WEBVTT 1 00:00:00.392 --> 00:00:02.094 Safer Chemicals Podcast. 2 00:00:02.834 --> 00:00:04.956 Sound science on harmful chemicals. 3 00:00:11.261 --> 00:00:11.982 Classification, 4 00:00:12.122 --> 00:00:12.523 labeling, 5 00:00:12.543 --> 00:00:16.946 and packaging is the cornerstone of the EU regulatory framework on chemicals. 6 00:00:17.207 --> 00:00:19.228 It is about understanding the hazards, 7 00:00:19.428 --> 00:00:20.309 communicating them, 8 00:00:20.489 --> 00:00:22.191 and adopting certain precautions. 9 00:00:22.691 --> 00:00:28.136 It aims to ensure the free circulation of chemicals while protecting public health and the environment. 10 00:00:29.816 --> 00:00:30.296 To date, 11 00:00:30.356 --> 00:00:34.360 we have provisionally concluded on several sectors in the proposal to restrict PFAS. 12 00:00:35.341 --> 00:00:37.482 These include areas such as consumer mixtures, 13 00:00:37.743 --> 00:00:38.423 cosmetics, 14 00:00:38.823 --> 00:00:40.345 textiles and food packaging. 15 00:00:41.546 --> 00:00:41.866 Next, 16 00:00:42.266 --> 00:00:45.569 the scientific committees will address applications of fluorinated gases, 17 00:00:46.169 --> 00:00:48.091 transport and also energy. 18 00:00:48.972 --> 00:00:49.712 And after them, 19 00:00:49.973 --> 00:00:51.754 we will move on to medical devices, 20 00:00:51.934 --> 00:00:54.176 lubricants and electronics and semiconductor. 21 00:00:55.237 --> 00:00:55.357 So, 22 00:00:55.777 --> 00:00:57.939 step by step and sector by sector, 23 00:00:58.099 --> 00:00:58.900 we are advancing. 24 00:01:01.192 --> 00:01:03.193 Welcome to the Safer Chemicals podcast. 25 00:01:03.734 --> 00:01:05.055 I'm here with Roberto and Maria, 26 00:01:05.095 --> 00:01:08.497 the chairs of our risk assessment and socio-economic analysis committees. 27 00:01:09.097 --> 00:01:13.881 The committees have just ended their last meetings of the year and we'll be going through the highlights as usual. 28 00:01:14.521 --> 00:01:17.583 We'll start with an update on the universal PFAS restriction proposal, 29 00:01:17.663 --> 00:01:20.886 something that we've been covering a lot in our recent episodes, 30 00:01:21.706 --> 00:01:26.349 but we'll also be talking quite a deep talk actually on the harmonized classification and labeling. 31 00:01:26.389 --> 00:01:30.232 So what is it all about and how it impacts the risk management of chemicals? 32 00:01:30.432 --> 00:01:40.458 And Maria will update us on the Socioeconomic Analysis Committee's review of new information submitted by companies on certain Chromium 6 applications following a court ruling. 33 00:01:41.298 --> 00:01:42.279 Good to have you both here again. 34 00:01:42.359 --> 00:01:42.939 Thanks for joining. 35 00:01:43.299 --> 00:01:44.180 Thanks for the invite. 36 00:01:44.300 --> 00:01:45.360 And very good to be back. 37 00:01:46.441 --> 00:01:47.382 But before we start, 38 00:01:47.502 --> 00:01:47.782 Maria, 39 00:01:48.422 --> 00:01:52.485 did I understand correctly that you have an announcement to make about a new deputy chair? 40 00:01:53.085 --> 00:01:53.405 Was it so? 41 00:01:53.985 --> 00:01:54.165 Yes, 42 00:01:54.226 --> 00:01:54.606 exactly. 43 00:01:54.626 --> 00:01:58.308 So Christian Lottmeier will start as deputy chair for SEAC in January. 44 00:01:58.824 --> 00:02:01.965 And Christian has quite a long history in ECA and also in SEAC. 45 00:02:02.206 --> 00:02:02.446 You know, 46 00:02:02.426 --> 00:02:07.128 he was part of the team setting up all our processes right at the beginning when SEAC started operating. 47 00:02:07.588 --> 00:02:08.608 So most recently, 48 00:02:08.668 --> 00:02:10.609 he's been part of the scientific secretariat. 49 00:02:10.609 --> 00:02:11.490 So a little bit different. 50 00:02:11.510 --> 00:02:15.631 He's been supporting the reporters and the members in their opinion making. 51 00:02:16.032 --> 00:02:18.753 But now he comes back to work on the running of the committee, 52 00:02:18.773 --> 00:02:19.213 basically. 53 00:02:19.273 --> 00:02:21.474 So he will be supporting me in that task. 54 00:02:21.574 --> 00:02:26.216 And he will have a particular focus on preparing us for the new tasks that are coming up in the future. 55 00:02:26.512 --> 00:02:26.852 Okay, 56 00:02:26.952 --> 00:02:27.172 right. 57 00:02:27.212 --> 00:02:27.332 Well, 58 00:02:27.352 --> 00:02:28.373 congrats to Christian. 59 00:02:28.573 --> 00:02:29.713 Best of luck with the new task. 60 00:02:29.833 --> 00:02:32.354 Good to hear that it's someone who has some experience, 61 00:02:32.434 --> 00:02:34.194 quite a lot of experience from the beginning of time. 62 00:02:34.214 --> 00:02:34.674 Definitely. 