Safer Chemicals Podcast.
Sound science on harmful chemicals.
Welcome to the Safer Chemicals Podcast.
I'm Adam Elwan,
and today I'm joined by Roberto Scazzola.
He's the chair of our Committee for Risk Assessment,
as well as Maria Ottati,
who chairs our Socio-Economic Analysis Committee.
Now,
today we'll be going through key updates from the recent meetings of the committees,
and to kick us off,
we'll cover the latest on the universal PFAS restriction proposal.
After that,
we'll get an outlook on new tasks that are coming to both committees and how they will be expanding their evaluations to new areas of work.
To wrap up today's episode,
we'll talk to Roberto about a recent court ruling on the harmonised classification and labelling of titanium dioxide.
Roberto,
Maria,
it's great to have you both on the podcast again.
And for the first time,
Roberto,
you're actually joining us remotely from a much warmer climate,
I hear.
Not that I'm,
you know,
jealous or anything at all,
but where are you joining from?
Thank you very much,
Adam,
for inviting us and to our listeners for joining.
Indeed,
I managed to escape from the start of the autumn in Helsinki and I'm here in Venice,
actually Italy.
So I'll try to share some of the sun and the energy that I got from this nice trip.
Please do.
We need it desperately here.
At least I do.
I don't know about you,
Maria.
It's quite an overcast day.
So definitely,
I think that will be much needed.
And thank you very much from my side as well,
Adam.
I'm really looking forward to telling you a little bit more about what we discussed in the plenary.
All right,
let's get started then with the universal PFAS restriction proposal.
Now,
here,
the committees have been evaluating it for quite some time.
And I know from Roberto's side,
RAC is nearing completion of its risk-based evaluation.
But there was a milestone recently with the submission of a background document.
And I'd like to hear a bit more about that.
So maybe Maria,
you can shed some light on this one.
Okay,
so first of all,
maybe I can tell you what we mean by a background document.
So basically,
the five countries submitted way back in January 2023,
their proposal on the universal PFAS restriction.
And as it enters the opinion making,
then we start calling that proposal the background document as it gets updated.
So what's been happening is that,
as you know,
we had a very big consultation on the proposal.
And the five countries have been analyzing the comments that came in,
and they have been progressively updating their proposal based on those comments.
So we have been receiving staged updates,
basically.
So they have started sector by sector and use by use,
sending us updates.
So the opinions that we have been discussing all these past two years have been based on these graduated updates that we've received.
But now they have finally finished it.
And whereas those,
you know,
stage updates we were making available only to those participating to the meetings and,
of course,
to the committee,
now this has been published,
you know,
for everyone.
So that's on our website now and that can be found.
So in addition to adding more information about the sectors that they had already analysed,
they have added some new sectors and they have also developed what we would call a new sector.
could call horizontal issues,
so areas that apply to all the different sectors.
So that has been developed quite a lot more.
And that's now in what you can find online.
Okay,
I know we'll talk about the horizontal issues later on as well.
We will,
because we looked at it in both of the committees.
Yes.
So basically,
this background document is actually the backbone then of what you should be looking at and feeds into your opinion or the committee's opinion.
Yes,
exactly.
But now it's stable and finalized.
So you don't expect any changes,
which I assume is a good thing at this point.
So you can go ahead without worrying about new information coming.
Exactly.
So this is basically what the committees are assessing.
So that's very important that it's out there so that people when they see our opinions,
which is coming,
they will understand now what their opinions are.
Yes.
And the reasoning behind it as well on the basis for it.
Okay,
good.
Let's then move on to the Risk Assessment Committee's discussion on these.
So,
Roberto,
can you shed some light on different sectors?
Sure.
Perhaps we can start from the most complex and most interesting given sector.
I would say electronics and semiconductors.
PFASs are used in this sector due to their properties,
their electrical properties,
thermal stability,
but also chemical resistance.
It's probably the biggest sector in terms of received comments and also quite complex with many,
many different applications.
So when it goes to electronics,
we refer to wires,
cables,
printed circuit boards,
flat panel displays and so forward.
