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January 1, 2013

Global Regulatory Update for January 2013

The ACTA Group

OECD Updates Environmental Risk Assessment Toolkit: The Organization for Economic Cooperation and Development (OECD) announced on December 12, 2012, that it updated its environmental risk assessment toolkit. According to OECD, the toolkit provides practical tools for the environmental risk assessment of chemicals. The toolkit describes the general process of environmental risk assessment and provides examples of risk assessment. The toolkit also provides links to relevant tools developed by OECD and Member Countries that can be used in each step of the process. OECD notes that the examples are not full risk assessments; rather they provide a roadmap of the process, showing the steps involved in each case and the tools which were used. The toolkit is available online.


Australia Releases IMAP Assessments For 137 Industrial Chemicals: Australia announced on December 11, 2012, the availability of chemical safety information for 137 industrial chemicals. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) assessed the first round of chemicals under its Inventory Multi-tiered Assessment and Prioritization (IMAP) framework, which is intended to accelerate the assessment of chemicals that are already available for use in Australia but that have not been assessed for their human health and environmental impacts. On the basis of the Tier 1 assessments, NICNAS identified 129 as low concern to human health. Because the Tier 1 assessments for the remaining eight indicated the need for further investigation, NICNAS evaluated the chemicals individually. Comments on the assessment outcomes for the 137 chemicals are due January 31, 2013. NICNAS seeks comments where information that has the potential to affect the outcome of an assessment has not been considered. According to NICNAS, the comments should be evidence-based and the relevance of submitted information should be highlighted. NICNAS intends to assess approximately 3,000 chemicals during the first stage of the IMAP framework, which will last four years. More information is available online.


Canada Seeks Updated Information For Approximately 2,700 Substances: Canada published a notice in the December 1, 2012, Canada Gazette that applies to approximately 2,700 substances in Phase 2 of the Domestic Substances List (DSL) Inventory Update. According to Canada, the mandatory survey seeks to obtain updated information on the commercial status of substances that are remaining priorities, to support any subsequent risk assessment and risk management activities, if applicable. Responses are due September 4, 2013. Canada encourages persons who do not meet the reporting requirements but who have a current or future interest in any of the listed substances to identify themselves as a stakeholder by completing a voluntary Declaration of Stakeholder Interest. According to Canada, organizations that may be interested in submitting additional information include those that manufacture, import, export, or use a substance in a product or in a manufactured item. Canada intends to make available in February 2013 Environment Canada’s Single Window, which will provide a single point of access to view and update information with Environment Canada’s regulatory program reporting applications. More information is available online.


China Begins Consultation On Draft Rules For Classification Of Physical Hazards: The State Administration of Work Safety (SAWS) began a consultation on December 3, 2012, on the “Measures for Identification and Classification of Physical Hazards of Chemicals (draft).” The draft rules would define four categories of chemicals with unknown hazards that must be assessed and classified:

  • Chemicals listed in the Catalogue of Hazardous Chemicals, but which contain newly discovered physical hazards;
  • Mixtures containing more than one physical hazardous component listed in the Catalogue;
  • Chemicals not listed in the Catalogue, but with unknown physical hazards; and
  • Newly developed chemicals that lack physical hazard data.

Hazard assessments would be required to be conducted by government-certified institutions and classified by the companies before registration. Manufacturers and importers would be required to produce classification reports based on the assessment results, and submit them to the National Registration Center of Chemicals (NRCC) for evaluation and confirmation. Chemicals with sufficient proof of data and documentation that they are not physically hazardous will be exempt from assessment and classification. Once companies have classified substances as hazardous chemicals, and NRCC confirms the classification, companies must provide safety data sheets (SDS) and labels carrying the information, and must register the chemicals within six months. Companies must also establish and keep records of chemicals for safety management. Comments were due January 4, 2013. More information is available, in Chinese, online.

China Publishes MRLs For Pesticides In Food: The Ministry of Agriculture (MOA) and Ministry of Health (MOH) published on December 6, 2012, a notice concerning the “Maximum Residue Limits for Pesticides in Food” (GB 2763-2012), which will be effective on March 1, 2013. The notice sets 2,293 maximum residue limits (MRL) for over 300 pesticides in ten different categories. MOA and MOH published a November 16, 2012, notice announcing, in Chinese, the standards that will be annulled March 1, 2013. The December 6, 2012, notice is available, in Chinese, online. The November 16, 2012, notice is available, in Chinese, online.


ECHA Revokes Decisions To Protect SME Privilege: The European Chemicals Agency (ECHA) announced on November 16, 2012, that it has revoked a number of previous decisions in which it confirmed the completeness of registrations and assigned registration numbers, and replaced the revoked decision with rejections of the registrations. According to ECHA, for the registrations in question, it emerged only after the assignment of the registration number that the registrant had not paid the full registration fee, thereby failing the completeness check under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. When submitting a registration dossier, the registrant self-declares its size. If it falls under one of the small- or medium-sized enterprise (SME) categories, it benefits from reduced registration fees. ECHA automatically invoices the reduced registration fee to ensure a swift registration process, and subsequently verifies the self-declared size. Where the registrant cannot demonstrate its entitlement to the fee reduction, ECHA requires payment of the balance of the fees applicable to the correct size. If the registrant fails to pay, ECHA revokes the registration decision, which had confirmed the completeness of the registration, and replaces it with a rejection of the registration. More information is available online.

