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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
Substance evaluation – a powerful new tool
Testing proposal examinations and compliance checks are evaluation activities done by ECHA but substance evaluation is the role of the Member States. In substance evaluation the focus is on the substance itself, and not on individual dossiers. The task is to find out if more information is needed to understand the potential risk of a substance to human health and the environment. ECHA Newsletter spoke with Member State representatives from Germany and France to learn about their experiences of evaluating substances.
Experts looking into the risks
The annually updated Community rolling action plan (CoRAP) lists the substances that are being prioritised for substance evaluation. The substances are selected by the Member States and ECHA.
|Dr Mark Schwägler. Image: M. Schwägler.|
Although the Member States are involved in screening and proposing substances for the CoRAP list, their key task is to evaluate the substances assigned to their country. "If a substance is listed in the CoRAP and Germany is chosen as the evaluating Member State, we have to clarify whether or not the uses of that substance are a risk to human health or the environment," says Dr Mark Schwägler from the German Federal Institute for Occupational Safety and Health (BAuA). The evaluation is based on data available in REACH registrations and other sources.
Ms Corinne Belveze from the Ministry of Ecology, Sustainable Development and Energy explains that in France, substance evaluations are carried out by the French Agency for Food, Environmental and Occupational Health & Safety (Anses). For each substance, an expert team is created at Anses to carry out the assessment. "The expert team consists of toxicologists, ecotoxicologists and chemists. When needed, external scientific experts may intervene with particular parts of the evaluation, subject to Anses's conflicts of interest rules," she clarifies.
Working with registrants
In substance evaluation, all registration dossiers for the same substance are assessed to find out if further information is needed. Therefore, good cooperation between the evaluating Member State competent authority and the registrants is important. Both Ms Belveze and Dr Schwägler say that industry is contacted at the beginning of the 12-month evaluation period to explain what the substance evaluation process involves.
|Ms Corinne Belveze. Image: ECHA.|
"During the process, Anses sends requests to industry for clarification, and organises informal meetings to discuss specific endpoints or sections of the dossiers," Ms Belveze explains. According to Dr Schwägler, BAuA has a very similar approach. "Until now, in most cases at least one face-to-face meeting has been organised. These meetings help us to better understand the information that the registrants have provided. They also help the registrants to better understand the substance evaluation procedure," he points out.
Although cooperation with registrants during the evaluation has proven to be useful for both parties, the procedure can still be improved. "When discussions are organised before the start of the evaluation, the registrant may be able to update their dossier, which may greatly improve the effectiveness of the evaluation process," Ms Belveze emphasises.
Generating new information to manage risks
The substance evaluation process gives the evaluating Member State the responsibility to assess if there is enough data available to decide on possible risks that the substance may cause to human health and the environment. The outcome of the work will influence future risk management measures.
"Substance evaluation is not necessarily a pre-requisite to the risk management processes," Ms Belveze says and continues, "but it is a key and powerful process in REACH, especially for generating new information about substances for which there is a suspected concern." This is particularly useful when there are data gaps or a lack of available scientific literature. "If there is a risk that cannot be addressed without specific data, substance evaluation allows us to ask precisely for this data. For example, substance evaluation can help us to clarify if a substance meets the criteria to be identified as a substance of very high concern (SVHC)," Dr Schwägler explains.
Tangible benefits for consumers and industry
Thanks to substance evaluation, we will know more about substances and their impact on human health and the environment. According to Ms Belveze, the more industry knows about the substances they deal with, the better they can protect their workers and control possible releases into the environment. Dr Schwägler emphasises that this could also bring substantial reputational benefits. "If a substance evaluation concludes that certain uses are not a risk, it might help industry in demonstrating that chemicals are being used in a safe way. Industry will benefit from an increased confidence in chemical safety".
However, it is not only industry that benefits from the increased amount of information that will be available. "If, for example, a suspected carcinogen can be clearly identified, consumer health will improve because of the increased restriction measures that will be placed on such chemicals," Dr Schwägler concludes.
Substance evaluation in member states
Dr Mark Schwägler works in the German Federal Office for Chemicals (BfC) located in the Federal Institute for Occupational Safety and Health (BAuA). In Germany, several authorities are involved in substance evaluation. The Federal Office for Chemicals is the German competent authority and is responsible for coordinating the work.
Ms Corinne Belveze works in the French Ministry of Ecology, Sustainable Development and Energy which is the French competent authority for REACH. It shares the responsibility for substance evaluation with the French Agency for Food, Environmental and Occupational Health & Safety (Anses). The Ministry defines the policy and sets priorities in terms of substances to be evaluated, while Anses carries out the evaluations.
The next CoRAP update covering 2015-2017 will be submitted to the Member State Committee for its opinion in October. The draft list will be published on ECHA's website by the end of October. The adoption of the list is expected to take place in March 2015.
Interviews by Päivi Jokiniemi
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26 February-1 March
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Committee for Socio-Economic
18-22 March (tentative)
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13-17 May (tentative)