Transcription

• Speaker #0

  Safer Chemicals Podcast. Sound science on harmful chemicals.

• Speaker #1

  Main concern with PFAS relates to their high persistency, which means that these substances can stay in the environment for a very long time. In addition, many of them can negatively affect human health and environment. If releases continue, the stock in the environment and exposure to people and the environment will also increase.

• Speaker #2

  The discussions on the universal PFAS restriction are continuing and in September we're aiming to focus on textiles, upholstery, leather, apparel and carpets, that's a single sector that we call TULAC, on the food contact materials and packaging sector and also on petroleum and mining. And then after that, the sectors that we're going to be focusing on are fluorinated gases, transport and construction products.

• Speaker #0

  Welcome to the Safer Chemicals podcast. I'm Adam, your host today, and I'm joined by Roberto Scazzola, the chair of our Risk Assessment Committee, as well as Maria Otati, who chairs our Socioeconomic Analysis Committee. Hi to you both.

• Speaker #1

  Thank you, Adam. Nice to be here.

• Speaker #2

  Very nice to be here, Adam.

• Speaker #0

  We'll be starting with an update on where the committees are with evaluating the universal PFAS restriction proposal. We'll also be talking with Roberto about the first discussions around harmonizing the classification and labeling for TALK, and also the initial steps towards recommending an occupational exposure limit, so an OEL, for bisphenol A BPA. Okay, let's start with the universal restriction proposal for per-and polyfluoroalkyl substances PFAS. So this proposal aims to restrict around 10,000 PFAS both in the EU and EEA. the restriction looks to address their persistent nature as they contaminate water sources and cause toxic accumulation in both people, animals, and plants. So as we've mentioned in our previous episodes, the committees are currently evaluating the proposal and will carry out their opinion making in batches addressing different PFAS sectors that are potentially impacted. Can you tell me a bit more about why this approach in batches for this one?

• Speaker #2

  Well, this is a very wide proposal. It covers a lot of sectors, a lot of uses. And if we don't take them in batches, it becomes a little bit unmanageable. So we've decided to put them together in groups and we'll take them, you know, a few at a time in each plenary.

• Speaker #0

  Good. So in your June meetings, the committee has covered PFAS now specifically in metal plating and also in the manufacture of metal products. Maybe if we start with you, Roberto, what more can you tell us about the discussions you've had in the committee?

• Speaker #1

  Indeed, we focus first on metal sectors, both metal manufacturing and metal plating, but we also reach final conclusions with sectors that were discussed previously, namely consumer mixtures, cosmetic products and ski walks. RAC went through the proposals for sectors, particularly focusing on volumes, but also on the related emissions of PFAS, but also on the measures that are in place to control the emissions. For instance, we had a look at the voluntary ban for ski waxes that has been carried out by the Ski International Federation and related effects in terms of emissions. So all these elements are taken into account to assess whether there is a risk to people or to the environment. And although some elements are still to be finalized on the waste phase, I think we made a very good progress.

• Speaker #0

  I also understand that you concluded on the hazards of PFAS, is that correct?

• Speaker #1

  Yes, indeed, hazards are really the starting point for any restriction because we have to look at the intrinsic properties of substances, whether they can cause harm to people or to the environment. Then we can look at the emissions and therefore exposure because the risk exists only if there is hazard and there is an exposure. So a raw conclusion on hazard can be summarized as follows. The main concern for PFAS is related to Their ability to stay for a long time into the environment, so what we call indeed persistency or even very persistent according to the rich criteria. And this is also logical from the chemistry point of view because there is this exceptionally stable bond between the carbon and the fluorine atoms that makes them very persistent into the environment. On top of the persistency, there are also other hazards of concerns. They relate to the possibility to travel long distances, but also to affect the global warming potential, but also adverse effects to human health. Notably they can be toxic for reproduction or they can even cause cancer in some cases. All those instances have been looked at and the committee also considered a lot of studies that look into the potential. pollution even in pristine environment or in very remote areas due to the properties of this group of substances. So, if the releases will continue, the stock into the environment will increase and the same goes into the risk for the people and for the environment. Therefore, RAC concluded that the mentioned hazards are sufficient concern to be taken within this process. I should also mention this is a provisional conclusion. What does it mean is that if no new elements will be gathered during the process, the committee will not come back discussing those elements. I also have to mention that there are some factors. into the waste phase that will be discussed again, but I would say there are specific elements that will take only due time by the committee.

