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Safer Chemicals Podcast.

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 Sound science on harmful chemicals.

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 Hello,

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 I'm your host,

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 Adam Elwan,

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 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.

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 We'll be speaking with the Chair,

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 Roberto Scazzola,

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 about what the opinion concludes and what it means going forward.

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 The Committee for Socio-Economic Analysis has also agreed on its draft opinion during their latest meeting.

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 The opinion has not yet been formally adopted and a

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 60-day consultation will now start.

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 We'll be joined by Maria Otati,

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 the Committee Chair,

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 to explore the key points of the draft and what information the Committee is looking for during the consultation.

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 We'll also briefly cover two other topics,

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 the harmonised classification of cannabidiol and the latest developments on the restriction proposal for chromium-6 substances.

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 So,

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 Roberto,

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 Maria,

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 thank you both for joining us.

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Pleasure to join you,

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 Adam.

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Absolute pleasure.

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Always good to have you.

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 Now,

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 for our listeners,

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 I'm sure you've all heard about the wide uses of PFAS in things like cookware,

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 waterproof jackets,

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 and food packaging.

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 In this episode,

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 we explain why the Risk Assessment Committee considers their very persistent nature,

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 combined with properties such as mobility,

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 bioaccumulation,

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 and long-range environmental transport,

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 to pose a concern for both human health and the environment.

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 We'll walk you through the key points of the opinion step by step with Roberto.

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 So let's kick things off by talking about the hazards of PFAS.

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 The committee points to persistence as the kind of big driver for action,

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 even though toxicity does vary among different PFAS.

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 So why persistence?

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 Why on its own?

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 Why is it such a powerful reason to regulate these substances?

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If you allow me,

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 Adam,

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 I would like first to express my big thanks to the team of people for this big achievement.

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 I think this is a...

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 result of the work of rapporteurs,

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 members and stakeholders.

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 So we all worked together to make this possible.

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 It was about three years of work for RAC.

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 And finally,

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 we reached the adoption of the RAC opinion.

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 So that's clearly a great achievement.

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 However,

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 this is only half of the work,

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 right,

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 Maria?

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Exactly.

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 And I would like to second the thanks that

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 Roberto has made to all these parties and most especially to the rapporteurs who did a huge amount of work in both committees.

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So why we did so?

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 Good to remind that we had five countries submitting a restriction proposal.

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 And the main reason,

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 as you have mentioned,

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 is the very persistent properties of PFAS.

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 So what does it mean?

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 Once the PFAS reach into the environment,

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 they stay there for a very,

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 very long time.

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 And in addition,

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 there are also other hazards that result in significant concern for human health and the environment.

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 In addition,

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 many studies found that PFAS,

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 once it is in the environment,

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 can really interact with different matrices.

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 even reaching the blood of workers and growing stock over time.

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 This is also probably the reason why the five countries started in its first place this specific restriction dossier.

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Right,

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 okay.

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 And with such a broad and persistent group of chemicals,

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 it makes sense that the definition of kind of what counts as a PFAS becomes incredibly important,

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 which actually brings us to the next point.

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 So the committee also supports using the OECD definition when grouping PFAS.

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 That's the one that captures any chemical with at least

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 one fully fluorinated CF2 or CF3 group.

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 So what does using such a broad definition actually mean in practice,

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 especially for companies trying to stay compliant across the EU?

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That's probably the most important point.

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 Substance identity is fundamental.

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 All relevant actors must understand what is in the scope of the restriction and what is not.

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 This is really a grouping approach so that one harmful PFAS is not substituted by another one.

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 that is slightly different,

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 but displays actually the same as Ardos property.

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 Perhaps to mention that the dossier submitter had in mind also to exclude specific subgroups related to their possible degradability.

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 Unfortunately,

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 RAC didn't find enough evidence to support this.

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 So we stick basically to the OECD broad definition for this case.

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Once you define PFAS this broadly,

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 the next question becomes,

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 how do you treat them?

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 from a risk management perspective.

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 Here,

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 the committee is proposing to treat them as non-threshold substances,

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 so similar to persistent,

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 bioaccumulative,

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 and very persistent,

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 and very bioaccumulative substances.

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 So in simple terms,

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 non-threshold means that there's no safe level of exposure,

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 and any release is considered potentially harmful.

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 What does that mean in practice when we talk about acceptable exposure levels?

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That's a scientific concept that is based on the adverse effects.

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 irrespective of the concentration of specific chemicals.

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 So in a way you can say there is no safe concentration once it is released into the environment.

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 In such a way,

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 any release,

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 any emission...

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 could mean actually that there is a risk.

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 This was also proposed by the dossier submitter and RAC basically agreed with this specific approach.

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 And as you mentioned,

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 it's something that RAC has been used in other dossiers related to persistent bioaccumulative and toxic substances.

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 There is also another aspect is the fact that,

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 however,

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 the greater the amount of emissions into the environment,

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 also the greater is the risk because the stock into the environment will continue to increase.

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 So there is also this dimension that has been considered by RAC.

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 So,

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 of course,

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 this is the purely risk assessment scientific approach.

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 And we acknowledge that the decision maker or SEC,

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 they could also consider other elements that not necessarily linked only to the risk related to the release of a substance.

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Right.

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 At this perspective is important because it does put all PFAS under a,

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 or let's say PFAS uses under a much brighter spotlight.

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 So even those where...

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 You know,

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 toxicity or bioaccumulation might be less clear,

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 which actually brings us to fluoropolymers.

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 So the committee recognizes that fluoropolymers have limited evidence of bioaccumulation and ecotoxicity,

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 yet they still fall within scope of the restriction proposal.

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 So firstly,

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 what exactly are fluoropolymers?

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 Let's start with the basics.

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 And what made the committee conclude that they're part of the broader PFAS restriction?

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Fluoropolymers are actually a plastic made from monomers that contain this strong

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 carbon-fluorine bonds.

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 So they make them extremely stable,

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 also resistant to heat and chemicals.

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 So all very good properties that are normally looked at when you engineer actually a product.

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 There are a lot of different kinds of fluoropolymers.

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 Perhaps the most well-known is polytetrafluoroethylene.

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 Definitely know that one.

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 Yeah.

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 My favorite.

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 Probably,

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 you know,

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 it's commercial name we will not mention today,

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 but it's used widely in cookware and other actually uses.

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 So it's true that fluoropolymers

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 are persistent,

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 but it's also true they are generally not mobile or bioaccumulative,

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 as you have mentioned earlier.

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 Most of the concerns are related to the emissions once they are produced.

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 So in the production of fluoropolymers,

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 other PFAS are emitted.

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 There are also concerns related to the waste stage of fluoropolymers.

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 For instance,

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 when you dispose them via incineration,

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 you can produce additional PFAS that can be volatile or non-volatile,

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 or you can even have emission of micro and nano size.

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 polymer particles.

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 So RAC assesses this as sufficient ground for concern to act.

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Right.

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 So even though fluoropolymers themselves may not show the same toxicity or mobility as other PFAS,

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 their life cycle still creates PFAS emissions.

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 So during production,

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 use,

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 and from what I hear,

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 especially during disposal.

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 And that's really the key here.

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 So the concern isn't just the polymer,

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 but everything that comes with it.

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Indeed.

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Well,

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 let's move on to volatile PFAS,

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 like fluorinated gases.

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 These can easily evaporate into the air,

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 and they're used in things like refrigerators.

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 I guess the most common example that people can relate to.

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 The committee calls them very persistent and very mobile,

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 with global warming potential and long-range transport.

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 And their degradation increases trifluoroacetic acid,

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 or TFA,

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 levels globally.

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 Can you tell us more about the issue with fluorinated gases?

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 How?

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 well understood are the environmental and health impacts of rising TFA levels,

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 and what are the biggest knowledge gaps?

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Well,

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 some PFASs,

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 as you have mentioned,

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 are volatile,

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 so especially fluorinated gases.

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 So they can evaporate,

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 drift with the wind,

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 and also contribute to the widespread environmental pollution,

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 even to very remote areas,

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 mountains,

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 or even the arctic.

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 So fluorinated gases are also the major contributors to PFAS submissions,

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 as you've mentioned,

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 because they have...

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 uses,

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 they can actually result in high emissions.

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 Can you imagine when a refrigerator actually leaks a fluorinated gas,

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 so you will have immediate release into the environment.

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 So they're found in refrigerants,

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 cooling systems,

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 but also electronics.