ECHA Publishes Company Names And Registration Numbers: ECHA announced on November 28, 2012, that it published the company names and registration numbers as submitted in REACH registration dossiers, per substance registered. According to ECHA, this amounts to approximately 26,000 company names and registration numbers. ECHA will publish the remaining company names for a minority of the registration dossiers over the coming months. ECHA is not publishing company names from registration dossiers for which registrants have requested that their company name be kept confidential and where ECHA assesses their request as valid. ECHA states that the next release will include the publication of the persistent, bioaccumulative, and toxic (PBT)/very persistent and very bioaccumulative (vPvB) assessment results. More information is available online.

ECHA Reminds Companies Of Obligations For Substances And Mixtures Coming Into Effect: ECHA issued a November 29, 2012, press release to remind companies that they must label and package all hazardous substances according to the Classification, Labeling, and Packaging (CLP) Regulation and update their SDSs for substances and mixtures to comply with the REACH amendments by December 1, 2012. ECHA states that, concerning substances, companies must re-label and re-package in accordance with the CLP Regulation all substances that are currently labeled and packaged according to the Dangerous Substances Directive (DSD). ECHA notes that all hazardous substances must continue to be classified in accordance with both the CLP Regulation and the DSD until June 1, 2015, after which only the CLP classification applies. Effective December 1, 2012, companies must update the SDSs of substances and mixtures according to the amended REACH Annex II. This update includes changes in format and content. Changes with respect to classification, labeling, and packaging of mixtures in accordance with the CLP Regulation are required by December 1, 2015. More information is available online.

Preliminary Results Of Enforcement Project Point To High Rates Of Incompliance Among Chemical Formulators: ECHA announced on December 4, 2012, that the preliminary results of REACH-EN-FORCE-2 were presented to the participants of the 13th plenary meeting of the Forum held on November 27-20, 2012, in Helsinki. The project looked at the obligations of formulators of mixtures and the quality of SDSs. ECHA states that the results highlighted the “serious efforts” Member States are taking to establish a harmonized approach to enforcement. In total, 29 Member States participated in the project, with national inspectors carrying out approximately 1,200 inspections; 85 percent of the inspected companies were SMEs. The rate of companies submitting non-compliant SDSs was 52 percent, the rate of incompliance with the (pre)registration obligations was 12 percent, while the rate of incompliance with CLP notification obligations was 25 percent. More information is available online.

ECHA Begins Publishing Dossier Evaluation Decisions: ECHA announced on December 13, 2012, that, to improve the transparency of its decision making process, it will publish on its website non-confidential versions of all dossier evaluation decisions originating from compliance checks and examination of testing proposals. The decisions will be available and, in most cases, will include a link to the related aggregated registration information as contained in ECHA’s dissemination portal. ECHA states that it will continue publishing available decisions on a regular basis. ECHA notes that the decisions will be published some time after their adoption, since before publishing, ECHA will contact the addressees of the decisions to get their feedback on the non-confidential version it intends to publish. Published documents represent redacted decisions, with information removed that has been claimed confidential by the registrants and was deemed to harm their commercial interest if disclosed. The decisions are only available in their original language. More information is available online.

ECHA Adds 54 SVHCs To Candidate List: ECHA announced on December 19, 2012, that, with the addition of 54 new substances of very high concern (SVHC), the Candidate List now contains a total of 138 substances, meeting the target set by Vice-President Tajani and Commissioner Potočnik to have 136 SVHCs on the Candidate List by the end of 2012. ECHA notes that the legal obligations that companies may have resulting from the inclusion of SVHCs on the Candidate List apply to the listed substances on their own, in mixtures, or in articles. Producers and importers of articles containing any of the 54 substances included on the Candidate List by December 19, 2012, have six months to notify ECHA if both of the following conditions apply: (1) the substance is present in those articles in quantities totaling over one tonne per producer or importer per year; and (2) the substance is present in those articles above a concentration of 0.1 percent weight by weight. There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded. More information, including the list of SVHCs added to the Candidate List, is available online.

EC Begins Consultation On Three Requests For RoHS Exemptions: The European Commission (EC) began a consultation on December 21, 2012, on three requested exemptions from the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive:

  • Exemption request 17a: Lead in glass of electronic components and fluorescent tubes, or in electronic ceramic parts (including dielectric ceramic capacitors) used in industrial monitoring and control instruments (only sub-category 9 industrial), exemption to expire in 2024;
  • Exemption request 18a: Lead used in compliant pin connector systems for use in industrial monitoring and control instruments (only sub-category 9 industrial), exemption to expire in 2024; and
  • Exemption request 20a: Mercury in cold cathode fluorescent lamps (CCFL) for back-lighting liquid crystal displays not exceeding five milligrams per lamp used in industrial monitoring and control instruments (only sub-category 9 industrial).

