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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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 I'm Adam Elwan,

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 your host,

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 and today I'm joined by Roberto Scazzola and Maria Otati.

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 Now,

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 yesterday when I was going through the topics we'll be talking about today,

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 I realised that we've done probably tens of episodes together.

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 And I've never actually given you the chance to properly introduce yourself.

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 So maybe to start us off a bit differently than usual,

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 could I ask you to tell our listeners a bit about who you are?

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 I mean,

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 what is your background and what brought you to ECHA?

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 Sorry to put you on the spot like this,

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 but who would like to go first?

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Maria,

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 please.

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I'll start then,

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 yes.

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 So

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 I'm actually an Italian citizen,

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 but grew up in Uruguay.

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 So I always joke with Roberto that I'm a fake Italian.

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 And I started working there in the civil service.

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 I'm an economist by background.

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 And my first type of work that I did was in international trade,

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 which is very topical at the moment.

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 So about 15 years ago,

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 I moved to the UK.

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 I went to do a master's there.

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 And then I started working at what was the competent authority for REACH there.

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 I wasn't actually working on REACH.

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 I was working on other types of risks to workers,

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 but including some chemicals.

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 And in 2018,

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 I moved here to ECHA and since 2020,

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 I have been chair of the Committee for Socio-Economic Analysis.

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And Roberto?

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Roberto Scazzola.

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 I'm fully Italian,

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 as you can see from my strong accent.

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 Not a fake Italian then?

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 Well,

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 maybe.

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 Who knows?

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 Well,

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 what to say?

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 I have an experience in the Environmental Protection Agency in Italy.

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 I worked for six,

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 seven years there.

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 Then I moved to the private sector.

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 I was doing a bit of consulting and also working for a trade body.

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 And then I had

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 10 years of experience,

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 more or less,

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 in the European Commission,

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 working on international negotiations in a couple of United Nations conventions.

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 And then I worked for the Chemical Strategy for Sustainability,

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 Classification and Labelling,

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 cosmetic products.

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 So I had a quite wide range of experiences in the Commission.

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 And I really wanted to join ECHA because I think it's the place to be if you want to work for the safety of chemicals.

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 Since 2023,

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 I'm the chair of the Risk Assessment Committee.

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All right.

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 Thank you both.

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 So I learned something new about both of you.

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 So pleasure to meet you both finally,

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 properly.

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 All right.

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 Let's then actually jump into the topics for today.

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 So you are,

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 I hesitate to say fresh out of the first committee meetings of 2025,

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 but hopefully still awake enough to do the episode today.

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 And we'll be discussing the highlights.

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 So we'll begin as usual with the big topic the committees are discussing.

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 That's the universal PFAS restriction proposal.

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 Followed by a brief overview of the harmonised classification and labelling proposals for two substances,

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 so silver nitrate and silicon dioxide.

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 Then last but not least,

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 we'll also give an update on the Risk Assessment Committee's preparations for the Drinking Water Directive.

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 Maybe we then start with PFAS.

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 So the committee talked about PFAS uses in new sectors.

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 So we have fluorinated gases,

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 transport and energy now being discussed for the first time.

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 Roberto,

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 what were the highlights from the discussion?

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Well,

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 I think we had three big sectors and I'm very satisfied by the fact that RAC was able to agree on the provisional conclusions on all of them.

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 They are,

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 as mentioned,

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 large and complex sectors and they have been assessed carefully by the committee and they relate to transport.

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 It's about vehicle conditioning and refrigeration,

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 coatings or foam moldings,

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 also fluorinated gases.

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 Again,

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 it's about refrigeration,

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 heating,

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 conditioning,

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 foam blowing agents like the ones used for producing mattresses.

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 And then energy,

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 very important sector with renewable energy generations,

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 the transport of energy,

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 storage and batteries.

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 When it goes to what RAC does,

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 actually,

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 this means identifying the volumes and the related emissions that are calculated per sector for the major sub-application.

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 And I think it's worth mentioning for fluorinated gases,

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 these resulted in the highest emissions so far estimated by the committee,

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 about 40,000 tons per year.

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 That's quite a lot.

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 and this is due to the high release factors that is embedded in actually in their use compared to other sectors.

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 RAC also agreed on a common approach on the analysis of risks of alternatives.

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 This is mostly based on the CLH properties of the substances,

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 so their hazards,

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 but also on additional information when this is available about impurities or monomers.

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 However,

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 we have to signal that there is often a lack of detailed information on hazards and risks and this means that this

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 adds to the overall uncertainty when it goes to the overall relevance of the dossier.

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 RAC also looks into the effectiveness of the restriction options to reduce the risks,

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 but also the sector-specific derogations,

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 but only,

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 let me clarify,

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 based on risk considerations.

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 All such economic aspects are carried out by our sister committee,

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 SEAC.

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 And of course,

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 I should also mention we had a record number of stakeholders.

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 I think if I remember well,

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 at a certain point,

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 we had over 140 people.

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 Not all of them are stakeholders,

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 of course,

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 but many of them are.

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 And so this,

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 of course,

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 is a measure of the interest and the importance of the sector that have been looked at by the committee.

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 And as usual,

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 those are provisional conclusions.

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 It means that the overall approval will be carried out later on in the process.

