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March 1, 2015

Global Regulatory Update for March 2015

The ACTA Group


Australia Publishes Twelfth Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the twelfth 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 on information that has the potential to affect the outcome of an assessment, but 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 April 10, 2015.


Canada Publishes Final Approach For A Subset Of Substances Prioritized During Categorization That Have Already Been Addressed: On February 7, 2015, Environment Canada posted a document entitled Approach for a Subset of Substances Prioritized during Categorization That Have Already Been Addressed. The document outlines 248 substances on the Domestic Substances List (DSL) that Canada identified as priorities through categorization that, upon further analysis, can be associated with other risk assessment or risk management initiatives under Canadian Environmental Protection Act (CEPA). Canada states that, as a result, “it is concluded that these substances do not require further risk assessment at this time. This does not preclude further data collection, risk assessment or risk management activities triggered through other initiatives.” The document states that a number of substances prioritized during categorization also appear on the List of Toxic Substances in CEPA Schedule 1.

Canada Promulgates Regulations Related To GHS Implementation For Workplace Hazardous Chemicals: On February 11, 2015, Canada promulgated regulations amending its Hazardous Products Regulations to adopt the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and more closely align Canada’s Regulations with the U.S. Hazard Communications Standard. To give suppliers, employers, and workers time to adjust to the new system, implementation of the GHS will take place over a three-stage transition period that is synchronized nationally across federal, provincial, and territorial jurisdictions. Canada states that the purpose of the transition period is to enable:

  • Time for partners and stakeholders to make the necessary legislative, regulatory, and system adjustments;
  • Old labels and material safety data sheets (MSDS) to be moved out of the supply chain and workplaces in a predictable manner;
  • Increased employer and worker awareness and understanding of changes to hazard classification and communication in Workplace Hazardous Materials Information System 2015 (WHMIS 2015); and
  • Consistency across Canada through coordination and alignment between federal, provincial and territorial jurisdictions.

The transition period allows manufacturers and importers the flexibility to use either system of classification and labeling until June 1, 2017. More information is available in The Acta Group’s (Acta®) February 23, 2015, memorandum, “Canada Publishes Hazardous Products Regulation.”

Canada Issues New Substances Notification Advisory Concerning Replacement Of Definition Of MSDS By SDS: On March 12, 2015, Canada issued New Substances Notification Advisory Note 2015-03, “Replacement of definition of ‘Material Safety Data Sheet’ under the New Substances Notification Regulations (Chemicals and Polymers) by the definition of Safety Data Sheet.” The Advisory Note provides guidance concerning the replacement of the definition of material safety data sheet (MSDS) in the new substances notification regulations (chemicals and polymers), including guidance on the sections affected in the regulations and the guidelines for the notification and testing of new substances (chemicals and polymers). The Advisory Note states that while the new GHS requirements are already in force under the regulations, a transitional period is provided during which importers and manufacturers of substances that are not on the DSL may use an MSDS, as defined in the regulations before February 11, 2015, or an SDS as defined in subsection 1(1) of the regulations. The transitional period applies until May 31, 2018. After this date, importers or manufacturers will have to use SDSs as defined in subsection 1(1) of the regulations.


SAWS Announces Final Updated Catalog Of Hazardous Chemicals: The State Administration of Work Safety (SAWS) announced on March 9, 2015, the availability of the final updated Catalog of Hazardous Chemicals. The final Catalog includes almost 3,000 chemical substances based on their physical, human health, or environmental hazard properties. In general, the chemical substances listed are subject to Decree 591 and its subordinate regulations addressing their safe management throughout the supply chain. Listed substances would need a license to be produced, used, or imported. The Catalog will enter into force on May 1, 2015.


