WEBVTT 1 00:00:00.296 --> 00:00:02.017 Safer Chemicals Podcast. 2 00:00:02.737 --> 00:00:04.858 Sound science on harmful chemicals. 3 00:00:08.699 --> 00:00:12.581 Welcome to the European Chemicals Agency's Safer Chemicals Podcast. 4 00:00:13.681 --> 00:00:19.624 Our Biocidal Products Committee had its first meeting of 2026 during the last week of February. 5 00:00:20.304 --> 00:00:20.864 As usual, 6 00:00:21.205 --> 00:00:26.427 the committee had on its agenda some active substance and union authorisation applications, 7 00:00:26.827 --> 00:00:27.687 among other topics. 8 00:00:28.788 --> 00:00:29.808 In this episode... 9 00:00:29.968 --> 00:00:30.708 of the podcast, 10 00:00:30.988 --> 00:00:34.490 we've decided to only focus on one active substance application, 11 00:00:34.970 --> 00:00:36.451 and that is the one for ethanol. 12 00:00:37.451 --> 00:00:38.271 So in this meeting, 13 00:00:38.391 --> 00:00:44.414 the committee concluded that ethanol may be approved for use in hand and general disinfectants, 14 00:00:44.934 --> 00:00:47.395 but didn't take position on its classification. 15 00:00:48.355 --> 00:00:48.656 Today, 16 00:00:49.096 --> 00:00:51.257 we'll talk about what led to this opinion, 17 00:00:51.837 --> 00:00:52.497 what it means, 18 00:00:52.957 --> 00:00:54.098 and what will happen next. 19 00:00:54.978 --> 00:00:55.919 I am Päivi Jokiniemi, 20 00:00:56.199 --> 00:00:56.679 your host, 21 00:00:57.179 --> 00:00:59.280 and I'm joined again by Joost van Galen, 22 00:00:59.800 --> 00:01:02.141 the Chair of our Biocidal Products Committee. 23 00:01:02.741 --> 00:01:02.901 Hello, 24 00:01:03.021 --> 00:01:03.401 Joost. 25 00:01:03.601 --> 00:01:03.921 Welcome. 26 00:01:05.342 --> 00:01:05.522 Hello. 27 00:01:05.842 --> 00:01:07.202 Thank you so much for having me again. 28 00:01:08.503 --> 00:01:09.263 Good to see you again. 29 00:01:10.483 --> 00:01:10.963 As said, 30 00:01:11.263 --> 00:01:14.304 we're going to do things a little bit different this time. 31 00:01:14.764 --> 00:01:17.985 So instead of going through the summary of the meeting, 32 00:01:18.165 --> 00:01:22.407 we are really just focusing on one active substance, 33 00:01:22.487 --> 00:01:24.887 and the spotlight is on ethanol. 34 00:01:25.388 --> 00:01:26.908 And we're talking about your opinion 35 00:01:27.244 --> 00:01:30.665 on the application to use ethanol in product types 1, 36 00:01:30.765 --> 00:01:31.465 2 and 4. 37 00:01:31.945 --> 00:01:34.766 And this means hand and general disinfectants. 38 00:01:36.106 --> 00:01:39.867 But before we go into the conclusion and what led to that, 39 00:01:40.568 --> 00:01:47.049 could you give us a short recap on why the Biocidal Products Committee has been looking at ethanol? 40 00:01:49.070 --> 00:01:51.831 And I think if you want to understand that, 41 00:01:51.832 --> 00:01:54.832 you need to go back to the basic principles of the BPR. 42 00:01:56.332 --> 00:01:59.174 Before a product can be placed on the market, 43 00:01:59.194 --> 00:02:00.674 it requires an authorisation. 44 00:02:01.175 --> 00:02:03.516 And that authorisation requires, 45 00:02:04.717 --> 00:02:04.957 first, 46 00:02:04.958 --> 00:02:08.979 an approval of the active substance that is present in this product. 47 00:02:09.019 --> 00:02:09.139 So, 48 00:02:09.499 --> 00:02:09.839 for instance, 49 00:02:09.840 --> 00:02:17.864 you have hand disinfectants that contain ethanol as an active substance that really does the job of the disinfection. 50 00:02:18.144 --> 00:02:21.526 But it usually also has some coformulants. 