If you imagine chemicals as being stars in the sky, together they form a universe of substances, some closer to each other and others further apart with different properties and hazard profiles.
To help map this universe and speed up the identification of chemicals that need to be regulated, ECHA currently assesses them in groups. This means that we put structurally similar chemicals together, with the assumption that they are likely to have a similar hazard and can be used in a similar way. The outcomes of the assessments for the first groups of chemicals are now available.
By assessing substances in groups, the risk management of chemicals becomes more efficient, and making the assessments public brings more predictability for companies. It also helps them to avoid replacing a harmful chemical with another that could be equally harmful but has not yet made it to the authorities’ radar.
We interview Chrystele Tissier, who works as a Regulatory Officer in ECHA’s Prioritisation Unit. She talks about how ECHA assesses the regulatory needs for groups, what information is made public, and how it can be used by companies and authorities.
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Disclaimer: Views expressed by interviewees do not necessarily represent the official position of the European Chemicals Agency. All content is up to date at the time of publication.
Safer Chemicals podcast. Sound science on harmful chemicals. Welcome to the Safer Chemicals podcast. I am your host, Pivi Jokiniemi. In this episode, we'll take a journey through the chemical universe if you imagine chemicals as being stars in the sky, together, they form a universe of substances, some closer to each other and others further apart, with different properties and hazard profiles. To help map this universe and speed up the identification of chemicals that need to be regulated, ECHA now assesses them in groups. This means that we put structurally similar chemicals together with the assumption that they are likely to have a similar hazard and can be used in a similar way by assessing substances in groups. The risk management of chemicals becomes more efficient, and making the assessments public, brings more predictability for companies. It also helps them to avoid replacing a harmful chemical with another that could be equally harmful, but has not yet made it to the authorities' radar. Now we have published the outcomes of the assessments for the first groups of chemicals. My guest in this episode is Chrystele Tissier, who works as a regulatory officer in ECHA's prioritisation unit. Welcome Chrystele, and thank you for joining us. Thanks, Pivi also for inviting me today. Could you tell us about your role in this grouping work? So with other colleagues, actually, we are coordinating all the group work and recently also we decided to have everything published. So as part of this work, I follow almost all assessments and also I have ensured that we can publish those this year. So to start with, can you tell us how do you assess the regulatory needs of substances and what is the basis for your assessment? So our starting point is a group that is based on structural similarity of substances. And from there, we look at all information available in particular in our REACH registration database being on the key hazard of those substances. Any information on uses and potential for exposure that we can find also. Usually it's really based on what we have in the registration information. Sometimes we can go outside, but really, this is our starting point. Then we would look also whether some of the substances have already some measures that are in place, for instance, if some would have a classification already or whether actually also they would fall under some other legislation, such as, for instance, biocides, cosmetic. So this is information we see from the dossier. Then, because we look at structurally similar substances and we look also how they are used, we have some insight into potential substitution, but at a very high level. So it's not like we do a full analysis of that, but just to get the feeling whether some substances could replace others just based on their structure. From there, we will actually look and try to understand whether those substances would need additional regulatory action. And what kind of regulatory action are we talking about? Can you give some examples? That could be whether they need some more data generation. Let's say we see that there is not enough hazard information, then we will flag this or whether actually they would already need a harmonised classification. So some more risk management measures. It can go as far as restriction and authorisation. One thing may be to note is that this assessment will be iterative. So we do a first assessment based on what we see in the dossier and also based on information that is available. We make assumptions also sometimes on the hazard because we don't have yet enough information and we decide based on that what we would do actually from a risk management. So let's say I have substances where we see, OK, maybe it could be a potential reprotoxic, but I don't have yet enough information. We would still, based on the uses, try to understand if the substance are later confirmed as being reprotoxic. What would I do based on the uses? Would I, for instance, restrict the uses of such substances? Or would I simply do nothing? The aim is also to flag action for member states in particular, for instance, for harmonised classification or restriction or any other regulatory measures. So over the last two and a half years, you have looked at more than 3000 substances in 120 groups. And now the first assessments of regulatory needs for groups of chemicals are published. If we talk a little bit about the outcomes of the assessment, what kind of measures are you suggesting for these groups of substances? So quite diverse measures, but as said, it is an iterative assessment and we started from what we have in our hands. What we have seen is that for most of those substances for now, the really first action will be generation of hazard data. And for that, we have some tools. Compliance check is clearly the first one. And then for some substances we would have some substance evaluation also identified, but really for many substances, that is the first step will be the generation of hazard data to get some confirmation of those hazards because now we are more at the level of this potential. And of course, before going to any regulatory measures, we need some more clarification of that. As said, we still based on that, look forward because we want to anticipate, we want to be able, once we have this clarity on the hazards, to be able to act as soon as possible. So even though the first step will be generation of data, we will still flag that if hazard confirmed, next step will be a restriction, for instance. Some substances, we will also conclude that they don't need action, so we have a few of these lower hazard types of substances where we actually don't see much hazard for those, so we don't flag the need for action. For some, we will still as a forcing really last action, say no need for action. But first, let's clarify the hazard. There will be one group published in this first batch, which is one of those. Finally, I think we have a few groups or substances for which we can flag already direct regulatory risk management measures. In most cases, harmonised classification and labeling. So we have also direct action. So would it be correct to assume that when you assess a group, you also conclude on the same action for all the substances in that group? This is very rare. So you will see that sometimes it has been possible to conclude with the same action on the group. Let's say harmonised classification for the full group of substances. But in most cases, we have either subgroups, which I think is most frequent or even we identify action at substance level. How does this happen? Why is it not the whole group? Why is it, for example, just an individual substance? We build a group around structural similarity only, so it's really based on the chemical structure. At that point, we don't look much yet at this similarity in hazard. Of course, the two are linked. But there are many different factors that make similarity of hazard not only the chemical structure as we do it. We decided to go for this grouping mainly to pool substances together and to speed up our assessment. But we knew from the beginning that what we do is not the similarity of hazard purely so that's something we expected and we wanted simply to speed up the work by doing that. Then maybe going to some examples, so now that you have have published the first groups of substances, could you give some examples of where grouping has now led to proposing regulatory action and are there any substances there that have been already under public debate recently? Of course, in all the groups, I guess a lot of the substances that the general public will see will not tell them much. But we have also looked at quite well-known substances. One is, for instance, the phthalates that will be published in this first batch where we have actually tried to group all the phthalates we know based on chemical structure, at least those that we have in our database, and we have assessed this full group of substances. You will see that actually we have split in two, but in total we have really looked at all of them. And what we see is that for some of those substances, we have identified the need for direct risk management measures looking at following up on existing measures for already well known other phthalates. So for instance, looking at presence of those in articles which may tell also, people a lot about the concern. So we have identified this action, but we have also some phthalates where actually we are really in this situation where we don't have enough information in particular to confirm the hazard. And we have also identified those and we have already listed them as needing, for instance, compliance check or substance evaluation. So the hazard will be clarified and we will know whether or not we also impose some risk management measures on them. And of course, we have a few, which may also be of interest, where we say no need for action. So hopefully this brings some more clarity also on this wider group of substances. So what information is now then available and where can we find it? The best entry for you to find it is via the PACT, which is the Public Activities Coordination tool, which lists all the activities that are ongoing on substances, and it provides you an overview of all processes. And this you can find on ECHAs website. Yes. From there, you can see all substances for which you have an assessment of regulatory needs. So in the past, this was under regulatory management option analysis, RMOA and now we have replaced this with this assessment of regulatory needs list, which will also cover actually the RMOAs done by member states before. And that we continue to cover some RMOAs as well. So this is where you can find at least the list and then you can always go to the details to have more information on those substances. So in the PACT, you can find information on individual substances. But is there a way to get an overview of the assessments for all substances in a given group? I would recommend to go directly to the list of assessment of regulatory needs, which is the list of all those assessments and where you see only this information. So you will get a bit more information, for instance, what we foresee as immediate next action being compliance check and what we foresee as last action, for instance, restriction. So there you can find more information. You have also the link to the reports. You will have also the group name, but you really need to go to these details because we cannot put all this unfortunately in this first page. For each substance, you will have the report and each substance in a group will have, of course, the same report. So if you want to have access to the report as such, you just need to go to one entry, but at least you get the overview of all substances being covered. And that's the way also for you to know all substances within a group because we won't publish a list of groups as such. And what about then, when new information is coming, for example, how do you keep this information up to date? Yes. So that's back to this iterative assessment. So we will always publish once we have the first iteration of those reports. And of course, every time we will have some new information in particular on the generation of data because it may actually change the outcome of our assessment, we will revisit and then publish again. So every time we have some changes that may actually change the outcome of our report, we will update those also on the website. So for example, if there's a company who is interested in knowing what's happening with their substance, they should be continuously following up this information on the website. Yes, this is really something we would recommend in any case that the company keeps following what we are doing on those assessments of regulatory needs, as they do for any other activities on their substances, and really see what we recommend also in there and understand how much they can already act. For instance, sometimes at those early stages of assessment, we may need to take some assumptions. We try to reflect on uncertainties, but we base it on the information we have in the registration dossier. And, for instance, on the uses, sometimes we need to make approximations and simply base it on what we have. And we know that in some cases, this is not necessarily the most up to date information we have on the uses so we would definitely recommend to have a look at that from the company perspective, because they have time, most probably also before the next iteration to actually update their dossier so that before we do this revision, they can update their registration. We would actually favour any update of a registration dossier rather than receiving also ad-hoc type of information. I think that would be better. How is this information then useful? How do you expect companies or organisations or people to use it? We really wanted to increase transparency for everyone interested in chemicals to see what we foresee as action on those substances, and we will continue to do that for all substances that are registered under REACH. I think our main message are really towards companies because they can act on those substances. They should really look at what we have been doing. Try to understand whether they can update their registration dossiers so that any revision of the report is actually based on actual data. But also, we do look at structurally similar substances. We look at their uses, so we have some ideas on potential substitution, even though we don't do a full analysis of that. But of course, companies, they know which alternative substances they are using or they would like potentially to use. So it's also very good for them to have a look because they can get also some insight what can happen to those substances in the future. And maybe it helps them also avoiding this regrettable substitution. Really recommend industry to have a look at what we publish, try to act in advance before actually the substance enters formal regulatory processes. What if there is a company now who is having a look at the list and noticing that all those known alternatives for their substance are in the same group and there are already some regulatory risk management proposed? I think this is very hard to say. I mean, it's back to their own strategy of handling chemicals. But if really we have in a full group that, for instance, we flag all the substances as being potentially reprotoxic, they really have to think twice before using those substances for consumer application or even to some professional application. So they will have quite some tips also in the report we have developed because we explain also what would be the impact of such classification. So they have really good tips, what not to do potentially and maybe to look for some other alternatives than any substances being hazardous in that group. So a little bit more predictability, maybe for companies. Thank you very much, Chrystele. This was a very interesting discussion. I'm happy that you had some time to join us today and we'll continue following up this topic. Thanks a lot for having me today. Before we conclude, let's summarise the most important tips we got from Chrystele. If you have registered chemicals under REACH, go and check if your substance has been assessed and what kind of regulatory actions are planned. A good place to start is the Public Activities Coordination Tool that you can find at echa.europa.eu/pact. The outcomes of the assessments can give you valuable information when you are considering, for example, how to replace harmful chemicals. And last but not least, make sure to keep your registration data up to date so that the authorities can base their work on the most accurate information. I'd like to thank you our listeners for tuning in. Safer Chemicals podcast. Sound science on harmful chemicals.