Transcription

• Adam Elwan - Host, ECHA

  Safer Chemicals Podcast. Sound science on harmful chemicals. Welcome to the Safer Chemicals Podcast. In this episode, we will deconstruct the meetings of the Risk Assessment and Socio-Economic Analysis Committees' December meetings. This time, we're doing things a little bit differently. So you might remember that at the end of our last episode, we invited you, our listeners, to send in questions on PFAS. Thank you very much to everyone who contributed. We'll be tackling those questions during the PFAS segment, so stay tuned for that. We'll keep doing this also for upcoming episodes, so if you do have specific questions for Roberto and Maria, or if you have suggestions for topics you would like us to cover in the podcast, send them to us at video@echa.europa.eu. Today we'll be covering two major topics from the December meetings. The first is the ongoing work on the universal PFAS restriction proposal, something that's been recurring since this restriction proposal came to us, including which sectors were discussed and what's coming up next. We'll also talk about a new milestone for the Risk Assessment Committee. And this was the first classification opinion using new hazard classes from the CLP regulation, focusing on a substance identified as very persistent and very bioaccumulative or VPVB. Roberto Maria. Thank you both for joining us again.

• Roberto Scazzola, ECHA

  Thank you. Thank you, Adam. It's a pleasure to be back. Last time in 25,

• Adam Elwan - Host, ECHA

  right, Maria?

• Maria Ottati, ECHA

  Last time in 25, yes, indeed. A pleasure, Adam.

• Adam Elwan - Host, ECHA

  Yes, indeed. This is our last episode of the year. But okay, let's start with the universal PFAS restriction proposal. So, Roberto, could you give us an overview of the discussions in the committee during this round of meetings? And why did you find the PFAS manufacturing discussion so interesting?

• Roberto Scazzola, ECHA

  Indeed, the discussion was focused on the PFAS manufacturing and horizontal issues, so we had those big sectors and PFAS manufacturing was indeed a special discussion to me. Why so? Well, first of all, it is about the production of PFAS chemicals and not much they're use in a specific sector as we did so far. In addition, I think it's a bit at the origin of everything. And I found, if I can say it's somewhat amusing that it came to RAC toward the end of it and not at the start of it. And why so? Because there were a number of pollution cases in some European manufacturing sites, in some European countries. I can remember something like Italy, Belgium, or the Netherlands. And this caused contamination of soil, water, groundwater. And so local governments, they took action. And probably this was also the result of the submission of the restriction itself. And this is what we are discussing here today. We also learned that experiences in remediation can be very costly when they can apply at all. Also, maybe to say that manufacturing affects all other sectors because it is about the production of PFAS that then it's used to make something else. I think we discussed this in other sectors such as cosmetics, medical devices and others.

• Adam Elwan - Host, ECHA

  Well, actually, going back to what you said there, something you mentioned, you said that this local action was somehow tied to this restriction proposal. Can you just clarify how? Why is that?

• Roberto Scazzola, ECHA

  Well, we have learned from a number of documents that have been shared by the dossier submitters that in some specific instances, local authorities, they took action, they implemented more restrictive emission factors for the companies that are acting there. In some cases, there are even court cases that are ongoing. So it's definitely something that caught the attention of local authorities and even public media, I would say.

• Adam Elwan - Host, ECHA

  Okay. Okay. Well, I mean, I see now why the sector caught your attention. And what about then the content of the discussion? So is there something else that kind of puts aside this sector?

• Roberto Scazzola, ECHA

  Well, as usual, we must take into account what are the volumes, try to estimate the emissions, but also having a view from the risk reduction perspective, whether some options are better than others. What was special was that the five authorities proposed a possible maximum emission limit. to the emissions for PFAS manufacturers. This was based on a voluntary initiative that was proposed by industry. However, on the emission factors, RAC supported rather the applicability of the Industrial Emission Directive, that is an existing legal framework at local level. This would be able to establish actually a site-specific limit value rather than a generic one. We also benefited from the input of European Commission experts from the Industrial Emission Directive. We also discussed, by the way, the limitations of this directive. Unfortunately, there are not yet specific best available techniques. They are called BATs in the sector for PFAS, and it could take several years to get them. We also discussed the possibility to implement risk management measures to actually improve the current situation, reducing total emissions. And finally, a lot of stakeholders attended again, and they commented a lot during the various presentations. So overall, a good discussion and good progress achieved.

• Adam Elwan - Host, ECHA

  Okay, glad to hear that. And I understand that the Socio-Economic Analysis Committee also talked about the manufacturing sector, right?