63 00:02:34.674 --> 00:02:38.015 He brings a lot to the committee and I look forward to working with him. 64 00:02:38.555 --> 00:02:38.895 All right, 65 00:02:38.935 --> 00:02:43.557 then maybe we dive right in and start with the universal restriction of PFAS. 66 00:02:43.617 --> 00:02:46.037 So in the November meetings, 67 00:02:46.077 --> 00:02:50.298 the committees discussed PFAS in construction products for the first time, 68 00:02:50.338 --> 00:02:51.139 if I'm correct, 69 00:02:51.239 --> 00:02:54.280 and continued considering its uses in textiles, 70 00:02:54.320 --> 00:02:54.900 upholstery, 71 00:02:55.080 --> 00:02:55.340 leather, 72 00:02:55.380 --> 00:02:55.780 apparel. 73 00:02:56.000 --> 00:02:58.962 carpets and food contact materials and packaging, 74 00:02:59.042 --> 00:02:59.302 right? 75 00:02:59.802 --> 00:03:00.323 So Roberto, 76 00:03:00.463 --> 00:03:03.164 what were the highlights from the risk assessment committee for PFAS? 77 00:03:03.425 --> 00:03:03.625 Well, 78 00:03:03.685 --> 00:03:04.905 for three sectors, 79 00:03:05.026 --> 00:03:07.467 RAC was able to agree on provisional conclusions, 80 00:03:07.647 --> 00:03:10.889 particularly for food contact material and what we call TULAC, 81 00:03:10.909 --> 00:03:13.671 so textile and similar other applications. 82 00:03:13.711 --> 00:03:22.116 We benefited of previous discussion and the focus was mostly on the changes and update on the emissions and analysis of risk of alternatives. 83 00:03:22.748 --> 00:03:23.789 For construction products, 84 00:03:23.789 --> 00:03:24.389 on the other hand, 85 00:03:24.409 --> 00:03:25.690 this was the first discussion, 86 00:03:25.771 --> 00:03:32.696 but RAC supported the draft opinion pending some verification on calculations that will be carried out in the weeks to come. 87 00:03:33.697 --> 00:03:34.378 It's also nice, 88 00:03:34.378 --> 00:03:34.598 I think, 89 00:03:34.598 --> 00:03:43.926 to mention that the draft opinion is based on what we call a background document that is prepared by submitting competent authorities so that they are at the origin of this dossier. 90 00:03:44.526 --> 00:03:49.531 And they take into account also the comments provided during the consultation by third parties. 91 00:03:50.692 --> 00:03:50.912 And... 92 00:03:51.576 --> 00:03:53.036 The same competent authorities, 93 00:03:53.036 --> 00:03:58.838 they also participate to the meeting and they contribute during the discussion alongside with observers, 94 00:03:58.938 --> 00:03:59.798 so NGOs, 95 00:03:59.998 --> 00:04:00.499 industry, 96 00:04:00.699 --> 00:04:02.459 and they also bring along their own experts. 97 00:04:02.739 --> 00:04:04.020 So they are quite busy meetings. 98 00:04:04.080 --> 00:04:07.761 I think we had over 140 people attending online and in person. 99 00:04:07.781 --> 00:04:09.661 So that's quite something indeed. 100 00:04:10.761 --> 00:04:16.423 Good to see the possibility for so many organizations to participate and also representing such a wide range of interests. 101 00:04:16.443 --> 00:04:16.783 Something 102 00:04:17.363 --> 00:04:19.744 I imagine is quite important when we're talking about sector. 103 00:04:20.004 --> 00:04:25.388 such as these where the uses are so widespread and you also have a lot of ground to cover in your assessment. 104 00:04:26.649 --> 00:04:27.610 Turning then on to you, 105 00:04:27.670 --> 00:04:27.910 Maria, 106 00:04:27.950 --> 00:04:31.132 you covered the same sectors from the socio-economic perspective. 107 00:04:31.232 --> 00:04:32.353 What can you share with us on that? 108 00:04:32.853 --> 00:04:33.013 Well, 109 00:04:33.033 --> 00:04:36.776 we were also able to provisionally conclude on the same three sectors as RAC. 110 00:04:37.016 --> 00:04:38.477 And like in RAC, 111 00:04:38.577 --> 00:04:43.301 we had two that were coming back and the same ones with contract material and packaging and also the textiles, 112 00:04:43.381 --> 00:04:43.861 et cetera, 113 00:04:43.921 --> 00:04:44.201 let's say. 114 00:04:44.882 --> 00:04:47.964 And construction products were sold for the first time. 115 00:04:48.284 --> 00:04:49.306 And just as a reminder, 116 00:04:49.326 --> 00:04:51.269 when we're talking about provisional conclusions, 117 00:04:51.649 --> 00:04:59.482 we mean that the final conclusions will be available only once the full opinions have been agreed and we have been able to look across the board. 118 00:04:59.682 --> 00:04:59.882 Right. 119 00:05:00.323 --> 00:05:01.965 So people can't see anything yet. 120 00:05:02.006 --> 00:05:03.868 They have to wait until the progress gets to the end. 121 00:05:03.868 --> 00:05:04.169 Exactly. 122 00:05:05.253 --> 00:05:07.595 So in terms of the SEAC discussions, 123 00:05:07.615 --> 00:05:08.655 our focus is, 124 00:05:09.076 --> 00:05:09.576 first of all, 125 00:05:09.616 --> 00:05:12.698 we look at the availability of safer alternatives to PFAS. 126 00:05:13.039 --> 00:05:13.179 Then, 127 00:05:13.179 --> 00:05:13.539 of course, 128 00:05:13.559 --> 00:05:17.262 that informs us about the cost of implementing a restriction on this sector. 