chinese regulation guidance

An easy outline of Chinese Chemical Regulations

Special thanks to the contribution of

Cora Knutson

A revised version

HelpyouKnowit

HelpyouKnowit The file is made by Mai.Fung,

which intends to help you know more

about the content n of Chinese

chemical legislation.

Additional information please let me

know by sending email.

Mai Fung | Global Chemical Regulatory Consultant

HelpyouKnowit

Updated on 06 Mar 2012

Updated on 29 Feb 2012

Updated on 16 Dec 2011

Updated on 07 Mar 2012

What will come soon? A topic of label on industrial or consumer products is being planned

Narration is considered to be added in this presentation material

“Linkedin” me

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

Notification of New Chemicals

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

Existing Hazardous Chemicals

> China GHS, and labeling To be finished

> Hazardous Chemical of Import & Export AQSIQ implements inspection and enforcement

> 158 Toxic Chemicals restricted from Import & Export MEP released the 2012 version of the catalog of restricted toxic chemicals

> Order 27 by MOH Disinfectants Regulation in China

[email protected]

>> Content Recent update

Updated on 16 Mar 2012 (middle way)

http://cn.linkedin.com/pub/mai-fung/13/247/4b3

HelpyouKnowit

>> Key updates

Newly-added slides

Regulation of toxic chemicals import and export by MEP Mar 07 12

New regulatory added

Many mistakes fixed and format adjusted

Mar 14 12 Extremely Toxic

Catalog

The catalog added for download (English)

335 extremely toxic chemical substances under Decree 344

Mar 21 12 Decree 591;

China GHS inspection

One point to be noticed

Specific explanation of AQSIQ inspection over Haz. chemicals

HelpyouKnowit

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

HelpyouKnowit Driving Green Chemical

State Council

MEP

MoH

MoR

MoA

MIIP

MoT

MPS

Ministry of Environmental Protection

SAWS

Customs

AQSIQ

State Administration of Work Safety of State Council

The top rank

General Administration of Customs of China

General Administration of Quality Supervision, Inspection and Quarantine

The Ministry

The State Administration

Ministry of Health

Ministry of Railways

Ministry of Agriculture

Ministry of Industry and Information Technology

Ministry of Transport

Ministry of Public Security

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


State Council

Regulation releasing

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

Pollution prevention

Division(-MEP)

Chemical Registration

Center (-MEP)

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

…

Major Inspection and Enforcement

Regulation Releasing and Management Leading

MIIP

MEP

Local CIQ of AQSIQ

Local MEP

MoT

MoH

MoR

MoA

MPS

SAWS

National Registration

Center for Chemical (-SAWS)

MEP

SAWS

Customs

AQSIQ


CHINAREACH Order 7 by MEP >


China REACH is not a proper name NEXTPAGE >

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

Non-Phase-in substance Phase-in substance

China REACH: Order 7 by MEP for new

chemicals Make an enquiry to the authority for the confirmation whether the chemical substance is new or not; the complaint implementation would be different dependent on tonnage band or according to some detailed requirements. Limited data is required as well

New Chemical (similar to Non phase-in substance)

Existing chemical (especially hazardous

chemicals) The management may be involved in data requirements, testing data r, risk assessment report required, national standard of risk assessment is being drafted and discussion >> By Xiao (X) Zhang from Dow Corning

Existing chemical (similar to phase-in substance)

China REACH is just a name that helps you to quickly understand

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


15 Oct 2003

Order 7 by MEP Entered into force

Order 7 by MEP is New

Order 7 by MEP Issued 19 Jan 2010

Order 17 by SEPA Entered into force

15 Oct 2010

7 years

SEPA changed to MEP Order 17 changed to Order 7 .

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

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

NEXTPAGE >

X


Notification under Order 7 matters to you & your Business

NEXTPAGE > Updates on 05 Dec 2011

No Notification, No Market Your new substances shall be prohibited in China without notification

Severe punishment If a new substance notification failed to be submitted The company will be warned, fined and even forced to close

And not be allowed to submit notifications within next 3 years;

It also matters to the environment Whether a new substance has been notified is a crucial aspect of environmental

impact assessment, so please do obey the rules


If you do have been affected,

then learn how to comply with it

Whether those chemicals

are new in China

NEXTPAGE > Updated on 29 Feb 2012

Step by step To evaluate if you have been affected by the regulation before

you start your compliance

Whether your products

have be affected because of some chemicals

Who affected What substances are new

Comply


A chemical regulation on New Chemical Substances NEXTPAGE >

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

IECSC: Inventory of Existing Chemicals Substances - 45,602 existing chemical substances (till Dec 7 2010)

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

The new rule clearly specify what should be regulated and taken under control

New Chemicals (Not in IECSC)

A New Substance itself

New substances in Preparation

New substances in articles intended to be released

-----------------------------------------------------

New substances used as ingredients or intermediates for producing

Pharmaceuticals

Pesticides

Veterinary drugs

Cosmetics

Food additives

Feed additives

Please be informed, we are now confirm TGAI(Technical Grade Active Ingredient) and technical are not in the scope of Order 7 by MEP, because the use of those products have been identified as pesticide products.


