China has significantly changed how foreign chemical manufacturers can obtain market access for new chemical substances. Effective August 15, 2026, foreign enterprises are no longer being accepted as applicants for new chemical substance environmental management registrations. The previous arrangement—under which an overseas manufacturer or trading company could apply through a designated Chinese agent—is being replaced…
U.S. Environmental Protection Agency (EPA) is advancing its review of ethylene dibromide under the Toxic Substances Control Act (TSCA) by releasing its draft risk evaluation. Ethylene dibromide is primarily used in fuels and related products as a lead scavenger in leaded aviation gasoline and in certain industrial and commercial applications. EPA evaluated potential risks across…
On August 11, 2026, the U.S. Food and Drug Administration published a proposed rule that would fundamentally change how companies use the Generally Recognized as Safe—or GRAS—pathway for substances added to human and animal food. Under the proposal, companies generally would be required to notify FDA when introducing a substance into interstate commerce based on…
The Occupational Safety and Health Administration’s updated Hazard Communication Standard is no longer a distant regulatory development. The first major compliance deadline has passed, and additional deadlines affecting workplace labels, safety data sheets, hazard communication programs, and employee training are approaching. OSHA published the updated Hazard Communication Standard, commonly called HCS 2024, on May 20,…
U.S. Environmental Protection Agency (EPA) is advancing its review of a widely used solvent, 1,1,2-trichloroethane, under the Toxic Substances Control Act (TSCA) by releasing its draft risk evaluation. 1,1,2‑Trichloroethane is a colorless liquid used mainly in industry as a solvent and as a building block to make other chemicals. Because it can evaporate into air…
An instructional video has been added to provide step-by-step guidance on applying the Expanded Decision Tree for food chemical toxicity screening. If not evaluated or used properly, some chemicals in food may have toxic properties that could pose a risk to human health. The FDA helps to safeguard the food supply by evaluating the safe…
FDA’s Cosmetics News FDA Finds Six Additional Cosmetic Products Marketed as Gel Nail Polish Remover To Contain Methylene Chloride The U.S. Food and Drug Administration (FDA) has discovered through testing that six additional cosmetic products marketed as gel nail polish remover contain methylene chloride, a prohibited ingredient in cosmetics. The testing is part of the…
U.S. Environmental Protection Agency (EPA) is advancing its review of four chemicals under the Toxic Substances Control Act (TSCA)—1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB), phthalic anhydride, o-dichlorobenzene (oDCB) and p-dichlorobenzene (pDCB)—by releasing draft documents related to the review of these chemicals and convening a peer review meeting of the Science Advisory Committee on Chemicals (SACC). These chemicals are…
For non-EU chemical manufacturers and formulators selling into Europe, an Only Representative under EU REACH can be an effective way to simplify compliance and support continued market access. An Only Representative is an EU-based entity appointed to handle certain REACH obligations on behalf of a non-EU company. This can be especially useful when a business…
For non-EU chemical manufacturers, formulators, and exporters, understanding the role of an Only Representative under EU REACH is essential for maintaining access to the European market. If your company places chemical substances, mixtures, or certain articles into the EU, appointing an EU REACH Only Representative can help centralize compliance, reduce importer burden, and improve supply…
cGMP Audit: Why It Matters for Quality and Compliance A cGMP audit is one of the most important tools for evaluating whether a company’s quality systems, manufacturing processes, and documentation practices meet current Good Manufacturing Practice requirements. In regulated industries such as pharmaceuticals, biotechnology, medical devices, dietary supplements, and cosmetics, cGMP audits help identify compliance…
December 31, 2025 Contact Information EPA Press Office (press@epa.gov) WASHINGTON – U.S. Environmental Protection Agency (EPA) announced today that it will move to regulate dozens of applications of five widely used phthalate chemicals to address environmental and workplace risks. This decision is based on final risk evaluations, released today, for each of these chemicals: Butyl Benzyl Phthalate (BBP),…
December 31, 2025 Contact Information EPA Press Office (press@epa.gov) WASHINGTON – In compliance with a court ordered deadline, U.S. Environmental Protection Agency (EPA) completed a robust review of 1,3-butadiene using gold standard science. We used the best research, data, and testing available, along with input from the public and independent expert peer reviewers to complete this thorough…
