Global Regulatory Update for December 2014

The Acta Group (Acta^®) extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, and peaceful New Year. As we have for many years, Acta has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.

Acta Holds Webinar To Assist Companies In Preparing For K-REACH: On December 4, 2014, Acta held a webinar entitled “K-REACH: What You Need to Know to Do Business in South Korea in 2015.” Online access to the archived webinar, copies of the webinar slides, complete Q&A transcription, and related materials are available by contacting Chad Howlin.

Topics included:

• The Act for the Registration and Evaluation of Chemicals (K-REACH) Overview;
   
• Current Regulatory Environment;
   
• K-REACH Key Milestones;
   
• Data Sharing, Data Compensation, and Measures to Protect Data Investment;
   
• Strategy for Foreign Companies under K-REACH; and
   
• Where Companies Should Be Now in Their Planning for K-REACH.

Speakers included well-recognized experts on K-REACH: Leslie S. MacDougall, Acta’s Director of Regulatory Affairs; J. Brian Xu, M.D., Ph.D., DABT^®, Acta’s Asian Scientific Affairs Expert and Toxicologist; Lara A. Hall, MS, RQAP-GLP, Acta’s Data Development Expert; Yongsoon Park, President of SHES Chemical Consulting (SHES) of South Korea; and Dr. Eunjung Lee, Director, SHES. The webinar was moderated by Lynn L. Bergeson, President of Acta.

Global Chemical Control Handbook Published By ABA SEER:

The attorneys, scientists, and regulatory professionals of Bergeson & Campbell, P.C. (B&C^®) and Acta are proud to have authored Global Chemical Control Handbook: A Guide to Chemical Management Programs, recently released by the American Bar Association Section of Environment, Energy, and Resources (SEER). Lynn L. Bergeson, Managing Partner of B&C and President of Acta, provided the guiding vision for this comprehensive desk reference book as editor and co-author.

Reflecting on the work of her colleagues, and others, on this book, Ms. Bergeson stated: “The Global Chemical Control Handbook reflects the expert counsel and advice of seasoned professionals that have been honed by years of “in the trenches” experience with the global chemical programs outlined in the book. Readers can expect from the Handbook the hands-on information they need quickly to point them in the right direction when addressing an increasingly complex set of legal, regulatory, and commercial challenges occasioned by these global chemical management regulations.”

The Handbook is organized by country and/or regulatory program and includes stand-alone sections discussing forecasts and trends, and includes sections on:

• United States — Toxic Substances Control Act (TSCA)/Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and State Law.
   
• Canada — Canadian Environmental Protection Act, 1999 (CEPA 1999).
   
• Europe — European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Restriction of Hazardous Substances (RoHS), Waste from Electric and Electronic Equipment (WEEE), and Biocidal Products Regulation (BPR).
   
• Mexico, Central America, and South America chemical regulation.
   
• Asia — K-REACH, Toxic Chemicals Control Act (TCCA), Order No. 7, and Decree No. 591.

Each of the focused chapters in the Handbook, and the helpful commentary and resources, help to ground environmental professionals and readers-at-large in the diverse regulatory structures that they may encounter in hands-on interactions with chemical management regulations in the United States or abroad. Knowing what to expect, and how to prepare for it, are essential steps in successfully navigating these systems.

Global Chemical Control Handbook: A Guide to Chemical Management Programs is available for purchase via the ABA online bookstore for $149.95, or $119.95 for ABA SEER members.

AUSTRALIA

Australia Publishes Eleventh Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the eleventh tranche of human health and environmental assessments for chemicals identified as part of the Stage One implementation of the Inventory Multi-tiered Assessment and Prioritization (IMAP) Framework. NICNAS states that it seeks comments where information that has the potential to affect the outcome of an assessment has not been considered in the assessment. Comments provided should be evidence-based and the relevance of submitted information should be highlighted. Comments are due January 23, 2015. More information is available online.

