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May 1, 2012

Global Regulatory Update for May 2012

The ACTA Group

OECD Publishes Proposal For Harmonized List Of PRTR Pollutants: On April 12, 2012, the Organization for Economic Cooperation and Development (OECD) announced the availability of the Global Pollutant Release and Transfer Register, Proposal for a Harmonized List of Pollutants, which outlines the results of the work of the OECD Task Force on Pollutant Release and Transfer Registers (PRTR). In 2009, the Task Force noted that while there are 1,200 chemicals in the PRTR data center, only 14 of them are common to all PRTRs. According to the Proposal, the Task Force recognized that the problem was partly due to issues such as the use of incorrect Chemical Abstract Service (CAS) numbers and different names for the same substance. The Task Force agreed to eliminate mistakes and aggregate the existing chemicals to produce a more harmonized list of chemicals and thereby improve the comparability of PRTR data on a global scale. The Proposal identifies general pollutant classes, proposes unique identifiers for pollutants, and identifies common substances across different national/regional PRTRs. The Proposal is available online.


Canada Announces Second Phase Of DSL Inventory Update: On April 21, 2012, Canada announced that it was moving forward with consultations on the second phase of the Domestic Substances List (DSL) Inventory Update. According to Canada, based on the first phase of the DSL Inventory Update that began in October 2009, during which Canada collected basic information on approximately 500 chemicals, Canada proposes to request basic information on rounded quantities, use simple “yes/no” questions, and use pre-defined codes for function and product type. Canada also proposes to target those who manufacture and import the substances to capture the substance at the point of entry into Canadian commerce. Canada states that it is considering the use of a concentration threshold for reporting and the exclusion of certain manufactured items of lesser concern for releases to the environment or exposure to humans. Canada proposes to launch the Section 71 survey in September 2012, and states that the end of the data collection period will be in Spring/Summer 2013. More information is available online.

Canada Posts Comprehensive List Of Substances Subject To A SNAc Notice: On May 4, 2012, Canada posted a comprehensive listing of substances subject to a significant new activity (SNAc) notice. Under the Canadian Environmental Protection Act (CEPA), Environment Canada and Health Canada may promulgate a SNAc notice if they suspect that a SNAc, in relation to a substance that has undergone an assessment, may pose new or increased risks to the environment and/or human health. The listing is an extract of the substances search engine and is intended to facilitate the identification and searchability of substances subject to a SNAc notice. The list includes eight sections:

  1. The Complete List: This section contains the comprehensive listing of substances that are subject to a SNAc notice;
  2. Public Inventory of SNAc Notices for Existing Substances: This section contains the list of substances on the DSL that are subject to a SNAc notice;
  3. Public Inventory of SNAc Notices for New Substances: This section contains the list of substances with a CAS number, notified under the New Substances Notification Regulations (Chemicals and Polymers) and subject to a SNAc notice;
  4. Confidential Inventory of SNAc Notices for New Substances: This section contains the list of substances with a confidential accession number, notified under the New Substances Notification Regulations (Chemicals and Polymers) and subject to a SNAc notice;
  5. Public Inventory of SNAc Notices for New Substances That Are Organisms or Micro-organisms: This section contains the list of organisms and micro-organisms with an American Type Culture Collection (ATCC) Number, notified under the New Substances Notification Regulations (Organisms) and subject to a SNAc notice;
  6. Confidential Inventory of SNAc Notices for New Substances That Are Organisms or Micro-organisms: This section contains the list of organisms and micro-organisms with a confidential accession number, notified under the New Substances Notification Regulations (Organisms) and subject to a SNAc notice;
  7. Notice of Intent to Amend the DSL: This section includes the substances for which Environment Canada and Health Canada have published a notice of intent to amend the DSL to indicate that the SNAc provisions apply to new activity relating to the substances; and
  8. SNAc Notices for Substances That Are Listed on CEPA Schedule 1: This section contains the list of substances on the DSL that are subject to a SNAc notice. These substances are suspected of being toxic or capable of becoming toxic within the meaning of CEPA Section 64 and are listed on Schedule 1.

According to the website, the list will be updated monthly. It is available online.


