The Chinese Ministry of Emergency Management (MEM) released the “Law on Safety of Hazardous Chemicals (Draft for Consultation)” (LSHC) on October 2, 2020, to replace the “Regulations on Safe Management of Hazardous Chemicals” (Decree No. 591). The deadline to submit comments to MEM regarding the LSHC is November 1, 2020. Comments can be submitted to MEM via e-mail (yjbzfs@163.com). What Is New? The draft LSHC was first introduced in 2017. This draft revision will replace the...
Category: International
On October 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse effects. This new draft guidance is part of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by...
September 30, 2020
EC Begins Public Consultation on Inception Impact Assessment for “Sustainable Products Initiative”
The European Commission (EC) began a public consultation on September 14, 2020, on the Inception Impact Assessment (Assessment) for a directive on the “Sustainable Products Initiative” (Initiative). According to the EC, this Initiative, which will revise the Ecodesign Directive and propose additional legislative measures as appropriate, intends to make products placed on the European Union (EU) market more sustainable. The EC states that consumers, the environment, and the climate...
September 29, 2020
EAASM Report on Patient Safety and Nanomedicines Calls for Centralized Regulatory Procedure
On September 17, 2020, the European Alliance for Access to Safe Medicines (EAASM) announced the availability of a report entitled Patient Safety and Nanomedicines: The need for a centralised regulatory procedure. According to EAASM, “[n]anomedicines and their follow-on products, also referred to as nanosimilars, are complex molecules and so regulatory oversight must be scientifically fit for purpose.” The report makes three key recommendations intended to...
September 16, 2020
China Tariffs: Court of International Trade Lawsuit Challenges Section 301 Tariffs
A recent legal challenge may be of interest to some of our clients. The challenge involves a case filed in the U.S. Court of International Trade (CIT) challenging President Trump’s authority to impose supplemental tariffs on goods from China identified on Lists 3 and 4A and seeking refunds. As our clients know well, some pesticides and cleaning products are listed on List 3 and thus subject to 25% China tariffs. There are two prongs to the argument....
September 3, 2020
ECHA Publishes Final Evaluation of MWCNTs, Synthetic Graphite in Tubular Shape and Tangled
The European Chemicals Agency (ECHA) has posted the German Federal Institute for Occupational Safety and Health’s (BAuA) substance evaluation conclusion document for multi-walled carbon nanotubes (MWCNT), synthetic graphite in tubular shape and tangled. The conclusion provides a summary of how the information on the substance can be used for the purposes of regulatory risk management. Concern(s) Subject to Evaluation MWCNTs were originally selected for substance evaluation to...
September 1, 2020
EUON Publishes Nanopinion on Nanosilver in Healthcare
On August 31, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanosilver in healthcare — does the silver bullet exist?” by Dr. Dorota Napierska, Chemicals Policy and Projects Officer, Health Care Without Harm Europe (HCWH Europe). Napierska examines how beneficial the properties of nanosilver are in clinical settings and the risks involved. Napierska notes that a key point in assessing the toxicity of nanosilver is to adopt...
August 21, 2020
Comments on GRACIOUS Framework Due August 31
The European Union’s (EU) Horizon 2020 project GRACIOUS has launched its stakeholder engagement platform and started an open consultation on the GRACIOUS Framework. The GRACIOUS project invites stakeholders from industry, regulators, policy makers, consultants, non-governmental organizations (NGO), and academia to use the platform to provide their opinions on the progress within the project, including whether the structure of the GRACIOUS Framework is “clear and...
August 20, 2020
China Publishes Draft Guidance for Environmental Management Registration of New Chemical Substances
The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12) on April 29, 2020, which will replace the current MEP Order No. 7 on January 1, 2021. To implement MEE Order No. 12, the MEE released the “Guidance for Environmental Management Registration of New Chemical Substances (Draft for Consultation)” (Draft Guidance) on August 17,...
August 19, 2020
September Webinar Will Review How OECD Develops Test Guidelines
The European Union (EU)-funded projects NanoHarmony and NANOMET-Organization for Economic Cooperation and Development (OECD) have jointly organized a September 16, 2020, webinar on “The Pathway to Test Guidelines: from science to standards for nanomaterials.” Participants will learn how OECD develops Test Guidelines, using case studies from the Test Guidelines that are supported through the projects for expansion into nanomaterials. The webinar will explain how novel...