- Speaker #0
Safer Chemicals Podcast. Sound science on harmful chemicals.
- Päivi Jokiniemi, host
Welcome to the European Chemicals Agency's Safer Chemicals Podcast. Our Biocidal Products Committee had its first meeting of 2026 during the last week of February. As usual, the committee had on its agenda some active substance and union authorisation applications, among other topics. In this episode... of the podcast, we've decided to only focus on one active substance application, and that is the one for ethanol. So in this meeting, the committee concluded that ethanol may be approved for use in hand and general disinfectants, but didn't take position on its classification. Today, we'll talk about what led to this opinion, what it means, and what will happen next. I am Päivi Jokiniemi, your host, and I'm joined again by Joost van Galen, the Chair of our Biocidal Products Committee. Hello, Joost. Welcome. Hello. Thank you so much for having me again. Good to see you again. As said, we're going to do things a little bit different this time. So instead of going through the summary of the meeting, we are really just focusing on one active substance, and the spotlight is on ethanol. And we're talking about your opinion on the application to use ethanol in product types 1, 2 and 4. And this means hand and general disinfectants. But before we go into the conclusion and what led to that, could you give us a short recap on why the Biocidal Products Committee has been looking at ethanol?
- Joost van Galen, ECHA
And I think if you want to understand that, you need to go back to the basic principles of the BPR. Before a product can be placed on the market, it requires an authorisation. And that authorisation requires, first, an approval of the active substance that is present in this product. So, for instance, you have hand disinfectants that contain ethanol as an active substance that really does the job of the disinfection. But it usually also has some coformulants. So that's what you need to realise, that the active substances... need to have been approved, and only then can products based on the active substance be authorised. Of course, the regulation was at some point established, but there were already some products on the market. 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. So in that review programme, all active substances will be assessed and eventually approved, which then in sequence will allow the authorisation of products based on that active substance. Ethanol is included in that review programme for active substances for PT1, 2, and 4. That's the hand disinfection and the general service disinfection and the disinfection of surfaces that come into contact with food and feed. Currently, ethanol is used already. It's on the market in many products, and it's all based on national... authorisation. So every country still has their national authorisation scheme. At the moment that ethanol will be approved, it will allow the member states to no longer authorise those products on a national scheme, but instead they will be authorised under the Biocidal Products Regulation. This is being done to ensure that all the biocidal products in the EU are All authorised in a harmonised manner. So it's being done in the same way in every member state. And it also ensures that all the biocidal products that are on the EU market can be used in a safe and efficacious manner. Andif you look, for instance, at a disinfectant, a hand disinfectant, also establishing that the product actually works, that it's efficacious. part of making the product safe, right? You use disinfectants and hand disinfectants to kill bacteria and viruses. You cannot see whether you are actually killing them, right? I mean, you may have them on your hand and they may be dead or they may be alive. You will not be able to judge yourself. So establishing whether the product actually does what it promises to do It's a very important step also in the authorisation process of biocidal products that are intended for these users.
- Päivi Jokiniemi, host
Okay, good. All clear. If we think back a little bit, so the February meeting was not the first one, for the committee to discuss ethanol. What has happened in the previous meetings then? What has led to this February meeting where you adopted an opinion?
- Joost van Galen, ECHA
Actually, this dossier has a long history, a very long history, I would almost say. This was actually submitted before I had even heard of the term biocides. It was submitted in July 2007. The first assessment of this dossier was actually submitted back then still to the European Commission in July 2013. So in July 2013, the first version of the assessment was already finalised. At that point in time, it was still normal to actually wait for the CLP classification on the classification of the active substance to be provided and to not move ahead with such a dossier yet. However, in December 2023, member states decided together that they would no longer wait for those CLP classification anymore and that they would instead move ahead with the BPC opinions. And that was the reason why at that point, the Greek authorities, who are the evaluated competent authorities for the ethanol dossier, submitted their assessment report to the BPC and its working groups. So extensive scientific discussions took place at the working groups prior to the discussions in the BPC meeting, of course. And in the human health working group, it was identified that drinking alcoholic drinks, which contain ethanol, of course, may cause cancer and may cause negative effects on the development of the unborn child. The carcinogenic and reprotoxic potential of ethanol, when actually consumed as part of an alcoholic drink, was recognised already in that working group. And in November, the BPC discussed their draft opinion with this specific conclusion and indicated that they, at that point, did not feel that they were in the position to really conclude on ethanol as such. They recognised that if you drink alcoholic drinks, yeah, that's maybe regarded as carcinogenic and reprotoxic. But really to have that generic conclusion for ethanol, they were not very convinced about that. And therefore, it was decided that that wouldn't have to be reflected in the opinion. So following that meeting, the November BBC meeting, the opinions were completely revised and the discussion was. scheduled for further discussion in February.
