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Safer Chemicals Podcast.

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 Sound science on harmful chemicals.

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Both committees were able to draw provisional conclusions on the use of PFAS in the petroleum and mining industries.

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 We will also take a further look at the textiles,

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 upholstery,

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 leather,

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 apparel and carpet sector and at the food contact materials and packaging sector in November.

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 And this is to incorporate the change in the way that RAC calculates the PFAS emissions.

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 And then in the November meetings,

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 we will also discuss a new sector,

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 and that's construction products.

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Talc is widely used in several products,

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 including in many consumer products.

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 However,

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 given also its widespread use,

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 there were concerns about its potential to harm our health.

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 After extensive discussions and reviewing a lot of scientific studies,

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 the committee recommended classifying talc as a substance that can cause cancer.

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 These findings were based on the latest scientific data and our independent assessment considered all the information submitted during the consultation as well.

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Welcome to the Safer Chemicals podcast.

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 I'm here again with Roberto and Maria,

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 the chairs of our Risk Assessment and Socio-Economic Analysis Committees.

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 The committees have just ended their September meetings and we'll be going through the highlights.

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 We'll first start with an update on evaluating the universal PFAS restriction proposal.

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 We'll also be talking about the harmonised classification and labeling for talc and committee opinions on authorising the use of chromium-6 compounds in the aeronautics and defense industries.

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 Great to have you both back after the summer break.

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 Did you do anything exciting?

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Thank you for asking.

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 Not really.

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 What about you,

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 Maria?

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 Yeah,

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thanks very much for asking,

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 Adam.

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 I went on a cycling holiday in the Baltics,

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 which was lovely.

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Oh,

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 wow.

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 How many kilometers?

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50 per day,

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 more or less. 

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Very painful.

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Nice scenery?

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Very lovely,

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 yes.

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All right,

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 good to have you here.

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 So let's start with the universal restriction proposal for PFAS.

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 In the September meetings,

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 the committee has covered PFAS in petroleum and mining,

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 a long list coming up here,

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 so bear with me,

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 textiles, upholstery,

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 leather,

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 apparel,

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 carpets,

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 and food contact materials and packaging.

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 Roberto,

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 what did the risk assessment committee look at in particular?

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Thank you,

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 Adam,

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 for the question.

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 And perhaps I would start from an horizontal discussion that...

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 is affecting horizontally all sectors,

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 so I think it makes sense to start from there.

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 And this relates particularly to the fate of PFAS at the end of its life.

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 And the committee is looking to the possibility that PFAS could be released in the form of particles,

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 in the form of polymer

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 PFAS, polymeric PFAS,

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 versus leachate of leachable PFAS.

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 And they actually behave differently into the environment and

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 this leads to different emission factors.

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 So we had a good discussion into this.

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 And this related also what happens once they reach the end of their life.

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 So for instance,

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 if they are disposed in a landfill or whether incinerated in waste incinerators.

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 And this actually resulted in different emission factors that will affect the quantities that effectively reach the environment and then can cause damages.

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All right,

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 so that covers the horizontal aspects.

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 What other sectors did you look at then in particular?

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Perhaps we can start with petroleum mining,

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 where we reached final provisional conclusions.

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 In that sector PFAS are used in some applications such as water tracers or anti-foaming agents.

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 We looked of course at emissions and also the volumes that are linked to this.

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 I think the committee had a good discussion and we are not planning actually to come back to this specific sector.

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 On the contrary,

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 additional two sectors that we looked at,

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 the so-called

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 TULAC,

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 so the textiles and similar sectors,

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 and also the food contact materials have been looked at.

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 But there we will have to come back in November and we will explain you later why this is so.

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Right,

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 okay.

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 So for provisional conclusions our audience won't know what those are until the actual final opinion?

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That's correct indeed,

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 because there will be a sort of finalisation at the very end of the process,

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 we'll have the full picture for all the elements and this will allow the committee to reach definitely a final conclusion.

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So fair to say that the evaluation is progressing then from the risk assessment side.

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 What about you then,

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 Maria? 

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You covered the same sectors from the socio-economic perspective.

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 So what can you share with us?

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Well,

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 on the petroleum and mining,

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 similarly to RAC,

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 we were able to reach provisional conclusions.

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 And as always in SEAC,

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 we start by looking at the availability of alternatives to PFAS.