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All right.

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 So the same process as for any restriction,

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 essentially.

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 There's nothing,

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 exceptional here.

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 All right.

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 Well,

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 thank you,

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 Roberto,

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 for those insights.

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 I think it's encouraging to see that there's so much detailed work going in and being done on these sectors.

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 Now,

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 a couple of follow-ups.

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 So you highlighted that there was kind of high stakeholder engagement during the meetings.

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 How does the Risk Assessment Committee then ensure that all these multitudes of views are sufficiently considered in the decision-making process?

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 It must be quite challenging to do.

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Well,

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 we try to do our best.

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 And the first point is that we allow the highest possible number of stakeholders attending physically the meeting,

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 even if sometimes we have to limit this because there are some physical capacities in the way we can accommodate them.

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 Stakeholders are invited to take the floor and to provide their input during the discussion.

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 And of course,

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 this is taken into account during the opinion making.

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 But also all the comments that have been provided during the consultation are looked at

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 and there will be a response to them into the final opinion once it will be finalised.

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Okay,

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 thank you.

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 Another thing that kind of jumped at me when you were talking was that there was this lack of detailed information on hazards and risks for the alternatives for these uses.

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 So how does the committee handle these kinds of information gaps in their assessments?

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Well,

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 we do our best also because this is a very wide restriction with a lot of sub-applications and therefore we have to look at a very high number of possible alternatives.

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 Every time this information is available in the dossier submitted by the dossier submitters,

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 by the countries that are behind this proposal,

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 the committee can look carefully into it,

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 but sometimes this information is not available.

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 So if there is no other possible source of information,

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 the committee adds these into the uncertainties into their assessment.

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 So we try to navigate through the availability of the information.

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 And when it's not available,

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 of course,

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 we take into account these in form of uncertainty.

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Right.

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 So then ultimately the decision makers will be looking over these,

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 including the uncertainties

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 and taking those into account in the final decision to regulate these chemicals.

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That's the idea.

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Maybe then,

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 Maria,

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 jumping to you on the same topic.

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 So you covered actually the same sectors,

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 but from the socio-economic perspective,

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 anything you can share with us?

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Well,

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 I can mention that for energy and for transport,

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 we actually had only introductory discussions.

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 So the rapporteurs provided a presentation introducing the sectors.

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 There have been some changes since the dossier was submitted,

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 updates made by the five authorities.

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 And there we will continue actually in June with the discussions.

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 For applications of fluorinated gases,

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 there we came to provisional conclusions.

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 So that one we have finished,

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 basically.

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 And there,

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 as usual,

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 we have looked at the availability of alternatives,

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 and then we've looked at the cost and benefits and what derogations are needed to ensure proportionality.

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You talked about the socio-economic benefits and costs for implementing the restrictions,

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 but can you elaborate on the key benefits that you expect,

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 you know,

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 if and when these restrictions take place?

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Yes.

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 Well,

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 the benefits are an area where the link between the work of RAC and SEAC is very close.

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 So...

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 the benefits that we see are as a result of the emission reduction,

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 which is something that RAC gives us as information.

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 So what we've got there are environmental benefits.

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 And,

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 you know,

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 these are very persistent substances.

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 So also there's fewer costs of remediation because we know that it's technically and economically very,

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 very difficult to clean up these PFAS from the environment.

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 When it's possible,

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 the remediation techniques are known to be very,

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 very expensive as well.

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 So,

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 you know,

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 if fewer emissions...

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 less PFAS in the stock and then less cost to remediate.

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 Also,

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 in some cases,

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 we know that there are human health impacts.

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 So if there is fewer emissions into the environment,

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 there's less exposure and fewer of those negative health impacts that can happen.

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 So,

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 you know,

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 on the whole,

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 those are the benefits that we're talking about.

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So essentially cheaper to clean up because you don't have to clean up as much,

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 less health impact and less persistent chemicals in the environment.

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Exactly.

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Okay,

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 what about then leading on from those benefits, one task of the committee is to look at proportionality of any measures that are taken.

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 Can you talk a bit more about how you do that?

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Yeah,

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 so we basically bring together these benefits with also the costs.

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 So we start out by looking at the availability of alternatives,

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 because obviously,

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 if there are alternatives,

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 that influences what the costs are of not using PFAS.

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 You know,

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 it's different if you've got something to replace them with than if you don't.

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 Then we look at what the benefits are in terms of the emissions reduction,

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 and we bring it all together when we talk about proportionality.

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 And then what we do as a result of this is we start out by thinking,

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 okay.

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 given the risk,

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 we know that as long as the right derogations are proposed,

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 the restriction would be proportionate.

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 So we look sector by sector at what we know about the cost,

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 the benefits,

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 the availability of alternatives,

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 and we make or not a recommendation as to whether we can conclude about whether derogation is necessary to ensure the proportionality.

266
00:10:44.155 --> 00:10:44.816
 In some cases,

267
00:10:44.816 --> 00:10:46.156
 the information is just not there.

268
00:10:46.636 --> 00:10:47.356
 But in some cases,

269
00:10:47.396 --> 00:10:49.077
 we're able to say that yes,

270
00:10:49.357 --> 00:10:52.638
 one would be needed to ensure proportionality or that in some cases,

271
00:10:52.738 --> 00:10:53.718
 one would not

272
00:10:53.798 --> 00:10:55.540
 be needed to ensure proportionality.

