WEBVTT 1 00:00:00.329 --> 00:00:02.037 Safer Chemicals Podcast. 2 00:00:02.760 --> 00:00:04.788 Sound science on harmful chemicals. 3 00:00:09.630 --> 00:00:10.093 Recently, 4 00:00:10.294 --> 00:00:12.568 we've seen a change in attitude from the authorities. 5 00:00:13.128 --> 00:00:19.268 They're no longer shy to propose non-authorisation or non-approval at the moment a dossier is incomplete. 6 00:00:20.648 --> 00:00:28.268 Applicants really should take note of this and take a critical look at the dossiers they've submitted in the past or are going to submit in the near future. 7 00:00:29.116 --> 00:00:36.056 It really should be clear by now that it's the sole responsibility of the applicant to make sure that their dossier is complete. 8 00:00:37.940 --> 00:00:39.756 Welcome to the Safer Chemicals Podcast. 9 00:00:40.817 --> 00:00:44.736 Our Biocidal Products Committee met again during the last week of May. 10 00:00:45.236 --> 00:00:47.563 And today I'm joined by the committee Chair, 11 00:00:47.944 --> 00:00:48.907 Joost van Galen, 12 00:00:49.368 --> 00:00:52.096 to discuss the most important items of this meeting. 13 00:00:53.050 --> 00:01:03.668 The committee's task is to prepare scientific opinions for the European Commission on biocidal active substances and on EU-wide authorisations on biocidal products. 14 00:01:04.449 --> 00:01:08.288 The Commission then takes the final decision based on these opinions. My name is Päivi Jokiniemi and in this episode we will discuss for example what happens when the assessment of endocrine disrupting properties is lacking from the applications and we'll also come back to the topic of data gaps and missing information. 15 00:01:25.650 --> 00:01:27.980 But to start with I'd like to welcome Joost. 16 00:01:28.483 --> 00:01:29.588 Thank you for joining us again. 17 00:01:30.148 --> 00:01:30.269 Thank you for the invite and nice to be here again. 18 00:01:33.558 --> 00:01:36.244 So it's fair to say that you've had a packed meeting. 19 00:01:36.484 --> 00:01:37.887 If I counted correct, 20 00:01:38.508 --> 00:01:42.516 you adopted altogether 18 opinions during the May meeting. 21 00:01:42.897 --> 00:01:45.024 Before we go into more details, 22 00:01:45.526 --> 00:01:48.256 what's your spontaneous reflection after the meeting? 23 00:01:49.207 --> 00:01:49.367 Yeah, 24 00:01:49.447 --> 00:01:49.768 I think, 25 00:01:50.329 --> 00:01:50.590 for me, 26 00:01:50.670 --> 00:01:51.091 for sure, 27 00:01:51.091 --> 00:01:52.234 it was an all-time high, 28 00:01:52.394 --> 00:01:52.515 but 29 00:01:53.136 --> 00:01:56.464 I'm not quite sure whether in the past we ever had more than that. 30 00:01:57.004 --> 00:01:58.790 So it was a really nice meeting. 31 00:01:58.790 --> 00:01:59.030 It was, 32 00:01:59.151 --> 00:01:59.412 again, 33 00:01:59.432 --> 00:02:03.444 a physical meeting here in Helsinki and a really nice way to go on top of it. 34 00:02:03.644 --> 00:02:03.765 So, yeah, 35 00:02:04.750 --> 00:02:07.162 this was really one of the better meetings, 36 00:02:07.202 --> 00:02:07.524 I would say. 37 00:02:08.104 --> 00:02:09.911 As there were so many opinions this time, 38 00:02:09.951 --> 00:02:13.164 I was thinking that we wouldn't go through all of them case by case. 39 00:02:13.679 --> 00:02:19.096 But we'd focus on some themes that you saw repeating during this meeting in many applications. 40 00:02:20.119 --> 00:02:20.279 Well, 41 00:02:20.319 --> 00:02:23.287 maybe we can start with active substances actually. 