Transcription

• Adam Elwan - Host

  Safer Chemicals Podcast. Sound science on harmful chemicals. Welcome to the Safer Chemicals Podcast. I'm Adam Elwan, your host, and today I'm joined by Roberto Scazzola and Maria Otati. Now, yesterday when I was going through the topics we'll be talking about today, I realised that we've done probably tens of episodes together. And I've never actually given you the chance to properly introduce yourself. So maybe to start us off a bit differently than usual, could I ask you to tell our listeners a bit about who you are? I mean, what is your background and what brought you to ECHA? Sorry to put you on the spot like this, but who would like to go first?

• Roberto Scazzola, ECHA

  Maria, please.

• Maria Ottati, ECHA

  I'll start then, yes. So I'm actually an Italian citizen, but grew up in Uruguay. So I always joke with Roberto that I'm a fake Italian. And I started working there in the civil service. I'm an economist by background. And my first type of work that I did was in international trade, which is very topical at the moment. So about 15 years ago, I moved to the UK. I went to do a master's there. And then I started working at what was the competent authority for REACH there. I wasn't actually working on REACH. I was working on other types of risks to workers, but including some chemicals. And in 2018, I moved here to ECHA and since 2020, I have been chair of the Committee for Socio-Economic Analysis.

• Adam Elwan - Host

  And Roberto?

• Roberto Scazzola, ECHA

  Roberto Scazzola. I'm fully Italian, as you can see from my strong accent. Not a fake Italian then? Well, maybe. Who knows? Well, what to say? I have an experience in the Environmental Protection Agency in Italy. I worked for six, seven years there. Then I moved to the private sector. I was doing a bit of consulting and also working for a trade body. And then I had 10 years of experience, more or less, in the European Commission, working on international negotiations in a couple of United Nations conventions. And then I worked for the Chemical Strategy for Sustainability, Classification and Labelling, cosmetic products. So I had a quite wide range of experiences in the Commission. And I really wanted to join ECHA because I think it's the place to be if you want to work for the safety of chemicals. Since 2023, I'm the chair of the Risk Assessment Committee.

• Adam Elwan - Host

  All right. Thank you both. So I learned something new about both of you. So pleasure to meet you both finally, properly. All right. Let's then actually jump into the topics for today. So you are, I hesitate to say fresh out of the first committee meetings of 2025, but hopefully still awake enough to do the episode today. And we'll be discussing the highlights. So we'll begin as usual with the big topic the committees are discussing. That's the universal PFAS restriction proposal. Followed by a brief overview of the harmonised classification and labelling proposals for two substances, so silver nitrate and silicon dioxide. Then last but not least, we'll also give an update on the Risk Assessment Committee's preparations for the Drinking Water Directive. Maybe we then start with PFAS. So the committee talked about PFAS uses in new sectors. So we have fluorinated gases, transport and energy now being discussed for the first time. Roberto, what were the highlights from the discussion?

• Roberto Scazzola, ECHA

  Well, I think we had three big sectors and I'm very satisfied by the fact that RAC was able to agree on the provisional conclusions on all of them. They are, as mentioned, large and complex sectors and they have been assessed carefully by the committee and they relate to transport. It's about vehicle conditioning and refrigeration, coatings or foam moldings, also fluorinated gases. Again, it's about refrigeration, heating, conditioning, foam blowing agents like the ones used for producing mattresses. And then energy, very important sector with renewable energy generations, the transport of energy, storage and batteries. When it goes to what RAC does, actually, this means identifying the volumes and the related emissions that are calculated per sector for the major sub-application. And I think it's worth mentioning for fluorinated gases, these resulted in the highest emissions so far estimated by the committee, about 40,000 tons per year. That's quite a lot. and this is due to the high release factors that is embedded in actually in their use compared to other sectors. RAC also agreed on a common approach on the analysis of risks of alternatives. This is mostly based on the CLH properties of the substances, so their hazards, but also on additional information when this is available about impurities or monomers. However, we have to signal that there is often a lack of detailed information on hazards and risks and this means that this adds to the overall uncertainty when it goes to the overall relevance of the dossier. RAC also looks into the effectiveness of the restriction options to reduce the risks, but also the sector-specific derogations, but only, let me clarify, based on risk considerations. All such economic aspects are carried out by our sister committee, SEAC. And of course, I should also mention we had a record number of stakeholders. I think if I remember well, at a certain point, we had over 140 people. Not all of them are stakeholders, of course, but many of them are. And so this, of course, is a measure of the interest and the importance of the sector that have been looked at by the committee. And as usual, those are provisional conclusions. It means that the overall approval will be carried out later on in the process.

