WEBVTT 1 00:00:00.316 --> 00:00:01.997 Safer Chemicals Podcast. 2 00:00:02.737 --> 00:00:04.857 Sound science on harmful chemicals. 3 00:00:10.959 --> 00:00:14.120 Hello and welcome to this episode of the Safer Chemicals Podcast. 4 00:00:14.620 --> 00:00:15.020 I'm Adam, 5 00:00:15.140 --> 00:00:17.001 working here at the Communications Unit at ECHA, 6 00:00:17.121 --> 00:00:18.181 and I'm also your host today. 7 00:00:19.101 --> 00:00:19.301 Now, 8 00:00:19.761 --> 00:00:23.562 Europe wants to phase out animal testing for chemical safety assessments, 9 00:00:23.922 --> 00:00:27.263 but how do you actually move from ambition to actual implementation? 10 00:00:27.823 --> 00:00:29.704 That's what we're going to be looking at in this episode. 11 00:00:30.220 --> 00:00:32.822 We'll talk about what the Commission's roadmap sets out to do, 12 00:00:33.323 --> 00:00:35.404 what new approach methodologies can already deliver, 13 00:00:36.025 --> 00:00:38.447 where the main scientific and regulatory hurdles remain, 14 00:00:38.887 --> 00:00:42.690 and how ECHA is helping to build the structures needed for the transition. 15 00:00:43.371 --> 00:00:47.154 And I'm very pleased to say that today we're joined by Tomasz Zabanski from ECHA, 16 00:00:47.294 --> 00:00:50.957 who comes to this conversation straight from the first meeting of ECHA's 17 00:00:51.338 --> 00:00:53.940 Collaborative Platform on Alternatives to Animal Testing. 18 00:00:54.540 --> 00:00:55.081 So Tomasz, 19 00:00:55.501 --> 00:00:58.904 this is a very timely day to speak with you about how the roadmap can move from 20 00:00:59.248 --> 00:01:02.429 this kind of policy ambition to practical regulatory progress. 21 00:01:02.889 --> 00:01:05.810 So thank you very much for taking the time to join and welcome. 22 00:01:06.210 --> 00:01:06.570 Thank you. 23 00:01:06.910 --> 00:01:07.150 Yes, 24 00:01:07.310 --> 00:01:08.471 I'm happy to be here with you. 25 00:01:09.231 --> 00:01:09.871 So Tomasz, 26 00:01:10.271 --> 00:01:12.112 before we bring in the wider perspectives, 27 00:01:12.552 --> 00:01:13.872 maybe we should start with the basics. 28 00:01:14.632 --> 00:01:17.253 When we talk about these new approach methodologies or NAMs, 29 00:01:17.713 --> 00:01:18.714 what do we actually mean? 30 00:01:19.014 --> 00:01:20.854 What kind of methods are we talking about? 31 00:01:21.635 --> 00:01:21.795 Yes, 32 00:01:21.835 --> 00:01:26.536 new approach methodologies are a broad set of scientific methods. 33 00:01:26.996 --> 00:01:36.040 and approaches used to generate information on hazardous properties of the chemicals without relying on traditional observations in animal experiments. 34 00:01:36.640 --> 00:01:38.221 But then really for a layperson, 35 00:01:38.222 --> 00:01:40.722 are we talking about computer modeling? 36 00:01:40.842 --> 00:01:42.883 What are the actual kind of methods that you use? 37 00:01:42.884 --> 00:01:42.983 Yes, 38 00:01:43.003 --> 00:01:44.443 so indeed, 39 00:01:45.684 --> 00:01:47.385 some methods are computer models, 40 00:01:48.905 --> 00:01:55.168 which are allowing us first to predict certain properties and as well integrate different data streams together. 41 00:01:55.648 --> 00:02:04.652 There are as well in vitro methods when you are using the cell-based assays to measure some biological responses at cellular or tissue level. 42 00:02:05.492 --> 00:02:11.354 There are as well those methods which are allowing you to predict how substance will behave in the organism. 43 00:02:11.635 --> 00:02:15.016 So how it is absorbed and then distributed within the organism. 44 00:02:15.396 --> 00:02:17.557 We call those methods like toxicokinetics, 45 00:02:17.617 --> 00:02:18.517 Brody or ADMI. 46 00:02:19.958 --> 00:02:20.118 Well, 47 00:02:20.658 --> 00:02:24.280 why are these methods then becoming so important now? 48 00:02:24.860 --> 00:02:26.400 chemical safety assessment particularly? 49 00:02:27.341 --> 00:02:30.522 I think we need to look at NAMs from the broader perspective, 50 00:02:30.582 --> 00:02:33.422 not only from the animal replacement perspective, 51 00:02:33.462 --> 00:02:35.803 but why they are key. 52 00:02:36.283 --> 00:02:49.287 They are allowing you to get out from the traditional reliance on traditional toxicology when we've been observing how animals are reacting to the different chemical treatments. 53 00:02:50.047 --> 00:02:50.867 From one side, 54 00:02:50.868 --> 00:02:54.528 it's very pragmatic and very efficient because basically you are observing Thank you. 55 00:02:54.588 --> 00:02:55.289 what's going on. 56 00:02:55.689 --> 00:03:03.294 But this does not allow you to extrapolate from those observations and learn what was the reason, 57 00:03:03.414 --> 00:03:05.635 what was the cause for those adversities. 58 00:03:06.676 --> 00:03:08.878 And so if you want to make more informed decisions, 59 00:03:08.998 --> 00:03:09.658 move faster, 60 00:03:09.958 --> 00:03:14.101 you need to better understand what is behind the adverse outcomes. 61 00:03:14.622 --> 00:03:15.922 And this is what NAMS allows. 62 00:03:16.883 --> 00:03:17.003 So 63 00:03:17.363 --> 00:03:20.546 I guess it would be fair to say that NAMS are not kind of one single method, 64 00:03:20.626 --> 00:03:23.828 but a broad set of approaches that can help us assess chemical safety. 65 00:03:24.208 --> 00:03:27.870 in new ways that we don't necessarily even know yet are out there. 66 00:03:28.471 --> 00:03:37.676 And I think this discussion is especially timely because of the commission's roadmap that was just published earlier this month on phasing out animal testing for chemical safety assessments. 67 00:03:38.157 --> 00:03:38.337 Now, 68 00:03:38.737 --> 00:03:39.717 from your perspective, 69 00:03:39.998 --> 00:03:42.339 what is the roadmap trying to actually achieve? 70 00:03:42.659 --> 00:03:45.961 Is it mainly about reducing animal testing or is it also about changing, 71 00:03:46.001 --> 00:03:46.902 as you hinted already, 72 00:03:48.363 --> 00:03:50.324 how chemical safety assessment may work in the future? 73 00:03:51.024 --> 00:03:51.304 You know, 74 00:03:51.344 --> 00:03:52.605 for the simpler endpoints, 75 00:03:52.685 --> 00:03:55.527 when we've been measuring some direct effects of chemicals, 76 00:03:56.407 --> 00:03:59.129 the process of replacement was relatively straightforward. 