Toxic Chemicals on Road

* GB12268-2012: (here in Chinese) the inventory of dangerous goods (Be advised: some chemicals also found in the Catalog of Hazardous Chemicals ver.2002)

* GB 6944-2012: (here in Chinese) the classification of dangerous goods * Inventory of Toxic Chemicals

- English version please follow the link below http://issuu.com/mai.fung/docs/inventory_of_toxic_chemicals__for_transport_and_pu?mode=window&backgroundColor=%23222222

 Report of toxic chemicals and quantity to be transported  The details of transport, plan, destination, route, fixed date  Purchase license or import license issued by the Customs  The qualification of drivers and other certificates

MoT: http://www.mot.gov.cn/

Updates on 09 Dec 2011

Your roles decide your obligations under Decree 591

NEXTSECTOR >

Different roles mean different obligations and enforcement authorities

Manufacturers in China Chemical User A Company using hazardous chemicals as major materials or even additives in its production

Obligation

License of Using Safety

Responsible Authorities

Local Work Safety Department – (City-level)

Implementation (different forms and documents usually)

 Emergency Rescue Plan & Record  Emergency Rescue document  Technical Safety Instruction of Chemicals  Emergency response (people equipment and checklist)  Safety assessment report by 3rd party  Manufacturing Safety document and rules …

SAWS: http://www.chinasafety.gov.cn/newpage/ 

Please be noticed, hazardous chemicals need to apply for this license under Decree 591 only meet two descriptions below:

-

The Directory of Industries Criteria for Limit Volume Find the copies for your information : http://issuu.com/mai.fung/docs/the_directory_of_industries_for_the_application_of ?mode=window&backgroundColor= 

Also please be informed that you may find the contact information of Local Work Safety Departments, however we do not believe that is necessary, simply ask for help from your local distributors or consultants , they have ways.

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NEXTPAGE >

Next sector is about

“China GHS – SDS + Label”

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Updates on 27 Apr 2012

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+

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Updates on 27 Apr 2012

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Chemicals

Updates on 27 Apr 2012

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Updates on 27 Apr 2012

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  

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For whose >>

Chemicals listed in “Catalog of Hazardous Chemicals” under SC Decree 591 Or products in “Statutory Inspection Catalogue 2012” AQSIQ Regulation on Import & Export of Hazardous Chemicals

>>

The company will have to follow 2 GB to prepare SDS and Labels under China GHS

 GB16483-2008

Instruction of Safety Data Sheet, Content and Section

 GB15258-2009 General Rule for Preparation of Precautionary Label for Chemicals

 GB/T 22234-2008 Labeling of Chemicals Based on GHS

Updates on 13 Apr 2012

NEXTPAGE >

Grab some key points in authoring Chinese SDS

Should it be China SDS or China MSDS?

China SDS would be the correct name, however

in China, we hardly tell the differences between SDS and MSDS (SDS is official name, but we treat 2 names the same often).

Please be informed: No official template of SDS issued so far .

HelpyouKnowit Driving Green Chemical

Updates on 13 Apr 2012

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Content â&#x20AC;&#x201C; Introduction of the SDS part

China SDS

National Standard Download

GB 16483-2008 English ver.

GHS Comparison

Content and Section

Sample of SDS (qualified copy)

Updates on 13 Apr 2012

NEXTPAGE >

Content â&#x20AC;&#x201C; Introduction of the SDS part

China SDS

National Standard Download

GHS Comparison

Content and Section

Now please follow the currently-valid China GHS (Version 2007 UN GHS)

Although

The Up-coming new version of China GHS would completely adopt the content of 4th generation of UN GHS

New China GHS and Catalog of Hazardous Chemicals (first 4000 substances) would be published first half year of 2012 Download classification national standards Chinese ver.

Sample of SDS (qualified copy)

NEXTPAGE >

China | UN | EU GHS comparison table helps you work easily

Physical Hazards

Health Hazards

Environmental Hazards

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Updates on 13 Apr 2012

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UN GHS 4th â&#x20AC;&#x201C; Do you know something new happened?

Hazardous statement newly added in 4th Version

P281 P285

H229 Pressurized container: may burst if heated.

H230 May react explosively even in the absence of air.

H231 May react explosively even in the absence of air at elevated pressure and/or temperature.

Precautionary statement newly added in 4th Version

+

P364 And wash it before reuse.

P308+311 IF exposed or concerned: Call a POISON CENTER/doctor/...

P361+364 Take off immediately all contaminated clothing and wash it before reuse.

P362+P364 Take off contaminated clothing and wash it before reuse.

Find UN GHS

-

Content deleted in 4th Version

+

P307 | P309 | P322 | P341 P350 | P302+350 | P304+341 | P307+311 P309+311 Statements slightly modified in 4th Version P223

P244

P251

P284

P310

P311

P312

P340

P352

P361

P362

P378

P301+310

P301+312

P302+352

P304+312

P304+340

P342+311

!

Download table of statement modified

Updates on 13 Apr 2012

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China GHS â&#x20AC;&#x201C; Category Table I : physical hazards Hazard categories under GHS in different areas

UN GHS (2011 Ver. 04)

Physical Hazards

Download GB

2.1 Explosive 2.2 Flammable gases 2.3 Flammable aerosols 2.4 Oxidising gases 2.5 Gases under pressure 2.6 Flammable liquids 2.7 Flammable solids 2.8 Self-reactive substances and mixtures 2.9 Pyrophoric liquids 2.10 Pyrophoric solids 2.11 Self-heating substances and mixtures 2.12 Substances and mixtures which in contact with water emit flammable gases 2.13 Oxidising liquids 2.14 Oxidising solids 2.15 Organic peroxides 2.16 Corrosive to metals 16 hazards

EU CLP (EC 1272/2008)

Current China GHS

Replacing DSD & DPD since Jun 1 2015

Based on UN GHS 2007 Ver.02

The same as UN GHS

Slightly different

Slightly different

GB 20576-2006 Explosive GB 20577-2006 Flammable gases GB 20578-2006 Flammable aerosols GB 20579-2006 Oxidizing gases GB 20580-2006 Gases under pressure GB 20581-2006 Flammable liquids GB 20582-2006 Flammable solids GB 20583-2006 Self-reactive substances(mixture included) GB 20584-2006 Self-heating substances (mixture included) GB 20585-2006 Pyrophoric Liquids GB 20586-2006 Pyrophoric Solids GB 20587-2006 Substance which, in contact with water, emit flammable gases (water reactive) GB 20588-2006 Corrosive to Metals GB 20589-2006 Oxidizing liquids GB 20590-2006 Oxidizing solids GB 20591-2006 Organic peroxides

16 hazards

16 hazards

Remark: please be noticed, compared with UN GHS or EU CLP, physical hazard category is generally remained the same under China GHS. Only the order of GB 20584 â&#x20AC;&#x201C; GB 20586(2.9-2.11) , GB 20588-GB 20591 (2.13-2.16) have been changed slightly, which may cause you confused while reading. Some classification could be different: Flammable gases | Flammable aerosols

EU CLP Timeline

DSD - 67/548/EEC DPD -1999/45/EC

Dec 01 2010

Classification Labeling Packaging (EC 1272/2008) + DPD & DSD

Jun 01 2015

Only CLP remained

Updates on 13 Apr 2012

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Help you to read the following content

Building-block-adopted differentiation China GHS UN GHS 4th

EU GHS Unstable | Div. 1.1

Div.1.2

Div. 1.3

Div. 1.4

Div. 1.5

Div. 1.6

Building blocks

GHS 01

GHS 02

GHS 03

GHS 04

GHS 05

GHS 06

GHS 07

GHS 08

GHS 09

Updates on 13 Apr 2012

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China GHS – classification and pictogram for physical hazards A combination with which you work even more easily

GB 20576-2006

Explosive

China GHS UN GHS 4th EU GHS

Unstable | Div. 1.1

Div.1.2

Div. 1.3

Flammable Gases

No

No

Danger | 危险

Warning | 警告

Danger | 危险

H 200 | H 201

H 202

H 203

H 204

H 205

Category 1

Category 2

Danger | 危险

Warning | 警告

H 220

H 221 China GHS EU GHS

(Flammable) Aerosols

Div. 1.6

Danger | 危险

UN GHS 4th A (Chemically unstable gases)

No

GB 20578-2006

Div. 1.5

Danger | 危险

China GHS EU GHS

GB 20577-2006

Div. 1.4

Category 1

Category 2

Danger | 危险

Warning | 警告

H 222

H 223

UN GHS 4th Category 3

B (Chemically stable gases)

