Transcription

• Speaker #0

  Safer Chemicals Podcast. Sound science on harmful chemicals.

• Speaker #1

  Classification, labeling, and packaging is the cornerstone of the EU regulatory framework on chemicals. It is about understanding the hazards, communicating them, and adopting certain precautions. It aims to ensure the free circulation of chemicals while protecting public health and the environment.

• Speaker #2

  To date, we have provisionally concluded on several sectors in the proposal to restrict PFAS. These include areas such as consumer mixtures, cosmetics, textiles and food packaging. Next, the scientific committees will address applications of fluorinated gases, transport and also energy. And after them, we will move on to medical devices, lubricants and electronics and semiconductor. So, step by step and sector by sector, we are advancing.

• Speaker #0

  Welcome to the Safer Chemicals podcast. I'm here with Roberto and Maria, the chairs of our risk assessment and socio-economic analysis committees. The committees have just ended their last meetings of the year and we'll be going through the highlights as usual. We'll start with an update on the universal PFAS restriction proposal, something that we've been covering a lot in our recent episodes, but we'll also be talking quite a deep talk actually on the harmonized classification and labeling. So what is it all about and how it impacts the risk management of chemicals? And Maria will update us on the Socioeconomic Analysis Committee's review of new information submitted by companies on certain Chromium 6 applications following a court ruling. Good to have you both here again. Thanks for joining.

• Speaker #1

  Thanks for the invite.

• Speaker #2

  And very good to be back.

• Speaker #0

  But before we start, Maria, did I understand correctly that you have an announcement to make about a new deputy chair? Was it so?

• Speaker #2

  Yes, exactly. So Christian Lottmeier will start as deputy chair for SEAC in January. And Christian has quite a long history in ECA and also in SEAC. You know, he was part of the team setting up all our processes right at the beginning when SEAC started operating. So most recently, he's been part of the scientific secretariat. So a little bit different. He's been supporting the reporters and the members in their opinion making. But now he comes back to work on the running of the committee, basically. So he will be supporting me in that task. And he will have a particular focus on preparing us for the new tasks that are coming up in the future.

• Speaker #0

  Okay, right. Well, congrats to Christian. Best of luck with the new task. Good to hear that it's someone who has some experience, quite a lot of experience from the beginning of time.

• Speaker #2

  Definitely. He brings a lot to the committee and I look forward to working with him.

• Speaker #0

  All right, then maybe we dive right in and start with the universal restriction of PFAS. So in the November meetings, the committees discussed PFAS in construction products for the first time, if I'm correct, and continued considering its uses in textiles, upholstery, leather, apparel. carpets and food contact materials and packaging, right? So Roberto, what were the highlights from the risk assessment committee for PFAS?

• Speaker #1

  Well, for three sectors, RAC was able to agree on provisional conclusions, particularly for food contact material and what we call TULAC, so textile and similar other applications. We benefited of previous discussion and the focus was mostly on the changes and update on the emissions and analysis of risk of alternatives. For construction products, on the other hand, this was the first discussion, but RAC supported the draft opinion pending some verification on calculations that will be carried out in the weeks to come. It's also nice, I think, to mention that the draft opinion is based on what we call a background document that is prepared by submitting competent authorities so that they are at the origin of this dossier. And they take into account also the comments provided during the consultation by third parties. And... The same competent authorities, they also participate to the meeting and they contribute during the discussion alongside with observers, so NGOs, industry, and they also bring along their own experts. So they are quite busy meetings. I think we had over 140 people attending online and in person. So that's quite something indeed.

• Speaker #0

  Good to see the possibility for so many organizations to participate and also representing such a wide range of interests. Something I imagine is quite important when we're talking about sector. such as these where the uses are so widespread and you also have a lot of ground to cover in your assessment. Turning then on to you, Maria, you covered the same sectors from the socio-economic perspective. What can you share with us on that?

• Speaker #2

  Well, we were also able to provisionally conclude on the same three sectors as RAC. And like in RAC, we had two that were coming back and the same ones with contract material and packaging and also the textiles, et cetera, let's say. And construction products were sold for the first time. And just as a reminder, when we're talking about provisional conclusions, we mean that the final conclusions will be available only once the full opinions have been agreed and we have been able to look across the board.

• Speaker #0

  Right. So people can't see anything yet. They have to wait until the progress gets to the end. Exactly.