129 00:05:17.262 --> 00:05:20.043 It's a bit different if you have alternatives and if you don't. 130 00:05:21.104 --> 00:05:22.545 And then we look at the benefits. 131 00:05:22.585 --> 00:05:23.046 And for that, 132 00:05:23.066 --> 00:05:26.748 we rely very much on the RAC work in terms of emissions, 133 00:05:26.788 --> 00:05:29.230 because those then become the benefits of our restriction. 134 00:05:29.930 --> 00:05:33.553 And then we'll bring it all together by considering the proportionality of PFAS. 135 00:05:33.833 --> 00:05:40.539 restriction in the sector and also the needs for having derogations to ensure that the restriction is proportionate in that sector. 136 00:05:40.899 --> 00:05:44.322 So that is the basics of the work that we do in SEAC. 137 00:05:44.762 --> 00:05:44.963 Okay. 138 00:05:45.383 --> 00:05:49.326 Can you talk a bit more about what kind of uses are included in construction products? 139 00:05:49.426 --> 00:05:51.208 And in terms of safer alternatives, 140 00:05:51.608 --> 00:05:54.250 are you able to tell us anything about alternatives to PFAS? 141 00:05:54.310 --> 00:05:56.032 Are they available for construction products? 142 00:05:56.272 --> 00:05:56.412 Well, 143 00:05:57.173 --> 00:05:59.075 construction products is quite a varied sector. 144 00:05:59.095 --> 00:05:59.275 I mean, 145 00:05:59.295 --> 00:06:01.837 we're going from things like bridge and building bearings. 146 00:06:02.397 --> 00:06:07.121 to things like film and foil from greenhouses and quite a lot of other things in between. 147 00:06:07.141 --> 00:06:11.385 I think we had like 11 or 12 little sub-uses in different combinations. 148 00:06:12.446 --> 00:06:18.491 The assessment that we do for alternatives is actually pretty granular and we have different conclusions for the different sub-uses. 149 00:06:19.272 --> 00:06:25.277 But indeed we can say that for some there was good evidence that there is what we call high substitution potential. 150 00:06:25.337 --> 00:06:29.781 So it is possible to substitute with different amounts of time. 151 00:06:30.641 --> 00:06:30.781 Well, 152 00:06:30.841 --> 00:06:31.282 for others, 153 00:06:31.302 --> 00:06:31.502 I mean, 154 00:06:32.002 --> 00:06:32.843 this is not the case. 155 00:06:33.203 --> 00:06:33.403 Okay. 156 00:06:33.563 --> 00:06:33.864 All right. 157 00:06:34.284 --> 00:06:34.424 Well, 158 00:06:34.544 --> 00:06:35.745 thank you both for those insights. 159 00:06:35.765 --> 00:06:36.826 So to summarize, 160 00:06:36.846 --> 00:06:38.967 you covered PFAS in construction products, 161 00:06:39.047 --> 00:06:40.228 textiles and upholstery, 162 00:06:40.288 --> 00:06:42.710 as well as food contact materials and packaging. 163 00:06:43.250 --> 00:06:43.470 Now, 164 00:06:43.591 --> 00:06:44.411 for all these uses, 165 00:06:44.451 --> 00:06:46.293 you reached your provisional conclusions. 166 00:06:46.373 --> 00:06:46.833 Exactly. 167 00:06:46.833 --> 00:06:47.613 So that's good to hear. 168 00:06:48.334 --> 00:06:49.635 But what about then the next steps? 169 00:06:49.735 --> 00:06:53.898 What are the sectors on the horizon for 2025 and beyond? 170 00:06:54.258 --> 00:06:54.398 Yeah. 171 00:06:54.518 --> 00:06:55.419 In 2025, 172 00:06:55.419 --> 00:06:55.779 basically, 173 00:06:55.779 --> 00:06:57.841 we continue taking it sector by sector. 174 00:06:58.337 --> 00:06:59.458 And next, 175 00:06:59.478 --> 00:07:02.040 we will continue with fluorinated gases applications, 176 00:07:02.581 --> 00:07:04.442 with transport and with energy. 177 00:07:04.762 --> 00:07:08.365 And we can also announce now that medical devices, 178 00:07:08.726 --> 00:07:14.090 lubricants and electronics and semiconductors are planned for the upcoming meetings in 2025 as well. 179 00:07:14.530 --> 00:07:15.031 And of course, 180 00:07:15.051 --> 00:07:15.611 as usual, 181 00:07:15.691 --> 00:07:20.255 we are very dependent on how the five authorities can update their initial restriction report, 182 00:07:20.295 --> 00:07:23.017 what Roberto was talking about as the background document. 183 00:07:23.938 --> 00:07:24.659 And they are doing this, 184 00:07:24.679 --> 00:07:25.039 of course, 185 00:07:25.099 --> 00:07:26.440 following the consultation input. 186 00:07:26.620 --> 00:07:26.881 And. 187 00:07:27.521 --> 00:07:27.641 yeah, 188 00:07:27.801 --> 00:07:29.502 more information will become available. 189 00:07:29.543 --> 00:07:31.404 So quite busy for the months to come, 190 00:07:31.584 --> 00:07:32.024 definitely. 191 00:07:32.405 --> 00:07:32.605 Yeah, 192 00:07:32.745 --> 00:07:33.185 sounds like it. 193 00:07:33.165 --> 00:07:33.345 I mean, 194 00:07:33.846 --> 00:07:34.086 to me, 195 00:07:34.186 --> 00:07:34.726 this sounds like, 196 00:07:34.746 --> 00:07:34.966 again, 197 00:07:34.986 --> 00:07:38.149 a very wide use across these different sectors. 