And then we have also semiconductors that are very important due to the electrical conductivity between a conductor and an insulator.
and this means uses within...
o-rings,
gaskets,
wafers and coatings.
And as usual Rack assess the volumes.
PFAS that are used in those sectors,
but also the expected emissions that are therefore uncontrolled and could reach the environment.
So we look at the volumes,
as mentioned,
for both sub-uses,
electronics and semiconductors.
And we found also interesting figures.
And electronics seems to be the sub-application that results in higher emissions in the order of 380 tons per year,
while semiconductors...
is in the order of 50 tons per year as a midpoint.
We also expressed a view on the effectiveness of the restriction options,
and we looked whether there are potential alternatives and what are the risks and the hazards possibly related to the use of those alternatives.
Okay.
And I understood quite a lot of stakeholders.
I mean,
this topic has a lot of interest,
but here as well,
there was a high attendance rate from stakeholders,
right?
Indeed,
Adam.
I think you have a-
a point here.
We had a great attendance.
Many stakeholders expressed an interest.
And I have to admit,
there was a constructive and very collaborative way of working.
And we definitely appreciate it because the input of stakeholders is very important to make this right.
All right.
Great to hear that.
Thanks.
Thanks for the update on that.
And good to see that stakeholders are contributing and coming up with useful information that you can make use of in your opinion forming.
What about then the next bigger sector,
I assume?
PFAS manufacturing sector.
Indeed,
that's a very important one and even a special one if you want,
because actually it's the starting point of everything because you first manufacture PFAS and then they are provided and purchased for multiple uses.
But we are also aware that in several,
in some
PFAS manufacturing sites across Europe,
there have been serious pollution cases that affected soil,
sediment and water.
And we've also found that the remediation of those cases is very costly,
and if possible,
at all.
And this also resulted in national measures and possibly ultimately to this restriction because a number of
European countries found that we should act at European level.
In this sector,
we had the usual assessment in RAC,
estimating the volumes and also the emissions.
And maybe one element I would like to mention is we have also been informed that there is an industry-led initiative,
a voluntary one.
on actually reducing emissions and controlling them.
And this has been taken forward by the dossiers submitters in a restriction proposal that would build actually,
starting from this voluntary initiative and proposing also other measures that could really reduce emissions.
We found this very interesting,
and this is linked to an unlimited derogation,
linked to a maximum emission limits to be respected both for...
air emissions,
but also for any wastewater,
a production site.
Okay,
interesting.
On this unlimited derogation idea,
what would then be,
I mean,
what would the emissions limits look like?
And how would compliance actually be demonstrated?
That's a very good question.
And we had a preliminary discussion,
this time at RAC,
and we have actually requested the dossier submitter to provide additional elements.
How can we demonstrate compliance?
How can...
economic operators being sure to fulfill those criteria if,
of course,
this restriction will be finalized in the way it has been presented today.
So we actually plan to come back in December with additional elements,
and we know that the dossier submitter is already,
they are already working on that.
Then let's go to these horizontal issues that we mentioned earlier.
Can you,
first of all,
explain a little bit more about what they are exactly?
They are cross-cutting issues.
That means that they're not sector-specific,
but they apply horizontally.
So you can think of them like the backbone of the restriction.
And they apply to the concentration limits,
above which PFAS will be restricted,
but also the hazard assessment and the general risk management measures that are needed to monitor and to reduce environmental emissions.
We have already discussed this.
However,
few topics needed to be...
fine-tune or I would say re-discussed.
And that's what we have done actually last week.
Okay.
And Maria,
I understand that also in the socio-economic analysis committee,
you've looked at horizontal issues for the same sectors.
So how does that play in?
Yeah,
well,
in
SEAC, we look at different horizontal issues or well,
some of them we look at in both committees,
but it's slightly different from the ones that Roberto has named.
It's the same kinds of issues that apply across the board for all the sectors and all the uses.
And we're talking,
for instance,
things about spare parts,
recycling,
that sort of thing that we haven't discussed yet,
but that is coming.
So this time we discuss practicality only.
And in SEAC,
we also have what we call more general approach issues,
which we discuss in the same sort of slot in the committee.
