In 2016, the European Chemicals Agency (ECHA) will release new versions of the IT tools used for creating (IUCLID) and submitting (REACH-IT) registrations. The main changes will be an updated completeness check process and an improved system to make sure that all registrations for the same substance are made with a single joint registration. What are these about?
Who does the updated completeness check affect?
It affects all companies submitting dossiers, both new registrations and updates. The legal requirements do not change – we are simply reviewing the implementation of the legal requirements in the submission process. So, if you do your job well and submit a complete dossier, the improved completeness check process will have no effect on you.
What will be different?
There will be improved IUCLID formats that will help you make sure that your dossiers contain all the information required for a REACH registration. In addition, we will complement the automated check with a manual check of those elements that cannot be checked automatically. The aim is to make sure that all the elements required by the legislation have been included in the dossier.
What does the manual check mean?
We will manually check some parts of the dossier. We will not assess the quality of information – that is the dossier evaluation – but rather make sure that data is provided where it should have been. The aim is to pick up those registrants who just add irrelevant text to bypass an information requirement.
Will it be harder to pass the updated completeness check?
No it will not. On the contrary, we expect that the updated IUCLID formats will help you to build a complete dossier. The IUCLID Validation Assistant plug-in is a must for all. It allows you to run most of the checks that ECHA does and correct any failures before submitting your dossier.
Why is ECHA updating the completeness check process now?
Firstly, there have been regulatory changes, for example, amendments to the REACH annexes that need to be incorporated into the IUCLID templates. One example of this is the introduction of the extended one-generation reproductive toxicity study (EOGRTS) as the standard information requirement for reproductive toxicity under REACH (Annexes IX and X). Secondly, we have the experience of the first two registration deadlines and know, for example, where the limitations in our automated check have been. The commitment to review the process was made already in the Multi-annual Work Programme 2014-2018 and again in the REACH 2018 Roadmap. We have worked with industry associations and the Member States to develop our plans. And we will continue to discuss the practical implementation with them too.
ECHA are also tightening up on the ‘one substance, one registration’ principle.
How will ECHA make sure that there is only one registration per substance?
We are updating the entry point of REACH-IT so that the system only allows registrations to be submitted as part of an existing joint submission or as a lead dossier. Submitting outside a joint submission will not be possible. However, you will still be able to submit data as an opt-out. For example, if you have disagreements with your co-registrants about the data, you can submit parts or all of the data on your own. But you still need to be part of a joint registration. In this case, you would not need to share the cost of the data for which you have opted out, but still be part of the same registration.
Why is ECHA taking firmer action on this?
Ensuring that companies submit their registration jointly is one of the main principles of REACH. We want to make sure that submitting outside a joint registration is not allowed. ‘One substance, one registration’ minimises costs for industry, makes best use of the information and reduces animal testing. There have also been concerns on the quality of data submitted outside joint registrations and on intellectual property right issues. Some registrants, for example, may not have wanted to take part in the substance information exchange forum (SIEF) but instead submitted some other data on their own. Further examples are cases where a registrant refers to data without the consent of the data owner. In addition, the Implementing Regulation on Data Sharing, which is being prepared in the European Commission, will reinforce ECHA’s role in making sure that there are no multiple registrations for one substance.
ECHA Newsletter, September 2015 ;http://echa.europa.eu ;