ECHA’s Safer Chemicals Podcast

Group assessment identifies need to restrict more than 30 bisphenols

June 17, 2022 European Chemicals Agency Season 3 Episode 6
ECHA’s Safer Chemicals Podcast
Group assessment identifies need to restrict more than 30 bisphenols
Show Notes Transcript Chapter Markers

Bisphenols are widely used and many are also known endocrine disruptors, which means that they can affect the hormonal systems of people and animals.

Bisphenol A, or BPA, is probably the most known chemical in this group. It has been used since the 1960s in many consumer goods like re-usable plastic tableware, plastic bottles, CDs and sports equipment, such as helmets.

Due to its harmful properties, BPA’s use has already been limited. But it’s not a secret that when authorities have regulated one substance companies often switch to another substance with a similar structure – and many times, one that also has similar effects. This has happened, for example, with BPA in thermal paper where it has largely been replaced by Bisphenol S.

Together with some EU Member States, we have been assessing the need to regulate bisphenols as a group. Our expert, Maarten Roggeman, joins us to explain how the assessment was done and what we can expect as next steps for managing their risks.

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Safer Chemicals Podcast - Sound science on harmful chemicals. Today we're going to be talking about a group of substances called bisphenols. They are widely used, but many are also known endocrine disruptors, which means that they can affect the hormonal systems of people and animals. Bisphenol A, or BPA, is probably the most known chemical in this group. It has been used since the 1960s in many consumer goods like reusable plastic tableware, plastic bottles, CDs and sports equipment such as helmets. Due to its harmful properties, BPA's use has already been limited. But it's not a secret that when authorities have regulated one substance, companies often switch to another one with a similar structure. And many times one that also has similar effects. Our expert this time is Maarten Roggeman, who is a Scientific Officer in our Risk Management unit. And together with some EU Member States. Maarten and his team have been assessing the need to regulate bisphenols as a group. In this episode, you will find out how the assessment was done and what we can expect as next steps for managing the risks of these chemicals. You're listening to Safer Chemicals podcast and my name is Päivi Jokiniemi. So during the past couple of years, the focus has clearly shifted to assessing groups of similar substances in one goal rather than individually And this is also something that has happened with bisphenols lately. So to start with, could you tell us why this change was needed? Yes, you're absolutely right. Today we are assessing groups of substances rather than substances individually. And one of the main reasons to do that is to avoid regrettable substitution. Since January 2020, BPA was not allowed in thermal paper anymore. However, many of the companies have used bisphenol S to replace BPA in thermal paper. And this actually, despite the warning of our scientific committee for Risk Assessment that using BPA as a substitute, the BPS is not sustainable because it has very similar toxicological properties to BPA. And so a substitution, it's not a good idea. So when we can avoid running like in this case behind the facts and dealing with one regrettable substitute after another, we get more efficient from a regulatory point of view. And so in that sense, we hope that grouping will help the authorities to be more efficient and protecting people and the environment from harmful chemicals. So another important benefit of assessing substances in groups is that we can assess hazard information in a holistic manner. This allows authorities to consider to use data from one substance and use it to assess also other substances in the group. And that may mean that they don't need to generate data and that saves time. So they may be able to act instead of waiting for information to come back from a certain data gap. So in that sense, we also think that the assessment of groups of substances may allow for faster action. I think assessments at the level of a group of substances will also lead to more consistent regulatory actions for substances in the group that have similar concerns. Because you look at the bigger picture and with the group work, we also increase the predictability of the authorities' actions. And that allows companies also to prepare and be proactive. Yes, absolutely. Sounds like there are many benefits actually with this approach. So a logical step forward. But if we then continue from this overview and talk about the best kennels, which is the topic of the day, this is quite a big group of chemicals. And as I said earlier, they're widely used. I think quite a many of us have seen in stores certain products where you can find nowadays this label saying BPA free, for example. So I was thinking that maybe you could give some examples that what are bisphenols actually used for. And why are they problematic? Yeah, yeah. It's a big group indeed. And BPA free labels that you refer to, that's actually just one substance not being present, but