Presentation on GlobalChem 2013

CHINA CHEMICAL LEGISLATION PRESENTATION Feb 27 | GLOBALCHEM 2013 Gaylord National Resort & Convention Center

Mai Fung REACH24H Consulting Group

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

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China New Chemicals China Hazardous Chemicals & China GHS SDS + Labeling

(MEP Order 7- Revision of Provisions on the Environmental Administration of New Chemical Substances)

(State Council Decree 591 | SAWS Order 53 | MEP Order 22 | SAWS Order 55)

(National standards | AQSIQ Inspection Letter [2012] NO.30)

PRESENTED BY MAI FUNG OF REACH24H SPECIALLY FOR GLOBALCHEM 2013

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

Class in legislation system From top to lower level

Top level

2nd level

3rd level

4th level

Law:

Administrative Law:

Measures:

GB & GB/T

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

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

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

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

For example Constitution

For example State Council Decree 591

For example MEP Order 7 MEP Order 22 SAWS Order 53

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

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Competent authorities This page is just for your reference.

Administration

Ministry MEP

Ministry of Environmental Protection (Replacing SEPA)

環保部

SAWS

State Administration of Work Safety

安監局

MOR

Ministry of Railways

鐵道部

CUSTOMS (GAC)

General Administration of Customs of P.R.C.

海關總署

MOA

Ministry of Agriculture

農業部

AQSIQ

General Administration of Quality Supervision, Inspection and Quarantine

品質監督檢驗檢 疫總局

MIIT

Ministry of Industry and Information Technology

工信部

SAIC

State Administration for Industry and Commerce

工商總局

MPS

Ministry of Public Security

公安部

SDPC

National Development and Reform Commission

國家發展和改革 委員會

MOT

Ministry of Transport

交通運輸部

MOH

Ministry of Health

衛生部

Responsible institutes NRCC-SAWS

National Registration Center For Chemicals 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 45,000+ • 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 reissued) + extremely toxic chemicals + …

Existing Chemical substances with no particular management

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

Existing chemicals Ministry of Environmental Protection

• General new chemical substances • New hazardous chemical substances • New hazardous chemicals of priority environmental concern (NHCPEC)

MEP Order 7 “Revision of Provisions on the Environmental Administration of New Chemical Substances”

New chemicals Ministry of Environmental Protection

State Administration of Work Safety

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China New Chemicals Never call me “China REACH” please Overview of MEP Order 7

Preparation | Notification | Post-notification

Roadmap of MEP Order 7

The key part

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China New Chemicals

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.

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

under the regulation

Issued 2010

Invalid 2002

Exemption from notification

Came into force Oct 15 2010

X

• 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 Who will be affected Territories

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

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

• • • •

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.

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

China New Chemicals

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

406 Jan-Jun 2012

484 Jul-Dec2012

1,474

11

Jan-Jun2012

3,402 Jul-Dec2012

Jan-Jun 2012

30 Jul-Dec 2012

47.9%

42.7%

95.3%

890/1,854

3402/7,969

41/43

Scientific Research Record Notification

Simplified Notification Special case | General case (3,009) (393)

Regular Notification 14 submission in 2012 left to be approved Approved 14 general hazardous substances | 21 NHCPEC

China New Chemicals

Notification Preparation Details of notification procedures will be unfolded at each stage.

5+ years before listed in IECSC Notification

Preparation

Post-notification

42,436 (200M software) IECSC inquiry IECSC since 2003 • To get to know whether your chemical substance is new or not

42,436 Online (Free)

It additionally includes 3,166 Confidential substances

8,175 with no CAS# included Search with one of 3 identities: English name | Chinese name | CAS#

Not easy for some products with same generic name but different CAS#

PC version of IECSC

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

• No need for additional information at this stage

8,500CNY (1,400USD)

42,436 (10 work day) It additionally includes 3,166 confidential substances Up-to-date database CRC-MEP has its own internal identification method for substances with no CAS#

Useful link: Different IECSC version on CRC-MEP

Additional information: Valued tips for applying IESCE inquiry

Formal inquiry 600CNY (100USD)

China New Chemicals

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

IECSC database 2010

IECSC database 2013

42,436 8,175 with no CAS# included

• •

42,342 Updated on Jan 30 2013

• •

3,166 confidential chemical substances

3,270 confidential chemical substances

45,602 in total IECSC Ver. 2010

45,612 in total IECSC Ver. 2013

Online database (free) Pc version

What is new?