A chemical regulation on New Chemical Substances NEXTPAGE >

Chemical substances or related products

Category 1: Products subject to other existing regulations

Some categories of chemicals may benefit from exemption from this law

Category 2: Substances exist in nature

Category 3: Substances of noncommercial purpose or unintentionally produced

Category 4: Substances of special categories

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

1. Chemical substances unprocessed or only processed in the ways below 1) Manual; 2) Mechanical; 3) Gravitational; 4) Soluble in water; 5) Floatation in water; 6) Heat dehydration. 2. By any means, substances extracted from the air 3. Natural polymer with no chemical modification 4. Biomacromolecule like RNA, DNA or protein

Exempt from the Order 7 by MEP

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

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


Notification body – like EU REACH, only within China

Updates on 03 Dec 2011

China Mainland Out of China Mainland

Foreign Companies Selling new substances to China

1

Who shall and who is not obligated

NEXTPAGE >

Notification not required Notification required

Chinese NA*

Notify on behalf of Foreign companies http://www.cirs.ie/China_Chemical_Regulation/IECSC_China_REACH_China_New_Chemical_Registration.html

Manufacturers of New Chemicals

Importer of New Chemicals or

Companies hope to change the registered uses of New Chemicals

The uses under “Priority hazards for environmental management” on IECSC

* Notification Agent= NA

Hong Kong & Macao are not affected by this law

Subsidiary of Foreign Companies

CRC-MEP

MEP Ministry of State Council

What the notification Process looks like?

Receive Registration Application Formal Check of materials （CRC）

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

Notification Body

Search through IECSC portal to find your substance in the list or not Make enquiry for 3166 confidential Substances (22Euro or 30USD)

+86 10 8491 765 6 Call for technical supports from CRC

Taskforce for Evaluation Technical evaluation provide Feedbacks

Submit related dossier and data 9 qualified labs in China for eco-toxic

Confidential substance: another database to help define substance

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

Local MEP

Inspection

Process

Different Roles

Catalog of Hazardous Chemicals (SAWS)

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

NEXTPAGE >

Service Providers playing as NA will serve Foreign companies

better. They are not involved in real business, but offer

technical supports and keep confidentiality.

Foreign companies – choosing notification bodies strategically

Updates on 29 Nov 2011

China Mainland Out of China Mainland

Role A : *

Parent Companies Role B : Assigned by A NA Company

Belongs to A: Importer Factory Plant & Subsidiary

Belongs to A: Notification Agent Factory Plant & Subsidiary

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

Role D: Unqualified Distributor X

1

The Factories or Subsidiary Companies applying for certificate

as importer will benefit more themselves when they sell or

make purchase .

2

The Factories or Subsidiary Companies assigned as NA will be

allowed to notify on behalf of their Parent companies(Role A)

But they have to meet NA requirements* as Role B.

3

Your business partners, Importers or Manufacturers , as

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

4

If Distributors are not the direct importers of the substance,

they are unobligated to complete notification .

5

1

2

3

4

5

* Predominant

Predominant

*Predominant: - This is more about what Role A may benefit

*NA requirements: - approx. 330,000euro registered capital (for more, please make requests)

NA’s name is Certificate Holder

Role A’s name is Applicant 1 3

2 4 Importer(Manufacturer)’s name is both

Certificate Holder & Applicant

Who is the Certificate Holder?

NEXTPAGE >

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

Implementation- before notification


NEXTPAGE >

Preparation Notification Post-notification

Necessary

Steps

IECSC

Certificate

Management What information needed during inquiry Company information Substance profile (CAS# | molecular formula etc.) - CIRS will help you with information collection and make inquires.

Preliminary Stage

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

Inquiry For confidential substances

Typical Notification

Simplified Notification

Scientific Research Record

No obligation under the law

The inquiry is submitted online, after payment. The result would be sent back as paper copy. 200RMB + (service charge by 3rd party consultant)

No need for other information here


3 Notification types based on different cases


NEXTPAGE >

Simplified Notification > Typical Notification >

• Specific condition: A specific report for new chemicals (now developed by notification bodies on their own)

• PPORD: Product and Process Oriented Research and Development

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

Annual Volume of New Chemicals Between 0.1 Ton to 1 Ton

Annual Volume of New Chemicals Less than 0.1 Ton

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

Divided into 2 parts Basic condition and Specific condition

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

4-18 Months (largely dependent on testing arranged and

conducted)

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

14 workdays

For polymers containing less than 2% new chemical substance (w/w), if the polymer is planned to be included in the IECSC, then typical notification is required (not recommended)

Basic :

Specific: * a) New chemicals for export lower than 1tpa b) For scientific research with tonnage between 0.1

to 1 ton per year c) For technological research with tonnage less

than 10 ton per year d) For polymer consisting of monomers already

listed in IECSC e) for polymers containing less than 2% new

chemical substance weight by weight （no quantity limit of such polymer imported） a) for low concern polymers (if the polymer itself

is not listed in IECSC);.