273
00:10:56.401 --> 00:11:02.286
Maybe if we can then talk a bit more about the types of uses that are included in these three applications.

274
00:11:03.628 --> 00:11:05.750
So among the applications of fluorinated gases,

275
00:11:05.770 --> 00:11:07.551
 we discuss things like refrigeration,

276
00:11:07.652 --> 00:11:08.172
 heat pumps,

277
00:11:08.212 --> 00:11:11.215
 and there we're talking also about the ones that are used in households,

278
00:11:11.916 --> 00:11:12.676
 air conditioning,

279
00:11:12.797 --> 00:11:14.098
 so those types of things.

280
00:11:14.538 --> 00:11:18.182
 And this is quite a difficult sector in the sense that it interacts

281
00:11:18.362 --> 00:11:20.183
 quite a bit with existing regulations.

282
00:11:20.203 --> 00:11:23.004
 The main one there being the Fluorinated Gases Regulation,

283
00:11:23.464 --> 00:11:28.646
 which covers already many of the substances which are looked at in the PFAS restriction.

284
00:11:29.326 --> 00:11:32.068
We can also provide some examples for the energy sector,

285
00:11:32.128 --> 00:11:32.648
 for instance,

286
00:11:32.668 --> 00:11:35.629
 as mentioned batteries are very important for the green transition,

287
00:11:35.669 --> 00:11:37.290
 but also solar collectors,

288
00:11:37.470 --> 00:11:39.331
 fuel cells involving hydrogen,

289
00:11:39.791 --> 00:11:40.631
 or more in general,

290
00:11:40.791 --> 00:11:42.372
 renewable energy generation,

291
00:11:42.452 --> 00:11:44.413
 so quite important applications.

292
00:11:44.953 --> 00:11:45.993
 When it goes to transport,

293
00:11:46.033 --> 00:11:47.074
 it's about cars,

294
00:11:47.214 --> 00:11:47.634
 boats.

295
00:11:47.834 --> 00:11:49.155
 airplanes and trains,

296
00:11:49.635 --> 00:11:50.956
 and when they are manufactured,

297
00:11:51.656 --> 00:11:53.997
 like the body or the fuselage construction,

298
00:11:54.558 --> 00:11:55.678
 but also fuel,

299
00:11:55.938 --> 00:11:56.979
 engine systems,

300
00:11:56.979 --> 00:11:57.1000
 hydraulic fluids.

301
00:11:58.320 --> 00:12:01.361
 So there are really a wide range of possible examples.

302
00:12:02.262 --> 00:12:02.622
All right,

303
00:12:02.682 --> 00:12:04.483
 thank you both for those insights.

304
00:12:04.523 --> 00:12:05.684
 So to summarise,

305
00:12:05.784 --> 00:12:09.166
 you covered PFAS in applications of fluorinated gases,

306
00:12:09.266 --> 00:12:10.066
 transport and energy,

307
00:12:10.226 --> 00:12:12.207
 all very big sectors with a lot of uses.

308
00:12:12.628 --> 00:12:13.508
 For all these uses,

309
00:12:13.688 --> 00:12:16.870
 the Risk Assessment Committee reached provisional conclusions.

310
00:12:17.306 --> 00:12:23.410
 Whereas the Socio-Economic Analysis Committee will still continue discussing transport and energy in the next plenary.

311
00:12:23.410 --> 00:12:24.270
 And you mentioned June,

312
00:12:24.330 --> 00:12:24.550
 right?

313
00:12:25.351 --> 00:12:25.551
Yes,

314
00:12:25.591 --> 00:12:25.991
 exactly.

315
00:12:26.011 --> 00:12:26.551
 So in SEAC,

316
00:12:26.571 --> 00:12:28.853
 we will obviously continue with energy and transport,

317
00:12:28.913 --> 00:12:29.853
 which we started now.

318
00:12:30.394 --> 00:12:33.755
 And we will also start discussing medical devices and lubricants.

319
00:12:34.316 --> 00:12:34.696
 In RAC,

320
00:12:34.876 --> 00:12:37.478
 they will do also medical devices and lubricants.

321
00:12:37.558 --> 00:12:38.238
 And in their case,

322
00:12:38.258 --> 00:12:40.799
 they will introduce electronics and semiconductors.

323
00:12:41.260 --> 00:12:42.160
 And then in September,

324
00:12:42.220 --> 00:12:45.202
 RAC will continue with electronics and semiconductors and SEAC

325
00:12:45.362 --> 00:12:46.702
 will have their discussion,

326
00:12:46.702 --> 00:12:48.803
 the full discussion in that month.

327
00:12:49.943 --> 00:12:50.643
 And as usual,

328
00:12:50.683 --> 00:12:53.264
 we are really dependent on how the five authorities,

329
00:12:53.284 --> 00:12:54.785
 who as a reminder are Germany,

330
00:12:55.025 --> 00:12:55.565
 Netherlands,

331
00:12:55.665 --> 00:12:56.165
 Denmark,

332
00:12:56.245 --> 00:12:57.145
 Sweden and Norway,

333
00:12:58.026 --> 00:13:00.466
 how they can update their initial restriction report,

334
00:13:00.726 --> 00:13:02.587
 which is following the consultation input.