198 00:07:38.729 --> 00:07:40.510 Is this something similar to what you've just done, 199 00:07:40.550 --> 00:07:46.795 or is this going to take it up a notch and be even more kind of thorough then and more things to cover in your assessment? 200 00:07:47.055 --> 00:07:47.195 Well, 201 00:07:47.315 --> 00:07:49.997 in terms of the number of comments that were received in particular, 202 00:07:50.277 --> 00:07:55.001 I think some of the sectors that are coming to us now have much higher number. 203 00:07:55.601 --> 00:08:00.003 And that is one of the reasons why they're coming later to give time to be able to take that into account. 204 00:08:00.063 --> 00:08:02.764 So I think the work is definitely intensifying. 205 00:08:02.784 --> 00:08:03.024 Yeah, 206 00:08:03.024 --> 00:08:05.225 I think it's fair to say complexity might increase, 207 00:08:05.265 --> 00:08:06.245 but we are ready for it. 208 00:08:06.586 --> 00:08:06.926 All right. 209 00:08:07.006 --> 00:08:07.386 Good to hear. 210 00:08:08.086 --> 00:08:08.486 And also, 211 00:08:08.586 --> 00:08:08.747 yeah, 212 00:08:08.807 --> 00:08:10.127 just as a reminder to our listeners. 213 00:08:10.127 --> 00:08:15.129 So the five authorities that you mentioned are the ones that submitted this restriction proposal to ECHA for evaluation. 214 00:08:15.189 --> 00:08:16.190 So that's Germany, 215 00:08:16.690 --> 00:08:17.450 the Netherlands, 216 00:08:17.650 --> 00:08:18.110 Denmark, 217 00:08:18.211 --> 00:08:18.591 Sweden, 218 00:08:18.751 --> 00:08:19.531 and Norway. 219 00:08:20.431 --> 00:08:22.372 Maybe we then move on to our next topic. 220 00:08:22.812 --> 00:08:23.873 Park PFAS for now. 221 00:08:24.133 --> 00:08:26.594 will definitely come back already in the next meeting. 222 00:08:27.094 --> 00:08:31.496 But now a bit of a deeper dive into harmonized classification and labeling. 223 00:08:31.576 --> 00:08:39.699 So this area has recently included some pretty notable substances that have sparked interest among our listeners and our audiences. 224 00:08:40.240 --> 00:08:43.141 Harmonized classification is for the most hazardous substances. 225 00:08:43.261 --> 00:08:46.942 Could you explain what we mean by most hazardous exactly? 226 00:08:46.942 --> 00:08:50.784 And what are the main goals of taking this harmonized approach for those? 227 00:08:51.484 --> 00:08:51.764 Sure. 228 00:08:52.104 --> 00:08:53.225 So this approach... 229 00:08:53.525 --> 00:08:57.887 is really focusing on very serious hazards such as carcinogenicity, 230 00:08:58.087 --> 00:09:00.308 mutagenicity or toxic for reproduction, 231 00:09:00.548 --> 00:09:02.049 respiratory sensitizers. 232 00:09:02.549 --> 00:09:04.030 And now with the revision of CLP, 233 00:09:04.390 --> 00:09:08.591 we have also the introduction of endocrine disrupting properties of persistency, 234 00:09:08.792 --> 00:09:10.392 bioaccumulation or toxicity. 235 00:09:11.093 --> 00:09:14.454 And there are also some uses that are considered so sensitive, 236 00:09:14.474 --> 00:09:18.696 such as pesticides or biocidal products that require to have such an approach. 237 00:09:19.616 --> 00:09:21.377 And what is also interesting is the... 238 00:09:21.737 --> 00:09:28.242 European Union did this for 50 years and we have over 4,000 substances that have this specific approach. 239 00:09:28.922 --> 00:09:29.563 And the main goal, 240 00:09:29.563 --> 00:09:29.983 of course, 241 00:09:29.983 --> 00:09:32.184 is protecting human health and environment, 242 00:09:32.745 --> 00:09:37.088 and also to standardize the way you identify and communicate chemical hazards. 243 00:09:37.088 --> 00:09:39.189 And that's very important for a common market, 244 00:09:39.710 --> 00:09:42.532 and also to prevent health risks for workers, 245 00:09:42.572 --> 00:09:43.172 consumers, 246 00:09:43.212 --> 00:09:44.593 and to protect the environment, 247 00:09:44.753 --> 00:09:45.634 of course. 248 00:09:45.634 --> 00:09:48.536 What makes CLP so relevant in the EU? 249 00:09:49.737 --> 00:09:49.897 Well, 250 00:09:49.897 --> 00:09:50.097 it's 251 00:09:50.297 --> 00:09:57.145 Probably the fact that in Europe this is used as a basis for implementing regulatory risk management actions. 252 00:09:57.325 --> 00:10:04.894 So it sounds quite complicated but actually it's about banning or restricting the use of those substances in certain applications. 253 00:10:04.954 --> 00:10:05.695 This is the case 254 00:10:06.055 --> 00:10:07.675 for cosmetics or toys, 255 00:10:08.156 --> 00:10:13.237 but also in specific sectors such as biocidal or pesticides. 256 00:10:13.677 --> 00:10:19.559 There are specific regulations that forbid the use of specific ingredients when they are severely classified under CLP. 257 00:10:20.299 --> 00:10:20.499 Right, 258 00:10:20.539 --> 00:10:27.081 so these classifications essentially form the foundation for further regulatory actions on substances. 259 00:10:27.541 --> 00:10:30.102 How do substances then end up in the CLH process? 