ECHA Publishes Regulatory Science Strategy: The European Chemicals Agency (ECHA) announced in its February 2015 newsletter the availability of its first Regulatory Science Strategy, which is intended to provide a framework for ECHA’s scientific activities, steering ECHA’s cooperation with regulatory partners and the scientific community. The current priority areas for ECHA’s regulatory science activities include:

  • Improved methodologies for risk assessment;
  • Non-animal alternative methods and new approaches to hazard assessment, in particular rational integration of different lines of evidence and other means of reduction or refinement when non-animal approaches are not yet available;
  • Exposure assessment, in particular, quality and interpretation of exposure models, and the assessment of the presence and release of chemicals from articles;
  • Tools and methods for identifying and assessing endocrine disrupting substances, and effects of exposure during sensitive life stages;
  • Improved tools and methods for assessing persistence and bioaccumulation;
  • Characterization, hazard, and exposure assessment, risk assessment, and risk management of nanomaterials;
  • Approaches to screening and priority setting of substances;
  • Methods for combining evidence and integrating assessment methods, such as weight-of-evidence approaches;
  • Assessing, describing, and communicating uncertainty and incomplete knowledge, including the impact on the conclusions; and
  • Health and environmental impact, socio-economic analysis, and risk-benefit approaches (including social science approaches).

EC Begins Consultation On REACH Authorization Applications: The European Commission (EC) began a public consultation on February 5, 2015, on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) authorization applications for low volumes and on extension of transitional arrangements for uses in legacy spare parts. The EC seeks the following information:

  • REACH authorization for uses of substances in low volumes: Stakeholders are invited to provide comments on the proposed scope, conditions, and review period for the specific case of authorization applications for “low volumes.” This includes the question whether the level of detail on the information required in applications for this specific case is sufficient. The current existing obligations for authorization, which are related to Annex I of REACH, should be taken into account; and
  • REACH authorization for uses of substances in legacy spare parts: Stakeholders are invited to provide comments on the proposed definitions and scope of “legacy spare parts” and indicate which substances listed in Annex XIV of REACH are used in the production of legacy spare parts. Information provided should include the name of the substance and a description of the articles concerned, as well as the approximate volume used in the production of legacy spare parts. It should also include, if relevant, a description of mixtures intended for the repair and maintenance of articles no longer produced after the sunset date, as well as the usual time-length, during which the legacy spare parts are expected to be supplied, so as to preserve the functionality of the articles for which they are intended.

Comments are due April 30, 2015.

Advocate General Issues Opinion On The Concept Of Article Composed Of Several Articles: The Advocate General issued on February 12, 2015, an opinion on the concept of an article that is composed of several articles and the duties to provide information in connection with the use of substances of very high concern (SVHC). Under REACH, when an article contains more than 0.1 percent of an SVHC, there are certain duties to provide information to ECHA and recipients and consumers of the article. Various Member States and the EC have disagreed on how the concentration threshold is calculated where an article consists of several components that are themselves articles. In 2014, two French trade bodies initiated legal proceedings to resolve the issue. The Federations of Commerce and Distribution Undertakings and of Do-It-Yourself (DIY) and Home Improvement Stores lodged a request for a preliminary ruling with the French Council of State, challenging the position of the French Ministry of Ecology, Sustainable Development, and Energy. The parties sought a ruling on whether REACH applies only with regard to the assembled article or to each of the elements that meet the definition of’ “article.” The EC, supported by a majority of the Member States, has maintained that the proportion of the SVHC should be calculated by reference to the assembled article. Some Member States, including the majority of the parties to the case, contend that it is sufficient if the proportion is reached in the individual components. The French Council of State referred the following question to the European Court of Justice:

Where an ‘article’ within the meaning of the REACH Regulation is composed of several elements which themselves meet the definition of ‘article’ in the regulation, are the obligations resulting from Article 7(2) and Article 33 of the regulation to apply only with regard to the assembled article or with regard to each of the elements which meet the definition of ‘article’?

The Advocate General proposed that the court answer the request for a preliminary ruling as follows:

  1. If the other conditions laid down in Article 7(2) of the REACH Regulation are satisfied:
    1. The producer of an entire article consisting of component articles that, despite being integrated into an entire article, retain a shape, surface, or design of their own, but were made or assembled by other producers, is required to notify ECHA if a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) is present in the entire article above a concentration of 0.1 percent weight by weight (w/w); and
    2. The importer of an entire article consisting of component articles that, despite being integrated into an entire article, retain a shape, surface, or design of their own is required to notify ECHA if a substance meeting the criteria laid down in Article 57 and identified in accordance with Article 59(1) is present in a component article above a concentration of 0.1 percent weight by weight (w/w).
  2. The supplier of an entire article consisting of component articles that, despite being integrated into an entire article, retain a shape, surface, or design of their own is required to provide information to recipients and, on request, consumers under REACH Article 33 on a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) if it is present in a component article above a concentration of 0.1 percent weight by weight (w/w) and relevant information is available to the supplier.

