Safer Chemicals Podcast.
Sound science on harmful chemicals.
Hello,
I'm your host,
Adam Elwan,
and today we're focusing most of the episode of the Safer Chemicals Podcast to unpacking our Risk Assessment Committee's opinion on restricting PFAS.
We'll be speaking with the Chair,
Roberto Scazzola,
about what the opinion concludes and what it means going forward.
The Committee for Socio-Economic Analysis has also agreed on its draft opinion during their latest meeting.
The opinion has not yet been formally adopted and a
60-day consultation will now start.
We'll be joined by Maria Otati,
the Committee Chair,
to explore the key points of the draft and what information the Committee is looking for during the consultation.
We'll also briefly cover two other topics,
the harmonised classification of cannabidiol and the latest developments on the restriction proposal for chromium-6 substances.
So,
Roberto,
Maria,
thank you both for joining us.
Pleasure to join you,
Adam.
Absolute pleasure.
Always good to have you.
Now,
for our listeners,
I'm sure you've all heard about the wide uses of PFAS in things like cookware,
waterproof jackets,
and food packaging.
In this episode,
we explain why the Risk Assessment Committee considers their very persistent nature,
combined with properties such as mobility,
bioaccumulation,
and long-range environmental transport,
to pose a concern for both human health and the environment.
We'll walk you through the key points of the opinion step by step with Roberto.
So let's kick things off by talking about the hazards of PFAS.
The committee points to persistence as the kind of big driver for action,
even though toxicity does vary among different PFAS.
So why persistence?
Why on its own?
Why is it such a powerful reason to regulate these substances?
If you allow me,
Adam,
I would like first to express my big thanks to the team of people for this big achievement.
I think this is a...
result of the work of rapporteurs,
members and stakeholders.
So we all worked together to make this possible.
It was about three years of work for RAC.
And finally,
we reached the adoption of the RAC opinion.
So that's clearly a great achievement.
However,
this is only half of the work,
right,
Maria?
Exactly.
And I would like to second the thanks that
Roberto has made to all these parties and most especially to the rapporteurs who did a huge amount of work in both committees.
So why we did so?
Good to remind that we had five countries submitting a restriction proposal.
And the main reason,
as you have mentioned,
is the very persistent properties of PFAS.
So what does it mean?
Once the PFAS reach into the environment,
they stay there for a very,
very long time.
And in addition,
there are also other hazards that result in significant concern for human health and the environment.
In addition,
many studies found that PFAS,
once it is in the environment,
can really interact with different matrices.
even reaching the blood of workers and growing stock over time.
This is also probably the reason why the five countries started in its first place this specific restriction dossier.
Right,
okay.
And with such a broad and persistent group of chemicals,
it makes sense that the definition of kind of what counts as a PFAS becomes incredibly important,
which actually brings us to the next point.
So the committee also supports using the OECD definition when grouping PFAS.
That's the one that captures any chemical with at least
one fully fluorinated CF2 or CF3 group.
So what does using such a broad definition actually mean in practice,
especially for companies trying to stay compliant across the EU?
That's probably the most important point.
Substance identity is fundamental.
All relevant actors must understand what is in the scope of the restriction and what is not.
This is really a grouping approach so that one harmful PFAS is not substituted by another one.
that is slightly different,
but displays actually the same as Ardos property.
Perhaps to mention that the dossier submitter had in mind also to exclude specific subgroups related to their possible degradability.
Unfortunately,
RAC didn't find enough evidence to support this.
So we stick basically to the OECD broad definition for this case.
Once you define PFAS this broadly,
the next question becomes,
how do you treat them?
from a risk management perspective.
Here,
the committee is proposing to treat them as non-threshold substances,
so similar to persistent,
bioaccumulative,
and very persistent,
and very bioaccumulative substances.
So in simple terms,
non-threshold means that there's no safe level of exposure,
and any release is considered potentially harmful.
What does that mean in practice when we talk about acceptable exposure levels?
