WEBVTT 1 00:00:00.316 --> 00:00:01.998 Safer Chemicals Podcast. 2 00:00:02.738 --> 00:00:04.859 Sound science on harmful chemicals. 3 00:00:11.226 --> 00:00:13.109 Welcome to the Safer Chemicals Podcast. 4 00:00:13.265 --> 00:00:13.711 I'm Adam, 5 00:00:13.851 --> 00:00:16.187 and today I'm joined by Roberto Scazzola, 6 00:00:16.218 --> 00:00:18.093 who chairs our Committee for Risk Assessment, 7 00:00:18.500 --> 00:00:19.640 as well as Maria Ottati, 8 00:00:19.781 --> 00:00:22.297 the Chair of our Socio-economic Analysis Committee. 9 00:00:23.031 --> 00:00:26.515 So today we're diving into some key updates from the recent meetings. 10 00:00:26.828 --> 00:00:29.562 We'll kick things off first with the latest on the universal... 11 00:00:29.672 --> 00:00:30.913 PFAS restriction proposal, 12 00:00:31.434 --> 00:00:36.417 and then get into the details of the plan to restrict certain chromium-6 substances in the EU. 13 00:00:37.460 --> 00:00:37.960 After that, 14 00:00:38.241 --> 00:00:43.726 we'll be talking about bisphenol A and the new occupational exposure limit that the Risk Assessment Committee has adopted. 15 00:00:44.405 --> 00:00:44.804 Roberto, 16 00:00:44.890 --> 00:00:45.163 Maria, 17 00:00:45.265 --> 00:00:46.788 it's great to have you on the podcast again. 18 00:00:47.476 --> 00:00:48.023 Good to be here. 19 00:00:48.210 --> 00:00:49.163 Happy to be here too. 20 00:00:50.210 --> 00:00:50.538 All right, 21 00:00:50.570 --> 00:00:55.632 let's kick things off with the big PFAS restriction proposal that the Risk Assessment Committee has been working on. 22 00:00:56.195 --> 00:00:58.132 So the committee has been looking into how... 23 00:00:58.348 --> 00:01:02.112 PFAS is used in things like medical devices and lubricants. 24 00:01:02.714 --> 00:01:03.093 Roberto, 25 00:01:03.151 --> 00:01:04.534 can you break down the key points for us? 26 00:01:05.616 --> 00:01:08.100 We are very satisfied with the progress in the discussions, 27 00:01:08.116 --> 00:01:08.538 I would say, 28 00:01:08.561 --> 00:01:10.718 in both committees and for these two sectors. 29 00:01:11.140 --> 00:01:15.179 I'm very happy to say that RAC was able to agree on its provisional conclusions. 30 00:01:15.772 --> 00:01:17.694 To briefly describe the two sectors, 31 00:01:17.788 --> 00:01:20.007 medical devices include medical implants, 32 00:01:20.163 --> 00:01:23.257 invasive medical devices such as tubes and catheters, 33 00:01:23.694 --> 00:01:27.710 but also other items such as wound treatment products and also 34 00:01:27.912 --> 00:01:29.434 packaging of medical devices. 35 00:01:29.794 --> 00:01:32.817 So it's a quite diverse and I would say very important sector. 36 00:01:33.438 --> 00:01:34.259 And then lubricants, 37 00:01:34.298 --> 00:01:36.942 I think it's maybe a sector where everybody's familiar. 38 00:01:36.997 --> 00:01:37.864 So our fluids, 39 00:01:38.544 --> 00:01:44.247 their main scope is to reduce friction or to allow also to reduce the wear or the heat between moving parts. 40 00:01:44.341 --> 00:01:46.247 So you can imagine automotive, 41 00:01:46.606 --> 00:01:47.388 medical industry, 42 00:01:47.466 --> 00:01:48.497 food processing. 43 00:01:48.778 --> 00:01:51.450 So a lot of uses also in that area. 44 00:01:52.216 --> 00:01:57.044 Also to demonstrate and to measure the importance of those sectors, 45 00:01:57.504 --> 00:02:03.051 I think the RAC look into the amount of volumes and emissions and they are quite remarkable. 46 00:02:03.251 --> 00:02:04.430 For medical devices, 47 00:02:04.973 --> 00:02:10.157 we have a possible emissions close to 12,000 tons over a period of 30 years. 48 00:02:10.680 --> 00:02:12.243 And that's quite significant. 49 00:02:12.337 --> 00:02:17.649 And lubricants is even higher with about 50,000 tons over a period of 30 years. 50 00:02:18.102 --> 00:02:24.571 So this shows how they are definitely relevant when we will look into the potential risk related to their use. 51 00:02:25.188 --> 00:02:29.293 We also look into the effectiveness of the restriction options to reduce the risks, 52 00:02:29.671 --> 00:02:32.394 but also possible sector-specific derogations. 53 00:02:32.593 --> 00:02:32.957 However, 54 00:02:33.156 --> 00:02:34.796 only on risk-based considerations, 55 00:02:34.859 --> 00:02:40.960 because our sister committee is actually looking more into the socioeconomic aspects of those considerations. 56 00:02:41.679 --> 00:02:41.867 Also, 57 00:02:41.868 --> 00:02:43.320 a lot of stakeholders attended, 58 00:02:43.367 --> 00:02:43.632 again, 59 00:02:43.648 --> 00:02:44.148 the meeting, 60 00:02:44.149 --> 00:02:47.085 and this demonstrates the interest that is out there for this. 61 00:02:47.617 --> 00:02:48.070 And finally, 62 00:02:48.132 --> 00:02:48.789 let me remind, 63 00:02:48.804 --> 00:02:50.476 those are provisional conclusions, 64 00:02:50.477 --> 00:02:53.617 so final conclusions will be available toward the end of the... 65 00:02:53.640 --> 00:02:59.846 process while there will be a sort of benchmarking with all the previous opinions that have been agreed so far. 66 00:03:00.686 --> 00:03:01.166 So yeah, 67 00:03:01.268 --> 00:03:02.272 as with all of these sectors, 68 00:03:02.273 --> 00:03:04.514 I would imagine there's quite a lot of interest from the outside. 69 00:03:04.530 --> 00:03:10.459 But what would you then say are the most important takeaways for audience from the committee's work on these sectors? 70 00:03:10.944 --> 00:03:12.256 Were there anything that you'd like to highlight? 71 00:03:12.475 --> 00:03:12.741 Yeah, 72 00:03:12.803 --> 00:03:15.678 I think I found very good the interaction with stakeholders. 73 00:03:15.725 --> 00:03:15.959 You know, 74 00:03:15.975 --> 00:03:17.522 they play such an important role. 75 00:03:17.678 --> 00:03:22.569 They provide input and information that might not be necessarily available for the committee. 76 00:03:23.084 --> 00:03:26.908 And I was also pleased by the announcement of voluntary initiatives and projects, 77 00:03:26.969 --> 00:03:27.430 for instance, 78 00:03:27.431 --> 00:03:28.891 in the medical devices sector, 79 00:03:29.672 --> 00:03:32.457 for the possibility to look for alternatives in the use of PIFA. 80 00:03:32.590 --> 00:03:33.176 So actually, 81 00:03:33.316 --> 00:03:35.699 even before this has kind of gone through the formal process, 82 00:03:35.715 --> 00:03:38.301 there's already actions being taken to start- That seems to be the case. 83 00:03:38.379 --> 00:03:39.676 Those are voluntary actions. 84 00:03:39.785 --> 00:03:45.691 And so probably shows the productiveness of a sector that would like really to take on this problem in a, 85 00:03:45.879 --> 00:03:46.207 let's say, 86 00:03:46.363 --> 00:03:47.441 serious and effective manner. 87 00:03:47.535 --> 00:03:48.848 So quite positive, 88 00:03:48.895 --> 00:03:49.270 definitely. 89 00:03:50.440 --> 00:03:50.640 Okay, 90 00:03:50.680 --> 00:03:51.722 thanks Roberto for sharing that. 91 00:03:51.741 --> 00:03:56.167 So you also started looking into electronics and I think it was semiconductors. 92 00:03:56.206 --> 00:04:00.292 So can you tell us a bit about how those sectors then use PFAS? 93 00:04:01.214 --> 00:04:01.433 Yes, 94 00:04:01.628 --> 00:04:02.175 of course. 