WEBVTT 1 00:00:00.316 --> 00:00:01.997 Safer Chemicals Podcast. 2 00:00:02.737 --> 00:00:04.859 Sound science on harmful chemicals. 3 00:00:09.982 --> 00:00:18.867 The MSC taking the science-based decisions has a crucial role in ensuring that all chemicals could be used more safely, 4 00:00:19.247 --> 00:00:27.792 has a crucial role as well in promoting the view that substances of concern are minimised and substituted as far as possible. 5 00:00:28.648 --> 00:00:30.310 We are there when there's divergence, 6 00:00:30.350 --> 00:00:33.092 so we are getting the difficult cases to decide upon. 7 00:00:33.673 --> 00:00:37.396 And that's why it's so very important that when we are at this meeting, 8 00:00:37.396 --> 00:00:41.760 we all have the same view to find convergence and to find agreements in the way forward. 9 00:00:42.741 --> 00:00:47.765 We really work together to bring and carefully consider different scientific, 10 00:00:47.885 --> 00:00:49.547 technical and legal aspects. 11 00:00:50.668 --> 00:00:55.052 The European Union is a partnership of 27 European countries 12 00:00:55.436 --> 00:00:58.518 that have joined forces to build a better future together. 13 00:00:59.478 --> 00:01:00.679 Much like the EU itself, 14 00:01:01.259 --> 00:01:16.007 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. 15 00:01:17.028 --> 00:01:17.688 For example, 16 00:01:18.068 --> 00:01:24.672 the committee helps to decide whether substances of very high concern should be included in the candidate list, 17 00:01:25.080 --> 00:01:28.382 for eventual inclusion in the REACH authorisation list. 18 00:01:29.283 --> 00:01:34.046 This process is important for controlling the use of chemicals that are carcinogenic, 19 00:01:34.467 --> 00:01:35.047 mutagenic, 20 00:01:35.547 --> 00:01:36.828 toxic for reproduction, 21 00:01:37.509 --> 00:01:41.471 or pose other serious risks to people or the environment. 22 00:01:42.912 --> 00:01:43.813 In this episode, 23 00:01:44.173 --> 00:01:45.774 we meet Katinka van der Jagt, 24 00:01:46.495 --> 00:01:48.616 the Chair of the Member State Committee, 25 00:01:49.457 --> 00:01:51.378 as well as the members from Sweden, 26 00:01:52.279 --> 00:01:53.780 Katarzyna Malkiewicz, 27 00:01:54.568 --> 00:01:57.209 and the Polish member Agnieszka Dudra. 28 00:01:58.770 --> 00:02:00.631 We will talk about the role of the committee, 29 00:02:01.071 --> 00:02:03.072 its tasks and responsibilities, 30 00:02:03.532 --> 00:02:06.413 and how its work contributes to chemical safety. 31 00:02:07.553 --> 00:02:08.754 My name is Päivi Jokiniemi, 32 00:02:09.154 --> 00:02:11.595 and this is the Safer Chemicals podcast. 33 00:02:12.816 --> 00:02:13.416 Welcome all. 34 00:02:13.676 --> 00:02:16.357 Thank you for joining us during a busy week. 35 00:02:17.197 --> 00:02:18.378 Thank you for inviting me. 36 00:02:18.378 --> 00:02:18.638 Indeed, 37 00:02:18.738 --> 00:02:19.138 thank you. 38 00:02:19.278 --> 00:02:20.059 I'm happy to be here. 39 00:02:20.159 --> 00:02:20.499 Thank you. 40 00:02:21.319 --> 00:02:23.040 I was thinking we'll dive right in. 41 00:02:23.532 --> 00:02:29.857 And I'd like to start by asking what each of you finds unique about this committee. 42 00:02:30.097 --> 00:02:36.022 And how would you yourself describe your role in ensuring chemical safety in the EU? 43 00:02:37.804 --> 00:02:37.964 Well, 44 00:02:38.084 --> 00:02:46.090 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, 45 00:02:46.150 --> 00:02:46.290 etc. 46 00:02:46.911 --> 00:02:48.032 It actually helps already. 47 00:02:48.472 --> 00:02:55.879 quite before that because it for example identifies the chemicals that are considered to be of high risk, 48 00:02:55.879 --> 00:02:57.540 so the substances of very high risk. 49 00:02:57.900 --> 00:02:59.422 So I think it starts with the MSC, 50 00:02:59.702 --> 00:03:01.523 this is at least something I would like to add. 51 00:03:02.084 --> 00:03:04.906 And one thing that I want to stress, 52 00:03:04.946 --> 00:03:07.709 and I think you already said that also, 53 00:03:08.249 --> 00:03:10.491 is that we are there with all member states, 54 00:03:10.531 --> 00:03:12.853 we're all there together taking decisions, 55 00:03:12.873 --> 00:03:15.336 so it's a very broadly carried decision. 56 00:03:15.980 --> 00:03:18.402 And I think that's something I would like to emphasise now. 57 00:03:19.864 --> 00:03:21.746 What about from the national points of view? 58 00:03:22.987 --> 00:03:32.936 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. 59 00:03:33.497 --> 00:03:38.522 We really work together to bring and carefully consider different scientific, 60 00:03:38.622 --> 00:03:40.304 technical and legal aspects. 61 00:03:41.344 --> 00:03:44.287 And in a great majority of issues and cases, 62 00:03:44.367 --> 00:03:48.771 we are able to understand what are the grounds of those diverging views. 