• Maria Ottati, ECHA

  Yeah, that's correct. I mean, in the last plenary, we had had an initial discussion just presenting the proposal by the dossier submitter and initial impressions, but now we discussed it properly and we actually concluded as well. So quite a lot of good progress as well. so this one is one that is also a little bit atypical for us normally we spend quite a lot of time on a I've explained several times when talking about other sectors. We do a lot of work on the analysis of alternatives. So you look at sub-use by sub-use and see other alternatives for the use of PFAS here or not. But in PFAS manufacturing, mostly, for the most part, PFAS has no function per se. An analysis of alternatives is just not relevant because it's been produced to be used in other sectors. And those are the other sectors that we were assessing. So, you know, this analysis of alternatives wasn't so much of a thing here. There's one small exception, which is the use of PFAS as polymerisation aids. There you can do more of a traditional analysis of alternative. And we did that, of course. But for the most part, we were looking at the other aspects that we normally look at. We looked at the cost, of course, the benefits, the proportionality and derogations. And for this topic, we also considered the potential for emission minimization as part of the proportionality assessment. That was also a little bit different than in other sectors. Roberto was talking about this coming at the end and this being a little bit funny. I guess in a way it makes sense because at the end, we kind of we have a better view as to where we think that derogations will actually be needed. So what will we need PFAS for if the restriction comes in? So you get a little bit of a better picture as to what could happen if under the first restriction option, if everything is banned, for instance. Right.

• Adam Elwan - Host, ECHA

  So to me,

• Roberto Scazzola, ECHA

  it made sense to have it this way. Looks better now.

• Adam Elwan - Host, ECHA

  Okay, great. So then both committees discussed and concluded also on horizontal issues, right? And could you tell us kind of why this is so central, these horizontal issues to this restriction proposal?

• Roberto Scazzola, ECHA

  Yeah, what we call a horizontal issue is really at the heart of what we are doing in this restriction. And they are about cross-cutting. issues that are not sector specific, but they apply to the oil restriction as a single entity. And when it goes to RAC, this is about establishing the chemical identity of the PFAS that are actually subject to the restriction, what are the hazards, the potential risks, and why they must be controlled, but also the concentration limits above which PFAS will have to be restricted. And also recycling related aspects and general risk management measures to monitor and to reduce environmental emissions.

• Adam Elwan - Host, ECHA

  Across all the sectors. Yes, yes, indeed.

• Maria Ottati, ECHA

  We've also got things like practicality, for instance, including enforceability as well. So, you know, can it actually be applied, the restriction? Can it be enforced? Can you monitor the progress made? So those are topics that we both look at, actually. And then there are other aspects that are more related only to SEAC. For instance, overarching impacts on trade and competitiveness, cumulative impacts, all those things we also looked at ourselves.

• Adam Elwan - Host, ECHA

  Okay, so really a holistic picture overall of the impact of this. Good. What were then the highlights from the Risk Assessment Committee on these horizontal issues particularly?

• Roberto Scazzola, ECHA

  Well, first, this was not actually the first time we discussed the topic. It came already to the committee a number of times. So already many things were concluded in previous meetings. What we discussed this time and agree was about the general approach to estimate emissions in the virus life cycles, special focus on fluoropolymers and on the waste stage. But also we updated the effectiveness, the practicality and also the additional regulatory risk management options. The highlight for me was also the discussion on the site specific PFAS management plans. So this is something that RAC proposed to apply to all companies. possibly benefiting from derogations that could be granted by the institutions. The dossier submitter proposed those plans for some uses to incentivize substitution with other materials that have different properties than the PFAS one. However, RAC wanted to put more the emphasis on reducing emissions. So the plans should contain risk management measures to reduce those emissions such as preventing leaks or reducing emissions whenever possible. monitoring them because we need to know what actually happens, but also to communicate and inform across the supply chain because if you don't get the information you cannot act actually, that's a quite important element. There was also a focus on emissions related to the circular economy activities such as recycling, reuse, the use of spare parts, and also from potential derogations related to this sector. And finally some sectors were proposed to be excluded from the restriction and we looked at what this would mean for the restriction itself.

• Adam Elwan - Host, ECHA

  All right. Thanks, Roberta. And for you, Maria?

• Maria Ottati, ECHA

  Well, we have discussed this topic in the past as well, quite a few times. It was one of the first ones we discussed when we started several years back already. And we kept bringing it back periodically. So in the past, and especially in the last plenary, we have discussed more topics like what do we think of the dossier submittance approach? How will we assess it? But we didn't go much into that this time. That's already closed down. So here we looked at more general topics. I mentioned some earlier and some of the ones that Roberto also talked about, like recycling, secondhand articles, spare parts. So there we had quite a lot of discussion and quite a lot of information. So, for instance, for recycling, we went into quite a lot of detail looking at recycling of plastics, of paper and board, of textiles, of metals. Conclusions are a little bit different for each of them. So we spent quite a lot of time doing that. So these are topics that were introduced in the dossier in the last update that the dossier submitted. So this is the first opportunity we have had to assess those.