51 00:02:22.586 --> 00:02:23.887 So that's what you need to realise, 52 00:02:24.227 --> 00:02:25.428 that the active substances... 53 00:02:25.728 --> 00:02:27.009 need to have been approved, 54 00:02:27.349 --> 00:02:31.472 and only then can products based on the active substance be authorised. 55 00:02:32.433 --> 00:02:33.253 Of course, 56 00:02:33.333 --> 00:02:36.515 the regulation was at some point established, 57 00:02:36.976 --> 00:02:39.177 but there were already some products on the market. 58 00:02:39.477 --> 00:02:48.764 And the active substances that were actually present in those products that were already on the market were then incorporated in the review program for active substances. 59 00:02:49.244 --> 00:02:50.545 So in that review programme, 60 00:02:51.105 --> 00:02:54.848 all active substances will be assessed and eventually approved, which then in sequence will allow the authorisation of products based on that active substance. 61 00:03:02.430 --> 00:03:06.851 Ethanol is included in that review programme for active substances for PT1, 62 00:03:07.312 --> 00:03:07.452 2, 63 00:03:07.492 --> 00:03:07.912 and 4. 64 00:03:07.992 --> 00:03:14.434 That's the hand disinfection and the general service disinfection and the disinfection of surfaces that come into contact with food and feed. 65 00:03:15.014 --> 00:03:15.494 Currently, 66 00:03:15.834 --> 00:03:19.175 ethanol is used already. 67 00:03:19.235 --> 00:03:20.955 It's on the market in many products, 68 00:03:21.356 --> 00:03:22.876 and it's all based on national... 69 00:03:23.396 --> 00:03:24.057 authorisation. 70 00:03:24.097 --> 00:03:28.400 So every country still has their national authorisation scheme. 71 00:03:28.800 --> 00:03:31.662 At the moment that ethanol will be approved, 72 00:03:32.282 --> 00:03:39.487 it will allow the member states to no longer authorise those products on a national scheme, 73 00:03:39.988 --> 00:03:46.132 but instead they will be authorised under the Biocidal Products Regulation. 74 00:03:46.372 --> 00:03:52.296 This is being done to ensure that all the biocidal products in the EU are All 75 00:03:52.476 --> 00:03:54.537 authorised in a harmonised manner. 76 00:03:54.657 --> 00:03:57.279 So it's being done in the same way in every member state. 77 00:03:57.759 --> 00:04:06.144 And it also ensures that all the biocidal products that are on the EU market can be used in a safe and efficacious manner. 78 00:04:06.404 --> 00:04:09.586 Andif you look, 79 00:04:10.727 --> 00:04:11.207 for instance, 80 00:04:11.707 --> 00:04:13.028 at a disinfectant, 81 00:04:13.029 --> 00:04:13.968 a hand disinfectant, 82 00:04:14.369 --> 00:04:18.071 also establishing that the product actually works, 83 00:04:18.151 --> 00:04:19.272 that it's efficacious. 84 00:04:20.172 --> 00:04:21.993 part of making the product safe, 85 00:04:22.013 --> 00:04:22.273 right? 86 00:04:22.713 --> 00:04:28.616 You use disinfectants and hand disinfectants to kill bacteria and viruses. 87 00:04:28.836 --> 00:04:30.857 You cannot see whether you are actually killing them, 88 00:04:30.937 --> 00:04:31.157 right? 89 00:04:31.177 --> 00:04:31.458 I mean, 90 00:04:31.698 --> 00:04:35.259 you may have them on your hand and they may be dead or they may be alive. 91 00:04:35.319 --> 00:04:37.120 You will not be able to judge yourself. 92 00:04:37.501 --> 00:04:43.483 So establishing whether the product actually does what it promises to do 93 00:04:44.664 --> 00:04:51.968 It's a very important step also in the authorisation process of biocidal products that are intended for these users. 