CHINA CHEMICAL LEGISLATION PRESENTATION

Feb 27 | GLOBALCHEM 2013Gaylord National Resort & Convention Center

Mai FungREACH24H Consulting Group

REACH24H Consulting Group \ GlobalChem 2013

About my presentation

This is a presentation tells what chemical legislation system looks like in China through the introduction of main regulations.

This is a presentation giving you the knowledge and providing you with tips, useful links as well as additional information for practical your use in compliance with Chinese regulations.

Useful links

Additional information

PRESENTED BY MAI FUNG OF REACH24H SPECIALLY FOR GLOBALCHEM 2013

China New Chemicals (MEP Order 7- Revision of Provisions on the Environmental Administration of New Chemical

Substances)

China Hazardous Chemicals (State Council Decree 591 | SAWS Order 53 | MEP Order 22 | SAWS Order

55) & China GHS SDS + Labeling (National standards | AQSIQ Inspection Letter [2012] NO.30)

REACH24H Consulting Group \ GlobalChem 2013

4th level

Chemical legal frameworkDifferent from the western developed countries, chemical legislation framework in China could be shown as the chart below in general.

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

For exampleConstitution

Administrative Law:On this level, the laws was legislated through the state Council

For exampleState Council Decree 591

3rd level

Measures:On this level, the laws was legislated by each functional Ministry

For exampleMEP Order 7MEP Order 22 SAWS Order 53

GB & GB/TKnown as National Standard; usually be divided into GB(/T)GB: National Standard (Compulsory)GB/T: Recommended Standard

For exampleGB 15258-2009GB 20584 – GB 20586 (CN GHS Classification)

2nd levelTop level

Class in legislation systemFrom top to lower level

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Competent authoritiesThis page is just for your reference.

AdministrationSAWS State Administration of Work Safety 安監局

CUSTOMS(GAC)

General Administration of Customs of P.R.C. 海關總署

AQSIQ General Administration of Quality Supervision, Inspection and Quarantine 品質監督檢驗檢

疫總局

SAIC State Administration for Industry and Commerce 工商總局

SDPC National Development and Reform Commission 國家發展和改革

委員會

MinistryMEP Ministry of Environmental Protection

(Replacing SEPA) 環保部

MOR Ministry of Railways 鐵道部

MOA Ministry of Agriculture 農業部

MIIT Ministry of Industry and Information Technology 工信部

MPS Ministry of Public Security 公安部

MOT Ministry of Transport 交通運輸部

MOH Ministry of Health 衛生部Responsible institutesNRCC-SAWS National Registration Center For Chemic

als of SAWS

化學品登記中心

CRC-MEP Chemical Registration Center of MEP 環保部化學品登記中心

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Chem-environmental Management in China

• General hazardous chemicals• HCPEC (list to be released). • Toxic chemicals restricted to be

imported or exported

MEP Order 22

3,800+ 7,000+Catalog of Hazardous Chemicals (to be re-issued) + extremely toxic chemicals + …

State Council Decree 591SAWS Order 53(registration system)SAWS Order 41 55 57…(License system)

45,000+ Existing Chemical substances with no particular management MEP Order

7“Revision of Provisions on the

Environmental Administration of New Chemical Substances”

Ministry of Environmental Protection

State Administration of Work Safety

Ministry of Environmental Protection

• General new chemical substances• New hazardous chemical substances• New hazardous chemicals of priority

environmental concern (NHCPEC)

Existing chemicals New chemicals

REACH24H Consulting Group \ GlobalChem 2013

China New ChemicalsNever call me “China REACH”

Overview of MEP Order 7 Roadmap of MEP Order 7Preparation | Notification | Post-notification

The key part

China New Chemicals

Who will be affected Territories under the regulation

What chemical substances are subject to it

• New chemical substance out of IECSC• New substance in preparation/mixtures (surfactants, plasticizers, preservatives etc.)• Article with intended release of new substance• UVCB (Substances of Unknown or Variable

Composition, Complex)• Polymer

Exemption from notification• Finished products subject to other existing regulations • Substances exist in nature• Substances of noncommercial purpose or unintentionally produced (Impurity <10% w/w | Chemical produced from reactions | Waste water, gas or solid waste or other by-products) • Substances of special categories (Material: glass materials, ceramics, etc. | Homogeneous and heterogeneous alloys | Non-isolated intermediates New chemicals in Articles: intended release chemical in article excluded)

Applied to a Chinese entity• Affiliate of a foreign company in China• Manufacturers of new chemicals• Importer of new chemicals• Representative agent in China assigned by a foreign company (A representative agent shall meet some requirements)

A notifier could be a foreign entity; the applicant and holder of a certificate will be Chinese entity.

X

Territories Applicable • Within Chinese Customs

Boundary• Bonded areas & Export

Processing Zones

Inapplicable • Hong Kong, Macau, Taiwan• Cargos temporarily stored in

processing zones or to be exported with no processing

Overview of Order 7“Revision of Provisions on the Environmental Administration of New Chemical Substances”. It is administered by the MEP and implemented by Chemical Registration Center (CRC-MEP). SEPA has replaced by MEP.

Invalid2002

Issued2010

Came into forceOct 15 2010

Order 17 by SEPAProvisions on the Environmental Management of New Chemical Substances in China

Order 7 by MEPRevision of Provisions on the Environmental Administration of New Chemical Substances in China

China New Chemicals

Statistics recap of Order 7Recap notification cases under MEP Order 7 in 2012Source: Chemlinked.com | CRC-MEP (Jan 30 2013)

406Jan-Jun 2012

484Jul-Dec2012

890/1,854Scientific Research Record Notification

1,474Jan-Jun2012

3,402Jul-Dec2012

3402/7,969Simplified Notification

Special case | General case

30Jul-Dec 2012

11Jan-Jun 2012

41/43Regular Notification

14 submission in 2012 left to be approvedApproved 14 general hazardous substances | 21 NHCPEC

47.9% 42.7% 95.3%

(393)(3,009)

China New Chemicals

Notification PreparationDetails of notification procedures will be unfolded at each stage.

Preparation Notification Post-notification

5+ yearsbefore listed in IECSC

IECSC inquiryIECSC since 2003

• To get to know whether your chemical substance is new or not

• No need for additional information at this stage

42,436 Online (Free)8,175 with no CAS# includedSearch with one of 3 identities:English name | Chinese name | CAS#

It returns with either of 2 results:…listed in IECSC…is not found in IECSC

PC version of IECSC8,500CNY (1,400USD)

Formal inquiry600CNY (100USD)

42,436 (10 work day)It additionally includes3,166 confidential substancesUp-to-date database

CRC-MEP has its own internal identification method for substances with no CAS#

42,436 (200M software)It additionally includes3,166 Confidential substances

Not easy for some products withsame generic name but different CAS#

Useful link:Different IECSC version on CRC-MEP

Additional information:Valued tips for applying IESCE inquiry

China New Chemicals

IECSC 2013 was publishedPDF of IECSC has come out and been kept updated.

Additional information:IECSC (2013) PDF download

42,4368,175 with no CAS# included

3,166 confidential chemical substances

45,602 in totalIECSC Ver. 2010

• Online database (free)• Pc version

42,342

3,270 confidential chemical substances

45,612 in totalIECSC Ver. 2013

• PDF• Online database updated in

early Feb.• Pc version (2010 ver. purchasers

get updated for free) released in early Feb.

IECSC database 2013

What is new?

• Minor mistakes of chemical name and molecular formula fixed;

• Some new chemicals notified under SEPA Order 17 (2002) included;

• Chemicals through IECSC supplementation (Supplementation should be submitted before Dec 01 2011) during Nov. 2010 & Nov.2011 in accordance with MEP Notice [2011] No. 1366

IECSC database 2010

Updatedon Jan 30

2013

China New Chemicals

Notification implementationDetails of notification procedures will be unfolded at each stage.