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 And then that allows us to continue looking,

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 for instance,

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 into the costs,

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 because depending on how many alternatives are available and what needs to be done to implement them,

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 the cost will be higher or lower.

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 Then we also consider the benefits,

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 which are basically those that are associated with lower emissions from PFAS as a result of a restriction.

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 And then we always bring it all back together by considering for particular sectors of particular uses,

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 are derogations needed to be able to ensure that the restriction is proportionate.

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 So that's always the analysis that SEAC does.

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 And as I mentioned,

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 in petroleum and mining,

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 we were able to arrive at provisional conclusions as well.

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 Then,

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 we also looked at the other sectors,

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 this famous TULAC and the food contact materials and packaging.

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 And for those,

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 the discussions will continue in the next meeting as well.

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 And that is because of what Roberto said earlier about the emissions potentially changing.

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 For these sectors,

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 the emissions coming from fluoropolymers are quite a substantial proportion.

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 So the emissions will change.

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 Therefore,

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 the benefits change and then the final considerations also change.

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 So aspects such as availability of alternatives,

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 we can consider that they are pretty much closed.

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 Then the rest we will have to rediscuss.

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Well,

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 let's then focus a little bit more on the famous TULAC,

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 as you said it.

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 So,

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 can you talk a bit more about the kinds of uses within this sector?

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So,

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 within this,

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 as you say,

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 famous tulak,

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 the uses that are discussed were quite a variety.

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 So,

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 you have got,

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 for instance,

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 home textiles,

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 and there we have items such as carpets,

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 curtains,

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 you know,

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 that sort of thing.

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 Then you have consumer and professional wear.

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 They were talking,

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 for instance,

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 of outdoor garments and footwear.

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 And also there is a use of PFAS in personal protective equipment,

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 which is quite an important use within that sector.

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 And this was all discussed within the disciplinary.

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 But also there were other uses of

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 PFAS that one may think could be part of the textiles sector,

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 but they are not discussed this time and they will be discussed later on.

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 So an example of that would be the use of PFAS in industrial equipment for the manufacturing of textiles,

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 such as conveyor belts and that sort of thing.

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 So that will come later on.

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All right.

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 Okay.

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 So a wide range of uses for the committee to assess.

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 What about then the food contact materials and packaging?

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 Can we talk a little bit about that?

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This is also an important sector with a variety of uses.

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 According to the dossier submitted proposal,

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 we group them in four categories.

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 So the first one is food packaging,

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 such as the...

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 plastics for food packaging that you can normally buy in any supermarket,

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 but also feed packaging,

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 like for instance,

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 pet food.

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 The third category is non-food packaging.

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 So any packaging used for goods,

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 even like car wrapping or similar.

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 And finally,

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 the considered food content materials,

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 such as the cookware and bakeware,

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 like non-sticking pans or similar items.

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 So it's a quite diverse,

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 let's say,

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 sector,

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 but I think the committee was able to...

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 to address them in a coherent and homogeneous manner.

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 So I think they did a good job.

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And just,

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 I think we might have talked about this in a previous episode,

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 but now we're talking about food contact materials.

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 Does this fall also somehow within the remit of EFSA?

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 Do they have some kind of a role?

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 Will this impact their work in any way?

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Yes,

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 indeed.

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 There are relationships that have been looked at by the committee because there is a specific regulatory environment.

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 And so we need to be sure to harmonize any provisions that REACH will.

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 take into this area with the existing regulatory framework.

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 And indeed,

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 EFSA also colleagues are participating attending the discussion as observers.

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Right,

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 okay.

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 Well,

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 thank you both for your insights and to summarize,

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 you covered first of all PFAS in petroleum mining,

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 textiles and upholstery,

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 as well as food contact materials and packaging.

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 So for petroleum you reached your provisional conclusions,

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 while for textiles and food packaging discussions will then continue in November.

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 I think this is actually a nice bridge to what is coming next.

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 And I think our listeners are also eager to hear what new sectors are on the horizon for November,

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 but also beyond.

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Well,

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 as you mentioned,

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 in November,

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 we continue with TULAC and with food contact material and packaging.

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 But then we take a new sector as well,

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 which is construction products.

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And then when we move to 2025,

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 we expect to cover fluorinated gases applications,

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 transport and energy.

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 And I think we should also remind that,

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 as usual,

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 we are...