HelpyouKnowit China GHS – H statement

GB 20576-2006

Explosive 不稳定爆炸物

D

爆炸物：整体爆炸危险

Unstable | Div. 1.1

D

爆炸物；严重喷射危险

Div.1.2

D Div. 1.3

W

爆炸物：燃烧，爆 轰或喷射危险

燃烧或喷射危险

Div. 1.4

No

D

燃烧中可爆炸

Div. 1.5

No Div. 1.6

•

X please follow GB 22234-2008

HelpyouKnowit China GHS – H statement

GB 20577-2006

Flammable Gases

D

极易燃气体

Category 1

W No Category 2

UN GHS A

UN GHS B

易燃气体

HelpyouKnowit China GHS – H statement

GB 20578-2006

(Flammable) Aerosols

D 易燃性极高的压力下气体（加热可能爆炸）

Category 1

W Category 2

UN GHS

可燃，易燃压力下气体

W Category 3

• 易燃性极高的压力下气体 极易燃气溶胶

X

可燃，易燃压力下气体 易燃气溶胶

X

Updates on 13 Apr 2012

China GHS – classification and pictogram for physical hazards A combination with which you work even more easily

GB 20579-2006

Oxidizing Gases

China GHS UN GHS 4th EU GHS Category 1

Danger | 危险 H 270 China GHS UN GHS 4th EU GHS

GB 20580-2006

Gases under pressure

Compressed gases

Liquefied gases

Refrigerated liquefied gases

Dissolved gases

Warning | 警告

Warning | 警告

Warning | 警告

Warning | 警告

H 280

H 280

H 281

H 280

EU GHS

GB 20581-2006

Flammable Liquids

Category 1

Category 2

Category 3

China GHS UN GHS Category 4

No Danger | 危险

Danger | 危险

Warning | 警告

H 224

H 225

H 226

H 227

NEXTPAGE >

HelpyouKnowit China GHS – H statement

GB 20579-2006

Oxidizing Gases

D Category 1

可能导致或加剧燃烧； 氧化剂

Labeling of Chemicals Based on GHS

X

HelpyouKnowit China GHS – H statement

GB 20580-2006

Gases under pressure

W Compressed gases

压力下 气体；加热可能爆炸

W Liquefied gases

压力下气 体；加热可能爆炸

W Refrigerated liquefied gases

冷冻液化气体；可能造成低温灼伤或损伤

W Dissolved gases

压力下气 体；加热可能爆炸

HelpyouKnowit China GHS – H statement

GB 20581-2006

Flammable Liquids

D

极易燃的液体及气体

Category 1

D Category 2

W

高度易燃的液体及气 体

易燃的液体及气体

Category 3

W No Category 4

可燃性气体

Updates on 13 Apr 2012

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China GHS – classification and pictogram for physical hazards A combination with which you work even more easily

GB 20582-2006

Flammable Solids

China GHS UN GHS 4th EU GHS Category 1

Category 2

Danger | 危险

Warning | 警告

H 228

H 228 China GHS UN GHS 4th EU GHS

Self-reactive Substances (mixtures included) GB 20583-2006

Type A

Type B

Type C & D

Type E& F

Type G

No Danger | 危险

Danger | 危险

Danger | 危险

Warning | 警告

H 240

H 241

H 242

H 242

China GHS UN GHS EU GUS

Self-heating Substances (mixtures included) GB 20584-2006

Category 1

Category 2

Danger | 危险

Warning | 警告

H 251

H 252

HelpyouKnowit China GHS – H statement

GB 20582-2006

Flammable Solids

D

易燃固体

Category 1

W Category 2

易燃固体

HelpyouKnowit China GHS – H statement

GB 20583-2006

Self-reactive substances (mixtures included)

D

加热可能引起爆炸

Type A

D Type B

D

加热可能引发火灾或 爆炸

加热可能引发火灾

Type C & D

W Type E & F

No Type G

加热可能引发火灾

HelpyouKnowit China GHS – H statement

GB 20584-2006

Self-heating substances (mixtures included)

D

自热，可能引起火灾

Category 1

W Category 2

大量时，自热， 可能引起火灾

Updates on 13 Apr 2012

China GHS – classification and pictogram for physical hazards A combination with which you work even more easily

GB 20585-2006 Pyrophoric

Liquids

China GHS UN GHS 4th EU GHS Category 1

Danger | 危险 H 250 China GHS UN GHS 4th EU GHS

GB 20586-2006 Pyrophoric

Solids

Category 1

Danger | 危险 H 250 China GHS UN GHS 4th EU GUS

Substance which, in contact with water, emit flammable gases (water reactive) GB 20587-2006

Category 1

Category 2

Category 3

Danger | 危险

Danger | 危险

Warning | 警告

H 260

H 261

H 261

NEXTPAGE >

HelpyouKnowit China GHS – H statement

GB 20585-2006 Pyrophoric

Liquids

D Category 1

与空气会发生自 燃

HelpyouKnowit China GHS – H statement

GB 20586-2006 Pyrophoric

Solids

D Category 1

与空气会发生自 燃

HelpyouKnowit China GHS – H statement

Substance which, in contact with water, emit flammable gases (water reactive) GB 20587-2006

D 接触到水后，会产生可能引起自燃的可燃性， Category 1

易燃性气体

D Category 2

接触到水后， 会产生可燃性，易燃性气体

W Category 3

接触到水后， 会产生可燃性，易燃性气体

Updates on 13 Apr 2012

China GHS – classification and pictogram for physical hazards A combination with which you work even more easily

GB 20588-2006 Corrosive

to Metals

China GHS UN GHS 4th EU GHS Category 1

Warning | 警告 H 290 China GHS UN GHS 4th EU GHS

GB 20589-2006 Oxidizing

Liquids

Category 1

Danger | 危险 H 271

Category 2

Danger | 危险 H 272

Category 3

Warning | 警告 H 272 China GHS UN GHS 4th EU GUS

GB 20590-2006

Oxidizing Solids

Category 1

Category 2

Category 3

Danger | 危险

Danger | 危险

Warning | 警告

H 271

H 272

H 272

NEXTPAGE >

HelpyouKnowit China GHS – H statement

GB 20588-2006 Corrosive

W Category 1

to Metals

可能腐蚀金属

HelpyouKnowit China GHS – H statement

GB 20589-2006 Oxidizing

Liquids

D Category 1

可能会引起燃烧 或者发生爆炸；强氧化物

D

可能助加剧燃烧；氧化物

Category 2

W

可能助加剧燃烧；氧化物

Category 3

Labeling of Chemicals Based on GHS

X

HelpyouKnowit China GHS – H statement

GB 20590-2006

Oxidizing Solids

D Category 1

可能会引起燃烧 或者发生爆炸；强氧化物

D

可能助加剧燃烧；氧化物

Category 2

W

可能助加剧燃烧；氧化物

Category 3

Labeling of Chemicals Based on GHS

X

Updates on 13 Apr 2012

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China GHS – classification and pictogram for physical hazards A combination with which you work even more easily

China GHS UN GHS 4th EU GHS

GB 20591-2006

Organic peroxides

Type A

Type B

Type C & D

Type E& F

Type G

No Danger | 危险

Danger | 危险

Danger | 危险

Warning | 警告

H 240

H 241

H 242

H 242

HelpyouKnowit Driving Green Chemical

HelpyouKnowit China GHS – H statement

GB 20591-2006

Self-reactive substances (mixtures included)

D

加热可能引起爆炸

Type A

D Type B

D

加热可能引发火灾或 爆炸

加热可能引发火灾

Type C & D

W Type E & F

No Type G

加热可能引发火灾

Updates on 13 Apr 2012

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China GHS – Category Table II : health hazards Hazard categories under GHS in different areas

UN GHS (2011 Ver. 04)

Health Hazards

Download GB

3.1 Acute toxicity(Oral | Skin | Inhalation) 3.2 Skin corrosion/irritation 3.3 Serious eye damage/eye irritation 3.4 Respiratory or skin sensitization 3.5 Germ cell mutagenicity 3.6 Carcinogenicity 3.7 Reproductive toxicity 3.8 Specific target organ toxicity — single exposure 3.9 Specific target organ toxicity — repeated exposure 3.10 Aspiration hazard

10 hazards

EU CLP (EC 1272/2008)

Current China GHS

Replacing DSD & DPD since Jun 1 2015

Based on UN GHS 2007 Ver.02

The same as UN GHS

GB 20592-2006 Acute toxicity(Oral | Skin | Inhalation) GB 20593-2006 Skin corrosion/irritation GB 20594-2006 Serious eye damage/eye irritation GB 20595-2006 Respiratory or skin sensitization GB 20596-2006 Germ cell mutagenicity GB 20597-2006 Carcinogenicity GB 20598-2006 Reproductive toxicity GB 20599-2006 Specific target organ system toxicitysingle exposure GB 20601-2006 Specific target organ system toxicityrepeated exposure Absent from China GHS

