ECHA

Good quality information in registration dossiers is fundamental for the success of REACH in ensuring the safe use of chemicals. Without reliable information, it is not possible to carry out appropriate chemical safety assessments and to put the necessary operational conditions and risk management measures in place. Concerns about the quality of data have, however, been raised by the Agency in the annual evaluation reports as well as by external stakeholders. ECHA Newsletter asked Director of Registration Christel Musset why quality matters and what ECHA has done to support companies to improve their dossiers.

 

The quality of REACH data has been a hot topic in recent years. Could you explain to our readers why it is important to improve the quality of information in dossiers, and what ECHA is doing about it?

High-quality data is important for both industry and authorities.

For industry, it is crucial that the information in the registration dossiers supports appropriate communication in the supply chain through the extended safety data sheets. A high-quality registration signals that adequate safe use advice is given further down the supply chain, eventually to the end users like consumers and workers.

For the authorities like ECHA and the national authorities, it is important for the regulatory work done, for example, identifying substances of very high concern.

Good data enables effective decision making for further risk management measures and leads to better information being published for the general public.

Our first strategic objective for 2014-2018 is to ‘maximise the availability of high-quality data to enable the safe manufacture and use of chemicals'. We have taken a number of actions to achieve this objective, including a campaign to improve the substance identity information in the registrations; reviewing the use descriptor system* to ensure a better identification of uses; enhancing the support and tools available with a special focus on the next registration deadline in 2018; and putting in place more efficient processes for evaluating the information received and giving feedback to registrants on how to improve.

In 2015, we will launch an improved public database of chemicals with simpler information that is more accessible for non-scientific users.

 

Christel Musset, Director of Registration.

How is ECHA helping companies to improve their dossiers?

ECHA has developed a wide range of support material and tools over the years. The Dossier Quality Assistant (featured in the Validation assistant plug-in for IUCLID) is one of the main tools that ECHA offers to help companies improve. It can be used to check registration dossiers before they are submitted to ECHA. It gives companies an overview of the main inconsistencies found in the dossiers and advises on how to fix them.

We have also launched a web page called ‘How to improve your dossier', which is a one-stop shop where registrants can easily find practical support to enhance the quality of their data. It includes information based on IT screenings of registrations for intermediates and recently on substance identity; the Dossier Quality Assistant; and webinars.

In addition, the annual evaluation reports highlight the lessons learnt from dossier evaluation and give practical recommendations for registrants on how to improve their dossiers.

On top of the support offered by ECHA, the industry associations are an important source of information for companies. We work closely with many of the associations (they are accredited stakeholders of ours) and they provide valuable sector-specific support to their members.

Companies can also always seek advice from the network of national helpdesks and the ECHA Helpdesk, which can help with registrant-specific questions.

 

You mention IT based screening on substance identity. Could you tell us a bit more?

We conducted an IT-based screening on information elements for the substance identity of all REACH registrations. Over 400 companies whose registrations were picked up by the screening received a letter from ECHA at the beginning of April giving advice on how to fix the identified shortcomings. We sent altogether 1 350 letters. Companies were given three months to update their registrations. First updates are now coming in and a number of companies have also contacted ECHA to agree on their update strategy.

Our aim with these letters is to help industry to proactively improve the quality of their information before we follow up with heavier regulatory actions such as a compliance check.

In addition, those registrants whose dossiers were picked up in the screening were invited to a webinar on substance identity held on 30 April. The presentations and recording of this webinar are available on our website for all to see.

Additional IT screenings may be done in the future as they appear to be an efficient and effective way to inform companies about potential improvements which often trigger companies to update their dossiers.

 

What are your top three tips for companies that want to improve the quality of their dossiers?

Firstly, companies should consult the web page ‘How to improve your dossier' before updating their registration or submitting a new one. On this web page they can find out what ECHA expects from a good quality dossier. This page also includes links to the annual evaluation reports.

Secondly, registrants should use the latest version of the Dossier Quality Assistant and address the issues identified by the tool before submitting their dossiers to ECHA through REACH-IT.

Lastly, it is very important to keep the registration dossier up-to-date - for example, if new information becomes available. It is good practice to review the registration to make sure that it is in line with the latest advice on safe use and current supply chain practice, and that all new uses are described and covered by the chemical safety report, where applicable. Only in this way, can we continue to make sure that chemicals are used safely in the whole supply chain.

Remember that the regulatory decisions made by authorities are based on the information in the dossiers. By making sure that the information responds to the situation at hand, companies can potentially avoid unnecessary regulatory scrutiny while helping ECHA and national authorities take the right decisions, for example, in determining a need for further risk management measures.

 

*Use descriptor system: a system developed by ECHA to describe uses and standardise the descriptions in the supply chain. The system will facilitate the identification of uses which needs to be provided in the registration dossier, the building of exposure scenario and short titles and the communication up and down the supply chain.

 

Further information:

How to improve your dossier

Evaluation reports

Webinars

e-News 9 April 2014:
ECHA targets substance identity - letters sent to companies with shortcomings in their registrations

 

Interview by Mercedes Viñas and Annika Mälkiä

Top image: Fotolia