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Safer Chemicals Podcast. Sound science on harmful chemicals.

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So the new hazard classes are added to CLP mainly because they weren't adequately addressed by the existing hazard classes.

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Adding them to CLP brings a lot of clarity in terms of defining criteria,

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how to classify them, and inform users,

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those who use them, what to be aware of and how to handle them best.

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It allows them to be regulated similarly to other severe hazards with lots of downstream consequences possible in other legislation.

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CLP is very strongly linked to other legislation so classification can reach very far in terms of impact so it's quite a key change.

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The Classification, Labelling and Packaging Regulation,

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also known as the CLP Regulation, requires companies to appropriately classify,

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label and package their hazardous chemicals before placing them on the EU market.

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The aim is to protect health and the environment,

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but also to ensure free movement of substances,

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mixtures and articles. In this episode,

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we'll talk about the amendment that introduced new hazard classes to the regulation.

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These entered into force in April 2023.

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We'll also discuss the ongoing CLP revision that is one of the key deliverables of the European Commission's

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Chemical Strategy for Sustainability. It aims to update and optimize the regulation by ensuring that dangerous chemicals are properly identified,

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labelled and classified. At the same time,

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it's also an important element in Europe's move towards a toxic-free environment.

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My guest today is Paul Ryan, the head of our Hazard Classification Unit here at the European Chemicals Agency.

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Welcome, Paul, and thanks for joining us. Thank you.

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Good to be here. My name is Päivi Jokiniemi,

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and this is the Safer Chemicals Podcast.

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So I was thinking, let's start with the big picture.

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So if we look at the CLP, the Classification,

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Labelling and Packaging Regulation, what is it all about and how is it linked to EU's other chemical laws?

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Well, it's a key piece of European legislation, I would start there maybe, on chemicals,

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it's... It's hazard focused,

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so it differs to other legislation in that respect.

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It means it provides information on potential to cause harm and other pieces of legislation then take care of risk,

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the second part of the equation. It's also linked to many other parts of European legislation.

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So quite central and a key piece of regulation.

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It requires companies to classify, label and package their chemicals before they sell them.

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The objective obviously to protect people and the environment against hazardous chemicals.

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It's very linked to the global system. So there's a UN GHS,

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Globally Harmonized System, which is translated into European regulation via CLP.

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And this ensures free movement of substances and mixtures across the EU and globally.

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Because you have the same rules, the same principles to classify,

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the same criteria. So it allows this.

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Also consumers, people probably are very familiar with the little hazard pictograms you might see in the detergent aisle in your supermarket or in your hardware store.

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The little diamonds with the red border. So consumers get information through those pictograms and the warning labels and statements that go along with those.

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It's very linked to other regulations, as I said. Some examples being a classification in certain criteria can mean certain REACH restrictions kick in,

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or if it's a biocide or a plant protection product,

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it means maybe no market access if it's a certain classification applied.

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Similar for cosmetics also, for severe hazards,

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there's bans in place. And then for worker safety,

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for industrial accident legislation,

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the list goes on and on. CLP is quite central to everything.

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And there's been hazard classes earlier and now there are three new that came into force in April 2023.

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They are endocrine disruption, both for human health and the environment.

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Persistent, bioaccumulative and toxic,

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so PBT or very persistent and very bioaccumulative properties.

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And persistent, mobile and toxic,

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so PMT, or very persistent and very mobile properties.

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How would you describe these new hazard classes and the criteria that was introduced by the delegated regulation?

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Sure. Maybe me start by saying they're not entirely new.

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They're new to CLP, but they're not new to regulation.

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For example, SVHC, the substance of very high concern process,

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biocides and plant protection products have all assessed

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PBT and endocrine disruptors in the past and continue to do so in the risk part of the equation.

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PMT is relatively new across the board.

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Endocrine disruptors, I think people would be aware what that means.

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They affect the endocrine system, so hormones, and they can lead to many different adverse outcomes or effects in humans and other species,

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so quite important hazard class.

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PBT and vPvB are problematic because they don't degrade in the environment.

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So they persist, they bioaccumulate and they can continue to cause effects over long periods of time.

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PMT and vPvM, so this is similar in terms of the persistent criteria. The criteria is actually the same for PBT and for PMT,

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the P part. But these are mobile,

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so they move via water bodies and they end up in places where they can cause issues over a long period of time again.

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And all of these are considered to be fairly severe hazards in the context of CLP.

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So they're particularly important to identify clearly and to take action on.

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So clearly, as you said, severe hazards.

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So how, in practice, how does this now help improve chemicals management or consequently safety of chemicals that these hazards are now in CLP?

