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Hazardous Chemicals Registration vs. Environmental Management Registration of HCs
Identification and Classification of Physical Hazards for Chemicals
Hazardous Chemicals Registration vs. Environmental Management Registration of HCs
In the area of the HC registration, two significant legislations will impact both domestic manufacturers and importers of hazardous chemicals. The two rules are formulated and governed by two separate competent authorities.
SAWS Order 53, “Measures for the Administration of Hazardous Chemicals Registration”, which has been enacted on 1 July and put into effect from 1 August by the State Administration of Work Safety, has extended the mandatory obligation of HC registration to HC importers for the first time.The compliance difficulties lie in more refined registration content and more rigorous application documentation that will incorporate GHS classification and labelling information, toxicological and ecotoxicological data as well as upgraded requirements on HC exposure, safe use, storage, transport and emergency measures, etc. Specific guidance can be seen in the SAWS Notice 144 issued shortly afterward, which provides the final version of 8 application related documents required for the registration.
The other milestone legislation, the MEP Order 22 in the full title of “Measures for the Environmental Management Registration (in short as “EM registration”) of Hazardous Chemicals (Trial)”, which has been published by the Ministry of Environmental Protection on 10 Oct and will take effect from 1 Mar 2013, is created to address the environmental emission or discharge monitoring and risk assessment on general HCs and Hazardous Chemicals of Priority Environmental Concern (HCPEC). The environmental management registration and post-registration maintenance of these two types of HCs follow different working routes as indicated in the MEP Order 22. There is also obvious discrepancy in the environmental management registration submitted by the HC manufacturer/user or the HC importer/exporter.
Though both SAWS Order 53 and MEP Order 22 are enacted to regulate the registration management of existing HCs, the two have been designed with differentiated focuses and subject applicants (see the detailed comparison in ChemLinked Expert Article: A Comparative Analysis of MEP Order 22 and SAWS Order 53).
Identification and Classification of Physical Hazards for Chemicals
With regard to the identification of a hazardous chemical, which are being extensively questioned among the potential HC registrants, China is planning on a series of supporting measures that may help clarify the confusion . The SAWS-issued “Draft Measures on the Management of Physical Hazard Identification and Classification for Chemicals” is one in the series.
Released on 3 Dec 2012 as an opinion-soliciting draft though, this document has first proposed the official definition of chemicals with unidentified physical hazards, thus suggesting a set of tentative handling modes for the identification, classification or even potential registration duties regarding this massive group of chemicals.
However, the industry is still anticipating more plausible and flexible procedures for subject mixtures, preparations, and solutions etc. Not ever subsiding are concerns over the identification and classification of environmental or health hazards for chemicals.
Permit and License System under the HC Registration
When it comes to the associated licensing systems under China’s HC registration, the year 2012 has witnessed notable and continued achievements. Two ministerial orders are successively revised to regulate the management of HC Safe Use Permit and HC Operation Permit (In some literature, they are called HC operating license or other similar terms).
The SAWS Order 55, “Measures for the Administration of Hazardous Chemicals Operation Permit”, enacted on 17 July and coming into force on 1 Sep 2012, requires that all the enterprises engaged in the sale and operation (including storage business) of any given hazardous chemicals listed in Chinese C&L Inventory (also known as the Catalogue of Hazardous Chemicals) within the territory of Chinese mainland must, prior to their operation activities, apply and obtain the HC Operation Permit. Yet operations of civil explosives, radioactive materials, nuclear materials and town gas are excluded.
Later on 16 November, the SAWS Order 57, “Measures for the Administration of Hazardous Chemicals Safe Use Permit”, was announced to be in effect since 1 May 2013. Concerned companies should identify if they are included in a national “Catalogue of applicable industries for hazardous chemicals safe use permit” and, more importantly, if they are using HCs (for the purpose of production) in quantities that reach the minimum annual tonnage specified in the “Use Quantities Standard for Hazardous Chemicals”.
HC Inventory Compilation
With regard to the compilation of HC related inventories, the authority is still in the final reviewing stage on the Chinese C&L Inventory (first batch) based on its 2002 edition. “The updated list will cover above 7, 000 substances, with a little more than 4,000 substances expected to be released in the first batch list at the beginning of 2013. Furthermore, the classification information will be released separately later,” commented Mr. Guo Zongzhou from the NRCC, SAWS.
As for the regulated hazardous chemicals, the Second Batch of Hazardous Chemicals under Priority Management (draft)” was released in Oct 2012, with 14 new nominated chemicals added to the first Batch List that contains 60 priority hazardous chemicals. Along with the updated inventory, three supporting documents were published, indicating respectively:
Safety treatment and emergency disposal guidance for the second batch of Priority HCs;
Process technologies for the second batch of Priority HCs;
Process safety control specifications, key monitoring parameters and recommended control for the second batch of Priority HCs.
Formal editions of the latter two documents have been published on 15 Jan 2013. The official second batch list is going to be published in the spring of 2013, with one substance removed from the 2012 draft list.
Dangerous Goods
As for the legislative development concerning dangerous goods, two national compulsory standards are introduced in 2012 to regulate the classification and packing of dangerous goods for their commercial transport, storage, distribution, operation and other related activities.
