Transcription

• Joost van Galen

  Safer Chemicals Podcast Sound science on harmful chemicals. Hello and welcome back to the Safer Chemicals Podcast. Today, it's finally time to talk about biocides again. I am your host, Päivi Jokiniemi, and I'm joined by the chair of our Bicidal Products Committee, Joost van Galen. In this episode, we'll be discussing the recent committee meeting and its highlights. This time, there was one topic that stood out from the rest, and that was the discussion about the renewal of anticoagulant rodenticide substances. But before we dive into that, Joost will give us some takeaways related to union authorizations, and we'll also learn more about the harmonized list of endpoints for pyrethroid metabolites. So without further ado, welcome back, Joost. Nice to see you again. How are you? Yeah, nice to be back. It indeed has been a while.

• Host - Päivi Jokiniemi

  It has been a while.

• Joost van Galen

  I prefer to actually only have a podcast when I've got something to say. And clearly there was something to say in this meeting.

• Host - Päivi Jokiniemi

  Very good. Before we go into those main topics, there were a lot of interesting things that you have gone through. But this May meeting was, again, one of these long ones. It lasted for five days. I was thinking what was your favorite moment of this meeting and why?

• Joost van Galen

  If you're really talking about a single moment, that's for sure the agreement by the members on the analysis of alternatives and then the assessment of the Article 5.2 derogation criteria for the rodenticides. I mean that was such a huge amount of work that has been put into those documents, a co-collaboration of ECHA and the Member States. So to have that finalised, that was a great achievement. And perhaps this is also a nice moment to actually acknowledge the work that has been done by the ECAs (evaluating competent authorities), by the ECHA staff here supporting that. And also we would like to mention the work that has been put in by the colleagues from the German Umweltbundesamt UBA who have done a lot of work on the assessment of several studies on traps for mice and rats. I mean, that was, yeah, all that work combined. And then coming to this agreement by the BPC was a great moment. But maybe also to mention, right, we only meet physically twice per year. And this was a physical meeting. So all those moments where... The members were meeting informally in the coffee breaks, in the lunch breaks, in the evening programme, where actually the connections were sometimes re-established or established with new members and actually building the team as a whole. That was special to see as well and very useful. It really accommodates future decision making if people know each other, understand each other and form a team as such.

• Host - Päivi Jokiniemi

  Great to have those reflections, maybe also afterwards. I guess often it's a very busy period and you don't really stop and think, what did we actually do? But it seems that there were good achievements there and nice connections. So good to hear about that. If we then talk about the meeting itself, the big topic was, of course, the rodenticides. And that's going to be also the main topic of this episode. But... Before that, I wanted to quickly run through the Union authorisation cases of this meeting. There were five of them. And if I understood correctly, you faced similar challenges with data gaps and quality issues this time as you've already faced earlier. Can you fill us in on what happened?

• Joost van Galen

  Yeah, and I think that it's especially true for those families that were in a... attempt was made to make them as big as possible and perhaps that also made them more complex. And what you saw there is that the dossiers were not complete upon submission. And also during the evaluation phase, the applicants were unable, sometimes unwilling, to actually complete their dossiers. And as a result of that, several uses and products were not authorised. So yeah, that's a shame for the applicants. And we hope that future applicants will take note and will consider to not construct such big and complex families. And at the same time, will ensure that their dossier is complete when they submit it. And will actually respond to the ECAs in a positive way when more information is requested. I think it's important to take note of a document that we already published quite a while ago and are on our website the guiding principles for providing data during the Union authorisation process. It gives a very clear overview of the responsibilities and the expectations, both with regards to the authorities, but also towards the applicants on how to behave and what type of information to provide at what point in time. Yeah, so that's one message that I would like to give. Another message is the quality of the SPC.

• Host - Päivi Jokiniemi

  And the SPC stands for?

• Joost van Galen

  The Summary of Product Characteristics. Yes. A while ago, we made a document with a sort of quality checklist. And the checklist really contains certain information on what both applicants as well as authorities should pay attention to. That needs to be in there, some things that should not be in there, etc. So that document is also available online and would also encourage both authorities and applicants to take note of that document, and to compile their SPCs accordingly.

• Host - Päivi Jokiniemi

  Very good reminders about the support material that we have available. We can also add links to these documents that you mentioned to this episode so that you can easily just go there and find the link and find the document. But then moving on, another interesting item on the agenda was the harmonised list of endpoints for pyrethroid metabolites. And so we're talking about the breakdown products of pyrethroid insecticides, right? Which include active substances such as permethrin, cypermethrin and deltamethrin, to mention some. At this meeting, you agreed to revise the endpoints for environmental hazards that need to be assessed when applying for active substance approval or product authorization. Why is it important to have this harmonized list available and who do you think should take a look at it when it's published?