260 00:10:30.742 --> 00:10:30.902 Well, 261 00:10:30.942 --> 00:10:33.443 normally our member states that can submit 262 00:10:34.083 --> 00:10:36.204 a proposal for a specific classification. 263 00:10:36.224 --> 00:10:37.785 In few justified cases, 264 00:10:38.025 --> 00:10:39.245 also industry can do it. 265 00:10:39.865 --> 00:10:40.606 And lately, 266 00:10:40.726 --> 00:10:43.227 with the revised CLP regulation, 267 00:10:43.287 --> 00:10:45.888 also commission has been entrusted of this possibility. 268 00:10:47.048 --> 00:10:54.291 It's also important to mention that we have in the ECHA website what is called a registry of intentions, 269 00:10:54.411 --> 00:10:59.513 where you can actually follow what are the intentions of member states in submitting new dossiers. 270 00:10:59.874 --> 00:11:03.355 And there are some basic descriptions also of the kind of classification. 271 00:11:03.855 --> 00:11:09.778 So this is quite relevant also to understand what will be assessed by the committee in the near future. 272 00:11:10.759 --> 00:11:11.039 Alright, 273 00:11:11.079 --> 00:11:16.542 so the selection of substances is then based on a consideration from member state authorities or companies. 274 00:11:16.622 --> 00:11:18.323 Is there a certain trigger for these? 275 00:11:18.943 --> 00:11:19.143 Well, 276 00:11:19.163 --> 00:11:23.886 I think that's definitely related to the seriousness of specific hazards, 277 00:11:23.966 --> 00:11:26.608 where there is really a focus on targeting them. 278 00:11:26.668 --> 00:11:27.748 As you can imagine, 279 00:11:27.988 --> 00:11:30.550 we want to be sure that a substance is carcinogen, 280 00:11:30.570 --> 00:11:32.671 is classified and labeled accordingly. 281 00:11:33.359 --> 00:11:39.863 Sometimes there are also other considerations due to these downstream effects that I was mentioning earlier. 282 00:11:40.244 --> 00:11:51.732 So it's a sort of risk management measures and a country might decide that the most effective way to deal with the risk managing such a substance could be through a CLH proposal, 283 00:11:51.752 --> 00:11:53.853 so an harmonized classification proposal. 284 00:11:54.854 --> 00:11:57.796 I would also like to mention that ECHA can support member states. 285 00:11:57.836 --> 00:12:02.239 We provide guidance that is available both for competent authorities but also for industry. 286 00:12:02.859 --> 00:12:05.781 there is quite a lot of material that is available for this process. 287 00:12:06.421 --> 00:12:06.681 Alright, 288 00:12:06.681 --> 00:12:12.164 so the first concrete step is that a proposal to harmonize the classification of a substance is submitted to ECHA. 289 00:12:12.604 --> 00:12:13.325 What happens then? 290 00:12:14.425 --> 00:12:17.227 Once ECHA receives a specific CLH report, 291 00:12:17.387 --> 00:12:20.168 this contains a proposal for a specific classification. 292 00:12:20.348 --> 00:12:26.252 So there are information that are included into this dossier and there are criteria to be fulfilled. 293 00:12:26.832 --> 00:12:32.395 So everything is checked by the ECHA staff in charge of the specific dossier. 294 00:12:32.899 --> 00:12:35.160 And so they run a sort of quality check. 295 00:12:35.300 --> 00:12:36.740 And if the quality is sufficient, 296 00:12:36.980 --> 00:12:44.922 also a consultation is launched where third parties have 45 days to provide any input that is relevant for this classification proposal. 297 00:12:44.922 --> 00:12:50.384 And that's a very important moment because it's really the moment where the right to be heard applies. 298 00:12:51.164 --> 00:12:54.165 This means also that the moment the consultation is concluded, 299 00:12:54.605 --> 00:12:57.806 the committee will really focus on the evidence that is available. 300 00:12:58.186 --> 00:13:01.007 And so submission of plate information normally is not. 301 00:13:01.223 --> 00:13:06.084 taken into account because everything must be completed in a period of about 18 months. 302 00:13:06.224 --> 00:13:11.906 So there is quite some time pressure to deliver also due to the complexity of the discussions that will take place. 303 00:13:13.066 --> 00:13:13.326 All right, 304 00:13:13.326 --> 00:13:13.566 got it. 305 00:13:13.546 --> 00:13:16.227 So the process begins with the submission of a 306 00:13:16.707 --> 00:13:18.568 CLH report to ECHA. 307 00:13:18.968 --> 00:13:20.828 That then includes all the supporting data, 308 00:13:21.128 --> 00:13:22.429 suggested classifications, 309 00:13:22.909 --> 00:13:26.770 and once ECHA ensures the proposal meets the requirements under CLP, 310 00:13:27.270 --> 00:13:30.411 it then goes to public consultation allowing stakeholders to weigh in. 311 00:13:30.939 --> 00:13:34.961 I think it's interesting to hear how stakeholders can provide input early in the process. 