Wrap-up of International Chemical Regulatory Developments - August 2014

by Bergeson & Campbell, P.C.


Australia Publishes Ninth Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the ninth 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 August 15, 2014. More information is available online.

Australia Consults On Options To Reduce Risks From 84 Chemicals Of Security Concern: Australia is accepting comments on a Regulation Impact Statement (RIS) that examines policy options to reduce the national security risks posed by 84 toxic chemicals of security concern. The Attorney General's Department engaged PricewaterhouseCoopers to prepare the RIS, which examines the proposed measures to enhance chemical security in relation to 84 toxic chemicals of security concern. The Chemical Security Coordination Unit, in consultation with industry and government representatives, drafted a range of security measures to address the vulnerabilities identified through the risk assessment process. The measures are contained in the National Code of Practice for Chemicals of Security concern and currently apply to 11 homemade explosives precursors. The RIS states that the measures are suitable to apply to all chemicals of security concern. Options include:

  • Continuing with the status quo;
  • Launching a targeted awareness campaign;
  • Expanding the National Code of Practice that currently applies to the 11 precursors to homemade explosives to cover the 84 toxic chemicals of security concern; or
  • Other, less feasible options that are not the focus of the RIS (regulation, industry codes, enhanced enforcement of -- and increased penalties attached to -- existing laws/increased monitoring of potential terrorists, action at the state/territory level).

The RIS states that extending the National Code of Practice is the preferred option for the purpose of the consultation RIS, "although it is acknowledged that this conclusion could change to the extent that further information and the consultation process is not able to demonstrate that the benefits of this option outweigh the costs. This option would include awareness raising to support implementation of this option." Comments on the RIS are due August 27, 2014. More information is available online.


Canada Releases CMP Progress Report: On July 3, 2014, Canada published the second issue of the Chemicals Management Plan (CMP) Progress Report. Canada publishes the Report twice a year, and it reports on advances in major initiatives and highlights key activities related to Canada's most recent work under the CMP. According to the Report, the government is on track to complete the objectives identified in the second phase of the program by 2016. Key deliverables of this second phase include:

  • Phase 2 of the Domestic Substances List Inventory Update;
  • Risk assessments and risk management if required for:
    • Substance Groupings Initiative;
    • Rapid Screening Approach;
    • Continuation of Petroleum Sector Stream Approach;
    • Remaining Challenge substances; and
    • Other chemicals of interest (e.g., triclosan);
  • Over 450 pre-market evaluations on new substances per year;
  • Development of the Polymer Approach;
  • Prioritization of the Revised In-Commerce List;
  • Environmental and health monitoring, surveillance, and research programs; and
  • International engagement and cooperation.

According to the Report, Environment Canada and Health Canada will continue to work closely with stakeholders to reduce risks posed by chemical substances to Canadians and their environment. More information is available online.


RISCTOX Database Available Online: The European Trade Union Institute (ETUI) announced on June 27, 2014, that the RISCTOX database is available online. ETUI worked with the Spanish Trade Union Institute to develop the database. Users can access data cards through the ETUI website on over 100,000 chemicals. ETUI states that each card specifies the chemical's classification and labeling under the regulations, its main work uses (solvent, cleaner, paint stripper, etc.), how it affects health, and the occupational diseases it causes. The database is available online.

ECHA Reviews Approach For Compliance Check To Optimize Impact On REACH Dossier Quality: The European Chemicals Agency (ECHA) announced on June 30, 2014, that it is updating its strategy on checking the compliance of Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers for the coming years (2014-2018). ECHA's goal is to improve dossier quality as efficiently as possible using compliance checks and other measures. ECHA held a strategic workshop in March-April 2014, which kicked off the revision of its approach on using compliance checks and other measures to improve the REACH dossier quality. ECHA has published the proceedings and states that it will discuss the lessons learned and the future principles on compliance checks with stakeholders, Member State representatives, and the European Commission (EC). The revised strategy on compliance checks will concentrate ECHA's regulatory activities towards the right substances of concern and address aspects that are most relevant for their safe use. According to ECHA, other actions are also needed to improve dossier quality, including communication and enforcement measures, and pre-warning campaigns. ECHA will discuss the elements for the updated strategy with the Member States at the July 2014 Competent Authorities for REACH and CLP (CARACAL) meeting. ECHA's Management Board will be informed about the strategy in September 2014. The workshop proceedings are available online.

EU Ombudsman Closes Complaint In ECHA's Favor: ECHA announced on July 1, 2014, that the EU Ombudsman closed a complaint in its favor. A non-governmental organization (NGO) complained to the Ombudsman that, in the context of doing compliance checks, ECHA should follow the process described in one of its published factsheets. The Ombudsman concluded that ECHA had been clear in its factsheet and did not challenge the interpretation of REACH as reflected in the factsheet. Moreover, ECHA states, the Ombudsman did not recognize a case of maladministration in the fact that ECHA's guidance covers the situations where registrants may wish to consider testing beyond the minimum requirements established in REACH. More information is available online.