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Well, firstly, these hazards were not addressed by the existing hazard classes,

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so they weren't there. They weren't covered by the existing hazard classes under CLP.

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Adding them there brings a lot of clarity, I think, in terms of defined criteria.

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for how to classify them and to inform users what to be aware of when they handle them.

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It also allows them to be regulated by other pieces of regulation.

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Like I said, CLP is linked to many other pieces of legislation,

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so there's opportunities by putting it in CLP to have more impact in terms of when something is classified,

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what that means in other pieces of regulation,

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sectoral regulation and so on. In terms of one substance,

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one assessment also, this change serves that goal quite well,

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I think, because it centralises the hazard assessment for these hazard classes along with the others,

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prevents different regulatory bodies from having different conclusions as regards the hazard part.

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As I explained, risk assessment belongs in other pieces,

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but as regards the hazard part, this is centralised now in CLP and serves the one substance,

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one assessment goal very well. And last but not least,

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labels and warnings about hazardous properties. So the new hazard classes have now been in force for about a year.

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This means, for example, that since April 2023,

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the member states have been able to make proposals for harmonised classification and labelling with the new hazard classes.

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Yeah, how it works is we get intentions,

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as they're called, from Member States or industry if they intend to harmonise the classification.

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So we have proposals, we have six proposals at the moment ongoing.

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So they start to come already. Member States are taking action straight away.

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One of those is for an entry for a group of substances,

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a new entry, and the others involve changes to existing entries.

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So they're adding this hazard to the existing ones.

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So they're being active right away. Active right away.

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Yes, that's good. If we then move from the authority perspective to the company perspective.

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So could you give some examples of what companies now need to take into consideration when the new

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hazard classes have entered into force,

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what do they need to do or know? I think the starting point for companies will be to assess and review their portfolio of substances and mixtures against the criteria.

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And where they have information that indicates the classification criteria are met,

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they should take action, inform ECHA of the new classification,

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for example, by updating their REACH dossier.

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If the substance or mixture was not previously classified,

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that triggers an obligation to notify the substance to the Classification and labelling inventory,

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which is hosted on the ECHA website, or to make a new poison centre notification for the mixture.

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And you mentioned the poison centre notification.

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So poison centres are these instances that citizens can call,

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or through doctors, get help if there has been accidental poisoning,

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for example. Exactly. So these are hosted by the Member States and they provide information in those events.

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So also important that that information is correct and up to date.

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Exactly. And last but not least, companies have to take into account the new classification when preparing safety data sheets for the supply chain information.

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And when should companies then do this? Can they already start,

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for example, sending information to ECHA about the new hazards?

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They can. The new hazard classes are going to be added to the IUCLID software from April this year,

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April 2024. After this, companies can start including the information already when submitting dossiers under different regulations to ECHA.

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There's transition times for applying the new classification criteria to substances and to mixtures,

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so different transition rules for both. And while this is ongoing,

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it's not obligatory. You have to follow the timelines for that.

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But you can do it as from April. So as soon as the IUCLID software is updated,

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you can start submitting this information if you are active and enthusiastic.

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Very good. Then in very concrete terms,

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if companies, for example, need some support meeting these obligations,

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they're not sure how to do something, what applies to them,

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what kind of help is available for them? The main source of advice will come in guidance that we're preparing.

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So we're working hard on this at the moment to get it out in time.

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We've had a lot of interest from stakeholders in the draft guidance that we prepared over the past year now,

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some thousands of comments from different stakeholders. Lots of good advice,

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lots of good help. And it should be published hopefully this autumn.

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And the guidance is focused on the new hazard classes and the criteria.

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Yeah, maybe just to clarify that. So it's actually existing guidance on the CLP criteria and we're adding these parts.

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So we're adding advice for how to classify endocrine disruptors and PBTs and PMTs and so on.

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So not a new guidance, but an updated guidance. An update with these new sections,

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yeah. Maybe just for history,

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like I said earlier, these hazard classes,

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they come from other places already. So there's existing guidance.

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For example, there's an ECAA-EFSA guidance for endocrine disruptors,

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for that process in existence already.

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And then for PBT, there's an existing REACH guidance,

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guidance R11 is the number, on how to do PBT assessment.

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And many of the elements from these pieces of guidance will be translated into CLP.

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So there was information out there,

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but now it's being harnessed and used for the CLP guidance.

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Yes, and then there is also a support page on ECHA's website,

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right? Exactly. You can go to the website. Plenty of information there.

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You can also read the draft of the guidance already there and get more advice.