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 dependent on how the five authorities,

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 what we call the dossier submitters,

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 are able to update with regard to their initial restriction report.

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 And also following the consultation input that resulted in many comments.

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And as a reminder to our listeners,

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 these authorities are the ones that submitted the proposal to ECHA for evaluation.

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 So that would be Germany,

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 Netherlands,

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 Denmark,

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 Sweden,

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 and Norway.

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Indeed,

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 and that's correct.

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 And we work very,

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 very closely with them.

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 I think we have,

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 I would say,

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 daily contacts,

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 because indeed...

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 The amount of information to be processed and the dossier that they have to be assessed by the committees is very large.

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 And so this requires a constant,

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 indeed,

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 exchange with them.

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 And I think I have to say we work very well with the dossier submitters.

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All right.

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 Thank you.

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 Let's then move on to the next topic.

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 And this is now a proposal from the Netherlands to harmonize the classification and labeling of talk.

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 Now,

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 the Dutch authorities propose to classify talk as a substance suspected of causing cancer,

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 as well as damage to lungs if inhaled.

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 Roberto,

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 we did cover this already a bit in June,

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 but now the committee has adopted its opinion.

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 So to get us started,

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 can you first remind us where talk is used?

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It definitely has a widespread use,

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 probably the most well-known is as a cosmetic product for baby powder or similar uses,

270
00:10:32.204 --> 00:10:33.985
 but it's also used as a food additives,

271
00:10:33.985 --> 00:10:35.325
 in pharmaceutical products,

272
00:10:35.365 --> 00:10:36.086
 in paints.

273
00:10:36.426 --> 00:10:39.767
 So it's really a quite widespread use indeed.

274
00:10:40.668 --> 00:10:44.429
 If I can now move to the scientific assessment that was carried out by the committee,

275
00:10:44.930 --> 00:10:48.371
 I would like to start mentioning that the dataset was really impressive.

276
00:10:48.551 --> 00:10:49.552
 I think for also

277
00:10:50.280 --> 00:10:51.281
 For different reasons,

278
00:10:51.361 --> 00:10:51.561
 really,

279
00:10:51.561 --> 00:10:54.022
 the rapporteur said to go through a huge amount of data.

280
00:10:54.723 --> 00:10:59.045
 And this also triggered an exceptional level of discussion at RAC level.

281
00:10:59.065 --> 00:11:02.787
 We had a very high number of members participating and inputting to the discussion.

282
00:11:03.468 --> 00:11:05.889
 The main issue was related to the carcinogenicity,

283
00:11:06.109 --> 00:11:06.449
 indeed.

284
00:11:06.569 --> 00:11:09.691
 So the dossier submitter proposed a carcinogenicity category 2.

285
00:11:10.452 --> 00:11:12.113
 The committee reached a different conclusion,

286
00:11:12.253 --> 00:11:13.113
 namely category

287
00:11:13.493 --> 00:11:17.936
 1b. And this was based on limited evidence.

288
00:11:18.236 --> 00:11:19.756
 in animal experiments,

289
00:11:19.896 --> 00:11:23.838
 namely female rats developing lung cancer,

290
00:11:24.938 --> 00:11:28.159
 associated with also limited evidence in humans,

291
00:11:28.319 --> 00:11:33.020
 specifically ovary cancer due to perineal use of talc by women.

292
00:11:35.181 --> 00:11:47.624
 Also worthwhile to mention that this was based on a novel approach by the committee that used an existing provision in CLP that allows to use data from animal plus limited data from human.

293
00:11:48.176 --> 00:11:50.337
 and put it together to support a category

294
00:11:50.797 --> 00:11:52.558
 1b that is a quite serious category.

295
00:11:53.798 --> 00:12:07.024
 There is also an issue about the route of exposure because we were not able to conclude or to exclude specific route of exposure such as oral because CLP does not allow to do this unless you can prove that this route of exposure is excluded.

296
00:12:07.984 --> 00:12:10.265
 And really if I can say the last word on that,

297
00:12:11.265 --> 00:12:12.066
 coincidentally,

298
00:12:12.586 --> 00:12:12.866
 IARC,

299
00:12:12.946 --> 00:12:17.328
 that is the agency of WHO on cancer research,

300
00:12:17.868 --> 00:12:19.129
 reach a similar conclusion.