• Speaker #0

  You mentioned that you've looked at a lot of studies. Can you elaborate a little bit more on what kind of studies and where do you get the studies from?

• Speaker #1

  The dossier has been definitely based on the information provided by the dossier submitters, but we also received very good input in the consultation. This means that we got additional information, peer-reviewed scientific studies that had a look into the impacts of those substances, their presence into the environment, but also what they can cause in terms of human health or in the damage to the environment. So definitely, I think the consultation is an important step into the process.

• Speaker #0

  Thank you, Roberto. Let's move on to you, Maria. What's your recap from the socioeconomic side?

• Speaker #2

  Well, similarly to RAC, we also looked at the same sector. So we started out by looking at metal plating and manufacture of metal products. We have hard chrome plating and also other types of chrome plating, decorative chrome plating, both on metal and all plastics. Plating with other metals like nickel, for instance. And then when we're talking about manufacture of metal products, we were talking about metal coating, razor blade coating, and also solvents for metal cleaning.

• Speaker #0

  Right, so quite a wide spectrum of things actually.

• Speaker #2

  Quite a lot of different things, different things that may have different availability of alternatives and therefore different costs and so on. So you know, things get quite detailed sometimes when we get into this. This is, you know, what I mentioned earlier about taking it in batches because there is a lot of complexity in here.

• Speaker #0

  Sounds almost like a mini restriction within this whole restriction for the different sectors. So a lot of work.

• Speaker #2

  Exactly. So, When we were discussing the sector, we start out by looking at the availability of safer alternatives to PFAS in these sectors for the different specific uses. And then that determines what the cost would be of implementing a ban, of course, because it's different if there are alternatives ready to go and if there aren't.

• Speaker #0

  It would also, I guess, impact on derogations then, depending on the availability eventually.

• Speaker #2

  Yes, exactly. So, you know, we consider the benefits. how many releases would be stopped if we banned the use in a particular sector. And then we bring it all together by considering, are derogations needed here to ensure that the restriction is proportionate? So that's kind of where we bring everything into final conclusion, let's say. And then also, like in RAC, we went back to the sectors that were on the table in March already. Then we looked, of course, at consumer mixtures, cosmetics and ski wax. We had their additional information on the wastage, for instance, and also there were some discussions in March that the reporters reconsidered and made some changes.

• Speaker #0

  Sorry to interrupt, but you mentioned consumer mixtures. Can you just give a few examples of what kind of mixtures we're talking about?

• Speaker #2

  Well, there's quite a lot of stuff there, but to give you a couple of examples, we're talking about cleaners for glass, metal, ceramic, carpet and upholstery. We're talking about waxes and polishes, for instance, dishwashing products. So quite a few different small things.

• Speaker #0

  So we are moving forward then with this proposal, clear to see that. What's on the agenda for upcoming meetings? What will you be discussing? I'm particularly interested in the upcoming sectors then in your batches.

• Speaker #2

  Yeah, well, in September, we are talking about the following. So the first one is what we call internally TULAC. It's quite a nice name. So we're talking here about textiles, upholstery, leather, apparel, and carpets. Then we have food contact materials and packaging. So if you remember, this was one that we covered already a while ago before the consultation had closed. So now the consultation has closed. We've got all the information and this is coming back to the committees. And the final one for September is petroleum and mining. Right. And of course, Adam, we are dependent on how the five authorities are able to update their initial restriction report. So, you know, they are the ones who are looking at the consultation input and then updating the proposal and that we assess that. I'll also look ourselves at the comments. So, but in any case, we are confident that we will be able to address these sectors. We're really learning while we're progressing with the analysis.