Preparation Notification Post-notification

5+ yearsbefore listed in IECSC

Existing Substancesnot subject to MEP Order 7

New substancesSubject to MEP Order 7

X

Regular Notification

Simplified Notification

Scientific Research Record(SRRN)

3 types of notification

• Data gap analysis• Testing proposal• (Scientific Research Record)• Testing execution• (Risk Assessment )• Dossier generation

Dossier and submission material

(SRRN): for testing sample(Risk Assessment): for regular notification

1 2

IECSC inquiry

3

CRC-MEPSubmission & (Review)

Certification orPublic announcement

(Review): for regular notification & general case of simplified notification

Submission and certification

Simplified NotificationRegular Notification Scientific Research Record (SRRN)

Appliedtonnage band

Tier 1: 1-10t/a Tier 2: 10-100t/a Tier 3: 100-1000t/a Tier 4: 1000+t/a

0.1 – 1t/a <0.1t/a

Supplementalinformation General case

Special case• Intermediate, <1t/a• only for export, <1t/a• for scientific research 0.1 to 1t/a• for polymer with new monomer

(<2%w/w) (no volume limited) • new polymer of low concern (No volume

limited)• for PPORD,1-10t/a (2-year validity)

NotificationDuration

8-18 Months(largely dependent on testing

arrangements: Tier 4 may need much more time)

5-10 Months(general case) 2-3 Months (special case)

14 workdays

PPORD: Process and Product Orientated Research & Development

For the scientific research purpose

Testing samples imported for compulsory eco-toxicological testsSRRN is necessary for regular notification and general case of simplified notification because of sample needed for tests.

Complication indicator documents | data | procedures

Special cases of regular notification• Serial Notification Similar substances notification once• Joint Notification Joint notification(data or cost-share)• Repeated Notification Notification by referring to the data owned by previous notifiers.• Re-notification Tonnage increase; registered use change• Joint Serial Notification

3 types of notification

1

+

+

Notification Application FormNotification Application FormNotification Application Form

Research informationEnglish and Chinese chemical name

Testing institute information

Eco-toxic test reports (general case) (1-3 tests)

Compliance statement (special case)Scientific Record Form (general case)

Scientific Record Form

Regular notification Simplified notification SRRN

• Test reports/data (Phyiso-chemical, toxicology & eco-toxicology)• C&L for hazardous substances (China

GHS)• Risk Assessment Report(since 1t/a) • SDS…

Tests required according to different tiers; Phyiso-chemical and toxic data could be

secured from testing institutes out of China but preferred being generated from GLP labs, following OECD methods

Some eco-toxic data must be generated by MEP-accredited Chinese testing institute* with Chinese organism

Phyiso-chemical data Melting point Water-solubility Partition coefficient noctanol/water

Data could be secured from testing institutes out of China but preferred being generated from GLP labs, following OECD methods (preferred): Data from SDS could be also acceptable

Eco-toxic data within China Ready biodegradation (only for organic) Acute toxicity test for fishes Acute toxicity test for earthworm

Eco-toxic data generated by MEP-accredited Chinese testing institute with Chinese organism;

No data requirement for special case

Useful link: 10 (8+2) MEP-accredited testing institutes The list of MEP-accredited Eco-toxic testing institutes

Laboratory test report

Publish literature

Database

QSAR

Expert

Complication indicator documents | data | procedures

Data acceptable indicator Data sources acceptance by MEP

Accreditation proof of lab provided

Full official document will be accepted only

Details on the database requiredname, publish institute, edition etc. Models, parameter, developing unit, edition, effectiveness provided

Profile of expert is a must; statement only as supplemental support

2

Dossier and submission material

General case through Expert Committee review

3

Submission and certification

Regular notification Simplified notification SRRN

Hardcopy

+

• Application form &Hazardous classification form

• Test reports required and risk assessment report, SDS & label

• Printed Application form with stamp and signature

• Other necessary documents (POA, authorization letter if a foreign company appoints 3rd party to carry out notification)

Online

Hardcopy

• Online submission software (only in simplified Chinese) is the only accepted submission method since Jan 2012

• Original copy printed through the submission software shall be submitted with stamp and signature as well

• Online submission software (only in simplified Chines) is the only accepted submission method since May 2012

• Original copy printed through the submission software shall be submitted with stamp and signature as well

or

Notification CertificateIssued by MEP for Simplified and regular notification

Submit to CRC-MEPSubmit to CRC-MEP Submit to CRC-MEP

Reviewed by MEP and decided to approve (much time consumed)

1

2

3

Regular notification through Expert Committee review

• Regular notification- Valid since date of issue till being listed in IECSC after 5 years.

• Simplified notification – Valid since date of issue till the certificate cancellation applied for or repealed by the holder.

• Post-notification obligation shall be fulfilled to remain the validity of the certificate.

Online Public Announcement For Scientific Research Record Notification (SRRN)

• Notification number• Notification type• Certificate holder (Foreign company is presented)• Notifier • EN & CN chemical substance name• CAS#

Email or CD

China New Chemicals

Post-notification obligationDetails of notification procedures will be unfolded at each stage. Done

Preparation Notification Post-notification

IECSC inquiry Submission & Notification Certificate

General new chemical substances

New hazardous chemical substances

New hazardous chemicals of priority environmental concern (NHCPEC)

Obligation will be fulfilled according to 3 different management categories based on “Guidance for Hazardous Identification of new chemical substances” HJ 154-201* to replace HJ/T 154-2004

Obligation indicator More obligations put on

Useful link: HJ/T 154-201* (Chinese ver.)Guidance for Hazardous Identification of new chemical substances

General new chemical substances

New hazardous chemical substances

NHCPEC

Obligation indicator More obligations put on

• Communicate MSDS to downstream users

• Implement risk management measures

• Do not sell chemicals to downstream users who are not capable of implementing risk management measures

• Submit first-activity(manufacture or import) report

• Keep documents on file for over 10 years

• Submit updates if new hazard arises

• Submit Annual Report (for previous year, submitted before Feb 01 each year)

• Comply with <<Measures for The Administration of Registration of Hazardous Chemicals>> SAWS order 53

1

2

• Submit report on disposal information

• Submit substance flow chart

• Submit annual plan (for next year)

3

Additional information: Annual ReportGuidance on Annual Report of New Chemical Substances (Trial | En)

The categories of “new hazardous chemical substances” and “new hazardous chemicals with priority environmental concern” are decided according to evaluation of substances through regular notification or simplified notification (general case) given by expert committee based on HJ/T 154-201.

1 1 2 1 2 3

General substances will be listed in IECSC after 5 years since the first activity.

Hazardous chemicals (with priority concern) will be decided to be included by the 5-year activity report submitted 6 months before the 5-year duration.

Substances through SRRN or Simplified notification will NOT be listed in IECSC automatically.

In pursuant of Decree 591, new chemicals with hazardous properties shall be registered, and the competent authority is NRCC-SAWS .

China New Chemicals

Roadmap of Order 7It will be a long way before stricter enforcement implemented, but you have to remain alert on that. Last Page of MEP Order 7

MEP Order 7 published Improving and progressing Fully inspection & enforcement

MilestoneMEP Order 7 came into force on 15 Oct. 2010, replacing SEPA Order 17 in 2003

EnforcementMEP, CRC-MEP, local Environmental Protection Bureaus.

Short in man power and experience, that will need more time to be changed.

What is the focus for now?• Improve the internal work flow• Consolidate the communication with active notifiers for better mutual understanding• Erase the unclear points in the regulation, and make it “applicable” and “unambiguous”• Guidance and supportive documents like: Guidance on Risk Assessment Report Guidance for Hazardous Identification of new chemical substances Measures on Expert Management for Chemical Environmental Management Notice

CurrentlyThe authority is now being much

stricter with assessment and verification of notification submitted.

Case 1: Generic name of a serial products

Case 2: Plant extract – whether a plant extract shall be notified only for itself (but purification seems difficult); or notification of plant extract in a solvent is allowed

Penalty: • 10,000CNY-30,000CNY• Repeal certificate

“Mild” punishment

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China Hazardous Chemicals

Overview of the legislation framework SAWS Order 53 and MEP Order 22 (Comes into force Mar 2013) SAWS Order 57

China Hazardous Chemicals

Permit for (SAWS Order 41, SAWS Order 55 and SAWS Order 57)Manufacturer | Importer | Operation | Distributor & storage | Transporting | User

Overview of Hazardous Chemical legislation

Feb 1987Regulation on the Safe Management of Hazardous Goods

Mar 2002 Decree 344Regulation on the Control over Safety of Hazardous Chemicals

2011 Decree 591Regulation on Safe Management of Hazardous Chemicals

Invalid1986

Invalid2002

Issued2011

Came into forceDec 01 2011

Came into forceAug 01 2012

Aug 2012 SAWS Order 53Measures for the Administration of Registration of Hazardous Chemicals

State Council Decree 591Regulations on the Control over Safety of Hazardous Chemicals (top law)

Sep 2012 SAWS Order 55Measures for the Administration of Hazardous Chemicals Operation Permit

Came into forceSep 01 2012

Come into forceMar 01 2013

Mar 2013 MEP Order 22Measures for Environmental Management of Registration of Hazardous Chemicals

Registration System

Permit & License

China GHS

Catalog of Hazardous Chemicals (China Classification & Labeling (C&L) inventory)

SAWS Order 53 | MEP Order 22 (SEPA Order [1994] NO.140 | MEP Notice [2009] NO.113)

Leave to the 3rd part

Dec 2011 SAWS Order 41Measures for the Administration of Hazardous Chemicals Safe Production Permit

Come into forceMay 01 2013

May 2013 SAWS Order 57Measures for the administration of Hazardous Chemicals Safe Use Permit

China Hazardous Chemicals

State Council Decree 591Hazardous chemicals are administrated through a complex regulatory network in China, with more than ten ministries involved. As the key legal document, Decree 591 sits at the top of this structure. English ver. available on Chemlinked.comWho will be the enforcement

bodies? ?MIIT (Primary authorities)

NRCC-SAWS + SAWS

MEP

MOT

SAIC

AQSIQ

Each enforcement body will be responsible for specific part.

