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A briefing interpretation of the administration of Hazardous Chemicals in China SAWS Order 53 2012 | MEP Order 22 under Decree 591 by State Council Find China Chemical Legislation Professionals Group on Linkedin
Christine Xu
Erin Wu
Charles Feng
Mai Fung
GHS specialist in REACH24H
RA Consultant in REACH24H
RA Consultant in REACH24H
RA specialist in REACH24H
A sub-group of REACH24H Consulting Group on Linkedin
Legislation Evolved
Decree 591 by State Council of the P.R.C The core legislation of hazardous chemical control in China Currently the core legislation of hazardous chemicals in China is “Regulation on Safe Management of Hazardous Chemicals� (Decree 591) issued by State Council on 1 March 2011, which finally came into force on 1 December 2011. This newly-born law of hazardous chemicals has successfully replaced Decree 344 also published by State Council in early 2002 with which the catalog of hazardous chemicals (version 2002) was brought up in the meantime. Moreover, Decree 591 supported by some amount of different measures and national standards is also the primary base which the implementation of new China GHS is relying on.
Dec 2011 Decree 591
Regulation on Safe Management of Hazardous Chemicals
Mar 2002 Decree 344
Regulation on the Control over Safety of Hazardous Chemicals
Feb 1987
Regulation on the Safe Management of Hazardous Goods
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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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Legal System
Constitution
Decree 591 “Regulation on Safe Management of Hazardous Chemicals”
Top Level
2nd Level
2nd level, Administrative law sets up direction or legal reference
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”
3rd Level
3rd & 4th level as the supportive regulations used for specific guidance of the execution and implementation of 2nd level, Administrative law
GB 15258-2009 “General Rule for Preparation of Precautionary Label for Chemicals”
4th Level
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Quick Lesson of Chinese Authorities
People’s Congress
Top Level
2nd Level
Ministry MEP: 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
3rd Level
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）
4th Level
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Catalog of Hazardous Chemicals under Decree 591 First batch will come out early next year New Version of Catalog
Product name Other name
English name Other EN name
CAS#
UN#
Hazardous classification
Newest Version
GHS pictogram
“In the new version of Catalog, the chemicals will come with the information and hazardous properties above.�
Signal word
Hazardous statement
7000+ chemicals to be confirmed
Version 2002
Download Catalog 2002 Ver.2002 Currently still valid
3800 chemicals
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2 Major Measures
Entered into force 1st Aug 2012 Measures for the Administration of Registration of Hazardous Chemicals
Focus on
data collection and administration of hazardous chemicals, protection measures against hazardous chemicals.
Measure for the Environmental Management of Hazardous Chemical Registration
Focus on
preventing impacts of hazardous chemicals against human health and environment.
Published 10th Oct 2012
Will enter into force 1st Mar 2012
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Legislation history
Order 53 by SAWS of the P.R.C Measures for the Administration of Registration of Hazardous Chemicals
1st Aug 2012 Order 53
Entered into force formally
This new regulation specifies the procedures of registration of hazardous chemicals, and stresses the implementation of China GHS. Key arears being covered:
1ST Jul 2002 Order 53
Physical & Hazardous Properties
Classification & Labeling
Protection measures
Uses & Restricted uses
Storage & Transportation
Published by SAWS
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)
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2 sources of hazardous chemicals
> Catalog of Hazardous chemicals 3800+ chemicals (version 2002) to be re-issued
> Chemicals not subject to the Catalog but classified hazardous by certified institutions Specific guidance will be published later for hazardous identification and classification 1) Measures for the Administration of hazardous identification and classification 2) List of chemicals to be through hazardous identification and classification
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Roles
Registration
Main License
Subject to Regulation
Supervision Division
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 Registration Certificate and downstream chemical user)
License of Operation of hazardous chemicals
Order 53 under Decree 591; C&L; SDS
NRCC of SAWS; Local Work Safety Department
Distributor Warehousing
Not applicable
License of Operation of hazardous chemicals
Order 55 under Decree 591;
Local Work Safety Department
Transportation Companies
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
Manufacturer
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 and warehousing companies of hazardous chemicals, transportation companies of hazardous chemicals, chemical users of hazardous chemicals will have to fulfill related obligations.”