Featured image republished from FDA news release. Today, the U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. While the report reviews available scientific evidence on potential safety concerns, the FDA’s…
Occupational exposure assessment is a cornerstone of occupational and environmental health. It provides the evidence needed to understand how workers come into contact with hazardous agents and guides decisions that protect health, improve workplace safety, and ensure regulatory compliance. Whether addressing chemical, physical, or biological hazards, exposure assessment transforms workplace observations into actionable data. What…
Under EU REACH, data submitted more than 12 years ago is no longer protected by compensation provisions, meaning new registrants may no longer be required to negotiate or pay data-sharing fees to the original data owners for the data that makes up many of the REACH registrations. Once this protection period expires, the data effectively…
Safety Data Sheets (SDSs) are often associated with industrial chemicals, manufacturing environments, or laboratory operations—but they play an equally critical role in the pharmaceutical sector. From active pharmaceutical ingredients (APIs) to excipients and intermediates, properly authored SDSs help protect workers, ensure regulatory compliance, and strengthen product stewardship throughout the drug-development lifecycle. In an industry where…
Safety Data Sheets (SDSs) play a critical role in chemical hazard communication. But if your organization manufactures, formulates, or distributes chemicals across multiple regions, you already know that SDS requirements are not the same everywhere. The U.S., EU, and UK each maintain their own regulatory frameworks—aligned in some ways, yet different enough to cause compliance…
Understanding the Role of an Only Representative under EU REACH The European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation is one of the most comprehensive chemical regulatory frameworks in the world. Designed to protect human health and the environment, EU REACH places strict requirements on companies manufacturing or importing substances…
Today, U.S. Environmental Protection Agency (EPA) released a proposal to improve the scope of its perfluoroalkyl and polyfluoroalkyl substances (PFAS) reporting regulations under the Toxic Substances Control Act (TSCA) to make them more practical and implementable and reduce unnecessary, or potentially duplicative, reporting requirements for businesses while maintaining the ability to obtain important use and…
When the United Kingdom left the European Union, it brought significant regulatory changes—especially for the chemical industry. With UK REACH now operating as an independent system, companies manufacturing or supplying substances to the UK market must ensure compliance under this separate regime. For non-UK manufacturers, one of the most effective ways to remain compliant is…
Accurate SDS Authoring: The Foundation of Chemical Safety A Safety Data Sheet (SDS) is more than a regulatory requirement — it’s a critical communication tool that protects workers, consumers, and the environment. Yet, many companies struggle to maintain fully compliant, up-to-date SDS documentation. At Experien Health Sciences, we’ve reviewed thousands of SDSs across industries and…
Why Toxicology Matters in Chemical Safety Documentation Behind every well-authored Safety Data Sheet (SDS) lies a foundation of accurate and scientifically sound toxicology data. This data provides the critical link between a chemical’s properties and the potential risks it poses to human health and the environment. At Experien Health Sciences, toxicology isn’t just a checkbox…
A New Era in Chemical Safety The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) revolutionized the way the world communicates about chemical hazards. Before GHS, safety data and hazard communication varied dramatically between countries—creating confusion, inefficiency, and safety risks. Today, GHS has become the universal framework that underpins chemical safety documentation, labeling,…
Understanding the Evolution of Safety Documentation If you’ve worked with chemicals, pharmaceuticals, or industrial materials, you’ve likely come across both MSDS and SDS. These acronyms represent two generations of safety documentation that help communicate crucial information about chemical products. But what’s the difference between an MSDS (Material Safety Data Sheet) and an SDS (Safety Data…
The U.S. Environmental Protection Agency (EPA) is opening a 30-day public comment period on its 2024 final risk management rule for perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). This is the first step in EPA’s efforts to reconsider and, if appropriate, revise the final risk management rule. This review is being done in…
Today, the U.S. Environmental Protection Agency (EPA) released its final risk evaluation for 1,1-dichloroethane conducted under the Toxic Substances Control Act (TSCA). EPA determined that 1,1-dichloroethane presents an unreasonable risk of injury to human health driven by three conditions of use (COUs). EPA did not identify exposures to the general population, or to the environment,…
