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February 1, 2012

Global Regulatory Update for February 2012

The ACTA Group


GHS Regulations Enter Into Force — On January 1, 2012, the Work Health and Safety (WHS) Regulations in 2012 entered into force. The WHS Regulations, which create a new system of chemical classification and hazard communication on labels and safety data sheets (SDS) based on the third revised edition of the United Nations (UN) Globally Harmonized System of Chemical Classification and Labeling (GHS), will be mandatory from January 1, 2017, allowing for a five-year transition period. Workplace chemicals will not need to be re-classified or re-labeled immediately. During the five-year transition period, manufacturers may use either the GHS for classification, labeling, and SDS, or the previous hazardous substances and dangerous goods classification systems. After December 31, 2016, at the end of the five-year period, all workplace chemicals must be classified according to the GHS, and labels and SDS must be updated. The WHS Regulations apply to the use of hazardous substances in the workplace. Companies must continue to comply with the Australian Code for the Transport of Dangerous Goods by Road and Rail and relevant state and territory laws for the transport of dangerous goods by road and rail. More information is available online.


China Working On Chemical Guidelines: China’s Ministry of Environmental Protection (MEP) is working on two sets of guidelines for appraising chemical risks and identifying hazards posed by new chemicals. MEP is seeking expert opinion on its draft Guidelines for Chemical Substance Risk Appraisal, which will outline the expert review process for new chemical substances. The Guidelines will serve as a technical reference for businesses completing appraisal reports, and will guide risk appraisals of existing substances. The Guidelines will cover both environmental and health risk appraisals. MEP is also seeking expert opinion on draft Guidelines for New Chemical Substance Hazard Identification, which will include technical methods for identifying hazards and requirements for classification based on health and environmental risks. The expert comment period began on September 26, 2011.

China Publishes 2012 Toxic Substances Directory: On December 28, 2011, MEP announced the availability of the 2012 version of its toxic substances directory, which lists substances subject to import and export restrictions as of January 1, 2012. The list takes into account Annex II of the UN Rotterdam Convention on the Prior Informed Consent Procedure for trade in hazardous chemicals. More information is available in Chinese online.


Croatia Publishes List Of Substances Permitted In Biocides: Croatia published a list of existing active substances permitted in biocidal products, as well as a list of substances not permitted. The list of permitted existing substances is available online. The list of substances not permitted is available online.


EC Begins Consultation On Delivering More Sustainable Consumption And Production: The European Commission (EC) began a public consultation on January 11, 2012, concerning delivering more sustainable consumption and production. The EC states that it seeks targeted feedback on:

  • Policies regarding product design, recycling, and waste management, etc.;
  • Green public procurement (encouraging public bodies to favor ecologically friendly solutions);
  • Actions for improving the environmental performance of products; and
  • Actions for improving the environmental performance of organizations.

The background document discusses sustainable industrial policy, including improving waste management and recycling. Specific measures could include requiring products to conform to certain materials efficiency standards; revising European Union (EU) laws on packaging and packaging waste; tightening regulations on the use of terms such as “eco,” “green,” and “natural” in product marketing; and setting quotas for retailers to ensure they hold minimum stocks of eco- or energy-labeled products. Comments are due April 3, 2012. More information is available online.

EP Approves WEEE Compromise: The European Parliament (EP) approved on January 19, 2012, legislation to revise the Waste Electrical and Electronic Equipment (WEEE) Directive. Under the legislation, the binding collection levels would increase to 85 percent by 2019. Member states would be required to collect 45 percent of electrical and electronic equipment put on their markets by 2016, and then achieve 65 percent by 2019, or opt alternatively for a target of 85 percent of waste generated. The legislation will require exporters to test and provide documents on the nature of their shipments when the shipments run the risk of being waste. Member states’ registers for producers of electrical and electronic equipment will have to be integrated more closely. The EC, in collaboration with the member states, will adopt a harmonized format to be used for the supply of information. More information is available online.