- Päivi Jokiniemi, host
So finally, in the February meeting, the committee concluded that ethanol may be approved for use in hand and general disinfectants. I guess the main issue that needed to be solved after the previous meeting was related exactly to this that you said, to the carcinogenic and reprotoxic properties and how to conclude on them. So tell us, how was this solved?
- Joost van Galen, ECHA
The committee acknowledged that when drinking ethanol as part of alcoholic beverages should be considered as carcinogenic and reprotoxic, but did not want to decide in general that ethanol should be regarded as carcinogenic and reprotoxic. This is due to a combination of a number of factors. And yeah, the important factors are that the dossier as submitted by the applicant was considered to be complete. All required information was present and therefore BPC is not in the position to ask for additional data. However, for the uses in biocidal products, the dermal and inhalation exposure routes are the relevant ones. And for both these exposure routes, the data is either absent or has not been performed in accordance with the standard guidelines. So then the BPC actually comes in this unique situation, for biocidal active substances, that they would have to base their conclusion on mainly on epidemiological data, on the voluntary oral exposure to an active substance. And at the same time, the BPC is aware that studies are ongoing with relevant exposure routes. And these studies are ongoing for CLP classification and therefore are not within the remit of the BPR. However, BPC is of the opinion that any conclusion on carcinogenic and reprotoxic properties should actually include an analysis of those studies. The BPC didn't want to wait any longer. 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. 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. Therefore, the BPC has... decided to adopt their opinion, which allows the approval of the active substance, but there is no conclusion in the opinion on the carcinogenic and reprotoxic properties of ethanol.
- Päivi Jokiniemi, host
Okay, you mentioned the new studies there. So there are new studies underway. I'm wondering a little bit, what's the role of these new studies? So as you said, the committee has now adopted its opinion. It will soon be sent to the European Commission for decision making. What do you expect will happen when the new studies are complete? And do you have any kind of estimation? How long would it take to get those results?
- Joost van Galen, ECHA
That's a very good question, because that is actually the whole core of why the current opinion actually does not conclude on carcinogenic or reprotoxic potential. We just don't know when those studies will be finalised. 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. So there are a lot of unknowns there. The combination of those unknowns is actually the reason why the BPC did not want to wait any longer. We have already waited for so long already since 2013 right And we do not want to continue to wait any longer. Also keeping in mind that the deadline for the review programme is approaching. It's in 2030 and we would like to comply with that deadline. In addition, products remain on the market under transitional legislation in the various member states. And that means that there currently is no harmonisation in the extent to which these products have been regulated in the member states. And that's what we want. We want to have harmonisation in the market. 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.
- Päivi Jokiniemi, host
If the Commission now follows your opinion, the committee opinion, and decides to approve the use of ethanol as active substance in hand and general disinfectants, what will happen next? I'm thinking, what does it mean for... on one hand for the companies who are using this active substance and what does it mean for the safety of all of us, European citizens?
- Joost van Galen, ECHA
Actually, what is going to happen right now is exactly the same as what normally happens for other active substances. There's no difference between how ethanol will be treated compared to other active substances. If it is decided to approve the active substance, An implementing regulation is prepared and published by the European Commission, which includes a date of approval. An application for the authorisation of any products based on ethanol for PT1, 2 and 4 will have to be submitted by that approval date. And in those applications, the applicant should provide evidence that the product is efficacious and safe to use. And that information will then be used by the evaluating competent authorities. So that's the member states authorities. They will assess the use of the products and that indeed can be used in a safe and efficacious manner. And at the moment that that is indeed the case, they can actually authorise those products. This is a very important step in ensuring the safety of the users of all biocidal products in all countries of the European Union, because this is really the pinnacle of a harmonized assessment and authorisation of safe and efficacious products.
- Päivi Jokiniemi, host
Thank you, Joost. We will be back with more biocides updates later this year. Thanks, Joost, once again for joining.
- Joost van Galen, ECHA
Thank you for having me again.
- Päivi Jokiniemi, host
Very interesting to hear a little bit more on what happened behind the scenes. What was behind your recent opinion to support the approval of ethanol in disinfectants. Although our episode this time only focused on the ethanol conclusion, the BPC, of course, also discussed other topics, such as other active substance applications and union authorisation cases. If you want to know more about these topics, read our highlights in our news. And you can find that, of course, on our website at echa.europa.eu.
- Speaker #0
Safer Chemicals Podcast. Sound science on harmful chemicals.