That's a scientific concept that is based on the adverse effects.
irrespective of the concentration of specific chemicals.
So in a way you can say there is no safe concentration once it is released into the environment.
In such a way,
any release,
any emission...
could mean actually that there is a risk.
This was also proposed by the dossier submitter and RAC basically agreed with this specific approach.
And as you mentioned,
it's something that RAC has been used in other dossiers related to persistent bioaccumulative and toxic substances.
There is also another aspect is the fact that,
however,
the greater the amount of emissions into the environment,
also the greater is the risk because the stock into the environment will continue to increase.
So there is also this dimension that has been considered by RAC.
So,
of course,
this is the purely risk assessment scientific approach.
And we acknowledge that the decision maker or SEC,
they could also consider other elements that not necessarily linked only to the risk related to the release of a substance.
Right.
At this perspective is important because it does put all PFAS under a,
or let's say PFAS uses under a much brighter spotlight.
So even those where...
You know,
toxicity or bioaccumulation might be less clear,
which actually brings us to fluoropolymers.
So the committee recognizes that fluoropolymers have limited evidence of bioaccumulation and ecotoxicity,
yet they still fall within scope of the restriction proposal.
So firstly,
what exactly are fluoropolymers?
Let's start with the basics.
And what made the committee conclude that they're part of the broader PFAS restriction?
Fluoropolymers are actually a plastic made from monomers that contain this strong
carbon-fluorine bonds.
So they make them extremely stable,
also resistant to heat and chemicals.
So all very good properties that are normally looked at when you engineer actually a product.
There are a lot of different kinds of fluoropolymers.
Perhaps the most well-known is polytetrafluoroethylene.
Definitely know that one.
Yeah.
My favorite.
Probably,
you know,
it's commercial name we will not mention today,
but it's used widely in cookware and other actually uses.
So it's true that fluoropolymers
are persistent,
but it's also true they are generally not mobile or bioaccumulative,
as you have mentioned earlier.
Most of the concerns are related to the emissions once they are produced.
So in the production of fluoropolymers,
other PFAS are emitted.
There are also concerns related to the waste stage of fluoropolymers.
For instance,
when you dispose them via incineration,
you can produce additional PFAS that can be volatile or non-volatile,
or you can even have emission of micro and nano size.
polymer particles.
So RAC assesses this as sufficient ground for concern to act.
Right.
So even though fluoropolymers themselves may not show the same toxicity or mobility as other PFAS,
their life cycle still creates PFAS emissions.
So during production,
use,
and from what I hear,
especially during disposal.
And that's really the key here.
So the concern isn't just the polymer,
but everything that comes with it.
Indeed.
Well,
let's move on to volatile PFAS,
like fluorinated gases.
These can easily evaporate into the air,
and they're used in things like refrigerators.
I guess the most common example that people can relate to.
The committee calls them very persistent and very mobile,
with global warming potential and long-range transport.
And their degradation increases trifluoroacetic acid,
or TFA,
levels globally.
Can you tell us more about the issue with fluorinated gases?
How?
well understood are the environmental and health impacts of rising TFA levels,
and what are the biggest knowledge gaps?
Well,
some PFASs,
as you have mentioned,
are volatile,
so especially fluorinated gases.
So they can evaporate,
drift with the wind,
and also contribute to the widespread environmental pollution,
even to very remote areas,
mountains,
or even the arctic.
So fluorinated gases are also the major contributors to PFAS submissions,
as you've mentioned,
because they have...
uses,
they can actually result in high emissions.
Can you imagine when a refrigerator actually leaks a fluorinated gas,
so you will have immediate release into the environment.
So they're found in refrigerants,
cooling systems,
but also electronics.
The concerns,
as you've mentioned,
is that they are very persistent,
very mobile,
and some have global warming potential.
So they can increase actually the effect of climate change,
but also long range transport.
So you can find them very far away from the point.
of emission,
even if the committee has acknowledged there are some exceptions.
What is also quite important is that many of the fluorinated gases can degrade and break down into other PFASs such as TFA.
