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July 1, 2011

Global Regulatory Update for July 2011

The ACTA Group


Canada Announces Updated Draft Screening Assessment Of Substances Of Low Concern: On June 18, 2011, Canada published the updated draft screening assessment of substances of low concern using the rapid screening approach in the Canada Gazette. After evaluating 1,047 substances of low concern using the rapid screening approach, Canada proposes that, based on available information, 545 of the substances do not meet the criteria set out under Section 64 of the Canadian Environmental Protection Act (CEPA). Canada states that it “is committed to identifying and addressing all substances that may pose risks to the environment or to human health.” Therefore, to validate the assumptions it made under the rapid screening approach, Canada will obtain further information regarding the current quantities of these substances that are in commerce in Canada through its inventory update program. In addition, substances that have been found, through rapid screening, not to meet the criteria under CEPA Section 64 may still be addressed under future research and monitoring programs, or as part of future assessments of groups of substances. The remaining 502 substances that underwent rapid screening have been identified as requiring further screening assessment to evaluate their potential to cause harm. These substances have therefore been incorporated into the group of substances that are of remaining priority for assessment as a result of categorization. Comments on the draft screening assessment are due August 17, 2011. More information is available online.


Member State Committee Identifies Seven New SVHCs; ECHA Updates Candidate List: The European Chemicals Agency (ECHA) announced on May 31, 2011, that the Member State Committee identified seven new substances of very high concern (SVHC) during its 18th meeting: 2-ethoxyethyl acetate; strontium chromate; 1,2-benzenedicarboxylic acid, di-C7-11 branched and linear alkyl esters; hydrazine; 1-methyl-2-pyrrolidone; 1,2,3-trichloropropane; and 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich. According to ECHA, these substances are either carcinogenic, mutagenic, or reprotoxic substances. In addition, as a result of the procedure for identification as SVHC, a new identification basis (toxic for reproduction) will be added for cobalt dichloride, which ECHA states is already on the Candidate List because of its carcinogenic hazards. ECHA received no comments challenging the new identification basis during the public consultation, and thus no formal agreement of the Committee was necessary. ECHA announced on June 20, 2011, the availability of the updated Candidate List, which includes “toxic for reproduction” as the basis for identification as an SVHC for cobalt dichloride. More information is available online.

France Publishes Opinion Indicating That It Will Use Its Interpretation To Calculate SVHCs In Articles: According to an opinion published in the June 8, 2011, Legifrance, France intends to calculate the content of SVHCs in articles based on a “once an article, always an article” approach, meaning that it would consider a complex product, such as a computer, to be several articles, and the 0.1 percent threshold for SVHCs would apply to each individual article. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import, no later than six months after inclusion on the SVHCs Candidate List, if both the following conditions are met:

  • The SVHC is present in those articles at a volume of > one metric ton per manufacturer/importer per year; and
  • The SVHC is present in those articles above a concentration of 0.1 percent weight by weight (w/w).

The ECHA Guidance for Articles maintains the European Commission’s (EC) view, as well as that stated in the previous Guidance, that the threshold of 0.1 percent w/w applies to the article as a whole. Six member states (Germany, France, Sweden, Austria, Belgium, and Denmark) and Norway advocated a dissenting minority view pertaining to the threshold of each component in an article. When asked about France’s June 8, 2011, notice, a spokesperson for the EC stated: “The Commission will raise the matter bilaterally with the French authorities and consider further steps in the light of the outcome of these discussions.” The other dissenting countries have since indicated that they intend to follow their interpretation, as well. In May, Austria sent a letter to the European Commission Services responsible for REACH to request the proposal of a revision in 2012 to clarifying text with respect to the meaning of the 0.1 percent in REACH Articles 7 and 33. Germany expressed interest in participating in a working group to draft guidance on how to apply the “once an article, always an article” approach, and Norway expressed interest in cooperating with other countries supporting this approach. Denmark plans to publish a fact sheet on the approach in August 2011. Belgium states on its website: “Belgium considers that an article does not loose its function if it is integrated in a more complex whole of articles. As a consequence the 0.1% critical value shall be calculated as the average concentration for each article considered individually.”

