One Substance, One Assessment

EU reform consolidating chemical safety assessment across agencies to eliminate duplication and ensure consistent hazard evaluation.

Foresight tracks One Substance, One Assessment 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 May 2026, 18:56

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Latest One Substance, One Assessment developments

Source-backed regulatory and guidance signals tracked by Foresight, with the newest developments first.

European Commission Conference On Animal-Free Chemical Safety Assessment Roadmap Implementation

In June 2026 the European Commission and EPAA will host a three-day conference in Brussels to advance implementation of the EU roadmap to phase out animal testing in chemical safety assessments. The event will influence how regulators and industry use safe-space dialogues, AI tools and EPAA collaboration to accelerate regulatory acceptance of non-animal methods over the next five years.

single-market-economy.ec.europa.euEuropean UnionEuropean Union

EFSA Adopts 2025 Consolidated Annual Activity Report on Chemicals Strategy and Risk Assessment Transformation

EFSA’s 2025 Consolidated Annual Activity Report, adopted in March 2026, sets out how the Authority is reshaping food and chemical risk assessment around higher throughput, structured data, and joint implementation of the EU Chemicals Strategy for Sustainability and One Substance, One Assessment. For businesses, this signals a medium-term shift toward faster but more data‑ and IT‑intensive evaluations (notably IUCLID-based dossiers, NAMs, and AI-enabled evidence workflows), reinforcing the need for high-quality submissions and proactive portfolio planning as CSS-related processes mature.

europarl.europa.euEuropean UnionEuropean Union

EFSA Issues Statement on FAIR Principles for Mechanistic Effect Models in Pesticide Environmental Risk Assessment

EFSA’s pesticides peer review working group has issued a November 2025 statement interpreting the FAIR principles for mechanistic effect models in regulatory environmental risk assessment of pesticides, setting expectations for how data, models, and assessments should be identified, documented, and shared. This guidance signals that future pesticide submissions using complex models will need stronger, standardised data stewardship and model transparency, shaping how companies, consultants, and regulators build, review, and reuse modelling work across EU risk assessments.

efsa.onlinelibrary.wiley.comEuropean UnionEuropean Union

PARC and JRC Strengthen Collaboration at Annual Meeting 2026

In February 2026, PARC and the European Commission’s Joint Research Centre agreed a stronger collaboration roadmap on SSbD training, chemicals monitoring data, and implementation of the One Substance, One Assessment approach. This signals how key EU chemicals policy tools and data platforms will be operationalised over the next few years, helping companies anticipate future expectations for risk assessment, data sharing, and alternatives to animal testing.

eu-parc.euEuropean UnionEuropean Union

EU Parliament ENVI Committee Adopts Report on ECHA Basic Regulation and Amendments to REACH, BPR, PIC and POPs

In April 2026 the European Parliament’s ENVI Committee adopted its report on the new ECHA basic regulation, setting Parliament’s first-reading position on ECHA’s mandate and amendments to REACH, BPR, PIC and the POPs Regulation. The draft significantly strengthens ECHA’s independence, transparency, focus on non-animal and One Health science, and funding model, signalling future changes in how chemical assessments are coordinated and financed and warranting close monitoring by compliance and regulatory teams.

europarl.europa.euEuropean UnionEuropean Union

EU Commission Positively Assesses PARC Phasing-Out Strategy for Chemical Risk Assessment

In March 2026 the European Commission positively assessed the phasing-out strategy of the Partnership for the Assessment of Risks from Chemicals (PARC), clearing the way for formal adoption of a multi-scenario plan to sustain EU chemical risk assessment activities, data and networks beyond Horizon Europe funding. The strategy aligns PARC with the new One Substance, One Assessment framework and common EU chemicals data platform, clarifying how PARC outputs will be channelled to ECHA, EFSA and EEA without itself changing data ownership rules or creating new legal obligations for industry.

eu-parc.euEuropean UnionEuropean Union

Netherlands Bureau REACH Publishes 2025 REACH/CLP Activity Overview

The Netherlands Bureau REACH 2025 overview details priority dossiers on enzyme risk management, Bisphenol A exposure limits, and new CLP hazard classifications. These Dutch-led initiatives serve as a critical early warning for upcoming EU-wide restrictions and harmonized classification changes affecting product composition and labeling.

bureau-reach.publiqa.onlineNetherlandsNetherlandsEuropean UnionEuropean Union

ECHA Announces Webinar On Key Areas Of Regulatory Challenge – 2026 Update

ECHA will update its Key Areas of Regulatory Challenge in June 2026 to define the scientific research priorities shaping future EU chemicals policy. Monitoring these priorities provides early insight into the technical evidence that will underpin upcoming substance restrictions and hazard assessment frameworks.

echa.europa.euEuropean UnionEuropean Union

EU Parliament Budgets Committee Adopts Budgetary Assessment on Proposed ECHA Regulation

The European Parliament's Budgets Committee has endorsed a new financing model for ECHA, proposing a stricter three-year fee review cycle to ensure full cost recovery for regulatory services. Companies should prepare for more frequent and potentially higher administrative fees across REACH, CLP, and Biocidal product applications as the agency moves toward a self-financing model.