335
00:13:03.667 --> 00:13:05.027
This brings up another question I have.

336
00:13:05.027 --> 00:13:05.608
 So how does this,

337
00:13:05.748 --> 00:13:11.269
 the fact that it's been submitted by the five authorities and the expertise that you have in the committees in general,

338
00:13:11.709 --> 00:13:13.790
 how does that play in the work of the committee? So,

339
00:13:13.830 --> 00:13:13.950
 how do you ensure that there's independence?

340
00:13:17.373 --> 00:13:19.275
 Because obviously you have different viewpoints coming in.

341
00:13:20.136 --> 00:13:20.696
 How do you make sure?

342
00:13:21.197 --> 00:13:21.357
Well,

343
00:13:21.377 --> 00:13:24.960
 the first thing to say is that our members are independent experts.

344
00:13:24.960 --> 00:13:26.682
 So they're not ECHA staff,

345
00:13:26.902 --> 00:13:27.503
 for instance.

346
00:13:27.943 --> 00:13:30.045
 They are nominated by each of the member states.

347
00:13:30.425 --> 00:13:35.110
 But it's also really important to note that they're not coming to represent their member states.

348
00:13:35.170 --> 00:13:36.071
 They are independent.

349
00:13:36.091 --> 00:13:37.372
 They're only nominated by them.

350
00:13:37.672 --> 00:13:39.074
 Our management board appoints them.

351
00:13:39.598 --> 00:13:42.719
 And they are coming there to bring in their own expertise.

352
00:13:42.939 --> 00:13:43.559
 And actually,

353
00:13:43.819 --> 00:13:46.140
 they are able to change their mind even during the meeting.

354
00:13:46.200 --> 00:13:46.620
 Sometimes,

355
00:13:46.620 --> 00:13:46.840
 you know,

356
00:13:46.820 --> 00:13:47.940
 they listen to the evidence,

357
00:13:47.940 --> 00:13:51.281
 they have a discussion and actually decide that they can change their mind.

358
00:13:52.001 --> 00:13:55.362
 And we have several processes in place to ensure this independence,

359
00:13:55.442 --> 00:13:56.923
 both from their member states.

360
00:13:56.923 --> 00:13:59.083
 So they cannot take instructions from the member state.

361
00:13:59.163 --> 00:14:03.985
 But also we make sure that they are not influenced by any other interest they may have.

362
00:14:03.985 --> 00:14:05.925
 And we're talking here about economic interest.

363
00:14:05.925 --> 00:14:07.766
 So we make sure that they are independent.

364
00:14:07.806 --> 00:14:08.546
 We check that.

365
00:14:08.946 --> 00:14:10.727
 They all declare what their interests are.

366
00:14:10.727 --> 00:14:11.807
 And as Chairs,

367
00:14:11.867 --> 00:14:15.889
 Roberto and I make sure that there isn't anything there that is unduly influencing them.

368
00:14:16.629 --> 00:14:16.829
Right.

369
00:14:16.829 --> 00:14:17.209
 So really,

370
00:14:17.209 --> 00:14:20.551
 the committees are mostly made up of people from outside of ECHA.

371
00:14:21.131 --> 00:14:24.953
 And ECHA provides kind of the secretariat and the support and the chairing of the meetings.

372
00:14:24.993 --> 00:14:25.833
That's exactly it.

373
00:14:25.933 --> 00:14:26.713
 We support them,

374
00:14:26.813 --> 00:14:29.054
 but they are the ones who are coming to the conclusions.

375
00:14:29.214 --> 00:14:33.376
 And also important to note that the opinions are the opinions of the whole committee.

376
00:14:33.396 --> 00:14:37.938
 So we have certain committee members who are taking the pen and actually drafting the opinions.

377
00:14:38.470 --> 00:14:40.395
 But the whole committee needs to agree.

378
00:14:41.611 --> 00:14:41.771
Okay,

379
00:14:41.811 --> 00:14:41.931
 well,

380
00:14:41.951 --> 00:14:44.252
 let's wrap up PFAS then for now.

381
00:14:44.372 --> 00:14:48.793
 This will be coming back to probably all of our episodes in the near future and beyond.

382
00:14:49.233 --> 00:14:52.294
 And let's talk about harmonised classification and labelling,

383
00:14:52.534 --> 00:14:54.715
 specifically for silver nitrate.

384
00:14:54.755 --> 00:14:58.056
 So it already has harmonised classifications,

385
00:14:58.136 --> 00:14:58.776
 for example,

386
00:14:58.996 --> 00:15:02.037
 as a substance that causes severe skin burns and eye damage.

387
00:15:02.557 --> 00:15:08.099
 But now the Swedish authorities have proposed to introduce quite a few new classifications.

388
00:15:08.239 --> 00:15:09.299
 So also including...

389
00:15:09.899 --> 00:15:11.019
 things like reaprotoxicity,

390
00:15:11.219 --> 00:15:13.980
 so it could damage fertility and the unborn child.

