News & Analysis as of

REACH

Foley & Lardner LLP

Risk Bearing Entity Requirements: An Introduction

Foley & Lardner LLP on

Providers and provider organizations are increasingly contracting with payors to manage specific patient pools and diseases on a risk basis. They are taking new and increasing financial risk to better align with payors’...more

Bergeson & Campbell, P.C.

RAC and SEAC Will Continue to Evaluate Proposed PFAS Restriction in 2025

According to the European Chemicals Agency’s (ECHA) September 2024 summary of the current status of the scientific evaluation of the proposal to restrict per- and polyfluoroalkyl substances (PFAS), ECHA’s Scientific...more

McDermott+

CMMI’s Accountable Care Strategy: A Perspective

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. October 10, 2024 – For several years, the Center for Medicare & Medicaid...more

Bergeson & Campbell, P.C.

EC Adopts REACH Restriction for PFHxA and Related Substances

The European Commission (EC) announced on September 19, 2024, that it adopted new measures under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation to protect human health and the...more

Bergeson & Campbell, P.C.

Defra Consults on Proposal to Amend UK REACH Use and Exposure Information Requirements

On May 16, 2024, the United Kingdom’s (UK) Department for Environment, Food and Rural Affairs (Defra) began a public consultation on the UK government’s proposals to amend the current transitional provisions under UK REACH...more

Bergeson & Campbell, P.C.

UBA Concludes REACH Evaluation of Environmental Aspects of Nano Zinc Oxide

On April 29, 2024, the German Environment Agency (UBA) posted an item entitled “ZnO nanoforms – REACH substance evaluation: environmental aspects.” The Federal Office for Chemicals, the Federal Institute for Risk Assessment...more

Bergeson & Campbell, P.C.

Germany Posts Information on Dossier Submitter’s Ongoing Role in Proposed REACH Restriction for PFAS

On April 15, 2024, Germany’s Federal Institute for Occupational Safety and Health (BAuA) REACH-CLP-Biozid Helpdesk published an item entitled “Dossier Submitter’s ongoing role in the PFAS restriction proposal.” While the...more

Bergeson & Campbell, P.C.

ECHA Checks More than 20 Percent of REACH Registration Dossiers for Compliance

The European Chemicals Agency (ECHA) announced on February 27, 2024, that between 2009 and 2023, it performed compliance checks of approximately 15,000 Registration, Evaluation, Authorisation and Restriction of Chemicals...more

Bergeson & Campbell, P.C.

ECHA Clarifies Next Steps for PFAS Restriction Proposal

The European Chemicals Agency (ECHA) issued a press release on March 13, 2024, to outline how the Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will progress in evaluating the proposal...more

Bergeson & Campbell, P.C.

ECHA Begins Public Consultation on Recommending Authorization for Five SVHCs and Adding a New Hazard to DBP

The European Chemicals Agency (ECHA) announced on February 7, 2024, that it is considering recommending the following substances for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)...more

McDermott Will & Emery

EU Carbon Border Adjustment Mechanism: Reporting Deadlines Approaching

McDermott Will & Emery on

By 31 January 2024, as part of the Carbon Border Adjustment Mechanism, importers of cement, iron and steel, aluminium, fertilisers and hydrogen must report to the European Commission the embedded carbon emissions relating to...more

Bergeson & Campbell, P.C.

EU Academy Offers Free Online Course on Nanomaterials in EU Legislation

The EU Academy, an online hub owned by the European Union (EU), is offering an online course on how EU legislation addresses nanomaterials. The target audience includes...more

Sheppard Mullin Richter & Hampton LLP

CMS Announces Changes to ACO REACH Model

On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) released guidance on changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance...more

BCLP

U.S. Healthcare and Life Sciences Alert: CMS Updates ACO REACH Program to Encourage Increased Participation

BCLP on

This August, the Centers for Medicare and Medicaid Services (CMS) announced multiple changes (to take effective in performance year 2024)  to one of its alternative payment models, the Accountable Care Organization Realizing...more

Bergeson & Campbell, P.C.

ANSES Calls for the EC to Adopt a “More Protective” Definition of Nanomaterials

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) issued a May 17, 2023, news item stating that it believes that the European Commission’s (EC) revised Recommendation on the definition of...more

Bergeson & Campbell, P.C.

UK Calls for Evidence to Support RMOA for Formaldehyde and Formaldehyde Releasers

The United Kingdom’s (UK) Health and Safety Executive (HSE) issued a call for evidence on April 26, 2023, to gather information and evidence that will support HSE and the UK Health and Security Agency (UKHSA) with the...more

Bergeson & Campbell, P.C.

EC Implements New Hazard Classes to CLP

On April 20, 2023, the European Commission (EC) announced the implementation dates for the introduction of new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labelling, and...more

J.S. Held

Crosscurrents: EU REACH, EMA & Product Stewardship for Sustainability

J.S. Held on

Meta description: Learn more about possible ways to leverage the EU’s REACH and EMA regulations for product stewardship and reaching sustainability goals. Product Stewardship as a Leverage for Sustainability Goals...more

Bergeson & Campbell, P.C.

ECHA Convenes Online Information Session Regarding the Proposal to Restrict More than 10,000 PFAS under REACH

On April 5, 2023, the European Chemicals Agency (ECHA) convened an online information session as part of the consultation period regarding the proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS)...more

Bergeson & Campbell, P.C.

ECHA Publishes Proposal to Restrict More Than 10,000 PFAS under REACH

On February 7, 2023, the European Chemicals Agency (ECHA) announced the availability of a much anticipated detailed proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration,...more

Mintz - Health Care Viewpoints

CMS Issues Additional Flexibilities to the ACO REACH Model’s Benefit Enhancements

As Accountable Care Organizations (ACOs) and providers gear up for the start of the new ACO REACH Model in 2023, CMS recently issued helpful policy updates to the model’s benefit enhancements (BEs). Under BEs, CMS waives...more

Hogan Lovells

Spotlight on REACH Regulation

Hogan Lovells on

Manufacturers, importers, and users of chemicals often operate across borders, sourcing, and supplying their products across EU borders and operating with chemical substances in many different locations around the world. For...more

Bergeson & Campbell, P.C.

EC Opens Call for Evidence on a Proposal for a Basic Regulation for ECHA

On September 12, 2022, the European Commission (EC) opened a call for evidence on a proposal for a basic regulation for the European Chemicals Agency (ECHA). According to the EC, this initiative aims to strengthen ECHA...more

Nelson Mullins Riley & Scarborough LLP

The Importance of Carefully Drafted ACO REACH Agreements

The Centers for Medicare & Medicaid Services (“CMS”) recently announced that 124 applicants have been provisionally approved to participate in the new Accountable Care Organization Realizing Equity, Access, and Community...more

Bergeson & Campbell, P.C.

Defra Begins Public Consultation on Extending the UK REACH Transitional Registration Deadlines

The Department for Environment, Food and Rural Affairs (Defra) has begun a public consultation on extending the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) submission deadlines for...more

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