95 00:04:02.652 --> 00:04:04.995 This was just an introductory discussion. 96 00:04:05.073 --> 00:04:09.472 What does it mean is that we look into the proposal made by the dossier submitters, 97 00:04:09.503 --> 00:04:13.238 so the various countries that are at the origin of this proposal. 98 00:04:15.060 --> 00:04:18.663 The sector uses PFAS for a number of specific properties. 99 00:04:18.724 --> 00:04:20.024 They're chemical resistance, 100 00:04:20.126 --> 00:04:20.985 thermostability, 101 00:04:21.087 --> 00:04:22.767 but also electrical insulation. 102 00:04:23.345 --> 00:04:26.071 And they are used in a lot of different applications, 103 00:04:26.290 --> 00:04:26.790 wires, 104 00:04:26.852 --> 00:04:27.329 cables, 105 00:04:27.470 --> 00:04:28.649 printed circuit boards, 106 00:04:29.032 --> 00:04:30.095 flat panel displays. 107 00:04:30.096 --> 00:04:32.118 So you can imagine it's very widespread. 108 00:04:32.634 --> 00:04:33.977 But also semiconductors, 109 00:04:34.102 --> 00:04:40.165 and those are materials that are used for their electrical conductivity between a conductor and an insulator. 110 00:04:40.212 --> 00:04:41.931 So quite specific and technical. 111 00:04:42.399 --> 00:04:44.306 And these include seals or rings. 112 00:04:44.776 --> 00:04:45.257 wafers, 113 00:04:45.337 --> 00:04:46.978 coatings and similar stuff. 114 00:04:47.920 --> 00:04:48.099 Okay, 115 00:04:48.179 --> 00:04:48.340 right. 116 00:04:48.619 --> 00:04:53.244 So what kind of questions are you then hoping to further explore in the next discussions? 117 00:04:54.040 --> 00:04:54.200 Well, 118 00:04:54.260 --> 00:04:57.601 now we focus on the proposal made by the dossier submitter, 119 00:04:57.859 --> 00:05:01.879 and our aim was to get initial input from stakeholders, 120 00:05:01.941 --> 00:05:04.558 and many stakeholders actually provided such an input. 121 00:05:04.941 --> 00:05:07.480 The next step will be actually to draft the RAC opinion, 122 00:05:07.519 --> 00:05:10.379 so we really look into the elements such as volumes, 123 00:05:10.441 --> 00:05:11.051 emissions, 124 00:05:11.160 --> 00:05:12.191 risk of alternatives, 125 00:05:12.691 --> 00:05:15.941 and this will be discussed in the upcoming meeting in September. 126 00:05:16.472 --> 00:05:16.660 Okay, 127 00:05:16.722 --> 00:05:21.301 and what would you say makes the electronics and semiconductor sectors... 128 00:05:21.448 --> 00:05:25.791 particularly interesting when it comes to the PFAS restriction proposal? 129 00:05:26.549 --> 00:05:26.791 Well, 130 00:05:27.010 --> 00:05:28.189 we noticed, 131 00:05:28.431 --> 00:05:35.650 and that's a fact that we had probably the highest number of comments that were triggered during the consultation that was carried out a year and a half ago, 132 00:05:35.853 --> 00:05:36.314 more or less. 133 00:05:36.892 --> 00:05:38.767 We had about 1200 comments. 134 00:05:39.439 --> 00:05:40.189 If I remember well, 135 00:05:40.205 --> 00:05:41.330 it's something like 20% 136 00:05:41.736 --> 00:05:45.611 of the total number of comments and considering we had about 13, 137 00:05:45.674 --> 00:05:46.830 14 different sectors, 138 00:05:46.892 --> 00:05:48.221 that's really quite a lot. 139 00:05:48.799 --> 00:05:49.158 And also, 140 00:05:49.456 --> 00:05:56.685 probably the high and diverse number of applications require an in-depth assessment by both the dosis submitter and also by RAC. 141 00:05:56.782 --> 00:06:00.587 So we expect definitely September to be a very interesting discussion. 142 00:06:00.626 --> 00:06:02.087 So stay tuned for more info. 143 00:06:02.688 --> 00:06:04.009 Are you able to kind of compare, 144 00:06:04.188 --> 00:06:04.454 you know, 145 00:06:04.470 --> 00:06:07.579 this 1,200 to other restrictions that you have? 146 00:06:07.580 --> 00:06:08.376 How does it compare? 147 00:06:08.938 --> 00:06:09.095 Well, 148 00:06:09.142 --> 00:06:09.532 by far, 149 00:06:09.563 --> 00:06:10.376 I think is the biggest. 150 00:06:10.438 --> 00:06:11.298 Maria might remember, 151 00:06:11.313 --> 00:06:12.251 it has been longer than me. 152 00:06:13.063 --> 00:06:16.188 I think the biggest one that I can remember was about 500. 153 00:06:16.388 --> 00:06:16.788 comments. 154 00:06:16.989 --> 00:06:20.151 So even for just this small part of this restriction, 155 00:06:20.712 --> 00:06:22.696 it's over twice that. 156 00:06:22.697 --> 00:06:23.255 So yeah, 157 00:06:23.634 --> 00:06:24.235 this is huge. 158 00:06:24.735 --> 00:06:24.954 Okay. 159 00:06:24.993 --> 00:06:25.274 All right. 160 00:06:25.298 --> 00:06:25.415 Well, 161 00:06:25.438 --> 00:06:26.376 thank you so much for that. 162 00:06:26.438 --> 00:06:28.821 And it's nice to see that the PFAS work is moving forward. 163 00:06:29.180 --> 00:06:29.337 Okay, 164 00:06:29.384 --> 00:06:29.579 Maria, 165 00:06:29.641 --> 00:06:30.243 over to you then. 166 00:06:30.384 --> 00:06:34.165 So you've been looking into medical devices and lubricants, 167 00:06:34.493 --> 00:06:39.509 and you've also gone back to the discussions that you started back in March on transport. 168 00:06:40.009 --> 00:06:40.805 How's that coming along? 169 00:06:41.227 --> 00:06:42.868 It was an extremely productive meeting, 170 00:06:42.930 --> 00:06:43.321 actually. 171 00:06:43.604 --> 00:06:43.884 Indeed, 172 00:06:43.924 --> 00:06:44.485 as you said, 173 00:06:44.686 --> 00:06:52.356 we had a discussion on medical devices and lubricants where we covered the whole sector and all the aspects that we need to cover in an opinion. 174 00:06:53.152 --> 00:06:56.856 And we were able to provisionally conclude on medical devices. 175 00:06:57.817 --> 00:06:59.442 Roberto's already explained what's in there. 176 00:06:59.443 --> 00:07:00.504 I'm not going to repeat that. 177 00:07:01.520 --> 00:07:02.629 And then on transport, 178 00:07:02.785 --> 00:07:07.254 we also brought it back and then we were able to finish the discussion there as well. 179 00:07:07.301 --> 00:07:10.504 So I think we probably discussed this in a previous podcast. 180 00:07:10.505 --> 00:07:11.598 But just as a reminder, 181 00:07:11.676 --> 00:07:12.535 these are very... 182 00:07:13.040 --> 00:07:15.460 wide variety of uses that are covered within transport. 183 00:07:15.461 --> 00:07:16.562 It's a very wide sector. 184 00:07:16.581 --> 00:07:19.421 So we're talking about automotive, 185 00:07:19.620 --> 00:07:20.542 aerospace, 186 00:07:21.066 --> 00:07:21.878 watercraft, 187 00:07:22.019 --> 00:07:22.464 rail, 188 00:07:23.402 --> 00:07:25.042 agriculture and forestry vehicles, 189 00:07:25.402 --> 00:07:26.206 all sorts of things, 190 00:07:26.261 --> 00:07:29.691 even to the point of some transport related infrastructure like signage. 191 00:07:29.722 --> 00:07:32.159 So it's all sorts of things that come in there. 192 00:07:32.519 --> 00:07:33.487 And even within that, 193 00:07:33.581 --> 00:07:33.831 I mean, 194 00:07:33.847 --> 00:07:36.659 we have some assessment that is more general, 195 00:07:36.800 --> 00:07:37.159 but then... 196 00:07:37.628 --> 00:07:39.771 There is also assessment that is EU specific. 197 00:07:39.810 --> 00:07:47.060 So we're talking about very concrete things like tubes and hoses in combustion engine systems and coatings for windshields, 198 00:07:47.599 --> 00:07:49.123 all sorts of things that we're talking there. 