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August 1, 2012

Global Regulatory Update for August 2012

The ACTA Group


Australia Amends ICNA Regulations: The National Industrial Chemicals Notification and Assessment Scheme’s (NICNAS) July 2012 Chemical Gazette includes a notice regarding amendments to the Industrial Chemicals (Notification and Assessment) (ICNA) Act and regulations arising from changes to the Work Health and Safety Legislation. The Governor-General approved the amendments to the ICNA r egulations on May 24, 2012, and they include:

  • Amendment of the definition of a hazardous chemical;
  • Inclusion of a definition for Globally Harmonized System of Classification and Labeling of Chemicals (GHS); and
  • Replacement of criteria for health effects that applied under the approved criteria with corresponding hazard classes that apply under the GHS (used for determination of eligibility for certain new chemical permit categories).

The notice states that NICNAS will include the amendments in its revised handbook, which is expected to be released by the end of 2012. More information is available online.

NICNAS Revises New Chemicals Notification Forms: In a notice in the July 2012 Chemical Gazette, NICNAS announced the availability of revised notification forms for use when notifying new industrial chemicals in the certificate categories. The release of the new forms coincides with the implementation of the 2012-2013 revised notification fees. More information is available online.


Association Issues Updated SDS Standard: On August 3, 2012, the Brazilian Association of Technical Standards (ABNT) issued a new version of its safety data sheet (SDS) standard for chemicals. ABNT NBR 14725-4:2012 replaces the previous version published in 2009. The updated standard includes a model SDS, the 16 sections that must be included in the SDS, the sequence and numbering of sections, the information to be completed, and the conditions of the SDS’s use or applicability. The standard is available for purchase online.


China Extends Hazardous Chemicals Registration Requirement To Importers: On July 11, 2012, China’s State Administration of Work Safety (SAWS) published Order Number 53, Measures for the Administration of Registration of Hazardous Chemicals, which replaces its 2002 predecessor. Order Number 53 extends the chemical registration requirements to importers and manufacturers/producers. An increase in the number of substances defined as “hazardous chemicals” in China is also expected. The Order entered into force on August 1, 2012, and the chemicals must be registered with SAWS’ National Registration Center of Chemicals (NRCC) before being imported. Order Number 53 includes procedures for registering and updating a registration when new hazard information is available for manufacturers/producers and importers of hazardous substances as required by Article 67 of Decree 591, China’s main law governing hazardous chemicals. The Order is available, in Chinese, online. More information is available in the Acta Group’s July 26, 2012, memorandum, which is available online.

MIIT Releases Draft RoHS Declarations Of Conformity For Comment: On July 24, 2012, the Ministry of Industry and Information Technology (MIIT) released for comment draft specifications for supplier declarations of conformity (SDoC) under China’s legislation concerning the Restriction on the use of Hazardous Substances in electrical and electronic equipment (RoHS). The draft specifications would apply to all manufacturers and importers of electronic and electrical products in China, and would require them to be responsible for the conformity of their products and declarations. The draft specifications include details on:

  • Objects or areas applied;
  • Content of declaration;
  • Documents based for declaration;
  • Means for declaring; and
  • Registration requirements.

Comments are due August 22, 2012. More information is available, in Chinese, online.


ECHA Enforcement Forum Will Create “Manual Of Conclusions” For Enforcement Agencies: During the June 18-20, 2012, meeting of the European Chemicals Agency (ECHA) Enforcement Forum, participants agreed on common approaches to enforcement issues, including the presentation and wording of the solutions. The outcomes of these discussions will be distributed in a “manual of conclusions” to enforcement authorities and inspectors. According to Szilvia Deim, Chair of the Enforcement Forum, the manual will provide “non-binding” advice and will not be publicly available. The issues covered include obligations relating to substances in articles, classification, labeling, and packaging (CLP) labeling requirements, and extended SDS-related issues, and the discussions and conclusions on these issues will be available to the public through the Enforcement Forum’s meeting minutes. More information regarding the Enforcement Forum is available online.

