Companies are submitting technically incomplete REACH registration dossiers and are trying to register several substances per file, while failing to be precise enough on the exact composition of their substances, the executive director of the European Chemicals Agency (ECHA), Geert Dancet, told EurActiv in an interview.
Geert Dancet is the executive director of the European Chemicals Agency (ECHA).
What lessons have been learned from the first registrations reviewed?
It is of course a bit early to say, because we are still collecting evidence. But one of the most important ones is that we absolutely want to avoid that companies register many substances in one file. That is something we already see. There can only be a registration for one substance. You cannot take a group of substances and register them as one.
Even if they have a similar base substance and they may have some similar effects, they can still be different. So, one substance equals one registration.
Another lesson learnt is that companies don’t understand the business rules we apply in checking the files. And we have very recently issued what our business rules are. The rules explain what the dossier needs to contain before we check technical completeness. The business rules are very much an automated process. Also, on technical completeness, we have already completed four cases and hope to complete more by end of May, and then draw more lessons, but I don’t have all the details we need right now.
So, the registrations so far do not all comply with all the technical rules, and there is the problem that many substances are being registered in one file. And we already have many that have to register three times, and this is something we want to avoid in the future.
Is there something that eventually holds companies back from registering their substances?
What holds them back is the fact that first of all they should, as much as possible, register in groups. There are elements in the legislation that allow opting out from a group and the joint registration, but basically, for the existing substances, companies have to prepare a joint registration.
The lead registrant prepares the joint package. And it is very important for the companies that they actually organise themselves in a way that the lead registrant registers not just few days before the others, but sufficiently in time to make sure that ECHA has been able to check the dossier, that the dossier has been accepted, and that it is technically complete and in order before the others register.
Of course, the legislation does not say so, but if the companies all want to wait until the very end to do that, it could well be that when we check the dossier, it is not technically complete, and they will have to withdraw their products from the market until they have made a complete registration. So they have every interest in making sure that the timing of the joint registration is really well coordinated.
Are the Substance Information Exchange Forums (SIEFs) your way of trying to speed up joint registration?
Yes. SIEFs are the groups aimed at preparing the joint registration.
Of course, we also already get registrations for new substances, which come from individual companies that have finished their R&D and want to put a product on the market. So they come to us as well and we check their files. And we will try to draw some lessons from the analysis of these cases.
Another element I’d like to stress is that companies have a lot of difficulties in writing down what the exact composition of a substance is.
They have difficulties, or they just don’t want to write them down?
I don’t know. They seem not to have been used to this in the past, as the previous legislation was not as precise on how the substances needed to be identified. This legislation has very precise guidance on what we need to have, and companies are not used to that.
That is actually why many of the dossiers are not good enough and we need to send them back, because they don’t clearly distinguish which substances we are talking about.
And what if they spell out everything out very clearly? How do you protect intellectual property rights (IPR)?
We protect the IPR. That’s why we have the 12-year protection in the REACH legislation. When a company registers a substance, it can declare the substance’s identity confidential, as well as all the studies they have done on the properties of that particular IP-protected substance. They have to tell us when the studies have been made, but we cannot disclose any information on them to another registrant.
What should industry be prepared for this year?
They should prepare for the formation of SIEFs. But also, what is extremely important for us is that they communicate to us who the lead registrant is, because we will prepare a whole package and help the lead registrant, because they have to prepare the joint registration.
We also want to organise, later in the year, a special workshop for the lead registrants: only so that they can learn best practices between themselves, because they are not used to doing this. A lead registrant making a dossier in one chemical can learn things from a lead registrant making a dossier on another. So there are things that are still common on how you organise things.
So we wish there was some learning across the SIEFs: even if they have nothing in common, they are not competitors, and have nothing to do with each other.
Who should take the lead in forming the SIEFs? Cefic?
Yes, but not necessary Cefic alone. We have to talk to all the associations involved in the business of making substances, including for example the recycling community, which also needs to register, and which, after, may have a different substance to register than the one that is the original chemical from which the recycled unit comes.
You said that regardless of the legislation and its implementation rules, there are complications in regarding enforcement. What do you mean?
Enforcement laws are national, so they are not necessarily the same. What in one country is a grave mistake or non-compliance can in another country be only an average non-compliance. They don’t need to qualify every wrong-doing the same way. There are countries that even traditionally have only financial penalties, whereas in another you can even have imprisonment. So the enforcement laws can be extremely difficult.
You said there were still some countries that are yet to adopt enforcement laws. Who are they?
I don’t know them all by name. You should ask the Commission, because it is up to them to pursue the countries that have not done it. But I know that Belgium is one of them, if I understand correctly.
You also mentioned future stakeholder participation in scientific committee meetings. How will this happen?
We started this at the end of last year. There are already up to 15 stakeholder observers in committee meetings. So it is really rather new that stakeholders can participate. This is a big learning process for them, also because it is not very common for them to have a role to play in scientific committees. Normally in scientific committees of the European Commission, there are no stakeholders.
So why have you allowed this in REACH scientific committees?
It is extremely important to create transparency, but also general acceptance of our decision-making process. It also facilitates the discussion. And anyway, the observers can also speak at certain points in time. It is not that they can only watch.
So at some point they can declare their interest in contributing to the paper or intervening in the discussion. And then the chair will have to give them the word. So that’s how it operates.