77 00:03:59.449 --> 00:04:00.549 Like skin irritation, 78 00:04:00.890 --> 00:04:04.071 you measure how different chemicals might irritate your skin. 79 00:04:04.712 --> 00:04:05.412 That was almost, 80 00:04:05.512 --> 00:04:07.293 we called it one-to-one replacements. 81 00:04:07.373 --> 00:04:07.533 Now, 82 00:04:08.034 --> 00:04:10.275 when you are shifting to more complex endpoints, 83 00:04:10.695 --> 00:04:16.058 this is not anymore about taking out one element of the system and putting the new one, 84 00:04:16.178 --> 00:04:17.119 which is animal-free. 85 00:04:17.659 --> 00:04:18.860 This requires hole. 86 00:04:19.528 --> 00:04:21.209 redesigning the whole structure, 87 00:04:21.329 --> 00:04:23.189 how we are regulating chemicals. 88 00:04:23.649 --> 00:04:27.230 And this redesign needs some policy choices and policy tools. 89 00:04:27.570 --> 00:04:29.311 And that's why roadmap is very important, 90 00:04:29.351 --> 00:04:31.491 because it gives us those directions, 91 00:04:32.011 --> 00:04:32.952 policy ambitions, 92 00:04:33.032 --> 00:04:33.892 policy directions, 93 00:04:33.952 --> 00:04:36.293 and some tools how we can implement it in the future. 94 00:04:37.313 --> 00:04:40.354 So how should listeners kind of understand the ambition here? 95 00:04:40.434 --> 00:04:42.314 Is this something that can happen quickly? 96 00:04:42.754 --> 00:04:44.275 I'm guessing I know the answer to this already. 97 00:04:44.535 --> 00:04:46.596 Or are we talking about a transition with kind of short, 98 00:04:46.716 --> 00:04:48.336 medium and longer term steps? 99 00:04:49.001 --> 00:04:49.161 Yes, 100 00:04:49.201 --> 00:04:52.964 I think in the roadmap you have provisions with the different timelines. 101 00:04:53.024 --> 00:05:00.288 There are certain things and easy fixes which we can do almost immediately and they call it short-term actions or short-term basket. 102 00:05:00.969 --> 00:05:11.196 Then for those there is a common kind of belief at least at the commission level that those things can move relatively forward and it's more a matter of implementing it in the legal system. 103 00:05:12.037 --> 00:05:15.418 So almost all elements scientifically are in place. 104 00:05:15.559 --> 00:05:16.580 And can you give some examples? 105 00:05:16.840 --> 00:05:17.020 Yes. 106 00:05:17.021 --> 00:05:18.121 Just a couple of what those short-term… 107 00:05:18.661 --> 00:05:19.181 wins would be? 108 00:05:19.882 --> 00:05:20.502 For example, 109 00:05:21.204 --> 00:05:31.752 one of our proposals is to replace acute oral toxicity test which is normally the test done on rodents with QSAR predictions for that. 110 00:05:32.193 --> 00:05:32.394 Okay, 111 00:05:32.474 --> 00:05:33.454 and QSAR is the... 112 00:05:33.555 --> 00:05:41.062 QSAR is the computer model which based on the structure of the substance can predict the toxic outcome. 113 00:05:41.882 --> 00:05:44.505 For this particular case it is predicting the 114 00:05:45.297 --> 00:05:47.198 acute oral toxicity potential. 115 00:05:47.218 --> 00:05:47.798 So basically, 116 00:05:48.159 --> 00:05:50.720 whether the substance will be acutely toxic or not. 117 00:05:51.220 --> 00:05:51.420 Okay, 118 00:05:51.480 --> 00:05:51.741 thank you. 119 00:05:51.742 --> 00:05:53.021 And then the medium term, 120 00:05:53.181 --> 00:05:53.562 long term? 121 00:05:53.862 --> 00:05:54.522 Medium term, 122 00:05:54.742 --> 00:05:59.345 there are a few things which we believe scientifically almost all elements are in place, 123 00:05:59.425 --> 00:06:01.506 but there are still some fine tuning needed. 124 00:06:01.546 --> 00:06:04.568 Some test needs to be better validated. 125 00:06:04.888 --> 00:06:07.889 Maybe we need as well to develop a bit more robust methodology. 126 00:06:08.250 --> 00:06:08.790 For example, 127 00:06:08.810 --> 00:06:09.770 toxicokinetics. 128 00:06:09.810 --> 00:06:11.171 This is one of our proposals, 129 00:06:11.191 --> 00:06:14.493 which is considered to be midterm because we not yet 130 00:06:14.877 --> 00:06:16.837 ready for immediate implementation, 131 00:06:16.998 --> 00:06:19.277 there is still some homework which needs to be done. 132 00:06:19.817 --> 00:06:21.758 Sounds like a complex workload, 133 00:06:21.858 --> 00:06:23.219 but good that things are happening. 134 00:06:23.719 --> 00:06:23.860 Now, 135 00:06:23.979 --> 00:06:25.200 to set the policy context, 136 00:06:25.200 --> 00:06:27.361 we actually contacted the European Commission, 137 00:06:28.000 --> 00:06:32.721 asking them why this roadmap matters and what successful implementation could look like. 138 00:06:32.762 --> 00:06:36.282 So let's listen to a soundbite from Georg Streck from DG Grow. 139 00:06:37.363 --> 00:06:41.904 The roadmap towards phasing out animal testing for chemical safety assessment. 140 00:06:42.125 --> 00:06:50.130 contains 22 policy actions and more than 30 recommendations for specific human health or environmental endpoints. 141 00:06:50.771 --> 00:06:56.935 The Commission will now start to establish the organizational structures that are mentioned in the roadmap, 142 00:06:57.136 --> 00:06:57.856 for example, 143 00:06:57.875 --> 00:06:59.057 the roadmap steering team. 144 00:06:59.778 --> 00:07:05.622 The roadmap identifies options for animal testing that can be replaced in the short term. 145 00:07:05.862 --> 00:07:08.103 These should be implemented in the coming years. 146 00:07:09.024 --> 00:07:09.945 I would consider it 147 00:07:10.125 --> 00:07:16.208 as a great success if in two or three years you would have consensus among regulators in the EU, 148 00:07:17.228 --> 00:07:18.889 but hopefully also beyond the EU, 149 00:07:19.489 --> 00:07:24.050 what are the important elements of such a new regulatory risk assessment? 150 00:07:25.512 --> 00:07:32.514 So the roadmap is now moving from kind of policy direction again into implementation and identifying kind of the regulatory needs, 151 00:07:32.595 --> 00:07:38.077 looking at where animal testing can be replaced sooner and also preparing for deeper changes in how safety assessment work. 152 00:07:38.981 --> 00:07:40.101 is done in the longer term. 153 00:07:40.442 --> 00:07:40.582 Now, 154 00:07:41.103 --> 00:07:42.943 what does this mean for ECA in practice? 155 00:07:44.084 --> 00:07:45.164 For us in practice, 156 00:07:45.565 --> 00:07:50.548 roadmap gives clearer direction in which commission would like us to go. 157 00:07:51.310 --> 00:07:51.889 Not only us, 158 00:07:51.950 --> 00:07:53.750 but as well other important players. 