Stakeholder Consultation Begins On RoHS Exemptions: A RoHS stakeholder consultation began on June 26, 2012, covering the following exemption requests:

  • Exemption request 1: Hexavalent chromium in alkali dispensers for in-situ production of photocathodes;
  • Exemption request 2: Reuse of parts [containing lead, cadmium and hexavalent chromium] from medical devices including X-ray tube components in new X-ray tube assemblies;
  • Exemption request 3: Lead in solders for Positron Emission Tomography detectors and data acquisition units installed in Magnetic Resonance Imaging equipment;
  • Exemption request 4: Lead in solders used in Directive 93/42/EEC class IIa and IIb portable and mobile medical equipment;
  • Exemption request 5: Decorative ceramic lamp bases or other ceramic components of luminaires containing lead and/or cadmium in the glaze/coloring;
  • Exemption request 6: Decorative lamp shades and bases (luminaires) containing lead in the solder used to join/coat the copper foil mounting strips for the glass/shell/other material used in tiffany (like stained glass windows), capiz shell, and similar products;
  • Exemption request 7: 3,5 mg mercury per lamp in single capped compact fluorescent lamps for general lighting purposes <30 W with a lifetime >15,000 hrs (“long-life”);
  • Exemption request 8: Mercury in cold cathode fluorescent lamps for general lighting purposes;
  • Exemption request 9: Mercury in cold cathode fluorescent lamps for luminous sign for advertising or decorative purposes;
  • Exemption request 10: Lead in micro-channel plate for medical devices and monitoring and control instruments; and
  • Exemption request 11: Lead as an activator in the fluorescent powder of discharge lamps when used as photophoresis lamps containing phosphors such as BSP (BaSi2O5:Pb).

Comments are due September 4, 2012. More information is available online.

ECHA Fact Sheet Explains Communication Obligations For Certain Substances Exempted From Registration: ECHA announced on June 26, 2012, the availability of a fact sheet explaining that, even though some substances may be legally placed on the market without a registration number, suppliers of such substances should communicate information down the supply chain to enable their safe use. Substances exempted from the registration requirement include:

  • Substances included in Annex IV of the regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as they present minimum risk because of their intrinsic properties (e.g., water, nitrogen);
  • Substances covered by REACH Annex V as for these substances (substances occurring in nature, e.g., minerals, ores, and ore concentrates if they are not chemically modified) registration is deemed inappropriate or unnecessary;
  • Substances already registered and recovered through a recovery process in the EU; and
  • Substances already registered and exported from and re-imported into the EU.

The fact sheet is available online.

ECHA Publishes Practical Guide On Exposure Scenarios For Downstream Users: ECHA announced on June 28, 2012, a new guide for downstream users providing an overview of the main duties of downstream users with regard to exposure scenarios under REACH and the associated timescale. The guide includes examples that ECHA states illustrate common issues faced by downstream users when they compare their actual uses and the conditions of use with the information provided by suppliers; provides practical tips on how to undertake a check and the options for follow up actions; and offers advice on how and when to prepare a downstream user chemical safety report and to report unsupported use to ECHA. To develop further the guide and the examples, ECHA encourages downstream users to submit actual experiences. More information is available online.

Report Published On Impact Assessment Of Final RoHS Recast: A July 6, 2012, report entitled Measures to be implemented and additional impact assessment with regard to scope changes, pursuant to the new RoHS Directive assesses the impact of the final RoHS recast, which did not go through an impact assessment after changes were made to the scope of the proposed RoHS recast. The objective of the study was to assist the European Commission (EC) in such an assessment and recommend any necessary amendments to the scope. The report recommends excluding two product groups from the scope of the RoHS recast: electric bicycles that are not type-approved and pipe organs. According to the report, the main problems encountered in complying with RoHS concentration limits are related to very thin coatings and passivation coatings. The report states that the analysis of hexavalent chromium in passivation coatings “is the most difficult analytical problem because standard measurement methods do not give results as percent by weight.” The report notes that guidance developed as part of the review shows that, if coating density and thickness were assumed, then a reasonable estimate of hexavalent chromium concentration can be made from the result of a hot water extraction test. The report states that the issue in analyzing very thin coatings shows that the types of coatings used in electrical and electronic equipment (EEE) that are thinner than 100 nanometers rarely contain restricted RoHS substances, except for some thin passivation coatings. According to the report, guidance has been developed showing that these types of coatings would not necessarily need to be analyzed, and the report recommends that the guidance documents concerning the analysis of very thin and passivation coatings be included in the frequently asked questions document with a clarification for the assessment of very thin coatings. The report also recommends the development of several new RoHS harmonized standards to help the demonstration of RoHS compliance. The report is available online.

