Safer Chemicals Podcast.
Sound science on harmful chemicals.
Recently,
we've seen a change in attitude from the authorities.
They're no longer shy to propose non-authorisation or non-approval at the moment a dossier is incomplete.
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.
It really should be clear by now that it's the sole responsibility of the applicant to make sure that their dossier is complete.
Welcome to the Safer Chemicals Podcast.
Our Biocidal Products Committee met again during the last week of May.
And today I'm joined by the committee Chair,
Joost van Galen,
to discuss the most important items of this meeting.
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.
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.
But to start with I'd like to welcome Joost.
Thank you for joining us again.
Thank you for the invite and nice to be here again.
So it's fair to say that you've had a packed meeting.
If I counted correct,
you adopted altogether 18 opinions during the May meeting.
Before we go into more details,
what's your spontaneous reflection after the meeting?
Yeah,
I think,
for me,
for sure,
it was an all-time high,
but
I'm not quite sure whether in the past we ever had more than that.
So it was a really nice meeting.
It was,
again,
a physical meeting here in Helsinki and a really nice way to go on top of it.
So, yeah,
this was really one of the better meetings,
I would say.
As there were so many opinions this time,
I was thinking that we wouldn't go through all of them case by case.
But we'd focus on some themes that you saw repeating during this meeting in many applications.
Well,
maybe we can start with active substances actually.
Indeed,
we discussed four of them.
Two of them were actually renewals and that's what we are going to see much more often.
Until now we've seen quite some of the new active substances and active substances from the review programme,
but now it's really getting up to speed with the renewals of the active substances as well.
We discussed two,
medetomidine and dinotefuran.
For medetomidine it's important to realise it's an anti-fouling paint,
that substance will be used in anti-fouling paints,
and it's an endocrine disruptor.
So in that sense it's of additional concern.
Sufficient alternatives were found actually by the member state that did the evaluation,
so that's also recognised in our opinion.
For dinotefuran,
not sufficient alternatives were found,
so also that is written down clearly.
Then we also discussed polymeric betaine,
which was a substance from the review programme.
And that has now been finalised and the opinion is actually proposing approval of this active substance.
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.
So that may mean actually that at the moment that products will be authorised and will be assessed for other use classes,
probably that needs to be assessed a bit deeper than would normally be the case.
Then we talked about CIT,
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.
So that concludes what we discussed on active substances.
Yes and seven Union authorisation cases.
As usual,
I would almost say the discussions on the Union authorisations were quite smooth.
We had one non-authorisation and it was based on missing information on efficacy.
And yeah,
this was a bit...
This was the only
case where the discussions were a bit more in-depth and I think the other cases the discussions went very smooth.
In general it's a bit of a shame that information is lacking and therefore a non-authorisation should be proposed.
The data requirements are quite clear and they have not changed since the entry into force of the BPR.
So
We hope that actually applicants will pay a bit better attention to those data requirements.
This is actually something that we have touched upon already earlier.
So at the end of 2023, we had this same discussion in one of the episodes.
So data gaps,
missing information.
And this now turned out to be another common theme in this meeting.
Do you still see the same trends as earlier with the missing information or is there something else that tops the lists now?
No,
I think the message that I gave back then still stands.
And it's a bit unfortunate that I have to come back to it over and over.
Because,
I mean,
it's avoidable.
What I also mentioned last podcast.
The data requirements are there,
have been in place for quite a while,
and simply need to be adhered to.
What we have seen in the past is that member states gave
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
the finalisation of the applications.
New from now on I think is that member states are more
open to actually propose non-authorisation and non-approvals.
And that's what we are seeing more and more,
that member states are not shy anymore to say like,
okay,
we have asked for the information,
you have not provided it,
then from now on,
this is a non-authorisation or a non-approval.
And that's what applicants need to be
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.
Maybe you will find out that,
well,
your dossier was not fully complete,
not as complete as you thought it was when you submitted it.
