New Approach Methodologies (NAMs)
Non-animal testing methods for chemical safety assessment including in vitro, in silico, and computational approaches to replace, reduce, and refine animal testing.
Foresight tracks New Approach Methodologies (NAMs) developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.
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Last updated
9 April 2026, 07:30
Latest New Approach Methodologies (NAMs) alerts
The most recent regulatory and guidance signals tracked by Foresight
EU-Focused Perspective Calls for P-NAMs to Modernise Chemical Persistence Assessment
Regulators and scientists are advocating for Persistence New Approach Methodologies (P-NAMs) to address critical data gaps in chemical persistence assessments under REACH and CLP. This shift signals a transition toward high-throughput and in silico testing, likely redefining PBT/PMT determinations and data requirements for Safe and Sustainable by Design (SSbD) innovation.
European UnionNetherlands Bureau REACH Publishes 2025 REACH/CLP Activity Overview
The Netherlands Bureau REACH 2025 overview details significant progress on REACH restrictions, CLP hazard classifications, and occupational exposure limits for priority substances. These Dutch-led dossiers often drive broader EU-level regulatory shifts, providing an early warning for upcoming changes to substance restrictions and harmonized classification requirements.
NetherlandsEuropean UnionEU JRC Publishes 2025 EURL ECVAM Status Report on Non-Animal Methods and Previews 2026 Animal-Testing Phase-Out Roadmap
The EU JRC has released its 2025 status report on non-animal methods, serving as the evidence base for a 2026 roadmap to phase out animal testing. Businesses should prepare for a shift in regulatory data requirements as the EU accelerates the integration of alternative methods into chemical and product safety assessments.
European UnionECHA Schedules 2026 Science Seminar, IUCLID 6 Webinar and Drinking Water Directive Workshops
ECHA has announced its 2026 technical schedule, highlighting the IUCLID 6 version 10 release and implementation workshops for the Drinking Water Directive. Stakeholders must prepare for updated data submission formats and the operationalization of the European positive list for materials in contact with drinking water.
European UnionECHA Opens REACH Testing Proposal Consultation On Dibutyl Maleate
ECHA has initiated a REACH testing proposal consultation for dibutyl maleate regarding long-term fish toxicity, with a deadline of May 8, 2026. Stakeholders should assess existing data to avoid redundant vertebrate testing and anticipate potential impacts on environmental hazard classifications.
European UnionEU Proposes Major Overhaul of MDR/IVDR to Cut Burdens and Protect Device Availability
The European Commission has proposed a major overhaul of the MDR and IVDR frameworks to simplify compliance and prevent supply shortages, with adoption expected by mid-2027. This shift toward open-ended certification and risk-based surveillance offers significant operational relief for manufacturers but requires careful navigation of emerging digital and cybersecurity reporting obligations.
European Union
United KingdomOPSS Publishes Areas Of Research Interest For UK Product Safety
The UK Office for Product Safety and Standards (OPSS) has published its strategic research priorities to strengthen the national product safety framework. Businesses should anticipate future regulatory shifts in chemical risk assessment, battery safety, and online marketplace oversight as this evidence base matures.
United KingdomEFSA Develops Adverse Outcome Pathway Network for Reproductive Toxicity to Support Endocrine Disruptor Identification
EFSA published a new toxicological framework in March 2026 to standardize endocrine disruptor identification under EU biocides and pesticides regulations. This signals a shift toward mechanistic data and New Approach Methodologies (NAMs), increasing the technical requirements for demonstrating substance safety in reproductive toxicity assessments.
European UnionUK Government to Expand NC3Rs Gateway on F1000Research for Non-Animal Methods by End 2026
The UK government has confirmed the expansion of the NC3Rs Gateway by the end of 2026 to provide all researchers access to non-animal testing methodologies. This move strengthens the infrastructure for New Approach Methodologies (NAMs), supporting the strategic transition away from animal testing in regulatory compliance and R&D.
United KingdomNetherlands Parliament Debates Motions on Animal Testing, BPRC Funding and TPI
The Dutch government has signaled its intent to secure alternative funding for primate research beyond 2030 while advancing the national transition to animal-free innovation. Companies in the life sciences and chemicals sectors should monitor the shift toward New Approach Methodologies (NAMs) as the Netherlands aligns research infrastructure with evolving animal welfare priorities.