199 00:07:49.124 --> 00:07:50.263 So it's a complex sector. 200 00:07:50.865 --> 00:07:52.201 Lots of comments there as well. 201 00:07:52.505 --> 00:07:54.130 Lots of work done by the rapporteurs. 202 00:07:54.646 --> 00:07:55.568 And like I said, 203 00:07:55.584 --> 00:08:00.771 we were able to reach conclusions both on the analysis of alternatives and also on the socioeconomic side. 204 00:08:01.130 --> 00:08:02.052 And just as a reminder, 205 00:08:02.053 --> 00:08:05.255 we bring that all together by looking at the proportionality. 206 00:08:05.664 --> 00:08:10.470 And then we look at the need for derogations to ensure that there is proportionality in the proposal. 207 00:08:10.471 --> 00:08:10.587 Right, 208 00:08:10.611 --> 00:08:11.369 as always. 209 00:08:11.709 --> 00:08:11.830 Yeah, 210 00:08:11.931 --> 00:08:12.310 exactly. 211 00:08:12.349 --> 00:08:13.212 That's as always. 212 00:08:13.251 --> 00:08:13.373 So, 213 00:08:13.955 --> 00:08:14.095 yeah, 214 00:08:14.150 --> 00:08:15.814 for medical devices and for transport, 215 00:08:15.837 --> 00:08:17.478 we were able to wrap everything up. 216 00:08:18.439 --> 00:08:19.056 For lubricants, 217 00:08:19.119 --> 00:08:20.322 which we also looked at, 218 00:08:20.455 --> 00:08:20.720 again, 219 00:08:21.142 --> 00:08:23.361 Roberto explains very well what's in there. 220 00:08:24.142 --> 00:08:32.330 There we concentrated only on the analysis of alternatives and also aspects such as whether a restriction under reach is the best way to deal with the risk. 221 00:08:33.345 --> 00:08:33.470 So... 222 00:08:34.508 --> 00:08:36.892 There we were able to have provisional conclusions. 223 00:08:37.792 --> 00:08:41.255 And we also had an introductory discussion to the socioeconomic analysis. 224 00:08:41.256 --> 00:08:43.220 So there it's these aspects I've mentioned before, 225 00:08:43.259 --> 00:08:43.501 like, 226 00:08:43.540 --> 00:08:43.681 well, 227 00:08:43.759 --> 00:08:44.540 cost and benefits, 228 00:08:44.579 --> 00:08:49.282 and then the bringing everything together with the proportionality and the derogations. 229 00:08:49.704 --> 00:08:52.329 So that comes back in September. 230 00:08:52.782 --> 00:08:54.986 And there we will wrap up the whole of the sector. 231 00:08:55.814 --> 00:09:01.142 I'm just interested because you mentioned that you looked at whether a restriction under reach is the most appropriate measure, 232 00:09:01.814 --> 00:09:02.611 as opposed to what? 233 00:09:03.052 --> 00:09:03.292 you know, 234 00:09:03.293 --> 00:09:04.392 what would be the other alternative? 235 00:09:04.412 --> 00:09:04.573 Well, 236 00:09:04.632 --> 00:09:13.511 quite often there's sector-specific regulation that also applies to the sector and we need to check whether the risk is also dealt with in that way. 237 00:09:13.636 --> 00:09:15.378 So we look at whether, 238 00:09:15.534 --> 00:09:15.855 you know, 239 00:09:16.472 --> 00:09:19.238 some stuff is already covered and it's also dealing with the risk. 240 00:09:19.972 --> 00:09:20.613 And we look at it for, 241 00:09:20.831 --> 00:09:21.659 you know, 242 00:09:21.738 --> 00:09:24.238 overall and then for every one of the sectors that we look at. 243 00:09:24.409 --> 00:09:24.738 Okay. 244 00:09:24.769 --> 00:09:26.253 And we always have that conclusion there. 245 00:09:26.440 --> 00:09:28.202 Quite the puzzle that you're putting together then. 246 00:09:28.502 --> 00:09:30.183 It's a very wide restriction. 247 00:09:30.263 --> 00:09:33.568 So there is a lot of regulation out there is already impacting the sector. 248 00:09:33.587 --> 00:09:34.525 And in some cases, 249 00:09:34.548 --> 00:09:34.806 you know, 250 00:09:35.048 --> 00:09:37.228 it may have an impact on the work that we do as well. 251 00:09:37.689 --> 00:09:37.814 Well, 252 00:09:37.815 --> 00:09:40.416 it's reassuring to hear that you've managed to find consensus, 253 00:09:40.517 --> 00:09:43.791 even with such a wide sector and different uses. 254 00:09:43.822 --> 00:09:44.181 So that's, 255 00:09:44.322 --> 00:09:44.603 I guess, 256 00:09:44.604 --> 00:09:45.275 a positive thing. 257 00:09:45.353 --> 00:09:46.322 A very positive thing, 258 00:09:46.353 --> 00:09:46.494 yes. 259 00:09:46.603 --> 00:09:47.212 All right. 260 00:09:47.322 --> 00:09:50.369 Then if we go into the kind of more broader benefits. 261 00:09:50.844 --> 00:09:51.705 What then would you say, 262 00:09:51.765 --> 00:09:52.025 Maria, 263 00:09:52.125 --> 00:09:57.490 are some of the more broader benefits that you see from progressing with this restriction proposal? 264 00:09:58.150 --> 00:09:58.310 Well, 265 00:09:58.392 --> 00:10:01.435 this is the broadest and biggest proposal to date, 266 00:10:01.615 --> 00:10:04.279 and it covers very widespread of sectors, 267 00:10:04.333 --> 00:10:05.279 even within each sector, 268 00:10:05.302 --> 00:10:06.927 as we've been talking about with transport. 269 00:10:06.943 --> 00:10:08.302 That already covers quite a lot. 270 00:10:09.099 --> 00:10:11.036 It covers a lot of substances as well. 271 00:10:11.521 --> 00:10:13.380 So basically it... 272 00:10:13.728 --> 00:10:16.591 It means that we can deal with lots of risk at the same time. 273 00:10:16.690 --> 00:10:22.300 We can avoid also that we substitute something with something else that also then proves problematic. 274 00:10:22.417 --> 00:10:23.456 So regrettable substitution. 275 00:10:23.495 --> 00:10:24.542 Regrettable substitution, 276 00:10:24.596 --> 00:10:25.018 exactly. 277 00:10:25.096 --> 00:10:26.862 So this is the benefit of these, 278 00:10:26.901 --> 00:10:28.339 which we call group restrictions. 279 00:10:28.846 --> 00:10:29.792 And of course, 280 00:10:29.839 --> 00:10:31.885 now we are learning a lot about how to deal with them. 281 00:10:32.042 --> 00:10:33.229 If we get some in the future, 282 00:10:33.230 --> 00:10:35.167 in addition to the benefits of this restriction. 283 00:10:35.612 --> 00:10:38.094 we are able to process future restrictions, 284 00:10:38.155 --> 00:10:39.135 attack group restrictions, 285 00:10:39.276 --> 00:10:39.778 much quicker. 286 00:10:40.016 --> 00:10:40.196 Then, 287 00:10:40.278 --> 00:10:40.715 of course, 288 00:10:40.739 --> 00:10:43.957 we get to reduce the risk much faster when we get future restrictions. 289 00:10:43.981 --> 00:10:45.606 So it's win-win all around. 290 00:10:45.699 --> 00:10:45.879 Right. 291 00:10:45.880 --> 00:10:47.285 So faster protection for everyone. 292 00:10:47.301 --> 00:10:47.465 Yes, 293 00:10:47.543 --> 00:10:47.887 exactly. 294 00:10:48.465 --> 00:10:48.668 Okay, 295 00:10:48.723 --> 00:10:48.887 good. 296 00:10:49.848 --> 00:10:50.004 Well, 297 00:10:50.387 --> 00:10:52.371 thanks for the updates to both of you. 298 00:10:52.809 --> 00:10:55.028 So just to do my best to recap. 299 00:10:55.090 --> 00:10:57.981 So we've looked at PFAS in medical devices and lubricants. 300 00:10:58.168 --> 00:11:03.715 And the Socioeconomic Analysis Committee also concluded on transport and closing. 301 00:11:03.904 --> 00:11:06.145 that discussion that was started on transport in March. 