10 hazards

9 hazards

Remark: China GHS mostly copied from UN GHS 2007 version, but some classification has been changed. Specifically

Skin | Respiratory sensitization STOT-single exposure Aspiration hazard

Updates on 13 Apr 2012

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China GHS – classification and pictogram for health hazards A combination with which you work even more easily EU GHS

GB 20592-2006

Acute Toxicity

Category 1

Category 2

Category 3

Category 4

(Oral)

China GHS UN GHS 4th Category 5

No

+

Danger | 危险

Danger | 危险

Danger | 危险

Warning | 警告

Warning | 警告

H 300

H 300

H 301

H 302

H 303

EU GHS

GB 20592-2006 Acute

Toxicity

Category 1

Category 2

Category 3

Category 4

(Skin)

China GHS UN GHS 4th Category 5

No

+

Danger | 危险

Danger | 危险

Danger | 危险

Warning | 警告

Warning | 警告

H 310

H 310

H 311

H 312

H 313

EU GHS

GB 20592-2006 Acute

Toxicity

Category 1

Category 2

Category 3

Category 4

(Inhalation)

China GHS UN GHS 4th Category 5

No Danger | 危险

Danger | 危险

Danger | 危险

Warning | 警告

Warning | 警告

H 330

H 330

H 331

H 332

H 333

HelpyouKnowit China GHS – H statement

GB 20592-2006

Acute Toxicity (Oral)

D

吞咽致命 （口服）

Category 1

D

吞咽致命（口服）

Category 2

D

吞咽会中毒（口服）

Category 3

W

吞咽有害（口服）

Category 4

No

W Category 5

吞咽可能有害（口服）

HelpyouKnowit China GHS – H statement

GB 20592-2006

Acute Toxicity (Skin)

D

接触皮肤致命 皮肤

Category 1

D

接触皮肤致命 皮肤

Category 2

D

接触皮肤会中毒 皮肤

Category 3

W

接触皮肤有害 皮肤

Category 4

W No Category 5

接触皮肤可能 有害 皮肤

HelpyouKnowit China GHS – H statement

GB 20592-2006

Acute Toxicity (Inhalation)

D Category 1

吸入致命（气体 蒸汽 粉尘 烟雾）

D

吸入致命（气体 蒸汽 粉尘 烟雾）

Category 2

D

吸入会中毒（气体 蒸汽 粉尘 烟雾）

Category 3

W

吸入有害（气体 蒸汽 粉尘 烟雾）

Category 4

W No Category 5

吸入可能有害（气体 蒸 汽 粉尘 烟雾）

Updates on 13 Apr 2012

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China GHS – classification and pictogram for health hazards A combination with which you work even more easily

EU GHS

GB 20593-2006

Skin corrosion/

Category 1A

Category 1B

Category 1C

Category 2

China GHS UN GHS 4th Category 3

irritation No Danger | 危险

Danger | 危险

Danger | 危险

Warning | 警告

Warning | 警告

H 314

H 314

H 314

H 315

H 316

EU GHS

GB 20594-2006 Serious

eye damage

Category 1

Category 2A

China GHS UN GHS 4th Category 2B

/eye irritation No Danger | 危险

Warning | 警告

Warning | 警告

H 318

H 319

H 320

HelpyouKnowit China GHS – H statement

GB 20593-2006

Skin corrosion/ irritation

D Category 1A

严重灼伤皮肤，损 伤眼睛

D Category 1B

严重灼伤皮肤，损 伤眼睛

D Category 1C

W

严重灼伤皮肤，损 伤眼睛

对皮肤有刺激

Category 2

W No Category 3

对皮肤有轻度刺激

HelpyouKnowit China GHS – H statement

GB 20594-2006

Serious eye damage /eye irritation

D

造成眼的严重损伤

Category 1

W

对眼有强烈的刺激

Category 2A

No

W Category 2B

刺激眼

Updates on 13 Apr 2012

China GHS – classification and pictogram for health hazards A combination with which you work even more easily

China GHS EU GHS

Respiratory sensitization GB 20595-2006

+

UN GHS 4th

Category 1

Category 1A

Category 1B

Danger | 危险

Danger | 危险

Danger | 危险

H 334

H 334

H 334

China GHS EU GHS

GB 20595-2006

Skin sensitization

UN GHS 4th

Category 1

Category 1A

Category 1B

Warning | 警告

Warning | 警告

Warning | 警告

H 317

H 317

H 317

NEXTPAGE >

HelpyouKnowit China GHS – H statement

GB 20595-2006 Respiratory

sensitization

D Category 1

吸入后可能引起过敏，哮喘或呼吸困难

HelpyouKnowit China GHS – H statement

GB 20595-2006 Skin

sensitization

W Category 1

可能引起皮肤过敏

Updates on 13 Apr 2012

China GHS – classification and pictogram for health hazards A combination with which you work even more easily

GB 20596-2006 Germ

cell

China GHS UN GHS 4th EU GHS Category 1A

Category 1B

Category 2

Danger | 危险

Danger | 危险

Warning | 警告

H 340

H 340

H 341

mutagenicity

China GHS UN GHS 4th EU GHS

GB 20597-2006 Carcinogenicity

GB 20598-2006 Reproductive

Category 1A

Category 1B

Category 2

Danger | 危险

Danger | 危险

Warning | 警告

H 350

H 350

H 351

Category 1A

Category 1B

Category 2

China GHS UN GHS 4th EU GHS Additional: Lactation

toxicity No Danger | 危险

Danger | 危险

Warning | 警告

H 360

H 360

H 361

H 362

NEXTPAGE >

HelpyouKnowit China GHS – H statement

GB 20596-2006

Germ cell mutagenicity

D Category 1A

D Category 1B

W Category 2

可能导致遗传性疾病（如果很确定地证明没有其他接触 途径会产生这一危险，那么应说明会产生这一会还的接触途径）

可能导致遗传性疾病（如果很确定地证明没有其他接触 途径会产生这一危险，那么应说明会产生这一会还的接触途径）

怀疑有可能导致遗传性疾病（如果很确定地证明没有 其他接触途径会产生这一危险，那么应说明会产生这一会还的接 触途径）

HelpyouKnowit China GHS – H statement

GB 20597-2006

Carcinogenicity

D Category 1A

D Category 1B

W Category 2

可能致癌 （如果很确定地证明没有其他接触途径会产生这一危险，那么应 说明会产生这一会还的接触途径）

可能致癌 （如果很确定地证明没有其他接触途径会产生这一危险，那么应 说明会产生这一会还的接触途径）

怀疑有可能致癌（如果很确定地证明没有其他接触途径 会产生这一危险，那么应说明会产生这一会还的接触途径）

HelpyouKnowit China GHS – H statement

GB 20598-2006

Reproductive toxicity

D Category 1A

D Category 1B

D Category 2

No

可能影响生育能力或胎 儿有损害（如果已明确，要说明影响的具体内容）或（如果很确 定地证明没有其他接触途径会产生这一危险，那么应说明会产生 这一会还的接触途径）

可能影响生育能力或胎 儿有损害（如果已明确，要说明影响的具体内容）或（如果很确 定地证明没有其他接触途径会产生这一危险，那么应说明会产生 这一会还的接触途径）

怀疑影响生育能力或胎 儿有损害（如果已明确，要说明影响的具体内容）或（如果很确 定地证明没有其他接触途径会产生这一危险，那么应说明会产生 这一会还的接触途径）

W Additional: Lactation

造成伤害

“

可能对哺乳期的婴儿 ”（可能）

Updates on 13 Apr 2012

China GHS – classification and pictogram for health hazards A combination with which you work even more easily China GHS

GB 20599-2006 Specific

target organ system toxicity-single exposure (STOT)

Category 1

Category 2

Category 3

Danger | 危险

Warning | 警告

Warning | 警告

H 370

H 371

H 335 | H 336

China GHS UN GHS 4th EU GHS

GB 20601-2006 STOT-repeated

Category 1

Category 2

exposure Danger | 危险

Warning | 警告

H 372

H 373

EU GHS

Aspiration hazard Currently absent from China GHS

！

UN GHS 4th EU GHS

UN GHS 4th

Category 1

Category 2

Danger | 危险

Warning | 警告

H 304

H 305

NEXTPAGE >

HelpyouKnowit China GHS – H statement

GB 20599-2006 Specific

D Category 1

W Category 2

UN GHS

target organ system toxicity-single exposure

造成器官的损害 （如 果已明确，要说明受影响的所有器官）或（如果很确定地证明没 有其他接触途径会产生这一危险，那么应说明会产生这一会还的 接触途径）

可能造成器官的损害 （如果已明确，要说明受影响的所有器官）（如果很确定地证明 没有其他接触途径会产生这一危险，那么应说明会产生这一会还 的接触途径）

W Category 3

• （刺激气管）可能造成对呼吸器官的刺激

麻醉作用 可能引起嗜睡或头晕

X

X

HelpyouKnowit China GHS – H statement

GB 20601-2006 Specific

D Category 1

W Category 2

target organ system toxicity-repeated exposure

由长期或反复接触引起的器官损害 （如果已明 确，要说明受影响的所有器官）或（如果很确定地证明没有其他 接触途径会产生这一危险，那么应说明会产生这一会还的接触途 径）