42 00:02:24.109 --> 00:02:24.350 Indeed, 43 00:02:24.370 --> 00:02:25.432 we discussed four of them. 44 00:02:26.876 --> 00:02:31.976 Two of them were actually renewals and that's what we are going to see much more often. 45 00:02:32.096 --> 00:02:38.479 Until now we've seen quite some of the new active substances and active substances from the review programme, 46 00:02:38.519 --> 00:02:44.080 but now it's really getting up to speed with the renewals of the active substances as well. 47 00:02:44.904 --> 00:02:45.647 We discussed two, 48 00:02:45.989 --> 00:02:47.656 medetomidine and dinotefuran. 49 00:02:48.186 --> 00:02:53.274 For medetomidine it's important to realise it's an anti-fouling paint, 50 00:02:53.715 --> 00:02:55.899 that substance will be used in anti-fouling paints, 51 00:02:57.221 --> 00:02:58.643 and it's an endocrine disruptor. 52 00:03:00.167 --> 00:03:04.402 So in that sense it's of additional concern. 53 00:03:06.051 --> 00:03:11.227 Sufficient alternatives were found actually by the member state that did the evaluation, 54 00:03:11.568 --> 00:03:15.365 so that's also recognised in our opinion. 55 00:03:16.148 --> 00:03:17.151 For dinotefuran, 56 00:03:17.692 --> 00:03:20.178 not sufficient alternatives were found, 57 00:03:20.399 --> 00:03:22.584 so also that is written down clearly. 58 00:03:23.988 --> 00:03:26.738 Then we also discussed polymeric betaine, 59 00:03:26.919 --> 00:03:29.308 which was a substance from the review programme. 60 00:03:30.927 --> 00:03:40.344 And that has now been finalised and the opinion is actually proposing approval of this active substance. 61 00:03:41.502 --> 00:03:56.500 It's a wood preservative for which now two use classes have been proposed for approval out of five and it's only uses that are indoors or under covering. 62 00:03:58.222 --> 00:04:04.720 So that may mean actually that at the moment that products will be authorised and will be assessed for other use classes, 63 00:04:05.241 --> 00:04:08.980 probably that needs to be assessed a bit deeper than would normally be the case. 64 00:04:11.012 --> 00:04:13.136 Then we talked about CIT, 65 00:04:13.437 --> 00:04:27.680 which is a new active substance and for that a non-approval proposal is in the opinion based on the fact that not sufficient information was available on endocrine disruption criteria. 66 00:04:28.528 --> 00:04:33.306 So that concludes what we discussed on active substances. 67 00:04:33.788 --> 00:04:36.122 Yes and seven Union authorisation cases. 68 00:04:37.231 --> 00:04:38.346 As usual, 69 00:04:40.265 --> 00:04:43.736 I would almost say the discussions on the Union authorisations were quite smooth. 70 00:04:44.880 --> 00:04:51.757 We had one non-authorisation and it was based on missing information on efficacy. 71 00:04:52.983 --> 00:04:53.673 And yeah, 72 00:04:53.652 --> 00:04:54.180 this was a bit... 73 00:04:54.916 --> 00:04:55.639 This was the only 74 00:04:57.242 --> 00:05:05.168 case where the discussions were a bit more in-depth and I think the other cases the discussions went very smooth. 75 00:05:06.419 --> 00:05:15.313 In general it's a bit of a shame that information is lacking and therefore a non-authorisation should be proposed. 76 00:05:16.379 --> 00:05:23.832 The data requirements are quite clear and they have not changed since the entry into force of the BPR. 77 00:05:24.580 --> 00:05:24.787 So 78 00:05:25.527 --> 00:05:30.923 We hope that actually applicants will pay a bit better attention to those data requirements. 79 00:05:31.824 --> 00:05:35.523 This is actually something that we have touched upon already earlier. 80 00:05:36.083 --> 00:05:38.391 So at the end of 2023, we had this same discussion in one of the episodes. 