REACH at a Glance

When registration according to the REACH guideline became mandatory as of 2007, the focus was placed on the first registration of all chemicals available in the EU.  In most cases a dossier for registration was prepared.

Besides substance identification, initially, only limited experimental data (acc. to Annex VII and VIII) from the REACH testing requirements were generated.  Alternatively, it could be waived through modelling or by referring to existing data of comparable substances. From the submitted dossiers, only about 5% had been checked by ECHA for completeness and were evaluated for additional requirements. Currently, more than 23,000 unique substances are registered in ECHA’s database.

What has changed and what is the current situation?

Since early 2020, ECHA has begun reviewing the submitted dossiers for all registered compounds. In order to manage the complexity, ECHA is prioritizing substances based on their tonnage level, focusing on high tonnage band substances and those ones with high-potential safety issues for example PBT and vPvB (PBT substances are substances that are Persistent, Bioaccumulative and Toxic and vPvB substances are substances that are very Persistent and very Bio-accumulative)

Since the beginning of 2020, we have observed two major changes in study requests driven by ECHA:

1. More requests for dossier updates and completion in accordance with the Annex based study requirements (mainly environmental safety and higher tier toxicology data)

2. Rejection of TOC-based (Total organic carbon) - based analytical data mainly for UVCB’s (unknown or variable composition, complex reaction products or of biological materials) and compounds with low water solubility) to be substituted by substance - specific high end analytic. Also, requests from ECHA are becoming stricter and read-across or waiving arguments are often not accepted.

The fact that ECHA is reviewing the content of dossiers more strictly has a recognizable impact on the current testing environment. In the past, registrants tended to favor the most basic study designs and, wherever possible, waivers.  There is now a clear shift in demand towards high quality data endpoints to enable a successful registration. A shift towards a superior, solution-oriented business model is currently underway.

Additionally, there is a strong increase for aquatic studies and a shift towards analytical capabilities. This is driven by the fact that a substance-specific high end analytic under GLP conditions became mandatory.  As a result of this increased demand, the industry is seeing longer lead times from service providers which means that planning is essential to meet deadlines.

With our holistic approach, long-year expertise in higher tier studies and our extensive state of the art analytical equipement Eurofins is ideally equipped to support our clients with these challenging requirements.