On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug, and Cosmetic Act FDCA, certain laboratory-developed tests used to diagnose, monitor, or determine treatment for diseases and conditions. The decision, American Clinical Laboratory Assoc. v. FDA, No. … Continue Reading
After what has amounted to a multi-year rulemaking process, the California Office of Environmental Health Hazard Assessment (OEHHA) finalized amendments to the short-form warnings under Proposition 65 on December 6, 2024. The amendments (outlined in full here) require that short-form warnings include at least one chemical name, along with other options for safe harbor warning. … Continue Reading
On February 28, 2024, the Food and Drug Administration (“FDA”) published a news release regarding the voluntary market phase-out of per and polyfluoroalkyl substances (PFAS) in grease-proofing substances used on food packaging. The FDA stated that the completion of this phase-out “eliminates the primary source of dietary exposure to PFAS from authorized food contact uses.”… Continue Reading
The most anticipated developments for 2024 in UK chemicals regulation are the long-awaited publication of the UK’s Chemicals Strategy, and a consultation on the UK government’s alternative transitional registration model (ATRm). In November 2023, a policy paper was issued outlining the government’s high-level plans for ATRm, but the questions and details for stakeholders are still … Continue Reading
On November 9, 2023, the FDA published notice of final guidance that delays FDA’s enforcement of some facilities’ registration and product listing compliance requirements under MOCRA to July 1, 2024. This enforcement delay applies to facilities that “engaged in manufacturing or processing of a cosmetic product” or products as of MOCRA’s enactment date (December 29, … Continue Reading
In August 2023, the FDA released draft guidance on upcoming regulatory changes pursuant to MOCRA, including guidance on cosmetic product facility registrations and product listings. MOCRA applies to any establishment that manufactures or processes cosmetics products. According to the draft guidance, the FDA is in the process of creating a new online portal for facility … Continue Reading
From October 2023, a broad range of products moving from Great Britain (GB) to Northern Ireland (NI) (and that are intended for “final consumption” in NI) will be processed through a “green lane” and be subject to fewer checks and controls. While this will ultimately facilitate movements of various products, there are implications for businesses … Continue Reading
The Environmental Law Institute will host its seventh annual Toxic Substances Control Act (TSCA) Reform conference on Thursday, June 29, 2023 from 8:00 a.m. – 5:30 p.m. ET. In this webinar, panelists will discuss challenges and accomplishments since the implementation of the 2016 Lautenberg Amendments and where the TSCA stands today. Topics will include risk … Continue Reading
With a planned launch date of 16 August 2023, the pressure is on for the Scottish government to deliver the deposit return scheme (“DRS”) for drinks containers. Despite increased scrutiny of industry readiness, Circularity Scotland (“CSL”) reaffirmed on 2 March that the scheme is on track and that producers responsible for more than 95% of … Continue Reading
In 2022, US EPA indicated that it would take a more aggressive stance on per- and polyfluoroalkyl substances (PFAS). US EPA developed a PFAS Strategic Roadmap for 2021-2024 that sets timelines by which US EPA plans to take specific actions and sets out its three main directives: 1) research PFAS exposure; 2) restrict PFAS from … Continue Reading
As interest in regulating the production and use of plastics continues to grow, users of chemicals related to plastics should take note of the newly proposed “Protecting Communities from Plastics Act,” introduced in Congress on December 1, 2022 (the Act). The Act is intended to identify potential health effects of certain plastics, limit their production, and … Continue Reading
We have been monitoring the progress China’s Ministry of Ecology and Environment (MEE) has been making on the goals set in its New Pollutant Control Action Plan, released in May 2022. One of the goals of the Plan was to release a list of key “new pollutants” for regulation and control, the categories of which … Continue Reading
A recording of PFAS, REACH and Other Chemical Regulatory Issues the second webinar in our two-part 2022 Chemicals Workshop webinar series, in partnership with the Ohio Chemistry Technology Council (OCTC), is now available. In this session, we provided an overview of the rapidly evolving landscape related to per- and polyfluoroalkyl substances (PFAS), including the proposed … Continue Reading
A recording of TSCA Developments and US EPA Updates, the first webinar in our two-part 2022 Chemicals Workshop webinar series in partnership with the Ohio Chemistry Technology Council (OCTC), is now available. In this session, we reviewed US EPA’s implementation of the Toxic Substances Control Act (TSCA), including proposed “whole chemical” determinations and other Biden … Continue Reading
On October 5, 2022, the U.S. Environmental Protection Agency (EPA) announced its intent to streamline the review process of mixed metal oxides (MMOs). MMOs are a key component in lithium-ion batteries, which are used in electric vehicles and other clean energy initiatives, including in semi-conductors, and renewable energy generation and storage, such as in solar … Continue Reading
As we noted in a prior post, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed tailored Prop 65 safe harbor warnings for THC and marijuana smoke, following listing THC for reproductive harm and marijuana smoke as cancer-causing in January 2020 (marijuana smoke was already listed for reproductive harm as of 2009). After considerable … Continue Reading
While rulemakings under the Administrative Procedure Act typically take several years from proposal to enactment, that can vary significantly. While some rules run a fairly standard course, others languish for years with no action nor any apparent reason for inaction. EPA’s recent revival of a proposed rule that is now, were it a person, old … Continue Reading
The United States Environmental Protection Agency (US EPA) continues to advance various aspects of its chemicals regulatory agenda under the Toxic Substances Control Act (TSCA). A key part of the Biden Administration’s revisions to the TSCA program is its planned new screening approach for assessing ambient air and water exposures to fenceline communities. This screening … Continue Reading
It is no secret that China has long struggled with implementing measures for pollution control and regulating hazardous chemicals. We have watched this issue closely and published about it in years past here. However, on May 24, 2022, the China State Council issued its most focused plan yet, known as the “New Pollutant Control Action … Continue Reading
There is less than a month to go before the UK’s new Calorie Labelling (Out of Home Sector) (England) Regulations 2021 (the “Regulations”) come into force (6 April 2022). The Regulations include obligations for calorie labelling for ‘non-prepacked foods’ in England, which are sold in a form suitable for ‘immediate consumption’. They will require businesses … Continue Reading
The OPSS has published details of its enforcement actions during the six months from 1 April 2021 to 30 September 2021. Actions related to product safety included orders for forfeiture and destruction, compliance notices and the issue of mandatory withdrawal and recall notices. Relevant businesses included businesses based in Great Britain, but also a significant … Continue Reading
Our European Public Policy team is pleased to share with you our monthly newsletter, Sustainability Outlook – European Union which looks at key developments in EU sustainability law and policy. This month’s edition includes the following:… Continue Reading
The consultations seek views on regulated product applications for six novel foods that have been submitted for authorisation to the FSA and on precautionary allergen labelling and precautionary allergen information, such as “may contain”, on many types of food.… Continue Reading
Our European Public Policy team is pleased to share with you our monthly newsletter, which looks at key developments in EU sustainability law and policy. This month’s edition includes the following:… Continue Reading
