Toxicology Consultants

Toxiqua provides expert representation at key regulatory meetings, including ECHA’s RAC and Biocidal Products Committee (BPR WG). We advocate for our clients’ interests, prepare technical dossiers, and ensure compliance with REACH, BPR, and other regulatory frameworks.

Toxiqua develops tailored classification and labelling (C&L) strategies that comply with global standards such as CLP Regulation and GHS. Our services include hazard assessments, technical argumentation, and risk-based labelling recommendations.

We help clients choose the most suitable Contract Research Organisations (CROs) by evaluating their expertise, compliance history, and cost-efficiency. Toxiqua ensures that the selected CRO meets the project’s specific needs and timelines.

Testing strategy development involves designing efficient testing programs to address regulatory requirements. Toxiqua prioritises cost-effective solutions, including New Approach Methodologies (NAMs) and risk assessment frameworks, to meet REACH, BPR, and PPP standards.

A data gap analysis identifies missing information in regulatory submissions and provides a roadmap to address those gaps. Toxiqua uses techniques like QSAR models and read-across approaches to propose alternative solutions and ensure compliance.

OECD and IUCLID dossiers are regulatory submissions required for compliance with frameworks like PPP, BPR, and REACH. Toxiqua specialises in preparing these dossiers to ensure accuracy and alignment with global regulatory requirements.

“An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations.”  (WHO/IPCS, 2002)

Simplified, this means that endocrine disruptors are chemicals, or chemical mixtures, that interfere with normal hormone action.

Since 2018, in the EU…

• ED assessments have been required under EU legislation for plant protection
  products (PPP) and biocides (BPR).
• ED Assessments are conducted by EFSA for PPP and ECHA for BPR.
• These are conclusions (not classifications) and are cut-off criteria in the EU.
• In 2023, ED was included into the CLP legislation (classification)…
• ECHA will take over responsibility for assessments
  (mandatory for substances from November 2026).
• The CLP guidance document on how to classify for ED has just been finalized
  in November 2024.
• During the build-up to the inclusion of ED into CLP, EU REACH data requirements were also being considered and 2 options underwent a consultation, it should be noted though that this activity is currently in stasis in the EU but the direction of travel indicates these kinds of data requirements are highly likely in the future, even if not one of the previous 2 options.

Toxiqua offers clear, actionable answers to regulatory queries, including guidance on REACH and BPR frameworks, interpretation of technical requirements, and advice on submissions. We provide rapid responses to ensure your compliance needs are met efficiently.