Archive:Chemicals - monitoring REACH with indicators

Since June 2007, REACH, the new European Union (EU) Regulation on the Registration, Evaluation, Authorisation and restriction of CHemicals', is in force.

Eurostat, in collaboration with the services responsible for environment and for industry of the European Commission, has developed a baseline study and a set indicators to monitor the implementation of REACH.

The baseline study can measure progress towards two major objectives of REACH: to ensure a high level of protection of human health and the environment as well as enhancing innovation in the development of safer chemicals.

In 2009, the first assessment was made. It presented a baseline of the (nominal-) 'risk' caused by chemicals and the 'quality' of the underlying data which was available when REACH came into force in June 2007. In 2012 a second 'risk and quality snapshot' was taken.

This article provides an overview of the methodology and the assessment of the main changes from the first study in 2009 to its update in 2012.

Figure 1: The REACH baseline study - a tool to monitor the new EU policy on chemicals

Main statistical findings

Background

Work carried out by Eurostat in the field of 'Chemicals management statistics' dates back to the period from the mid-1990s to 2000 when some Environmental Pressure Indicators (EPI) related to chemicals were developed. Recent priorities of Eurostat have been the development of indicators on toxic- and environmentally harmful chemicals. They measure progress towards the headline objective for ‘public health’ established in the EU - Sustainable Development Strategy and towards the long term vision of a non-toxic environment as set out in the 7th Environmental Action Programme for the European Union.

REACH introduces a new era of chemicals policy in Europe. It will increase our knowledge of the hazardous properties of chemicals. It is expected to enhance the communication and implementation of conditions of safe use in supply chains and the substitution of dangerous substances by less dangerous ones. Through different types of measures, REACH is expected to cause a decrease in risks to human health and the environment associated with the use of chemicals (see Figure 2).

Did activities related to REACH already reduce the risk caused by chemicals? How did the quality of the underlying data evolve? This article, based on the two comprehensive assessment reports aims to make the methodology better known and to trigger the discussion on the results.

The http://ec.europa.eu/eurostat/statistics-explained/index.php/Chemicals_-_monitoring_REACH_with_indicators

Policy monitoring by indicators

Figure 2: Possible evolution of the risk caused by chemicals

It is difficult to foresee which reductions in the real risks caused by chemicals will be a result of REACH; different risk evolutions are also possible. The European Commission has therefore developed the REACH Baseline Study as an instrument to monitor which evolutions really occur. Has our limited knowledge about the properties of substances and their safe uses increased due to REACH? The REACH Baseline Study aims to provide an indicator set to monitor whether such changes take place or not — indicating the success of REACH. In doing this, the focus of the Baseline Study is not restricted to indications for the risk itself. The indicator system also enables changes in the quality of the public data on substances and their safe use to be detected. A first ‘snapshot’ has been taken in 2007 for a picture of the situation before REACH (“Pre-REACH-Baseline”). A second snapshot has been made in 2012. Further assessments can follow. Comparing the pictures allows for monitoring and assessing the success of the REACH legislation.

The 'risk and quality' indicator system

Table 1: The objectives of REACH and the indicators to measure progress

The central element of the REACH Baseline Study is the risk and quality indicator system. It tracks two major goals of REACH: • reduction in the risks of chemicals for humans and the environment as well as • improvement in the quality of publicly available data.

Risks to three impact areas (see Figure 3) are addressed: the environment, workers and the general population. Impacts on the general population are divided into direct impact on consumers (resulting from the use of chemicals e.g. paints or glues) and impact on humans via the environment (e.g. drinking water).

Figure 3: The impact areas addressed by the REACH baseline study

This indicator system directly assesses the nominal risk caused by exposure to chemicals and characterises the quality of the data on which this risk assessment is based. These characterisations can be followed over time.

Since the calculation of the risk and the assessment of the quality is not manageable for all of the (approximately) 30 000 substances within the focus of REACH, a subset of 237 substances has been selected from the known high (HPV), medium (MPV) and low (LPV) production volume chemicals (approx. 10 000 existing substances in volumes >10 tonnes/year as reported to the European Commission). It includes 27 substances of very high concern (SVHC).

This set is considered large enough to detect with sufficient sensitivity changes taking place in the risks related to these chemicals and the quality of the databases for their assessment. Two figures are calculated for each reference substance: the 'Risk Score' and the 'Quality Score'.

Risk score

Figure 4: Aggregated baseline risk scores

The risk score is a nominal value that indicates to what extent a risk could be associated with the production and use of the substance. This score can range from far below 1 to 10000 and more. High risk scores are indications of high risk; however, no attempt to define a value discriminating risk from no-risk has been made.

