ECHA

The REACH Regulation has led to an improvement in the quality of data available for the assessment of chemicals as well as better control of risks according to the five year update of the REACH Baseline Study. The study was published in 2012 as part of the REACH Review and is based on a comparison of the situation between 2007, pre-REACH, and 2011.

The baseline study uses a certain indicator system to track the two major goals of REACH: reduction of the risks of chemicals to humans and the environment; and improvement in the quality of publicly available data.

The study refers to a set of 237 randomly selected reference substances, which will be followed until 2022, when the 15 year update of the study will be published. The statistical sample was designed together with EUROSTAT. The five year update concentrates on 62 substances that are either high production volume substances or substances of very high concern. These substances were to be registered by the first REACH deadline of 31 November 2010.

The methodology to calculate the nominal risk of the reference substances follows the same logic as the REACH chemical safety assessment. Exposure estimates and toxicity estimates are the key parameters to calculate the risk characterisation ratios (RCRs) and risk scores for the reference substances. In addition, a specific ranking system has been developed to assess the quality of the toxicity data and the exposure data. Both risk scores and quality scores are determined for four impact areas: workers, the environment, consumers and humans via the environment.  

Dirk Bunke. Image: Ökö-Institut.

The five year study concludes that, due to the REACH registration, there has been a significant improvement in the knowledge on substance properties and exposures from 2007 to 2011.

"Registration of high volume chemicals under REACH leads to a considerable improvement in the quality of the data available for the assessment of these substances. In addition, a marked decrease has been found in the risk characterisation ratios from 2007 to 2011. This indicates a better control of risk. It is largely believed to be due to REACH," says Professor Dr Dirk Bunke from the German Ökö-Institut, one of the contractors for the study.

Thanks to REACH registration, for the first time for many substances, existing data has been used to calculate toxicity estimates such as derived no effect levels (DNELs), derived minimum effect levels (DMELs) and predicted no effect concentrations (PNECs).

"In addition, more detailed information has been gathered on exposure situations, for example whether industrial or professional spraying takes place," says Jan Oltmanns from the Research Institute FoBIG, another contractor for the study.  

Benefits of REACH are concrete

According to Dr Bunke, the chemicals industry and anyone who uses chemicals, benefit from the increased knowledge on how to use chemicals safely. "The industry and other actors have a more profound knowledge about the conditions of use. This knowledge enhances the ability to recommend appropriate risk management measures."

As a concrete example Jan Oltmanns gives one reference substance, which is used in many different work places. "At baseline (2007), there was not much information available on the toxicity of the substance. We therefore had to derive a surrogate value for occupational exposure at the workplace simply from knowing that the substance is irritating to the skin. Obviously, this is a very rough procedure. For REACH purposes, registrants derived a DNEL for this substance at the workplace on the basis of an experimental repeated dose toxicity study, which led to better quality data. In terms of exposure, we only knew at baseline that the substance may be present in dusts in the occupational setting, for which we had to apply a default value because of a lack of information. Due to REACH, registrants performed exposure modelling and clearly identified the operational conditions and risk management measures required at the different workplaces and for the different handling of the substance. This clearly improves the exposure assessment compared to the situation at baseline," he says.

Challenges

The study, although very promising, gives also an indication of the challenges of REACH. One challenge is that REACH registration relates to a huge number of substances and the results cannot be seen overnight. "A robust assessment of substance properties, including in many cases exposure estimations and risk characterisations, takes time and requires expertise," Dr Bunke says.

"In addition, knowledge of the use pattern of the substances and the real-life conditions of use is essential for making realistic exposure scenarios. This requires a structured exchange of information in the supply chain," he explains and continues, "even if appropriate instruments have been developed over the years, experience on how to use them is still lacking. It will still take some time before the use descriptor system becomes a real communication tool. In addition, you cannot expect that the end users of chemicals, for example in a car repair shop, are able to understand the exposure scenarios without adapting them into their own sector-specific language."

Next updates in 2017 and 2022 

The study gives a brief preliminary analysis of a small number of medium production volume (MPV) and low production volume (LPV) substances, which already indicates a similar improvement in data availability as for the now assessed 62 substances.

"These medium production and low production volume substances where checked in relation to classification information and availability of reference values for toxicity to humans. Due to the low number of medium and low production volume chemicals included in this preliminary screening, these findings are not representative," Dr Bunke clarifies.

He says, however, that it can be expected that similar improvements in data quality will occur for hundreds if not thousands of substances registered for the second and third REACH deadline. "This can eventually be confirmed by the 10 and 15 year updates of the REACH Baseline Study in 2017 and 2022. We must wait and see."

REACH Baseline Study   The European Commission – EUROSTAT – has developed the REACH Baseline Study as an instrument to monitor the effectiveness of REACH and to see whether decrease in the real risks caused by chemicals are actually a result of the implementation of REACH.   The project team, consisting of the Öko-Institut, FoBiG, DHI and INERIS started work on the REACH Baseline Study in January 2006. The first assessment, setting "the baseline", was performed in 2007. In 2012, the second assessment was presented.

Further information:

The REACH Baseline Study five year update, full and summary reports: