Dive into our team’s expertise on the Biocides and REACH markets.

Once a month, our experts will gather all the news and updates in Biocides and REACH markets. They will select major news to help you navigate in the regulations framework.

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BIOCIDES

1. Significant ANSES Fee Increases

The French Order of June 4, 2026 introduces a major revision of ANSES’ fees for biocidal active substances and biocidal products, repealing the previous Order of November 2017.

Here is what you need to know about the new framework:

• Steep Increases: Significant fee increases apply across most procedures, including active substance approvals, product authorisations, renewals, modification, etc. Some fees are rising by as much as 87.5%.
• Exceptions: Fees related to the simplified authorisation procedure (Article 25 of the BPR) remain largely unchanged.
• Timeline: The new fee structure will be strictly applied to all invoices issued from August 2026.

If your company is planning biocidal submissions in France, it is crucial to review these changes carefully and anticipate the potential budget impact on your planned regulatory activities.

Are you prepared for this financial impact? Contact our team today to ensure your regulatory roadmap remains on track!

2. Updated Efficacy Technical Agreement for Biocides (EFF-TAB)

ECHA has published the updated Technical Agreements for Biocides – Efficacy (EFF-TAB), release date June 30, 2026.

The new entry No. 36 introduces a clarification for PT19 repellents, focusing on the interpretation of efficacy studies where one or more replicates show no protection at the first observation time point.

A small update, but one with practical implications for repellency claims, including those based on Complete Protection Time or ≥80% / ≥90% repellency.

As a clarification of existing guidance, it applies immediately to both active substance approvals and product authorisations.

3. Substances of Concern under the BPR: finally a dedicated guidance?

ECHA’s draft Volume V guidance on Substance of Concern identification and evaluation does not completely rewrite the rules, but it brings some long-awaited clarity to an area that has often left room for interpretation.

The draft confirms a more structured approach to SoC screening and assessment, with clearer criteria, practical examples and dedicated reporting templates.

Among the key points:

• A SoC cannot be a mixture, non-active substances within mixtures must be screened individually
• Clearer treatment of PBT/vPvB, POPs, synergists, EQS and other grounds for concern
• Better integration of newer CLP environmental hazard classes, including PMT/vPvM and ED ENV
• A more harmonised approach to document and justify conclusions

For companies preparing BPR dossiers, the message is simple: SoC assessment should not be treated as a box-ticking exercise.

It is becoming an increasingly strategic part of the dossier, and one that should be anticipated early.

4. Biocidal Active Substance Renewals: IUCLID becomes unavoidable

ECHA has reminded applicants that, from July 1 2026, renewal applications for biocidal active substance approvals must include the approval data in IUCLID format.

This will also cover data from the original active substance application, including legacy Review Programme dossiers that were historically accepted in a less structured format.

The message is clear: companies should not wait until the renewal deadline to start converting and organising their data.

IUCLID is expected to support:

• More structured and accessible approval data
• Smoother validation and assessment
• Better alignment with the “one substance, one assessment” approach
• Future automation of reports and data analysis

ECHA also encourages applicants to become familiar with the IUCLID Validation Assistant, which can help identify missing or misplaced information before submission.

For companies with upcoming active substance renewals, this is more than an IT exercise: it is a dossier strategy and data-readiness exercise.

5. Ethanol PT1, 2, 4 – Competent Authority Report (CAR) published by ECHA

The Competent Authority Report (CAR) for ethanol in Product Types (PT) 1, 2 and 4 has now been published by ECHA.

While the final decision on the potential CMR classification of ethanol is still expected in September, the CAR provides the toxicological, ecotoxicological and environmental reference values (endpoints) required to perform the risk assessments of your products.

This important milestone enables companies to start their regulatory strategy for ethanol-based disinfectants, including the Data Gap Analysis (DGA) and the Preliminary Risk Assessment (PRA) for your product authorisation dossiers.

Staphyt has the expertise, experience and capacity to support you at every stage of this process, from defining your regulatory strategy to delivering your DGA, PRA and full authorisation dossier.

REACH

1. ECHA publishes fourth report on the operation of REACH and CLP

This report uses data gathered between 2021 and 2025 to assess the implementation of REACH and CLP as they continue to protect health and environment in the EU while supporting innovation and competitiveness.