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 The concerns,

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 as you've mentioned,

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 is that they are very persistent,

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 very mobile,

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 and some have global warming potential.

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 So they can increase actually the effect of climate change,

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 but also long range transport.

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 So you can find them very far away from the point.

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 of emission,

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 even if the committee has acknowledged there are some exceptions.

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 What is also quite important is that many of the fluorinated gases can degrade and break down into other PFASs such as TFA.

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 And this substance is currently under scrutiny by RAC in a different process.

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 So they are looking into specific hazards.

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 And probably by the end of this year,

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 there will be more information related to this point.

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 you

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 There are some exceptions.

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 This has been mentioned in the opinion.

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 However,

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 all the concerns that I've mentioned earlier have been sufficient to include this category in the scope of this restriction.

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The committee has also been calculating the PFAS volumes and related emissions.

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 Can you tell more about the committee's conclusions on those?

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 Does this also include the eight new sectors that were not assessed in detail by the committee?

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Yeah,

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 this is a fundamental step to identify the most relevant sectors where PFAS are used,

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 both in terms of volumes and emissions.

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 So RAC has developed its own approach,

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 partially modifying what the dosage submitter has proposed.

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 The focus was on the original 14 sectors plus the PFAS manufacturing.

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 So what are the results?

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 Is that based on the available information,

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 a total volume of about 270,000 tons of PFAS have been estimated to be in use in the European Economic Area in 2020.

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 And the top three uses were what we call TULAC,

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 so textile,

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 upholstery,

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 leather and similar uses,

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 fluorinated gases and transport.

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 RAC also estimated the emissions.

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 However,

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 there is a different degree of certainty about this,

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 and we will comment on this in a moment.

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 And the top few uses are basically the same.

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 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.

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 However,

265
00:11:10.600 --> 00:11:18.667
 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.

266
00:11:18.907 --> 00:11:20.447
 if any action will be taken on them.

267
00:11:21.928 --> 00:11:22.108
Right.

268
00:11:22.148 --> 00:11:22.348
 Okay.

269
00:11:22.468 --> 00:11:23.348
 Thanks for clarifying that.

270
00:11:23.888 --> 00:11:24.089
 Now,

271
00:11:24.529 --> 00:11:25.109
 looking ahead,

272
00:11:25.389 --> 00:11:27.850
 how effective could this restriction actually be?

273
00:11:28.190 --> 00:11:31.351
 A full ban would obviously reduce PFAS risks the most,

274
00:11:31.771 --> 00:11:36.512
 but restrictions always involve balancing the risk reduction with socioeconomic aspects.

275
00:11:37.192 --> 00:11:37.352
 Now,

276
00:11:37.492 --> 00:11:39.473
 the committee supports a broad restriction,

277
00:11:39.693 --> 00:11:42.474
 but also gives guidance if derogations are considered.

278
00:11:42.514 --> 00:11:43.754
 Can you walk us through that?

279
00:11:44.695 --> 00:11:44.835
Well,

280
00:11:44.875 --> 00:11:45.995
 from a risk reduction,

281
00:11:46.443 --> 00:11:47.844
 A restriction on manufacture,

282
00:11:48.044 --> 00:11:53.546
 use and placing on the market of PFAS is the most effective measure because being non-threshold substance,

283
00:11:54.086 --> 00:11:55.467
 the more you reduce emissions,

284
00:11:55.607 --> 00:11:58.068
 the lower will be actually the relevant risk.

285
00:11:58.869 --> 00:12:04.451
 So therefore the proposed derogations were normally not supported by the committee with a few exceptions,

286
00:12:04.531 --> 00:12:05.112
 for instance,

287
00:12:05.113 --> 00:12:07.533
 the protective equipment where the,

288
00:12:08.553 --> 00:12:08.833
 let's say,

289
00:12:08.913 --> 00:12:12.535
 restriction in the use of PFAS could actually lower the performance and expose

290
00:12:12.875 --> 00:12:16.817
 actually the user of those equipment to significant health and safety risks.

291
00:12:17.297 --> 00:12:22.979
 So a full restriction could definitely avoid an important quantity of PFAS emitted.

292
00:12:22.999 --> 00:12:26.581
 The committee estimated in the order of a million of tons in a period of 30 years,

293
00:12:26.582 --> 00:12:29.022
 so very high actually volumes,

294
00:12:29.182 --> 00:12:29.542
 despite,

295
00:12:29.543 --> 00:12:29.902
 of course,

296
00:12:29.903 --> 00:12:32.023
 the uncertainties that we already mentioned.

297
00:12:32.523 --> 00:12:42.407
 The committee recommended strongly to input actually additional risk management measures that will actually help reducing and minimize the emissions into the environment.

298
00:12:42.767 --> 00:12:47.088
 And this can be achieved through supply chain communication on PFAS uses,

299
00:12:47.628 --> 00:12:53.210
 clear consumer labeling for consumer about safe use and proper disposal of waste,

300
00:12:53.710 --> 00:13:00.672
 but also site-specific PFAS management plans where information is provided about the use of those products,

301
00:13:00.872 --> 00:13:01.833
 emission monitoring,

302
00:13:02.053 --> 00:13:03.613
 including also reporting to ECHA.

303
00:13:04.674 --> 00:13:05.914
So listening to all this,

304
00:13:06.054 --> 00:13:09.175
 it's kind of clear that even the most ambitious restriction And.

305
00:13:09.667 --> 00:13:11.989
 only works if the rules can actually be enforced,

306
00:13:12.109 --> 00:13:12.309
 right,

307
00:13:12.349 --> 00:13:12.849
 on the ground.

308
00:13:13.410 --> 00:13:15.551
 And that nicely bridges us to enforcement,

309
00:13:15.571 --> 00:13:22.076
 because even the best designed restriction depends on whether it can be enforced consistently across all EU countries.

310
00:13:22.096 --> 00:13:25.178
 So what does the committee say about the enforcement aspect?

311
00:13:26.199 --> 00:13:26.399
Well,

312
00:13:26.419 --> 00:13:28.020
 that's a very important point.

313
00:13:28.680 --> 00:13:29.201
 First of all,

314
00:13:29.241 --> 00:13:36.105
 we took note of the forum opinion that covers exactly the enforcement possible issues related to the implementation of the restriction.

315
00:13:36.466 --> 00:13:38.247
 The committee found it very useful.

316
00:13:38.739 --> 00:13:42.342
 And there were some elements related to how to apply analytical methods,

317
00:13:42.422 --> 00:13:47.827
 but also the concentration limit and whether they could be achievable or not for certain PFAS.

318
00:13:48.407 --> 00:13:50.969
 What is clear is that in agreement with Forum,

319
00:13:51.249 --> 00:13:57.635
 RAC is calling for an harmonized enforcement and standardization of the methods that are needed for sampling and analysis.

320
00:13:57.695 --> 00:14:01.418
 This will be very important to make actually this restriction work.

321
00:14:02.298 --> 00:14:02.479
Right.

322
00:14:02.499 --> 00:14:02.919
 And anyway,

323
00:14:02.999 --> 00:14:03.800
 enforcement authorities,

324
00:14:03.820 --> 00:14:04.240
 I suppose,

325
00:14:04.260 --> 00:14:07.663
 have quite some time to prepare because any restriction will only come into place once.

326
00:14:07.903 --> 00:14:08.864
 the decision has been made.

327
00:14:09.044 --> 00:14:09.364
Indeed,

328
00:14:09.544 --> 00:14:09.844
 indeed.

329
00:14:10.204 --> 00:14:10.384
 Right.

330
00:14:10.785 --> 00:14:10.925
Well,

331
00:14:11.085 --> 00:14:11.805
 last question for me,

332
00:14:11.825 --> 00:14:12.305
 I promise.

333
00:14:12.766 --> 00:14:14.827
 So if a full PFAS ban,

334
00:14:14.867 --> 00:14:16.107
 as opposed to a wide restriction,

335
00:14:16.268 --> 00:14:16.968
 works so well,

336
00:14:17.608 --> 00:14:18.509
 what's holding us back?

337
00:14:19.029 --> 00:14:22.011
 Is it that some uses just simply can't be replaced yet?

338
00:14:22.171 --> 00:14:25.312
 Or is the challenge more about feasibility and implementation?

339
00:14:26.073 --> 00:14:27.954
This is a difficult question for RAC,

340
00:14:27.994 --> 00:14:29.895
 and it's more in the territory of SEAC.