• •

•

PDF Online database updated in early Feb. Pc version (2010 ver. purchasers get updated for free) released in early Feb.

Additional information: IECSC (2013) PDF download

•

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

China New Chemicals

Notification implementation Details of notification procedures will be unfolded at each stage.

5+ years before listed in IECSC Notification

Preparation

IECSC inquiry

Existing Substances not subject to MEP Order 7

Post-notification

X

New substances Subject to MEP Order 7

(SRRN): for testing sample (Risk Assessment): for regular notification Regular Notification Simplified Notification Scientific Research Record

• • • • • •

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

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

CRC-MEP Submission & (Review)

Certification or Public announcement

(SRRN)

3 types of notification

Dossier and submission material

Submission and certification

1

2

3

1 3 types of notification

Regular Notification Applied tonnage band Supplemental information

Notification Duration

Tier 1: 1-10t/a Tier 3: 100-1000t/a

Simplified Notification

Scientific Research Record (SRRN)

0.1 – 1t/a

<0.1t/a

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

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

8-18 Months (largely dependent on testing arrangements: Tier 4 may need much more time)

General case

For the scientific research purpose

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)

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

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

Complication indicator documents | data | procedures

14 workdays

PPORD: Process and Product Orientated Research & Development

2 Complication indicator

Dossier and submission material

documents | data | procedures

+ +

Regular notification

Simplified notification

SRRN

Notification Application Form

Notification Application Form

Notification Application Form

Scientific Record Form • 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

Compliance statement (special case) Scientific Record Form (general case) Eco-toxic test reports (general case) (1-3 tests) 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 MEPaccredited 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

Research information English and Chinese chemical name Testing institute information

Data acceptable indicator Data sources acceptance by MEP Accreditation proof of lab provided Full official document will be accepted only Details on the database required name, publish institute, edition etc.

Models, parameter, developing unit, edition, effectiveness provided Profile of expert is a must; statement only as supplemental support

Laboratory test report

Publish literature

Database

QSAR Expert

3 Submission and certification

Regular notification

Email

or

• Application form &Hazardous classification form

CD

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

or

+

• Printed Application form with stamp and signature • Other necessary documents (POA, authorization letter if a foreign company appoints 3rd party to carry out notification)

Hard copy

Submit to CRC-MEP

2

Regular notification through Expert Committee review

Simplified notification

SRRN

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

• 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

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

Submit to CRC-MEP

Submit to CRC-MEP

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

Notification Certificate Issued by MEP for Simplified and regular notification

Online

Hard copy

1

General case through Expert Committee review

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

Online

Public Announcement For Scientific Research Record Notification (SRRN)

• 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.

3

China New Chemicals

Post-notification obligation Details of notification procedures will be unfolded at each stage.

Preparation

Notification

IECSC inquiry

Submission & Notification Certificate

Post-notification

Obligation will be fulfilled according to 3 different management categories based on â&#x20AC;&#x153;Guidance for Hazardous Identification of new chemical substancesâ&#x20AC;? HJ 154-201* to replace HJ/T 154-2004

Obligation indicator More obligations put on

General new chemical substances New hazardous chemical substances New hazardous chemicals of priority environmental concern (NHCPEC)

Useful link: HJ/T 154-201* (Chinese ver.)

Guidance for Hazardous Identification of new chemical substances

Obligation indicator More obligations put on

General new chemical substances 1 • 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

1

New hazardous chemical substances

NHCPEC

2

1

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

1

2

3

• Submit report on disposal information • Submit substance flow chart

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

• Submit annual plan (for next year)

2

3

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.

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 .