312 00:13:35.021 --> 00:13:35.561 But of course, 313 00:13:35.741 --> 00:13:36.581 after this stage, 314 00:13:36.982 --> 00:13:41.143 it sounds like the focus then really shifts to evaluating the evidence that's already been submitted. 315 00:13:41.944 --> 00:13:44.345 This actually brings us nicely to the next step in the process, 316 00:13:44.365 --> 00:13:46.205 so the role of the Risk Assessment Committee. 317 00:13:46.286 --> 00:13:49.107 Could you tell us more about what the committee does in this context? 318 00:13:49.667 --> 00:13:49.807 Well, 319 00:13:49.807 --> 00:13:52.688 the first step is to appoint what we call a rapporteur. 320 00:13:53.048 --> 00:13:54.609 It's one of the RAC members. 321 00:13:55.229 --> 00:13:59.111 Those are independent scientific experts that have been nominated by member states. 322 00:13:59.691 --> 00:14:07.433 And he is entrusted into drafting the opinion and to take into account and to defend also the very same opinion in front of the committee. 323 00:14:08.513 --> 00:14:11.974 And there is also a chance for stakeholders and observers to participate. 324 00:14:12.014 --> 00:14:12.955 So NGOs, 325 00:14:13.155 --> 00:14:17.376 industry experts can input and participate during the discussion of the committee. 326 00:14:17.376 --> 00:14:25.558 And that's quite an important element because it allows also the opinion making to be better and to be more robust in our own conclusions. 327 00:14:25.938 --> 00:14:27.059 Sometimes might not agree, 328 00:14:27.339 --> 00:14:28.699 but that's part I think of. 329 00:14:29.079 --> 00:14:30.400 what a scientific committee does. 330 00:14:31.020 --> 00:14:35.622 Another important element is that RAC really focuses on the hazard property, 331 00:14:35.702 --> 00:14:40.044 so the intrinsic ability of a substance to create harm to human health or environment. 332 00:14:40.084 --> 00:14:42.264 So this means we do not look at exposure, 333 00:14:42.364 --> 00:14:44.025 we do not look at risk assessment, 334 00:14:44.525 --> 00:14:47.106 this is done in different bodies or different framework, 335 00:14:47.547 --> 00:14:51.508 and we do not take into account as well the potential consequences, 336 00:14:51.548 --> 00:14:52.849 the socio-economic aspects. 337 00:14:52.909 --> 00:14:55.110 This is something that this committee doesn't do it. 338 00:14:55.450 --> 00:14:56.030 And finally, 339 00:14:56.050 --> 00:14:58.331 I think the most important part of it is that the 340 00:14:58.671 --> 00:15:04.603 opinion of Braque is then sent to the European Commission for their own decision-making process. 341 00:15:05.107 --> 00:15:06.408 And if this is successful, 342 00:15:06.628 --> 00:15:08.969 it results in an update of the CLP regulation. 343 00:15:09.009 --> 00:15:11.430 So the finalization of the process is, 344 00:15:11.450 --> 00:15:11.791 of course, 345 00:15:11.791 --> 00:15:14.672 a responsibility of the European Commission and member states. 346 00:15:14.692 --> 00:15:15.773 All right. 347 00:15:15.833 --> 00:15:21.156 So the committee then is really at the core of ensuring that the classification is based on, 348 00:15:21.716 --> 00:15:21.836 say, 349 00:15:21.956 --> 00:15:29.340 solid scientific evidence with the rapporteur and the committee working together to carefully review the proposal, 350 00:15:29.920 --> 00:15:32.302 as well as the feedback received in the consultation. 351 00:15:32.982 --> 00:15:34.043 I think it's also important to, 352 00:15:34.263 --> 00:15:34.543 again… 353 00:15:35.323 --> 00:15:36.244 say again what you said, 354 00:15:36.604 --> 00:15:41.108 which is that the committee focuses strictly then on the hazardous properties of a substance, 355 00:15:41.148 --> 00:15:43.830 so without considering use or exposure. 356 00:15:44.791 --> 00:15:45.351 And of course, 357 00:15:45.611 --> 00:15:46.212 as you mentioned, 358 00:15:46.212 --> 00:15:52.136 the ultimate goal then is to have the decision-making happening then in the European Commission together with the member states. 359 00:15:52.977 --> 00:15:54.438 Let's explore that side of things. 360 00:15:54.498 --> 00:15:55.539 So the impact, 361 00:15:55.619 --> 00:16:00.663 what impact does harmonized classificational labeling ultimately have once it's adopted? 362 00:16:01.595 --> 00:16:06.176 I think it's fair to say that CLP is a bit the cornerstone of the 363 00:16:06.936 --> 00:16:12.518 EU regulatory framework on chemicals because it is the start of so many different other processes. 364 00:16:12.698 --> 00:16:13.158 And of course, 365 00:16:13.198 --> 00:16:14.819 this starts for classification, 366 00:16:14.939 --> 00:16:15.439 labeling, 367 00:16:15.919 --> 00:16:16.619 and packaging. 368 00:16:17.179 --> 00:16:17.839 And for instance, 369 00:16:17.879 --> 00:16:26.182 not many know that the child-resistant fastenings that are applied to some corrosive products or the tactile warnings for visually impaired people, 370 00:16:26.262 --> 00:16:28.462 they are actually a direct consequence of CLP. 371 00:16:28.642 --> 00:16:31.163 So because we want to inform or to protect our... 372 00:16:31.343 --> 00:16:31.723 children. 