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Safer Chemicals Podcast.

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 Sound science on harmful chemicals.

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 Welcome to the Safer Chemicals Podcast.

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 In this episode,

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 we will deconstruct the meetings of the Risk Assessment and Socio-Economic Analysis Committees' December meetings.

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 This time,

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 we're doing things a little bit differently.

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 So you might remember that at the end of our last episode,

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 we invited you,

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 our listeners,

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 to send in questions on PFAS.

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 Thank you very much to everyone who contributed.

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 We'll be tackling those questions during the PFAS segment,

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 so stay tuned for that.

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 We'll keep doing this also for upcoming episodes,

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 so if you do have specific questions for Roberto and Maria,

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 or if you have suggestions for topics you would like us to cover in the podcast,

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 send them to us at video@echa.europa.eu.

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 Today we'll be covering two major topics from the December meetings.

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 The first is the ongoing work on the universal PFAS restriction proposal,

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 something that's been recurring since this restriction proposal came to us,

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 including which sectors were discussed and what's coming up next.

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 We'll also talk about a new milestone for the Risk Assessment Committee.

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 And this was the first classification opinion using new hazard classes from the CLP regulation,

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 focusing on a substance identified as very persistent and very bioaccumulative or VPVB.

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 Roberto Maria.

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 Thank you both for joining us again.

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Thank you.

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 Thank you,

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 Adam.

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 It's a pleasure to be back.

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 Last time in 25,

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right,

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 Maria?

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Last time in 25,

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 yes,

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 indeed.

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 A pleasure,

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 Adam.

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Yes,

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 indeed.

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 This is our last episode of the year.

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 But okay,

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 let's start with the universal PFAS restriction proposal.

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 So,

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 Roberto,

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 could you give us an overview of the discussions in the committee during this round of meetings?

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 And why did you find the PFAS manufacturing discussion so interesting?

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Indeed,

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 the discussion was focused on the PFAS manufacturing and horizontal issues,

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 so we had those

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 big sectors and

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 PFAS manufacturing was indeed a special discussion to me.

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 Why so?

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 Well,

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 first of all,

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 it is about the production of PFAS chemicals and not much they're use in a specific sector as we did so far.

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 In addition,

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 I think it's a bit at the origin of everything.

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 And I found,

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 if I can say it's somewhat amusing that it came to RAC toward the end of it and not at the start of it.

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 And why so?

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 Because there were a number of

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 pollution cases in some European manufacturing sites,

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 in some European countries.

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 I can remember something like Italy,

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 Belgium,

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 or the Netherlands.

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 And this caused contamination of soil,

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 water,

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 groundwater.

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 And so local governments,

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 they took action.

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 And probably this was also the result of the submission of the restriction itself.

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 And this is what we are discussing here today.

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 We also learned that experiences in remediation can be very costly when they can apply at all.

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 Also,

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 maybe to say that manufacturing affects all other sectors because it is about the production of PFAS that then it's used to make something else.

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 I think we discussed this in other sectors such as cosmetics,

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 medical devices and others.

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Well,

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 actually,

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 going back to what you said there,

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 something you mentioned,

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 you said that this local action was somehow tied to this restriction proposal.

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 Can you just clarify how?

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 Why is that?

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Well,

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 we have learned from a number of documents that have been shared by the dossier submitters that in some specific instances,

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 local authorities,

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 they took action,

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 they implemented more restrictive emission factors for the companies that are acting there.

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 In some cases,

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 there are even court cases that are ongoing.

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 So it's definitely something that caught the attention of local authorities and even public media,

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 I would say.

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Okay.

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 Okay.

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 Well,

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 I mean,

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 I see now why the sector caught your attention.

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 And what about then the content of the discussion?

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 So is there something else that kind of puts aside this sector?

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Well,

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 as usual,

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 we must take into account what are the volumes,

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 try to estimate the emissions,

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 but also having a view from the risk reduction perspective,

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 whether some options are better than others.

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 What was special was that the five authorities proposed a possible maximum emission limit.

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 to the emissions for PFAS manufacturers.

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 This was based on a voluntary initiative that was proposed by industry.

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 However,

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 on the emission factors,

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 RAC supported rather the applicability of the Industrial Emission Directive,

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 that is an existing legal framework at local level.

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 This would be able to establish actually a site-specific limit value rather than a generic one.

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 We also benefited from the input of

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 European Commission experts from the Industrial Emission Directive.

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 We also discussed,

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 by the way,

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 the limitations of this directive.

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 Unfortunately,

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 there are not yet specific best available techniques.

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 They are called BATs in the sector for PFAS,

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 and it could take several years to get them.

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 We also discussed the possibility to implement risk management measures to actually improve the current situation,

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 reducing total emissions.

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 And finally,

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 a lot of stakeholders attended again,

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 and they commented a lot during the various presentations.

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 So overall,

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 a good discussion and good progress achieved.

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Okay,

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 glad to hear that.

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 And I understand that the Socio-Economic Analysis Committee also talked about the manufacturing sector,

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 right?

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Yeah,

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 that's correct.

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 I mean,

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 in the last plenary,

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 we had had an initial discussion just presenting the proposal by the dossier submitter and initial impressions,

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 but now we discussed it properly and we actually concluded as well.

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 So quite a lot of good progress as well.

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 so this one is one that is also a little bit atypical for us normally we spend quite a lot of time on a

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 I've explained several times when talking about other sectors.

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 We do a lot of work on the analysis of alternatives.

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 So you look at sub-use by sub-use and see other alternatives for the use of PFAS here or not.

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 But in PFAS manufacturing,

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 mostly,

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 for the most part,

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 PFAS has no function per se.

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 An analysis of alternatives is just not relevant because it's been produced to be used in other sectors.

