Transcription

• Adam Elwan - Host, ECHA

  Safer Chemicals Podcast. Sound science on harmful chemicals.

• Roberto Scazzola, ECHA

  Both committees were able to draw provisional conclusions on the use of PFAS in the petroleum and mining industries. We will also take a further look at the textiles, upholstery, leather, apparel and carpet sector and at the food contact materials and packaging sector in November. And this is to incorporate the change in the way that RAC calculates the PFAS emissions. And then in the November meetings, we will also discuss a new sector, and that's construction products.

• Maria Ottati, ECHA

  Talc is widely used in several products, including in many consumer products. However, given also its widespread use, there were concerns about its potential to harm our health. After extensive discussions and reviewing a lot of scientific studies, the committee recommended classifying talc as a substance that can cause cancer. These findings were based on the latest scientific data and our independent assessment considered all the information submitted during the consultation as well.

• Adam Elwan - Host, ECHA

  Welcome to the Safer Chemicals podcast. I'm here again with Roberto and Maria, the chairs of our Risk Assessment and Socio-Economic Analysis Committees. The committees have just ended their September meetings and we'll be going through the highlights. We'll first start with an update on evaluating the universal PFAS restriction proposal. We'll also be talking about the harmonised classification and labeling for talc and committee opinions on authorising the use of chromium-6 compounds in the aeronautics and defense industries. Great to have you both back after the summer break. Did you do anything exciting?

• Roberto Scazzola, ECHA

  Thank you for asking. Not really. What about you, Maria? Yeah,

• Maria Ottati, ECHA

  thanks very much for asking, Adam. I went on a cycling holiday in the Baltics, which was lovely.

• Adam Elwan - Host, ECHA

  Oh, wow. How many kilometers?

• Maria Ottati, ECHA

  50 per day, more or less. Very painful.

• Adam Elwan - Host, ECHA

  Nice scenery?

• Maria Ottati, ECHA

  Very lovely, yes.

• Adam Elwan - Host, ECHA

  All right, good to have you here. So let's start with the universal restriction proposal for PFAS. In the September meetings, the committee has covered PFAS in petroleum and mining, a long list coming up here, so bear with me, textiles, upholstery, leather, apparel, carpets, and food contact materials and packaging. Roberto, what did the risk assessment committee look at in particular?

• Roberto Scazzola, ECHA

  Thank you, Adam, for the question. And perhaps I would start from an horizontal discussion that... is affecting horizontally all sectors, so I think it makes sense to start from there. And this relates particularly to the fate of PFAS at the end of its life. And the committee is looking to the possibility that PFAS could be released in the form of particles, in the form of polymer PFAS, polymeric PFAS, versus leachate of leachable PFAS. And they actually behave differently into the environment and this leads to different emission factors. So we had a good discussion into this. And this related also what happens once they reach the end of their life. So for instance, if they are disposed in a landfill or whether incinerated in waste incinerators. And this actually resulted in different emission factors that will affect the quantities that effectively reach the environment and then can cause damages.

• Adam Elwan - Host, ECHA

  All right, so that covers the horizontal aspects. What other sectors did you look at then in particular?

• Roberto Scazzola, ECHA

  Perhaps we can start with petroleum mining, where we reached final provisional conclusions. In that sector PFAS are used in some applications such as water tracers or anti-foaming agents. We looked of course at emissions and also the volumes that are linked to this. I think the committee had a good discussion and we are not planning actually to come back to this specific sector. On the contrary, additional two sectors that we looked at, the so-called TULAC, so the textiles and similar sectors, and also the food contact materials have been looked at. But there we will have to come back in November and we will explain you later why this is so.

• Adam Elwan - Host, ECHA

  Right, okay. So for provisional conclusions our audience won't know what those are until the actual final opinion?

• Roberto Scazzola, ECHA

  That's correct indeed, because there will be a sort of finalisation at the very end of the process, we'll have the full picture for all the elements and this will allow the committee to reach definitely a final conclusion.