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So as mentioned in the beginning,

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the introduction of the new hazard classes is not the only change that is ongoing for CLP.

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We're also expecting the European Parliament and the Council to formally adopt the revised regulation proposed by the Commission.

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So the revision is said to clarify rules on labelling and also,

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for example, rules for chemicals sold online,

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but also to speed up the pace at which hazardous chemicals are identified.

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And of course, all of this to even better protect people and the environment.

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So what exactly does the new regulation propose to change so that these goals are reached?

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Yeah, this is ongoing, as you said, but what the Commission is doing is looking at ways to improve consistency of hazard classification of chemicals, for more efficient assessment,

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better communication between different actors dealing with hazardous chemicals.

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So there's quite a few changes, but I'll highlight a few.

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One is the Commission's right to initiate proposals for harmonised classification and labelling,

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which means they might mandate us here in ECHA or the European Food Safety Authority

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to prepare a proposal for a harmonised classification on behalf of the Commission.

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And this is completely new. This has not existed before.

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Completely new, yeah, because at the moment it's Member States or industry who can initiate harmonised classification dossiers.

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So there's potential for more actors in this dossier preparation task,

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which potentially could mean more dossiers for harmonised classification over time.

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And also groups of substances is... mentioned in the update to the regulation as being a priority.

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The aim here is to broaden the scope of classification entries and use where feasible and sensible group entries.

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Another change is clarifications to the rules for classification of mixtures and for substances with more than one constituent.

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There's also been changes to the Classification and labelling inventory,

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which is where you notify or companies can notify their self-classifications.

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And then ECHA hosts on the website. A few more things,

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maybe quickly. There's changes concerning the poison centre notifications.

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There's changes to to the online sales rules and to the labelling and packaging requirements.

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So to give better communication on hazards. Quite a many items on the list.

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So you mentioned the substances with more than one constituent.

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Maybe we can explore this a little bit further.

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So what is this all about? Can you tell a little bit more about this and what does it mean?

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Sure. Maybe we start with explaining the difference between substances and mixtures briefly because it's not straightforward.

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Sounds good. So,

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mixtures are basically, they can be two distinct substances or chemicals that are blended after they've been manufactured.

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And that's what you call a mixture. Substance might sound simple,

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but actually substance can be quite complex. So substance can be a very simple substance with a small number of constituents,

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but it can also be very complicated with thousands of constituents.

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So there's a broad spectrum of possibilities within the definition of a substance.

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In CLP currently, there's rules for mixtures.

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And basically, a mixture which contains

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CMR, which means carcinogen,

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mutagen, or reprotoxic chemicals, or constituents,

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if you have an ingredient or a constituent with those properties in your substance,

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you have to follow the rules in CLP and you can't override that information with information on the substance as a whole.

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So this is already in the regulation today for mixtures.

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So if you have a mixture, for example, with a known carcinogenic constituent above a threshold,

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which is set by the regulation, you have to classify accordingly,

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even if you have data on the mixture as a whole. So,

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as I said, substance is actually quite a broad definition.

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It can be simple or complex with many constituents.

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So the starting point for this change is there's no real reason to treat mixtures,

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which can be blended versions of different substances or chemicals together,

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to make any difference between the rules for those and the rules for substances.

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So it's a clarification from a certain point of view.

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So it clarifies this and it imposes similar rules for substances as those for mixtures.

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And generally speaking, this is the change, but there's also

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some exemptions to this and a lot of discussion about what sectors this should apply to or what are the rules for different sectors of chemistry.

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You mentioned the exemptions there, so is there anything more you can say about that?

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Currently in the proposal there's an exemption for a sector which is natural complex substances, defined in the actual change to the regulation now,

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with a clause that this should be reviewed in the next few years.

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So this work will take place and there'll be an examination as to whether the exemption should remain or not.

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Okay, so the work will continue. Yeah. Good.

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That's all I had this time. Thank you, Paul, for taking some time to join us.

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Also sharing your insights on this topic.

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Thank you also to our listeners for tuning in.

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You can find more information about the new hazard classes and,

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for example, links to the guidance existing now and the

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ECHA-EFSA guidance that you mentioned there.

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In the episode description, we will add all that information there so it's easy for you to go and explore and read more.

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Also, if you have any feedback, please let us know by using our feedback form.

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This is also linked in the episode description.

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And finally, if you would like to hear more of our episodes of Safer Chemicals Podcast, navigate to our website at echa.europa.eu/podcasts.

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That's all this time. Thank you very much and bye bye.

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Thank you. Safer Chemicals podcast.

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Sound science on harmful chemicals.