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A briefing interpretation of the administration of Hazardous Chemicals in ChinaSAWS Order 53 2012 | MEP Order 22 under Decree 591 by State Council

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Christine XuGHS specialist in REACH24H

Erin WuRA Consultant in REACH24H

Charles FengRA Consultant in REACH24H

Mai FungRA specialist in REACH24H

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Decree 591 by State Council of the P.R.CThe core legislation of hazardous chemical control in China

Currently the core legislation of hazardous chemicals in China is “Regulation onSafe Management of Hazardous Chemicals” (Decree 591) issued by State Council on1 March 2011, which finally came into force on 1 December 2011. This newly-bornlaw of hazardous chemicals has successfully replaced Decree 344 also published byState Council in early 2002 with which the catalog of hazardous chemicals (version2002) was brought up in the meantime. Moreover, Decree 591 supported by someamount of different measures and national standards is also the primary base whichthe implementation of new China GHS is relying on.

Feb 1987Regulation on the Safe Management of Hazardous Goods

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

Dec 2011 Decree 591Regulation on Safe Management of Hazardous Chemicals

Legislation Evolved

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Only Chinese companies need to comply with Decree 591,

why it also matters to Overseas Companies?

On one hand, even though your company is located far away from China Mainland, your suppliers or importers of hazardous chemicals listed in the catalogue in China will have to face ever stricter inspection from the enforcement authorities. So ensure your business partners (supplier of hazardous chemicals or related products) are clear about what responsibilities they shall fulfill by reviewing the briefing in the table shown in page 10-” Who shall be subject to Order 53 by SAWS”.

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

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Top Level

Legal System

2nd Level

3rd Level

4th Level

Constitution

Decree 591“Regulation on Safe Management of Hazardous Chemicals”

Order 22 by MEP & Order 53 by SAWS“Measure for the Environmental Management of Hazardous Chemical Registration”

“Measures for the Administration of Registration of Hazardous Chemicals”

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

3rd & 4th level as the supportive regulations used for specific guidance of the execution and implementation of 2nd level, Administrative law

2nd level, Administrative law sets up direction or legal reference

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People’s Congress

Quick Lesson of Chinese Authorities

Top Level

2nd Level

3rd Level

4th Level

MinistryMEP: Ministry of Environmental Protection

MOH: Ministry of Health

MOR: Ministry of Railways

MOA: Ministry of Agriculture

MIIT: Ministry of Industry and Information Technology

MOT: Ministry of Transport

MPS: Ministry of Public Security

MOH: Ministry of Health

State of Administration SAWS:State Administration of Work Safety of State Council

Customs: General Administration of Customs of China

AQSIQ: General Administration of Quality Supervision, Inspection and Quarantine

（In charge of local CIQ）

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Version 2002

3800chemicals

Newest Version

7000+chemicals to be confirmed

Catalog of Hazardous Chemicals under Decree 591

Download Catalog 2002 Ver.2002

Currently still valid

New Version of Catalog

Product nameOther name

English nameOther EN name

CAS# UN# Hazardous classification

GHS pictogram Signal word Hazardous statement

First batch will come out early next year

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

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2 Major Measures

Measures for the Administration of Registration of Hazardous Chemicals

Focuson

Measure for the Environmental Management of Hazardous Chemical Registration

Focuson

Entered into force1st Aug 2012

Published10th Oct 2012

Will enter into force1st Mar 2012

data collection and administration of hazardous chemicals, protection measures against hazardous chemicals.

preventing impacts of hazardous chemicals against human health and environment.

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Order 53 by SAWS of the P.R.CMeasures 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.

Key arears being covered:

8rd Oct 2002 (Now invalid)Measures for the Administration of Registration of Hazardous Chemicals by the former State Economic

Trade Commission (now integrated in the Ministry of Commerce)

1ST Jul 2002 Order 53Published by SAWS

1st Aug 2012 Order 53Entered into force formally

Legislation history

Physical & Hazardous Properties

Classification & LabelingStorage &

Transportation

Uses &Restricted uses

Protection measures

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2 sources of hazardous chemicals

> Catalog of Hazardous chemicals3800+ chemicals (version 2002) to be re-issued

> Chemicals not subject to the Catalog but classified hazardous by certified institutionsSpecific guidance will be published later for hazardous identification and classification1) Measures for the Administration of hazardous identification and

classification 2) List of chemicals to be through hazardous identification and

classification

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Who shall be subject to Order 53 by SAWS

“According to Order 53 under Decree 591, the roles including Manufacturers

of hazardous chemicals, importers (traders/downstream) of hazardous

chemicals, distributors andwarehousing companies of hazardous chemicals, transportation companies

of hazardous chemicals, chemical users of hazardous chemicals will have

to fulfill related obligations.”

