Editorial chemie report spezial 05/2011

ECHA’s Top Five Tips for Successful Registration

Geert Dancet, Executive Director European Chemicals Agency (ECHA) about strategies concerning handling of REACH´s next registration deadline.

Geert Dancet, Executive Director European Chemicals Agency (ECHA)
Geert Dancet, Executive Director European Chemicals Agency (ECHA)

Two years may seem like a long time until the next registration deadline will hit you! However, we in ECHA have learned that two years is actually very short if you are planning to register one or more substances for the first time in 2013. New registrants can benefit from the experience gained by ECHA and industry in meeting the first deadline in 2010. I want to share our top five tips for successful registration with you.

Firstly, it is essential to make contact with the companies who pre-registered the same substance as you. You can find them in the pre-SIEF pages of REACH-IT. You need to assess whether you do indeed intend to register the same substance in 2013, and consequently, form a Substance Information Exchange Forum or SIEF. Therefore it is essential that you develop a good understanding of the identity of the substances that you intend to register, that you have access to the relevant analytical data and that you are able to identify the substances using the recommended nomenclature (i.e. EC name and number, CAS number and IUPAC name). This is a critical part of the process because it will ensure that all members of the SIEF are co-operating on the same substance. The SIEF members need to agree at an early stage on the basic principles of cooperation and communication. Reaching these founding agreements takes time, but is worth the effort before dossier preparation starts. One of the crucial issues to settle early is which company will be nominate the lead registrant and prepare the joint submission on behalf of all the others under a contract called a ‘SIEF agreement’. If you consider volunteering for lead registrant, you may consider taking expert advice. Various industry associations have developed best practice guidelines and even templates for this. Make also sure that the lead registrant informs us of his nomination via our webform.

Secondly, get familiar with the IT tools necessary for your own registration. You will need to download IUCLID, which is the software to store information on substances and to create your registration dossier. Install IUCLID as soon as possible and reserve adequate time to get used to it and to enter the substance data. You will also need to be familiar with REACH-IT, which is an online application you will use to submit the registration dossier to the Agency. If you ultimately have to prepare separately the chemical safety report for your substance, the Chesar tool developed by ECHA provides a structured workflow to help you.

Thirdly, invest some time in understanding what happens to the dossiers when they arrive in ECHA. Dossier Submission Manual 4 is your best guide through the different steps. We have also developed very useful plug-in tools for IUCLID, which you should use to give yourself the best chance of a successful submission. The most important tool is the TCC plug-in, which checks if your dossier is technically complete and contains also checks for the most common ‘business rules’. They are the administrative and technical prerequisites that need to be fulfilled before ECHA can accept your dossier for processing. The fee calculator plug-in calculates your expected registration fee and the dissemination plug-in shows which parts of your dossier will be published on ECHA website.

Fourthly, if you are not the lead registrant you will need to follow the work of the lead registrant and decide with him and the other members how to share data, how to share costs and how to agree on the classification of the substance. Perhaps, the SIEF can also agree on sharing fully or in part the work on the chemical safety report. You should do maximum efforts in trying to agree on data sharing as you can only opt out from parts of the joint registration when specific criteria are met, and ECHA can only intervene in specific types of dispute, which are described in the data sharing section of our website to successfully register and provide you the token for your registration.

Finally, if you have a number of substances to register, we would recommend that you prioritise one of them for early registration. Taking one early will give you the opportunity to learn the submission process at first hand, to streamline your REACH processes in-house (e.g. internal working instructions), and, consequently, make successful registrations of all your substances more smoothly by the registration deadline of 31 May 2013.

All in all, two years is short to take all the steps that you need to register in time and make sure that you are manufacturing or importing legally. But don’t despair, thousands of companies registered successfully in 2010 and we, together with your national helpdesk, are committed to helping you and to making sure that we learn the lessons of that first experience.

So, make the commitment to get started on your registration tomorrow and know that, together, we are working towards a healthier and safer Europe.

Für Fragen und Anregungen nehmen Sie gerne Kontakt mit uns auf.

Ansprechpartner

Stud. Ass. Manfred Ritz

E-Mail: ritz@vci.de