RAC Adopts Ten Scientific Opinions: The Committee for Risk Assessment (RAC) adopted opinions on eight proposals for harmonized classification and labeling across Europe and two opinions on restriction proposals during its June 7-10, 2011, meeting. The opinions on harmonized classification and labeling include: three types of white spirit; chloroform; bifenthrin; reaction mass of 2,4,4-trimethylpent-1-ene and 2,4,4-trimethylpent-2-ene; aluminium-magnesium-zinc-carbonate-hydroxide; indoxacarb and indoxacarb (enantiomeric reaction mass 75:25 S:R); flufenoxuron; and vinyl acetate. RAC adopted opinions on restrictions intended to reduce the emissions of mercury. The restrictions would address mercury in measuring devices and phenylmercury. The final decision for harmonized classification and labeling, as well as for proposals for restrictions will be made by the EC through a committee procedure. ECHA will post the opinions on harmonized classification and labeling online. The opinions regarding the proposed restrictions will be posted online.

SEAC Adopts First Opinion And Agrees On Two Draft Opinions On Restriction Proposals: During the June 14-16, 2011, meeting of the Committee for Socio-Economic Analysis (SEAC), SEAC adopted its opinion on a restriction of dimethylfumarate in articles and agreed on draft opinions on restrictions concerning mercury in measuring devices and phenylmercury compounds. SEAC concluded that restricting the use of dimethylfumarate in articles is the most appropriate Community-wide measure and that the measure is justified from a socio-economic point of view. SEAC concluded, in its draft opinion on mercury in measuring devices, that there are technically and economically feasible alternatives available for these devices and that the restriction is justified from a socio-economic point of view. SEAC concluded that the proposed restriction of the five phenylmercury compounds is the most appropriate Community-wide measure, and that the action is justified from a socio-economic point of view. Comments on the draft opinions are due August 16, 2011. The final opinions are scheduled to be adopted September 24, 2011. More information is available online.

ECHA Begins Consultation On Inclusion Of 13 Substances In The Authorization List: ECHA announced on June 15, 2011, a public consultation on its draft recommendation of 13 new substances to be prioritized from the Candidate List for the Authorization List. ECHA states that, based on an assessment of the available information on the substances on the Candidate List, ECHA currently plans to recommend the following substances:

  1. Chromium trioxide;
  2. Chromic acid, Oligomers of chromic acid and dichromic acid;
  3. Sodium dichromate;
  4. Potassium dichromate;
  5. Ammonium dichromate;
  6. Potassium chromate;
  7. Sodium chromate;
  8. Trichloroethylene;
  9. Cobalt(II) sulphate;
  10. Cobalt dichloride;
  11. Cobalt(II) dinitrate;
  12. Cobalt(II) carbonate; and
  13. Cobalt(II) diacetate.

According to ECHA, on the basis of the comments received, it may modify the draft recommendation, which further specifies the conditions to the authorization requirement for each selected substance. These conditions include the possible exemptions of uses from the authorization requirement and the latest application and sunset dates. Comments are due September 14, 2011. More information is available online.

ECHA Releases Web Portal For REACH And CLP Inspectors: ECHA announced on June 28, 2011, the available of the REACH Information Portal for Enforcement (RIPE), which provides online access for inspectors to key information submitted by companies to ECHA and, according to ECHA, facilitates more effective enforcement in the European Union (EU). The new web portal, developed as a separate application from REACH-IT, allows REACH and Classification, Labeling, and Packaging (CLP) inspectors to search for key information indicated by companies in their dossiers, including whether a dossier was submitted, by whom and when, the tonnage band, production and use sites, intended uses, information on classification and labeling, and guidance on safe use. Other key information on physicochemical, toxicological, and eco-toxicological properties of substances is also available. ECHA expects almost 2,500 inspectors working in the REACH and CLP local authorities of the EU to use RIPE. RIPE will not be available to the general public, and ECHA states that “the access to it is strictly controlled by the Member States and ECHA.” More information is available online.