MOA

MPS

SDPC

SAWS: • Implementation of registration of hazardous chemicals;• License system (Order 41 Order 55 Order 57 –

manufacturing; operation; use)

The specific responsibilities

AQSIQ: • Implementation of registration of hazardous chemicals;• Implementation of enforcement actives over packaging and

storing of hazardous chemicals; also the QS license(license for industrial product manufacturing)

MPS: • License of purchase of extremely toxic chemicals ;• Permit of transport of extremely toxic chemicals on road;

China Hazardous Chemicals

Who will be affected by the Decree 591? ?

Manufacturer in China

Importer in China

Distributor and storage company

Transportation company in China

Chemical user in China

Only Chinese companies will be affected directly.

What actions shall be subject to the Decree 591?

Production

Sales and storage

Use

Transportation

It will affect the whole supply chain

Whose obligation?

China Hazardous Chemicals

Why Decree 591 also matters to foreign companies?

It is a domestic law, then why it matters to overseas enterprises?

On one hand, even though your company is located far away from China Mainland, the suppliers or importers of hazardous chemicals listed in the catalogue in China will have to face even stricter inspection of the enforcement authorities. So get to know whether your business partners have been aware of the responsibilities they shall fulfill in pursuant of SAWS Order 53.

One the other hand, because the implementation of China GHS draws extremely high attention of the competent authorities, companies outside China shall pay much more attention to their preparation of GHS compliance, especially classification, labeling, SDS and packaging instead of roughly doing translation or simply ignoring differences of standards applied from area to area.

?

1

2

China Hazardous Chemicals

Catalog of Hazardous ChemicalsThe to-be-released new Catalog of Hazardous Chemicals (China C&L Inventory) is the spirit of China GHS.

What are the hazardous chemicals under Decree 591? Those chemicals have been defined as “highly toxic chemicals” or other chemicals with toxic, corrosive, explosive, flammable and other properties, which will do harm to people , facilities and environment.

?

Additional information:335 Extremely Toxic Chemicals(2002rev.| EN)

Additional information:3800+ Catalog of Hazardous Chemicals (2002rev.|EN)

The current Catalog of Hazardous Chemicals came up with Decree 344

+

• came from Catalog of Hazardous Chemicals (2002).

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

• Under Decree 591, Art (23) (24) (25) (35) (38) (39) (40) (48) (50) has regulated the production, use, sell and purchase, transporting of extremely toxic chemicals

3800+ (2002ver.)

335+ Extremely Toxic chemicals synthetic substances & mixtures(agrochemicals)

Hazardous chemicals or those with priority environmental concern under MEP Order 7 may likely be one source where the new Catalog of Hazardous Chemicals come from

in the future

To be updated

7000+ Inventory of Hazardous Chemicals (China C&L Inventory), first batch of

4,000 chemicals might be released around Jun.(But with no classification this time…)

C&L Inventory from EU, Japan will also be referred to for the update of the new Catalog

335 toxic chemicals: Company holding safe production, operation, use permit (SAWS Order 41 55 57) to conducting purchase.

Out of scope (under specific control laws)- explosives for civil use ;- fire cracker, fireworks;- radio-active substances;- dangerous chemical for national defense;

China Hazardous Chemicals

Current version 2002

3800+

New Version to be published

7000+

Current Catalog of Hazardous Chemicals

New Catalog of Hazardous Chemicals(China C&L Inventory)

Product nameOther name

English nameOther EN name

CAS# UN# Hazardous classification

GHS pictogram Signal word Hazardous statement

Remark

“In the new version of Catalog, the chemicals will come with the information and hazardous properties .”

What new Catalog looks like?The new catalog(China C&L Inventory) will be specific, more elements introduced.

China Hazardous Chemicals

Emergency Response CallA question everyone will ask. ER call has been a must for registration of hazardous chemicals (Art.22 SAWS Order 53), China GHS-compliantSDS and label. Last page of overview of Decree 591

1) For companies those are planning ER Unit on their own• ER call should be a Chinese landline; • designated staffer as 24h supporter; • staffer should be well trained with competent capabilities of hazardous chemicals handling;

2) Other companies shall appoint accredited agent to handle ER responsibilities. Importers of hazardous chemicals shall set up ER unit or commit the preparation of ER work to import agent or registration institutes. As we have noticed there is only one qualified 24h ER call institute (NRCC- SAWS Order 53 Art.6(4)) located in China so far till now.

3) Penalty: <30,000CNY for failure in preparation of ER call.

We have been aware that NRCC will take random inspection over the ER call installation.

Useful link: NRCC emergency response callhttp://er.nrcc.com.cn | t: (+86) 0532 8388 9090

24h on-dutyChinese Landline

Designated-&-trained staff

Hand this to service provider

Or

+

Keep these in mind

Registration systemOverview of SAWS Order 53 (I)Measures for the Administration of Registration of Hazardous Chemicals. This new regulation specifies the procedures of registration of hazardous chemicals, and stresses the implementation of China GHS. English ver. is available on chemlinked.com

2012 SAWS Order 53Measures for the Administration of Registration of Hazardous Chemicals

Invalid2002

Issued2012

Came into forceAug 01 2012

Oct 2002Measures for the Administration of Registration of Hazardous Chemicals by the former State Economic Trade Commission (now integrated in the Ministry of Commerce)

Focuson

• Phyiso-chemical and hazardous properties;• Classification and labelling;• Storage condition, safe use &transport;• Protection and emergency response; • Main uses & restricted uses

Whoaffected

• Manufacturer of hazardous chemicals in China• Importer of hazardous chemicals in ChinaChemical users or storage companies of hazardous chemicals have been released from registration obligation under this new order.

Registration online

CompetentAuthority

NRCC-SAWS | SAWS

China Hazardous Chemicals

• Build files for hazardous chemicals;• Register hazardous chemicals & accept inspection;• Designate staff to be responsible for registration;• Entrust qualified institutes to conduct hazard identification;• Set up 24h emergency telephone consultation.

Whatchemicals

• Catalog of Hazardous Chemicals3800+ chemicals (version 2002) to be re-issued or know as China C&L Inventory

• Chemicals not subject to the Catalog but with hazardous classification by accredited institutes

Specific guidance will be published later for hazardous identification and classification1) List of chemicals of required for hazard identification and classification(unavailable)2) Measures for the Administration of hazardous identification and classification update: Measures on the Management of Physical Hazard Identification and Classification for Chemicals and more practical guidance will be given3) Accredited institutes• For physical hazards identification: 2 Labs (one attached to NRCC)• For toxic hazards identification: 20 MOA-accredited labs• For eco-toxic hazard identification: 9 MEP-accredited labs

Useful link:Measures for the Management of Physical Hazard Identification and Classification for Chemicals (chemlinked.com)

Registration systemOverview of SAWS Order 53 (II)

Registrantobligation

Notice

• A Company producing and importing same hazardous chemicals shall register as manufacturer, providing the information of the imported hazardous chemicals.

• An importer importing same hazardous chemicals from different manufacturers shall register chemicals of the manufacturers for its first trade , and furthermore provide the information of such chemicals from other manufacturers.

• Manufacturers and importers importing same hazardous chemicals from the same manufacturers for many times shall only register the chemical once.