CANADA

Environment Canada Announces Availability Of List Of Substances For Which No Information Was Reported Under Phase 2 Of The DSL IU: Environment Canada announced on November 15, 2014, the availability of a list of substances for which no information was reported under Phase 2 of the Domestic Substances List (DSL) Inventory Update (IU). According to Environment Canada, analysis of mandatory and voluntary responses received from the Section 71 notice published under Phase 2 of the DSL IU in December 2012 indicates that there are approximately 1,325 substances for which no information was submitted, including 260 polymers and 65 substances currently on the DSL under masked names. Environment Canada states that it will share further updates from the analysis of survey results “in the coming months.” The December 2012 notice applied to approximately 2,700 substances, including 560 polymers and 90 masked substances. Environment Canada has published a list of substances for which no information was submitted. It will consider these substances under the Rapid Screening and Polymer approaches. Environment Canada “encourages” any person who did not meet the reporting requirements listed in the Notice but was, or is currently, involved with the substances in Phase 2 of the DSL IU or has relevant information to provide the applicable information. More information is available in Environment Canada’s “Update: Substances for which no information was submitted under Phase 2 of the DSL Inventory Update.”

Environment Canada Announces Approach For Identification Of Chemicals And Polymers As Risk Assessment Priorities Under CEPA 1999: On December 3, 2014, Environment Canada published an approach for the identification of chemicals and polymers as risk assessment priorities under CEPA 1999. Environment Canada states that, while the Chemicals Management Plan (CMP) will continue to address remaining priorities identified through the categorization of approximately 23,000 existing substances on the DSL and new substances notifications, the government of Canada has recently taken steps to enhance the way new information from the other feeders is acquired, evaluated, and incorporated into forward work planning. The approach for the identification of chemicals and polymers as risk assessment priorities includes the following guiding principles:

• Information is relevant and scientifically reliable;
   
• Prioritization is risk-based — greater priority is assigned to substances for which there is new information suggesting a potential concern for both exposure and hazard;
   
• Higher weight may be given when new information comes from multiple sources;
   
• Information is reviewed in the context of other domestic and international assessment or information-gathering activities that could provide an opportunity for efficiencies, collaboration, and/or alignment;
   
• Information is reviewed in the context of the assessment and management activities of other federal, provincial, and territorial programs to determine the most appropriate course of action under CEPA 1999;
   
• Information is reviewed in the context of past assessment conclusions;
   
• Information is reviewed in the context of existing risk management, as well as risk management actions that are under development; and
   
• Information is reviewed in the context of existing CMP commitments; allocation of resources toward additional priorities is done in consideration of existing commitments and other program priorities.

According to Environment Canada, this more systematic compilation and review of information from a large number of information sources enables Canada to be better positioned to recognize concerns, to track emerging issues, and to identify and prioritize substances requiring further work. This also helps to increase transparency in the process of identifying new priorities. Environment Canada states that it will consult stakeholders on initiatives that might derive from the collection and analysis of data under this approach.

CHINA

CCCMC Releases Guidelines For Social Responsibility In Outbound Mining Investments, Signs MOU With OECD: On October 24-25, 2014, the China Chamber of Commerce of Metals, Minerals and Chemicals Importers and Exporters (CCCMC) hosted Exploration Exchange China 2014, which was endorsed by China’s Ministry of Commerce. During the conference, CCCMC presented the Guidelines for Social Responsibility in Outbound Mining Investments, which are intended to regulate Chinese mining investments and operations, and to guide Chinese companies in improving corporate social responsibility and sustainability strategies, as well as management systems. During the conference, CCCMC and the Organization for Economic Cooperation and Development (OECD) signed a memorandum of understanding (MOU) setting out the conditions for cooperation to promote the implementation by Chinese companies of responsible business conduct in global mineral supply chains.