ECHA Announces Availability Of Updated Q&A On Inquiry And Substance Identification: ECHA announced on June 28, 2011, that it updated the questions and answers (Q&A) on inquiry and augmented it with a new section on substance identification. According to ECHA, the revised document covers several topics that have proven difficult for inquirers, and is one of many steps undertaken by ECHA to reduce the backlog of open inquiries. ECHA states that, based on its experience so far, it cannot assess many inquiries due to missing or inconsistent information in the dossiers. ECHA hopes the updated Q&A will help inquirers to improve the quality of their dossiers. In addition, ECHA has posted on its website a webinar on the inquiry process under REACH. The webinar outlines the basics of the inquiry process and highlights the most frequently observed deficiencies related to substance identification. The updated Q&A is available online. The webinar is available online.

ECHA Updates Guidance On Requirements For Substances In Articles: On June 29, 2011, ECHA announced that it updated the Guidance in a Nutshell on Requirements for Substances in Articles. According to ECHA, the updated Guidance aims to explain in simple terms the main elements of ECHA’s April 2011 guidance on requirements for substances in articles. The document’s goal is to help companies producing, importing, or supplying articles to identify their obligations regarding substances in articles. The Guidance briefly explains key aspects such as the concept of an article, obligations for registration, notification and communication, and possible exemptions from these obligations. More information is available online.

ECHA Releases Draft Revised REACH Data Sharing Guidance: ECHA has sent to the Partner Expert Group (PEG) a draft of a second version of the guidance on data sharing for phase-in and non-phase-in substances under REACH (Data Sharing Guidance). The first edition of the Data Sharing Guidance was published in 2007. ECHA has revised the entire Data Sharing Guidance document, including correcting mistakes and inconsistencies, proposing to remove sections already covered by technical manuals or falling under the scope of other guidance documents and instead providing links to that information, and other more substantive changes. Specifically with regard to content changes, ECHA states: “The content has been reworked with the aim to restrict the scope to Title III of the REACH Regulation and to add the description of dispute processes.” Some of these proposed changes include the following:

  • Pre-Registration Information Reduced: Since the pre-registration process is now complete, ECHA proposes to revise or reduce the information in this section and instead focus on late pre-registration and those actors entitled to late pre-registration.
  • Right to Refer/Legitimate Possession: Under REACH Article 10, registrants must “be in legitimate possession of or have permission to refer to the full study report summarised [in a study summary or a robust study summary] for the purpose of registration.” ECHA’s initial Data Sharing Guidance provided guidance regarding when a company has “legitimate possession of the full study report” and the “right to refer to the full study report.” In the proposed revised Data Sharing Guidance, ECHA expands on this discussion, including but not limited to information that may be protected by copyright. ECHA states: “In summary, registrants may be entitled to use the content of a published article in a different form, as long as the appropriate national copyright and/or data protection law(s) have been previously checked and respected. In case of uncertainty, it is recommended to seek legal advice from a national lawyer specialised in the copyright field.”
  • Data Sharing Disputes: ECHA has proposed an entirely new section devoted to the data sharing dispute processes under REACH Article 30. This section now includes data sharing examples, figures, and a discussion outlining the process under Article 30(2) (dispute regarding new testing requirement), Article 30(3) (dispute before joint registration submitted), and Article 30(3) (dispute after joint registration submitted).
  • Inquiry Process: ECHA has significantly modified and updated its guidance with respect to the inquiry process under Articles 26 and 27 for non-phase-in substances and phase-in substances that were not pre-registered. ECHA has added a discussion of the information that must be submitted with an inquiry and the possible outcomes of the process. ECHA states that its “stepwise workflow has been extended and better described in order to provide a comprehensive set of information to those involved in the inquiry process.”

Consultation with PEG is the initial step in the consultation process once ECHA identifies a need for updating existing guidance. Other consultations following PEG can be with ECHA’s Committees and/or Forum, where relevant; and then a concluding consultation of the European Commission and Member States Competent Authorities via the meeting of the Competent Authorities for REACH and the CLP Regulations (CARACAL). See online.

The revised Data Sharing Guidance is available online.