159 00:07:53.890 --> 00:08:00.716 And this is quite important because already in ECA strategy for 2024-2028, 160 00:08:00.716 --> 00:08:03.957 we had very strong actions on the promotion of alternatives. 161 00:08:04.599 --> 00:08:06.560 Those were mainly our initiatives, 162 00:08:06.620 --> 00:08:07.940 those things which we believed 163 00:08:08.221 --> 00:08:10.282 are useful and important and needed. 164 00:08:10.782 --> 00:08:16.424 So now we can better link what we believe is needed to what Commission believes is necessary. 165 00:08:17.085 --> 00:08:24.348 Most probably will help us to gain coherence with other players in the direction in which we are going, 166 00:08:24.968 --> 00:08:27.729 and as well will help us prioritize our own activity. 167 00:08:28.649 --> 00:08:28.869 Okay, 168 00:08:28.909 --> 00:08:30.270 so on a kind of strategic level, 169 00:08:30.630 --> 00:08:31.230 I see that, 170 00:08:31.310 --> 00:08:32.731 and now also the direction setting. 171 00:08:33.171 --> 00:08:35.652 But then kind of in the day-to-day, 172 00:08:35.832 --> 00:08:37.452 so what does ECA need to do to help? 173 00:08:37.944 --> 00:08:41.086 kind of make non-animal approaches more usable in real regulatory decisions? 174 00:08:41.106 --> 00:08:42.446 What kind of role do we play there? 175 00:08:43.167 --> 00:08:45.486 We are contributing in three different areas. 176 00:08:45.587 --> 00:08:46.246 First of all, 177 00:08:47.648 --> 00:08:55.590 by communicating what we believe is important and what are the biggest stoppers for moving towards alternatives. 178 00:08:56.210 --> 00:08:56.970 So this is the first, 179 00:08:57.270 --> 00:09:04.513 just kind of informing and inspiring the research where we believe there is still more long-term research needed. 180 00:09:04.553 --> 00:09:05.533 So this is the first thing. 181 00:09:06.880 --> 00:09:15.125 We can as well facilitate and discuss how certain solutions could be implemented in practice in the different regulatory applications. 182 00:09:15.684 --> 00:09:17.046 So this is the second part. 183 00:09:17.505 --> 00:09:22.567 And then as well sharing the guidance and the best practices with member states, 184 00:09:22.607 --> 00:09:23.548 with registrants, 185 00:09:24.769 --> 00:09:27.210 both at the OECD level and on the different… 186 00:09:27.730 --> 00:09:33.032 I'm glad that you mentioned the OECD level because this is not just an EU operation. 187 00:09:33.072 --> 00:09:35.472 This has a lot of impact also internationally. 188 00:09:36.385 --> 00:09:42.140 Since few years already our strategy was that whenever we decided that something is worth to develop 189 00:09:43.027 --> 00:09:44.828 As soon as we feel we are ready, 190 00:09:44.928 --> 00:09:46.509 we wanted to bring it to OECD. 191 00:09:47.129 --> 00:09:47.450 Of course, 192 00:09:48.230 --> 00:09:50.211 OECD's QSAR toolbox was the first, 193 00:09:50.311 --> 00:09:51.412 this kind of development, 194 00:09:51.492 --> 00:09:56.074 which we are already doing since almost the beginning of ECA since 2008. 195 00:09:56.555 --> 00:09:59.276 There is no something like European hazard assessment. 196 00:09:59.556 --> 00:10:02.498 The main players in the chemical market are international players, 197 00:10:02.538 --> 00:10:04.999 which are not only present on the European market, 198 00:10:05.039 --> 00:10:06.540 but as well in the other markets. 199 00:10:06.541 --> 00:10:08.461 So this harmonization of the approaches, 200 00:10:08.541 --> 00:10:10.583 how we want to move forward with hazard. 201 00:10:11.443 --> 00:10:13.204 and risk assessment is very important. 202 00:10:13.224 --> 00:10:13.345 Well, 203 00:10:13.545 --> 00:10:17.548 maybe we move then a bit more towards the kind of the one important question, 204 00:10:17.608 --> 00:10:17.908 obviously, 205 00:10:17.948 --> 00:10:20.070 which is what does this all look like for companies, 206 00:10:20.430 --> 00:10:20.670 you know, 207 00:10:20.671 --> 00:10:24.514 who need to generate and submit the safety data that is then used by regulators? 208 00:10:24.894 --> 00:10:27.256 We did actually ask CEFIC what, 209 00:10:27.316 --> 00:10:28.497 from an industry perspective, 210 00:10:28.597 --> 00:10:32.900 would help to accelerate the regulatory uptake of non-animal approaches. 211 00:10:32.960 --> 00:10:35.462 So we have Katja Lakas from CEFIC with a soundbite. 212 00:10:35.463 --> 00:10:36.163 So I'll play that now. 213 00:10:37.615 --> 00:10:39.116 From an industry perspective, 214 00:10:39.136 --> 00:10:42.078 the biggest accelerator is not simply more data. 215 00:10:42.838 --> 00:10:47.121 It's about prioritizing the right non-animal methods. 216 00:10:48.082 --> 00:10:50.683 So we need more data. 217 00:10:51.664 --> 00:10:55.906 We need methods that are fit for real regulatory decisions, 218 00:10:56.567 --> 00:11:00.149 that are designed to replace the animal testing over time, 219 00:11:00.409 --> 00:11:03.151 not just add another layer to today's requirements. 220 00:11:03.831 --> 00:11:06.132 When it comes to the more complex endpoints, 221 00:11:06.192 --> 00:11:09.994 these one-to-one replacements are clearly not realistic. 222 00:11:10.474 --> 00:11:21.019 So where we need here is a more tiered and integrated approach and make sure that we have the stronger exposure and toxicokinetic information available. 223 00:11:21.559 --> 00:11:25.301 That means clear readiness and acceptance criteria, 224 00:11:25.961 --> 00:11:27.682 early dialogue with regulators, 225 00:11:28.362 --> 00:11:30.703 and space to learn from practical use. 226 00:11:31.511 --> 00:11:33.493 These are the essential requirements. 227 00:11:34.053 --> 00:11:39.638 So if new methods are only added on top of the existing requirements, 228 00:11:39.698 --> 00:11:44.902 we risk slowing innovation instead of accelerating the phase out of animal testing. 229 00:11:45.742 --> 00:11:45.862 So, 230 00:11:46.103 --> 00:11:46.443 Thomas, 231 00:11:46.583 --> 00:11:47.544 from ECHA's side, 232 00:11:47.744 --> 00:11:52.147 what can realistically be clarified in the short term for industry and others? 233 00:11:52.368 --> 00:11:56.411 And what depends on longer term changes to the full kind of regulatory framework behind? 234 00:11:57.635 --> 00:12:00.257 I don't know if you remember in our first NAMM workshop, 235 00:12:00.477 --> 00:12:08.082 we came up with this three-step proposal how to phase out animal testing when our first step was really analyzing the critical gaps, 236 00:12:08.142 --> 00:12:09.824 what is stopping us from moving forward. 