New Biocidal Regulations Enter Into Force: On July 17, 2012, the new regulation on biocides entered into force. In a July 17, 2012, press release, the EC states that biocidal products include disinfectants used at home or in hospitals, rat poison, insect repellents, anti-mold sprays and paints, and water purification tablets, in addition to many other products. According to the EC, ECHA is being allocated 100 staff to work on biocides activities, and the number of opinions it will deliver is expected to increase from 80 in 2014 to 300 in 2020. Beginning September 1, 2013, companies will have two options to request permission to place their products on the market. The first, which ECHA states is likely to be used by large firms, requires companies to submit an application to ECHA and if the product is judged safe, it may be sold throughout the EU. The second, which ECHA notes “may appeal more to the numerous small and medium-sized enterprises in this business,” requires companies to submit an application to their own national authority, to sell a product in their home country. If the authorization is granted, they can subsequently put the product on the market of other Member States, according to the mutual recognition principle. Questions and answers on the new regulation are available online.

ECHA Publishes Question And Answer Document On REACH Annex XVII: ECHA published on July 18, 2012, a document entitled Questions and Answers: Implementation of Annex XVII to REACH on the restrictions on the manufacturing, placing on the market and use of certain dangerous substances, mixtures and articles, which provides questions and agreed answers concerning the interpretation of the provisions in REACH Annex XVII. The document states that the answers were first developed for the purpose of implementing Council Directive 76/769/EEC of July 27, 1976, on the approximation of the laws, regulations, and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. The document states that the questions and answers will be complemented by further questions and answers, if and when they arise from the implementation of Annex XVII. Annex XVII sets out the list of restrictions on the manufacture, placing on the market, and use of certain dangerous chemical substances, mixtures, and articles. The document is available online.

ECHA Will Publish Additional Information On Chemical Substances: ECHA announced on July 24, 2012, that it will make more information from registration dossiers available on its website beginning in November 2012. The information will include the name of the registrant and the registration number of the substance, as well as any information that is generally contained in a SDS. ECHA encourages registrants to use the upgraded IUCLID 5.4 dissemination plug-in to review their dossiers, as it will identify the data that will be published. ECHA further advises registrants that dossiers that need to be updated with confidentiality requests should be resubmitted by October 31, 2012. Beginning November 2012, ECHA will publish all SDS information that has not been claimed confidential. ECHA encourages registrants to complete the newly introduced section on the persistent, bioaccumulative, and toxic (PBT) and very persistent, very bioaccumulative (vPvB) assessment of their substance and notes that this information will also be made public. More information is available online.

ECHA Publishes Guidance In A Nutshell On Data Sharing: ECHA announced on July 31, 2012, that it has published a new Guidance in a Nutshell on data sharing following the update of the guidance on the same subject. ECHA states that the new guidance intends to introduce, in simple and concise terms, the data sharing obligations for registrants of both phase-in and non phase-in substances under REACH. It briefly describes the main principles of data sharing and the mechanisms that should be followed by companies that either are required to or are willing to share data under the provisions of REACH. It also introduces the joint submission obligations for companies that have to register the same substance. More information is available online.

Recast Of WEEE Directive Enters Into Force: On August 13, 2012, the recast of the Directive on Waste Electrical and Electronic Equipment (WEEE) entered into force in the EU. Beginning in 2016, the collection target of 45 percent of electronic equipment sold will apply, and, in 2019, a target of 65 percent of equipment sold or 85 percent of electronic waste generated. Member States will be able to choose which way to measure the target they wish to report. Beginning in 2018, the Directive will be extended from its current restricted scope to all categories of electronic waste, subject to an impact assessment beforehand. More information is available on the EC’s website online.


Japan And Vietnam Sign Memorandum Of Cooperation On Chemical Management: Japan’s Ministry of Economy, Trade, and Industry (METI) and Vietnam’s Ministry of Industry and Trade signed a memorandum of cooperation (MOC) on July 15, 2012, under which Japan will help Vietnam develop laws and regulations to improve its management of chemical risks. Over a three-year period, Japan will help Vietnam develop laws and regulations similar to its Law on Examination and Regulation of Manufacture of Chemical Substances, known as Kashinho. The length of the MOC could be extended upon mutual agreement. Japan’s summary states that the countries will begin to discuss the following activities:

  • Development of an implementation plan to realize a chemical management system based on risk assessment and risk management;
  • Development of a chemicals database system and a chemicals list for supporting the implementation of the “Law on Chemicals” as a component of the “Asian Sustainable Chemical Safety Plan”;
  • Making recommendations and a guideline on the development of implementation documents such as guidance under the “Law on Chemicals,” including documents to implement GHS;
  • Providing training courses to strengthen capacity for chemical risk assessment and management to related government officials and private sectors; and
  • Providing training courses to implement safety factory management of toxic chemicals.