由长期或反复接触 可能引起的器官损害 （如果 已明确，要说明受影响的所有器官）或（如果很确定地证明没有 其他接触途径会产生这一危险，那么应说明会产生这一会还的接 触途径）

Updates on 13 Apr 2012

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China GHS â&#x20AC;&#x201C; Category Table III : environmental hazards Hazard categories under GHS in different areas

UN GHS (2011 Ver. 04)

Environmental Hazards

EU CLP (EC 1272/2008)

Current China GHS

Replacing DSD & DPD since Jun 1 2015

Based on UN GHS 2007 Ver.02

4.1 Hazardous to the aquatic environment 4.2 Hazardous to the ozone layer

GB 20602-2006 Hazardous to the aquatic environment Absent from China GHS

Download GB

The same as UN GHS

2 hazards

2 hazards

1 hazards

Remark: China GHS mostly copied from UN GHS 2007 version, but some classification has been changed. Specifically

Hazardous to the ozone layer

Updates on 13 Apr 2012

China GHS – classification and pictogram for environmental hazards

NEXTPAGE >

A combination with which you work even more easily China GHS UN GHS 4th

EU GHS

Hazardous to the aquatic environment (Acute) GB 20602-2006

Category 1

Category 2

Category 3

No

No

Warning | 警告

+ GB 20602-2006 Hazardous

to the aquatic environment (Chronic | Long-term)

H 400

H 401

H 402 China GHS UN GHS 4th EU GHS

Category 1

Category 2

Category 3

Category 4

No

No

H 412

H 413

Warning| 警告 H 411

H 410

UN GHS 4th

EU GHS

Hazardous to the Ozone Layer Currently absent from China GHS

！

Category 1

No

Category 1

VS

Danger | 危险

Warning | 警告

EUH 059

H 420

EUH 059 Hazardous to the ozone layer

H 420 Harms public health and the environment by destroying ozone in the upper atmosphere

HelpyouKnowit China GHS – H statement

GB 20602-2006

Hazardous to the aquatic environment (Acute)

W

对水生生物有非常强的毒害

Category 1

对水生生物有毒害

No Category 2

对水生生物有害

No Category 3

HelpyouKnowit China GHS – H statement

GB 20602-2006

Hazardous to the aquatic environment (Chronic | Long-term)

W Category 1

对水生生物 毒性非常大并且有长期持续影响 对水生生物有

Category 2

毒并且有长期持续影响

对水生生物有

No Category 3

害并且有长期持续影响

可能对

No Category 4

水生生物产生长期持续的有害影响

Updates on 13 Apr 2012

Pictogram and classification precedence rules – same as EU GHS

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You may have been quite familiar with this part

Physical hazards

If

then GHS 01

&

optional except

GHS 02

 Self-reactive (Type B) | GB20583-2006  Organic peroxides (Type B) | GB 20591

GHS 03

Physical | Health hazards

If

or GHS 06

then GHS 02

optional GHS 04

Health hazards

Health hazards

If

then

absent

If

GHS 07

GHS 06

then GHS 08

absent GHS 07

Health hazards For Respiratory sensitization

If

then GHS 05

absent GHS 07

In hazards of Skin or eye irritation (GB20593-2006 | GB 20594-2006)

For Skin sensitization or Skin & Eye irritation

Updates on 13 Apr 2012

Hazard Statement precedence rules â&#x20AC;&#x201C; same as UN GHS

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A combination with which you work even more easily

Environmental Hazards

If H410 (Very toxic to aquatic life with long lasting effects), H400 (Very toxic to aquatic life) NOT APPEAR Environmental Hazards

If H411 (Toxic to aquatic life with long lasting effects), H401 (Toxic to aquatic life) NOT APPEAR Environmental Hazards

If H412 (Harmful to aquatic life with long lasting effects), H402 (Harmful to aquatic life) NOT APPEAR Health Hazards

If H314 (Causes severe skin burns and eye damage), H318 (Causes serious eye damage) NOT APPEAR Tips: you could apply this rule in the SDS section 2.1 (Classification), however, you could still keep all of those Hazard statements in 2.2 (Label element) on China SDS.

Updates on 13 Apr 2012

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SDS â&#x20AC;&#x201C; hazard communication always matters

China SDS

National Standard Download

Under Regulation (EC) No 1907/2006 (REACH)

GHS Comparison

EU SDS REACH Registration Number DPD/DSD classification CSA | exposure scenario (eSDS) Emergency response call Different concentration limits H/P statements in local language XV section, local regulations added XVI section, Risk phrases

Content and Section

Sample of SDS (qualified copy)

Under GB16483-2008 Instruction of Safety Data Sheet, Content and Section

China SDS

NO 24hr emergency response phone number Different concentration limits H/P statements in Chinese XV section, Chinese regulations XVI section, NO Risk phrases

Major differentiation between EU SDS & China MSDS

GB 16483-2008 English ver.

Updates on 13 Apr 2012

SDS â&#x20AC;&#x201C; hazard communication always matters

Before you read

NEXTPAGE >

Largely, current SDS guidance (GB 16483-2008) is quite a copy cat of both guidance on the preparation of safety (UN GHS) & Annex II (EU REACH) The requirements of each section are not specified in detail, which means that you may not easily prepare your China SDS by following the GB 16483-2008 Moreover, some translation mistakes in the GB 16483-2008 from EU REACH or UN GHS might lead you to confusion

So you may need more assistance

HelpyouKnowit Driving Green Chemical

Updates on 13 Apr 2012

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Content – 16 sections one by one （Part I） National Standard: GB 16483-2008

S1

Identification (of product and supplier) 1

Chemical Name | Product Code

2

Identification of supplier | Contact | 24h ER #

3

Recommended & Restriction on use

Section 1 or Heading 1

S2

S3

Hazard identification (Substances or mixture) 1

Classification of products under China GHS

2

Hazards profile (H statements) Physical | Health | Environmental

3

Pictogram | Signal word | H statements P Statements (in four sectors) | Other hazards

Composition/information on ingredients Define the product Substance or Mixture

Substance GHS classification applied

Mixture (not all ingredients) Only classified ones

Substance Name

+

+

CAS #

EC#

All ingredient (impurities included) GHS classification + Concentration (range)

+

Each name of Classified ingredients

Concentration (range) & Classification

+

Confidential ingredients : name of these ingredients are allowed to be replaced by other names on SDS or Label. However, hazards of them shall be fully unfolded.

S4

First-aid measures 1

General description

4

Professional assistance Or doctor’s advice

Subheading：Treatments for different routes Skin | Eye | Inhalation | Ingestion

2

+

Medical attention or Special treatment

3

Most important symptoms/effects, acute and delayed (detailed in section 11)

Updates on 13 Apr 2012

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Content – 16 sections one by one （Part II） National Standard: GB 16483-2008

S5

S6

S7

S8

Fire-fighting measures 1

Suitable extinguishing media Unsuitable extinguishing media

2

Special hazards of the product & Special hazards arising from the product

3

Special protective equipment & precautions for fire-fighters

Accidental release measures 1

Personal precautions, Protective equipment Emergency procedures

2

Environmental precautions

3

Methods and materials for containment & cleaning up (Specify methods if different from Section 13)

Not existing in UN or EU GHS

4

Methods applied to prevent from next accident

+

Handling and storage 1

Precautions for safe handling including advice on technical measures

2

Advice on preventing from contact in ways of …

3

Special protection under special conditions

Exposure controls/personal protection 1

Control parameters or Exposure limit value (Content same as it under EU Annex II under EU REACH)

2

Appropriate engineering controls; providing supplemental information besides Section 7

Conditions for safe storage (including incompatibilities) & requirements such as materials used in packaging and container of product (substance or mixture)

3

Individual protection measures - Respiratory - Hand - Eye - Skin

-

and equipment EU SDS requires environmental exposure control

Updates on 13 Apr 2012

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Content – 16 sections one by one （Part III） National Standard: GB 16483-2008