302 00:11:06.427 --> 00:11:11.532 The Risk Assessment Committee then shared its initial thoughts on the electronics and semiconductor sectors, 303 00:11:12.075 --> 00:11:17.294 and the Socioeconomic Analysis Committee will pick up the lubricants discussion again later. 304 00:11:17.755 --> 00:11:19.036 I hope I got that more or less right. 305 00:11:19.137 --> 00:11:19.622 Perfect, 306 00:11:19.661 --> 00:11:19.817 yes, 307 00:11:19.880 --> 00:11:20.614 exactly right. 308 00:11:20.755 --> 00:11:20.958 Okay, 309 00:11:21.020 --> 00:11:21.161 good. 310 00:11:21.223 --> 00:11:22.958 So what's then coming up next? 311 00:11:23.005 --> 00:11:23.239 I mean, 312 00:11:23.864 --> 00:11:25.348 I'm sure we have enough sectors as it is, 313 00:11:25.364 --> 00:11:26.489 but I'm sure more are coming in. 314 00:11:26.583 --> 00:11:27.489 So what's coming up, 315 00:11:27.630 --> 00:11:30.005 and are there any new sectors that we should be keeping on our radar? 316 00:11:30.006 --> 00:11:30.536 Yeah, 317 00:11:30.552 --> 00:11:30.723 well, 318 00:11:30.895 --> 00:11:31.505 in September, 319 00:11:31.567 --> 00:11:32.005 insect 320 00:11:32.252 --> 00:11:32.673 As you said, 321 00:11:32.873 --> 00:11:33.413 lubricants, 322 00:11:33.493 --> 00:11:34.435 we wrap it up. 323 00:11:34.534 --> 00:11:37.198 We do the socioeconomic analysis and bring everything together. 324 00:11:37.819 --> 00:11:39.761 We will also discuss energy there. 325 00:11:39.980 --> 00:11:42.038 And we will take the whole thing as well. 326 00:11:42.062 --> 00:11:42.882 That's the intention. 327 00:11:43.484 --> 00:11:46.304 And we will start discussing electronics and semiconductors. 328 00:11:46.327 --> 00:11:47.585 That is a big one. 329 00:11:47.624 --> 00:11:50.991 So we expect that that will be September and then we will continue in December. 330 00:11:51.538 --> 00:11:54.507 We will also take some horizontal topics as well. 331 00:11:54.569 --> 00:11:54.898 We've got... 332 00:11:55.964 --> 00:11:58.647 We've been looking at the general approach in how we assess things. 333 00:11:58.827 --> 00:12:01.129 And we saw that earlier on in the process. 334 00:12:01.188 --> 00:12:01.770 But of course, 335 00:12:02.289 --> 00:12:03.871 once we've seen quite a lot of sectors, 336 00:12:03.895 --> 00:12:08.700 we want to go back and ensure that what we did then still works now that we've seen lots of examples. 337 00:12:08.817 --> 00:12:09.895 So we're bringing that back. 338 00:12:11.340 --> 00:12:12.496 And then after September, 339 00:12:12.575 --> 00:12:13.918 we've got PFAS manufacturing. 340 00:12:13.965 --> 00:12:18.059 That's about the production or synthesis of specific PFAS compounds. 341 00:12:18.060 --> 00:12:18.934 We're talking liquids, 342 00:12:18.950 --> 00:12:19.262 gases, 343 00:12:19.309 --> 00:12:19.684 polymers, 344 00:12:19.715 --> 00:12:19.965 whatever. 345 00:12:20.403 --> 00:12:21.403 And of course, 346 00:12:21.512 --> 00:12:23.496 we finish electronics and semiconductors. 347 00:12:24.136 --> 00:12:28.540 We're also going to be looking at horizontal issues that are like enforceability, 348 00:12:28.720 --> 00:12:29.962 concentration limits, 349 00:12:30.020 --> 00:12:30.942 analytical methods, 350 00:12:31.005 --> 00:12:31.462 monitoring, 351 00:12:31.563 --> 00:12:35.450 all those sorts of things that then you have to bring in for a restriction. 352 00:12:35.950 --> 00:12:37.848 You mentioned horizontal issues at the start, 353 00:12:38.247 --> 00:12:39.708 but then you mentioned it again at the end. 354 00:12:39.924 --> 00:12:41.485 We're talking about slightly different things. 355 00:12:41.526 --> 00:12:45.710 So we're talking about the approach to how we deal with the analysis in the sectors. 356 00:12:45.811 --> 00:12:51.175 And then we talk about kind of more cross-cutting issues like the practicality of the restriction as a whole. 357 00:12:51.253 --> 00:12:51.893 For example, 358 00:12:51.917 --> 00:12:52.776 enforcement authority. 359 00:12:52.956 --> 00:12:53.393 Exactly. 360 00:12:53.698 --> 00:12:56.846 Some of these we look at from a sectoral point of view, 361 00:12:56.925 --> 00:12:59.768 looking at the areas that are relevant for a particular sector, 362 00:12:59.784 --> 00:13:02.159 but then we look at it overall as well. 363 00:13:02.362 --> 00:13:02.909 So yeah, 364 00:13:02.987 --> 00:13:05.315 it's kind of both horizontal but slightly different. 365 00:13:05.409 --> 00:13:05.596 Right. 366 00:13:05.643 --> 00:13:06.550 And you mentioned energy. 367 00:13:07.148 --> 00:13:08.569 Remind me if you've already covered that. 368 00:13:09.009 --> 00:13:11.468 We had an introductory discussion on energy, 369 00:13:11.570 --> 00:13:11.949 exactly. 370 00:13:11.968 --> 00:13:13.910 And I think this is one that RAC has already covered. 371 00:13:14.191 --> 00:13:14.410 Yes, 372 00:13:14.531 --> 00:13:14.691 yes, 373 00:13:14.749 --> 00:13:15.027 indeed. 374 00:13:15.028 --> 00:13:15.972 RAC is very efficient. 375 00:13:16.792 --> 00:13:17.706 Let's see. 376 00:13:18.370 --> 00:13:19.269 Also for September, 377 00:13:19.449 --> 00:13:19.714 RAC, 378 00:13:19.949 --> 00:13:23.058 the main goal will be to conclude on electronic and semiconductors. 379 00:13:23.089 --> 00:13:26.589 It was provisionally discussed for the first time a week ago. 380 00:13:27.167 --> 00:13:30.308 And then we will start PFAS manufacturing and horizontal issues, 381 00:13:30.355 --> 00:13:31.808 as Maria was describing, 382 00:13:31.809 --> 00:13:32.386 in September, 383 00:13:32.449 --> 00:13:35.402 with a view to possibly complete them by December this year. 384 00:13:36.074 --> 00:13:36.433 and and 385 00:13:36.576 --> 00:13:43.622 Are there any kind of cross-cutting themes or challenges that have emerged across all the different sectors you've looked at so far? 386 00:13:44.864 --> 00:13:45.020 Well, 387 00:13:45.106 --> 00:13:45.567 basically, 388 00:13:45.622 --> 00:13:48.130 the huge amount of information that we need to deal with. 389 00:13:48.145 --> 00:13:48.848 That's one of them, 390 00:13:48.911 --> 00:13:49.325 of course. 391 00:13:49.528 --> 00:13:50.145 Very wide, 392 00:13:50.208 --> 00:13:50.950 lots of comments. 393 00:13:50.973 --> 00:13:51.333 Of course, 394 00:13:51.334 --> 00:13:52.513 there is a lot of information. 395 00:13:53.458 --> 00:13:54.989 From a SEAC point of view, 396 00:13:54.990 --> 00:13:58.739 I would say the substitution challenges are something that keeps recurring. 397 00:13:58.755 --> 00:13:58.973 I mean, 398 00:13:59.020 --> 00:14:00.880 these are compounds with unique properties. 399 00:14:01.583 --> 00:14:02.864 And in some industries, 400 00:14:03.864 --> 00:14:05.692 they find it difficult to replace them. 401 00:14:05.693 --> 00:14:05.864 And so... 402 00:14:06.840 --> 00:14:10.041 It's hard to find something that works and, 403 00:14:10.121 --> 00:14:10.361 you know, 404 00:14:10.582 --> 00:14:11.340 in a sufficient way, 405 00:14:11.383 --> 00:14:12.562 provides sufficient performance. 406 00:14:12.582 --> 00:14:15.039 So we're seeing that across many different sectors. 407 00:14:15.445 --> 00:14:15.820 Of course, 408 00:14:15.821 --> 00:14:16.602 for some of them, 409 00:14:16.742 --> 00:14:18.859 the situation is different than from others. 410 00:14:18.883 --> 00:14:19.266 Some of them, 411 00:14:19.305 --> 00:14:19.602 actually, 412 00:14:19.641 --> 00:14:20.859 there are alternatives out there. 