Transcription

• Katinka van der Jagt - Chair, Member State Committee

  Safer Chemicals Podcast. Sound science on harmful chemicals.

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  The MSC taking the science-based decisions has a crucial role in ensuring that all chemicals could be used more safely, has a crucial role as well in promoting the view that substances of concern are minimised and substituted as far as possible.

• Katinka van der Jagt - Chair, Member State Committee

  We are there when there's divergence, so we are getting the difficult cases to decide upon. And that's why it's so very important that when we are at this meeting, we all have the same view to find convergence and to find agreements in the way forward.

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  We really work together to bring and carefully consider different scientific, technical and legal aspects.

• Päivi Jokiniemi - Host, ECHA

  The European Union is a partnership of 27 European countries that have joined forces to build a better future together. Much like the EU itself, ECHA's Member State Committee also brings together representatives from all EU member states to seek agreements and resolve divergences when giving opinions on different processes of the EU's chemicals legislation REACH. For example, the committee helps to decide whether substances of very high concern should be included in the candidate list, for eventual inclusion in the REACH authorisation list. This process is important for controlling the use of chemicals that are carcinogenic, mutagenic, toxic for reproduction, or pose other serious risks to people or the environment. In this episode, we meet Katinka van der Jagt, the Chair of the Member State Committee, as well as the members from Sweden, Katarzyna Malkiewicz, and the Polish member Agnieszka Dudra. We will talk about the role of the committee, its tasks and responsibilities, and how its work contributes to chemical safety. My name is Päivi Jokiniemi, and this is the Safer Chemicals podcast. Welcome all. Thank you for joining us during a busy week.

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  Thank you for inviting me. Indeed,

• Katinka van der Jagt - Chair, Member State Committee

  thank you.

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  I'm happy to be here. Thank you.

• Päivi Jokiniemi - Host, ECHA

  I was thinking we'll dive right in. And I'd like to start by asking what each of you finds unique about this committee. And how would you yourself describe your role in ensuring chemical safety in the EU?

• Katinka van der Jagt - Chair, Member State Committee

  Well, I guess I first would like to pick up on your description earlier about the committee helping to decide on these inclusions in the candidate list, etc. It actually helps already. quite before that because it for example identifies the chemicals that are considered to be of high risk, so the substances of very high risk. So I think it starts with the MSC, this is at least something I would like to add. And one thing that I want to stress, and I think you already said that also, is that we are there with all member states, we're all there together taking decisions, so it's a very broadly carried decision. And I think that's something I would like to emphasise now.

• Päivi Jokiniemi - Host, ECHA

  What about from the national points of view?

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  I think that the voting procedure for this committee that is based on the anonymous agreement has a positive impact on the way how we work. We really work together to bring and carefully consider different scientific, technical and legal aspects. And in a great majority of issues and cases, we are able to understand what are the grounds of those diverging views. And this really helps to find the best outcome and the outcome that can be supported by all the members. And this can be decisions with the testing requirements, but it can be also agreements in the identification of substances of very high concern or yet another process that is a recommendation to Annex 14. The work of the MSC is very useful for understanding the challenges with implementation of REACH. And being it, for instance, the limitation and uncertainties of the testing methods that we are using, but also the legal text itself. And sometimes those challenges that we experience cannot be fixed by MSC work, but they could be approached in another fora. For instance, like updates of the test methods that could be approached in the OECD level, the global level. but also supporting the Commission work in the revision of the legal text.

• Päivi Jokiniemi - Host, ECHA

  Very good concrete examples. What about you, Agnieszka?

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  I think that the committee should continue the role of a body which is well equipped to be involved in providing opinions to the ECHA's existing processes, like, for example, classification of the substances, and to take part in new tasks which will be covered by the ECHA's future extended mandate. The other point is that MSC taking the science-based decisions has a crucial role in ensuring that all chemicals could be used more safely, has a crucial role as well in promoting the view that substances of concern are minimised and substituted as far as possible, and a crucial role as well in phasing out the most harmful ones for non-essential social use, in particular in consumer products. The unique value of MSC is a high transparency of the processes, what ensures the high level of trust in the ECHA's work. MSC ensures high quality of decisions and its outputs are clear, complete and conclusive.