237 00:12:10.344 --> 00:12:11.164 Second step was, 238 00:12:11.224 --> 00:12:11.425 okay, 239 00:12:11.725 --> 00:12:15.207 what we can do already now to gain experience, 240 00:12:15.227 --> 00:12:16.468 to build confidence. 241 00:12:16.528 --> 00:12:18.109 And then based on those two, 242 00:12:18.770 --> 00:12:20.531 how we can redesign the overall system. 243 00:12:20.611 --> 00:12:20.951 And now 244 00:12:21.832 --> 00:12:23.353 I think regarding the step one, 245 00:12:23.773 --> 00:12:26.075 we've been already quite good in indicating. 246 00:12:26.899 --> 00:12:28.740 many of those critical gaps, 247 00:12:29.200 --> 00:12:33.422 and they are frequently reported on our report, 248 00:12:33.442 --> 00:12:33.722 you know, 249 00:12:33.742 --> 00:12:36.083 these key areas of regulatory challenges, 250 00:12:36.563 --> 00:12:40.425 and when you have a very extensive chapter on alternatives to animal testing. 251 00:12:40.985 --> 00:12:41.765 We just published, 252 00:12:41.965 --> 00:12:42.385 if I'm not wrong, 253 00:12:42.386 --> 00:12:45.086 the 2026 update. 254 00:12:45.207 --> 00:12:45.847 Yes, 255 00:12:45.848 --> 00:12:46.427 new update. 256 00:12:46.947 --> 00:12:47.307 And now 257 00:12:47.788 --> 00:12:55.951 I agree with Katia on the thing that the next step now is that we indicated already what we believe are the most critical. 258 00:12:56.387 --> 00:12:57.068 things to cover, 259 00:12:57.468 --> 00:13:04.594 but we've not yet been very explicit on how we would like to see those gaps be covered. 260 00:13:04.654 --> 00:13:06.956 So we have to be more explicit on the criteria. 261 00:13:07.516 --> 00:13:12.440 What we would like to see as an evidence on the table to comfortably conclude that, 262 00:13:12.520 --> 00:13:12.760 okay, 263 00:13:12.821 --> 00:13:13.961 this is not the gap anymore. 264 00:13:14.542 --> 00:13:15.002 And this is, 265 00:13:15.042 --> 00:13:15.343 I guess, 266 00:13:15.483 --> 00:13:20.547 one of the first priority for us to be more explicit what we want to see in the system for the future. 267 00:13:21.119 --> 00:13:21.299 Right. 268 00:13:21.300 --> 00:13:21.559 And this, 269 00:13:21.599 --> 00:13:21.859 I guess, 270 00:13:21.879 --> 00:13:28.802 in turn translates then into the guidance that you were talking about earlier so that the people doing the tests are able to adequately meet these needs. 271 00:13:29.363 --> 00:13:30.183 Not always. 272 00:13:30.243 --> 00:13:36.966 It's only the guidance because sometimes there is still some research needed and we need to set up like objective success criteria. 273 00:13:37.426 --> 00:13:37.606 Right. 274 00:13:38.466 --> 00:13:46.850 And to do it before the solution just to be able to then objectively conclude whether we reach the objectives and we cover the gap or not. 275 00:13:47.750 --> 00:13:48.871 Once we will cover the gap. 276 00:13:49.459 --> 00:13:51.380 Once we conclude that this works well, 277 00:13:51.880 --> 00:13:54.741 then is the time for the guidance to inform registrants, 278 00:13:54.781 --> 00:13:54.981 okay, 279 00:13:55.061 --> 00:14:00.063 how now you can use this new evidence in your regulatory applications. 280 00:14:00.384 --> 00:14:03.225 So the guidance comes later as an outcome. 281 00:14:04.125 --> 00:14:04.245 Now, 282 00:14:04.246 --> 00:14:06.986 you mentioned research there and getting the right research. 283 00:14:07.246 --> 00:14:08.227 Who does this research? 284 00:14:08.747 --> 00:14:10.708 Are we able to commission studies at ECHO? 285 00:14:11.168 --> 00:14:12.148 Is it other players? 286 00:14:13.389 --> 00:14:14.069 Who does the work, 287 00:14:14.089 --> 00:14:16.730 the actual scientific research to help with this? 288 00:14:17.771 --> 00:14:18.011 They are. 289 00:14:19.141 --> 00:14:24.635 different scientific consortia which are taking this on board and the best example is the park. 290 00:14:25.703 --> 00:14:27.905 So this is this partnership between member states, 291 00:14:27.945 --> 00:14:28.886 academia and us, 292 00:14:29.306 --> 00:14:30.347 when we are trying to, 293 00:14:30.507 --> 00:14:33.209 in this collaboration between regulators and scientists, 294 00:14:33.229 --> 00:14:33.990 try to solve this. 295 00:14:34.530 --> 00:14:38.733 Then there is as well a lot of private funding from the industry associations, 296 00:14:39.053 --> 00:14:42.256 other initiatives at the European level, 297 00:14:42.296 --> 00:14:44.918 like this Horizon 2020 or Horizon Europe. 298 00:14:45.518 --> 00:14:46.399 I think we at ECHA, 299 00:14:46.739 --> 00:14:51.443 as an agency who is responsible for implementing different laws, 300 00:14:51.859 --> 00:14:55.903 We are not necessarily those which should drive the research and development, 301 00:14:56.724 --> 00:14:58.586 but we have a responsibility, 302 00:14:58.967 --> 00:15:00.549 and this is already well recognized, 303 00:15:00.769 --> 00:15:02.511 to indicate where are the needs, 304 00:15:02.651 --> 00:15:04.753 especially from the implementation point of view, 305 00:15:04.793 --> 00:15:06.315 where are still the needs to do more. 306 00:15:06.775 --> 00:15:13.603 We can inspire the projects and make sure that they have a good regulatory focus. 307 00:15:14.287 --> 00:15:14.487 Right. 308 00:15:14.587 --> 00:15:14.767 Okay. 309 00:15:14.807 --> 00:15:15.108 Thank you. 310 00:15:15.128 --> 00:15:16.949 Very much appreciate the concrete examples. 311 00:15:16.969 --> 00:15:22.552 I think they help shed a lot of light as to how many players are involved and how much work there is and who is actually taking it on. 312 00:15:22.553 --> 00:15:23.192 So thanks for that. 313 00:15:24.353 --> 00:15:26.314 When people hear about phasing out animal testing, 314 00:15:26.315 --> 00:15:27.775 it can sound like something that sits, 315 00:15:27.875 --> 00:15:28.115 you know, 316 00:15:28.135 --> 00:15:29.195 very far in the future. 317 00:15:29.636 --> 00:15:29.956 But ECHA, 318 00:15:30.036 --> 00:15:31.337 as you've indicated already, 319 00:15:31.457 --> 00:15:38.421 is already kind of working with several tools and approaches that can help reduce or replace animal testing or support regulatory conclusions. 320 00:15:38.441 --> 00:15:42.543 So what are the kind of most tangible examples that you can give? 321 00:15:43.263 --> 00:15:44.865 on progress that Eke can point to today. 322 00:15:44.885 --> 00:15:46.566 I think you've hinted to some already. 