413 00:14:21.586 --> 00:14:22.203 For some of them, 414 00:14:22.266 --> 00:14:22.445 not. 415 00:14:22.547 --> 00:14:23.891 So that's the challenge, 416 00:14:23.984 --> 00:14:26.531 trying to dig into that and to get that information. 417 00:14:27.031 --> 00:14:27.625 And then it's, 418 00:14:27.672 --> 00:14:27.922 you know, 419 00:14:28.000 --> 00:14:35.328 bringing that information together with all the other socioeconomic side for us and actually coming to a view on derogation. 420 00:14:35.422 --> 00:14:35.547 So. 421 00:14:36.244 --> 00:14:39.547 That I would say are the main challenges from our side. 422 00:14:39.668 --> 00:14:40.726 I don't know if you've got some on that. 423 00:14:40.848 --> 00:14:41.090 Yeah, 424 00:14:41.250 --> 00:14:45.617 maybe I could point out to the fact that we have been doing this for about two years, 425 00:14:45.695 --> 00:14:47.414 so we have literally learned a lot. 426 00:14:47.476 --> 00:14:48.617 But also at the beginning, 427 00:14:48.773 --> 00:14:55.539 we had an approach that maybe is not fully consistent with the final decision and approval that we are getting through. 428 00:14:55.820 --> 00:15:01.414 So the idea is to have a sort of benchmarking toward the end of it to ensure that we are fully consistent across all the sectors. 429 00:15:01.415 --> 00:15:03.211 So that may be the biggest challenge, 430 00:15:03.258 --> 00:15:03.648 I would say. 431 00:15:03.944 --> 00:15:04.545 we have in front of us. 432 00:15:04.546 --> 00:15:05.987 And that we will do in both committees. 433 00:15:06.026 --> 00:15:06.567 We'll have to, 434 00:15:06.907 --> 00:15:10.852 once we've agreed all the different sectors that are within it and all these horizontal issues, 435 00:15:10.891 --> 00:15:15.196 then we go back and we look at the whole thing and we make sure that everything is consistent with each other. 436 00:15:15.219 --> 00:15:15.555 As you said, 437 00:15:15.594 --> 00:15:17.680 things evolve in this amount of time. 438 00:15:18.219 --> 00:15:18.439 I mean, 439 00:15:18.459 --> 00:15:22.479 maybe we need an episode on its own on the next thing that came to my mind. 440 00:15:22.498 --> 00:15:23.780 But it's interesting that we're doing, 441 00:15:23.920 --> 00:15:25.139 we have a lot of learnings from this, 442 00:15:25.221 --> 00:15:25.580 obviously, 443 00:15:25.682 --> 00:15:26.662 a lot of new things, 444 00:15:26.959 --> 00:15:27.725 a lot to cover. 445 00:15:28.342 --> 00:15:30.084 And we have this European angle to it. 446 00:15:30.085 --> 00:15:36.045 But I would imagine that these learnings that we get here will be beneficial for also other countries outside of Europe. 447 00:15:36.139 --> 00:15:41.842 And this kind of laying the foundation of how to assess and look at these sectors will also help others out there. 448 00:15:41.889 --> 00:15:43.748 So even though we're an EU agency, 449 00:15:44.389 --> 00:15:46.920 I'm hoping that the work that we'll do will also pay off for others. 450 00:15:47.267 --> 00:15:47.487 Yeah, 451 00:15:47.608 --> 00:15:47.788 well, 452 00:15:47.848 --> 00:15:51.052 there's a lot of eyes on this process from all across the globe. 453 00:15:51.173 --> 00:15:52.954 So they're definitely paying attention. 454 00:15:53.032 --> 00:15:55.353 And we also have some fora where we exchange, 455 00:15:55.392 --> 00:15:55.993 for instance, 456 00:15:56.196 --> 00:15:59.517 there's a working group in the OECD where we exchange with other authorities. 457 00:15:59.556 --> 00:16:01.321 So that is something where, 458 00:16:01.524 --> 00:16:01.782 you know, 459 00:16:01.978 --> 00:16:04.040 we definitely share those lessons across. 460 00:16:04.056 --> 00:16:04.540 And we learn, 461 00:16:04.571 --> 00:16:04.931 of course, 462 00:16:04.932 --> 00:16:06.431 as well from other parts of the globe. 463 00:16:06.806 --> 00:16:10.306 But that's an interesting topic because also supply chains are global. 464 00:16:10.353 --> 00:16:13.415 So there's definitely an interest that goes beyond what Europe does. 465 00:16:13.696 --> 00:16:15.368 So in a way we can be. 466 00:16:15.507 --> 00:16:16.528 perhaps the front runner. 467 00:16:16.608 --> 00:16:17.909 Let's see at the end of the process. 468 00:16:17.910 --> 00:16:20.233 It will be up to the Commission and the legislators to decide, 469 00:16:20.272 --> 00:16:21.893 but we are here to help them, 470 00:16:22.034 --> 00:16:22.272 right? 471 00:16:22.694 --> 00:16:23.296 That's the point, 472 00:16:23.393 --> 00:16:23.557 yeah. 473 00:16:23.659 --> 00:16:23.893 Okay, 474 00:16:23.956 --> 00:16:24.253 thank you. 475 00:16:24.276 --> 00:16:25.674 Very interesting topic, 476 00:16:25.714 --> 00:16:27.018 very interesting restriction. 477 00:16:27.081 --> 00:16:28.799 We will be coming back to this regularly, 478 00:16:29.182 --> 00:16:31.690 but we've almost spent an entire episode talking about it already. 479 00:16:31.737 --> 00:16:34.362 So maybe we can move on then to Chromium 6. 480 00:16:35.221 --> 00:16:35.346 So 481 00:16:35.784 --> 00:16:40.331 ECHA suggested this new proposal based on a request from the European Commission. 482 00:16:40.753 --> 00:16:42.174 And the aim here is to cut... 483 00:16:42.267 --> 00:16:43.929 down the risks from these chemicals, 484 00:16:44.250 --> 00:16:46.332 particularly to workers and the public, 485 00:16:46.492 --> 00:16:48.773 since they are known to be harmful. 486 00:16:49.836 --> 00:16:51.019 The proposal was sent, 487 00:16:51.199 --> 00:16:52.160 was it back in April? 488 00:16:52.316 --> 00:16:54.996 And now it's up for the committees to do a conformity check. 489 00:16:55.059 --> 00:16:57.223 So what exactly is a conformity check? 490 00:16:57.363 --> 00:16:58.160 Can you walk us through that? 491 00:16:58.926 --> 00:16:59.098 Yeah, 492 00:16:59.099 --> 00:16:59.238 well, 493 00:16:59.285 --> 00:17:00.973 it's an administrative process, 494 00:17:01.004 --> 00:17:01.941 an administrative step, 495 00:17:02.129 --> 00:17:02.941 but it's a very, 496 00:17:02.988 --> 00:17:03.832 very important one. 497 00:17:03.833 --> 00:17:10.769 It's basically about ensuring that everything that needs to be there is there and that the proposal is actually ready to be assessed, 498 00:17:10.770 --> 00:17:11.035 you know. 499 00:17:11.455 --> 00:17:11.715 Checking, 500 00:17:11.716 --> 00:17:12.236 for instance, 501 00:17:12.237 --> 00:17:15.918 do we have enough information on what the identity of the substance is, 502 00:17:16.722 --> 00:17:19.402 on the hazards or risks to human health or to the environment, 503 00:17:19.425 --> 00:17:20.707 depending on what the proposal is. 504 00:17:22.363 --> 00:17:27.191 Is there justification that this needs to be dealt with at EU level rather than by member states? 505 00:17:28.168 --> 00:17:29.371 The restriction conditions, 506 00:17:29.433 --> 00:17:30.433 are they there? 507 00:17:30.449 --> 00:17:30.668 You know, 508 00:17:30.699 --> 00:17:35.058 there's all sorts of things that we need to check that is actually there before we can start working. 509 00:17:36.339 --> 00:17:36.464 So, 510 00:17:36.839 --> 00:17:36.964 yeah. 511 00:17:37.115 --> 00:17:37.515 Basically, 512 00:17:37.956 --> 00:17:38.717 that's the point. 