ToxHub Blog – Expert Insights on Toxicology & Regulatory Topics
Regulatory News and Scientific Publications
Welcome to the Tox Hub Blog, your go-to source for expert insights on toxicology, regulatory updates, and scientific advancements. Here, we cover essential topics including Environmental Risk Assessment (ERA), Toxicological Risk Assessment (TRA), cosmetic safety, medical device regulations, and more. Stay informed with the latest research, practical guidance, and industry news designed to support professionals in pharmaceuticals, cosmetics, chemicals, and healthcare sectors. Explore our in-depth articles and publications to enhance your knowledge and keep up with evolving regulatory landscapes.
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Product Information File: Why the Toxicologist Plays a Central Role in Cosmetic Safety
The Product Information File, commonly referred to as the PIF, is one of the cornerstone [...]
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Safety Data Sheets: Regulatory Requirements, Compliance and Chemical Risk Management
Safety Data Sheets, commonly referred to as SDSs, are essential regulatory documents for communicating information [...]
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Genotoxicity Assessment in Drug-Device Combination Products
Genotoxicity assessment for drug and device combination products, covering ISO 10993, extractables and leachables, patient [...]
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FDA Partial Recognition of EN ISO 10993-1:2025
The FDA officially recognized EN ISO 10993-1:2025 – “Biological evaluation of medical devices – Part [...]
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Non-Genotoxic Impurities Qualification: A Risk Based and Scientifically Justified Approach
The control and qualification of impurities remain among the most critical aspects in the development [...]
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ISO 10993-1 – What’s New in medical devices Biological Evaluation?
The 6th version of ISO 10993 – Biological evaluation of medical devices — Part 1: [...]
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Navigating ICH Q3E: A Critical Look at Risk Assessment for Extractables and Leachables
The newly released draft of the ICH Q3E guideline represents a significant milestone in the [...]
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Glyphosate under scrutiny again: what the new carcinogenicity data means for EU safety levels
Glyphosate has been undes scrutiny since many years. Discovered in 1970 by a scientist at [...]
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Environmental Risk Assessment of Medicinal Products: A Streamlined Regulatory Overview
The Environmental Risk Assessment (ERA) play a key role in regulatory submissions for medicines in the [...]
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Publications
A proposal for the development of a feed consumption database using a standardised feed classification system
We are excited to finally reveal a project we’ve been working on for the past [...]
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Evaluating the Use and Impact of PFAS in the Cosmetic Industry
What are PFAS and Why Should We Care? Per- and polyfluoroalkyl substances (PFAS), also known [...]
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Cosmetic Packaging Safety: Key Considerations and Insights
Cosmetic products constitute an extremely broad and heterogeneous category of consumer goods that, in accordance [...]
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Environmental Risk Assessment – ERA
🌍 In today’s world, ensuring the safety of our environment is crucial. One key component in [...]
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Investigator’s Brochures for Medical Devices: key elements
Right in April 2024, the European Commission’s Medical Device Coordination Group (#MDCG) published their latest [...]
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Toxicological Risk Assessment – TRA
One topic in which we are experts here at ToxHub are Toxicological Risk Assessment (TRA) [...]
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Valproate, Topiramate, and emerging neurodevelopmental concerns
Part of our Team here at ToxHub published a commentary on the journal Archives of [...]
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Botanicals in food supplements – Uses and regulatory framework
Botanicals, also known as herbal or plant-based supplements, are preparations derived from various parts of [...]
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New Approach Methodologies (NAMs)
In recent years, there has been interest in developing new, faster and less expensive approaches [...]
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MoCRA (Modernization of Cosmetics Regulatory Act)
What is MoCRA? MoCRA stands for Modernization of Cosmetic Regulation Act, and represents the most [...]
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Borderline Products: Medical Devices or Medicinal Products?
In the pharmaceutical industry, the correct classification of medical devices and medicines is of pivotal [...]
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Nanomaterials: a brief review and regulatory considerations
Nanomaterials are defined as a natural, incidental or manufactured materials consisting of solid particles that [...]
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Companion Diagnostics: A Vital Component in Medical Device Advancements
In the rapidly evolving landscape of healthcare, precision medicine has emerged as a groundbreaking approach [...]
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Occupational Exposure Limit (OEL) Determination and its Relevance for Workers’ Safety
Workers’ safety is a fundamental concern in any industry. Employees in pharmaceutical and chemical manufacturing [...]
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Free From Claims: the assessor’s position
In the realm of cosmetics, it is imperative that product labels encompass a comprehensive array [...]
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D4, D5 and D6: Substances of Very High Concern
Back in November 9, 2023 the European Court of Justice, after a long legal battle [...]
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Overview of the Toxicological Risk Assessment | Medical Devices
The Regulation (EU) 2017/745 on medical devices is designed to establish a robust regulatory framework, [...]
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Publications
Benzydamine and inflammatory pain – Molecular Pain
A new article was released in Molecular Pain magazine, in which our estimated colleague Giorgina [...]
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Permitted Daily Exposure (PDE) for Veterinary Drugs in Shared Facilities
In our earlier discussion, we delved into the intricacies of the classic Permitted Daily Exposure [...]
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The Product Information File (PIF) – A Cornerstone for Cosmetics
According to the European regulation for cosmetics (EU Reg. n° 1223/2009) the responsible person who [...]
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IUCLID latest update, 07.11.2023
ECHA has recently released a comprehensive IUCLID dataset comprising 528 approved pharmaceuticals, showcasing information gathered [...]
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Permitted Daily Exposure (PDE): A Vital Metric in Product Safety
One of the most critical tools employed by toxicologists when assessing the safety of drug [...]
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Publications
Effect of Sodium Hypochlorite 0.05% in Chronic Wounds – Journal of Clinical Medicine
We’re thrilled to present the paper published by the Journal of Clinical Medicine, in which [...]
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Octocrylene – Ally or Threat?
Octocrylene (OCR) is an organic chemical compound commonly used in various skincare and sun protection [...]
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Nature News: India’s DNA Covid-19 vaccine is a world first
September 2021 The ZyCoV-D vaccine heralds a wave of DNA vaccines for various diseases that [...]
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Food toxicity: hazard versus risk
Traditionally, consuming food has been considered a low-risk activity. However, the advent of industrialization in [...]
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Toxicity of Anticancer Therapies – Editorial in Archives of Clinical Toxicology
Any drug treatment may be accompanied by adverse events or toxicity. This is especially true [...]
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Latest update on cytokines and their subset chemokines
Cytokines and chemokines play a crucial role in safeguarding the body against external threats and [...]
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