341
00:14:29.975 --> 00:14:32.736
 And I think Maria will comment in a second.

342
00:14:33.257 --> 00:14:37.339
 I can only say that RAC have found a lot of uses of PFAS in many sectors.

343
00:14:37.679 --> 00:14:43.545
 And decision makers must consider many aspects that are not only related to the risk for human health and environment.

344
00:14:43.605 --> 00:14:47.228
 And this is probably why the role of SEAC on opinion making is so important,

345
00:14:47.248 --> 00:14:49.871
 because it complements the opinion of RAC.

346
00:14:50.860 --> 00:14:51.000
Well,

347
00:14:51.040 --> 00:14:51.340
 thank you,

348
00:14:51.400 --> 00:14:51.781
 Roberto.

349
00:14:51.841 --> 00:14:53.122
 So to wrap up this part,

350
00:14:53.682 --> 00:14:56.004
 PFAS are a complex family of chemicals,

351
00:14:56.064 --> 00:14:57.525
 if that wasn't clear already by now,

352
00:14:57.865 --> 00:15:00.026
 but the committee's takeaway is even clearer.

353
00:15:00.066 --> 00:15:02.128
 So because they persist and accumulate,

354
00:15:02.528 --> 00:15:04.890
 any release adds to a long-term problem.

355
00:15:05.470 --> 00:15:07.151
 That's why minimizing emissions,

356
00:15:07.271 --> 00:15:10.613
 whether through a full ban or carefully controlled derogations,

357
00:15:11.034 --> 00:15:11.834
 is so important.

358
00:15:12.615 --> 00:15:16.978
 And whatever direction the decision makers take next will have a real impact on Europe's health,

359
00:15:17.238 --> 00:15:17.638
 industry,

360
00:15:17.878 --> 00:15:19.279
 and innovation for years to come.

361
00:15:20.644 --> 00:15:21.064
 Time for you,

362
00:15:21.125 --> 00:15:21.385
 Maria.

363
00:15:21.485 --> 00:15:24.047
 Let's bring you in to look at the socioeconomic side of all this.

364
00:15:24.087 --> 00:15:26.329
 So to give our listeners a bit of context,

365
00:15:26.590 --> 00:15:30.253
 what exactly is the committee's role in the PFAS evaluation process?

366
00:15:30.473 --> 00:15:33.756
 And how does it differ from the scientific risk assessment side of things?

367
00:15:35.017 --> 00:15:35.217
Well,

368
00:15:35.218 --> 00:15:36.539
 as Roberto has explained,

369
00:15:36.739 --> 00:15:40.883
 the Committee for Risk Assessment looks at the risk to human health and the environment.

370
00:15:41.403 --> 00:15:43.125
 But then SEAC takes that into account,

371
00:15:43.185 --> 00:15:44.606
 but looks at the broader picture,

372
00:15:44.626 --> 00:15:45.046
 I would say.

373
00:15:45.146 --> 00:15:46.608
 So our role is to assess...

374
00:15:46.928 --> 00:15:49.490
 all the socioeconomic impacts of the proposed restriction,

375
00:15:49.571 --> 00:15:51.612
 not just what RAC is looking at,

376
00:15:51.813 --> 00:15:54.615
 but also the full picture and much more than that.

377
00:15:55.476 --> 00:16:00.060
 It's necessary to do that before you can take a decision on whether the proposed restriction is proportionate,

378
00:16:00.080 --> 00:16:00.581
 which is done,

379
00:16:00.721 --> 00:16:00.961
 you know,

380
00:16:01.021 --> 00:16:02.622
 later on in the process.

381
00:16:03.823 --> 00:16:08.488
 So what do I mean when I say socioeconomic impacts of the proposed restriction?

382
00:16:09.308 --> 00:16:14.811
 People tend to think about socioeconomic impacts as cost to industry or monetary costs,

383
00:16:14.871 --> 00:16:16.392
 but it's a lot wider than that.

384
00:16:16.412 --> 00:16:16.692
 I mean,

385
00:16:17.153 --> 00:16:20.635
 we are talking about costs and benefits of a restriction.

386
00:16:21.415 --> 00:16:22.736
 When we're talking about the benefits,

387
00:16:22.776 --> 00:16:26.258
 we mean all the good impacts to society of implementing a restriction.

388
00:16:26.298 --> 00:16:33.002
 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.

389
00:16:33.003 --> 00:16:33.822
 That's one of the,

390
00:16:33.962 --> 00:16:34.222
 you know,

391
00:16:34.242 --> 00:16:36.964
 it's always the key positive impact.

392
00:16:37.540 --> 00:16:39.901
 But when we are talking about negative impacts to society,

393
00:16:40.662 --> 00:16:44.324
 we in general will start by looking at the availability of alternatives.

394
00:16:44.464 --> 00:16:46.465
 So that allows us to understand the impacts.

395
00:16:47.005 --> 00:16:47.125
 So,

396
00:16:47.345 --> 00:16:47.925
 for instance,

397
00:16:48.026 --> 00:16:51.467
 if alternatives are easily available and replacing them is cheap,

398
00:16:51.627 --> 00:16:53.969
 then the negative impacts of a restriction won't be huge.

399
00:16:54.029 --> 00:16:55.690
 They should be fairly straightforward.

400
00:16:55.750 --> 00:16:56.690
 Costs are going to be low.

401
00:16:57.430 --> 00:16:59.471
 But if alternatives are not available...

402
00:17:00.592 --> 00:17:03.033
 and this may be that they're not available at all,

403
00:17:03.173 --> 00:17:08.496
 or there may be some available alternatives that they have performance that's much inferior to PFAS,

404
00:17:09.357 --> 00:17:10.938
 then we try to understand what happens.

405
00:17:11.478 --> 00:17:14.440
 And that's what really determines what the cost would be.

406
00:17:14.840 --> 00:17:15.801
 So in some cases,

407
00:17:15.841 --> 00:17:16.261
 it may be,

408
00:17:16.281 --> 00:17:16.621
 of course,

409
00:17:16.622 --> 00:17:17.702
 that companies may close.

410
00:17:17.703 --> 00:17:19.182
 There would be impacts on employment there,

411
00:17:19.222 --> 00:17:19.783
 for instance,

412
00:17:19.784 --> 00:17:20.103
 as well.

413
00:17:21.484 --> 00:17:22.264
 In some cases,

414
00:17:22.364 --> 00:17:25.846
 it may be that the performance of what they produce may be lower.

415
00:17:26.266 --> 00:17:27.307
 And depending on the sector,

416
00:17:27.308 --> 00:17:29.108
 the impact of that could range from

417
00:17:29.592 --> 00:17:29.952
 I don't know,

418
00:17:29.953 --> 00:17:32.354
 a consumer product which performs a little bit worse,

419
00:17:33.094 --> 00:17:38.417
 to certain medical devices not being available and not working with consequent health impacts.

420
00:17:38.657 --> 00:17:40.538
 There may also be environmental impacts if,

421
00:17:40.578 --> 00:17:41.279
 for instance,

422
00:17:41.619 --> 00:17:45.681
 a battery can't work and therefore there may be more carbon emissions.

423
00:17:46.102 --> 00:17:53.546
 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.

424
00:17:53.886 --> 00:17:55.867
So just for my own understanding,

425
00:17:56.288 --> 00:17:56.808
 the kind of

426
00:17:57.088 --> 00:18:01.290
 an analysis of alternatives that feeds into the kind of impacts then to society.

427
00:18:01.631 --> 00:18:03.432
 Is that something that will be covered also as part of,

428
00:18:03.492 --> 00:18:04.452
 I guess we'll come to this later,

429
00:18:04.472 --> 00:18:07.514
 but also part of the consultation that it'll serve to feed into that?

430
00:18:08.755 --> 00:18:09.015
Yes.

431
00:18:09.075 --> 00:18:09.335
 I mean,

432
00:18:09.575 --> 00:18:17.419
 conclusions on the analysis of alternative are part of the consultation and those conclusions are quite crucial to understand the impact.

433
00:18:17.439 --> 00:18:17.839
 So yes,

434
00:18:17.900 --> 00:18:22.422
 definitely this is something where in some cases we've got quite a lot of info,

435
00:18:22.462 --> 00:18:23.503
 in some not so much,

436
00:18:23.703 --> 00:18:24.963
 and we're looking for it.

437
00:18:25.123 --> 00:18:25.324
Okay.