And
I would advise all applicants to proactively contact their member state and discuss with them what can be done.
And I think that would be a good way forward.
It's not the responsibility of the member state to ensure that the dossier is complete.
That really is the responsibility of the applicant.
So
I would like to remind all applicants of that.
This is your responsibility.
Make sure that your dossier is complete before you submit it preferably.
But also now,
if you look at it,
at your dossier and hinsight,
is this really what you wanted to submit?
Are you really still satisfied with what you submitted?
And if not,
maybe you should undertake some action.
And there is a lot of support also available for companies.
So if you are preparing an application,
you can find support material.
What would you recommend?
We've also discussed this already earlier,
but maybe we can just give a short reminder.
What are those top three resources that companies should take a look at when they are preparing,
before they are submitting,
just to go through before you finalise?
Yeah,
I think it's important to look at the BPR first.
I mean,
in the BPR,
there are annexes with the data requirements.
There it's set what is a core data set and what is not.
The core data set simply needs to be there.
So then you already know which data points you must cover in your dossier.
Then there are all kinds of guidance documents on our website.
There is guidance on the procedure,
which is an important one as well.
And there are plenty of guidance documents on the data that needs to be provided.
Finally,
there is the possibility to have early working group discussions.
For instance,
if you are having a bit of a discussion between the member state and the applicant,
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.
So there's plenty of support going on for the member states and for the applicants.
So we would actually encourage everybody to make use of all those possibilities.
So really no excuses not to prepare a full dossier and send it to us.
Exactly.
And what perhaps is also nice to mention,
before the end of this month,
the member state should have requested the information on the endocrine disruption criteria.
So at the moment if you have not heard anything from your member state,
get in touch with them and make sure that they know what they want with regards to endocrine disruption.
And I would also like to flag that
ECHA and the member states,
behind the scenes, are in direct contact with each other on this.
So we are providing support to the member states to really define what needs to be provided and by what date.
And on that note,
we actually come to the next point that I wanted to discuss with you.
So the endocrine disrupting properties and the assessment related to that.
That seems to be another big theme of this meeting,
right?
Yeah, actually it has been a big theme for years already and that's the reason why I already flagged,
right?
Take a look at your dossier proactively.
Take a look with the guidance next to it and really see whether what you submitted was the right thing.
And get in touch with the Member States.
And if the Member State maybe is a bit uncertain as well about what needs to be done,
they can always get in touch with us.
And I think we need to do this together and we at ECHA are definitely ready for it.
And I hope that the applicants and the Member States
are also ready for it and will engage with us.
But what do you think,
what is the reason behind this increasing number of applications that are now missing the ED assessment?
What we are seeing is that actually the member states are a bit more proactive in moving forward.
And quite often what happened in the past was that member states were internalising the problems,
trying to solve it.
themselves and that I have the feeling that there is a bit of a change in attitude there.
I mean,
Member States are not trying to,
are trying less to solve themselves,
but are more open to discuss with us and
more open to finalise assessments,
right?
I mean,
Member States have been
Maybe at the center of criticism for delays in the review program,
delays in all kinds of processes.
And
I think what member states are doing right now is they're actually finalising assessments with the data that's there.
And that may actually be quite detrimental for the applicants.
In the past,
I have a history of working for a competent authority as well.
And what happened in the past that we went back and forth,
back and forth,
back and forth with applicants,
trying to get all the information gradually in.
And what I'm seeing right now is that Member States maybe give less opportunities to the applicants.
So that should be a message to the applicants.
I mean,
at the moment.
The Member State is really asking for certain information,
take that seriously and provide that information.
If it's not clear to you what they actually mean,
get in touch with them.
Don't guess and send something that's incomplete.
Get in touch with your Member State,
ask for an explanation and at the moment that it's clear what you need to provide,
provide it within the deadline.
And by doing so you can avoid unfortunate situations where your application actually results in a non-authorisation or non-approval.