• Speaker #2

  So in terms of the SEAC discussions, our focus is, first of all, we look at the availability of safer alternatives to PFAS. Then, of course, that informs us about the cost of implementing a restriction on this sector. It's a bit different if you have alternatives and if you don't. And then we look at the benefits. And for that, we rely very much on the RAC work in terms of emissions, because those then become the benefits of our restriction. And then we'll bring it all together by considering the proportionality of PFAS. restriction in the sector and also the needs for having derogations to ensure that the restriction is proportionate in that sector. So that is the basics of the work that we do in SEAC.

• Speaker #0

  Okay. Can you talk a bit more about what kind of uses are included in construction products? And in terms of safer alternatives, are you able to tell us anything about alternatives to PFAS? Are they available for construction products?

• Speaker #2

  Well, construction products is quite a varied sector. I mean, we're going from things like bridge and building bearings. to things like film and foil from greenhouses and quite a lot of other things in between. I think we had like 11 or 12 little sub-uses in different combinations. The assessment that we do for alternatives is actually pretty granular and we have different conclusions for the different sub-uses. But indeed we can say that for some there was good evidence that there is what we call high substitution potential. So it is possible to substitute with different amounts of time. Well, for others, I mean, this is not the case.

• Speaker #0

  Okay. All right. Well, thank you both for those insights. So to summarize, you covered PFAS in construction products, textiles and upholstery, as well as food contact materials and packaging. Now, for all these uses, you reached your provisional conclusions. Exactly. So that's good to hear. But what about then the next steps? What are the sectors on the horizon for 2025 and beyond?

• Speaker #2

  Yeah. In 2025, basically, we continue taking it sector by sector. And next, we will continue with fluorinated gases applications, with transport and with energy. And we can also announce now that medical devices, lubricants and electronics and semiconductors are planned for the upcoming meetings in 2025 as well. And of course, as usual, we are very dependent on how the five authorities can update their initial restriction report, what Roberto was talking about as the background document. And they are doing this, of course, following the consultation input. And. yeah, more information will become available.

• Speaker #1

  So quite busy for the months to come, definitely.

• Speaker #0

  Yeah, sounds like it. I mean, to me, this sounds like, again, a very wide use across these different sectors. Is this something similar to what you've just done, or is this going to take it up a notch and be even more kind of thorough then and more things to cover in your assessment?

• Speaker #2

  Well, in terms of the number of comments that were received in particular, I think some of the sectors that are coming to us now have much higher number. And that is one of the reasons why they're coming later to give time to be able to take that into account. So I think the work is definitely intensifying. Yeah,

• Speaker #1

  I think it's fair to say complexity might increase, but we are ready for it.

• Speaker #0

  All right. Good to hear. And also, yeah, just as a reminder to our listeners. So the five authorities that you mentioned are the ones that submitted this restriction proposal to ECHA for evaluation. So that's Germany, the Netherlands, Denmark, Sweden, and Norway. Maybe we then move on to our next topic. Park PFAS for now. will definitely come back already in the next meeting. But now a bit of a deeper dive into harmonized classification and labeling. So this area has recently included some pretty notable substances that have sparked interest among our listeners and our audiences. Harmonized classification is for the most hazardous substances. Could you explain what we mean by most hazardous exactly? And what are the main goals of taking this harmonized approach for those?

• Speaker #1

  Sure. So this approach... is really focusing on very serious hazards such as carcinogenicity, mutagenicity or toxic for reproduction, respiratory sensitizers. And now with the revision of CLP, we have also the introduction of endocrine disrupting properties of persistency, bioaccumulation or toxicity. And there are also some uses that are considered so sensitive, such as pesticides or biocidal products that require to have such an approach. And what is also interesting is the... European Union did this for 50 years and we have over 4,000 substances that have this specific approach. And the main goal, of course, is protecting human health and environment, and also to standardize the way you identify and communicate chemical hazards. And that's very important for a common market, and also to prevent health risks for workers, consumers, and to protect the environment, of course.

• Speaker #0

  What makes CLP so relevant in the EU?

• Speaker #1

  Well, it's Probably the fact that in Europe this is used as a basis for implementing regulatory risk management actions. So it sounds quite complicated but actually it's about banning or restricting the use of those substances in certain applications. This is the case for cosmetics or toys, but also in specific sectors such as biocidal or pesticides. There are specific regulations that forbid the use of specific ingredients when they are severely classified under CLP.