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 And those are the other sectors that we were assessing.

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 So,

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 you know,

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 this analysis of alternatives wasn't so much of a thing here.

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 There's one small exception,

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 which is the use of PFAS as polymerisation aids.

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 There you can do more of a traditional analysis of alternative.

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 And we did that,

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 of course.

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 But for the most part,

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 we were looking at the other aspects that we normally look at.

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 We looked at the cost,

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 of course,

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 the benefits,

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 the proportionality and derogations.

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 And for this topic,

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 we also considered the potential for emission minimization as part of the proportionality assessment.

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 That was also a little bit different than in other sectors.

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 Roberto was talking about this coming at the end and this being a little bit funny.

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 I guess in a way it makes sense because at the end,

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 we kind of we have a better view as to where we think that derogations will actually be needed.

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 So what will we need PFAS for if the restriction comes in?

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 So you get a little bit of a better picture as to what could happen if under the first restriction option,

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 if everything is banned,

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 for instance.

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 Right.

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So to me,

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it made sense to have it this way.

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 Looks better now.

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Okay,

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 great.

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 So then both committees discussed and concluded also on horizontal issues,

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 right?

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 And could you tell us kind of why this is so central,

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 these horizontal issues to this restriction proposal?

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Yeah,

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 what we call a horizontal issue is really at the heart of what we are doing in this restriction.

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 And they are about cross-cutting.

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 issues that are not sector specific,

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 but they apply to the oil restriction as a single entity.

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 And when it goes to RAC,

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 this is about establishing the chemical identity of the PFAS that are actually subject to the restriction,

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 what are the hazards,

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 the potential risks,

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 and why they must be controlled,

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 but also the concentration limits above which PFAS will have to be restricted.

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 And also recycling related aspects and general risk management measures to monitor and to reduce environmental emissions.

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Across all the sectors.

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 Yes,

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 yes,

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 indeed.

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We've also got things like practicality,

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 for instance,

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 including enforceability as well.

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 So,

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 you know,

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 can it actually be applied,

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 the restriction?

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 Can it be enforced?

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 Can you monitor the progress made?

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 So those are topics that we both look at,

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 actually.

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 And then there are other aspects that are more related only to SEAC.

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 For instance,

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 overarching impacts on trade and competitiveness,

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 cumulative impacts,

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 all those things we also looked at ourselves.

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Okay,

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 so really a holistic picture overall of the impact of this.

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 Good.

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 What were then the highlights from the Risk Assessment Committee on these horizontal issues particularly?

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Well,

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 first,

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 this was not actually the first time we discussed the topic.

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 It came already to the committee a number of times.

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 So already many things were concluded in previous meetings.

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 What we discussed this time and agree was about the general approach to estimate emissions in the virus life cycles,

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 special focus on fluoropolymers and on the waste stage.

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 But also we updated the effectiveness,

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 the practicality and also the additional regulatory risk management options.

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 The highlight for me was also the discussion on the site specific PFAS management plans.

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 So this is something that RAC proposed to apply to all companies.

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 possibly benefiting from derogations that could be granted by the institutions.

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 The dossier submitter proposed those plans for some uses to incentivize substitution with other materials that have different properties than the PFAS one.

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 However,

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 RAC wanted to put more the emphasis on reducing emissions.

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 So the plans should contain risk management measures to reduce those emissions such as preventing leaks or reducing emissions whenever possible.

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 monitoring them because we need to know what actually happens,

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 but also to communicate and inform across the supply chain because if you don't get the information you cannot act actually,

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 that's a quite important element.

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 There was also a focus on emissions related to the circular economy activities such as recycling,

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 reuse,

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 the use of spare parts,

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 and also from potential derogations related to this sector.

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 And finally some sectors were

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 proposed to be excluded from the restriction and we looked at what this would mean for the restriction itself.

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All right.

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 Thanks,

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 Roberta.

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 And for you,

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 Maria?

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Well,

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 we have discussed this topic in the past as well,

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 quite a few times.

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 It was one of the first ones we discussed when we started several years back already.

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 And we kept bringing it back periodically.

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 So in the past,

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 and especially in the last plenary,

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 we have discussed more topics like what do we think of the dossier submittance approach?

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 How will we assess it?

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 But we didn't go much into that this time.

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 That's already closed down.

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 So here we looked at more general topics.

267
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 I mentioned some earlier and some of the ones that Roberto also talked about,

268
00:10:49.926 --> 00:10:51.027
 like recycling,

269
00:10:52.012 --> 00:10:53.371
 secondhand articles,

270
00:10:53.433 --> 00:10:54.230
 spare parts.

271
00:10:54.652 --> 00:10:58.676
 So there we had quite a lot of discussion and quite a lot of information.

272
00:10:58.754 --> 00:10:58.879
 So,

273
00:10:59.097 --> 00:10:59.715
 for instance,

274
00:11:00.090 --> 00:11:00.902
 for recycling,

275
00:11:00.918 --> 00:11:04.418
 we went into quite a lot of detail looking at recycling of plastics,

276
00:11:04.449 --> 00:11:05.402
 of paper and board,

277
00:11:05.418 --> 00:11:06.090
 of textiles,

278
00:11:06.121 --> 00:11:06.777
 of metals.

279
00:11:07.199 --> 00:11:10.168
 Conclusions are a little bit different for each of them.

280
00:11:10.693 --> 00:11:12.694
 So we spent quite a lot of time doing that.

281
00:11:12.714 --> 00:11:20.444
 So these are topics that were introduced in the dossier in the last update that the dossier submitted.

282
00:11:20.460 --> 00:11:23.226
 So this is the first opportunity we have had to assess those.

283
00:11:24.124 --> 00:11:30.905
And I understood that the Socioeconomic Analysis Committee also finalized its conclusions on electronics and semiconductors,

284
00:11:30.968 --> 00:11:31.234
 right?