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

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

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


Tonnage band Criteria

Other Criteria

Time for Notification

Remark

For specific case

Where you may find the required data for Notification:

http://www.cirs.ie/China_Chemical_Regulation/Data_Requirements_New_Chemical_Notification_in_China_REACH.html

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

Not Low-concern polymer: Full tests for typical notification

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


Implementation- Compliant guidance


NEXTPAGE >

Preparation Notification

Preliminary

Stage

IECSC

Necessary Steps

Serial Notification - Similar substances notification at same time Joint Notification - Co-notification(data or cost-share policy needed to be talked

between co-notification bodies) Repeated Notification - Notification by referring to the data owned by previous

notification bodies. Re-notification - Notification for amount increased or uses changed; additional

data required; old notification certificate replaced by the new one

Find more by contacting [email protected] or [email protected]

4 Special formats of typical notification Tonnage level unrelated

Data & Dossier The body of notification

Post-notification

Inquiry

Certificate

Management



Implementation- Compliant guidance NEXTPAGE >

Preparation

Preliminary

Stage

IECSC Inquiry

Necessary Steps Data & Dossier The body of notification

Post-notification

Data gap analysis

Testing Proposal

Testing arrangement

Dossier generation

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

Largely dependent on the capacity of the contracted lab

Largely dependent on the capacity of the contracted lab

Spectrum Chem-physic data

Toxic data Eco-toxic data 1 2 3


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

Certificate

Management


Notification

Submission

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

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

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

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

Spectrum Chem-physic data

Toxic data Eco-toxic data 1 2 3

Mostly Not Many companies would be worried about

whether data generated outside China

accepted.

It turns out that the data acceptance is not so

exclusive as its political system of this country

showed in front of the western nations. Most

studies may be referenced if they were performed

to accepted standards by a lab meeting MEP

requirements.

Please be informed again:

Scientific Record is needs here for the sample of

the substance to be tested in China

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

& (At least) one study on Degradation

10-100tpa Around 3-5 Months 14 days extended toxicity study in fish (about 3Months)

Or Daphnia magna Reproduction study (about 4-5Months)

Or Bioaccumulation (about 4-5Months) Please be advised, at least one test must be picked between

all above 3 tests

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

Minimum tests conducted in China





Preliminary

Stage

IECSC Inquiry

Post-notification


Necessary

Steps

Notify

Certificate Management

Approved

by MEP

MSDS and hazardous information communicated to downstream users

Risk management measures conducted

First-activity report submission Registered information to be updated

(tonnage level, uses, activity, the holder of the notification certificate)

Keep documents on file for over 10 years

New hazard to be updated if needed be Only downstream users who are

capable of the implementation of risk measures allowed to buy products from the certificate holders.

General New Chemicals

Hazardous New Chemicals

Authorized

Priority hazardous new chemical substances for

environmental management

Restricted

For those 2, more obligations added




5-year

Notification completed

New chemicals Added in IECSC

This period decided by the MEP is more like a

transitional time after the first activity date before

new chemicals allowed to be added in IECSC

For general new chemicals, after 5 years, they would

triggered the action of being added in the IECSC automatically.

For other 2 categories, Hazardous new chemicals, Priority hazardous

new chemical substances for environmental management would

be evaluated from multi-aspect during the 5 years. So the process

could be much more complex.

First activity

Using (sale) or Manufacturing of the new chemical for the first time after its notification in China

The 1st activity should be reported to the MEP as the first date of 5-year period. (Report template given by MEP)

5-year

Hazardous New Chemicals(Authorization) - 1st activity report + annual activity report

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

+



Simplified Notification > Basic Condition Studies required


Preliminary

Stage

IECSC Inquiry

Data & Dossier & Doc Development

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

Chem-physic data Eco-toxic data within China

1 2

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


Annual Report to the authority: Before 01 Feb The figures of the production of

notified new chemical substance

(annual tonnage, production days ); or

tonnage imported etc.

The transfer information of the notified

new chemicals, including the overall

tonnage of transfer and major

recipients etc. in last year

The updated or renewed information

of the notified new chemical

substances during last year.

Post-notification

Submission

melting point water-solubility Partition coefficient

n-octanol/water

Ready biodegradation Acute toxicity test for fishes Acute toxicity test for

earthworm

Test duration: 4-6 Months

Notification duration: 5-10 Months

Simplified Notification > Specific Condition


No Studies required

Post-notification Preparation Notification

Preliminary

Stage

IECSC Inquiry

Dossier and Document Development

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


Submission

Polymer: GPC – Gel Permeation Chromatography

Notification duration: 3-4 Months

Annual Report to the authority: Before 01 Feb The figures of the production of

notified new chemical substance

(annual tonnage, production days ); or

tonnage imported etc.