323 00:15:47.547 --> 00:15:47.747 Yes, 324 00:15:47.868 --> 00:15:53.232 and this is maybe as well a very good moment to say that actually we have as well some funding possibilities. 325 00:15:54.513 --> 00:15:56.075 We have the NAM framework contract, 326 00:15:56.936 --> 00:16:00.519 which allows us to invest in some specific NAM generation, 327 00:16:00.899 --> 00:16:04.362 which is more filling the gap between research and implementation. 328 00:16:04.763 --> 00:16:05.263 And as well, 329 00:16:05.264 --> 00:16:09.527 we have a framework contract for scientific services. 330 00:16:10.323 --> 00:16:16.085 QSAR toolbox is another example that this constant development of the toolbox is as well financed from our resources. 331 00:16:16.925 --> 00:16:26.868 The other concrete example is we are basically doing the feasibility test study on enhanced fish embryo tests. 332 00:16:26.869 --> 00:16:36.090 So basically test which is using fish embryos and after relatively short exposure with combined with transcriptomics measurements. 333 00:16:36.091 --> 00:16:37.331 So we are measuring how... 334 00:16:38.851 --> 00:16:44.895 fish embryos are response to the toxicants at the transcript level to predict chronic effects, 335 00:16:44.915 --> 00:16:48.838 which normally you would see after a few weeks of chronic exposure on the adult fish. 336 00:16:50.099 --> 00:16:52.560 One aspect is the collaboration also that you've hinted here. 337 00:16:52.580 --> 00:16:54.201 So maybe we could move a little bit towards that. 338 00:16:54.202 --> 00:16:55.843 You mentioned already Cefek and other players. 339 00:16:56.863 --> 00:16:57.123 I mean, 340 00:16:57.143 --> 00:16:58.404 collaboration is essential, 341 00:16:59.025 --> 00:17:00.426 both in Europe and internationally also, 342 00:17:00.466 --> 00:17:01.526 as we've touched upon. 343 00:17:02.407 --> 00:17:03.408 One example is this 344 00:17:03.968 --> 00:17:07.290 European Partnership for Alternative Approaches to Animal Testing, 345 00:17:07.370 --> 00:17:07.891 EPAA. 346 00:17:08.471 --> 00:17:10.032 We asked Gavin Maxwell, 347 00:17:10.532 --> 00:17:11.413 who is the chair, 348 00:17:11.573 --> 00:17:11.973 I believe, 349 00:17:12.433 --> 00:17:13.114 of the platform, 350 00:17:13.914 --> 00:17:21.018 why this kind of cross-sector collaboration matters if Europe wants to move from promising methods to methods that regulators can then actually trust. 351 00:17:21.078 --> 00:17:22.559 So let's listen to Gavin. 352 00:17:24.160 --> 00:17:32.585 The European Partnership for Alternative Approaches to Animal Testing is a collaboration between the European Commission and industry stakeholders to replace, 353 00:17:32.685 --> 00:17:36.887 reduce and refine animal use for meeting regulatory requirements. 354 00:17:37.699 --> 00:17:41.061 ECHA is a very active partner within EPA, 355 00:17:41.421 --> 00:17:47.304 contributing to many of our scientific projects and hosting our annual NAM user forum. 356 00:17:48.165 --> 00:17:56.670 EPA is focused on supporting the Commission roadmaps through helping identify research methods that could address unmet regulatory requirements, 357 00:17:57.310 --> 00:18:03.353 building confidence in non-animal approaches through facilitating scientific dialogue between regulators, 358 00:18:03.914 --> 00:18:06.275 industry safety assessors and NAM experts. 359 00:18:06.823 --> 00:18:14.752 and enabling the transition to a new global regulatory paradigm that uses NAMs to strengthen human health and environmental protection. 360 00:18:15.252 --> 00:18:28.807 I'm hopeful that the collaborative platform and alternatives to animal testing continues to provide this space to open up conversations and how we can build confidence in animal-free safety signs for regulatory decision making. 361 00:18:29.651 --> 00:18:29.771 Now, 362 00:18:30.011 --> 00:18:32.193 that point about confidence building from Gavin, 363 00:18:32.233 --> 00:18:32.473 I think, 364 00:18:32.474 --> 00:18:33.254 is really important. 365 00:18:33.274 --> 00:18:35.516 So it's not only about kind of individual methods. 366 00:18:35.616 --> 00:18:38.899 It's also about creating these conditions so that regulators, 367 00:18:38.959 --> 00:18:43.282 companies and other actors can understand when and how these methods can be used. 368 00:18:43.943 --> 00:18:47.806 And that actually brings us to one of the most concrete implementation tools in this area. 369 00:18:47.886 --> 00:18:52.110 So the new collaborative platform on alternatives to animal testing that ECHA is hosting. 370 00:18:52.130 --> 00:18:52.250 So, 371 00:18:52.890 --> 00:18:53.251 Tomás, 372 00:18:53.451 --> 00:18:56.053 you're joining us just after the first meeting of this new platform. 373 00:18:56.834 --> 00:18:58.375 Maybe we start with why. 374 00:18:58.803 --> 00:19:02.105 Does ECHA need a dedicated platform to begin with? 375 00:19:02.746 --> 00:19:04.727 So to some extent, 376 00:19:04.787 --> 00:19:08.170 we've been doing all those dialogue before already, 377 00:19:09.091 --> 00:19:09.771 like with EPA, 378 00:19:09.911 --> 00:19:10.832 like Gavin mentioned, 379 00:19:10.833 --> 00:19:13.174 we had this long lasting collaboration. 380 00:19:13.494 --> 00:19:19.578 But what we've been missing a bit in all this landscape was direct platform, 381 00:19:19.638 --> 00:19:22.981 which allows us to have this dialogue as well with our member states, 382 00:19:23.021 --> 00:19:25.823 with those experts which are contributing to those decisions. 383 00:19:26.873 --> 00:19:31.254 And it was quite clear when we started to work on the roadmap that they would like to be heard, 384 00:19:31.614 --> 00:19:33.715 that would like to actively contribute, 385 00:19:33.815 --> 00:19:34.835 because at the end, 386 00:19:35.336 --> 00:19:38.917 those are the people which are dealing with practical cases. 387 00:19:39.857 --> 00:19:42.238 They are deciding on risk management measures, 388 00:19:42.278 --> 00:19:43.698 on hazard outcomes, 389 00:19:43.718 --> 00:19:44.098 and so on. 390 00:19:44.099 --> 00:19:46.059 So we need to have them on board. 391 00:19:46.579 --> 00:19:47.679 And that was a bit missing. 392 00:19:47.739 --> 00:19:54.001 And the main idea behind the platform is to bring them on board on those discussions. 