Comments are due February 15, 2013. More information is available online.


Draft Bill Of Chemical Law Expected To Be Approved By House Of Representatives By 2013: The House of Representatives was expected to approve by 2013 a draft “Bill of Chemical Law,” which would revise Decree 87/2009 and apply to a wide range of chemicals, including pesticides and industrial chemicals. Decree 87/2009 covers chemical classification, SDSs, and labeling, and requires companies to follow the “latest version” of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). An industry spokesperson noted that, as a result, companies must revise their SDSs and labels every two years, and that this requirement should be revised. According to the spokesperson, the draft bill will extend the deadline for mandatory GHS compliance for mixtures to 2016. Under Decree 87/2009, companies had to comply with the GHS for substances in 2010. Decree 87/2009 did not address mixtures, however, because an earlier decree included a deadline of 2013 for GHS compliance. Other revisions include confidential business information (CBI) provisions and rules on risk-hazard communication.


Japan Announces Notification Periods For Low Volume Chemicals: The deadlines for manufacturers and importers to notify Japan of new chemicals in volumes of one tonne or less are:

  • January 21-30, 2013 (for new chemicals manufactured or imported between April 1, 2013, and March 31, 2014);
  • June 3-10, 2013 (for new chemicals manufactured or imported between July 1, 2013, and March 31, 2014);
  • September 2-10, 2013 (for new chemicals manufactured or imported between October 1, 2013, and March 31, 2014); and
  • December 2-10, 2013 (for new chemicals manufactured or imported between January 1, 2014, and March 31, 2014).

Applications must be submitted and approved before manufacture or importation. Beginning in February 2013, the Ministry of Economy, Trade, and Industry (METI) intends to e-mail online notifiers to confirm quantity prior to mailing confirmation notices. More information is available, in Japanese, online.

Japan Adds 43 Chemicals To List Of PACs: On December 21, 2012, Japan designated 43 substances as priority assessment chemicals (PAC). Under the Chemical Substances Control Law, manufacturers and importers must notify METI between April and June each year of those PACs they produced or imported in the previous calendar year. Manufacturers and importers also must tell customers if their substances are, or if their products contain, PACs. The list of 43 PACs is available, in Japanese, online.


Mexico Publishes Inventory Of Existing Chemical Substances: According to an Institute of Ecology and Climate Change (INECC) spokesperson speaking at ChemCon The Americas 2012, Mexico published in November 2012 an inventory of existing chemical substances. Leonor Cedillo Becerril, Director of Chemical Research and Ecotoxicological Risk, stated that the inventory currently contains just 5,852 substances out of an estimated 15,000 thought to be in industrial use in the country. Companies at ChemCon questioned the status of the inventory and implications for substances not included. According to Cedillo Becerril, there are no implications as there is currently no legal framework behind the inventory, although INECC welcomes any additional information companies wish to provide. While preparing the inventory, INECC analyzed Mexico’s current legal framework and consulted stakeholders to propose options to maintain and enhance the inventory, based on the existing legal framework. Cedillo Becerril stated that requirements for regular reporting and registration of chemicals, and the creation of a group dedicated to managing the inventory, are being considered as part of this analysis. INECC intends to complete the proposal in spring 2013 and present it to the newly-elected government. While the inventory is currently available only on paper and CD, INECC intends to make the inventory available online.


Taiwan Updates Existing Chemical Substances Inventory: Taiwan announced on December 22, 2012, the availability of its updated existing chemical substances inventory. According to Taiwan, over 370,000 dossiers covering more than 79,000 substances were notified by 5,500 companies. Approximately 40 percent of the nominated chemical substances are handled in quantities over one tonne per year. Taiwan states that the inventory identifies 19,000 existing chemical substances possessing GHS hazards, and that less than one percent of all substances are listed under data protection. Taiwan’s Environmental Protection Agency stated previously that substances listed on the inventory will need to be pre-registered. Taiwan will then identify priority substances that will be subject to registration. More information is available online. The updated existing chemical substances inventory is available online, and can be searched in English.

Executive Yuan Approves Proposed Legislation To Amend Labor Safety And Health Act: The Executive Yuan approved on November 15, 2012, proposed legislation that would revise the Labor Safety and Health Act to create a legal basis for regulating new chemicals and other substances in the workplace. The proposed legislation would change the name of the law to the Occupational Safety and Health Act, and would require employers to label dangerous or hazardous chemicals based on the GHS. Chemical manufacturers, importers, and distributors would have to provide the appropriate labels and material safety data sheets (MSDS). Under the proposed legislation, employers would be required to adopt procedures for handling various classifications of chemicals based on the health risks they pose, the usage amount, and other characteristics. Manufacturers and importers would also be required to report new chemicals and submit safety evaluation information. The draft legislation would also prohibit the manufacture, import, distribution, or use of certain highly-regulated chemicals. The proposed legislation will be sent to the legislature for approval. More information is available, in Chinese, online.