81 00:05:42.546 --> 00:05:43.494 So data gaps, 82 00:05:43.675 --> 00:05:44.583 missing information. 83 00:05:46.005 --> 00:05:50.703 And this now turned out to be another common theme in this meeting. 84 00:05:51.622 --> 00:05:58.399 Do you still see the same trends as earlier with the missing information or is there something else that tops the lists now? 85 00:05:59.395 --> 00:05:59.515 No, 86 00:05:59.896 --> 00:06:04.171 I think the message that I gave back then still stands. 87 00:06:04.251 --> 00:06:07.711 And it's a bit unfortunate that I have to come back to it over and over. 88 00:06:08.171 --> 00:06:08.717 Because, 89 00:06:08.717 --> 00:06:08.980 I mean, 90 00:06:09.060 --> 00:06:10.031 it's avoidable. 91 00:06:10.693 --> 00:06:13.511 What I also mentioned last podcast. 92 00:06:14.432 --> 00:06:15.821 The data requirements are there, 93 00:06:16.022 --> 00:06:17.511 have been in place for quite a while, 94 00:06:17.891 --> 00:06:19.510 and simply need to be adhered to. 95 00:06:20.192 --> 00:06:23.011 What we have seen in the past is that member states gave 96 00:06:23.699 --> 00:06:40.073 multiple rounds of providing that additional data just informed the applicant over and over again now you need to provide this data and without we cannot take a decision etc and what we've seen is that this has caused a lot of delays as well in 97 00:06:40.052 --> 00:06:42.442 the finalisation of the applications. 98 00:06:45.295 --> 00:06:48.514 New from now on I think is that member states are more 99 00:06:49.388 --> 00:06:53.283 open to actually propose non-authorisation and non-approvals. 100 00:06:53.886 --> 00:06:56.722 And that's what we are seeing more and more, 101 00:06:57.487 --> 00:07:00.123 that member states are not shy anymore to say like, 102 00:07:00.204 --> 00:07:00.425 okay, 103 00:07:00.707 --> 00:07:02.016 we have asked for the information, 104 00:07:02.036 --> 00:07:03.043 you have not provided it, 105 00:07:03.505 --> 00:07:04.290 then from now on, 106 00:07:04.451 --> 00:07:06.543 this is a non-authorisation or a non-approval. 107 00:07:06.845 --> 00:07:08.921 And that's what applicants need to be 108 00:07:09.986 --> 00:07:30.202 aware of that maybe there is a bit of change in attitude and I think it would be worthwhile for many applicants to look at their dossier proactively so not waiting for the member state to come back at them but really look at your own dossier right now with fresh eyes and be critical of what you have submitted. 109 00:07:31.169 --> 00:07:32.632 Maybe you will find out that, 110 00:07:33.274 --> 00:07:33.594 well, 111 00:07:35.097 --> 00:07:36.901 your dossier was not fully complete, 112 00:07:36.941 --> 00:07:39.627 not as complete as you thought it was when you submitted it. 113 00:07:40.590 --> 00:07:40.710 And 114 00:07:41.472 --> 00:07:48.959 I would advise all applicants to proactively contact their member state and discuss with them what can be done. 115 00:07:49.827 --> 00:07:51.778 And I think that would be a good way forward. 116 00:07:53.447 --> 00:07:58.306 It's not the responsibility of the member state to ensure that the dossier is complete. 117 00:07:58.567 --> 00:08:00.382 That really is the responsibility of the applicant. 118 00:08:01.027 --> 00:08:01.148 So 119 00:08:01.972 --> 00:08:04.426 I would like to remind all applicants of that. 120 00:08:05.531 --> 00:08:06.856 This is your responsibility. 121 00:08:07.318 --> 00:08:11.332 Make sure that your dossier is complete before you submit it preferably. 