Insights

Our senior consultants are certified human toxicologists or environmental specialists with substantial regulatory experience in the application of sector- relevant human and environmental health legislation. We closely follow scientific and regulatory developments in our field and highlight our insights on a number of topics within our domain.

Next generation risk assessment (NGRA) for skin sensitisation: Case studies with resorcinol and propyl paraben

Skin sensitisation is one of the key adverse health effects to be addressed in the safety assessment of cosmetic ingredients. In the past, guinea pig assays such as the Guinea pig maximization test (GPMT) were mostly used for skin sensitisation hazard identification. In an attempt to reduce the use of experimental animals and have better […]

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Initial reflections on a way forward to update the REACH Annexes in relation to endocrine disruption properties – OPEN FOR FEEDBACK UNTIL 16 NOVEMBER

The European Commission is looking for comments on its intention to update REACH data requirements for identifying and assessing endocrine disruptors (EDs). The Competent Authorities for REACH and the CLP Expert Group on Endocrine Disrupters recently published their initial reflections on the update of the REACH Annexes to include data requirements on endocrine disruption (Annex […]

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Implementing Regulation (EU/2020/1435) on the duties placed on registrants to update their registrations along with proposed deadlines under the EU REACH Regulation

Article 22(1) of Regulation (EC) No 1907/2006 (REACH regulation) places a responsibility on registrants (whether individual registrants or the lead registrant and other members of a joint submission) to update their registrations without undue delay with relevant new information and submit them to the European Chemicals Agency (ECHA). Information counts as ‘new’ if the registrant […]

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The European Commission’s Joint Research Centre (EC- JRC) tender to collect and organise mechanistic knowledge related to the toxicological effects on target organs observed in animal models after repeated exposure to chemicals

In recent years, considerable progress has been made towards promoting the development, validation, acceptance and use of alternative approaches to animal experimentation in life sciences. A range of alternative methods have been validated and accepted by regulatory bodies across the world. However, the validation and acceptance of animal alternative methods allowing to assess systemic toxicity […]

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Ecotoxicological assessment of pharmaceuticals and personal care products using predictive toxicology approaches

With their widespread and ever increasing use, active pharmaceutical ingredients (API) and personal care products (PCP) represent contaminants of emerging concern for the aquatic and terrestrial environments. Today, numerous countries worldwide have issued regulations and guidance to cover the environmental risk assessment of these substances, but in many cases the necessary hazard data is missing […]

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Nanomaterials in cosmetics – The next priority of the Commission?

Since a number of new developments have taken place in the area of nanomaterial safety research, the EC Scientific Committee on Consumer Safety (SCCS) has updated its Guidance in October 2019 to ensure compliance of nanomaterials intended for use as cosmetic ingredients under the current EU legislation (EC No 1223/2009). We have provided a summary […]

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Alternatives to the use of vertebrate animals in ecotoxicity testing – Progress so far

There is a growing need for alternatives to the use of vertebrate animals in the hazard assessment of chemicals. Many regulatory frameworks, including REACH (e.g., the European Union’s regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals), stipulate that vertebrate tests should be conducted only as a last resort. Nevertheless, there is still a […]

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SCCS Guidance on the Safety Assessment of Nanomaterials in Cosmetics

The European Commission’s Scientific Committee on Consumer Safety (SCCS) published in November 2019 an up-to-date revision of the existing Guidance on the Safety Assessment of Nanomaterials (NMs) used in Cosmetic Products (SCCS/1484/12). The discussion to revise the Guidance on safety assessment of NMs started in May 2017 within a dedicated SCCS working group and aimed at providing key recommendations for safety of NM used in cosmetics including data requirements.

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Requirement of second species testing for evaluating developmental toxicity potential

Over the last decade, there has been ongoing debate on the regulatory requirement of a second-species testing requirement to identify developmental toxicity. A recent article by Braakhuis et al. (2019) has questioned the reproducibility of developmental toxicity results and the comparison approach using NOAELs. The current insight attempts to present the state-of-the-art information on the ongoing discussion.

