ECHA

Kevin Pollard, Head of the Registration and Dossier Submission Unit, advises companies to get familiar with the submission system and the key manuals, consult the webinars on ECHA's website and pay their registration invoice in time. Follow this and they will be able to submit their registrations and notifications of classification and labelling successfully.

Kevin Pollard.

Kevin Pollard and his team are in charge of the submission pipeline through which the registrations and notifications are received and the company and substance information is checked, invoices created, and the registration number is issued. Then the dossiers move on in a workflow to other units dealing with their contents e.g. dossier evaluation.

Prior to joining ECHA, Mr Pollard was working in the UK competent authority for pesticides, mainly in the field of exposure assessment. He was among the first staff members to join ECHA in autumn 2007 and in February of this year, he was appointed Head of the Registration and Dossier Submission Unit.

Mr Pollard, how are registrations of chemicals submitted to ECHA?

The actual submission of the registration to ECHA relies on two pieces of software, the first one is IUCLID 5 and the second one is REACH-IT. What companies need to do is to compile the dossier in IUCLID 5 and then submit it via REACH-IT.

In general, are companies registering successfully?

The vast majority of companies register their substances successfully. In fact, we have a less than 2% rejection rate for the final registration decisions. However, a number of steps need to take place before the registration number is issued, and for those earlier steps there are slightly lower first time success rates. Currently, approximately 65–70% of the dossiers pass in the initial business rules check which is made to ensure that ECHA is able to process the dossier. Companies who do not succeed at this stage can correct their dossier and resubmit it before the deadline.

What seems to be most difficult for the registrants?

The most challenging aspect seems to have been the work in Substance Information Exchange Forums (SIEFs). Companies are having complex negotiations within the SIEFs to assess the extent of available data and then to assess and share the data and compile, where necessary, the Chemical Safety Report. In terms of the submission itself, the main challenge is passing the business rules – making sure that we have the information we need to process the dossier – and the technical completeness check (TCC) where we verify that the dossier is complete. The other challenge is paying the invoice on time! It is important that companies make arrangements with their financial departments to pay the invoice on time – the law is strict on this. These are three practical areas where companies really need to focus and make sure they understand the system.

What else could help registrants succeed in registering?

It is very important that companies take a close look at the technical manuals and other information which assist in ensuring that the business rules and technical completeness check can be successfully carried out. For both the business rules and the technical completeness check there is a IUCLID 5 plug-in called the TCC tool which allows companies to pre-check their dossiers. This tool checks all of the TCC rules and the majority of the business rules. It is absolutely essential that companies do that, and this will give a much greater security of successfully meeting the deadline.

What is ECHA doing to help the registrants?

In addition to the technical manuals, ECHA has carried out quite an extensive information campaign including a series of detailed technical webinars, which are available on our website to assist with dossier compilation and submission. And on top of that, there has been a Directors' Contact Group working with representatives from the Commission, industry and ECHA, to identify and solve any outstanding issues during the lead up to the deadline.

How can a company submit a notification of classification and labelling to ECHA?

You always submit via REACH-IT on ECHA's website. We have a range of different methods for preparing the notification. The most straightforward method is to make your C&L notification directly online via REACH-IT, and this is a system which has been deliberately kept as simple as possible. For companies having a large portfolio of substances for which they need to submit a C&L notification, there are other systems. They can make a bulk submission for many substances and also have the possibility to form a group of companies who make a single notification for a range of substances.

Do you have any special advice to companies that need to notify their classification and labelling?

Of course number one is to prepare to notify in time. And remember that you need to keep this information up to date after the initial submission to ECHA. For the submission itself it means you need to familiarise yourself well in advance with the different submission systems and decide which one is most appropriate for you, and also of course to consult the associated material on our website including the technical manuals. Our recent Stakeholder Day presentations which are available online give some pointers on how to identify and select the best submission system for you. This information is all available on the CLP section of ECHA's website.

How many registrations and classification and labelling notifications does ECHA expect to receive?

There are a range of estimations on how many registration dossiers could be submitted this year. The latest information from industry would indicate that we could receive around 40 000 dossiers, but the estimations vary, and we have planned for a range of between 25 000 to 75 000 dossiers. The number of classification and labelling notifications is quite difficult to estimate, but we currently believe that it will be in the millions.

How will ECHA be able to cope with these large volumes?

This has been an area of substantial work for myself and my colleagues during the last couple of years. We have made a number of significant improvements to the efficiency of REACH-IT, and our colleagues in IT are currently carrying out intensive stress and performance testing of the system to ensure that it can cope with these high volumes. We in addition have developed a backup system to be able to accept dossiers if REACH-IT needs to be down. We also have a detailed resource planning in place to ensure that we have the right people here at ECHA to process these dossiers properly and correctly.

Have you a message for companies who would like to register and notify as smoothly as possible?

The key message is to familiarise yourself with the submission system, to take time to read the key manuals, and if any doubt, to check the more detailed information such as the wide range of webinars we have available on our website. For companies who need to make multiple submissions, I would strongly advise to prioritise at least one dossier for submission as early as possible in order to develop first hand experience of the submission system. And one area where I would suggest that companies particularly focus on is the initial submission functionalities. In other words: to carefully consult the Data Submission Manual number 4 on passing the business rules.