MEP Publishes Statistics For New Chemical Substance Registrations: According to the Ministry of Environmental Protection (MEP), it issued 2,997 new chemical substance registration certificates under the simplified notification procedure between July and December 2011. MEP released the names of substances and the entities applying for registration. According to MEP, since it implemented the Provisions on the Environmental Administration of New Chemical Substances in October 2010, it has issued 964 scientific research record notification certificates, 4,567 simplified notification certificates, and two typical notification certificates. MEP’s announcement is available, in Chinese, online.


ECHA Updates Guidance On Data Sharing: The European Chemicals Agency (ECHA) announced on April 3, 2012, an update to the guidance on data sharing. According to ECHA, several corrections and improvements were needed to clarify the duties and roles of the involved actors and to reflect its experience in implementing the data sharing processes. ECHA “thoroughly revised” the text of the guidance, amending both content and structure. Information already covered by technical manuals or falling under the scope of other guidance documents has been removed, reduced, or amended to minimize overlapping and ensure consistency. ECHA states that it altered the structure of the guidance to make it clearer and more readable by creating two new sections covering a comprehensive set of information on the data sharing process for respectively phase-in and non-phase-in substances. ECHA also added new sections on the data sharing dispute processes, and all the existing examples have been improved or replaced by new ones. ECHA also developed a new section addressing post-registration data sharing obligations. More information is available online.

ECHA Publishes Draft Work Program For 2013-2015: ECHA’s draft Multi-Annual Work Programme 2013-2015 outlines ECHA’s planned activities for the coming three years. According to ECHA, 2013-2015 is an important three-year period for ECHA. It includes work on four individual pieces of EU legislation: Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); Classification, Labeling and Packaging (CLP); Prior Information Consent on Export and Import of Hazardous Substances; and Biocidal Products. ECHA notes that the latter two regulations “are entirely new to us and come at a time of peak activity under REACH and CLP.” During this time period, ECHA will also begin the examination of authorization applications, “an essential new part of REACH,” and “a formidable challenge to all parties concerned.” ECHA notes that “[t]he expectations of this risk management instrument are high for all stakeholders given that a clear pathway will be set for industry to work towards phasing out the use of chemicals of very high concern. However, the opinion and decision making process around authorisation is designed also to take proper account of the socio-economic impact concerns.” The draft Multi-Annual Work Programme 2013-2015 is available online.

ECHA Will Publish Total Tonnage Band For Registered Substances: ECHA announced on April 18, 2012, that it has decided on the method by which it will calculate the total tonnage bands for substances in its registered substances database. ECHA will publish the total tonnage bands for registered substances on its website during June 2012. ECHA will extract tonnage data from the latest disseminated dossier of each full (non-intermediate) registration, aggregate them, convert them to a total tonnage band, and publish the results in its registered substances database. ECHA will publish the total tonnage bands for joint submissions and for individual submissions. ECHA will not extract tonnage data from dossiers for intermediate registrations under REACH Articles 17 or 18, or from dossiers for full (non-intermediate) registrations where the tonnage band is claimed to be confidential in accordance with REACH Article 119(2)(b), unless the tonnage data are being aggregated from four or more registrants in a joint submission. ECHA states that this is because the aggregation of tonnages of four or more registrants cannot reveal the individual tonnage of a specific registrant, and as such will allow a fuller set of information on tonnages to be published without compromising commercially sensitive information. Registrants who have not claimed their tonnage band confidential but wish to do so should submit an updated dossier with a confidentiality claim on the tonnage band as soon as possible. For confidentiality claims under REACH, ECHA notes that the claim must be justified in accordance with Data Submission Manual 16, and will attract a fee. ECHA will grant confidentiality only where it accepts the claim as valid. ECHA will not extract tonnage data from dossiers where the tonnage band is claimed confidential while the confidentiality claim is under assessment, unless the tonnage data are being aggregated from four or more registrants in a joint submission. The total tonnage bands will be displayed for substances in ECHA’s registered substances database from those listed in the following table:

Dossier types
to be
No confidentiality claim(s) or > 4 full registrationsConfidentiality claim(s) and < 4 full registrations< 4 full registrations and all dossiers contain confidentiality claim
Full (non-
intermediate) Registration(s)*
1 – 10 tonnes, or
10 – 100 tonnes, or
100 – 1 000 tonnes, or
1000 – 10 000 tonnes, or
10 000 – 100 000 tonnes, or
100 000 – 1 000 000 tonnes, or
1 000 000 – 10 000 000 tonnes, or
10 000 000 – 100 000 000 tonnes etc.
1+ tonnes, or
10+ tonnes, or
100+ tonnes, or
1 000+ tonnes, or
10 000+ tonnes, or
100 000+ tonnes, or
1 000 000+ tonnes, or
10 000 000+ tonnes etc.
Tonnage Data Confidential
Intermediate Registration(s) onlyIntermediate use onlyIntermediate use onlyTonnage Data Confidential

More information is available online.

ECHA Will Release Chesar 2.0 In June

ECHA announced on April 18, 2012, that after a successful first round of testing by industry, it will release a new version of the Chemical Safety Assessment and Reporting Tool (Chesar) by the end of June 2012. ECHA will release Chesar 2.0 in three steps. According to ECHA, the step-wise release of functionalities will support the stability of the tool with a view to the 2013 registration deadline and beyond. The release at the end of June 2012 will include the functionalities for carrying out chemical safety assessments (CSA) based on an IUCLID 5.4 dataset and to generate chemical safety report (CSR) Chapters 9 and 10. This release will not yet contain a tool to estimate exposure for consumer uses, and the functionality for automatically generating exposure scenarios for communication will not be included. ECHA plans to release Chesar 2.1 in early Autumn 2012. This release will include the exposure estimation tool for consumers developed by the European Centre for Ecotoxicology. Ecotoxicology and. Toxicology of Chemicals (Targeted Risk Assessment). Depending on the progress made in the European Chemical Industry Council’s Exposure Scenario Communication project, the standard phrases library to prepare for the generation of exposure scenarios for communication may also be included in the Chesar 2.1 release. Finally, Chesar 2.2 will add the functionalities related to the generation of exposure scenarios for communication. ECHA expects to release Chesar 2.2 in late 2012 or early 2013. ECHA states that, in parallel, the current CSR generator (IUCLID plug-in) will be updated to enable the export of information on uses from Chesar 2.0 to IUCLID 5.4 and the generation of the full CSR by combining information from IUCLID 5.4 and Chesar 2.0. The updated software is planned for release in the third quarter of 2012. More information is available online.

EC Releases Interim Evaluation Of The European Chemical Market After REACH: On April 18, 2012, the European Commission (EC) posted a report entitled Interim Evaluation: Functioning of the European Chemical Market After the Introduction of REACH, which is intended to provide a comprehensive assessment on how REACH changed the dynamics on the chemicals market. The report reviews categories of market players and what has changed from their perspective, and addresses issues such as reputation improvement, barriers for entering market, competition rules, common market rules, costs for compliance, administrative burden, workability, consumer choice, and relocation of production. The report includes the following summary of findings:


  • REACH is relevant in enhancing the competitiveness of the EU chemical industry and for the development of a harmonized market for chemicals. An important part of the potential benefits still remains to materialize, however, while there is scope for reducing costs without a detrimental effect on achieving the objectives of the regulation; and
  • REACH is clearly relevant to the development of a level playing field and a harmonized market. Differences among Member States in market surveillance and enforcement and in the interpretation of the regulations — including the notification requirements for substances of very high concern (SVHC) in articles — do not serve this objective, however.

Costs of Compliance

  • The costs of compliance with REACH are sizeable and, in the short term, they appear to have some impact on the profitability of firms and the competitiveness of certain sectors in relation to their access to non-EU markets. The negative impacts are expected to be reduced in the future as experience builds up and as third countries also introduce certain registration requirements for chemicals;
  • Based on the data collected, the total cost for all firms involved in registration to the end of the first registration period is estimated at around €2.1billion. The typical cost of registration cost per substance by one firm has been about €70,000. ECHA fees, costs for required data through testing, studies or letters of access, and human resources were the three key cost drivers. The costs represent about one percent of firms’ total annual turnover; and
  • Additional costs arise from the information exchange requirements and the handling of safety data sheets (SDS) and affect all firms in the chemicals supply chain. The main problem at this stage is the absence of a standardized format of SDSs that makes development and extraction of information problematic. In addition, limited awareness of the requirements among many downstream users makes information exchange a difficult process for all actors involved.