Source: officer from NRCC-SAWS

China Hazardous Chemicals

Registration of Manufacturerunder SAWS Order 53Key points of registration to be carried out by a manufacturerof hazardous chemicals

Manufacturer: Companies make concentrated hazardous chemicals. However, hazardous chemical purchasers, repacking or dilute it with non-hazardous solvents are not considered as manufacturer

Prior to the final acceptance of a newly-built chemical plant

What to be submitted

• 2 original copies of Registration form of hazardous chemical producer/manufacturer;

• Business license of registrant;• 1 copy of SDS and China GHS-compliant

Precautionary Label (GB 15258-2009);• Emergency response call number (Art.22 SAWS

Order 53) or 1 copy Emergency service contract; • Product standard of the hazardous chemicals to

be registered (national standard-GB or industrial standard to be provided)

Content of registration

When to register

• Information of manufacturer (the registrant)1) Extremely toxic chemicals (the list of 335 substances)2) Hazardous Chemicals under Priority Management (2 batches, 13 chemicals in the 2nd batch have been published formally on 10 Feb 2013) List of produced chemicals (all chemicals in one certificate) Identification of source of major hazards Identification of priority-management process of hazardous

chemicals

• Information of each hazardous chemical (core)1) information of chemical2) the manufacturer of hazardous chemicals imported3) composition4) classification & labeling (hazard category, pictogram, warning signals, hazard statements, precautionary statements)5) physic and chemical properties6) main uses and advised uses against7) hazardous properties (physical hazards, health hazards & environmental hazards)8) occupational exposure limits in working place9) storage conditions and transportation information10) protection measures and emergency response

Useful link:The interpretation of registration form for manufacturer and importer of hazardous chemicals in China

Useful link:List of Hazardous Chemicals under Priority Management (2nd Batch) (chemlinked.com)

China Hazardous Chemicals

Registration of importerunder SAWS Order 53Key points of registration to be carried out by an importerof hazardous chemicals

Importer (trader or downstream chemical user)• Companies have secured business

licenses and the certain documents or certificates, being allowed to conduct importing activities of hazardous chemicals.

• For chemical user after importing activities, company will put hazardous chemicals into industrial production.

Prior to any importing activities

What to be submitted

• 2 original copies of Registration form of hazardous chemical producer/manufacturer;

• Business license of registrant and 1 copy of any of following document or certificate: Foreign trader registration certificate or Import and export enterprise qualification certificate

or Foreign investment approval certificate; or Hong Kong and Macao and overseas Chinese

investment enterprise approval certificate.• 1 copy of SDS and China GHS-compliant Precautionary

Label (GB 15258-2009);• Emergency response call number (Art.22 SAWS Order

53) or 1 copy Emergency service contract; • Product standard of the hazardous chemicals to be

registered (national standard-GB or industrial standard to be provided)

Content of registration

When to register

• Information of downstream user of chemicals imported or Information of trader of chemical imported

1) Extremely toxic chemicals (the list of 335 substances)2) Hazardous Chemicals under Priority Management List of imported chemicals (all chemicals in one certificate) Identification of source of major hazards Identification of priority-management process of hazardous

chemicals (only for downstream user or companies with storage facilities)

• Information of each hazardous chemical (core)1) Information of chemical2) the manufacturer of hazardous chemicals imported3) composition4) classification & labeling (hazard category, pictogram, warning signals, hazard statements, precautionary statements)5) physic and chemical properties6) main uses and advised uses against7) hazardous properties (physical hazards, health hazards & environmental hazards)8) occupational exposure limits in working place9) storage conditions and transportation information10) protection measures and emergency response

China Hazardous Chemicals

Registration procedureunder SAWS Order 53In this section, let’s go through the registration procedure for importer of hazardous chemicals under Order 53.

Useful link:Online registration software (NRCC-Chinese only)Chrome “Adblock plus” may block the pop-out tab

Registration CertificateValidity period: 3 years• Remain the information on the certificate

up-to-date (update online within 15 days when changes occur)

• Extend the certificate after 3 years (apply for verification of extension of certificate online 3 months before it expires)

• Fail in registering• Fail in updating information of

hazardous chemicals or new hazards

Fine:<50,000 or 50,000-100,000CNY

• Fail to provide ER number or unqualified ER service

• Fail to update information of registrant, ER number, company seat

• Fail to apply for extension as certificate expires

• Forge certificate etc.• Illegally obstruct enforcement

activities and inspection

Fine:<30,000 CNY

Legal liabilities

Apply through online registration software

(NRCC)

Step1

3 work days

Step2

Registration office

(provincial level)

format check

FailNotice of rejection of registration application

Submit hardcopies of registration materials

to registration office at provincial level

20 work days

Registration office

(provincial level)format check

FailNotice of rejection of registration application

15 work days

NRCCFinal check

China Hazardous Chemicals

Supportive documentsThis page is just for your reference. SAWS Notice [2012] No. 144

8Doc.

Oct.17 2012

2 major supportive documents

Registration form of hazardous chemical producer/manufacturer1

2Registration form of hazardous chemical importer (Sections to be finished by trader & downstream user separately)

3-8• Application form of subject registrant• Application form of registration modification• Evidential document of registration modification

(no registration certificate to be re-issued after modification)

• Application form of registration certificate renewal (certificate expires)

• Notice of rejection of registration application• Notice of requesting supplementary materials

Useful link:NRCC Consults on 8 Supporting Documents for SAWS Order 53 (chemlinked.com)

China Hazardous Chemicals

SAWS Order 53 is different from

Roadmap of Order 53Brief the plans of the authority for the registration and management of hazardous chemicals. Last Page of SAWS Order 53

Currently Look into future

Supportive documents, tons of guidelines to be published (8 documents and more)

Heavy workload of online registration system optimization

No clear timeline for the implementation of plan

above specifically

Registration officers to be trained with necessary knowledge – GHS, data evaluate, procedure (Mar 2013)Guidance for the registration of substances & mixtures with unknown hazardous properties

The registration of hazardous chemicals is promoted mainly amongst Chinese importers at the 1st stage

Source: officer from NRCC-SAWS

Complete the procedure of registration and post-registration (review and renewal)

The implementation of hazardous identification for chemicals with unknown hazardous properties

New database of hazardous chemicals is planned to be established within 3 years in the future

Registration systemOverview of MEP Order 22 (I)Measures for Environmental Management of Registration of Hazardous Chemicals. Taking existing hazardous chemicals under control. English ver. is available on chemlinked.com

2012 MEP Order 22Measures for Environmental Management of Registration of Hazardous ChemicalsOrder 140 and Notice 113 to be incorporated into MEP Order 22

May 01 1994SEPA replaced by MEP

Issued (Trail)Oct 2012

Come into forceMar 2013

1994 SEPA Order [1994] 140Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals

Focuson

the management of general hazardous chemicals, toxic chemicals and chemicals with higher hazardous properties against human health and environment. Some content may be also shared with SAWS Order 53

ValidJan 2 2003

1994 SEPA Order [1994] No.140Revision of Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals

ValidSEP 2009

2009 MEP Notice [2009] No.113Notice of the Environmental Administration of Registration of the Import and Export of Toxic Chemicals (practical guidance on toxic import & export registration)

Whoaffected

• Manufacturer and user of hazardous chemicals in China• Importer and exporter of toxic chemicals in China (foreign

companies qualified under MEP Notice [2009] No. 113)Application scope is to be confirmed. However, in Art.2 of MEP Order 22, it indicates that only companies located in China will be subject to the law;

No regulations for production or use of

toxic chemicals

]=

CompetentAuthority

CRC-MEP | MEP

another registration regulationMEP Order 22

41 items revised

Useful link:MEP Order 22 vs SAWS Order 53 (chemlinked.com)

China Hazardous Chemicals

Whatchemicals

Registration systemOverview of MEP Order 22 (II)

Refer to extremely toxic chemicals and other chemicals listed in Catalog of Hazardous Chemicals.

Additional information: 158 chemicalsList of Toxic Chemicals Severely Restricted to be Imported into or Exported from China

Useful link:Chinese Official Clarifies Must-Know Issues on MEP Order 22 (chemlinked.com)

Supportivedocuments

Only the regulation of MEP Order 22 has been published, other guidance or supportive documents are still absent.

