Download PDF
September 1, 2013

Global Regulatory Update for September 2013

The ACTA Group


China Consults On Draft GHS Standards: China held a public consultation on the Phrase and Codification of Chemical Hazard Statements, which are draft Globally Harmonized System of Classification and Labeling of Chemicals (GHS) standards for pictograms, hazard and precautionary statements, and codes for chemicals. The draft standards are based on the fourth edition of the GHS. The final standards will supplement standards GB/T 16483-2008 on safety data sheets (SDS) and GB 15258-2009 on labeling. The public consultation ended on August 2, 2013. More information is available, in Chinese, online.

China Publishes Physical Hazard Assessment Rules: On July 10, 2013, the State Administration of Work Safety (SAWS) published Administrative Measures for Physical Hazards Assessment and Classification, which concern how to assess and classify the physical hazards of “substances with unknown hazards.” Three categories of chemicals with unknown physical hazards must be assessed and classified: those that contain one or more chemicals listed in the hazards chemicals catalogue; those not listed in the catalogue; and those used for research and development (R&D) purposes and with production or usage above one tonne per year. The rules will enter into force on September 1, 2013. Companies must compile SDSs and labels for verified hazardous chemicals. China is expected to publish draft guidelines before September 1, 2013, on how to implement the rules. More information is available, in Chinese, online.

China Consults On New Chemicals Notification Process: The Chemical Registration Center (CRC) of the Ministry of Environmental Protection (MEP) held a consultation concerning the new chemicals notification process. CRC solicited comments concerning the registration application forms; the understanding and implementation of certain rules in the guidance; issues affecting labeling, testing, chemical safety, environmental protection, and risk assessment and control; and ways to enhance the management and processes of the notification requirements. Comments were due August 5, 2013. More information is available, in Chinese, online.

China Intends To Update RoHS In 2013: According to a Ministry of Industry and Information Technology (MIIT) spokesperson, China intends to update its Restriction of Hazardous Substances (RoHS) in 2013. The spokesperson stated that a major change is to expand the product scope to include all electrical and electronic products. China RoHS currently applies only to electronic information products containing lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers. MIIT is also updating supporting standards, including a revised standard on information that has to be included on products. China will rename RoHS the Administrative Measures on RoHS in Electrical and Electronic products, and the associated list of products included will be known as the catalogue of electrical and electronic products subject to compliance management in the restriction of hazardous substances. The updated RoHS will require products listed in the catalogue to be managed under a national conformity assessment regime, restricting hazardous substances in electrical and electronic products. An MIIT spokesperson stated that it will issue rules on the updated RoHS within two years.


EFSA Opens Consultation On Cumulative Assessment Group Methodology For Pesticides: The European Food Safety Authority (EFSA) announced on July 17, 2013, a public consultation on its methodology identifying pesticides to be included in cumulative assessment groups. According to EFSA, the approach is based on grouping pesticides that exhibit similar toxicological properties in a specific organ or organ system. EFSA invites stakeholders to provide feedback to enable it to refine the way the methodology is applied in practice and to support forthcoming activities to establish further cumulative assessment groups for organs and systems other than the thyroid and central nervous systems. EFSA also asks stakeholders to identify issues meriting specific consideration in future coordination activities between EFSA and the European Commission (EC) for implementing cumulative risk assessment for pesticides under EU law. Comments are due September 30, 2013. More information is available online.

ECHA Publishes Roadmap Intended To Improve Chemical Safety Reports And SDSs: The European Chemicals Agency (ECHA) published on July 17, 2013, a roadmap intended to improve the generation and communication of exposure scenarios for the different uses of chemical substances and mixtures by 2018, the next and last Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration deadline. ECHA states that the roadmap is a collaborative effort of ECHA and its stakeholders, and ECHA “now calls for more stakeholders to join in.” The actions cover:

  • Improving understanding among stakeholders on the purpose and use of the information in the exposure scenarios included in the chemical safety report or the extended SDSs;
  • Improving information on how substances are used as an essential input to the chemical safety assessment and developing the associated IT tools;
  • Providing more support for downstream users, particularly formulators of mixtures and users at the end of the supply chain, on how to interpret and make the best use of the information they receive in the extended SDS.

More information is available online.