• Adam Elwan - Host, ECHA

  And I understood that the Socioeconomic Analysis Committee also finalized its conclusions on electronics and semiconductors, right? As kind of the last sector to be announced. Yes,

• Maria Ottati, ECHA

  exactly. That's a... bit of a beast of a sector. It's the biggest one in terms of received comments. And it's very, very complex. I mean, first of all, it's got two separate kind of sub sectors of electronics and semiconductors. And then when you go within that, there's even much, much, much more detail. So in the last plenary, we had discussed for semiconductors, the analysis of alternatives and the costs. So now this time we have brought that all together and also done the same for electronics and looked at the whole electronics and semiconductors as a whole. So there is quite a lot there. And it's a very technical sector as well, let's say. So that was quite a lot of work done by the teams to get to grips with things, to understand really how different things work within it and to understand the applications. And yeah, I think that was quite a long discussion as well.

• Adam Elwan - Host, ECHA

  And I suppose there, the kind of the stakeholder expertise that you get in the committees also supports this kind of knowledge sharing and understanding work.

• Maria Ottati, ECHA

  Yes, it helps. We had some very helpful interventions from stakeholders explaining things. And also, of course, the information submitted is crucial there. So, you know, that really allows to do the assessment properly.

• Adam Elwan - Host, ECHA

  Okay, good to hear. Well, with this then, both committees have concluded their discussions on the 14 sectors and PFAS manufacturing. What happens next?

• Roberto Scazzola, ECHA

  Well, I think this is amazing and I think it's a great achievement. Now for RAC, we have the last mile to be concluded, but I'm...

• Maria Ottati, ECHA

  They see the light at the end of the tunnel. We don't quite.

• Roberto Scazzola, ECHA

  Not yet. I think it's not yet time to celebrate. I'm sure Maria will join me in spending a few words of appreciation for the amazing work that reporters and the ECAS secretary have put into it at the end of the day. This is about real people and non-artificial intelligence. So this is the hard work of human. So let's acknowledge this. I think it's nice. And on RAC's side, now we will have to carefully draft the final opinion text and ensure that all cross-horizontal issues are reflected in the same manner across all various sectors. So we need 14 sectors and PFAS manufacturing to be put together. Our goal, as usual, is to have a scientifically sound and consistent opinion ready for March 2026, when RAC will adopt its opinion.

• Maria Ottati, ECHA

  And on the CX side, it's very similar. we put everything together? Well, first of all, we have to go back, make sure that everything is consistent across all the sectors. It's been a long time. Things have changed. Sometimes, you know, things are not completely consistent with each other. So we'll do that. And then we'll put everything together as the, you know, the general opinion. And that, again, is coming for, in circuits, for agreement in March. So what's the difference between agreement and adoption? All it means is that it's not final yet. So we agree it and then we open the consultation. So after the March meeting, we launch a 60-day consultation on this draft opinion. So it doesn't get adopted until after that, basically. So, yeah, this is how it's built in the regulation. We have an additional consultation while RAC adopts a little bit earlier. It helps because we then get a stable rack opinion to work with, because of course there's quite a lot of interactions in between and most of them are going more in the rack towards SEAC direction than the opposite.

• Adam Elwan - Host, ECHA

  Okay, well, so for RAC, well, Risk Assessment Committee, the finishing line is on the horizon for the Socioeconomic Analysis Committee. Let's talk about that consultation a little bit. So kind of what should stakeholders expect and how can they best contribute?

• Maria Ottati, ECHA

  Well, just maybe first thing to mention is we announced in the last podcast that we were going to do a webinar and that now has happened. It happened in October and that can be found on our website. There's quite a lot of information there. So what we're basically asking the stakeholders to do is to start preparing already for the consultation. There is also going to be a mapping of PFAS uses. Well, one is already available and we continue to work on that and many further support materials will follow as well. So the idea is that we would like people to engage really early and start preparing what they will submit. It is a short consultation and that is, I think, going to be one of the big challenges that are coming.

• Adam Elwan - Host, ECHA

  Well, actually going to challenges and opportunities, what do you foresee in terms of those in the consultation process?

• Maria Ottati, ECHA

  Well, with consultations on the SEAC draft opinion, the big challenge is always the same. It's matching our needs. What do we need to make this opinion the best possible? And the stakeholders decide to provide their information, just trying to make sure that those match, that the information provided is actually what we need. Yep. So. this consultation is about our SEAC draft opinion. It's not a general consultation on the topic.