• Adam Elwan - Host, ECHA

  So fair to say that the evaluation is progressing then from the risk assessment side. What about you then, Maria? You covered the same sectors from the socio-economic perspective. So what can you share with us?

• Maria Ottati, ECHA

  Well, on the petroleum and mining, similarly to RAC, we were able to reach provisional conclusions. And as always in SEAC, we start by looking at the availability of alternatives to PFAS. And then that allows us to continue looking, for instance, into the costs, because depending on how many alternatives are available and what needs to be done to implement them, the cost will be higher or lower. Then we also consider the benefits, which are basically those that are associated with lower emissions from PFAS as a result of a restriction. And then we always bring it all back together by considering for particular sectors of particular uses, are derogations needed to be able to ensure that the restriction is proportionate. So that's always the analysis that SEAC does. And as I mentioned, in petroleum and mining, we were able to arrive at provisional conclusions as well. Then, we also looked at the other sectors, this famous TULAC and the food contact materials and packaging. And for those, the discussions will continue in the next meeting as well. And that is because of what Roberto said earlier about the emissions potentially changing. For these sectors, the emissions coming from fluoropolymers are quite a substantial proportion. So the emissions will change. Therefore, the benefits change and then the final considerations also change. So aspects such as availability of alternatives, we can consider that they are pretty much closed. Then the rest we will have to rediscuss.

• Adam Elwan - Host, ECHA

  Well, let's then focus a little bit more on the famous TULAC, as you said it. So, can you talk a bit more about the kinds of uses within this sector?

• Maria Ottati, ECHA

  So, within this, as you say, famous tulak, the uses that are discussed were quite a variety. So, you have got, for instance, home textiles, and there we have items such as carpets, curtains, you know, that sort of thing. Then you have consumer and professional wear. They were talking, for instance, of outdoor garments and footwear. And also there is a use of PFAS in personal protective equipment, which is quite an important use within that sector. And this was all discussed within the disciplinary. But also there were other uses of PFAS that one may think could be part of the textiles sector, but they are not discussed this time and they will be discussed later on. So an example of that would be the use of PFAS in industrial equipment for the manufacturing of textiles, such as conveyor belts and that sort of thing. So that will come later on.

• Adam Elwan - Host, ECHA

  All right. Okay. So a wide range of uses for the committee to assess. What about then the food contact materials and packaging? Can we talk a little bit about that?

• Maria Ottati, ECHA

  This is also an important sector with a variety of uses. According to the dossier submitted proposal, we group them in four categories. So the first one is food packaging, such as the... plastics for food packaging that you can normally buy in any supermarket, but also feed packaging, like for instance, pet food. The third category is non-food packaging. So any packaging used for goods, even like car wrapping or similar. And finally, the considered food content materials, such as the cookware and bakeware, like non-sticking pans or similar items. So it's a quite diverse, let's say, sector, but I think the committee was able to... to address them in a coherent and homogeneous manner. So I think they did a good job.

• Adam Elwan - Host, ECHA

  And just, I think we might have talked about this in a previous episode, but now we're talking about food contact materials. Does this fall also somehow within the remit of EFSA? Do they have some kind of a role? Will this impact their work in any way?

• Maria Ottati, ECHA

  Yes, indeed. There are relationships that have been looked at by the committee because there is a specific regulatory environment. And so we need to be sure to harmonize any provisions that REACH will. take into this area with the existing regulatory framework. And indeed, EFSA also colleagues are participating attending the discussion as observers.

• Adam Elwan - Host, ECHA

  Right, okay. Well, thank you both for your insights and to summarize, you covered first of all PFAS in petroleum mining, textiles and upholstery, as well as food contact materials and packaging. So for petroleum you reached your provisional conclusions, while for textiles and food packaging discussions will then continue in November. I think this is actually a nice bridge to what is coming next. And I think our listeners are also eager to hear what new sectors are on the horizon for November, but also beyond.

• Roberto Scazzola, ECHA

  Well, as you mentioned, in November, we continue with TULAC and with food contact material and packaging. But then we take a new sector as well, which is construction products.

