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Medical devices and regulatory compliance – know your geographical market

Medical devices and regulatory compliance – know your geographical market

With hundreds of medical device companies continuously producing new, innovative technologies to improve and expand on their product ranges as well as an ever-increasing demand for these important devices, the global medical device market value is predicted to rise to $483.8 billion by 2022. But…

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Suitability of the TTC approach – exclusions, “special cases” and the “Cohorts of Concern”

Suitability of the TTC approach – exclusions, “special cases” and the “Cohorts of Concern”

It has been a while, but if you recall in the previous (and first) blog in this series, we gave the potted history of the main TTC benchmarks that can used to assess an untested chemical. For any exuding a structural suspicion of genotoxicity, the…

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DIY risk assessment

DIY risk assessment

You cannot turn the page of a newspaper these days without catching the latest worrying headline regarding the next thing that’s bad for you (which often conflicts with the previous day’s dire warnings!) – drink coffee / don’t touch caffeine, enjoy a glass of wine…

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Developmental neurotoxicity (DNT) testing – is industry doing enough?

Developmental neurotoxicity (DNT) testing – is industry doing enough?

Neurodevelopmental disorders in children have increased significantly in recent years (according to the European Joint Research Centre), which adds urgency to the need to evaluate new and existing chemicals for their potential activity in this area. This is difficult when the existing OECD DNT study,…

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The Threshold of Toxicological Concern (TTC) approach to risk assessment: “Origins”

The Threshold of Toxicological Concern (TTC) approach to risk assessment: “Origins”

A wide spectrum of risk assessors are enamoured of the TTC, which essentially uses a knowledge of the toxicological properties of the universe of tested chemicals to make conservative predictions of the likely toxicity of untested materials. It gives them pragmatic respite from the onward…

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Public Health England reviews the evidence on e-cigarettes and heated tobacco

Public Health England reviews the evidence on e-cigarettes and heated tobacco

The effects of vaping on public health remains a newsworthy and interesting topic of discussion, with a range of views and opinions. Public Health England (PHE) is committed to reviewing the evidence regarding e-cigarette use and the effects of vaping on consumer health. PHE has…

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EFSA/ECHA guidance on identifying endocrine disruptors (EDs)

EFSA/ECHA guidance on identifying endocrine disruptors (EDs)

Hormonal disruption is a hot topic these days. Following 2016 draft EU legislation setting scientific criteria for identifying EDs (under plant protection and biocidal products Regulations), EFSA and ECHA have issued a draft guidance document on this subject. It includes advice on how to gather,…

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End of the line for the in vivo unscheduled DNA synthesis (UDS) assay?

End of the line for the in vivo unscheduled DNA synthesis (UDS) assay?

Establishing whether or not a substance is genotoxic is critical in risk assessment, as it determines whether the substance can be assessed as a threshold or non-threshold toxin. The OECD Test Guidelines (TGs) on genetic toxicology are considered the “gold standard” on how the favoured…

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Updating REACH dossiers – the whys and hows

Updating REACH dossiers – the whys and hows

Following on from our last blog about ECHA-instigated updates to REACH registration dossiers (e.g. following an ECHA Evaluation (draft) decision), it’s worth taking a look at the update process more generally: Why are updates so important and how should we go about actioning them? A…

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QRA 2: The SCCS puts skin sensitisation risk assessment to the test

QRA 2: The SCCS puts skin sensitisation risk assessment to the test

Feeling a bit itchy? Skin sensitisation from fragrance ingredients in cosmetics, personal care products and household goods is relatively common and causes considerable concern for fragrance manufacturers and regulators. The QRA2 model, developed by the International Fragrance Association as part of the International Dialogue for…

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