• Adam Elwan - Host

  All right. So the same process as for any restriction, essentially. There's nothing, exceptional here. All right. Well, thank you, Roberto, for those insights. I think it's encouraging to see that there's so much detailed work going in and being done on these sectors. Now, a couple of follow-ups. So you highlighted that there was kind of high stakeholder engagement during the meetings. How does the Risk Assessment Committee then ensure that all these multitudes of views are sufficiently considered in the decision-making process? It must be quite challenging to do.

• Roberto Scazzola, ECHA

  Well, we try to do our best. And the first point is that we allow the highest possible number of stakeholders attending physically the meeting, even if sometimes we have to limit this because there are some physical capacities in the way we can accommodate them. Stakeholders are invited to take the floor and to provide their input during the discussion. And of course, this is taken into account during the opinion making. But also all the comments that have been provided during the consultation are looked at and there will be a response to them into the final opinion once it will be finalised.

• Adam Elwan - Host

  Okay, thank you. Another thing that kind of jumped at me when you were talking was that there was this lack of detailed information on hazards and risks for the alternatives for these uses. So how does the committee handle these kinds of information gaps in their assessments?

• Roberto Scazzola, ECHA

  Well, we do our best also because this is a very wide restriction with a lot of sub-applications and therefore we have to look at a very high number of possible alternatives. Every time this information is available in the dossier submitted by the dossier submitters, by the countries that are behind this proposal, the committee can look carefully into it, but sometimes this information is not available. So if there is no other possible source of information, the committee adds these into the uncertainties into their assessment. So we try to navigate through the availability of the information. And when it's not available, of course, we take into account these in form of uncertainty.

• Adam Elwan - Host

  Right. So then ultimately the decision makers will be looking over these, including the uncertainties and taking those into account in the final decision to regulate these chemicals.

• Roberto Scazzola, ECHA

  That's the idea.

• Adam Elwan - Host

  Maybe then, Maria, jumping to you on the same topic. So you covered actually the same sectors, but from the socio-economic perspective, anything you can share with us?

• Maria Ottati, ECHA

  Well, I can mention that for energy and for transport, we actually had only introductory discussions. So the rapporteurs provided a presentation introducing the sectors. There have been some changes since the dossier was submitted, updates made by the five authorities. And there we will continue actually in June with the discussions. For applications of fluorinated gases, there we came to provisional conclusions. So that one we have finished, basically. And there, as usual, we have looked at the availability of alternatives, and then we've looked at the cost and benefits and what derogations are needed to ensure proportionality.

• Adam Elwan - Host

  You talked about the socio-economic benefits and costs for implementing the restrictions, but can you elaborate on the key benefits that you expect, you know, if and when these restrictions take place?

• Maria Ottati, ECHA

  Yes. Well, the benefits are an area where the link between the work of RAC and SEAC is very close. So... the benefits that we see are as a result of the emission reduction, which is something that RAC gives us as information. So what we've got there are environmental benefits. And, you know, these are very persistent substances. So also there's fewer costs of remediation because we know that it's technically and economically very, very difficult to clean up these PFAS from the environment. When it's possible, the remediation techniques are known to be very, very expensive as well. So, you know, if fewer emissions... less PFAS in the stock and then less cost to remediate. Also, in some cases, we know that there are human health impacts. So if there is fewer emissions into the environment, there's less exposure and fewer of those negative health impacts that can happen. So, you know, on the whole, those are the benefits that we're talking about.

• Adam Elwan - Host

  So essentially cheaper to clean up because you don't have to clean up as much, less health impact and less persistent chemicals in the environment.

• Maria Ottati, ECHA

  Exactly.

• Adam Elwan - Host

  Okay, what about then leading on from those benefits, one task of the committee is to look at proportionality of any measures that are taken. Can you talk a bit more about how you do that?