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

China New Chemicals

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

MEP Order 7 published

Fully inspection & enforcement

Currently The authority is now being much stricter with assessment and verification of notification submitted.

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

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

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

Enforcement MEP, CRC-MEP, local Environmental Protection Bureaus.

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

Penalty: • 10,000CNY-30,000CNY • Repeal certificate “Mild” punishment

China Hazardous Chemicals Overview of the legislation framework

SAWS Order 53 and MEP Order 22 (Comes into force Mar 2013)

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SAWS Order 57

China Hazardous Chemicals

Overview of Hazardous Chemical legislation Catalog of Hazardous Chemicals (China Classification & Labeling (C&L) inventory) Registration System

State Council Decree 591

Permit & License

Regulations on the Control over Safety of Hazardous Chemicals (top law)

China GHS

SAWS Order 53 | MEP Order 22 (SEPA Order [1994] NO.140 | MEP Notice [2009] NO.113) Permit for (SAWS Order 41, SAWS Order 55 and SAWS Order 57) Manufacturer | Importer | Operation | Distributor & storage | Transporting | User

Leave to the 3rd part

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

Feb 1987 Regulation on the Safe Management of Hazardous Goods

Invalid 1986

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

Invalid 2002

May 2013 SAWS Order 57

Aug 2012 SAWS Order 53

Measures for the administration of Hazardous Chemicals Safe Use Permit

Measures for the Administration of Registration of Hazardous Chemicals

2011 Decree 591

Sep 2012 SAWS Order 55

Mar 2013 MEP Order 22

Regulation on Safe Management of Hazardous Chemicals

Measures for the Administration of Hazardous Chemicals Operation Permit

Measures for Environmental Management of Registration of Hazardous Chemicals

Issued Came into force Came into force 2011 Dec 01 2011 Aug 01 2012

Came into force Sep 01 2012

Come into force Mar 01 2013

Come into force May 01 2013

China Hazardous Chemicals

State Council Decree 591 Hazardous 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.com

?

Who will be affected by the Decree 591?

Manufacturer in China

?

Who will be the enforcement bodies?

Importer in China

Only Chinese companies will be affected directly.

Distributor and storage company MIIT (Primary authorities)

Transportation company in China

NRCC-SAWS + SAWS Chemical user in China

MEP MOT SAIC MOA

Each enforcement body will be responsible for specific part.

?

What actions shall be subject to the Decree 591

MPS

Production

Use

AQSIQ

Sales and storage

Transportation

SDPC

It will affect the whole supply chain

China Hazardous Chemicals

Why Decree 591 also matters to foreign companies?

1

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.

?

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

2

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.

China Hazardous Chemicals

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

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…)

To be updated

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

3800+ (2002ver.)

?

What are the hazardous chemicals under Decree 591?

The current Catalog of Hazardous Chemicals came up with Decree 344

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.

+

• 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

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

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

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

Additional information:

Additional information:

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

335 Extremely Toxic Chemicals(2002rev.| EN)

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

China Hazardous Chemicals

What new Catalog looks like?

The new catalog(China C&L Inventory) will be specific, more elements introduced.

â&#x20AC;&#x153;In the new version of Catalog, the chemicals will come with the information and hazardous properties .â&#x20AC;?

New Version to be published

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

English name Other EN name

CAS#

UN#

Hazardous classification

GHS pictogram

Signal word

Hazardous statement

Remark

7000+ Current version 2002

Current Catalog of Hazardous Chemicals

3800+

China Hazardous Chemicals

Emergency Response Call A question everyone will ask. ER call has been a must for registration of hazardous chemicals (Art.22 SAWS Order 53), China GHS-compliant SDS 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;

Keep these in mind 24h on-duty Chinese Landline

+

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

Or

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 call http://er.nrcc.com.cn | t: (+86) 0532 8388 9090

Designated-& -trained staff

Hand this to service provider

Registration system Overview of SAWS Order 53 (I)

Registration online

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

Focus on

• • • • •

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

Who affected Competent Authority

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

Invalid 2002

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

Issued 2012

Came into force Aug 01 2012

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

NRCC-SAWS | SAWS

China Hazardous Chemicals

Registration system Overview of SAWS Order 53 (II) What chemicals

• Catalog of Hazardous Chemicals 3800+ 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 classification 1) 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 given 3) 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)

Registrant obligation

• • • • •

Notice

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.