391
00:15:15.060 --> 00:15:15.901
 To start us off with,

392
00:15:16.181 --> 00:15:18.061
 where is silver nitrate used?

393
00:15:18.281 --> 00:15:19.842
 Can you give a few examples?

394
00:15:21.062 --> 00:15:21.322
Indeed,

395
00:15:21.362 --> 00:15:24.263
 there is quite a broad use of this kind of substance.

396
00:15:24.623 --> 00:15:25.023
 Mostly,

397
00:15:25.023 --> 00:15:31.105
 it is to provide human hygiene or disinfection or to help veterinary hygiene.

398
00:15:31.225 --> 00:15:31.485
 Also,

399
00:15:32.085 --> 00:15:34.086
 as an additive for food and feeds,

400
00:15:34.366 --> 00:15:35.386
 also in drinking water.

401
00:15:35.886 --> 00:15:38.427
 So it's a quite wide range of consumer applications.

402
00:15:38.907 --> 00:15:43.708
 This also probably is a measure of the interest of the dossier submitter in providing such a proposal.

403
00:15:44.869 --> 00:15:46.949
And what did the committee then conclude,

404
00:15:47.029 --> 00:15:47.609
 in its opinion?

405
00:15:48.590 --> 00:15:54.771
It was quite a long process because also we took into account new information that was made available.

406
00:15:55.332 --> 00:16:00.833
 And the main outcome of it was that the committee concluded for reprotoxicity category

407
00:16:01.173 --> 00:16:03.474
 1b. So it's a quite severe classification.

408
00:16:03.514 --> 00:16:07.855
 It means that the substance may damage the fertility or the unborn child

409
00:16:08.419 --> 00:16:11.582
 but it was also classified as suspected of causing cancer,

410
00:16:11.822 --> 00:16:13.403
 is a category 2 carcinogen.

411
00:16:14.324 --> 00:16:18.628
 It is also of interest the specific target organ toxicity,

412
00:16:19.008 --> 00:16:20.870
 what is called in jargon STOT,

413
00:16:21.430 --> 00:16:29.077
 for repeated exposure because the substance has been found to cause damage to the nervous system through prolonged or repeated exposure.

414
00:16:29.537 --> 00:16:34.481
 So there is overall quite a high set of severe classification.

415
00:16:35.142 --> 00:16:36.463
 And I would like to add that

416
00:16:36.643 --> 00:16:47.030
 There were many references to a former RAC opinion on the silver ion that was issued a few years ago that could not reach consensus at that time.

417
00:16:47.070 --> 00:16:47.971
 But this time,

418
00:16:48.451 --> 00:16:50.933
 even if there is a certain similarity of the substance,

419
00:16:51.073 --> 00:16:53.895
 new data allowed the committee to reach a consensus decision.

420
00:16:53.915 --> 00:16:55.636
 So there was no minority opinion.

421
00:16:55.777 --> 00:17:01.541
 And this was due definitely to the broader amount of information that was looked at by the committee.

422
00:17:02.221 --> 00:17:04.783
 And also to mention that this was based on a read-across.

423
00:17:05.123 --> 00:17:14.487
 and this also resulted in quite some complex discussions because other similar substances could be used up to a certain extent to support such a classification.

424
00:17:14.607 --> 00:17:17.488
And just can you explain read across in a nutshell just for our listeners too?

425
00:17:18.548 --> 00:17:34.475
Well in a nutshell read across means that you can establish a link between the substance at stake and a similar substance and if data on the similar substance are available we can use them with certain precautions and in a way you don't need to test or to add new information because

426
00:17:34.863 --> 00:17:38.825
 the similarity is so strong that allows to make this step.

427
00:17:39.466 --> 00:17:39.686
Okay.

428
00:17:39.706 --> 00:17:40.506
 And then ultimately,

429
00:17:40.766 --> 00:17:41.747
 as with all of these,

430
00:17:42.027 --> 00:17:43.608
 the European Commission together with the

431
00:17:44.428 --> 00:17:47.190
 EU countries will decide on the final harmonised classification.

432
00:17:47.190 --> 00:17:47.430
Of course,

433
00:17:47.550 --> 00:17:50.372
 we will submit this opinion to the European Commission.

434
00:17:50.392 --> 00:17:54.414
 They will decide whether it deserves to be added into the so-called Annex VI.

435
00:17:54.774 --> 00:17:56.095
 And the moment it does,

436
00:17:56.195 --> 00:18:00.397
 it means that it becomes the obligatory harmonised classification at European level.

437
00:18:00.798 --> 00:18:03.319
 And this has important consequences in terms of

438
00:18:03.419 --> 00:18:04.800
 hazard information.

439
00:18:04.880 --> 00:18:05.821
 So through the label,

440
00:18:06.202 --> 00:18:06.622
 people,

441
00:18:07.102 --> 00:18:11.686
 workers will be informed of what they should do to be safe when they use such substance.

442
00:18:12.747 --> 00:18:12.967
Okay,

443
00:18:13.007 --> 00:18:13.308
 thank you,

444
00:18:13.328 --> 00:18:13.728
 Roberto.

445
00:18:13.788 --> 00:18:18.192
 Let's then move on to the second substance on the list of harmonised classifications.

446
00:18:18.272 --> 00:18:19.633
 So silicon dioxide.

