The European Partnership for the Assessment of Risks from Chemicals (PARC) has been designed to address various challenges associated with innovating chemical risk assessment. Its overall goal is to consolidate and strengthen the European research and innovation capacity for chemical risk assessment to protect human health and the environment. With around 200 participating organisations from all over Europe, including three European agencies and a total budget of over 400 million euros, PARC is one of the largest projects of its kind. This exciting talk will host two experts from the Federal Institute for Risk Assessment (BfR), a key organization in PARC, for its leadership of the “Toxicology” work package. Dr. Matthias Herzler and Dr. Philip Marx-Stölting will walk us through the project and highlight the ongoing work to develop and improve innovative and predictive methods for identifying chemical hazards. The participants will also learn about the project activities to ensure that the results achieved in PARC find their way into the work of the regulating authorities in Europe.
Okay so welcome everybody see people are starting to join and um yeah welcome to talking Tri science webinar my name is Georgia paloka and today I will chare together with Marcel and I leave to him to the first words in the welcome good also welcome from my side good
Afternoon um I first welcome our speakers Kara aelo Holden and Matias herzler and of course all the participants and uh I’m I’m happy to share this really interesting seminar on a new topic on a nice connection now today from Constance to Berlin and just as a very brief
Background because you will learn more from the speakers and they need their time we have a federal Institute of risk assessment and this is our connection today and then even on a larger scale we are talking about a big European project coordinating institutes like the bfr in different countries this is the park
Project that’s the topic today is probably the biggest Topic in alternative methods at all in Europe and I’m happy happy that we can have this topic and make everybody aware of what’s going on there so I think Kara you are the one to start and I give the microphone and the
Screen to you thank you very much for the opportunity so I’m GNA share my slide um thank you for the introduction I’m very proud to be part of the biggest partnership in Europe so far um working for improving the assessment of the risk for from chemicals and today I will
Present you an overview on behalf of Philip maralin that kindly prepare all these presentation so um as you just mentioned um Marcel we are 28 countries and hopefully even more because the idea is to be as like all the countries in Europe we also have Partners from
UK and we have um participants as three agencies from EU AA epsa EA and five dgs so from the European commission we have a budget of 400 millions and this is co-funded so half is from the European commission and half is coming from the partners and as you can see it’s almost
All e park is going to last last seven years it had recently his first birthday um the 11 and 12th of May 2023 was the first uh birthday of Park and then it’s going to last until April 2029 yes so um Park was the outcome of many many things and activities
Happening along the time um we have different framework and different um directive calls from the commission through time and many different projects maybe you might be familiarized with the aspis cluster that is ongoing aerox risk human uh biom monitoring for EU that finalized last year and the ones on the
Bottom are still ongoing like panoramics and now we are gathering all these outputs and having Park and the goal is really to feed and for follow the chemical strategy for sustainability and reach the goals that we have set for E for 2030 if you want to know and be updated
About pack we have uh our new website that I invite you to check it out and sign in our newsletter and of course as any partnership we have some structures to make it functional we have um our coordination team by ancest and also a coordination exchange between National
Hubs in each country the EU Hub we have the governing board advising bodies and the management body that is from from aners as I mentioned and if you are very curious because I only have 20 minutes I invite you to read or paper a walk in the park
And there you can find all the details of each of the work packages I’m going to describe next so par has nine word packages and here you’re seeing the coordination team of each one of them and all the institutions involved and it has three main uh objectives that are of course linked
With how we organize the partnership so we have word package one that is um the coordination word package two that really wants to have this common science policy agenda so it’s very connected with regulation and the Regulatory Agencies so it’s not only science it’s also the applicability of this then we have word
Package seven for fair data and in the middle in Blue uh we also like highlight the more active like word package four is biom monitoring or monitoring and exposure word package five is hazard assessment word package six is innovation in regulatory risk assessment and eight concept and toolbox and what I mean with
More H active I mean in the lab so word package four five um are the Key Stone of research and Innovation together with six and eight but of course we cannot exist one without the other we also need word package three with all the synergy collaboration communication and word
Package nine with the infrastructure and human capacity so from these specific objectives of park I think the diagram is really nicely um highlighting word package two with this highlevel network that’s one of our objective word h word package seven four five six and eight as I explained with
Research and Innovation and then for capacities and platform is we package three and nine and now I’m going to give you some overview of each one of the word packages so for example in the core as I mentioned we have word package four five six and eight together with work package