ECHA Announces REACH And CLP Regulations Are Working Well: On June 30, 2011, ECHA announced the publication of a report on the operation of REACH and CLP. According to ECHA, the overarching message of the report is that REACH and CLP “are working well and that the various actors responsible for the work are responding as required. This is largely attributable to the commitment and collaborative work between industry, stakeholders, the Member States, the European Commission and ECHA.” ECHA states that there are three key lessons to learn from this first experience of REACH and CLP:

  • The uncertainty over the number of registrations for the first deadline was a challenge to manage and more accurate estimates would be helpful in future;
  • Close working relationships with industry and stakeholders are vital to ensure success and ECHA can help by providing stable tools and guidance; and
  • The interrelationship between the various elements of the two regulations is important and has become increasingly apparent. For example, ambiguities in substance identification can lead to problems in forming Substance Information Exchange Fora (SIEF), evaluation, and risk management activities.

The report also contains recommendations for improving the implementation of the legislation. The report is available online.

EC Conducting Survey To Determine Impact Of REACH On EU Businesses: The EC is conducting a survey to assess the impact of REACH registration on EU businesses. According to the EC, the survey is intended in particular to assess the impact of REACH on the operation of the single market and the competitiveness of the European chemicals industry. The EC will use the data from the survey, along with information from 11 other studies, for a “first extensive evaluation of REACH.” The EC will publish a summary of the results together with the study report. The survey will close on July 15, 2011. More information is available online.

RoHS Recast Will Enter Into Force On July 21, 2011: The recast of the Directive on the Restrictions of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The recast updates the RoHS Directive, extending it to a wider range of products, including medical devices, electronic toys, cables, and spare parts. The RoHS Directive currently lists six materials as being restricted: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers. The recast includes transitional periods: monitoring and control devices and medical devices will be covered in three years, on July 22, 2014in vitro medical devices in five years, on July 22, 2016; and industrial control appliances in six years, on July 22, 2017. Under the recast, the EC must regularly review and adapt the list of restricted substances according to a number of criteria, meaning that further substances in electrical and electronic equipment may be banned in the future. The recast exempts photovoltaic panels to produce energy from solar light, and temporarily exempts energy-saving light bulbs. The recast RoHS will enter into force on July 21, 2011, and member states have until January 2, 2013, to transpose it into national law. The recast is available online.


India Rules On E-Waste Also Ban RoHS Substances: The Ministry of Environment and Forests published on May 12, 2011, the E-Waste (Management and Handling) Rules 2011, which include a ban on lead, mercury, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers, and cadmium in new electrical and electronic equipment, except in very small amounts. Foreign companies producing for or selling electronic and information technology goods in India will have to conform to these standards for products sold in India and will have to take on extended producer responsibility for e-waste thus generated. The Rules are intended to bring India’s e-waste management sector up to par with the best global practices by adopting an “extended producer responsibility” framework, which will require producers to collect, recycle, or dispose of e-waste. The Rules include a detailed list of responsibilities for stakeholders down the supply chain, including manufacturers, distributors, consumers, waste-collection centers, dismantlers, refurbishers, and recyclers. The Rules are available online.


Japan Receives 10,000 Notifications Under CSCL: According to a spokesperson for the Ministry of Economy, Trade, and Industry (METI), as of late June 2011, Japan had received over 10,000 notifications under the Chemical Substances Control Law (CSCL). The spokesperson stated that, while Japan would be able to report quickly the total number of notifications, it will require additional time and effort to sort through the information and check substance identity before it can then begin the risk-based screening process to develop a prioritized list of chemicals to be assessed. Japan will use the production/import volume and use information for general chemicals submitted by companies to calculate estimated exposures based on an emissions ration table. Japan will then determine each substance’s hazard class, based on existing data and input from industry or, if no data exists, apply a default classification. There are four hazard classes for toxicity to humans — repeat dose toxicity; carcinogenicity; mutagenicity; and reprotoxicity — and four hazard classes of ecotoxicity. For each category, Japan set criteria based on hazard assessment values. Japan will combine the hazard class with the exposure class to prioritize substances. The spokesperson stated that Japan estimates that 1,000 will be categorized as a high priority and designated as priority assessment chemicals (PAC). Japan expects to publish a second PACs reporting list by March 2012, but it may not include all high priority substances. Three exemption categories currently exist — evaluated and low concern polymers, chemicals that occur in nature, and chemicals covered by other marketing regulation — and approximately 1,500 substances have already been published for initial exemption.