• Joost van Galen

  Yeah, for sure the applicants for new products based on these active substances need to take a close look. At the moment that you perform an assessment, you use certain parameters in the models that you need to use. And those parameters are contained in the list of endpoints. So at the moment that you look... at these active substances where there are quite some overlaps, it's important to have a harmonized list of endpoints so that all active substances are being treated in a similar way. So that's what this harmonized list of endpoints aims to achieve, to ensure consistency, to ensure alignment between the different assessments that need to be performed and in the long run, of course, alignment in... the authorisations of these products so that's the reason why it's important. This list was already compiled about five years ago and was never published on our website. W got quite some questions from applicants like where is this, where can we find it. Then we decided to actually think it over and update it according to the latest developments. I mean, previously this was already five years old to publish and all this seemed to be a bit weird in our view. So we first updated it and now we're going to make sure that it will be published on our website so that all the applicants can take note, but also the Member States, of course, when they perform their assessments.

• Host - Päivi Jokiniemi

  So it's useful both for the applicants and the Member States?

• Joost van Galen

  Exactly. But in the first instance, of course, for the applicants, because they need to prepare their applications accordingly. And afterwards, the authorities can actually check whether they did a good job.

• Host - Päivi Jokiniemi

  Yeah, absolutely. You said that it's going to be soon published on our website. Do you have a timeframe there?

• Joost van Galen

  Yeah, going for the first half of June. Good And then now, finally, let's talk about the rodenticides, the big topic. And this has also been a recurring topic in many of our recent podcasts. So at least I'm very excited to hear what now actually has happened. Yo u dedicated two full meeting days to discuss this topic. So covering both the analysis of alternatives for anticoagulant rodenticides and also you went through the renewal applications of active substances that are used in rodenticides. Shall we kick off with the analysis of alternatives? Yeah, for sure. And there were actually two documents, right. The analysis of alternatives and the assessment of the Article 5.2 derogation criteria. And those were general documents that underpin all eight applications for renewal and approval of those rodenticides. And we spent an entire day going through those documents in a completely unhurried way, so that really everybody had sufficient time to reflect on it and to discuss it and to really know what they were agreeing on. And also taking into consideration all the comments that were coming, both from other authorities, but also from stakeholder organisations and from the applicants, that nobody was left unheard and that we would... amend the documents if necessary based on those discussions. So that's what we did. We spent the entire day on these two documents. Also with keeping in mind that these two documents would actually be annexed to these opinions on these eight rodenticides. So it made sense to first get all the issues out of the way in these two documents. Also because quite a few of the issues in these documents actually were recurring in the opinions. So to discuss everything in one day made sense. So that's what we did. And what you should remember is that this concerns substances meeting the exclusion criteria, and normally that they should not be approved at all. I mean, because of the nature of these substances. And the only legal possibility to approve these substances actually for very specific uses, specifically described uses, as if there are no alternatives and they're absolutely essential to control serious dangers to the environment or human or animal health, or where non-approval would have a disproportionate impact on society. So that's the frame in which we are working in, right? I mean, normally we should not be approving these substances, period. Unless, of course, they are used that we actually, that we really need. In order to do so, we performed an analysis of alternatives and we received a lot of input during a third-party consultation. And based on that input, we identified 11 uses that are currently on the market. And in our analysis of alternatives, we determined that for two of these 11 uses, there actually are chemical and non-chemical alternatives. These two uses are the non-professional use against mice, for which we have identified non-chemical alternatives, in normal words, traps. And for the other use, that's actually the use by professional users in permanent baiting, we have identified both non-chemical as well as chemical alternatives.

• Host - Päivi Jokiniemi

  Could you still remind us, what is permanent baiting actually? What does it mean?

• Joost van Galen

  It's a good question because it was actually subject to discussion at the meeting even. What it means is that in a situation where there is no indication that there's actually an infestation, so there is no indication that there are rats or mice running around, that nonetheless certain measures are taken to prevent rodents from outside coming in. So what is being done is that bait stations or traps are being placed with the intention that if a rodent walks in that they are immediately caught and killed. So that's the intention of permanent baiting.

• Host - Päivi Jokiniemi

  Permanent referring to that it stays there? Exactly. So there are two things, that it's permanent so it's always there and there are no indications that there is currently an infestation going on. So that's the whole principle of that use. Yeah, so for the permanent baiting, we actually identified that there are chemical, non-chemical alternatives. And then for the non-professional use against mice, there are mechanical alternatives. So therefore, we concluded that for these two uses, the derogation criteria are not met. So it's not essential for certain dangers to the environment or the health and society can function without chemicals for these two uses. This was actually confirmed by several Member States because several Member States have already on their own initiative in the past years banned the use of these rodenticides in these two specific uses. So they confirmed that indeed as a society you don't need these anti-curriculant rodenticides for these two specific uses. So that was actually a reassurance that our conclusions of our analysis of alternatives and of the derogation criteria are actually also correct in practice. Very interesting. What happened with the rest of the renewal applications?