The Advocate General’s ruling is not binding on the court. The court is expected to issue a decision in the next few months.

ECHA Publishes Practical Guides Intended To Clarify Data Sharing Under The Biocides Regulation: On February 23, 2015, ECHA announced the availability of a new series of practical guides on data sharing that are intended to provide “hands-on” advice to companies dealing with biocides. ECHA states that it developed the guides in cooperation with the EC and stakeholders, and particularly aims to help small- and medium-sized enterprises (SME) with the September 1, 2015, deadline for inclusion on the Article 95 list. As of September 1, 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the EU market if the substance supplier or product supplier is not included in the Article 95 list for the product type to which the product belongs. ECHA notes that while the final practical guides will not be published until late March 2015, the working documents are currently available. More information is available in ECHA’s press release, “Four new practical guides clarify data sharing under the biocides regulation.”

ECHA Publishes REACH Evaluation Report 2014: On February 26, 2015, ECHA announced the release of its REACH Evaluation Report 2014, which it states shows that a considerable number of the examined registration dossiers still require improvement. At the same time, more registrants complied with ECHA’s dossier evaluation decisions. To achieve high quality data-rich registration dossiers, ECHA developed a new compliance check strategy in 2014, focusing on checking the quality of hazard, use, and exposure information for higher-volume substances having the biggest potential impact on human health and the environment. The REACH Evaluation Report provides specific recommendations for both future registrants for the 2018 deadline and existing registrants who may need to update their dossiers. ECHA offers the following recommendations:

  • The correct identity and composition of the substance is crucial;
  • Report hazard information clearly;
  • Adapt according to REACH rules;
  • The chemical safety report should reflect realistic uses and conditions of use; and
  • Use ECHA’s guidance and tools.

EFSA Will Open “Treasure Trove” Of Food Safety Data: The European Food Safety Agency (EFSA) announced on March 2, 2015, that it intends to make available as much as possible of the data collected by EFSA, its network in EU Member States, and submitted by other data providers. EFSA states that to support its scientific work, it has collected and used a large body of information on zoonotic diseases, antimicrobial resistance, foodborne outbreaks, pesticide residues, chemical contaminants, food consumption, and chemical hazards. According to EFSA, through the data warehouse, much of these data will be accessible through specific web reporting tools such as tables, reports, graphs, maps, and dashboards. EFSA states that over the course of 2015, different stakeholders (for example, data providers, EFSA scientific staff and experts, risk managers, the general public) will be granted access. The access rules will apply at least for the duration of the data warehouse project from 2015 to 2016, after which the rules may be revised if necessary. More information is available in EFSA’s press release, “Opening EFSA’s ‘treasure trove’ of food safety data.”

ECHA Publishes Report Assessing Reliability Of SpERCs: ECHA announced in its March 4, 2015, e-News that it published a report assessing the reliability of Specific Environmental Release Categories (SpERC) within the context of REACH information requirements related to chemical safety assessment. ECHA states that the report is useful for industry preparing SpERCs and for registrants using them. It proposes a best practice format and suggests streamlining SpERC factsheets, as well as providing explanatory information in a background document. The report also recommends discussing the draft best practice format with industry and Member States to clarify remaining issues.

EP Committee Rejects EC’s Proposed Voluntary Scheme Concerning Conflict Minerals: The European Parliament (EP) Development Committee voted on March 9, 2015, on an opinion on the EC’s proposed legislation concerning conflict minerals. The EC proposed a draft regulation that would create a voluntary EU system of self-certification for importers of tin, tantalum, tungsten, and gold that choose to import responsibly into the EC. The self-certification would require EU importers to exercise due diligence by monitoring and administering their purchases and sales in line with the five steps of the Organization for Economic Cooperation and Development (OECD) Due Diligence Guidance. The Development Committee’s opinion calls for a mandatory system that would apply “at all points in the minerals and metals supply chain.” The International Trade Committee, which drafted the main legislative report, and International Trade Committee Rapporteur Iuliu Winkler (Christian Democrat, Romania) support the EC’s proposal for a voluntary scheme, however. The International Trade Committee intends to vote on the final report in April 2015. An EP plenary vote is planned for May 2015.