Roles Registration Main License Subject to Regulation Supervision Division

Manufacturer Registration Certificate License of production of hazardous chemicals

Order 53 under Decree 591; C&L; SDS

NRCC of SAWS; Local Work Safety Department

Importer in (Trader and downstream chemical user)

Registration Certificate License of Operation of hazardous chemicals

Order 53 under Decree 591; C&L; SDS

NRCC of SAWS;Local Work Safety Department

DistributorWarehousing

Not applicable License of Operation of hazardous chemicals

Order 55 under Decree 591; Local Work Safety Department

TransportationCompanies

Not applicable License of Transportation on Road, License of Transportation in Water

GB 12268-2012, GB6944-2012 Ministry of Transport of P.R.C, Transport of Dangerous Goods on Road

Chemical User Not applicable License of Safe use permit Trial Version Local Work Safety Department

“Only companies within China Mainland shall be subject to Order 53”

* Under Order 53, warehousing companies and chemical users will not be required for registration.

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8 documents for Registration of HC

Attached to Order 53, eight supporting documents for registration of hazardous chemicals were published on 17th

Oct 2012

1) Registration form of hazardous chemical producer/manufacturer 2) Registration form of hazardous chemical importer (separated sector for trader and downstream user correspondingly)

3) Application form of subject company registrant4) Application form of registration modification5) Evidential document of registration modification(No registration certificate to be re-issued after modification)6) Application from of registration certificate renewal (certificate expires)7) Notice of rejection of registration application8) Notice of requesting supplementary materials

For more details of each forms, you may find this article helps“http://www.reach24h.com/en/news-a-events/item/742-to-dos-after-saws’s-latest-publication-of-documents-for-

hazardous-chemical-registration-saws-order-53-of-2012.html”

（ ）

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Order 22(Trial) by MEP of the P.R.CMeasures for the Administration of Registration of Hazardous Chemicals

This new regulation strictly regulate the general hazardous chemicals, and chemicals with higher hazardous properties against human health and environment. Some content in this regulation is also shared by the Order 53by SAWS.

Moreover, If the company were caught of producing/using the hazardous chemicals under Order 22 by MEP without the registration certification or other illegal activities, they will meet a fine ranging from 10,000 Yuan to 50, 000 Yuan. Even criminal responsibilities would be imposed in some cases.

10rd Oct 2012 Order 22Trail version published

1st Mar 2013 Order 22Will Enter into force formally

Legislation history

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2 sources of hazardous chemicals

> General hazardous chemicalsThe new Catalog of Hazardous Chemicals to be published by SAWS

> Hazardous Chemicals of High Environmental Concern （HCHEC）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.

> List of Toxic Chemicals Severely Restricted to be Imported into or Exported from China by MEP （158 chemicals）

The “List of Toxic Chemicals Severely Restricted to Be Imported into or Exported from China” is subject to registration requirement under Order 113 by MEP (2009). Please note that foreign companies could complete registration on them own or commit the registration work to a Chinese importer. (We might expect the relation between Order 113 and Order 22 later)”.

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Responsibilitiesunder Order 22 by MEP

“According to Order 53 under Decree 591, the roles including Manufacturers

of hazardous chemicals, importers (traders/downstream) of hazardous

chemicals, distributors andwarehousing companies of hazardous chemicals, transportation companies

of hazardous chemicals, chemical users of hazardous chemicals will have

to fulfill related obligations.”