• Speaker #0

  Right, so these classifications essentially form the foundation for further regulatory actions on substances. How do substances then end up in the CLH process?

• Speaker #1

  Well, normally our member states that can submit a proposal for a specific classification. In few justified cases, also industry can do it. And lately, with the revised CLP regulation, also commission has been entrusted of this possibility. It's also important to mention that we have in the ECHA website what is called a registry of intentions, where you can actually follow what are the intentions of member states in submitting new dossiers. And there are some basic descriptions also of the kind of classification. So this is quite relevant also to understand what will be assessed by the committee in the near future.

• Speaker #0

  Alright, so the selection of substances is then based on a consideration from member state authorities or companies. Is there a certain trigger for these?

• Speaker #1

  Well, I think that's definitely related to the seriousness of specific hazards, where there is really a focus on targeting them. As you can imagine, we want to be sure that a substance is carcinogen, is classified and labeled accordingly. Sometimes there are also other considerations due to these downstream effects that I was mentioning earlier. So it's a sort of risk management measures and a country might decide that the most effective way to deal with the risk managing such a substance could be through a CLH proposal, so an harmonized classification proposal. I would also like to mention that ECHA can support member states. We provide guidance that is available both for competent authorities but also for industry. there is quite a lot of material that is available for this process.

• Speaker #0

  Alright, so the first concrete step is that a proposal to harmonize the classification of a substance is submitted to ECHA. What happens then?

• Speaker #1

  Once ECHA receives a specific CLH report, this contains a proposal for a specific classification. So there are information that are included into this dossier and there are criteria to be fulfilled. So everything is checked by the ECHA staff in charge of the specific dossier. And so they run a sort of quality check. And if the quality is sufficient, also a consultation is launched where third parties have 45 days to provide any input that is relevant for this classification proposal. And that's a very important moment because it's really the moment where the right to be heard applies. This means also that the moment the consultation is concluded, the committee will really focus on the evidence that is available. And so submission of plate information normally is not. taken into account because everything must be completed in a period of about 18 months. So there is quite some time pressure to deliver also due to the complexity of the discussions that will take place.

• Speaker #0

  All right, got it. So the process begins with the submission of a CLH report to ECHA. That then includes all the supporting data, suggested classifications, and once ECHA ensures the proposal meets the requirements under CLP, it then goes to public consultation allowing stakeholders to weigh in. I think it's interesting to hear how stakeholders can provide input early in the process. But of course, after this stage, it sounds like the focus then really shifts to evaluating the evidence that's already been submitted. This actually brings us nicely to the next step in the process, so the role of the Risk Assessment Committee. Could you tell us more about what the committee does in this context?

• Speaker #1

  Well, the first step is to appoint what we call a rapporteur. It's one of the RAC members. Those are independent scientific experts that have been nominated by member states. And he is entrusted into drafting the opinion and to take into account and to defend also the very same opinion in front of the committee. And there is also a chance for stakeholders and observers to participate. So NGOs, industry experts can input and participate during the discussion of the committee. And that's quite an important element because it allows also the opinion making to be better and to be more robust in our own conclusions. Sometimes might not agree, but that's part I think of. what a scientific committee does. Another important element is that RAC really focuses on the hazard property, so the intrinsic ability of a substance to create harm to human health or environment. So this means we do not look at exposure, we do not look at risk assessment, this is done in different bodies or different framework, and we do not take into account as well the potential consequences, the socio-economic aspects. This is something that this committee doesn't do it. And finally, I think the most important part of it is that the opinion of Braque is then sent to the European Commission for their own decision-making process. And if this is successful, it results in an update of the CLP regulation. So the finalization of the process is, of course, a responsibility of the European Commission and member states.

• Speaker #0

  All right. So the committee then is really at the core of ensuring that the classification is based on, say, solid scientific evidence with the rapporteur and the committee working together to carefully review the proposal, as well as the feedback received in the consultation. I think it's also important to, again… say again what you said, which is that the committee focuses strictly then on the hazardous properties of a substance, so without considering use or exposure. And of course, as you mentioned, the ultimate goal then is to have the decision-making happening then in the European Commission together with the member states. Let's explore that side of things. So the impact, what impact does harmonized classificational labeling ultimately have once it's adopted?