EP Approves Biocides Legislation — On January 19, 2012, the EP approved the biocides legislation that the EU Council provisionally agreed to in November 2011. Under the legislation, biocides — ranging from rat poisons to disinfectants — will be subject to tougher safety checks. According to the EP, the legislation is intended to protect better human health and the environment, while streamlining the marketing approval process. The updated legislation closes a loophole so that treated products, such as furniture sprayed with fungicide or anti-bacterial kitchen worktops, will be included under the rules and labeled. Agricultural pesticides will continue to be covered by other EU legislation. The most problematic substances — such as those that are carcinogenic, affect genes or hormones, or are toxic to reproduction — should in principle be banned. Exceptions should only be made in member states where strictly necessary, for example if a biocide is needed to safeguard against a specific danger to health. Approvals and renewals will be time-limited, while safer alternatives are developed. The legislation would require separate safety checks and labeling for products containing nano-sized materials. The new legislation further harmonizes the EU market for biocidal products and sets deadlines for applications to be assessed. The recognition of approvals among member states will be improved and the possibility to apply for authorization at the EU level will be phased in from 2013, becoming possible for most biocidal products by 2020. The legislation must now be approved by the EU Council. The legislation is expected to apply from September 1, 2013.

ECHA Intends To Post C&L During Week Of February 13: On January 18, 2012, the European Chemicals Agency (ECHA) announced that, during the week of February 13, 2012, it intends to open a new portal for the Classification and Labeling (C&L) Inventory on the ECHA website. The Inventory will include information on notified and registered substances that has been received from manufacturers and importers. The ECHA website is available online.

ECHA Submits Study On Communication On The Safe Use Of Chemicals: ECHA announced on January 23, 2012, that it submitted to the EC its study on communication of information on the safe use of chemicals to the general public. ECHA listed the following highlights from the study:

  • Awareness among the general public of the new international hazard labels that appear on the packaging of chemical substances is mostly low, but consumers rarely purchase these chemicals, the labels are relatively new, and awareness will surely grow. Work is needed at national, industry, and EU level, however, both to raise awareness and, crucially, understanding of what the labels mean.
  • The perception of hazardousness varies between countries, as well as between specific sub-groups of the general public. Awareness-raising activities therefore need to address national hazard perception patterns, as well as the differing approaches to hazards exhibited by specific audiences such as families, single households, workers, school children, etc.
  • Most people make their choices on the safe use and storage of household chemical products on the basis of their acquaintance with the product, as well as other emotional drivers which rely more on experience than on information found on the package. Awareness-raising activities therefore also need to take into account these emotional and experience-based drivers.
  • A further analysis of the impact of the hazard labels on EU citizens’ behavior and understanding could be useful after 2015 — the date by which new labels replace the old ones on all chemical mixtures like paint and glues for example.

ECHA states that industry “should be encouraged to bring product appearance and packaging more in line with the hazard information on labels, making use of behavioural drivers to amplify the label’s message, thereby promoting the appropriate safety behaviour in consumers.” ECHA does not recommend changes to the Classification, Labelling, and Packaging (CLP) labels themselves “as it is more beneficial to allow the public to get used to the new system — now in use globally — steadily improving their overall understanding of the hazards posed by chemicals and encouraging a safer use of household chemicals in particular.” ECHA notes that, according to Article 34 of the CLP Regulation, the EC will, on the basis of the study, submit a report to the EP and the European Council to, if justified, present a legislative proposal to amend the Regulation. More information is available online.

ECHA Announces ORs Can Apply For Authorization: In December 2011, the EC informed ECHA that, in its view, an Only Representative (OR) of a non-EU manufacturer can also apply for authorization. ECHA announced on January 24, 2012, that it has updated its webforms to allow ORs to send their applications while ECHA develops long-term functionalities in REACH-IT. ECHA is also updating the relevant Data Submission Manual Part 22 — How to Prepare and Submit an Application for Authorisation Using IUCLID 5, and expects to publish it once the new version of IUCLID is released, which is currently expected to be during Summer 2012. More information is available online.

New RoHS Exemption Requests Open For Consultation: On January 24, 2012, a stakeholder consultation began on 18 exemptions from the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive. The consultation, which will close on March 20, 2012, covers the following 18 exemption requests (requests 2 and 11 are not part of the current consultation and thus are not listed):