63 00:03:49.351 --> 00:03:58.820 And this really helps to find the best outcome and the outcome that can be supported by all the members. 64 00:03:59.632 --> 00:04:03.933 And this can be decisions with the testing requirements, 65 00:04:04.113 --> 00:04:14.777 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 66 00:04:15.257 --> 00:04:15.677 14. 67 00:04:17.458 --> 00:04:18.858 The work of the 68 00:04:19.458 --> 00:04:24.440 MSC is very useful for understanding the challenges with implementation of REACH. 69 00:04:25.328 --> 00:04:25.928 And being it, 70 00:04:25.988 --> 00:04:26.589 for instance, 71 00:04:26.609 --> 00:04:30.851 the limitation and uncertainties of the testing methods that we are using, 72 00:04:30.931 --> 00:04:32.993 but also the legal text itself. 73 00:04:33.793 --> 00:04:40.237 And sometimes those challenges that we experience cannot be fixed by MSC work, 74 00:04:40.997 --> 00:04:43.619 but they could be approached in another fora. 75 00:04:44.539 --> 00:04:45.140 For instance, 76 00:04:45.200 --> 00:04:49.482 like updates of the test methods that could be approached in the 77 00:04:49.843 --> 00:04:50.663 OECD level, 78 00:04:51.143 --> 00:04:51.984 the global level. 79 00:04:52.893 --> 00:04:57.906 but also supporting the Commission work in the revision of the legal text. 80 00:04:58.750 --> 00:05:00.591 Very good concrete examples. 81 00:05:01.171 --> 00:05:01.751 What about you, 82 00:05:01.911 --> 00:05:03.772 Agnieszka? 83 00:05:03.772 --> 00:05:07.073 I think that the committee should continue the role of a body 84 00:05:07.634 --> 00:05:13.336 which is well equipped to be involved in providing opinions to the ECHA's existing processes, 85 00:05:13.496 --> 00:05:13.756 like, 86 00:05:13.836 --> 00:05:14.497 for example, 87 00:05:14.897 --> 00:05:16.838 classification of the substances, 88 00:05:17.138 --> 00:05:22.680 and to take part in new tasks which will be covered by the ECHA's future extended mandate. 89 00:05:23.160 --> 00:05:24.461 The other point is that 90 00:05:24.861 --> 00:05:27.342 MSC taking the science-based decisions 91 00:05:27.870 --> 00:05:33.472 has a crucial role in ensuring that all chemicals could be used more safely, 92 00:05:33.833 --> 00:05:42.416 has a crucial role as well in promoting the view that substances of concern are minimised and substituted as far as possible, 93 00:05:42.916 --> 00:05:48.759 and a crucial role as well in phasing out the most harmful ones for non-essential social use, 94 00:05:49.099 --> 00:05:51.100 in particular in consumer products. 95 00:05:51.820 --> 00:05:56.042 The unique value of MSC is a high transparency of the processes, 96 00:05:56.478 --> 00:05:59.500 what ensures the high level of trust in the ECHA's work. 97 00:06:00.300 --> 00:06:04.483 MSC ensures high quality of decisions and its outputs are clear, 98 00:06:04.863 --> 00:06:06.084 complete and conclusive. 99 00:06:07.805 --> 00:06:13.608 You already now all referred to kind of several tasks of the committee. 100 00:06:14.869 --> 00:06:16.170 But I was thinking still, 101 00:06:16.530 --> 00:06:17.330 in your opinion, 102 00:06:17.390 --> 00:06:21.873 if you need to raise one task that you think is most important, 103 00:06:22.714 --> 00:06:23.374 what would you say? 104 00:06:25.470 --> 00:06:28.612 I have a difficulty to point on one, 105 00:06:28.672 --> 00:06:32.935 but I have examples of two, 106 00:06:33.135 --> 00:06:33.756 if possible. 107 00:06:34.416 --> 00:06:43.543 So most important is the MSC involvement in generation of experimental data for thousands of industrial chemicals, 108 00:06:44.263 --> 00:06:52.589 as this data is the basis for identification of hazardous chemicals and management of the risks that they pose. 109 00:06:53.830 --> 00:06:53.950 So, 110 00:06:54.570 --> 00:06:55.471 as an example, 111 00:06:55.711 --> 00:06:57.132 last year, 112 00:06:57.132 --> 00:06:58.853 2023, 113 00:06:58.853 --> 00:07:10.460 ECHA issued around 400 decisions for about 360 substances with the testing requirement to fulfill the standard data requirement. 114 00:07:11.201 --> 00:07:14.363 And in about 10% of those decisions, 115 00:07:14.583 --> 00:07:18.706 MSC has been involved to resolve diverging views. 116 00:07:20.046 --> 00:07:25.509 And this proportion of the decisions that we are involved in has diminished through the years. 117 00:07:26.009 --> 00:07:36.695 And that is because we have worked towards finding agreed and aligned testing strategies that are being implemented now. 118 00:07:37.235 --> 00:07:38.476 So in this way, 119 00:07:38.576 --> 00:07:40.297 we have gained agreement, 120 00:07:40.337 --> 00:07:41.838 a long term agreement, 121 00:07:42.358 --> 00:07:45.580 and now the decision process can run smoothly. 122 00:07:46.941 --> 00:07:49.102 So another task that I cannot omit is the identification of substances of very high concern. 