447
00:18:20.114 --> 00:18:20.374
 Now,

448
00:18:20.954 --> 00:18:24.237
 this substance doesn't yet have a harmonised classification,

449
00:18:24.618 --> 00:18:30.643
 but the Dutch authorities are proposing to harmonise it in the EU as a substance that causes ...

450
00:18:31.171 --> 00:18:33.272
 damage to the respiratory tract when inhaled.

451
00:18:34.392 --> 00:18:37.194
 Can you give some examples of where this chemical is used?

452
00:18:38.254 --> 00:18:38.534
Sure.

453
00:18:38.714 --> 00:18:41.575
 There are wide uses in a large variety of applications,

454
00:18:41.635 --> 00:18:45.017
 but first I should also mention this substance is known with different names,

455
00:18:45.077 --> 00:18:45.537
 including,

456
00:18:45.597 --> 00:18:46.097
 for instance,

457
00:18:46.117 --> 00:18:47.558
 synthetic amorphous silica.

458
00:18:47.718 --> 00:18:53.460
 So I really invite our listeners to check carefully the opinion to be sure that we refer to the same substance.

459
00:18:53.480 --> 00:18:54.381
I took the easy way out.

460
00:18:54.401 --> 00:18:56.121
 I just said the short version to make it easier.

461
00:18:56.602 --> 00:18:57.162
Absolutely.

462
00:18:57.542 --> 00:18:59.543
 So the uses were related to paints,

463
00:18:59.783 --> 00:19:00.083
 rubber

464
00:19:00.203 --> 00:19:00.643
 products,

465
00:19:00.683 --> 00:19:01.743
 but also cosmetics,

466
00:19:01.903 --> 00:19:02.764
 food additives,

467
00:19:02.964 --> 00:19:04.644
 even in manufacturing of textiles.

468
00:19:04.664 --> 00:19:06.685
 So quite a broad range of uses.

469
00:19:07.285 --> 00:19:12.446
 And even biocidal products like disinfectants and pest control and plant protection products.

470
00:19:12.446 --> 00:19:13.907
 So quite a wide range.

471
00:19:14.787 --> 00:19:16.728
And what was the committee's conclusion then?

472
00:19:17.488 --> 00:19:18.568
As you mentioned very well,

473
00:19:18.728 --> 00:19:22.809
 it's about specific target organ toxicity for repeated exposure.

474
00:19:22.809 --> 00:19:26.750
 So it means that the substance has the intrinsic property to damage an organ,

475
00:19:27.230 --> 00:19:27.871
 in this case,

476
00:19:27.871 --> 00:19:29.271
 the respiratory tract through

477
00:19:29.431 --> 00:19:33.513
 inhalation because it can cause certain inflammatory responses.

478
00:19:34.093 --> 00:19:36.214
 And this deserves a category one,

479
00:19:36.254 --> 00:19:38.455
 so it's a quite severe classification.

480
00:19:39.736 --> 00:19:48.379
 I think it's also a nice case to remind of the importance of the hazard communication because in the case the European Commission will decide to follow the RAC opinion,

481
00:19:49.740 --> 00:19:55.283
 this will have important consequences in terms of hazard information that will be made available to consumers,

482
00:19:55.283 --> 00:19:56.003
 to workers.

483
00:19:56.756 --> 00:19:59.567
 So this information will allow the users

484
00:20:00.810 --> 00:20:02.251
 to take the precautions,

485
00:20:02.271 --> 00:20:07.913
 the risk management measures or any protection that is needed to avoid an undue exposure to the chemical.

486
00:20:09.454 --> 00:20:09.734
All right,

487
00:20:09.734 --> 00:20:12.855
 now let's shift our focus to the Drinking Water Directive.

488
00:20:12.915 --> 00:20:28.161
 So this directive is actually playing a very important role in safeguarding the well-being of citizens and the environment and it addresses the potential risks that are associated with contaminated drinking water so it ensures also better access to clean drinking water.

489
00:20:29.362 --> 00:20:30.163
 In 2021,

490
00:20:30.203 --> 00:20:34.026
 the European Commission gave ECHA specific tasks under the directive.

491
00:20:34.587 --> 00:20:42.734
 And one of the most interesting ones is setting up lists of chemicals that can be safely used in any materials that come into contact with drinking water.

492
00:20:43.214 --> 00:20:44.615
 These are so-called positive lists.

493
00:20:44.756 --> 00:20:46.517
 And for maintaining these lists,

494
00:20:46.637 --> 00:20:49.380
 the Risk Assessment Committee also plays a key role.

495
00:20:49.840 --> 00:20:50.280
 Roberto,

496
00:20:50.521 --> 00:20:54.104
 the committee has now been getting ready for the Drinking Water Directive.

497
00:20:54.384 --> 00:20:56.506
 Could you give us an update on where we are with the work?

498
00:20:57.886 --> 00:20:58.026
Well,

499
00:20:58.066 --> 00:20:58.426
 firstly,

500
00:20:58.466 --> 00:21:02.109
 I'm really proud RAC has been entrusted with this new important task.