• 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 Manufacturer under SAWS Order 53

Content of registration

Key points of registration to be carried out by a manufacturer of hazardous chemicals

When to register Manufacturer: Companies make concentrated hazardous chemicals. However, hazardous chemical purchasers, repacking or dilute it with nonhazardous solvents are not considered as manufacturer

• 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

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

• 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)

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

• Information of each hazardous chemical (core)

What to be submitted

1) information of chemical 2) the manufacturer of hazardous chemicals imported 3) composition 4) classification & labeling (hazard category, pictogram, warning signals, hazard statements, precautionary statements) 5) physic and chemical properties 6) main uses and advised uses against 7) hazardous properties (physical hazards, health hazards & environmental hazards) 8) occupational exposure limits in working place 9) storage conditions and transportation information 10) protection measures and emergency response

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

China Hazardous Chemicals

Registration of importer under SAWS Order 53

Content of registration

Key points of registration to be carried out by an importer of hazardous chemicals

When to register

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.

• 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)

Prior to any importing activities

• 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)

What to be submitted

• Information of each hazardous chemical (core) 1) Information of chemical 2) the manufacturer of hazardous chemicals imported 3) composition 4) classification & labeling (hazard category, pictogram, warning signals, hazard statements, precautionary statements) 5) physic and chemical properties 6) main uses and advised uses against 7) hazardous properties (physical hazards, health hazards & environmental hazards) 8) occupational exposure limits in working place 9) storage conditions and transportation information 10) protection measures and emergency response

China Hazardous Chemicals

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

Legal liabilities

Step2

Step1

Fail

Fail

Notice of rejection of registration application

Notice of rejection of registration application

Apply through online registration software (NRCC)

Registration office (provincial level) format check

Submit hardcopies of registration materials to registration office at provincial level

Registration office (provincial level) format check

• Fail in registering • Fail in updating information of hazardous chemicals or new hazards

Fine:<50,000 or 50,000-100,000CNY NRCC Final check

Registration Certificate Validity period: 3 years •

•

3 work days

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

20 work days

15 work days

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 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

China Hazardous Chemicals

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

1 8 Doc.

2

Oct.17 2012

3-8

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

2 major supportive documents

• 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

Roadmap of Order 53 Brief 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)

Registration officers to be trained with necessary knowledge â&#x20AC;&#x201C; GHS, data evaluate, procedure (Mar 2013)

Complete the procedure of registration and postregistration (review and renewal)

Heavy workload of online registration system optimization

Guidance for the registration of substances & mixtures with unknown hazardous properties

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

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

The implementation of hazardous identification for chemicals with unknown hazardous properties

Source: officer from NRCC-SAWS

SAWS Order 53 is different from

No clear timeline for the implementation of plan above specifically

another registration regulation MEP Order 22

Registration system Overview 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

Focus on

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

Who affected

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

Competent Authority

â&#x20AC;˘ Manufacturer and user of hazardous chemicals in China â&#x20AC;˘ 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;

CRC-MEP | MEP

1994 SEPA Order [1994] 140

1994 SEPA Order [1994] No.140

2009 MEP Notice [2009] No.113

2012 MEP Order 22

Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals

Revision of Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals

Notice of the Environmental Administration of Registration of the Import and Export of Toxic Chemicals (practical guidance on toxic import & export registration)

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

41 items revised

May 01 1994 SEPA replaced by MEP

]=

Valid Jan 2 2003

No regulations for production or use of toxic chemicals

Valid SEP 2009

Issued (Trail) Oct 2012

Come into force Mar 2013

China Hazardous Chemicals

Registration system Overview of MEP Order 22 (II) What chemicals

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

Manufacturer 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)