Two to really fulfill this SO2 this objective word package two we are lucky because we’re going to have Matias giving an overview next so I don’t want to um take much time here where package three as I describ is communication for example is very broad
Um because it have to deal with all the ambassadors the stakeholder Forum International um board and National hubs but of course um it’s also like our face is dealing with all the social media the communication the website and as I mentioned at the beginning word package four is is um
Taking on the outcomes of human biom monitoring for EU and he have these three specific goals so the human biom monitoring the environmental monitoring and then of course Innovation tools and methodologies derived from their work in word package six is more focused on AATA construction and um they have
Available different woming if you want to find out their goals and their outcomes directly from the source sort to say um work package seven is working on data policy data management making it fair it have a whole structure of training so that everybody involved in park especially those generating data um
Of course they’re already familiarized but that everything is easily accessible in the future and can be used by any other partnership that comes after part and word package four have all this concept and toolbox and trainings and of course it’s the safe and sustainable by Design and warning system integrative mod
Models where package nine um is building all the infrastructure and human capacities which is also related with the um trainings so all the network of Laboratories building exposure monitoring capacities so of course each one of these word packages have to closely work with each other because
From the needs of you saw word package 4 for example they develop an Innovative method so of course we want to spr spread that next with trainings is not only getting isolated with word pack each word package word package n will make sure that it’s reaching whoever needs these um new
Tools and now I’m going to talk about word package five which maybe I should have told you from the beginning um I am um working closely in word package five coordination team we are a team of um five and what is word package five so we are concentrated on hazard assessment so
Filling up data gaps and developing Innovative method and developing quantitative system toxicology to move forward in hazard assessment so we are divided in three and if you read the paper a walk in the part you’re going to notice that each of these word packages that I just mentioned
Briefly in internally they are also divided in different groups so us for example we have these three uh divisions that are fitting each other in reality in practicality we are 12 projects so as I mentioned we have filling up data gaps novel methodologies
And um NG or um so each one of these are going to fit each other and each one of these have two Focus so data gaps is going to focus in human health and other projects in environment same for nams and in h task 5.3 is H
Diverse because this is more um working or related with developing pbk or kinetic modeling a and system toxicology so these 12 projects of course have their own own project leads and each one of these projects I’m talking about around ranging from three some 12 some 22 different partners so each one of
Them is a big joint effort per se inside word package F if you go into details um if you’re curious of what we are doing in word package five so of course these data gaps we have very specific questions that were H selected from workshops with all the people um relevant for these
Topics it was decided what to um fill up first the first need that was highlighted in already epsa Publications was with toxins and the toxins are alternaria and ananti so these are natural toxins that are in the environment they’re not developed by any industry they don’t have um anybody that
Really applies to make any apply on reach to test and so it’s very important that we fill up this data gaps and another important topic is be phenol Alternatives so we really want to avoid regrettable substitutions and that’s why um this was one of the substances selected for data gaps in human health
And similar for the environment at the next um task or group of projects we have developing novel methodologies so we have um five and these are divided per end points and these are end points that are also highlighted in the chemical strategy so the focus is to really create novel
Methodologies to assess faster and better assess hopefully also with less animals and more efficient and and um cheaper if possible these five end points that you can see here in green so non genotoxic carcinogens metabolic disruptions thyroid hormone disruption immunotoxicity neurotoxicity and also we have similar in this five end point for environment
But at the moment we have them link with filling up data gaps so this is a very big project this is just some examples of we have um already some outputs for DNT this is sort to say a Hot Topic very well everything is relevant um DNT is just an
Example of one of the outputs we have at the moment um this is one of our first Publications in word package five and also in metabolism if you are curious in our website of Park you can find all the publications of everything I’m showing you right now so you can go ahead and
Read it and um in three so we have uh is is more the goal is to use everything and all the outputs that have been generated in all the projects I’ll showed you already and we are also working closely together with word package six because if you remember they are the ones
Developing anatas and this is closely linked with our and pbtk modeling and everything that these projects are doing so I’m sorry if I talk too fast or too slow I don’t know um this is us I’m missing the photo of my colleague Talia um and yeah if you have any question
Feel free to do it at the end of the presentation if I understood right Mattias you want to continue and indeed the question will be collected at the end via the Q&A yes so hello everybody my name is Matias uh I’m heading the unit coordination and assessment strategies in the department