438
00:18:25.344 --> 00:18:26.084
 And that will then impact.

439
00:18:26.104 --> 00:18:26.584
 the opinion.

440
00:18:27.644 --> 00:18:27.925
 All right.

441
00:18:28.265 --> 00:18:28.405
 Well,

442
00:18:28.605 --> 00:18:30.565
 thanks for reminding us of the committee's role in all this.

443
00:18:31.105 --> 00:18:35.227
 Can you then talk about the key points of the draft opinion that will go for our consultation?

444
00:18:36.327 --> 00:18:36.487
Well,

445
00:18:36.547 --> 00:18:42.949
 basically SEAC supported a broad restriction with you specific derogations where cost to society outweigh the benefits.

446
00:18:43.209 --> 00:18:46.370
 And this is to ensure the proportionality of the proposed restriction.

447
00:18:46.390 --> 00:18:46.890
 So basically,

448
00:18:46.891 --> 00:18:52.572
 we consider that there will be some derogations that are required to make a restriction proportionate.

449
00:18:53.548 --> 00:18:57.291
 So for each of the sectors and uses identified by the dossier submitter,

450
00:18:57.652 --> 00:18:59.613
 we analysed case by case,

451
00:18:59.693 --> 00:19:00.394
 use by use,

452
00:19:00.754 --> 00:19:05.318
 whether derogations are indeed justified and needed to ensure that proportionality.

453
00:19:05.918 --> 00:19:09.702
 And we had basically three broad categories of conclusions.

454
00:19:09.703 --> 00:19:10.822
 We had yes,

455
00:19:10.902 --> 00:19:13.905
 no and can't conclude for some uses.

456
00:19:14.105 --> 00:19:14.225
 So,

457
00:19:14.345 --> 00:19:14.926
 for instance,

458
00:19:14.946 --> 00:19:16.527
 here we're talking about cosmetics,

459
00:19:16.707 --> 00:19:17.288
 ski wax,

460
00:19:17.608 --> 00:19:18.308
 that type of thing.

461
00:19:19.309 --> 00:19:22.232
 We concluded that no derogations are needed and...

462
00:19:22.812 --> 00:19:24.393
 In some cases here,

463
00:19:24.513 --> 00:19:24.773
 you know,

464
00:19:24.793 --> 00:19:25.693
 we were quite firm,

465
00:19:25.853 --> 00:19:27.234
 definitely not justified.

466
00:19:27.314 --> 00:19:28.054
 In some cases,

467
00:19:28.214 --> 00:19:29.355
 likely not justified.

468
00:19:29.395 --> 00:19:31.556
 So there's all sorts of gradations there.

469
00:19:32.496 --> 00:19:33.376
 For some uses,

470
00:19:34.037 --> 00:19:35.797
 we say that derogations are needed.

471
00:19:36.158 --> 00:19:37.638
 Here we can mention,

472
00:19:37.698 --> 00:19:38.178
 for instance,

473
00:19:38.198 --> 00:19:39.819
 several kinds of medical devices.

474
00:19:41.260 --> 00:19:41.700
 For those,

475
00:19:41.720 --> 00:19:43.501
 we concluded more unambiguously.

476
00:19:43.661 --> 00:19:46.202
 But there are also many uses where we concluded,

477
00:19:46.282 --> 00:19:46.882
 for instance,

478
00:19:47.222 --> 00:19:48.242
 likely justified,

479
00:19:48.363 --> 00:19:49.303
 maybe justified.

480
00:19:49.563 --> 00:19:51.704
 So what we were trying to do there is to avoid...

481
00:19:52.104 --> 00:19:59.047
 They cannot conclude a conclusion as much as possible to give the decision maker as much as we could in terms of guidance.

482
00:19:59.507 --> 00:20:00.148
 But of course,

483
00:20:00.208 --> 00:20:01.948
 for some of the of the uses,

484
00:20:02.749 --> 00:20:04.410
 we were not able to conclude at all.

485
00:20:05.770 --> 00:20:07.131
 Or maybe in some cases,

486
00:20:07.251 --> 00:20:08.211
 it may be that there's,

487
00:20:09.052 --> 00:20:09.272
 you know,

488
00:20:09.312 --> 00:20:10.612
 there was not enough information.

489
00:20:10.833 --> 00:20:11.433
 In some cases,

490
00:20:11.473 --> 00:20:15.975
 it may be that the conclusion would need to be based on aspects that are not for SEAC to decide.

491
00:20:15.976 --> 00:20:16.315
 Of course,

492
00:20:16.335 --> 00:20:17.415
 we're a scientific committee.

493
00:20:17.576 --> 00:20:18.236
 when it comes to

494
00:20:18.692 --> 00:20:20.958
 Policy preference for some things over others,

495
00:20:21.159 --> 00:20:22.402
 we cannot say that.

496
00:20:25.162 --> 00:20:30.485
 The other thing to mention is that we have some difference to the derogations proposed by the dossier submitter.

497
00:20:31.526 --> 00:20:40.412
 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.

498
00:20:41.032 --> 00:20:41.712
 In some cases,

499
00:20:41.752 --> 00:20:45.335
 we did not agree with the availability of alternatives conclusion.

500
00:20:45.355 --> 00:20:46.495
 In some cases we did,

501
00:20:46.576 --> 00:20:48.217
 but then the cost and benefits,

502
00:20:48.237 --> 00:20:50.178
 we were not able to balance them out.

503
00:20:51.190 --> 00:20:51.610
 But yeah,

504
00:20:51.630 --> 00:20:52.731
 all the information is there,

505
00:20:52.751 --> 00:20:54.752
 including some notes to the decision maker.

506
00:20:54.772 --> 00:20:57.694
 So it's quite useful to see at a glance.

507
00:20:58.854 --> 00:21:10.821
 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,

508
00:21:11.141 --> 00:21:12.041
 but not sufficient.

509
00:21:12.082 --> 00:21:12.722
 So basically,

510
00:21:13.222 --> 00:21:20.146
 we cannot say whether or not there may be some additional derogations required for certain sub-uses for...

511
00:21:20.446 --> 00:21:21.687
 to make a restriction proportion.

512
00:21:21.727 --> 00:21:23.649
 It's a very broad one that applies to everything,

513
00:21:23.689 --> 00:21:24.309
 basically.

514
00:21:24.830 --> 00:21:25.050
 I mean,

515
00:21:25.070 --> 00:21:31.095
 we have identified a couple of derogations that the dossier submitter was not proposing and that we are proposing that they are needed,

516
00:21:31.615 --> 00:21:32.316
 but there may be more.

517
00:21:32.396 --> 00:21:32.756
 Basically,

518
00:21:32.776 --> 00:21:36.719
 there is lack of data to be able to come up with more examples.

519
00:21:37.600 --> 00:21:44.366
 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.

520
00:21:44.367 --> 00:21:44.706
 Of course,

521
00:21:44.726 --> 00:21:47.328
 SEAC wasn't able to come to specific conclusions either.

522
00:21:48.049 --> 00:21:48.849
 But for those...

523
00:21:49.690 --> 00:21:52.972
 we still are able to make some recommendations.

524
00:21:52.973 --> 00:21:57.656
 We cannot conclude whether the derogations proposed within are justified,

525
00:21:58.556 --> 00:22:02.279
 nor whether we may need some more derogations there.

526
00:22:02.639 --> 00:22:08.223
 But what we're recommending is that an evaluation of all these uses is done as soon as possible.

527
00:22:08.483 --> 00:22:09.404
 And in the interim,

528
00:22:09.864 --> 00:22:13.047
 we are recommending a time-limited derogation for all the users'

529
00:22:13.067 --> 00:22:15.088
 applications within the scope of those sectors,

530
00:22:15.089 --> 00:22:17.550
 so not just the ones proposed by the dossier submitter.

531
00:22:17.930 --> 00:22:19.271
 And when we say time limited,

532
00:22:19.591 --> 00:22:23.432
 we don't mean for the periods that are being proposed by the dossier submitter,

533
00:22:23.873 --> 00:22:25.834
 but until an evaluation is performed.

534
00:22:25.874 --> 00:22:33.957
 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.

535
00:22:35.478 --> 00:22:36.078
 And finally,

536
00:22:36.178 --> 00:22:42.141
 Roberto mentioned the recommendations by RAC to implement additional risk management measures.

537
00:22:42.461 --> 00:22:43.882
 We also have a conclusion on that,

538
00:22:43.902 --> 00:22:44.402
 of course.