122 00:08:11.753 --> 00:08:12.516 But also now, 123 00:08:12.837 --> 00:08:13.760 if you look at it, 124 00:08:13.900 --> 00:08:15.385 at your dossier and hinsight, 125 00:08:15.646 --> 00:08:17.414 is this really what you wanted to submit? 126 00:08:17.474 --> 00:08:19.785 Are you really still satisfied with what you submitted? 127 00:08:20.307 --> 00:08:20.638 And if not, 128 00:08:21.502 --> 00:08:22.895 maybe you should undertake some action. 129 00:08:23.475 --> 00:08:27.335 And there is a lot of support also available for companies. 130 00:08:27.475 --> 00:08:30.055 So if you are preparing an application, 131 00:08:31.161 --> 00:08:32.555 you can find support material. 132 00:08:32.655 --> 00:08:33.635 What would you recommend? 133 00:08:34.457 --> 00:08:36.615 We've also discussed this already earlier, 134 00:08:36.675 --> 00:08:39.515 but maybe we can just give a short reminder. 135 00:08:39.636 --> 00:08:46.406 What are those top three resources that companies should take a look at when they are preparing, 136 00:08:46.607 --> 00:08:47.615 before they are submitting, 137 00:08:47.895 --> 00:08:50.535 just to go through before you finalise? 138 00:08:51.043 --> 00:08:51.163 Yeah, 139 00:08:51.204 --> 00:08:54.079 I think it's important to look at the BPR first. 140 00:08:54.519 --> 00:08:54.761 I mean, 141 00:08:54.761 --> 00:08:55.445 in the BPR, 142 00:08:55.486 --> 00:08:57.459 there are annexes with the data requirements. 143 00:08:57.679 --> 00:09:00.879 There it's set what is a core data set and what is not. 144 00:09:01.200 --> 00:09:03.119 The core data set simply needs to be there. 145 00:09:03.499 --> 00:09:08.419 So then you already know which data points you must cover in your dossier. 146 00:09:09.140 --> 00:09:12.539 Then there are all kinds of guidance documents on our website. 147 00:09:12.899 --> 00:09:14.547 There is guidance on the procedure, 148 00:09:14.888 --> 00:09:17.079 which is an important one as well. 149 00:09:17.783 --> 00:09:20.098 And there are plenty of guidance documents on the data that needs to be provided. 150 00:09:23.800 --> 00:09:24.263 Finally, 151 00:09:24.485 --> 00:09:29.279 there is the possibility to have early working group discussions. 152 00:09:29.559 --> 00:09:30.022 For instance, 153 00:09:30.042 --> 00:09:36.319 if you are having a bit of a discussion between the member state and the applicant, 154 00:09:37.568 --> 00:09:52.567 such a discussion can actually be forwarded to an early working group discussion so that during the working group there can already be an exchange of thoughts between the other member states on what they think of the data that has been provided and the assessment that has been performed. 155 00:09:53.129 --> 00:09:59.767 So there's plenty of support going on for the member states and for the applicants. 156 00:10:00.127 --> 00:10:04.867 So we would actually encourage everybody to make use of all those possibilities. 157 00:10:05.893 --> 00:10:11.850 So really no excuses not to prepare a full dossier and send it to us. 158 00:10:12.170 --> 00:10:12.571 Exactly. 159 00:10:12.611 --> 00:10:15.196 And what perhaps is also nice to mention, 160 00:10:15.917 --> 00:10:16.879 before the end of this month, 161 00:10:16.979 --> 00:10:23.010 the member state should have requested the information on the endocrine disruption criteria. 162 00:10:23.770 --> 00:10:28.522 So at the moment if you have not heard anything from your member state, 163 00:10:28.943 --> 00:10:31.649 get in touch with them and make sure that they know what they want with regards to endocrine disruption. 