For hazards of highest concern (e.g., carcinogenicity, mutagenicity, reproductive toxicity), the European harmonised classification and labelling (CLH) system is set […]

Skin sensitisation is one of the key adverse health effects to be addressed in the safety assessment of cosmetic ingredients. […]

The European Commission is looking for comments on its intention to update REACH data requirements for identifying and assessing endocrine […]

Article 22(1) of Regulation (EC) No 1907/2006 (REACH regulation) places a responsibility on registrants (whether individual registrants or the lead […]

In recent years, considerable progress has been made towards promoting the development, validation, acceptance and use of alternative approaches to […]

With their widespread and ever increasing use, active pharmaceutical ingredients (API) and personal care products (PCP) represent contaminants of emerging […]

Since a number of new developments have taken place in the area of nanomaterial safety research, the EC Scientific Committee […]

There is a growing need for alternatives to the use of vertebrate animals in the hazard assessment of chemicals. Many […]

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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. 

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.

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.

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

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.

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.

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.