The agreement is part of the Asian Sustainable Chemical Safety Plan, which Japan proposed at the October 2010 Japan-Association of Southeast Asian Nations (ASEAN) summit. More information is available online.

Japan Selects 18 PACs For Tier 2 Assessment: Japan has completed the Tier 1 assessments for the first set of priority assessment chemicals (PAC). Of the 87 substances, 86 are manufactured and imported in an amount above ten tons, and Japan completed risk assessments for these. For the substance manufactured and imported in an amount less than ten tons, Japan did not complete a risk assessment. Of the 86 substances, Japan has selected 18 for Tier 2 assessment; will adjust the prioritization order of 63 based on the outcome of the Tier 1 assessments; and will monitor tonnages for five. The following substances were selected for Tier 2 assessment based on risk to human health:

  • Hydrazine;
  • 1,3-Butadiene;
  • Dichloromethane;
  • 1,2-Dichloropropane;
  • Chloroethylene;
  • Ethylene oxide;
  • 1,2-Epoxypropane;
  • Formaldehyde;
  • Acrylonitrile;
  • Benzene; and
  • Toluidine.

The following substances were selected for Tier 2 assessment based on risk to the environment:

  • 1,3-Dichloropropene;
  • N-butyl acrylate;
  • Isopropenylbenzene;
  • Dichlorobenzene;
  • 2,6-Di-tert-butyl-4-methylphenol;
  • [3-(2-Ethylhexyl) propylamine] triphenylboron; and
  • 4,4′-(Propane-2,2-diyl)bis(phenol).

For the Tier 2 assessment, Japan will consider the Tier 1 information, plus exposure information from manufacturers and importers, Pollutant Release and Transfer Register data, governmental monitoring data, and other information. More information is available, in Japanese, online.

Japan Proposes To Add Ten Chemicals To List Of Poisonous Or Deleterious Substances: On August 7, 2012, the Ministry of Health, Labor, and Welfare proposed to add ten chemicals to Japan’s list of poisonous or deleterious substances, thus subjecting them to stricter requirements. Companies that produce, distribute, import, export, or consume the substances would have to register them and meet standards for manufacturing, storing, labeling, and transferring them. The following chemicals would be classified as poisonous, and subject to more stringent restrictions than deleterious:

  • Tetramethyl orthosilicate;
  • Dithianon;
  • 1,1-Dimethylhydrazine;
  • Tributylamine; and
  • Hexakis (fenbutatin oxide).

The following chemicals would be classified as deleterious:

  • 2,3-Dicyano-1, 4-dithia-anthraquinone;
  • 2,4-Dichloro-1-nitrobenzene;
  • 2,3-Dibromop-1-propanol;
  • Ammonium metavanadate; and
  • Methylenesuccinic acid (itaconic acid).

The Ministry also proposed deleting germanium arsenide selenide in glass form from the poisonous list and cyantraniliprole from the deleterious list. Comments are due September 7, 2012. More information is available, in Japanese, online.


South Korea Will Consider Legislation Similar To REACH: A spokesperson for the Ministry of Environment’s (MOE) Chemicals Management Division confirmed on July 23, 2012, that the National Assembly will consider the Law on the Registration and Evaluation of Chemicals in September 2012. 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. The current Toxic Chemicals Control Act regulates only new chemicals, while the proposed bill would regulate new chemicals as well as the approximately 6,574 existing chemicals manufactured or imported in amounts that equal or exceed one metric ton per year. The bill would require high-volume hazardous chemicals, selected by a government evaluation committee for every two-year cycle based on usage purposes and manufacturing and import volumes, to proceed through the REACH process. The National Assembly is expected to pass the proposed legislation and related regulations at the beginning of 2013, with the bill coming into force in 2015.


Turkey Publishes List Of Priority Substances: Turkey’s Ministry of Environment and Urban Planning has published its first list of 131 priority substances that will be subject to government-performed risk assessments. Under Turkey’s 2008 Regulation on the Inventory and Control of Chemicals, the Ministry must prepare and publish a list of prioritized substances or groups of substances that require attention due to their potential hazards posed to human health and the environment. Factors considered include effects of the substance on human health and the environment; human and environmental exposure to the substance; inadequacy of data on effects of the substance on human health and environment; studies carried out by international organizations and under the international conventions to which Turkey is a party; and other national legislation on dangerous substances. The regulation calls for “special attention” to substances that have a chronic effect, in particular if it is carcinogenic, toxic for reproduction, and/or mutagenic, or it is well known for aggravating these effects, or it causes such suspicion. The list is available, in Turkish, online.