News

ECHA Webinar 21 May 2026: Preparing Biocides Active Substances in IUCLID and R4BP 3 - Key updates and deadline

Today, the European Chemicals Agency (ECHA) held a highly relevant webinar.

The session focused on key IT developments and practical guidance for preparing active substance dossiers under the Biocidal Products Regulation (BPR).

Main topics included:

Recent improvements in the IUCLID format and validation rules
How to correctly structure and compile data in IUCLID
Important changes coming into force on 1 July 2026: renewal dossiers must include all data previously used for the initial approval
Rules and best practices for submissions via R4BP 3

This webinar is particularly useful for manufacturers, authorisation holders, consultants, and anyone preparing new, renewal, or review dossiers for active substances and biocidal products.

At Alliance Regulatory we closely monitor these technical and regulatory developments that directly affect dossier preparation and authorisation strategies. Need a detailed analysis of the impact on your products? Feel free to contact us.

Published 21/05/2026

A substantial upgrade to ECHA’s central platform IUCLID for chemical data management under REACH, CLP, BPR, PPP and more

Key Changes in v10

Major format updates including harmonised OECD templates and new EU-specific fields
Enhanced support for Biocides (BPR), Plant Protection Products (PPP), microplastics, drinking water, toys, and microorganisms
Improved user interface and new functionalities for better data quality and interoperability
Refined validation tools and simplified migration rules

Impact on Your Business

Existing dossiers must be updated and migrated
New data requirements for biocides and PPP submissions
Compatibility checks required with your current tools (Chesar, Extractor, etc.)
Early preparation is essential to avoid submission delays in 2026 - 2027

Alliance Regulatory is ready to support you

Expert review and migration of your IUCLID dossiers
Full compliance support for BPR, PPP, REACH & CLP
Certified consultant
Don’t wait until the last minute.

Published 13/05/2026

The Resurgence of Hyalomma lusitanicum in Europe

Hyalomma lusitanicum - the “Giant Mediterranean Tick” - is rapidly re-emerging across southern Europe, including France.

Key drivers of resurgence

Climate change: warmer temperatures and altered rainfall expand suitable habitats northward

Host population growth: increasing numbers of wild hoofed animals (deer, wild boar) and migratory birds

Human and animal movements: trade, traffic, travel, and livestock transport accelerate spread

Public and veterinary health concerns

Crimean-Congo Haemorrhagic Fever virus (CCHFV): severe viral haemorrhagic fever in humans with high fatality rates; an emerging public-health threat in southern Europe
Theileria annulata: causes bovine theileriosis (Mediterranean theileriosis), leading to major economic losses in cattle farming
Coxiella burnetii: responsible for Q fever, a zoonotic disease that can affect both humans (flu-like illness, pneumonia, chronic complications) and livestock
Various Rickettsia, Anaplasma and Babesia species: associated with spotted fevers, anaplasmosis and babesiosis in humans and animals

Why it matters now

Increasing presence in France and southern Europe creates urgent need for surveillance and control
ARL expertise; EFF guidance compliant efficacy testing using locally collected Hyalomma lusitanicum
Generation of robust, Europe-relevant data for acaricides and topical repellents for humans, pets, horses

Ready to Move Forward?

Contact us at contact@allianceregulatory.com to discuss tailored testing and regulatory solutions for this emerging tick species.

Published 21/04/2026

Bee Risk Guidance update of ECHA / EFSA - Act now!

Start acting – in case of questions or if you´d like to receive service around Bee Risk Guidance

reach out to us under contact@allianceregulatory.com to exchange on your regulatory needs!

Published 08/04/2026

ECHA Bee Risk Guidance for Biocides – Prepare Now!

Guidance published: February 2024 (Version 1.0)

Mandatory for new applications: On or after 1 February 2026

Focus: PT18 (insecticides/acaricides) – major impact; may apply to other PTs with insecticidal MoA + plausible exposure

Exclusions: Direct baits, small-scale spot/nest sprays

Main Changes Tiered RA: Exposure + Effects (acute/chronic, dietary/contact, adults/larvae)

Honey bee Specific Protection Goal: ≤10% colony strength reduction

Required studies (if exposure plausible): Acute oral/contact (OECD 213/214), chronic adult, larval toxicity

Exposure: Tailored scenarios (e.g., treated surfaces, manure/sludge, garden irrigation)

Tool: B-risk for biocides (released December 2025) – essential for modelling & risk characterisation

Implications: Higher data demands, costs & timelines

How We Help

We support your bee risk assessments & dossiers:

Portfolio review & strategy (pre- vs post-2026 submissions)
Exposure modelling with B-risk tool
Bee toxicity testing via our partner EDARA ERF in India – GLP/OECD-compliant, fast, cost-effective, open apiary networks (ideal EU alternative)
Full hazard/effect assessment & regulatory integration

Act Early – Pollinator protection is key for compliance & marketing.

Reach out to us at contact@allianceregulatory.com to exchange on your PT18 needs & EDARA options

Published 27/01/2026

Restricted Purchase of Professional Plant Protection Products (PPP) and Biocides

Ensuring Safe & Compliant Use in France and Germany

Safe & Responsible Use: Strict national rules protect health and the environment while ensuring products reach qualified users only.

No Free Access: Professional PPP and biocides cannot be purchased "off the shelf" – certification and verification are essential.

Evolving Regulations: France and Germany implement robust EU frameworks (Regulation 1107/2009 for PPP; BPR 528/2012 for biocides) with national enforcement (Biocidal Products Implementation Regulation: Arrêté «Certibiocide», Arrêté «Certiphyto» and ChemBiozidDV).

ARL is fully Certified & Equipped to Guide You

France: Certibiocide (professional biocides) & Certiphyto (PPP)
Germany: Equivalent “Sachkundenachweis” (proven competence for biocides & plant protection products)