EU

European Companies Appeal ECHA Titanium Dioxide Decision: The European Chemicals Agency (ECHA) published on November 3, 2014, an announcement of appeal of a June 17, 2014, contested decision following a compliance check of the REACH registration submitted by Tioxide Europe Limited for titanium dioxide. In the contested decision, ECHA requested Tioxide Europe Limited submit the following information: name or other identifier of the substance; composition of the substance; and description of the analytical methods used. The appellants request that the Board of Appeal annul the contested decision in so far as it requests the submission of information related to phases, nanoforms, and surface treated nanoforms as described in the contested decision. According to the appellants, the information related to the identification of titanium dioxide currently included in the registration dossier complies fully with the REACH requirements, taking into account the available guidance documents, and in particular the ECHA guidance for identification and naming of substances under REACH and the regulation on classification, labeling, and packaging of substances and mixtures.

New Enforcement Project Will Focus On Restrictions: ECHA announced on November 10, 2014, that the Forum for Exchange of Information on Enforcement decided that its next major project will focus on enforcing REACH Annex XVII restrictions. According to ECHA, the scope and individual restrictions to be covered will be confirmed in early 2015. Inspections will take place during 2016. The final report will be available in 2017. ECHA states that the Forum also agreed on two new smaller scale pilot projects:

• Checking that the packaging of chemical products available to the general public have appropriate child resistant fastenings where needed; and
   
• Following up specific cases where ECHA has identified deficiencies in harmonized classification and labeling. These will focus on substances with carcinogenic, mutagenic, or toxic to reproduction (CMR) or sensitizing properties.

The reports on both pilot projects are expected in the first half of 2016. More information is available in ECHA’s press release, “Restrictions are focus of new enforcement project.”

CARACAL Extends Mandate Of CASG Nano: The Competent Authorities for REACH and CLP (CARACAL) extended the mandate of the CARACAL Subgroup on Nanomaterials (CASG Nano) until June 1, 2016. CASG Nano was scheduled to finish its work on January 1, 2015, but its mandate was extended due to continuing impact assessments on amendments to the REACH annexes and potential EU-wide transparency measures for nanomaterials.

ECHA Announces Updated Guidance Intended To Support R&D And Innovation: On November 27, 2014, ECHA announced that to support innovation, especially by small- and medium-sized enterprises (SME), it published an update to its Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD) simultaneously with a new guidance in a nutshell on the same subject. According to ECHA, the updated Guidance and the associated guidance in a nutshell “will support companies better in their decisions to innovate by clarifying the obligations and necessary actions required of those wishing to take advantage of these exemptions. It also gives additional information on conditions that ECHA can impose and on the procedures for renewal of an exemption.” More information is available in ECHA’s press release, “Updated guidance to support R&D and innovation.”

ECHA Announces Availability Of New Improved Version Of R4BP 3: ECHA announced on December 3, 2014, that a new, improved version of R4BP 3 is available. ECHA states that R4BP 3.2 “is a major upgrade of the biocides central hub that significantly enhances its usability and productivity with 27 new features.” The significant additions and improvements include:

• Harmonized and simplified submission of applications with less workarounds and less supporting documents;
   
• E-mail notification of important business events for applicants;
   
• Possibility to delegate assets or nominate someone (e.g., a consultant) to work on your behalf;
   
• Consolidated mutual recognitions renewal (implementation of Regulation (EU) No 492/2014);
   
• Printing of case details; and
   
• Export of asset, case, and task lists.

ECHA notes that, for the authorization of biocidal products, the new release integrates data present in the Summary of Product Characteristics (SPC). This will require companies and competent authorities to use the new SPC format supported by the SPC editor, which ECHA released on October 28, 2014. More information is available in ECHA’s press release, “New improved version of R4BP 3 now available.”