Physical and chemical properties (endpoints to be filled) S9

1

9.1 General Info Appearance (形态) Form (形状) Color (颜色) Odour (气味)

2

9.2 Other Info Odour threshold (气味阀值) Evaporation rate (蒸发速率) Flammability (Solid, gas) 易燃烧 Explosive properties (爆炸性)

pH (pH值) Melting point/freezing point (熔点/凝固点) Initial boiling point and boiling range (沸点 沸程) Flash point (闪点) Upper/lower flammability or explosive(燃烧上下 极限 或爆炸极限)

Vapour pressure (20°C) (蒸汽压) Vapour density (蒸气密度) Relative Density (20°C)(密度/相对密度) Water solubility (g/l) (溶解性) n-Octanol/Water (log Po/w) (n-辛醇/水分配系数) Auto-ignition temperature (自燃温度) Decomposition temperature (分解温度)

Supplementary information

Radioactivity (放射性) Bulk Density (体积密度)

Testing methods required if necessary

Stability and reactivity S10

1

Chemical Stability

2

Reactivity

3

Condition to avoid

4

Toxicological information S11

1

Toxicokinetics, metabolism and distribution (Supplementary part)

Incompatible materials

5

Hazard decomposition products

Acute toxicity (oral Dermal Inhalation) – mammal

2

1

Provide reliable data generated from tests or referred to competitive source

2

If hazards of a mixture has not been identified through test, then hazards of each ingredients shall be offered

Info on toxicological effects

-

Skin corrosion/Irritation Serious eye damage/irritation

EU SDS needs “Aspiration hazard” but China GHS does not require this classification

Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT-single exposure

STOT-repeated exposure

Updates on 13 Apr 2012

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Content – 16 sections one by one （Part IV） National Standard: GB 16483-2008

S12

More data provided is highly recommended.

Please indicate the reference.

Ecological information 1

Eco-Toxicity (data on aquatic life and Other organisms)

2

Persistence and degradability

3

Bioaccumulative potential

4

Mobility in soil

Disposal Considerations S13

1

Disposal methods

2

Contaminated container and packaging treatment methods

Informed the Down-stream users of the disposal methods

Transport information S14

In accordance with each of the modal regulations:

ADR/RID | IMDG | ICAO/IATA

• UN Number • UN Proper Shipping Name • Transport hazard classes • Packing group, if applicable • Environmental hazards (Marine pollutant) • Special precautions for user

S15

S16

Regulatory information 1

Whether a substance / mixture (main ingredients) has been included in some Catalogue or Inventory

2

Safety, health & environmental legislation in China for this chemical product

3

-

Informed the Down-stream users of the disposal methods EU SDS requires Chemical safety assessment under EU REACH (EU 453/2010)

Other information 1

-

Indication of changes Version amended, if applicable EU SDS requires relevant R phrase in this part.

2

Advice on professional training, if applicable

3

Disclaimer or other information, Recommended restrictions on use

Updates on 13 Apr 2012

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Last tips – 16 sections one by one （Part VI） National Standard: GB 16483-2008

Heading

for 16 sections

 Ensure the format of the SDS well designed for the DU and authority review  Each heading and sub-heading should be clearly marked with index No.  Sub-headings under each section should be arranged in accordance with the order given in Content – 16 sections one by one(I-V) previously.

1

2

3

Other requirements  Ensure the name of the chemical product put on each page of the SDS The abbreviation of a longer chemical name should be explained in S1 & S3

 SDS No. together with date of SDS generated should be given on each page  Ensure words selected for the SDS readable and understandable

Congratulations !

You almost finish China SDS part

Updates on 13 Apr 2012

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Content â&#x20AC;&#x201C; Introduction of the SDS part

China SDS

National Standard Download

GHS Comparison

Content and Section

Sample of SDS (qualified copy)

I am sorry, but you may have to contact me for this template

Contact me

Or Linkedin me

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GHS | SDS part is gone

Now, it is about GHS Label

HelpyouKnowit Driving Green Chemical

Updates on 24 May 2012

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GHS label and packaging

Combination packaging

Single packaging

Language on label The explanatory text of the label shall be written in Chinese. However, foreign languages will be used if 1) the meaning stated corresponding with it indicated in written Chinese text and; 2) the font size shall be smaller than the Chinese

HelpyouKnowit Driving Green Chemical

Updates on 30 Mar 2012

NEXTPAGE >

Label elements - GHS hazard warning label I National Standard: GB 15258-2009

In accordance with 4.2.1 of GB 15258-2009

Part I: Name of the product

1

CAS号： 浓度：

2

 Chemical or chemical substance: name should be given in Chinese (English is optional) on top  Substance or Mixture: Trade name / product name should be given ; main ingredients in mixture contributed to specific classification of the whole product should be added (Name, Concentration or range | CAS# is highly recommended)

No more than 5 ingredients recommended

 Confidential ingredients : name of these ingredients are allowed to be replaced by other names on SDS or Label. However, hazards of them shall be clearly listed.

Different from “Alternative chemical name in mixtures” (EU CLP) You are not required to request for an alternative name for your confidential ingredient in China if you promise hazards and concentration to be disclosed on SDS and Label.

3 GB 15258-2009 (English)

24小时

Updates on 30 Mar 2012

Label elements - GHS hazard warning label II

NEXTPAGE >

National Standard: GB 15258-2009

In accordance with 4.2.2-4.2.5 of GB 15258-2009

1

CAS号： 浓度：

Part II: Body of Label What needs to be put in this part:

2

- One signal word (Danger or Warning) - GHS pictogram Hazard Statement (Below Signal word) - Precautionary Statements (Put all statement rather than pick at most 6 statements like guidance of EU label regulatory)

In accordance with 4.2.9 of GB 15258-2009 The rules of making this part: - Pictogram applied should follow the same precedence of UN GHS (No specific rules for pictogram size in label) - Hazard Statement: all statements arranged in order Physical hazards | Health hazards | Environment hazards - Precautionary Statements: all statement (under EU CLP, only 6 selected in accordance with certain rules) shall be listed but correspondingly arranged in [Prevention] [Response] [Storage] [Disposal] also in order

For specific classification rules Reference Documentation (National Standards) GB 20576-2009 - GB 20599-2009 GB 20601-2009 - GB 20602-2009

3

24小时

Updates on 30 Mar 2012

Label elements - GHS hazard warning label III

NEXTPAGE >

National Standard: GB 15258-2009

1

CAS号： 浓度：

2

In accordance with 4.2.6 -4.2.8 of GB 15258-2009

Part III: Supplier Identification  “Please refer to Safety Data Sheet” (a must)  Supplier identification: supplier name | company seat | Contact number | Zip code (a must)  24/7 Emergency Response Call. The call shall be Chinese phone number, either of the supplier itself or qualified service provider assigned.

NRCC 24/7 ER service will be charged 3000RMB

3

annually for 8 chemical products

http://en.nrcc.com.cn/

24小时

Updates on 30 Mar 2012

Label , Label , Label- Combination Packaging I

NEXTPAGE >

National Standard: GB 15258-2009

Normal GHS Label Container capacity

Applies to GHS label on Single packaging

Size for China label

EU GHS label

0.1 L - 3 L (3 included)

50 * 75 (mm)

52*74 (mm)

3 L- 50 L (50 included)

75 * 100 (mm)

74*105 (mm)

50 L-500 L (500 included)

100 * 150 (mm)

105*148 (mm)

500 L-1000 L (1000 included)

150 * 200 (mm)

148*210 (mm)

over 1000 L

200 * 300 (mm)

Inner packaging

Black Border Line of China GHS label

Printed GHS pictogram color

- A space remained outside the border line of label (3mm at least) - The width of border Line should be remained as 1mm at least

- All black & white Or Red frame | White background | Black icon

Simplified GHS Label If either container or packaging is less than or equal to 100ml, simplified label is allowed to be utilized.

No requirements for Size was specified.

Elements same as normal GHS label - Chemical product name - Signal word and pictogram - Hazard statement - â&#x20AC;&#x153;Please refer to Safety data sheetâ&#x20AC;?

- Supplier name and contact - 24/7 ER contact (Chinese landline) -------------------------------------------------Elements deleted from normal label - Precautionary Statements

Updates on 10 Apr 2012

NEXTPAGE >

Label , Label , Label- Combination Packaging II National Standard: GB 15258-2009 & GB 190-2009

Normal GHS Label

Should I put on a GHS hazard warning label on the outer packaging?