Impacts on Chemicals Market and Industry

  • It is still too early to identify long term impacts of REACH on the firms’ financial position. The general rule that applies is that firms active in basic chemicals and metals that are treated as commodities absorb the costs. In the specialty chemicals markets, firms have greater capacity to pass costs down the supply chain;
  • REACH costs and the introduction of substances in the candidate list has led to the withdrawal of some chemical substances. While this differs in certain sectors, the general picture is that this is not a widespread phenomenon and that there are only limited cases where this has become problematic for the access of firms to critical raw materials. On the other hand, there are indications that REACH leads to a reduction in the number of suppliers of certain substances increasing concentration in some chemicals markets. The scale of this effect is so far rather limited;
  • On the basis of the limited information available, the overall conclusion is that REACH has not had a sizeable impact on the prices of final consumer products; and
  • There is no supportive evidence as to the effect of REACH on consumer confidence or the development of new substances and creation of new business opportunities at this stage. It is probably too early for a proper assessment. There is some evidence that REACH contributes to the strengthening of communication along the chemicals supply chain, even though this has yet to materialize, however.

REACH Mechanisms

  • The Substance Information Exchange Fora (SIEF) are generally seen as a relevant mechanism for reducing testing and registration costs. There have been important communication and coordination problems that introduced additional costs and reduced their effectiveness, however. The operation of consortia appears to be much more effective and in many respects addresses the problems related to SIEFs;
  • There is no evidence that REACH mechanisms have led to the loss of confidential information or, despite certain concerns, due to the abuse of dominant market position. The participation in SIEFs provides information on the substance a firm is intending to use and its volume that can present important business intelligence;
  • There is generally a positive view on the role of ECHA and national helpdesks and the respective tools developed. Still, firms also need the assistance of trade associations and private consultants for more practical and tailored guidance; and
  • Despite concerns about the quality of some Only Representatives (OR), overall, they appear to have a positive role in supporting non-EU firms and facilitating their access to the EU chemicals market.

The interim report is available online.

ECHA Announces Updated Guidance On Applying CLP Criteria: On April 27, 2012, ECHA announced the availability of an updated version of the Guidance on the Application of the CLP Criteria, which was revised following the Second Adaptation to Technical Progress (ATP) amending the CLP Regulation. ECHA prepared a draft for the revised Part 1 (general principles for classification), Part 4 (environmental hazards) and for all Annexes of the Guidance, and revised and amended the content and structure to align with the second ATP to the CLP Regulation. The re-structuring involved the addition of a new Part 5 (additional hazards), as well as improvement or replacement of some of the classification examples. ECHA states that, during the consultation on the revisions, the need for further discussion on the validity of the concept of “rapid removal” for aquatic environmental classification of metals and inorganic metal compounds under the CLP Regulation was identified. ECHA organized a workshop on this topic on February 8, 2012. Following the workshop, it was decided that references to the concept of “rapid removal” from Annex IV (metals and inorganic metal compounds) of the Guidance should be removed for the time being, and that further expert discussions on this particular concept should be initiated. The workshop report is available online. The updated Guidance is available online.

ECHA Updates Guidance For Monomers And Polymers: On April 27, 2012, ECHA announced the availability of an update to the guidance for monomers and polymers following the conclusion of the consultation process. According to ECHA, the update was necessary following the European Court of Justice Judgment C-558/07, which clarified that the concept of monomer substances refers to both reacted and unreacted monomers (REACH Article 6(1) and 6(3)). This potentially has a direct impact on the registration obligations as previously outlined in the guidance. ECHA states that it clarified relevant concepts in specific sections. In particular, it added additional reference to REACH Article 6(1) to cover the registration obligations for unreacted monomers and other substances in a polymer. ECHA also aligned the guidance with the newly agreed interpretation on natural polymers already outlined in ECHA’s Frequently Asked Questions on REACH. The updated guidance is available online.