there are many more bisphenols. And so that's why we grouped together 148 structurally similar bisphenols together. Many Bisphenols are endocrine disrupters for both human health and the environment. But many Bisphenols also may be toxic for reproduction and that means that they may affect our fertility or the development of the unborn child. In fact, three bisphenols; bisphenol A, bisphenol B and 2,2-bis(4'-hydroxyphenyl)-4-methylpentane, have already been identified as substances of very high concern because they are endocrine disruptors or may be toxic for reproduction. Then there are also other bisphenols where sufficient information on hazards is already available to identify them as substances of very high concern or to propose harmonised classification and labeling. And these are, for example, BPS, BPAF and BPF. However, for many group members, more data needs to be generated to confirm that, indeed, they are endocrine disruptors or may be toxic for reproduction. And about the uses then? The uses are of course varied in such a big group of substances, but mostly they are used as intermediates in the manufacture of polymers, such as polycarbonate plastics and epoxy resins. And as mentioned, they are also used in thermal paper, but also in inks and coatings, adhesives, textiles and paper, for example. And among these uses, a lot of them are industrial uses. And generally, you could expect them to lead to relatively low exposures. Whereas professional and consumer use this may lead to higher exposures. So many bisphenols are widely used and can be used interchangeably. And that's also why it's important that they are looked at together in a group. So this means that based on our current understanding, many but not all, bisphenols can be seen as problematic. If we then talk about the actual practical work that you have done, you have assessed, as you said, 148 chemicals as a group. It must have required quite some organisation. How did you go about this work? Yeah, indeed. There's quite a number of substances, 148. So we we divided them first into six manageable subgroups. So there's a subgroup on BPA and BPA derivatives, a subgroup on BPS and BPS derivatives and the subgroup on BPF and BPF derivatives and so on. And then with a small, but amazing team of experts, we assessed first each of these subgroups, we also involved several interested Member States from the very beginning. And we discussed with them how to approach the assessment. And they provided input and feedback on the draft documents for each of these subgroups. And then for the report of the entire group, we consulted also the Member States more widely and and the European Commission as well. What we did concretely is that we assessed which substances should be in or out of the group and whether there's a need for subgroups within the subgroups. And we assessed, of course, the hazards for both human health and the environment. We assessed the uses and the uses we use as a proxy for exposure potential. And the main source of information is the registration dossiers. We have quite powerful tools for data mining and automation which help our colleagues doing their assessments of the groups of substances. Basically, they receive summaries on the uses and the hazard data for each substance in the group. However, in the case of bisphenols, I have to say that the experts went the extra mile and looked quite a lot also at the source information, so the registration dossiers. And sometimes, they also looked at other sources. Then based on the hazard and use pattern we draw conclusions whether we think there will be a need for regulatory risk management. We don't actually conclude at this stage whether there is a risk in this kind of assessment. We do conclude whether there is a need for regulatory risk management. And that can be, for example, restriction. And then the risk assessment will need to be carried out when, for example, a restriction proposal will be prepared under the restriction process. We consider also the potential for substitution of substances in the group. So basically we want to answer the question whether they are likely to be interchangeable based on what we know of their uses and technical functions. And of course, this is important because we want to consider that a regulation is needed for more than single substance set so that we can avoid that they become regrettable substitutes to each other. So then all the subgroups were assessed. We took a step back and looked at the overall group and the patterns in terms of hazards and uses in the subgroups, but also across the subgroups, and then draw conclusions whether there is a need for regulatory action and also what that action should be. The conclusions that we then reached are the ones that you can read in the published report on our website. So as I mentioned earlier, quite some organisation needed to get all that work done. But a lot of work has gone into this, so based on the assessment done now, I guess it's fair to say that you know quite a lot more about these bisphenols now than than what you did earlier. Could you perhaps tell us a little bit what you've learned and if there are still questions when it comes to their safety? Yeah, a good question. We learnt about the similarities and hazard properties of