• Maria Ottati, ECHA

  And then when we move to 2025, we expect to cover fluorinated gases applications, transport and energy. And I think we should also remind that, as usual, we are... dependent on how the five authorities, what we call the dossier submitters, are able to update with regard to their initial restriction report. And also following the consultation input that resulted in many comments.

• Adam Elwan - Host, ECHA

  And as a reminder to our listeners, these authorities are the ones that submitted the proposal to ECHA for evaluation. So that would be Germany, Netherlands, Denmark, Sweden, and Norway.

• Maria Ottati, ECHA

  Indeed, and that's correct. And we work very, very closely with them. I think we have, I would say, daily contacts, because indeed... The amount of information to be processed and the dossier that they have to be assessed by the committees is very large. And so this requires a constant, indeed, exchange with them. And I think I have to say we work very well with the dossier submitters.

• Adam Elwan - Host, ECHA

  All right. Thank you. Let's then move on to the next topic. And this is now a proposal from the Netherlands to harmonize the classification and labeling of talk. Now, the Dutch authorities propose to classify talk as a substance suspected of causing cancer, as well as damage to lungs if inhaled. Roberto, we did cover this already a bit in June, but now the committee has adopted its opinion. So to get us started, can you first remind us where talk is used?

• Maria Ottati, ECHA

  It definitely has a widespread use, probably the most well-known is as a cosmetic product for baby powder or similar uses, but it's also used as a food additives, in pharmaceutical products, in paints. So it's really a quite widespread use indeed. If I can now move to the scientific assessment that was carried out by the committee, I would like to start mentioning that the dataset was really impressive. I think for also For different reasons, really, the rapporteur said to go through a huge amount of data. And this also triggered an exceptional level of discussion at RAC level. We had a very high number of members participating and inputting to the discussion. The main issue was related to the carcinogenicity, indeed. So the dossier submitter proposed a carcinogenicity category 2. The committee reached a different conclusion, namely category 1b. And this was based on limited evidence. in animal experiments, namely female rats developing lung cancer, associated with also limited evidence in humans, specifically ovary cancer due to perineal use of talc by women. Also worthwhile to mention that this was based on a novel approach by the committee that used an existing provision in CLP that allows to use data from animal plus limited data from human. and put it together to support a category 1b that is a quite serious category. There is also an issue about the route of exposure because we were not able to conclude or to exclude specific route of exposure such as oral because CLP does not allow to do this unless you can prove that this route of exposure is excluded. And really if I can say the last word on that, coincidentally, IARC, that is the agency of WHO on cancer research, reach a similar conclusion. And what is interesting is they use a slightly different data set, different criteria, but the conclusions are comparable to the ones that has been reached by our committee.

• Adam Elwan - Host, ECHA

  Okay. Reassuring to know that both agencies have then reached the same conclusion in this. So in terms of the next step then, so I guess for the commission to consider the committee's opinion and whether an adopted classification labeling for TALC should then be included in the CLP regulation. And just to mention that if it is... This would then, of course, lead to kind of clearer communication about the risks. So, I mean, thinking about workers, for example, it would mean better safety measures in the workplace for wearing protective gear or improving ventilation. And for consumers, I suppose, labels on products with warnings or instructions to help them use safely the products in question, right?

• Maria Ottati, ECHA

  Yes, that's correct. In a way, CLP, the classification and labeling and packaging regulation, is the cornerstone of the regulatory framework on chemicals. And... is really the basis. So we assess the hazards and once the hazards have been established and the commission will look whether this deserves to be included in so-called annex 6 of the CLP regulation, then it becomes obligatory and then all users, be it workers and industry or even products that are available to consumers, will need to report the correct hazard communication. And there might also be downstream consequences in the sense that specific regulation could decide to restrict certain products as a result of the hazard communication and classification, of course.

• Adam Elwan - Host, ECHA

  Then let's move on to Chromium 6. So here, both committees adopted their opinions on applications for authorization to use this substance in aviation and defense in particular. So this involves a large number of applications and review reports that were managed by the Aerospace and Defense Chromates Reauthorization Consortium. What were the key points in the opinions?