• Speaker #0

  So sounds like you have your September meeting cut out for you. What about beyond September?

• Speaker #2

  Well, the next sectors that will be discussed were also announced during these plenaries, and they will be fluorinated gases, transport and construction products. So we are committed to keep everyone updated on what's coming next. We understand that, for instance, stakeholders need to be ready to find experts that can come with them to the plenaries and so on. So it's important that we announce this in advance and we will continue. Of course,

• Speaker #0

  this is such a wide impact because it's looking at so many different sectors. So the more time you give. for people to react the better so transparency yes indeed that's exactly right undertaken

• Speaker #2

  Finally, I would like to reassure everyone that we are taking every effort to progress the opinion making and we will be delivering these opinions to the Commission in the shortest possible time frame while making sure that the opinions are as high quality as can be.

• Speaker #0

  Okay, thank you both. Is there anything else you'd like to highlight still on this?

• Speaker #2

  Well, I think the final thing I'd like to highlight is that this is a restriction that has had a high interest from our accredited stakeholders in this work. We've had a lot of people asking to attend and a lot of people, in fact, both from industry, from NGO and other civil society organizations coming to the meeting. I think it was over 125 different people. And, you know, the contributions that these people are bringing are very important. You know, they have scientific and technical expertise in particular sectors. As we have mentioned, this is a very wide restriction. We cannot have specialists in every single one of these sectors, so we're really relying on the stakeholders to bring that information to us. So I would like to just give a reminder that for the sector-specific discussions, we're only allowing to participate those organizations that have a very specific interest in the sector. For the more general discussions, we're a little bit more open to allowing those who... have signed up for it.

• Speaker #0

  Complex puzzle that needs to be managed. And I understand that actually you have to be an accredited stakeholder to attend the committee meetings. So there is a kind of a procedure for that. You have to apply through our website. There's certain criteria you have to fulfill and you have to be an umbrella organization, so to speak, representing different fields and sectors, all working at an EU level and representative of their area of competence.

• Speaker #2

  I think that's important to remember. So if organizations are interested in participating, they need to check those criteria. And. you know, submit their application in advance. That's why we're announcing things quite a lot in advance. And if they fulfill the criteria, they can become accredited and then request to participate in the meetings.

• Speaker #0

  So next we'll be talking about the Dutch authorities proposing to classify talc as a substance suspected of causing cancer and a substance that causes damage to lungs if inhaled. Roberta, talc is quite familiar to many people, myself included, so especially those that have children. It's used in this white baby powder, is that correct?

• Speaker #1

  Indeed, among many other uses. So talc is a naturally occurring material and it's used in pharmaceuticals to help bind or disperse medication, but also in plastic to improve their mechanical properties, as a filler or coating pigment, in paints, also in ceramics, even as a food additive. And of course, maybe the most well known to the general population is the use in cosmetic products like in baby powders or eye shadow. So Quite a broad variety of uses indeed. It's also interesting to know that there is the involvement of our sister agency, EFSA, because indeed there is a use as a food additive and they are also in the process of reviewing it. So the decision the RAC will take might also have an influence in that specific process. And we are working together with EFSA to ensure that there is a coordination and alignment.

• Speaker #0

  Okay, and I understand that the committee talked about the classification proposal, but didn't yet conclude on an opinion. Is that right?

• Speaker #1

  That's correct. I think we are well progressing. There was a preliminary conclusion on STOT, so specific target organ toxicity, repeated exposure, particularly the committee decided for category 1, specifying lungs and inhalation are the organs of concern. On carcinogenicity, we also progress significantly. I think the committee reached a provisional conclusion that there is some evidence for carcinogenicity. However, we are in the middle of the evaluation, so there is not yet a proposal by the rapporteur. And we will need a bit more time to look at all the available evidence. And there is quite a lot out there on this substance. So we hope to be in the condition to finalize this by the end of the year, I would say.