many bisphenols. But interestingly, we also learned that not all substances in the group have the same properties. So we have these 148 substances grouped together because of their structural similarity. Basically, they have the common bisphenol structure but the bridge between the two phenols is variable and the groups attached to them can be very diverse. So many substances are also so-called UVCBs, which are substances that are complex and where the composition is unknown or variable. So although there are definitely similarities, there are also differences and this translates into differences in their use profile and also in the toxicity. For 34 of the bisphenols in the group we are quite confident that they are all endocrine disruptors for both human health and the environment and may have reproductive toxicity properties and that they will need regulation. Many are widely used and may be used interchangeably as well. So here clearly there is a commonality among a large subset of the bisphenols in the group. And this is also why a group restriction has been identified as the best way to manage the potential risks of these 34 bisphenols. The basic idea behind the restriction on a group of substances rather than individual substances is that authorities avoid running behind the facts and dealing with one regrettable substitute after another. But also, industry can benefit from the approach, since they also receive more certainty on the substances to be restricted in the long term. And substituting one substance after another for them also requires each time that industry adapts which can mean, for instance, reformulation costs or process adaptations, for instance. And these are also costs that could be could be avoided. We also learned that although a large subset of substances in the group need restriction, for other substances, in the group, this is not needed. This applies to 26 bisphenols where we are quite confident that they are not endocrine disruptors or toxic to the reproduction. And so there will be no need to regulate these substances based on those properties then either. They may, however, still be regulated in consumer products because most of these substances are actually skin sensitises. Then there's another 22 bisphenols where we just don't know yet if they need regulation because currently available data is not enough to conclude on their properties. And that's why for these substances, data generation is ongoing. And when we have the new data, it will allow us to conclude whether they also need to be regulated or not. Then there is still about 60 substances left. And for those, we concluded that there is no need to act currently as they are not registered or only registered below ten tonnes a year. And for these substances actually we have no data to conclude on their properties. That said, data on on hazards is being generated as said on other bisphenols. And this new data could perhaps be used in the future to assess some of these low volume or non-registered substances. And then, of course, also in the future, some of these substances may become registered or their volume when they are already registered, may increase and then we may get more data on these substances as well. I should say that although we have no data to conclude on their properties, of course there is also no or very little exposure when they are not used in the EU or only at very low volumes. So there are questions regarding these substances in terms of their properties, but not so much actually in terms of their safety. Can I ask about the data generation that you mentioned? How is this being done? Well, we have two processes for that. One is compliance check and the other is substance evaluation. And through those processes, we can request further information from companies. And that basically means that they will usually have to do either animal testing or other testing and provide that information to us. You said that some bisphenols should be restricted and for many others more information is needed to clarify if and how their use should be regulated. But if we talk about in more concrete terms, what happens next actually? In fact, at the moment, Germany is developing a proposal to restrict the emissions of BPA and bisphenols with endocrine disrupting properties in the environment. And Germany may propose to restrict also bisphenols that only in the future will be identified as endocrine disruptors. And the restriction proposal is expected to be submitted in October this year. The restriction may address the use of these bisphenols as such in mixtures and in articles and may also cover the presence of these substances as constituents or impurities in other substances and examples of materials or articles expected to be in the scope are thermal paper, plastics, textiles, leather and fur. And so in the run up to the submission of this restriction proposal in October, there is now also a consultation on the endocrine disrupting properties to the environment of BPF as well as BPAF and eight BPAF salts. And this consultation is open until the 20 June 2022. So then the Member State Committee of ECHA will provide an opinion on whether these substances are endocrine disruptors to the environment. Then once it's clearer how the German proposal will look