• Maria Ottati, ECHA

  Yeah, so we basically bring together these benefits with also the costs. So we start out by looking at the availability of alternatives, because obviously, if there are alternatives, that influences what the costs are of not using PFAS. You know, it's different if you've got something to replace them with than if you don't. Then we look at what the benefits are in terms of the emissions reduction, and we bring it all together when we talk about proportionality. And then what we do as a result of this is we start out by thinking, okay. given the risk, we know that as long as the right derogations are proposed, the restriction would be proportionate. So we look sector by sector at what we know about the cost, the benefits, the availability of alternatives, and we make or not a recommendation as to whether we can conclude about whether derogation is necessary to ensure the proportionality. In some cases, the information is just not there. But in some cases, we're able to say that yes, one would be needed to ensure proportionality or that in some cases, one would not be needed to ensure proportionality.

• Adam Elwan - Host

  Maybe if we can then talk a bit more about the types of uses that are included in these three applications.

• Maria Ottati, ECHA

  So among the applications of fluorinated gases, we discuss things like refrigeration, heat pumps, and there we're talking also about the ones that are used in households, air conditioning, so those types of things. And this is quite a difficult sector in the sense that it interacts quite a bit with existing regulations. The main one there being the Fluorinated Gases Regulation, which covers already many of the substances which are looked at in the PFAS restriction.

• Roberto Scazzola, ECHA

  We can also provide some examples for the energy sector, for instance, as mentioned batteries are very important for the green transition, but also solar collectors, fuel cells involving hydrogen, or more in general, renewable energy generation, so quite important applications. When it goes to transport, it's about cars, boats. airplanes and trains, and when they are manufactured, like the body or the fuselage construction, but also fuel, engine systems, hydraulic fluids. So there are really a wide range of possible examples.

• Adam Elwan - Host

  All right, thank you both for those insights. So to summarise, you covered PFAS in applications of fluorinated gases, transport and energy, all very big sectors with a lot of uses. For all these uses, the Risk Assessment Committee reached provisional conclusions. Whereas the Socio-Economic Analysis Committee will still continue discussing transport and energy in the next plenary. And you mentioned June, right?

• Maria Ottati, ECHA

  Yes, exactly. So in SEAC, we will obviously continue with energy and transport, which we started now. And we will also start discussing medical devices and lubricants. In RAC, they will do also medical devices and lubricants. And in their case, they will introduce electronics and semiconductors. And then in September, RAC will continue with electronics and semiconductors and SEAC will have their discussion, the full discussion in that month. And as usual, we are really dependent on how the five authorities, who as a reminder are Germany, Netherlands, Denmark, Sweden and Norway, how they can update their initial restriction report, which is following the consultation input.

• Adam Elwan - Host

  This brings up another question I have. So how does this, the fact that it's been submitted by the five authorities and the expertise that you have in the committees in general, how does that play in the work of the committee? So, how do you ensure that there's independence? Because obviously you have different viewpoints coming in. How do you make sure?

• Maria Ottati, ECHA

  Well, the first thing to say is that our members are independent experts. So they're not ECHA staff, for instance. They are nominated by each of the member states. But it's also really important to note that they're not coming to represent their member states. They are independent. They're only nominated by them. Our management board appoints them. And they are coming there to bring in their own expertise. And actually, they are able to change their mind even during the meeting. Sometimes, you know, they listen to the evidence, they have a discussion and actually decide that they can change their mind. And we have several processes in place to ensure this independence, both from their member states. So they cannot take instructions from the member state. But also we make sure that they are not influenced by any other interest they may have. And we're talking here about economic interest. So we make sure that they are independent. We check that. They all declare what their interests are. And as Chairs, Roberto and I make sure that there isn't anything there that is unduly influencing them.

• Adam Elwan - Host

  Right. So really, the committees are mostly made up of people from outside of ECHA. And ECHA provides kind of the secretariat and the support and the chairing of the meetings.

• Maria Ottati, ECHA

  That's exactly it. We support them, but they are the ones who are coming to the conclusions. And also important to note that the opinions are the opinions of the whole committee. So we have certain committee members who are taking the pen and actually drafting the opinions. But the whole committee needs to agree.

• Adam Elwan - Host

  Okay, well, let's wrap up PFAS then for now. This will be coming back to probably all of our episodes in the near future and beyond. And let's talk about harmonised classification and labelling, specifically for silver nitrate. So it already has harmonised classifications, for example, as a substance that causes severe skin burns and eye damage. But now the Swedish authorities have proposed to introduce quite a few new classifications. So also including... things like reaprotoxicity, so it could damage fertility and the unborn child. To start us off with, where is silver nitrate used? Can you give a few examples?