Importer and exporter of toxic chemicalsManufacturer and user of hazardous chemicals

Catalog of Hazardous Chemicals• General hazardous chemicals 3800+ chemicals (version 2002) to be re-issued or know as China C&L Inventory but not listed in HCPEC list. • Hazardous Chemicals of High Priority

Concern （ Currently more important) Chemicals listed in the New Catalog will be through assessment according to the certain benchmark of hazardous and environmental risk level and later be decided as HCHEC or not. Chemicals like PBT, vPvB, EDC or seriously environmentally-hazardous chemicals with solid evidential proof will mostly be treated as HCHEC (This list will be published by MEP)

List of Toxic Chemicals Severely Restricted to be Imported into or Exported from China 158 chemicals (version 2012) for 2009 MEP Notice [2009] 113 “Notice of the Environmental Administration of Registration of the Import and Export of Toxic Chemicals”

Notice:Under SAWS Order 53, before import of these 158 toxic chemicals, a Chinese importer should be register them by submitting application to NRCC-SAWS as well. CRC-MPE is mainly taking in charge of the management of those 158 toxic chemicals

China Hazardous Chemicals

Role Chemicals Registration & License Materials prepared Related regulation

Responsibleauthorities

Manufacturer &User of hazardous chemicals

General hazardous chemicals (in Catalog of hazardous chemical)

Registration Certificate of environmental management of hazardous chemicals

Application form of registration certificate; registrant information; produced or used hazardous chemicals including quantity; classification; SDS; prevention and control measures; emission of the typical pollutants; Environmental Impact Assessment(EIA); contingency plans for emergency; disposal; annual report (Jan each year) to public on hazards, emission of pollutants, protection measures; Environmental monitoring report

MEP Order 22(Trial) under Decree 591

Local environmental protection authorities

(County level)

Manufacturer &User of hazardous chemicals

HCPEC Registration Certificate of environmental management of hazardous chemicals

Addition to the material required from general hazardous chemicals; Environmental Risk Assessment(ERA) conducted by qualified institutes; Annual report of emission, migration and monitoring result of particular pollutants, and protection measures against pollutants and environmental risks

MEP Order 22(Trial) under Decree 591

Local environmental protection authorities

(provincial level)

Importer and exporter of toxic chemicals

Toxic Chemicals Severely Restricted to be Imported into or Exported from China

• Registration Certificate for environmental management on Import (and export) of Chemicals

& Import release permit for importer• Export release permit for exporter

• Application through CRC software + other documents submission

• Materials are different according to foreign companies; importer as user; importer as trader; importer as representative of foreign companies:

MEP Notice [2009] NO. 113

In future MEP Order 22

CRC-MEP & MEP

EIA: MEP will issue guidance for EIA operationEnvironmental monitoring report: shall be generated by the applicant or the qualified environmental monitoring agency

Importer and exporter of toxic chemicals(a foreign company could do registration on their own or appoint Chinese importers to finish it on their behalf)

Annual report: For manufacturer or user of HCPEC to submit before Jan 31 each year to the administration of Environmental Protection at county level.

Obligation of each role in one tableUnder MEP Order 22

Useful link:MEP Order No 22: A Big Step but Long Way Ahead (chemlinked.com)

China Hazardous Chemicals

Registration procedureof manufacturer and user

If a company were caught of producing/using listed hazardous chemicals without a registration certificate under MEP Order 22 or committing other illegal activities.

Legal liabilities

Fine:10,000-30,000 or criminal responsibilities

Submit registration material to

Environmental Protection

administration

Registrant

5 work days

Environmental Protection

administration Format check

15 work days

County Level City Level

Register for general hazardous chemicalsRegister for HEPEC

5+ work days

Environmental Protection

Administration

Re-check

On-site inspection

Unknown

Environmental Protection

Administration

Provincial Level

Technical Review

10 work days

Registration Certificate of Production & Use (3 year valid)One company one certificate

Whenregister

Prior to the final acceptance of the project of production or use of hazardous chemicals

NoticeRegistration procedure of HCPEC shall be applied if a company produce or use both HCPEC or general hazardous chemicals.

• HEPEC manufacturer or user should submit annual repot to Environmental protection administration (county level) before Jan 31 each year and also Environmental monitoring report.

• Companies with general hazardous chemicals shall publish annual report on environmental management to the public in Jan each calendar year.

Before Order 22, no obligation should be fulfilled by manufacturer or user of toxic chemicals but manufacturer and user of imported toxic chemicals for the 1st time shall submit environmental protection report

Post-registration obligation

China Hazardous Chemicals

Comparison of Order 22 and Notice [2009] No.113last page of MEP Order22

MEP Notice [2009] No. 113 (Valid)

Who affected

MEP Order 22 (Mar 01 2013)

• Foreign companies exporting to China• Importer (Trader) in China• Importer (downstream user) in China• Exporter in China

Exporter and Importer in China(to be confirmed)

Responsibilities

Registration Certificate for Environmental Management on Import and Export of Chemicals- 3 year validity+

Import or Export release permit issued by the Customs

Registration Certificate for Environmental Management on Import of Chemicals (only for importer or Foreign companies) – 2-year validity; importer could register on behalf of a foreign company

Import release permit for each batch of registered chemicals issued by the Customs (6 month validity)

Export release permit for each batch of registered chemicals issued by the Customs (6 month validity)

No specific explanation of practical registration procedure at this time

• CRC online registration and permit application software + other documents submitted to CRC-MEP;

• The materials to be submitted by importer as trader and downstream user would be different;

• Pay the registration fee (10,000USD/certificate) prior to submission of application.

Notice

China Hazardous Chemicals

Permit & License SAWS Order 57In 2011 and 2012, SAWS Order 41 and 55 known as Production Permit) and Safe Operation Permit have come into force, here is another important license under Decree 591, ”Measures for the Administration of Hazardous Chemicals Use Permit.” –SAWS Order 57. Search database of Chemlinked.com

2012 SAWS Order 57Measures for the Administration of Hazardous Chemicals Use Permit

IssuedNov 2012

Came into forceMay 01 2013

Whoaffected

Companies hold Hazardous Chemicals Safe Production Permit already (SAWS Order 41)

Whoexempted

Companies using hazardous chemicals for certain industries and the quantity of usage exceeding certain threshold volumes will have to apply for Safe Use Permit under Order 57. Companies using hazardous chemicals used fuel shall be exempted from obligation Order 57.

Useful link: The Directory of Industries (Ver 2013) and use quantities limitfor hazardous chemicals in China under SAWS Order 57

If a company were caught of using the hazardous chemicals and reaching volume limit but without the Safe Use Permit under SAWS Order 57 will face 100,000-200,000CNY fine, or even suspending operations for consolidation.

Legal liabilities If a company fails in updating the information of permit when changes occur, it will meet 10,000-30,000CNY fine.Notice

• Materials to be submitted for registration shall include GHS-compliant SDS and precautionary label from the chemical supplier.

• Work Safety administration (City level) will be responsible for the verification of application and certificate to be granted.

• With respect to the use quantities, either of planned quantity or actual quantity whichever is larger will be applied.

• The valid period of a Safe Use Permit will be 3 years. Application for extension of permit shall be submitted 3 months before it expires.

Recently, SAWS updated the industries under the Scope of Order 57 (Feb26-Chemlinked.com)

China Hazardous Chemicals

Roles Registration Main License Subject to Regulation Enforcement Bodies

Manufacturer Registration Certificate

Hazardous Chemicals Safe Production Permit

SAWS Order 53 under Decree 591; SAWS Order 41 under Decree 591

GB for C&L

NRCC of SAWS; Local Work Safety Department

Importer (Trader/ chemical user after import)

Registration Certificate

Hazardous Chemicals Operation Permit /

Hazardous Chemicals Safe Use Permit

SAWS Order 53 under Decree 591; SAWS Order 55 under Decree 591/SAWS Order 57 under Decree 591

GB for C&L

NRCC of SAWS;Local Work Safety Department

DistributorStorage companies

Inapplicable Hazardous Chemicals Operation Permit

SAWS Order 55 under Decree 591; Local Work Safety Department

TransportationCompanies

Inapplicable Hazardous Chemicals Transportation Permit

GB 12268-2012 (List of Dangerous Goods), GB 6944-2012 (Classification & Code of

Dangerous Goods)

Ministry of Transport of P.R.C, Transport of Dangerous Goods on Road

Downstream chemical User

Inapplicable Hazardous Chemicals Safe Use Permit

SAWS Order 57 under Decree 591(May 01 2013)

Local Work Safety Department

Re-cap of corresponding obligationThe obligation of each supply chain roles dealing with hazardous chemicals under Order 53 and related permit & license.

