Transcription

• Paul Ryan

  Safer Chemicals Podcast. Sound science on harmful chemicals. So the new hazard classes are added to CLP mainly because they weren't adequately addressed by the existing hazard classes. Adding them to CLP brings a lot of clarity in terms of defining criteria, how to classify them, and inform users, those who use them, what to be aware of and how to handle them best. It allows them to be regulated similarly to other severe hazards with lots of downstream consequences possible in other legislation. 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.

• Host - Päivi Jokiniemi

  The Classification, Labelling and Packaging Regulation, also known as the CLP Regulation, requires companies to appropriately classify, label and package their hazardous chemicals before placing them on the EU market. The aim is to protect health and the environment, but also to ensure free movement of substances, mixtures and articles. In this episode, we'll talk about the amendment that introduced new hazard classes to the regulation. These entered into force in April 2023. We'll also discuss the ongoing CLP revision that is one of the key deliverables of the European Commission's Chemical Strategy for Sustainability. It aims to update and optimize the regulation by ensuring that dangerous chemicals are properly identified, labelled and classified. At the same time, it's also an important element in Europe's move towards a toxic-free environment. My guest today is Paul Ryan, the head of our Hazard Classification Unit here at the European Chemicals Agency. Welcome, Paul, and thanks for joining us.

• Paul Ryan

  Thank you. Good to be here.

• Host - Päivi Jokiniemi

  My name is Päivi Jokiniemi, and this is the Safer Chemicals Podcast. So I was thinking, let's start with the big picture. So if we look at the CLP, the Classification, Labelling and Packaging Regulation, what is it all about and how is it linked to EU's other chemical laws?

• Paul Ryan

  Well, it's a key piece of European legislation, I would start there maybe, on chemicals, it's... It's hazard focused, so it differs to other legislation in that respect. It means it provides information on potential to cause harm and other pieces of legislation then take care of risk, the second part of the equation. It's also linked to many other parts of European legislation. So quite central and a key piece of regulation. It requires companies to classify, label and package their chemicals before they sell them. The objective obviously to protect people and the environment against hazardous chemicals. It's very linked to the global system. So there's a UN GHS, Globally Harmonized System, which is translated into European regulation via CLP. And this ensures free movement of substances and mixtures across the EU and globally. Because you have the same rules, the same principles to classify, the same criteria. So it allows this. 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. 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. 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, or if it's a biocide or a plant protection product, it means maybe no market access if it's a certain classification applied. Similar for cosmetics also, for severe hazards, there's bans in place. And then for worker safety, for industrial accident legislation, the list goes on and on. CLP is quite central to everything.

• Host - Päivi Jokiniemi

  And there's been hazard classes earlier and now there are three new that came into force in April 2023. They are endocrine disruption, both for human health and the environment. Persistent, bioaccumulative and toxic, so PBT or very persistent and very bioaccumulative properties. And persistent, mobile and toxic, so PMT, or very persistent and very mobile properties. How would you describe these new hazard classes and the criteria that was introduced by the delegated regulation?

• Paul Ryan

  Sure. Maybe me start by saying they're not entirely new. They're new to CLP, but they're not new to regulation. For example, SVHC, the substance of very high concern process, biocides and plant protection products have all assessed PBT and endocrine disruptors in the past and continue to do so in the risk part of the equation. PMT is relatively new across the board. Endocrine disruptors, I think people would be aware what that means. They affect the endocrine system, so hormones, and they can lead to many different adverse outcomes or effects in humans and other species, so quite important hazard class. PBT and vPvB are problematic because they don't degrade in the environment. So they persist, they bioaccumulate and they can continue to cause effects over long periods of time. PMT and vPvM, so this is similar in terms of the persistent criteria. The criteria is actually the same for PBT and for PMT, the P part. But these are mobile, so they move via water bodies and they end up in places where they can cause issues over a long period of time again. And all of these are considered to be fairly severe hazards in the context of CLP. So they're particularly important to identify clearly and to take action on.

• Host - Päivi Jokiniemi

  So clearly, as you said, severe hazards. So how, in practice, how does this now help improve chemicals management or consequently safety of chemicals that these hazards are now in CLP?