94 00:04:53.228 --> 00:04:53.448 Okay, 95 00:04:53.488 --> 00:04:53.668 good. 96 00:04:53.809 --> 00:04:54.229 All clear. 97 00:04:55.789 --> 00:04:57.470 If we think back a little bit, 98 00:04:57.710 --> 00:05:00.692 so the February meeting was not the first one, 99 00:05:01.306 --> 00:05:03.267 for the committee to discuss ethanol. 100 00:05:04.367 --> 00:05:06.128 What has happened in the previous meetings then? 101 00:05:06.228 --> 00:05:09.869 What has led to this February meeting where you adopted an opinion? 102 00:05:11.549 --> 00:05:11.829 Actually, 103 00:05:12.089 --> 00:05:14.790 this dossier has a long history, 104 00:05:15.431 --> 00:05:16.371 a very long history, 105 00:05:16.411 --> 00:05:17.111 I would almost say. 106 00:05:17.251 --> 00:05:22.493 This was actually submitted before I had even heard of the term biocides. 107 00:05:22.494 --> 00:05:26.134 It was submitted in July 2007. 108 00:05:26.394 --> 00:05:32.937 The first assessment of this dossier was actually submitted back then still to the 109 00:05:33.357 --> 00:05:36.799 European Commission in July 2013. 110 00:05:36.800 --> 00:05:38.820 So in July 2013, 111 00:05:38.821 --> 00:05:42.061 the first version of the assessment was already finalised. 112 00:05:42.661 --> 00:05:43.642 At that point in time, 113 00:05:43.662 --> 00:05:53.646 it was still normal to actually wait for the CLP classification on the classification of the active substance to be provided and to not 114 00:05:53.826 --> 00:05:55.887 move ahead with such a dossier yet. 115 00:05:56.648 --> 00:05:57.028 However, 116 00:05:57.429 --> 00:05:57.549 in 117 00:05:57.989 --> 00:06:00.290 December 2023, 118 00:06:00.291 --> 00:06:04.754 member states decided together that they would no longer wait for those 119 00:06:05.114 --> 00:06:11.378 CLP classification anymore and that they would instead move ahead with the BPC opinions. 120 00:06:13.960 --> 00:06:16.041 And that was the reason why at that point, 121 00:06:17.422 --> 00:06:18.463 the Greek authorities, 122 00:06:18.523 --> 00:06:21.905 who are the evaluated competent authorities for the ethanol dossier, 123 00:06:23.382 --> 00:06:28.266 submitted their assessment report to the BPC and its working groups. 124 00:06:29.887 --> 00:06:35.451 So extensive scientific discussions took place at the working groups prior to the discussions in the BPC meeting, 125 00:06:35.452 --> 00:06:35.851 of course. 126 00:06:36.691 --> 00:06:38.753 And in the human health working group, 127 00:06:39.053 --> 00:06:42.315 it was identified that drinking alcoholic drinks, 128 00:06:42.576 --> 00:06:43.776 which contain ethanol, 129 00:06:43.796 --> 00:06:44.217 of course, 130 00:06:46.578 --> 00:06:51.682 may cause cancer and may cause negative effects on the development of the unborn child. 131 00:06:52.062 --> 00:06:55.745 The carcinogenic and reprotoxic potential of ethanol, 132 00:06:56.225 --> 00:06:59.308 when actually consumed as part of an alcoholic drink, 133 00:06:59.989 --> 00:07:02.230 was recognised already in that working group. 134 00:07:03.892 --> 00:07:04.652 And in November, 135 00:07:05.133 --> 00:07:12.078 the BPC discussed their draft opinion with this specific conclusion and indicated that they, 136 00:07:12.859 --> 00:07:13.480 at that point, 137 00:07:13.600 --> 00:07:21.066 did not feel that they were in the position to really conclude on ethanol as such. 138 00:07:21.726 --> 00:07:22.826 They recognised that 139 00:07:23.707 --> 00:07:25.587 if you drink alcoholic drinks, 140 00:07:25.607 --> 00:07:25.847 yeah, 141 00:07:26.387 --> 00:07:29.668 that's maybe regarded as carcinogenic and reprotoxic. 