• Päivi Jokiniemi - Host, ECHA

  You already now all referred to kind of several tasks of the committee. But I was thinking still, in your opinion, if you need to raise one task that you think is most important, what would you say?

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  I have a difficulty to point on one, but I have examples of two, if possible. So most important is the MSC involvement in generation of experimental data for thousands of industrial chemicals, as this data is the basis for identification of hazardous chemicals and management of the risks that they pose. So, as an example, last year, 2023, ECHA issued around 400 decisions for about 360 substances with the testing requirement to fulfill the standard data requirement. And in about 10% of those decisions, MSC has been involved to resolve diverging views. And this proportion of the decisions that we are involved in has diminished through the years. And that is because we have worked towards finding agreed and aligned testing strategies that are being implemented now. So in this way, we have gained agreement, a long term agreement, and now the decision process can run smoothly. So another task that I cannot omit is the identification of substances of very high concern. And in this respect, especially those with the hazard for endocrine disruption that were identified as substances of equivalent level of concern, but also those with properties so-called PBTs, VPVBs, PMTs, and those abbreviations refer to the properties of persistence, bioaccumulation, toxicity and substances that are globally mobile. Those are very important hazard classes that MSC has contributed to because so far they have not been a part of the CLP classification hazard classes. So out of the 240 entries that we have now in the SVHC list, about 30 of those entries are for ED properties and 70 are for the PBTV, VPVB, PMT properties. So that is a quite significant amount of the substances identified for those hazardous properties.

• Päivi Jokiniemi - Host, ECHA

  What about Agnieszka?

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  My impression is the same as Katarzyna has already said. And I'm a committee member since 2020, and I can confirm that this body is very effective in achieving the objectives in terms of producing the scientific decisions on the legislative processes. And in my opinion, MSC's responsibility for resolving divergences of opinions among member states on proposals for substances of very high concern identification is very important because it can have an impact on all actors in the chemicals management system.

• Katinka van der Jagt - Chair, Member State Committee

  Yes, and perhaps to add, I also feel in deed, the information generation that we are part of in the MSC and in a way a crucial part of, is very much important for the REACH process. And that, of course, feeds in also to the further processes, because without this data, it would not be possible to take certain decisions on hazardous substances. So I think that's one thing. And I think another thing, indeed, for the SVHC that now have been highlighted, I can just add that because of these really good and in-depth discussions that we have at the MSC, we have been able to have quite a flawless record in litigation of the SVHCs to stand strong. And I think it's very important. That shows how this work is really contributing in a very solid way to a safer chemical situation in Europe.

• Päivi Jokiniemi - Host, ECHA

  Would you have some examples of decisions that the committee has taken that you think that, well, this had a significant impact on the public health or environmental safety?

• Katinka van der Jagt - Chair, Member State Committee

  I think, of course, it's always very difficult to pinpoint one case. And I think especially for me, that's a little bit difficult because I think all the decisions we take are important because that's exactly the role of the MSC. We are there when there's divergence. So we are getting the difficult cases to decide upon. And that's why it's so very important that when we are at this meeting, we all have the same view to find convergence and to find agreement in the way forward. And we do. So I guess I would like to stress that rather.

• Päivi Jokiniemi - Host, ECHA

  A nice example.

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  So MSC has a crucial role in elimination of substances considered to have ED properties, as Katarzyna mentioned before, which could cause probably serious effects to human health, like phthalates, bisphenols. They are the examples which we were working on. We discussed the evidence for ED properties for those substances before criteria of these specific hazard classes were implemented into the revised CLP regulations. So we are one step ahead. And as the next step, the committee opinions on that issue were used for further EU regulatory actions. So this is the point which should be underlined.

• Päivi Jokiniemi - Host, ECHA

  And Katarzyna?