And this substance is currently under scrutiny by RAC in a different process.
So they are looking into specific hazards.
And probably by the end of this year,
there will be more information related to this point.
you
There are some exceptions.
This has been mentioned in the opinion.
However,
all the concerns that I've mentioned earlier have been sufficient to include this category in the scope of this restriction.
The committee has also been calculating the PFAS volumes and related emissions.
Can you tell more about the committee's conclusions on those?
Does this also include the eight new sectors that were not assessed in detail by the committee?
Yeah,
this is a fundamental step to identify the most relevant sectors where PFAS are used,
both in terms of volumes and emissions.
So RAC has developed its own approach,
partially modifying what the dosage submitter has proposed.
The focus was on the original 14 sectors plus the PFAS manufacturing.
So what are the results?
Is that based on the available information,
a total volume of about 270,000 tons of PFAS have been estimated to be in use in the European Economic Area in 2020.
And the top three uses were what we call TULAC,
so textile,
upholstery,
leather and similar uses,
fluorinated gases and transport.
RAC also estimated the emissions.
However,
there is a different degree of certainty about this,
and we will comment on this in a moment.
And the top few uses are basically the same.
I should also mention that RAC could not assess in detail the eight new sectors that have been added in the final revision of the background document by the dossier submitter.
However,
RAC mentioned the estimation provided by the dossier submitter and provided them to the decision maker in a way that they can also consider them.
if any action will be taken on them.
Right.
Okay.
Thanks for clarifying that.
Now,
looking ahead,
how effective could this restriction actually be?
A full ban would obviously reduce PFAS risks the most,
but restrictions always involve balancing the risk reduction with socioeconomic aspects.
Now,
the committee supports a broad restriction,
but also gives guidance if derogations are considered.
Can you walk us through that?
Well,
from a risk reduction,
A restriction on manufacture,
use and placing on the market of PFAS is the most effective measure because being non-threshold substance,
the more you reduce emissions,
the lower will be actually the relevant risk.
So therefore the proposed derogations were normally not supported by the committee with a few exceptions,
for instance,
the protective equipment where the,
let's say,
restriction in the use of PFAS could actually lower the performance and expose
actually the user of those equipment to significant health and safety risks.
So a full restriction could definitely avoid an important quantity of PFAS emitted.
The committee estimated in the order of a million of tons in a period of 30 years,
so very high actually volumes,
despite,
of course,
the uncertainties that we already mentioned.
The committee recommended strongly to input actually additional risk management measures that will actually help reducing and minimize the emissions into the environment.
And this can be achieved through supply chain communication on PFAS uses,
clear consumer labeling for consumer about safe use and proper disposal of waste,
but also site-specific PFAS management plans where information is provided about the use of those products,
emission monitoring,
including also reporting to ECHA.
So listening to all this,
it's kind of clear that even the most ambitious restriction And.
only works if the rules can actually be enforced,
right,
on the ground.
And that nicely bridges us to enforcement,
because even the best designed restriction depends on whether it can be enforced consistently across all EU countries.
So what does the committee say about the enforcement aspect?
Well,
that's a very important point.
First of all,
we took note of the forum opinion that covers exactly the enforcement possible issues related to the implementation of the restriction.
The committee found it very useful.
And there were some elements related to how to apply analytical methods,
but also the concentration limit and whether they could be achievable or not for certain PFAS.
What is clear is that in agreement with Forum,
RAC is calling for an harmonized enforcement and standardization of the methods that are needed for sampling and analysis.
This will be very important to make actually this restriction work.
Right.
And anyway,
enforcement authorities,
I suppose,
have quite some time to prepare because any restriction will only come into place once.
the decision has been made.
Indeed,
indeed.
Right.
Well,
last question for me,
I promise.
So if a full PFAS ban,
as opposed to a wide restriction,
works so well,
what's holding us back?
Is it that some uses just simply can't be replaced yet?
Or is the challenge more about feasibility and implementation?
This is a difficult question for RAC,
and it's more in the territory of SEAC.