142 00:07:29.969 --> 00:07:32.549 But really to have that generic conclusion for ethanol, 143 00:07:33.189 --> 00:07:35.850 they were not very convinced about that. 144 00:07:36.410 --> 00:07:36.811 And therefore, 145 00:07:36.812 --> 00:07:40.892 it was decided that that wouldn't have to be reflected in the opinion. 146 00:07:41.172 --> 00:07:42.272 So following that meeting, 147 00:07:43.172 --> 00:07:44.673 the November BBC meeting, 148 00:07:45.313 --> 00:07:48.654 the opinions were completely revised and the discussion was. 149 00:07:49.014 --> 00:07:51.616 scheduled for further discussion in February. 150 00:07:52.597 --> 00:07:53.157 So finally, 151 00:07:53.158 --> 00:07:54.178 in the February meeting, 152 00:07:54.578 --> 00:08:00.822 the committee concluded that ethanol may be approved for use in hand and general disinfectants. 153 00:08:02.003 --> 00:08:07.567 I guess the main issue that needed to be solved after the previous meeting was related exactly to this that you said, 154 00:08:08.087 --> 00:08:12.891 to the carcinogenic and reprotoxic properties and how to conclude on them. 155 00:08:13.931 --> 00:08:14.512 So tell us, 156 00:08:15.032 --> 00:08:15.953 how was this solved? 157 00:08:17.113 --> 00:08:17.674 The committee 158 00:08:18.014 --> 00:08:25.040 acknowledged that when drinking ethanol as part of alcoholic beverages should be considered as carcinogenic and reprotoxic, 159 00:08:25.741 --> 00:08:32.286 but did not want to decide in general that ethanol should be regarded as carcinogenic and reprotoxic. 160 00:08:32.646 --> 00:08:35.549 This is due to a combination of a number of factors. 161 00:08:36.089 --> 00:08:37.170 And yeah, 162 00:08:37.450 --> 00:08:43.235 the important factors are that the dossier as submitted by the applicant was considered to be complete. 163 00:08:44.296 --> 00:08:46.438 All required information was present and therefore 164 00:08:46.698 --> 00:08:50.920 BPC is not in the position to ask for additional data. 165 00:08:52.300 --> 00:08:52.601 However, 166 00:08:52.661 --> 00:08:55.222 for the uses in biocidal products, 167 00:08:55.282 --> 00:08:59.223 the dermal and inhalation exposure routes are the relevant ones. 168 00:08:59.624 --> 00:09:02.045 And for both these exposure routes, 169 00:09:03.465 --> 00:09:08.467 the data is either absent or has not been performed in accordance with the standard guidelines. 170 00:09:10.048 --> 00:09:14.130 So then the BPC actually comes in this unique situation, 171 00:09:15.390 --> 00:09:16.911 for biocidal active substances, 172 00:09:18.792 --> 00:09:24.815 that they would have to base their conclusion on mainly on epidemiological data, 173 00:09:25.336 --> 00:09:28.778 on the voluntary oral exposure to an active substance. 174 00:09:31.479 --> 00:09:32.440 And at the same time, 175 00:09:32.940 --> 00:09:36.542 the BPC is aware that studies are ongoing with relevant exposure routes. 176 00:09:37.022 --> 00:09:43.466 And these studies are ongoing for CLP classification and therefore are not 177 00:09:43.966 --> 00:09:45.689 within the remit of the BPR. 178 00:09:46.310 --> 00:09:46.730 However, 179 00:09:47.271 --> 00:09:58.286 BPC is of the opinion that any conclusion on carcinogenic and reprotoxic properties should actually include an analysis of those studies. 180 00:10:00.366 --> 00:10:02.267 The BPC didn't want to wait any longer. 