373 00:16:31.943 --> 00:16:32.164 That's, 374 00:16:32.224 --> 00:16:32.684 for instance, 375 00:16:32.684 --> 00:16:33.865 a direct implication. 376 00:16:34.345 --> 00:16:38.108 But what is even more important are probably the downstream consequences, 377 00:16:38.168 --> 00:16:43.392 because a lot of different sectoral regulations decided that they don't want to have, 378 00:16:43.552 --> 00:16:46.854 or they want to control the use of the very hazardous substances. 379 00:16:46.854 --> 00:16:49.756 So the moment we go for a certain classification, 380 00:16:49.816 --> 00:16:54.360 so the committee decides that the substance reaches a certain criteria, 381 00:16:54.420 --> 00:16:55.761 such as being carcinogen, 382 00:16:56.081 --> 00:16:58.943 this could have direct or indirect effect. 383 00:16:59.023 --> 00:17:00.103 downstream consequences, 384 00:17:00.143 --> 00:17:01.024 including a ban, 385 00:17:01.144 --> 00:17:01.984 a restriction, 386 00:17:02.204 --> 00:17:03.724 or a request for a derogation. 387 00:17:04.044 --> 00:17:05.105 But it really depends, 388 00:17:05.165 --> 00:17:06.825 and it can be very different. 389 00:17:06.845 --> 00:17:10.026 But it's also important to mention this is out of the hands of the committee. 390 00:17:10.606 --> 00:17:16.668 This is really in the ramets of the specific regulation that's where any question should be addressed. 391 00:17:16.788 --> 00:17:19.369 It's not much to the committee to look into this. 392 00:17:20.009 --> 00:17:20.189 Right. 393 00:17:20.349 --> 00:17:20.629 All right. 394 00:17:20.669 --> 00:17:20.789 Well, 395 00:17:20.809 --> 00:17:24.230 thank you very much for explaining the process so clearly. 396 00:17:24.290 --> 00:17:28.331 I think it's evident that harmonized classification labeling under CLP 397 00:17:28.351 --> 00:17:31.433 LP is it's not just about identifying hazards, 398 00:17:31.513 --> 00:17:34.336 but it's also about ensuring that this information, 399 00:17:34.376 --> 00:17:34.776 as you said, 400 00:17:34.816 --> 00:17:36.878 translates into meaningful safety measures. 401 00:17:37.498 --> 00:17:37.738 All right, 402 00:17:37.738 --> 00:17:37.939 Maria, 403 00:17:37.979 --> 00:17:44.344 let's now then move on to the additional assessments that you're doing on chromium-6 substances following this court judgment. 404 00:17:44.704 --> 00:17:45.665 What can you tell us about that? 405 00:17:46.205 --> 00:17:53.351 So this is one of those pieces of work that we do in addition to our regular opinions on applications for authorization and restrictions. 406 00:17:53.791 --> 00:18:00.597 Because REACH establishes that the commission can ask the committees to provide opinions on any aspects that are coming from REACH. 407 00:18:00.617 --> 00:18:01.498 And this is one of them. 408 00:18:01.918 --> 00:18:09.785 So the background of this is that there was a court judgment that annulled certain authorizations that had been given from Chrome 6 users. 409 00:18:10.306 --> 00:18:12.508 And in addition to the annulment itself, 410 00:18:12.948 --> 00:18:19.974 the court judgment also provided some clarifications as to how the availability of alternatives for the applicants should be assessed. 411 00:18:20.635 --> 00:18:20.815 Now. 412 00:18:21.759 --> 00:18:31.802 They have established that there needs to be a higher level of granularity in the way that the different products that are covered in the application for authorization are described. 413 00:18:32.242 --> 00:18:36.483 Because quite often companies will apply for a big, 414 00:18:36.563 --> 00:18:36.683 big, 415 00:18:36.723 --> 00:18:41.165 big portfolio of products with things that are quite different sometimes from each other within it. 416 00:18:41.965 --> 00:18:50.107 And also that there needs to be a stricter burden of proof in terms of the functionalities that an alternative must provide for each of the products. 417 00:18:50.147 --> 00:18:54.850 groups and also what the performance level must be for those functionalities. 418 00:18:54.850 --> 00:18:56.131 And here we're talking about things like, 419 00:18:56.151 --> 00:18:56.612 for instance, 420 00:18:56.632 --> 00:18:57.712 corrosion resistance. 421 00:18:57.753 --> 00:19:04.277 We need to justify that corrosion resistance is required and also up to what level. 422 00:19:04.577 --> 00:19:09.941 So this is something that is basically a little bit more stringent than we had had before. 423 00:19:10.762 --> 00:19:17.066 And the commission has had a look at the cases where they already had SEAC opinions and RAC opinions, 424 00:19:17.066 --> 00:19:17.507 of course. 