393 00:19:54.241 --> 00:20:13.357 maintaining still connection to other important key stakeholders we have still ngos and industry but we want to focus here from on member states as well and just to add you know the building confidence and dialogue is not only important for eca stakeholders we need to as well align with other agencies in europe we 394 00:20:13.397 --> 00:20:23.225 need to align internationally at this ocd level but it's really very complex interaction between many different players and many different levels and 395 00:20:23.665 --> 00:20:27.428 So how to make sure that all contributing actors, 396 00:20:27.708 --> 00:20:28.929 they have their place, 397 00:20:29.209 --> 00:20:29.889 they have their say, 398 00:20:29.970 --> 00:20:32.471 and we are not redoing those things in parallel. 399 00:20:33.332 --> 00:20:33.572 Okay, 400 00:20:34.032 --> 00:20:43.499 so how do you think that this platform can then kind of help move the discussion from general support for NAMs to these specific regulatory use cases? 401 00:20:43.539 --> 00:20:45.280 What concretely can the platform do there? 402 00:20:46.461 --> 00:20:48.923 At least at the beginning to gain momentum, 403 00:20:49.023 --> 00:20:51.985 to build confidence and to have this feel of achievement. 404 00:20:52.473 --> 00:20:57.716 We are starting with things which we've been already investing as ECA and as other stakeholders like EPA, 405 00:20:57.876 --> 00:20:58.216 SEFIC, 406 00:20:58.556 --> 00:21:00.658 already for quite many years. 407 00:21:01.218 --> 00:21:04.540 We believe that many of those elements are already ready. 408 00:21:05.040 --> 00:21:08.962 We want to bring those elements and discuss how it can work in the rich context, 409 00:21:08.963 --> 00:21:10.123 in the biocide context, 410 00:21:10.124 --> 00:21:12.464 in the water drinking directly context, 411 00:21:12.684 --> 00:21:15.906 how we can use them directly in our different regulatory processes. 412 00:21:16.427 --> 00:21:20.369 And we want to discuss it together with our colleagues from the member states. 413 00:21:20.729 --> 00:21:24.772 with the input from industry and NGOs to gain this consensus, 414 00:21:24.892 --> 00:21:26.713 because then at the end, 415 00:21:26.853 --> 00:21:32.137 all the changes in the legal frameworks needs to happen with approval of those players. 416 00:21:32.377 --> 00:21:40.082 And so it's better to build first consensus rather than have never-ending discussions during the policy discussions later on. 417 00:21:41.403 --> 00:21:41.603 Now, 418 00:21:42.704 --> 00:21:43.885 you've had the first meeting. 419 00:21:44.005 --> 00:21:45.706 So I'm curious as to, 420 00:21:46.086 --> 00:21:46.326 you know, 421 00:21:46.327 --> 00:21:48.628 any outcomes from this one that you could already share. 422 00:21:48.728 --> 00:21:48.968 Have you... 423 00:21:50.169 --> 00:21:54.752 I would understand that the first meeting is always about roles and next steps and so on, 424 00:21:54.772 --> 00:21:56.934 and how do we set up the governance and these kinds of things. 425 00:21:56.935 --> 00:22:01.697 But is there anything that you've come up with as a plan other than what you just mentioned? 426 00:22:02.758 --> 00:22:03.498 So first of all, 427 00:22:03.578 --> 00:22:04.319 before the meeting, 428 00:22:04.499 --> 00:22:06.560 after the nomination process was concluded, 429 00:22:06.821 --> 00:22:08.702 we asked all the nominated members, 430 00:22:09.483 --> 00:22:11.944 please give us your ideas about the work items. 431 00:22:12.525 --> 00:22:13.185 And basically, 432 00:22:13.605 --> 00:22:14.646 based on this discussion, 433 00:22:14.686 --> 00:22:18.609 we ended up with four main working topics for the first two years. 434 00:22:19.317 --> 00:22:20.817 in silico methods and QSARs, 435 00:22:21.678 --> 00:22:27.259 refinement of the in vitro toxicokinetic battery in the context of rich information requirements, 436 00:22:27.399 --> 00:22:29.340 but then we can as well use it for other things. 437 00:22:30.300 --> 00:22:35.301 And the third one is use of OMICS for reader cross-and-grouping applications is the first step, 438 00:22:35.621 --> 00:22:36.822 just to make it more concrete. 439 00:22:37.542 --> 00:22:44.664 And then the fourth one is use of NAMs for nanomaterials and other advanced materials. 440 00:22:46.064 --> 00:22:46.324 Okay, 441 00:22:46.444 --> 00:22:46.624 good, 442 00:22:46.725 --> 00:22:47.085 thank you. 443 00:22:48.065 --> 00:22:48.265 Well... 444 00:22:48.545 --> 00:22:53.066 Moving on to the next stakeholder group who are also very active and very needed in this work. 445 00:22:53.086 --> 00:22:58.188 So civil society obviously has an important role in how this transition to NAMS happens. 446 00:22:58.808 --> 00:23:00.949 Maybe we start with the animal welfare perspective. 447 00:23:00.969 --> 00:23:03.949 So we have Julia Baines from PETA and let's play her soundbite. 448 00:23:05.650 --> 00:23:07.830 We really value and welcome the roadmap, 449 00:23:07.930 --> 00:23:13.652 which makes it clear that the future of chemical safety assessment is based on non-animal approaches. 450 00:23:14.252 --> 00:23:16.713 But the question now is one of delivery. 451 00:23:17.369 --> 00:23:20.972 And that's because progress will be measured by what changes in practice. 452 00:23:21.492 --> 00:23:27.376 And that's whether non-animal approaches become the default and if the system evolves to support them. 453 00:23:27.856 --> 00:23:30.939 Because without these types of changes to regulations, 454 00:23:31.299 --> 00:23:33.160 tests on animals will continue. 455 00:23:33.801 --> 00:23:39.905 And that's also why initiatives like ECHA's collaborative platform on alternatives to animal testing is so important, 456 00:23:40.365 --> 00:23:41.626 as it brings regulators, 457 00:23:41.726 --> 00:23:45.609 industry and NGOs together to help build confidence. 458 00:23:46.093 --> 00:23:54.899 So we now look to ECHA to act swiftly and decisively in leading the way to build trust in these methods across the agency and beyond. 459 00:23:56.480 --> 00:24:02.743 There is also the question how to make that transition while keeping the chemical safety decisions protective. 460 00:24:03.564 --> 00:24:04.625 So we also asked HEAL, 461 00:24:05.365 --> 00:24:07.466 this is the Health and Environment Alliance, 462 00:24:07.626 --> 00:24:09.348 for an environmental health perspective. 