ECHA Updates Guidance On Registration: ECHA announced on May 2, 2012, the availability of an updated version of the guidance on registration following the conclusion of the consultation process. According to ECHA, although it had corrected or amended its 2007 guidance on several occasions, a complete revision was necessary to provide a clearer, simpler, and more user friendly document for registrants. ECHA revised the structure and content of the guidance, and removed duplications and inconsistencies resulting from the successive previous amendments. ECHA notes that the restructuring involves the division of the guidance into two well-defined parts: Part I focuses on the explanation and clarification of the registration requirements; and Part II provides practical instructions to registrants on how to prepare and submit a dossier with reference to the different IT tools and manuals. Additionally, the updated guidance offers further clarifications and examples based on the experience gathered since the REACH regulation’s entry into force. The guidance is available online.

ECHA Will Allow ORs To Submit C&L Notifications: ECHA announced on May 3, 2012, that the EC has clarified that ECHA may allow third parties, such as ORs appointed under REACH, to submit classification and labeling (C&L) notifications under Article 40 of the CLP regulation. If the C&L notification is submitted by a third party on behalf of a group of manufacturers/importers, ECHA states that the submitting company will need to be able to document that it has been mandated to act on behalf and in the name of the manufacturers/importers that are part of the group and that the manufacturers/importers acknowledge that they remain solely and fully responsible for fulfilling all their obligations associated with the notification. According to ECHA, the documentation related to the creation of this group of manufacturers/importers, together with the data and information on which the C&L is based, may need to be made available on request to the national Competent Authorities or to the relevant Enforcement Authorities. Group notification can be done via REACH-IT. ECHA will implement the relevant changes with the forthcoming REACH-IT release scheduled for Summer 2012. ECHA states that it will update guidance and other supporting documents “in the following weeks.” More information is available online.

Study Assesses Overlaps Between REACH And Other EU Legislation: As part of its review of REACH, the EC contracted a study entitled Technical Assistance Related to the Scope of REACH and Other Relevant EU Legislation to Assess Overlaps, which compares REACH to 155 other EU legal acts regulating inter alia product safety and efficacy, environmental protection, workers’ protection, and food safety. The analysis compared each legal act to REACH in terms of aim and scope, definitions, and specific links within REACH, including exemptions, risk assessment methods, and risk management mechanisms. The study focuses on identifying possible overlaps with other EU legislation that might constitute instances of double regulation. At the same time, it detects a number of gaps in the coverage provided by REACH and the sectoral legislation. Finally, it also pinpoints specific interactions between REACH and other EU legislation that could lead to synergies, e.g., enhanced protection for human health, reduced administrative costs for dutyholders, and incentives for innovation. The study is available online.

EU Council Adopts Biocidal Products Regulation: On May 10, 2012, the EU Council announced the adoption of a regulation concerning the placing on the market and use of biocidal products, which include insecticides, disinfectants, and repellents, but not medicines or agricultural pesticides. The regulation will take effect September 1, 2013, with a transitional period for certain provisions. The EU Council states that the purpose of the regulation is to simplify the authorization procedures in the internal market through the harmonization of legislation on biocidal products, while ensuring a high level of protection for both human and animal health and the environment. The regulation includes provisions concerning:

  • The establishment at EU level of a list of active substances that may be used in biocidal products;
  • The granting of an authorization to biocidal products;
  • The mutual recognition of authorizations within the EU, so as to reduce the administrative burden on producers;
  • The making available on the market and the use of biocidal products within one or more Member States or the EU; and
  • The placing on the market of treated articles (articles incorporating pest control chemicals: they may not be treated with unauthorized chemicals anymore and must be labeled under the conditions specified. These obligations apply to all articles treated with biocidal products on the EU market, including imported ones).

The regulation incorporates the EC’s recommendation on the definition of a nanomaterial, and requires that, where nanomaterials are used in a product, the risk to the environment and to health be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word “nano” in brackets. The regulation states that “approval of an active substance shall not cover nanomaterials except where explicitly mentioned.” The EU Council’s press release is available online.