• Roberto Scazzola, ECHA

  Indeed, there is quite a broad use of this kind of substance. Mostly, it is to provide human hygiene or disinfection or to help veterinary hygiene. Also, as an additive for food and feeds, also in drinking water. So it's a quite wide range of consumer applications. This also probably is a measure of the interest of the dossier submitter in providing such a proposal.

• Adam Elwan - Host

  And what did the committee then conclude, in its opinion?

• Roberto Scazzola, ECHA

  It was quite a long process because also we took into account new information that was made available. And the main outcome of it was that the committee concluded for reprotoxicity category 1b. So it's a quite severe classification. It means that the substance may damage the fertility or the unborn child but it was also classified as suspected of causing cancer, is a category 2 carcinogen. It is also of interest the specific target organ toxicity, what is called in jargon STOT, for repeated exposure because the substance has been found to cause damage to the nervous system through prolonged or repeated exposure. So there is overall quite a high set of severe classification. And I would like to add that There were many references to a former RAC opinion on the silver ion that was issued a few years ago that could not reach consensus at that time. But this time, even if there is a certain similarity of the substance, new data allowed the committee to reach a consensus decision. So there was no minority opinion. And this was due definitely to the broader amount of information that was looked at by the committee. And also to mention that this was based on a read-across. and this also resulted in quite some complex discussions because other similar substances could be used up to a certain extent to support such a classification.

• Adam Elwan - Host

  And just can you explain read across in a nutshell just for our listeners too?

• Roberto Scazzola, ECHA

  Well in a nutshell read across means that you can establish a link between the substance at stake and a similar substance and if data on the similar substance are available we can use them with certain precautions and in a way you don't need to test or to add new information because the similarity is so strong that allows to make this step.

• Adam Elwan - Host

  Okay. And then ultimately, as with all of these, the European Commission together with the EU countries will decide on the final harmonised classification.

• Roberto Scazzola, ECHA

  Of course, we will submit this opinion to the European Commission. They will decide whether it deserves to be added into the so-called Annex VI. And the moment it does, it means that it becomes the obligatory harmonised classification at European level. And this has important consequences in terms of hazard information. So through the label, people, workers will be informed of what they should do to be safe when they use such substance.

• Adam Elwan - Host

  Okay, thank you, Roberto. Let's then move on to the second substance on the list of harmonised classifications. So silicon dioxide. Now, this substance doesn't yet have a harmonised classification, but the Dutch authorities are proposing to harmonise it in the EU as a substance that causes ... damage to the respiratory tract when inhaled. Can you give some examples of where this chemical is used?

• Roberto Scazzola, ECHA

  Sure. There are wide uses in a large variety of applications, but first I should also mention this substance is known with different names, including, for instance, synthetic amorphous silica. So I really invite our listeners to check carefully the opinion to be sure that we refer to the same substance.

• Adam Elwan - Host

  I took the easy way out. I just said the short version to make it easier.

• Roberto Scazzola, ECHA

  Absolutely. So the uses were related to paints, rubber products, but also cosmetics, food additives, even in manufacturing of textiles. So quite a broad range of uses. And even biocidal products like disinfectants and pest control and plant protection products. So quite a wide range.

• Adam Elwan - Host

  And what was the committee's conclusion then?

• Roberto Scazzola, ECHA

  As you mentioned very well, it's about specific target organ toxicity for repeated exposure. So it means that the substance has the intrinsic property to damage an organ, in this case, the respiratory tract through inhalation because it can cause certain inflammatory responses. And this deserves a category one, so it's a quite severe classification. I think it's also a nice case to remind of the importance of the hazard communication because in the case the European Commission will decide to follow the RAC opinion, this will have important consequences in terms of hazard information that will be made available to consumers, to workers. So this information will allow the users to take the precautions, the risk management measures or any protection that is needed to avoid an undue exposure to the chemical.

• Adam Elwan - Host

  All right, now let's shift our focus to the Drinking Water Directive. So this directive is actually playing a very important role in safeguarding the well-being of citizens and the environment and it addresses the potential risks that are associated with contaminated drinking water so it ensures also better access to clean drinking water. In 2021, the European Commission gave ECHA specific tasks under the directive. And one of the most interesting ones is setting up lists of chemicals that can be safely used in any materials that come into contact with drinking water. These are so-called positive lists. And for maintaining these lists, the Risk Assessment Committee also plays a key role. Roberto, the committee has now been getting ready for the Drinking Water Directive. Could you give us an update on where we are with the work?