123 00:07:56.587 --> 00:07:58.068 And in this respect, 124 00:07:58.609 --> 00:08:08.556 especially those with the hazard for endocrine disruption that were identified as substances of equivalent level of concern, 125 00:08:09.256 --> 00:08:12.419 but also those with properties so-called PBTs, 126 00:08:12.519 --> 00:08:13.459 VPVBs, 127 00:08:13.579 --> 00:08:14.320 PMTs, 128 00:08:14.460 --> 00:08:16.782 and those abbreviations refer to the properties of persistence, 129 00:08:19.503 --> 00:08:20.543 bioaccumulation, 130 00:08:20.623 --> 00:08:24.125 toxicity and substances that are globally mobile. 131 00:08:25.325 --> 00:08:34.689 Those are very important hazard classes that MSC has contributed to because so far they have not been a part of the 132 00:08:35.170 --> 00:08:37.491 CLP classification hazard classes. 133 00:08:38.511 --> 00:08:39.872 So out of the 134 00:08:40.392 --> 00:08:45.414 240 entries that we have now in the SVHC list, about 30 of those entries are for ED properties and 70 are for the 135 00:08:52.390 --> 00:08:53.370 PBTV, VPVB, 136 00:08:53.590 --> 00:08:54.791 PMT properties. 137 00:08:56.392 --> 00:09:04.717 So that is a quite significant amount of the substances identified for those hazardous properties. 138 00:09:05.757 --> 00:09:06.197 What about 139 00:09:06.598 --> 00:09:07.138 Agnieszka? 140 00:09:08.086 --> 00:09:10.867 My impression is the same as Katarzyna has already said. 141 00:09:11.087 --> 00:09:11.467 And 142 00:09:12.008 --> 00:09:14.489 I'm a committee member since 2020, 143 00:09:14.669 --> 00:09:24.133 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. 144 00:09:24.713 --> 00:09:25.633 And in my opinion, 145 00:09:25.873 --> 00:09:37.118 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. 146 00:09:42.939 --> 00:09:43.099 Yes, 147 00:09:43.139 --> 00:09:43.919 and perhaps to add, 148 00:09:44.780 --> 00:09:46.140 I also feel in deed, 149 00:09:46.160 --> 00:09:55.522 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. 150 00:09:55.562 --> 00:09:55.783 And that, 151 00:09:55.843 --> 00:09:56.223 of course, 152 00:09:56.263 --> 00:09:58.303 feeds in also to the further processes, 153 00:09:58.363 --> 00:09:59.464 because without this data, 154 00:09:59.944 --> 00:10:04.685 it would not be possible to take certain decisions on hazardous substances. 155 00:10:04.725 --> 00:10:06.545 So I think that's one thing. 156 00:10:06.566 --> 00:10:07.666 And I think another thing, 157 00:10:07.746 --> 00:10:08.066 indeed, 158 00:10:08.526 --> 00:10:10.807 for the SVHC that now have been highlighted, 159 00:10:10.867 --> 00:10:11.767 I can just add that because of these really good and in-depth discussions that we have at the MSC, 160 00:10:16.859 --> 00:10:23.784 we have been able to have quite a flawless record in litigation of the SVHCs to stand strong. 161 00:10:23.885 --> 00:10:32.331 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. 162 00:10:33.713 --> 00:10:39.297 Would you have some examples of decisions that the committee has taken that you think that, 163 00:10:39.477 --> 00:10:39.617 well, 164 00:10:39.637 --> 00:10:41.359 this had a significant impact 165 00:10:42.616 --> 00:10:45.778 on the public health or environmental safety? 166 00:10:47.179 --> 00:10:47.479 I think, 167 00:10:47.479 --> 00:10:47.819 of course, 168 00:10:47.839 --> 00:10:50.101 it's always very difficult to pinpoint one case. 169 00:10:50.101 --> 00:10:51.241 And I think especially for me, 170 00:10:51.341 --> 00:10:57.385 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. 171 00:10:57.706 --> 00:10:59.387 We are there when there's divergence. 172 00:10:59.427 --> 00:11:02.169 So we are getting the difficult cases to decide upon. 173 00:11:02.749 --> 00:11:06.472 And that's why it's so very important that when we are at this meeting, 174 00:11:06.472 --> 00:11:10.835 we all have the same view to find convergence and to find agreement in the way forward. 175 00:11:10.875 --> 00:11:11.255 And we do. 176 00:11:11.831 --> 00:11:13.712 So I guess I would like to stress that rather. 177 00:11:14.652 --> 00:11:16.733 A nice example. 178 00:11:16.813 --> 00:11:22.176 So MSC has a crucial role in elimination of substances considered to have 179 00:11:22.616 --> 00:11:24.017 ED properties, 180 00:11:24.057 --> 00:11:25.658 as Katarzyna mentioned before, 181 00:11:27.559 --> 00:11:31.521 which could cause probably serious effects to human health, 182 00:11:31.901 --> 00:11:32.641 like phthalates, 183 00:11:32.721 --> 00:11:33.422 bisphenols. 184 00:11:33.762 --> 00:11:36.103 They are the examples which we were working on. 185 00:11:36.567 --> 00:11:45.012 We discussed the evidence for ED properties for those substances before criteria of these specific hazard classes were implemented into the revised 186 00:11:46.172 --> 00:11:47.213 CLP regulations. 187 00:11:47.253 --> 00:11:48.874 So we are one step ahead. 188 00:11:49.674 --> 00:11:51.335 And as the next step, 189 00:11:51.395 --> 00:11:56.158 the committee opinions on that issue were used for further EU regulatory actions. 