Supportive documents

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

Importer and exporter of toxic chemicals

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 NRCCSAWS as well. CRC-MPE is mainly taking in charge of the management of those 158 toxic chemicals

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

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

China Hazardous Chemicals

Obligation of each role in one table Under MEP Order 22 Role

Chemicals

General hazardous Manufacturer & User of hazardous chemicals (in Catalog of hazardous chemicals

Registration & License

Registration Certificate of environmental management of hazardous chemicals

chemical)

Manufacturer & User of hazardous HCPEC chemicals

Importer and exporter of toxic chemicals

Registration Certificate of environmental management of hazardous chemicals

Materials prepared

Application form of registration certificate; registrant information; produced or used hazardous chemicals including quantity; MEP Order 22(Trial) classification; SDS; prevention and control under Decree 591 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 Addition to the material required from general hazardous chemicals; Environmental Risk MEP Order 22(Trial) Assessment(ERA) conducted by qualified under Decree 591 institutes; Annual report of emission, migration and monitoring result of particular pollutants, and protection measures against pollutants and environmental risks

• Registration Certificate for • Toxic Chemicals environmental management on Severely Restricted to Import (and export) of Chemicals • be Imported into or & Import release permit for importer Exported from China • Export release permit for exporter

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

Related regulation

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

Responsible authorities Local environmental protection authorities (County level)

Local environmental protection authorities (provincial level)

CRC-MEP & MEP

EIA: MEP will issue guidance for EIA operation Environmental monitoring report: shall be generated by the applicant or the qualified environmental monitoring agency Annual report: For manufacturer or user of HCPEC to submit before Jan 31 each year to the administration of Environmental Protection at county level.

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)

China Hazardous Chemicals

Registration procedure of manufacturer and user When register

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

Post-registration obligation

Notice

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

Register for general hazardous chemicals Register for HEPEC

Registrant

Submit registration material to Environmental Protection administration

Environmental Protection administration Format check

5 work days County Level

5+ work days

Unknown

On-site inspection

Technical Review

Environmental Protection Administration

Environmental Protection Administration

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

Re-check

15 work days City Level

10 work days

Provincial Level

â&#x20AC;˘ HEPEC manufacturer or user should submit annual repot to Environmental protection administration (county level) before Jan 31 each year and also Environmental monitoring report. â&#x20AC;˘ 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

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

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

China Hazardous Chemicals

Comparison of Order 22 and Notice [2009] No.113 last page of MEP Order22 MEP Notice [2009] No. 113 (Valid) Who affected

Responsibilities

• • • •

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

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)

Notice

• 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.

MEP Order 22 (Mar 01 2013)

Exporter and Importer in China (to be confirmed)

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

+

Import or Export release permit issued by the Customs

No specific explanation of practical registration procedure at this time

China Hazardous Chemicals

Permit & License SAWS Order 57

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

In 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

Who affected

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.

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

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

Issued Nov 2012

Who exempted

Notice

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

• 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.

Came into force May 01 2013

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

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.

China Hazardous Chemicals

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

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

Distributor Storage companies

Inapplicable

Hazardous Chemicals Operation Permit

SAWS Order 55 under Decree 591;

Local Work Safety Department

Transportation Companies

Inapplicable

Hazardous Chemicals Transportation Permit

Downstream chemical User

Inapplicable

Hazardous Chemicals Safe Use Permit

GB 12268-2012 (List of Dangerous Goods), Ministry of Transport of P.R.C, Transport GB 6944-2012 (Classification & Code of of Dangerous Goods on Road Dangerous Goods)

SAWS Order 57 under Decree 591 (May 01 2013)

Local Work Safety Department

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

China Hazardous Chemicals

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

1

2

â&#x20AC;˘ 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. â&#x20AC;˘ 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.

China GHS Overview of China GHS

China GHS-compliant SDS and label

AQSIQ Quality Inspection Letter [2012] No. 30

REACH24H Consulting Group \ GlobalChem 2013

China GHS SDS +Labeling

China GHS It 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.