like, ECHA and the European Commission will consider any further needs for regulatory action on top of this restriction on bisphenols, as also actually announced in the Restrictions Roadmap. Meanwhile, for many substances, as said data generation is ongoing. And when we have the new data, it will allow us to conclude whether they also need. whether these substances also need to be regulated or not. And it will also allow us to verify whether our assumptions regarding their toxicity were correct. And important, of course, we also rely on the Member States to initiate proposals for harmonised classification and substance evaluation on several substances. So the substance evaluation is what I mentioned earlier, as one of the processes to generate further data. You mentioned, when talking about restrictions, the Restrictions Roadmap. This was published by the European Commission. Could you say a couple of words about the roadmap and what it means? Sure. The Restrictions Roadmap prioritises group restrictions for the most harmful substances to human health and the environment. And this is one of the actions in the European Commission's Chemical Strategy for Sustainability. And as part of the roadmap, there's a rolling list of substances. And this list will become the basis for the multiannual planning under REACH for restrictions. This list will also be regularly reviewed and updated and should ensure a balance between needed flexibility and also commitments from the authorities to ensure progress in the actions. And as part also of the Restrictions Roadmap, it's intended to have a focus on restricting groups of substances, again, rather than regulating substances one by one. And indeed, bisphenols are on this rolling list as well. So earlier you mentioned the assessment report for these bisphenols, that was published in April. That is also available on our website. If you think about that report, who would you recommend to take a closer look at it and why do you think it would be beneficial? The assessment of regulatory needs is not part of the processes defined in the legislation. And so there are no direct legal implications, for that we need authorities to take actions and progress the proposed strategy, as said. The German authorities are already preparing a proposal to restrict the use of Bisphenol-A and other bisphenols, and then, companies can provide information in the consultation on the proposal once it's submitted, as said. There's also this consultation ongoing on BPAF, its salts and BPF, but also other actions from authorities are needed. So clearly authorities should be familiar with the reports and we know that a lot of them are. As mentioned, we have worked together with several of them. But also for companies, the report gives an insight in what can be expected in terms of regulatory actions. And companies can see what might happen then with their substances in the near future because they can see which substances are in the limelight. They can then also use that information to consider proactive substitution and avoid basically to use substances with similar hazard properties as alternatives. They can also be proactive in keeping their registrations up to date. And I would also recommend them to follow up the progress with the actions on their substances and that they can do via the Public Activities Coordination Tool on ECHA's website, the so-called PACT tool. So yeah, I think overall the report is of interest to authorities and companies, but I think also wider for stakeholders such as also NGOs. So at this point, Maarten, I would like to thank you very much for taking the time to explain why assessing chemicals in groups is so important. And especially for telling us more about bisphenols. If you go to our website, you can find there more information on bisphenols. The assessment report is already there. We also have a topical page on bisphenols with more details and links to further information. The ongoing consultation is open until 20 June, 2022, and then anyone who is interested in the German restriction proposal on bisphenol A, they should be keeping an eye on our home page and the part for consultations after October when we expect to get the proposal. So then also anyone interested can have their say. As we already talked about the website, all the episodes of our Safer Chemicals Podcast can also be found there, as well as, of course, on your favorite podcast channel. Safer Chemicals Podcast Sound Science on Harmful Chemicals.

Focus has shifted to assessing groups of chemicals in one go rather than individually. Why was this change needed?
What are bisphenols used for and why are they problematic?
Assessing 148 chemicals as a group must require quite some organisation. How did you go about this work?
Based on your assessment, can you tell us what you have learnt about bisphenols? Are there still questions when it comes to their safety?
You mentioned that some bisphenols should be restricted, and, for many, more information is needed to clarify if and how their use should be regulated. So, what happens next?
Could you tell more about the European Commission's Restrictions Roadmap and what it means?
Who would you recommend to read the assessment report on bisphenols and why?
Check our website for more info on bisphenols.