SUBSPORT Will Officially Launch On May 24, 2012: The Substitution Support Portal (SUBSPORT) will officially launch on May 24, 2012, and the case story database will then be made publicly available online. The case story database is an interactive tool to search for practical real-case substitution examples provided by companies and other stakeholders, as well as examples and information on substitution options found in literature. The portal is intended to support companies in fulfilling substitution requirements of EU legislation, such as those specified under the REACH authorization procedure, the Water Framework Directive, or the Chemical Agents Directive. Furthermore, the website states, other stakeholders like authorities, environmental and consumer organizations, as well as scientific institutions will benefit from the portal. Companies are invited to contribute to the SUBSPORT case story database under construction by sharing their experience in substituting hazardous chemicals with safer alternatives. The Project Team includes Kooperationsstelle Hamburg IFE GmbH (KOOP), Instituto Sindical de Trabajo Ambiente y Salud (ISTAS), International Chemical Secretariat (ChemSec), and Grontmij A/S. The EU, Germany, and Austria have provided financial support. More information is available online.


India Proposes Draft National Chemical Policy: On March 29, 2012, India’s Department of Chemicals and Petrochemicals (DCPC), located within the Ministry of Chemicals and Fertilizers, announced the availability of a draft National Chemical Policy, 2012. The draft Policy is intended to facilitate the growth and development of the chemical sector in India. DCPC states that the policy “accords high importance” to research and development (R&D), technology up-gradation, safety and sustainability, pollution and environmental aspects, effluent/waste disposal and treatment, and green chemicals. The draft Policy is available online. DCPC notes that in 2008, the EU’s REACH legislation replaced around 40 different environment-related legislations. Other countries, including Australia, Canada, Japan, and China, are adopting similar policies to retain their position in the global market, and “India may also have to pursue similar measures.” DCPC states that, apart from multiplicity of regulations, there are no specific Indian laws pertaining to:

  • Registration of substances;
  • Preparation of a national inventory;
  • Restrictions on hazardous substances;
  • Banning of certain substances;
  • Detailed classification and labeling criteria; and
  • Transport classification.

Though some of these issues have been briefly considered under certain legislations, according to DCPC, “they are yet to be addressed adequately in a comprehensive scientific and coherent manner.” DCPC concludes that there “is a need to create REACH like legislation in India for safe use of chemicals for protection of human health & environment.” More information is available in The Acta Group’s April 12, 2012, memorandum, which is available online.


MHLW Issues Notices Concerning Labeling And Notification For Dangerous And Harmful Substances: In mid-March 2012, the Ministry of Health, Labor, and Welfare (MHLW) issued Guidelines on the Promotion of Labeling and Notification for Dangerous and Harmful Chemical Substances (MHLW No. 133), which specify packaging labeling requirements for manufacturers and for the transportation of dangerous and harmful chemical substances; requirements for the notification by manufacturers of specific dangerous or harmful chemical substances; requirements governing documentation and labeling by manufacturers or importers; and SDS requirements. MHLW also issued Measures Concerning the Guidelines on the Promotion of Labeling and Notification for Dangerous or Harmful Chemical Substances (MHLW No. 0329), which provide more detailed explanations and instructions for following the Guidelines. The Measures became effective on April 1, 2012. According to MHLW, companies have an obligation to implement the guidelines and measures, but they are allowed a certain degree of discretion in determining the extent of their implementation. The Guidelines are available, in Japanese, online. The Measures are available, in Japanese, online.

Japan Revises SDS And Labeling Regulations To Align With The GHS: The Ministry of Economy, Trade, and Industry (METI) announced on April 20, 2012, the revision of ordinances to conform with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). METI states that it revised related ordinances and others based on the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (Pollutant Release and Transfer Register (PRTR) and SDS systems) (PRTR Law). To be consistent with the provisions of the revised GHS, METI added six sections, such as “first-aid measures” and “exposure controls/personal protection,” as information requirements in SDSs under the PRTR Law. Japanese Industrial Standard (JIS) Z7253, published on March 26, 2012, replaced two current standards concerning GHS material safety data sheets (MSDS) (Z7250) and GHS labeling (Z7251). Under JIS Z7253, companies are obligated to make an effort to comply with its provisions by December 31, 2016, when the transitional period ends and use of Z7250 and Z7251 is no longer allowed. METI’s April 20, 2012, announcement includes the following table concerning the coordination of the Management Act with 16 sections of GHS as information requirements (the sections in bold have changed from recommendations to requirements):

