ECHA

With nearly one quarter of the production and use of chemicals in Europe, it is hardly surprising that Germany has volunteered to take the largest share of substance evaluation work during the first year of CoRAP: the German Authorities for REACH will evaluate five of the 36 substances in the plan for 2012.

The task is not only big and broad, but also challenging. Germany has selected substances that are potentially persistent, bioaccumulative or toxic for the environment, or the source of concern for safety for consumers or in the work place. Some of the substances are also high on the public debate. For bisphenol A, which is well known and has been controversially discussed for a long time, the German authorities are now analysing whether the environmental exposure aspects and risks to consumers are correctly addressed and hope that on the basis of this analysis it will be possible to draw final conclusions. They have also initiated informal cooperation on bisphenol A with France, especially with regard to the assessment of human health and the French proposals for harmonised classification and labelling and intended restriction. In Germany the evaluation workload, as other REACH tasks, are shared by the Federal Institute for Occupational Safety and Health (BAuA), which is also the Federal Office for Chemicals, the Federal Environment Agency (UBA), and the Federal Institute for Risk Assessment (BfR).

Another substance evaluated by Germany is tetrafluoropropene, which will be the new cooling agent in car air conditioners. This means that it will enter wide use, but there are concerns regarding the environmental impact and the toxicity of its degradation and/or combustion products. The list of substances to be evaluated by Germany also includes n-hexane – a solvent with neurotoxic properties that have been known for a long time. It is registered under REACH for high volumes and has many industrial uses, but some of them may also be linked to significant human exposure despite the existence of safer substances. Therefore, the main focus in evaluating n-hexane is occupational safety, while for naphtylaniline the aim is to clarify whether it may prove to be persistent, bioaccumulative and toxic for the environment. For iminodiethanol the aim is to verify whether it could form carcinogens during use of the substance in cooling lubricants for metal working.

Elmar Böhlen, who is head of the Unit for Evaluation and Risk Management in the German Federal Office for Chemicals, is quick to point out that the inclusion of any substance on the list as such does not necessarily have direct implications for companies. "Substance evaluation is an open process. It may turn out that our concerns are justified and that regulatory action is required, but it may also be the other way round: the evaluation clarifies that the substance is of no concern. That is why we do the evaluation. Otherwise, we would immediately propose harmonised classification and labelling, authorisation or restriction. Evaluation means that we are not yet certain about the result."

The German authorities are open to dialogue with stakeholders if they want to contribute to the process. "This is our principle and it is true for all steps of REACH and also for substance evaluation", says Mr Böhlen. He also points out that the national authorities are in charge of the substance evaluation, while the main task of industry is to ensure data quality and the safe handling of chemicals through the registration process.

Need for quality registrations

Substance evaluation may result in the request for information beyond the standard requirements of REACH, but Mr Böhlen points out that the most important source of information for their evaluation is the registration data. This will be the basis from which to assess, for example, whether the quality of the tests is sufficient for predicting the concentration and/or deriving the levels below which the use of the substances will not have adverse effects of concern for human health or the environment. "Registration dossiers should be good enough for the purpose of doing substance evaluation. If this is not the case, it would be better to look for general actions to improve dossier quality rather than to request information case by case." Mr Böhlen also shares the view that the good quality of the registration data will not only ease the process of substance evaluation, but also save tax payers' money, as the authorities are paid by ECHA for this work.

Building up cooperation with ECHA

According to Mr Böhlen the registration data and its screening will have much more significance for future updates of the CoRAP than it had on the first plan. "There we expect support from and cooperation with ECHA, so that we can do this more efficiently in the future." This is quite important not only for substance evaluation, but for the entire work of his team, which is also in charge of the dossiers for restriction, authorisation and the proposals for harmonised classification of hazardous chemicals.

In both cases, the work must be based on up-to-date registration data for formal as well as scientific reasons. "What is important for me is to look at all the dossiers, not only those that are already of public concern. There may be some substances hidden in the large number of registration dossiers that are dangerous", says Mr Böhlen and explains that it would be beneficial for the Member States to continue cooperation with ECHA on screening tools that can help them to identify substances that raise concern from the REACH registration database.

A beneficial task

Substance evaluation requires intensive scientific work. Mr Böhlen says that his team now has to divide resources between this and the dossiers on restriction, authorisation and the harmonisation of the classification and labelling. However, he thinks that this can only have a positive outcome, because substance evaluation broadens the basis for further risk management options under REACH, e.g. identifying substances of very high concern. He is convinced that it is wise to invest in substance evaluation. "Neglecting substance evaluation and going directly for proposing further risk management measures only on well known substances would be tempting and even popular, but it would mean, in the end, that the substances which need regulation the most, are not being regulated."

Did you know?

Member States are in the driving seat of substance evaluation under REACH – they agree and refine the criteria for the selection of the substances, they propose (jointly with ECHA) substances for the CoRAP list and most importantly, they carry out the actual evaluation work. Based on the outcome of the scientific analysis, it is the Member States that conclude whether there is sufficient evidence to drop the initial concerns regarding the use of a particular substance or whether there is a need to request further information from the registrants. ECHA's decisions regarding such requests are based on the proposals of the Member States. Furthermore, if the initial concerns are confirmed, Member States may also use the results from the substance evaluation to propose Community-wide measures for addressing the risks through authorisation, restriction or harmonised classification and labelling.

Interview by Virginia Mercouri
Image: Elmar Böhlen