The transfer information of the notified

new chemicals, including the overall

tonnage of transfer and major

recipients etc. in last year

The updated or renewed information

of the notified new chemical

substances during last year.

Simplified Notification > Specific Condition

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

NEXTPAGE >

No Studies required

A Special case to know new substances in polymer

Please remember, polymers containing less than 2% each new chemical substance weight by weight. Simplified Notification(Specific Condition) is enough

2%

<

Polymer product exempted from notification under Order 17

( later replaced by Order 7 by MEP )

Sep 2010

Order 7 by MEP entered into force Oct 2010

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

Aug 2011

Case Study

1 year



“Please be noticed: One year of exemption transitional time has passed.”

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

Implementation- Compliant guidance


NEXTPAGE >

Preparation Scientific

Research Record

Preliminary

Stage

IECSC

Post-notification

Inquiry

Typical notification

Simplified notification basic condition

Notification Material Development

Submission

2 weeks

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

Documents to be prepared: The Record Form (template offered) Attachments including license of

notification companies and scientific research institutions (apply substances directly; test proposal

More than one substances notified together allow to be covered in one scientific research record

Scientific project starts to be conducted

Laboratories conduct related tests for new substances


For scientific research use only


Administrative Local agent service fee Test fee

About notification cost- you need to know

Updates on 17 Feb 2012

NEXTPAGE >

To help you understand the structure of notification cost, and make it cost-effective

80%

17%

3%

Test cost 80% (Dependent on specific cases)

Source: Eric Xiong from CIRS

Smart-cost tips

Cost breakdown

Administrative fee

Local agent fee

Test fee

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

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

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

Special formats of typical notification may save you much money: Serial Notification -Similar substances notification for avoiding unnecessary tests on group substances.

Joint Notification - Data or cost-sharing between co-notification bodies of the same substances.

(like Joint-submission of registration dossier under REACH)

Repeated Notification - Notification by referring to the data owned by previous notification bodies (Like

the game rule of LOA purchase under REACH)

Reasonable data source is a key point: Avoiding unnecessary testing by taking advantage of referring to literature,

some database or data resulted from QSAR, reading-across reference etc. Consider the lowest-required tests according to different notification types. Foreign companies may use GLP-generating data for notification using More information please refer to previous pages Data & Lab- Must all data be generated in China?

Be sure your notification type is correct: More information please refer to previous pages 3 Notification types based on different cases

Strategic arrangements of studies: basic studies first, then come the advanced Finish basic or compulsory studies, and then higher-level studies to be carried out; In some

cases, based on the results from previous studies, higher-level studies would benefit from waiving.

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

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

Try saving test cost

How we offer our help


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

NEXTPAGE >

1

2

Preparation

3

Notification

Post-Notification & follow up

1. Typical Notification 2. Simplified Notification 3. Scientific Record

1. Preparation and Updating of information 2. Keep contacting the local authorities, reporting

necessary issues to fulfill obligation

IECSC Search & Decide

Scientific Record The easiest notification



Preliminary Stage

Basic Condition + Scientific Record Forms and documents Studies analysis and tests

proposal Eco-toxicology properties

tests arrangement & follow up

Dossier develop and submission; progress report

Specific Condition Information collection

and document preparation

Notification dossier submission and follow up

Basic or Specific Condition?

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

Information collection document preparation

CRC-MEP

Please be advised-Way of Simplified Notification has changed

Notification

Body

Alternative 1: Paper Notification Material （SEAL）

Client-side Download:

http://www.crc-

mep.org.cn/news/NEWS_DP.aspx?TitID=379&T0=01000&Lan

guageType=CH&Sub=125

Updates on 22 Nov 2011

Online Simplified Notification Started 2012 Transitional Time Till 31 Dec 2011

Alternative 2: Email Notification Material （SEAL）

On test: Web-based Notification System

X

Alternative 1: Paper Notification Material （SEAL）

Alternative 2: Web-based Notification System CRC-MEP

Contact： Ma Xin - [email protected],cn

IT Support： Deng Qing- [email protected],cn

Basic condition: Limited Information & 3 Studies needed

Specific condition: Very Limited information needed

Simplified Notification Material

Ok

NEXTSECTOR >


DECREE591by State Council >


Decree 591 is revised

State Council

17 Feb 1987

Decree 591 by SC Will Enter into force

Decree 591by SC Issued

02 Mar 2011

1st Regulation by SC Issued & Entered into force

01 Dec 2011

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

1987: Regulation On the safe Management of Hazardous Goods

15 Mar 2002 Decree 344 by SC Entered into force

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

Decree 591: Regulation on Safe Management of Hazardous Chemicals

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

NEXTPAGE >

X

X

Substance + Mixture regulated at same time

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


What the registration looks like?

