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November 1, 2012

Global Regulatory Update for November 2012

The ACTA Group

OECD Announces Improved Tool To Predict Hazards Of Chemicals: On November 5, 2011, the Organization for Economic Cooperation and Development (OECD) announced the availability of Quantitative Structure-Activity Relationships (QSAR) Toolbox (03), which includes new features and additional data sources; facilitates prediction accounting for metabolism; provides possibilities for predicting the hazard for mixtures; and possesses a more advanced search and reporting engine to handle single chemicals, mixtures, and metabolites. The new version also contains tools to predict repeated dose toxicity. OECD states that the new version benefitted from advice and contributions from governments, non-governmental organizations, and chemical industry. QSAR Toolbox (03) is available online.


China Issues Trial Measures For Environmental Management Of Hazardous Chemical Registration: The Ministry of Environmental Protection (MEP) issued on October 10, 2012, trial measures for the environmental management of hazardous chemical registration (MEP Order No. 22). The trial measures, which take effect on March 1, 2013, require entities producing, using, and importing or exporting hazardous chemicals to register with the local environmental protection department at the county level and above. Upon registration, a production and use registration certificate will be issued at the city level for hazardous chemicals, and at the province level for priority hazardous chemicals for environmental management. The registration certificate will be valid for three years. Enterprises already built and engaged in the production and use of hazardous chemicals before the implementation of the trial measures should, within three years, complete environmental management registration for the production and use of hazardous chemicals. According to the trial measures, MEP will issue a list of priority hazardous chemicals for environmental management, based on the Catalogue of Hazardous Chemicals. More information is available, in Chinese, online.

China Begins Public Consultation On Priority Substance Substitutes: The Ministry of Industry and Information Technology (MIIT) has begun a public consultation on substitutes for priority substances identified earlier this year. The Catalogue of Encouraged Substitutes to Toxic and Hazardous Raw Materials (2012) proposes substitutes for heavy metals, organic pollutants, pesticides, and other toxic and hazardous substances. Three types of substitutes are proposed, based on technical stages: development (safe alternatives in urgent need of development); application (safe alternatives that have been developed and expect promising marketing promotion); and promotion (safe alternatives of mature promotion and in need of expanding range of application). Comments are due November 27, 2012. More information is available, in Chinese, online.


ECHA Advises Registrants To Check Information Submitted In Their Dossiers: In an October 17, 2012, press release, the European Chemicals Agency (ECHA) advises all registrants to check the information they have submitted in their dossiers by the end of November 2012 to avoid unexpected disclosure of information. A new feature in REACH-IT will provide full transparency to all registrants who have used the same numerical identifier for their substance in their dossiers, and registrants will see all the names of legal entities that have received a registration or an inquiry number for the same substance. According to ECHA, the co-registrants page will provide “real time” information on the identity, the contact details of other registrants, and their role within the joint submission. The list of data requested during the inquiry process or after a tonnage update will also be displayed. ECHA “strongly recommends that existing and potential registrants, having successfully inquired and/or registered, check the consistency of the information they have submitted in their dossiers to avoid their own company details from being unexpectedly disclosed.” Legal entities that wish to amend the current status of their dossier will need to submit a spontaneous update of their registration dossier before the end of November 2012. More information is available online.

ECHA Releases Draft CoRAP: On October 23, 2012, ECHA announced the draft Community Rolling Action Plan (CoRAP) update for 2013-2015. The CoRAP includes substances that ECHA suspects could pose a risk to human health or the environment. The draft CoRAP includes 63 substances newly allocated to the Member States, and 53 substances already included in the current CoRAP. ECHA tentatively divided the substances for evaluation in years 20132014, and 2015, and the Member State who intends to conduct the substance evaluation. According to ECHA, “n many cases the initial concerns are related to PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive use or consumer uses. In general, the uses of these substances cover various areas and are not limited to particular industrial, professional or consumer uses.” ECHA intends to adopt the final CoRAP update by the end of March 2013. ECHA states that, by publishing the draft CoRAP now, it “wishes to inform the stakeholders of the progress made and to facilitate early communication between the involved registrants and the relevant evaluating Member State.” More information is available online.