190 00:11:56.178 --> 00:11:59.500 So this is the point which should be underlined. 191 00:12:00.421 --> 00:12:01.041 And Katarzyna? 192 00:12:02.382 --> 00:12:04.303 So I would like to bring an example of the testing strategy for mutagenicity that we have developed through years. 193 00:12:12.306 --> 00:12:16.908 And that was an effort from experts from ECHA, 194 00:12:18.189 --> 00:12:22.651 MSCAs and a broad range of stakeholders via MSC. 195 00:12:23.671 --> 00:12:29.573 But we have also organised a targeted workshop with our colleagues from 196 00:12:30.034 --> 00:12:32.975 RAC in 2018. 197 00:12:33.563 --> 00:12:45.890 And we have together considered pros and cons of different methods and also how the newly approved methods on OECD level, 198 00:12:46.010 --> 00:12:47.291 like the COMET assay, 199 00:12:47.891 --> 00:12:55.555 how they fit together to make this testing strategy straightforward, 200 00:12:55.695 --> 00:12:56.576 efficient, 201 00:12:57.496 --> 00:13:01.439 also to save money and animals. 202 00:13:03.107 --> 00:13:05.489 We are also using experience from 203 00:13:05.989 --> 00:13:16.417 MSC and experts from different stakeholders and have supported Commission to include clarifying amendments in 204 00:13:16.817 --> 00:13:18.538 REACH data requirements, 205 00:13:19.059 --> 00:13:21.421 among others also mutagenicity. 206 00:13:22.862 --> 00:13:26.844 We are also now getting indications that the laboratories, 207 00:13:26.925 --> 00:13:28.045 so-called CROs, 208 00:13:28.145 --> 00:13:29.867 that they are very active in 209 00:13:30.675 --> 00:13:38.280 validation of the specific elements of those newly adopted methods for mutagenicity. 210 00:13:40.122 --> 00:13:45.505 We see still the room for improvement when it comes to genotoxicity testing, 211 00:13:46.446 --> 00:13:57.473 but we realised that those would require a REACH revision and adjustment of the legal text in the hopefully near future. 212 00:13:58.694 --> 00:13:59.875 If we then move on 213 00:14:00.315 --> 00:14:02.378 from the tasks to the committee itself. 214 00:14:02.998 --> 00:14:08.285 Considering the diverse backgrounds and interests of each member state, 215 00:14:09.086 --> 00:14:17.136 how do you navigate the differing national priorities and regulatory preferences when taking the decisions? 216 00:14:18.504 --> 00:14:18.664 Well, 217 00:14:19.044 --> 00:14:19.465 of course, 218 00:14:19.485 --> 00:14:20.885 when we come to the committee, 219 00:14:21.546 --> 00:14:26.588 we already have received the documents that will be there for discussion. 220 00:14:27.149 --> 00:14:31.191 And we try to kind of understand how that would impact the different members. 221 00:14:31.671 --> 00:14:33.292 And then when we get to the meeting, 222 00:14:33.592 --> 00:14:40.816 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. 223 00:14:41.937 --> 00:14:42.977 And I think also here, 224 00:14:43.057 --> 00:14:43.377 again, 225 00:14:44.978 --> 00:14:48.080 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. 226 00:14:52.817 --> 00:14:58.739 And I can see that our members are also always willing to listen to each other and ask clarifying questions. 227 00:14:59.299 --> 00:15:00.520 So I think in general, 228 00:15:01.180 --> 00:15:03.561 that sets the stage for finding agreement. 229 00:15:03.981 --> 00:15:04.501 And yes, 230 00:15:04.541 --> 00:15:04.961 of course, 231 00:15:05.001 --> 00:15:14.404 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. 232 00:15:16.565 --> 00:15:18.686 But I would say that in general, 233 00:15:19.186 --> 00:15:22.188 all the members are willing to find this agreement. 234 00:15:22.228 --> 00:15:23.929 And especially also in, 235 00:15:24.089 --> 00:15:24.669 for example, 236 00:15:24.669 --> 00:15:26.770 the pauses that we have between the breaks. 237 00:15:26.810 --> 00:15:34.734 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. 238 00:15:35.194 --> 00:15:36.455 And that helps very much, 239 00:15:36.455 --> 00:15:36.975 in my view, 240 00:15:37.075 --> 00:15:38.596 for finding this agreement. 241 00:15:40.252 --> 00:15:43.395 When making the decisions from the public health perspective, 242 00:15:43.435 --> 00:15:46.557 because my bureau is supervised directly by the Minister of Health, 243 00:15:47.018 --> 00:15:51.802 I always have in mind that chemicals should be safe under normal conditions of use. 244 00:15:51.882 --> 00:15:52.742 And in particular, 245 00:15:53.063 --> 00:15:55.104 from the public health perspective, 246 00:15:55.124 --> 00:15:58.947 a risk-benefit reasoning should not justify a risk to human health. 247 00:15:59.388 --> 00:16:05.193 So this is the main point we have in mind when taking such decisions. 248 00:16:06.173 --> 00:16:06.353 Yes, 249 00:16:06.434 --> 00:16:07.534 from my perspective, 250 00:16:07.554 --> 00:16:09.276 I think we have been very much... 251 00:16:09.636 --> 00:16:18.040 involved in attempts to resolve diverging views by going into the core of science. 