The overarching piece of legislation on management of

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1 Olivia Sun Main pillars of legislation of hazardous chemicals in China OLIVIA SUN ChemLinked Team, REACH24H Consulting Group 6 F, #2 Building, Hesheng World Trade Centre, No. 327 Tianmu Mountain Rd, , Hangzhou, China KEYWORDS DECREE 591 Hazardous chemicals; decree 591; China GHS; registration; license/permit; entry-exit inspection. ABSTRACT A number of regulations concerning the management of hazardous chemicals in China, among which the overarching one is the revised Regulation on the Control over Safety of Hazardous Chemicals (State Council Decree 591), also called Decree 591, which came into force on 1 Dec, This article mainly focuses on Decree 591 with its complex regulatory framework to support its full-scale implementation in four major areas: China GHS (Globally Harmonized System), Registration, Permit and Licenses as well as Entry-Exit Inspection. The most recent developments of the corresponding legislative documents are discussed with the upcoming major updates summarized in a concise manner. Besides, two relevant legislations, Regulation on the Control over Monitored Chemicals (Decree 190) and Regulation on the Administration of Precursor Chemicals (Decree 445) are briefl y introduced. Figure 1. Regulatory Framework under Decree 591 (2012 updated). The overarching piece of legislation on management of hazardous chemicals, Decree 591 ( Regulation on the Control over Safety of Hazardous Chemicals ) came into force on 1 Dec, It regulates hazardous chemicals through the entire supply chain, ranging from manufacture and importation to distribution and storage, transportation and use. Its earlier version, Decree 344, came into effect in Both of these regulations could date back to the 1987 Regulation on the management of hazardous goods. The implementation of Decree 591 demonstrates the authorities intention to strengthen the safety controls governing hazardous chemicals in China, to prevent and reduce accidents, and to protect life, property and the environment. Enterprises involved in hazardous chemicals should be aware of the significance of this recently released regulation. Although Decree 591 turns out to be a far-reaching regulation for stakeholders involved in the hazardous chemicals industry, there have been little practical guidance documents released so far to help enterprises with clarification. However, the year 2012 has witnessed a raft of legislative documents (either official version, trial or consultation draft) going released in support of the full-scale implementation of the Decree 591. Hazardous chemicals are administrated through a complex regulatory network in China, with more than ten departments or ministries involved (see figure 1). Under the key legislation of Decree 591, four main categories, based on their corresponding obligations can be organized, with a number of supporting measures and standards; e.g, national standards related to the China Globally Harmonized System (GHS) of chemicals classification and labeling (e.g GB xxx or GB/T xxx ), measures on Registration (SAWS Order 53) and 33