463 00:24:09.388 --> 00:24:10.168 So this is 464 00:24:10.608 --> 00:24:11.629 Sandra Jen from HEAL. 465 00:24:12.920 --> 00:24:13.320 At HEAL, 466 00:24:13.500 --> 00:24:17.364 we see the implementation of the Commission Roadmap as a crucial opportunity, 467 00:24:17.944 --> 00:24:23.929 both to reduce the dependency on animal testing and to strengthen regulatory management of chemicals in the EU. 468 00:24:24.630 --> 00:24:27.372 It's important to stress the core principle of the roadmap, 469 00:24:27.592 --> 00:24:34.578 that non-animal approaches must deliver a level of protection equivalent to that of currently established methods. 470 00:24:35.278 --> 00:24:36.839 So in line with this core principle, 471 00:24:36.859 --> 00:24:40.683 the protection of health and the environment must always be given priority. 472 00:24:41.503 --> 00:24:41.843 Therefore, 473 00:24:41.844 --> 00:24:42.444 we support the... 474 00:24:42.544 --> 00:24:44.705 cautious transition to new approach methods, 475 00:24:44.706 --> 00:24:45.146 or in short, 476 00:24:45.226 --> 00:24:45.566 NAMs. 477 00:24:46.166 --> 00:24:54.791 These methods are not yet available to fully replace animal tests for the regulatory identification and risk management of the most serious hazards, 478 00:24:55.171 --> 00:24:56.652 such as carcinogenicity, 479 00:24:56.932 --> 00:24:58.213 reproduction toxicity, 480 00:24:58.453 --> 00:25:00.174 and endocrine disrupting properties. 481 00:25:00.795 --> 00:25:07.038 But several promising tools like grouping and read-across are already available to help reducing animal testing. 482 00:25:07.579 --> 00:25:09.840 So let's start making the most of them as well. 483 00:25:11.268 --> 00:25:14.129 So we've heard now two civil society expectations, 484 00:25:14.289 --> 00:25:22.051 faster and more visible progress away from animal testing and still a cautious transition that maintains strong protection for health and the environment. 485 00:25:22.431 --> 00:25:22.771 Tomasz, 486 00:25:23.031 --> 00:25:27.432 how can ECA help bring these expectations together in a practical regulatory setting? 487 00:25:28.413 --> 00:25:29.253 Excellent question. 488 00:25:29.293 --> 00:25:33.754 And I think if you want to have the alternatives to be default option, 489 00:25:34.274 --> 00:25:38.576 you need to first set up what are the performance expectations, 490 00:25:38.816 --> 00:25:39.856 how you can make sure. 491 00:25:40.116 --> 00:25:44.260 that the predictions are as good as the experimental data from animal tests. 492 00:25:45.140 --> 00:25:49.184 This is very important because we don't want to compromise on level of protection. 493 00:25:49.864 --> 00:25:57.891 So the first step is to agree how we will judge the performance of the method against the existing data. 494 00:25:58.572 --> 00:26:02.135 We need to make sure that at least half of the substance can work, 495 00:26:02.195 --> 00:26:02.355 right? 496 00:26:02.375 --> 00:26:08.360 Because otherwise there is no sense to propose as a default option something which can only work for 10 or 5. 497 00:26:08.720 --> 00:26:25.075 percent of cases right then it will create problem for everybody for us for registrants create many confusions and the most important is to be explicit where it can work and when it cannot this is what we are referring as this domain of applicability for those tests now 498 00:26:25.095 --> 00:26:34.664 we've talked about the ambition the tools that already exist and the role of collaboration how important that is but i think it's also important not to make this sound simpler than it actually is 499 00:26:35.600 --> 00:26:38.961 Several of the contributors we've had today have pointed to confidence, 500 00:26:39.001 --> 00:26:41.082 acceptance criteria and protection standards, 501 00:26:41.522 --> 00:26:42.442 as we've just discussed. 502 00:26:43.222 --> 00:26:47.423 What are the kind of biggest misconceptions about how quickly animal tests can be phased out? 503 00:26:48.564 --> 00:26:49.404 To some extent, 504 00:26:49.464 --> 00:26:55.526 it really depends on your regulatory case and your regulatory scenario. 505 00:26:56.426 --> 00:27:01.927 I think those which are more enthusiastic and believe it can move faster are the people where... 506 00:27:04.608 --> 00:27:08.570 from the sector where the exposure context is very well known. 507 00:27:09.130 --> 00:27:11.251 They know exactly how the substance is used, 508 00:27:11.291 --> 00:27:13.272 what are the concentrations you are exposed to, 509 00:27:13.632 --> 00:27:19.494 and basically then it's enough to measure that at this concentration levels which you are exposed to, 510 00:27:19.495 --> 00:27:20.735 you don't see any signs. 511 00:27:20.855 --> 00:27:23.476 Even at the basic molecular level, 512 00:27:23.496 --> 00:27:27.237 you don't see any signs of toxicological response. 513 00:27:27.658 --> 00:27:30.859 And then you can believe that you can conclude on safety. 514 00:27:31.559 --> 00:27:33.460 The problem is that... 515 00:27:33.756 --> 00:27:38.298 A sector like industrial chemicals is a relatively open sector. 516 00:27:38.338 --> 00:27:40.460 It means the way how you can use chemicals. 517 00:27:41.300 --> 00:27:43.561 If you are putting something on the consumer market, 518 00:27:43.621 --> 00:27:45.562 you are losing control how it will be used. 519 00:27:45.582 --> 00:27:50.585 And probably you know that people are very innovative in the way how they can use chemicals. 520 00:27:50.725 --> 00:27:56.388 And they can use it in a completely uncontrolled and not necessarily predicted way. 521 00:27:56.989 --> 00:27:57.229 Plus, 522 00:27:57.249 --> 00:27:59.470 we have to keep in mind that there is co-exposure, 523 00:27:59.490 --> 00:28:02.211 that the fact that you predict that if you are using shampoo, 524 00:28:02.231 --> 00:28:02.972 are getting this 525 00:28:03.460 --> 00:28:10.624 This exposure from the substance does not mean that the same substance is not in the furnitures which we are using every day in your office. 526 00:28:10.644 --> 00:28:11.905 They are not in your textiles. 527 00:28:11.925 --> 00:28:13.345 They are not somewhere else. 528 00:28:13.826 --> 00:28:16.027 So the level of exposure can be actually quite a lot higher. 529 00:28:16.087 --> 00:28:16.627 Exactly. 530 00:28:16.887 --> 00:28:20.409 Chemicals which we believe they are inert and that we shouldn't have any exposure, 531 00:28:20.429 --> 00:28:25.492 we found those chemicals in the bloodstream of the general population everywhere. 532 00:28:25.552 --> 00:28:26.452 So for that, 533 00:28:26.552 --> 00:28:32.956 we need to as well be able to characterize the hazard without this exposure. 