Serbia Publishes Final Regulation Concerning Chemical Safety Assessments: Serbia published in the June 1, 2011, Official Gazette of the Republic of Serbia a final regulation that establishes the requirements for performing chemical safety assessments. The regulation also establishes the format and content of chemical safety reports. The regulation came into force on June 8, 2011. More information is available, in Serbian, online.

Serbia Issues Final Regulation On Methods Of Testing Hazardous Properties Of Chemicals: Serbia published in the June 13, 2011, Official Gazette (No. 42/11) the Regulation on Methods of Testing Hazardous Properties of Chemicals. The Regulation is comprised of three annexes establishing the testing methods used to determine substances’ physical and chemical hazards, human health hazards, and environmental hazards. The Regulation was effective June 21, 2011. The Regulation is available in Serbian online.


South Korea Completes List of Chemicals To Comply With GHS Labeling: South Korea completed a list of toxic substances that by July 1 must comply with the chemical registry requirements under the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). South Korea’s National Institute of Environmental Research stated on June 21, 2011, that the updated and final list of GHS-labeled chemicals was published on its website June 17 for industry-wide implementation starting July 1. South Korea has been aligning its chemicals classification regime with the GHS since 2008 when chemicals recently introduced into the country were first required to comply with GHS labeling. The second phase, which began July 1, covers these and substances based on homogeneous materials. The third and final phase, slated to begin July 1, 2013, will extend GHS to mixed substances containing two or more ingredients.


Sweden Begins Collaboration With Southern African Countries To Improve Chemical Control: Sweden’s Chemicals Agency (KemI) began collaborating with the Africa Institute to improve chemical control in English-speaking countries in southern Africa, including South Africa, Tanzania, and Nigeria. According to KemI, the project includes a review of the current scheme within each country, what mechanisms are currently in place to control chemicals, how agencies are organized, and what barriers exist. KemI states that the goal of the project is to make it easier for countries to work towards the Strategic Approach to International Chemicals Management (SAICM) and other chemical-related conventions, including the Stockholm Convention, Rotterdam Convention, and the Basel Convention, and to introduce GHS. More information is available, in Swedish, online.


Taiwan Expected To Publish Draft National Inventory Of Existing Chemicals At End Of 2011: Taiwan is likely to publish a draft national inventory of existing chemical substances by the end of 2011. During an interagency meeting held the week of June 20, 2011, participants chose to delay publication of the draft inventory to align it with legislation for new chemicals notification. Taiwan will introduce new chemicals notification by amending two laws — the Labor Safety and Health Act (LSHA), managed by the Council of Labor Affairs, and the Toxic Chemical Substance Control Act (TCSCA), which is under the responsibility of the Environmental Protection Administration. The Executive Yuan passed a review of proposed amendments to the LSHA in May 2011, and it is now awaiting formal approval. Taiwan sent a notification of the proposed amendments to the World Trade Organization’s Technical Barriers to Trade Committee in June. The Legislative Yuan, which reconvenes in September, will now need to review the proposed amendments.

Nominations for existing chemical substances were due December 31, 2010. According to Taiwan’s Council of Labor Affairs, it confirmed approximately 64,200 substances as unique entries. Of these, about 2,100 substances were reported at over 1,000 metric tons annually and 24,000 substances over one metric tonne annually. Most of the nominators were from Japan, Korea, United States, Canada, Australia, and the EU. Half of the nominators were in the following industry sectors: chemical materials industry; international trade industry (chemical suppliers); and other chemical industry.

Taiwan reportedly intends to allow a “supplementary notification” of chemicals to the existing chemicals inventory, probably later this year. Once Taiwan establishes a final inventory, it will focus on the next phases of its chemicals management strategy involving risk-based screening and management of chemicals and disseminating information on chemicals to the public. This could include restrictions and permitting for chemicals of concern.