285
00:11:31.593 --> 00:11:33.140
 As kind of the last sector to be announced.

286
00:11:33.141 --> 00:11:33.452
 Yes,

287
00:11:33.515 --> 00:11:33.999
exactly.

288
00:11:34.062 --> 00:11:34.359
 That's a...

289
00:11:34.457 --> 00:11:35.698
 bit of a beast of a sector.

290
00:11:35.759 --> 00:11:38.161
 It's the biggest one in terms of received comments.

291
00:11:38.181 --> 00:11:38.761
 And it's very,

292
00:11:38.823 --> 00:11:39.382
 very complex.

293
00:11:39.401 --> 00:11:39.741
 I mean,

294
00:11:40.081 --> 00:11:40.522
 first of all,

295
00:11:40.523 --> 00:11:46.667
 it's got two separate kind of sub sectors of electronics and semiconductors.

296
00:11:46.706 --> 00:11:48.534
 And then when you go within that,

297
00:11:49.268 --> 00:11:50.175
 there's even much,

298
00:11:50.292 --> 00:11:50.448
 much,

299
00:11:50.495 --> 00:11:51.214
 much more detail.

300
00:11:51.339 --> 00:11:52.839
 So in the last plenary,

301
00:11:52.870 --> 00:11:55.042
 we had discussed for semiconductors,

302
00:11:55.136 --> 00:11:57.792
 the analysis of alternatives and the costs.

303
00:11:58.339 --> 00:11:59.761
 So now this time we have brought

304
00:11:59.849 --> 00:12:06.750
 that all together and also done the same for electronics and looked at the whole electronics and semiconductors as a whole.

305
00:12:06.809 --> 00:12:09.153
 So there is quite a lot there.

306
00:12:09.848 --> 00:12:13.215
 And it's a very technical sector as well,

307
00:12:13.254 --> 00:12:13.629
 let's say.

308
00:12:13.731 --> 00:12:18.637
 So that was quite a lot of work done by the teams to get to grips with things,

309
00:12:18.638 --> 00:12:25.137
 to understand really how different things work within it and to understand the applications.

310
00:12:25.340 --> 00:12:26.137
 And yeah,

311
00:12:26.138 --> 00:12:28.200
 I think that was quite a long discussion as well.

312
00:12:28.277 --> 00:12:28.938
And I suppose there,

313
00:12:28.939 --> 00:12:34.444
 the kind of the stakeholder expertise that you get in the committees also supports this kind of knowledge sharing and understanding work.

314
00:12:34.483 --> 00:12:34.784
Yes,

315
00:12:34.785 --> 00:12:35.144
 it helps.

316
00:12:35.163 --> 00:12:39.210
 We had some very helpful interventions from stakeholders explaining things.

317
00:12:39.288 --> 00:12:40.608
 And also,

318
00:12:40.648 --> 00:12:41.046
 of course,

319
00:12:41.069 --> 00:12:43.491
 the information submitted is crucial there.

320
00:12:43.694 --> 00:12:43.812
 So,

321
00:12:44.054 --> 00:12:44.288
 you know,

322
00:12:44.913 --> 00:12:47.319
 that really allows to do the assessment properly.

323
00:12:48.335 --> 00:12:48.616
Okay,

324
00:12:48.694 --> 00:12:49.101
 good to hear.

325
00:12:49.179 --> 00:12:49.319
 Well,

326
00:12:49.757 --> 00:12:50.382
 with this then,

327
00:12:50.491 --> 00:12:55.819
 both committees have concluded their discussions on the 14 sectors and PFAS manufacturing.

328
00:12:56.382 --> 00:12:57.148
 What happens next?

329
00:12:57.889 --> 00:12:58.029
Well,

330
00:12:58.049 --> 00:13:01.031
 I think this is amazing and I think it's a great achievement.

331
00:13:01.453 --> 00:13:01.973
 Now for RAC,

332
00:13:01.992 --> 00:13:03.613
 we have the last mile to be concluded,

333
00:13:03.633 --> 00:13:03.894
 but I'm...

334
00:13:04.457 --> 00:13:05.758
They see the light at the end of the tunnel.

335
00:13:05.759 --> 00:13:06.578
 We don't quite.

336
00:13:06.656 --> 00:13:07.195
Not yet.

337
00:13:07.742 --> 00:13:09.539
 I think it's not yet time to celebrate.

338
00:13:09.578 --> 00:13:18.164
 I'm sure Maria will join me in spending a few words of appreciation for the amazing work that reporters and the ECAS secretary have put into it at the end of the day.

339
00:13:18.914 --> 00:13:21.680
 This is about real people and non-artificial intelligence.

340
00:13:21.681 --> 00:13:23.367
 So this is the hard work of human.

341
00:13:23.711 --> 00:13:24.711
 So let's acknowledge this.

342
00:13:24.758 --> 00:13:25.898
 I think it's nice.

343
00:13:26.713 --> 00:13:27.434
 And on RAC's side,

344
00:13:27.474 --> 00:13:37.059
 now we will have to carefully draft the final opinion text and ensure that all cross-horizontal issues are reflected in the same manner across all various sectors.

345
00:13:37.122 --> 00:13:40.989
 So we need 14 sectors and PFAS manufacturing to be put together.

346
00:13:41.606 --> 00:13:42.004
 Our goal,

347
00:13:42.028 --> 00:13:42.411
 as usual,

348
00:13:42.450 --> 00:13:47.340
 is to have a scientifically sound and consistent opinion ready for March 2026,

349
00:13:47.575 --> 00:13:49.512
 when RAC will adopt its opinion.