This is the fourth report published, however while the first three reports covered REACH registration deadlines, this one has a focus on examination of substances already present in the database. It identifies the challenges with implementing legislation and issues with the availability and quality of data. The report highlights the increased workload of ECHA’s scientific committees as a limitation of the current framework.

2. EU Commission indicates that they will utilise comitology rather than pursue a full REACH revision

Following recent EU council discussions on the modernisation of the REACH regulation several Member States have co-signed a document outlining regulatory actions which would implement a modernisation and revised enforcement of REACH.

Key steps included tackling illegal imports by enforcing stricter controls on online sales and e-commerce platforms and updating REACH annexes to introduce new information requirements for the newly established EU hazard classes, specifically targeting Endocrine disruption, persistence and mobility.

While the full REACH revision is no longer planned, we can still expect targeted REACH updates in the future. Companies are recommended to begin auditing their substance portfolios for endocrine disruption and mobility properties ahead of any changes which come down the line.

3. ECHA to publish C&L notifier company names from July 2026

Starting from July 1st 2026 ECHA will begin publishing the names of companies who have submitted notifications to the Classification and Labelling (C&L) inventory. This change follows the 2024 revision of the CLP Regulation and will affect any manufacturer or importer that has previously filed a C&L notification.

According to ECHA this measure is intended to support alignment by making notifier identities visible, in order to facilitate agreement on classification and labelling entries for the same substance across different companies

Companies should review all C&L notifications they have submitted and consider whether they wish to request confidentiality.

4. The OECD has just released its latest test guideline updates as of July 2, 2026.

While some documents received minor administrative updates, several introduced significant advancements to toxicological product assessment, strongly supporting the global phase-out of animal testing.

These updates are particularly critical for REACH registrations, which require both toxicity and ecotoxicity studies, and are highly relevant given potential future amendments to the REACH Annexes via comitology over the next few years. These upcoming changes aim to adapt information requirements to new hazard classes, including endocrine disruptors (ED), persistent, mobile, and toxic (PMT) substances, and very persistent and very mobile (vPvM) substances.

Notably, new specific nanomaterial test guidelines, such as OECD TG 322 and TG 127, have been released (nanomaterial registration having been mandatory since 2020) . Previously, no guidelines for hazard evaluation existed that provided internationally harmonised methods for determining dissolution behaviour of nanoforms under environmentally relevant conditions. This new test guideline supports companies in the  performance of higher-tier tests.

Additionally, the new OECD TG 446A (ToxTracker) serves as a key regulatory screening test under REACh Regulation. It will enable companies to screen-out numerous genotoxicity endpoints required across various Annex levels, potentially resolving the frequent false-positive results often encountered with tests like OECD TG 471.

CROSS DISCIPLINARY

DWD

1. ECHA Drinking Water Directive Stakeholders’ Workshop

ECHA will host a Drinking Water Directive Stakeholders’ Workshop on 21-22 October 2026. Closing dates for registration is August 14, 2026

2. DWD Positive List: June 2026 Marks First Informal Deadline for Notifications of Intention

June 2026 marks the first informal deadline to submit a Notification of Intent (NoI) for updating or including substances in the Drinking Water Directive (DWD) Positive List (EUPL). Because the legal text grants extra time for applications submitted at least 18 months prior to their expiry dates, and since an NoI is a mandatory step recommended one year before the application itself, the time to notify for substances expiring in 2028 is now.

PPWR

1. EU publishes final guidance on the Packaging and Packaging Waste Regulation

This non-binding guidance follows the previously published draft and is well received ahead of PPWR coming into effect on 12 August 2026. However it is worth noting that several EU countries believe that greater clarification is needed with PPWR, since present legislation is still insufficient to ensure legal certainty and a consistent understanding of key obligations across the EU.

In particular it is felt that PFAS is insufficiently addressed with no harmonised EU methodology provided for testing in food-contact packaging and no transitional period for stock exhaustion. Other concerns raised include the impact to supply-chain management and excessive labelling changes occurring prior to the 2028 adoption of harmonised labelling rules.

Whether you need assistance about compliance, product registration or any other regulatory issue, our experts are here to provide support: Aviron-Violet Sophie, Elena Campagnoli, Benjamin Heal, ALESSANDRO CASELLATO, Hélène Detrimont, George Leathley

Contact us contact@staphyt.com