Useful link: GB 12268-2012 & GB 6944-2012English version of GB 12268-2012 and GB 6944-2012 (chemlinked.com)

China Hazardous Chemicals

Hazardous chemicals legislation & China GHSChina GHS is fully supported by the major hazardous chemical legislation known as State Council Decree 591. The last page of China Hazardous Chemicals

• Decree 591 attached by different measures, standards are the major legislation which enforces the China GHS. Chemical products shipped into China usually do not pass the inspection of enforcement because of failure in classification, packaging and labeling. In some cases, SDS poorly translated or prepared in languages other than Chinese also see direct REJECTION.

• In accordance with Article 78(3) (4) (6) (7) of Decree 591, manufacturers and traders fail in providing SDS, labeling and packaging in line with related standards will face a maximal penalty of 50,000CNY.

So how to comply with China GHS? That will be the topic we are going to talk about.

1

2

REACH24H Consulting Group \ GlobalChem 2013

China GHS

Overview of China GHS AQSIQ Quality Inspection Letter [2012] No. 30China GHS-compliant SDS and label

China GHS SDS +Labeling

China GHSIt once was a soft law (recommended), and is now full implemented by being supported by State Council Decree 591, now the legal framework is shown as below. 3 national standards GB 190-2009, GB 13690-2009, GB 15258-2009 entering into force on May 01 2010 have been considered as signal of China GHS mandatory implementation. The focal point is MIIT of P.R.C.

State Council Decree 591Regulations on the Control over Safety of Hazardous Chemicals (top law)

Catalog of Hazardous Chemicals (China C&L inventory)

Classification (China C&L inventory) | Safety Data Sheet | Precautionary label | Packaging (AQSIQ Quality Inspection Letter [2012] No. 30)

Registration System

Permit & License

China GHS

All supported by national standards

Permit for (SAWS Order 41, SAWS Order 55 and SAWS Order 57)Manufacturer | Importer | Operation | Distributor & storage | Transporting | User

SAWS Order 53 | MEP Order 22 (SEPA Order [1994] NO.140 | MEP Notice [2009] NO.113)

REACH24H Consulting Group \ GlobalChem 2013

The most often used GBs

National Standards Scope When came into force

Interested?EN version to be shred on request

GB 13690-2009 General rule for classification and hazard communication of chemicals

1st May 2010 (the core of China GHS)

to be revised in 2014

GB 20576-2011- GB 20591-2011

Physical-hazard category under GB 13690-2009

1st Jan 2008

GB 20592-2011 & GB 20601-2011

Health-hazard category under GB 13690-2009

1st Jan 2008

GB 20602-2011Environmental-hazard category under

GB 13690-20091st Jan 2008

GB/T 16483-2008 Instruction of Safety Data Sheet, Content and Section

1st Feb 2009

GB 15258-2009 General Rule for Preparation of Precautionary Label for Chemicals

1st May 2010 (with one-year transitional period)

GB 190-2009 Packing symbol of dangerous goodsBased on UN 15th Revised Edition <Transport of Dangerous Goods>

1st May 2010

GB/T 22234-2008 Labeling of Chemicals Based on GHS 1st Feb 2009

National Standards of China GHS

Some are compulsory, and some are still recommended

REACH24H Consulting Group \ GlobalChem 2013

China-GHS compliant SDS China-GHS compliant Label

Chapter 2, Art 15 of State Council Decree 591“The manufacturers of hazardous chemicals shall provide SDS and affix chemical precautionary labels on package . SDS and labels shall be prepared in pursuant of national standard.”

Chapter 4, Article 37 of State Council Decree 591“Companies shall not sell any hazardous chemicals with no SDS and precautionary label compliant with national standards.”

The next topics would be focused on

Hazardous classification

China GHS SDS +Labeling

China GHS-classification categoryNational Standard:GB 20576-2006-GB 20591-2006GB 20592-2006-GB 20599-2006 & GB 20601-2006 GB 20602-2006

Will be replaced with GB 20576-2011-GB 20591-2011GB 20592-2011-GB 20599-2011 & GB 20601-2011GB 20602-2011In my material, you find the update in 2011 ver.

China GHS SDS +Labeling

2.1 Explosive2.2 Flammable gases 2.3 Flammable aerosols2.4 Oxidising gases2.5 Gases under pressure2.6 Flammable liquids2.7 Flammable solids2.8 Self-reactive substances and mixtures2.9 Pyrophoric liquids2.10 Pyrophoric solids2.11 Self-heating substances and mixtures2.12 Substances and mixtures which in contact with water emit flammable gases2.13 Oxidising liquids2.14 Oxidising solids2.15 Organic peroxides2.16 Corrosive to metals

The same as UN GHS

GB 20576-2011 ExplosiveGB 20577-2011 Flammable gasesGB 20578-2011 Flammable aerosolsGB 20579-2011 Oxidizing gasesGB 20580-2011 Gases under pressureGB 20581-2011 Flammable liquidsGB 20582-2011 Flammable solidsGB 20583-2011 Self-reactive substances(mixture included)GB 20584-2011 Self-heating substances (mixture included)GB 20585-2011 Pyrophoric LiquidsGB 20586-2011 Pyrophoric SolidsGB 20587-2011 Substance which, in contact with water, emit flammable gases (water reactive)GB 20588-2011 Corrosive to MetalsGB 20589-2011 Oxidizing liquidsGB 20590-2011 Oxidizing solidsGB 20591-2011 Organic peroxides

16 hazards 16 hazards 16 hazards

China GHS-hazards category ICurrent China GHS

Based on UN GHS 2007 Ver.02UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008)

Replacing DSD & DPD since Jun 1 2015

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 – 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

Current China GHS Based on UN GHS 2007 Ver.02

UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008)Replacing DSD & DPD since Jun 1 2015

Slightly different

Slightly different

China GHS SDS +Labeling

3.1 Acute toxicity(Oral | Skin | Inhalation)3.2 Skin corrosion/irritation3.3 Serious eye damage/eye irritation3.4 Respiratory or skin sensitization3.5 Germ cell mutagenicity3.6 Carcinogenicity3.7 Reproductive toxicity3.8 Specific target organ toxicity — single exposure3.9 Specific target organ toxicity — repeated exposure3.10 Aspiration hazard

The same as UN GHS

GB 20592-2011 Acute toxicity(Oral | Skin | Inhalation)GB 20593-2011 Skin corrosion/irritationGB 20594-2011 Serious eye damage/eye irritationGB 20595-2011 Respiratory or skin sensitizationGB 20596-2011 Germ cell mutagenicityGB 20597-2011 CarcinogenicityGB 20598-2011 Reproductive toxicityGB 20599-2011 Specific target organ system toxicity-single exposureGB 20601-2011 Specific target organ system toxicity-repeated exposure

10 hazards 10 hazards 9 hazards

China GHS-hazards category IICurrent China GHS

Based on UN GHS 2007 Ver.02UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008)

Replacing DSD & DPD since Jun 1 2015

Newly included in China GHS

Currently, new version of China GHS has included this hazard (new version has been drafted for public comment)

China GHS SDS +Labeling

Current China GHS Based on UN GHS 2007 Ver.02

UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008)Replacing DSD & DPD since Jun 1 2015

4.1 Hazardous to the aquatic environment4.2 Hazardous to the ozone layer

The same as UN GHS

GB 20602-2011 Hazardous to the aquatic environment

2 hazards 2 hazards 1 hazards

Absent from China GHS

China GHS-hazards category III

The new version of China GHS has NOT yet included this hazard (new version has been drafted for public comment). But this hazard will be seen in the revised national standard in 2014.

Building blocks adopted in China GHS: 2011 ver.Comparison of blocks adopted in UN, EU CLP & China GHS

China GHS SDS +Labeling

SDS under China GHSNational Standard: GB/T 16483-2008 for all hazardous chemical substances andmixtures

Additional information:GB/T 16483-2008 (English)

Some points you must know1) 24h Emergency Response Phone number is a must in GHS SDS and label;2) Concentration limits (the analysis on differences would be available on

request);3) Hazard and precautionary statement shall be written in Chinese;4) The Section 15 (heading 15) shall be focused on relevant Chinese legislation.