350
00:13:50.075 --> 00:13:50.981
And on the CX side,

351
00:13:50.997 --> 00:13:51.762
 it's very similar.

352
00:13:51.840 --> 00:13:51.965
 we

353
00:13:52.297 --> 00:13:53.217
 put everything together?

354
00:13:53.237 --> 00:13:53.377
 Well,

355
00:13:53.398 --> 00:13:53.858
 first of all,

356
00:13:53.859 --> 00:13:54.618
 we have to go back,

357
00:13:54.677 --> 00:13:57.519
 make sure that everything is consistent across all the sectors.

358
00:13:57.960 --> 00:13:58.917
 It's been a long time.

359
00:13:59.019 --> 00:13:59.898
 Things have changed.

360
00:13:59.980 --> 00:14:00.499
 Sometimes,

361
00:14:00.538 --> 00:14:00.796
 you know,

362
00:14:00.882 --> 00:14:03.616
 things are not completely consistent with each other.

363
00:14:03.679 --> 00:14:04.757
 So we'll do that.

364
00:14:05.241 --> 00:14:07.062
 And then we'll put everything together as the,

365
00:14:07.218 --> 00:14:07.460
 you know,

366
00:14:07.483 --> 00:14:08.741
 the general opinion.

367
00:14:09.241 --> 00:14:09.554
 And that,

368
00:14:09.585 --> 00:14:09.819
 again,

369
00:14:09.835 --> 00:14:11.023
 is coming for,

370
00:14:11.444 --> 00:14:11.960
 in circuits,

371
00:14:12.023 --> 00:14:13.601
 for agreement in March.

372
00:14:14.023 --> 00:14:17.023
 So what's the difference between agreement and adoption?

373
00:14:17.545 --> 00:14:19.747
 All it means is that it's not final yet.

374
00:14:19.808 --> 00:14:23.409
 So we agree it and then we open the consultation.

375
00:14:23.569 --> 00:14:25.394
 So after the March meeting,

376
00:14:25.413 --> 00:14:25.972
 we launch a

377
00:14:26.417 --> 00:14:28.737
 60-day consultation on this draft opinion.

378
00:14:29.339 --> 00:14:32.737
 So it doesn't get adopted until after that,

379
00:14:32.839 --> 00:14:33.339
 basically.

380
00:14:33.956 --> 00:14:34.081
 So,

381
00:14:34.534 --> 00:14:34.659
 yeah,

382
00:14:34.706 --> 00:14:36.206
 this is how it's built in the regulation.

383
00:14:36.222 --> 00:14:39.862
 We have an additional consultation while RAC adopts a little bit earlier.

384
00:14:41.217 --> 00:14:44.621
 It helps because we then get a stable rack opinion to work with,

385
00:14:44.720 --> 00:14:51.343
 because of course there's quite a lot of interactions in between and most of them are going more in the rack towards SEAC direction than the opposite.

386
00:14:52.439 --> 00:14:52.619
Okay,

387
00:14:52.659 --> 00:14:52.779
 well,

388
00:14:52.780 --> 00:14:53.379
 so for RAC,

389
00:14:53.580 --> 00:14:53.740
 well,

390
00:14:53.840 --> 00:14:54.682
 Risk Assessment Committee,

391
00:14:54.683 --> 00:14:58.783
 the finishing line is on the horizon for the Socioeconomic Analysis Committee.

392
00:14:59.287 --> 00:15:01.068
 Let's talk about that consultation a little bit.

393
00:15:01.108 --> 00:15:04.873
 So kind of what should stakeholders expect and how can they best contribute?

394
00:15:05.490 --> 00:15:05.670
Well,

395
00:15:05.748 --> 00:15:12.303
 just maybe first thing to mention is we announced in the last podcast that we were going to do a webinar and that now has happened.

396
00:15:12.443 --> 00:15:15.381
 It happened in October and that can be found on our website.

397
00:15:15.382 --> 00:15:17.225
 There's quite a lot of information there.

398
00:15:17.815 --> 00:15:24.640
 So what we're basically asking the stakeholders to do is to start preparing already for the consultation.

399
00:15:25.241 --> 00:15:27.601
 There is also going to be a mapping of PFAS uses.

400
00:15:28.187 --> 00:15:28.304
 Well,

401
00:15:28.546 --> 00:15:33.804
 one is already available and we continue to work on that and many further support materials will follow as well.

402
00:15:34.257 --> 00:15:39.835
 So the idea is that we would like people to engage really early and start preparing what they will submit.

403
00:15:39.882 --> 00:15:43.179
 It is a short consultation and that is,

404
00:15:43.180 --> 00:15:43.476
 I think,

405
00:15:43.585 --> 00:15:46.710
 going to be one of the big challenges that are coming.

406
00:15:47.067 --> 00:15:47.187
Well,

407
00:15:47.188 --> 00:15:49.008
 actually going to challenges and opportunities,

408
00:15:49.389 --> 00:15:52.573
 what do you foresee in terms of those in the consultation process?

409
00:15:52.772 --> 00:15:52.913
Well,

410
00:15:53.053 --> 00:15:55.491
 with consultations on the SEAC draft opinion,

411
00:15:56.092 --> 00:15:57.499
 the big challenge is always the same.

412
00:15:57.538 --> 00:15:58.999
 It's matching our needs.

413
00:15:59.256 --> 00:16:02.225
 What do we need to make this opinion the best possible?

414
00:16:02.881 --> 00:16:06.522
 And the stakeholders decide to provide their information,

415
00:16:06.631 --> 00:16:08.163
 just trying to make sure that those match,

416
00:16:08.272 --> 00:16:10.569
 that the information provided is actually what we need.

417
00:16:10.803 --> 00:16:10.928
 Yep.

418
00:16:11.335 --> 00:16:11.444
 So.

