ECHA Newsletter

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Johanna Salomaa-Valkamo

Editor:
Päivi Jokiniemi

Article related to: News from ECHA

Getting to grips with REACH information

The REACH Regulation aims to improve understanding on the chemicals used in Europe by making information available on their impact and safe use. So far, the REACH database contains information on more than 8 000 chemicals on the EU market from over 33 000 registration dossiers. The amount of data has grown enormously compared to the past. How is ECHA making the best use of this information? ECHA Newsletter finds out.

It has been said that prior to REACH, for over 85% of the chemicals produced in high volumes basic information was unavailable. The introduction of REACH has made a huge improvement: there is now a lot of information available. "To have this data is the first great step of REACH," says Mike Rasenberg, ECHA's Head of Unit for Computational Assessment.

"However, this also means that we have to change the way we work in ECHA. In the past, we were looking at chemicals one by one, now we have the challenge to make best use of all the information that we have. This is what we are now working on."

ECHA want to use the data in the most efficient way possible. "The fact that the REACH registration process is automated is one example. IT screening of dossiers and targeting areas of concern for compliance checks are another," Mr Rasenberg says.

Mike Rasenberg.

Putting our effort where it matters most

ECHA is using IT tools more and more to analyse the information it receives in registrations or C&L notifications. "With IT screening, we are trying to spot where there are potential problems, inform registrants of them and support them in making improvements. It also helps us to make sure that we use our resources in the right way; that we use the regulatory and other measures, such as informal advice, in a cost-efficient mix," Mr Rasenberg points out.

A recent example of IT screening is intermediate registrations. ECHA screened all 5 500 intermediate registrations and found inconsistencies in nearly 2 400 dossiers. It wrote to 574 registrants and invited them to improve the information. "We are pushing registrants to make sure that what they put in the dossier makes sense. With intermediates, many had made an administrative mistake, which was easy to fix," Mr Rasenberg says, and continues, "We have now received over 2 000 dossier updates and are left with less than 300 cases where the registrant did not act. We are now concentrating on those."

Helping with compliance checks

IT screening also helps by exposing areas of concern for compliance checks, where ECHA aims to check at least 5% of the dossiers motivated by the 2010 deadline by the end of 2013. According to Mr Rasenberg, this 5% might sound like spot checking, but with IT helping, 5% is a lot more. "We are actually looking at the entire database with ‘IT-eyes'. Based on the manual assessment of the dossiers, for instance during evaluation, we spot issues. These issues, which we prioritise by endpoints that matter most, enables us to develop screenings to identify all dossiers with similar inconsistencies. After manual verfication, we can send them all the same draft decision," he says.

ECHA is now starting to look at the chemical safety reports. "We are now able, to some degree, to analyse also text files with the help of computers. For instance, based on the classification of a chemical, we can check whether the expected elements are in the chemical safety report."

Aiming for an integrated approach

Presently, the screenings are done as individual projects, but ECHA is looking to build a more integrated approach that would enable monitoring and measuring the quality of information that it receives in real time. "We want to build an extended REACH-IT, where we could immediately know when a dossier comes in, whether there are inconsistencies where we can help registrants by providing direct feedback; whether there is a compliance issue or whether the substance is a potential candidate for substance evaluation, harmonised classification and labelling or a potential substance of very high concern," Mr Rasenberg says. This is a good service for companies and a faster way of identifying chemicals of concern.

Selecting the chemicals that matter in terms of human health and the environment, is the thread of ECHA's data mining activities. "Data analysis helps us to know what issues industry is struggling with and where we can improve for instance our Guidance. In any case it will help us to define where we should use our resources to be as effective as possible," Mike Rasenberg concludes.

Further information:

ECHA receives updates for intermediate dossiers and announces further follow-up actions, News alert 13 February 2013

Improve you dossier - use the Dossier Quality Assistant

The Dossier Quality Assistant, released in February 2013, helps industry to prepare high quality dossiers. The tool enables registrants to voluntarily check certain areas of the dossiers before submitting them. "Registrants can proactively improve their dossiers before our checks and screenings, by detecting potential inconsistencies themselves," says Mike Rasenberg.

Erwin Annys of Cefic.

The European Chemical Industry Council's (Cefic) Director Erwin Annys supports the tool. "We are grateful to have a tool which checks inconsistencies at an early stage. IUCLID has over 9 000 fields and it is easy to put in contradictory information there by mistake. This will help to harmonise the IUCLID dossier," Mr Annys says.

The downside for industry is that the tool creates a lot of error messages. "We would have hoped that this was introduced at a later stage. At the moment the tool is, unfortunately, seen as an additional burden for the preparations for 2013," says Mr Annys.

Further information:

New tool to support registrants in improving dossier quality now available, News alert 11 February 2013

Interview by Hanna-Kaisa Torkkeli

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Events

October-December 2020

Enforcement Forum:
4-7 November

Biocidal Products Committee:
6-8 October;
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
Analysis:
30 November-4 December (tentative);
7-11 December (tentative)

Member State Committee:
7-11 December (tentative)

Management Board meeting:
16-17 December

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Getting to grips with REACH information

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April 2013 - Issue 2

April 2013

Issue 2