• Adam Elwan - Host, ECHA

  That's an important distinction. That's a very important distinction.

• Maria Ottati, ECHA

  And this is why we're spending so much effort providing guidance and designing the consultation so that it focuses on the areas where we really need more evidence. And we are able to communicate that to the stakeholders. We're telling them exactly, this is what we need. This is where we need information. And they can already start preparing it. So, I mean... When we talk about timing, that really is a challenge. It's a short consultation. It's 60 days. That's reached us. And the other thing as well is that the actual opinion only becomes available at the point when we open the consultation. So there is a limited amount of time to reach the end desk. Of course, the stakeholders who have been following the process through the committees, they have had access to the draft versions. Those may change a bit, of course, and many people won't have had access to that. So what we are going to, what we are doing at the moment is providing them the information about what information we'll be asking about, so that even without reading the opinion and seeing it, you can already start preparing. You can already start looking at all the data that you have and drawing out things at the right level and at the right level of granularity as well, which is where we need to be able to conclude properly. And yeah, I think that that's if people spend time. preparing, I think we can get something really good at the end of it.

• Adam Elwan - Host, ECHA

  This bridges nicely to our audience questions. So we got two, and both were on the upcoming consultation. So the first one was about these eight sectors that the five authorities added to the proposal following the first consultation. This question has two parts. So first of all, I'd like to explain what the issue is with these eight sectors. And then the actual question is, how can stakeholders submit new information on these during the consultation?

• Maria Ottati, ECHA

  Okay, yeah. So the issue with these eight sectors is that although they are part of the proposal, they're covered, RAC and SEAC will not be doing a sector-specific evaluation of these sectors. So that is the reason why people are asking about how can they submit information about them and they want to understand how it will work. So it's important to be very clear. The SEAC draft opinion and the RAC draft opinion, they cover the full scope of the restriction proposal. So all PFAS. and all uses except for firefighting forms, which is covered elsewhere. Yes, indeed. So we're asking people to provide comments on any of the aspects of the CERC evaluation that they wish, including the eight additional sectors if they wish to do so. So they can submit the consultation. So the consultation has two parts, let's say. They have very specific questions on the sectors where we do this sector-specific evaluation. there we're asking about. analysis of alternatives, costs, benefits, proportionality, all those details. But there are also more general questions on all the different sections of the SEAC opinion. And this also includes analysis of alternatives, costs, benefits. So they are able to submit information about those eight sectors in those sections of the consultation. I think that's really important to know.

• Adam Elwan - Host, ECHA

  So to summarize, the consultation is not just about the 14 sectors and PFAS manufacturing. It covers all aspects of the draft opinion, so anyone interested can share their thoughts on any part of the committee's evaluation. That includes things like alternatives, costs, benefits, as you mentioned, so the whole picture. Good to keep in mind that any relevant information you give will help the committee check or update its conclusions in the opinion. So basically, if you've got insights on the draft opinion, now's the time to speak up. The second question we received was on the decision to not allow attachments in the upcoming consultation. Very specific. So can you explain the thinking here and why is that potentially such a sensitive issue?

• Maria Ottati, ECHA

  Yeah, so the reason why we have structured the consultation in the way we have by using a survey approach is to, you know, resolve this challenge that I mentioned a little while back about making sure that what is provided actually matches what we need. So we want to make sure that people don't waste their time sending us things that won't be able to be used because they're not at the right level, they're not the right thing. So that's why we are providing the information this way and asking for the information this way rather. And we provide quite a lot of space to give us data, even if attachments are not allowed. There are multiple questions and they cover all aspects of the draft opinion. So there's quite a lot of space to provide information. There are, of course, character limits, but they are very generous, I must say. And collecting also the comments in a way that's more structured also allows us to process the information more effectively. And for the information that comes in to have a bigger impact on the opinion making process as well, which is the whole point of why we run the consultation.

• Adam Elwan - Host, ECHA

  Right. And you've run a few consultations in the past. So I guess you've also understood from there that once these attachments start coming in, you do get a lot of things that may not be included at all because they're just not relevant. So it's also a left unlearned. Yeah,

• Maria Ottati, ECHA

  I think we have learned a lot from previous consultations, including the one on the Annex 15 dossier in this case. And all these lessons that we have learned, we have applied to try to make this consultation the best possible.