• Paul Ryan

  Well, firstly, these hazards were not addressed by the existing hazard classes, so they weren't there. They weren't covered by the existing hazard classes under CLP. Adding them there brings a lot of clarity, I think, in terms of defined criteria. for how to classify them and to inform users what to be aware of when they handle them. It also allows them to be regulated by other pieces of regulation. Like I said, CLP is linked to many other pieces of legislation, so there's opportunities by putting it in CLP to have more impact in terms of when something is classified, what that means in other pieces of regulation, sectoral regulation and so on. In terms of one substance, one assessment also, this change serves that goal quite well, I think, because it centralises the hazard assessment for these hazard classes along with the others, prevents different regulatory bodies from having different conclusions as regards the hazard part. As I explained, risk assessment belongs in other pieces, but as regards the hazard part, this is centralised now in CLP and serves the one substance, one assessment goal very well. And last but not least, labels and warnings about hazardous properties.

• Host - Päivi Jokiniemi

  So the new hazard classes have now been in force for about a year. This means, for example, that since April 2023, the member states have been able to make proposals for harmonised classification and labelling with the new hazard classes.

• Paul Ryan

  Yeah, how it works is we get intentions, as they're called, from Member States or industry if they intend to harmonise the classification. So we have proposals, we have six proposals at the moment ongoing. So they start to come already. Member States are taking action straight away. One of those is for an entry for a group of substances, a new entry, and the others involve changes to existing entries. So they're adding this hazard to the existing ones.

• Host - Päivi Jokiniemi

  So they're being active right away.

• Paul Ryan

  Active right away.

• Host - Päivi Jokiniemi

  Yes, that's good. If we then move from the authority perspective to the company perspective. So could you give some examples of what companies now need to take into consideration when the new hazard classes have entered into force, what do they need to do or know?

• Paul Ryan

  I think the starting point for companies will be to assess and review their portfolio of substances and mixtures against the criteria. And where they have information that indicates the classification criteria are met, they should take action, inform ECHA of the new classification, for example, by updating their REACH dossier. If the substance or mixture was not previously classified, that triggers an obligation to notify the substance to the Classification and labelling inventory, which is hosted on the ECHA website, or to make a new poison centre notification for the mixture.

• Host - Päivi Jokiniemi

  And you mentioned the poison centre notification. So poison centres are these instances that citizens can call, or through doctors, get help if there has been accidental poisoning, for example.

• Paul Ryan

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

• Host - Päivi Jokiniemi

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

• Paul Ryan

  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.

• Host - Päivi Jokiniemi

  And when should companies then do this? Can they already start, for example, sending information to ECHA about the new hazards?

• Paul Ryan

  They can. The new hazard classes are going to be added to the IUCLID software from April this year, April 2024. After this, companies can start including the information already when submitting dossiers under different regulations to ECHA. There's transition times for applying the new classification criteria to substances and to mixtures, so different transition rules for both. And while this is ongoing, it's not obligatory. You have to follow the timelines for that. But you can do it as from April.

• Host - Päivi Jokiniemi

  So as soon as the IUCLID software is updated, you can start submitting this information if you are active and enthusiastic. Very good. Then in very concrete terms, if companies, for example, need some support meeting these obligations, they're not sure how to do something, what applies to them, what kind of help is available for them?

• Paul Ryan

  The main source of advice will come in guidance that we're preparing. So we're working hard on this at the moment to get it out in time. We've had a lot of interest from stakeholders in the draft guidance that we prepared over the past year now, some thousands of comments from different stakeholders. Lots of good advice, lots of good help. And it should be published hopefully this autumn.

• Host - Päivi Jokiniemi

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

• Paul Ryan

  Yeah, maybe just to clarify that. So it's actually existing guidance on the CLP criteria and we're adding these parts. So we're adding advice for how to classify endocrine disruptors and PBTs and PMTs and so on.

• Host - Päivi Jokiniemi

  So not a new guidance, but an updated guidance.

• Paul Ryan

  An update with these new sections, yeah. Maybe just for history, like I said earlier, these hazard classes, they come from other places already. So there's existing guidance. For example, there's an ECAA-EFSA guidance for endocrine disruptors, for that process in existence already. And then for PBT, there's an existing REACH guidance, guidance R11 is the number, on how to do PBT assessment. And many of the elements from these pieces of guidance will be translated into CLP. So there was information out there, but now it's being harnessed and used for the CLP guidance.