539
00:22:45.002 --> 00:22:45.242
 You know,

540
00:22:45.403 --> 00:22:50.647
 RAC's view is the main one in terms of the impact of those on risk reduction.

541
00:22:51.568 --> 00:22:54.650
 But we're looking at basically the proportionality of such measures,

542
00:22:54.670 --> 00:22:55.251
 for instance.

543
00:22:55.711 --> 00:22:56.452
 And there,

544
00:22:56.492 --> 00:22:57.092
 unfortunately,

545
00:22:57.112 --> 00:23:00.075
 we don't have information on the costs and benefits associated.

546
00:23:00.175 --> 00:23:02.096
 We don't know how much it would cost to implement.

547
00:23:02.737 --> 00:23:06.280
 And although RAC considers that it would reduce the risk,

548
00:23:06.420 --> 00:23:07.481
 we don't know by how much.

549
00:23:07.581 --> 00:23:09.542
 So we're not able to say whether it's proportional.

550
00:23:09.622 --> 00:23:12.585
Is it something that you expect to get more information on in the consultation?

551
00:23:12.705 --> 00:23:13.546
 So the cost of these...

552
00:23:14.062 --> 00:23:15.123
 risk mitigation measures.

553
00:23:15.704 --> 00:23:16.144
Exactly.

554
00:23:16.204 --> 00:23:18.646
 That's where we hope that we can get that information.

555
00:23:18.686 --> 00:23:20.448
 This was a RAC recommendation,

556
00:23:20.508 --> 00:23:24.291
 so it wasn't part of the initial consultation on the Annex 15 dossier.

557
00:23:24.331 --> 00:23:31.557
 So this will be the first time when people will be able to give us some information about what the implications are,

558
00:23:31.597 --> 00:23:32.378
 not just the cost,

559
00:23:32.438 --> 00:23:35.700
 but also how practical it is to implement these things.

560
00:23:35.701 --> 00:23:36.501
 Is it possible?

561
00:23:36.581 --> 00:23:37.562
 How long will it take?

562
00:23:38.443 --> 00:23:42.026
 We also have some concerns about the enforceability.

563
00:23:42.638 --> 00:23:43.759
 We support them in general,

564
00:23:43.879 --> 00:23:45.380
 but with the specific ones,

565
00:23:45.381 --> 00:23:51.465
 we consider that we may need some guidance to really allow things to be enforced.

566
00:23:52.405 --> 00:23:52.786
 And yes,

567
00:23:52.866 --> 00:23:55.708
 I think that that was a good reminder that you made,

568
00:23:55.728 --> 00:23:55.928
 Adam.

569
00:23:55.968 --> 00:23:57.389
 This is not the final opinion.

570
00:23:57.429 --> 00:24:02.473
 We launched a consultation and I think we'll talk about that later on a little bit more very soon.

571
00:24:02.533 --> 00:24:02.673
 Well,

572
00:24:02.713 --> 00:24:05.235
 I think by the time this podcast is released,

573
00:24:05.236 --> 00:24:09.378
 the consultation will already be out there and we're expecting to receive.

574
00:24:09.558 --> 00:24:12.659
 very valuable information there that will allow us to finalize the opinion.

575
00:24:13.519 --> 00:24:13.839
Okay,

576
00:24:13.959 --> 00:24:14.500
 thanks a lot.

577
00:24:14.580 --> 00:24:15.580
 Very detailed overview.

578
00:24:15.620 --> 00:24:20.101
 And people can also find that out then in the draft opinion that will be published together with the podcast.

579
00:24:20.102 --> 00:24:20.321
 Yes,

580
00:24:20.361 --> 00:24:20.741
and indeed,

581
00:24:21.062 --> 00:24:21.842
 maybe to mention,

582
00:24:21.902 --> 00:24:25.883
 there are some very useful summary sections at the beginning summary of the opinion.

583
00:24:25.983 --> 00:24:30.004
 So I really suggest people to have a look at that in the opinion.

584
00:24:30.005 --> 00:24:32.945
 We try to actually summarize the whole thing for Rack and Fusayak.

585
00:24:33.545 --> 00:24:35.226
So based on what you've seen,

586
00:24:35.566 --> 00:24:38.647
 In which sectors are PFAS alternatives already available?

587
00:24:38.927 --> 00:24:42.669
 And where do we see the kind of the toughest challenges in finding substitutes?

588
00:24:42.670 --> 00:24:44.049
 You mentioned a few examples.

589
00:24:44.050 --> 00:24:45.510
 You mentioned medical devices,

590
00:24:45.511 --> 00:24:45.990
 for example,

591
00:24:46.250 --> 00:24:49.552
 at least needing a derogation because they might not be that easily replaced.

592
00:24:49.553 --> 00:24:52.213
 So can you give us another feeling of other areas?

593
00:24:52.533 --> 00:24:52.713
Yeah,

594
00:24:52.833 --> 00:24:53.113
 I mean,

595
00:24:53.173 --> 00:24:56.795
 the derogation there is not just because of the conclusion on analysis of alternatives.

596
00:24:56.815 --> 00:25:00.276
 It was also because of the potential impact of not having the medical devices.

597
00:25:00.656 --> 00:25:02.037
 So that's important to remember.

598
00:25:02.337 --> 00:25:05.098
 while the dossier submitter recommended the derogations.

599
00:25:05.218 --> 00:25:07.379
 purely based on the availability of alternatives.

600
00:25:08.380 --> 00:25:11.181
 SEAC said that that was an important element,

601
00:25:11.221 --> 00:25:12.142
 but not the only one.

602
00:25:12.143 --> 00:25:14.543
 So that's an important clarification to make.

603
00:25:14.544 --> 00:25:16.624
 We also have to take account of the cost and benefits.

604
00:25:17.464 --> 00:25:17.985
 But yeah,

605
00:25:18.145 --> 00:25:18.825
 to your question.

606
00:25:19.445 --> 00:25:21.206
 In some consumer applications,

607
00:25:21.246 --> 00:25:22.727
 so some textiles,

608
00:25:22.787 --> 00:25:23.608
 cosmetics,

609
00:25:23.728 --> 00:25:24.408
 ski wax,

610
00:25:25.048 --> 00:25:25.309
 you know,

611
00:25:25.789 --> 00:25:26.409
 that kind of thing,

612
00:25:26.449 --> 00:25:27.830
 alternatives already exist.

613
00:25:28.395 --> 00:25:29.595
 So that is quite clear.

614
00:25:29.655 --> 00:25:30.936
 There's a lot of evidence there.

615
00:25:30.937 --> 00:25:34.057
 The conclusions that SEA can reach can be quite certain.

616
00:25:35.297 --> 00:25:40.939
 But there are greater challenges basically in the highly technical applications.

617
00:25:40.959 --> 00:25:42.399
 That's where we tend to find them.

618
00:25:42.479 --> 00:25:45.720
 Things like uses within electronics and semiconductors,

619
00:25:45.840 --> 00:25:47.120
 some medical devices,

620
00:25:47.280 --> 00:25:48.761
 some industrial processes.

621
00:25:49.221 --> 00:25:52.242
 And it's particularly where performance and safety requirements are very,

622
00:25:52.282 --> 00:25:53.082
 very stringent,

623
00:25:53.462 --> 00:25:55.303
 either because of the consequences to,

624
00:25:55.523 --> 00:25:56.183
 for instance,

625
00:25:56.323 --> 00:25:56.903
 people's health.

626
00:25:57.463 --> 00:25:59.785
 or because of consequences to safety.

627
00:25:59.825 --> 00:26:00.565
 So for instance,

628
00:26:00.885 --> 00:26:02.967
 in some applications,

629
00:26:03.027 --> 00:26:08.391
 there are very strict regulations as to what performance must be reached to protect safety.

630
00:26:08.471 --> 00:26:10.532
 So I think that that is very important.

631
00:26:10.533 --> 00:26:15.376
 So there is where we're finding that the alternatives are more difficult to find,

632
00:26:15.416 --> 00:26:15.776
 let's say.

633
00:26:16.176 --> 00:26:16.656
 And of course,

634
00:26:16.676 --> 00:26:17.257
 as we mentioned,

635
00:26:17.258 --> 00:26:17.977
 the consultation,

636
00:26:18.017 --> 00:26:21.100
 that's the opportunity to get more information on all of this.