And this is,
OK,
what has been the approach used?
to develop the dossier and what is the approach we use to assess that.
So we have quite a lot of discussion on that because that helps to set out how we're going to do things before we actually do them.
And that helps the discussions a lot.
Okay.
And what would you then say are the most important takeaways for our audience from this Risk Assessment Committee meeting regarding the proposed restriction?
Well,
first of all,
I think very good progress has been made.
I mean,
this is a very big exercise and there are a lot of colleagues that are actually involved into it and we are moving forward.
So that's a big thank you to the committee members and to all stakeholders that participated constructively in this.
And also,
I think we are for the first time,
as Maria explained earlier,
with the submission of the final version of the background document,
we have finally visibility when we can conclude this activity,
at least for RAC.
So we expect to conclude discussions on the 14 sectors and on PFAS manufacturing by end of this year.
And then RAC should be in the condition to adopt the opinion in March 2026.
That sounds indeed promising.
I'm sure many of our listeners are also happy to hear that there's a timeline now available.
Can you explain then the gap of the three months then by the end of the year and then March next year for the opinion?
Well,
Fingers crossed,
we will conclude the discussion in December,
but then we will still need some time to carefully draft the opinion text and to ensure that all horizontal issues are reflected in the same way in all the different applications.
For instance,
the risk of alternatives that we are doing as a committee.
This takes time,
as the proposal is very big,
as already mentioned and commented multiple times.
And we need to put together all the 14 sectors and the PFAS manufacturing.
in a way that this will be coherent and homogeneous and could be then processed by the European Commission and member states.
So we want basically to have a scientific sound,
but also a consistent opinion.
And our goal now,
I think we can be outspoken,
is to conclude at least in RAC by March 2026.
So on to you then,
Maria.
The
Socioeconomic Analysis Committee covered lubricants,
energy,
electronics,
and semiconductors,
as well as
PFAS manufacturing and...
The horizontal issues that you mentioned earlier.
So what were kind of the highlights from these?
Well,
first highlights,
the sheer number of sectors that we were able to cover in one meeting.
That was a challenge,
but we were able to juggle all these different opinions that we had.
These sectors have all been covered to differing levels.
Let's say some we finished,
some we started,
some we continued.
So it's all different.
And so basically...
horizontal issues.
We continue then in December.
This has been going on throughout the process.
We periodically have brought this back to the committee to discuss what we have learned,
what we should change and so on.
So that is one that continues.
Now PFAS manufacturing also continues.
There we had what we call just a key issues discussion,
let's say.
So it was first describe what the dossier submitter has done,
give some initial impressions,
get some feedback from the committee as to what the rapporteurs proposed to do.
but no real opinion yet and no discussion.
That's coming in December and we expect to finish it then.
With electronics and semiconductors,
we focused just on semiconductors in this first meeting and we looked at the analysis of alternatives and also at the costs.
But we still need to bring it all back together by looking at the benefits,
then looking at the proportionality and derogations.
And also to look at electronics as a whole.
So that's quite a big sector.
Roberto mentioned that it's one of the sectors,
these two together,
electronics and semiconductors,
where we have received most comments.
And it is quite a lot of sub-uses as well.
So that's quite a lot of work.
But again,
we expect to finish in December.
And then we have finished energy,
which is good.
Also quite,
quite,
quite big one.
And they were talking about things like renewable energy generation,
hydrogen technology,
batteries.
So,
you know,
big,
chunky things to discuss.
So that one,
we had a key issues discussion,
as I mentioned,
for Vivas Manufacturing.
This one we had in March.
So now we have brought,
you know,
the actual opinion here.
And that one has been provisionally concluded as well.
And then finally,
lubricants.
Lubricants,
we had discussed in the last plenary.
We had discussed the analysis of alternatives,
basically.
And now we have done all the socioeconomic analysis,
so cost,
benefits,
proportionality,
and looked at the need for derogations.
And that's quite an interesting sector because it's a little bit different from the others.
It's,
well,
it's not a sector for starters,
it's more a use,
and it's very transferential.