In replace of its 2005 version, the GB 12268-2012 presents the whole list of dangerous goods under control in China. When a substance is specifically listed by name in the List of Dangerous Goods, it shall be identified in transport by the proper shipping name in the List. This GB also specifies determination rules for dangerous articles containing impurities or additives. When these impurities or additives affect the overall classification of a dangerous article, the article should be viewed as a mixture or solution; and in general cases, it should be identified according to the shipping name of its main component as covered on the List.
The GB 6944-2012 in replace of its 2005 version, stipulates the classification, precedence of hazards and Code (UN number) of dangerous goods. Keeping the old nine classes of dangerous goods consistent with the old version, the new GB however manages to amend or add the following technical content: 1) terms, definitions and specific criteria for the determination of the class and division of some dangerous goods; 2) the classification and combination rules for compatible groups of explosives; 3) the hazard precedence for dangerous goods; and 4) newly added packing groups of dangerous goods.
HC Packaging, Transport and Entry-Exit Inspection
In most practical circumstances, the official enforcement on HC packaging or transport has often been made a focus in the corresponding entry-exit inspection and quarantine items. On the other hand, the differentiated supervision on the packaging of hazardous chemicals and dangerous goods has still much to be desired. This is because the classification criteria of dangerous goods actually do not equal that of hazardous chemicals (i.e. GHS classification). For instance, a hazardous substance classified in the GHS hazard category of AcuteTox. 3 can be considered dangerous goods at division 6.1 (Toxic substances) if it will be exposed by oral or dermal routes; but if it is by routes of inhalation in the status of gas, vapor or dust/mist, the substance may not be defined as dangerous goods. Lack of sufficient knowledge in hazard classification and labelling as described above has led to various problems in multidisciplinary enforcement that involves the AQSIQ, the Ministry of Transport (MOT), local CIQ bureaus and the Ministry of Public Security (MPS).
Nevertheless, two announcements issued by the AQSIQ in 2012 have attempted to provide more sensible instructions for the inspection of HC packaging at the Customs Clearance. First, the AQSIQ, working with the State General Administration of Customs (GAC), announced at the end of 2011 to adjust the Chinese Catalogue of Entry-Exit Commodities Inspected and Quarantined by the CIQ Authority, namely the 2012 adjusted Catalogue of Inspection and Quarantine. In the amended Catalogue, new “regulatory conditions” and “inspection & quarantine type” have been applied to 160 hazardous chemicals since 1 Feb 2012.
On 29 Feb, 2012, the AQSIQ reiterated its compulsory requirements on the inspection of entry-exit hazardous chemical products and their packaging in the Announcement No. 30 of 2012. A strong focus on the China GHS-aligned Safety Data Sheet and Precautionary Labels could be observed from the pertinent declaration documents for HC import and export. The customs declaration for exported hazardous chemicals needs to prepare additionally a report on the identification and classification of hazard properties which must include both classification in line with the Transport of Dangerous Goods and the GHS classification.
With respect to the HC transport legislation, the SAWS has released a draft guideline for traffic safety management of hazardous chemicals on 21 Dec 2012. The draft proposal is right on a 30-day public consultation till 8 Feb 2013. HC transport companies are advised to determine the HC package category (or packing group) based on the status and hazard properties of a chemical as per GB/T 15098 and GB 12268. They also need to adopt the technical specifications provided in GB 15258, GB 190 and GB/T 191 for the Precautionary Label, the Dangerous Goods packing symbol and the storage & transport symbol during the transport process.
GHS development in 2012
China is considering updating the current 26 GHS-related national standards to 28 standards by adding the “aspiration hazard” and “hazard to the ozone layer”, the later one has already been officially put onto agenda now. On 13 Aug 2012, the Standardization Administration of China (SAC) has released a plan to formulate and revise a bunch of national standards: one is the revision of GB 13690 and another is a new GB standard that will introduce the “hazard to the ozone layer” for the first time into China GHS system. Both standards are scheduled to be finished by 2014.
The GB 13690, “General rule for classification and hazard communication of chemicals” has experienced one revision in 2009. It provides general but mandatory directions for GHS classification in China. Companies are also advised to refer to the specific 26 GB rules (GB 20576 - GB 20599 and GB 20601 - GB 20602) for detailed hazard categories, precautionary labelling or precautionary statements of chemicals. Currently the upcoming version is going to adopt the fourth revision of UN GHS (ST/ST/AC.10/30/Rev. 4).
Equally important and new to the chemical industry are the following recommended GB/Ts: the “Guidance addressing consumers risk assessment based on GHS chemical labels”, the “General rules for the chemical risk assessment” and the “Norm on warning marks for chemical workplaces”. All of documents mentioned above are to be drafted for the 1st time and the recommended guidance will adopt the UN GHS Rev. 4.
What is to be Expected in 2013?
Looking into 2013, it is believed that a new phase of HC safety control and product stewardship will be ushered in the industry. Apart from the long-awaiting Chinese C&L Inventory and other related HC catalogues, more sensible and workable implementation details or guidance papers are expected to address the procedure of HC registration and the environmental management registration of HCs. The upcoming guidance on the hazard identification and risk assessment for mixtures or chemicals with uncertain hazard properties, as well as a supporting document for the HC registration are expected to be formulated .