164 00:10:36.166 --> 00:10:37.393 And I would also like to flag that 165 00:10:38.338 --> 00:10:39.524 ECHA and the member states, 166 00:10:40.586 --> 00:10:44.642 behind the scenes, are in direct contact with each other on this. 167 00:10:44.682 --> 00:10:51.802 So we are providing support to the member states to really define what needs to be provided and by what date. 168 00:10:52.422 --> 00:10:53.246 And on that note, 169 00:10:53.246 --> 00:10:56.382 we actually come to the next point that I wanted to discuss with you. 170 00:10:56.922 --> 00:11:01.362 So the endocrine disrupting properties and the assessment related to that. 171 00:11:01.843 --> 00:11:05.761 That seems to be another big theme of this meeting, 172 00:11:05.841 --> 00:11:06.022 right? 173 00:11:06.544 --> 00:11:06.665 Yeah, actually it has been a big theme for years already and that's the reason why I already flagged, 174 00:11:13.901 --> 00:11:14.061 right? 175 00:11:16.468 --> 00:11:18.493 Take a look at your dossier proactively. 176 00:11:18.854 --> 00:11:24.386 Take a look with the guidance next to it and really see whether what you submitted was the right thing. 177 00:11:25.408 --> 00:11:27.732 And get in touch with the Member States. 178 00:11:27.732 --> 00:11:33.543 And if the Member State maybe is a bit uncertain as well about what needs to be done, 179 00:11:33.843 --> 00:11:35.286 they can always get in touch with us. 180 00:11:35.426 --> 00:11:40.965 And I think we need to do this together and we at ECHA are definitely ready for it. 181 00:11:41.446 --> 00:11:44.481 And I hope that the applicants and the Member States 182 00:11:44.887 --> 00:11:48.302 are also ready for it and will engage with us. 183 00:11:49.163 --> 00:11:49.866 But what do you think, 184 00:11:50.027 --> 00:11:56.362 what is the reason behind this increasing number of applications that are now missing the ED assessment? 185 00:11:57.462 --> 00:12:04.262 What we are seeing is that actually the member states are a bit more proactive in moving forward. 186 00:12:06.142 --> 00:12:11.782 And quite often what happened in the past was that member states were internalising the problems, 187 00:12:11.902 --> 00:12:12.781 trying to solve it. 188 00:12:13.557 --> 00:12:19.954 themselves and that I have the feeling that there is a bit of a change in attitude there. 189 00:12:20.154 --> 00:12:20.456 I mean, 190 00:12:20.998 --> 00:12:22.283 Member States are not trying to, 191 00:12:22.444 --> 00:12:24.091 are trying less to solve themselves, 192 00:12:24.111 --> 00:12:28.264 but are more open to discuss with us and 193 00:12:28.325 --> 00:12:30.631 more open to finalise assessments, 194 00:12:30.692 --> 00:12:30.892 right? 195 00:12:31.514 --> 00:12:31.899 I mean, 196 00:12:32.040 --> 00:12:32.991 Member States have been 197 00:12:34.192 --> 00:12:40.084 Maybe at the center of criticism for delays in the review program, 198 00:12:40.245 --> 00:12:42.790 delays in all kinds of processes. 199 00:12:43.650 --> 00:12:43.851 And 200 00:12:44.412 --> 00:12:50.590 I think what member states are doing right now is they're actually finalising assessments with the data that's there. 201 00:12:51.311 --> 00:12:54.170 And that may actually be quite detrimental for the applicants. 202 00:12:54.756 --> 00:12:55.483 In the past, 203 00:12:57.831 --> 00:13:02.586 I have a history of working for a competent authority as well. 204 00:13:02.987 --> 00:13:05.252 And what happened in the past that we went back and forth, 205 00:13:05.292 --> 00:13:05.894 back and forth, 206 00:13:05.934 --> 00:13:07.297 back and forth with applicants, 207 00:13:07.578 --> 00:13:10.525 trying to get all the information gradually in. 208 00:13:11.866 --> 00:13:18.086 And what I'm seeing right now is that Member States maybe give less opportunities to the applicants. 