419
00:16:12.403 --> 00:16:15.225
 this consultation is about our SEAC draft opinion.

420
00:16:15.266 --> 00:16:17.348
 It's not a general consultation on the topic.

421
00:16:17.508 --> 00:16:18.348
That's an important distinction.

422
00:16:18.349 --> 00:16:19.954
 That's a very important distinction.

423
00:16:20.610 --> 00:16:28.423
And this is why we're spending so much effort providing guidance and designing the consultation so that it focuses on the areas where we really need more evidence.

424
00:16:28.891 --> 00:16:31.501
 And we are able to communicate that to the stakeholders.

425
00:16:31.563 --> 00:16:32.829
 We're telling them exactly,

426
00:16:33.344 --> 00:16:34.126
 this is what we need.

427
00:16:34.626 --> 00:16:36.001
 This is where we need information.

428
00:16:36.469 --> 00:16:38.126
 And they can already start preparing it.

429
00:16:38.407 --> 00:16:38.532
 So,

430
00:16:38.533 --> 00:16:38.735
 I mean...

431
00:16:39.347 --> 00:16:40.368
 When we talk about timing,

432
00:16:40.608 --> 00:16:41.649
 that really is a challenge.

433
00:16:41.650 --> 00:16:42.911
 It's a short consultation.

434
00:16:42.989 --> 00:16:44.071
 It's 60 days.

435
00:16:44.130 --> 00:16:45.153
 That's reached us.

436
00:16:45.872 --> 00:16:52.321
 And the other thing as well is that the actual opinion only becomes available at the point when we open the consultation.

437
00:16:52.438 --> 00:16:55.423
 So there is a limited amount of time to reach the end desk.

438
00:16:55.923 --> 00:16:56.282
 Of course,

439
00:16:56.283 --> 00:16:59.391
 the stakeholders who have been following the process through the committees,

440
00:16:59.907 --> 00:17:03.157
 they have had access to the draft versions.

441
00:17:03.532 --> 00:17:04.595
 Those may change a bit,

442
00:17:04.610 --> 00:17:05.079
 of course,

443
00:17:05.516 --> 00:17:08.016
 and many people won't have had access to that.

444
00:17:08.695 --> 00:17:10.296
 So what we are going to,

445
00:17:10.717 --> 00:17:15.641
 what we are doing at the moment is providing them the information about what information we'll be asking about,

446
00:17:16.063 --> 00:17:18.785
 so that even without reading the opinion and seeing it,

447
00:17:18.786 --> 00:17:20.168
 you can already start preparing.

448
00:17:20.169 --> 00:17:28.231
 You can already start looking at all the data that you have and drawing out things at the right level and at the right level of granularity as well,

449
00:17:28.278 --> 00:17:31.403
 which is where we need to be able to conclude properly.

450
00:17:32.059 --> 00:17:32.871
 And yeah,

451
00:17:32.872 --> 00:17:35.434
 I think that that's if people spend time.

452
00:17:35.839 --> 00:17:36.339
 preparing,

453
00:17:36.379 --> 00:17:39.001
 I think we can get something really good at the end of it.

454
00:17:40.044 --> 00:17:41.903
This bridges nicely to our audience questions.

455
00:17:41.986 --> 00:17:42.986
 So we got two,

456
00:17:43.286 --> 00:17:46.232
 and both were on the upcoming consultation.

457
00:17:46.310 --> 00:17:54.841
 So the first one was about these eight sectors that the five authorities added to the proposal following the first consultation.

458
00:17:55.357 --> 00:17:56.544
 This question has two parts.

459
00:17:56.575 --> 00:17:57.419
 So first of all,

460
00:17:57.435 --> 00:18:00.419
 I'd like to explain what the issue is with these eight sectors.

461
00:18:00.560 --> 00:18:01.810
 And then the actual question is,

462
00:18:02.232 --> 00:18:05.544
 how can stakeholders submit new information on these during the consultation?

463
00:18:06.411 --> 00:18:06.591
Okay,

464
00:18:06.651 --> 00:18:06.791
 yeah.

465
00:18:06.871 --> 00:18:11.376
 So the issue with these eight sectors is that although they are part of the proposal,

466
00:18:11.396 --> 00:18:11.896
 they're covered,

467
00:18:12.657 --> 00:18:16.942
 RAC and SEAC will not be doing a sector-specific evaluation of these sectors.

468
00:18:17.239 --> 00:18:25.036
 So that is the reason why people are asking about how can they submit information about them and they want to understand how it will work.

469
00:18:25.849 --> 00:18:27.771
 So it's important to be very clear.

470
00:18:28.005 --> 00:18:30.833
 The SEAC draft opinion and the RAC draft opinion,

471
00:18:30.989 --> 00:18:33.599
 they cover the full scope of the restriction proposal.

472
00:18:33.614 --> 00:18:34.724
 So all PFAS.

473
00:18:35.051 --> 00:18:37.253
 and all uses except for firefighting forms,

474
00:18:37.294 --> 00:18:38.554
 which is covered elsewhere.

475
00:18:38.675 --> 00:18:38.874
 Yes,

476
00:18:39.075 --> 00:18:39.395
 indeed.

477
00:18:39.997 --> 00:18:46.118
 So we're asking people to provide comments on any of the aspects of the CERC evaluation that they wish,

478
00:18:46.845 --> 00:18:49.727
 including the eight additional sectors if they wish to do so.

479
00:18:49.743 --> 00:18:51.805
 So they can submit the consultation.

480
00:18:52.212 --> 00:18:54.524
 So the consultation has two parts,

481
00:18:54.587 --> 00:18:54.977
 let's say.

482
00:18:55.165 --> 00:19:02.274
 They have very specific questions on the sectors where we do this sector-specific evaluation.