Board Of Appeal Annuls An ECHA Decision: ECHA announced on August 1, 2013, that the Board of Appeal annulled an ECHA decision because “it failed to clearly and precisely communicate an important deadline in the decision-making process to the Registrant in due time.” Following a compliance check under the dossier evaluation procedure, ECHA issued a final decision requiring the appellant to conduct tests to satisfy certain information requirements and to submit a robust study summary for a test already conducted. During the course of the decision-making process, after a draft decision was sent to the Member State Competent Authorities (MSCA), the appellant updated its registration dossier to include the requested robust study summary and an exposure-based waiving strategy addressing the information requirements. As the registration dossier update was received after the draft decision had been sent to the MSCAs, ECHA did not consider the updated dossier for the purposes of its final decision. The Board of Appeal found that ECHA infringed the principle of legal certainty as it had not clearly and precisely indicated to the appellant, in due time, that registration dossier updates would not be taken into account for the purposes of a final decision if submitted after the draft decision had been sent to the MSCAs for their comments. The Board of Appeal remitted the case to ECHA for reevaluation. More information is available online.

ECHA Begins Public Consultation On The First Application For Authorization For DEHP: On August 14, 2013, ECHA announced that it received the first application for authorization under REACH. Rolls-Royce applied for the processing of a stop-off formulation containing bis(2-ethylhexyl) phthalate (DEHP) during the diffusion bonding and manufacture of aero engine fan blades. Interested parties can submit relevant information on alternatives via ECHA’s website. ECHA will post submitted comments, unless the information needs to be treated as confidential. If the applicant provides a response to the comments, ECHA will publish the response on its website. The Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) will review and consider all the information on alternatives submitted during the public consultation. Based on the final opinions of the two committees, the EC will decide whether to grant the applicant an authorization. The public consultation ends October 9, 2013, “but contributions are welcome as soon as possible.” More information is available online.

ECHA Publishes Guidance On Applications For Technical Equivalence Concerning Biocides: ECHA announced on August 19, 2013, the availability of guidance intended to inform potential applicants about how and when they need to apply for an assessment of technical equivalence of an active substance and on the procedural steps in making such an application under Article 54 of the Biocidal Products Regulation (BPR). The guidance also provides information about the assessment process conducted by ECHA and the approach used for assessing the technical equivalence of the alternative source of an active substance versus its reference source. ECHA notes that, unlike under the Biocidal Products Directive, where technical equivalence was assessed by the Member State competent authority, ECHA will assess the technical equivalence under the BPR for approved active substances. More information is available online.

EC Holds Stakeholder Consultation RoHS Exemption Requests: The EC began a stakeholder consultation on August 19, 2013, on five requests for exemptions from the RoHS Directive. The EC website lists the following information regarding the requests:

  • Exemption request 2013-1: Lead as thermal stabilizer in polyvinyl chloride (PVC) used as base for substrates in amperometric, potentiometric, and conductometric electrochemical sensors;
  • Exemption request 2013-2: Cadmium in color converting II-VI LEDs (< 10 µg Cd per mm2 of light-emitting area) for use in solid state illumination or display systems (request for renewal of Exemption 39 of Annex III of Directive 2011/65/EU);
  • Exemption request 2013-3: Lead in solders used in boards of heart-lung machines, exemption to expire in 2017;
  • Exemption request 2013-4: Mercury used in high speed rotating electrical connectors (slip ring) with electrical conduction paths that have sealed liquid mercury, molecularly bonded to the contacts; and
  • Exemption request 2013-5: Cadmium in light control materials used for display devices.

Responses are due November 11, 2013. More information is available online.

EC And ECHA Will Hold REACH SMEs Workshop: The EC and ECHA will hold a workshop in Brussels on December 10-11, 2013, for small-, medium-, and micro-sized enterprises (SME) to meet with other REACH actors. The EC notes that, in view of the upcoming 2018 registration deadline for smaller tonnages (one tonne to ten tonnes per year), many SMEs will be involved. The EC and ECHA will use the results of an online survey, available online, to determine the scope of workshop discussions. Due to the limited capacity of the room, only 50 participants will be selected to participate in the workshop. The selection process is intended to ensure a fair representation of stakeholders. Travel expenses and accommodation of SME participants will be reimbursed. The survey will be open until October 18, 2013.


ANSES Begins Public Consultation On Recommendations Of An Ototoxic Notation For Certain OELs: The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) began a public consultation on the report of its Expert Committee on expert appraisal for recommending occupational exposure limits for chemical agents (OEL Committee). According to ANSES, the public consultation is intended to allow interested parties to share their comments regarding the scientific data collected for and used in the expertise work. The OEL Committee reviewed certain substances for which it had already recommended occupational exposure limits (OEL), by considering co-exposure to noise, with a view to assigning an “ototoxic” notation where appropriate. The consultation document states: “The OEL Committee considers it necessary to pay special attention to the effects of co-exposure to chemicals and noise. In conclusion, it recommends assigning the ‘ototoxic’ notation to the following substances: styrene, toluene and carbon monoxide.” Comments are due October 27, 2013. More information is available online.