So it covers,
you know,
it's used in many,
many of the different sectors that we have already looked at.
So it's,
you know,
a bit different in the approach that we have taken.
We've looked at it a little bit more.
across the board,
let's say.
So that one again,
finished for,
you know,
provisionally concluded in this plenary and done for now.
All right.
So I saw that in all the sectors that you've covered,
you also discussed this options other than the restrictions.
So can you clarify to our audience,
what exactly does that mean?
Yeah,
so basically one of the first things that we do when we start analysing a sector is to see,
is a restriction actually needed here?
Is a restriction the best way to deal with the risks that have been identified?
Because,
of course,
there's a lot of regulation out there,
a lot of regulation that even looks at environmental risks of some of the uses covered.
And we need to consider whether is there stuff out there that already does what needs to be done.
So there's many other different kinds of...
you know,
regulations and so on.
So that's the first step always when we start looking at things,
whether,
you know,
other voluntary initiatives already do what needs to be done,
are there other directives or regulations.
And so far,
we have always found that that's not the case.
Right.
So restriction would be...
A restriction under reach is the most appropriate risk management option that we have seen.
Okay.
Thanks for clarifying that.
So how about the timelines then for you in terms of the next steps and opinions?
Is it the same as for the Risk Assessment Committee?
Very similar,
but with one major difference.
So similarly to RAC,
we expect to conclude all our sector discussions in December.
But then,
of course,
there is quite a big job in putting everything together.
Exactly what Roberto said,
we'll have to do the same.
We have learned quite a lot as we've gone through.
So we really need to look at particularly some of the earlier sectors to make sure that everything is consistent there.
And yeah,
in March,
we expect to agree the SEAC draft opinion.
So you may notice,
you know,
the careful listeners may notice that I say,
I don't say adopt,
I say agree.
And that is because after that,
for SEAC,
there is a whole new stage out there,
which is a consultation on the SEAC draft opinion.
So the SEAC draft opinion is published and then there is a
60-day consultation that takes place on it.
and then we consider
all that information.
And then the plan is that by the end of 2026,
we will present to the committee an updated
SEAC opinion for adoption in this case.
So that's when we come to the end.
Great.
So actually a good thing,
I would say that stakeholders will be able to have their say in the evaluation of this proposal.
Now,
given the interest on PFAS,
I'd assume you expect a lot of information through this consultation.
I know that was the case in previous consultations that we ran on this topic.
Some records were broken there.
So...
Can you talk a bit more about that?
What kind of things do you expect?
Yeah,
exactly.
We expect quite a lot of contributions.
We know that there has been quite a lot of work being done throughout this evaluation by stakeholders out there to gather more information.
And we would be quite happy to receive that and to check whether that changes our conclusions in any way.
So it's important to note that the consultation now is on the SEAC draft opinion.
It's not on the proposal as a whole,
but on our opinion.
So...
What we're going to do is to be very careful about making sure that we are clear about what information is needed.
And for that,
we are organizing the consultation a little bit differently this time.
So what we will be doing is using what we call a survey format.
So we will be asking very concrete questions of the respondents,
basically on the key things for SEAC,
which are what is the impact of restricting the use of PFAS in the different sectors.
And also on the availability and feasibility of alternatives.
So those are the core.
So when I'm talking about potential impacts,
you know,
costs,
benefits and so on.
So basically,
as I said,
a survey.
And that means that no attachments can be submitted as part of the consultation.
So what we're asking respondents to do is to take the information that they have and use it to be able to answer our questions.
So the idea there is that we can help.
the stakeholders to make sure that they give us the information that we actually need and that we don't have to fish for it,
let's say,
in quite a lot of information that some of which may not be as relevant.
Yeah,
and this will also help the committee organise,
analyse and use the contributions very efficiently and effectively as well.
So this helps us reach our final opinion by the end of 2026 as expected.
And
I would also like to mention,
and this hopefully will be helpful to stakeholders,
that we will organise an online info session on the
30th of October 2025,
where we will provide quite a lot of information on the questions that we'll be asking.
And we will take questions as well,
because obviously,
you know,
new things may emerge.