• Speaker #1

  I think it's fair to say that CLP is a bit the cornerstone of the EU regulatory framework on chemicals because it is the start of so many different other processes. And of course, this starts for classification, labeling, and packaging. And for instance, not many know that the child-resistant fastenings that are applied to some corrosive products or the tactile warnings for visually impaired people, they are actually a direct consequence of CLP. So because we want to inform or to protect our... children. That's, for instance, a direct implication. But what is even more important are probably the downstream consequences, because a lot of different sectoral regulations decided that they don't want to have, or they want to control the use of the very hazardous substances. So the moment we go for a certain classification, so the committee decides that the substance reaches a certain criteria, such as being carcinogen, this could have direct or indirect effect. downstream consequences, including a ban, a restriction, or a request for a derogation. But it really depends, and it can be very different. But it's also important to mention this is out of the hands of the committee. This is really in the ramets of the specific regulation that's where any question should be addressed. It's not much to the committee to look into this.

• Speaker #0

  Right. All right. Well, thank you very much for explaining the process so clearly. I think it's evident that harmonized classification labeling under CLP LP is it's not just about identifying hazards, but it's also about ensuring that this information, as you said, translates into meaningful safety measures. All right, Maria, let's now then move on to the additional assessments that you're doing on chromium-6 substances following this court judgment. What can you tell us about that?

• Speaker #2

  So this is one of those pieces of work that we do in addition to our regular opinions on applications for authorization and restrictions. Because REACH establishes that the commission can ask the committees to provide opinions on any aspects that are coming from REACH. And this is one of them. So the background of this is that there was a court judgment that annulled certain authorizations that had been given from Chrome 6 users. And in addition to the annulment itself, the court judgment also provided some clarifications as to how the availability of alternatives for the applicants should be assessed. Now. They have established that there needs to be a higher level of granularity in the way that the different products that are covered in the application for authorization are described. Because quite often companies will apply for a big, big, big portfolio of products with things that are quite different sometimes from each other within it. And also that there needs to be a stricter burden of proof in terms of the functionalities that an alternative must provide for each of the products. groups and also what the performance level must be for those functionalities. And here we're talking about things like, for instance, corrosion resistance. We need to justify that corrosion resistance is required and also up to what level. So this is something that is basically a little bit more stringent than we had had before. And the commission has had a look at the cases where they already had SEAC opinions and RAC opinions, of course. and checked whether in those cases which were submitted and the opinions quite often were agreed before the judgment, whether the right level of burden of proof had been provided. These are applications where a decision hadn't been made yet. So they're kind of in the middle of the opinion and the decision. So what they have done is they have asked the applicants to submit further information on this topic. and have asked SEAC to assess that information, basically. So what we're doing is to assess the completeness and the robustness of the applicant certifications for these topics, for functionalities and performance requirements. And we are looking at whether they have described the products in the right way, provided the right level of proof on these aspects. And... Something else that we are doing that is related to this is that for cases which already we have in the work of the committee, but that has been submitted before the court judgment, is that we're already asking the applicants for this information before we agree the opinion. So this is something that those of the applicants who have submitted applications are still being assessed by SEAC. They may expect us to ask. some questions about these topics and this is the background. We don't want opinions to come back to us very often, so we're making sure that we comply with the burden of proof required by the court judge.

• Speaker #0

  Okay, so Maria, to clarify then for me especially, but also maybe for some of our listeners, so this court ruling and assessment of additional information, does this mean that this impacts also other applications for authorization, not just the QRO M6 that we're talking about?

• Speaker #2

  Yeah. It does indeed. It applies to all applications, not just Chrome 6, but any other substance for which there are applications for authorization. So companies need to be aware of that when they prepare their applications and make sure that the analysis of alternatives is done in a way that complies with the court's requirements. So with that level of granularity and with that level of proof regarding the performance requirements as well.

• Speaker #0

  Okay, so quite a big impact and also I assume very useful then for future applicants to use this case as a basis then for. for doing the applications in the future. Thank you. That's all the time we actually have for today. So once again, thank you both for your explanations and insight into the committee work. The next committee meetings then are in March and we will be continuing our regular update episodes. So do tune in after those. This is also the last Safer Chemicals podcast episode for this year. And I want to thank you all for listening and tuning in throughout the year. We're always looking for new topics to cover and ways to improve. So if you have suggestions, you can use the feedback form in this episode's description. Wishing you a happy holiday season. And once again, thank you both.

• Speaker #1

  Thank you. Thank you.

• Speaker #2

  Thank you very much. Goodbye. And happy Christmas.

• Speaker #0

  Safer Chemicals Podcast. Sound science on harmful chemicals.