RAC And SEAC Agree On Restriction Proposals And Evaluate Applications For Authorization, Agreeing On 43 Draft Opinions For Individual Uses: ECHA announced on December 4, 2014, that during the plenary meeting at the end of November to early December 2014, the Committee for Risk Assessment (RAC) adopted opinions on restriction proposals for chrysotile and cadmium and its compounds in artist paints. The Committee for Socio-Economic Analysis (SEAC) agreed on draft opinions on the same proposals. SEAC also adopted its final opinion on restriction proposals on cadmium and its compounds in paints and on 1-methyl-2-pyrrolidone (NMP). In addition, RAC agreed on an opinion of the Netherland’s National Institute for Public Health and the Environment (RIVM) report on “Consumer exposure to benzene contained in natural gas” relating to a request from ECHA’s Executive Director under Article 77(3). In addition, RAC and SEAC evaluated 19 applications for authorization, agreeing on 43 draft opinions for individual uses. The following final opinions were agreed by RAC and SEAC:

The following draft opinions were agreed by RAC and SEAC and will be sent to the applicants for their comments before they are prepared in final by RAC and SEAC:

ECHA states that to increase the efficiency of their work, RAC and SEAC also agreed on a streamlined Working Procedure for developing opinions on the applications for authorization. More information is available in ECHA’s press release, “RAC and SEAC agree on restriction proposals and evaluate applications for authorisation, agreeing on 43 draft opinions for individual uses.”

ECHA Updates Guidance On BPR Article 95: ECHA announced on December 10, 2014, that it updated guidance concerning Article 95 of BPR. Beginning September 1, 2015, a biocidal product consisting of, containing, or generating a relevant substance cannot be placed on the EU market if the substance supplier or product supplier is not included in the Article 95 list for the product type(s) to which the product belongs. ECHA states that to make sure that the product stays legally on the market, companies need to:

• Ensure within their supply chain that either a substance supplier or product supplier in the supply chain applies to be on the Article 95 list;
   
• Start their preparations in time, especially for data sharing negotiations;
   
• Submit the application in time to allow ECHA to assess it by September 1, 2015; and
   
• Allow sufficient time to cover the need to provide additional data if the ECHA draft decision is negative.

ECHA’s press release, “Stay on the market with your biocidal product after 1 September 2015,” states that ECHA has updated the guidance on active substances and suppliers to explain the obligations for companies in light of the revisions to Article 95 that came into force on April 25, 2014. Furthermore, the guidance now explains how active substances generated in situ should be dealt with, and how Article 95 submissions can be made by consortia. The guidance also provides further clarification on several sections, in particular on information requirements for Article 95 applications and on ECHA’s process for updating the Article 95 list.

MSC Unanimously Agrees To Identify DEHP As An SVHC: ECHA announced on December 11, 2014, that the Member State Committee (MSC) unanimously agreed to identify bis(2-ethylhexyl) phthalate (DEHP) as a substance of very high concern (SVHC) because of its endocrine disrupting properties in the environment. Denmark proposed four phthalates, DEHP, dibutyl phthalate (DBP), diisobutyl phthalate (DiBP), and benzyl butyl phthalate (BBP), to be identified as SVHCs for their endocrine disrupting properties for human health and the environment. For the other three phthalates (DBP, BBP, and DiBP) Denmark chose to withdraw its proposals to identify these substances as SVHCs under Article 57(f) for the environment to elaborate further on the justifications provided in the documentation. ECHA notes that these four phthalates are already listed in the Candidate List and Authorization List due to their toxic for reproduction properties. Regarding the human health parts of Denmark’s proposals, the MSC unanimously acknowledged that for all four phthalates there is scientific evidence concerning the endocrine activity and on the link between this activity and the adverse effects to human health. The MSC did not reach unanimous agreement on whether this constitutes an equivalent level of concern to CMRs (majority view), however, as a minority of members were of the view that the concern related to endocrine disruption is already covered by the existing identification as SVHCs due to toxicity to reproduction. The ECHA Secretariat will submit the MSC opinion on the Danish proposals to the European Commission (EC) after its adoption at the MSC meeting scheduled to be held in February 2015. Within three months of the receipt of the MSC opinion, the EC shall prepare a draft proposal on the identification of the phthalates as SVHCs because of their endocrine disrupting properties for human health. The EC will take the final decision in the committee procedure. More information is available in ECHA’s press release, “The Member State Committee unanimously agreed to identify the phthalate DEHP as an SVHC because of its endocrine disrupting properties in the environment.”

