ECHA

The publication of the Community Rolling Action Plan (CoRAP) at the end of February starts up a new process in REACH: substance evaluation. The aim of substance evaluation is to clarify whether the manufacture or uses of a chemical substance pose a risk to human health or the environment.

Substance evaluation is an integral part of the REACH implementation. It is one of the three evaluation processes under REACH, the other two - examination of testing proposals and dossier compliance checks – are also collectively known as dossier evaluation."The basic difference between dossier and substance evaluation is that dossier evaluation aims to ensure that the standard information requirements are fulfilled in each registration dossier, whereas substance evaluation starts from a potential concern for human health and the environment. To clarify any potential risk, the registrants may be asked for information beyond the standard information requirements", says Claudio Carlon, one of the ECHA Heads of Unit for Evaluation. Another difference is that substance evaluation is carried out by the Member States, while ECHA primarily evaluates dossiers under dossier evaluation.

Substance evaluation involves an assessment of all registration dossiers from all registrants of the same substance. "With substance evaluation we cross read the information from all the registrants of the same substance and we can assess concerns that go beyond the control of the single registrant. For example we see better the potential effects coming from the cumulative exposure from different sources of the same substance", says Mr Carlon.

COMMUNITY ROLLING ACTION PLAN LISTS THE SUBSTANCES TO BE EVALUATED

The Community Rolling Action Plan (CoRAP) specifies the substances that are to be evaluated over a period of three years. The first CoRAP addresses 90 substances that are suspected of posing risk to human health or the environment. These substances are to be evaluated in 2012, 2013 and 2014. The plan also indicates which Member State is responsible for the evaluation of each substance. The selection and prioritisation of substances for evaluation is made according to risk-based criteria, which include hazard and exposure information as well as the aggregated tonnage of the registrations. These criteria are refined in collaboration with the Member States.

In 2012, 36 substances will be evaluated by 17 Member States. The rolling nature of the plan means that the plan is annually updated to cover the following three years.

SUBSTANCE EVALUATION PROCESS

From the publication of the CoRAP, the evaluating Member State has, for those substances to be evaluated in that year, 12 months to consider a need for further information to clarify the concern and to prepare the request in the form of a draft decision. The draft decision is sent to the registrants for comments, and to the other Member States and ECHA for possible amendments. ECHA will then adopt the final decision. "We have a clear responsibility in planning and coordinating the overall process. We are ready to support the Member States on the administrative, scientific and legal aspects of the substance evaluation, and we also offer the possibility of a consistency screening during the preparation of draft decisions, in order to ensure that the process is harmonised across the EU. This is very important especially in the first years", explains Mr Carlon.

OUTCOME OF SUBSTANCE EVALUATION

It can be that the Member States clarify the risk without the need to request further information. However, substance evaluation is expected to very often result in a request for further information from the registrants of a substance. The registrants are legally bound to submit the information specified in the final decision.

The request for further information might be needed to confirm certain hazard effects, relevant exposure routes or both. The way the registrants provide this information is through a dossier update. The conclusion might also be that the risks are sufficiently under control with the measures already in place. In other cases the generation of new information might lead to the identification of further risk management measures to be put in place by the registrants. "Substance evaluation can lead to the confirmation of concerns but also to the identification of adequate risk management measures by the registrants. So, certain suspected hazardous properties, for instance, can be confirmed but at the same time the registrant can decide to put in place risk management measures to adequately control them", says Mr Carlon and continues, "in some cases, however, the information obtained might trigger the proposal of Community level risk management measures. This could happen, for instance, when specific measures need to be ensured and harmonised across Europe, or when the risk management is beyond the possibility of action for single registrants, as for the effects of aggregated emissions." Mr Carlon stresses that substance evaluation is focused on the production of all necessary information. "The two evaluation processes (dossier and substance) are the only processes under REACH to request more information. Substance evaluation is an instrument for the Member States to get all the information, also beyond standard information requirements, that is required to assess the safe use of chemicals and the need for any further risk management measures."

It is the responsibility of the evaluating Member State to complete the evaluation and consider whether the concern is clarified and no action is required, or whether Community level risk management measures should be proposed. These proposals may refer to processes under the REACH and the CLP Regulations, such as restriction, authorisation or harmonised classification and labelling, but possibly also to other regulatory instruments in the field of occupational and consumer safety or environmental protection. "The final aim is not to produce peer reviewed EU risk assessments. The time schedule of the process does not allow this. The final report is the conclusion of the evaluating Member State only, and has a very functional role under REACH for the further actions to be taken", Mr Carlon points out. Eventually, the reports will be published on the ECHA website.

UPDATING THE CORAP

The first decisions expressing the need for further information from the registrants are expected in early 2013. But the CoRAP is a rolling plan and the work for the next annual update has already started. "In the next CoRAP update in 2013 we foresee the need to identify a good number of new substances for the list because Member States are able to evaluate more substances than what is anticipated at the moment for the second and third year, and because we have to add substances for the year 2015. In addition, the inclusion of some substances in the plan for 2013 and 2014 might be revised and eventually be withdrawn from the CoRAP. For instance, if new information becomes available clarifying the concern, or if we consider other substances to be of higher priority", Mr Carlon explains.

The screening for new substances has already started, in collaboration with the Member States. "We apply our prioritisation criteria to screen all the registration dossiers and shortlist potential substances that may cause concern. This is initially done by using IT applications. Then a manual screening is done, which means that ECHA and Member States' experts open the dossier, examine the information and assess whether the concern picked up by the automated screening is confirmed", Mr Carlon illustrates. "For the update of the next CoRAP covering 2013, 2014 and 2015 we have strengthened our cooperation with the Member States and planned a joint project to share and enhance our capacity of manual screening."

ECHA recognises that companies may be concerned about substance evaluation. Therefore, the aim is to make the process very transparent. "We have produced communication material, such as a Q&A and a fact sheet to clarify the nature of the process and what the registrants and the general public can expect as a result. The process is new and we want to respond to concerns that our stakeholders might have", Mr Carlon concludes.

Interview by Hanna-Kaisa Torkkeli
Image: Claudio Carlon