534 00:28:34.056 --> 00:28:35.076 context component. 535 00:28:35.577 --> 00:28:44.139 So we would like to know whether certain chemicals are intrinsically dangerous because we don't want to put into the general, 536 00:28:44.359 --> 00:28:48.320 expose general population to the things which are carcinogens, 537 00:28:48.940 --> 00:28:50.141 which are mutagens, 538 00:28:50.241 --> 00:28:50.661 which can, 539 00:28:51.141 --> 00:28:51.421 you know, 540 00:28:51.961 --> 00:28:53.182 affect our reproduction, 541 00:28:54.022 --> 00:28:54.782 health and so on, 542 00:28:54.802 --> 00:28:55.042 right? 543 00:28:55.402 --> 00:28:59.363 So we need to characterize those things before putting chemicals in the market. 544 00:28:59.364 --> 00:29:01.644 And this is the biggest challenge. 545 00:29:02.024 --> 00:29:07.252 And this is the biggest misunderstanding between those different stakeholders groups and ABDs. 546 00:29:07.312 --> 00:29:08.754 Because to change that, 547 00:29:09.275 --> 00:29:09.696 we need to... 548 00:29:10.804 --> 00:29:15.367 rethink how we will do this hazard identification and characterization. 549 00:29:16.088 --> 00:29:16.908 And this is not easy. 550 00:29:18.249 --> 00:29:18.549 Actually, 551 00:29:19.130 --> 00:29:27.796 this idea that you're exposed to potentially the same chemical through different settings or different products leads to this cocktail effect as well. 552 00:29:27.896 --> 00:29:31.638 Is this something that new approach methodologies can somehow help deal with? 553 00:29:31.658 --> 00:29:39.043 The fact that combinations of chemicals and their levels of exposure and building kind of scenarios as to how that affects people in the environment? 554 00:29:39.044 --> 00:29:40.164 Is this something that's considered? 555 00:29:41.468 --> 00:29:41.769 Yes, 556 00:29:41.989 --> 00:29:44.432 and this is one of the promises of the NAMs, 557 00:29:44.492 --> 00:29:46.094 which did not yet materialize, 558 00:29:46.534 --> 00:29:55.164 but I believe it is one of the important tools which can help us break through some of the limitations which we have today. 559 00:29:55.732 --> 00:29:58.253 Because in the classical toxicological testing, 560 00:29:58.553 --> 00:30:03.714 the outcome of the test is the knowledge that chemical X in test 561 00:30:04.295 --> 00:30:08.416 Y cannot give you response Z. 562 00:30:09.936 --> 00:30:10.416 And that's it. 563 00:30:10.437 --> 00:30:13.717 It's very difficult to extrapolate this knowledge to anything else. 564 00:30:13.718 --> 00:30:16.098 You don't know what will happen if you will change the composition. 565 00:30:16.118 --> 00:30:20.300 You don't know what will happen if you add a new component. 566 00:30:20.540 --> 00:30:21.000 With NAMS, 567 00:30:21.020 --> 00:30:21.880 it's a bit different. 568 00:30:21.980 --> 00:30:27.065 because we start to measure the biological responses on the molecular levels, 569 00:30:27.705 --> 00:30:34.431 we can think about it like specific fingerprints for the different type of toxicity caused by different kind of, 570 00:30:34.451 --> 00:30:36.033 let's call them library chemicals. 571 00:30:36.894 --> 00:30:39.816 And then we can deconvolute. 572 00:30:39.856 --> 00:30:44.140 If you have a very complex toxicological response from the mixture effect, 573 00:30:44.360 --> 00:30:48.304 you can try to decompose this for those individual fingerprints. 574 00:30:48.808 --> 00:30:52.850 And then you can try to understand what was the contributing factors to that. 575 00:30:53.250 --> 00:30:54.871 So I think in the future, 576 00:30:54.971 --> 00:30:58.113 once we will learn to build those library of those fingerprints, 577 00:30:58.153 --> 00:31:05.097 it will be much easier to identify which type of components were responsible for this toxic outcome. 578 00:31:05.157 --> 00:31:11.580 And it will be much easier to deconvolute those complex responses to those individual contributing factors. 579 00:31:13.152 --> 00:31:13.272 Now, 580 00:31:13.292 --> 00:31:13.992 before we close, 581 00:31:14.032 --> 00:31:16.573 let me briefly summarize what we've covered today. 582 00:31:16.673 --> 00:31:22.295 So the roadmap gives Europe a clearer direction for moving away from animal testing and chemical safety assessment. 583 00:31:22.715 --> 00:31:23.515 But as we've heard, 584 00:31:23.795 --> 00:31:27.256 implementation will depend on practical and credible steps. 585 00:31:27.856 --> 00:31:30.717 Identifying where non-animal approaches can already be used, 586 00:31:31.217 --> 00:31:33.778 building confidence where more evidence is still needed, 587 00:31:34.238 --> 00:31:36.279 adapting regulatory practice over time, 588 00:31:36.459 --> 00:31:40.460 and keeping the protection of health and the environment at the forefront of this work. 589 00:31:41.020 --> 00:31:41.160 Now, 590 00:31:41.260 --> 00:31:46.542 ECHA's role is to help make this transition workable in real regulatory settings together with the Commission, 591 00:31:46.782 --> 00:31:47.582 member states, 592 00:31:47.842 --> 00:31:48.262 industry, 593 00:31:48.562 --> 00:31:49.963 researchers and civil society. 594 00:31:50.703 --> 00:31:56.725 The Collaborative Platform on Alternatives to Animal Testing is one way to support this by bringing together regulatory needs, 595 00:31:57.045 --> 00:31:59.505 scientific developments and stakeholder expectations. 596 00:32:01.046 --> 00:32:04.167 And ECHA's role is to help turn that ambition into regulatory reality. 597 00:32:05.307 --> 00:32:05.647 Tomás, 598 00:32:05.867 --> 00:32:08.088 thank you so much for joining us today after a... 599 00:32:08.688 --> 00:32:11.209 busy two days and for sharing your insights on this. 600 00:32:11.730 --> 00:32:12.670 Thank you for having me. 601 00:32:14.972 --> 00:32:15.772 And to our listeners, 602 00:32:15.832 --> 00:32:16.693 thank you for listening. 603 00:32:17.013 --> 00:32:19.554 Science is becoming increasingly important in ECHA's work. 604 00:32:19.634 --> 00:32:22.416 And if you want to learn more about our scientific priorities and activities, 605 00:32:22.976 --> 00:32:28.079 visit the science section of our website at eccha.europa.eu forward slash science. 606 00:32:28.639 --> 00:32:30.320 To stay up to date with the latest developments, 607 00:32:30.520 --> 00:32:32.001 you can also subscribe to our news. 608 00:32:34.783 --> 00:32:36.484 Safer Chemicals podcast. 609 00:32:37.201 --> 00:32:39.318 Sound Science on Harmful Chemicals.