181 00:10:02.307 --> 00:10:08.029 They didn't want to wait for the finalisation of these studies because they don't know for how long they would have to wait. 182 00:10:08.769 --> 00:10:26.117 And it would not be in line with the whole purpose of the BPR and of the review programme to wait any longer because what we want to do at some point is ensure the safety and the efficaciousness of the products that are on the market. 183 00:10:27.817 --> 00:10:28.277 Therefore, 184 00:10:28.778 --> 00:10:29.558 the BPC has... 185 00:10:30.014 --> 00:10:32.275 decided to adopt their opinion, 186 00:10:32.796 --> 00:10:36.278 which allows the approval of the active substance, 187 00:10:36.858 --> 00:10:43.943 but there is no conclusion in the opinion on the carcinogenic and reprotoxic properties of ethanol. 188 00:10:44.683 --> 00:10:44.903 Okay, 189 00:10:45.303 --> 00:10:46.944 you mentioned the new studies there. 190 00:10:46.945 --> 00:10:48.806 So there are new studies underway. 191 00:10:49.746 --> 00:10:50.647 I'm wondering a little bit, 192 00:10:50.727 --> 00:10:52.988 what's the role of these new studies? 193 00:10:53.008 --> 00:10:53.608 So as you said, 194 00:10:53.609 --> 00:10:55.770 the committee has now adopted its opinion. 195 00:10:56.358 --> 00:10:59.620 It will soon be sent to the European Commission for decision making. 196 00:11:01.101 --> 00:11:05.563 What do you expect will happen when the new studies are complete? 197 00:11:05.623 --> 00:11:08.405 And do you have any kind of estimation? 198 00:11:08.905 --> 00:11:11.606 How long would it take to get those results? 199 00:11:11.727 --> 00:11:14.308 That's a very good question, 200 00:11:14.328 --> 00:11:25.294 because that is actually the whole core of why the current opinion actually does not conclude on carcinogenic or reprotoxic potential. 201 00:11:26.395 --> 00:11:29.618 We just don't know when those studies will be finalised. 202 00:11:30.038 --> 00:11:40.306 And we don't know at what point the studies will actually be taken into consideration in the adoption of the opinion on the CLP classification. 203 00:11:40.667 --> 00:11:42.768 So there are a lot of unknowns there. 204 00:11:43.389 --> 00:11:49.414 The combination of those unknowns is actually the reason why the BPC did not want to wait any longer. 205 00:11:49.634 --> 00:11:54.118 We have already waited for so long already since 2013 right 206 00:11:55.067 --> 00:11:58.149 And we do not want to continue to wait any longer. 207 00:11:58.709 --> 00:12:03.053 Also keeping in mind that the deadline for the review programme is approaching. 208 00:12:03.133 --> 00:12:07.376 It's in 2030 and we would like to comply with that deadline. 209 00:12:08.597 --> 00:12:09.138 In addition, 210 00:12:09.878 --> 00:12:15.863 products remain on the market under transitional legislation in the various member states. 211 00:12:16.424 --> 00:12:24.190 And that means that there currently is no harmonisation in the extent to which these products have been regulated in the member states. 212 00:12:24.638 --> 00:12:25.358 And that's what we want. 213 00:12:25.359 --> 00:12:27.400 We want to have harmonisation in the market. 214 00:12:27.900 --> 00:12:36.485 And we want to make sure that all the products that are on the market currently can be used in a safe and efficacious manner. 215 00:12:36.945 --> 00:12:39.727 If the Commission now follows your opinion, 216 00:12:39.747 --> 00:12:40.847 the committee opinion, 217 00:12:41.387 --> 00:12:47.871 and decides to approve the use of ethanol as active substance in hand and general disinfectants, 218 00:12:49.032 --> 00:12:50.072 what will happen next? 219 00:12:50.192 --> 00:12:50.753 I'm thinking, 220 00:12:51.473 --> 00:12:52.674 what does it mean for... 221 00:12:52.994 --> 00:12:59.457 on one hand for the companies who are using this active substance and what does it mean for the safety of all of us, 222 00:13:00.057 --> 00:13:00.937 European citizens? 