Of chemical and product safety at the bfr in our department we are responsible for a lot of different um chemical risk assessments regarding reach but also food contact materials tobacco tattoos specific focus on nanom materials and so on and so forth we also have a research
Or research groups and um I’m also and that’s why I’m here and speaking to you today co-lead of one of the tasks in park work package two which I’m going to present you in a minute and park work page two is actually called as um Kiara already pointed out a common science policy
Agenda and it contains both aspects you know the input from the regulatory World from the policy world into the work of Park but also the uptake of the work of Park eventually into regulatory practice work package 2 is led by the European environment agency EA but also by the Austrian environmental Authority
EAA and task 2.1 which is one of three tasks in work page 2 is on priority setting it’s led by the French colleagues from anes and by the two European agencies eeka and epsa the chemicals agency and the food safety Authority and basically they are responsible for yes coordinating a
Global structured approach to priorities and the framework for priority setting I show you some slides from them then there’s task 2.2 which we are co-leading at bfr together with our colleagues from uh the National Institute of Health in Portugal insa and that’s called Knowledge Management and uptake into
Policy and I will present you a lot of slides on this task because I know it very well the task 2.3 then is called sustainability this is however not about the sustainability of uh you know chemicals or sustainable development or something that’s is in fact about the sustainability of Park itself because
Park will end in 2029 as Cara pointed out and somehow we want to establish some kind of continuity beyond that point so task 2.2 a brief slide how does prioritization work this is actually a scheme that should work this year the first year of Park was prioritized
Before Park was even in place naturally but the process is about as follows it starts with work packages or task leads making a proposal they submit a template uh to the CT which is the coordination team of Park work package one uh they check it for some formal issues and then
Um then there’s a regulator first regulatory relevance check and then this project proposal is sent to reviewers they do a PE review come to some conclusions and either they recommend it as as it is or they propose some refinements after all and then this goes to the management board which is as was
Shown before um the Assembly of all work package lead leaders and they will have a vote on this and either the project in this form as proposed is rejected or it is accepted in which case then the normal project cycle starts and uh sometime later is concluded but this is
Not in the remit of task 2.1 anymore so what are criteria for prioritization that were used in the first round before Park so the next round will maybe see some slightly different criteria so there was one Park is kind of a followup to to certain initiatives one of these is hbm foru
Which some of you might know a project on human biom monitoring in the EU and developing new methods there and they had a prioritization scheme and some of the priorities were carried over into park also there were servies then as mentioned by Kara there’s the chemical strategy for sustainability or
Css um then the work package leaders and task leaders were asked to identify regulatory needs that should be addressed and then and some other priorities were used as well also as was already shown there are some priority substances on the right hand side of this table you see the three work
Packages four five and six on exposure Hazard and risk assessment methodology which have slightly different focus in some uh areas but you see um there are obviously some very prominent candidates like pest or bisol a and analoges that were mentioned already but also some metals um are there and some broader
Cate categories such as endocrine disrupting compounds or metabolic disrupting compounds which is rather a new thing to add to the mix I guess uh so on the other side of the of the work package we have task 2.3 2.3 on sustainability and uh one of the two activities they have is coordinating
What’s called the national hubs the national hubs are actually in each country that is participating in park in each M state or country day um there is a national Hub formed mostly by by colleagues from the academic community and so the national hubs gather their input and also the park output is
Presented to them and discussed and uh so this is connecting you to the local or or national landscape of research and also the regulatory landscape to some degree some authorities are there as well and this Tas 2.2 three I’m sorry 2.3 coordinates a process where the needs of these National hubs are
Gathered um there is something called um the national H contact points in each country and they have a meeting and so there are surveys there are meetings and training and capacity activities to connect Park here and also the second important thing they do is develop an exit strategy as I mentioned already for
Park um they need to identify the activities that need to be continued Beyond Park um and also they will try to develop an overarching and and rather holistic long-term approach to establish research and Innovation and chemical risk assessment in the European Union which can then continue after Park so
Park is the starting point maybe but this can live on without Park M also as with every great project you have success indicators and of course there are indicators regarding this sustainability thing and they are monitoring this indic they have helped create these indicator and how they help
Monitoring them and the success or not of Park so after this brief introduction to the two other tasks um I’ll come to the task where I know more about which is the task that we are co-leading and it has two projects two basic activities one is called or the working title