513 00:17:38.718 --> 00:17:38.957 I mean, 514 00:17:38.977 --> 00:17:41.481 if we try to assess something that's incomplete, 515 00:17:41.559 --> 00:17:43.039 then we run into trouble very quickly. 516 00:17:43.102 --> 00:17:43.422 Indeed, 517 00:17:43.423 --> 00:17:44.344 a very important step. 518 00:17:44.383 --> 00:17:45.344 If you get those wrong, 519 00:17:45.422 --> 00:17:48.188 then the whole thing can go wrong as well. 520 00:17:48.524 --> 00:17:48.946 And indeed, 521 00:17:48.969 --> 00:17:57.930 I think the good news is that both committees concluded that the Chromium 6 proposal is in conformity and therefore the evaluation process can begin and we will see the outcome of it in a few months. 522 00:17:58.774 --> 00:17:58.930 Okay, 523 00:17:58.931 --> 00:17:59.055 well, 524 00:17:59.056 --> 00:17:59.680 that's good news. 525 00:18:00.133 --> 00:18:01.914 The substance does sound very familiar. 526 00:18:01.946 --> 00:18:04.977 I think we've talked about it a lot in the REACH authorization process, 527 00:18:05.039 --> 00:18:05.242 right? 528 00:18:06.095 --> 00:18:06.315 Yeah, 529 00:18:06.576 --> 00:18:06.976 exactly. 530 00:18:06.996 --> 00:18:11.962 We have seen quite a lot of applications for authorization dealing with chromium-6 substances. 531 00:18:11.963 --> 00:18:12.079 So, 532 00:18:12.341 --> 00:18:12.583 you know, 533 00:18:12.642 --> 00:18:14.665 these substances are on the rich authorization list, 534 00:18:14.907 --> 00:18:15.485 as mentioned. 535 00:18:16.024 --> 00:18:18.306 But in September 2023, 536 00:18:18.307 --> 00:18:21.634 the European Commission asked ECHA to prepare a restriction proposal on them. 537 00:18:23.227 --> 00:18:24.509 ECHA did quite a lot of work. 538 00:18:25.118 --> 00:18:26.040 As part of their work, 539 00:18:26.118 --> 00:18:31.165 they identified substances like barium chromate that could be a reversible substitute. 540 00:18:31.166 --> 00:18:32.384 So that's included as well. 541 00:18:33.087 --> 00:18:34.899 And now we have received the restriction. 542 00:18:35.591 --> 00:18:35.811 Okay, 543 00:18:35.972 --> 00:18:36.152 good. 544 00:18:36.272 --> 00:18:45.764 So kind of using the expertise here to build upon the restriction proposal and make it more encompassing and to cover more substances that could result in worse things happening, 545 00:18:45.818 --> 00:18:46.084 actually, 546 00:18:46.085 --> 00:18:47.881 or more regrettable things happening if they substituted. 547 00:18:47.967 --> 00:18:48.342 Exactly. 548 00:18:48.381 --> 00:18:55.873 We have a lot of data here because we have received such a big number of applications for authorization that there's a lot of knowledge in ECHA. 549 00:18:56.092 --> 00:18:57.592 So when preparing the dossier, 550 00:18:57.593 --> 00:18:59.435 a lot of that information was used. 551 00:18:59.873 --> 00:19:02.670 And also in the committees in terms of how things work, 552 00:19:02.904 --> 00:19:04.279 what's the situation in industry. 553 00:19:05.247 --> 00:19:05.368 So, 554 00:19:05.628 --> 00:19:06.048 of course, 555 00:19:06.188 --> 00:19:07.569 this is a restriction proposal. 556 00:19:07.589 --> 00:19:08.690 It's a different process. 557 00:19:09.452 --> 00:19:12.116 The objectives of the process are different as well. 558 00:19:13.538 --> 00:19:14.413 So the challenge, 559 00:19:14.436 --> 00:19:14.655 I think, 560 00:19:14.656 --> 00:19:17.780 for the committees is that to assess this as a restriction, 561 00:19:17.897 --> 00:19:25.343 but also while benefiting from the knowledge base that we've built about how things work in this area. 562 00:19:25.421 --> 00:19:27.468 So I think it's going to be quite an exciting challenge. 563 00:19:27.843 --> 00:19:28.030 Okay, 564 00:19:28.093 --> 00:19:34.171 it's nice to see the data and the knowledge built by ECHA being used more widely than maybe some of the specificities. 565 00:19:34.527 --> 00:19:36.807 specificities of restrictions. 566 00:19:36.887 --> 00:19:39.406 But maybe then the next steps on this, 567 00:19:39.508 --> 00:19:39.949 what are they? 568 00:19:40.648 --> 00:19:40.809 Well, 569 00:19:40.930 --> 00:19:41.469 first of all, 570 00:19:41.730 --> 00:19:44.707 now that the dossier is found in conformity, 571 00:19:44.910 --> 00:19:45.730 as we have said, 572 00:19:46.230 --> 00:19:47.449 we start with a consultation. 573 00:19:47.488 --> 00:19:51.629 So this is a six-month consultation that starts very soon on the 574 00:19:52.129 --> 00:19:52.785 18th of June, 575 00:19:53.473 --> 00:19:55.129 and everyone can take part of it. 576 00:19:56.435 --> 00:19:57.736 And there will be actually, 577 00:19:57.856 --> 00:19:58.398 I understand, 578 00:19:58.437 --> 00:20:06.905 an online information session where participants can ask questions from experts so that they can provide us information that's actually relevant and very, 579 00:20:07.046 --> 00:20:07.827 very targeted. 580 00:20:08.366 --> 00:20:09.991 So what we're looking for here is, 581 00:20:10.046 --> 00:20:11.773 as usual for these cases, 582 00:20:12.538 --> 00:20:13.726 evidence-based information, 583 00:20:14.132 --> 00:20:15.679 data that is scientifically sound. 584 00:20:16.319 --> 00:20:17.288 And then, 585 00:20:17.679 --> 00:20:17.960 you know, 586 00:20:18.069 --> 00:20:20.179 as the consultation starts, 587 00:20:20.241 --> 00:20:22.444 also the opinion making starts in the committee. 588 00:20:22.460 --> 00:20:24.523 So we start considering the proposal. 589 00:20:24.948 --> 00:20:28.191 and also as they come in the consultation comments to come to a final opinion. 590 00:20:29.210 --> 00:20:29.430 Right. 591 00:20:29.750 --> 00:20:34.070 So I guess the tip then for listeners interested in this is to join the info session. 592 00:20:34.093 --> 00:20:34.710 And if you can't, 593 00:20:34.773 --> 00:20:35.491 these are recorded, 594 00:20:35.570 --> 00:20:35.812 right? 595 00:20:36.011 --> 00:20:36.152 Yeah, 596 00:20:36.191 --> 00:20:38.753 they are recorded and then they will be on the ECA website. 597 00:20:38.769 --> 00:20:44.316 So if you're listening to this a little bit later and you would like to see what was said in this information session, 598 00:20:44.331 --> 00:20:45.128 you can go and listen. 599 00:20:45.597 --> 00:20:45.894 All right. 600 00:20:46.081 --> 00:20:46.487 Thanks a lot, 601 00:20:46.534 --> 00:20:46.769 Maria. 602 00:20:47.519 --> 00:20:55.378 Now let's go to BISFINAL-A and how we handle worker safety with occupational exposure limits or OELs. 603 00:20:56.066 --> 00:20:56.647 Can you start, 604 00:20:56.847 --> 00:20:57.227 Roberto, 605 00:20:57.267 --> 00:20:58.688 by explaining what these limits are? 606 00:20:58.710 --> 00:21:00.292 I know we've covered it before, 607 00:21:00.331 --> 00:21:03.655 but just a little brief update on that and what the committee actually does with them. 608 00:21:04.237 --> 00:21:04.534 Sure. 609 00:21:04.612 --> 00:21:05.174 And first, 610 00:21:05.378 --> 00:21:08.479 I'm very glad we are able to talk about this activity. 611 00:21:08.542 --> 00:21:13.464 That's quite a new activity and we don't really often give the right visibility. 612 00:21:13.526 --> 00:21:14.760 And I think it's quite important. 