2 34 Environmental Registration of hazardous chemicals (MEP Order 22), measures on licenses for manufacturing, use or storage and the entry-exit legal inspection. REGULATORY SCOPE Under Decree 591, hazardous chemicals are defined as highly toxic chemicals or other chemicals of toxic, corrosive, explosive, flammable and other properties, which will do harm to human body, facilities and environment. Generally, all chemicals included Figure 2. Chinese C&L Inventory. in the Catalogue of Hazardous Chemicals, which is also known as the Chinese C&L Inventory, are covered by Decree 591. Originally issued in 2002, the catalogue is being revised and the new version is expected to contain around 7,000 chemicals, which almost doubles the amount of the current version (see figure 2). Nevertheless, due to the heavy workload, the C&L inventory is likely to be released batch-wise in the next few years by the NRCC, SAWS, with the first batch of around 4,000 substances to be published in June 2013 the earliest. The recurring delay of the release of the inventory could be ascribed to the difficulties in reaching consensus among the authorities involved. However, the scope of Decree 591 will not be limited to the C&L Inventory. According to the SAWS National Registration Centre for Chemicals (NRCC), chemicals classified as hazardous under the country s standards on classification, which will be revised (see below), should also comply with Decree 591. MAJOR OBLIGATIONS UNDER DECREE591 AND THEIR LEGISLATIVE SUPPORT China GHS: SDS, labeling and packaging One major responsibility under Decree 591 is to comply with the country s GHS requirements. There is no single piece of legislation called China GHS : instead, the UN GHS model is being implemented, under the aegis of Decree 591, through a series of measures and national standards. For example, the Measures for the Administration of the Registration of Hazardous Chemicals, states that companies must provide a safety data sheet (SDS) and label according to SDS standard GB/T , labeling standard GB , etc, in order to obtain a registration certificate from the NRCC. Articles 15 and 79 of Decree 591 state that companies handling hazardous chemicals must comply with China GHS obligations, including those related to classification, labeling and SDSs, according to the specific national standards. China s classification and labeling standards do not include some of the hazards, such as aspiration hazard or hazard to the ozone layer. The new national standard on the hazard to the ozone layer has been officially put on agenda. According to the announcement by the national Standardization Administration in August, 2012, China will complete the revision on GB 13690, which is the general rule for classification and hazard communication of chemicals and the formulation of the a new GB standard to introduce the hazard to the ozone layer, both by 2014 (1). The government is planning to update the full set of 26 related national standards to bring them in line with the fourth version of the UN GHS. Registration: SAWS Order 53 vs MEP Order 22 SAWS Order 53 Under Decree 591, hazardous chemicals and the enterprises involved are identified through the hazardous chemicals registration system. Manufacturers and importers of hazardous chemicals are obliged to submit registrations to the NRCC prior to the first time manufacture and import, according to the provisions set out in the 2012 revised Measures for the Administration of Registration of Hazardous Chemicals (SAWS Order No. 53), which has entered into force on 1 August Unlike its predecessor, SAWS Order No.53 extends the registration obligation to the hazardous chemicals importers for the first time, while enterprises storing or using the substance remain exempt. Potential registrants must provide more detailed information, including classification, labeling, physical and chemical properties, main uses, hazardous properties and the safety requirements of storage, use and transport, plus emergency response measures (2). The official eight registration-related documents were released in the SAWS Notice 144 issued in Dec MEP Order 22 As milestone legislation, the Measures for the Environmental Management Registration MEP Order 22 was published by the MEP on 10 Oct, 2012 and will take effect from 1 Mar, Generally, MEP Order 22 was created to reinforce the environmental management on the HCs, prevent/reduce the harm of HCs to the environment, human health, as well as the environmental risks caused by the HCs. Since the MEP Order 22 and SAWS Order 53 are independently implemented by the MEP and the SAWS, the two measures are distinct in their functions, registration scope, subject entities, and dossier requirements, etc (3). Two groups will be affected by the newly formulated Measures, namely, manufacturers/downstream users of chemicals included in the Chinese C&L Inventory and importers/exporters of HCs included in the List of Toxic Chemicals Severely Restricted for Import and Export in China (2012). A list of Hazardous Chemicals of Priority Environmental Concern (HCPEC) will be compiled by selecting from the Chinese C&L Inventory and will be susceptible to more complex registration procedure and more severe supervision from the MEP Order 22. License System A license system is implemented to regulate the various activities of hazardous chemicals through the supply chain. Different actors in the supply chain must apply to different departments or ministries for different licenses (see figure 3). With the release of Decree 591, a number of supporting measures have been revised and released recently. Besides the revised measures for the implementation of work safety licenses for hazardous chemical production enterprises (SAWS Order 41), which was published in July 2011, separate measures for the administration of operation licenses (SAWS Order 55) and safe use licenses (SAWS Order