252 00:16:18.700 --> 00:16:26.783 So we have been searching for more information that could help to understand why there are diverging views. 253 00:16:27.564 --> 00:16:36.968 We have also experienced that the committee is working towards practical and pragmatic ways on how to 254 00:16:37.588 --> 00:16:39.109 resolve those diverging views. 255 00:16:39.970 --> 00:16:54.122 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 256 00:16:54.162 --> 00:16:54.283 the 257 00:16:54.643 --> 00:17:00.048 Commission for decision making that is based on the majority agreement, 258 00:17:00.168 --> 00:17:02.009 that at that level, 259 00:17:02.229 --> 00:17:04.732 unanimous agreement is no longer needed. 260 00:17:06.212 --> 00:17:09.935 So to exemplify this story, 261 00:17:10.936 --> 00:17:19.762 I thought of the example with implementation of the reproductive toxicity study, 262 00:17:19.962 --> 00:17:22.004 so-called EOGRTS, 263 00:17:22.184 --> 00:17:23.985 and we also call it yogurt. 264 00:17:26.206 --> 00:17:29.829 So that is a relatively new method, 265 00:17:31.070 --> 00:17:33.892 has been proven to be very challenging. 266 00:17:34.928 --> 00:17:36.069 And under reach, 267 00:17:36.209 --> 00:17:38.831 the scope of this evaluation, 268 00:17:38.911 --> 00:17:40.712 there are different sub-endpoints, 269 00:17:41.813 --> 00:17:49.458 needs to be decided on a case by case for each substance and based on the evidence that is existing. 270 00:17:50.119 --> 00:17:57.644 And it is about specific investigation for neurotoxicity and immunotoxicity. 271 00:17:58.345 --> 00:18:02.988 And the experiences show that there are really diverging views of how much 272 00:18:03.784 --> 00:18:12.391 and what is the level of evidence and type of information to bring this concern and to trigger those additional testing. 273 00:18:13.772 --> 00:18:14.773 And for instance, 274 00:18:14.893 --> 00:18:21.839 ECHA has commissioned preparation of scientific reviews to provide further insight on, 275 00:18:22.380 --> 00:18:22.880 for instance, 276 00:18:22.960 --> 00:18:27.064 association between narcotic effects and developmental neurotoxicity. 277 00:18:27.648 --> 00:18:37.155 but also connection between another mechanism based on sex steroid hormone and developmental neurotoxicity and immunotoxicity. 278 00:18:38.196 --> 00:18:41.218 We have in the scope of this formal decision, 279 00:18:41.758 --> 00:18:43.019 as I mentioned before, 280 00:18:43.820 --> 00:18:54.928 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 281 00:18:55.636 --> 00:19:02.023 to the Commission and they were decided there based on majority agreement. 282 00:19:03.264 --> 00:19:04.005 Interestingly, 283 00:19:04.446 --> 00:19:07.389 for one case on narcotic effects, 284 00:19:08.149 --> 00:19:11.633 the case was also challenged and defended at EU Court. 285 00:19:12.114 --> 00:19:18.200 So we have used several ways of getting to the agreement. 286 00:19:19.212 --> 00:19:19.332 Yeah, 287 00:19:19.392 --> 00:19:20.953 perhaps to pick up on what both 288 00:19:21.413 --> 00:19:23.554 Agnieszka and also Katarzyna were saying, 289 00:19:23.554 --> 00:19:24.154 is that indeed 290 00:19:24.654 --> 00:19:28.556 I see that the science is an important part of finding agreement, 291 00:19:28.576 --> 00:19:29.917 because in a way that's also, 292 00:19:29.957 --> 00:19:30.397 of course, 293 00:19:30.437 --> 00:19:34.118 where we're here in ECHA and in the Member State Committee. 294 00:19:35.299 --> 00:19:35.419 So 295 00:19:35.939 --> 00:19:37.820 I think if you work from science, 296 00:19:37.860 --> 00:19:41.441 it's indeed much easier to find common ground, 297 00:19:41.942 --> 00:19:42.562 because then, 298 00:19:42.822 --> 00:19:43.202 let's say, 299 00:19:43.222 --> 00:19:47.324 the more political pressures do not need to be taken into consideration. 300 00:19:47.784 --> 00:19:55.947 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, 301 00:19:56.107 --> 00:19:57.447 that is the first step. 302 00:19:57.927 --> 00:19:58.167 And then, 303 00:19:58.167 --> 00:19:58.508 of course, 304 00:19:58.508 --> 00:20:05.610 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, 305 00:20:05.710 --> 00:20:06.370 because that's then, 306 00:20:06.410 --> 00:20:06.750 of course, 307 00:20:06.830 --> 00:20:08.851 always a different way to express. 308 00:20:09.491 --> 00:20:11.312 And that's where we also need to find agreement. 309 00:20:11.932 --> 00:20:12.932 I think in that sense, 310 00:20:13.132 --> 00:20:15.693 the work in the committee is both very scientific, 311 00:20:15.753 --> 00:20:21.515 but also very much related to the legal requirements of implementing the legislation. 312 00:20:22.136 --> 00:20:23.236 And I think these examples, 313 00:20:23.496 --> 00:20:25.417 and like also Katarzyna said, 314 00:20:25.617 --> 00:20:26.137 of course, 315 00:20:26.337 --> 00:20:26.997 the yogurts, 316 00:20:27.097 --> 00:20:27.798 let's call it that, 317 00:20:28.378 --> 00:20:30.258 is a very complex endpoint. 