Parkopedia and as the name suggests something sounds a little bit like encyclopedia or Wikipedia or something this refers to our task title which is Knowledge Management and uptake into policy this refers mostly to the Knowledge Management Park so it started as a knowledgement platform in our heads an online knowledge platform where you
Could create and share knowledge on chemical risk assessment all its facets and specifically new methods of course but then the longer we thought about it we also felt that we need some kind of a community space for Professionals in chemical risk assessment so cra is for chemical risk assessment here
And um to connect actually people from different disciplines you know the chemical risk assessment is a multi-disciplinary um world we have researchers risk assessors Risk Managers academics people from authorities uh industry and so on and so forth although industry is not a direct partner in park
I should mention that um and we really felt that part of the problems that we have in establishing new methods come from the fact that we do not have a Central meeting point where people can discuss and uh also yeah push for Innovation together we have these
Meetings within projects and so on but there is no Central space for this and we hope to be able to establish s such a space with pipedia why do we need such a space if we really want to bring about the change also in the spirit of the three hours in
Chemical risk assessment then we need consensus within the broad and diverse Community as I just mentioned and that uh for one requires good understanding of new methods on all sides and as we all know there’s different views but also sometimes a real lack of of understanding the potential or the lack
Of potential of certain new methods um for instance on the world of risk assessors or Risk Managers so we felt there’s a a tool needed to connect people to share their work to present themselves to exchange ideas and also discuss new approaches and hopefully also in a critical
Fashion because as you all are probably also aware we have kind of a Tower of Babel situation I’m sorry where many people speak different languages people from environmental risk assessment do not speak always speak the same language as people from the human health side inv vitro people are maybe different from
Invivo people and so on and so forth and we hope that over the period of Park and maybe even Beyond we will be able to better connect these people and make them understand better each other so uh how do we imagine typical parkopedia users it is the chemical risk assessment
Community so some kind of a professional level is expected uh you should have expertise within the scientific domain or other fields of of risk assessment risk communication management policymaking Etc the everybody joining there probably requires a general understanding of the chemical risk assessment process but may have a different role there and people
Might not have detailed knowledge about particular aspects outside of their own direct line of work so we also need to take care that the content presented at least the main content is understandable for everyone however having said that is it will not be limited in the way that
People are excluded so registration will be open to users from both in in and outside of Park but I can tell you if you are not familiar with certain aspects then it’s probably maybe not the best experience that you will have on this platform what can you find in pipedia there will
Be a knowledge base very much like a Viki hopefully looking better than Wikipedia but a knowledge base covering eventually all aspects of chemical risk assessment I mean we will start with a certain set of information but we’ll build on that gradually there will be a specific focus on Innovation on new
Approach methods nams and Next Generation risk assessment NG and as I said there will be a community space which is very much like the social media platform uh you will have profiles you can post blogs you can take part in discussion groups Etc and if I say you I really mean you because
You are working in the field of 3r I understand and if you’re also working in fields of chemical assessment which I don’t know for sure some may more more be in the medical field or so on but if you are interested you are invited to present yourself in your work to
Exchange points of view to comment on what’s new in parkopedia ETC and to interact with a lively and interdisciplinary community and ultimately help us shape the CRA chemical risk assessment of Tomorrow the timeline uh is shown here you don’t have to look at in detail the important point
For you is um that we’re still building it but the launch is foreseen for the end of October possibly end of November um so we already presented a scoping study as a deliverable within Park this will eventually be available on the website I think it’s not yet but it’s
Approved so it should be there soon um where is the park we already know the name of the parkopedia domain parkopedia EU but it’s not live yet it will start in at the end of October or possibly mid November because there will be a launch event accompanying this the second
Product that we have or activity in our portfolio in task 2.2 is a totally different thing and it’s called Park rot and park rot as it says here is a horizontal project which will develop and oversee the implementation of strategic road maps in order to promote the uptake of
Innovative science in chemical risk assessment practice and uh in fact the the the task is set up such that different road maps can be generated but we have started with just one and that we called NG route because it proposes a path for the regulatory update of Next Generation risk assessment in European
Legislation and the focus is really on the legal uptake part because uh of course we’re not a legislator we can only make proposals and point out how this could be done but this is actually an aspect that has been missing in many of the otherwise very successful great European projects but
They always somehow stopped at the scientific level they maybe considered regulatory needs but they never actively planned for the for how to implement their knowledge the knowledge they generated into regulatory practice why why why do we need Next Generation risk assessment our current system has procedural issues efficiency