EEA Publishes Report On Resource-Efficient Green Economy And EU Policies: On July 15, 2014, the European Environment Agency (EEA) published a report entitled Resource-efficient green economy and EU policies, which highlights the major forces fostering the shift to a resource-efficient green economy in Europe, including the role of EU policies. The report examines trends in major environment and climate areas, which it states "show that the underlying economic and technological changes leading towards green economy objectives are weak, slow, or, in many cases, have ground to a halt." The main conclusions include:

  • Adequate financial resources are essential to the realization of a resource-efficient green economy. Estimated financial needs for investment in green technologies, infrastructure, and innovation at the European and global scale are huge. For example, the estimated investment need for the diffusion of advanced low carbon technologies in the EU is EUR 270 billion a year for the next 40 years;
  • There are opportunities for creating and directing financial resources to the green economy through many different channels. Some of these are publicly driven, including specific initiatives undertaken by the EU and its financial institutions; others are in the private domain, for example, pension funds and socially responsible investments. A third category is made of hybrid players -- sovereign wealth funds -- and hybrid instruments -- green bonds and the Project Bond Initiative;
  • Among the positive trends emerging, some novel approaches to green and socially sustainable finance, as in the case of socially responsible investments, could become mainstream, and already are in some European countries, e.g., France and the United Kingdom. This selectiveness of funding, based on sustainability criteria, could be a powerful mechanism to redirect resources towards the green economy in a competitive financial market;
  • Among international scale opportunities, financial resources mobilized to fund climate-related projects in developing countries can be a fast growing support for a global green economy. After the commitment by Annex I countries of the United Nations Framework Convention on Climate Change to provide USD 100 billion per year by 2020 for projects in non-Annex I countries, climate finance has evolved rapidly into a complex web of different funds, up to the establishment in 2013 of the Green Climate Fund;
  • The expected flow of climate-related spending in the near future is huge and EU Member States have pledges in place corresponding to around one third of the total global amount. These channels can be important for the international transfer of green knowledge;
  • To realize these opportunities and avoid competition with conventional allocations and strategies being adopted by the financial system in times of crisis, a high level of commitment, persistence, and risk reducing strategies are needed. Furthermore, even if activating most of the above channels proves to be successful, there may still be a financing gap making a green economy transition out of reach, in which case additional instruments will be needed;
  • Financing the shift to a green economy is a macro-economic scale process that may require public policy initiatives to act as catalyzers as well as the incorporation of the financial dimension in environmental policies; and
  • As leading financial institutions increasingly appreciate the imperative of climate change, resource scarcity, and other environmental challenges, current financial regulations may not be well suited to accelerate this shift.

The report is available online.

Final Report Available On Scope Provisions Of RoHS Directive: Öko-Institut e.V. announced on July 15, 2014, that the final report entitled Additional Input to the Commission Impact Assessment for a Review of the Scope Provisions of the RoHS Directive Pursuant to Article 24(1) is now available online. The report presents the results of a review of possible amendments to the scope of the Restriction of Hazardous Substances (RoHS) Directive, including a possible exclusion of electric bicycles and possible changes to Articles 2(2), 4(3), and 4(4) regarding electrical or electronic equipment (EEE) newly in scope.

ECHA Publishes Illustrative Example Of Exposure Scenarios For Communication In The Supply Chain: ECHA published on August 4, 2014, an illustrative example of exposure scenarios for a hypothetical hazardous substance to be annexed to a safety data sheet (SDS). According to ECHA, the main objective of the publication is to promote ways of efficiently communicating on the safe use of chemicals down the supply chain. The publication is organized in three parts: (1) an overview of the format for the exposure scenarios to be annexed to the SDS, advice regarding the selection of standard phrases, and how this was done in the illustrative example; (2) the illustrative example of exposure scenarios, how to extract information from a Chemical Safety Report, and how to report it in the exposure scenario; and (3) the Chesar 2.3 file from which the exposure scenarios have been generated. ECHA states that, to complement the example, three annotated templates are published; one each for an industrial, professional, and consumer use of a substance. More information is available online.


Ministry Of Labor Announces Two-Stage Implementation Of Occupational Safety And Health Act: The Ministry of Labor announced on July 4, 2014, that the amended Labor Safety and Health Act, renamed the Occupational Safety and Health Act, took effect on July 3, 2014, and is implemented in two stages. During the first stage, the amended provisions of existing regulations (41 subordinate regulations) are in effect as of July 3, 2014. The second stage new schemes and measures will be launched on January 1, 2015. According to the Ministry, the new regulatory measures effective January 1, 2015, include: a machinery, equipment, appliance, and chemical source management system; maternity protection and employment equality measures for maternity health and protection; and regular process safety assessment and supervision for high-risk business. The Ministry states that by a phase-in approach to the regulation implementation, source control and control banding management systems are expected to ensure improved occupational safety and health. More information is available online.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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