June 20, 2017

June 20, 2017

Subscribe to Latest Legal News and Analysis

June 19, 2017

Subscribe to Latest Legal News and Analysis

Top International News in Chemical Policy and Regulation- June 2017: Asia, Australia and OECD

AUSTRALIA

Industrial Chemicals Bill 2017 Would Replace NICNAS With New Scheme: The Australian government has presented the Industrial Chemicals Bill 2017 to Parliament. The bill describes the legislative framework for a reformed, risk-based regulatory scheme for Australia to continue to regulate the introduction of industrial chemicals in Australia. The core elements of the reformed scheme, the Australian Industrial Chemicals Introduction Scheme (AICIS), include:

  • Rebalancing the regulatory burden through the revision of industrial chemical introduction categories, with regulatory effort focused on assessing higher risk chemicals;

  • Improved approaches to reviewing chemicals on the market by replacing an overly prescriptive post-market assessment process with a more responsive and flexible evaluation process;

  • Greater transparency by striking a balance between confidentiality and publicly available information through publication of more meaningful information, with confidentiality achieved through masking the chemical name or end use; and

  • A new statutory power for the Executive Director of the scheme to refuse introduction of an industrial chemical if its risks to human health or the environment cannot be managed.

AICIS will replace the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) effective July 1, 2018. The bill also implements a national ban on the use of new animal test data for chemicals used exclusively as cosmetic ingredients, as part of the Australian government’s 2016 election commitment.

Bill Would Amend ICNA Act: The Australian government introduced the Industrial Chemicals (Notification and Assessment) (ICNA) Amendment Bill 2017 in Parliament. The amendments to the ICNA Act include:

  • Revising the definition of a new synthetic polymer to align more closely with international approaches;

  • Revising the notification requirements for new chemicals, such that polymers of low concern would be exempt from notification;

  • Removing the requirement for introducers to provide annual reports to NICNAS for permits and self-assessed assessment certificates;

  • Removing the requirement for introducers to provide a final statement of the value of relevant industrial chemicals actually introduced in a registration year; and

  • Making consequential changes to the ICNA Act related to these changes.

These amendments enable the early introduction of certain aspects of the Australian government’s NICNAS reforms.

NICNAS Reform Consultation Paper 5 Available For Comment, Public Meetings Will Be Held: Consultation Paper 5 seeks feedback from stakeholders on the detail to be included in delegated legislation made under the framework established by the Industrial Chemicals Bill. The paper and supporting material focus on technical matters related to the categorization and assessment of unlisted chemical introductions into Australia:

  • Part 1: Provides a general overview of the NICNAS reforms;

  • Part 2: Focuses on the development of the technical detail to be set out in the delegated legislation and guidance material;

  • Part 3: Describes the objective hazard and exposure criteria. These criteria will provide a structured and transparent approach to self-categorization of industrial chemical introductions. The chemical categorization outcomes (Exempted, Reported, or Assessed) will allow risk-based regulation;

  • Part 4: Describes the requirements for information that an introducer must consider in categorizing their chemical introduction and that Australia will need as part of an assessment certificate application;

  • Part 5: Provides the detail of the hazard information required to categorize chemical introductions the right way for both human health and environmental risks. The level of hazard characterization required will vary with the predicted level of exposure;

  • Part 6: Describes additional information requirements. These will apply for a limited set of specified chemical introductions where minimum information requirements will not be enough to determine the indicative risk, and thus the appropriate introduction category;

  • Part 7: Proposes the categorization of industrial chemicals introduced at the nanoscale. It presents options for the properties of nanoscale chemicals that should be used as criteria to define the chemicals that require pre-introduction assessment;

  • Part 8: Describes the criteria for the commercial evaluation authorization pathway that will be prescribed in the delegated legislation. It will include the volume threshold and the circumstances related to public exposure;

  • Part 9: Presents the details to be included in the delegated legislation to implement the national ban on the use of new animal test data for chemicals used exclusively as cosmetic ingredients; and

  • Part 10: Discusses other matters to be included in the delegated legislation, including prescribed bodies for consultation; prescribed bodies for disclosure of confidential business information (CBI); definitions to be elaborated on in the delegated legislation (including article and industrial chemical); and requirements for the annual compliance declaration.

NICNAS will hold two public workshops on June 16, 2017, and June 28, 2017. Comments are due July 12, 2017. The Department of Health will review feedback received on the Consultation Paper and use it to develop advice to the Australian government on drafting the delegated legislation.

CHINA

China Developing Standards Concerning Hazardous Chemicals In Consumer Products And SVHCs: A Chinese recommended national standard, “Safety Requirements for Hazardous Chemicals in Consumer Products (Draft for Public Comments), was issued on March 28, 2017. The standard would create limit values for 103 chemical substances, listed with Chemical Abstracts Service (CAS) numbers, including heavy metals and hazardous chemicals. Another Chinese recommended national standard, “List of Substances of Very High Concern (SVHC) in Consumer Products (Submitted Draft)” was released in March 2017, in which 205 SVHCs with CAS numbers and uses are reportedly listed. This submitted draft for official review has not been released to the public. On April 24, 2017, the Standardization Administration of China (SAC) published a list of 209 national standards to be established (2nd batch of 1017) for public comments. According to the list, SAC plans to establish a recommended national standard, “Guidelines on Identification and Evaluation of SVHCs” in 24 months. The technical standard will provide guidelines for determination, classification, risk assessment, restrictions, and management of SVHCs.

OECD

OECD Publishes Report On Economic Features Of Chemical Leasing: OECD on May 11, 2017, published a new report, Economic Features of Chemical Leasing. OECD describes chemical leasing as “a service-oriented business model that aligns the interests of the chemical supplier with those of the chemical user by compensating the service of the chemical rather than the chemical volume sold and used.” The report presents a review of the literature on the economic features of chemical leasing and of similar business models, focusing on the drivers and barriers and comparing their functioning to traditional contracts. The report provides:

  • An overview of the potential market of chemical leasing and examples of practical implementation;

  • A description of the stakeholders involved;

  • A description of the costs and benefits, drivers, and barriers of implementing the model;

  • An analysis of the functioning of chemical leasing versus traditional contracts; and

  •  Proposed initiatives that could be undertaken to facilitate the take-up of the model.

TAIWAN

Taiwan EPA Begins Consultation Period On Proposed TCSCA Revisions: The Taiwan Environmental Protection Administration (Taiwan EPA) has begun a public consultation on proposed changes to the Toxic Chemical Substance Control Act (TCSCA). Changes include:

  • Coordinating central and local government agencies by establishing a national chemical regulation advisory reporting system;

  • Removing Class 4 toxic chemical substances (substances deemed to endanger human health or the environment);

  • Introducing a “chemical substances for investigation” category;

  • Generating a chemical substances regulation fund to introduce new regulatory fees; and

  • Provisions to improve emergency response procedures for toxic chemical incidents.

Comments on the proposed revisions are due June 16, 2017.

© 2017 The Acta Group All Rights Reserved

TRENDING LEGAL ANALYSIS


About this Author

The Acta Group (Acta®) is the consulting affiliate of Bergeson & Campbell, P.C. (B&C®), established to complement B&C’s legal services by providing a full-range of support for the process of marketing chemicals, biocides, and products of industrial biotechnology, nanotechnology, and synthetic biology. Acta knows that clients must function optimally in all jurisdictions in which they market and/or place products to remain competitive. We help them get there through our global reach....

202-557-3801