Stakeholder Consultation Begins On Four Requests For RoHS Exemptions: On November 9, 2012, Öko-Institut began a stakeholder consultation on four exemption requests from the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive:

  • Exemption Request 12: Leaded solder utilized in stacked, area array electronics packaging within ionizing radiation detectors including CT and X-ray;
  • Exemption Request 13: Lead in platinized platinum electrodes for measurement instruments;
  • Exemption Request 14: Lead in solders for the ignition module and other electronic engine controls mounted directly on or close to the cylinder of hand-held engines (classes SH: 1, SH: 2, SH: 3 of 2002/88/EC); and
  • Exemption Request 15: Hand crafted luminous discharge tubes (HLDT) used for signs, decorative or general lighting and light-artwork.

The consultation period ends February 1, 2013. More information is available online.


Japan Simplifies Notification Procedure For New Chemicals: The Ministry of Health, Labor, and Welfare (MHLW) published Ordinance No. 143 on October 1, 2012, amending several regulations, including the Ordinance on the Industrial Safety and Health Act (ISHA). Under the ISHA revisions, MHLW simplified the notification procedures for new chemical substances that will take effect beginning January 1, 2013. Notification forms for manufacturing or importing new chemical substances will require less data when accompanied by one of the following notification documents required under the Chemical Substances Control Law (CSCL):

  • Notification of new substances manufactured or imported;
  • Requests for confirmation of manufacturing or importing new chemical substances as intermediates;
  • Requests for confirmation of manufacturing or importing new chemical substances as those in a closed system;
  • Requests for confirmation of new chemical substances manufactured or imported exclusively for export; and
  • Requests for confirmation of new chemical substances manufactured or imported in small amounts.

Manufacturer locations, the physico-chemical properties of new substances, and other information will no longer be required. MHLW also adopted simplified notification procedures for polymer compounds. Qualified polymer compounds will be treated as existing chemicals, and thus no longer need to be notified. Ordinance No. 143 is available, in Japanese, online. A letter from MHLW explaining the revisions is available, in Japanese, online.

Japan Releases Notification Deadlines For 2013: Japan released the first of two deadlines for manufacturers and importers submitting new chemical pre-notification evaluation dossiers in 2013. The deadlines are for new chemical notifications of tonnages over ten tonnes and new chemical notifications of low volumes for tonnages between one and ten tonnes. There are ten deadlines each year for pre-notification evaluation submissions. More information is available, in Japanese, online.

Japan Adds 203 Chemicals To List Requiring GHS Labels: On October 23, 2012, the National Institute of Technology and Evaluation (NITE) added 203 chemicals to the list of substances for which risk labeling and material safety data sheets (MSDS) will be required under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). A NITE spokesperson stated that Japan has now adopted GHS standards for 2,898 chemicals. According to the spokesperson, Japan adds chemicals to the list of substances once a year, typically by the Ministry of Economy, Trade, and Industry (METI), MHLW, and Ministry of the Environment (MOE). Of the 203 chemicals added, MHLW nominated 200. Of those 200, 168 were new chemicals and 32 were reclassified based on risks detected after their earlier listings. MOE nominated three chemicals because of risks they pose to the environment. The 203 chemicals are available, in Japanese, online. A complete list of chemicals with GHS standards is available, in Japanese, online.