And I think Maria will comment in a second.
I can only say that RAC have found a lot of uses of PFAS in many sectors.
And decision makers must consider many aspects that are not only related to the risk for human health and environment.
And this is probably why the role of SEAC on opinion making is so important,
because it complements the opinion of RAC.
Well,
thank you,
Roberto.
So to wrap up this part,
PFAS are a complex family of chemicals,
if that wasn't clear already by now,
but the committee's takeaway is even clearer.
So because they persist and accumulate,
any release adds to a long-term problem.
That's why minimizing emissions,
whether through a full ban or carefully controlled derogations,
is so important.
And whatever direction the decision makers take next will have a real impact on Europe's health,
industry,
and innovation for years to come.
Time for you,
Maria.
Let's bring you in to look at the socioeconomic side of all this.
So to give our listeners a bit of context,
what exactly is the committee's role in the PFAS evaluation process?
And how does it differ from the scientific risk assessment side of things?
Well,
as Roberto has explained,
the Committee for Risk Assessment looks at the risk to human health and the environment.
But then SEAC takes that into account,
but looks at the broader picture,
I would say.
So our role is to assess...
all the socioeconomic impacts of the proposed restriction,
not just what RAC is looking at,
but also the full picture and much more than that.
It's necessary to do that before you can take a decision on whether the proposed restriction is proportionate,
which is done,
you know,
later on in the process.
So what do I mean when I say socioeconomic impacts of the proposed restriction?
People tend to think about socioeconomic impacts as cost to industry or monetary costs,
but it's a lot wider than that.
I mean,
we are talking about costs and benefits of a restriction.
When we're talking about the benefits,
we mean all the good impacts to society of implementing a restriction.
And there is the closest link to RAC because we take their assessment regarding how the risks to human health and the environment are reduced.
That's one of the,
you know,
it's always the key positive impact.
But when we are talking about negative impacts to society,
we in general will start by looking at the availability of alternatives.
So that allows us to understand the impacts.
So,
for instance,
if alternatives are easily available and replacing them is cheap,
then the negative impacts of a restriction won't be huge.
They should be fairly straightforward.
Costs are going to be low.
But if alternatives are not available...
and this may be that they're not available at all,
or there may be some available alternatives that they have performance that's much inferior to PFAS,
then we try to understand what happens.
And that's what really determines what the cost would be.
So in some cases,
it may be,
of course,
that companies may close.
There would be impacts on employment there,
for instance,
as well.
In some cases,
it may be that the performance of what they produce may be lower.
And depending on the sector,
the impact of that could range from
I don't know,
a consumer product which performs a little bit worse,
to certain medical devices not being available and not working with consequent health impacts.
There may also be environmental impacts if,
for instance,
a battery can't work and therefore there may be more carbon emissions.
So basically our task is to get to the bottom of this and to provide the decision makers some advice on how these negative and positive impacts balance together.
So just for my own understanding,
the kind of
an analysis of alternatives that feeds into the kind of impacts then to society.
Is that something that will be covered also as part of,
I guess we'll come to this later,
but also part of the consultation that it'll serve to feed into that?
Yes.
I mean,
conclusions on the analysis of alternative are part of the consultation and those conclusions are quite crucial to understand the impact.
So yes,
definitely this is something where in some cases we've got quite a lot of info,
in some not so much,
and we're looking for it.
Okay.
And that will then impact.
the opinion.
All right.
Well,
thanks for reminding us of the committee's role in all this.
Can you then talk about the key points of the draft opinion that will go for our consultation?
Well,
basically SEAC supported a broad restriction with you specific derogations where cost to society outweigh the benefits.
And this is to ensure the proportionality of the proposed restriction.
So basically,
we consider that there will be some derogations that are required to make a restriction proportionate.
So for each of the sectors and uses identified by the dossier submitter,
we analysed case by case,
use by use,
whether derogations are indeed justified and needed to ensure that proportionality.
And we had basically three broad categories of conclusions.
