Ms. Akanksha S. Nagpure

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 […]

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 […]

Mr. Kashif Sheikh

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 […]

Ms. Neha Barai

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 […]

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.

Page 1 of 212