JAPAN

Japan Publishes FY 2013 GHS Classification Results: The National Institute of Technology and Evaluation (NITE) published on November 28, 2014, a list of the new and revised Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classifications conducted by Ministry of Health, Labor, and Welfare (MHLW) and Ministry of Environment (MOE) in fiscal year (FY) 2013. NITE notes that “[t]his is a provisional English translation of classification results and is subject to revision without notice.” In addition, “[t]he responsibility for any resulting GHS labelling and [safety data sheet (SDS)] referenced from this site is with users.” The new and revised GHS classifications are available online.

NEW ZEALAND

EPA Issues Consultation Documents On Proposals For Notices That Would Amend The HSNO Act: On December 2, 2014, the Environmental Protection Authority (EPA) began a consultation on amendments to the Hazardous Substances and New Organisms (HSNO) Act that are intended to improve its workability and make it easier to know what the obligations are with hazardous substances. EPA states that part of the reform is the development of EPA notices that will allow it to simplify the key requirements set under the HSNO Act. The notices will also allow EPA to consolidate and update requirements that are currently spread across regulations, transfer notices, individual approvals, and group standards. EPA released two consultation documents on proposals for five notices. The first consultation document provides proposals for four EPA notices: hazard classification system; labeling; SDSs; and packaging. EPA proposes to align the HSNO hazardous substances classification system and controls more closely with the GHS and to implement GHS in a way that is consistent with how it has been implemented by New Zealand’s major trading partners. Comments on the first consultation document are due February 20, 2015. The second consultation document concerns proposals for changing the requirements for hazardous substances enforcement officer qualifications under the HSNO Act. EPA proposes simplifying the current qualification requirements and basing these on competency and experience. EPA also proposes removing the requirement that prospective officers need to work under the supervision of an HSNO enforcement officer for a specified period of time. No changes are proposed to the new organisms enforcement officer qualifications. Comments on the second consultation document are due February 9, 2015. The consultation documents are available on EPA’s website.

OECD

OECD Releases Proposal For Harmonized List Of PRTR Pollutants: On November 14, 2014, OECD released a report entitled Global Pollutant Release and Transfer Register, Proposal for a Harmonised List of Pollutants. In 2009, during the 12th meeting of the OECD Task Force on Pollutant Release and Transfer Registers (PRTR), the Task Force noted that while there are about 1,200 chemicals in the PRTR Data Center, only 14 of them are common to all PRTRs. The Task Force agreed to eliminate mistakes and aggregate the existing chemicals to produce a more harmonized list of chemicals than is available at present and thereby improve the comparability of PRTR data on a global scale. This report outlines the results of this work. It identifies all chemicals covered by five PRTRs and the Kiev Protocol, categorizes these chemicals into general pollutant classes, proposes unique identifiers for pollutants, and identifies common substances across different national/regional PRTRs. According to the report, the chemical lists developed in this work could form the basis for the future development of guidance or recommendations for core elements of PRTRs. The Task Force developed a harmonized list of pollutants (Long Chemical List), from which a common list of pollutants (Short Chemical List) was developed. The report states that the Short Chemical List is meant to be comprised of chemicals that most countries would agree represent the most toxic or environmentally relevant chemicals in commerce and, therefore, may be considered to be included in any PRTR system. The report is available online.

SOUTH KOREA

English Translation Of K-REACH Available From K-REACH Help Desk: The K-REACH Help Desk has posted an English translation of K-REACH, which will enter into force on January 1, 2015. If there are discrepancies between the English translation and the Korean legislation, the Korean text will prevail. The English text is available online.