We had yes,
no and can't conclude for some uses.
So,
for instance,
here we're talking about cosmetics,
ski wax,
that type of thing.
We concluded that no derogations are needed and...
In some cases here,
you know,
we were quite firm,
definitely not justified.
In some cases,
likely not justified.
So there's all sorts of gradations there.
For some uses,
we say that derogations are needed.
Here we can mention,
for instance,
several kinds of medical devices.
For those,
we concluded more unambiguously.
But there are also many uses where we concluded,
for instance,
likely justified,
maybe justified.
So what we were trying to do there is to avoid...
They cannot conclude a conclusion as much as possible to give the decision maker as much as we could in terms of guidance.
But of course,
for some of the of the uses,
we were not able to conclude at all.
Or maybe in some cases,
it may be that there's,
you know,
there was not enough information.
In some cases,
it may be that the conclusion would need to be based on aspects that are not for SEAC to decide.
Of course,
we're a scientific committee.
when it comes to
Policy preference for some things over others,
we cannot say that.
The other thing to mention is that we have some difference to the derogations proposed by the dossier submitter.
So there is a big table near the end of the general aspects part of the opinion where we list all the derogations that were proposed by the dossier submitter and what SEAC's conclusion was.
In some cases,
we did not agree with the availability of alternatives conclusion.
In some cases we did,
but then the cost and benefits,
we were not able to balance them out.
But yeah,
all the information is there,
including some notes to the decision maker.
So it's quite useful to see at a glance.
Maybe the other thing to mention as well is that we note quite strongly in the opinion that the derogations that we consider justified should be regarded as necessary to ensure proportionality,
but not sufficient.
So basically,
we cannot say whether or not there may be some additional derogations required for certain sub-uses for...
to make a restriction proportion.
It's a very broad one that applies to everything,
basically.
I mean,
we have identified a couple of derogations that the dossier submitter was not proposing and that we are proposing that they are needed,
but there may be more.
Basically,
there is lack of data to be able to come up with more examples.
The other thing to mention is for the eight additional sectors where Roberto mentioned that in RAC they had not been able to come to specific conclusions.
Of course,
SEAC wasn't able to come to specific conclusions either.
But for those...
we still are able to make some recommendations.
We cannot conclude whether the derogations proposed within are justified,
nor whether we may need some more derogations there.
But what we're recommending is that an evaluation of all these uses is done as soon as possible.
And in the interim,
we are recommending a time-limited derogation for all the users'
applications within the scope of those sectors,
so not just the ones proposed by the dossier submitter.
And when we say time limited,
we don't mean for the periods that are being proposed by the dossier submitter,
but until an evaluation is performed.
So we're hoping that that provides maybe a little bit of information to the decision maker as to what we feel that should be done with those.
And finally,
Roberto mentioned the recommendations by RAC to implement additional risk management measures.
We also have a conclusion on that,
of course.
You know,
RAC's view is the main one in terms of the impact of those on risk reduction.
But we're looking at basically the proportionality of such measures,
for instance.
And there,
unfortunately,
we don't have information on the costs and benefits associated.
We don't know how much it would cost to implement.
And although RAC considers that it would reduce the risk,
we don't know by how much.
So we're not able to say whether it's proportional.
Is it something that you expect to get more information on in the consultation?
So the cost of these...
risk mitigation measures.
Exactly.
That's where we hope that we can get that information.
This was a RAC recommendation,
so it wasn't part of the initial consultation on the Annex 15 dossier.
So this will be the first time when people will be able to give us some information about what the implications are,
not just the cost,
but also how practical it is to implement these things.
Is it possible?
How long will it take?
We also have some concerns about the enforceability.
We support them in general,
but with the specific ones,
we consider that we may need some guidance to really allow things to be enforced.
And yes,
I think that that was a good reminder that you made,
Adam.
This is not the final opinion.
We launched a consultation and I think we'll talk about that later on a little bit more very soon.