637
00:26:22.320 --> 00:26:22.441
Now,

638
00:26:22.581 --> 00:26:25.823
 with some sectors ready to move away from PFAS and others facing...

639
00:26:26.083 --> 00:26:27.164
 real technical barriers.

640
00:26:27.504 --> 00:26:30.627
 How does the committee decide what transition periods are realistic,

641
00:26:30.707 --> 00:26:31.708
 but also proportionate?

642
00:26:32.588 --> 00:26:32.769
Well,

643
00:26:33.009 --> 00:26:33.649
 in general,

644
00:26:33.689 --> 00:26:41.976
 the goal is always to allow sufficient time to transition away from the substance while avoiding unnecessary delays in reducing emissions.

645
00:26:41.977 --> 00:26:43.337
 So it's a bit of a balancing act.

646
00:26:43.878 --> 00:26:50.443
 And normally the recommendations on the length of the derogations would look at very specific aspects of each use and consider in detail,

647
00:26:50.523 --> 00:26:50.743
 okay,

648
00:26:50.843 --> 00:26:52.725
 what will actually be needed to substitute,

649
00:26:53.185 --> 00:26:54.506
 where are we the alternatives?

650
00:26:55.507 --> 00:26:55.907
 Ideally,

651
00:26:55.947 --> 00:26:57.529
 we would come up with bespoke lengths,

652
00:26:58.089 --> 00:27:00.951
 but as you may be able to tell by the fact I'm talking about ideally,

653
00:27:01.572 --> 00:27:02.272
 in this case,

654
00:27:02.312 --> 00:27:07.276
 with so many different specific uses and quite a lot of lack of specific information,

655
00:27:08.076 --> 00:27:11.058
 the dossier submitter took a bit of a different approach.

656
00:27:11.339 --> 00:27:13.720
 They came up with two general derogation lengths,

657
00:27:14.501 --> 00:27:18.544
 and those were five and 12 years after entry into force,

658
00:27:18.545 --> 00:27:19.324
 so after the

659
00:27:19.745 --> 00:27:22.527
 18-month transition period that is in general for the whole proposal.

660
00:27:23.347 --> 00:27:30.571
 So they decided that they would recommend five years where there were no alternatives at the point of entry into force,

661
00:27:31.832 --> 00:27:33.773
 or no alternatives were expected to be available.

662
00:27:34.013 --> 00:27:35.814
 Some have been identified already,

663
00:27:36.634 --> 00:27:39.116
 or maybe there are some alternatives identified,

664
00:27:39.216 --> 00:27:41.577
 but they're not available in sufficient quantities.

665
00:27:42.217 --> 00:27:45.259
 So there may need to be some steps taken before they may be implemented,

666
00:27:45.319 --> 00:27:47.100
 like some approvals and that sort of thing.

667
00:27:47.980 --> 00:27:51.743
 Twelve years they recommended where no alternatives had been identified yet.

668
00:27:51.763 --> 00:27:52.483
 So it's likely.

669
00:27:52.703 --> 00:27:54.624
 They won't become available in the near future.

670
00:27:55.605 --> 00:28:01.670
 Or there are situations where the certifications or regulatory improvements cannot be achieved with a five-year derogation.

671
00:28:01.690 --> 00:28:02.710
 They take longer than that.

672
00:28:03.091 --> 00:28:05.693
 And there are some sectors where we know that that tends to be the case,

673
00:28:05.733 --> 00:28:06.853
 like some medical sectors,

674
00:28:06.893 --> 00:28:07.494
 for instance.

675
00:28:08.074 --> 00:28:09.055
 And in general,

676
00:28:09.135 --> 00:28:10.776
 SEAC endorsed this approach.

677
00:28:10.836 --> 00:28:11.076
 I mean,

678
00:28:11.096 --> 00:28:13.278
 we did note that the lengths were a little bit arbitrary,

679
00:28:13.418 --> 00:28:14.339
 but in general,

680
00:28:14.839 --> 00:28:18.742
 we think this is the right way to go in this type of very,

681
00:28:18.802 --> 00:28:19.763
 very broad restriction.

682
00:28:20.299 --> 00:28:22.360
 And we applied it in our analysis as well.

683
00:28:22.420 --> 00:28:26.461
 So our recommendations will be also about the 5 and 12 years.

684
00:28:27.161 --> 00:28:28.081
 In some cases,

685
00:28:28.662 --> 00:28:33.203
 when we are recommending our own derogations that the assessor method didn't propose,

686
00:28:33.223 --> 00:28:34.563
 we see if we can say something,

687
00:28:34.603 --> 00:28:36.524
 but it may be that there isn't enough information.

688
00:28:37.104 --> 00:28:37.384
Okay.

689
00:28:37.544 --> 00:28:37.824
 All right.

690
00:28:37.844 --> 00:28:38.064
 Thank you.

691
00:28:38.065 --> 00:28:43.046
 And I suppose one kind of consequence of all this is that there will be a push to develop those alternatives,

692
00:28:43.166 --> 00:28:44.966
 essentially a much more bigger push,

693
00:28:45.026 --> 00:28:46.927
 because there is now a set time limit to get them.

694
00:28:47.655 --> 00:28:48.036
 applied.

695
00:28:48.096 --> 00:28:50.638
 So I guess that's a positive outcome also of this restriction.

696
00:28:51.118 --> 00:28:51.298
Yeah,

697
00:28:51.418 --> 00:28:51.839
 basically,

698
00:28:51.879 --> 00:28:54.301
 when you have derogations that are time limited,

699
00:28:54.761 --> 00:28:59.685
 we all know what is going to happen at the end of the derogation period.

700
00:28:59.765 --> 00:29:00.546
 So of course,

701
00:29:00.566 --> 00:29:02.107
 there's going to be a lot of work happening.

702
00:29:02.347 --> 00:29:02.587
 I mean,

703
00:29:02.688 --> 00:29:03.148
 to be fair,

704
00:29:03.188 --> 00:29:04.949
 there is a lot of work happening already now.

705
00:29:05.210 --> 00:29:05.430
 I mean,

706
00:29:05.450 --> 00:29:07.872
 we see a lot of activity to develop alternatives.

707
00:29:07.952 --> 00:29:12.135
 And I think this is a positive impact that the restriction proposal is already having.

708
00:29:12.956 --> 00:29:14.977
Given kind of all those moving pieces,

709
00:29:15.018 --> 00:29:16.359
 so technical feasibility,

710
00:29:17.448 --> 00:29:18.630
 supply chain readiness,

711
00:29:18.850 --> 00:29:20.072
 essential uses.

712
00:29:20.552 --> 00:29:24.057
 Where does the committee still see the biggest uncertainties in the draft opinion?

713
00:29:25.319 --> 00:29:27.703
I will talk mainly about types of uncertainty,

714
00:29:27.863 --> 00:29:29.486
 not about specific uses.

715
00:29:30.427 --> 00:29:32.149
 One of them is this covers...

716
00:29:33.156 --> 00:29:33.977
all the uses,

717
00:29:34.617 --> 00:29:39.802
 but not all of them were assessed by the dossier submitter and evaluated by SEAC.

718
00:29:40.403 --> 00:29:41.924
 So that is one uncertainty.

719
00:29:41.964 --> 00:29:44.807
 There's maybe a lot of uses that we don't even know about,

720
00:29:44.927 --> 00:29:48.390
 or that didn't pop up in the information that was received.

721
00:29:48.770 --> 00:29:49.111
 Of course,

722
00:29:49.112 --> 00:29:51.012
 we may get something in the consultation still.

723
00:29:51.733 --> 00:29:53.615
 And the other one is the lack of data.

724
00:29:53.616 --> 00:29:53.835
 I mean,

725
00:29:53.875 --> 00:29:55.777
 the dossier submitter did a huge job.

726
00:29:56.177 --> 00:29:58.719
 They put in a lot of work to try to get the information,

727
00:29:58.820 --> 00:29:59.000
 but

728
00:29:59.620 --> 00:30:01.742
 There are still some areas where this is lacking,

729
00:30:01.822 --> 00:30:04.924
 and this should be very clear when people look at the opinion.

730
00:30:04.964 --> 00:30:07.566
 I mentioned the table with all the derogations earlier,

731
00:30:07.986 --> 00:30:10.988
 but please remember that that table shouldn't be read in isolation.

732
00:30:11.668 --> 00:30:17.753
 Each of the conclusions that we talk about there on derogations should be read in conjunction with the sector-specific documents.