Issues mainly we you spend a lot of resources the speed is gruesome that we we should be much faster we should be able to assess risks from a much higher number of chemicals than we are currently capable um there are also scientific problems as most of you will
Know for sure if you are in this webinar uh in Vio toxicity testing is still largely a black box we need better mechanistic understanding we need to cross the Spees chees bar we should use tissue relevant to the organism um for which we do the assessment and so on and
There are new challenges that are not very well addressed within animal testing um such as combination effects or to integrate human health and environmental chemical risk assessment uh of course there are the ethical components um I thought I didn’t have to mention that here so what can park offer
Here park for me at least is a one in a generation chance although there are challenges but first to the chances in park as was shown we have a partnership of the European authorities in the driver seat so the mid member states but also the European agencies the European
Commission there are risk assessors and managers on board and I don’t know why I forgot it but also researchers of course are on board from the academic field uh and there is an explicit focus on new methods K showed that there’s one of the specific goals explicitly mentioning um Next Generation risk
Assessment and and there’s a strategic focus on regulatory needs and implementation besides um if you have taken Park in C part in certain meetings over the last years and if you have read the green deal and the chemical strategy there’s somehow a general feeling of departure into a new era here so these
Are great chances for us there are also challenges of course there are unsolved scientific questions such as inv vitro to invivo extrapolation quantitative adverse outcome Pathways and a lot of other things that need to be sorted out and people are working on this and it’s I I’m very confident that we will be
Able to establish very good new methods here new strategies but in park over the years you will have hundreds of different projects and those need strategic alignment and we need to engage a significant fraction of the community to find acceptance and again that needs a strategy or a vision and a
Strategy which are used because one popular example of how you could do this is the talkx 21 project program in the US so in 2004 they presented a vision and then a roadmap document then in 2007 this probably very well-known uh document Vision in the strategy toxicity
Testing in the 21st century and they continued working on that in they make institutional agreements um renewed this and now this program is fully running although that must also be said again for this strategy or vision this was very much focusing on the scientific strategy to establish the new system
Whereas the strategy for regulatory uptake is equally important but was not yet covered in their road map to a big large extent also owing to differences in the legal system in the US so the point is that if we want to install such a change here we need a
Collective effort and we need to have a dialogue between science and policy but we also need a good structure and a good strategy you don’t have to see all read all the details here but the basic um statement is here that you have a regulatory policy level that defines the
Policy needs and identifies possible gaps or needs I’ve pointed out some of those and then you could you could you know you see the need for a change but then you also need to define the specific goals of the change top down what do you need to you know up there in
The legislation and then you can try to develop a concept for how to bring about this change this just the general Logic for such a road map if you do know that then you can start identifying key players in the regulatory processes also in the processes for changing
Legislation um you can analyze the odds and resources and timelines and then you are able eventually to write such a strategic road map what do you want to install how can you do it what is the process who are the responsible people that you need to convince and so on but
For that we want a broad consensus assigns to policy Network which we gradually are starting to build now it includes first and foremost of course the park colleagues in the work packages management board governing board Grand signatory board the national hubs I mentioned also the stakeholder Forum
Where industry is present and also the international board um where colleagues from the US for instance are involved and they can be give us very good guidance here I think uh and then other external Partners will be uh considered as well we already have started establishing um collaboration with
Projects from the aspis cluster I myself as Marcel in Georgia and so on am involved in in the risk hter project which is part of the Asis cluster uh other colleagues from wisc are also active under Parks so there’s a big Network being built and being growing
Here which is really helpful but who knows even non governmental organizations eventually need to be involved probably for acceptance building so the current vision for the road map and I’m almost done with my presentation the current Vision which is an interim formulation it will need much
More discussion but we came up with a with a vision that by April 2025 this is the deadline for presenting the first road map that we will provide a concrete and applicable road map proposal for implementing Next Generation risk assessment as the default approach to chemical risk assessment in new chemes
Legislation now this needs to be explained what do I mean by default approach it doesn’t mean uh we can live you know by April 2025 we already know exactly in all fields of risk assessment how NG can replace the current paranoid it means that we should have a mindset