209 00:13:18.686 --> 00:13:21.446 So that should be a message to the applicants. 210 00:13:21.832 --> 00:13:22.177 I mean, 211 00:13:22.339 --> 00:13:22.786 at the moment. 212 00:13:23.654 --> 00:13:27.365 The Member State is really asking for certain information, 213 00:13:27.766 --> 00:13:30.033 take that seriously and provide that information. 214 00:13:30.053 --> 00:13:32.805 If it's not clear to you what they actually mean, 215 00:13:33.267 --> 00:13:34.051 get in touch with them. 216 00:13:34.332 --> 00:13:36.921 Don't guess and send something that's incomplete. 217 00:13:37.664 --> 00:13:39.671 Get in touch with your Member State, 218 00:13:40.314 --> 00:13:44.008 ask for an explanation and at the moment that it's clear what you need to provide, 219 00:13:44.590 --> 00:13:45.634 provide it within the deadline. 220 00:13:46.015 --> 00:13:48.605 And by doing so you can avoid unfortunate situations where your application actually results in a non-authorisation or non-approval. 221 00:13:56.969 --> 00:14:00.382 So time for companies to step up their game a little bit. 222 00:14:01.004 --> 00:14:01.586 I would say so. 223 00:14:01.686 --> 00:14:02.288 You would say so. 224 00:14:03.551 --> 00:14:17.153 Is there anything else than the endocrine disrupting properties assessment that you would like to kind of highlight when it comes to these missing information and data gaps? 225 00:14:17.293 --> 00:14:18.917 Is there anything else that you feel that 226 00:14:19.805 --> 00:14:27.398 you'd like to tell the companies that pay attention to this or remember that when you're preparing your application? 227 00:14:28.019 --> 00:14:32.998 What is important to realise is that the assessment initially needs to be performed by the applicant. 228 00:14:33.801 --> 00:14:41.395 And what my key message would be to the applicant and also to the consultants that are supporting the applicants is 229 00:14:43.412 --> 00:14:52.910 be honest to yourself and don't try to make your assessment fit what you hope the outcome will be. 230 00:14:53.651 --> 00:14:54.092 Instead, 231 00:14:54.413 --> 00:14:59.550 really look at the data that you have and perform your assessment accordingly. 232 00:15:00.030 --> 00:15:03.529 And maybe the outcome will not be what you hope it will be. 233 00:15:04.252 --> 00:15:04.580 However, 234 00:15:04.580 --> 00:15:04.949 it may 235 00:15:05.873 --> 00:15:20.539 avoid disappointments in the future because the authorities really will look at it in a critical way and they will find out where corners have been cut so I think that that would be the take-home message, be honest with yourself and 236 00:15:20.620 --> 00:15:25.488 avoid disappointments. And another reminder what companies should remember is that they actually need to include the proof, 237 00:15:31.865 --> 00:15:32.647 the evidence, 238 00:15:33.609 --> 00:15:34.431 in their dossiers. 239 00:15:34.631 --> 00:15:38.281 So it's not enough to know that something is fine, 240 00:15:38.341 --> 00:15:39.705 something is efficacious, 241 00:15:39.886 --> 00:15:41.570 but you need to actually prove it, 242 00:15:41.630 --> 00:15:41.831 right? 243 00:15:42.738 --> 00:15:42.979 Yes, 244 00:15:43.059 --> 00:15:45.625 and that needs to be proven over and over again. 245 00:15:46.127 --> 00:15:47.791 You may think like, 246 00:15:47.831 --> 00:15:48.112 okay, 247 00:15:48.553 --> 00:15:50.881 a similar product has already been authorised, 248 00:15:50.881 --> 00:15:53.652 so why do I need to provide the data? 249 00:15:53.994 --> 00:15:54.977 But that's a requirement. 