• Adam Elwan - Host, ECHA

  All right. Well, thank you. I think that concludes the audience questions. part. And as you mentioned, we did organize a webinar on this in October, I think it was, and we'll be adding a link to that in this episode's description. So do check that out. But now let's conclude on PFAS for today. We'll come back to it next year. Long sigh of relief. Good. Let's move on to our second topic. So this was the first time classification opinion from the Risk Assessment Committee on new hazard classes under the CLP regulation. Roberto, can you explain? Why this is such a significant milestone to the committee?

• Roberto Scazzola, ECHA

  We should probably start from the revision of the CLP regulation, classification, labeling and packaging regulation in 23 that was modified introducing new hazard classes, both for environment and human health. And for some of them, we had some previous experience in other processes such as PBT, persistent bioaccumulative and toxic substances in SVHC, substances of very high concern, a lot of acronym, sorry. But what is new is indeed that those new hazard classes were not available earlier, and particularly PMT, so persistent mobility and toxicity, or for instance, endocrine-disrupting properties for human health or environment. And for the first time, RAC assessed a first case. I will not read the name of the substance, not to confuse our listeners, but the conclusion was that it was very persistent and very bioaccumulative into the environment. And this definitely sets a... precedent is the first time and more proposals to classify substances with the new hazard classes will come and this will include for instance endocrine disrupting properties in 26 and the committee as usual will face new challenges because those are new criteria we have guidance but guidance is often not everything we need to test the system with real data and this is what we have done but i think we are in a good position to to make this happen and to be to have a successful assessment also in 26 for the upcoming new substances.

• Adam Elwan - Host, ECHA

  Right. Well, could you briefly outline kind of the scientific basis for the very persistent, very bioaccumulative classification in this case?

• Roberto Scazzola, ECHA

  Indeed, well, we can start saying that in the specific cases about the property, the intrinsic property of a substance to persist into the environment, to stay without being naturally biodegraded in something else, in normal environmental conditions. and to accumulate in a living organism. So the possibility to basically build a stock in time in a specific organism. And this was considered as a relevant hazard that should be subject to classification and also to labeling to inform also potential users. To do so, we use what we call specific markers. For instance, if the substance shows a very long half-life, so the time that it needs to actually have at least... its concentration into the environment within a certain period of time. Usually we use 180 days, it's a bit the standard, or bioconcentration factor in fish. So how much actually this can concentrate when the fish is exposed to a substance. And if those limits are exceeded, this means that they are very persistent and very biocumulative. As usual, also this relies on so-called weight of evidence because we can have... multiple simulation studies or bioaccumulation tests according to the CLP criteria. And it is the task of the committee to weigh all the data and to decide what is the best approach in a weight of evidence approach. This is what we do. It's also we need to be transparent because everybody needs to apply the criteria in the same way. So it's very important that we also make informed decisions that are very logical and also transparent for the users, actually, of the CLP classification.

• Adam Elwan - Host, ECHA

  So what's the impact? What does this mean for industry and regulators going forward?

• Roberto Scazzola, ECHA

  Well, we expect more proposals, as I mentioned to you, covering new hazard classes. And we also expect that the industry could gain actually knowledge through what RAC is doing, because also they will have to apply actually the very same criteria. And this will also result in labeling requirements. So we see a benefit in terms of increased consistency in hazard. identification. And RAC being the first actually to implement those criteria, I think the outcome of it will be fundamental to really decide how those criteria should be applied. And at the end of the day, it will be for the benefit of member state, commission, industry, and interested parties at large. And as usual, we send our opinions to the European Commission, and then with member states, they decide whether it deserves to be included and become an obligatory classification, of what we call harmonized.

• Adam Elwan - Host, ECHA

  Okay, well, what's left to say except congratulations on this first milestone. Maybe still to wrap this up. So the committee has taken a very big step by applying the new hazard classes for the first time, classifying this substance, which I'm not even going to attempt to pronounce, as a very persistent and very bioaccumulative. So this now sets the tone for future decisions with more proposals expected next year, including endocrine disruption. For industry, It means getting ready for updated labeling and for regulators, more consistency, I guess, could be said than in hazard identification. We've actually come to the end of our episode. So again, thank you very much for taking the time right after, fresh from the committee meetings. Thank you, Adam.

• Maria Ottati, ECHA

  It's always a pleasure.

• Adam Elwan - Host, ECHA

  Thank you. Stay tuned for further updates in our upcoming episodes and by subscribing to our news. As mentioned at the start, do take the opportunity to send us your questions and topic suggestions so we can cover them in our future episodes. You can send those to us at video at eka.europa.eu. Well, that's it for this year. Wishing you all happy holidays and looking forward to another year of the Safer Chemical podcast in 2026. Goodbye from Helsinki. Safer Chemicals podcast. Sound science on harmful chemicals.