RolesChemicals

Registration &License

Material to be submittedSubject to regulation

Supervision Division

Manufacturer &User of hazardous chemicals

General hazardous chemicals (in Catalog

of hazardous chemical)

Registration Certificate of environmental

management on hazardous chemicals

Application form of registration certificate; registrant information;

classification; SDS; prevention measures; emission about the typical pollutants;

Environmental Impact Assessment(EIA); Contingency plans for emergency; Environmental monitoring report

Order 22(Trial) under Decree 591

local environmental protection authorities

(County level)

Manufacturer &User of hazardous chemicals

HCHEC Registration Certificate of environmental

management on hazardous chemicals

Addition to the material required from general hazardous chemicals;

Environmental Risk Assessment(ERA); annual report of emission, migration and monitoring result of particular pollutants, and protection measures on pollution and

environmental risks

Order 22(Trial) under Decree 591

local environmental protection authorities

(provincial level)

Importer and exporter of toxic chemicals

Toxic Chemicals Severely Restricted to Be Imported into

or Exported from China

1)Registration Certificate of

environmental management for each

Toxic chemical imported

2)Import or Export

Clearance Notification

1)Application through CRC software

2)Materials are different according to

Foreign companies; importer as user; importer as trader; importer as

representative of foreign companies:

Order 113 by MEP (2009)

CRC (chemical registration center)-

MEP and MEP

“Companies in or out of China Mainland shall be subject to Order 133- Toxic Chemicals Severely

Restricted to be Imported into or Exported from China”

* A registration certificate is issued by MEP under Order 22, which is different from the one issued by the SAWS.* More guidance in regard to registration of hazardous chemicals or toxic chemicals will be released in CCLP.

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

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

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National Standards related toChina GHS

National Standards

Scope When came into force Download

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

1st May 2010 (the core of China GHS)

English version:https://www.box.net/shared/rs1kz4yhvfghkomcm1zb

GB 20576-2006-GB 20591-2006

Physical-hazard category under GB 13690-2009

1st Jan 2008 Only Chinese version

GB 20592-2006-GB 20601-2006

Health-hazard category underGB 13690-2009

1st Jan 2008 Only Chinese version

GB 20602-2006 Environmental-hazard category under GB 13690-2009

1st Jan 2008 Only Chinese version

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

1st Feb 2009 English version:https://www.box.net/shared/ssz9zywfhyw08bdivgx9

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

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

English version:https://www.box.net/shared/zfowqilreoeztxg1wdss

GB 190-2009Packing symbol of dangerous goods

1st May 2010 Only Chinese version

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

1st Feb 2009 Only Chinese version

* Consider to receive a template of MSDS or GHS label complied with China GHS, simply make your request in the “China Chemical Legislation Professionals” group.

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Emergency Response Call1) For companies those are plan ER Unit themselvesER call should be a Chinese landline; designated staffer as 24h supporter; staffer should be well trained with competent abilities of hazardous chemicals handling;

2) Other companies shall appoint approved 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 located in China so far till now.

Companies fail to provide qualified ER call will receive no-more-than-30,000CNY fine.

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What NEXT?After we finish the legal system of hazardous chemicals management in China, in next material we will much more focus on the explanation of “Measures for the Administration of Registration of Hazardous Chemicals” (Order 53 by SAWS). How is the registration completed by a specific role within the supply chain; what should be submitted; how to prepare the documents and any valuable tips?

Even more information of the system of China GHS, comparison between GHS in other areas, practical guidance on GHS compliance will be related in each CCLP Sharing.

Do us a favor, share CCLP group and let more enjoy sharing experience http://www.linkedin.com/groups?gid=4643707&trk=myg_ugrp_ovr

About CCLP:

"China Chemical Legislation Professionals", an official sub-group of REACH24H Consulting group, aims at helping to establish a professional network where experts who hold EHS or regulatory backgrounds could achieve the most updated information of chemical legislation and enforcement in China, exchanging practical compliance experience, finding answers to tough cases and also benefiting from valuable learning materials shared.

Discussions on new chemical (China REACH), hazardous chemical (China GHS), cosmetics, pharmaceutical, agrochemical or related environment laws in China would be initiated here. However, this group is not an open group yet, and all discussions will only be available to members. We are looking forward to the participation of anyone who may be interested in sharing knowledge.

“We have huge database of regulatory information in China (over 100 authorities) and even from other Asia-pacific countries.”