425 00:19:17.927 --> 00:19:24.612 and checked whether in those cases which were submitted and the opinions quite often were agreed before the judgment, 426 00:19:24.812 --> 00:19:29.036 whether the right level of burden of proof had been provided. 427 00:19:29.076 --> 00:19:33.139 These are applications where a decision hadn't been made yet. 428 00:19:33.179 --> 00:19:36.221 So they're kind of in the middle of the opinion and the decision. 429 00:19:36.902 --> 00:19:43.727 So what they have done is they have asked the applicants to submit further information on this topic. 430 00:19:44.519 --> 00:19:46.981 and have asked SEAC to assess that information, 431 00:19:47.021 --> 00:19:47.502 basically. 432 00:19:48.122 --> 00:19:54.468 So what we're doing is to assess the completeness and the robustness of the applicant certifications for these topics, 433 00:19:54.488 --> 00:19:56.570 for functionalities and performance requirements. 434 00:19:57.170 --> 00:20:03.216 And we are looking at whether they have described the products in the right way, 435 00:20:03.296 --> 00:20:06.659 provided the right level of proof on these aspects. 436 00:20:07.279 --> 00:20:07.540 And... 437 00:20:08.408 --> 00:20:16.756 Something else that we are doing that is related to this is that for cases which already we have in the work of the committee, 438 00:20:16.776 --> 00:20:20.539 but that has been submitted before the court judgment, 439 00:20:20.599 --> 00:20:25.984 is that we're already asking the applicants for this information before we agree the opinion. 440 00:20:26.064 --> 00:20:32.250 So this is something that those of the applicants who have submitted applications are still being assessed by SEAC. 441 00:20:32.290 --> 00:20:34.012 They may expect us to ask. 442 00:20:34.416 --> 00:20:37.077 some questions about these topics and this is the background. 443 00:20:37.097 --> 00:20:40.539 We don't want opinions to come back to us very often, 444 00:20:40.599 --> 00:20:45.641 so we're making sure that we comply with the burden of proof required by the court judge. 445 00:20:46.562 --> 00:20:46.742 Okay, 446 00:20:47.042 --> 00:20:47.422 so Maria, 447 00:20:47.442 --> 00:20:49.303 to clarify then for me especially, 448 00:20:49.303 --> 00:20:50.763 but also maybe for some of our listeners, 449 00:20:50.803 --> 00:20:54.425 so this court ruling and assessment of additional information, 450 00:20:54.425 --> 00:20:58.047 does this mean that this impacts also other applications for authorization, 451 00:20:58.107 --> 00:21:00.008 not just the QRO M6 that we're talking about? 452 00:21:00.728 --> 00:21:00.848 Yeah. 453 00:21:01.028 --> 00:21:01.648 It does indeed. 454 00:21:01.648 --> 00:21:02.949 It applies to all applications, 455 00:21:02.989 --> 00:21:03.689 not just Chrome 6, 456 00:21:03.769 --> 00:21:06.770 but any other substance for which there are applications for authorization. 457 00:21:07.330 --> 00:21:17.173 So companies need to be aware of that when they prepare their applications and make sure that the analysis of alternatives is done in a way that complies with the court's requirements. 458 00:21:17.193 --> 00:21:22.754 So with that level of granularity and with that level of proof regarding the performance requirements as well. 459 00:21:23.054 --> 00:21:23.334 Okay, 460 00:21:23.394 --> 00:21:29.596 so quite a big impact and also I assume very useful then for future applicants to use this case as a basis then for. 461 00:21:29.832 --> 00:21:31.472 for doing the applications in the future. 462 00:21:32.053 --> 00:21:32.393 Thank you. 463 00:21:33.113 --> 00:21:35.234 That's all the time we actually have for today. 464 00:21:35.354 --> 00:21:36.254 So once again, 465 00:21:36.414 --> 00:21:39.075 thank you both for your explanations and insight into the committee work. 466 00:21:39.555 --> 00:21:44.956 The next committee meetings then are in March and we will be continuing our regular update episodes. 467 00:21:45.016 --> 00:21:46.357 So do tune in after those. 468 00:21:46.937 --> 00:21:50.358 This is also the last Safer Chemicals podcast episode for this year. 469 00:21:50.478 --> 00:21:53.919 And I want to thank you all for listening and tuning in throughout the year. 470 00:21:54.339 --> 00:21:57.380 We're always looking for new topics to cover and ways to improve. 471 00:21:57.440 --> 00:21:58.780 So if you have suggestions, 472 00:21:58.940 --> 00:22:01.481 you can use the feedback form in this episode's description. 473 00:22:02.102 --> 00:22:03.482 Wishing you a happy holiday season. 474 00:22:03.603 --> 00:22:04.163 And once again, 475 00:22:04.223 --> 00:22:04.723 thank you both. 476 00:22:05.183 --> 00:22:05.524 Thank you. 477 00:22:05.744 --> 00:22:06.104 Thank you. 478 00:22:06.144 --> 00:22:06.844 Thank you very much. 479 00:22:07.224 --> 00:22:07.565 Goodbye. 480 00:22:07.585 --> 00:22:08.245 And happy Christmas. 481 00:22:09.105 --> 00:22:10.826 Safer Chemicals Podcast. 482 00:22:11.547 --> 00:22:13.668 Sound science on harmful chemicals.