1. Identification of the substance or mixture and of the supplier9. Physical and chemical properties
2. Hazard identification10. Stability and reactivity
3. Composition/ information on ingredients11. Toxicological information
4. First aid measures12. Ecological information
5. Firefighting measures13. Disposal considerations
6. Accidental release measures14. Transport information
7. Handling and storage15. Regulatory information
8. Exposure controls/personal protection16. Other information including information on preparation and revision of the SDS

METI states that, to be consistent with the GHS provisions, business operators are obligated to make an effort to provide information on the properties and handling of designated chemical substances in accordance with the PRTR Law, through new labeling of such chemical substances following JIS Z7253. METI provides the following examples of labeling and symbols:

FlammableAcute toxicityHazardous to the aquatic environment

More information is available online.


DOE Working On Final Chemical Rules: According to a spokesperson for the Department of Environment (DOE), Malaysia intends to adopt two final chemical rules in “mid-2012.” The Attorney General is currently reviewing the regulation on occupational safety and health (chemicals classification, labeling, and SDSs (CLASS)). Malaysia is also close to a final regulation on the notification and registration of environmentally hazardous substances (EHS), which would make the voluntary notification and registration scheme mandatory. DOE would use information submitted by industry to establish the Malaysian Chemicals Register, which would contain information about the identity of substances that have been notified, their uses in Malaysia, their hazard classification, and the accumulated amounts placed on the Malaysian market.

Workshops On GHS Will Be Held In May, June, And July: The National Institute of Occupational Safety and Health (NIOSH), within the Ministry of Human Resources, will hold one-day awareness seminars on May 21, June 25, and July 16, 2012, concerning GHS in Malaysia. NIOSH will hold two-day advanced training workshops on May 22-23, June 26-27, and July 17-18, 2012. According to the NIOSH website, the seminars and workshops are suitable for chemical manufacturers and suppliers; technical advisors and officers responsible for chemical classification and labeling or preparing chemical/MSDs; consultants; chemists; and researchers/academicians. Registration is available online.


Taiwan Announces New System For Toxic Substances Notification: According to an April 2012 notice issued by the Environmental Protection Agency (EPA), companies in Taiwan producing toxic chemical substances must submit their application documents for registration, including for extension and changes, to their local government agencies through the central government designated network transmission system beginning September 1, 2012. Applicants approved by local government agencies for submitting paper applications are exempt. More information is available, in Chinese, online.

Taiwan Will Accept Supplementary Existing Chemical Substance Nominations Beginning June 1, 2012: From June 1, 2012, to August 31, 2012, the Council of Labor Affairs (CLA) will accept nominations of existing chemical substances. CLA encourages eligible nominators to nominate their chemical substances. CLA intends to release complementary measures, including nomination tools, a draft existing chemical substances inventory information system, guidance, and relevant documents, to provide potential nominators with the necessary resources. Beginning in May 2012, CLA will hold information sessions around Taiwan to provide companies with training. CLA states that the completeness of the national existing chemical substance inventory “is significant to companies’ business operation and future new chemical substances regulatory measures. Therefore, stakeholders are highly encouraged to nominate their chemical substances in order to be included in the national existing chemical substance inventory.” The draft existing chemical substances inventory is available online, and supplementary tools are available online. More information is available online.


Thailand Publishes Notification Rule For Hazardous Substances: In March 2012, Thailand published a notification rule on hazard classification and communication for hazardous substances. Effective March 13, 2012, notification is based on the third revised edition of the GHS. Substances will be covered beginning March 13, 2013, and mixtures beginning March 13, 2017. The notification rule is available, in Thai, online.


Abu Dhabi Environment, Health, and Safety Center Updates EHSMS: On March 29, 2012, the Abu Dhabi Environment, Health, and Safety Center announced an update to its Environmental, Health, and Safety Management System (EHSMS), including the adoption of several mandatory documents regulating chemicals, with the aim of harmonizing regulatory requirements across local and emirate levels of government, eliminating duplicative processes, and aligning requirements with international standards. The Code of Practice stipulates that classification of hazardous materials must comply with “applicable international model regulations,” meaning that manufacturers may choose from among such regulations, including the GHS. November 1, 2012, is the deadline for full compliance with the updated EHSMS. The Center’s press release is available online. The Code of Practice is available online.