301
00:12:19.409 --> 00:12:22.590
 And what is interesting is they use a slightly different data set,

302
00:12:22.710 --> 00:12:23.590
 different criteria,

303
00:12:24.131 --> 00:12:28.953
 but the conclusions are comparable to the ones that has been reached by our committee.

304
00:12:29.533 --> 00:12:29.713
Okay.

305
00:12:29.793 --> 00:12:33.314
 Reassuring to know that both agencies have then reached the same conclusion in this.

306
00:12:33.735 --> 00:12:35.395
 So in terms of the next step then,

307
00:12:35.615 --> 00:12:45.059
 so I guess for the commission to consider the committee's opinion and whether an adopted classification labeling for TALC should then be included in the CLP regulation.

308
00:12:45.139 --> 00:12:46.860
 And just to mention that if it is...

309
00:12:47.376 --> 00:12:47.996
 This would then,

310
00:12:48.016 --> 00:12:48.396
 of course,

311
00:12:48.456 --> 00:12:50.958
 lead to kind of clearer communication about the risks.

312
00:12:51.218 --> 00:12:51.338
 So,

313
00:12:51.638 --> 00:12:51.878
 I mean,

314
00:12:51.918 --> 00:12:52.678
 thinking about workers,

315
00:12:52.698 --> 00:12:53.258
 for example,

316
00:12:54.159 --> 00:12:58.881
 it would mean better safety measures in the workplace for wearing protective gear or improving ventilation.

317
00:12:59.521 --> 00:13:00.582
 And for consumers,

318
00:13:00.822 --> 00:13:01.302
 I suppose,

319
00:13:01.382 --> 00:13:06.984
 labels on products with warnings or instructions to help them use safely the products in question,

320
00:13:07.064 --> 00:13:07.244
 right?

321
00:13:07.785 --> 00:13:07.965
Yes,

322
00:13:08.225 --> 00:13:08.825
 that's correct.

323
00:13:08.925 --> 00:13:09.285
 In a way,

324
00:13:09.685 --> 00:13:09.965
 CLP,

325
00:13:10.125 --> 00:13:12.566
 the classification and labeling and packaging regulation,

326
00:13:12.747 --> 00:13:15.888
 is the cornerstone of the regulatory framework on chemicals.

327
00:13:15.908 --> 00:13:16.028
 And...

328
00:13:16.308 --> 00:13:17.309
 is really the basis.

329
00:13:17.409 --> 00:13:26.435
 So we assess the hazards and once the hazards have been established and the commission will look whether this deserves to be included in so-called annex 6 of the CLP regulation,

330
00:13:26.495 --> 00:13:29.798
 then it becomes obligatory and then all users,

331
00:13:29.878 --> 00:13:34.461
 be it workers and industry or even products that are available to consumers,

332
00:13:34.901 --> 00:13:38.584
 will need to report the correct hazard communication.

333
00:13:38.664 --> 00:13:44.368
 And there might also be downstream consequences in the sense that specific regulation could decide to restrict

334
00:13:44.568 --> 00:13:48.512
 certain products as a result of the hazard communication and classification,

335
00:13:48.512 --> 00:13:49.713
 of course.

336
00:13:49.993 --> 00:13:51.334
Then let's move on to Chromium 6.

337
00:13:51.714 --> 00:13:52.355
 So here,

338
00:13:53.096 --> 00:13:59.521
 both committees adopted their opinions on applications for authorization to use this substance in aviation and defense in particular.

339
00:14:00.142 --> 00:14:08.609
 So this involves a large number of applications and review reports that were managed by the Aerospace and Defense Chromates Reauthorization Consortium.

340
00:14:09.190 --> 00:14:11.552
 What were the key points in the opinions?

341
00:14:12.572 --> 00:14:15.113
Perhaps I can start from the risk assessment perspective.

342
00:14:15.313 --> 00:14:16.213
 And as you mentioned,

343
00:14:16.233 --> 00:14:18.794
 this is about the aviation and defense industry.

344
00:14:19.454 --> 00:14:21.815
 And those substances are used for coating,

345
00:14:21.895 --> 00:14:24.915
 plating and other forms of surface treatment.