Catalog of Hazardous Chemicals (China C&L inventory) Registration System

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

Permit & License

China GHS

SAWS Order 53 | MEP Order 22 (SEPA Order [1994] NO.140 | MEP Notice [2009] NO.113) Permit for (SAWS Order 41, SAWS Order 55 and SAWS Order 57) Manufacturer | Importer | Operation | Distributor & storage | Transporting | User Classification (China C&L inventory) | Safety Data Sheet | Precautionary label | Packaging (AQSIQ Quality Inspection Letter [2012] No. 30)

All supported by national standards

Some are compulsory, and some are still recommended

National Standards of China GHS The most often used GBs

National Standards

Scope

When came into force



GB 13690-2009

General rule for classification and hazard communication of chemicals



GB 20576-2011GB 20591-2011

Physical-hazard category under GB 13690-2009

1st May 2010 (the core of China GHS) to be revised in 2014 1st Jan 2008



GB 20592-2011 & GB 20601-2011

Health-hazard category under GB 13690-2009

1st Jan 2008

1st Jan 2008

GB 20602-2011

Environmental-hazard category under GB 13690-2009

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 goods Based 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



Interested?

EN version to be shred on request



REACH24H Consulting Group \ GlobalChem 2013

The next topics would be focused on

Hazardous classification

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.”

REACH24H Consulting Group \ GlobalChem 2013

China GHS SDS +Labeling

China GHS-classification category National Standard: GB 20576-2006-GB 20591-2006 GB 20592-2006-GB 20599-2006 & GB 20601-2006 GB 20602-2006 Will be replaced with GB 20576-2011-GB 20591-2011 GB 20592-2011-GB 20599-2011 & GB 20601-2011 GB 20602-2011 In my material, you find the update in 2011 ver.

China GHS SDS +Labeling

China GHS-hazards category I UN GHS (2011 Ver. 04)

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

16 hazards

GB 20576-2011 Explosive GB 20577-2011 Flammable gases GB 20578-2011 Flammable aerosols GB 20579-2011 Oxidizing gases GB 20580-2011 Gases under pressure GB 20581-2011 Flammable liquids GB 20582-2011 Flammable solids GB 20583-2011 Self-reactive substances(mixture included) GB 20584-2011 Self-heating substances (mixture included) GB 20585-2011 Pyrophoric Liquids GB 20586-2011 Pyrophoric Solids GB 20587-2011 Substance which, in contact with water, emit flammable gases (water reactive) GB 20588-2011 Corrosive to Metals GB 20589-2011 Oxidizing liquids GB 20590-2011 Oxidizing solids GB 20591-2011 Organic peroxides 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

China GHS SDS +Labeling

China GHS-hazards category II UN GHS (2011 Ver. 04)

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 â&#x20AC;&#x201D; single exposure 3.9 Specific target organ toxicity â&#x20AC;&#x201D; repeated exposure 3.10 Aspiration hazard

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 20592-2011 Acute toxicity(Oral | Skin | Inhalation) GB 20593-2011 Skin corrosion/irritation GB 20594-2011 Serious eye damage/eye irritation GB 20595-2011 Respiratory or skin sensitization GB 20596-2011 Germ cell mutagenicity GB 20597-2011 Carcinogenicity GB 20598-2011 Reproductive toxicity GB 20599-2011 Specific target organ system toxicitysingle exposure GB 20601-2011 Specific target organ system toxicityrepeated exposure Newly included in China GHS

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

10 hazards

10 hazards

9 hazards

China GHS SDS +Labeling

China GHS-hazards category III UN GHS (2011 Ver. 04)

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 20602-2011 Hazardous to the aquatic environment Absent from China GHS

The same as UN GHS

2 hazards

2 hazards

Building blocks adopted in China GHS: 2011 ver.

Comparison of blocks adopted in UN, EU CLP & China GHS

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.

1 hazards

China GHS SDS +Labeling

SDS under China GHS National Standard: GB/T 16483-2008 for all hazardous chemical substances and mixtures

Some points you must know 1) 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.