ECHA Adopts 2015-2017 CoRAP: ECHA announced on March 17, 2015, that it adopted the final Community Rolling Action Plan (CoRAP) for 2015-2017. In the next three years, 21 Member States will evaluate 66 newly selected substances and 68 substances from the previous CoRAP update. Beginning March 17, 2015, Member States have 12 months to evaluate the 48 substances specified for 2015. In addition to the initial grounds for concern, other concerns on the substance may be identified and addressed during the evaluation. Where necessary, the evaluating Member State will prepare a draft decision for requesting further information to clarify the suspected risks. ECHA notes that registrants of listed substances will have an opportunity to comment before any decision to request further information is made. The other Member States and ECHA will review such draft decisions, and, when necessary, the Member State Committee will be consulted before ECHA issues the final decision. More information is available in ECHA’s press release, “Evaluation kicks off for 48 substances in 2015.”

ECHA Posts Revised Working Procedure For Biocidal Active Substance Approval Online: ECHA announced in its March 18, 2015, e-News that the revised working procedure for biocidal active substance approval is now online. According to ECHA, compared to previous versions, the revised working procedure clarifies responsibilities, actors, and timelines, and includes a few additional elements. ECHA states that it will publish the separate annex containing the timelines for the process flows “soon.”


Updates Regarding The Lists Of Chemicals To Be Regulated: The list of Observational Chemicals, formerly regulated under the Toxic Chemicals Control Act (TCCA), is now rescinded. Approximately fifty percent of the substances previously on the Observational Chemicals list, however, are now considered as phase-in substances, which are subject to registration under the Act on Registration, Evaluation, Authorization, and Restriction of Chemicals (K-REACH). On March 12, 2015, the Ministry of Environment (MoE) updated the Toxic, Restricted, and Prohibited Substances list (MoE Notification No. 2015-29).

Updates Concerning Material Safety Data Sheet (MSDS) And Classification: On February 17, 2015, Korea’s National Institute of Environmental Research (NIER) issued additions to the List of Classification and Labeling (NIER Notification No. 2015-4). The classification and labeling requirements for the substance 2-Aminoethanol reaction products with ammonia by-products (CAS Number 68910-05-4) were added.

On January 28, 2015, the MoE issued, in accordance with K-REACH Article 34, a new set of standards regarding the safety, classification, and labeling of risk concerned products, (MoE Notification No. 2015-34) in draft. The Designation of Risk Concerned Products and Standards for Safety and Labeling is to prevent the risks due to potential exposure to hazardous substances contained within household products.

Alterations To Material Safety Data Sheets: As of January 1, 2015, the MSDS provisions as outlined in Annex 25 of the Ministerial Decree of K-REACH are mandatory. Annex 25 content is similar to that of GHS MSDS requirements, but also includes provisions for inclusion of information related to exposure and risk within the MSDS. Annex 26 allows for the original MSDS to be supplemented with information related to exposure and risk. General MSDS requirements are regulated by the Ministry of Employment and Labor (MoEL) under the Korean Occupational Safety and Health Act (Article 41 and MoEL Announcement No. 2013-37).


UNEP Releases Guide To Mediate Natural Resource Conflicts: On February 19, 2015, the United Nations Environment Program (UNEP) announced that, with the UN Department of Political Affairs, it jointly produced a publication entitled Natural Resources and Conflict: A Guide for Mediation Practitioners. According to UNEP, the Guide provides best practices and strategies for mediating different types of resource conflicts. UNEP states that, by focusing on a broad range of benefits tied to natural resources, including employment opportunities, revenue, services, access, and infrastructure, mediators have been able to get past zero-sum positions to options that yield mutual gain. Moving discussions away from political and ideological topics towards more technical aspects of resource disputes can progress negotiations. Technical aspects may include resource quality, quantity, or consumption and demand trends.