BfR research project to enhance the quality of registration dossiers on chemicals
The European chemicals regulation REACH stipulates that chemicals may only be used in the European Union (EU) if the health risk that emanates from them has been suitably controlled. Manufacturers must register all chemicals with the European Chemicals Agency (ECHA) by means of a registration dossier. "In our research project, we have checked the completeness of the registration dossiers and assessed whether they comply with the requirements defined in the REACH regulation," explains BfR President Professor Dr. Dr. Andreas Hensel. "If data is missing, criticism is called for, because it increases scientific uncertainty and makes it more difficult to estimate health risks," Hensel continued. "The responsible European Chemicals Agency has already implemented and planned measures to improve efficiency during the compliance check".
In the ‘REACH Compliance’ research project, the BfR in collaboration with the Federal Environment Agency (UBA) examined the quality of registration dossiers in a comparison with the information requirements of REACH. The information contained in 1814 registration dossiers on substances in the quantity band above 1000 tonnes per annum (tpa) in March 2014 was checked in order to verify that it contained the necessary information on human toxicity, eco-toxicity and exposure to the environment. The checks were later expanded to include substances in quantities of 100-1000 tpa and additional 2053 dossiers were scrutinised. The check comprised primarily the information obligations for high-tonnage substances which must be fulfilled in addition to the information requirements for low-tonnage substances, e.g. on the long-term health effects of a substance. The BfR established that for substances above 1000 tpa, the information on a total of eight examined endpoints was assessed on average in a third of the registration dossiers as being in conformance with the REACH requirements according to the specifications of the project. Important data were missing in another third and additional 33% of the registration dossiers could not be conclusively assessed within the scope of the project.
In the quantity band 100-1000 tpa, an average of 45% of the information checks made on the examined endpoints ultimately proved to be in conformance with the REACH requirements. Around a quarter of the endpoint checks made in the registration dossiers showed shortcomings in the form of data gaps on the one hand and in the justification of data waivers on the other.
It cannot, therefore, be concluded that all of the dossiers in question are incomplete. In order to avoid unnecessary tests with animals, it is an important obligation of the industry to examine data waiver options and opportunities for data fitting and make use of them whenever possible. The requirements of the REACH regulation are very complex and demand a step-by-step approach which builds on all available data which sometimes also depends on the results of studies conducted within lower tonnages, as well as a justified reason for data waivers pursuant to the information requirements and defined exceptions outlined in the annexes to the REACH regulation.
The project results concur with the results of the quality reviews conducted by ECHA which see no necessity to request more data in roughly one-third of the dossiers.
The European Commission has also ordered ECHA to considerably expand the scope of legally prescribed compliance checks of registration dossiers. Although the responsibility for these compliance checks lies with ECHA, the Union legislators in the REACH regulation have stipulated that ECHA only has to conduct quality assurance checks for 5% of the registration dossiers of a tonnage band (1-100 tpa, 100-1000 tpa, >1000 tpa). In its strategic plan for 2019 – 2023, ECHA describes dossier quality as a new priority and plans to significantly increase in the number of quality checks along with the streamlining of the process.
About the BfR
The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.
This text version is a translation of the original German text which is the only legally binding version.