318 00:20:30.438 --> 00:20:31.479 And of course, 319 00:20:31.939 --> 00:20:34.540 we had to find a way forward in how to apply that. 320 00:20:34.964 --> 00:20:37.165 But I can say that in the last decision rounds, 321 00:20:37.205 --> 00:20:39.246 the YoS decisions came through quite, 322 00:20:39.426 --> 00:20:39.726 let's say, 323 00:20:39.886 --> 00:20:50.031 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. 324 00:20:50.171 --> 00:20:52.832 So I think that's a big achievement indeed. 325 00:20:53.032 --> 00:20:54.253 Thank you for highlighting that. 326 00:20:55.833 --> 00:21:00.375 So if you think about these kind of difficult cases and how they are resolved, 327 00:21:00.495 --> 00:21:01.636 I heard here already. 328 00:21:01.996 --> 00:21:02.936 You mentioned science, 329 00:21:03.036 --> 00:21:05.678 both by Katarzyna and Katinka. 330 00:21:06.078 --> 00:21:09.739 You also raised in the beginning the importance of collaboration, 331 00:21:10.240 --> 00:21:10.720 listening, 332 00:21:10.920 --> 00:21:12.140 understanding each other. 333 00:21:12.601 --> 00:21:21.444 Is there something else that you would like to add at this point to how this kind of difficult situation can be resolved? 334 00:21:23.145 --> 00:21:23.325 Yes, 335 00:21:24.386 --> 00:21:25.586 I remember my first 336 00:21:25.946 --> 00:21:26.587 MSC meeting. 337 00:21:26.627 --> 00:21:28.788 It was the case of resorcinol. 338 00:21:28.828 --> 00:21:29.468 I would like to... 339 00:21:30.044 --> 00:21:34.527 I highlight the topic here because Poland, 340 00:21:34.648 --> 00:21:36.749 together with other two member states, 341 00:21:36.789 --> 00:21:48.598 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, 342 00:21:48.698 --> 00:21:51.060 causing probably serious effects to human health. 343 00:21:51.968 --> 00:22:03.299 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. 344 00:22:04.020 --> 00:22:04.360 And 345 00:22:04.780 --> 00:22:13.609 I came to my first meeting with the experts'opinion that I cannot agree for this kind of decision. 346 00:22:13.669 --> 00:22:16.632 That's why I have to join to this minority position. 347 00:22:17.464 --> 00:22:21.467 Some members abstained from sharing their views on this, 348 00:22:21.607 --> 00:22:26.151 and one of them described this as a borderline case. 349 00:22:26.751 --> 00:22:28.292 So that's why it was, 350 00:22:28.592 --> 00:22:29.293 from the beginning, 351 00:22:29.333 --> 00:22:31.054 it was very difficult to solve. 352 00:22:31.635 --> 00:22:34.357 And MSC was unable to reach an enmity, 353 00:22:34.677 --> 00:22:35.658 and in the result, 354 00:22:35.678 --> 00:22:44.064 the European Commission's committee took the final decision on the SVHC proposal and its committee procedure. 355 00:22:44.688 --> 00:22:52.259 and decision-making process for this substance due to its endocrine disrupting properties to human health has not been solved yet. 356 00:22:53.221 --> 00:22:53.441 Yes, 357 00:22:53.621 --> 00:23:00.051 and I think it's an important subject to raise on how this works in practice. 358 00:23:01.853 --> 00:23:16.105 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. 359 00:23:16.525 --> 00:23:18.127 So perhaps to stress that 360 00:23:18.507 --> 00:23:24.492 I think all possibilities and routes at MSC were sufficiently explored to showing how difficult this case was. 361 00:23:25.368 --> 00:23:28.150 So in addition to the Member State Committee here at ECHA, 362 00:23:28.210 --> 00:23:30.751 we also have other scientific committees. 363 00:23:31.211 --> 00:23:31.672 For example, 364 00:23:31.672 --> 00:23:35.814 we have the Risk Assessment Committee that Katarzyna already earlier referred to, 365 00:23:35.914 --> 00:23:36.214 the RAC. 366 00:23:37.335 --> 00:23:39.176 And then we have the Socioeconomic 367 00:23:39.516 --> 00:23:41.957 Analysis Committee as well as the Bicycle Products 368 00:23:42.438 --> 00:23:46.360 Committee. How is your work related to the work of these other committees? 369 00:23:47.744 --> 00:23:49.166 Perhaps I can start on that. 370 00:23:49.266 --> 00:23:49.846 But yeah, 371 00:23:49.866 --> 00:23:50.427 for example, 372 00:23:51.267 --> 00:23:52.428 for the work at MSC, 373 00:23:52.669 --> 00:23:53.409 it feeds into, 374 00:23:53.549 --> 00:23:54.070 for example, 375 00:23:54.070 --> 00:23:55.791 the processes in RAC and SEAC. 376 00:23:56.812 --> 00:24:02.637 When it comes to the identification of substances of very high concern and the eventual inclusion in the candidate list, 377 00:24:03.137 --> 00:24:05.1000 this information is then recommended. 