• Joost van Galen

  Actually, after this very long discussion on the analysis of alternatives and then Article 5.2 assessment of derogation criteria, the discussions on the applications of the renewal and one approval actually, were really straightforward because the main items, the really big discussion items had already been resolved. So actually there were only some smaller items per substance that still needed to be covered. And that's what we did. But yeah, we managed to discuss everything. And there are some minor differences between the different active substances, to which I will not go into detail now, are described in the opinions, which will be published in the first half of June.

• Host - Päivi Jokiniemi

  And as usual, then these will go to the European Commission for them to take the final decision?

• Joost van Galen

  Exactly. So our deadline is the 6 of June. So then we will submit them to the Commission, because good that you... point it out, indeed what everybody needs to understand, these opinions are more like an advice for the European Commission on how to take a decision. So in the end, it's up to the Commission to write their implementing regulations based on these opinions.

• Host - Päivi Jokiniemi

  Very good. Is there some time limit now for these kind of opinions or then if the European Commission approves the use? Will there be a time limit or? When will be the next renewal round again?

• Joost van Galen

  Well, actually, because these substances, like I already said, meet exclusion criteria. They automatically also meet the substitution criteria. You can find the details in the regulation if you are interested. However, what you need to realide is that at the moment that a substance meets the substitution criteria, it cannot be renewed for more than seven years. So at the moment... That the Commission decides like, okay, from this date on, they are being renewed. That renewal will expire again in seven years. So there again needs to be an application for renewal for all these active substances.

• Host - Päivi Jokiniemi

  So we know that the saga will continue in the future then?

• Joost van Galen

  That's the whole thing of what we do under the BPR, right? There's a continuous cycle of renewals and that differs for the products and for the active substances. And I think what is good to realise is that for active substances that are considered meeting exclusion, substitution criteria, the renewal cycle is shorter. And the idea behind it is that, especially the exclusion substances, normally they should not be approved in the first place. So it's good to continue to look at these substances and make sure that at the moment that there are alternatives on the market and available for use, that these substances should not be renewed for such specific uses.

• Host - Päivi Jokiniemi

  Well, actually related to that, I was thinking that, what do these conclusions now mean for the future of those uses of AVK rodenticides that you now recommend to be authorised? Are we locked into using anticoagulant rodenticides for these specific uses, or is there still hope for safer alternatives?

• Joost van Galen

  I think BPC has given a strong message with their current opinions. At the moment that there are viable alternatives, the BPC will consider these alternatives very carefully. And BPC is not afraid to propose a non-approval for uses for which alternatives have been identified. And this actually is maybe also a signal to those companies that are... producing or considering to develop any further alternative uses. So these innovative companies that actually are considering to develop alternatives, non-chemical alternatives or chemical alternatives, should be encouraged by these opinions from the BPC. Yes, at the moment that you develop an alternative, that you show that they are efficacious, then the BBC will consider that they shall replace these anticoagulant rodenticides. And what I would like to point out, there is guidance available, which actually aims to develop some kind of framework to show that, for instance, traps are efficacious. Applicants or industry that is developing alternatives should take a close look at that guidance when actually performing their efficacy studies, because we are very much interested in getting these studies, but they should be performed according to the rules. And then they can really be considered as an alternative.

• Host - Päivi Jokiniemi

  I really like that last recommendation there, really continue working on this and follow the guidelines and we'll see in the future how the discussion then continues.

• Joost van Galen

  Yeah, and I really liked those considerations of the BPC as well, right? I mean, it's not so that we will continue to renew these active substances indefinitely. For sure not. At the moment that there is an alternative, we are not afraid, at all, to propose to not renew these active substances. And that's the message, I think, for all producers of... substances that meet the exclusion criteria.

• Host - Päivi Jokiniemi

  Also a very good message to end our episode with, I think. Very encouraging. Good. Thank you again, Joost. Very good to have you here with us. And interesting to hear about these discussions that you've had in your meeting. So in addition to our main topic, rodenticides, we've also explored the latest on Union authorisation cases, given some reminders there also to have a look at the supporting material and make sure that the data is complete. And also we've discussed the harmonised list of environmental endpoints for pyrethroid metabolites. And this will be published during the summer on our website. So everyone go and have a look and make use of this material when preparing your applications. A big thank you also to our listeners for the attention. We will be back with more updates and insights soon. And until then, remember that you can always listen to more episodes of the Safer Chemicals podcast on our website at echa.europa.eu/podcasts. Safer Chemicals Podcast. Sound science on harmful chemicals.