In order to determine the risk score, an exposure assessment and a toxicity assessment have to be made. Data on production volumes, use patterns and physico-chemical properties are needed to assess the exposure. Toxiclogical data are required for the assessment of the effects on human health (workers, consumers, humans via the environment) and eco-toxicological data ;for the effects on the environment.

Graph 4 presents the aggregated baseline risk scores for workers, consumers, the environment and humans via the environment (GM = geometric mean of aggregated baseline risk score, DBE = dibutyl ether)

Quality score

Figure 5: Aggregated quality scores

Data sets can be of very different quality: If input data are highly uncertain (default assumptions) the quality of the assessment is regarded as poor. If representative monitoring data and a well defined threshold value are available, the quality of the assessment is regarded as good. A score which ranges from 1 (very good quality of data) to 100 (very poor quality of data) characterises data quality. This quality assessment is a key element of the risk and quality indicator system.

It is expected that REACH will lead to more complete testing of toxicological properties, to better data provided by alternative testing methods such as modelling, improved reporting, and better information on exposure.

Figure 5 presents the aggregated baseline quality scores for workers, consumers, the environment and humans exposed via the environment (geometric means of aggregated baseline quality scores).

Results: Snapshot 2007, setting the baseline

In order to rank the aggregated baseline risk score, it is helpful to know that a risk score of 0.1 would certainly be called 'low', whereas a risk score of 1000 would certainly be called 'elevated'. However, calculated risk scores for the substances vary over a much wider range. Additionally, the risk scores between workers, consumers, the environment and humans via the environment are not comparable due to differences in the methodology. Therefore, no upper or lower bounds were set. Instead, it may be helpful to compare the mean risk score for the substances with the risk scores of well known substances.

For the impact areas workers, consumers, the environment and humans via the environment, the results for the reference substances chlorine, benzene, butadiene, dibutyl ether (DBE), ethyl acetoacetate and aniline are indicated in Figure 4. The reference substances show risk scores that spread over a wide range. In a future snapshot, the risk scores will be calculated with then available updated data. The risk scores should move to the left to demonstrate the success of the measures undertaken.

At this level, the calculated mean risk and quality scores are mainly intended for comparison to later points in time, i.e. in the year 2012 or later. The change over the years in the aggregated baseline risk scores and quality scores may become a headline indicator for political communication. As these single figures are much too complex for further interpretation and analysis, disaggregated levels are supplemented. The quality score and the risk score cannot be amalgamated into a single figure. Moreover, any comparisons between different impact areas should be strictly avoided. Such comparisons would be a misinterpretation because — for example — different reference points for risk calculations are used in different impact areas.

Outlook: Snapshot 2012

Figure 6: Desired results after 5 years of REACH: Lower risk and better data for most high production volume substances

Figure 6 illustrates the 'desired' result from five years of advanced protection of the environment and human health due to REACH and corresponding chemicals legislation: A 'movement' of the bulk of the reference substances, mainly the high production volume substances, to the part of the figure where the exposures and toxicity are well known, indicating that risk has been reduced or no risk is expected. In 2012, in the frame of the first report to the European Parliament and to the Council on the experience gained through the operation of REACH, a second 'snapshot' will be taken in order to see whether REACH has already reduced the (nominal) risk caused by chemicals by that time and to see how the quality of the underlying data has evolved. Further snapshots can then be made later. Comparing the results should enable the success of the REACH Regulation to be monitored and assessed.

Data sources and availability

The data used for the calculation of the baseline scenario and the indicators have been obtained from different data sources or by modelling according to the Guidance Documents on Information Requirements and Chemical Safety Assessment. A main source for production statistics is the PRODCOM database (Eurostat). Movements of chemicals have been calculated by the use of the foreign trade statistics database COMEXT (Eurostat). The chemical and toxicological properties and the information on use patterns have been obtained from IUCLID (International Uniform Chemical Information Database, ECHA and Eurostat).

Context

The Sixth Environment Action Programme 2002-2012 (sixth EAP) requires a complete overhaul of EU policies on chemicals management, of which REACH is the central element. The major objective of REACH is to ensure a high level of protection for human health and the environment. This includes promoting alternative methods (to animal testing) to assess the hazards of substances, the free circulation of substances on the internal market, and the enhancement of competitiveness and innovation in the EU chemical industry.

By increasing knowledge about the hazardous properties of chemicals, REACH is expected to enhance the communication and implementation of conditions of safe use in supply chains and the substitution of dangerous substances by less dangerous ones. Through different types of measures, REACH should lead to a reduction of the risks to human health and to ecosystems.

Further Eurostat information

Publications

Main tables

Sustainable Development Iindicators

Indicators

Public health

Sub-theme: DETERMINANTS OF HEALTH

Index of production of toxic chemicals, by toxicity class (QP)

External links