We will publish in advance some consultation guidelines and we will answer the questions that come in there.
And maybe something important to mention that we will do,
you know,
by popular demand,
let's say,
is we'll be doing some sector mapping.
So basically,
questions that we've been getting a lot during the plenaries and outside of the plenaries are,
where does my use fit in?
In which sector is it?
So we are doing our best to create a map of where everything fits in,
which we understand that the stakeholders will find quite helpful.
I'm sure that'll be useful,
yes.
That's what we've heard.
Yeah.
And of course,
we won't be able to cover everything in the first go,
but it'll be a living document.
So as questions come in about different sectors,
we'll keep asking them.
So that way people will know when the consultation comes out,
where should they answer,
where should they provide the information as well.
So,
yeah,
please tune in
30th of October this year.
And,
you know,
the information will continue to be added to the guidance documents after that.
Okay,
thanks.
So I think the info session,
I really echo you there to invite people to join that.
I think it would be a useful way to understand what exactly is needed during the consultation.
Then the consultation will follow in March,
you said,
this is after the committee meeting,
right?
Yes,
exactly.
So we will discuss in the March plenaries.
And once the opinions are adopted in RAC and agreed in SEAC,
then the
SEAC opinion will be published and the consultation will start soon after the plenaries.
Okay,
well,
that wraps up the
PFAS segment.
And as until now,
we will be coming back to this throughout the committee's opinion making.
The next obvious step there is after the December meetings.
So we will still be back with updates this year for you on that.
But next,
let's briefly discuss kind of what's ahead for the committees outside of PFAS.
There is also life outside of PFAS for the committees.
And one big part of this is ECHA,
our agency,
receiving new tasks under different regulations.
So...
due to these new tasks,
both committees will begin reviewing new kinds of restriction and exemption proposals,
which may lead to also new types of opinions.
It's quite early days,
so we don't know yet fully how these will materialize.
Can we go through which committee does what under each new task?
And when do you expect the first kind of dossiers to land?
Sure,
maybe I can start.
But first,
I would like to express that I think we are pleased that new tasks are assigned,
have been assigned to both committees.
I think it's a major
of the good work we have done so far.
Of course,
this brings challenges and well,
you will hear from us in a second.
So maybe indeed,
in terms of new tasks,
I can mention the packaging and packaging waste,
where we will have to do sort of rich restrictions like for those in case the European Commission will ask us to carry out them.
We have also toys,
for instance,
the toys regulation where we have to look into
establish limit values for hazardous substances,
but also to check any migration limits that would be applicable.
So quite interesting.
What about from your side,
Maria?
Yeah,
quite a few as well.
For instance,
to add one that Roberto didn't mention is the restriction of hazardous substances.
There we have potentially,
you know,
restrictions as well,
restriction type work,
but also SEAC will be looking at exemptions from that restriction as well and we expect quite a few
different applications.
And you were asking as well,
when is the earliest time that we expect things?
So probably for this one and for toys are the ones that we expect things to come soonest.
So already 27.
Okay.
What about in the batteries regulation?
ECA has had that task now for some time.
I don't remember exactly when we got it over,
but is there anything you can add from that?
Are there new tasks coming also through there?
Well,
yes,
there will be restrictions coming in to the committee.
And,
well,
this has been the entry into force was already in 2023.
But,
of course,
there's work that needs to be done first before anything comes to the committee.
For starters,
there's a scoping study that is being done outside of the committees.
But then the restrictions are expected to start coming.
And the first one we expect may be 2029.
That's quite a long runway.
What's kind of driving this 2029 start?
Well,
usually with restrictions,
we are assessing a proposal.
So the proposal needs to first be done by outside of the committees for the committees to analyze.
So first we have the scoping study.
Then based on that,
there will be potential restrictions being prepared.
And then they come to the committee.
Okay,
thank you.
That clarifies it.
And how will the,
well,
actually both committees interface with the existing?
ROS,
let's call it with its acronym,
exemption process.
So will the committees handle both the restriction proposals and the exemption reviews?
I think you mentioned actually already that you will also deal with the exemptions.