• Host - Päivi Jokiniemi

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

• Paul Ryan

  Exactly. You can go to the website. Plenty of information there. You can also read the draft of the guidance already there and get more advice.

• Host - Päivi Jokiniemi

  So as mentioned in the beginning, the introduction of the new hazard classes is not the only change that is ongoing for CLP. We're also expecting the European Parliament and the Council to formally adopt the revised regulation proposed by the Commission. So the revision is said to clarify rules on labelling and also, for example, rules for chemicals sold online, but also to speed up the pace at which hazardous chemicals are identified. And of course, all of this to even better protect people and the environment. So what exactly does the new regulation propose to change so that these goals are reached?

• Paul Ryan

  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, better communication between different actors dealing with hazardous chemicals. So there's quite a few changes, but I'll highlight a few. One is the Commission's right to initiate proposals for harmonised classification and labelling, which means they might mandate us here in ECHA or the European Food Safety Authority to prepare a proposal for a harmonised classification on behalf of the Commission.

• Host - Päivi Jokiniemi

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

• Paul Ryan

  Completely new, yeah, because at the moment it's Member States or industry who can initiate harmonised classification dossiers. So there's potential for more actors in this dossier preparation task, which potentially could mean more dossiers for harmonised classification over time. And also groups of substances is... mentioned in the update to the regulation as being a priority. The aim here is to broaden the scope of classification entries and use where feasible and sensible group entries. Another change is clarifications to the rules for classification of mixtures and for substances with more than one constituent. There's also been changes to the Classification and labelling inventory, which is where you notify or companies can notify their self-classifications. And then ECHA hosts on the website. A few more things, maybe quickly. There's changes concerning the poison centre notifications. There's changes to to the online sales rules and to the labelling and packaging requirements. So to give better communication on hazards.

• Host - Päivi Jokiniemi

  Quite a many items on the list. So you mentioned the substances with more than one constituent. Maybe we can explore this a little bit further. So what is this all about? Can you tell a little bit more about this and what does it mean?

• Paul Ryan

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

• Host - Päivi Jokiniemi

  Sounds good.

• Paul Ryan

  So, mixtures are basically, they can be two distinct substances or chemicals that are blended after they've been manufactured. And that's what you call a mixture. Substance might sound simple, but actually substance can be quite complex. So substance can be a very simple substance with a small number of constituents, but it can also be very complicated with thousands of constituents. So there's a broad spectrum of possibilities within the definition of a substance. In CLP currently, there's rules for mixtures. And basically, a mixture which contains CMR, which means carcinogen, mutagen, or reprotoxic chemicals, or constituents, if you have an ingredient or a constituent with those properties in your substance, you have to follow the rules in CLP and you can't override that information with information on the substance as a whole. So this is already in the regulation today for mixtures. So if you have a mixture, for example, with a known carcinogenic constituent above a threshold, which is set by the regulation, you have to classify accordingly, even if you have data on the mixture as a whole. So, as I said, substance is actually quite a broad definition. It can be simple or complex with many constituents. So the starting point for this change is there's no real reason to treat mixtures, which can be blended versions of different substances or chemicals together, to make any difference between the rules for those and the rules for substances. So it's a clarification from a certain point of view. So it clarifies this and it imposes similar rules for substances as those for mixtures. And generally speaking, this is the change, but there's also 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.

• Host - Päivi Jokiniemi

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

• Paul Ryan

  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, with a clause that this should be reviewed in the next few years. So this work will take place and there'll be an examination as to whether the exemption should remain or not.

• Host - Päivi Jokiniemi

  Okay, so the work will continue. Yeah. Good. That's all I had this time. Thank you, Paul, for taking some time to join us. Also sharing your insights on this topic. Thank you also to our listeners for tuning in. You can find more information about the new hazard classes and, for example, links to the guidance existing now and the ECHA-EFSA guidance that you mentioned there. In the episode description, we will add all that information there so it's easy for you to go and explore and read more. Also, if you have any feedback, please let us know by using our feedback form. This is also linked in the episode description. 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. That's all this time. Thank you very much and bye bye.

• Paul Ryan

  Thank you. Safer Chemicals podcast. Sound science on harmful chemicals.