China GHS SDS +Labeling

Hazard identification (Substances or mixture)

Composition/information on ingredients

First-aid measures

Content – 16 headings in China SDS

1

2

Identification (of product and supplier)

3

4

1 Chemical Name (Product identifier)

2 Recommendation & Restriction on use 3

1 Classification of products under China GHS

2 Pictogram | Signal word | H statementsP Statements | Emergency response measures

3Hazardous properties (H statements)Physical | Health | Environmental

Define the productSubstance or Mixture

Substance

Mixture (not all ingredients)only classified ones

Substance Name + CAS # + EC#

+ All ingredient (impurities & stabilizer)GHS classification + Concentration (range)

GHS classification applied

Each name of Classified ingredients + Concentration (range)

Confidential ingredients : CBI claimNo clear guidance on CBI claim• Main ingredients contributing to the

hazardous classification and their concentration (ranges) shall be indicated.

• name of these ingredients are allowed to be replaced by other names(generic name) on SDS. For those replaced with specific substance name, the range of concentration shall be given. Moreover, hazards of chemical substances shall be fully indicated.

Classification of ingredients in mixtures• Classification of ingredients in a

mixture is not a compulsory part, but recommended to be put on

1 General description 2Subheading ： Treatments for different routesSkin | Eye | Inhalation | Ingestion 3

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

4 Professional assistanceor doctor’s advice + Medical attention or

Special treatment

Identification of supplier |Contact | 24h ER call GB/T 16483-2008S2 section1

Impurity and stabilizer in substanceOnly if with hazardous properties, classification of impurity or stabilizer should be indicated mandatorily.

China GHS SDS +Labeling

6

7

8

1 Suitable extinguishing mediaUnsuitable extinguishing media 2 Special hazards of the product &

Special hazards arising from the product 3 Special protective equipment &

precautions for fire-fighters

1Personal precautions, Protective equipment Emergency procedures

2 Methods and materials for containment & cleaning up (Specify methods if different from Section 13)3Environmental precautions

5

! 4 Methods applied to prevent from next accident Not existing in UN GHS

Handling and storage

1Precautions for safe handling including advice on technical measures

2 Advice on preventing from contact in ways of … 3

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

Exposure controls/personal protection

1 Control parameters or Exposure limit value

2Appropriate engineering controls; providing supplemental information besides Section 7

3Individual protection measures and equipment- Respiratory - Hand - Eye - Skin

Special protection under special conditions

Heading 5-8

Fire-fighting measures

Accidental release measures

GBZ 2.1-2007Occupational exposure limits for hzardous agents in the workplacePart1: Chemical hazardous agents

China GHS SDS +Labeling

Physical and chemical properties (endpoints to be filled)

9.1 General InfoAppearance ( 形態 )Form ( 形狀 )Colour ( 顏色 )Odour ( 氣味 )

1

pH (pH 值 )Melting point/freezing point ( 熔點 / 凝固點 )Initial boiling point and boiling range ( 沸點 沸程 )Flash point ( 閃點 )Upper/lower flammability or explosive( 燃燒上下極限 或爆炸極限 )

Vapour pressure (20°C) ( 蒸汽壓 )Vapour density ( 蒸氣密度 )Relative Density (20°C)( 密度 / 相對密度 )Water solubility (g/l) ( 溶解性 )n-Octanol/Water (log Po/w) (n- 辛醇 / 水分配係數 )Auto-ignition temperature ( 自燃溫度 )Decomposition temperature ( 分解溫度 )

Testing methods required if necessary2

9.2 Other InfoOdour threshold ( 氣味閥值 )Evaporation rate ( 蒸發速率 )Flammability (Solid, gas) ( 易燃燒 )Explosive properties ( 爆炸性 )

Radioactivity ( 放射性 )Bulk Density ( 體積密度 )

Supplementary information

10

Stability and reactivity

1 Chemical Stability 2 Condition to avoid 3 Incompatible materials 4 Hazard decomposition products

11

Toxicological information

1 Toxicokinetics, metabolism and distribution (Supplementary part)

2 Info on toxicological effects

Acute toxicity (oral Dermal Inhalation) – mammal

Skin corrosion/Irritation

Serious eye damage/irritation

Respiratory or skin sensitization

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

STOT-single exposure STOT-repeated exposure

-

“Aspiration Hazard” will be included in China GHS formally

Provide reliable data generated through tests or referred to competent source2

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

9

Heading 9-11

Consider adding “Aspiration Hazard” in this part if the classification is given1

China GHS SDS +Labeling

Ecological information

Disposal Considerations

1Eco-Toxicity (data on aquatic life and Other organisms)

2 Persistence and degradability

3 Bioaccumulative potential

1 Disposal methods

14

13

4 Mobility in soil

More data provided is highly recommended. Please indicate the reference.

2 Contaminated container and packaging treatment methods

Informed the Down-stream users of the disposal methods

Transport informationIn 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

Regulatory information15

1Whether a substance / mixture (main ingredients) has been included in some Catalogue or Inventory

2 Safety, health & environmental legislation in China for this chemical product （ GB ）

3 Informed the Down-stream users of the disposal methods

16

Other information

1 Indication of changesVersion amended, if applicable

2Advice on professional training, if applicable 3

Disclaimer or other information, Recommended restrictions on use

12

Heading 12-16

China GHS SDS +Labeling

Tips for 16 sections and corresponding headings• Ensure the format of the SDS well designed for the DU and authority

review;• Each heading shall be clearly marked with index number; we suggest

index number also for sub-headings for easier reading;• Sub-headings in each section should be arranged in accordance with

the given order given as the guidance mentioned in slides

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 Heading 1 & Heading 3• Except content of heading 16, never leave blanks in SDS even if information

is unavailable or inapplicable, please also indicate “NA” or “Inapplicable”• SDS NO. together with generation date of SDS shall be given on each page

(Figure 1)• Ensure words selected for the SDS readable and understandable

Tips for China SDS

化学品安全技术说明书根据 GB/T 16483-2008 标准制作

醋酸乙烯SDS NO. *******修订日期： 2013.02.27

Figure 1

打印日期： 2013.02.27

1. 化学品及企业标识 1.1 产品识别 化学品名 产品代码 产品识别信息 1.2 产品推荐及限制用途 推荐用途

1 2 3Heading 2: Hazard identification Heading 1: Identification

Heading 3: Composition/information on ingredients

China SDS template REACH24H Consulting GroupGenerating | Auditing | Software

info@reach24h.com

China GHS SDS +Labeling

GHS Labeling under China GHSNational Standard: GB 15258-2009

Additional information:GB 15258-2009 (English)

Some points you must knowAbout languageThe 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

Other tips• Prepare the China GHS label before your exports arrive;• You are allowed to apply China GHS label on the product ASAP in the place

assigned at the Customs;• Make proper explanation to the officials at the Customs• Emergency Response phone number is a must

China GHS SDS +Labeling

Part I: Name of the product

• 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 (CBI claim): no specific

guidance for CBI claim name of these ingredients are allowed to be replaced label. But if with hazardous properties, those hazards shall be clearly stated.

In accordance with 4.2.1 of GB 15258-2009

24 小时

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 hazards and concentration will be disclosed in SDS and on precautionary label.

CAS 号：浓度：

China GHS SDS +Labeling

Part II: Body of Label

What needs to be presented here:• One signal word (Danger or Warning)• GHS pictogram besides signal word• Hazard Statement (Below Signal word)• Precautionary Statements (Put all statements rather than

pick at most 6 statements like guidance of EU label regulatory)

In accordance with 4.2.2-4.2.5 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 Statements: all statements arranged in the order of

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

In accordance with 4.2.9 of GB 15258-2009

CAS 号：浓度：

24 小时

China GHS SDS +Labeling

Part III: Supplier Identification• “Please refer to Safety Data Sheet”- 请参阅化学品安全技术

说明书 (this sentence is a must)• Supplier identification: Supplier name | Company seat |

Contact number | Zip code (information must be given)24/7 Emergency Response Call. The call shall be a Chinese landline number, either of the supplier itself or a qualified service provider assigned (Art 22 of SAWS Order 53). And in 4.2.7 “Emergency phone number”- Fill in the manufacturer of the chemical or the 24-hour emergency phone number(s) for chemical accidents which are entrusted by the manufacturer.

In accordance with 4.2.6 -4.2.8 of GB 15258-2009CAS 号：浓度：

24 小时

China GHS SDS +Labeling

Elements same as normal-size GHS label• Chemical product name• Signal word and pictogram• Hazard statement • “Please refer to Safety data sheet”• Supplier name and contact• 24/7 ER contact (Chinese landline)--------------------------------------------------Elements absent from normal-size GHS labelPrecautionary Statements

• If either container or packaging is less than or equal to 100ml, simplified label is allowed to be applicable.