Change actually we should install NG as the first here the first line of risk assessment which you always have to try and only if that’s not possible can you go to some higher tier possibly even with invivo testing which will stay with us for quite some time um but there need
To be strict rules and this is the mindset change which really could could also bring to life things like you know under reach we have article 25 I believe it is where it says animal testing is only The Last Resort but that never has been filled with life this is a
Translation this vision is sort of a translation of that Paradigm um maybe I skip this a little these are only the steps I that we will um have to go it’s a long journey towards this road map we have established the vision and scope we need to capture contextual aspects of NG and
Then do some Focus research we’re in the middle of that and categorize the information that we have from the literature from existing projects uh so that if we work on a different specific topic and a specific contextual aspect of NG we find all the material that’s already there
And we do not reinvent the whe and then and this is happening currently I don’t know if you that know that in in projects such as RIS counter or the aspis cluster we need to kind of generalize ngr framework corresponding to certain risk assessment workflows this is another presentation you will
Probably hear of this later on in in the coming years in another webinar uh then we can identify the needs the necessary changes as I showed the gaps and obstacles and so on bringing us to Strate strategy for transitioning and ultimately we can finalize the roadmap document so the timeline for this is
That we are still in the middle of the research work over the summer we will uh continue the research we will also develop we have started developing a detailed work plan for the different aspects and chapters of the road map and by 2024 April 204 we will probably have
A first uh draft document which we can then discuss with a broad circle of people and hopefully by end of April 2025 we’ll have the final road map only now we can say that for the part where where we are working on the human health assessment it’s likely that we can do it
But we have already identified that in the area of environmental risk assessment there are many new interesting approaches many many Next Generation risk assessment approaches but as in terms of developing a framework they are not probably quite as far as the human health sector yet so it
Might be that by April 2025 they will not have been able to develop such a comparable um road map we’ll see for that and with that I’d like to conclude I’d like to thank my colleague Isabella uh for helping with me prepare the slides and also some other colleagues
From work package 2 who contributed some of the slides on the other tasks thank you for your attention thank you very much Matias and and Kiara so um it was a great overview I I think everybody should be aware of what is going on and I’m sorry for those that missed it
Because it’s really enormous activity and you also presented a very big Vision yeah let let let’s perhaps start like to to get warm Matias you you are like the perfect German like with all the big planning and and doing everything decently involving everyone and then having the readymade product ready in in
Two years so we have seen the others have had a road map like the EPA EPA they are relatively light and thin and and some of them have had to kind of re it already of course they they have um political input um change of government in the US and different
Things what would you say like um would there be also a way to have kind of intermediate steps or a light version in between something to be prediscussion or achieve no let’s stay optimistic and I’m realistic too because I mean let’s face it if it’s not April
2025 but June or July 2025 nobody will be hurt but still I think it’s feasible and what I made me did not make clear so much is that of course or I use the word transitioning so certainly this road map will have steps how to get there and
Will not say 2025 we’re ready and now you need two years and then 2027 it’s done it’s not working like that but as I said I think we need this mindset change if we can establish that if people say okay from now on we do it the NG way and
Only if we can’t do it then um we have to do something else but then we know exactly what to work on which needs to be removed quickly I mean hell we we could start now you know we could just say now every time we start with n what
Little we have in our hands we try all the time and only then we have to prove that this is not enough and then we go to the second testing also if I may say at something I don’t know I don’t want to speak all the time um the point is
That currently our system is very I’m talking mostly about reach which is the world I’m coming from and that’s quite an inflexible system we have a lot of standard information requirements for hon substances but in many of the big invivo tests we find in the end that the
Chemical didn’t cause any adverse effect I mean the numbers vary but people say up to 70% of the chemicals do not produce very many adverse effects 20 or 30% do and we have to take care of them but how to be more flexible how to maybe find out better before for which
Chemicals these tests are really valuable and promising to show us I mean and then maybe the things like the developmental prenatal developmental toxicity test will stay with us for quite some time I’m quite convinced of that but up for other tests we might have better better Solutions perhaps a
Short follow up so so the these ideas have been promoted in in the scientific world for 20 years or longer and um it it has had a a very partial success let’s call it like this optimistically uh in in other worlds and other areas a bit more than in reach and
And the chemical legislation and as you mentioned it is very rigid so what gives me hope is if people people like you now have this Vision because you come from the regulatory side so scientists are a bit further away so on the one hand perhaps in being realistic about what