NRCC-SAWS Receive Registration Application Formal Check of materials （NRCC）

State Council Regulation releasing

Regulation issued by State Council

Process

Different Roles

SAWS State Administration of Work

Safety of State Council

SAWS takes charge of management SAWS plays as leader role in Decree 591 & releases Catalog of Hazardous Chemicals

Catalog of Hazardous Chemicals (2002) To be renewed

…

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

Registrant Importer &

Manufacturer in CHINA

Search through the Catalog to see if registration

needed; Obligation: safety evaluation report, production

license, safe use license, operating license, registration of hazardous chemicals, SDS and chemical labels (China GHS)

Other government bodies involved in implementation of the law

MIIP | MoH | MEP | MoR | MoT | MoA | MPS Administration of Custom | AQSIQ

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

+86 532 8378 659 3 Registration Call-in

NEXTPAGE > Updates on 28 Nov 2011


2 Major catalog of chemicals under Decree 591

Catalog of Hazardous Chemicals

NEXTPAGE > Updates on 16 Dec 2011

Catalogue of Extremely Toxic Chemicals(2002rev.) Pure Substance

Over3,800 Version 2002 came up with Decree 344,

and the new Catalog is to be published early

next year

Manufacturers, Importer, other roles (distributors,

warehousing and storing companies ) chemicals

within Chinese territory need to be sure whether

any of their chemical products are listed in the

Catalog, especially sensitive to the newest version

upcoming.

But as we believe, the new version firstly comes

up as a draft before it become the decided one.

335 Version 2002, substances majorly came from

Catalog of Hazardous Chemicals , but some

chemical substances were borrowed from

“List of Dangerous Goods (GB12268-90)” or

even other lists.

If purchase or transport of chemicals in the

inventory of toxic chemicals happens, companies

will be required to apply for some licenses before

actions.

Over 7,000 in new version

Likely to be merged

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

Download

http://www.box.com/s/2bf175eba811436ad9b9


You may feel less interested,

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

However,

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

Be sure

those companies are fully

understanding their requirements

so that your business

Stays Out of Trouble

You will also find information of

China GHS

NEXTPAGE >

Under Decree 591,

registration is the responsibility of

Importer & Manufacturers in China

NEXTPAGE >

But, If you are the roles below,

what are your obligations?

Manufacturer in China

Importer in China

Distributor and warehouse, storage

company

Transportation company in China

Manufacturer (chemical user)

in China

obligation, registration, license, implementation,

enforcement authorities

Key words found in next several pages

Companies located outside China

You may have your contracted suppliers or partners in

China be aware of this law

You should pay more attention to under 591

GHS compliant, SDSs and labels are necessary


Obligation: Registration & License Led by SAWs

Main License Registration

Manufacturer China

Registration Certificate License of Manufacturing Safety

Importer China

Registration Certificate

License of Operation Safety Classification & labels SDS

Distributor Warehousing

License of Operation Safety

Transportation Companies

License of Transportation on Road License of Transportation in Water

Manufacturer Chemical User

License of Using Safety

X

X

Chinese Manufacturers

Distributors

Chinese Manufacturer

Chemical User

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

Criteria for Limit Volume

The Directory of Industries

Chemical List

1

2

3

4

1

2

3

5

Roles

Roles

Bulk Chinese producers of Hazardous Chemicals

Hazardous Chemicals importers within Chinese territory

Hazardous Chemicals Distributor s or warehousing service providers

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

NEXTPAGE >

X 5

4 Bulk Chinese producers of Hazardous Chemicals Chinese Manufacturers

Distributors Inventory of Toxic Chemicals


http://issuu.com/mai.fung/docs/the_directory_of_industries_for_the_application_of?mode=window&backgroundColor=




Obligation

Your roles decide your obligations under Decree 591

Different roles mean different obligations and enforcement authorities

Responsible Authorities What to be prepared

(different forms and documents usually) Manufacturers in China

Submit Registration

NRCC of SAWS - (final check) Local registration

offices(province) - (receive registration and check)

Registration Form Technical Safety Instruction of

chemicals (Important) Label (Important) Emergency call (or contracted service) Business license issued by Industrial and

Commercial Bureau

License of Manufacturing Safety Information changed

State Administration of Work Safety of State Council (SAWS)

Documents and Application Manufacturing Safety rules Routine Practice Stewardship Documents Safety Management personnel document Safety Assessment Report by 3rd party Emergency Rescue Plan & Record Emergency Rescue Checklist …

Safety License of Occupational Hygiene

NA NA

NRCC registration platform:

http://register.nrcc.com.cn/

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

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

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

In case that a company

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

This company should be considered as a Manufacturer rather than a Manufacturer (Chemical User) If new hazardous chemicals

are being manufactured after acquiring registration certificate and license, the manufacturer needs to update both certificate as well as License of Manufacturing Safety


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What to be prepared (different forms and documents usually)