346
00:14:25.636 --> 00:14:27.816
 They are really helpful against corrosion,

347
00:14:27.956 --> 00:14:28.296
 wear,

348
00:14:28.416 --> 00:14:29.357
 heat resistance,

349
00:14:29.357 --> 00:14:36.118
 and they play a very important role also in the quality of the aircraft that we might take every time we fly around Europe.

350
00:14:36.779 --> 00:14:38.159
 This was indeed a major process,

351
00:14:38.219 --> 00:14:41.520
 21 initial applications and review reports that covered.

352
00:14:41.700 --> 00:14:43.741
 11 uses and 5 chromates.

353
00:14:44.781 --> 00:14:49.563
 And what is striking is that there were hundreds of downstream user sites all across Europe.

354
00:14:50.584 --> 00:14:50.964
 However,

355
00:14:51.384 --> 00:14:52.205
 these substances,

356
00:14:52.385 --> 00:14:53.985
 they also have hazardous properties.

357
00:14:54.105 --> 00:14:55.306
 Some can be carcinogens.

358
00:14:55.766 --> 00:14:57.427
 So great care must be taken,

359
00:14:58.087 --> 00:14:58.467
 of course,

360
00:14:58.487 --> 00:15:01.689
 when workers are using them actually to perform their tasks.

361
00:15:02.809 --> 00:15:06.491
 RAC expressed some concerns on specific aspects,

362
00:15:06.971 --> 00:15:09.632
 particularly on the residual manual uses.

363
00:15:10.000 --> 00:15:20.840
 that are sometimes carried out and rather recommending corrective activities such as implementing automated or closed processes that will prevent exposure of workers.

364
00:15:21.884 --> 00:15:22.104
I mean,

365
00:15:22.144 --> 00:15:27.688
 what really stands out for me here is the effort to balance kind of these industrial needs and worker safety.

366
00:15:28.268 --> 00:15:28.388
 So,

367
00:15:28.588 --> 00:15:28.828
 you know,

368
00:15:28.888 --> 00:15:33.331
 the committee's concerns and push for tighter controls like these automated or closed processes,

369
00:15:33.511 --> 00:15:34.172
 as you mentioned.

370
00:15:34.572 --> 00:15:38.314
 I think this really shows how important it is to manage these risks and do it carefully.

371
00:15:38.915 --> 00:15:41.717
 Maybe we can then turn to the socioeconomic side.

372
00:15:41.777 --> 00:15:41.897
 So,

373
00:15:41.977 --> 00:15:42.237
 Maria,

374
00:15:42.337 --> 00:15:43.638
 what did the committee conclude on this?

375
00:15:44.598 --> 00:15:45.099
So in SEAC,

376
00:15:45.099 --> 00:15:46.880
 we always look at two aspects here.

377
00:15:47.260 --> 00:15:47.760
 First of all,

378
00:15:47.920 --> 00:15:52.103
 we look at whether there are technically and economically feasible alternatives for the applicants or,

379
00:15:52.223 --> 00:15:52.463
 you know,

380
00:15:52.463 --> 00:15:53.603
 the authorization holders,

381
00:15:53.623 --> 00:15:55.004
 as we call it when it's a review report.

382
00:15:56.005 --> 00:16:02.348
 And here we found that despite there having been progress in the research and development of safer alternatives,

383
00:16:03.709 --> 00:16:03.949
 you know,

384
00:16:04.009 --> 00:16:11.133
 what we found was that these alternative solutions to Chrome 6 have been successfully implemented only in a very limited number of niche applications.

385
00:16:11.153 --> 00:16:16.376
 So we finally determined that there are no economically and technically feasible alternatives for the applicants.

386
00:16:17.713 --> 00:16:18.353
 Additionally,

387
00:16:19.254 --> 00:16:26.380
 we noted that there are very long and complex regulatory recertification processes when something is changed.

388
00:16:26.820 --> 00:16:28.682
 This is to ensure that there is airworthiness,

389
00:16:28.762 --> 00:16:31.124
 so to make sure that it's safe to fly.

390
00:16:31.744 --> 00:16:36.068
 And this means that we can be certain that there are no alternatives available for these uses.

391
00:16:36.808 --> 00:16:36.929
 Now,

392
00:16:36.969 --> 00:16:40.652
 because of these very long processes that are required to make any changes,

393
00:16:41.072 --> 00:16:42.673
 SEAG is recommending to grant a

394
00:16:43.014 --> 00:16:43.854
 12-year review period.