250 00:15:55.178 --> 00:16:01.400 Every company for themselves needs to show that their products are efficacious and that it's safe to use. 251 00:16:01.700 --> 00:16:01.981 I mean, 252 00:16:02.162 --> 00:16:07.279 that's the requirement that the BPR sets on every single company. 253 00:16:07.601 --> 00:16:10.014 That's the requirement for every single dossier. 254 00:16:10.316 --> 00:16:10.504 So make sure that your dossier is complete. 255 00:16:14.031 --> 00:16:15.159 The message is not like, 256 00:16:15.300 --> 00:16:15.481 hey, 257 00:16:15.743 --> 00:16:16.166 companies, 258 00:16:16.206 --> 00:16:16.951 you're doing bad. 259 00:16:17.051 --> 00:16:17.831 You need to do better. 260 00:16:17.951 --> 00:16:18.112 I mean, 261 00:16:18.293 --> 00:16:21.611 that's not the purpose of the message that I just gave. 262 00:16:22.072 --> 00:16:27.238 The purpose is to identify what everybody's responsibilities are and that in the end, 263 00:16:27.238 --> 00:16:29.051 we all follow up on our responsibilities. 264 00:16:29.511 --> 00:16:30.218 That's the applicants, 265 00:16:30.259 --> 00:16:31.026 that's the Member States, 266 00:16:31.067 --> 00:16:31.471 that's ECHA. 267 00:16:31.651 --> 00:16:32.550 Together we can do this. 268 00:16:33.861 --> 00:16:35.686 That was a strong message to companies, 269 00:16:35.887 --> 00:16:36.488 also to, 270 00:16:36.589 --> 00:16:37.190 as you said, 271 00:16:37.571 --> 00:16:40.439 consultants helping out companies in these issues. 272 00:16:41.284 --> 00:16:42.099 Take this seriously. 273 00:16:42.842 --> 00:16:44.819 Take a look at the material that is available. 274 00:16:45.379 --> 00:16:55.599 Contact your competent authority if you need help and make sure that your application is complete before you submit it. 275 00:16:55.700 --> 00:16:57.459 And also you mentioned the timelines. 276 00:16:57.659 --> 00:17:02.759 Make sure you send your updates in time and without delay. 277 00:17:03.242 --> 00:17:10.739 And I think that's an important one because you should not only focus on the guidance with regards to the information requirements. 278 00:17:10.839 --> 00:17:15.059 What we see quite often is that companies are complaining that they don't get more chances. 279 00:17:15.639 --> 00:17:15.920 However, 280 00:17:17.706 --> 00:17:21.899 the procedures are very clear and there are documents available 281 00:17:22.876 --> 00:17:30.335 on our website that really explain during which parts of the procedure you're actually able to submit new information. 282 00:17:30.375 --> 00:17:33.555 And that's a very limited number of possibilities. 283 00:17:34.375 --> 00:17:36.535 And that's what some companies don't realise. 284 00:17:36.955 --> 00:17:37.216 I mean, 285 00:17:37.799 --> 00:17:41.175 you are allowed to submit information when you submit your application, 286 00:17:42.137 --> 00:17:43.847 once during the validation, 287 00:17:44.008 --> 00:17:45.195 once during the evaluation. 288 00:17:46.098 --> 00:17:49.467 And then if the working group thinks it's necessary, 289 00:17:49.768 --> 00:17:52.075 you can get a fourth possibility 290 00:17:52.728 --> 00:17:55.419 within 10 working days after the working group. 291 00:17:55.1000 --> 00:17:56.682 But that's it. 292 00:17:56.842 --> 00:18:03.039 Those are all the possibilities that you get within a process to submit new information. 293 00:18:03.960 --> 00:18:10.319 And that's what we see quite often at the moment that non-authorisation or non-approval is being proposed. 