Can be reached on the other hand also with what they can do and who they can reach but but also Regulators like you they are not legislators and and still you you need to transition to another sector and pool to have the legislation changed and and in Europe for instance
There’s classification labeling which is not an an issue so much in the US and and then also the ngia has to address the classification labeling requirements and the fixed data requirements so is there any more defined Vision already now how this can be done on the legislative level because
Even if people want to they you know like EA often claims we can’t behave in a different way because we have our law this is exactly what this park root project is all about but I see of course that there are forces of uh continuation or of um forces that are
Kind of uh they do not Embrace change let me call it that but there is this general feeling I think that that that more can be achieved now and the partnership really consists of all the member states Authority and so even if you know if it comes from them and
Proposals to the legislature are made from that side also for instance in Germany we have the environmental Ministry they are also part of the uh governing board of Park so they have an shown interest and the hope is what I showed also with the parkia thing those
This is a place where these people now start talking to each other about it of course as in all the projects I’m not representative of all the people in bfr the guys from the ministry or the colleagues who are in park are specifically interested in this probably more than other colleagues in the
Ministry but they are multiplicators the commission overall will not will not be enthusiastic about letting other people tell them how they could change the legislation but we have to work hard for this otherwise it will it needs to be a top- down thing that’s I’m convinced of but on at the same time
We need to have the acceptance with the everyday risk assessor and so on but they you know if it comes from top down if it comes from above if oecd tells them yes that’s a good thing if the law tells them you can do it then they can
Be trained to accept that and in the US they have a total different approach they can basically use FDA uses this qualifying approach they say these methods are basically fine and now you can use them you know they don’t wait for an OCD validation all the time but
It’s a long way in Europe to this it is a a very difficult question in the chat say that it’s very impressive work but how is finance and has the project enough funding no as every no maybe Kiara wants to save for white page five but they
Have a little more funding but a lot of more projects uh no as was said the project budget is 400 million which seems a lot then it’s seven years then you have 200 I repeat 200 Partners so that’s 2 million on average per part partner for 7 years that’s 300,000 per
Partner and year you know so you see the what sounds a lot isn’t that much in the end but it’s co-fund and also the funding is co-funding so the basic principle is not the coordination stuff but member states contribute 200 million or up to 200 one should say and
Commission pays half or actually member states contribute 400 and the commission will pay them 200 back but if the member states only spend 100 um million then the commission only pays them 50 so whether really 400 million will be spent in the end you’ll see for instance in
The first year setting up things uh was quite slow in some areas and not all the person months that were calculated have really been used I also a question about the priorization of the project so then I I don’t know if I miss it but also then what is already ongoing was
Considered in uh selecting the project because for instance so now in park that there is a call also for synergies so one can if one is around a project would uh be in contact so I was wondering if then in selecting the project one also
Have try to find the the gaps of what is not yet what is not uh already ongoing in Europe or in other initiatives um maybe K also wants to say something on that but synergies are definitely a topic I try to make it clear that for the road map we need to
Embrace really a lot of other initiatives and projects and the good thing is there is a duplication of stuff because there’s not enough funding and there’s not enough people it’s always the same people only now they also work in park and this is a big connecting
Thing but Kara maybe you want to com that’s a very good question and I can only speak for word package five which is the most like heavily research Focus um what we do we have um Cycles so we have projects at the moment that have been selected these 12 projects that I
Share and they are going to go for three to four years and then afterwards of course um the second round of of projects will continue most likely is a followup of what have been set up um with different questions depending on the outcomes for example in data gaps and then
Continuously if a if some partner ERS have the budget and and is between the the when when some partners are from Park and they have the budget between the frame and they have a new question they can apply again as Matias show we have this annual cycle to approve new
Projects so that’s the beauty of park that is kind of established but it also have some flexibility and it’s going to fit it itself also like if we in data Guide ABS see something relevant for BPA alternative of has some other questions about natural toxins then the idea is
That word package four biom monitoring my follow up this in the next cycle so we have some flexibility but we also need to establish some framework to to work so we have this first cycle of three years and yeah I hope I answer your question yeah Matas I don’t know I
Understood it thanks you also referred to things happening outside of park or did I get that wrong yes because I think as I said people are very well uh connected the people in park and they are aware of these initiatives and collectively with our swarm intelligence
We know them all so to speak and hopefully or at least that’s foreseen in the prioritization process one would identify uh things that basically duplicate something that’s happening outside of Park this really needs to be avoided and this is the intention whether it will succeed all of the time