Yeah,
we will be doing both,
exactly.
In
SEAC, we will be taking care of all the requests from exemptions from the industry.
RAC will be a little bit more ad hoc,
so we expect a proportion of them to go to RAC.
These are already,
of course,
being looked at.
There's a system out there,
so that will be coming to...
us.
So the way things are being done now,
I think with consultants looking at things,
is coming to the committees.
I think the idea is that they want something that has got the independence that the committees bring and,
you know,
rigorousness that the committees bring.
Right.
Okay.
What about another acronym ELVs?
So end of life vehicles.
This was also something that was mentioned in the new tasks.
Can you say anything about that?
That's quite similar in terms of the type of tasks that we are discussing,
scoping study,
restrictions,
and then review of existing exemptions.
And similar also in that the exemptions are more to be done by SEAC than by RAC.
All right.
Well,
I mean,
a packed outlook.
And as you said,
you know,
Clear kind of recognition of the work that the committees have been doing and a clear sign that the committee's remits are expanding across multiple pieces of legislation.
I think the takeaway for our audience is that the timelines are staggered.
We're at very early stages.
Evidence needs are evolving.
And early data,
I guess,
would matter.
So as soon as we have some kind of structure and things in place,
then getting your data prepared to carry these processes forward will be quite important also from the listener's sides.
So we'll keep you posted on these ones.
But then going into our final topic for today,
so titanium dioxide.
Roberto,
could you update us on where we are?
So just as a background,
in 2017,
the committee considered the substance to be a possible carcinogen,
category 2,
when inhaled.
The European Commission added this classification then to the CLP regulation in 2019.
However,
the European Court of Justice has now overturned that classification.
So from the committee's perspective,
How do you see this development?
What impact does it have?
Yes,
I think it's good to spend a couple of minutes on this point.
We found that this case attracted quite some attention in the CLP community.
We also acknowledge it concerns a very specific set of circumstances,
and our taking of it does not alter overall BRAC's general approach to the scientific opinion-making.
Could you spell out those specific circumstances that you mentioned?
And do you see any kind of lessons learned for similar cases more broadly?
Yeah,
indeed.
In our preliminary assessment,
we had the impression,
for instance,
that RAC was not very clear in listing the key evidence that led to the classification conclusion.
Apparently,
the court,
that's an element that has been criticizing the opinion.
So we are carefully looking into it.
probably restructuring,
reformatting the information in a way that every time you use weight of evidence or you identify the key evidence,
this is very clearly stated and drafted in a way that would lead actually to an easy-to-even assessment to no scientific,
let's say,
audience when it is the case.
I think also from the practical point of view,
as a result of the judgment,
It means that the classification of titanium dioxide that was issued by the European Commission has been annulled.
And this means that actually this is no longer bounding.
And we're also updating our own RAC opinion,
mentioning for full transparency also the outcome of this judgment.
And
I think we will come back maybe on this point once we will have a more,
let's say,
general overview on what we intend to do to be sure to address any potential follow-up.
Okay.
Good.
Thank you.
I think that wraps up the titanium dioxide point then.
And actually also brings us to the end of our episode today.
So we've covered quite a lot of ground,
obviously PFAS taking up the bulk of our episode as it usually does,
where both committees,
as mentioned before,
are moving toward year end conclusions.
We also have a packed pipeline of new tasks across packaging,
toys,
batteries,
ROS and end of life vehicles that will involve new areas of work over the next few years.
And then we also got the update on the latest on titanium dioxide,
including what the court's recent ruling had in it.
Now,
before we close,
something that we would like to try,
something a little bit different in the format,
is to engage a bit more with you,
our listeners,
and to collect questions for our episodes,
particularly for this committee podcast series that we do.
So if you have any questions or topics that you would like Roberto and Maria to unpack in our next episodes,
you can send them to us by email.
The address is video at eka.europa.eu.
You'll also find that in the episode description.
And we will then pick topics,
questions that fit into the overall scope of our episodes and try to address them in our next episode.
So you can already start submitting those now for the December episode.
But for today,
thank you for listening and goodbye.
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