* Under Order 53, warehousing companies and chemical users will not be required for registration.
“Only companies within China Mainland shall be subject to Order 53”
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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 registrant 4) Application form of registration modification 5) 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 application 8) Notice of requesting supplementary materials
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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-forhazardous-chemical-registration-saws-order-53-of-2012.html”
8 documents for Registration of HC
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Order 22(Trial) by MEP of the P.R.C Measures 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 53 by 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.
Legislation history 1st Mar 2013 Order 22
Will Enter into force formally
10rd Oct 2012 Order 22 Trail version published
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2 sources of hazardous chemicals
> General hazardous chemicals The 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 environmentallyhazardous 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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Roles Manufacturer & User of hazardous chemicals
Manufacturer & User of hazardous chemicals
Importer and exporter of toxic chemicals
Chemicals
Registration & License
Material to be submitted
Subject to regulation
General hazardous Registration Certificate of Application form of registration Order 22(Trial) under chemicals (in Catalog environmental certificate; registrant information; Decree 591 of hazardous management on classification; SDS; prevention measures; chemical) hazardous chemicals emission about the typical pollutants; Environmental Impact Assessment(EIA); Contingency plans for emergency; Environmental monitoring report HCHEC
Registration Certificate of Addition to the material required from Order 22(Trial) under environmental general hazardous chemicals; Decree 591 management on Environmental Risk Assessment(ERA); hazardous chemicals annual report of emission, migration and monitoring result of particular pollutants, and protection measures on pollution and environmental risks
1) Toxic Chemicals Registration Certificate of Severely Restricted environmental to Be Imported into management for each or Exported from Toxic chemical imported China 2) Import or Export Clearance Notification
1) Application through CRC software
Order 113 by MEP (2009)
Supervision Division local environmental protection authorities (County level)
local environmental protection authorities (provincial level)
Responsibilities under 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 and warehousing companies of hazardous chemicals, transportation companies of hazardous chemicals, chemical users of hazardous chemicals will have to fulfill related obligations.”
CRC (chemical registration center)MEP and MEP
2) Materials are different according to Foreign companies; importer as user; importer as trader; importer as representative of foreign companies:
* 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.
“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”
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The administration of hazardous chemicals & China GHS Decree 591 attached by different measures, standards are the major legislation which enforces the China GHS. Chemical products shipped into China usually do not pass the inspection of enforcement because of failure in classification, packaging and labeling. In some cases, SDS poorly translated or prepared in languages other than Chinese also see direct REJECTION. In accordance with Article 78(3) (4) (6) (7) of Decree 591, manufacturers and traders fail 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
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 20576-2006GB 20591-2006
Physical-hazard category under GB 13690-2009
1st Jan 2008
Only Chinese version
GB 20592-2006GB 20601-2006
Health-hazard category under GB 13690-2009
1st Jan 2008
Only Chinese version
GB 20602-2006
Environmental-hazard category under GB 13690-2009
1st Jan 2008
Only Chinese version
Instruction of Safety Data Sheet, Content and Section
1st Feb 2009
English version: https://www.box.net/shared/ssz9zywfhyw08bdivgx9
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
1st May 2010
Only Chinese version
1st Feb 2009
Only Chinese version
GB/T 16483-2008
GB 15258-2009 GB 190-2009
Packing symbol of dangerous goods GB/T 22234-2008 Labeling of Chemicals Based on GHS
National Standards related to China GHS
* 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 Call 1) For companies those are plan ER Unit themselves ER 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-than30,000CNY fine.
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About CCLP:
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
"China Chemical Legislation Professionals", an official subgroup 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 Asiapacific countries.”