K-REACH Presidential Decree Published: The Presidential Decree implementing K-REACH was published in the December 9, 2014, Official Gazette. The Presidential Decree addresses the obligations of manufacturers and importers of existing substances subject to registration; substances exempt from registration; substances that qualify for simplified registration; and the criteria for the designation of substances that can be made subject to authorization. In addition, the Presidential Decree addresses the appointment and responsibilities of members of the newly created Chemical Substance Evaluation Committee; operation of the chemical substance information processing system; and the role of a green chemical center. The Ministerial Decree is still pending before the Cabinet.

TAIWAN

Taiwan EPA Publishes Regulations To Register New And Existing Chemical Substances: The Taiwan Environmental Protection Administration (Taiwan EPA) published regulations for the registration of new and existing chemical substances under the revised Toxic Chemical Substances Control Act (TCSCA), which took effect December 11, 2014. The regulations also address information disclosure and the protection of confidential business information. The Chemical Substance Registration Center is available at (02) 2314-2000 and chemist@era.com.tw to answer industry questions on the new regulations. More information is also available, in Chinese, on the internet platform for the registration of toxic chemical substances. A spokesperson for the Taiwan EPA stated that an English language translation of the new regulations will be published within three months.

UNITED KINGDOM (UK)

UK BIS Publishes Draft Industry Guidance To Support The UK Regulations On Payments To Governments For The Extractive Industries: On November 25, 2014, the Department for Business, Innovation and Skills (BIS) published draft guidance developed by the International Association of Oil and Gas Producers (OGP) and International Council on Mining and Metals (ICMM) that is intended to help companies engaged in extractive and logging of primary forest activities meet the requirements of regulations that require the disclosure of payments that they make to governments in relation to those activities. BIS states that industry seeks comments on the draft to ensure that their interpretation meets the requirements of the EU Accounting Directive and UK regulations. They also seek views on whether the guidance is clear and easy to understand. BIS states that it will review the draft to consider whether it is compliant with the UK regulations. Following the consultation, BIS and industry will discuss amendments to the draft guidelines. Comments are due December 17, 2014. The draft guidance is available online.

UNITED NATIONS (UN)

UNEP States Report Makes Strong Business Case For Using Safer Chemicals In Products And Supply Chains: The UN Environment Program (UNEP) released on December 15, 2014, a report entitled The Business Case for Knowing Chemicals in Products and Supply Chains, which highlights the benefits to companies when they invest in an “Active Strategy” for chemicals management, proactively managing the chemicals in their products and supply chains to stay ahead of regulatory and market demands. UNEP prepared the report in collaboration with the environmental non-governmental organization (NGO) Clean Production Action. UNEP released the report at the Strategic Approach to International Chemicals Management (SAICM) Open-Ended Working Group meeting in Geneva, Switzerland. UNEP states that the report compares companies with differing chemical management strategies, concluding that those with Active Strategies reduce their risk to damaging chemicals “surprises” and generate long-term value through increased sales, enhanced brand reputation, and well-managed supply chains. According to UNEP, the report demonstrates how companies with “Passive Strategies” can face big fines, loss of market share and value, and tarnished reputations if an unknown hidden liability of hazardous chemicals in their products comes to public light. Conversely, the report states, proactive businesses that adopt an Active Strategy reap the rewards of their efforts: they avoid fines and product recalls, are well-prepared for new government regulations, and respond quickly to ever-growing market demands to know and control the chemicals in their products. Many sectors — apparel, footwear, outdoor industry, automotive, electronics, cleaning, personal care, building, and retail — have leaders advocating and building active chemicals management strategies, and the necessary complementing information systems. The report notes that progress is not uniform, however, and many sectors do not have sufficient systems in place to enable reliable exchange of the chemical content information that is needed to meet current and future regulatory and customer demands.