Well,
I think by the time this podcast is released,
the consultation will already be out there and we're expecting to receive.
very valuable information there that will allow us to finalize the opinion.
Okay,
thanks a lot.
Very detailed overview.
And people can also find that out then in the draft opinion that will be published together with the podcast.
Yes,
and indeed,
maybe to mention,
there are some very useful summary sections at the beginning summary of the opinion.
So I really suggest people to have a look at that in the opinion.
We try to actually summarize the whole thing for Rack and Fusayak.
So based on what you've seen,
In which sectors are PFAS alternatives already available?
And where do we see the kind of the toughest challenges in finding substitutes?
You mentioned a few examples.
You mentioned medical devices,
for example,
at least needing a derogation because they might not be that easily replaced.
So can you give us another feeling of other areas?
Yeah,
I mean,
the derogation there is not just because of the conclusion on analysis of alternatives.
It was also because of the potential impact of not having the medical devices.
So that's important to remember.
while the dossier submitter recommended the derogations.
purely based on the availability of alternatives.
SEAC said that that was an important element,
but not the only one.
So that's an important clarification to make.
We also have to take account of the cost and benefits.
But yeah,
to your question.
In some consumer applications,
so some textiles,
cosmetics,
ski wax,
you know,
that kind of thing,
alternatives already exist.
So that is quite clear.
There's a lot of evidence there.
The conclusions that SEA can reach can be quite certain.
But there are greater challenges basically in the highly technical applications.
That's where we tend to find them.
Things like uses within electronics and semiconductors,
some medical devices,
some industrial processes.
And it's particularly where performance and safety requirements are very,
very stringent,
either because of the consequences to,
for instance,
people's health.
or because of consequences to safety.
So for instance,
in some applications,
there are very strict regulations as to what performance must be reached to protect safety.
So I think that that is very important.
So there is where we're finding that the alternatives are more difficult to find,
let's say.
And of course,
as we mentioned,
the consultation,
that's the opportunity to get more information on all of this.
Now,
with some sectors ready to move away from PFAS and others facing...
real technical barriers.
How does the committee decide what transition periods are realistic,
but also proportionate?
Well,
in general,
the goal is always to allow sufficient time to transition away from the substance while avoiding unnecessary delays in reducing emissions.
So it's a bit of a balancing act.
And normally the recommendations on the length of the derogations would look at very specific aspects of each use and consider in detail,
okay,
what will actually be needed to substitute,
where are we the alternatives?
Ideally,
we would come up with bespoke lengths,
but as you may be able to tell by the fact I'm talking about ideally,
in this case,
with so many different specific uses and quite a lot of lack of specific information,
the dossier submitter took a bit of a different approach.
They came up with two general derogation lengths,
and those were five and 12 years after entry into force,
so after the
18-month transition period that is in general for the whole proposal.
So they decided that they would recommend five years where there were no alternatives at the point of entry into force,
or no alternatives were expected to be available.
Some have been identified already,
or maybe there are some alternatives identified,
but they're not available in sufficient quantities.
So there may need to be some steps taken before they may be implemented,
like some approvals and that sort of thing.
Twelve years they recommended where no alternatives had been identified yet.
So it's likely.
They won't become available in the near future.
Or there are situations where the certifications or regulatory improvements cannot be achieved with a five-year derogation.
They take longer than that.
And there are some sectors where we know that that tends to be the case,
like some medical sectors,
for instance.
And in general,
SEAC endorsed this approach.
I mean,
we did note that the lengths were a little bit arbitrary,
but in general,
we think this is the right way to go in this type of very,
very broad restriction.
And we applied it in our analysis as well.
So our recommendations will be also about the 5 and 12 years.
In some cases,
when we are recommending our own derogations that the assessor method didn't propose,
we see if we can say something,
but it may be that there isn't enough information.
Okay.
All right.
Thank you.
And I suppose one kind of consequence of all this is that there will be a push to develop those alternatives,
essentially a much more bigger push,
because there is now a set time limit to get them.
applied.
So I guess that's a positive outcome also of this restriction.