Importer in China

Submit Registration NRCC of SAWS - (final check) Local registration offices(province) - (receive registration and check

Registration Form Technical Safety Instruction of

chemicals (Important) Label (Important) Emergency call (or contracted service) License issued by Industrial and

Commercial Bureau

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

Local Work Safety Department – (province )

Application form of business license of hazardous chemicals

Catalog of relevant production safety documents

Work safety standards and manual Safety training and training materials Budget raised for manufacturing safety

of hazardous chemicals and budget report

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The Record of Hazardous Chemicals Imported

The Application for quarantine inspection

General Administration of Quality Supervision, Inspection and Quarantine

Local CIQ (for direct implementation

The Record is Optional (suggested) The Application composed with - self-declaration - SDS and label document - If the Record completed, submit it （to be confirmed）

NRCC registration platform:

http://register.nrcc.com.cn/

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

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

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

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


Obligation Responsible Authorities

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Distributor Warehousing & Storing

What to be prepared (different forms and documents usually)

License of Operation Safety (Same required as Importer )

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

warehousing business

Application form of business license of hazardous chemicals

Catalog of relevant production safety documents

Work safety standards and manual Safety training and training materials Budget raised for manufacturing safety

of hazardous chemicals and budget report

Injury Insurance for employees or production liability insurance proof

Business license issued by Industrial and Commercial Bureau

Property or leasing documents of business venues and facilities equipped with

Emergency Rescue Plan & Record Extra documents required when a

company is equipped with storage facilities(gas station for example)

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

chemicals(gas station etc.)

SAWS: http://www.chinasafety.gov.cn/newpage/ Please be informed that you may find the contact information of Local

Work Safety Departments, however we do not believe that is necessary, simply ask for help from your local distributors or consultants , they have ways.

All documents to be shown to city-level or county-level Work Safety

Department dependent on the business your companies are running.



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

chemicals

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Implementation (different forms and documents usually)

Transport License of Dangerous Goods on Road

(GB12268-2012 *) (GB6944-2012P *)

Ministry of Transport of P.R.C

Transport of Dangerous Goods on Road

“TDG business” Application Form Daft report of dangerous goods,

classification and operation plan Special vehicles used for transport Identification documents and copies of

Investor and personnel in charge Testimonial documents of parking area

for special vehicles, capabilities of safety protection, environmental protection and fire fighting device equipped

…

NA

NA

Transport of Dangerous Goods by Water

NA

Transport License of Toxic Chemicals on Road

(Inventory of Toxic Chemicals *)

Public Security Bureau (County-level)

Transport of Toxic Chemicals

on Road

Report of toxic chemicals and quantity to be transported

The details of transport, plan, destination, route, fixed date

Purchase license or import license issued by the Customs

The qualification of drivers and other certificates

* GB12268-2012: (here in Chinese) the inventory of dangerous goods MoT: http://www.mot.gov.cn/ (Be advised: some chemicals also found in the Catalog of Hazardous Chemicals ver.2002)

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

* Inventory of Toxic Chemicals - English version please follow the link below

http://issuu.com/mai.fung/docs/inventory_of_toxic_chemicals__for_transport_and_pu?mode=window&backgroundColor=%23222222

Transportation Companies Obligation Responsible Authorities


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http://www.cirs-reach.com/China_Chemical_Regulation/Gb_12268_2012_List of dangerous goods.pdf

http://www.cirs-reach.com/China_Chemical_Regulation/GB_6944_2012_Classification and code of dangerous goods.pdf




Implementation (different forms and documents usually)

Manufacturers in China Chemical User

License of Using Safety

Local Work Safety Department – (City-level)

Emergency Rescue Plan & Record Emergency Rescue document Technical Safety Instruction of

Chemicals Emergency response (people equipment

and checklist) Safety assessment report by 3rd party Manufacturing Safety document and

rules …

A Company using hazardous chemicals as major materials or even additives in its production


SAWS: http://www.chinasafety.gov.cn/newpage/ Please be noticed, hazardous chemicals need to apply for this license under Decree 591

only meet two descriptions below:

- The Directory of Industries - Criteria for Limit Volume Find the copies for your information : http://issuu.com/mai.fung/docs/the_directory_of_industries_for_the_application_of?mode=window&backgroundColor= Also please be informed that you may find the contact information of Local Work Safety

Departments, however we do not believe that is necessary, simply ask for help from your local distributors or consultants , they have ways.


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The comparison of differences between China and other areas.