So time for companies to step up their game a little bit.
I would say so.
You would say so.
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?
Is there anything else that you feel that
you'd like to tell the companies that pay attention to this or remember that when you're preparing your application?
What is important to realise is that the assessment initially needs to be performed by the applicant.
And what my key message would be to the applicant and also to the consultants that are supporting the applicants is
be honest to yourself and don't try to make your assessment fit what you hope the outcome will be.
Instead,
really look at the data that you have and perform your assessment accordingly.
And maybe the outcome will not be what you hope it will be.
However,
it may
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
avoid disappointments. And another reminder what companies should remember is that they actually need to include the proof,
the evidence,
in their dossiers.
So it's not enough to know that something is fine,
something is efficacious,
but you need to actually prove it,
right?
Yes,
and that needs to be proven over and over again.
You may think like,
okay,
a similar product has already been authorised,
so why do I need to provide the data?
But that's a requirement.
Every company for themselves needs to show that their products are efficacious and that it's safe to use.
I mean,
that's the requirement that the BPR sets on every single company.
That's the requirement for every single dossier.
So make sure that your dossier is complete.
The message is not like,
hey,
companies,
you're doing bad.
You need to do better.
I mean,
that's not the purpose of the message that I just gave.
The purpose is to identify what everybody's responsibilities are and that in the end,
we all follow up on our responsibilities.
That's the applicants,
that's the Member States,
that's ECHA.
Together we can do this.
That was a strong message to companies,
also to,
as you said,
consultants helping out companies in these issues.
Take this seriously.
Take a look at the material that is available.
Contact your competent authority if you need help and make sure that your application is complete before you submit it.
And also you mentioned the timelines.
Make sure you send your updates in time and without delay.
And I think that's an important one because you should not only focus on the guidance with regards to the information requirements.
What we see quite often is that companies are complaining that they don't get more chances.
However,
the procedures are very clear and there are documents available
on our website that really explain during which parts of the procedure you're actually able to submit new information.
And that's a very limited number of possibilities.
And that's what some companies don't realise.
I mean,
you are allowed to submit information when you submit your application,
once during the validation,
once during the evaluation.
And then if the working group thinks it's necessary,
you can get a fourth possibility
within 10 working days after the working group.
But that's it.
Those are all the possibilities that you get within a process to submit new information.
And that's what we see quite often at the moment that non-authorisation or non-approval is being proposed.
That companies are like,
yeah,
but I have some more information here and I would like to submit it.
That's super nice,
but I mean,
it's not possible anymore in the process that we have.
And that's what you need to realise.
If you have the information,
please submit it at the moment that you have that possibility.
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.
Before we close,
was there anything else in this meeting that you'd like to highlight?
Any other cases,
any other interesting topics that you'd like to share?
Yes,
we finalised with this quite interesting document on misuse.
In the legislation,
there's talk about that realistic worst case scenario should be assessed.
And for quite a while,
there has been discussion like,
is misuse also a realistic worst case?
It has now been clarified,
no,
misuse is not a realistic worst case.
At the moment that somebody deliberately uses a product in a way that it's not intended to be used,
that shall not be assessed.
I guess that's up to the enforcement actually to undertake action at the moment that people really deliberately misuse a product.
So that will not be part of the assessment.
It was already clarified,
like I said,
at the coordination group.
However,
now it's also
confirmed in the BPC.
So the documents describing that will be published online.
Thanks again,
Joost,
for joining us today.
And thank you also to all our listeners.
As usual,
we've linked all the material that Joost mentioned there earlier in the episode details.
So you can find their links to the BPR and to the guidance documents.
And also you can check the annex with all the details from the May meeting.
Finally,
if you want to listen to more episodes of the Safer Chemicals Podcast,
you will find them all on our website at echa.europa.eu/podcasts.
Safer Chemicals Podcast.
Sound science on harmful chemicals.