Yeah,
basically,
when you have derogations that are time limited,
we all know what is going to happen at the end of the derogation period.
So of course,
there's going to be a lot of work happening.
I mean,
to be fair,
there is a lot of work happening already now.
I mean,
we see a lot of activity to develop alternatives.
And I think this is a positive impact that the restriction proposal is already having.
Given kind of all those moving pieces,
so technical feasibility,
supply chain readiness,
essential uses.
Where does the committee still see the biggest uncertainties in the draft opinion?
I will talk mainly about types of uncertainty,
not about specific uses.
One of them is this covers...
all the uses,
but not all of them were assessed by the dossier submitter and evaluated by SEAC.
So that is one uncertainty.
There's maybe a lot of uses that we don't even know about,
or that didn't pop up in the information that was received.
Of course,
we may get something in the consultation still.
And the other one is the lack of data.
I mean,
the dossier submitter did a huge job.
They put in a lot of work to try to get the information,
but
There are still some areas where this is lacking,
and this should be very clear when people look at the opinion.
I mentioned the table with all the derogations earlier,
but please remember that that table shouldn't be read in isolation.
Each of the conclusions that we talk about there on derogations should be read in conjunction with the sector-specific documents.
There is a lot of information there about what we know,
what we don't,
what we would need to know.
So people should read all of that.
Okay,
an important tip for anyone participating in the consultation.
Well,
thank you.
That helps put the uncertainties into perspective.
Maybe then moving to the next step that we've referred to already many times,
the 60-day consultation.
So when is that expected to begin?
Well,
we are launching the consultation on the 26th of March.
So it's closing 60 days later in late May.
And we've informed our audience since really early about the upcoming consultation.
We've told them what questions we'll be asking so that they can start preparing.
I've talked about this in previous podcasts in quite a lot of detail.
There is a webinar that we did some time ago that is still relevant and it's still available for people to see.
And there is a lot of guidance as well.
There's also a mapping of the PFAS uses,
which may be useful so that people understand where they need to respond.
I should mention as well,
this is done in a survey format,
so we are not allowing attachments to be provided.
People need to...
do a little bit of work in trying to draw out the exact information at the level of aggregation,
let's say,
that SEAC needs it and in the type of format that we need it.
That will allow us to really process things as effectively as possible and to actually have an impact on the opinion.
And yeah,
basically,
we encourage everyone who has relevant information to provide,
to engage really early in this consultation and to provide us that data.
Because we will be looking at it,
we will be considering it,
and the opinion may change as a result.
Okay,
then what about for listeners who may want to take part in the consultation?
What does it actually focus on?
So kind of what sort of input are you hoping people will provide?
Well,
the scope is basically the SEAC draft opinion that was just agreed in March.
And it includes all 23 sectors and uses within those sectors.
I mean,
there will be detailed questions on the sectors that SEAC has evaluated.
So these are 15 sectors and there will not be any detailed questions for the eight sectors where we haven't,
but information can be provided as part of the general aspects and they can be provided on any topics related to anything.
Basically,
that's covered in the opinion.
Basically,
the relevant information,
as I mentioned,
will be assessed to either confirm or change if necessary.
CEAC conclusions that are presented in the CEAC draft opinion.
And maybe the other thing that I would like to mention is that we're not looking here to hear about whether you like the proposal or not.
We're looking for technical evidence-based information.
So it's not so much about your opinion.
It's about things that can be substantiated.
That's what we're really looking for.
Okay.
All right.
And after the consultation phase,
then how does the process move forward?
What can stakeholders expect next?
Well,
as information comes in,
we will be analysing and not just after the consultation closes,
but as soon as we start receiving information.
And we will be analysing it and considering whether there would need to be any reviews made to the opinion.
So the idea is that we will adopt the final opinion by the end of 2026 and send to the Commission.
And then the Commission will decide on the restriction in consultation with the member states.
Okay,
reading between the lines and knowing when the committee meetings are.
So we're skipping the June,
the September meeting,
but then there's one in November,
December.