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  So I would like to bring an example of the testing strategy for mutagenicity that we have developed through years. And that was an effort from experts from ECHA, MSCAs and a broad range of stakeholders via MSC. But we have also organised a targeted workshop with our colleagues from RAC in 2018. And we have together considered pros and cons of different methods and also how the newly approved methods on OECD level, like the COMET assay, how they fit together to make this testing strategy straightforward, efficient, also to save money and animals. We are also using experience from MSC and experts from different stakeholders and have supported Commission to include clarifying amendments in REACH data requirements, among others also mutagenicity. We are also now getting indications that the laboratories, so-called CROs, that they are very active in validation of the specific elements of those newly adopted methods for mutagenicity. We see still the room for improvement when it comes to genotoxicity testing, but we realised that those would require a REACH revision and adjustment of the legal text in the hopefully near future.

• Päivi Jokiniemi - Host, ECHA

  If we then move on from the tasks to the committee itself. Considering the diverse backgrounds and interests of each member state, how do you navigate the differing national priorities and regulatory preferences when taking the decisions?

• Katinka van der Jagt - Chair, Member State Committee

  Well, of course, when we come to the committee, we already have received the documents that will be there for discussion. And we try to kind of understand how that would impact the different members. And then when we get to the meeting, we first of all try to listen to each other and understand well the points that are being presented and where everybody's coming from. And I think also here, again, it's clear that our members know very well what the task is for the MSC and that's then to find a point of convergence. And I can see that our members are also always willing to listen to each other and ask clarifying questions. So I think in general, that sets the stage for finding agreement. And yes, of course, sometimes there's difficult decisions and also sometimes that causes a lot of emotions to rise because of course it affects everybody in different ways, the things that need to be achieved. But I would say that in general, all the members are willing to find this agreement. And especially also in, for example, the pauses that we have between the breaks. So the breaks in the meetings are very important for people to exchange a bit further and very much understand the details of the concerns. And that helps very much, in my view, for finding this agreement.

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  When making the decisions from the public health perspective, because my bureau is supervised directly by the Minister of Health, I always have in mind that chemicals should be safe under normal conditions of use. And in particular, from the public health perspective, a risk-benefit reasoning should not justify a risk to human health. So this is the main point we have in mind when taking such decisions.

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  Yes, from my perspective, I think we have been very much... involved in attempts to resolve diverging views by going into the core of science. So we have been searching for more information that could help to understand why there are diverging views. We have also experienced that the committee is working towards practical and pragmatic ways on how to resolve those diverging views. But I have to also admit that we have used the possibility that in the case that MSC cannot agree that the cases have been submitted to the Commission for decision making that is based on the majority agreement, that at that level, unanimous agreement is no longer needed. So to exemplify this story, I thought of the example with implementation of the reproductive toxicity study, so-called EOGRTS, and we also call it yogurt. So that is a relatively new method, has been proven to be very challenging. And under reach, the scope of this evaluation, there are different sub-endpoints, needs to be decided on a case by case for each substance and based on the evidence that is existing. And it is about specific investigation for neurotoxicity and immunotoxicity. And the experiences show that there are really diverging views of how much and what is the level of evidence and type of information to bring this concern and to trigger those additional testing. And for instance, ECHA has commissioned preparation of scientific reviews to provide further insight on, for instance, association between narcotic effects and developmental neurotoxicity. but also connection between another mechanism based on sex steroid hormone and developmental neurotoxicity and immunotoxicity. We have in the scope of this formal decision, as I mentioned before, we're not able to reach anonymous agreement at MSC for a few number of cases and for those we submitted the cases to the to the Commission and they were decided there based on majority agreement. Interestingly, for one case on narcotic effects, the case was also challenged and defended at EU Court. So we have used several ways of getting to the agreement.