In accordance with GB 15258-2009 Inner packaging: GHS label | Outer packaging: Product name + Transport symbol + UN number In case of no need for transport symbol, GHS label could be applied instead

Contradiction: In the light of Decree 591(Thanks for Chris’s contribution) –Article 15 Inner packaging: GHS label | Outer packaging: Transport symbol + GHS label

Conclusion:  Post both GHS label and Transport symbol on the Outer Packaging but separate them from each other (for example put the symbol on the opposite side of GHS label on a outer box)

Transport symbol

Outer packaging

Follow GB 190-2009 | Packing symbol of dangerous goods

GB 190-2009 (Chinese only)

Select correct transport symbol

Annex I of UN GHS 4 How to choose corresponding transport symbol according to GHS pictogram

Apply the color according to GB 190-2009

Symbol size category

The size rules apply to the transport symbol used for single packaging “UN Recommendations on the Transport of Dangerous Goods - Model Regulations”

Symbol size:

1

50 * 50 (mm)

2

100 * 100 (mm)

3

150 * 150 (mm)

4

200 * 200 (mm)

Transport symbol => 100*100mm

Updates on 24 May 2012

GHS label – industrial use and consumer product

NEXTPAGE >

The GHS label applies to both industrial uses and consumer goods

GB 15258-2009 GB/T22234-2008

Compulsory Recommended

In accordance with GB 13690-2009 (General rule for classification and hazard communication of chemicals), label generated based on the rules of China GHS could be used for industrial situation and consumer products as well.

GB 13690-2009

GB 15258-2009 used for consumer goods is not strictly implemented because of lacking in the enforcement from the competent authority.

General rules for classification and hazards communication of chemicals

Specific rules for labels of different kinds of consumer goods

GB/T 25322-2010: Safety label of consumer product （In Chinese） Download Download GB13690-2009 in Chinese

 GB 7719-2011 : National Standard of Food Safety-general standard for the labeling of prepackaged foods  QB/T 2952-2008 Requirements for detergent marks and packaging  GB 52963-2008 Instruction for use of consumer products-general labeling for cosmetics  BB/T 0005-2010 Labeling, classification and terms of aerosol products

Updates on 19 Apr 2012

Prepare Transport Symbol according to GHS pictogram

Physical Hazards

NEXTPAGE >

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Explosive

Flammable Gases

Unstable | Div. 1.1

Category 1

Div.1.2

Category 2

No

(Flammable) Aerosols

Category 1

Category 2

Div. 1.3

Div. 1.4

Div. 1.5

Div. 1.6

No

No

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Oxidizing Gases

Gases under pressure

Flammable Liquids

Category 1

Compressed gases

Category 1

Liquefied gases

Refrigerated liquefied gases

Category 2

Category 3

Dissolved gases

Category 4

No

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Flammable Solids

Category 1

Category 2

China GHS UN GHS 4th EU GHS

Self-reactive Substances (mixtures included)

Type A

Type B

Type C & D

Type E& F

Type G

No

Self-heating Substances (mixtures included)

Category 1

Category 2

Updates on 19 Apr 2012

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Pyrophoric Liquids

Category 1

Pyrophoric Solids

Category 1

Substance which, in contact with water, emit flammable gases (water reactive)

Category 1

Category 2

Category 3

NEXTPAGE >

Updates on 19 Apr 2012

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Corrosive to Metals

Category 1

Oxidizing Liquids

Category 1

Oxidizing Solids

Category 1

Category 2

Category 2

Category 3

Category 3

NEXTPAGE >

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Organic peroxides

Type A

Type B

Type C & D

Type E& F

Type G

No

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Updates on 19 Apr 2012

Prepare Transport Symbol according to GHS pictogram

Health Hazards

NEXTPAGE >

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Acute Toxicity (Oral)

Category 1

Category 2

Category 3

Category 4

Category 5

No

+ Acute Toxicity (Skin)

Category 1

Category 2

Category 3

Category 4

Category 5

No

+ Acute Toxicity (Inhalation)

Category 1

Category 2

Category 3

Category 4

Category 5

No

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Skin corrosion/ irritation

Category 1A

Category 1B

Category 1C

Category 2

Category 3

No

Serious eye damage /eye irritation

Category 1

Category 2A

Category 2B

No

Updates on 19 Apr 2012

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Respiratory sensitization

Category 1

+ Skin sensitization

Category 1

NEXTPAGE >

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

Category 1A

Category 1

Category 1

Category 1B

Category 2A

Category 2

Category 2

Category 2B

Category 3

Category 4

No

Updates on 19 Apr 2012

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Specific target organ system toxicity-single exposure (STOT)

STOT-repeated exposure

Aspiration hazard Currently absent from China GHS

ďź

Category 1A

Category 1

Category 2

Category 2

NEXTPAGE >

Updates on 19 Apr 2012

Prepare Transport Symbol according to GHS pictogram

Environmental Hazards

NEXTPAGE >

Updates on 19 Apr 2012

NEXTPAGE >

Convert your GHS pictogram to Transport symbol A combination with which you work even more easily

Hazardous to the aquatic environment (Acute)

Category 1

Category 2

Category 3

No

No

+ Hazardous to the aquatic environment (Chronic | Long-term)

Hazardous to the Ozone Layer

Category 1

Category 2

Currently absent from China GHS

Category 3

Category 4

No

No

ďź

Updates on 30 Mar 2012

Label , Label , Label- Single Packaging

NEXTPAGE >

National Standard: GB 15258-2009 | Decree 591

Follow GB 190-2009 | GB 15258-2009 Packing symbol of dangerous goods

In case of large

tanker or container

Product name

UN number Transport symbol Can not be treated as single packaging

GHS hazard warning Label  

Both labels are necessary on a single-packed product If pictogram(GHS) and symbol (Transport) are repeated, pictogram should not appear Annex I of UN GHS 4 How to choose corresponding transport symbol according to GHS pictogram

 Only Transport Symbol is applied, no GHS label needed  Large tanker or container Over 450L should be posted with Transport Symbol on both sides  The minimum size of transport symbol for a tanker vehicle shall be 250mm*250mm  Comply with Global transport convention (IATA etc.)

NEXTSECTOR >

Next sector is about “Regulation on Import & Export of Hazardous Chemicals ” Mainly focused on inspection over SDS and Label developed for hazardous chemical products exported and imported

in accordance with China GHS

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Regulation on Import & Export of Hazardous Chemicals >

AQSIQ

Specific implementations since 01 Feb 2012

HelpyouKnowit Driving Green Chemical

Updates on 10 Feb 2012

Import & export of Hazardous chemical products

NEXTPAGE >

The vehicle has been rolling since o1 Feb 2012

DECREE591 by State Council

…

 01 Dec 2011 Entered into force  Catalog of Hazardous Chemicals to be updated from Ver.2002 to a new version

AQSIQ + Customs  Importer or exporter of the chemicals in the Statutory Inspection Catalogue 2012 should fulfill the obligations under related regulations issued by the AQSIQ  Local CIQ implements inspection and management of compliance work of import & export of hazardous chemicals and packaging

Catalog of Hazardous Chemicals Ver.2002

Selected from the Catalog of Hazardous Chemicals Ver.2002

160*

The ver.2002 is to be updated under the Decree 591  SAWS is responsible for the Inspection and enforcement of the Decree 591 within China;  taking care of the new version of the Catalog new version

Part of Statutory Inspection Catalogue 2012

AQSIQ is responsible for the hazardous chemical products import and export; currently focused mainly on the Statutory Inspection Catalog ; for other chemicals in the Catalog of Hazardous Chemicals, they will not be taken as top priority of AQSIQ’s inspection work for now

• The Statutory Inspection Catalogue 2012 (over 200 products) –or named as “the list of hazardous chemicals in the Legal Inspection Catalog”

• But now only including 160 chemical products from the Catalog of Hazardous Chemicals Ver.2002 Please find the Statutory Inspection Catalogue 2012 in Chinese here

(http://www.box.com/s/vged6ilflnv285x1no5x)

Updates on 10 Feb 2012

The obligations of import & Export of Hazardous chemical goods

NEXTPAGE >

CHINA GHS | SDS | LABELLING

Import into China

1

-

SDS & Labeling preparation

Following the newest version of UN GHS(Ver. 4th) Documents should be prepared in Chinese

2

-

The report of hazard profile prepared by the approved labs including classification report of TDG & GHS

Export from China

Related Rules & Inventory

- SDS & Labeling preparation Documents should be translated in Chinese if the original copies written in foreign language (follow the local regulations where your products are about to be shipped to )

National laws and standards; Industrial standards

-

Special requirements agreed between national governments

-

Sample required to be tested in local CIQ approved labs The report of hazard profile prepared by local CIQ approved labs including classification report of TDG & GHS Packing decided by the exporter according to the classification report of TDG Exporter requires test reports of packaging and containers from packing suppliers

China TDG & GHS

Food additives 3

- Conformity Declaration of Hazardous-chemical importer (Template offered by the authority in Chinese)

- Conformity Declaration of Manufacturer of Hazardous-chemical imported (Template offered by the authority in Chinese)

4

The authority will be responsible for - Ensuring all information of components in the products to be imported or exported are the same as reported in the information included Conformity Declaration for inspections - Checking hazards classification information on the packing; checking if labeling is designed to be complied with TDG(or IMDG, IATA DGR) and GHS - Ensuring Chinese SDS provided affixed on packaging; checking if the SDS, labeling are correct - Identify whether the packing method meets standard requirements and whether the use of packaging is appropriate; check whether the packaging is sealed tightly; ensure whether the goods inside the packaged is not leaked.