Japan Updates Manual For New Chemicals Notification: On August 20, 2013, Japan updated its requirements for new chemicals notification. The revisions include removal of the new substance card, which will be replaced with one in Excel format only for paper submissions; the submission of a new substance card for same substance notification is no longer necessary; and notifiers no longer need to submit evidence materials for how their substances are named. More information is available, in Japanese, online.


New Zealand Announces Major Reform Of Workplace Health And Safety Regulation: New Zealand announced the “Working Safer” package of reforms on August 7, 2013. New Zealand intends to reduce its workplace injury and death toll by 25 percent by 2020. The reform package includes:

  • An overhaul of the law, supported by clear, consistent guidelines and information for business on their requirements;
  • More funding for WorkSafe New Zealand to strengthen enforcement and education and implement the changes;
  • A focus on high risk areas;
  • Stronger focus on occupational harm and hazardous substances;
  • Better coordination between government agencies;
  • Improved worker participation; and
  • Stronger penalties, enforcement tools, and court powers.

More information is available online.


Labor Secretary Reviewing Final Workplace Safety Guidelines: The Labor Secretary is currently reviewing draft mandatory guidelines that would ensure that product labels and SDSs in the workplace are marked according to the latest version of the GHS. The guidelines would apply to “all workplaces in the private sector, including their supply chain(s), that are using industrial chemicals.” According to a spokesperson for the Department of Environment and Natural Resources Environmental Management Bureau, 64 substances would be prioritized for action in 2015. The initial list of 64 substances includes seven covered by chemical control orders and 57 listed as toxic substances on the Philippines Priority Chemicals List. Other toxic chemicals could be added in 2017, and by 2018, additional toxic chemicals listed by the International Air Transport Association and International Maritime Dangerous Goods will be reviewed. The Labor Secretary is expected to approve the draft guidelines by the end of 2013, and implementation would be phased in starting in 2015.


BSMI Announces Voluntary RoHS Standards: The Bureau of Standards, Metrology, and Inspection (BSMI) announced on August 15, 2013, voluntary national standards in line with the EU’s RoHS requirements. According to BMSI, the standards will assist industry to “adapt to environmental trends in international trade and to promote the achievement of international environmental standards in products sold in the domestic market.” More information is available, in Chinese, online.


Thailand Issues Draft Amendment To Hazardous Substance Act: On July 16, 2013, the Department of Industrial Works (DIW) released a draft amendment to the Hazardous Substance Act, a comparison table for existing and proposed provisions, and the hearing form to submit comments. The revisions include redefining “import” as “bring or order into the country,” leaving “transit” as a separate condition. Companies engaged in the transit of hazardous chemicals would be subject to additional obligations that would be further clarified in the future. Comments were due August 16, 2013. More information is available, in Thai, online.


UK Posts Summary Of Comments Received On Implementing Recast WEEE Directive: On August 23, 2013, the UK Department for Business, Innovation and Skills posted a summary of the responses received in response to its consultation on the implementation of the recast Waste Electrical and Electronic Equipment (WEEE) Directive. The consultation focused on how the government should amend the existing WEEE regulations to ensure compliance with the recast WEEE Directive published on July 24, 2012, and on how to respond to concerns from UK producers of electrical and electronic equipment under the Environmental Theme of the Red Tape Challenge about the cost of meeting their financial obligations under the regulations. The Department intends to publish the full government response in September 2013, which will include final impact assessments and revised regulations. There will be an opportunity to comment on the revised regulations. More information regarding the consultation is available in our April 19, 2013, memorandum. The summary is available online.


MOIT Publishes Circular Regarding Prevention And Response Plans For Hazardous Chemical Incidents: The Ministry of Industry and Trade (MOIT) published on August 5, 2013, Circular 20/2013/TT-BCT, which replaces Circular 28/2010/TT-BCT Chapter V Article 4 concerning plan provisions on preventive measures and responses to chemical incidents in industrial areas. Circular 20/2013/TT-BCT provides detailed information regarding establishing a prevention and response plan for hazardous chemicals incidents. Beginning October 15, 2013, organizations and individuals involved in production, sales, storage, and use of mass amounts of hazardous chemicals in the industrial sectors are required to have prevention and response plans. Under Circular 20/2013/TT-BCT, the chemical quantity is considered to be mass when the highest storage amount of chemicals at a time is greater than or equal to the threshold set by Appendix IV of Decree 26/2011/ND-CP. More information is available, in Vietnamese, online.