294 00:18:10.739 --> 00:18:11.623 That companies are like, 295 00:18:11.864 --> 00:18:11.985 yeah, 296 00:18:12.025 --> 00:18:15.099 but I have some more information here and I would like to submit it. 297 00:18:15.440 --> 00:18:15.560 That's super nice, 298 00:18:16.703 --> 00:18:17.766 but I mean, 299 00:18:18.809 --> 00:18:22.359 it's not possible anymore in the process that we have. 300 00:18:22.721 --> 00:18:24.312 And that's what you need to realise. 301 00:18:24.533 --> 00:18:25.379 If you have the information, 302 00:18:26.320 --> 00:18:29.675 please submit it at the moment that you have that possibility. 303 00:18:30.015 --> 00:18:40.235 Because at some point the possibilities to submit new information run out and then we don't have the authority anymore to give you another opportunity. 304 00:18:41.015 --> 00:18:41.698 Before we close, 305 00:18:42.803 --> 00:18:45.735 was there anything else in this meeting that you'd like to highlight? 306 00:18:45.876 --> 00:18:46.941 Any other cases, 307 00:18:47.061 --> 00:18:50.095 any other interesting topics that you'd like to share? 308 00:18:50.871 --> 00:18:51.052 Yes, 309 00:18:51.313 --> 00:18:54.987 we finalised with this quite interesting document on misuse. 310 00:18:56.550 --> 00:18:57.493 In the legislation, 311 00:18:57.714 --> 00:19:01.787 there's talk about that realistic worst case scenario should be assessed. 312 00:19:02.507 --> 00:19:03.952 And for quite a while, 313 00:19:03.973 --> 00:19:05.438 there has been discussion like, 314 00:19:05.498 --> 00:19:07.827 is misuse also a realistic worst case? 315 00:19:09.199 --> 00:19:10.306 It has now been clarified, 316 00:19:10.667 --> 00:19:10.787 no, 317 00:19:11.108 --> 00:19:14.379 misuse is not a realistic worst case. 318 00:19:14.419 --> 00:19:19.999 At the moment that somebody deliberately uses a product in a way that it's not intended to be used, 319 00:19:20.359 --> 00:19:21.499 that shall not be assessed. 320 00:19:22.381 --> 00:19:29.159 I guess that's up to the enforcement actually to undertake action at the moment that people really deliberately misuse a product. 321 00:19:29.619 --> 00:19:31.239 So that will not be part of the assessment. 322 00:19:31.359 --> 00:19:32.367 It was already clarified, 323 00:19:32.649 --> 00:19:33.112 like I said, 324 00:19:33.132 --> 00:19:33.999 at the coordination group. 325 00:19:34.539 --> 00:19:34.801 However, 326 00:19:34.862 --> 00:19:35.487 now it's also 327 00:19:36.719 --> 00:19:37.762 confirmed in the BPC. 328 00:19:38.223 --> 00:19:41.715 So the documents describing that will be published online. 329 00:19:43.317 --> 00:19:43.759 Thanks again, 330 00:19:43.839 --> 00:19:44.160 Joost, 331 00:19:44.200 --> 00:19:45.265 for joining us today. 332 00:19:45.526 --> 00:19:47.835 And thank you also to all our listeners. 333 00:19:48.676 --> 00:19:49.278 As usual, 334 00:19:49.358 --> 00:19:54.898 we've linked all the material that Joost mentioned there earlier in the episode details. 335 00:19:55.440 --> 00:19:59.655 So you can find their links to the BPR and to the guidance documents. 336 00:20:00.095 --> 00:20:04.235 And also you can check the annex with all the details from the May meeting. 337 00:20:05.531 --> 00:20:05.932 Finally, 338 00:20:06.153 --> 00:20:10.284 if you want to listen to more episodes of the Safer Chemicals Podcast, 339 00:20:10.646 --> 00:20:17.164 you will find them all on our website at echa.europa.eu/podcasts. 340 00:20:18.307 --> 00:20:19.939 Safer Chemicals Podcast. 341 00:20:20.927 --> 00:20:22.785 Sound science on harmful chemicals.