733
00:30:18.153 --> 00:30:20.975
 There is a lot of information there about what we know,

734
00:30:21.055 --> 00:30:21.675
 what we don't,

735
00:30:21.715 --> 00:30:22.636
 what we would need to know.

736
00:30:22.756 --> 00:30:25.018
 So people should read all of that.

737
00:30:25.138 --> 00:30:25.338
Okay,

738
00:30:25.358 --> 00:30:28.060
 an important tip for anyone participating in the consultation.

739
00:30:28.456 --> 00:30:28.576
 Well,

740
00:30:28.696 --> 00:30:29.016
 thank you.

741
00:30:29.036 --> 00:30:31.377
 That helps put the uncertainties into perspective.

742
00:30:31.857 --> 00:30:34.918
 Maybe then moving to the next step that we've referred to already many times,

743
00:30:34.938 --> 00:30:36.138
 the 60-day consultation.

744
00:30:36.498 --> 00:30:38.319
 So when is that expected to begin?

745
00:30:39.139 --> 00:30:39.299
Well,

746
00:30:39.359 --> 00:30:42.000
 we are launching the consultation on the 26th of March.

747
00:30:42.140 --> 00:30:44.521
 So it's closing 60 days later in late May.

748
00:30:45.261 --> 00:30:49.062
 And we've informed our audience since really early about the upcoming consultation.

749
00:30:49.122 --> 00:30:52.103
 We've told them what questions we'll be asking so that they can start preparing.

750
00:30:52.123 --> 00:30:55.064
 I've talked about this in previous podcasts in quite a lot of detail.

751
00:30:55.912 --> 00:31:01.196
 There is a webinar that we did some time ago that is still relevant and it's still available for people to see.

752
00:31:01.456 --> 00:31:03.357
 And there is a lot of guidance as well.

753
00:31:04.158 --> 00:31:06.139
 There's also a mapping of the PFAS uses,

754
00:31:06.199 --> 00:31:09.862
 which may be useful so that people understand where they need to respond.

755
00:31:11.083 --> 00:31:12.083
 I should mention as well,

756
00:31:12.123 --> 00:31:14.225
 this is done in a survey format,

757
00:31:14.325 --> 00:31:17.067
 so we are not allowing attachments to be provided.

758
00:31:17.127 --> 00:31:17.867
 People need to...

759
00:31:19.168 --> 00:31:24.652
 do a little bit of work in trying to draw out the exact information at the level of aggregation,

760
00:31:24.692 --> 00:31:25.013
 let's say,

761
00:31:25.053 --> 00:31:28.075
 that SEAC needs it and in the type of format that we need it.

762
00:31:28.435 --> 00:31:34.680
 That will allow us to really process things as effectively as possible and to actually have an impact on the opinion.

763
00:31:35.661 --> 00:31:36.221
 And yeah,

764
00:31:36.281 --> 00:31:36.662
 basically,

765
00:31:36.682 --> 00:31:40.505
 we encourage everyone who has relevant information to provide,

766
00:31:40.585 --> 00:31:44.428
 to engage really early in this consultation and to provide us that data.

767
00:31:44.828 --> 00:31:46.129
 Because we will be looking at it,

768
00:31:46.149 --> 00:31:47.390
 we will be considering it,

769
00:31:47.550 --> 00:31:49.291
 and the opinion may change as a result.

770
00:31:50.412 --> 00:31:50.612
Okay,

771
00:31:50.652 --> 00:31:54.454
 then what about for listeners who may want to take part in the consultation?

772
00:31:55.755 --> 00:31:56.956
 What does it actually focus on?

773
00:31:57.036 --> 00:31:59.817
 So kind of what sort of input are you hoping people will provide?

774
00:32:01.318 --> 00:32:01.438
Well,

775
00:32:01.439 --> 00:32:05.181
 the scope is basically the SEAC draft opinion that was just agreed in March.

776
00:32:05.881 --> 00:32:10.024
 And it includes all 23 sectors and uses within those sectors.

777
00:32:10.856 --> 00:32:11.077
 I mean,

778
00:32:11.117 --> 00:32:14.540
 there will be detailed questions on the sectors that SEAC has evaluated.

779
00:32:14.560 --> 00:32:20.985
 So these are 15 sectors and there will not be any detailed questions for the eight sectors where we haven't,

780
00:32:20.986 --> 00:32:27.731
 but information can be provided as part of the general aspects and they can be provided on any topics related to anything.

781
00:32:27.811 --> 00:32:28.271
 Basically,

782
00:32:28.311 --> 00:32:29.913
 that's covered in the opinion.

783
00:32:31.574 --> 00:32:32.014
 Basically,

784
00:32:32.395 --> 00:32:33.436
 the relevant information,

785
00:32:33.456 --> 00:32:34.036
 as I mentioned,

786
00:32:34.076 --> 00:32:38.160
 will be assessed to either confirm or change if necessary.

787
00:32:38.720 --> 00:32:41.643
 CEAC conclusions that are presented in the CEAC draft opinion.

788
00:32:42.163 --> 00:32:49.610
 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.

789
00:32:50.011 --> 00:32:52.353
 We're looking for technical evidence-based information.

790
00:32:52.393 --> 00:32:53.994
 So it's not so much about your opinion.

791
00:32:54.054 --> 00:32:56.757
 It's about things that can be substantiated.

792
00:32:56.797 --> 00:32:57.978
 That's what we're really looking for.

793
00:32:58.459 --> 00:32:58.699
Okay.

794
00:32:58.719 --> 00:32:58.979
 All right.

795
00:32:59.019 --> 00:33:00.761
 And after the consultation phase,

796
00:33:00.762 --> 00:33:02.462
 then how does the process move forward?

797
00:33:02.522 --> 00:33:04.044
 What can stakeholders expect next?

798
00:33:04.540 --> 00:33:04.680
Well,

799
00:33:04.920 --> 00:33:05.961
 as information comes in,

800
00:33:05.981 --> 00:33:09.262
 we will be analysing and not just after the consultation closes,

801
00:33:09.302 --> 00:33:11.343
 but as soon as we start receiving information.

802
00:33:11.844 --> 00:33:17.667
 And we will be analysing it and considering whether there would need to be any reviews made to the opinion.

803
00:33:17.707 --> 00:33:24.490
 So the idea is that we will adopt the final opinion by the end of 2026 and send to the Commission.

804
00:33:24.990 --> 00:33:28.612
 And then the Commission will decide on the restriction in consultation with the member states.

805
00:33:29.328 --> 00:33:29.528
Okay,

806
00:33:29.588 --> 00:33:32.149
 reading between the lines and knowing when the committee meetings are.

807
00:33:32.189 --> 00:33:33.289
 So we're skipping the June,

808
00:33:33.349 --> 00:33:34.189
 the September meeting,

809
00:33:34.190 --> 00:33:35.190
 but then there's one in November,

810
00:33:35.250 --> 00:33:35.650
 December.

811
00:33:35.690 --> 00:33:36.810
 So would that be around the time,

812
00:33:36.811 --> 00:33:39.671
 if everything goes as planned and all timelines match?

813
00:33:39.951 --> 00:33:40.171
 Yeah,

814
00:33:40.191 --> 00:33:43.692
we haven't decided yet exactly what we will be doing on each of those meetings.

815
00:33:43.732 --> 00:33:45.353
 I would expect that probably in June,

816
00:33:45.354 --> 00:33:46.933
 we would have some information about the,

817
00:33:47.273 --> 00:33:47.573
 you know,

818
00:33:48.294 --> 00:33:51.535
 informing the committee about the consultation comments,

819
00:33:51.615 --> 00:33:52.555
 what was received,

820
00:33:52.615 --> 00:33:53.835
 maybe some initial views.

821
00:33:54.796 --> 00:33:55.156
 But yeah,

822
00:33:55.216 --> 00:33:55.736
 it will be.

823
00:33:56.496 --> 00:34:01.159
 basically the last plenary of the year where the timing is still to be fully confirmed.

824
00:34:02.019 --> 00:34:06.622
 We need to finalize it with enough time to then be able to send things to the commission.

825
00:34:07.562 --> 00:34:07.722
Now,

826
00:34:08.202 --> 00:34:10.784
 moving aside from the kind of the PFAS topic today,

827
00:34:11.644 --> 00:34:12.385
 can you talk us through,

828
00:34:12.425 --> 00:34:12.785
 Roberto,

829
00:34:12.845 --> 00:34:13.706
 about the CLH,

830
00:34:13.726 --> 00:34:18.068
 so the Harmonized Classification and Labeling opinion on cannabidiol that was mentioned earlier?