• Katinka van der Jagt - Chair, Member State Committee

  Yeah, perhaps to pick up on what both Agnieszka and also Katarzyna were saying, is that indeed I see that the science is an important part of finding agreement, because in a way that's also, of course, where we're here in ECHA and in the Member State Committee. So I think if you work from science, it's indeed much easier to find common ground, because then, let's say, the more political pressures do not need to be taken into consideration. And I think finding these scientific aspects and working them out in detail and then making sure that our experts are all on the same page, that is the first step. And then, of course, the next step is in the Member State Committee to make sure our members understand these things in a similar way in relation to the legal text, because that's then, of course, always a different way to express. And that's where we also need to find agreement. I think in that sense, the work in the committee is both very scientific, but also very much related to the legal requirements of implementing the legislation. And I think these examples, and like also Katarzyna said, of course, the yogurts, let's call it that, is a very complex endpoint. And of course, we had to find a way forward in how to apply that. But I can say that in the last decision rounds, the YoS decisions came through quite, let's say, easily because this convergence of how to take these sort of generic approaches developed by the committee allowed for that to now go without any further discussion. So I think that's a big achievement indeed. Thank you for highlighting that.

• Päivi Jokiniemi - Host, ECHA

  So if you think about these kind of difficult cases and how they are resolved, I heard here already. You mentioned science, both by Katarzyna and Katinka. You also raised in the beginning the importance of collaboration, listening, understanding each other. Is there something else that you would like to add at this point to how this kind of difficult situation can be resolved?

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  Yes, I remember my first MSC meeting. It was the case of resorcinol. I would like to... I highlight the topic here because Poland, together with other two member states, expressed the minority opinion that available scientific evidence did not show that resorcinol was a substance of very high concern because of its steroid-disrupting properties, causing probably serious effects to human health. And the MSC discussion for ResortsNOR was very difficult because of the fact that this substance was considered twice by two member states with different conclusions. And I came to my first meeting with the experts'opinion that I cannot agree for this kind of decision. That's why I have to join to this minority position. Some members abstained from sharing their views on this, and one of them described this as a borderline case. So that's why it was, from the beginning, it was very difficult to solve. And MSC was unable to reach an enmity, and in the result, the European Commission's committee took the final decision on the SVHC proposal and its committee procedure. and decision-making process for this substance due to its endocrine disrupting properties to human health has not been solved yet.

• Katinka van der Jagt - Chair, Member State Committee

  Yes, and I think it's an important subject to raise on how this works in practice. You can of course abstain from voting and in this case that happened and you can also form a minority opinion and as soon as that happens these decisions go to the REACH committee and sometimes it shows then that also in the REACH committee it's difficult to find agreement. So perhaps to stress that I think all possibilities and routes at MSC were sufficiently explored to showing how difficult this case was.

• Päivi Jokiniemi - Host, ECHA

  So in addition to the Member State Committee here at ECHA, we also have other scientific committees. For example, we have the Risk Assessment Committee that Katarzyna already earlier referred to, the RAC. And then we have the Socioeconomic Analysis Committee as well as the Bicycle Products Committee. How is your work related to the work of these other committees?

• Katinka van der Jagt - Chair, Member State Committee

  Perhaps I can start on that. But yeah, for example, for the work at MSC, it feeds into, for example, the processes in RAC and SEAC. When it comes to the identification of substances of very high concern and the eventual inclusion in the candidate list, this information is then recommended. to the Commission and in this recommendation also we adopt opinions at the MSC and then this recommendation results in inclusion in eventually inclusion in annex 14 and with that then RAC gets the authorities and together with the SEAC to work on authorization so that's for example how we feed into certain processes but of course in the connection for the committees we I can say as chair, we as chairs also work together to find as much convergence also in our procedures that we can. So we exchange information on how our rules of procedure are implemented. Of course, being mindful of the different roles the committees play. But yes, there is certainly also cooperation on that level.

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  Yes, perhaps I would like to add that. In the coming years, maybe there will be even a higher need to have a collaboration with RAC members, but also with the experts that are joining those informal groups on ED, endocrine disruptors, but also PBT groups. And my thoughts are about... the process that right now we have been one and the same committee, MSC committee, who were requesting the tests for those properties, but also later in the process identifying those substances for those properties. And now in the future, there will be one committee requesting the tests, but the other committee... identifying, classifying those substances for those properties. So there is a need to adjust the procedure and also improve the collaboration and also include those experts who are working in those informal processes via expert groups.