EPA Proposes Temporary Relief to Ensure Lab Compliance with Methylene Chloride Regulations under TSCA The U.S. Environmental Protection Agency (EPA) is proposing to extend various upcoming compliance dates in the final risk management rule for methylene chloride under the Toxic Substances Control Act (TSCA) in order to ensure long-term compliance with the rule’s requirements. The…
The U.S. Environmental Protection Agency (EPA) has released new resources to help companies with the requirements described in the December 2024 final rule governing the review of new chemicals under the Toxic Substances Control Act (TSCA). The new materials provide companies with clear instructions on how to include required data elements in the current system…
The US EPA’s recent changes to the information that must be submitted under TSCA Section 5, including information required in a Premanufacture Notice (PMN), are intended to help ensure that EPA is provided with the best available information on which to base its risk assessment. These changes extend to EPA’s CDX system, which is used…
Today, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for formaldehyde conducted under the Toxic Substances Control Act (TSCA). EPA has determined that formaldehyde presents an unreasonable risk of injury to human health, specifically to workers and consumers, under its conditions of use (COUs). Formaldehyde is found nearly everywhere. People and animals…
Brazil’s chemical inventory and chemicals management legislation is headed for President Lula’s signature. Once signed into law, Brazil will be among other developed countries that closely regulate which chemical substances can be manufactured or imported in Brazil and which companies are authorized to do so. While referred to by some as “Brazil REACH”, there are…
WASHINGTON – Today, Oct. 9, the U.S. Environmental Protection Agency issued the fifth Toxic Substances Control Act (TSCA) Test Order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy, the latest action taken under EPA’s PFAS Strategic Roadmap to confront contamination from “forever chemicals” nationwide. This action orders Innovative Chemical Technologies, The Chemours Company,…
Improves quality of information on labels, safety data sheets; takes effect July 19, 2024 WASHINGTON – The Department of Labor today announced a final rule from its Occupational Safety and Health Administration that will update the current Hazard Communication Standard to better protect workers by improving the amount and quality of information on labels and…
Today, the U.S. Environmental Protection Agency (EPA) issued the Fiscal Year (FY) 2023 Pesticide Registration Improvement Act (PRIA) Annual Report, the first one published since PRIA 5 was authorized in 2022. This report describes EPA’s implementation of PRIA 5 including: tracking and status for EPA’s review of pesticide registration actions, registration review cases, process improvements…
The Cosmetic Ingredient Hotlist has been updated and is now available. An overview of these changes can be found on the Changes to the Cosmetic Ingredient Hotlist webpage. Certain updates to entries included in the proposed changes are currently undergoing additional consultation, as indicated in a previous email to Cosmetics Mailing List subscribers. Future updates…
The U.S. Environmental Protection agency is requesting feedback on its plan to adopt digital pesticide labels that will make labeling information clearer, more consistent, and more accessible to users. The Agency is specifically requesting feedback on the proposed organization of digital labels and the proposed phases of developing these labels. EPA’s plan for digital labels…
Source: The National Review by: Lynn L. Bergeson , Carla N. Hutton of Bergeson & Campbell, P.C. – Toxic Substances Control Act Blog On October 2, 2023, the U.S. Environmental Protection Agency (EPA) announced 30 Safer Choice Partner of the Year award winners, recognizing their achievements in the design, manufacture, and the selection and use…
The U.S. Environmental Protection Agency (EPA) announced that it is beginning the process to prioritize five additional toxic chemicals for risk evaluation under the nation’s premier chemical safety law. If, during the 12-month long statutory process, EPA designates these five chemicals as High Priority Substances, EPA will then begin risk evaluations for these chemicals. EPA…
The U.S. Environmental Protection Agency (EPA) released a proposed rule to further protect people from exposure to two chemicals that are toxic, remain in the environment for long periods of time, and accumulate in the body. Both decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)) are persistent, bioaccumulative and toxic (PBT) chemicals that…
EPA released the meeting minutes and final report from the September 12-14, 2023, Science Advisory Committee on Chemicals (SACC) virtual public meeting regarding the Draft Supplement to the Risk Evaluation for 1,4-Dioxane. 1,4-Dioxane was one of the first 10 chemicals to undergo risk evaluations under the amended Toxic Substances Control Act (TSCA). The risk evaluation…