378 00:24:06.528 --> 00:24:19.638 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 379 00:24:21.119 --> 00:24:33.148 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 380 00:24:33.736 --> 00:24:34.576 I can say as chair, 381 00:24:34.697 --> 00:24:41.440 we as chairs also work together to find as much convergence also in our procedures that we can. 382 00:24:41.920 --> 00:24:46.182 So we exchange information on how our rules of procedure are implemented. 383 00:24:47.022 --> 00:24:47.383 Of course, 384 00:24:47.423 --> 00:24:49.844 being mindful of the different roles the committees play. 385 00:24:50.244 --> 00:24:51.004 But yes, 386 00:24:51.385 --> 00:24:54.486 there is certainly also cooperation on that level. 387 00:24:55.507 --> 00:24:55.647 Yes, 388 00:24:55.707 --> 00:24:58.088 perhaps I would like to add that. 389 00:24:59.608 --> 00:25:01.049 In the coming years, 390 00:25:01.189 --> 00:25:05.331 maybe there will be even a higher need to have a collaboration with 391 00:25:06.892 --> 00:25:07.952 RAC members, 392 00:25:08.172 --> 00:25:14.795 but also with the experts that are joining those informal groups on 393 00:25:17.317 --> 00:25:19.077 ED, endocrine disruptors, 394 00:25:19.198 --> 00:25:20.978 but also PBT groups. 395 00:25:21.579 --> 00:25:23.840 And my thoughts are about... 396 00:25:24.716 --> 00:25:29.378 the process that right now we have been one and the same committee, 397 00:25:29.499 --> 00:25:30.579 MSC committee, 398 00:25:31.740 --> 00:25:36.342 who were requesting the tests for those properties, 399 00:25:36.542 --> 00:25:41.685 but also later in the process identifying those substances for those properties. 400 00:25:42.225 --> 00:25:43.325 And now in the future, 401 00:25:43.385 --> 00:25:46.767 there will be one committee requesting the tests, 402 00:25:46.867 --> 00:25:48.508 but the other committee... 403 00:25:49.680 --> 00:25:50.481 identifying, 404 00:25:50.701 --> 00:25:53.544 classifying those substances for those properties. 405 00:25:53.584 --> 00:26:06.636 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. 406 00:26:07.352 --> 00:26:07.512 Yes, 407 00:26:07.532 --> 00:26:08.433 and of course, 408 00:26:08.513 --> 00:26:10.694 we have also the nanomaterials expert group, 409 00:26:10.814 --> 00:26:13.296 and that's something that's perhaps more emerging. 410 00:26:13.376 --> 00:26:15.277 And just to highlight that there, 411 00:26:15.898 --> 00:26:19.560 also the MSC is now working on the information requirements related to that. 412 00:26:19.620 --> 00:26:22.041 So that will be interesting to see how that develops. 413 00:26:22.522 --> 00:26:26.044 Because I would like to note that as soon as things are a bit different, 414 00:26:26.184 --> 00:26:29.266 it means usually there is a need for more divergence, 415 00:26:29.266 --> 00:26:31.928 so a development of generic approaches. 416 00:26:32.328 --> 00:26:35.749 to make the decision-taking more efficient on these dossiers. 417 00:26:35.809 --> 00:26:38.931 So I'm very much looking forward to this particular task. 418 00:26:40.531 --> 00:26:40.932 Finally, 419 00:26:41.692 --> 00:26:44.173 I would want to take a look ahead. 420 00:26:45.393 --> 00:26:53.937 What are those emerging chemical concerns or hot topics that you see in the future and that the committee is now preparing to address? 421 00:26:54.937 --> 00:26:55.238 We see, 422 00:26:55.238 --> 00:26:55.758 for example, 423 00:26:55.758 --> 00:26:57.218 when we look at research needs, 424 00:26:57.338 --> 00:26:59.319 the focus is going to come via PARC. 425 00:26:59.379 --> 00:26:59.980 This is this 426 00:27:01.276 --> 00:27:02.056 Cooperation, 427 00:27:02.176 --> 00:27:02.296 yeah, 428 00:27:02.316 --> 00:27:07.859 the partnerships for working together on developing the science in upcoming areas. 429 00:27:08.339 --> 00:27:09.820 And the things highlighted there are, 430 00:27:09.820 --> 00:27:10.300 of course, 431 00:27:10.420 --> 00:27:11.340 neurotoxicity, 432 00:27:11.640 --> 00:27:14.982 immunotoxicity and further knowledge on endocrine disruption. 433 00:27:15.562 --> 00:27:18.863 So I think that's an area that's potentially coming up. 434 00:27:18.944 --> 00:27:23.405 And I think this will be perhaps something that we can address in the in the nearby future. 435 00:27:24.646 --> 00:27:24.866 Yes, 436 00:27:25.246 --> 00:27:29.288 Katinka has now mentioned all the keywords of my... 437 00:27:30.264 --> 00:27:34.807 of my potential thoughts about the future emerging problems. 438 00:27:35.047 --> 00:27:38.188 But I would like to go back to nanomaterials. 439 00:27:38.989 --> 00:27:39.129 So 440 00:27:39.489 --> 00:27:40.270 ECHA, in fact, 441 00:27:40.350 --> 00:27:44.132 has started compliance check on nanomaterials, 442 00:27:44.672 --> 00:27:45.553 on nanoforms. 443 00:27:45.813 --> 00:27:51.676 And right now it has been focused on the physicochemical properties and also the grouping approach. 444 00:27:52.536 --> 00:27:53.697 But in the next step, 445 00:27:54.677 --> 00:27:55.278 pretty soon, 446 00:27:55.878 --> 00:27:57.099 what will follow is the, 447 00:27:57.739 --> 00:27:59.240 are the decisions for that. 448 00:27:59.420 --> 00:28:06.063 toxicity data and ecotoxicity data and we need specific expertise. 