• Roberto Scazzola, ECHA

  Well, firstly, I'm really proud RAC has been entrusted with this new important task. It's a clear sign, I think, that we have been successful in our activities in the past, and we hope we will be able to deliver also on those new tasks. The revised Drinking Water Directive, indeed, entered into force in 2021. We can describe it as a sort of permitting system for materials that come into direct contact with drinking water when you collect, purify, transport, or store that water. So it's a quite important task. And we are specifically looking at four materials like organic, metallic, cement tissues, or ceramic, or other inorganics. And they have, of course, different information requirements and different needs following their specific properties. The first European positive list were adopted in April 2024. And we have done a 15-year review program that starts with the overall goal to ensure the safe use of those materials. So ECHA is entrusted to carry out a regular maintenance of the European positive list. This means adding new entries, modifying them, or even removing them. And all entries in the first EU positive list need to be reviewed by 2039, if applied for.

• Adam Elwan - Host

  All right, one question. I mean, in terms of kind of the size of this whole thing, we're talking about water. What kind of impact do you foresee on the companies that are working on this? I mean, compared to the other tasks that ECHA is doing? How wide is this sector?

• Roberto Scazzola, ECHA

  That's quite a significant amount of work, I have to say. And if we try to approach this from the applicant's point of view, they first make up their mind if they wish to stay into the list. So this means that they have to apply and to prepare a dossier that will demonstrate actually the safety of those materials to be used in this specific sector. This is done first via notification to ECHA that will become possible as of 2026. And then for a substance to remain in the positive list, you need to submit an application following such a notification. And the first applications are expected to be received as of January 2027. That's the first date possible for such a submission. And then when the real RAC work will start. So we will also seek input from third parties on relevant information. So there will be the possibility also for third parties to input. And then the RAC task is relatively similar to what it does today. So it's to evaluate if those substances that are used, also their potential to migrate into drinking water, that's the main concern we want to address. And also overall assess whether there is a risk to consumers coming from the materials that are used for the purposes of transporting or being in contact with drinking water. It's also fair to mention this task requires new competencies that are not necessarily present today in the committee. And for this purpose, we have established a new working group that has a specific task to look into the aspects where the committee is not yet fully equipped in terms of competencies. And now we are really working into identifying process and procedures that will be applicable in the two years to come.

• Adam Elwan - Host

  Okay. I mean, it sounds like 2026 and 2027 are going to be critical years for both applicants and the committee. From the initial notifications to the start of applications, I think it sounds like there's also a lot of groundwork that's already being laid. You mentioned the creation of this working group to develop the processes and expertise. With all of this in motion, are there any suggestions or tips that you'd like to share with listeners who might be interested in this area?

• Roberto Scazzola, ECHA

  Yeah, thank you, Adam, for the question. I think the first one is that each application will be submitted to ECHA via a software that is called IUCLID. So... it's probably time that you familiarise with it. There is a lot of guidance available because that's the tool that will be used to submit the notification. We have also set up a user group for stakeholders that wish to learn more about how the future ECHA's IT tools will work. So trying them and also provide valuable feedback to further development. So in such a case, feel free to contact ECHA for more additional information.

• Adam Elwan - Host

  Right. And I think we also had a webinar recently on the drinking water directive. So another way to get familiar with that and ask questions. All right. Thank you. So to sum up, the committee plays a key role once again, in evaluating applications related to the directive, and in particular, in assessing then how these materials used in contact with drinking water might affect our safety. The process will involve applicants using IUCLID to submit their applications, as you mentioned. I think the user group is also interesting to mention again. So the stakeholders that are interested in engaging with ECHA's tools and providing feedback for their further development will be available. So we really get the feedback from those who will be using the tools on what they need. That wraps up our first episode of the year. Thank you, Maria and Roberto, for sharing your insights from the committees. And we'll then be seeing you back on the podcast in June. We have a lot of interesting topics lined up for you this year, including, of course, these regular committee updates. But we also have a few surprises in store. So subscribe to our news and get notified about new episodes and follow us on social media. You can now also find us on BlueSky and a link to that is in the episode description. So thank you for tuning in, and until next time, goodbye. Safer Chemicals Podcast. Sound science on harmful chemicals.