GB15258-2009

General Rule for Preparation of Precautionary Label for Chemicals

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

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You will also find information of

China GHS


Specific implementations since 01 Feb 2012

Regulation on Import & Export of Hazardous Chemicals >

AQSIQ

01 Dec 2011 Entered into force

Catalog of Hazardous Chemicals to be updated from Ver.2002 to a new version

Selected from the Catalog of Hazardous Chemicals Ver.2002

160*

Catalog of Hazardous Chemicals Ver.2002

DECREE591 by State Council

Import & export of Hazardous chemical products


…

AQSIQ + Customs

The vehicle has been rolling since o1 Feb 2012

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

The ver.2002 is to be updated under the Decree 591 SAWS is responsible for the Inspection

and enforcement of the Decree 591 within China;

taking care of the new version of the Catalog new version

Importer or exporter of the chemicals in the Statutory Inspection Catalogue 2012

should fulfill the obligations under related regulations issued by the AQSIQ

Local CIQ implements inspection and management of compliance work of import & export of hazardous chemicals and packaging

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• The Statutory Inspection Catalogue 2012 (over 200 products) –• But now only including 160 chemical products from the Catalog of Hazardous Chemicals Ver.2002 Please find the Statutory Inspection Catalogue 2012 in Chinese here (http://www.box.com/s/vged6ilflnv285x1no5x)

Part of Statutory Inspection Catalogue

2012

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


The obligations of import & Export of Hazardous chemical goods


National laws and standards; Industrial standards

Related Rules & Inventory

China TDG & GHS

Special requirements agreed between national governments

Import into China

Food additives

Hazardous chemicals used in

food as additives is supposed to

meet the requirements of food

hygiene and product inspection

as well as food safety

inspection accordingly.

Export from China

CHINA GHS | SDS | LABELLING

- SDS & Labeling preparation Following the newest version of UN GHS(Ver. 4th)

Documents should be prepared in Chinese

- SDS & Labeling preparation

Documents should be translated in Chinese if the

original copies written in foreign language

(follow the local regulations where your products are

about to be shipped to )

- The report of hazard profile prepared

by the approved labs

including classification report of TDG &

GHS

- Sample required to be tested in local CIQ approved

labs

- The report of hazard profile prepared

by local CIQ approved labs including classification

report of TDG & GHS

- Packing decided by the exporter according to the

classification report of TDG

- Exporter requires test reports of packaging and

containers from packing suppliers

- Conformity Declaration of Hazardous-chemical

importer (Template offered by the authority in Chinese)

- Conformity Declaration of Manufacturer of

Hazardous-chemical imported (Template offered by the

authority in Chinese)

The authority will be responsible for

- Ensuring all information of components in the products to be imported or exported are the same

as reported in the information included Conformity Declaration for inspections

- Checking hazards classification information on the packing; checking if labeling is designed to be complied

with TDG(or IMDG, IATA DGR) and GHS

- Ensuring Chinese SDS provided affixed on packaging; checking if the SDS, labeling are correct

- Identify whether the packing method meets standard requirements and whether the use of packaging is

appropriate; check whether the packaging is sealed tightly; ensure whether the goods inside the packaged is

not leaked.

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Inspection on chemical substances only, or chemicals in mixtures

Updates on 2 Mar 2012

The inspection is an extension of the implementation of Decree 591

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Decree 591 by SC

CIQ inspection

Outside China Inside China

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

Catalog of Hazardous Chemicals (2002) to be updated

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

CN SDS

Lab-el

According to CN GHS

CIQ inspections are only responsible

for Export & Import

24h Emergency Call

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

Notice

Decree 591 >>

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

Inspection list & Catalog of Hazardous Chemicals Ver.2002

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2 lists but quite closely related


(Ver.2002 currently still works)

Decree 591 >>

Existing hazardous chemical

New chemicals identified as hazardous chemicals

China REACH

160 chemicals (updated regularly)

The Statutory Inspection Catalogue 2012

Chemical substances

already listed in the Catalog Ver.2002

Chemical products

Ingredients are chemical substances listed in the Catalog

Ver.2002

How 2 lists are linked



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

• Ensure your implementation of compliance will be initiated with no delay

The inspection has been implemented


We list the areas where inspection is quite strict.

Zhejiang Province Shandong Province

Shandong Province

City Shanghai Fujian Province Jiangsu Province

Guangdong Province

Find out whether your business has been affected

Check the catalog | Have news from the local partner or your consultant

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

More & more…

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One point to be noticed


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(Ver.2002 currently still works)

AQSIQ

AQSIQ (local CIQ) Only inspect Chemicals in the Catalog of Haz. Chemicals

Imported chemical products are allowed to be put on with GHS label after clearance but in special warehouse

X AQSIQ shall not put any inspection upon chemicals out of the Catalog of Haz. Chemicals even with GHS label

GHS label could be referred to GHS rules of exporting countries.

Chemicals with GHS label but not in the Catalog


Toxic Chemicals Severely restricted from import & export>

MEP


Learning steps – it is about restricted toxic chemicals


What would be the key issues you need to know?