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

China GHS SDS +Labeling

Content – 16 headings in China SDS 1

2

3

Identification (of product and supplier) 1

Chemical Name (Product identifier)

2

Identification of supplier |Contact | 24h ER call

GB/T 16483-2008 S2 section1

Hazard identification (Substances or mixture) 1

Classification of products under China GHS

2

Hazardous properties (H statements) Physical | Health | Environmental

Pictogram | Signal word | H statements P Statements | Emergency response measures

3

Composition/information on ingredients Substance Define the product Substance or Mixture

GHS classification applied

Mixture (not all ingredients) only classified ones

4

3

Recommendation & Restriction on use

Substance Name

+

+

+

CAS #

EC#

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

Each name of Classified ingredients

+

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

Concentration (range)

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)

Confidential ingredients : CBI claim No 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

China GHS SDS +Labeling

Heading 5-8 5

6

Fire-fighting measures 1

Suitable extinguishing media Unsuitable extinguishing media

2

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

2

Environmental precautions

1

Personal precautions, Protective equipment Emergency procedures

4

3

Precautions for safe handling including advice on technical measures

2

Advice on preventing from contact in ways of â&#x20AC;Ś

3

Control parameters or Exposure limit value

2

GBZ 2.1-2007 Occupational exposure limits for hzardous agents in the workplace Part1: Chemical hazardous agents

Appropriate engineering controls; providing supplemental information besides Section 7

Not existing in UN GHS

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

Special protection under special conditions

Exposure controls/personal protection 1

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

Methods applied to prevent from next accident

Handling and storage 1

8

Special protective equipment & precautions for fire-fighters

Accidental release measures

!

7

3

3

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

China GHS SDS +Labeling

Heading 9-11 Physical and chemical properties (endpoints to be filled) 1

9.1 General Info Appearance (形態) Form (形狀) Colour (顏色) Odour (氣味)

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)

9 2

10

11

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)

Supplementary information

9.2 Other Info Odour 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)

Testing methods required if necessary

Stability and reactivity 1

Chemical Stability

2

Condition to avoid

3

Incompatible materials

1

1 2 3

Hazard decomposition products Acute toxicity (oral Dermal Inhalation) – mammal

Toxicological information Toxicokinetics, metabolism and distribution (Supplementary part)

4

Skin corrosion/Irritation

2

Info on toxicological effects

Consider adding “Aspiration Hazard” in this part if the classification is given Provide reliable data generated through tests or referred to competent source If hazards of a mixture has not been identified through test, then hazards of each ingredient shall be offered

“Aspiration Hazard” will be included in China GHS formally

-

Serious eye damage/irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT-single exposure

STOT-repeated exposure

China GHS SDS +Labeling

Heading 12-16 12

1

13

14

15

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

2

Persistence and degradability

3

Bioaccumulative potential

4

Mobility in soil

Disposal Considerations 1

Disposal methods

2

Contaminated container and packaging treatment methods

Informed the Down-stream users of the disposal methods

Transport information 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

Regulatory information 1

16

More data provided is highly recommended.

Please indicate the reference.

Ecological information

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 （GB）

3

Informed the Down-stream users of the disposal methods

3

Disclaimer or other information, Recommended restrictions on use

Other information 1

Indication of changes Version amended, if applicable

2

Advice on professional training, if applicable

China GHS SDS +Labeling

Tips for China SDS Tips for 16 sections and corresponding headings

Other requirements

• 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

Heading 1: Identification Heading 2: Hazard identification Heading 3: Composition/information on ingredients

1

2

• 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

3

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

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

China SDS template REACH24H Consulting Group Generating | Auditing | Software info@reach24h.com

Figure 1

China GHS SDS +Labeling

GHS Labeling under China GHS National Standard: GB 15258-2009

Some points you must know About language 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 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

Additional information: GB 15258-2009 (English)

China GHS SDS +Labeling

In accordance with 4.2.1 of GB 15258-2009

CAS号： 浓度：

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.

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.