  • Exemption Request 1: Cadmium and its compounds in electrical contacts or one shot pellet type thermal cut-offs with current ratings of five Amperes or more, for use in monitoring and control instruments (Category 9);
  • Exemption Request 3: Cadmium in phosphor coatings in image intensifiers for X-ray images;
  • Exemption Request 4: Lead acetate marker for use in stereotactic headframes for use with CT and MRI and in positioning systems for gamma beam and particle therapy equipment;
  • Exemption Request 5: Lead as an alloying element as a lubricant for bearings and wear surfaces in radiotherapy equipment and radiosurgery equipment and for patient and equipment support systems;
  • Exemption Request 6: Lead to enable thermal compression process to make a vacuum tight connection between aluminium and steel for X-ray image intensifiers;
  • Exemption Request 7: Lead in non-magnetic pin connector systems used at temperatures below -20°C;
  • Exemption Request 8: Lead in solder for electrical circuitry that is used at temperatures below -20°C;
  • Exemption Request 9: Lead in solders and solderable coatings used on non-magnetic components and circuits that are used in magnetic fields or are associated with circuits used inside strong magnetic fields;
  • Exemption Request 10: Lead in solders to printed circuit boards (PCB) for mounting cadmium telluride and cadmium zinc telluride digital array detectors;
  • Exemption Request 12: Lead and cadmium in optical and filter glass in monitoring and control instruments (Category 9);
  • Exemption Request 13: Lead and cadmium in metallic bonds creating superconducting magnetic circuits;
  • Exemption Request 14: Lead in alloys as a superconductor and thermal conductor in devices that depend on superconductivity for their operation;
  • Exemption Request 15: Lead not exceeding 20 percent in bronze bearings and bushes in monitoring and control instruments (Category 9);
  • Exemption Request 16: Lead in solders consisting of more than two elements for the connection between the pins and the package of microprocessors with a lead content of more than 80 percent and less than 85 percent by weight used in monitoring and control instruments (Category 9);
  • Exemption Request 17: Lead in glass of electronic components and fluorescent tubes, or in electronic ceramic parts (including dielectric ceramic capacitors) used in monitoring and control instruments (Category 9);
  • Exemption Request 18: Lead used in compliant pin connector systems for use in monitoring and control instruments (Category 9);
  • Exemption Request 19: Handicraft luminous discharge tubes (HLDT) used for signs, decorative lighting and light-artwork, in fixed or portable installations as per definition in EN50107-1(2002) “1 Scope” and in prHD60364-7-719 number 719-1; and
  • Exemption Request 20: Mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFL and EEFL) for special purposes not exceeding 5 mg per lamp in lighting applications for monitoring and control instruments (Category 9).

The EC contracted with Öko-Institut and Fraunhofer IZM to evaluate the requests for exemptions submitted according to Article 5(1)(a), as well as existing exemptions according to Article 5(1)(b). If a stakeholder workshop is appropriate, it will take place mid-2012. The draft final report is due to the EC by September 20, 2012. More information regarding the exemption requests is available online.

2,300 Substances Identified For Registration By 2013: ECHA announced on February 3, 2012, that, based on the preliminary results of a 2011 survey, 2,300 substances will be registered for the first time by the next deadline of May 31, 2013. ECHA will update the list on a monthly basis, and, to ensure it is as complete as possible, invites any potential registrants who intend to register by the 2013 deadline and whose substance is not yet on the list to respond to the ECHA survey. According to ECHA, for two thirds of the 2,300 substances, a Lead Registrant has been selected, and ECHA states that it would like to publish their names. ECHA thus invites any newly nominated Lead Registrant to notify ECHA. Lead Registrants who have already notified are also invited to update their entries. ECHA states that the list of substances will also be useful for downstream users to know whether the substance that they use has already been registered or is expected to be registered by 2013. ECHA cautions downstream users that, as the list is not linked to the specific uses of their substance, they are still advised to contact their suppliers and to communicate their specific uses to make sure they will be covered in the chemical safety assessment and exposure scenarios associated with a registration. More information is available online.

ECHA Publishes Information On Pre-Submission Information Sessions For Authorization Applicants: ECHA published on February 6, 2012, new web pages on pre-submission information sessions for future authorization applicants. According to ECHA, the one-to-one sessions are intended to give applicants the opportunity to ask case-specific questions on the procedure and would take place no later than six months before the submission of their application. More information is available online.


France Prepares Mandatory Nanomaterials Reporting Scheme: French authorities developed two texts dealing with a national commitment to introduce a compulsory declaration scheme for nanomaterials. The first is a decree defining how such a law would be applied. The second provides the information requirements that companies will have to meet to fulfill their obligations under the declaration. The second text, which was released in December 2011, is open for consultation until the end of March 2012. After the French Council of State approves the legislation, the authorities intend to publish the final decree in the next few weeks. The first declarations covering nanomaterials produced, imported, and distributed in France in 2012 are then expected in 2013. The draft decree is available online.


Manufacturers And Importers Will Have One Week To Register New Small Volume Chemicals For FY 2012: The Ministry of Economy, Trade, and Industry, Ministry of Health, Labor, and Welfare, and Ministry of the Environment announced on January 30, 2012, that Japan will accept applications for small-quantity domestic production and imports of new chemicals during fiscal year (FY) 2012 (April 1, 2012, through March 31, 2013). Applications will be accepted beginning February 28, 2012, and ending March 7, 2012. Manufacturers and importers of chemicals in annual quantities of one to 10 metric tons that are new in Japan must apply for registration and approval under the Chemical Substance Examination and Manufacturing Control Law. More information is available in Japanese online.