483
00:19:02.352 --> 00:19:03.524
 there we're asking about.

484
00:19:04.051 --> 00:19:05.191
 analysis of alternatives,

485
00:19:05.250 --> 00:19:05.731
 costs,

486
00:19:05.811 --> 00:19:06.392
 benefits,

487
00:19:06.431 --> 00:19:07.210
 proportionality,

488
00:19:07.511 --> 00:19:08.312
 all those details.

489
00:19:09.370 --> 00:19:14.730
 But there are also more general questions on all the different sections of the SEAC opinion.

490
00:19:15.175 --> 00:19:17.355
 And this also includes analysis of alternatives,

491
00:19:17.394 --> 00:19:17.691
 costs,

492
00:19:17.714 --> 00:19:18.214
 benefits.

493
00:19:18.574 --> 00:19:24.870
 So they are able to submit information about those eight sectors in those sections of the consultation.

494
00:19:24.871 --> 00:19:26.074
 I think that's really important to know.

495
00:19:27.433 --> 00:19:28.480
So to summarize,

496
00:19:28.558 --> 00:19:32.870
 the consultation is not just about the 14 sectors and PFAS manufacturing.

497
00:19:33.179 --> 00:19:35.320
 It covers all aspects of the draft opinion,

498
00:19:35.400 --> 00:19:39.685
 so anyone interested can share their thoughts on any part of the committee's evaluation.

499
00:19:40.346 --> 00:19:42.006
 That includes things like alternatives,

500
00:19:42.107 --> 00:19:42.467
 costs,

501
00:19:42.529 --> 00:19:42.990
 benefits,

502
00:19:43.068 --> 00:19:43.685
 as you mentioned,

503
00:19:43.686 --> 00:19:44.607
 so the whole picture.

504
00:19:45.389 --> 00:19:51.670
 Good to keep in mind that any relevant information you give will help the committee check or update its conclusions in the opinion.

505
00:19:52.139 --> 00:19:52.654
 So basically,

506
00:19:52.810 --> 00:19:54.420
 if you've got insights on the draft opinion,

507
00:19:54.717 --> 00:19:55.764
 now's the time to speak up.

508
00:19:56.752 --> 00:20:01.997
 The second question we received was on the decision to not allow attachments in the upcoming consultation.

509
00:20:02.036 --> 00:20:02.736
 Very specific.

510
00:20:02.779 --> 00:20:07.165
 So can you explain the thinking here and why is that potentially such a sensitive issue?

511
00:20:08.103 --> 00:20:08.282
Yeah,

512
00:20:08.423 --> 00:20:16.150
 so the reason why we have structured the consultation in the way we have by using a survey approach is to,

513
00:20:16.556 --> 00:20:16.806
 you know,

514
00:20:17.150 --> 00:20:23.118
 resolve this challenge that I mentioned a little while back about making sure that what is provided actually matches what we need.

515
00:20:23.816 --> 00:20:30.363
 So we want to make sure that people don't waste their time sending us things that won't be able to be used because they're not at the right level,

516
00:20:30.383 --> 00:20:31.363
 they're not the right thing.

517
00:20:31.863 --> 00:20:37.832
 So that's why we are providing the information this way and asking for the information this way rather.

518
00:20:38.332 --> 00:20:43.113
 And we provide quite a lot of space to give us data,

519
00:20:44.113 --> 00:20:46.004
 even if attachments are not allowed.

520
00:20:46.592 --> 00:20:49.715
 There are multiple questions and they cover all aspects of the draft opinion.

521
00:20:49.775 --> 00:20:52.799
 So there's quite a lot of space to provide information.

522
00:20:52.838 --> 00:20:53.100
 There are,

523
00:20:53.101 --> 00:20:53.396
 of course,

524
00:20:53.420 --> 00:20:54.139
 character limits,

525
00:20:54.158 --> 00:20:55.381
 but they are very generous,

526
00:20:55.420 --> 00:20:55.920
 I must say.

527
00:20:56.561 --> 00:21:04.709
 And collecting also the comments in a way that's more structured also allows us to process the information more effectively.

528
00:21:05.396 --> 00:21:09.896
 And for the information that comes in to have a bigger impact on the opinion making process as well,

529
00:21:09.928 --> 00:21:12.553
 which is the whole point of why we run the consultation.

530
00:21:12.912 --> 00:21:13.092
Right.

531
00:21:13.093 --> 00:21:14.954
 And you've run a few consultations in the past.

532
00:21:14.955 --> 00:21:18.118
 So I guess you've also understood from there that once these attachments start coming in,

533
00:21:18.196 --> 00:21:21.880
 you do get a lot of things that may not be included at all because they're just not relevant.

534
00:21:21.919 --> 00:21:23.185
 So it's also a left unlearned.

535
00:21:23.544 --> 00:21:23.685
 Yeah,

536
00:21:23.700 --> 00:21:26.325
I think we have learned a lot from previous consultations,

537
00:21:26.388 --> 00:21:29.810
 including the one on the Annex 15 dossier in this case.

538
00:21:30.388 --> 00:21:32.153
 And all these lessons that we have learned,

539
00:21:32.154 --> 00:21:35.341
 we have applied to try to make this consultation the best possible.

540
00:21:35.950 --> 00:21:36.638
All right.

541
00:21:36.639 --> 00:21:36.763
 Well,

542
00:21:36.778 --> 00:21:37.075
 thank you.

543
00:21:37.076 --> 00:21:38.856
 I think that concludes the audience questions.

544
00:21:38.984 --> 00:21:39.264
 part.

545
00:21:39.443 --> 00:21:40.204
 And as you mentioned,

546
00:21:40.205 --> 00:21:43.166
 we did organize a webinar on this in October,

547
00:21:43.205 --> 00:21:43.783
 I think it was,

548
00:21:44.264 --> 00:21:47.084
 and we'll be adding a link to that in this episode's description.