24小时

China GHS SDS +Labeling

In accordance with 4.2.2-4.2.5 of GB 15258-2009

CAS号： 浓度：

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 4.2.9 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 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

24小时

China GHS SDS +Labeling

In accordance with 4.2.6 -4.2.8 of GB 15258-2009

CAS号： 浓度：

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.

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China GHS SDS +Labeling

Label on combination packaging GHS label for inner or single packaging Container capacity

China GHS label

EU CLP label

Minimum label size

Inner packaging

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 recognized Black 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 least Simplified GHS Label • 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.

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

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 label Precautionary Statements

China GHS SDS +Labeling

Label on combination packaging GHS label for outer packaging

GB 15258-2009 Inner packaging: GHS label

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

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

Symbol size category

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

Outer packaging

Symbol size:

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50 * 50 (mm)

2

100 * 100 (mm)

Post both GHS label and Transport symbol on the Outer Packaging but separate them from each other

3

150 * 150 (mm)

For example put the symbol on the opposite side of GHS label on outer box

4

200 * 200 (mm)

Our advice

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

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

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

Transport symbol => 100*100mm

China GHS SDS +Labeling

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

Follow GB 190-2009 | GB 15258-2009

Large tanker or container

Packing symbol of dangerous goods

Can not be treated as single packaging

Label applying rules: Product name

• • •

UN number Transport symbol

GHS label • 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.

•

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.)

Legal liabilities 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

China GHS SDS +Labeling

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

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Who will be the enforcement bodies?

AQSIQ CIQ (Local Inspection and Quarantine Bureau)

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Who will be affected?

â&#x20AC;˘ Importer or representative agent of hazardous chemicals imported into in China â&#x20AC;˘ Exporter or representative agent of hazardous chemicals to be exported from China

China GHS SDS +Labeling

Compared with Decree 591 Responsible for almost each activity throughout the supply chain of a hazardous chemical

State Council Decree 591- SAWS Order 53 | MEP Order 22 â&#x20AC;Ś > 3800+ chemicals (version 2002) to be re-issued or know as China C&L Inventory

Outside China

AQSIQ - Statutory Inspection Catalog > 160 chemicals in the catalog under priority management of AQSIQ Only responsible for the activities of chemicals importation & exportation

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

China GHS SDS +Labeling

Hazardous chemicals under priority management of AQSIQ The Statutory Inspection Catalogue ver. 2012 updated on Feb 01 2012 Also it is known as “Catalog of Entry-Exit Commodities Inspected and Quarantined”, in which 160 hazardous chemical selected from Catalog of Hazardous Chemicals.

Chemical substances & chemicals in mixtures

AQSIQ + GAC 3800+ Catalog of Hazardous Chemicals 2002 ver.

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

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

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 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)

Submit to: Local CIQ at the place of clearing customs

Exporter or representative agent of hazardous chemicals 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) Submit to: Local CIQ at the place of origin where hazardous chemicals produced

Additional information: in Chinese Conformity declaration of operating entity of hazardous chemicals imported

Additional information: in Chinese Conformity declaration of manufacturing entity of hazardous chemicals exported

China GHS SDS +Labeling

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

Importer Not a listed hazardous chemicals

Whether chemicals in the Catalog of Hazardous Chemicals

Step 1

Apply for inspection by submitting required info & materials

Step 2

X

Conduct Rectifying & improving Inspection ceased

Clearance Permit

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

Step 3

If qualified for rectifying and improving or Unqualified for rectifying and improving

X

Return or Rejection

Fail in compliance check Succeed in inspection Export or import release permit issued by local CIQ for further customs clearance

Step 4

China GHS SDS +Labeling

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

Classification, label and SDS

1

2

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.

About inspection on packaging

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.

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2

Packaging for exported hazardous chemicals 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.

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.

China GHS SDS +Labeling

Pay special attention to Tips for companies export hazardous chemicals to China.

The last page of China GHS

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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1 • •

Prepare your China GHScompliant SDS before product shipped to China Affix label to the outer packaging

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2 •

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

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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

PRESENTED BY MAI FUNG OF REACH24H SPECIALLY FOR GLOBALCHEM 2013