I don’t know but um we have another question in the chat it’s in which way NOS can be involved to inform for instance the general public in an easy way so the bubbles could be overcome so you already saw one way from starting from October or November of course they
Are able to register for parkopedia for the platform where they get certain certain things from in and outside of Park firsthand um but also of course there is the Park website and the park work package 3 is the one that’s basically you know in in charge of the official dis dissemination
Thing when there are deliverables they put them on the website they have the newsletter that was mentioned the website is still also a little bit building up um but um all the information eventually will be there and NGS can access it there is I’m not sure actually do you know k
Whether the stakeholder Forum also includes NOS one would think so um yes um I if I’m not mistaken yes also some NOS have reached out and they there are many channels and normally stakeholder forum is one of them and we’re trying to see if some national hops so each member
State have their National Hub H each member State each um how would you explain and Mattias because I always yeah I think M states there are some nonu me people you know associated in so they are countries whatever but yeah um so because they want to have this
Outreach per country so maybe if the NGO is working locally this is another path to get in touch with Park but I will say the direct way the easy way besides parkopedia is also the website yeah and that’s already online so yes good so so that’s that’s why we
Have you here and I I hope you get lots of requests and contacts perhaps I can briefly follow up because the other big stakeholder group is industry and and and of there’s lots of experience there and and those are the ones that would need to do still the registrations so what’s the involvement
There because in in the beginning that was kind of out MH so they cannot be part it’s a public partnership so industry cannot be involved as a partner you know there are these so-called Affiliated entities such as the University of consense um from the academic field but again not industry
Industry is represented by means of the stakeholder Forum where we have the big associations I believe cific as talk these people so they have an input but I believe individual projects and activities are have some Liberty or leeway to consult with uh colleagues from industry for instance we for the
Road map certainly plan to involve them in what format will will be seen maybe workshops whatever surveys and so on but they would certainly have uh will be heard because otherwise you will not get ultimate acceptance for these things you know we also need to convince them that
It’s something that’s good for for them in the end it’s really important yeah but for instance for Next Generation risk assessment as you know in Risk Hunter we are very welcome connected to people from the Cosmetics industry who Again by a top down stipulation are forced to try
Their best to assess repeat dose toxicity without animal testing and um we know what these people do sometimes work together with them in other projects and even if it’s not officially in park I guess there will be a lot of influence from other initiatives on on this perhaps briefly so so time is
Running um in in the US there has been kind of similar activities and and then they they realized there’s an issue with setting the certainty level that needs to be reached because of course if The Regulators or the recipients require a certainty that cannot be provided by by
Nam then this is bound to fail and um the assumption is often that 100% certainty is only reached with animals now the the Americans started to re-evaluate the animals in order to set a certainty level wouldn’t that be really important to secure success of Park yes yes uh of course animal
Experiments do not give us 100% certainty because there is never 100% certainty in life and I think this again you know pertains to the to the mindset change that we somehow need so it’s rather to be in my view you cannot say like it’s 70% as certain as the other
Thing or so you don’t need numbers for that you need a general trust that the outcome of the whole framework that I was talking about uh will be of of of a comparable level of safety or will provide a comparable level of safety and um some initiatives actually have have
Been trying to compare points of departure for assessment from NS with um in Vio tests they found that the N pods are even lower but that again is also not maybe not desirable for society we don’t want to be have artificially low uh threshold values or an exaggerated
Risk from some weird inv vitra endpoint that’s never you know relevant in Vivo so it needs to be balanced and this is the tricky thing because once you start discussing this you need to admit that the current system also has its uncertainties and that’s obviously not popular with everybody that’s the point
I should make the point though that the current system is very safe and I mean it it really protects a high level provides a high level of protection for our health as you can see from us getting older all the time and staying healthy longer so we we try to keep this
Really crisp and sure so so people can follow many of these these seminars I I think this this was an extremely valuable hour um thank you again Kiara and and Matias we we hope for a followup I think we can already start planning now like see an intermediate stage and then
Especially the road map and um in the meantime we will have learned on some of the side aspects so Georgia is just showing on the screen there will be more of these seminars and I I think it’s nice to follow like really from the lab up to the big application and vision
That we have seen today and and to stay on track there so thanks everybody especially the presenters but of course also the discussions and the participants here in the seminar especially thanks to Georgia and all the team for organizing this series and have a nice Evening