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Who May be affected

Restricted Chemicals

Comply Strategy

If you do have been affected,

then learn how to comply with it

Whether those chemicals

have been or will be restricted in China

Who might be

affected because of some chemicals

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

Foreign companies that export toxic chemicals listed in the

“Catalog of toxic chemicals severely restricted to be imported or exported(the newest version is 2012)” shall apply one Registration for each type of toxic chemicals

Chinese importer should apply for import clearance Notification by the Registration Certificate during import of each batch of same toxic chemicals

Who may be affected ? What responsibilities? NEXTPAGE >


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

Foreign Companies Located outside China Export toxic chemicals into China

Responsibilities

Domestic Companies Located in China Importer & Exporter of toxic chemicals

Responsibilities

Please be informed

Please be informed

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

Import Clearance Notification Registration Certificate for the

Environmental Management on the Import of Toxic Chemicals

Export Clearance Notification

Importer Exporter

Who will be affected Who will be affected

In China

Out of China

+

An Import Clearance Notification is with a valid period of 6 Months

Import Clearance Notification shall be applied for each time

An Export Clearance is Notification with a valid period of 6 Months

Export Clearance Notification shall be applied for each time

CRC of MEP

Registration Certificate shall be applied each type of chemicals exported

to China once with a valid period of 2 years.

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

+ Importer could apply for Registration Certificate instead of a foreign

companies, but we recommend foreign companies should take the responsibilities on your own or assign Chinese representative to do so.

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Let’s review who would be responsible for application NEXTPAGE >


Under different regulations

Order 7 & Decree 591 Toxic chemical import & export

Out of China

In China

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

Foreign company

Chinese importer

Chinese representative

Subsidiary of Foreign Companies but in China

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

Business players

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

Decree 591 | Order 7

Chinese manufacturer

Decree 591 | Order 7

Order 7

Order 7*

* - if a subsidiary of a foreign companies in

China is acting as manufacturer or importer of hazardous chemicals under Decree 591, it shall apply for registration certificate.

Decree 591 >> Order 7 >> Registration body under Order 7 & Decree 591 |

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


The Catalog of restricted toxic chemicals NEXTPAGE >

158 Pure substances

& Chemicals

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

Check the catalog before export chemical products to China

Chinese version

English version

>

>

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

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

China MEP and Customs jointly issued the 91 statement on

2012 version of the “Catalog of Toxic Chemicals severely restricted to be imported or exported” News source in Chinese

http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID=387&T3=10&LanguageType=CH&Sub=12


2010 version of catalog Replaced

by 2012 version of catalog

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

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

Taskforce for Evaluation

CRC-MEP

MEP Ministry of State Council

The Registration Certificate application process

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

a) Discussion b) Publicity for comments (3 days) c) Final approval d) Certificate issued

Registration

applicant

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

Technical evaluation provide Feedbacks

• CRC software for some materials

• Other materials (hard copy) • Registration fee

Local MEP

Inspection

Process

Different Roles

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X Fail in preparation of registration materials

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


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

Division of pollution

prevention

Invoice or notify application failure

Fail in approval

Inspection and management after certificate issued

MEP Publicity board:

http://www.mep.gov.cn/zhxx/gsq/

X

X Failure in approval， CRC notifies the applicant

30 work days


What to be prepared for Regulation Certificate application

Help your with compliant work

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Foreign companies Type 1


CRC of MEP

CRC supports Tel: + 86 10 4915286 (hazardous chemical only) Email: [email protected]

+ 10,000USD or equivalent RMB

+ Necessary materials to be submitted

Application form of Registration Certificate (template avail.)

Business Contract (Original Copy)

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

Chinese importers Not all materials listed

Type 1

Importers of toxic chemicals as user

Importers of toxic chemicals as trader

Importers of toxic chemicals as representative of FC*

FC = Foreign companies

• Application form • Toxic chemical profile • Business license • Original business contract • Copy of import & export approval

certificate • Environment report for each

chemicals and comments from the authorities


• First 6 points are same • License of Operation Safety

(Decree 591) of both importers & Downstream trader

• Annual record of toxic chemicals sales

• Sales information of toxic chemicals within recent 2 years

• DU inventory(only applied to some certain chemicals)


• Include all materials of importer as trader

• First and second grade downstream roles’ License of Operation Safety (trader) and Environment report for each chemicals and comments from the authorities (users) required

• Business license of importer and first grade DU required + 10,000USD or equivalent RMB


Cosmetics Regulations >

SFDA license and label


Disinfectant Regulations >

MOH license and label


31 Aug 1992

Order 27 by MOH Entered into force

Order 27 by MOH since 2002

Order 27 by MOH Issued 28 Mar 2002

Order 22 by MOH Issued

01 Jul 2002

10 years

Order 22 changed to Order 27 by MEP

Order 22: Provision on Administration of Disinfection

Order 7: Revision of Provision on Administration of Disinfection in China

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X

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


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Afterwards, we talk mainly about Disinfectant

Be Noticed


Pesticide Regulations >

Pesticide & Agrochemical


Will be updated by Mai SOON

chinese regulation guidance

Education

mep order

mep helpyouknowit

toxic chemical substances

mep in2008

substance existing chemical

nextpage order

nextpage china reach

china xorder