Japan Identifies Chemicals That Could Be Exempt From Inspection And Registration Requirements: According to a spokesperson for the Ministry of Economy, Trade, and Industry, Japan has identified approximately 130 chemicals that could be exempted from government inspection and registration requirements under the Law on Chemical Substance Inspection and Production Regulations. The spokesperson stated that the chemicals are relatively stable substances that pose limited risks to humans and the environment, such as ethylene, polyethylene, arcylic acid compounds, ammonium compounds, thiamine, and glutamine acid. Japan posted the list for a one-month public comment period that will end on February 12, 2012. As of February 2, 2012, the Ministry has received few comments. The regulation could take effect mid-March 2012. More information is available in Japanese online.


Serbia Delays Deadline For Registering SVHCs: The Serbian Chemicals Agency published in the Official Gazette amendments to the regulations concerning the registration of chemicals. The amendments postpone the deadline for reporting substances of very high concern (SVHC) for chemicals produced or imported in 2013 in quantities less than 100 kilogram per year, until January 1, 2014. In addition, they reduce the amount of information that must be submitted for this category, removing the requirement for additional data, such as a detailed description of intended use, risk reduction measures, and proposed monitoring system. The registration deadline is also delayed for downstream users of SVHCs for industrial or professional purposes, to January 1, 2014. The amendments took effect on January 6, 2012. More information is available, in Serbian, online.

Serbia Promulgates Regulations On SDSs: The Serbian Chemicals Agency promulgated new regulations that will take effect on January 1, 2013. The regulations will harmonize those in Serbia with the EU legislation by increasing the information requirements of SDSs, including the introduction of mandatory sections for chemical composition and labeling. The Serbian Chemicals Agency intends to provide additional advice for manufacturers and importers to facility the implementation of the new requirements prior to the 2013 deadline. More information is available, in Serbian, online.


Outlook For South Korean REACH Is Uncertain: South Korea’s Ministry of Environment (MOE) proposed the Law on the Registration and Evaluation of Chemicals in March 2011, but has not yet introduced a bill in the National Assembly. In August 2011, the Korea Chamber of Commerce and Industry and other economic organizations and trade associations formally issued joint complaints to the government and the National Assembly, citing the heavy costs of compliance and a slow pace of international adoption of such chemicals controls. MOE had intended to submit the Law to the National Assembly in September 2011 and to begin registrations in 2014, but the outlook is uncertain.


Taiwan Proposes Amendments To Regulations Concerning Reporting Of Chemicals Handling And Emissions: On January 12, 2012, Taiwan’s Environmental Protection Agency (EPA) posted proposed amendments to the Toxic Chemical Substances Handling and Release Quantity Recording Regulations. The amendments include the following revisions:

  • The EPA would repeal the current toxic chemical substances handling and release quantity reporting form and replace it with a new one;
  • The reporting cycle for Class 1 to Class 3 toxic chemicals has changed to a monthly cycle, regardless of the quantity handled. Previously, annual, quarterly, or monthly reporting cycles applied, depending on the handling quantity;
  • Reporting is not required if the quantity of toxic chemicals is zero;
  • There are provisions for identifying false reporting of toxic chemicals; and
  • Companies must report their handling and release of a toxic chemical before they cease doing so.

More information is available in Chinese online.

Taiwan National Inventory Depends On Legislative Action: According to the Council of Labor Affairs, Taiwan could publish a national inventory of existing chemicals by the end of 2012 if the legislature revises two laws in its next session, which runs from February through June 2012. Chemicals that are not on the list of existing chemicals would be regarded as new substances, and could not be used without a government review of safety and other testing data. According to the Council, more than 64,200 substances have been voluntarily reported by approximately 5,000 companies for listing in the inventory. The 64,200 substances include about 2,100 chemicals with an average processing capacity exceeding 1,000 metric tons per year, including 1,300 that could be labeled as hazardous substances in accordance with the GHS. A spokesperson for the Council’s Department of Labor and Safety stated that the legislature is expected to prioritize revisions to the Labor Safety and Health Act and the Toxic Chemical Substances Control Act, which are needed to establish a legal basis for the inventory. Once the laws are revised, the government will need six months to establish rules for implementation. According to the spokesperson, the government intends to prioritize the control of highly hazardous chemicals, which would be identified based on GHS classification.