europarl.europa.euEuropean UnionEuropean Union

ECHA Schedules 2026 Science Seminar, IUCLID 6 Webinar and Drinking Water Directive Workshops

ECHA has scheduled key 2026 technical events covering the IUCLID 6 version 10 release and implementation workshops for the Drinking Water Directive. Companies should prepare for updated data submission formats and the operationalization of the European positive list for materials in contact with drinking water.

echa.europa.euEuropean UnionEuropean Union

EFSA Develops Adverse Outcome Pathway Network for Reproductive Toxicity to Support Endocrine Disruptor Identification

EFSA has launched a standardized toxicological framework using Adverse Outcome Pathway networks to identify endocrine disruptors in biocides and pesticides. This transition toward mechanistic data and New Approach Methodologies increases the technical requirements for safety substantiation and signals more rigorous regulatory scrutiny of reproductive toxicity.

efsa.europa.euEuropean UnionEuropean Union

EU Council Circulates Final Compromise Text for New Medicinal Products and EMA Regulation

The EU Council has finalized the compromise text for the new Pharmaceutical Regulation, consolidating the authorization and supervision framework for human medicines. Companies must prepare for stricter supply chain transparency, mandatory shortage prevention plans, and a recalibrated system of market exclusivity incentives.

data.consilium.europa.euEuropean UnionEuropean Union

EU EFSA Intake Of Application To Extend Benzyl Alcohol Use In Plastic Food Contact Materials

EFSA has initiated a safety assessment for the expanded use of benzyl alcohol in plastic food contact materials following a new industry application. A successful evaluation could broaden formulation options for plastic packaging manufacturers while signaling continued regulatory scrutiny of additives in food-grade plastics.

open.efsa.europa.euEuropean UnionEuropean Union

ECHA Webinar On IUCLID 6 Version 10 Major Release (12 May 2026)

The European Chemicals Agency is launching IUCLID 6 Version 10 in May 2026, introducing major format changes and harmonized templates for chemical data submissions. Businesses must audit their internal data management systems and reporting workflows to ensure seamless compliance with REACH, CLP, and Biocidal Products Regulation requirements.

echa.europa.euEuropean UnionEuropean Union

EU CA Meeting Reviews Progress of BPR Active Substance Review and Renewal Programme (March 2026)

The EU is significantly accelerating the biocidal active substance review programme to address a major backlog and meet upcoming statutory deadlines. Manufacturers face increased market-access risks as authorities tighten scrutiny on endocrine-disrupting impurities and move to cancel product authorisations for substances failing renewal.

circabc.europa.euEuropean UnionEuropean Union

EFSA Publishes 2025 Annual Report of the Advisory Group on Biomarkers of Effect

EFSA published its 2025 annual report on biomarkers of effect in March 2026, advancing methodological frameworks for chemical risk assessment. These developments signal a shift toward more sophisticated, effect-based monitoring that will likely influence future safety thresholds and cumulative risk evaluations.

open.efsa.europa.euEuropean UnionEuropean Union

Netherlands House of Representatives Publishes Report on EU REACH Revision and Chemicals Package

The Dutch Parliament has released a strategic report outlining the expected trajectory for the EU REACH revision and PFAS restrictions through 2026. Businesses should prepare for stricter enforcement on imports, the integration of digital product passports, and a shift toward essential use criteria that will redefine market access for chemical-intensive products.

zoek.officielebekendmakingen.nlNetherlandsNetherlandsEuropean UnionEuropean Union

European Commission Outlines Targeted REACH Revision Plans in Reply to Dutch Parliament

The European Commission has confirmed a targeted REACH revision focused on simplifying procedures and accelerating the transition from individual substance authorizations to broader restrictions. Businesses should prepare for a more aggressive regulatory pace, including stricter enforcement mechanisms like registration revocation and expanded data requirements for endocrine disruptors.

zoek.officielebekendmakingen.nlEuropean UnionEuropean Union

Northern Zone Updates Higher-Tier Birds And Mammals Risk Assessment Guidance (Version 2.2, March 2026)

Northern Zone regulators implemented updated higher-tier risk assessment guidance for birds and mammals in March 2026 to align regional pesticide approvals with the EFSA 2023 framework. Agrochemical companies must adopt these revised residue parameters and species scenarios to secure core zonal evaluations and maintain market access across Northern Europe.

kemi.seSwedenSwedenDenmarkDenmarkEstoniaEstoniaFinlandFinlandLatviaLatviaLithuaniaLithuaniaNorwayNorwayEuropean UnionEuropean Union

ECHA Announces Drinking Water Directive IUCLID Demonstration Workshop

ECHA is initiating technical training and releasing manuals for the mandatory digital submission process required to list substances for use in drinking water contact materials. Businesses must transition their data management to IUCLID formats to secure product compliance and maintain market access under the harmonized European positive list framework.

echa.europa.euEuropean UnionEuropean Union

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Definition

What is One Substance, One Assessment?

EU reform consolidating chemical safety assessment across agencies to eliminate duplication and ensure consistent hazard evaluation.

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One Substance, One Assessment developments can change product scope, supplier expectations, market access, reporting duties, and risk ownership. Foresight tracks the signals early so teams can respond before obligations become urgent.

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