549
00:21:47.225 --> 00:21:48.326
 So do check that out.

550
00:21:49.006 --> 00:21:52.350
 But now let's conclude on PFAS for today.

551
00:21:52.443 --> 00:21:53.623
 We'll come back to it next year.

552
00:21:54.123 --> 00:21:55.022
 Long sigh of relief.

553
00:21:55.209 --> 00:21:55.428
 Good.

554
00:21:56.412 --> 00:21:57.725
 Let's move on to our second topic.

555
00:21:57.772 --> 00:22:05.865
 So this was the first time classification opinion from the Risk Assessment Committee on new hazard classes under the CLP regulation.

556
00:22:06.428 --> 00:22:06.850
 Roberto,

557
00:22:06.943 --> 00:22:07.568
 can you explain?

558
00:22:07.936 --> 00:22:10.638
 Why this is such a significant milestone to the committee?

559
00:22:11.718 --> 00:22:14.984
We should probably start from the revision of the CLP regulation,

560
00:22:15.043 --> 00:22:15.664
 classification,

561
00:22:15.722 --> 00:22:21.085
 labeling and packaging regulation in 23 that was modified introducing new hazard classes,

562
00:22:21.585 --> 00:22:23.328
 both for environment and human health.

563
00:22:23.929 --> 00:22:25.757
 And for some of them,

564
00:22:25.820 --> 00:22:29.382
 we had some previous experience in other processes such as PBT,

565
00:22:30.070 --> 00:22:33.664
 persistent bioaccumulative and toxic substances in SVHC,

566
00:22:33.898 --> 00:22:35.570
 substances of very high concern,

567
00:22:35.664 --> 00:22:36.617
 a lot of acronym,

568
00:22:36.679 --> 00:22:36.992
 sorry.

569
00:22:39.249 --> 00:22:44.675
 But what is new is indeed that those new hazard classes were not available earlier,

570
00:22:44.796 --> 00:22:46.077
 and particularly PMT,

571
00:22:46.335 --> 00:22:48.421
 so persistent mobility and toxicity,

572
00:22:48.999 --> 00:22:49.616
 or for instance,

573
00:22:49.639 --> 00:22:52.561
 endocrine-disrupting properties for human health or environment.

574
00:22:52.624 --> 00:22:53.530
 And for the first time,

575
00:22:53.577 --> 00:22:55.171
 RAC assessed a first case.

576
00:22:56.171 --> 00:22:57.749
 I will not read the name of the substance,

577
00:22:57.780 --> 00:22:59.124
 not to confuse our listeners,

578
00:22:59.233 --> 00:23:04.499
 but the conclusion was that it was very persistent and very bioaccumulative into the environment.

579
00:23:05.108 --> 00:23:06.436
 And this definitely sets a...

580
00:23:06.452 --> 00:23:26.353
 precedent is the first time and more proposals to classify substances with the new hazard classes will come and this will include for instance endocrine disrupting properties in 26 and the committee as usual will face new challenges because those are new criteria we have guidance but guidance is often not everything

581
00:23:26.447 --> 00:23:35.697
 we need to test the system with real data and this is what we have done but i think we are in a good position to to make this happen and to be to have a successful assessment also in

582
00:23:35.832 --> 00:23:37.893
 26 for the upcoming new substances.

583
00:23:38.915 --> 00:23:39.116
Right.

584
00:23:39.456 --> 00:23:39.616
 Well,

585
00:23:39.756 --> 00:23:43.760
 could you briefly outline kind of the scientific basis for the very persistent,

586
00:23:43.862 --> 00:23:46.182
 very bioaccumulative classification in this case?

587
00:23:47.104 --> 00:23:47.502
Indeed,

588
00:23:47.565 --> 00:23:47.784
 well,

589
00:23:47.924 --> 00:23:53.588
 we can start saying that in the specific cases about the property,

590
00:23:53.651 --> 00:23:56.979
 the intrinsic property of a substance to persist into the environment,

591
00:23:56.995 --> 00:24:02.432
 to stay without being naturally biodegraded in something else,

592
00:24:02.916 --> 00:24:04.823
 in normal environmental conditions.

593
00:24:05.063 --> 00:24:06.943
 and to accumulate in a living organism.

594
00:24:07.305 --> 00:24:11.307
 So the possibility to basically build a stock in time in a specific organism.

595
00:24:11.725 --> 00:24:18.428
 And this was considered as a relevant hazard that should be subject to classification and also to labeling to inform also potential users.

596
00:24:18.787 --> 00:24:19.248
 To do so,

597
00:24:19.365 --> 00:24:21.709
 we use what we call specific markers.

598
00:24:22.943 --> 00:24:23.475
 For instance,

599
00:24:23.490 --> 00:24:26.490
 if the substance shows a very long half-life,

600
00:24:26.506 --> 00:24:31.068
 so the time that it needs to actually have at least...

601
00:24:31.312 --> 00:24:34.513
 its concentration into the environment within a certain period of time.

602
00:24:34.673 --> 00:24:36.571
 Usually we use 180 days,

603
00:24:36.614 --> 00:24:38.052
 it's a bit the standard,

604
00:24:38.552 --> 00:24:40.896
 or bioconcentration factor in fish.

605
00:24:41.396 --> 00:24:46.458
 So how much actually this can concentrate when the fish is exposed to a substance.

606
00:24:46.997 --> 00:24:49.169
 And if those limits are exceeded,

607
00:24:49.263 --> 00:24:52.169
 this means that they are very persistent and very biocumulative.

608
00:24:53.122 --> 00:24:53.560
 As usual,

609
00:24:53.591 --> 00:24:57.638
 also this relies on so-called weight of evidence because we can have...