NetherlandsUK MHRA Sets Out Approach To Medicines Using Non-Animal Methods
The UK MHRA has introduced a formal framework and a 2026 pre-review mechanism to facilitate the use of non-animal testing methods (NAMs) in medicines regulation. This provides a clear pathway for developers to de-risk animal-free evidence packages, signaling a long-term regulatory pivot that prioritizes scientific justification over traditional animal-based testing protocols.
United KingdomRIVM Researchers Publish Review on Epigenotoxicity and Regulatory Genetic Toxicology
RIVM and international experts have published a consensus review proposing the integration of epigenotoxicity data into standard regulatory genetic toxicology frameworks. This signals a long-term shift toward more sensitive testing requirements that could identify non-genotoxic carcinogens and transgenerational risks currently missed by standard assays.
NetherlandsUS NIH Invests Over $150 Million in Human-Based NAMs to Reduce Animal Testing
The US NIH has launched a $150 million initiative to accelerate the development and regulatory validation of human-based New Approach Methodologies (NAMs) to replace animal testing. This investment signals a strategic shift in US regulatory science, likely leading to new standardized non-animal protocols for chemical and pharmaceutical safety assessments.
United StatesUS EPA To Highlight NAMs and 2035 Animal-Testing Target at 2026 SOT Annual Meeting
The US EPA is reinforcing its commitment to phase out mammalian animal testing by 2035, prioritizing New Approach Methods (NAMs) for chemical risk assessments. This transition signals a long-term shift in regulatory data expectations, requiring industry to adapt testing strategies for future chemical evaluations and TSCA compliance.
United StatesWisconsin AB1185 Proposes Ban on Cosmetic Animal Testing and Sale of Animal-Tested Cosmetics
Wisconsin has introduced legislation to ban cosmetic animal testing and the sale of animal-tested products, with prohibitions proposed to take effect starting January 2027. If enacted, manufacturers must ensure supply chain compliance and alternative safety substantiation to maintain market access in Wisconsin, aligning the state with a growing number of US jurisdictions restricting animal-tested ingredients.
United StatesUS FDA Issues Draft Guidance on Use of New Approach Methodologies in Drug Development
The US FDA has issued draft guidance establishing a validation framework for New Approach Methodologies (NAMs) to modernize safety assessments in drug development. This signals a regulatory transition toward non-animal testing, requiring sponsors to align validation and reporting protocols with FDA evidentiary standards to ensure regulatory acceptance.
United StatesUS FDA Issues Draft Guidance On New Approach Methodologies In Drug Development
The US FDA has released draft guidance establishing a validation framework for using New Approach Methodologies (NAMs) as alternatives to animal testing in drug development and OTC monograph submissions. This move signals a strategic shift toward human-biology-based testing, offering a pathway to reduce animal data reliance provided that "fit-for-purpose" validation meets regulatory standards.
United StatesUS FDA Requests Comments Ahead of ICCR-20 Cosmetics Regulation Meeting
The US FDA is soliciting stakeholder input by May 17, 2026, to shape the agenda for the ICCR-20 meeting on global cosmetics regulatory convergence. This provides a critical window for industry to influence international alignment on non-animal testing methods, digital labeling standards, and safety assessment frameworks.
United StatesEU SCCS Methodologies Working Group Minutes Highlight Aggregate Exposure and Notes of Guidance Revision
The SCCS is progressing on a harmonised aggregate exposure framework and the 13th revision of its Notes of Guidance for cosmetic safety. Manufacturers should anticipate more complex exposure modeling requirements and updated toxicological assessment protocols for future product dossiers.
European UnionUS HHS, USDA And EPA Announce Over $1 Billion Investments To Modernise Farming And Reduce Pesticide Use
US federal agencies have committed over $1 billion to modernize farming and accelerate the transition away from chemical pesticides under the "Make America Healthy Again" (MAHA) agenda. This initiative signals a strategic shift toward regenerative agriculture and non-chemical weed control, likely driving future regulatory restrictions on traditional pesticides and incentivizing biological alternatives.
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