- Speaker #0
Safer Chemicals Podcast. Sound science on harmful chemicals. Welcome to the Safer Chemicals Podcast. I'm Adam, and today I'm joined by Roberto Scazzola, who chairs our Committee for Risk Assessment, as well as Maria Ottati, the Chair of our Socio-economic Analysis Committee. So today we're diving into some key updates from the recent meetings. We'll kick things off first with the latest on the universal... PFAS restriction proposal, and then get into the details of the plan to restrict certain chromium-6 substances in the EU. After that, we'll be talking about bisphenol A and the new occupational exposure limit that the Risk Assessment Committee has adopted. Roberto, Maria, it's great to have you on the podcast again.
- Speaker #1
Good to be here.
- Speaker #2
Happy to be here too.
- Speaker #0
All right, let's kick things off with the big PFAS restriction proposal that the Risk Assessment Committee has been working on. So the committee has been looking into how... PFAS is used in things like medical devices and lubricants. Roberto, can you break down the key points for us?
- Speaker #2
We are very satisfied with the progress in the discussions, I would say, in both committees and for these two sectors. I'm very happy to say that RAC was able to agree on its provisional conclusions. To briefly describe the two sectors, medical devices include medical implants, invasive medical devices such as tubes and catheters, but also other items such as wound treatment products and also packaging of medical devices. So it's a quite diverse and I would say very important sector. And then lubricants, I think it's maybe a sector where everybody's familiar. So our fluids, their main scope is to reduce friction or to allow also to reduce the wear or the heat between moving parts. So you can imagine automotive, medical industry, food processing. So a lot of uses also in that area. Also to demonstrate and to measure the importance of those sectors, I think the RAC look into the amount of volumes and emissions and they are quite remarkable. For medical devices, we have a possible emissions close to 12,000 tons over a period of 30 years. And that's quite significant. And lubricants is even higher with about 50,000 tons over a period of 30 years. So this shows how they are definitely relevant when we will look into the potential risk related to their use. We also look into the effectiveness of the restriction options to reduce the risks, but also possible sector-specific derogations. However, only on risk-based considerations, because our sister committee is actually looking more into the socioeconomic aspects of those considerations. Also, a lot of stakeholders attended, again, the meeting, and this demonstrates the interest that is out there for this. And finally, let me remind, those are provisional conclusions, so final conclusions will be available toward the end of the... process while there will be a sort of benchmarking with all the previous opinions that have been agreed so far.
- Speaker #0
So yeah, as with all of these sectors, I would imagine there's quite a lot of interest from the outside. But what would you then say are the most important takeaways for audience from the committee's work on these sectors? Were there anything that you'd like to highlight?
- Speaker #2
Yeah, I think I found very good the interaction with stakeholders. You know, they play such an important role. They provide input and information that might not be necessarily available for the committee. And I was also pleased by the announcement of voluntary initiatives and projects, for instance, in the medical devices sector, for the possibility to look for alternatives in the use of PIFA.
- Speaker #0
So actually, even before this has kind of gone through the formal process, there's already actions being taken to start- That seems to be the case.
- Speaker #2
Those are voluntary actions. And so probably shows the productiveness of a sector that would like really to take on this problem in a, let's say, serious and effective manner. So quite positive, definitely.
- Speaker #0
Okay, thanks Roberto for sharing that. So you also started looking into electronics and I think it was semiconductors. So can you tell us a bit about how those sectors then use PFAS?
- Speaker #2
Yes, of course. This was just an introductory discussion. What does it mean is that we look into the proposal made by the dossier submitters, so the various countries that are at the origin of this proposal. The sector uses PFAS for a number of specific properties. They're chemical resistance, thermostability, but also electrical insulation. And they are used in a lot of different applications, wires, cables, printed circuit boards, flat panel displays. So you can imagine it's very widespread. But also semiconductors, and those are materials that are used for their electrical conductivity between a conductor and an insulator. So quite specific and technical. And these include seals or rings. wafers, coatings and similar stuff.
- Speaker #0
Okay, right. So what kind of questions are you then hoping to further explore in the next discussions?
- Speaker #2
Well, now we focus on the proposal made by the dossier submitter, and our aim was to get initial input from stakeholders, and many stakeholders actually provided such an input. The next step will be actually to draft the RAC opinion, so we really look into the elements such as volumes, emissions, risk of alternatives, and this will be discussed in the upcoming meeting in September.
- Speaker #0
Okay, and what would you say makes the electronics and semiconductor sectors... particularly interesting when it comes to the PFAS restriction proposal?
- Speaker #2
Well, we noticed, and that's a fact that we had probably the highest number of comments that were triggered during the consultation that was carried out a year and a half ago, more or less. We had about 1200 comments. If I remember well, it's something like 20% of the total number of comments and considering we had about 13, 14 different sectors, that's really quite a lot. And also, probably the high and diverse number of applications require an in-depth assessment by both the dosis submitter and also by RAC. So we expect definitely September to be a very interesting discussion. So stay tuned for more info.
- Speaker #0
Are you able to kind of compare, you know, this 1,200 to other restrictions that you have? How does it compare?
- Speaker #2
Well, by far, I think is the biggest. Maria might remember, it has been longer than me.
- Speaker #1
I think the biggest one that I can remember was about 500. comments. So even for just this small part of this restriction, it's over twice that. So yeah, this is huge.
- Speaker #0
Okay. All right. Well, thank you so much for that. And it's nice to see that the PFAS work is moving forward. Okay, Maria, over to you then. So you've been looking into medical devices and lubricants, and you've also gone back to the discussions that you started back in March on transport. How's that coming along?
- Speaker #1
It was an extremely productive meeting, actually. Indeed, as you said, we had a discussion on medical devices and lubricants where we covered the whole sector and all the aspects that we need to cover in an opinion. And we were able to provisionally conclude on medical devices. Roberto's already explained what's in there. I'm not going to repeat that. And then on transport, we also brought it back and then we were able to finish the discussion there as well. So I think we probably discussed this in a previous podcast. But just as a reminder, these are very... wide variety of uses that are covered within transport. It's a very wide sector. So we're talking about automotive, aerospace, watercraft, rail, agriculture and forestry vehicles, all sorts of things, even to the point of some transport related infrastructure like signage. So it's all sorts of things that come in there. And even within that, I mean, we have some assessment that is more general, but then... There is also assessment that is EU specific. So we're talking about very concrete things like tubes and hoses in combustion engine systems and coatings for windshields, all sorts of things that we're talking there. So it's a complex sector. Lots of comments there as well. Lots of work done by the rapporteurs. And like I said, we were able to reach conclusions both on the analysis of alternatives and also on the socioeconomic side. And just as a reminder, we bring that all together by looking at the proportionality. And then we look at the need for derogations to ensure that there is proportionality in the proposal. Right,
- Speaker #0
as always.
- Speaker #1
Yeah, exactly. That's as always. So, yeah, for medical devices and for transport, we were able to wrap everything up. For lubricants, which we also looked at, again, Roberto explains very well what's in there. There we concentrated only on the analysis of alternatives and also aspects such as whether a restriction under reach is the best way to deal with the risk. So... There we were able to have provisional conclusions. And we also had an introductory discussion to the socioeconomic analysis. So there it's these aspects I've mentioned before, like, well, cost and benefits, and then the bringing everything together with the proportionality and the derogations. So that comes back in September. And there we will wrap up the whole of the sector.
- Speaker #0
I'm just interested because you mentioned that you looked at whether a restriction under reach is the most appropriate measure, as opposed to what? you know, what would be the other alternative? Well,
- Speaker #1
quite often there's sector-specific regulation that also applies to the sector and we need to check whether the risk is also dealt with in that way. So we look at whether, you know, some stuff is already covered and it's also dealing with the risk. And we look at it for, you know, overall and then for every one of the sectors that we look at. Okay. And we always have that conclusion there.
- Speaker #0
Quite the puzzle that you're putting together then.
- Speaker #1
It's a very wide restriction. So there is a lot of regulation out there is already impacting the sector. And in some cases, you know, it may have an impact on the work that we do as well.
- Speaker #0
Well, it's reassuring to hear that you've managed to find consensus, even with such a wide sector and different uses. So that's, I guess, a positive thing.
- Speaker #1
A very positive thing, yes.
- Speaker #0
All right. Then if we go into the kind of more broader benefits. What then would you say, Maria, are some of the more broader benefits that you see from progressing with this restriction proposal?
- Speaker #1
Well, this is the broadest and biggest proposal to date, and it covers very widespread of sectors, even within each sector, as we've been talking about with transport. That already covers quite a lot. It covers a lot of substances as well. So basically it... It means that we can deal with lots of risk at the same time. We can avoid also that we substitute something with something else that also then proves problematic.
- Speaker #0
So regrettable substitution.
- Speaker #1
Regrettable substitution, exactly. So this is the benefit of these, which we call group restrictions. And of course, now we are learning a lot about how to deal with them. If we get some in the future, in addition to the benefits of this restriction. we are able to process future restrictions, attack group restrictions, much quicker. Then, of course, we get to reduce the risk much faster when we get future restrictions. So it's win-win all around.
- Speaker #0
Right. So faster protection for everyone.
- Speaker #1
Yes, exactly.
- Speaker #0
Okay, good. Well, thanks for the updates to both of you. So just to do my best to recap. So we've looked at PFAS in medical devices and lubricants. And the Socioeconomic Analysis Committee also concluded on transport and closing. that discussion that was started on transport in March. The Risk Assessment Committee then shared its initial thoughts on the electronics and semiconductor sectors, and the Socioeconomic Analysis Committee will pick up the lubricants discussion again later. I hope I got that more or less right.
- Speaker #1
Perfect, yes, exactly right.
- Speaker #0
Okay, good. So what's then coming up next? I mean, I'm sure we have enough sectors as it is, but I'm sure more are coming in. So what's coming up, and are there any new sectors that we should be keeping on our radar?
- Speaker #1
Yeah, well, in September, insect As you said, lubricants, we wrap it up. We do the socioeconomic analysis and bring everything together. We will also discuss energy there. And we will take the whole thing as well. That's the intention. And we will start discussing electronics and semiconductors. That is a big one. So we expect that that will be September and then we will continue in December. We will also take some horizontal topics as well. We've got... We've been looking at the general approach in how we assess things. And we saw that earlier on in the process. But of course, once we've seen quite a lot of sectors, we want to go back and ensure that what we did then still works now that we've seen lots of examples. So we're bringing that back. And then after September, we've got PFAS manufacturing. That's about the production or synthesis of specific PFAS compounds. We're talking liquids, gases, polymers, whatever. And of course, we finish electronics and semiconductors. We're also going to be looking at horizontal issues that are like enforceability, concentration limits, analytical methods, monitoring, all those sorts of things that then you have to bring in for a restriction.
- Speaker #0
You mentioned horizontal issues at the start, but then you mentioned it again at the end.
- Speaker #1
We're talking about slightly different things. So we're talking about the approach to how we deal with the analysis in the sectors. And then we talk about kind of more cross-cutting issues like the practicality of the restriction as a whole.
- Speaker #0
For example, enforcement authority.
- Speaker #1
Exactly. Some of these we look at from a sectoral point of view, looking at the areas that are relevant for a particular sector, but then we look at it overall as well. So yeah, it's kind of both horizontal but slightly different.
- Speaker #0
Right. And you mentioned energy. Remind me if you've already covered that.
- Speaker #1
We had an introductory discussion on energy, exactly. And I think this is one that RAC has already covered.
- Speaker #2
Yes, yes,
- Speaker #1
indeed. RAC is very efficient.
- Speaker #2
Let's see. Also for September, RAC, the main goal will be to conclude on electronic and semiconductors. It was provisionally discussed for the first time a week ago. And then we will start PFAS manufacturing and horizontal issues, as Maria was describing, in September, with a view to possibly complete them by December this year.
- Speaker #0
and and Are there any kind of cross-cutting themes or challenges that have emerged across all the different sectors you've looked at so far?
- Speaker #1
Well, basically, the huge amount of information that we need to deal with. That's one of them, of course. Very wide, lots of comments. Of course, there is a lot of information. From a SEAC point of view, I would say the substitution challenges are something that keeps recurring. I mean, these are compounds with unique properties. And in some industries, they find it difficult to replace them. And so... It's hard to find something that works and, you know, in a sufficient way, provides sufficient performance. So we're seeing that across many different sectors. Of course, for some of them, the situation is different than from others. Some of them, actually, there are alternatives out there. For some of them, not. So that's the challenge, trying to dig into that and to get that information. And then it's, you know, bringing that information together with all the other socioeconomic side for us and actually coming to a view on derogation. So. That I would say are the main challenges from our side. I don't know if you've got some on that. Yeah,
- Speaker #2
maybe I could point out to the fact that we have been doing this for about two years, so we have literally learned a lot. But also at the beginning, we had an approach that maybe is not fully consistent with the final decision and approval that we are getting through. So the idea is to have a sort of benchmarking toward the end of it to ensure that we are fully consistent across all the sectors. So that may be the biggest challenge, I would say. we have in front of us.
- Speaker #1
And that we will do in both committees. We'll have to, once we've agreed all the different sectors that are within it and all these horizontal issues, then we go back and we look at the whole thing and we make sure that everything is consistent with each other. As you said, things evolve in this amount of time.
- Speaker #0
I mean, maybe we need an episode on its own on the next thing that came to my mind. But it's interesting that we're doing, we have a lot of learnings from this, obviously, a lot of new things, a lot to cover. And we have this European angle to it. But I would imagine that these learnings that we get here will be beneficial for also other countries outside of Europe. And this kind of laying the foundation of how to assess and look at these sectors will also help others out there. So even though we're an EU agency, I'm hoping that the work that we'll do will also pay off for others.
- Speaker #1
Yeah, well, there's a lot of eyes on this process from all across the globe. So they're definitely paying attention. And we also have some fora where we exchange, for instance, there's a working group in the OECD where we exchange with other authorities. So that is something where, you know, we definitely share those lessons across. And we learn, of course, as well from other parts of the globe.
- Speaker #2
But that's an interesting topic because also supply chains are global. So there's definitely an interest that goes beyond what Europe does. So in a way we can be. perhaps the front runner. Let's see at the end of the process. It will be up to the Commission and the legislators to decide, but we are here to help them, right?
- Speaker #1
That's the point, yeah.
- Speaker #0
Okay, thank you. Very interesting topic, very interesting restriction. We will be coming back to this regularly, but we've almost spent an entire episode talking about it already. So maybe we can move on then to Chromium 6. So ECHA suggested this new proposal based on a request from the European Commission. And the aim here is to cut... down the risks from these chemicals, particularly to workers and the public, since they are known to be harmful. The proposal was sent, was it back in April? And now it's up for the committees to do a conformity check. So what exactly is a conformity check? Can you walk us through that?
- Speaker #1
Yeah, well, it's an administrative process, an administrative step, but it's a very, very important one. It's basically about ensuring that everything that needs to be there is there and that the proposal is actually ready to be assessed, you know. Checking, for instance, do we have enough information on what the identity of the substance is, on the hazards or risks to human health or to the environment, depending on what the proposal is. Is there justification that this needs to be dealt with at EU level rather than by member states? The restriction conditions, are they there? You know, there's all sorts of things that we need to check that is actually there before we can start working. So, yeah. Basically, that's the point. I mean, if we try to assess something that's incomplete, then we run into trouble very quickly.
- Speaker #0
Indeed, a very important step. If you get those wrong, then the whole thing can go wrong as well.
- Speaker #2
And indeed, I think the good news is that both committees concluded that the Chromium 6 proposal is in conformity and therefore the evaluation process can begin and we will see the outcome of it in a few months.
- Speaker #0
Okay, well, that's good news. The substance does sound very familiar. I think we've talked about it a lot in the REACH authorization process, right?
- Speaker #1
Yeah, exactly. We have seen quite a lot of applications for authorization dealing with chromium-6 substances. So, you know, these substances are on the rich authorization list, as mentioned. But in September 2023, the European Commission asked ECHA to prepare a restriction proposal on them. ECHA did quite a lot of work. As part of their work, they identified substances like barium chromate that could be a reversible substitute. So that's included as well. And now we have received the restriction.
- Speaker #0
Okay, good. So kind of using the expertise here to build upon the restriction proposal and make it more encompassing and to cover more substances that could result in worse things happening, actually, or more regrettable things happening if they substituted.
- Speaker #1
Exactly. We have a lot of data here because we have received such a big number of applications for authorization that there's a lot of knowledge in ECHA. So when preparing the dossier, a lot of that information was used. And also in the committees in terms of how things work, what's the situation in industry. So, of course, this is a restriction proposal. It's a different process. The objectives of the process are different as well. So the challenge, I think, for the committees is that to assess this as a restriction, but also while benefiting from the knowledge base that we've built about how things work in this area. So I think it's going to be quite an exciting challenge.
- Speaker #0
Okay, it's nice to see the data and the knowledge built by ECHA being used more widely than maybe some of the specificities. specificities of restrictions. But maybe then the next steps on this, what are they?
- Speaker #1
Well, first of all, now that the dossier is found in conformity, as we have said, we start with a consultation. So this is a six-month consultation that starts very soon on the 18th of June, and everyone can take part of it. And there will be actually, I understand, an online information session where participants can ask questions from experts so that they can provide us information that's actually relevant and very, very targeted. So what we're looking for here is, as usual for these cases, evidence-based information, data that is scientifically sound. And then, you know, as the consultation starts, also the opinion making starts in the committee. So we start considering the proposal. and also as they come in the consultation comments to come to a final opinion.
- Speaker #0
Right. So I guess the tip then for listeners interested in this is to join the info session. And if you can't, these are recorded, right?
- Speaker #1
Yeah, they are recorded and then they will be on the ECA website. So if you're listening to this a little bit later and you would like to see what was said in this information session, you can go and listen.
- Speaker #0
All right. Thanks a lot, Maria. Now let's go to BISFINAL-A and how we handle worker safety with occupational exposure limits or OELs. Can you start, Roberto, by explaining what these limits are? I know we've covered it before, but just a little brief update on that and what the committee actually does with them.
- Speaker #2
Sure. And first, I'm very glad we are able to talk about this activity. That's quite a new activity and we don't really often give the right visibility. And I think it's quite important. It's about the safety of workers in Europe and the legislation aims to protect them from health risk associated with exposure to hazardous chemicals in the workplace. And those are those OELs, what we say in jargon, so occupational exposure limit values, are regulatory values which indicate the level of exposure below which workers are considered safe. So that's very important that they are not exceeded. But also intended to prevent workers mostly from inhaling chemicals, vapors, mists, or dust. So let's say the main route of exposure is inhalation.
- Speaker #0
And how then, more specifically, do these limits help ensure worker protection? across different industries, but also across the EU.
- Speaker #2
What is also a bit different is we are not approaching this via the usual REACH and CLP approach, but there is a different set of regulations, and to be precise, are directives. So it's the Carcinogens, Mutagens and Reprotoxic Substances Directive, so-called CMRD, but also the Chemicals Agents Directive. And there are also other relevant pieces of legislation, such as the Directive on Asbestos. And the European Commission Directorate General in charge of it is DG Employment, and they are responsible for setting those OELs at European level, and they rely on the advice of our committee.
- Speaker #0
And what would you say is the added value of the committee in this process?
- Speaker #2
Well, we assess the science and we issue an opinion on scientific facts, and this will support this commission legislative process. And besides OEL values, RAC may also provide recommendations for short term Limit values are so-called notations, for instance, when it goes about possible dermal exposure. So maybe workers have to protect their skin because exposure can also happen through dermal route. Additionally, RAC may recommend other values such as biological limit values or biological guidance values and they are quite important for monitoring purposes to ensure that actually workers are not really exposed to unacceptable limits.
- Speaker #0
And you assess what's known as an OEL report, right? And this is prepared by ECHA.
- Speaker #2
That's correct. That's the starting point. So ECHA collects all possible available information and produce a scientific report. And this is consulted. So it's usually published on our website and we give 60 days. So in what we call an open consultation and all interested parties are invited to provide inputs, comment, critical remarks, and all of that, it's looked by the RAC in a second. moment.
- Speaker #0
So bisphenol A is already well known and regulated. Some of its uses are restricted in the EU because of reach. It's even on the candidate list for substance of very high concern and classified for things like harm and reproduction and causing serious eye damage. Why is it important to continue refining how we regulate substances like BPA, even when they're already well known?
- Speaker #2
Well, that's a good question. The short answer is probably that it's up to the European Commission to select the kind of substances that should go through this process. And of course, this is very important because OELs are binding. So it means that they become immediately applicable across various member states. So they are directly enforceable and quite a powerful tool. And also scientific information is rapidly progressing. So what was known 10 years ago might now not be sufficient to ensure the protection of workers.
- Speaker #0
Right. And now we're also talking about getting a mandatory OEL as well here, right?
- Speaker #2
That's correct. That's the way this regulatory framework works. Maybe the news that's interesting is the focus in the past was on substances that were considered carcinogens or mutagenic. Now the focus is also on reproductive toxicants. And so also for those kinds of substances, an OEL is considered mandatory. And for BPA, we have an indicative OEL value of two milligram per cubic meter of inalienable air. but now new data have become available so this is why a new assessment has become relevant
- Speaker #0
And is there anything you could share with us and our listeners about RAC's conclusions?
- Speaker #2
Sure. So the exposure of workers have been identified through manufacture, but also use and production of polymers. And there is an important use as an additive in various applications, including the production of other chemicals. And the RAC main recommendation is an OEL that is two order of magnitude lower of the indicative limit value I mentioned earlier. 24 milligram of cubic meter over an eight hour period. So this is considered the level that should not be exceeded along the eight hour measurement periods. And this should guarantee the safety of workers. So it's quite...
- Speaker #0
So how do you maintain sort of scientific clarity when different agencies work in different regulatory frameworks and you all have to come together with opinions? How does that work?
- Speaker #2
That's a good question because on bisphenol A, there's been a lot of activity in the past from what we call sister agencies, such as EFSA, So the Food and Safety Agency or EMA, the European Medicine Agency, and they looked at the substance from different regulatory aspects. For instance, from the food safety, you would say that the oral exposure is much more relevant than inhalation exposure, such in our case. And what we have done, we have ensured also transparently the possibility for them to participate and to follow the progress of our discussion. And I think this resulted also in really benchmarking and making sure that everybody is on board.
- Speaker #0
Okay, thanks. And I guess then in terms of the next steps, this one is a little bit different to the other next steps that we've covered here. So for restrictions, commission with the EU countries decide, but here because there's other legislation involved, how does it work? How does the decision come up?
- Speaker #2
Yeah, probably the main difference here that the framework is done by directives and directives they work differently compared to regulations such as the REACH or CLP. The starting point is the same, so we will send our opinion to the European Commission and there will be some preparatory work and this is carried out in an advisory committee on safety and health at work that is advising DG employment. This also includes a sort of impact assessment that is carried out with the participation of industry, workers' group and member state authorities. And eventually, so an OEL for BPA will be included in a binding EU directive changes So, uh, update that will be carried out later on by the Commission. So in a way, it's not that different, but being through what is called ordinary legislative procedure, also European Council and Parliament will be involved. So it's a quite lengthy process, but this ensures that all parties actually have a fair chance to intervene.
- Speaker #0
Okay, so to put it simply, the Committee's job is to go through all the scientific data, figure out recommendations for these OELs, and then pass that on to the European Commission. who then takes it from there to make its final decision. Is there anything else you'd like to highlight from the Risk Assessment Committee's work, maybe on harmonized classification labeling?
- Speaker #2
Yeah, if you allow me maybe to finish the podcast. I think I would like to signal the good progress we made on some CLH dossier, but also the workload keep us quite busy. We have more than 50 CLH dossier every year, and we are facing some delays in the finalization of the... opinions that have been already adopted. And I think it's important to inform our listeners that some cases such as talk or burgeoning and cyclamal opinions are late, so we are working hard to complete swiftly them and to send them to the commission and then to publish on our website. So we open a few months to absorb such a workload peak, so be patient, stay tuned, and we are working hard to make sure that this information will become available as soon as possible.
- Speaker #0
Okay, thank you. Well, that's a perfect wrap up for the podcast. I don't think I need to do my usual spiel, but I'm going to do it anyway. So that's it for today. Big thanks to Maria and Roberto again for joining us today and sharing all that useful info going very much into detail, which I'm sure our listeners will appreciate. We'll catch up with you again after the summer break for the September committees. Now, we've got a lot of interesting stuff still coming up for you this year, including, of course, the regular committee updates and a few surprises on the way as well. So make sure to subscribe to our news so you don't miss our upcoming episodes. and follow us on social media. Thanks for tuning in and see you next time. Bye for now. Safer Chemicals Podcast. Sound science on harmful chemicals.