501
00:21:02.529 --> 00:21:03.270
 It's a clear sign,

502
00:21:03.310 --> 00:21:03.590
 I think,

503
00:21:03.610 --> 00:21:06.412
 that we have been successful in our activities in the past,

504
00:21:06.472 --> 00:21:09.534
 and we hope we will be able to deliver also on those new tasks.

505
00:21:10.214 --> 00:21:12.016
 The revised Drinking Water Directive,

506
00:21:12.036 --> 00:21:12.296
 indeed,

507
00:21:12.476 --> 00:21:15.678
 entered into force in 2021.

508
00:21:15.678 --> 00:21:23.263
 We can describe it as a sort of permitting system for materials that come into direct contact with drinking water when you collect,

509
00:21:23.403 --> 00:21:24.004
 purify,

510
00:21:24.144 --> 00:21:24.744
 transport,

511
00:21:24.844 --> 00:21:25.965
 or store that water.

512
00:21:25.985 --> 00:21:27.306
 So it's a quite important task.

513
00:21:27.974 --> 00:21:31.656
 And we are specifically looking at four materials like organic,

514
00:21:31.756 --> 00:21:32.277
 metallic,

515
00:21:32.377 --> 00:21:33.277
 cement tissues,

516
00:21:33.478 --> 00:21:34.238
 or ceramic,

517
00:21:34.278 --> 00:21:35.599
 or other inorganics.

518
00:21:36.139 --> 00:21:36.519
 And they have,

519
00:21:36.519 --> 00:21:36.940
 of course,

520
00:21:37.020 --> 00:21:41.823
 different information requirements and different needs following their specific properties.

521
00:21:42.603 --> 00:21:46.506
 The first European positive list were adopted in April 2024.

522
00:21:46.726 --> 00:21:47.586
 And we have done a

523
00:21:47.967 --> 00:21:53.030
 15-year review program that starts with the overall goal to ensure the safe use of those materials.

524
00:21:53.778 --> 00:21:58.180
 So ECHA is entrusted to carry out a regular maintenance of the European positive list.

525
00:21:58.420 --> 00:22:00.081
 This means adding new entries,

526
00:22:00.241 --> 00:22:01.061
 modifying them,

527
00:22:01.241 --> 00:22:02.342
 or even removing them.

528
00:22:03.042 --> 00:22:08.044
 And all entries in the first EU positive list need to be reviewed by 2039,

529
00:22:08.324 --> 00:22:09.104
 if applied for.

530
00:22:09.925 --> 00:22:10.185
All right,

531
00:22:10.845 --> 00:22:11.465
 one question.

532
00:22:11.485 --> 00:22:11.665
 I mean,

533
00:22:11.645 --> 00:22:13.706
 in terms of kind of the size of this whole thing,

534
00:22:13.926 --> 00:22:14.947
 we're talking about water.

535
00:22:15.487 --> 00:22:20.089
 What kind of impact do you foresee on the companies that are working on this?

536
00:22:20.129 --> 00:22:20.329
 I mean,

537
00:22:20.369 --> 00:22:22.350
 compared to the other tasks that ECHA is doing?

538
00:22:23.582 --> 00:22:25.583
 How wide is this sector?

539
00:22:25.763 --> 00:22:28.523
That's quite a significant amount of work,

540
00:22:28.644 --> 00:22:29.364
 I have to say.

541
00:22:30.204 --> 00:22:33.925
 And if we try to approach this from the applicant's point of view,

542
00:22:33.985 --> 00:22:38.806
 they first make up their mind if they wish to stay into the list.

543
00:22:38.967 --> 00:22:47.669
 So this means that they have to apply and to prepare a dossier that will demonstrate actually the safety of those materials to be used in this specific sector.

544
00:22:48.209 --> 00:22:50.730
 This is done first via notification to ECHA that

545
00:22:50.890 --> 00:22:53.431
 will become possible as of 2026.

546
00:22:54.332 --> 00:22:56.693
 And then for a substance to remain in the positive list,

547
00:22:57.714 --> 00:23:00.775
 you need to submit an application following such a notification.

548
00:23:01.276 --> 00:23:07.159
 And the first applications are expected to be received as of January 2027.

549
00:23:07.219 --> 00:23:09.800
 That's the first date possible for such a submission.

550
00:23:10.481 --> 00:23:12.982
 And then when the real RAC work will start.

551
00:23:13.522 --> 00:23:17.504
 So we will also seek input from third parties on relevant information.

552
00:23:17.544 --> 00:23:20.186
 So there will be the possibility also for third parties to

553
00:23:20.466 --> 00:23:20.786
 input.

554
00:23:21.347 --> 00:23:24.709
 And then the RAC task is relatively similar to what it does today.

555
00:23:24.889 --> 00:23:27.871
 So it's to evaluate if those substances that are used,

556
00:23:28.452 --> 00:23:31.394
 also their potential to migrate into drinking water,

557
00:23:31.434 --> 00:23:33.295
 that's the main concern we want to address.

558
00:23:33.875 --> 00:23:43.782
 And also overall assess whether there is a risk to consumers coming from the materials that are used for the purposes of transporting or being in contact with drinking water.

559
00:23:44.983 --> 00:23:49.606
 It's also fair to mention this task requires new competencies that are not necessarily

560
00:23:49.786 --> 00:23:51.067
 present today in the committee.