3 Figure 3. License System under Decree ) for hazardous chemicals were released in Note that only domestic companies can apply for the licenses. Entry/exit Legal Inspection On 29 Dec 2011, China s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and General Administration of Customs (GAC) jointly issued the Adjustment of 2012 Catalogue of Entry-Exit Commodities Inspected and Quarantined by the Competent Entry-Exit Inspection and Quarantine Authorities (hereinafter referred to as the Legal Inspection Catalog ), also known as AQSIQ Notice This AQSIQ Notice adds 160 hazardous chemicals listed in the Catalog of Hazardous Chemicals (2002 version) to the Legal Inspection Catalog. However, the AQSIQ Order No. 30 published on 29 Feb 2012 further expanded the inspection scope to cover all the hazardous chemicals listed in the Catalogue of Hazardous Chemicals. Since 29 February 2012 Companies are required to produce a range of documents to apply with CIQ for such inspections (see the blue box in Figure 4). Chinese companies exporting hazardous goods overseas must have a hazard identification and classification report produced by a Chinese accredited laboratory (4). Meanwhile, the CIQ will check the composition/constituent information, physical and chemical properties, hazard class etc. to confirm that they meet the requirements (see the yellow box in Figure 4). 35

4 36 A strong focus on the China GHS-aligned SDS and Precautionary Labels could be observed. Looking Ahead It is believed that the release of Decree 591 will bring about on-going major updates in the management of hazardous chemicals in China in the next few years, with only a few listed in the following: Revised Chinese C&L Inventory (with the first batch expected to be released June 2013 earliest); Update China GHS in line with the fourth edition of the UN GHS (to incorporate the aspiration hazard and hazard to the ozone layer ; Figure 4. Entry-Exit Legal Inspection. Meanwhile, revise the GB 13690); A guidance-like document to clarify practical issues during the HCs registration, including registration scope and identification of chemicals/mixtures of uncertain hazard properties; Finalized edition of Measures on the Management of Physical Hazard Identification and Classification for Chemicals by SAWS; Supporting documents for the implementation of MEP Order 22; and Drafting of the HCPEC list under MEP Order 22; OTHER MAIN PILLARS State Council Decree 190 In response to the China s signing of the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction in the Paris UNESCO headquarter, the State Council enacted the Regulation on the control over Monitored Chemicals in China (State Council Decree 190) on Dec 27, On Mar 10, 1997, a supporting legislation Implementation Specifications on the State Council Decree 190 (MCI Order 12) was published by the Ministry of Chemical Industry (MCI). Since then, China initiated the control over the monitored/controlled chemicals and a special permit system was adopted through the supply chains including production, storage, use, import, export and disposal. State Council Decree 445 Regulation on the Administration of Precursor Chemicals (Decree 445) was enforced by the State Council on Nov 1, 2005, aiming to strengthen the safety control over precursor chemicals in China, namely, prevent their illegal use in drug manufacturing. Production, distribution, purchase, transportation, import and export of precursor chemicals are subject to this regulation. Three supporting Measures were released: Measures for the Administration on Manufacturing and Operation License for non-pharmaceutical precursor chemicals (SAWS Order 5), which was published on 5 Apr, 2006 and entered into force on 15 Apr, Measures of Management for Purchase and Transport of Precursor Chemicals (MPS Order 87), which came into force on Oct 1, Measures for the Administration on the Pharmaceutical Precursor Chemicals (MOH Order 72), which has taken into effect from 1 May, CONCLUSIONS To sum up, hazardous chemicals are regulated through complex regulatory system, with Decree 591 as the core legislative piece. With its enactment in 2011, various obligations are prescribed for HC companies, including GHS-related Classification, Labeling and SDS, Registration, Permits& Licenses, and Entry-Exit Inspection. The year 2012 has witnessed a raft of legislative documents going released in support of the full-scale implementation of the Decree 591. Still much more regulatory developments are expected in the near future, such as the long-awaited release of the Chinese C&L Inventory and more specific relevant guidance documents to land down the practical obligations under Decree 591. REFERENCES AND NOTES 1. Liu, Lizzy, Combing China s Hazardous Chemical Legislation Development in 2012, 5 Feb Sun, Olivia, A Guidance-like Document to Clarify the Hazardous Chemicals Registration, 29 Sep Xu, Christine, MEP Order 22 vs SAWS Order 53, Cheminked.com.en, 11 Dec Zhu, Julian, Inspection and Supervision over Entry-Exit Hazardous Chemicals and their Packages in China, en, 7 Dec 2012.

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