Japan Will Designate 45 Chemicals As PACs: On October 31, 2012, METI published a notice announcing the designation of 45 priority assessment chemicals (PAC), including ethylamine, isopropyl alcohol, ethylene glycol, xylene, and tetrahydrofuran. Between April and June of each year, companies must submit the following data concerning PACs for the previous year: manufactured, imported and shipped quantities; manufactured quantities by prefecture, province, and county, and name and location of the manufacturer; imported quantities by country and region, and the name of the country or region they were imported from; and shipped quantities by prefecture, province, and county (or by country or region), as well as by usage (usage number and quantity relating to shipment). A spokesperson for METI stated that Japan will complete administrative procedures to designate the 45 chemicals as PACs by the end of 2012, and Japan will then publish in the official Gazette the formal names of the substances and their government identification numbers. Companies that manufacture and import PACs must also submit toxicity data, if requested. More information is available, in Japanese, online.


Notification And Registration Of EHSs Will Remain Voluntary: According to a spokesperson for the Department of Environment (DOE), DOE has decided that its notification and registration scheme for environmentally hazardous substances (EHS) will remain voluntary. DOE had prepared regulations that would require notification and registration of EHSs, but, in light of the Department of Occupational Safety and Health’s (DOSH) forthcoming Occupational Safety and Health Classification, Labeling, and Safety Data Sheets of Hazardous Chemicals (CLASS) regulations, decided that chemical companies should “only have to submit data once.” The CLASS regulations would require manufacturers, importers, and formulators to classify, label, package, and compile safety data sheets (SDS) in accordance with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Companies would also be required to report this information to an inventory created by DOSH. DOE intends to develop a reporting system that will link DOE to the chemical information management system that DOSH has developed for submissions to the inventory. The CLASS regulations are expected by the end of 2012 or early 2013. The requirements would be mandatory for substances one year after the regulations enter into force, and would be mandatory for mixtures after three years. More information on the CLASS regulations is available online.


South Korea Will Consider Legislation Similar To REACH: South Korea’s proposed Act on the Registration and Evaluation of Chemicals was submitted to the National Assembly and is expected to be adopted in the first half of 2013. Under the Act, manufacturers and importers of new chemicals and priority evaluation chemicals would register their chemicals with the Ministry of Environment (MOE) prior to manufacture and import. MOE first proposed the legislation in March 2011, and under the revised bill, the reporting cycle has been increased from one to two years and the volume threshold for registration has been increased from 0.5 metric tons to one metric ton. Foreign companies would be able apply for notification by using an Only Representative. The National Assembly is expected to pass the proposed legislation, with the bill coming into force in 2015.


Executive Yuan Approves Legislation To Revise TCSCA: On November 1, 2012, the Executive Yuan approved legislation to revise the Toxic Chemical Substances Control Act (TCSCA). Chemical manufacturers and importers would be required to register designated substances that meet “conditions of import/manufacturing, substance properties, hazard and exposure assessments [and] certain annual tonnages.” The revisions increase regulation of class 4 substances, which are those presenting a concern of environmental pollution or endangerment to human health. Companies that violate regulations on registering new chemicals would be subject to fines ranging from New Taiwan Dollar (TWD) 200,000 to 2 million and would be ordered to complete the registration in a certain period of time. Companies violating regulations on registering existing chemicals would be fined between TWD 30,000 and 300,000. Companies that receive the same penalty three times and fail to complete the registration would have their operations suspended. The draft bill will be sent to the Legislative Yuan “as soon as possible” for approval. If the Legislative Yuan, which is scheduled to end its current session in late December 2012, approves the proposal, the proposal will be submitted to the president for signature and formal announcement. According to an Environmental Protection Administration (EPA) spokesperson, Taiwan will hold public hearings and consultation meetings on the draft chemical registration management regulations before they are issued in final.

According to the Council of Labor Affairs (CLA), an updated version of Taiwan’s existing chemical substance inventory will be released in December 2012. Substances listed in the inventory will have to be pre-registered, and of these, some will be selected as priority substances and will be subject to registration. CLA stated that it is still processing applications for data protection of notified substances. CLA asked notifiers to submit complete relevant supplementary documents and check their requests for data to be classified as CBI. The draft inventory is available online.