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Mutagenicity assessment of drug impurities according to the ICH M7 (R1) guideline and the role of expert review

The evaluation of the genotoxicity potential of drug impurities has been the focus of regulatory recommendations issued by the United States Food and Drug Administration (FDA, 2008), European Medicines Agency (EMA, 2006 and 2010), and International Conference for Harmonization (ICH, 2014, 2015). In 2017, the ICH M7 issued a revised guideline providing a framework for the assessment and control of mutagenic impurities in pharmaceuticals.

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Natural ingredients, inherently safe?

The Executive Director of the Cosmetics Ingredient Review (CIR) addresses the myth of the perceived greater safety of natural versus synthetic and the importance of an expert safety assessment of ingredients in the journal Cosmetics & Toiletries.

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Severity of eye effects caused by accidental exposure to detergent and cleaning products

A most interesting study concerning the severity of eye effects caused by accidental exposure to detergent and cleaning product has recently been published by Scazzola et al., 2019. The study investigated the predictivity of a product’s classification for eye hazard following reported accidental human exposures to common household detergent and cleaning products.

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Endocrine disruptors – Recent policy developments and recommendations in the EU

In recent years, the Commission has taken steady actions and acted against EDs in line with the different requirements laid down in the relevant legislation. However, substances with endocrine disrupting properties are subject to case-by-case regulatory action on the basis of the general requirements of the legislation.

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Are you ready for the upcoming deadline for the poison centre notifications of hazardous mixtures?

Importers and downstream users placing hazardous mixtures will have to provide specific information in a harmonized notification format to the relevant national appointed bodies, who will make this information available to poison centres so that they can provide rapid medical advice in the event of an emergency.

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Adopting New Approach Methodologies (NAM) in the next generation risk assessment (NGRA)

The term “new approach methodologies” (NAMs) has been emerged as a descriptive reference to any non-animal-based approaches that can be used to provide information in the context of chemical hazard and risk assessment. These new approaches include integrated approaches to testing and assessment (IATAs), defined approaches for data interpretation, and performance-based evaluation of test methods.

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Developments on the identification of potential endocrine disruptors under EU legislation

Introducing 2018 developments in EU policy and legislation on endocrine disruptors and our first experiences with the EFSA/ECHA guidance.

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ECHA Public activities coordination tool

A new version of the Public activities coordination tool (PACT) has been integrated in the European Chemicals Agency (ECHA) website. This searchable and customizable database now includes substances for which dossier evaluation is ongoing and registries of CLP/restriction/SVHC intentions.

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13th SETAC Scientific Symposium: Extrapolation of effects across biological levels

The symposium discussed extrapolation tools for environmental risk assessment purposes across different biological levels, and more importantly, how to bring those models to regulatory conformity. 

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Update on the development of a regulatory framework for developmental neurotoxicity testing with specific focus on non-animal testing approaches

Reports of developmental neurotoxicity (DNT) incidences have become increasing over the last 2-3 decades, triggering the need for higher focus on this endpoint and an efficient, tiered testing approach to allow identifying developmental neurotoxicants.

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Application of in silico and TTC based decision tree for safety assessment of botanicals

Safety assessment of botanicals has always been a challenge, not only due to the difficulties in defining them analytically, but also due to data gaps in traditional toxicology endpoints.

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Evaluation of in vitro assays for the assessment of the skin sensitisation hazard of functional polysiloxanes and silanes

A published research programme investigating the skin sensitisation potential of a group of functional polysiloxanes and silanes in vivo and in vitro is an instructive example of what can happen in ‘real life’ when testing a group of chemical substances that seemingly belong to the same class of chemicals for skin sensitisation

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Principles underlying the next generation risk assessment approach (NGRA)

Next Generation Risk Assessment (NGRA) is defined as an exposure-led, hypothesis-driven risk assessment approach that integrates in silico, in chemico and in vitro approaches.

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Joint EFSA/ECHA guidance document for the identification of endocrine disruptors under EU Biocides and Pesticides Regulation

The European Food Safety Authority (EFSA) and the European Chemical Agency (ECHA) jointly published in June 2018 the long-awaited guidance for the identification of endocrine disruptors.

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Read-across – State of the art and next level!

In light of the limitations of existing non-animal based hazard assessment methodologies particularly for systemic endpoints, read-across is currently considered to be the most applicable strategy in the short- to medium-term in support of innovation.

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