610
00:24:57.880 --> 00:25:02.404
 multiple simulation studies or bioaccumulation tests according to the CLP criteria.

611
00:25:02.924 --> 00:25:09.853
 And it is the task of the committee to weigh all the data and to decide what is the best approach in a weight of evidence approach.

612
00:25:09.908 --> 00:25:11.033
 This is what we do.

613
00:25:11.752 --> 00:25:16.150
 It's also we need to be transparent because everybody needs to apply the criteria in the same way.

614
00:25:16.197 --> 00:25:23.259
 So it's very important that we also make informed decisions that are very logical and also transparent for the users,

615
00:25:23.291 --> 00:25:23.588
 actually,

616
00:25:23.589 --> 00:25:24.947
 of the CLP classification.

617
00:25:26.409 --> 00:25:27.551
So what's the impact?

618
00:25:27.611 --> 00:25:30.594
 What does this mean for industry and regulators going forward?

619
00:25:31.356 --> 00:25:31.594
Well,

620
00:25:31.614 --> 00:25:33.395
 we expect more proposals,

621
00:25:33.438 --> 00:25:34.395
 as I mentioned to you,

622
00:25:34.739 --> 00:25:36.199
 covering new hazard classes.

623
00:25:36.496 --> 00:25:42.903
 And we also expect that the industry could gain actually knowledge through what RAC is doing,

624
00:25:43.012 --> 00:25:46.106
 because also they will have to apply actually the very same criteria.

625
00:25:46.965 --> 00:25:50.387
 And this will also result in labeling requirements.

626
00:25:50.434 --> 00:25:54.871
 So we see a benefit in terms of increased consistency in hazard.

627
00:25:55.325 --> 00:25:56.105
 identification.

628
00:25:56.886 --> 00:26:00.306
 And RAC being the first actually to implement those criteria,

629
00:26:01.385 --> 00:26:06.150
 I think the outcome of it will be fundamental to really decide how those criteria should be applied.

630
00:26:06.611 --> 00:26:07.408
 And at the end of the day,

631
00:26:07.409 --> 00:26:09.486
 it will be for the benefit of member state,

632
00:26:09.549 --> 00:26:10.150
 commission,

633
00:26:10.447 --> 00:26:10.931
 industry,

634
00:26:11.072 --> 00:26:12.767
 and interested parties at large.

635
00:26:12.861 --> 00:26:13.705
 And as usual,

636
00:26:14.236 --> 00:26:16.470
 we send our opinions to the European Commission,

637
00:26:16.486 --> 00:26:17.783
 and then with member states,

638
00:26:17.845 --> 00:26:22.345
 they decide whether it deserves to be included and become an obligatory classification,

639
00:26:22.346 --> 00:26:23.689
 of what we call harmonized.

640
00:26:24.817 --> 00:26:25.037
Okay,

641
00:26:25.117 --> 00:26:25.297
 well,

642
00:26:25.698 --> 00:26:28.801
 what's left to say except congratulations on this first milestone.

643
00:26:29.262 --> 00:26:30.622
 Maybe still to wrap this up.

644
00:26:30.684 --> 00:26:35.087
 So the committee has taken a very big step by applying the new hazard classes for the first time,

645
00:26:35.524 --> 00:26:36.712
 classifying this substance,

646
00:26:36.727 --> 00:26:38.407
 which I'm not even going to attempt to pronounce,

647
00:26:39.133 --> 00:26:41.126
 as a very persistent and very bioaccumulative.

648
00:26:41.157 --> 00:26:46.860
 So this now sets the tone for future decisions with more proposals expected next year,

649
00:26:47.407 --> 00:26:48.938
 including endocrine disruption.

650
00:26:49.594 --> 00:26:50.141
 For industry,

651
00:26:50.317 --> 00:26:53.380
 It means getting ready for updated labeling and for regulators,

652
00:26:53.560 --> 00:26:54.460
 more consistency,

653
00:26:54.582 --> 00:26:54.863
 I guess,

654
00:26:54.960 --> 00:26:57.164
 could be said than in hazard identification.

655
00:26:57.863 --> 00:26:59.707
 We've actually come to the end of our episode.

656
00:26:59.808 --> 00:27:00.871
 So again,

657
00:27:00.964 --> 00:27:03.113
 thank you very much for taking the time right after,

658
00:27:03.246 --> 00:27:04.292
 fresh from the committee meetings.

659
00:27:04.308 --> 00:27:05.011
 Thank you,

660
00:27:05.152 --> 00:27:05.371
 Adam.

661
00:27:05.394 --> 00:27:06.253
It's always a pleasure.

662
00:27:06.558 --> 00:27:06.933
Thank you.

663
00:27:07.558 --> 00:27:12.183
 Stay tuned for further updates in our upcoming episodes and by subscribing to our news.

664
00:27:12.636 --> 00:27:13.636
 As mentioned at the start,

665
00:27:13.933 --> 00:27:19.308
 do take the opportunity to send us your questions and topic suggestions so we can cover them in our future episodes.

666
00:27:20.181 --> 00:27:23.984
 You can send those to us at video at eka.europa.eu.

667
00:27:24.886 --> 00:27:25.027
 Well,

668
00:27:25.425 --> 00:27:26.269
 that's it for this year.

669
00:27:26.570 --> 00:27:32.257
 Wishing you all happy holidays and looking forward to another year of the Safer Chemical podcast in 2026.

670
00:27:32.773 --> 00:27:33.695
 Goodbye from Helsinki.

671
00:27:37.257 --> 00:27:38.960
 Safer Chemicals podcast.

672
00:27:39.679 --> 00:27:41.804
 Sound science on harmful chemicals.