Hazardous chemicals used in food as additives is supposed to meet the requirements of food hygiene and product inspection as well as food safety inspection accordingly.

HelpyouKnowit Driving Green Chemical

Updates on 2 Mar 2012

Inspection on chemical substances only, or chemicals in mixtures

NEXTPAGE >

The inspection is an extension of the implementation of Decree 591

Decree 591

>>

Decree 591 by SC CIQ inspection

Catalog of Hazardous Chemicals (2002) to be updated

Inspection of CIQ on 160 hazardous chemical products ( Statutory Inspection Catalogue 2012 ) imported or exported is part of the implementation of Decree 591

CIQ inspections are only responsible for Export & Import

According to CN GHS

Both hazardous chemical substances or chemicals in mixtures should be complied with hazardous chemical control law.

Notice Emergency call should be Chinese domestic phone number and the contact also located in China.

CN SDS

Label

24h Emergency Call

Outside China

Inside China

National Standards help you with your SDS, labeling under China GHS -

GB/T 22234-2008 labelling for chemical products under China GHS GBT16483-2008 Content and each section in SDS GB 15258_2009 General rules for SDS development GB 13690-2009 General principles of hazard classification and profile under CN GHS

HelpyouKnowit Driving Green Chemical

Updates on 07 Mar 2012

Inspection list & Catalog of Hazardous Chemicals

NEXTPAGE > Ver.2002

2 lists but quite closely related

Decree 591

>>

How 2 lists are linked

Catalog of Hazardous Chemicals

160 chemicals (updated regularly) The Statutory Inspection Catalogue 2012

(Ver.2002 currently still works)

Chemical substances Existing hazardous chemical

China REACH New chemicals identified as hazardous chemicals

already listed in the Catalog Ver.2002

Chemical products Ingredients are chemical substances listed in the Catalog Ver.2002

Updates on 10 Feb 2012

NEXTPAGE >

The inspection has been implemented We list the areas where inspection is quite strict.

Zhejiang Province

Shandong Province

Shandong Province

Fujian Province

Jiangsu Province

City Shanghai

Guangdong Province

More & more…

The authorities of the above areas have started the inspection & enforcement already

Find out whether your business has been affected Check the catalog | Have news from the local partner or your consultant

•

Ensure your implementation of compliance will be initiated with no delay

•

Cooperate with your service agents or your business partners, get material well papered

HelpyouKnowit Driving Green Chemical

Updates on 21 Mar 2012

NEXTPAGE >

One point to be noticed

AQSIQ (local CIQ) Only inspect Chemicals in the Catalog of Hazardous Chemicals Imported chemical products are allowed to be put on with GHS label after clearance but in special warehouse

Catalog of Hazardous Chemicals (Ver.2002 currently still works)

AQSIQ

X

AQSIQ shall not put any inspection upon chemicals out of the Catalog of Haz. Chemicals even with GHS label GHS label could be referred to GHS rules of exporting countries.

Chemicals with GHS label but not in the Catalog

NEXTSECTOR >

Next sector is about

â&#x20AC;&#x153;Toxic Chemicals Severely restricted from import & exportâ&#x20AC;?

Be care if your products to be exported or imported listed in the newest version of Catalog of toxic chemicals severely restricted to be imported or exported

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Toxic Chemicals

Severely restricted from import & export>

MEP

HelpyouKnowit Driving Green Chemical

Updates on 07 Mar 2012

NEXTSECTOR >

Learning steps â&#x20AC;&#x201C; it is about restricted toxic chemicals What would be the key issues you need to know?

Who

Restricted

Comply

May be affected

Chemicals

Strategy

Who might be affected because of some chemicals

+

Whether those chemicals have been or will be restricted in China

If you do have been affected, then learn how to comply with it

The purpose of restriction regulation of toxic chemical import & export Toxic chemicals should be strictly under control. The authority will have clear minds of what toxic chemicals imported or exported, the amount, where the chemicals transported , who will be responsible people, and impacts against the environment caused by the toxic chemicals

HelpyouKnowit Driving Green Chemical

Updates on 07 Mar 2012

NEXTPAGE >

Who may be affected ? What responsibilities?

Who will be affected | what would be the main responsibilities?

Out of China In China

Domestic Companies Located in China Importer & Exporter of toxic chemicals

>

Who will be affected

>

Responsibilities

of MEP

Export Clearance Notification

Responsibilities

 An Import Clearance Notification is with a valid period of 6 Months  Import Clearance Notification shall be applied for each time

 An Export Clearance is Notification with a valid period of 6 Months  Export Clearance Notification shall be applied for each time

Please be informed

>

>

Exporter

 Import Clearance Notification  Registration Certificate for the Environmental Management on the Import of Toxic Chemicals

CRC

 Foreign companies that export toxic chemicals listed in the “Catalog of toxic chemicals severely restricted to be imported or exported(the newest version is 2012)” shall apply one Registration for each type of toxic chemicals  Chinese importer should apply for import clearance Notification by the Registration Certificate during import of each batch of same toxic chemicals

+

Who will be affected

Importer

Registration Certificate for the Environmental Management on the Import of Toxic Chemicals

>

>

Foreign Companies Located outside China Export toxic chemicals into China

 Registration Certificate shall be applied each type of chemicals exported to China once with a valid period of 2 years.  Import Clearance Notification shall be applied for each batch of each toxic chemical to be imported into China with a valid period of 6 months by providing Registration Certificate for this chemical.

+

Please be informed

 Importer could apply for Registration Certificate instead of a foreign companies, but we recommend foreign companies should take the responsibilities on your own or assign Chinese representative to do so.

Updates on 07 Mar 2012

NEXTPAGE >

Letâ&#x20AC;&#x2122;s review who would be responsible for application Under different regulations

Toxic chemical import & export

Order 7(China REAH) & Decree 591

Business players Foreign company Chinese manufacturer

Under toxic chemical import and export regulation, foreigners are recommended to finish application

X

Under Order 7 & Decree 591, foreign companies are not qualified for notification of registration

Chinese importer

Out of China Chinese representative Subsidiary of Foreign Companies but in China

In China Under toxic chemical import and export regulation, importers are qualified for registration but not preferred

Decree 591 | Order 7 Decree 591 | Order 7 Order 7 Order 7*

Notice: Importers could apply for registration certification on behalf of foreign companies

* - if a subsidiary of a foreign companies in China is acting as manufacturer or importer of hazardous chemicals under Decree 591, it shall apply for registration certificate.

Registration body under Order 7 & Decree 591 |

Order 7

>>

Decree 591

>>

Updates on 07 Mar 2012

NEXTPAGE >

The Catalog of restricted toxic chemicals Check the catalog before export chemical products to China

2012 version Catalog of toxic chemicals severely restricted to be imported or exported

158 Pure substances & Chemicals

2010 version of catalog

Replaced by

2012 version of catalog

Chinese version

>

http://www.box.com/s/illcyl3i95p0e1me04jd

English version

>

http://www.box.com/s/3jbg9g1tn69o6pk48r6r

China MEP and Customs jointly issued the 91 statement on 2012 version of the “Catalog of Toxic Chemicals severely restricted to be imported or exported” News source in Chinese http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID=387&T3=10&LanguageType=CH&Sub=12

HelpyouKnowit Driving Green Chemical

Updates on 07 Mar 2012

NEXTPAGE >

The Registration Certificate application process

30 work days

Different Roles

Process a) b) c) d)

MEP Ministry of State Council Division of pollution prevention

Taskforce for Evaluation

Failure in approval， CRC notifies the applicant

Discussion Public consultation (3 days) Final approval Certificate issued

X

MEP Publicity board: http://www.mep.gov.cn/zhxx/gsq/

Technical evaluation provide Feedbacks

X

Inspection and management after certificate issued

Local MEP Inspection

Registration applicant

！

Receive Registration Application Formal Check of materials (5 work days)

Invoice or notify application failure

CRC-MEP

• • •

CRC software for some materials Other materials (hard copy) Registration fee

(3 roles played by importer: chemical user, trader, or representative of foreign companies )

X

Fail in preparation of registration materials

 Check 2012 version Catalog of toxic chemicals severely restricted to be imported or exported

Online registration:

Certificate could be applied by either side of the business, a foreign company or its Chinese importer

Fail in approval

http://www.crc-mep.org.cn/A107/A107_R17.aspx

Updates on 07 Mar 2012

NEXTPAGE >

What to be prepared for Regulation Certificate application Help your with compliant work

Foreign companies

Type 1

+

Necessary materials to be submitted Application form of Registration Certificate (template avail.)