613 00:21:14.761 --> 00:21:24.432 It's about the safety of workers in Europe and the legislation aims to protect them from health risk associated with exposure to hazardous chemicals in the workplace. 614 00:21:25.022 --> 00:21:27.225 And those are those OELs, 615 00:21:27.445 --> 00:21:28.385 what we say in jargon, 616 00:21:28.426 --> 00:21:30.527 so occupational exposure limit values, 617 00:21:30.688 --> 00:21:36.875 are regulatory values which indicate the level of exposure below which workers are considered safe. 618 00:21:37.414 --> 00:21:39.797 So that's very important that they are not exceeded. 619 00:21:40.258 --> 00:21:44.094 But also intended to prevent workers mostly from inhaling chemicals, 620 00:21:44.235 --> 00:21:44.797 vapors, 621 00:21:44.922 --> 00:21:45.266 mists, 622 00:21:45.406 --> 00:21:45.922 or dust. 623 00:21:46.000 --> 00:21:49.031 So let's say the main route of exposure is inhalation. 624 00:21:49.719 --> 00:21:50.266 And how then, 625 00:21:50.594 --> 00:21:51.203 more specifically, 626 00:21:51.281 --> 00:21:53.375 do these limits help ensure worker protection? 627 00:21:53.706 --> 00:21:54.927 across different industries, 628 00:21:54.947 --> 00:21:55.968 but also across the EU. 629 00:21:56.648 --> 00:22:01.691 What is also a bit different is we are not approaching this via the usual REACH and CLP approach, 630 00:22:01.754 --> 00:22:04.738 but there is a different set of regulations, 631 00:22:04.754 --> 00:22:05.558 and to be precise, 632 00:22:05.582 --> 00:22:06.402 are directives. 633 00:22:06.660 --> 00:22:07.761 So it's the Carcinogens, 634 00:22:07.816 --> 00:22:10.441 Mutagens and Reprotoxic Substances Directive, 635 00:22:10.519 --> 00:22:12.379 so-called CMRD, 636 00:22:13.129 --> 00:22:15.347 but also the Chemicals Agents Directive. 637 00:22:15.847 --> 00:22:18.488 And there are also other relevant pieces of legislation, 638 00:22:18.550 --> 00:22:20.457 such as the Directive on Asbestos. 639 00:22:20.842 --> 00:22:25.168 And the European Commission Directorate General in charge of it is DG Employment, 640 00:22:25.625 --> 00:22:29.153 and they are responsible for setting those OELs at European level, 641 00:22:29.309 --> 00:22:31.575 and they rely on the advice of our committee. 642 00:22:32.395 --> 00:22:36.176 And what would you say is the added value of the committee in this process? 643 00:22:36.825 --> 00:22:37.012 Well, 644 00:22:37.043 --> 00:22:41.215 we assess the science and we issue an opinion on scientific facts, 645 00:22:41.403 --> 00:22:44.387 and this will support this commission legislative process. 646 00:22:44.918 --> 00:22:46.512 And besides OEL values, 647 00:22:46.668 --> 00:22:49.871 RAC may also provide recommendations for short term 648 00:22:50.310 --> 00:22:52.830 Limit values are so-called notations, 649 00:22:52.951 --> 00:22:53.631 for instance, 650 00:22:54.051 --> 00:22:56.713 when it goes about possible dermal exposure. 651 00:22:56.811 --> 00:23:04.131 So maybe workers have to protect their skin because exposure can also happen through dermal route. 652 00:23:04.733 --> 00:23:05.256 Additionally, 653 00:23:05.334 --> 00:23:18.014 RAC may recommend other values such as biological limit values or biological guidance values and they are quite important for monitoring purposes to ensure that actually workers are not really exposed to unacceptable limits. 654 00:23:19.398 --> 00:23:22.819 And you assess what's known as an OEL report, 655 00:23:22.918 --> 00:23:23.139 right? 656 00:23:23.158 --> 00:23:24.680 And this is prepared by ECHA. 657 00:23:24.699 --> 00:23:25.680 That's correct. 658 00:23:26.121 --> 00:23:27.180 That's the starting point. 659 00:23:27.219 --> 00:23:32.102 So ECHA collects all possible available information and produce a scientific report. 660 00:23:32.321 --> 00:23:33.899 And this is consulted. 661 00:23:33.961 --> 00:23:38.086 So it's usually published on our website and we give 60 days. 662 00:23:38.149 --> 00:23:43.930 So in what we call an open consultation and all interested parties are invited to provide inputs, 663 00:23:44.008 --> 00:23:44.399 comment, 664 00:23:44.461 --> 00:23:45.383 critical remarks, 665 00:23:45.883 --> 00:23:46.430 and all of that, 666 00:23:46.602 --> 00:23:48.430 it's looked by the RAC in a second. 667 00:23:48.830 --> 00:23:49.150 moment. 668 00:23:49.971 --> 00:23:52.494 So bisphenol A is already well known and regulated. 669 00:23:52.593 --> 00:23:54.976 Some of its uses are restricted in the EU because of reach. 670 00:23:55.058 --> 00:24:02.925 It's even on the candidate list for substance of very high concern and classified for things like harm and reproduction and causing serious eye damage. 671 00:24:03.527 --> 00:24:07.886 Why is it important to continue refining how we regulate substances like BPA, 672 00:24:08.089 --> 00:24:09.433 even when they're already well known? 673 00:24:10.324 --> 00:24:10.464 Well, 674 00:24:10.496 --> 00:24:11.449 that's a good question. 675 00:24:12.308 --> 00:24:16.652 The short answer is probably that it's up to the European Commission to select the 676 00:24:16.810 --> 00:24:19.434 kind of substances that should go through this process. 677 00:24:20.193 --> 00:24:20.812 And of course, 678 00:24:20.836 --> 00:24:23.398 this is very important because OELs are binding. 679 00:24:23.399 --> 00:24:27.023 So it means that they become immediately applicable across various member states. 680 00:24:27.039 --> 00:24:30.703 So they are directly enforceable and quite a powerful tool. 681 00:24:31.188 --> 00:24:34.344 And also scientific information is rapidly progressing. 682 00:24:34.422 --> 00:24:39.719 So what was known 10 years ago might now not be sufficient to ensure the protection of workers. 683 00:24:40.000 --> 00:24:40.156 Right. 684 00:24:40.656 --> 00:24:44.812 And now we're also talking about getting a mandatory OEL as well here, 685 00:24:44.859 --> 00:24:45.078 right? 686 00:24:45.531 --> 00:24:46.078 That's correct. 687 00:24:46.314 --> 00:24:48.676 That's the way this regulatory framework works. 688 00:24:48.916 --> 00:24:55.907 Maybe the news that's interesting is the focus in the past was on substances that were considered carcinogens or mutagenic. 689 00:24:56.500 --> 00:24:59.024 Now the focus is also on reproductive toxicants. 690 00:24:59.547 --> 00:25:01.789 And so also for those kinds of substances, 691 00:25:01.930 --> 00:25:03.844 an OEL is considered mandatory. 692 00:25:03.985 --> 00:25:04.735 And for BPA, 693 00:25:04.969 --> 00:25:10.922 we have an indicative OEL value of two milligram per cubic meter of inalienable air. 694 00:25:11.426 --> 00:25:16.781 but now new data have become available so this is why a new assessment has become relevant 695 00:25:17.488 --> 00:25:21.451 And is there anything you could share with us and our listeners about RAC's conclusions? 696 00:25:22.091 --> 00:25:22.353 Sure. 697 00:25:22.615 --> 00:25:26.599 So the exposure of workers have been identified through manufacture, 698 00:25:26.615 --> 00:25:28.599 but also use and production of polymers. 699 00:25:29.177 --> 00:25:32.880 And there is an important use as an additive in various applications, 700 00:25:32.904 --> 00:25:34.919 including the production of other chemicals. 701 00:25:35.482 --> 00:25:42.951 And the RAC main recommendation is an OEL that is two order of magnitude lower of the indicative limit value I mentioned earlier. 