561
00:23:51.527 --> 00:23:52.508
 And for this purpose,

562
00:23:52.628 --> 00:24:01.373
 we have established a new working group that has a specific task to look into the aspects where the committee is not yet fully equipped in terms of competencies.

563
00:24:02.133 --> 00:24:08.137
 And now we are really working into identifying process and procedures that will be applicable in the two years to come.

564
00:24:09.277 --> 00:24:09.478
Okay.

565
00:24:09.498 --> 00:24:09.818
 I mean,

566
00:24:09.878 --> 00:24:16.642
 it sounds like 2026 and 2027 are going to be critical years for both applicants and the committee.

567
00:24:17.850 --> 00:24:21.112
 From the initial notifications to the start of applications,

568
00:24:21.312 --> 00:24:24.553
 I think it sounds like there's also a lot of groundwork that's already being laid.

569
00:24:25.033 --> 00:24:29.815
 You mentioned the creation of this working group to develop the processes and expertise.

570
00:24:30.435 --> 00:24:31.356
 With all of this in motion,

571
00:24:31.416 --> 00:24:36.238
 are there any suggestions or tips that you'd like to share with listeners who might be interested in this area?

572
00:24:36.938 --> 00:24:37.178
Yeah,

573
00:24:37.298 --> 00:24:37.558
 thank you,

574
00:24:37.558 --> 00:24:37.718
 Adam,

575
00:24:37.718 --> 00:24:38.259
 for the question.

576
00:24:38.279 --> 00:24:44.941
 I think the first one is that each application will be submitted to ECHA via a software that is called IUCLID.

577
00:24:45.562 --> 00:24:45.682
 So...

578
00:24:46.402 --> 00:24:48.504
 it's probably time that you familiarise with it.

579
00:24:49.005 --> 00:24:53.710
 There is a lot of guidance available because that's the tool that will be used to submit the notification.

580
00:24:54.262 --> 00:25:02.584
 We have also set up a user group for stakeholders that wish to learn more about how the future ECHA's IT tools will work.

581
00:25:03.144 --> 00:25:08.046
 So trying them and also provide valuable feedback to further development.

582
00:25:08.106 --> 00:25:09.106
 So in such a case,

583
00:25:09.146 --> 00:25:12.027
 feel free to contact ECHA for more additional information.

584
00:25:13.267 --> 00:25:13.427
Right.

585
00:25:13.427 --> 00:25:16.288
 And I think we also had a webinar recently on the drinking water directive.

586
00:25:16.308 --> 00:25:19.769
 So another way to get familiar with that and ask questions.

587
00:25:20.129 --> 00:25:20.389
 All right.

588
00:25:20.409 --> 00:25:20.689
 Thank you.

589
00:25:20.749 --> 00:25:21.550
 So to sum up,

590
00:25:21.650 --> 00:25:23.190
 the committee plays a key role

591
00:25:23.410 --> 00:25:23.850
 once again,

592
00:25:23.870 --> 00:25:26.652
 in evaluating applications related to the directive,

593
00:25:27.152 --> 00:25:28.013
 and in particular,

594
00:25:28.453 --> 00:25:33.836
 in assessing then how these materials used in contact with drinking water might affect our safety.

595
00:25:34.476 --> 00:25:38.318
 The process will involve applicants using IUCLID to submit their applications,

596
00:25:38.338 --> 00:25:38.919
 as you mentioned.

597
00:25:39.779 --> 00:25:41.880
 I think the user group is also interesting to mention again.

598
00:25:41.940 --> 00:25:48.104
 So the stakeholders that are interested in engaging with ECHA's tools and providing feedback for their further development will be available.

599
00:25:48.164 --> 00:25:51.786
 So we really get the feedback from those who will be using the tools on what they need.

600
00:25:54.454 --> 00:25:56.876
 That wraps up our first episode of the year.

601
00:25:57.477 --> 00:25:57.877
 Thank you,

602
00:25:57.977 --> 00:25:58.878
 Maria and Roberto,

603
00:25:59.098 --> 00:26:01.139
 for sharing your insights from the committees.

604
00:26:01.600 --> 00:26:04.482
 And we'll then be seeing you back on the podcast in June.

605
00:26:05.423 --> 00:26:08.245
 We have a lot of interesting topics lined up for you this year,

606
00:26:08.425 --> 00:26:08.866
 including,

607
00:26:08.946 --> 00:26:09.486
 of course,

608
00:26:09.726 --> 00:26:11.128
 these regular committee updates.

609
00:26:11.528 --> 00:26:13.269
 But we also have a few surprises in store.

610
00:26:13.369 --> 00:26:18.794
 So subscribe to our news and get notified about new episodes and follow us on social media.

611
00:26:19.675 --> 00:26:23.818
 You can now also find us on BlueSky and a link to that is in the episode description.

612
00:26:24.734 --> 00:26:25.877
 So thank you for tuning in,

613
00:26:26.478 --> 00:26:27.441
 and until next time,

614
00:26:27.882 --> 00:26:28.263
 goodbye.

615
00:26:30.047 --> 00:26:31.751
 Safer Chemicals Podcast.

616
00:26:32.493 --> 00:26:34.598
 Sound science on harmful chemicals.