• Speaker #0

  Okay. Now, just maybe for personal reasons more than anything else. So, I mean, dose makes the poison. So, do you foresee that there will be some changes in the levels of talc used in products like baby powder?

• Speaker #1

  This is definitely too early to say. The moment the opinion from the committee will be issued to the Commission, the Commission with Member States will decide whether an harmonised classification is appropriate. In such a case, there might be some automatic consequences in the specific sectors. So it's definitely too early to predict. But indeed, there might be some changes according to the relevant legislation that are applicable.

• Speaker #0

  Right. Okay. Well, looking forward to coming back to this then again in September. Now, you also started talks on recommending an occupational exposure limit, so an OEL, for bisphenol A. Firstly, could you explain what these OELs are and what is the committee's role in them?

• Speaker #1

  Indeed, that's a relatively new task that has been entrusted to the committee. So the legislation in EU aims to protect workers from the health risk associated when they are exposed to hazardous substances in the workplace. OEL stands for Occupational Exposure Limit Values and they are there to establish a safe working environment for workers, particularly when they are exposed to vapours, mists or dust related to those specific substances. There are a number of directives such as the Carcinogens, Mutagens and Reprotoxins Substances Directive and some others that entrust the European Commission to the possibility to define such values. And in the past, those values were based on opinions issued by a committee called SCOIL, but in the recent years, this has been entrusted to the Risk Assessment Committee. Beside OEL values, RAC may also issue additional recommendations with regard to short-time limit values, or even so-called notations when there are specific hazards to be taken care of, such as dermal protection, use of gloves, and so forward.

• Speaker #0

  So, bisphetyl-A particularly then, so it's a very well-known and regulated substance. We've all heard about it in some way or another, I'm sure. And some uses of it are actually already restricted in the EU under REACH, the EU's chemical legislation. So, it's also on this candidate list of substances of very high concern, and it has many harmonized classifications, for example, causing toxic effects on our ability to reproduce, as well as serious eye damage. I understood it also potentially causes respiratory irritation and skin allergies, so quite a wide spectrum of concerns there. And now an OEL is in the making, so what can you share from the committee's first discussions on this one?

• Speaker #1

  Well, for sure, this is an interesting piece of work. Exposure of workers to BPA may occur during its manufacture, use, or in the production of polymers, also in its use as an additive in various applications. It should also be mentioned that recently other EU agencies reached divergent conclusions on BPA, particularly in the general population exposure by ingestion. So this also highlights how sometimes deliberations on regulatory science can be complex. In any case, RAC must reach its conclusion in an independent way, of course, looking at all available information, and this is what we intend to do. Currently, there is an indicative EU-wide OEL that has been in place since 2017. However, this is a non-binding value and now we are working towards a potential mandatory limit if the Commission will decide so. It's also important to notice that some European and non-European countries establish OEL and short-time limit values at national level. We aim also to harmonize this and I think this is quite a relevant point. So where we are, we had a short exchange last week and we plan to discuss further this in September and hopefully when everything goes well, we plan to issue a final opinion end of this year or if needed early 2025.

• Speaker #0

  So we will be revisiting this topic again later as well. Okay, that's actually all the time we have for today. So once again, thank you both for your explanations and key insight into the committee's work. I'm sure our listeners find it useful. The next committee meetings will be taking place, as mentioned throughout the podcast, in September. So tune in again then for the latest updates. So from all of us here, have a great summer break and see you in the autumn. Indeed.

• Speaker #1

  Thank you.

• Speaker #2

  Bye bye.

• Speaker #0

  Safer Chemicals Podcast. Sound science on harmful chemicals.