• Katinka van der Jagt - Chair, Member State Committee

  Yes, and of course, we have also the nanomaterials expert group, and that's something that's perhaps more emerging. And just to highlight that there, also the MSC is now working on the information requirements related to that. So that will be interesting to see how that develops. Because I would like to note that as soon as things are a bit different, it means usually there is a need for more divergence, so a development of generic approaches. to make the decision-taking more efficient on these dossiers. So I'm very much looking forward to this particular task.

• Päivi Jokiniemi - Host, ECHA

  Finally, I would want to take a look ahead. What are those emerging chemical concerns or hot topics that you see in the future and that the committee is now preparing to address?

• Katinka van der Jagt - Chair, Member State Committee

  We see, for example, when we look at research needs, the focus is going to come via PARC. This is this Cooperation, yeah, the partnerships for working together on developing the science in upcoming areas. And the things highlighted there are, of course, neurotoxicity, immunotoxicity and further knowledge on endocrine disruption. So I think that's an area that's potentially coming up. And I think this will be perhaps something that we can address in the in the nearby future.

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  Yes, Katinka has now mentioned all the keywords of my... of my potential thoughts about the future emerging problems. But I would like to go back to nanomaterials. So ECHA, in fact, has started compliance check on nanomaterials, on nanoforms. And right now it has been focused on the physicochemical properties and also the grouping approach. But in the next step, pretty soon, what will follow is the, are the decisions for that. toxicity data and ecotoxicity data and we need specific expertise. We need to be ready to be a part of this process via our experts and luckily we do have the expertise that is gathered in the nanoexpert group that was also mentioned by Katinka. The second keyword are the endocrine disruptors and What we hope for is that there will be a soon revision of REACH with inclusion of the specific data requirements to test for ED properties to be able to efficiently gather this type of data and identify substances with these hazard properties. And I would like to also refer to the Commission work on the roadmap towards animal free testing methods because this is a clear signal of the emerging changes in the context of how we will test for hazard properties and MSC has a role in this process and we should follow the Commission work. We should use the experiences that we gather via MSC work to impact and also help to prepare for smooth implementation of the roadmap.

• Katinka van der Jagt - Chair, Member State Committee

  Thinking about the future of MSC, I would like to see it much more general and having regard to the fact that more new tasks are to be transferred to ECHA. It seems that there could be new topics and tasks for the MSC for covering as well. Upcoming legal developments of the example of industrial emission directive, drinking water directive for sector products, specific regulations combined with increasing availability of data according. to the legislative package on the one substance, one assessment approach, resulting in the wider cooperation of all European agencies. So the other issue which should be underlined here is that just to implement what Katarzyna said, it's the development of the new non-animal testing methods regarding new approach methodologies that can be used to provide information on chemicals, hazard and risk assessment that avoids the use of animals. And what's the ambitions on this point? We can notice from many conferences and the meetings that the... The EHA's ambition is to find the answer to the question, how New approach methods can be used in the regulatory context to enhance the pace of EHA's work, to have better informed, more relevant decisions and reduce replace the need for studies on animals with a main focus on higher tier human health and environment endpoints. This is the question. And for MSC, it will be a challenge to use NAMs in the regulatory context where the legal and scientific certainty is critical.

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  Yes, and perhaps to pick up on these last points and also the point made by both Agnieszka and Katarzyna. Indeed, these new approach methods are very important. And of course, at MSC, we implement what's available to us via the regulation. And to help these two processes to come together, we make sure that we update the MSC on all new developments on a regular basis. Just to exemplify that even today, this is the last day of our committee, we will have such a presentation which proves quite useful also for interaction and updating each other on the latest stance on this new approach method.

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  Sounds like the interesting discussions in the Member State Committee will continue throughout this year and next year and the years to come. At this point, I would like to thank you all very much for taking the time to join and to give these small insights to the life in Member State Committee. Thank you very much.

• Agnieszka Dudra - Bureau for Chemical Substances, Poland

  Thank you for having us.

• Katarzyna Malkiewicz - Swedish Chemicals Agency

  Thank you also to all our listeners. Remember that if you want to tell us what you think about the Safer Chemicals podcast, you can do it through our feedback form linked in the episode details. And finally, you can find all our podcast episodes on our website at eka.europa.eu forward slash podcasts.