So would that be around the time,
if everything goes as planned and all timelines match?
Yeah,
we haven't decided yet exactly what we will be doing on each of those meetings.
I would expect that probably in June,
we would have some information about the,
you know,
informing the committee about the consultation comments,
what was received,
maybe some initial views.
But yeah,
it will be.
basically the last plenary of the year where the timing is still to be fully confirmed.
We need to finalize it with enough time to then be able to send things to the commission.
Now,
moving aside from the kind of the PFAS topic today,
can you talk us through,
Roberto,
about the CLH,
so the Harmonized Classification and Labeling opinion on cannabidiol that was mentioned earlier?
So that's used actually in several sectors,
apparently in vaping products,
so in electronic cigarettes or possible inhalation,
or even in cosmetic products or food ingredients or supplements for human and animals.
And apparently there is also even a medication against epilepsy that has been actually authorized in Europe.
So what RAC found was that there is enough evidence to recommend a quite severe hazard classification related to...
to category 1b in terms of reproductive toxicants,
so able to damage fertility or damage the unborn child,
and even hazardous to the breastfed child.
So that's something that will be published in a few weeks,
couple of months maximum.
And this opinion will then be transmitted to the European Commission.
And as usual,
the European Commission in conjunction with member states will decide whether an harmonized classification is needed actually for this specific substance.
And if this happens,
this classification could also trigger what we call downstream effects in other regulations.
Just to mention,
for instance,
the cosmetic products regulation,
where possible exemption could be needed in case this would go forward.
Also to mention that we have coordinated with EFSA because there are also discussions on food uses that are taking place.
So we ensure that we are aligned with our agency in charge of food.
Thanks.
So that's actually a significant development.
I mean,
CBD is used in such a wide range of products that a harmonized classification like this could have major implications across several sectors.
What about the chromium-6 restriction proposal that was also mentioned?
Can you share any details on that?
Yeah,
I can say a few words.
I mean,
we're making significant progress on that.
That was discussed in the March plenary in SEAC and in RAC.
I think it was done in the working group before,
but there was a lot of discussion.
I followed that.
There was a whole day of discussions and quite a lot of discussion in SEAC as well.
So basically,
the consultation ended a couple of months ago and the dossier submitter has updated their proposal based on the consultation comments that were submitted to the committees.
by the end of
February. So not in time to be able to be considered in March,
but it will be considered in June.
And the plan is for RAC to conclude in June and for SEAC to come to an agreement of the opinion and launch its consultation.
So the plan there is also to finish by the end of 2026.
It's going to be a busy second half of 2026.
Sounds like it.
Yes.
And Chromium 6 is yet another big file with far-reaching implications.
So it's good to hear that the evaluation is progressing on schedule.
And it'll be interesting to see how
the consultation input shapes the next steps on that one.
Yeah,
of course,
the committees will also consider the consultation comments.
They are considering them already.
Right.
Okay,
good.
Thanks for clarifying.
Well,
that brings us to the end of today's episode.
So we've covered a huge amount of ground from the science behind PFAS persistence to the committee's proposed approaches on grouping,
non-threshold treatment,
fluoropolymers,
volatile PFAS,
and the scale of PFAS emissions across Europe.
What really came through today is just how complex this restriction proposal is,
touching everything from textiles and cookware to medical devices,
industrial processes,
fluorinated gases,
and even the question of how enforcement will work in practice.
We also looked ahead at the next steps,
so the 60-day consultation,
which will be the key moment for stakeholders to contribute evidence,
clarify uncertainties,
and help shape the committee's final opinion.
As we heard,
this input is essential,
especially in uses where the committee
hasn't been able to reach very firm conclusions.
So thank you for joining us.
And thank you again,
Roberto and Maria,
for sharing your insights.
Thank you.
Oh,
bye-bye.
We'll continue following this process closely,
as always,
in future episodes.
Until then,
take care and stay safe.
Safer Chemicals Podcast.
Sound science on harmful chemicals.