• Maria Ottati, ECHA

  Perhaps I can start from the risk assessment perspective. And as you mentioned, this is about the aviation and defense industry. And those substances are used for coating, plating and other forms of surface treatment. They are really helpful against corrosion, wear, heat resistance, and they play a very important role also in the quality of the aircraft that we might take every time we fly around Europe. This was indeed a major process, 21 initial applications and review reports that covered. 11 uses and 5 chromates. And what is striking is that there were hundreds of downstream user sites all across Europe. However, these substances, they also have hazardous properties. Some can be carcinogens. So great care must be taken, of course, when workers are using them actually to perform their tasks. RAC expressed some concerns on specific aspects, particularly on the residual manual uses. that are sometimes carried out and rather recommending corrective activities such as implementing automated or closed processes that will prevent exposure of workers.

• Adam Elwan - Host, ECHA

  I mean, what really stands out for me here is the effort to balance kind of these industrial needs and worker safety. So, you know, the committee's concerns and push for tighter controls like these automated or closed processes, as you mentioned. I think this really shows how important it is to manage these risks and do it carefully. Maybe we can then turn to the socioeconomic side. So, Maria, what did the committee conclude on this?

• Roberto Scazzola, ECHA

  So in SEAC, we always look at two aspects here. First of all, we look at whether there are technically and economically feasible alternatives for the applicants or, you know, the authorization holders, as we call it when it's a review report. And here we found that despite there having been progress in the research and development of safer alternatives, you know, what we found was that these alternative solutions to Chrome 6 have been successfully implemented only in a very limited number of niche applications. So we finally determined that there are no economically and technically feasible alternatives for the applicants. Additionally, we noted that there are very long and complex regulatory recertification processes when something is changed. This is to ensure that there is airworthiness, so to make sure that it's safe to fly. And this means that we can be certain that there are no alternatives available for these uses. Now, because of these very long processes that are required to make any changes, SEAG is recommending to grant a 12-year review period. So that's the first aspect. Then we also look at what the benefits of allowing continued use are from the point of view of society and what are the associated risks that come with this continued use. So SEAC then there concludes that the benefits of allowing the use of 12 more years are higher than the risks that come with it. I would also like to note that in evaluating these applications and review reports, we have worked together very closely with the European Union Aviation Safety Agency, which is called EASA. And they have given a presentation at the plenary on the regulatory framework about airworthiness in the EU. And they were also very helpful in responding to technical questions from the committee when they were assessing the applications. So, you know, we were very grateful to them for the help that they gave us.

• Adam Elwan - Host, ECHA

  All right. So to summarize, then, chromium-6 substances are crucial, one would say, in aviation and defense because they prevent corrosion and resist heat. But... The big concern is then their harmful, even carcinogenic, properties. I guess it would be fair to say that the real challenge here has been finding a balance between keeping the aircraft safe on one hand and protecting workers on the other. What are the next steps then?

• Roberto Scazzola, ECHA

  The opinions have been adopted in both committees, and three of them actually have already been sent to the European Commission. The rest, we are in the process of sending them out, and then they will be basically published very soon. And the commission will move on this very swiftly, particularly on the three most urgent ones, where the authorization is actually expiring so that the companies get the decision as soon as possible.

• Adam Elwan - Host, ECHA

  Right. So we can expect things to move rather quickly with this one.

• Roberto Scazzola, ECHA

  Yes, indeed.

• Adam Elwan - Host, ECHA

  Well, that's all the time we have for today. Once again, thank you both for your explanations and insight into the committee work. The next committee meetings take place in November. So join us again then for the latest updates.

• Maria Ottati, ECHA

  Thank you both. Thank you.

• Roberto Scazzola, ECHA

  Thank you very much.

• Adam Elwan - Host, ECHA

  And thank you to you for listening. Bye bye. Safer Chemicals Podcast. Sound science on harmful chemicals.