395
00:16:44.575 --> 00:16:45.696
 So that's the first aspect.

396
00:16:46.060 --> 00:16:56.823
 Then we also look at what the benefits of allowing continued use are from the point of view of society and what are the associated risks that come with this continued use.

397
00:16:57.203 --> 00:17:04.585
 So SEAC then there concludes that the benefits of allowing the use of 12 more years are higher than the risks that come with it.

398
00:17:05.486 --> 00:17:08.907
 I would also like to note that in evaluating these applications and review reports,

399
00:17:08.907 --> 00:17:12.868
 we have worked together very closely with the European Union Aviation Safety Agency,

400
00:17:12.908 --> 00:17:13.768
 which is called EASA.

401
00:17:14.748 --> 00:17:20.590
 And they have given a presentation at the plenary on the regulatory framework about airworthiness in the EU.

402
00:17:21.190 --> 00:17:27.412
 And they were also very helpful in responding to technical questions from the committee when they were assessing the applications.

403
00:17:28.352 --> 00:17:28.472
 So,

404
00:17:29.072 --> 00:17:29.332
 you know,

405
00:17:29.492 --> 00:17:32.653
 we were very grateful to them for the help that they gave us.

406
00:17:34.294 --> 00:17:34.574
All right.

407
00:17:34.574 --> 00:17:35.354
 So to summarize,

408
00:17:35.394 --> 00:17:35.574
 then,

409
00:17:35.834 --> 00:17:38.175
 chromium-6 substances are crucial,

410
00:17:38.375 --> 00:17:38.895
 one would say,

411
00:17:38.955 --> 00:17:42.196
 in aviation and defense because they prevent corrosion and resist heat.

412
00:17:42.376 --> 00:17:42.536
 But...

413
00:17:43.164 --> 00:17:44.905
 The big concern is then their harmful,

414
00:17:45.005 --> 00:17:46.106
 even carcinogenic,

415
00:17:46.186 --> 00:17:46.686
 properties.

416
00:17:47.306 --> 00:17:55.311
 I guess it would be fair to say that the real challenge here has been finding a balance between keeping the aircraft safe on one hand and protecting workers on the other.

417
00:17:56.892 --> 00:17:57.892
 What are the next steps then?

418
00:17:59.233 --> 00:18:01.354
The opinions have been adopted in both committees,

419
00:18:01.915 --> 00:18:05.016
 and three of them actually have already been sent to the European Commission.

420
00:18:05.497 --> 00:18:06.017
 The rest,

421
00:18:06.077 --> 00:18:07.858
 we are in the process of sending them out,

422
00:18:08.018 --> 00:18:11.300
 and then they will be basically published very soon.

423
00:18:11.740 --> 00:18:13.781
 And the commission will move on this very swiftly,

424
00:18:13.881 --> 00:18:15.783
 particularly on the three most urgent ones,

425
00:18:16.463 --> 00:18:20.426
 where the authorization is actually expiring so that the companies get the decision as soon as possible.

426
00:18:20.826 --> 00:18:20.986
Right.

427
00:18:20.986 --> 00:18:23.588
 So we can expect things to move rather quickly with this one.

428
00:18:23.588 --> 00:18:23.788
Yes,

429
00:18:23.948 --> 00:18:24.228
 indeed.

430
00:18:26.150 --> 00:18:26.270
Well,

431
00:18:26.270 --> 00:18:27.751
 that's all the time we have for today.

432
00:18:27.991 --> 00:18:28.391
 Once again,

433
00:18:28.631 --> 00:18:31.633
 thank you both for your explanations and insight into the committee work.

434
00:18:32.214 --> 00:18:34.135
 The next committee meetings take place in November.

435
00:18:34.735 --> 00:18:36.877
 So join us again then for the latest updates.

436
00:18:37.397 --> 00:18:37.938
Thank you both.

437
00:18:38.318 --> 00:18:38.638
 Thank you.

438
00:18:38.918 --> 00:18:39.539
Thank you very much.

439
00:18:39.619 --> 00:18:40.800
And thank you to you for listening.

440
00:18:41.080 --> 00:18:41.340
 Bye bye.

441
00:18:44.524 --> 00:18:46.227
 Safer Chemicals Podcast.

442
00:18:46.948 --> 00:18:49.072
 Sound science on harmful chemicals.