702 00:25:44.840 --> 00:25:48.484 24 milligram of cubic meter over an eight hour period. 703 00:25:48.863 --> 00:25:53.972 So this is considered the level that should not be exceeded along the eight hour measurement periods. 704 00:25:54.409 --> 00:25:56.488 And this should guarantee the safety of workers. 705 00:25:56.489 --> 00:25:57.253 So it's quite... 706 00:25:57.550 --> 00:26:05.753 So how do you maintain sort of scientific clarity when different agencies work in different regulatory frameworks and you all have to come together with opinions? 707 00:26:05.784 --> 00:26:06.347 How does that work? 708 00:26:06.566 --> 00:26:08.863 That's a good question because on bisphenol A, 709 00:26:09.003 --> 00:26:12.894 there's been a lot of activity in the past from what we call sister agencies, 710 00:26:12.972 --> 00:26:13.956 such as EFSA, 711 00:26:14.544 --> 00:26:16.645 So the Food and Safety Agency or EMA, 712 00:26:16.905 --> 00:26:18.444 the European Medicine Agency, 713 00:26:18.964 --> 00:26:22.569 and they looked at the substance from different regulatory aspects. 714 00:26:22.663 --> 00:26:23.186 For instance, 715 00:26:23.546 --> 00:26:24.405 from the food safety, 716 00:26:24.764 --> 00:26:29.303 you would say that the oral exposure is much more relevant than inhalation exposure, 717 00:26:29.366 --> 00:26:30.225 such in our case. 718 00:26:30.882 --> 00:26:31.928 And what we have done, 719 00:26:32.007 --> 00:26:38.710 we have ensured also transparently the possibility for them to participate and to follow the progress of our discussion. 720 00:26:39.163 --> 00:26:41.835 And I think this resulted also in really 721 00:26:42.709 --> 00:26:45.932 benchmarking and making sure that everybody is on board. 722 00:26:47.051 --> 00:26:47.235 Okay, 723 00:26:47.293 --> 00:26:47.512 thanks. 724 00:26:47.594 --> 00:26:49.954 And I guess then in terms of the next steps, 725 00:26:50.075 --> 00:26:54.118 this one is a little bit different to the other next steps that we've covered here. 726 00:26:54.157 --> 00:26:55.141 So for restrictions, 727 00:26:55.461 --> 00:26:56.946 commission with the EU countries decide, 728 00:26:56.947 --> 00:26:59.985 but here because there's other legislation involved, 729 00:27:01.001 --> 00:27:01.547 how does it work? 730 00:27:01.594 --> 00:27:02.454 How does the decision come up? 731 00:27:02.455 --> 00:27:02.594 Yeah, 732 00:27:02.595 --> 00:27:10.360 probably the main difference here that the framework is done by directives and directives they work differently compared to regulations such as the REACH or CLP. 733 00:27:11.348 --> 00:27:12.650 The starting point is the same, 734 00:27:12.730 --> 00:27:25.504 so we will send our opinion to the European Commission and there will be some preparatory work and this is carried out in an advisory committee on safety and health at work that is advising DG employment. 735 00:27:25.926 --> 00:27:31.832 This also includes a sort of impact assessment that is carried out with the participation of industry, 736 00:27:32.035 --> 00:27:32.426 workers' 737 00:27:32.457 --> 00:27:34.035 group and member state authorities. 738 00:27:34.566 --> 00:27:35.176 And eventually, 739 00:27:35.207 --> 00:27:40.410 so an OEL for BPA will be included in a binding EU directive changes So, 740 00:27:40.411 --> 00:27:40.769 uh, 741 00:27:40.868 --> 00:27:43.748 update that will be carried out later on by the Commission. 742 00:27:44.369 --> 00:27:44.828 So in a way, 743 00:27:44.848 --> 00:27:45.891 it's not that different, 744 00:27:45.989 --> 00:27:50.168 but being through what is called ordinary legislative procedure, 745 00:27:50.309 --> 00:27:52.809 also European Council and Parliament will be involved. 746 00:27:52.810 --> 00:27:54.653 So it's a quite lengthy process, 747 00:27:55.012 --> 00:27:58.614 but this ensures that all parties actually have a fair chance to intervene. 748 00:27:59.067 --> 00:27:59.270 Okay, 749 00:27:59.286 --> 00:28:00.332 so to put it simply, 750 00:28:00.457 --> 00:28:03.332 the Committee's job is to go through all the scientific data, 751 00:28:03.911 --> 00:28:06.379 figure out recommendations for these OELs, 752 00:28:06.457 --> 00:28:08.567 and then pass that on to the European Commission. 753 00:28:08.936 --> 00:28:11.136 who then takes it from there to make its final decision. 754 00:28:12.376 --> 00:28:15.798 Is there anything else you'd like to highlight from the Risk Assessment Committee's work, 755 00:28:16.138 --> 00:28:18.021 maybe on harmonized classification labeling? 756 00:28:18.240 --> 00:28:18.459 Yeah, 757 00:28:18.521 --> 00:28:21.537 if you allow me maybe to finish the podcast. 758 00:28:21.560 --> 00:28:25.599 I think I would like to signal the good progress we made on some CLH dossier, 759 00:28:25.693 --> 00:28:29.162 but also the workload keep us quite busy. 760 00:28:29.318 --> 00:28:32.240 We have more than 50 CLH dossier every year, 761 00:28:32.443 --> 00:28:34.959 and we are facing some delays in the finalization of the... 762 00:28:35.024 --> 00:28:36.645 opinions that have been already adopted. 763 00:28:36.646 --> 00:28:44.555 And I think it's important to inform our listeners that some cases such as talk or burgeoning and cyclamal opinions are late, 764 00:28:44.633 --> 00:28:50.719 so we are working hard to complete swiftly them and to send them to the commission and then to publish on our website. 765 00:28:51.102 --> 00:28:54.180 So we open a few months to absorb such a workload peak, 766 00:28:54.290 --> 00:28:55.305 so be patient, 767 00:28:55.383 --> 00:28:56.040 stay tuned, 768 00:28:56.165 --> 00:29:00.290 and we are working hard to make sure that this information will become available as soon as possible. 769 00:29:00.728 --> 00:29:00.968 Okay, 770 00:29:01.028 --> 00:29:01.289 thank you. 771 00:29:01.290 --> 00:29:01.389 Well, 772 00:29:01.390 --> 00:29:02.951 that's a perfect wrap up for the podcast. 773 00:29:02.971 --> 00:29:05.092 I don't think I need to do my usual spiel, 774 00:29:05.111 --> 00:29:06.252 but I'm going to do it anyway. 775 00:29:06.315 --> 00:29:07.736 So that's it for today. 776 00:29:07.877 --> 00:29:13.697 Big thanks to Maria and Roberto again for joining us today and sharing all that useful info going very much into detail, 777 00:29:13.721 --> 00:29:15.299 which I'm sure our listeners will appreciate. 778 00:29:15.682 --> 00:29:19.494 We'll catch up with you again after the summer break for the September committees. 779 00:29:20.088 --> 00:29:20.229 Now, 780 00:29:20.291 --> 00:29:22.885 we've got a lot of interesting stuff still coming up for you this year, 781 00:29:22.947 --> 00:29:23.291 including, 782 00:29:23.307 --> 00:29:23.651 of course, 783 00:29:23.652 --> 00:29:26.526 the regular committee updates and a few surprises on the way as well. 784 00:29:26.635 --> 00:29:29.697 So make sure to subscribe to our news so you don't miss our upcoming episodes. 785 00:29:30.004 --> 00:29:31.285 and follow us on social media. 786 00:29:31.706 --> 00:29:33.709 Thanks for tuning in and see you next time. 787 00:29:33.947 --> 00:29:34.388 Bye for now. 788 00:29:35.291 --> 00:29:36.990 Safer Chemicals Podcast. 789 00:29:37.713 --> 00:29:39.834 Sound science on harmful chemicals.