831
00:34:18.967 --> 00:34:21.349
 So that's used actually in several sectors,

832
00:34:21.549 --> 00:34:23.570
apparently in vaping products,

833
00:34:23.730 --> 00:34:26.733
 so in electronic cigarettes or possible inhalation,

834
00:34:27.253 --> 00:34:31.876
 or even in cosmetic products or food ingredients or supplements for human and animals.

835
00:34:32.297 --> 00:34:38.481
 And apparently there is also even a medication against epilepsy that has been actually authorized in Europe.

836
00:34:39.082 --> 00:34:46.667
 So what RAC found was that there is enough evidence to recommend a quite severe hazard classification related to...

837
00:34:46.707 --> 00:34:50.528
 to category 1b in terms of reproductive toxicants,

838
00:34:50.588 --> 00:34:54.669
 so able to damage fertility or damage the unborn child,

839
00:34:55.149 --> 00:34:57.510
 and even hazardous to the breastfed child.

840
00:34:58.010 --> 00:35:01.291
 So that's something that will be published in a few weeks,

841
00:35:01.351 --> 00:35:02.711
 couple of months maximum.

842
00:35:03.152 --> 00:35:06.132
 And this opinion will then be transmitted to the European Commission.

843
00:35:06.272 --> 00:35:06.893
 And as usual,

844
00:35:07.293 --> 00:35:14.855
 the European Commission in conjunction with member states will decide whether an harmonized classification is needed actually for this specific substance.

845
00:35:15.275 --> 00:35:16.376
 And if this happens,

846
00:35:16.596 --> 00:35:22.598
 this classification could also trigger what we call downstream effects in other regulations.

847
00:35:22.818 --> 00:35:23.379
 Just to mention,

848
00:35:23.419 --> 00:35:23.879
 for instance,

849
00:35:23.880 --> 00:35:25.399
 the cosmetic products regulation,

850
00:35:25.960 --> 00:35:30.321
 where possible exemption could be needed in case this would go forward.

851
00:35:31.002 --> 00:35:38.865
 Also to mention that we have coordinated with EFSA because there are also discussions on food uses that are taking place.

852
00:35:38.885 --> 00:35:43.127
 So we ensure that we are aligned with our agency in charge of food.

853
00:35:44.087 --> 00:35:44.347
Thanks.

854
00:35:44.427 --> 00:35:46.729
 So that's actually a significant development.

855
00:35:46.749 --> 00:35:46.929
 I mean,

856
00:35:46.969 --> 00:35:54.755
 CBD is used in such a wide range of products that a harmonized classification like this could have major implications across several sectors.

857
00:35:55.456 --> 00:35:58.398
 What about the chromium-6 restriction proposal that was also mentioned?

858
00:35:58.399 --> 00:35:59.759
 Can you share any details on that?

859
00:36:00.531 --> 00:36:00.651
Yeah,

860
00:36:00.671 --> 00:36:01.552
 I can say a few words.

861
00:36:01.553 --> 00:36:01.792
 I mean,

862
00:36:01.852 --> 00:36:04.333
 we're making significant progress on that.

863
00:36:04.373 --> 00:36:08.155
 That was discussed in the March plenary in SEAC and in RAC.

864
00:36:08.215 --> 00:36:10.176
 I think it was done in the working group before,

865
00:36:10.177 --> 00:36:11.397
 but there was a lot of discussion.

866
00:36:11.417 --> 00:36:11.957
 I followed that.

867
00:36:11.958 --> 00:36:15.579
 There was a whole day of discussions and quite a lot of discussion in SEAC as well.

868
00:36:16.080 --> 00:36:16.640
 So basically,

869
00:36:17.100 --> 00:36:28.647
 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.

870
00:36:29.451 --> 00:36:30.271
 by the end of

871
00:36:30.612 --> 00:36:34.573
 February. So not in time to be able to be considered in March,

872
00:36:34.713 --> 00:36:36.134
 but it will be considered in June.

873
00:36:36.454 --> 00:36:43.717
 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.

874
00:36:43.777 --> 00:36:46.958
 So the plan there is also to finish by the end of 2026.

875
00:36:47.078 --> 00:36:49.419
 It's going to be a busy second half of 2026.

876
00:36:49.420 --> 00:36:50.100
 Sounds like it.

877
00:36:50.140 --> 00:36:50.400
Yes.

878
00:36:50.460 --> 00:36:54.261
 And Chromium 6 is yet another big file with far-reaching implications.

879
00:36:54.262 --> 00:36:56.742
 So it's good to hear that the evaluation is progressing on schedule.

880
00:36:57.202 --> 00:36:58.423
 And it'll be interesting to see how

881
00:36:58.883 --> 00:37:01.765
 the consultation input shapes the next steps on that one.

882
00:37:02.225 --> 00:37:02.345
Yeah,

883
00:37:02.445 --> 00:37:02.805
 of course,

884
00:37:02.825 --> 00:37:05.287
 the committees will also consider the consultation comments.

885
00:37:05.288 --> 00:37:06.508
 They are considering them already.

886
00:37:06.828 --> 00:37:07.008
Right.

887
00:37:07.188 --> 00:37:07.368
 Okay,

888
00:37:07.388 --> 00:37:07.668
 good.

889
00:37:07.969 --> 00:37:08.889
 Thanks for clarifying.

890
00:37:11.210 --> 00:37:11.371
 Well,

891
00:37:11.471 --> 00:37:13.252
 that brings us to the end of today's episode.

892
00:37:13.612 --> 00:37:19.715
 So we've covered a huge amount of ground from the science behind PFAS persistence to the committee's proposed approaches on grouping,

893
00:37:19.916 --> 00:37:21.036
 non-threshold treatment,

894
00:37:21.156 --> 00:37:22.097
 fluoropolymers,

895
00:37:22.217 --> 00:37:23.137
 volatile PFAS,

896
00:37:23.638 --> 00:37:25.739
 and the scale of PFAS emissions across Europe.

897
00:37:27.027 --> 00:37:30.908
 What really came through today is just how complex this restriction proposal is,

898
00:37:31.128 --> 00:37:34.829
 touching everything from textiles and cookware to medical devices,

899
00:37:34.949 --> 00:37:36.030
 industrial processes,

900
00:37:36.490 --> 00:37:37.530
 fluorinated gases,

901
00:37:37.630 --> 00:37:40.451
 and even the question of how enforcement will work in practice.

902
00:37:41.111 --> 00:37:42.611
 We also looked ahead at the next steps,

903
00:37:42.671 --> 00:37:44.152
 so the 60-day consultation,

904
00:37:44.392 --> 00:37:47.413
 which will be the key moment for stakeholders to contribute evidence,

905
00:37:47.813 --> 00:37:48.913
 clarify uncertainties,

906
00:37:49.193 --> 00:37:51.214
 and help shape the committee's final opinion.

907
00:37:51.974 --> 00:37:52.494
 As we heard,

908
00:37:52.654 --> 00:37:54.075
 this input is essential,

909
00:37:54.215 --> 00:37:55.695
 especially in uses where the committee

910
00:37:56.063 --> 00:37:58.365
 hasn't been able to reach very firm conclusions.

911
00:37:59.026 --> 00:38:00.107
 So thank you for joining us.

912
00:38:00.147 --> 00:38:00.848
 And thank you again,

913
00:38:01.128 --> 00:38:01.909
 Roberto and Maria,

914
00:38:01.989 --> 00:38:03.030
 for sharing your insights.

915
00:38:03.070 --> 00:38:03.470
 Thank you.

916
00:38:03.590 --> 00:38:03.710
 Oh,

917
00:38:03.750 --> 00:38:04.111
 bye-bye.

918
00:38:04.992 --> 00:38:06.673
 We'll continue following this process closely,

919
00:38:06.733 --> 00:38:07.294
 as always,

920
00:38:07.394 --> 00:38:08.355
 in future episodes.

921
00:38:08.615 --> 00:38:09.176
 Until then,

922
00:38:09.516 --> 00:38:10.717
 take care and stay safe.

923
00:38:12.338 --> 00:38:14.040
 Safer Chemicals Podcast.

924
00:38:14.761 --> 00:38:16.883
 Sound science on harmful chemicals.