• No requirements for Size was specified.

Simplified GHS Label

Container capacity China GHS labelMinimum label size

EU CLP 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)

The size of pictogram• No guidance on dimension of each pictogram but it shall be easily recognizedBlack frame of China GHS pictogram is acceptable, red preferred• A space remained outside the border line of label (3mm at least)• The width of border Line should be remained as 1mm at leastInner packaging

Printed color of GHS pictogram • All black & white or• Red frame | White background | Black icon

Label on combination packagingGHS label for inner or single packaging

China GHS SDS +Labeling

Useful link: choose corresponding transport symbol according to GHS pictogram Annex I of UN GHS 4

Label on combination packagingGHS label for outer packaging

Outer packaging

GB 15258-2009Inner packaging: GHS label

State Council Decree 591–Article 15Inner packaging: GHS label Outer packaging: Product name + Transport symbol + GHS label +UN number

• In case of no need for transport symbol, GHS label could be applied instead

Our advicePost 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 outer box

Symbol size category Symbol size:

1 50 * 50 (mm)

2 100 * 100 (mm)

3 150 * 150 (mm)

4 200 * 200 (mm)

“UN Recommendations on the Transport of Dangerous Goods - Model Regulations”

Transport symbol => 100*100mm

Transport symbolGB 190-2009Select correct transport symbolIf you need the chart of GHS label and corresponding transport symbol contact us

The size rule also applies to single packaging in the next slide

China GHS SDS +Labeling

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

Large tanker or containerCan not be treated as single packaging

Label applying rules:• 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.)

UN numberTransport symbol

GHS label

Product name

• Both Transport symbol and GHS label are necessary on a product with single packaging.

• If pictogram(GHS) and symbol (Transport) are repeated, pictogram (GHS) shall not be presented.

Label on single packagingGHS label for outer packaging. Last page for SDS and label

Companies that fail to provide China GHS-compliant SDS or

precautionary label will meet no more than 50,000CNY fine; in some serious cases, 50,000-100,000CNY fine or even suspending operations for consolidation

Legal liabilities

China GHS SDS +Labeling

AQSIQ Inspection Letter[2012] No.30Specifications on the Inspection and Supervision over Entry-Exit Hazardous Chemicals and Packages released on 29 Feb 2012.

Who will be the enforcement bodies? ?

AQSIQ

CIQ (Local Inspection and Quarantine Bureau)

Who will be affected? ?• Importer or representative agent of hazardous chemicals

imported into in China• Exporter or representative agent of hazardous chemicals to be

exported from China

China GHS SDS +Labeling

Compared with Decree 591

Outside China

State Council Decree 591- SAWS Order 53 | MEP Order 22 …> 3800+ chemicals (version 2002) to be re-issued or know as China C&L Inventory

Responsible for almost each activity throughout the supply chain of a hazardous chemical

AQSIQ - Statutory Inspection Catalog> 160 chemicals in the catalog under priority management of AQSIQ

Only responsible for the activities of chemicals

importation & exportation

Different requirements for importation and exportation of hazardous chemicals in accordance with Inspection Letter No.30

!

China GHS SDS +Labeling

The Statutory Inspection Catalogue ver. 2012 updated on Feb 01 2012

Hazardous chemicals under priority management of AQSIQ

Also it is known as “Catalog of Entry-Exit Commodities Inspected and Quarantined”, in which 160 hazardous chemical selected from Catalog of Hazardous Chemicals.

Additional information:The Statutory Inspection Catalogue 2012 (160 hazardous chemical | EN ver.)

AQSIQ + GAC

• AQSIQ working with GAC mainly focus on the Statutory Inspection Catalog ;

• For other chemicals in the Catalog of Hazardous Chemicals, they will not be taken as top priority.

Statutory Inspection Catalog (Ver.2012)160 chemicals from the Catalog

3800+ Catalog of Hazardous Chemicals2002 ver.

Chemical substances & chemicals in mixtures

China GHS SDS +Labeling

Information & materials submitted for inspection Importer and exporter of hazardous chemicals will have to be subject to different requirements.

Importer or representative agent of hazardous chemicals

Exporter or representative agent of hazardous chemicals

Submit to: Local CIQ at the place of clearing customs

Submit to:Local CIQ at the place of origin where

hazardous chemicals produced

Declare the name of hazardous chemicals in accordance with Catalogue of Hazardous Chemicals

Other materials:• Conformity declaration of operating entity of

hazardous chemicals imported• name, quantity (and other conditions) of inhibitors and

stabilizers contained in the imported products, if available

• China GHS-compliant SDS and precautionary label (bulk products exempted from label requirements)

Declare the name of hazardous chemicals in accordance with Catalogue of Hazardous Chemicals

Other materials:• Conformity declaration of manufacturing entity of hazardous

chemicals exported• name, quantity (and other conditions) of inhibitors and

stabilizers contained in the imported products, if available• Samples of GHS label(s) and Safety Data Sheet(s) the Chinese

translations should be supplied if the GHS label and Safety Data Sheet are in non-Chinese language(s)

• The Identification and Classification Report for Hazards of Chemicals

• The result of Packing Performance for Transportation of Exported Goods Transportation (bulk products exempted)

Additional information: in ChineseConformity declaration of operating entity of hazardous chemicals imported

Additional information: in ChineseConformity declaration of manufacturing entity of hazardous chemicals exported

China GHS SDS +Labeling

Fail in compliance check

Procedure of application for inspection to local CIQHere we illustrate the flow chart of imported hazardous chemicals.

Whether chemicals in the Catalog of

Hazardous Chemicals

Importer

Step 1

Apply for inspection by submitting required info & materials

Not a listed hazardous chemicals

Inspection ceased X

Step 2

Clearance Permit

Step 3

Compliance check:• Materials check• On-site inspection• Sample inspection

Succeed in inspectionExport or import release permit issued by local CIQ for further customs clearance

Step 4

If qualified for rectifying and improving

X Return or RejectionUnqualified for rectifying and

improving

Conduct Rectifying & improving or

China GHS SDS +Labeling

Inspection upon imported & exported hazardous chemicalsLocal CIQ will implement inspection over chemicals for the following content

Identify whether the composition/constituent information of goods, physical and chemical properties, hazard class, packaging category meet the requirements of relevant standards, and whether they are consistent with the hazard identification and classification report, SDS and chemical safety label provided when applying for an inspection;

Identify whether a Chinese SDS has been provided along with the goods, whether a Chinese label has been affixed on the packaging of goods; whether the contents in SDS and label meet the requirements of relevant standards and are consistent with the goods.

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2

Get to know clearly whether model, category, specification, unit quantity and mark of packaging meet the standards and whether the packaging has been adapted to the properties and uses of the inspected goods.

Always ensure the packing method meets standards and the use of packaging is appropriate, whether the packaging is sealed tightly to prevent the goods from leaking.

About inspection on packagingClassification, label and SDS

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Packaging for exported hazardous chemicals

Packaging for Imported hazardous chemicals

Items including packaging type, packaging method, weight per piece etc. will be inspected for the result whether packaging meets the standards of TDG, IMDG code, ICAO Technical Instruction and so on.

Dependent on the transportation, by sea, air, automobile, or railway, the result of Packing Performance for Transportation of Exported Goods (finished by the packaging suppliers by applying through local CIQ). The result of Packing Performance for Transpiration of Exported Dangerous Goods will be issued by the local CIQ later.

China GHS SDS +Labeling

Pay special attention toTips for companies export hazardous chemicals to China.The last page of China GHS

• Prepare your China GHS-compliant SDS before product shipped to China

• Affix label to the outer packaging

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• We suggest pre-viewed of your SDS and label by handling to your Chinese importers or service providers

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• Always ensure the information to be notified to the CIQ is the same as the actual information of products imported or exported

Qualified SDS & label are mostly required at this time !• The point mostly focused on is

whether the format of a label or SDS meets the Chinese national standards; whether the language is written in Chinese or with the translation at least.

• If fail in SDS and Label, companies shall conduct amendment of related content.

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PRESENTED BY MAI FUNG OF REACH24H SPECIALLY FOR GLOBALCHEM 2013

Thanks & Questions?Special thanks to professional supports from PhD Liang Dan, Xiang Guozhao,

Eric Sun, Xu Bin, PhD Sun Jing, Charles Feng and Erin Wu of REACH24H

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