International Issues

J. Brian Xu, Jane S. Vergnes, and Carla N. Hutton, "China Drafts Changes to Chemical Registration Rules," Bloomberg Environment Insights, July 29, 2019.

Manufacturers and importers should weigh in on China’s planned changes to registration requirements for new chemical substances, write Brian Xu and Jane Vergnes of The Acta Group, and Carla Hutton of Bergeson & Campbell.

Zameer Qureshi, "EU REACH: how’s life after the Registration deadlines?," Elements, the Magazine of Chemicals Northwest,, Spring 2019.

The registration deadlines for pre-registered “phase-in” chemical substances under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation presented for the chemicals industry a wide range of demanding tasks requiring substantial expertise from scientists, consultants, lawyers, and others. The transitional phase of REACH ended on 31 May 2018, and companies of all shapes and sizes are now engaged in a wide range of ongoing compliance activities. This column addresses certain important REACH-related activities being undertaken by numerous entitites in the ongoing post-deadline era, and provides comments on their significance. 

Lynn L. Bergeson, "Chemical Compliance: Get Ready for South Korean Deadline," Chemical Processing, May 17, 2019.

Global chemical substance notification deadlines continue to populate the regulatory horizon. For companies active in worldwide markets, it’s crucial to review and meet all important notification and registration deadlines in each country. This article focuses on South Korea’s policy and explains why it’s essential to meet these deadlines.

Cheryl B. Cleveland, Carrie R. Fleming, Jason E. Johnston, Angela S. Klemens, and Bruce M. Young, "Benchmarking the Current Codex Alimentarius International Estimated Short-Term Intake Equations and the Proposed New Equations," Journal of Agricultural and Food Chemistry, March 14, 2019.

The International Estimated Short-Term Intake IESTI equations are used during the establishment of Codex Maximum Residue Limits. A recent proposal to revise the equations sparked international debate regarding selection of residue inputs and the appropriate level of consumer protection. The 49th Codex Committee on Pesticide Residues meeting recommended benchmarking the IESTI equations against distributions of actual exposures. Using publicly available data and models, this work compares dietary exposures for strawberries, tomatoes, and apples at five levels of refinement to place these equations into context relative to real-world exposures. Case studies were based on availability of robust USDA PDP monitoring data, which is uniquely suited to refine dietary exposures for a population. Benchmarking dietary exposure involves several decision points. Alternate methodology choices are not expected to impact the large margins observed between the probabilistic estimates and the IESTI equations or to change the overall conclusion that existing IESTI equations are conservative and health-protective.

Zameer Qureshi, "Brexit: REACHing Compliance Goals Under Evolving Circumstances," Elements, the Magazine of Chemicals Northwest, Winter 2018.

Brexit is a moving target from a political viewpoint, but many matters for regulatory compliance and product stewardship teams globally appear clearer than before. This article suggests timely REACH compliance strategies companies should adopt and implement that account for wide-ranging Brexit repercussions.

Lynn L. Bergeson, "The Trump Administration and global chemical issues," Elements, the Magazine of Chemicals Northwest, Summer 2018.

This article reviews the Trump Administration’s engagement, to date, in key industrial chemical matters, domestically and internationally.  Topics include the Toxic Substances Control Act (TSCA), the UN’s Strategic Approach to International Chemicals Management (SAICM) and 2030 Agenda for Sustainable Development, and Ratification of the Stockholm Convention on Persistent Organic Pollutants.

Lynn L. Bergeson, "The New Administration and International Chemical Issues," Environmental Quality Management, Volume 27, Issue 4, Summer 2018.

As a candidate and now as president, President Trump has been uncharacteristically predictable in systematically dismantling signature environmental policies of prior administrations and ceding the United States’ leadership in combating climate change to other global powers. The administration’s industrial chemicals management policy has been less transparent and predictable, however. Some may have interpreted candidate Trump’s notable silence on the campaign trail as support for Toxic Substances Control Act (TSCA) reform, given the broad bipartisan support it enjoyed before its enactment on June 22, 2016. Others may have assumed that candidate Trump was simply unaware of the enactment of the most sweeping legislative changes to our domestic chemical management law in four decades and the significant commercial, legal, and trade implications occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). President Trump has kept his TSCA cards close to his vest, and the administration’s broader engagement in chemicals management on the world stage is similarly unclear. Some trends can be discerned, or at least inferred, as discussed in this article.

J. Brian Xu, M.D., Ph.D., DABT® and Scott J. Burya, Ph.D., "FCM regulations in China and the US - a comparison," CW+ AsiaHub, July 18, 2018.

While the intention of food contact regulations in both China and the US is to protect public health, the approaches taken, the obligations for industry and other facets of the regulations differ in notable ways. This article overviews the two regulatory systems, highlighting key similarities and differences between the emerging regulatory regime in China and the established US Food and Drug Administration (FDA) food contact regulations. 

Lynn L. Bergeson, "EFSA Publishes New Guidance on Nanotechnologies in Food and Feed," Nanotechnology Now, July 5, 2018.

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011. 

Zameer Qureshi, "Brexit: An examination of key developments and their potential influence on European chemical laws," Environmental Law & Management, Volume 29, Issue 4, 2017.

On 23 June 2016, more than 30 million people voted in a referendum to decide whether the United Kingdom (UK) should ‘Leave’ or ‘Remain’ in the European Union (EU). The referendum turnout was 71.8 per cent and the Leave campaign won by 52 per cent to 48 per cent, making ‘Brexit’ an important and imminent probability, with potentially substantial implications for a range of stakeholders, including the chemicals industry.

Between then and now, there have been significant developments in case law and statute, culminating in the triggering of Article 50 of the Lisbon Treaty and the issuing of a White Paper setting out the UK’s strategy for repealing the European Communities Act 1972 (ECA 1972) and ending the supremacy of EU law. The Brexit process and potential outcomes, including ‘knowns and unknowns’, are subject to change and are evolving at an exceptionally rapid pace, and will likely continue to do so. Terminology utilised for important documents and events has changed since the start of the Brexit story in June 2016. Many Brexit-related issues depend significantly or entirely on outcomes of political negotiations, and making any predictions has become a challenging endeavour. The global chemicals industry is well advised, as part of an effort to support regulatory and legal compliance, to monitor regularly news and consultations regarding Brexit

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