449 00:28:06.083 --> 00:28:19.388 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 450 00:28:19.989 --> 00:28:20.449 Katinka. 451 00:28:21.989 --> 00:28:26.631 The second keyword are the endocrine disruptors and 452 00:28:29.440 --> 00:28:45.734 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 453 00:28:47.435 --> 00:28:52.840 gather this type of data and identify substances with these hazard properties. 454 00:28:55.076 --> 00:28:57.437 And I would like to also refer to the 455 00:28:58.057 --> 00:29:14.002 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 456 00:29:14.102 --> 00:29:21.064 hazard properties and MSC has a role in this process and we should follow the Commission work. 457 00:29:21.444 --> 00:29:31.787 We should use the experiences that we gather via MSC work to impact and also help to prepare for smooth implementation of the roadmap. 458 00:29:33.493 --> 00:29:35.197 Thinking about the future of MSC, 459 00:29:35.197 --> 00:29:43.052 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. 460 00:29:43.372 --> 00:29:48.872 It seems that there could be new topics and tasks for the MSC for covering as well. 461 00:29:49.552 --> 00:29:54.204 Upcoming legal developments of the example of industrial emission directive, 462 00:29:54.224 --> 00:29:57.272 drinking water directive for sector products, 463 00:29:57.352 --> 00:30:02.252 specific regulations combined with increasing availability of data according. 464 00:30:02.884 --> 00:30:05.335 to the legislative package on the one substance, 465 00:30:05.415 --> 00:30:06.540 one assessment approach, 466 00:30:07.080 --> 00:30:10.780 resulting in the wider cooperation of all European agencies. 467 00:30:11.689 --> 00:30:16.994 So the other issue which should be underlined here is that just to implement what Katarzyna said, 468 00:30:17.074 --> 00:30:27.044 it's the development of the new non-animal testing methods regarding new approach methodologies that can be used to provide information on chemicals, 469 00:30:27.124 --> 00:30:31.408 hazard and risk assessment that avoids the use of animals. 470 00:30:31.829 --> 00:30:34.995 And what's the ambitions on this point? 471 00:30:35.196 --> 00:30:39.063 We can notice from many conferences and the meetings that the... 472 00:30:39.656 --> 00:30:43.590 The EHA's ambition is to find the answer to the question, 473 00:30:43.730 --> 00:30:43.991 how 474 00:30:45.845 --> 00:30:51.379 New approach methods can be used in the regulatory context to enhance the pace of EHA's work, 475 00:30:51.760 --> 00:30:53.084 to have better informed, 476 00:30:53.385 --> 00:31:03.520 more relevant decisions and reduce replace the need for studies on animals with a main focus on higher tier human health and environment endpoints. 477 00:31:04.045 --> 00:31:05.014 This is the question. 478 00:31:05.660 --> 00:31:06.403 And for MSC, 479 00:31:06.724 --> 00:31:12.959 it will be a challenge to use NAMs in the regulatory context where the legal and scientific certainty is critical. 480 00:31:14.095 --> 00:31:14.256 Yes, 481 00:31:14.276 --> 00:31:18.367 and perhaps to pick up on these last points and also the point made by both 482 00:31:19.189 --> 00:31:20.312 Agnieszka and Katarzyna. 483 00:31:21.274 --> 00:31:21.636 Indeed, 484 00:31:21.938 --> 00:31:24.412 these new approach methods are very important. 485 00:31:24.732 --> 00:31:25.254 And of course, 486 00:31:26.278 --> 00:31:26.418 at 487 00:31:26.900 --> 00:31:30.252 MSC, we implement what's available to us via the regulation. 488 00:31:31.153 --> 00:31:34.320 And to help these two processes to come together, 489 00:31:34.380 --> 00:31:39.232 we make sure that we update the MSC on all new developments on a regular basis. 490 00:31:39.779 --> 00:31:41.885 Just to exemplify that even today, 491 00:31:41.985 --> 00:31:43.530 this is the last day of our committee, 492 00:31:43.570 --> 00:31:52.114 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. 493 00:31:52.676 --> 00:32:01.656 Sounds like the interesting discussions in the Member State Committee will continue throughout this year and next year and the years to come. 494 00:32:01.837 --> 00:32:02.623 At this point, 495 00:32:03.422 --> 00:32:13.340 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. 496 00:32:13.640 --> 00:32:14.359 Thank you very much. 497 00:32:14.460 --> 00:32:16.119 Thank you for having us. 498 00:32:17.804 --> 00:32:19.680 Thank you also to all our listeners. 499 00:32:20.380 --> 00:32:25.130 Remember that if you want to tell us what you think about the Safer Chemicals podcast, 500 00:32:25.491 --> 00:32:29.960 you can do it through our feedback form linked in the episode details. 501 00:32:31.006 --> 00:32:31.607 And finally, 502 00:32:31.988 --> 00:32:40.124 you can find all our podcast episodes on our website at eka.europa.eu forward slash podcasts.