223 00:13:03.759 --> 00:13:04.039 Actually, 224 00:13:04.619 --> 00:13:09.901 what is going to happen right now is exactly the same as what normally happens for other active substances. 225 00:13:10.702 --> 00:13:15.804 There's no difference between how ethanol will be treated compared to other active substances. 226 00:13:17.424 --> 00:13:20.746 If it is decided to approve the active substance, 227 00:13:21.278 --> 00:13:26.560 An implementing regulation is prepared and published by the European Commission, 228 00:13:27.260 --> 00:13:29.321 which includes a date of approval. 229 00:13:31.362 --> 00:13:37.525 An application for the authorisation of any products based on ethanol for PT1, 230 00:13:37.925 --> 00:13:42.847 2 and 4 will have to be submitted by that approval date. 231 00:13:43.507 --> 00:13:45.168 And in those applications, 232 00:13:45.828 --> 00:13:50.690 the applicant should provide evidence that the product is efficacious and safe to use. 233 00:13:52.442 --> 00:13:58.264 And that information will then be used by the evaluating competent authorities. 234 00:13:58.284 --> 00:14:00.324 So that's the member states authorities. 235 00:14:01.544 --> 00:14:08.046 They will assess the use of the products and that indeed can be used in a safe and efficacious manner. 236 00:14:08.546 --> 00:14:10.647 And at the moment that that is indeed the case, 237 00:14:10.967 --> 00:14:15.328 they can actually authorise those products. 238 00:14:15.388 --> 00:14:22.110 This is a very important step in ensuring the safety of the users of all biocidal products in all countries of the 239 00:14:22.130 --> 00:14:22.750 European Union, 240 00:14:23.111 --> 00:14:30.515 because this is really the pinnacle of a harmonized assessment and authorisation of safe and efficacious products. 241 00:14:31.776 --> 00:14:32.076 Thank you, 242 00:14:32.116 --> 00:14:32.476 Joost. 243 00:14:33.056 --> 00:14:36.738 We will be back with more biocides updates later this year. 244 00:14:37.019 --> 00:14:37.299 Thanks, 245 00:14:37.379 --> 00:14:37.679 Joost, 246 00:14:37.759 --> 00:14:38.700 once again for joining. 247 00:14:39.500 --> 00:14:40.821 Thank you for having me again. 248 00:14:41.201 --> 00:14:45.543 Very interesting to hear a little bit more on what happened behind the scenes. 249 00:14:46.624 --> 00:14:49.806 What was behind your recent opinion to support 250 00:14:50.302 --> 00:14:53.065 the approval of ethanol in disinfectants. 251 00:14:54.546 --> 00:14:58.570 Although our episode this time only focused on the ethanol conclusion, 252 00:14:58.971 --> 00:14:59.431 the BPC, 253 00:14:59.651 --> 00:15:00.152 of course, 254 00:15:00.292 --> 00:15:01.994 also discussed other topics, 255 00:15:02.034 --> 00:15:06.318 such as other active substance applications and union authorisation cases. 256 00:15:06.950 --> 00:15:08.753 If you want to know more about these topics, 257 00:15:09.153 --> 00:15:10.715 read our highlights in our news. 258 00:15:10.835 --> 00:15:11.556 And you can find that, 259 00:15:11.557 --> 00:15:11.917 of course, 260 00:15:11.918 --> 00:15:14.661 on our website at echa.europa.eu. 261 00:15:16.744 --> 00:15:18.446 Safer Chemicals Podcast. 262 00:15:19.167 --> 00:15:21.290 Sound science on harmful chemicals.