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 […]

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 […]

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 […]

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 […]

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.