Business Contract (Original Copy) The source of toxic chemicals; hazardous profile; C&L; emergency response & fist aid ; disposal; environmental effects; chemical control laws of countries where the source located etc.

+

Type 2

10,000USD or equivalent RMB

Not all materials listed

CRC supports Tel: + 86 10 4915286 (hazardous chemical only) Email: weihua@crc-mep.org.cn

FC = Foreign companies

Importers of toxic chemicals as trader

Importers of toxic chemicals as representative of FC*

• • • • •

• •

•

+

of MEP

Chinese importers

Importers of toxic chemicals as user

•

CRC

Application form Toxic chemical profile Business license Original business contract Copy of import & export approval certificate Environment report for each chemicals and comments from the authorities 10,000USD or equivalent RMB

• • •

+

First 6 points are same License of Operation Safety (Decree 591) of both importers & Downstream trader Annual record of toxic chemicals sales Sales information of toxic chemicals within recent 2 years DU inventory(only applied to some certain chemicals) 10,000USD or equivalent RMB

•

•

+

Include all materials of importer as trader First and second grade downstream roles’ License of Operation Safety (trader) and Environment report for each chemicals and comments from the authorities (users) required Business license of importer and first grade DU required 10,000USD or equivalent RMB

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NEXTSECTOR >

Next several sectors are planned for regulatory over

“Pesticide | Cosmetics | Disinfectant Products”

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SFDA license and label Cosmetics Regulations >

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MOH license and label Disinfectant Regulations >

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NEXTPAGE >

*

+

* * * +

HelpyouKnowit Driving Green Chemical

NEXTPAGE >

Order 27 by MOH since 2002 “The Measures on Disinfection Management”

Order 22 changed to Order 27

by MOH

Order 27 by MOH Entered into force

01 Jul 2002

Order 27 by MOH Issued

28 Mar 2002

Order 27: The Measures on Disinfection Management

Order 22 by MOH Issued

X 31 Aug 1992

Order 22: Older version of The Measures on Disinfection Management

10 years

Order 27 by MOH http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohwsjdj/pgz/200804/16529.htm

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NEXTPAGE >

The Catalog Disinfectant Products (ver. 2002) Disinfectants in the Catalog

Disinfectants

The currently existing Catalog

:

Ver. 2002 3 Categories of Products in the Catalog

3 products erased from the scope of administrative inspection of MOH

Hygienic License for products below Suspended

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NEXTPAGE >

Your responsibilities under Regulations License to be applied for being issued by the authority:

! :

卫消证字

!

卫消进字

卫消备进 字

卫消备字

卫消字

One more thing about Manufacturer Hygienic License

NEXTPAGE >

Some additional information for your reference

卫消证字

HelpyouKnowit Driving Green Chemical

NEXTPAGE >

Nextâ&#x20AC;Ś The Major 4 organization 1)

Approved testing institutes (Produce data for the product to be licensed)

2)

Administrative Examinations and Approval Office (Receiving application and license issued)

3)

Assessment Committee (Taskforce for examine material submitted and offer comments to MOH for the approval of licensing)

4)

MOH (Approving)

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Hygienic Administrative Licensing for Domestic disinfectants

NEXTPAGE >

Disinfectant Product Hygienic License

卫消字

卫消证字

!

www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33327.htm www.hygiene.net.cn (in Chinese)

Hygienic Administrative Licensing for Imported disinfectants I Imported Disinfectant Product Hygienic License

卫消进字

!

www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm

NEXTPAGE >

Hygienic Administrative Licensing for Imported disinfectants II

NEXTPAGE >

Imported Disinfectant and disinfecting apparatus Hygienic License

卫消进字

Please be noticed: This application form applies to both disinfectants and disinfecting apparatus

+

Original Product Hygienic License (卫消进字) Product Formulation Quality Standard or Recorded Corporation Standard Label (or nameplate in disinfecting apparatus case) of disinfectant product on market The Product Catalogue If notified through authorized agent, then authorization letter is a must Other supportive material

+

www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm

One original copy of each submitted material + Sealed small-packaged sample product

Hygienic Administrative Licensing for Imported disinfectants II

NEXTPAGE >

Imported Disinfectant Product Hygienic License

卫消进字

Please be noticed: This application form applies to 1. Cosmetics products 2. Disinfectant and disinfecting apparatus 3. Products involved drinking water

The 1st case

+

1) Documents issued by the authority from the original place where disinfectants were manufactured should be provided as evidence in case of company name or seat change. Contract could also be valid in case of company name change resulting from mergence etc.

Other materials to be provide Case 1: Company name or Company seat changes

All documents used as evidence should be translated in Chinese and then formally notarized in China.

Case 2: Chinese name of imported disinfectant changes The reason of name change should be specified in the Application Form, and provide re-designed packaging of the product; Foreign name shall be remained unchanged.

2) If the subsidiary is invested by companies located in HK Macao or other places out of China Mainland, “Certificate of Approval for establishment of enterprises with foreign investment in the PRC” is a must.

3) Regarding changes of manufacturing sites,, hygienic testing report of imported disinfectants produced in the new site is a must. Testing over 3 batches of disinfectants for active ingredients, Ph value s and stability are required . The authority may put an onsite inspection over manufacturing place in some cases.

Original Product Hygienic License (卫消进字)

Case 3: Other content changes Reason of content change should be detailed and provide related documents.

If notified through authorized agent, then authorization letter is a must

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www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm

One original copy of each submitted material

Hygienic Administrative Licensing for Imported disinfectants II

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Imported Disinfectant Product Hygienic License

卫消进字

Please be noticed: This application form applies to 1. Cosmetics products 2. Disinfectant and disinfecting apparatus 3. Products involved drinking water

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1

In case of License destruction, the original license provided as evidence

2

In case of License Lost, lost notice on news paper provided as evidence For your information 1.

It should be provincial-level newspaper 2.

Notice published for a period no less than 20 days

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www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm

One original copy of each submitted material

Hygienic Administrative Licensing for New Disinfectants

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New Disinfectants to be licensed

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HelpyouKnowit Driving Green Chemical http://www.moh.gov.cn/sofpro/cms/previewjspfile/zwgkzt/cms_0000000000000000187_tpl.jsp?requestCode=33190&CategoryID=2798

Disinfectant products License I

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Certificate to be applied for being issued by the authority:

卫生许可证

卫消证字

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批准文号

卫消字

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+ HelpyouKnowit Driving Green Chemical

Disinfectant products License II

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Certificate to be applied for being issued by the authority:

HelpyouKnowit Driving Green Chemical

One more thing about Product Hygienic License

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Some additional information for your reference

卫消字

HelpyouKnowit Driving Green Chemical

Label and Product Catalogue of Disinfectants

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Only about the rules of label and catalogue of Disinfectants

1) Product Name 2) Disinfectant Product Hygienic License 3) The name & address of the license holder 4) Disinfectant Product Manufacturer Hygienic License(Imported disinfectants fall out of this scope) 5)Original place (Domestic disinfectants fall out of this scope 6)Date of Manufacture; Period of validity

Be noticed

1) Product Name 2) Disinfectant Product Hygienic License 3) The name & address of the license holder 4) Disinfectant Product Manufacturer Hygienic License(Imported disinfectants fall out of this scope) 5)Original place (Domestic disinfectants fall out of this scope 6)Active ingredients and contents 7)Date of Manufacture; Period of validity

1) Product Name 2) Disinfectant Product Hygienic License 3) The name & address & contact of the license holder 4) Disinfectant Product Manufacturer Hygienic License(Imported disinfectants fall out of this scope) 5)Original place (Domestic disinfectants fall out of this scope 6)Active ingredients and contents 7) Period of validity 8) General uses and guidance 9) Matters need attention 10) Dosage form and specification 11) Effective for what kinds of microbe

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Packaging example of disinfectant

批准文号

卫消字

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粤卫消证字 （2008）第0882号 卫生许可证

卫消证字

卫消字

卫消械字

Pesticide & Agrochemical Pesticide Regulations >

HelpyouKnowit Driving Green Chemical