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Targeting evaluation where safety matters most
To streamline the evaluation process, which is among its top priorities this year, ECHA is introducing a new, concern driven targeted compliance check for the registration dossiers from the first REACH deadline. This means screening across all the dossiers for specific concerns. It also means increased efficiency in using ECHA's resources. Wim De Coen, ECHA Head of Unit for Evaluation, explains the new approach.
Compliance checks are a powerful mechanism for ensuring the safe use of registered substances. They assess the quality of the data gathered for complying with the REACH information requirements and the conclusions of the registrants based on this data. This is part of so called 'dossier evaluation' where the requirement of REACH is to check at least 5% of all dossiers from every registration deadline. Compliance checks are intensive multidisciplinary tasks, which require the involvement of scientists with various backgrounds: in analytical chemistry, physico-chemistry, (eco)toxicology, environmental fate, occupational hygiene and more, to cover the multiple perspectives of one single dossier. There is also a legal complexity, especially when evaluation concludes with the need for a draft decision that requires the registrants to update their dossiers with specific information.
Currently, ECHA checks the compliance of dossiers on the basis of a part random, part targeted selection. Based on the experience gained, the Agency is now introducing a new, concern driven targeted selection. "The evaluation process has matured over the last three to four years", explains Wim De Coen, stressing the importance of the annual evaluation reports on the quality of the registration dossiers. "We have seen, during the past years, that there are certain endpoints or certain parts of documentation in the dossiers which need significant improvement. We also know what this could mean for the health and environment safety assessments. So, instead of going one by one, dossier by dossier, we decided to go for a concern driven approach."
From now on, a significant part of ECHA's compliance checks will focus on specific endpoints or elements rather than assessing the full dossier in one go. "We will systematically screen like a radar across the entire registration database for selected types of concern", says Wim De Coen. He also clarifies that full compliance checks, which are based on random selection and give everyone a fair chance to be selected, will continue. Currently, they represent about one quarter of all compliance checks, but he expects that their share may change over time. "If dossier quality is gradually improved over time, we can expect an increase in the random selections".
EXAMPLES OF CONCERNS
The first screening of the dossiers has already started and by the autumn ECHA will send out the first wave of draft decisions based on the results. Wim De Coen explains that every new wave of multiple draft decisions will potentially have a different focus related to different endpoints.
In the first phase during this year and next year, the focus will be on those endpoints that can immediately be linked to persistence, bioaccumulation and toxicity (PBT) and to the carcinogenic, mutagenic and reprotoxic (CMR) properties of the substances. "It is exactly for such endpoints, that significant improvement in the data was needed in the past. Now with REACH, one of the aims is to generate sufficient and good quality data for the safety assessment", reminds Wim De Coen. He stresses that reliable risk management measures can only be taken if the good quality data are used to underpin credible and scientifically sound safety assessments. To illustrate the approach, he mentions genotoxicity and aquatic toxicity as examples of endpoints that will be looked upon in this concern-based approach. The focus of the Agency is initially on whether the intrinsic properties of substances have been documented. Step-by-step, there will be more attention on how the conclusions have been made and then on the core of the chemical safety assessment. "You can only have good conclusions if you have good data", he points out. "If you have systematically failed to address the PBT properties for example, how can the PBT assessment be credible?" He also refers to the excessive use of waving statements without scientific justification and mentions that such dossiers are much more likely to be selected for compliance check.
The new approach also targets other types of general concern, such as missing chemical safety reports, and separate submissions. "Joint submission is not an option, it is a REACH requirement", Wim De Coen explains, drawing the attention of both current and future registrants. "Companies who have not submitted jointly will automatically undergo a targeted compliance check", he warns and adds that this is also on the radar of national enforcement authorities.
A WAKE UP CALL FOR COMPANIES
Wim De Coen is quick to underline that if a registrant receives a draft decision related to a specific concern, it is not a sign that the rest of the dossier is fully compliant. "Every draft decision should be seen by companies as a wake up call for them to look at the entire dossier. It is very possible that a few months later another draft decision could follow for the same dossier, but for another endpoint."
Receiving a draft decision is a wake up call. Receiving a second one is worrying and a third is serious. "In that case, you have to revise the overall registration strategy or the data generation strategy of the Substance Information Exchange Forum (SIEF)."
His best advice to registrants is for them to carefully read the recommendations in the annual evaluation report as soon as they have received a draft decision. "Even better… do not wait for the outcome from a compliance check but be proactive. Update voluntarily on the basis of our current recommendations."
A LEVEL PLAYING FIELD
The new concern driven compliance check is rewarding for companies that are doing a good job to comply with REACH. It treats all registrants equally, using the same benchmark and at the same time. It also increases ECHA's efficiency. "First of all, it gives us the advantage of selecting those endpoints that are considered critical for safe use. Secondly, if you have a group of scientists that are looking through all the dossiers at the same endpoints, there will be more consistency. Also, from a legal point of view this new take on compliance checks is more efficient", says Wim De Coen. With the new draft decisions, which will be sent by ECHA in waves, all the registrants who have to correct the same mistakes will get exactly the same message at the same time. "We want to ensure that the resources we spend on evaluation really matter and have an impact. It is not just about checking the boxes, because the boxes have to be checked, it is about creating a quality-based level playing field for all registrants. "
The new compliance check approach directly supports two of the main strategic objectives of ECHA and REACH – the quality of data about the chemicals on the European market and the need to address the substances of concern. "It is not about having the quality of information because it is nice to have", he says. "It is about having quality information that will ensure the safe use of chemicals and efficient spending of the tax payers' money."
There are still at least 800 dossiers to be checked before the end of 2013 when ECHA has set the date to evaluate 5% of the existing dossiers. However, compliance checks are not going to stop there. "We will continue beyond 2013", says Dr De Coen. "It is about the safety of chemicals and if it is poorly documented, we will have to act."
To read ECHA evaluation reports and follow the new targeted compliance check approach, visit ECHA's website.
Interview by Virginia Mercouri
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Biocidal Products Committee:
30 November-4 December (tentative)
Committee for Risk Assessment:
6-8 October (RAC-52B);
30 November-4 December (tentative);
7-11 December (tentative)
Committee for Socio-Economic
30 November-4 December (tentative);
7-11 December (tentative)
Member State Committee:
7-11 December (tentative)
Management Board meeting: